Enablement: Claimed “surfactant” not enabled by three working examples

Par Pharmaceuticals v. Roxane Labs (Fed. Cir. 2007) (Nonprecedential)

Par’s megestrol acetate suspension is prescribed to people who lose their appetites — often during treatment for cancer or AIDS. Interestingly, the company created this popular drug while attempting to design around a megestrol patent owned by BMS.

After obtaining patent protection, Par sued Roxane for infringement. The district court, however, granted summary judgment of invalidity under 35 USC 112 ¶ 1 — finding that “Par is not entitled to the broad claims it asserts.”

Enablement analysis begins with the presumptions that an issued claim is enabled and that a challenge to enablement requires clear and convincing evidence.  Unlike its close analog written description, enablement is reviewed by the CAFC on a de novo basis.

A claim is enabled when a PHOSITA can make and use the claim without undue experimentation. Broader claims, of course, require broader disclosure to ensure that their “full scope” is enabled. The unpredictable nature of an area of technology often serves patentees well as they argue non-obviousness. (It cannot be obvious if the results could not have been predicted). However, the enablement requirement demands more disclosure for unpredictable arts.

Broad Claims: Here, Par’s claim includes the following elements: “(a) megestrol acetate; … and (c) a surfactant.”  The CAFC finds this claim very broad because it would “allow the choice of any surfactant in any concentration.” (emphasis in original). In its disclosure, Par described three working examples and only one new surfactant. As a matter of law, the CAFC found that “these three working examples do not provide an enabling disclosure commensurate with the entire scope of the claims.”

Notes:

  • This opinion, drafted by Judge Moore may begin to provide some indication of her style.
  • Does this make sense: Because the applicant broadly claimed “a surfactant,” the specification must enable various types of surfactants. If, the claim had been written even more broadly — by eliminating that limitation — there would have been no need to include a description of various types of surfactants.

43 thoughts on “Enablement: Claimed “surfactant” not enabled by three working examples

  1. 43

    Sorry, for some reason that last post came out jumbled. Hopefully it’ll appear with the quoted parts this time.

    Just a couple of points in response to Gideon’s comments on EP translations:

    “If you do manage to get through the process and get a patent granted, you then will have the pleasure of paying to “validate” the patent in each of the countries of interest”.

    Why shouldn’t a country require you to translate a patent into its native language in order to bring the patent into effect in that country? If you don’t translate it, where’s the trade-off between monopoly and disclosure?

    I can’t imagine that most of the posters on this board would be particularly thrilled if there was an ‘Americas patent office’ that granted patents in English, Spanish and Portuegese, and where those patents immediately came into effect in the US in whichever language was used pre-grant.

    If you don’t translate at least the claims, a lot of the local population will have no idea what it is they are prevented from doing. That isn’t just.

    “First, you’ll translate the patent into French and German to appease the egos of the French and the Germans.”

    Not for much longer – with the London agreement coming into force next year, you’ll only have to translate the claims, which to me at least seems a reasonable compromise (see above).

    “Then, better yet, you’ll have to translate into each of the languages of the countries in which you want protection.

    Figure 100 grand, minimum, to file in your top 10 EU countries.

    Beautiful.”

    Again, as of some time next year there’ll be quite a few countries where you only have to translate the claims. If the patentee is not prepared to do that, why the hell do they think they merit a monopoly in that country? As already stated, this figure is going to drop fast.

    “Now they’re adding more countries. You’ve got Norway – figure twice the going rate to get a translation into precious Norwegian. What’s next? Serbia? Romania? Are they in yet? How about we add Byeloruss.

    Yep.

    the EU and EPO prosecution – in theory and on paper it looks great.”

    I really don’t get this, are you actually complaining about more countries joining the EPC? So at the moment, if your client wants a patent in Norway, you have to translate the US application into Norwegian, file it at the Norwegian Patent Office, pay the official fees, answer examination reports from the Norwegian patent office, each of your responses/amendments needing translation, and then eventually get a Norwegian patent.

    When Norway joins the EPC, you’ll only have to do one translation, after grant. The rest of the prosecution is combined with the EP application you would have filed anyway.

    Hence, if a client wants protection in Norway in addition to other EP countries, its now going to be much cheaper for them.

    On the ther hand, if the client doesn’t want to pay for the post/grant translation into Norwegian, then don’t bother! He’s no worse off. And as the old saying goes, you can’t get something for nothing.

    In summary, your missing the whole point – the member countries of the EPC are exactly that – separate COUNTRIES. Pretty remarkable if you ask me that 32 countries have harmonised their patent laws.

  2. 42

    Just a couple of points in response to Gideon’s comments on EP translations:

    If you do manage to get through the process and get a patent granted, you then will have the pleasure of paying to “validate” the patent in each of the countries of interest.

    > Why shouldn’t a country require you to translate a patent into its native language in order to bring the patent into effect in that country? If you don’t translate it, where’s the trade-off between monopoly and disclosure?

    I can’t imagine that most of the posters on this board would be particularly thrilled if there was an ‘Americas patent office’ that granted patents in English, Spanish and Portuegese, and where those patents immediately came into effect in the US in whichever language was used pre-grant.

    If you don’t translate at least the claims, a lot of the local population will have no idea what it is they are prevented from doing. That isn’t just. Not for much longer – with the London agreement coming into force next year, you’ll only have to translate the claims, which to me at least seems a reasonable compromise (see above). Again, as of some time next year there’ll be quite a few countries where you only have to translate the claims. If the patentee is not prepared to do that, why the hell do they think they merit a monopoly in that country? As already stated, this figure is going to drop fast I really don’t get this, are you actually complaining about more countries joining the EPC? So at the moment, if your client wants a patent in Norway, you have to translate the US application into Norwegian, file it at the Norwegian Patent Office, pay the official fees, answer examination reports from the Norwegian patent office, each of your responses/amendments needing translation, and then eventually get a Norwegian patent.

    When Norway joins the EPC, you’ll only have to do one translation, after grant. The rest of the prosecution is combined with the EP application you would have filed anyway.

    Hence, if a client wants protection in Norway in addition to other EP countries, its now going to be much cheaper for them.

    On the ther hand, if the client doesn’t want to pay for the post/grant translation into Norwegian, then don’t bother! He’s no worse off. And as the old saying goes, you can’t get something for nothing.

    In summary, your missing the whole point – the member countries of the EPC are exactly that – separate COUNTRIES. Pretty remarkable if you ask me that 32 countries have harmonised their patent laws.

  3. 41

    “Did any reader pick up the Australian cancellation, just the other day, of all its long-standing IDS requirements?”

    I did. An awesomely sane result.

  4. 40

    Thank you Erez Gur. Most of my time at my desk is spent attending on US patent attorneys who want patent rights in Europe. My interest in contributing to this blog is to ease more of them into the “nice client” category and out of the “total as..ole” category, by helping them to see the European point of view, so that my work becomes more enjoyable. Simple as that. You mention the IDS requirement. Did any reader pick up the Australian cancellation, just the other day, of all its long-standing IDS requirements? The AU Govt just concluded that the whole IDS ritual performs no useful purpose, in these days of every front rank Patent Offices doing online research in the internet-accessible files of its brother and sister Patent Offices in other parts of the world.

  5. 39

    I think some people have missed Max Drei’s point.

    This Blog is about how to improve the US patent system. Everyone seems to agree that the current changes (Continuation rules, IDS rules, new legislation) are bad. Max suggests that one study the EP system.

    Gideon is right that the EP system is expensive (which will soon change with a relaxed requirement for translation) and that EP attorneys are much more expensive than their altruistic American colleagues, but that is not the point of Max’s letter.

    There are many reasons why the EP system is preferable to the US system, but one reason is the relevance of cited art.

    A significant proportion (but not all) of US examiners find vaguely related or non related art, state that it is obvious to combine the art and then reject the claims.

    In contrast, the EP Examiners find a small number of highly relevant art (apparently found by a combination of superior search tools and experience). The Examiner does not need to explain why the art is relevant, rather the Applicant immediately sees what needs to be amended.

    The more USPTO Examiners cite relevant art, the fewer problems the clients of the USPTO will have.

    Ways to find more relevant art have already been discussed in this Blog: give the Examiners better search tools, give them more time per application and increase Examiner retention.

    I don’t know about search tools, but giving more time can include canceling the useless IDS, open USPTO branches in different part of the country and remove the draconian (and false) productivity requirements: just trust the Examiners that, when given reasonable conditions, they will do a good job.

  6. 38

    Here are excerpts from an excellent, extremely judicious and well written comment, one of the best ever, posted on Patently-O on Jun 26, 2007 at 07:33 AM on this thread-link:
    link to patentlyo.com
    ————————
    “ … The bottom line is that the majority of European law is based on a far more socialist leaning basis than we’ve adopted in the US … different in the manner in which individual contribution to the common good is measured.

    “In the area of patent law, especially patent enforcement, Europe is damn near the least cost effective playground in the world …

    “The bottom line is Europe doesn’t enjoy the benefit of independent inventor’s contribution to innovation to the extent we do in the US because they don’t compensate for it. We do, because we compensate for it. Being an independent inventor is, financially, among the highest risk professions. …

    “American culture embraces those who take risk and succeed in being correct despite the spewings of “experts”. European culture, broadly speaking, doesn’t. … we’ll continue to outstrip Europe while they take their 7 weeks of vacation every year. …

    “… the claims define the scope of what the pantentee excludes, the spec teaches that which society benefits from. Limiting an inventor’s ability to write claims does nothing but enable corporations to take advantage of the teachings that an inventor now can’t have the opportunity to claim. It’s bullsh@t. If a claim is supported by spec, and is truly useful and unanticipate by the prior effort of others, it should be subject to successful claim prosecution despite the whinings of industry which would much rather not pay a dime of royalties for stolen technology.”

    I wish I had written this post — it certainly bears repeating.

  7. 37

    MD – My complaints about EPO prosecution are beyond the translation costs . . . there’s the huge time gaps between office actions, the extremely high filing fees, and, worst, other than translation, there’s the ridiculously high legal fees. With the dollar dying, it’s even worse than it was 2 years ago when the dollar/euro was closer to 1.

    What’s this about Germany?

    Population of Germany is 80mil.

    Are you suggesting that, if you block Germany, you block the production of the car in the first place, so you don’t need protection against use in other countries?

    Well, that may work for cars, but it doesn’t work for every item out there.

    Even the French, with their 35 hour work week, still manage to make stuff.

  8. 36

    Gideon makes a succinct summary of what’s wrong with the European patent system: translation costs. Can’t argue with him, that translation costs are high, when you need a patent in every one of the 32 member countries. It could be worse. You don’t (yet) have to translate into Welsh (one of the two official languages of the UK Patent Office). But, who does have to cover all 32 States? Pharma, and they can take care of themselves. Wonder why TOYOTA validates only in Germany. Block Germany and you’ve blocked all 450 million folks from enjoying Toyota vehicle technology, no? The cost of obtaining protection in Germany goes up with the number of pages for translation, it’s true. But, as to delay, and quality issues, if you respond appropriately to the IPRP, you will get a Notice of Allowance as First OA soon after regional phase entry. The environment for testing claim validity in Europe is more hostile after issue than in the EPO. And, if ever you have to assert your issued EP it will be before a court working in a language other than English. Those pesky civil law judges, with no English, no binding precedent, no discovery and no cross-examination might not understand the invention either. Back to the point of this thread, in Europe the substantive law on enablement, sufficiency and written description is clear enough for Applicants, on scope of claim, to pay their money and take their choice.

  9. 35

    MAX (with a [false] thick skin),

    Re your last posted comment:
    “My point above was serious, even if expressed in such a clumsy, heavy-handed way”

    I must say old boy you missed my USA point entirely, or at least you pretend to.

    I did not think your earlier post was clumsy or heavy-handed, not at all.
    Oh, contraire!
    I said what I thought about your post. What I said was:
    “You [Max] are condescending, patronizing, demeaning, pompous, supercilious, snooty, snobbish, pretentious, arrogant … just so full of yourself you cannot fail to offend.”

    So please allow me to add to that plain insult, that you are also rather disingenuous.

  10. 33

    Yes. The Wonderful World of the EPO.

    Yes MD, it’s so wonderful. It’s refined. It’s civil. It’s premier.

    At least it used to be.

    The last 6-12 months worth of ISRs that I’ve gotten out of the EPO have been absolute crap.

    One case cited 12 X references.

    Upon review, it turns out that the searcher did not understand the invention at all. I don’t mean difference of opinion. I mean we claimed a rock and the search cited 12 references directed to turtles.

    Here’s the EPO in a nutshell . . .

    To file – 5 grand. That’s with the PCT EPO search discount.

    It’s about 3k in EPO fees and about 2k in attorney fees.

    Yes folks. 2k. To take the English spec, slap a cover sheet on it, and mail it to the EPO.

    If anybody is aware of a competent firm in the EPO that has English speakers and that charges a reasonable 1k or less to mail in an application, please let me know at gideonpope@aol.com.

    So now you’re in the EPO. You’ll wait a few years after entry into the regional phase to get a first OA, which will be a verbatim reiteration of the WO at the PCT.

    Recently, the Office Actions have become less coherent. I’ve had at least 2 in the last year where I had to ask the EU associate to write in to the EPO and ask, “huh???”.

    So you send in your reply. You’ve just spent 3k more for the EU associate.

    You then wait a year or more, in many cases, before you pester the EPO and get another action.

    If you do manage to get through the process and get a patent granted, you then will have the pleasure of paying to “validate” the patent in each of the countries of interest.

    First, you’ll translate the patent into French and German to appease the egos of the French and the Germans.

    Then, better yet, you’ll have to translate into each of the languages of the countries in which you want protection.

    Figure 100 grand, minimum, to file in your top 10 EU countries.

    Beautiful.

    Yes, the EPO is a wonderful wonderful system.

    IF AND ONLY IF you represent a corporation that is able to drop about 150 grand from start to finish to obtain patent protection in MOST, but not all of the EU.

    Now they’re adding more countries. You’ve got Norway – figure twice the going rate to get a translation into precious Norwegian. What’s next? Serbia? Romania? Are they in yet? How about we add Byeloruss.

    Yep.

    the EU and EPO prosecution – in theory and on paper it looks great.

    In the real world, the value of your patent in Europe, relative to the U.S. (which stinks for 100 other reasons) is substantially lower because the $ (or euros) per claim that you’ll spend will be about a 15 to 1 ratio relative to the US.

    I don’t what I dislike more . . .

    loud mouth, fake patriot braggart Americans or
    Phony, high fallutin’ Eurotrash ninnies.

  11. 32

    Dear Haveaniceday, thank you so much for the reaction to my post. Nice to know somebody is reading me. My point above was serious, even if expressed in such a clumsy, heavy-handed way, that advances in patent law come when one’s treasured assumptions are put on the block for learned criticism by intellectuals in other countries. Compare the way scientific knowledge advances. Presumably you would agree that the borderless world of mathematics or physics makes more progress than when the debate of physicists or mathematicians is confined within individual countries. The interesting thing about the European Patent Convention is that it was drawn up by a civil law/common law trade-off (DE/GB) and that by now 32 countries have signed up to it as full members, at a stroke rendering the decisions of all those national Supreme Courts fair game to be beaten up by the intellectuals of all the other member States. And, after 25 years of all this, the rest of the world eg China, Japan, Korea (in fact everybody except USA) is signing up to the basic model, whenever it can. Some want the USA to continue on its exceptional course. That’s OK with me, but I still think it would be a shame, because my US clients and their US counsel more or less every day enrich my views of the EPC.

  12. 31

    In his October 26 03:59 posting Malcolm Mooney pointed out exactly why the 5/25 claim limitation is bad. Thank you.

    But to the point, it seems that this decision is wrong.

    The Federal Circuit should have given Par claims having a scope commensurate with their contribution to human knowledge. This would seem to be the broad claim “megestrol acetate + surfactant” or even “megestrol salt + surfactant”.

    Also (as quoted from Graver Tank II in the previous thread), it is the Court’s duty not to make infringement too easy.

    A claim to “megestrol acetate + glycerol” would presumably have been held valid, but it is much narrower than what Par contributed to humanity and such a claim would have been easily infringed by Dr. Reddy chemists.

    It is as if the Federal Circuit is telling Par that they should not bother making new medicines. I wonder if the judges would have decided differently if Par had brought an AIDS or cancer victim to testify how the Par composition changed their life.

  13. 30

    Max,

    Thanks and thanks “… we [well-informed European readers] get a gratifying feeling of ‘Been there, done that.’”

    Do you think the purpose here is to gratify your affected ego?

    Why is that no matter what you have to say, whether interesting or not, you never fail to offend over here in some way.

    Let me count the ways:
    You are condescending, patronizing, demeaning, pompous, supercilious, snooty, snobbish, pretentious, arrogant … just so full of yourself you cannot fail to offend.

  14. 29

    Once again, interesting for a European looking in. Thanks contributors, and thanks Dennis. In Europe we have had, for the last 15 years or so, intense international multi-lingual, common law/civil law argument, based on the all-shared, mandatory, patentability provisions of the European Patent Convention, about how to judge enablement, written description, sufficiency of disclosure and entitlement to priority dates. Any intellectual weakness in the line peddled by one national supreme court (Say, House of Lords or German Federal Court of Justice) that can’t withstand the combined might of intellectual thought in the other countries gets rubbished throughout Europe. Thus Dennis, every time a well-informed European reader sees a case like this one , we get a gratifying feeling of “Been there, done that”.

  15. 28

    David French writes:

    In the Canadian Supreme Court of Canada decision Burton Parsons Chemicals, Inc. v. Hewlett-Packard (Canada) Ltd., [1976] 1 S.C.R. 555, link to scc.lexum.umontreal.ca the invention was a type of conductive cream to be smeared on the human body for the purpose of making electro-cardiograms. The mixture was of no fixed composition. The essential invention was “to combine a highly ionizable salt with an aqueous emulsion” (p. 564). It was put in evidence that hundreds, if not thousands, of substances would fit the description, including some that would be toxic or irritating to the skin. A toxic “conductive cream” would not be a useful therapeutic tool, and it was alleged on that account that the patent lacked utility and was invalid. These objections were swept away by Pigeon J. who held that the notional skilled workman would understand perfectly well the purpose of the combination and could therefore be expected to apply the teaching of the patent by sensibly choosing components suitable for that purpose (p. 563):

    “…the construction of a patent is … to be done on the basis that the addressee is a man skilled in the art and the knowledge such a man is expected to possess is to be taken into consideration. To such a man it must be obvious that a cream for use with skin contact electrodes is not to be made up with ingredients that are toxic or irritating, or are apt to stain or discolour the skin.”

    Conclusion: In order to avoid inoperability (or its mirror image, lack of support within the scope of the claim), include functional languages to specify the purpose of the elements recited in claim.

  16. 27

    Amen Gideon, you are correct on all counts. The lack of understanding of these patent law concepts by many persons who (apparently) profess to understand them is made incredibly apparent by some of the entries provided above. Most unfortunately, you are correct on the point that enablement is currently being distorted by some in the courts precisely to limit patentability. Any patent can be invalidated on these grounds in the Fed Circuit, assuming you get the right panel.

  17. 26

    Somebody wrote:”Yes, it does make sense that more direction and guidance are necessary to enable a narrower claim. ”

    Uggg.

    Proving my point that practitioners are lost on this matter.

    Reminds me of an Examiner who came to the Firm. They always come out of the Office full of beans, thinking they know something. They always defend the Office. If they happen to have a PhD, it’s even worse. Now you’ve got this newb clerk who doesn’t know his arse from his elbow, but because he worked at the PTO for 2 years and spent 6 years in a lab getting a degree he/she thinks he/she deserves some sort of automatic status.

    Unfortunately, the other clerks who are not former Examiners tend to buy into it.

    So this ex examiner one day says to another clerk: “well written description and enablement are really the same thing.”

    AHHHHHHHH.

    You add a claim in prosecution, I tell him. 1 year after the filing date.

    The claim is, “A method for chewing gum, comprising: placing gum in mouth, chewing gum with teeth in a 2 chew – pause – 3 chew – pause rhythmn, and spitting gum out.”

    The spec has no mention of gum in it.

    The claim is enabled but there is no WD support.

    The best part about the Ex Examiners is 1 year down the road when they are the loudest blasting the PTO and the 103 Office Actions:

    “How can he say that the claim is obvious! That’s crazy!”

    Welcome.

  18. 25

    Yes, it does make sense that more direction and guidance are necessary to enable a narrower claim. A real-life example (not mine): if your wife sends you to the store for a “loaf of bread”, that is one thing. But if she sends you to the store for a “loaf of whole grain bread that is fine-sliced”, you are going to need more information or you will be spending a lot of time in the bread aisle.

  19. 24

    Dennis wrote: “When I talk about a pharmaceutical composition comprising x, y, and z, the reasonable enablement of the full scope does not include large amounts of arsenic (unless x, y or z is a “typically harmful chemical”) or a tiny perpetual motion machine.”=

    This is just chatter.

    What the heck is “reasonable scope”?

    Which case nails that down?

    It’s, frankly, silly.

    One man’s reasonable is another man’s outrageous.

    I have not seen the case discussing “reasonable scope” before.

    It’s nice to see it added de novo here by Dennis, but . . .

    Until I see it at the CAFC, my conclusion remains the same. . .

  20. 23

    Athletic Alternatives is alive and well.

    When I talk about a pharmaceutical composition comprising x, y, and z, the reasonable enablement of the full scope does not include large amounts of arsenic (unless x, y or z is a “typically harmful chemical”) or a tiny perpetual motion machine.

  21. 22

    “Reasonable scope, Giddy. Reasonable scope. Don’t get carried away.”

    Isn’t the “reasonable scope” of a claim with a “comprising” transition, by definition, infinite? Perhaps the scope for infringement is distinct from the scope that must be enabled?

    These enablement mind games of divining the extent of “reasonable” bore me. Simply narrow the claim to its valid scope based on the spec. Long live Athletic Alternatives v. Prince!

    “Where there is an equal choice between a broader and a narrower meaning of a claim, and there is an enabling disclosure that indicates that the applicant is at least entitled to a claim having the narrower meaning, we consider the notice function of the claim to be best served by adopting the narrower meaning.”

  22. 21

    “Well, that includes a Hydundai with a doohicky and a Ford that includes a doohicky and a light saber. Well, clearly the light saber is not enabled, but it is well within the scope of the claim, so the claim is not enabled accross its scope.”

    Reasonable scope, Giddy. Reasonable scope. Don’t get carried away.

  23. 20

    This is a great post to show how clueless virtually the entire patent bar is about enablement. Let’s not even touch written description.

    Malcolm/Dennis wrote: “Unlike its close analog written description, enablement is reviewed by the CAFC on a de novo basis.”

    Enablement and Written Description are not “close analogs”. They are neither close, nor analogs. The only thing they have in common, in fact, is that they both (unfortunately) appear in the same statutory section.

    Malcolm/Dennis further wrote: “Broader claims, of course, require broader disclosure to ensure that their “full scope” is enabled.”

    Of course this is wrong. Broader claims do not, necessarily, demand any more disclosure than do narrow claims.

    For example:

    The very broad claim:
    “A clock.” is

    ENABLED. Period. No description needed at all. The bare claim is enabled by the existing art. The claim may not be patentable, but it’s surely enabled.

    On the other hand:
    “A nuclear device for repositioning satellites based on massive laser discharges and receptor black pads” had better have a very precise description supporting it.

    In other words, because enablement is based on BOTH the known art and the specification, it is flat out WRONG to suggest that the thickness of the disclosure is somehow relevant to an enablement discussion.

    Further, if the invention is a simple combination of known elements, then NO description is needed. If you claim “an alloy of 10%X and 10%Y and 80%Z” that is novel and the elements are all known, then the claim is enabled before it is even written down, and no further support is needed.

    In sum – and write this sh1t down boys so you can claim it as your own tomorrow – the only relevant question for enablement is . . .

    Does what is known in the art and the specification, together, allow a PHOSITA to practice the invention.

    Yes yes, there’s more, but that’s the basic question.

    I didn’t like this Moore chick when she signed on. I didn’t like her when she was spouting theoretical nonsense about continuations without having a reg number or filing a claim, and I really really don’t like her now after what appears to be a BS opinion that does nothing more than further raise the bar on what a patent needs to be to hold up.

    This judge came to the bar with a single intention – to narrow the legal definition of what is patentable. That’s it. This opinion is just one in what will, no doubt, be a lone line of opinions holding one way or another that an issued claim is invalid. Buckle up boys and girls.

    There’s this disturbing pretend concept in patent law that the scope of a comprising claim is finite.

    And from that we get the illogical conclusion that “claims must be enabled across their full scope”.

    Well la de freakin da.

    “A car comprising a doohicky”

    That’s our claim, right?

    Well, that includes a Hydundai with a doohicky and a Ford that includes a doohicky and a light saber. Well, clearly the light saber is not enabled, but it is well within the scope of the claim, so the claim is not enabled accross its scope.

    It’s all an illogical game that the courts are playing.

    Just like the definition of “obviousness” is an amorphous blob, enablement is being deconstructed.

    One more note, boys – nowhere in the law does it say that required components must be in the claims. That’s just plain stup1d.

    For example, a claim to a “microprocessor” would then require a recitation of every required part in the claim.

    Of course that’s stup1d.

    No. Instead, what’s done is the claim is written, “A microprocessor having a doohicky,” where the doohicky is the new part.

    What nobody wants to admit or decide on is exactly how much of a claim needs to be enabled.

    If you understand that every comprising claim is BY DEFINITION of limitless scope and has an INFINITE number of inoperable embodiments, then you will understand that it is completely irrational to attempt to argue “scope”.

    I’m not sure what the answer is.

    Perhaps the correct question should be, “is a sufficient number of embodiments enabled”. Perhaps the best way to do it would be . . .

    . . . to rule that a claim must have at least one enabled embodiment and . . .

    . . . that the limit of the claim scope is the limit of what is enabled.

    That, of course, would make too much sense – so it has no chance.

    So what’s the answer to this silly judicial can of worms?

    There is no answer.

    And the Empire is fading fast – 92 dollar oil – and you think we’re in the Middle East to spread democracy? Hah!

    You see, if you make the mistake of adding more and more limitations to your claims, or having them in the 24 or fewer dependent claims, then all you’ve done is narrow the scope of the claims (that’s for sure!) without removing the argument that the court has made.

  24. 19

    Mr. Mooney observed, “However, the typical chemistry or biotech applicant inevitably relied on the ‘unpredictable’ nature of the art, thereby blasting his/her feet off with a shotgun when it comes to asserting these absurdly broad claims.”

    That’s really the key here. If it’s really that unpredictable such that you’re claims are not obvious, you damn well better provide lots of examples if you want a broad claim to survive enablement challenges. You can’t have it both ways: low skill/unpredictability for obviousness, but high skill and predictability for enablement.

  25. 18

    One more thought re giant lists and agents comments: within such huge genera as “adhesives” there are many sub-genera. The best specification will include examples showing the utility of at *least* one species in each sub-genera. Such a showing would lkely enable the claims, notwithstanding foot-blasting admissions regarding the unpredictability of the art.

  26. 17

    agent — that is mostly correct with the caveat that giant lists may satisfy the so-called “written description requirement” in the US. Of course, the extent to which written description and enablement are conjoined is the subject of eternal gas-huffing.

  27. 16

    As a somewhat more general question, do such giant lists (e.g., of adhesives in the preceding example) ever really help?

    If the invention is in a predictable art, then simply saying any adhesive will do should suffice, and a long list adds nothing to the case.

    If the invention is in an unpredictable art, and some adhesives work and others do not, then a long list of allegedly “suitable” adhesives would also appear to be unhelpful, since the invention is really those adhesives that work, and would thus naturally be limited to what is actually taught (e.g., in the examples), and to what can be derived from the literal teaching without undue experimentation.

  28. 15

    Metoo, go luck at Hutz’s *original* 4:48 pm hypo to which my original response was directed. The issue is not about the merits of “giant lists” but rather about the merits of non-existent or microscopic lists.

  29. 14

    That’s not what I was suggesting at all. Even if a limitation such as “an adhesive” is the sole point of novelty in an independent claim, that does NOT mean that you necessarily have to disclose a giant list of exemplary adhesives.

  30. 13

    “Lionel, I think you are misinterpreting the case – and Malcolm’s answer is clearly wrong (at least if he intends his answer to be a general rule). ”

    Note that I was Lionel the benefit of the doubt and assuming that he wasn’t asking about a dependent claim where “an adhesive” is recited as some irrelevant limitation that has no bearing on the novelty/non-obviousness of the claim. The assumption is predicated on the fact that asking a question about such a trivial hypothetical would be an utter waste of everyone’s time.

  31. 12

    “All right Malcolm, let’s say I disclose all existing adhesives, but one. Should my claim be invalid?”

    Most likely, no.

    “where do you draw the line?”

    Reasonable enablement of the full scope. You know: the law, as set forth by the CAFC.

  32. 11

    Lionel, I think you are misinterpreting the case – and Malcolm’s answer is clearly wrong (at least if he intends his answer to be a general rule). The number of examples necessary for enablement varies greatly from case to case. If you’re claiming an apparatus in which one part is attached to another using an “adhesive,” one example would be sufficient in most instances. This case does NOT stand for the proposition that a claim which recites a chemical limitation using a broad term which potentially encompasses thousands of embodiments (e.g., a “surfactant”) is per se invalid if the spec does not include a significant number of examples.

  33. 10

    All right Malcolm, let’s say I disclose all existing adhesives, but one. Should my claim be invalid? If not, where do you draw the line?

  34. 9

    well if one of skill in the art has reasonable basis to believe that other surfactants would act as the one in their examples, then it should satisfy enablement. Just as a poster above showed that the application itself gave indication that this was not the case. An applicant should not have to list all and every surfactant that ever was or will be.

  35. 8

    “If one of my claim elements is an adehesive and I only disclose one specific adhesive, should my claim be invalid?”

    Probably. But more importantly, you should be sued for teaching only one specific adhesive and claiming the genus without adequate support.

    It’s 2007, folks. Get with the program.

  36. 7

    Malcolm,

    Limiting claims on the basis that their breadth is not enabled by the disclosure is ridiculous. 102, 103, and literally climing elements not disclosed in the description are all reasons claims should be invalidated. If one of my claim elements is an adehesive and I only disclose one specific adhesive, should my claim be invalid? Perhaps it could be limited to that adhesive, but it should not be invalid.

  37. 6

    “Malcolm, I’m not sure this patent would have held up even in the “good old days.”

    That is a wonderful sentiment. Regardless, rest assured that there are companies raking in tens, if not hundreds, of millions of dollars by aggressively licensing patents that are just as bad if not worse.

  38. 4

    This case doesn’t really seem all that surprising to me. First, the surfactant had to be in the claim since you couldn’t formulate the flocculated suspension without one. The Background section unequivocally states that you need a surfactant to make a suspension of megestrol acetate.

    Second, and perhaps most importantly, the Detailed Description of the Invention begins with this statement: “In accordance with the invention, a flocculated suspension of megestrol acetate can SURPRISINGLY be formulated in the presence of ANY surfactant and at least one compound selected from the group consisting of polyethylene glycol, propylene glycol, glycerol, and sorbitol.”

    Later they said this: “The surfactants in a stable flocculated suspension need to be selected carefully and be used within a critical concentration range because even minor changes can have an effect on the properties of such a stable formulation. This is particularly true for megestrol acetate because predictability based on prior art teachings does not apply in this case, as noted hereinabove. What is SURPRISING about the present invention is that ANY surfactant can effectively wet megestrol acetate.”

    Given all of the above, they certainly should have included a wider variety of examples in the specification – of course that may have been difficult given the apparent fact that one of the inventors couldn’t even get the invention to work with several surfactants. In other words, if you claimed to have invented a magic elixir that works with everything, you better be able to prove it.

  39. 3

    It’s true that there are a lot of issued patents with broad claims like this. The better ones include dependent claims that recite concentrations that track the disclosed Examples.

    The invalid ones lack such claims.

    In the “good old days” the unspoken (and legally bogus) justification for claims such as those at issue in this case was that the breadth was justified by the applicants “pioneering” contributions. Being the first to provide a single solution to the allegedly “generic problem”, the idea was that a patent covering ALL remotely similar solutions to the generic problem was warranted.

    However, the typical chemistry or biotech applicant inevitably relied on the “unpredictable” nature of the art, thereby blasting his/her feet off with a shotgun when it comes to asserting these absurdly broad claims.

    Note that this isn’t the case of merely one or two inoperative embodiments falling plainly within the reasonable scope of the claim but thousands or millions of them.

    Good riddance.

  40. 2

    “Does this make sense: Because the applicant broadly claimed “a surfactant,” the specification must enable various types of surfactants. If, the claim had been written even more broadly — by eliminating that limitation — there would have been no need to include a description of various types of surfactants. ”

    No, it doesn’t make sense.

    “es, Dennis, but then presumably the claim would have been inoperative”

    That also doesn’t make sense.

  41. 1

    Yes, Dennis, but then presumably the claim would have been inoperative, since my understanding is you need a surfactant, and that Par asserted that it had unexpectedly found that many (all?) surfactants seemed to work. The problem was they tried to distinguish over the prior art by claiming unpredictability, without understanding that this raised the level of disclosure needed to satisfy the enablement requirement. In view of the recent Fulbright and Jaworski malpractice case over the patent scope differences that arise with regard to “consisting/comprising” transitional phrases, and the reasonable expectation that a competent patent attorney would be aware of the inverse correlation between enablement and predictability, there may be some nervous patent lawyers out there somewhere.

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