Guest Post: What Ultimately Matters In Deciding the “Gene Patenting” Issue?

By Jacqueline Wright Bonilla, PhD, JD. Ms. Bonilla is a partner at Foley & Lardner and filed an amicus brief supporting Myriad's position.

In entering the fray of this discussion, I note that I, along with two of my colleagues at Foley & Lardner LLP, submitted an amicus brief in the AMP v. PTO (a/k/a ACLU v. Myriad) "gene patenting" case on behalf of our clients Rosetta Genomics and George Mason University. In addition to our brief, other colleagues at our firm submitted a different amicus brief on behalf of a different client, Alnylam Pharmaceuticals. Both briefs, along with Myriad's brief and a number of other amicus briefs filed last week, support a reversal of the district court opinion as it pertains to "isolated DNA" composition claims. These briefs agree that such claims are patent eligible under current law, and should continue to meet the threshold of 35 U.S.C. § 101 as a matter of policy and social considerations. We are sensitive to dire consequence to biotech innovation in the face of a possible alternative outcome.

As it turns out, however, while such briefs agree on patent eligibility of "isolated DNA" claims, a number of briefs differ in viewpoints regarding applicable law, and even which cases are relevant versus not. As such, a reading of just the briefs filed with the Federal Circuit so far—even without considering the ACLU brief yet to be filed, much less amicus briefs filed in support of the ACLU's position—underscores a point worth mentioning.

The point is this: reasonable minds can differ on an interpretation of what constitutes relevant case law and how it should be interpreted in this case. This point is often missed in the hubbub we see in the press. For instance, many have commented on the amicus brief filed by the Department of Justice last week. Some have accused the DOJ of misreading the law entirely and attempting to eviscerate biotechnology innovation altogether. Such viewpoints misread the point of the DOJ brief, in my opinion.

Look what the DOJ brief actually says. It argues that the district court got it wrong in certain important respects. As stated in the DOJ brief:

… the district court erroneously cast doubt on the patent-eligibility of a broad range of manmade compositions of matter whose value derives from the information encoding capacity of DNA. Such compositions—e.g., cDNAs, vectors, recombinant plasmids, and chimeric proteins, as well as countless industrial products, such as vaccines and genetically modified crops, created with the aid of such molecules—are in every meaningful sense the fruits of human ingenuity and thus qualify as "'human-made inventions'" eligible for patent protection under section 101. [] The district court therefore erred in invalidating the challenged composition claims, such as claim 2 of the '282 patent, that are directed solely to cDNAs.

DOJ brief, pages 9-10 (citations omitted). As part of this discussion, the DOJ likewise agrees with our position that claims directed to recombinant vectors comprising any isolated DNA—even DNA having a sequence exactly as it exists in nature—constitutes patentable subject matter. See DOJ brief, page 16, discussing claim 8 of the '282 patent. Thus, unlike the district court opinion, the DOJ proposal does not throw the entire biotech baby out with the bath water.

That said, it appears that the DOJ may cut off a hand of the biotech baby. It argues that "isolated DNA" comprising a sequence from genomic DNA as it exists in a body does not constitute patentable subject matter. The DOJ brief (pages 10-11) argues that the "chemical structure of native human genes is a product of nature," even "when that structure is 'isolated' from its natural environment."

This position presents a slippery slope of considerable concern to those affiliated with biotech innovators responsible for actually getting medical products to patients. For example, the DOJ sidesteps an important scientific fact: all isolated nucleotide compositions—regardless of sequence—are, in fact, engineered DNA molecules. Such DNA molecules are necessarily, by definition of their existence in an isolated form, "human made" inventions. These products simply do not exist without human intervention. Thus, how does one successfully distinguish what is really "human made"? Moreover, human involvement is needed to identify valuable isolated nucleic acid molecules, such as DNA vaccines, PCR probes, interfering or micro RNA, etc., and then isolate them. When exactly is the human involvement sufficient to meet § 101? An additional slippery slope in the DOJ position is that many non-nucleotide compositions also exist as "products of nature" in a human body or other natural physical state. These compositions include many valuable small molecule pharmaceuticals, proteins, antibodies, just to name a few. Such compositions could likewise be subject to the same legal reasoning propagated in the DOJ brief. In other words, the fallout of the DOJ's position has wide-sweeping implications, even if not as flabbergastingly debilitating as the district court opinion.

This all said, I propose that it does no good to simply assert that the DOJ (or any party or judge for that matter) incorrectly reads relevant case law and/or misunderstands the science wholesale. As mentioned already, reasonable minds can differ on case law interpretation in this case, and how to apply scientific facts to the law. The sheer number of briefs and differences in positions—see DOJ versus USPTO as just one example—indicates this phenomenon in vivid color.

Thus, at the end of the day, the Federal Circuit and/or Supreme Court may ultimately decide the outcome of this case based on policy and social/economic considerations. The courts will consider case law, of course, but in reality may only apply it after the fact. I also believe that any precedential decision issued here, either way, will necessarily have at least some negative fallout. In fact, the patent system itself intends negative fallout to some people by virtue of granting a right to exclude others for a limited time. Thus, keeping the ideals of patent law in mind, it will be critical for courts to choose a course of action that provides the most amount of good, while causing the least amount of collateral damage. In other words, forget all the clever legal mumbo-jumbo—what do we want to happen here for the better collective good?

My understanding of the patent system is that it exists for the very purpose of stimulating innovation, as well as public disclosure of that innovation. As discussed at length in our amicus brief (and by others), abolishing patent eligibility of genetic inventions—not to mention inventions in other areas of health and medicine potentially impacted by a decision here—will have more of a dampening effect on research, development and innovation than any patent right could ever have.

My hope is that courts will remain ever conscious of slippery slopes created by any one interpretation of the law and application of science. No one wins if we inappropriately dampen incentives for innovators to discover, apply and provide innovation to the benefit of humans.

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259 thoughts on “Guest Post: What Ultimately Matters In Deciding the “Gene Patenting” Issue?

  1. 255

    TINLA think it’s ironic that the posters here who advocate for narrower claim scope and villify NPEs, also claim to be lefty liberals irl, when their positions favor big business in every way

    Who are you talking about and what specific “positions” are you referring to?

  2. 254

    I think it’s ironic that the posters here who advocate for narrower claim scope and villify NPEs, also claim to be lefty liberals irl, when their positions favor big business in every way.

  3. 253

    You still run into the little problem that Beauregard claims were invented for the very purpose of not claiming the computer.

    This is a problem… why exactly?

    Feel free to correlate your answer with an example in the equivalent biologic arts.

  4. 252

    Ned: Viewed as such, therefor, Beuregard claims are justifiable as components of a stored programmed computer,

    You still run into the little problem that Beauregard claims were invented for the very purpose of not claiming the computer.

  5. 250

    And as for that OTHER infamous SPE that called me also. I sure hope that is not a grandfathered decision as to Firing them.
    Well anyway getting back to my two Pea Brain thought, someone referred to him as thinking he was G.O.D. They made a mistake on one of the initials.

  6. 249

    It is you SW. You are Malcolm Mooney.
    NO SOLICITING. I gave you all the evidence ,including the Fake Patent. And if there is anything missing? Elementary! You acted as double Agent. You even talked with me on the Phone, a few times at least.

  7. 248

    And if SW is involved that is a whole other matter. And I am stuck between a BPAI Rock and a Huge Crime. And if this were a Murder. It would be MAN 1.

  8. 247

    So SW is into readable Data. Is MM really SW or did he just get help from SW? And SW is not initials for some worm. Although maybe that’s why his momma gave him those initials.

  9. 244

    NWPA,

    It’s hardly stunning at all – in fact, it’s so “in character“, that it’s starting to be more than a tad bit b o r i n g.

    When yuz can identify a short list of predictable results, ya can say that he has become obvious.

  10. 242

    Yah Ned your getting it….. A Function to differentiate between who gets to read what is typed. and who does not. so therefore those that need to see what is going on may not be seeing what they need to see. I wonder if there is a case like that about tricky dickee software.

  11. 240

    Pingerino, ta da!,

    A computer has two essential components: a CPU and a stored program. The latter consists of non transitory CPU-readable media storing a program consisting of a sequence of instructions that can be described as “steps.”

    Now, assuming for the sake of argument, that the computer with a particular stored program performs a new, novel, non obvious and useful function, how does one claim the improved computer? I suggest it is quite properly claimed as a product by process, where the program steps of the stored program are laid out as steps. But traditionally, we claim the machine in terms of means plus function; but technically, the stored program itself is incapable of performing the recited function and the CPU is the same for each means element. It is the combination that performs the recited functions.

    But, viewing the computer as a combination of two critical components, I can easily see justification to allow claims to just the stored program as a necessary component of a computer.

    Viewed as such, therefor, Beuregard claims are justifiable as components of a stored programmed computer, but the stored program computer must itself pass 101, etc., or else.

    So, in some respects, it is a red herring to ask whether the structure of the computer readable medium is changed in any meaningful way, as the real question is rather whether the structure of the stored program computer has changed in some meaningful way by including the new program.

  12. 238

    I’ve talked about this will some of the best in the country. (And I am not just saying that, but really some of the ones that have written the books and get paid lots of money and some of the ones that set the standards for some of the boutique firms.)

    Please name a single name so we can put out a special request to have one of these very important and “serious” people step forward and defend Beauregard claims in light of current Federal Circuit case law. I’d really appreciate that, NWPA.

    did you know that some of the best in the industry say that the only way to protect a mechanical invention now with the sophitication of design arounds is to functionally claim a method? That comes from one of the best prep and pro boutiques in the country. I think they were rated number 1 in quality last year.

    Rated by whom? Names please. “Sophistication of design around these days”. LOL.

  13. 237

    But it’s certainly no indication of the talent or intellect of the guy who prepared it.

    from the guy who preaches that it is all about the client – now it is all about the talent and intellect of the guy who prepared it.

    W

    T

    F

    – get over yourself already.

  14. 236

    transcribe/translate the infringing gene using the only possible code, and you immediately know.

    Careful with this argument – this path leads to the logical conclusion that you have merely copied what is in nature, given tha the “only possible code” already pre-exists the claim.

  15. 235

    On the contrary, they are considered at the top of their game by corporations and by thier peers.

    Those would presumably be corporations who mostly outsource the function because they don’t know any better, and who generally want comically broad claims at all costs, and their peers who have to claim as broadly as them because they’re in direct competition?

    Functional claiming is a cop-out. If you can’t claim a mechanical invention structurally, you’re taking the easy way out. It’s quick and it’s lazy. Whether you’re doing it because you don’t understand the invention, because your client insists on hopelessly broad claims, or because Law Firm B does it, it amounts to the same. It’s the drafting equivalent of dumping everything you’ve ever seen into an IDS because you can’t be arsed to figure out what might be important. It’s no wonder you approve of the practice.

    I mean, of course it’s the “gold standard”. It results in really broad claims. An IDS containing everything under the sun is the gold standard too. But it’s certainly no indication of the talent or intellect of the guy who prepared it.

  16. 233

    IANAE: you can be pretty funny. “fan boy” and “you don’t listen a whole lot.” Good ones.

    Not very good at what they do? On the contrary, they are considered at the top of their game by corporations and by thier peers. And the gold standard is a functional method claim for mech.

    And, you don’t seem to have grasped that a/d converters make ee and cs merge. In fact, the last set of claims I wrote for a big product for one of the largest electronic companies (it is a big money maker for them) had to be functional claims because of the a/d problem.

    And yes the claims were beater around quite a bit.

  17. 232

    You see IANAE for those like me that do prep and pros as a big part of our practice this functional claiming is a big issue. We talk about it a lot.

    You do talk about this a lot, true. But you don’t listen a whole lot.

    It’s great to have your perspective, though. Because none of the rest of us do prep and pros at all.

  18. 231

    I think they were rated number 1 in quality last year.

    Let me guess, quality equals rejections?

    It doesn’t sound like they’re very good at drafting structural claims, if they can’t figure out how to do it. But at least when they claim things functionally they recite the actual function of the device they’re claiming. I’m sure if they thought about it they’d realize how ridiculous it is to claim “a disk that causes a computer to have a function”, which isn’t functional claiming at all. It’s wishful claiming.

    So, lots of good smoke, but I’ve got a fan bigger than your smoke machine.

    Yes, you’re the Beauregard claim’s biggest fan boy.

  19. 230

    You see IANAE for those like me that do prep and pros as a big part of our practice this functional claiming is a big issue. We talk about it a lot.

    I’ve talked about this will some of the best in the country. (And I am not just saying that, but really some of the ones that have written the books and get paid lots of money and some of the ones that set the standards for some of the boutique firms.)

    Go back and read Deener and then I will find some other cases and papers for you. I think you can be taught, but it will be painful for both of us.

  20. 229

    IANAE: you are being ridiculous.

    In EE there are only a few solutions? I don’t think so. And in fact one of the problems in ee claiming is that everything can be pushed into a/d converter and processed and pushed back out. So, circuits and processors can all be intermixed.

    I am afraid you are not trying. You want to yap on and on about this, but you are not trying to get the big picture and want to try to minimize the problem in other areas. Sorry not true as illustrated with circuits and a/d converters.

    Furthermore, sorry not true with mechanical arts either.

    For mechanical arts: did you know that some of the best in the industry say that the only way to protect a mechanical invention now with the sophitication of design arounds is to functionally claim a method? That comes from one of the best prep and pro boutiques in the country. I think they were rated number 1 in quality last year.

    So, lots of good smoke, but I’ve got a fan bigger than your smoke machine.

  21. 228

    This same problem arises in claiming electrical circuits. In fact, I’d say no –or almost–no electrical circuit could ever be claimed to your satisfaction without making a design around trivial.

    I might add that when a circuit is claimed functionally, the claimed function is typically actually performed by the circuit itself. It’s a circuit that receives inputs, performs some operation on them, and produces an output based on those inputs. It’s not a circuit that, when inserted into a computer, causes the computer to perform a function.

    This really isn’t “bigger than Beauregard” at all. Beauregard claims are the only ones that recite “a device for causing some other device to do what you want, period”, and that’s way beyond the point where functional claiming becomes problematic.

  22. 227

    The problem is that there are so many ways to perform a functional step. Those of us skilled in the art can easily imagine many.

    Yes, that’s what I was just saying. In fact, those of us skilled in the art (or even unskilled in the art) can easily imagine arbitrarily many. We can imagine that literally any sequence of bits could perform that functional step. That’s exactly the problem.

    If you do, then get that this is bigger than Beauregard claims.

    What, functional claiming is too big to fail? What’s good for the Syndicate is good for America? I’m sure there’s a catch in there somewhere.

    In circuits, there are generally a limited number of circuit elements that can perform a (rather specific) claimed function if you’ve properly stated the function, plus a host of well-known equivalents (equivalent logic, using triodes as diodes, etc.), and that’s it. In mechanical arts, a well-claimed function quickly narrows down the scope of the claim to a manageable level.

    In either art, if you claim too broad a function, or if the function can’t be ascertained without specifying the structure outside of the claim, the claim is indefinite and rightly so. If you can’t tell how the gear will work because you don’t know what kind of machine it’s going in, and literally any prior art gear could perform that function if you designed the right machine around it, your functional gear claim is well and truly invalid. You should have claimed it with the machine, at the very least.

    Do you see the problem? People have come up with lots of ways of doing things and the important part is the functional claim when the function is enabled.

    Do you see the other problem? Enablement is not the only requirement for patentability. It’s not even the requirement we’re talking about. Enablement is absolutely trivial for Beauregard claims. They’re generally self-enabling. They’re just hopelessly indefinite is all.

    Just because functional claiming has its place, that doesn’t mean every functional claim is automatically fine.

    Your isolated gene patent–interesting–don’t you need to know the structure of the copied gene to know if it infringes.

    Of course not. In fact, it’s nearly impossible to even draft an isolated gene claim that would require knowing the structure of anything in vivo. You’d have to claim something as ridiculous as a Beauregard, like “a gene which, when inserted into a human genome, produces [phenotype]”. If the claim specifies the DNA sequence, you sequence the infringing gene and you immediately know. If the claim specifies the corresponding RNA or amino acid sequence, you look at Wikipedia, transcribe/translate the infringing gene using the only possible code, and you immediately know.

  23. 226

    IANAE 2: >>The scope of the claim itself has to be >>definite, and which means that the functional >>language in a product claim has to specify >>definite structure.

    IANAE 1: >>because it set definite boundaries on the >>patent protection sought

    Your no. 1 is right. Your no. 2 is not. Dude, “definite structure” ?? No. The problem is that there are so many ways to perform a functional step. Those of us skilled in the art can easily imagine many.

    But, you know, seriously, IANAE, do you really care about understanding this? If you do, then get that this is bigger than Beauregard claims.

    This same problem arose when patent attorneys figured out that any machine could trivially be designed around when the “definite!!!” structure was claimed.

    This same problem arises in claiming electrical circuits. In fact, I’d say no –or almost–no electrical circuit could ever be claimed to your satisfaction without making a design around trivial.

    Do you see the problem? People have come up with lots of ways of doing things and the important part is the functional claim when the function is enabled.

    You aren’t really claiming all the definite structure of your isolated gene are you? Not only that you are saying that you are copying a real gene and the structure will be (!!!)–not is–whatever the structure of the real gene is.

    Sheesh. Read Deener again. Read some of the cases that talk about why functional claiming arose. And get that in computer science and ee the functional claim does set a reasonable boundary on the invention.

    Your isolated gene patent–interesting–don’t you need to know the structure of the copied gene to know if it infringes. don’t you need to be able to forget all those pesky atoms that you say don’t FUNCTIONALLY change the molecule for the purposes that you want.

    Man, if you have an integrity you will think about this and see why patent law has accommodatd the new inventions including your isolated gene.

  24. 225

    I think his position is that the structure of the “article of manufacture” is unchanged in any functional way with respect to the article manufacture. Thus the printed matter doctrine applies.

    Ned Ol boy – There is a reason why you were banned on commenting from the printed matter doctrine until you did your homework on that doctrine with case cites exploring the boundary of that doctrine. You would see why Sunshine boy is just tilting at windmills if ya had done your homework.

    Now get to it and be a good boy.

  25. 224

    If the infringement can be ascertained, then the claim is not indefinite.

    1. A composition for tungsten clamp modification, wherein said composition comprises a means capable of enhancing murastasis of a tungsten clamp.

    The specification discloses that the means can be “a platinum rod modified by novel etching to enhance murastasis of a tungsten clamp.” No examples of specific etchings which enhance murastasis are disclosed. The prior art contains 100 million examples of different platinum rod etchings.

    Assume that it’s easy to determine if something enhances murastasis.

    You think this claim is definite? Of course it’s not, even though it is very easy to determine if you infringe.

  26. 223

    Really moves the ball forward.

    Thanks. So you didn’t want to address the substance of the discussion at all, then?

  27. 221

    NWPA: Why is that you believe this when those of us with computer science/ee backgrounds do not feel this way?

    Considering that you’re also an “Attorney”, and in another thread you were shocked (SHOCKED!) that I believed a plaintiff could lose a court case without his lawyer being guilty of malicious prosecution, I don’t consider it probative that you can’t wrap your head around my beliefs.

  28. 220

    Look, the bottom line is that a software designer aware of the claim can determine whether or not the software he or she intends to write for an operating system he or she intends to write it for will infringe that claim. If the infringement can be ascertained, then the claim is not indefinite.

    He can determine whether he intends to infringe, but that’s clearly not the same thing. If it were, a non-infringement opinion would be a complete defense in every case.

    I could trivially design a one-time-pad decryption algorithm that would cause him to infringe despite his best efforts. It’s not even far-fetched, and it doesn’t take space aliens. Anybody could map any data onto any set of instructions using any computer, and everybody skilled in the art knows that. You can’t do that with DNA because the “computer” only has one code, and nobody skilled in the art could change that code even if they wanted to.

    You can’t hang your hat on “a person skilled in the art knows the most likely way for a programmer to infringe the claim”. The scope of the claim itself has to be definite, and which means that the functional language in a product claim has to specify definite structure.

  29. 219

    IANAE:will be doing the reading and what logic it will use to parse the data is completely indefinite.

    Why is that you believe this when those of us with computer science/ee backgrounds do not feel this way?

  30. 218

    I’m sure it would be asserted against a later-invented version of the instructions that would run only on a later-invented OS after being extracted by a later-invented decryption or decompression algorithm.

    As it should be.

    Look, the bottom line is that a software designer aware of the claim can determine whether or not the software he or she intends to write for an operating system he or she intends to write it for will infringe that claim. If the infringement can be ascertained, then the claim is not indefinite.

    These hypotheticals in which space aliens show up with super computers that just so happen to run “discs of tron” in such a way that it inringes the one click patent do not obtain. That’s just crazy talk. You could make the same argument that those space aliens’ super computers could be biological, and that they run isolated genes as software. Now go spend your weekend using a laser pointer to play with your cat while swinging sideways on a swing.

  31. 217

    Iza think the “three subtantially” similar reqs for infringement more than cover your argument IANAE – welcome to the dark side.

  32. 216

    TINLA Thus, the functional limitations recited in Beauregard claims are definite,

    Not in terms of defining structure they aren’t. Remember, it’s a composition claim, not a method claim. That’s the whole point. The infringing *structure* must be definite. There is nothing in a Beauregard claim to distinguish the “medium” structurally from the prior art “medium.”

    This is why Beauregard claims fail. They are no different from a means plus function claim reciting a single means with a novel function, where the means recited in the specification is old. That sort of claim is either anticipated or its indefinite. Take your pick.

  33. 215

    But in reality, where the rest of us practice, the operating systems and minimum requirements of processors with which the software is compatible are clearly listed on the product literature, advertising, and packaging, and the varieties available are few and finite.

    But in reality, the claim is not limited to those few and finite varieties. In particular, I’m sure it would be asserted against a later-invented version of the instructions that would run only on a later-invented OS after being extracted by a later-invented decryption or decompression algorithm.

    infringement can be redaily determined by ascertaining whether or not the software on the medium, when installed in the listed type of processor running the listed operating system and having the listed minimum requirements, has the recited functionality.

    Sure, assuming the infringer is kind enough to print on the package precisely what computer and what OS are required to run the software. Which, to be fair, they often do. But it makes no sense for that to be a factor in whether your claim is definite as drafted, when your claim makes no mention of the medium having processor specs written on it.

  34. 214

    Even a person skilled in the art wouldn’t be able to tell whether an arbitrary medium with arbitrary data infringes a Beauregard claim without knowing which arbitrary algorithms would be used by some hypothetical computer to extract, decode, and execute the instructions,

    But in reality, where the rest of us practice, the operating systems and minimum requirements of processors with which the software is compatible are clearly listed on the product literature, advertising, and packaging, and the varieties available are few and finite. Thus, the functional limitations recited in Beauregard claims are definite, and infringement can be redaily determined by ascertaining whether or not the software on the medium, when installed in the listed type of processor running the listed operating system and having the listed minimum requirements, has the recited functionality.

  35. 213

    It was held that the limitation used to define a radical on a chemical compound as “incapable of forming a dye with said oxidizing developing agent” although functional, was perfectly acceptable because it set definite boundaries on the patent protection sought. In re Barr, 444 F.2d 588, 170 USPQ 33 (CCPA 1971).

    There you have it. The functional language is acceptable if it sets definite boundaries on the patent protection sought.

    I’ve already explained why that’s the case for gene sequence listings coding for a protein, but not the case for instructions for telling a computer to do a thing. Specifying the function of a set of computer data without specifying what computer will be doing the reading and what logic it will use to parse the data is completely indefinite.

    Even a person skilled in the art wouldn’t be able to tell whether an arbitrary medium with arbitrary data infringes a Beauregard claim without knowing which arbitrary algorithms would be used by some hypothetical computer to extract, decode, and execute the instructions, and any computer could be programmed such that any code would infringe any claim. You can’t do that with genes, because all genes code for proteins in exactly the same way in all circumstances.

  36. 212

    You guys need to read the MPEP. Here, I’ll help you.

    2173.05(g) Functional Limitations [R-3] – 2100 Patentability

    2173.05(g) Functional Limitations [R-3]
    A functional limitation is an attempt to define something by what it does, rather than by what it is (e.g., as evidenced by its specific structure or specific ingredients). There is nothing inherently wrong with defining some part of an invention in functional terms. Functional language does not, in and of itself, render a claim improper. In re Swinehart, 439 F.2d 210, 169 USPQ 226 (CCPA 1971).

    A functional limitation must be evaluated and considered, just like any other limitation of the claim, for what it fairly conveys to a person of ordinary skill in the pertinent art in the context in which it is used. A functional limitation is often used in association with an element, ingredient, or step of a process to define a particular capability or purpose that is served by the recited element, ingredient or step. >In Innova/Pure Water Inc. v. Safari Water Filtration Sys. Inc., 381 F.3d 1111, 1117-20, 72 USPQ2d 1001, 1006-08 (Fed. Cir. 2004), the court noted that the claim term “operatively connected” is “a general descriptive claim term frequently used in patent drafting to reflect a functional relationship between claimed components,” that is, the term “means the claimed components must be connected in a way to perform a designated function.” “In the absence of modifiers, general descriptive terms are typically construed as having their full meaning.” Id. at 1118, 72 USPQ2d at 1006. In the patent claim at issue, “subject to any clear and unmistakable disavowal of claim scope, the term ‘operatively connected’ takes the full breath of its ordinary meaning, i.e., ‘said tube [is] operatively connected to said cap’ when the tube and cap are arranged in a manner capable of performing the function of filtering.” Id. at 1120, 72 USPQ2d at 1008.< Whether or not the functional limitation complies with 35 U.S.C. 112, second paragraph, is a different issue from whether the limitation is properly supported under 35 U.S.C. 112, first paragraph, or is distinguished over the prior art. A few examples are set forth below to illustrate situations where the issue of whether a functional limitation complies with 35 U.S.C. 112, second paragraph, was considered. It was held that the limitation used to define a radical on a chemical compound as "incapable of forming a dye with said oxidizing developing agent" although functional, was perfectly acceptable because it set definite boundaries on the patent protection sought. In re Barr, 444 F.2d 588, 170 USPQ 33 (CCPA 1971). In a claim that was directed to a kit of component parts capable of being assembled, the Court held that limitations such as "members adapted to be positioned" and "portions . . . being resiliently dilatable whereby said housing may be slidably positioned" serve to precisely define present structural attributes of interrelated component parts of the claimed assembly. In re Venezia, 530 F.2d 956, 189 USPQ 149 (CCPA 1976).

  37. 211

    Oh, but that would be so “unfair”.

    But it would be a valid “Beauregard” claim, wouldn’t it?

    Now, all we need to figure out is where to draw the line between the sequence listing claim and “an isolated gene comprising a sequence which, when inserted into a human genome, causes breast cancer”.

  38. 210

    What if you claimed a CD ROM (or other specific type of storage medium) with a sequence listing of the bits stored thereon? That’s kind of structural. You could even claim a bit string that is meaningful to a standard Windows computer or something.

    Indeed. What if? What if the PTO required software applicants to submit a CD ROM with exemplary bits and with the disclosed utility, and then limited the claims thereto? Then patentees could rely on the doctrine of equivalents to guard against “design arounds.”

    Oh, but that would be so “unfair”. Plus there’d be no more “innovation” and nobody would ever invent a way to automatically send NWPA’s mom an instant message and a coupon to buy more cheetohs when the stockpile is depleted.

  39. 209

    Again: there are no structural components whatsoever in a Beauregard claim except for the recitation of an invariably old computer-readable medium.

    What if you claimed a CD ROM (or other specific type of storage medium) with a sequence listing of the bits stored thereon? That’s kind of structural. You could even claim a bit string that is meaningful to a standard Windows computer or something.

  40. 208

    TINLA It’s not a problem.

    Uh, yes it is.

    It’s fair.

    No, it isn’t.

    Get over it.

    Never.

    Functional limitations are permitted in apparatus claims, and they do have limiting effect and patentable weight in any apparatus claim, so long as they limit how the structural components of the apparatus are operatively connected.

    Again: there are no structural components whatsoever in a Beauregard claim except for the recitation of an invariably old computer-readable medium.

    So: it is a problem, it is fair to recognize the problem, and the problem should be dealt with by eliminating it.

  41. 207

    That’s a solution wherever it is impractical to disclose every possible variation of structure of an invention.

    No, the problem is that you’re trying to claim structure when the invention is a series of method steps performed by a computer.

    There isn’t any meaningful structure to the invention at all. A list of steps is not a structure. It’s not a method either. You only get a semblance of structure by writing the idea down on some structure, and even that isn’t the actual method – just a recipe for performing the method.

    Other equivalent structures not specifically disclosed but required for use with other types of earth movers and variations between models thereof would also be covered by the claim. And you would have the same issue of looking at a component and not knowing if it infringes the claim unless you know which model and type of machine it is to be used with.

    If you claim the function of a mechanical component in such a way that you can’t tell what devices infringe without inspecting all possible unclaimed parts they might possibly attach to, that’s not a valid structural claim either. And for the same reason – the functional language doesn’t specify the structure.

  42. 206

    The problem with software is that what the function is depends on the machine.

    That’s not a problem. That’s a solution wherever it is impractical to disclose every possible variation of structure of an invention.

    I’m a bit tired of the protests over the functional limitations in Beauregard claims. Functional limitations are permitted in apparatus claims, and they do have limiting effect and patentable weight in any apparatus claim, so long as they limit how the structural components of the apparatus are operatively connected.

    For example, you could functionally claim a component of an earth moving device, and disclose different embodiments for back hoes than for bull dozers. Other equivalent structures not specifically disclosed but required for use with other types of earth movers and variations between models thereof would also be covered by the claim. And you would have the same issue of looking at a component and not knowing if it infringes the claim unless you know which model and type of machine it is to be used with.

    It’s not a problem. It’s fair. Get over it.

  43. 205

    But, as others have observed, are not parts of a machine are patentable even if they have no function except in a machine?

    Pretty much any device only has a function by interacting with the outside world. But that function is inherent in its structure (or should be nearly so, if you have a valid functional claim), and generally there aren’t very many ways for the device to interact with the outside world to perform that function. There’s only one way to put a gear in a machine, no matter what the machine does. Two if it’s a helical gear, but still. The teeth mesh with the teeth of another gear, and that’s the function.

    The problem with software is that what the function is depends on the machine. And not just in the sense of meshing gears having to have the same sized teeth. The machine has to be programmed to understand your software, and that programming is completely arbitrary. You can take any Beauregard claim and program a computer such that 11010110 on an otherwise blank disk infringes the claim. You can program a compression algorithm such that 11010110 on an otherwise blank disk auto-extracts to instructions per that Beauregard claim in any standard format. You can’t look at a series of ones and zeros and definitively say that it doesn’t infringe any Beauregard claim you choose, in the same way that you can look at a gear and immediately know whether it is capable of performing its claimed function when you stick it in a machine.

  44. 204

    Thanks Malcolm.

    I think you are on the right track. The program has a function only in the computer.

    But, as others have observed, are not parts of a machine are patentable even if they have no function except in a machine?

    Good question, this. I’d like to see a case.

  45. 202

    “and isolated means separated from a computer.”

    I thought it was understood that Beauregard claims were written to cover a “disk-in-a-box” separated from the computer. Excluding the computer from the claims doesn’t make the claims any better. In fact, including the computer would make the claims better, because then at least you’d have a functional relationship between the printed matter and something else in the claim.

  46. 201

    NWPA Let’s start with Malcolm Mooney giving the explicit statement that functional language is an appropriate way of claiming structural differences

    Only where the recited function is unambiguously associated with a defined structure or structures that would be recognized by a PHOSITA, as is the case with “DNA encoding protein of SEQ X”.

    This has been explained here at least a dozen times, txrdbrain. It’s not a difficult concept. Hence, the recognition by myself and others of your dishonesty and/or utter cluelessnees.

  47. 199

    Ping, et al., regarding Malcolm and Beauregard claims:

    I do not think that it is Malcolm’s position that functional language cannot be used to claim structure, and that that’s the problem is with Beauregard claims. I think his position is that the structure of the “article of manufacture” is unchanged in any functional way with respect to the article manufacture. Thus the printed matter doctrine applies.

    Knowing his position on Beauregard claims, I would still like Malcolm to tackle the following claim:

    “An isolated stored program comprising:” followed by a list of program steps, wherein both isolated and stored program are defined terms, where stored program is defined to mean a program stored in a non-transitory way on a computer-readable medium, and isolated means separated from a computer.

  48. 198

    “Sock puppet. check.”

    Translation: “Someone called me on my preemptive character attacks and hypocrisy. That proves I’m right!”

  49. 196

    NWPA will likely make some off topic remark about how even though MM hasn’t actually done a particular bad thing yet, he’s a horrible enough person that he’s likely to do it in the future.

    With the usual implication, of course, that NWPA would never do any such thing.

  50. 195

    MM will likely make some off topic remark in response and a sock puppet will defend MM.

  51. 194

    (swiveling towards the camera and tapping the sheath of papers on the desk)

    Here at the Daily Watch, we pride ourselves on covering the hard-hitting news of the day. In this instance, one Malcolm Mooney has been asked to provide a short, single unambiguous declarative statement on functional language as an appropriate way of claiming structural differences…

    (lays papers flat, drops head, then slowly lifts head and smiles)

    …as a sign of integrity.

    (guffaws, and leans toward camera)

    Not. Going. To Happen.

    (under his breadth, as he scribbles out the story line on the paper)
    The most integrity shown by Malcolm is his silence – and it’s a blessing at that.

  52. 193

    Personally, I am tired of the hand-waiving and poor legal arguments on this blog, wherein the mere “I said so” is taken as persuasive. It is not.

    Let’s start with Malcolm Mooney giving the explicit statement that functional language is an appropriate way of claiming structural differences, that he at the same time claims he has done (and led) dozens of times and yet still holds that Beauregard claims are somehow illegal. And let’s have this simple statement unencumbered with provisios of being applied to a particular art unit, or couched in similar weasel words.

    I am asking for just a little integrity here.

  53. 189

    NWPA: “You’ve made no attempt to explain why the DC argument is wrong where the DC’s arguments are fairly treated.”

    I’m sure I’ve discussed the DC decision at length. Have you checked the thread about the DC decision?

    If it turns out I haven’t, tell me what issues you’d like to hear about, and I’ll try to explain them. Very slowly.

    NWPA: “What you do is take a position and then stone wall.”

    Huh. Yet another similarity between this topic and your beloved Beauregard claims. I don’t suppose you’ve changed your mind yet?

    NWPA: “Very much what examiners do. Maybe you work with them too much.”

    I find it more productive than working against them.

    NWPA: “Other than that you seem to be a decent person.”

    Why, thank you. I, too, would eventually run out of bad things to say about you. Other than those, you’re quite a remarkable individual.

  54. 188

    Personally, I am tired of the hand-waiving and poor legal arguments on this blog, wherein the mere “I said so” is taken as persuasive. It is not.

    Let’s start with Malcolm Mooney giving the explicit statement that functional language is an appropriate way of claiming structural differences, that he at the same time claims he has done (and led) dozens of times and yet still holds that Beauregard claims are somehow illegal. And let’s have this simple statement unencumbered with provisios of being applied to a particular art unit, or couched in similar weasel words.

    I am asking for just a little integrity here.

  55. 186

    IANAE: You don’t address the issues. You’ve made no attempt to explain why the DC argument is wrong where the DC’s arguments are fairly treated. Furthermore, you don’t try to fairly address all the issues which is always necessary to get a good resolution.

    What you do is take a position and then stone wall. Very much what examiners do. Maybe you work with them too much.

    This is why you have a muddy brain that spews forth cloudy watery arguments that one desperately wants to avoid tasting.

  56. 185

    You can’t seem to follow the facts anyway.

    Awww, ya gonna spoil the love-in. Specially when Iza ask ya to back up such flippant statements and ya find that ya cant. Go ahead and show how Iza cant follow facts – which facts? how not followed? Hey, don’t blame me if ya find out ya cant handle your horse as well as ya thought and ya keep getting lost in Middle Earth. I done gave you my advice – stay out of those area’s ya don’t know the background to. Simple. Easy peasy japanesey.

    Sucks to be you sometimes.

  57. 184

    “Was that a responsive answer IANAE?”

    Responsive to what? I’m still waiting for a question that makes any sense. The DC didn’t do any “damage” at all, because this is a question of law.

    Besides, I and others have said enough about the DC decision that I hardly need to revisit it here for your benefit. You can’t seem to follow the facts anyway.

  58. 182

    “The burden is now on the patent owner. The DC did its damage.”

    I don’t think you understand how litigation works. Or logic, for that matter.

  59. 181

    The argument is made. Try to use some intelligence and come up with ways to refute the argument. Stone walling doesn’t work. The burden is now on the patent owner. The DC did its damage.

  60. 180

    “You know the argument the DC is putting forth.”

    I didn’t even realize Dennis was a party to this case.

  61. 179

    IANAE: come and confess your sins and start dealing with issues honestly.

    You know the argument the DC is putting forth. Deal with it and stopping trying to make an end around. That doesn’t work in court.

  62. 178

    NWPA: “Just as in Benson the shift registers were said to embody the abstract concept of the mathematical algorithm.

    Here, the isolated gene embodies the abstract concept of the encoding of the natural laws of how to build proteins.”

    Oh, are you still on about that?

    Regarding Benson, how would you go about converting between binary and BCD without a shift register? Also, would you say that the shift register is positively recited in the (method) claim? If so, you might well be excluding embodiments that Benson himself would consider infringements or equivalents, and you might even run afoul of BRI. It seems to me that “storing the input data in a place” is insignificant pre-solution activity if ever there was one.

    Regarding genes, are you saying that claiming a single gene preempts the entire concept of “how to build proteins”? It doesn’t even preempt the entire concept of transcription, because it doesn’t preempt transcription in vivo or of proteins not encoded by that particular claimed sequence. What’s more, “how to build proteins” is a much larger problem than transcription, currently unsolved in the field.

  63. 177

    Claim 8 therefore covers only a machine-implemented process and the apparatus for carrying it out has been disclosed.

    In re Benson, 58 C.C.P.A. 1134, 1142 (C.C.P.A. 1971) Emphasis added.

  64. 175

    In other words, the claim to [use of]the “isolated formula,” to the extent that it preempts uses of the “formula[in the device],” only preempts uses by man of that formula [in a specific and limited device]. Accordingly, the claim to the “formula [in the device]” is not a claim to the formula itself.

    Even fixed, this didn’t work for Benson.

  65. 174

    That is the funny thing about you IQ 120-130 range people. You contantly dig your own graves.

  66. 173

    Although, it is clear that you buddy Stevens–if he were still on the court–would be leading the charge to remove your isolated gene patents from 101.

  67. 172

    I wonder what they would do?

    Why of course, the honest thing full of integrity.

  68. 170

    Sorry, but you misunderstand Benson. That was a process claim

    Claim 8 reads:

    “The method of converting signals from binary coded decimal form into binary which comprises the steps of

    “(1) storing the binary coded decimal signals in a reentrant shift register,…

    Method – yes – Article of manufacture – yes as well. Must I supply the “dress up the claim” method-manufacture equivalency quote?

  69. 169

    Let us put both Malcolm and IANAE into examining the computer arts for one day and have them examine a claim along the lines of the following:

    “An isolated stored program, wherein the steps of the program comprise:”

    followed by a list of steps. In the specification, we define “stored program” to be a computer program stored on a non-transitory computer-readable medium. We define “isolated” to mean “separate and apart from all the other elements of a computer.”

    I wonder what they would do?

  70. 168

    I’d characterize your argumentation style as yap, yap, run, run, attack, yap, run, yap, yap, attack, yap, yap, run, run, run, …

  71. 167

    Just as in Benson the shift registers were said to embody the abstract concept of the mathematical algorithm.

    Here, the isolated gene embodies the abstract concept of the encoding of the natural laws of how to build proteins.

  72. 166

    “Benson requires that that claim preempt all practical uses, which is what you said he Myriad claim actually does.”

    It has to preempt all practical uses of an abstract concept. Preempting all practical uses of a physical thing is what patents are designed to do. If that were grounds for 101 invalidity, section 101 would have to be amended to allow only processes.

    So let’s try to figure out what abstract concept, if any, is preempted by a patent to a particular isolated gene. Suggestions?

  73. 165

    TINLA, you just made a great argument for the application of Benson to the present case. Benson requires that that claim preempt all practical uses, which is what you said he Myriad claim actually does.

    Earlier, I said I did not know the answer to that question which prevented me from forming the legal conclusion. But, TINLA, you now have supplied the necessary factual basis to draw the legal conclusion.

  74. 164

    Gottschalk v. Benson, 409 U.S. 63 (1972)

    Posted by: Friends of Douglas and Stevens

    Sorry, but you misunderstand Benson. That was a process claim, and the thing “preempted” was a “mathematical algorithm,” which was stated to fall under the category of “abstract idea,” not “natural phenomenon.”

    The preemption of the “abstract idea” is preemption of all uses of the “abstract idea,” whether by man or otherwise. But, as Malcolm has pointed out, the claim to the “isolated gene” does not preempt all uses of the “wild gene,” as can be seen in the use by nature of the gene to express biological characteristics in nature. In other words, the claim to the “isolated gene,” to the extent that it preempts uses of the “wild gene,” only preempts uses by man of that gene. Accordingly, the claim to the “isolated gene” is not a claim to the gene itself.

  75. 163

    “Your molecule cannot exist without all those other atoms that you chose to try and ignore.”

    There you have it. Skepticism by one of obvious skill in the art. That proves that isolating DNA is non-obvious.

  76. 162

    And, what you are really saying –since the molecule will react with differently depending on the atoms you are refusing to acknowledge–is that functionally you only care about the sequence of nucleotides since you plan on using them to determine markers.

    You absolutely refuse to see the similarities between you claim to only a sequence of nucleotides which ignores so much else about the molecule and implicitly is claiming a function and a Beauregard claim.

  77. 161

    Yes, IANAE, but the difference is that a windshield wiper can exist without the car. Your molecule cannot exist without all those other atoms that you chose to try and ignore.

    If you ever become intellectually honest you will confront this issue.

  78. 160

    When has “preemption” ever been applied with respect to a composition of matter or article of manufacture, on the basis that a “natural phenomenon” is preempted?

    Gottschalk v. Benson, 409 U.S. 63 (1972)

  79. 159

    Ned: “For example how would one prove infringement of such claim? Would one compare the structures of two DNA strings? Or would one prove that the two DNA strings encoded for the claimed protein?”

    One would sequence the infringing DNA, and then show (possibly using Wikipedia) that the sequence codes for the claimed protein. Probably the only reason the DNA was claimed in terms of the protein in the first place is because it’s a much easier (and equally definite) way to account for degeneracy in the DNA code. The key here is the direct two-way correspondence between structure and function, which you don’t get with software because software doesn’t always use the same code.

    But that’s something you’d probably only claim if you were after the utility of synthesizing the protein. Presumably if you were using your DNA as a diagnostic tool to detect its complement in vivo, you’d want/need to specify the DNA sequence directly.

    Ned: “Suppose for example I isolated DNA that coded not only for the claimed protein, but also coded for several other proteins not claimed. (I assume that one could do this by adding in other DNA sequences separated by the required ending or separation structures.) Obviously, such a DNA structure would not have the same structure as the DNA that encodes only for the claimed protein. But, I would contend, that it would still be an infringement because the structure in fact encoded the protein claimed. That is all that is required to infringe.”

    That depends on the exact wording of the claim. If you claim a sequence of nucleotides, the claim is no less infringed by adding more nucleotides to the end of the claimed sequence. Much like if you claim an intermittent windshield wiper your claim is no less infringed by adding a car on the end.

  80. 158

    RE the “preemption” argument endorsed by Ned and 6.

    When has “preemption” ever been applied with respect to a composition of matter or article of manufacture, on the basis that a “natural phenomenon” is preempted? Is there any basis for thinking that “preemption” applies to anything other than process claims that preempt all uses of abstract ideas?

  81. 157

    Personally, I am tired of the hand-waiving and poor legal arguments on this blog, wherein the mere “I said so” is taken as persuasive. It is not.

    Let’s start with Malcolm Mooney giving the explicit statement that functional language is an appropriate way of claiming structural differences, that he at the same time claims he has done (and led) dozens of times and yet still holds that Beauregard claims are somehow illegal. And let’s have this simple statement unencumbered with provisios of being applied to a particular art unit, or couched in similar weasel words.

    I am asking for just a little integrity here.

  82. 156

    There gonna need a bus. Hal you will be the first on. So now we know it’s Tamai. and the PTO is just saying. he is an inventor LOLOL. And because of that he can no longer work at the USPTO. LOL . now bring it on. And Gene you say Novena. you don’t know what a good catholic is. i wouldn’t even qualify you as an agnostic. That was clearly a great idea. to bad you failed.

  83. 155

    All will notice that the rust brains did not respond to my questions. Silence = my victory.

    Bozos.

    And, MM, so cute the way you abstract and say “structural differences.” So, the atoms are different they just don’t count in your book as “structural differences.” About as clever as as a pig claiming he is rice grain to get out of being roasted.

    Face it. You lose, again.

  84. 154

    Malcolm, without being too cute, could you identify precisely what the structural differences are between an isolated DNA that ecodes a specific protein and the wild DNA that encodes the same protein? — Ned Heller

    Ned Heller, let’s say you find some wild rice on the ground. No, that cannot be patented. Now, lets say instead that you find that same rice afixed to the rice plant. Now, if you isolate that rice … bingo! Patent city.

    Lets say you discover that such rice can be within a variation set and you still get what you want. So you list these variations in a table (Table I). The patent claim? Here is it:

    I claim:

    1. An isolated rice, comprising: rice from Table I.

    Please respect my invention. Thank you.

  85. 153

    Malcolm, without being too cute, could you identify precisely what the structural differences are between an isolated DNA that ecodes a specific protein and the wild DNA that encodes the same protein?

    Ned Heller, let’s say you find some wild rice on the ground. No, that cannot be patented. Now, lets say you find that same rice afixed to the rice plant. Now, if you isolate that rice … bingo! Patent city (assuming you get one of them there DNA patent examiners).

    Lets say you discover that such rice can be within a variation set and you still get what you want. So you list these variations in a table (Table I). The patent claim? Here is it:

    I claim:

    1. An isolated rice, comprising: rice from Table I.

    Please respect my invention. Thank you.

  86. 152

    Malcolm, without being too cute, could you identify precisely what the structural differences are between an isolated DNA that ecodes a specific protein and the wild DNA that encodes the same protein? — Ned Heller

    Ned Heller, let’s say you find some wild rice on the ground. No, that cannot be patented. Now, lets say you find that same rice afixed to the rice plant. Now, if you isolate that rice … bingo! Patent city (assuming you get one of them there DNA patent examiners).

    Lets say you discover that such rice can be within a variation set and you still get what you want. So you list these variations in a table (Table I). The patent claim? Here is it:

    I claim:

    1. An isolated rice, comprising: rice from Table I.

    Please respect my invention. Thank you.

  87. 151

    If this so called Patently O Court of Law was allowed, and the Judge maybe was told it would be fair, and it wasn’t, because whay I say is not recorded and filtered on other Computers . And the whole year was a tyrannical lying Joke. The Houston we have an even bigger problem. This is AWWEEESSSOOOMMEEEEEEEE!

  88. 149

    please understand that Malcolm will simply move the goalpost and start beating on some other strawman that he knows little or nothing about.

    Fixed. Sunshine, Iza be waiting for your earnest reply to Malcolm Bafoonery.

    A nice, short, quick sentence will set him straight, won’t it.

    C’mon, a single sentence – even you can plainly state a truth that you believe in, cantcha?

  89. 146

    Malcolm and IANAE, I never said that one could not determine the molecular sequence being claimed. I just don’t think that is relevant at all.

    For example how would one prove infringement of such claim? Would one compare the structures of two DNA strings? Or would one prove that the two DNA strings encoded for the claimed protein?

    Suppose for example I isolated DNA that coded not only for the claimed protein, but also coded for several other proteins not claimed. (I assume that one could do this by adding in other DNA sequences separated by the required ending or separation structures.) Obviously, such a DNA structure would not have the same structure as the DNA that encodes only for the claimed protein. But, I would contend, that it would still be an infringement because the structure in fact encoded the protein claimed. That is all that is required to infringe.

    Do you agree?

  90. 144

    >>For the time being, I’m having fun satisfying >>myself that NWPA’s isolated gene arguments are >>(1) even more damning of Beauregard claims, >>and (2) trivially refuted using high school >>biology and Wikipedia.

    So, you are asserting then that the isolated gene is being claimed with each atom of the molecule being part of the claim?

    Is that right wise guy?

  91. 143

    please understand that NWPA will simply move the goalpost and start beating on some other strawman that he knows little or nothing about.

    Trust me on this.

    Posted by: Malcolm Mooney | Nov 09, 2010 at 04:02 PM

    ________

    Well, Mooney I think we can all trust you are the king of strawmen.

  92. 140

    MM >>sequences and structure

    I never said they didn’t define a structure. I said that all the atoms and all the structure was not defined for the molecule that is being claimed. So, you are claiming a molecule by only partially specifying the molecule structure. Why is that? Why do you think you can not specify all the atoms and yet demand that the exact sequence of 1’s and 0’s be specified.

    >>You need me to explain to you how software works?
    You ran from this.

    >>If you know of any other atoms that are >>missing, now’s the time to show off your >>immense knowledge of this art.
    Yeah, what atoms are at the end of the sequence of nucleotides? (as one example).

    You still didn’t answer the question why machines were claimed functionally.

    Of course the Bearegard claims structure. You just can’t understand it. Or more likely chose not to understand it.

  93. 139

    “Trust me on this.”

    As soon as you learn to stop arguing with ping.

    For the time being, I’m having fun satisfying myself that NWPA’s isolated gene arguments are (1) even more damning of Beauregard claims, and (2) trivially refuted using high school biology and Wikipedia.

    He can move the goalposts and declare victory all he wants, and it doesn’t bother me one bit. Serious business, this internets thing.

  94. 138

    “>>Still printed matter
    This has been asserted and blow up a hundred times.”

    Nobody has ever shown that the printed matter on a computer-readable medium is functionally related to the medium. You always hand-wave about the function of the computer that is sold separately. The medium is just that – a medium. An inert substrate. It functions exactly the same no matter what code is on it.

    “Would you say that a gear depends on the material used so that it has no structure until you specify the material?”

    Of course not, because a gear is defined by its geometry, and its geometry does the same thing no matter what machine you put it in, for any reasonable choice of materials that would commend themselves to a person of skill in the art.

    Ones and zeros can be implemented in a variety of structural ways, depending on the medium – presence vel non of transistors, stored charge on transistors, stored charge on capacitors, orientation of magnetic dipoles, holes in a punch card, order of nucleotides… The code does not even come close to defining the structure.

    Also, try running PC software on a Mac, and you’ll see that the order of the ones and zeros doesn’t define the function or vice versa. And you don’t need to be skilled in the art to know that, either.

    “Just how do you explain that when you put that thing in a computer that the computer does some pretty amazing things, but without that thing the computer doesn’t do much of anything?”

    You need me to explain to you how software works?

    If you put food in a human, that human can do some pretty amazing things. If you don’t put any food in, the human doesn’t do much of anything. That’s a pretty solid demonstration of the utility of the food, but not of the patentability of the plate that supports the food. Now, if you’d invented the Krebs cycle, you’d really have something there.

    “You do not specify all the atoms. And you know it. Your isolated DNA has lots of atoms that are unspecified because you cuoldn’t specify the aotms without making it trivial to design around the claim.”

    Isolated DNA is described as a series of nucleotides. Each of those nucleotides is composed of a very well-known arrangement of atoms, and connected in a very well-known way. Put together, those nucleotides account for all the atoms in the isolated DNA.

    If you know of any other atoms that are missing, now’s the time to show off your immense knowledge of this art.

  95. 137

    IANAE, assuming you do manage to teach NWPA the basics of molecular biology and the direct relationship between sequences and structure (hint: you won’t succeed), please understand that NWPA will simply move the goalpost and start beating on some other strawman that he knows little or nothing about.

    Trust me on this.

  96. 136

    OK. So, I’ll sum up your argument as: Change issues.

    >>Still printed matter
    This has been asserted and blow up a hundred times.

    >>because the structure of 1’s and 0’s depends on the medium
    Would you say that a gear depends on the material used so that it has no structure until you specify the material?

    Why does the following matter? Does that mean that a gear has no utility until you know which machine it is going to be used in?
    >>until you know what computer is doing the >>reading.

    Just how do you explain that when you put that thing in a computer that the computer does some pretty amazing things, but without that thing the computer doesn’t do much of anything?

    You do not specify all the atoms. And you know it. Your isolated DNA has lots of atoms that are unspecified because you cuoldn’t specify the aotms without making it trivial to design around the claim.

    Sheesh. This is a joke.

  97. 135

    Sorry to disappoint you, NWPA. I can tell you desperately wanted to have a grown-up conversation about patents.

    Hey, is this the question you wanted answered?

    “what if one did specific all those 1’s and 0’s? What would happen?”

    Because I answered that one already. They’re still printed matter, they’re still not claimed structurally (because the “structure” of ones and zeros depends on the medium), and they still have no recognizable utility (or, if you prefer, any arbitrary utility you care to define) until you know what computer is doing the reading.

  98. 134

    >>does specify ALL the atoms

    It does not specify all the atoms. False.

    You did not answer the questions that were put to you, so you are a rust brain. Admittedly, I threw in some name calling and silliness, but there were substantive questions that you did not answer. Tou never do. Instead: Yapping.

  99. 133

    “Rust brain: the fact that those 1’s and 0’s bother you so much means you are not one of ordinary skill in the art.”

    The fact that you feel so threatened and defensive and resort to name-calling whenever anybody points out the obvious fundamental weaknesses of Beauregard claims means that you’re not one of ordinary skill in the art of lawyering. All you ever do is cling to your preconception that Beauregard claims are better than gene claims, despite the obvious analogies between them, for reasons you can’t even explain to yourself.

    “Why don’t you have to specify ALL (ALL!!!!!!!!!!!!!!! in your lingo) the atoms? ”

    The fact that you don’t realize a sequence listing does specify ALL the atoms means you are not one of ordinary skill in the art.

    And the fact that you use so many exclamation points means that you’re the sort of person who wears his underpants on his head.

  100. 132

    And why is it that when a machine is claimed made of rust (whoops iron) that each and every atom of the machine does not have to be claimed? Why is that huh? Yap. Yap. Yap.

    Why did they start claiming functions of machines? Can you answer that? If you can’t then it explains a lot. Yap. Yap. Yap.

    I see red dust coming out of your ears.

  101. 131

    I have a question: what if one did specific all those 1’s and 0’s? What would happen?

    And rusty brain, why is that your isolated molecule dingy can leave off all the atoms that may be hanging around? Why is that? Why don’t you have to specify ALL (ALL!!!!!!!!!!!!!!! in your lingo) the atoms?

    Rust boy stop the games. Yap no more and try to learn that you are nothing but a silly little rust brain.

  102. 130

    IANAE: endless yapping about Beauregard claims. Yap. Yap. Yap. Yap. Yap. Switch issues. Yap some more. Bully. Threaten. Yap. Change issues. Yap. Challenge. Yap. Run. Threaten. Yap.

    Rust brain: the fact that those 1’s and 0’s bother you so much means you are not one of ordinary skill in the art.

  103. 129

    “IANAE answers for Malcolm in the first person and Malcolm answers for IANAE in the first person.”

    Who asked you?

  104. 128

    The Bobsie Twins at work here – IANAE answers for Malcolm in the first person and Malcolm answers for IANAE in the first person.

    No wonder people think both are a joke.

  105. 127

    “Now let me get this straight, you are acknowledging that it is prefectly acceptable to claim distinguishing structure by functional claiming?”

    I just explained that, not two hours ago. It is perfectly acceptable to claim distinguishing structure by functional claiming when a person skilled in the art can readily determine all of the structures that can produce the claimed function from the functional language.

    Transcription and translation are reversible simple ciphers. It’s abundantly clear to even a person unskilled in the art but having access to Wikipedia which specific DNA sequences code for a particular amino acid sequence. You don’t even need the “reader” to know what the DNA codes for. The claim is both structural and definite.

    The claim is even more definite (if such a thing is possible) when the credible utility is for the sequence to detect its complement, because then you don’t even need to transcribe or translate the sequence to get the result. The function is the structure.

    Compare and contrast Beauregard claims. You can’t possibly know every bit string that produces the claimed function. The bit string stored on the medium doesn’t even make any sense without knowing what computer will be doing the reading.

    Even if you could account for every known computer language and every known operating system, you can’t account for later-invented languages or OSes, and you can’t account for all possible forms of encryption or compression. In fact, any prior art bit string can be made to infringe any Beauregard claim by suitably designing an encryption/compression algorithm or a new computer language. It’s impossible to know whether or not a Beauregard claim is infringed without producing the computer that generates the infringement.

  106. 126

    MB From one whose mantra has been “must distinguish by structure”, your evasion of this point is particularly glaring.

    Of course I haven’t evaded it. On the contrary, asked and answered dozens of times by myself and others

    Now let me get this straight, you are acknowledging that it is prefectly acceptable to claim distinguishing structure by functional claiming?

    You will pardon my skepticism and indulge me (and countless others) and provide a clear and unequivical express statement directly to this effect. Something short sweet and without any weasel addendums or adornments.

    This will be interesting, no – priceless to see.

  107. 123

    MD Has the court yet construed “isolated”?

    It’s often defined expressly in the specification, rendering the construction relatively straightforward.

  108. 122

    When ya started out I asked ya about the teleportation ya needed to match your analogy to what was goin on. Have ya “construed” that yet?

  109. 121

    Ned Still, the claim is functional. It is to DNA that encodes a specific protein. The protein is defined, not the DNA.

    As recognized by courts and the PTO, the nucleic acid coding for a specified protein sequence is immediately recognizable by the PHOSITA, given the well-known genetic code.

    IANAE explained this to you …. and it’s not the first time it’s been explained, Ned. More like the tenth. What is it with you?

  110. 120

    When we started out, I was likening “isolated” to photographing a selected yard of a thousand mile long strip of asphalt. But through the length of this not quite yet thousand part thread, I have gathered that, however wide the term “isolated” is, it is not wide enough to cover that.

    Or is it? Has the court yet construed “isolated”?

  111. 119

    So…

    Weza can claim the carbon molecule cause we can separate it?

    Also, your middle earth is showin as to what actually need be there for the computer arts, but it’s nice to see that at least ya aiint fightin the functional claim aspect like my pal Malcolm.

  112. 118

    Still, the claim is functional. It is to DNA that encodes a specific protein. The protein is defined, not the DNA.

    If the protein is defined, you know the sequence of the DNA, to within certain interchangeable codons that code for the same amino acid. Sure, it’s functional in that it’s a something-readable medium which, when read, produces a particular amino acid sequence, but unlike a Beauregard claim it can be unambiguously reverse-engineered to the exact sequence of zeros and ones. And twos and threes. And from there to the exact molecular structure.

    If you were in the mechanical arts and you claimed a female connector in terms of matingly engaging a specific standard and well-known male connector, is that a functional claim? Sure it is, but it’s also simple and unambiguous to deduce the actual structure necessarily implied by that function.

    Isolated simply says that the molecule being claimed is not in a specific location or combined with other molecules.

    The wild DNA is arranged in chromosomes, each of which is a single giant molecule. A small molecule consisting of a single isolated gene is very much a different physical structure, in the same way that a carbon atom isolated from aspirin is a different physical structure from aspirin. It’s not a question of sorting one type of molecules from another, it’s a whole different molecule.

    We can discuss whether it’s obvious or not to select out a particular piece of an existing aperiodic polymer as a stand-alone molecule (and that’s really the interesting discussion to have), but you can’t reasonably say it’s not a novel structure or that it’s not a structural claim.

  113. 117

    The filter to what I say is awesome from one to another. Do you really think I can’t and won’t hand deliver a letter to the poor District Court..What are you going to do ARREST ME. that will be AWESOME
    Dicks little sister.

  114. 116

    IANAE and Max, as always helpful. Still, the claim is functional. It is to DNA that encodes a specific protein. The protein is defined, not the DNA. All this talk about cutting, reading, etc., is irrelevant. All that matters in the end is that the DNA encode the protein. Not how, or when, etc.

    It is a given that the claim covers any DNA that encodes the protein. “Isolated” only excepts the wild DNA from infringement. It does not to me or to the government require any structure because the structure being claimed is instead defined by the functional requirements. Isolated simply says that the molecule being claimed is not in a specific location or combined with other molecules. But, in the end, this is does not change the structure being claimed as far as I can tell.

    The structure being claimed is any structure that encodes the specified protein. That structure is per se old.

  115. 115

    Lulz Malcolm, I see the answer is c) – whoops where’s the geometric factorin? Only dozens? for sure, I thought weza be in the hundreds.

  116. 113

    MB From one whose mantra has been “must distinguish by structure”, your evasion of this point is particularly glaring.

    Of course I haven’t evaded it. On the contrary, asked and answered dozens of times by myself and others. In fact, if you go back to the earlier threads on this subject, I’m quite sure you’ll find I was the first commenter to address the issue.

    Please learn to read.

  117. 112

    (Of course, I do have a utility for my stemless leaf, so let’s just avoid that non-sequitur altogether, shall we)

    Of course, we’ll avoid the central point of the discussion because it’s probably not relevant. We’ll also ignore what “non sequitur” means, apparently.

    Tell you what, if you actually have a credible utility for a stemless leaf, and you can show that it wasn’t obvious to a sane botanist to make the cut at the point where the leaf clearly begins, you can have your patent.

  118. 111

    I pluck a leaf from a tree, carefully at the base of the leaf rather than at the base of the stem, thereby changing its endpoint.

    I shall now run to the patent office to patent my new creation, a stemless leaf.

    (Of course, I do have a utility for my stemless leaf, so let’s just avoid that non-sequitur altogether, shall we)

  119. 110

    “Isolated” therefor is not structure. It is the absence of other structure.

    Isolated is structure when you’re talking about removing parts of a molecule. A DNA sequence that starts here and ends there is a different structure from a chromosome-sized molecule of DNA. It confers novelty, at least.

    How meaningful is the structure associated with isolation? That depends on how you look at it. Yes, the really important aspect is the gene sequence, and that may well be unchanged or trivially changed from the original chromosome. But another very important functional aspect of DNA is where you start and stop reading it. Some prokaryotes, if I recall, have overlapping genes so that the same DNA sequence, read from a different starting point, codes for one of two completely different functional proteins.

    The end points are also important for diagnostics, because you’re using the sequence to detect its complement. Too long, and you risk false negatives. Too short, and you risk false positives.

    Now, whether it’s obvious to start and end at a particular point, that’s a whole other debate. But it very much is a meaningful structural feature. Much more than, say, “on a disk”.

  120. 109

    I doubt that Mooney will reply. I had thought there was no doubt that, to the relevant PHOSITA, “isolated” delivers novelty and a structure that is not identical. Imagine a kernmantel climbing rope 30 meters long. Now imagine “isolating” a chunk of it, a long way from both ends, by marking it, then severing it from the long strand, without using heat. Examine the state of the braided fibers of the marked “isolated” section a) remote from the cut end and b) right next to the cut end. Are the fibers adjacent to the cut end spaced apart from each other by the same distance as the braid fibers remote from the cut end? The “isolated” section of the rope has a structure different from that of the section prior to isolation. The isolated section is a new and different thing with a different structure and different properties.

    And we haven’t even begun yet to look at electron field densities.

    As to my “marking” step, remember the old story about the expert with the stick of white chalk, who alone of all experts can overcome the factory shut-down simply by putting a white cross on the exact location in the giant machine where the fault is located?

  121. 108

    Here, the legal AND policy arguments in favor of patenting new and useful chemical compositions

    That’s the key, isn’t it – new – How new is it, if it is exactly like the item in nature (at least the claimed part)?

    And please tell those followers of this blog how structurally different the claimed molecule is different than the wild one. Ned Heller’s point about “isolated” not being a structural difference is on point, his point about that limitation being a functional one is on point.

    From one whose mantra has been “must distinguish by structure”, your evasion of this point is particularly glaring.

    Oh, which of Malcolm’s precious defenses will this board see?
    a)I don’t know what you are talking about
    b)I don’t want to answer
    c)I already told you – see I just told you again
    d)BIG COMPUTER BRAIN

  122. 107

    In addition, you’ll find policy arguments (in addition to legal arguments) against such patents.

    Haven’t seen any real legal arguments yet, only wishful thinking and policy wonking.

  123. 106

    patent litigation I’ve noticed that most biotech proponents, in particular, base their pro-patenting contentions on policy arguments, rather than on legal ones

    And just to be clear, it’s not just “biotech proponents” that do this. At least with respect to methods of analyzing genetic information (e.g., for the purposes of making a diagnosis), I’m sure you can find many “software proponents” who can make a pro-patenting contention “based on policy arguments rather than on legal ones.”

    In addition, you’ll find policy arguments (in addition to legal arguments) against such patents.

    Here, the legal AND policy arguments in favor of patenting new and useful chemical compositions (and treating DNA like chemical compositions because, uh, that’s what they are) are more compelling than the policy arguments against such patents.

    The method claims may rest on shakier legal grounds, depending on how they are drafted.

  124. 104

    Although some gene patent proponents argue that this patent litigation is about legal precedent and reliance, I honestly think that this is one of those issues that is largely about one’s politics and policy. Whether or not human genes are legally patentable is a question rather like the “if a tree falls in the forest” hypo. I’ve noticed that most biotech proponents, in particular, base their pro-patenting contentions on policy arguments, rather than on legal ones — perhaps because there is no real legal answer. That being the case, although I’d like to read a Supreme Court opinion deciding this issue, perhaps this is really one for Congress to deal with.

  125. 103

    Malcolm, now, let’s revist your testimony in the Therasense case.

    Right. Like I want to spend the next week and two pages of comments explaining why your characterizations of my earlier comments are wrong and/or irrelevant to this thread.

    No thanks.

  126. 101

    Ned A claim to an isolated leaf, i.e., the leaf outside the context of the tree, is a claim to the leaf per se. It is not defining new structure, just the absence of irrelevant structure.

    The tree is irrelevant to a tree’s leaf? Wow, you learn something new here every day.

  127. 100

    Malcolm, the cow or the test tube? You do seem to endorse the government’s analogy to the leaf and the tree. A claim to an isolated leaf, i.e., the leaf outside the context of the tree, is a claim to the leaf per se. It is not defining new structure, just the absence of irrelevant structure.

    The “active” structure of the wild and the isolated DNA is the structure being claimed. It is claimed not by a sequence, but by its function, the function being to encode or to express a certain protein where the protein is identified by its structure. The structure that does this, either wild or isolated, is IDENTICAL. Other structure that may be present in the wild, is not claimed. The word isolated means that it is not claimed.

    “Isolated” therefor is not structure. It is the absence of other structure. Recall our discussion of this issue in the “membrane” case (Therasense) where the absence of the membrane for use in whole blood was the claimed invention. There you were quite derisive IIRC in concluding that there was no invention in the absence of something and that the patent attorney advancing the thesis that it was not being entirely candid at best.

    These claims are almost like Beauregard claims. The real invention, if any, is the programmed machine. The Bearegard claims, by analogy, are to the isolated program.

    (Love these anologies.)

  128. 97

    Tell you what, when Anon restricts his shoveling to only dirt, we’ll resume our discussion of this metaphor.

  129. 95

    Anon: I was addressing your error as to even obtaining the second patent.

    I wasn’t even talking about the second patent in the first place. I’m impressed that you think you found an error in something I didn’t say. It’s somewhat akin to finding a hole right in the middle of a larger area that has no dirt.

    Ned: When anybody does this in a brief or other argument, I ALWAYS take to mean that this is done to hide a central weakness.

    What does it mean when both sides are doing it?

  130. 94

    could you identify precisely what the structural differences are between an isolated DNA that ecodes a specific protein and the wild DNA that encodes the same protein?

    Done this already many times. I’m sure you were there.

    Let’s put it this way Ned: other than the sequence of nucleotides, there are no other structural similarities between the isolated DNA and the DNA in the wild. Let’s take the gene encoding bovine insulin. Have you ever seen a cow before? That’s what the gene looks like “in the wild.”

    Now look at a tiny tube of water with an isolated nucleic acid encoding bovine insulin floating in it (hint: it looks just like a tiny tube of water). Now look at the cow. Do you see any structural differences between these two compositions?

    Yes, this is simplistic and somewhat silly but not nearly as simplistic and silly as the arguments in the district court’s opinion.

  131. 93

    BTW, IF this structural difference is discussed in any brief, just point me too it. IIRC, almost all the briefs in favor of patentability wave their hands at this point in their argument, frantically diverting attention to other issues like the value of such patents. When anybody does this in a brief or other argument, I ALWAYS take to mean that this is done to hide a central weakness.

  132. 92

    Malcolm, without being too cute, could you identify precisely what the structural differences are between an isolated DNA that ecodes a specific protein and the wild DNA that encodes the same protein?

  133. 91

    Anon Was anyone addressing you?

    LOL. Because you are really concerned about people jumping into conversations here. Hilarious.

    No one was discussing infringement

    As I noted upthread, MaxDrei was discussing infringement.

    You’re making this too easy, Anon.

  134. 90

    Ned What defines the structure of the molecules being claimed? “Isolated” or the protein encoded?

    Both, of course.

    The government brief says the latter.

    If so, the government is wrong. I’ve already noted that the government’s characterizations of the claims are misleading.

  135. 89

    Malcolm,

    MaxDrei asked the question, which in itself has no error. I took issue (or to use your words ragged on) the person who gave the answer with the error in it.

    Do you have a problem here? Was anyone addressing you? Do you have a problem with people posing questions, but not one with people giving errant answers? IANAE is perfectly capable of devising his own non-answer, and doesn’t need your cheerleading, as misplaced as it is.

    IANAE,

    Your comment at 12:38 PM only digs the hole deeper. You ask a question that you should have asked yourself prior to your first answer. No one was discussing infringement and it is perfectly known that patents on advancements of ideas do not give the second patentee any rights over the substance of the first patentee – I was addressing your error as to even obtaining the second patent. Trying to hide your error in cleverness is not very clever. Clearly you recognize your own error. Just admit to it instead of covering it up.

  136. 88

    Malcolm,

    What defines the structure of the molecules being claimed? “Isolated” or the protein encoded?

    The government brief says the latter.

    But this means, does it not, that the structure that encodes the protein in the isolated DNA is the SAME structure that encodes the protein in the wild DNA. (Other parts of the wild DNA that do other things are not part of the claimed structure.) In other words, the structure being claimed is identical to the structure of the wild DNA, not different as you have consistently claimed in these threads.

    That is why I suggest you are reading some structure into the claim that does not exist in fact.

    Turning to Max’s point that most new molecules are per se obvious, but they are patented to the first discover of an use. Others here have hotly contended, however, that one cannot patent a pre-existing molecule even if one were the first to discover a use for it. Per se structural novelty is the minimal requirement.

    The distinctiions are fine, and do not appear to make much sense. But let’s go with the flow.

    Given the simple fact that the “structure” being claimed in the present case is old, the majority view here would be that one cannot claim that structure even if one were to discover a new use for it.

    However, if the “structure” is new, man made, not old, one could patent the novel structure to the extent that one also finds a use for it.

    Now we understand the government brief. The structures claimed that are new, cDNA, or vectors, are entirely patentable subject matter. But structures that are old are not patentable even if one discovers a use for them.

  137. 87

    Oops, sorry, I should have written “prima facie” obvious. I did not intend it to be a blanket, “per se”, exclusion. See, I’m not an academic, just an anonymous hobby scribbler.

    IANAE forgive me that I can’t hold in my head all our previous discussions. Perhaps we have already rehearsed the point I will now make.

    Obviousness in Europe is decided as of the date of constructive reduction to practice ie the day the inventor reports the invention to the Patent Office. When is it in America? Might it be the date of conception and, if so, might that be the explanation of our different mindsets here? Thinking on, is this going to be just one more intellectual challenge, if ever “harmonisation” comes, between US patent law and that of the rest of the world?

  138. 86

    I’ll come clean IANAE: I’m in a 101 thread on a 103 point.

    Shall we split the difference and talk about 102?

    A new molecule, per se, is obvious. Thus, what makes a “new” molecule “non-obvious” is the “technical effect” it delivers.

    You already know where I stand on that sort of thing. Nothing you discover about your invention after the fact should have any relevance to whether it was obvious to make that invention when you did. If a molecule was obvious before it had a use, now it’s obvious-but-useful, which is still undeserving of a patent.

    These are the sort of problems we run into when we start declaring whole classes of otherwise meritorious inventions “per se obvious”. We have to start making exceptions to the obviousness determination based on factors other than obviousness, and then we have no way of filtering out the inventions that actually are obvious.

  139. 85

    I’ll come clean IANAE: I’m in a 101 thread on a 103 point.

    What I cannot get out of my mind is EPO thinking that the scope of protection should be commensurate with the contribution to the art, and EPO thinking on obviousness (which sets what the “contribution” is). A new molecule, per se, is obvious. Thus, what makes a “new” molecule “non-obvious” is the “technical effect” it delivers. In engineering, the only claim that gets through to issue is the one that delivers the very technical effect that is relied upon for patentability. In chemistry though, once you show the effect, you get a 20 year monopoly for the molecule as such, which without the effect would be found obvious. If it is discovered that medication containing a dose of molecule X can cure disease Y then the claim should be directed to the medication (not the molecule per se).

    I’m angling for a Grand Unifying Theory to reconcile EPO obviousness law in chemistry with its obviousness law in engineering. But my discussion with you is leading me to think that I am seeing difficulties where none exist, and that the EPO Technical Boards of Appeal have already got there.

  140. 84

    another Anon loser:

    It is obvious that a patent to a device does not cover uses undisclosed, as method patents are available for novel uses of the device after the initial patent.

    Instead of ragging on IANAE, perhaps you should take it up with MaxDrei. It was he who asked: “is it right that the original “inventor” of aspirin or AZT can monopolise also the later unrelated use, totally unenvisioned by the original inventor?”

  141. 83

    I do not recall owners of use claims being unable to enforce them.

    Max, I would be very surprised if it were common to discover a second, completely independent use for a drug during its patent term. If there is only one known use, it doesn’t take much to prove on a balance of probabilities that any prescription or ingestion of that drug is for that one use. However, if the claims are drafted such that the off-label use is non-infringing, and the parties involved are aware of the patent, I can imagine that it would be very difficult to find evidence of how many times the drug was prescribed specifically for the patented use. I suspect you may be assessing the risk based on a low probability of it occurring, which is not necessarily indicative of how much it costs when it does occur or whether that’s a result we want to have.

    Besides which, I’m more concerned with the principle than with whether the practical effects are large or small, particularly when we can agree on what the qualitative effects would be. If you invent a thing, you should be entitled to claim the thing, and your claim should be assertable during its term against any making, using, or selling of the thing. I see no reason why that rule should change based on what sort of thing has been invented.

  142. 82

    as method patents are available for novel uses of the device after the initial patent.

    Speaking of being obtuse, do you really need to be reminded that the same device or method can be both patentable and infringing?

  143. 81

    IANAE,

    Grow up and stop taking so much delight in being obtuse.

    It is obvious that a patent to a device does not cover uses undisclosed, as method patents are available for novel uses of the device after the initial patent.

  144. 80

    IANAE you write:

    “If you give the original inventor protection only for his disclosed utility, you run the risk that an off-label utility could render his patent virtually worthless. He’d have to show that everyone taking the drug was taking it for his claimed utility, and possibly even that the drug was effective in producing that utility in that patient.”

    but I’m having a hard time seeing much risk. If (as you say) there is only in very rare cases any more than the one disclosed utility, then what could anybody legitimately be doing commercially with Molecule X if not using it for its only known utility?

    When it comes to the burden of proving infringement, the standard that applies is the usual civil law “balance of probability” is it not? Thinking about litigating claims to medicaments, is there really going to be the practical difficulty you apprehend?

    30 years of practice with “Use” claims has done something in Europe to etch away at the prejudice against “purpose limited” composition claims. I do not recall owners of use claims being unable to enforce them.

    In engineering, in reality, meaningful claims to devices are more or less “purpose limited”. Think how a Patent Office classifies the subject matter of device claims? Field of use? Is this the same as with claims to molecules per se? Only asking.

  145. 79

    I am not following your correlation between molecules and the mechanical arts.

    My “correlation” is that the same rules should apply to all arts unless there’s a very good reason why the rules ought to be different. Claims to structure should cover the structure per se in all arts. Claims to printed matter on a prior art substrate should be treated the same in all arts. Equal under the law, and all that.

    If inventing a new and useful device allows you to claim the device structurally and capture any instance of the same device as an infringement, why not for the inventor of a new drug or a new gene?

    Are you implying that the mechanical arts patents on the device also covers undisclosed uses of that device?

    Doesn’t it? The patent covers the device sitting in a room, even if it’s not being used at all. Making or selling, without more, is an act of infringement. On what legal basis does that device escape infringement merely by being put to an undisclosed use?

  146. 78

    IANAE,

    I am not following your correlation between molecules and the mechanical arts.

    Are you implying that the mechanical arts patents on the device also covers undisclosed uses of that device?

  147. 77

    I had supposed that, apart from rare genetically pre-ordained diseases like the sickle cell thing, every gene was involved in everything.

    Genes code for proteins, and proteins have very complex structures that generally can perform only one highly specific task. I think there are some isolated examples of different enzymes having the same sequence but different folding, which would give one gene two functions.

    If you want to know what genes do, look what goes wrong when they break. Sickle cell anemia appears to affect only hemoglobin, and nothing else in the body except in its reliance on hemoglobin making its regular deliveries.

    Of course, this is all just armchair genetics, but doesn’t it feel correct?

    Tell me, is it right that the original “inventor” of aspirin or AZT can monopolise also the later unrelated use, totally unenvisioned by the original inventor? If so, why?

    Good question. Maybe they should get some benefit from it, if they’re the ones who gave the public this useful molecule in the first place. The second utility would not have been discovered without the prior existence of the molecule.

    If you give the original inventor protection only for his disclosed utility, you run the risk that an off-label utility could render his patent virtually worthless. He’d have to show that everyone taking the drug was taking it for his claimed utility, and possibly even that the drug was effective in producing that utility in that patient.

    In the mechanical arts, when you invent a new device that has a utility, you claim the device. Nobody has a problem with that, because the device is the invention. You gave the world that device, and the patent is your reward.

  148. 76

    IANAE, you’ve got me there, when you ask:

    “…how many genes really affect the human body in more than one fundamental way? Very few, I imagine.”

    I had never imagined that a chunk of the naturally occurring DNA molecule affects the human body in one (and one only) fundamental way. There was me, supposing (to be frank) exactly the opposite. I had supposed that, apart from rare genetically pre-ordained diseases like the sickle cell thing, every gene was involved in everything. I had thought this to be the reason why all the hype about sequencing the genome has now dissipated. But, as I say, I’m not a biochemist. Anybody here who can say more?

    Tell me, is it right that the original “inventor” of aspirin or AZT can monopolise also the later unrelated use, totally unenvisioned by the original inventor? If so, why?

  149. 75

    MaxDrei: Suppose the new molecule X is a “classic” organic “small” molecule that delivers a pharmaceutical effect. It doesn’t matter whether the inventor gets absolute protection for all uses of the molecule, or just the use revealed by the written description in the app as filed. This because the only use there is ever going to be is the use found in that written description. So, keep it simple, give her a claim to “Molecule X” per se. No harm done.

    Max, I’m not a chemist either, but aspirin is a pretty classic case of a patentable small molecule that is very slightly changed from a naturally-occurring compound having pretty much the same utility, that was later found to have other uses.

    I believe thalidomide and AZT have also been put to uses beyond those envisioned by the inventor of the compound.

    Sure, those are isolated cases and most drugs are only ever put to the one use, but how many genes really affect the human body in more than one fundamental way? Very few, I imagine. Unless there’s some science to the correlation between hair color and certain essential brain chemicals.

  150. 74

    sarah, what is dumbfounding is how you do not see that Mikey wants your invention too. Just ask him if he is the inventor of your concept and he will tell you. Do you really find such skulduggery entertaining?

  151. 72

    This is what i now know
    I know KT was denied Registered status.
    Iknow JS was fired.
    I know DT is also in the mess. And of course the great RL moved so he could be the Man.
    I also know the little pimp squeek, shouldn’t have claimed to file one thing and then filed another instead. Because no matter what hw says… he haf to have had designs when he lied to me and told me to get lost after he took me for a another needless financial ride. And then line his pockets.
    And then goes the third. broken Record by now. It’s skipping da duc her da duck her duck her da duck her. Do you know that Record, Ducher? I even know that phone number.

  152. 71

    sarah,

    it’s not who i am that’s important – it’s who you think i am, when i am not that person that is important. I am not thinking of me – i am thinking of you.

    As for Mikey, I can’t tell you how many times I have to deal with people who with their three grandfathers have invented everything, yet can’t invent a legal way to protect themselves and only want to blame everyone else and say that everyone else doesn’t understand anything. He’s not even original in his psychosis. When he stops whining and actually does something to make his grandfathers even remotely proud of him, then he maybe he have a be otch to pe otch. Until then, he wastes more of his valuable time whining and his grandfathers spin more quickly in their graves.

  153. 68

    Q man is Licensed in Virginia. I know Q man is not licensed in the Sunshine State. Sunshine? How mant times has he said that JD? It must be a sign.
    Ping you like my Joke?

  154. 67

    6 The utility requirement is not at issue here

    And that’s just one of the reasons why this case is a loser with a capital ‘L’, 6.

    Bank it.

  155. 65

    You all had better get used to it. you won’t win. DNA is found in nature. Squeeze Oranges make Orange juice. Squeeze Lemons make Lemonade. Move a DNA sequence make it different. Stack large Pancake small Pancake. Switch it all. Stack em large then all small.It’s still a stack of Pancakes.

  156. 64

    Kev just told me several uses for wild DNA MM. Seems like there is plenty of utility for them. Not that it matters. The utility requirement is not at issue here, nor does it impact the inquiry into whether or not a judicial exception is applicable to a given claim.

  157. 63

    Fisher fan,

    No matter the outcome of this case/argument, all of those could have been patented for their use (e.g., as a hormone therapy, lowering blood pressure, etc).

    Seems like the scope of protection should go with the scope of the invention.

  158. 62

    6 I’m pretty sure that they were addressing EST’s in In Re Fisher MM.

    Me, too. Congrats, 6! You can read.

    I do not recall them stating that wild DNA had no uses.

    I don’t recall them saying that the moon isn’t made of green cheese.

    I also do not recall them stating that a claim to the same DNA then having been isolated did not preempt all (or nearly all) uses of the wild DNA.

    I don’t recall them stating that Ronald Reagan invented the electric bong.

    I think we’re pretty much on the same page. But you should educate yourself on the utility requirement of 101, as applied in In re Fisher.

  159. 61

    We prosecutors…

    We good prosecutors don’t jump directly into 102/103’s from 101.

    one step at a time WCG – make sure that first step isn’t into the path of an oncoming semi.

  160. 60

    ping,

    “The rest of your 9:24 post is nonsensicle and ya seem to be caught up in semantics. “removing the isolated DNA…isolating the isolated” – um, this is a bit redundant as the process of removing is what creates the state of isolated – how ya goin to isolate the isolated? Do ya always include extra words in your mechanical or electrical claims?”

    We prosecutors of patent applications argue over semantics, it’s what removes a 101 issue while retaining issues of 102, 103, and 112.

    By analogies, I see these issues. One issue is a claim of oxygen v. versus a claim of isolating oxygen from water. Another issue is a claim for a polypeptide coding as being akin to a claim of a formula and not the use of such formula to do something else.

    Too simple? Analogies not on point?

  161. 59

    Okay, but wouldn’t it take it out of § 101? and make moot the patentability issue?

    Not sure just what your question is here WCG. Are you saying that to avoid the 101 issue that the inventor should still try to get a patent on something old (the method) in order to get around the 101? That would be like avoiding the oncoming bus by stepping out of the way of the bus and into the way of the oncoming semi.

    The rest of your 9:24 post is nonsensicle and ya seem to be caught up in semantics. “removing the isolated DNA…isolating the isolated” – um, this is a bit redundant as the process of removing is what creates the state of isolated – how ya goin to isolate the isolated? Do ya always include extra words in your mechanical or electrical claims?

  162. 58

    From the p. 23 of the rosetta genetics brief:

    “…the human body never, at any time, produces ‘isolated DNA.'”

    I don’t see an element in the claims that recites “removing the isolated DNA having sequence No. _____”, “isolating the isolated DNA having sequence No. _____”, etc….

    If the claims included and recited in such elements, then it should take resolve the § 101 issue, shouldn’t it? Why can’t patent attorneys/agents include such elements when drafting the claims?

    The molecular structure of each isolated DNA appears in nature and is not man-made. It seems to me that the man-made invention lies in isolating (or producing) the naturally-occuring molecule (or some other atomic structure if my biotech terms-of-art are incorrect).

  163. 57

    ping,

    A bit more of a response from me.

    “Easy – because the Method is old.”

    Okay, but wouldn’t adding these elements to the claim it take it out of § 101? and make moot the patentability issue?

  164. 56

    ping,

    “Easy – because the Method is old.”

    Okay, but wouldn’t it take it out of § 101? and make moot the patentability issue?

  165. 55

    If this is the case, why not claim the method (system, etc…) of isolating the isolated DNA molecule drawn to the specific sequence and not the isolated DNA itself?

    Easy – because the Method is old.

  166. 54

    From the commentator’s comments:

    “For example, the DOJ sidesteps an important scientific fact: all isolated nucleotide compositions—regardless of sequence—are, in fact, engineered DNA molecules. Such DNA molecules are necessarily, by definition of their existence in an isolated form, “human made” inventions. These products simply do not exist without human intervention.”

    If this is the case, why not claim the method (system, etc…) of isolating the isolated DNA molecule drawn to the specific sequence and not the isolated DNA itself? By analogy, this is akin to claiming a method of generating an electrical signal and not the signal itself.

    If one could present the issue using a mechanical or electrical analogy, it would help many to understand the issue. Is there no analogy?

  167. 53

    Sarah, if I were you I would not worry. The writer of this piece surmised that the court will decide it on public policy considerations, and the United States Constitution has some nice words which suggest to me that public policy should be to promote the general welfare.

    It’s week-end now. I’m looking forward to an answer next week to my point, that a middle position is possible, between Y) absolute protection for all future uses of any enabled, useful, DNA fragment of DNA found in nature, and N) prohibiting its patentability, namely, M) limit the substance claims to the substantial utility enabled in the written description of the application.

    In the context of small molecules, it is a very old debate.

  168. 52

    Have any of you ever.. I mean ever thought about all the Countries out there trying to find Cures? And what they will do when they find it? Do you think Medicine is expensive now? And only the Rich and Insured are sure to be protected. Look at it this way, there is plenty of money out there to find the cure. Because that in itself is expensive enough without some drug company or some Country holding it over the heads of people that need it. This way the Drug Companies still make their money. License the formula. But make it affordable for all the companys that produce it, including a lowered Generic type. And all people hopefully will benefit. Think of it as a step up for everybody. Invent something that doesn’t control a persons quality of life. Invent something to make life easier. Making drugs for a better life should be for everyone. Not a payment to stay alive ONLY if you can afford it. And if you think making a better healthy life for all is Socialism, you’re all missing the Train.

  169. 51

    I’m pretty sure that they were addressing EST’s in In Re Fisher MM. I do not recall them stating that wild DNA had no uses. I also do not recall them stating that a claim to the same DNA then having been isolated did not preempt all (or nearly all) uses of the wild DNA.

  170. 50

    DOJ,

    Here are some drugs which DOJ presumably doesn’t think should be patentable under 101 (some or all may be anticipated or obvious now, but not when they were discovered).

    vinblastine sulfate (derived from periwinkle).
    Digitalis — leaves of Digitalis purpurea
    Reserpine – sedative from tropical shrubs
    Taxol – Cancer drug from yew trees
    Magainins – antibiotic from african frogs
    Captopril – Blood pressure med from vipers
    Premarin – hormone therapy from horse urine
    TM601 – anti-cancer drug from scorpions

    All of these are “isolated” from plant or animal sources. The only difference between these and DNA is that the DNA is even more changed, since it is in much smaller pieces than those found in nature, while these compounds are otherwise unchanged, except for being purified.

  171. 49

    Ned,

    Deuel is dead. KSR killed it and Kubin drove the nails into the coffin.

    Fisher is the central case here, and Fisher clearly implies that some isolated DNAs have utility while others don’t.

    Fisher says:

    Congress did not intend for these practical implications to affect the determination of whether an invention satisfies the requirements set forth in 35 U.S.C. §§ 101, 102, 103, and 112. They are public policy considerations which are more appropriately directed to Congress as the legislative branch of government, rather than this court as a judicial body responsible simply for interpreting and applying statutory law. Under Title 35, an applicant is entitled to a patent if his invention is new, useful, nonobvious, and his application adequately describes the claimed invention, teaches others how to make and use the claimed invention, and discloses the best mode for practicing the claimed invention. What is more, when Congress enacted § 101, it indicated that “anything under the sun that is made by man” constitutes potential subject matter for a patent. S. Rep. No. 82-1979, at 7 (1985). Policy reasons aside, because we conclude that the utility requirement of § 101 is not met, we hold that Fisher is not entitled to a patent for the five claimed ESTs.

  172. 48

    Ned I wonder whether you are reading into the claim structure that is not claimed?

    I’m not reading any claim, Ned. What claim should I be reading?

    You asked me what I thought about the passage from the DOJ brief. I answered the question and I was perfectly clear. Now you’re mumbling about what I may or may not be thinking? C’mon.

  173. 46

    However, Malcolm, the way I read it, the segment that “encodes” the protein identified in the claim is identical. Everything else in the wild DNA does other things and therefor not part of the claimed structure.

    I wonder whether you are reading into the claim structure that is not claimed?

  174. 45

    Ned, I think it’s very poorly written and misleading. As I noted above, a utility argument can be made that relates to the second sentence in the quoted passage from the brief. But the first sentence is basically stating that “The structure of the claimed composition is identical to the prior art, except for the parts where it’s not identical.” Seriously? This is an argument for subject matter ineligibility?

  175. 44

    Malcolm, you have said before there are structural differences between wild and isolated DNA. What do you make of this passage from page 31 of the Government’s brief:

    “The “pure” human BRCA1 polynucleotide claimed in the ‘282 patent is structurally identical to the DNA segment that occurs in the human body, apart from the fact of its isolation itself. Indeed, the structural identity of the isolated gene in the wild-type gene is the very point of the patent.”

  176. 42

    Ned if the only way to determine whether a gene was present is to detect the proteins it expressed, and the only way to do that would be to first isolate them.

    Yes, if these assumptions were correct (they’re not) and the claim was broad enough to cover the isolated gene in the form which it appears momentarily in the machine, then you would have momentary infringement.

    I have no idea why you think this is important.

  177. 41

    Malcolm, I asked before in another thread, but I still don’t have an answer that I fully understand.

    Suppose I invent a machine that takes a sample, does some magic, and then lists the sequences of all the genes in the sample. Perhaps the sample could be one chromosome of interest.

    Would the magic part of such a machine infringe, even momentarily, a patent on one of the genes in isolated form? I suspect that would be the case if the only way to determine whether a gene was present is to detect the proteins it expressed, and the only way to do that would be to first isolate them.

  178. 40

    Fisher held that DNA was not obvious over known protein (given cloning) because the DNA that could encode the known protein was still not known to any degree of precision. It did NOT hold, AFAIK, that isolated DNA is not per se obvious over known wild DNA.

    Why are you addressing this to me and what is the relevance to the 101 issue that we are discussing? Seems like a non-sequitur and the last sentence is particularly absurd.

  179. 39

    Malcolm, Fisher held that DNA was not obvious over known protein (given cloning) because the DNA that could encode the known protein was still not known to any degree of precision. It did NOT hold, AFAIK, that isolated DNA is not per se obvious over known wild DNA.

  180. 38

    6 I’m pretty sure that taking a person’s DNA, isolating it, and then having it available for testing is “meaningful”.

    I’m pretty sure that your argument was rejected by the Federal Circuit in In re Fisher.

  181. 37

    “Note the word “meaningful.””

    Oh I did MM, and I’m pretty sure that taking a person’s DNA, isolating it, and then having it available for testing is “meaningful”. Or else what are we all sitting around arguing about?

    I’m pretty sure that you’re just making a better case for the ACLU.

  182. 36

    MM, go easy on me. Bear in mind that I’m not a chemist or a biotecher. I was merely thinking that the new small molecule in itself is hardly a ubiquitous research or diagnosis tool and that the likelihood that it also cures a disease unconnected with the one mentioned in its app’s written description is negligible, whereas the likelihood is (I suppose) that the isolated and claimed DNA fragment will be needed in the commercialisation of the later inventions of other American inventors.

  183. 35

    “The “wild” DNA has no meaningful use, ”

    Don’t they use it to make isolated DNA?

    Note the word “meaningful.” The wild DNA could also be used as a source of phosphorous when added to bird seed. Also not meaningful.

  184. 34

    The expansion could logically be found to preclude a finding of substantial utility where the only credible, disclosed utility of a claimed sequence at the time of filing is (1) to detect its complement or (2) to express a protein for the purpose of studying the protein’s activity or to generate antibodies against the protein. According to this theory, a disclosure that merely postulated that a protein encoded by the nucleic acid could be used for a therapeutic purpose would not suffice to meet the utility requirement.

    Just to be clear, according to this theory, downstream uses of information obtained from (1) (such as correlating the presence/absence of detection with a disease state) would not be sufficient to overcome the lack of utility. Myriad’s composition claims would therefore fail 101’s utility requirement.

  185. 31

    MD Suppose the new molecule X is a “classic” organic “small” molecule that delivers a pharmaceutical effect. It doesn’t matter whether the inventor gets absolute protection for all uses of the molecule, or just the use revealed by the written description in the app as filed. This because the only use there is ever going to be is the use found in that written description.

    Huh? How in heck can you or anyone else possibly know this?

  186. 30

    Rader’s dissent in In re Fisher (2005):

    In truth, I have some sympathy with the Patent Office’s dilemma.   The Office needs some tool to reject inventions that may advance the “useful arts” but not sufficiently to warrant the valuable exclusive right of a patent.   The Patent Office has seized upon this utility requirement to reject these research tools as contributing “insubstantially” to the advance of the useful arts.   The utility requirement is ill suited to that task, however, because it lacks any standard for assessing the state of the prior art and the contributions of the claimed advance.   The proper tool for assessing sufficient contribution to the useful arts is the obviousness requirement of 35 U.S.C. § 103.   Unfortunately this court has deprived the Patent Office of the obviousness requirement for genomic inventions.   See In re Deuel, 51 F.3d 1552 (Fed.Cir.1995);  Martin J. Adelman et al., Patent Law, 517 (West Group 1998) (commenting that scholars have been critical of Deuel, which “overly favored patent applicants in biotech by adopting an overly lax nonobviousness standard.” (citing Anita Varma & David Abraham, DNA Is Different:  Legal Obviousness and the Balance Between Biotech Inventors and the Market, 9 Harv. J.L. & Tech. 53 (1996)));  Philippe Ducor, The Federal Circuit and In re Deuel:  Does § 103 apply to Naturally Occurring DNA?, 77 J. Pat. & Trademark Off. Soc’y 871, 883 (Nov.1995) (“The Court of Appeals for the Federal Circuit could have formulated its opinion in only one sentence:  ’35 U.S.C. § 103 does not apply to newly retrieved natural DNA sequences.” ’);   Philippe Ducor, Recombinant Products and Nonobviousness:  A Typology, 13 Santa Clara Computer and High Tech. L.J. 1, 44-45 (Feb.1997) (“This amounts to a practical elimination of the requirement for nonobviousness for these products, even when all the information necessary to discover them is previously available.”);   see also over fifty additional articles critical of Deuel in the “Citing References” tab for Deuel on Westlaw.   Nonetheless, rather than distort the utility test, the Patent Office should seek ways to apply the correct test, the test used world wide for such assessments (other than in the United States), namely inventive step or obviousness.

  187. 29

    IANAE am somewhat bothered by gene patents to the extent that they protect the diagnosis at the expense of research on the treatment, but that’s a policy issue and I can’t think of a valid legal reason to disallow them on that basis. The strongest argument is probably that diagnosis is either abstract or not a credible utility, but I can’t formulate a legal reasoning I find convincing – particularly when the diagnostic utility is not part of the claim.

    I agree that the utility angle represents the strongest point of attack. In effect, you would need to expand the holding of In re Fisher, which held that expressed sequence tags (“ESTs”) were unpatentable under 101 as lacking a substantial and specific utility, where the only disclosed use of the ESTs was to bind to and/or detect the corresponding gene or messenger RNA, without any indication that the claimed ESTs were in any way exceptional when compared to any of the thousands of other ESTs in the genome (in Fisher, the ESTs were derived from the maize genome).

    The expansion could logically be found to preclude a finding of substantial utility where the only credible, disclosed utility of a claimed sequence at the time of filing is (1) to detect its complement or (2) to express a protein for the purpose of studying the protein’s activity or to generate antibodies against the protein. According to this theory, a disclosure that merely postulated that a protein encoded by the nucleic acid could be used for a therapeutic purpose would not suffice to meet the utility requirement.

  188. 28

    This is in reply to IANAE at 2.31pm.

    Suppose the new molecule X is a “classic” organic “small” molecule that delivers a pharmaceutical effect. It doesn’t matter whether the inventor gets absolute protection for all uses of the molecule, or just the use revealed by the written description in the app as filed. This because the only use there is ever going to be is the use found in that written description. So, keep it simple, give her a claim to “Molecule X” per se. No harm done.

    But what if “Molecule X” is a bit of DNA? Is it the same as with the pharmaceutical? Any harm done, if you allow claims to “Isolated DNA Fragment X” per se? What else might others want legitimately to do, with that DNA fragment?

    And on obviousness at the EPO, yes IANAE, because EPO-PSA necessarily toggles between the technical “features” of the claim in view and the technical “effects” delivered by that new combination of technical features, as the way to decide whether or not the claimed subject matter is obvious.

  189. 25

    >>No, it indicates that there are a lot of >>people who desire a certain outcome and are >>willing to ignore the law and the facts to get >>there.

    This is exactly right. There are several issues here that should be sorted out, but I am afraid all these points of view are not equal. One must follow our patent law. Feeling good about your views is not enough.

  190. 24

    Ned question is rather does such a claim to isolated “preempt” in all meaningful uses of the wild DNA so as to effectively be a patent on the wild DNA?

    The “wild” DNA has no meaningful use, Ned. And a claim to an isolated nucleic acid sequence isn’t infringed by “wild” DNA so it can hardly be characterized as “effectively … a patent on the wild DNA.”

    As noted in my previous comment, a “reasonable” person can disagree with this, but he/she would be wrong. It has nothing to do with “policy” and/or “social issues/costs.”

  191. 22

    This all said, I propose that it does no good to simply assert that the DOJ (or any party or judge for that matter) incorrectly reads relevant case law and/or misunderstands the science wholesale. As mentioned already, reasonable minds can differ on case law interpretation in this case, and how to apply scientific facts to the law.

    Who exactly is “simply asserting” these things? The “simple assertions” are in the district court judge’s opinion, in the ACLU’s briefs, and in Judge Dyk’s weirdo dissent. Sure, “reasonable” people can have different opinions, but there aren’t two equally “reasonable” interpretations of the law and facts competing here.

    The sheer number of briefs and differences in positions—see DOJ versus USPTO as just one example—indicates this phenomenon in vivid color.

    No, it indicates that there are a lot of people who desire a certain outcome and are willing to ignore the law and the facts to get there.

    Thus, at the end of the day, the Federal Circuit and/or Supreme Court may ultimately decide the outcome of this case based on policy and social/economic considerations.

    And throw the constitution out the window? Gosh, I hope not.

  192. 21

    “Unless of course Rader writes for the majority and his one-sentence opinion is that the claims are abstract. At least now when he does that he can cite Bilski.”

    Sounds very simple to me.

    “a de novo analysis of the legal rules regarding section 101 and possibly even a second look at the findings of fact.”

    That also sounds pretty simple to me. Shouldn’t take more than an hour or two. Three if you take a 45 minute break after the first hour or so.

    “Everything is simple to 6. When you’re not encumbered by pesky details like fact and law, life’s a breeze.”

    Your overencumbering yourself with concerns of fact and law in your practice is no reason for the rest of us to overencumber ourselves in making determinations for cases JD.

    Also, try not to be so bitter after getting taken for a ride w/respect to enablement the other day. It’s only like the 5th time I’ve one-upped you. Considering your background in toiletpaper holders you’re doing quite well to have only had me do so on such few occasions.

  193. 20

    ping, look at the replies I received to the question about whether the first person to disclover a use to a known compound obtain a patent on the compound (as opposed to the use). The answer was a flat no.

    Now, review your answer to Withheld. You essentially said the opposite. You essentially contended that the first to discover the use of wild DNA could patent the wild DNA rather than the use.

  194. 19

    “In order to constitute anticipatory prior art, a reference must identically disclose the claimed compound, but no utility need be disclosed by the reference. In re Schoenwald, 964 F.2d 1122 (Fed. Cir. 1992)…”no utility need be disclosed for a reference to be anticipatory of a claim to an old compound.” 964 F.2d at 1124″

    At first glance, that seems surprising, but it makes sense… if prior art discloses a widget, but now how to use it, and you claim the widget… well, it’s not a new widget.

  195. 18

    Ned – double LOL on ya, agreeing with 6 (always a sign of a loose grip on reality) and then agreeing with Withheld.

    Ya really really need to brush up on the prosecution side, ancient one.

  196. 17

    Can the first person to discover a use for a known composition obtain a patent on the known composition?

    As ben said, the answer is no. Specifically, see MPEP 2122.

    “In order to constitute anticipatory prior art, a reference must identically disclose the claimed compound, but no utility need be disclosed by the reference. In re Schoenwald, 964 F.2d 1122 (Fed. Cir. 1992)…”no utility need be disclosed for a reference to be anticipatory of a claim to an old compound.” 964 F.2d at 1124″

  197. 16

    Withheld,

    You should be.

    Your application of logic is completely vacuous in the realm of patent law. Audit a class and achieve some minimal level of understanding before offering the comments as you have. The human intervention that is spoken of simply is not required to be in the claim, but merely pertains to the subject matter of the claim.

  198. 14

    I agree with 6. It is a given that isolated DNA is a human manufactured composition — presumptively eligible for that reason for patentability as an article of manufacture or as a compositon.

    The question is rather does such a claim to isolated “preempt” in all meaningful uses of the wild DNA so as to effectively be a patent on the wild DNA?

    Ask the right question and perhaps we will get the right answer.

    Obviously the briefs are all over the map because the focus is on all sorts of side issues, such as whether biotech is valuable, etc., and/or whether isolated is man made. No one can seriously argue these points, but they are substantially irrelevant.

  199. 13

    “These products simply do not exist without human intervention.”

    Politics does not belong in patent law.

    When you look at a typicaly isolated DNA claim and perform a 101 review on that claim, you cannot escape the conclusion that the claim does not meet 101. The human intervention conduct (method) is not clamied. The product is not claimed in connection with the human intervention process of creating it. So there is no relevance to the argument that “These products simply do not exist without human intervention” to any given isolated DNA claim.

    You would never get away with such claims in the electrical and mechanical art area and allowing isolated DNA claims to receive a 101 pass makes for inconsistent patent law with other art areas.

  200. 11

    Q: Can the first person to discover a use for a known composition obtain a patent on the known composition?

  201. 9

    The EPO uses its 103 provision to get some of the way towards accomplishing this public policy objective. New molecules are often found obvious, but less so when they deliver surprising or unexpected performance.

    Do you think that comes more naturally to an examiner applying a problem-solution approach to obviousness? That is to say, the molecule is less likely to be obvious if it solves a real problem in a really clever way, which represents a greater contribution to the art.

    Must it be a straight choice between no protection and full monopoly covering every use under the sun off the claimed fragment? Is there no compromise position?

    What of other arts? If one invents a new drug, or material, or even a new mechanical device, could we not ask the same question about the inventor’s entitlement to claim the product for all uses?

    I am somewhat bothered by gene patents to the extent that they protect the diagnosis at the expense of research on the treatment, but that’s a policy issue and I can’t think of a valid legal reason to disallow them on that basis. The strongest argument is probably that diagnosis is either abstract or not a credible utility, but I can’t formulate a legal reasoning I find convincing – particularly when the diagnostic utility is not part of the claim.

  202. 8

    Is there in the USA any appreciation that the scope of the patent monopoly awarded should be commensurate with the inventor’s contribution to the art? The EPO uses its 103 provision to get some of the way towards accomplishing this public policy objective. New molecules are often found obvious, but less so when they deliver surprising or unexpected performance. Claims on gene fragments per se put the floodlight on any claim that gives absolute protection for a molecule, even when its known utility is only one very special application.

    Some say an award of absolute protection, covering all uses of the new molecule, is too much to be commensurate with the inventor’s contribution. Must it be a straight choice between no protection and full monopoly covering every use under the sun off the claimed fragment? Is there no compromise position? I suspect it might interest the court, if there was one available.

  203. 7

    “The DC found that they did. It is a simple question as to whether or not they are right.

    It’s actually not that simple.”

    Everything is simple to 6. When you’re not encumbered by pesky details like fact and law, life’s a breeze.

    Lulz

  204. 6

    The DC found that they did. It is a simple question as to whether or not they are right.

    It’s actually not that simple. There are a lot of degrees of “right” here. Various parties are arguing in their briefs that different types of gene patents are valid or invalid. Besides, if the DC is even slightly wrong, the Circuit will have to substitute its own reasoning for or against these claims, which requires a de novo analysis of the legal rules regarding section 101 and possibly even a second look at the findings of fact.

    Unless of course Rader writes for the majority and his one-sentence opinion is that the claims are abstract. At least now when he does that he can cite Bilski.

  205. 5

    103 is probably what should be used here.

    This.

    If the argument against (some?) gene patents is that they copy or remake what is already known, 101 is not the place for it.

  206. 4

    Psyki, I pretty much agree with you. Despite the writer’s attempt at a group hug, I think that patent law does not permit us to say that an isolated gene is not an invention just because a real gene was used as a template to form it.

    103 is probably what should be used here.

  207. 3

    It is ridiculous to call a molecule that is made in a lab by man a product of nature. In fact, the first gene cloning was a profound innovation and doubtless deserved patent protection. On the other hand virtually no one in the public supports “gene” patenting because it implicates the very core of their unique biological code and appears to be only one step removed from patenting human beings.

    There is an easy solution which I hope the CAFC will consider. If someone obtains the gene sequence from nature using routine procedures and clones the gene using routine procedures, then it seem likely that your “invention” is obvious under KSR.
    There is no need to split the baby. Genes can be patentable subject matter, but if all you do is copy the sequence from nature, then you probably don’t deserve a patent, not because it is a product of nature, but rather because it is entirely obvious.

    My 2cents.

    Psykl

  208. 2

    “all isolated nucleotide compositions—regardless of sequence—are, in fact, engineered DNA molecules. Such DNA molecules are necessarily, by definition of their existence in an isolated form, “human made” inventions. These products simply do not exist without human intervention.”

    I disagree. To synthesize DNA molecules as it existed in nature is COPY, REMAKE, is NOT INVENT.

  209. 1

    I can see you are a keeper of the faith o blessed Jacqueline.

    Btw, what “really matters” is not up for “reasonable people” to disagree or agree on. There are three exclusions to patentable subject matter that the courts need pay attention to. All that remains is to see if, factually speaking, isolated genes preempt anything in any of those. The DC found that they did. It is a simple question as to whether or not they are right.

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