CAFC: Construction of Essential Features and Impermissible Recapture

MBO v. Becton Dickinson (Fed. Cir. 2007).

MBO’s patent is directed to a hypodermic syringe that helps avoid needle sticks. After claim construction, the district court awarded summary judgment of noninfringement to BD.

On appeal, the CAFC recited the rules for claim construction sources:

The most relevant source is the patent’s specification, which is "the single best guide to the meaning of a disputed term." Next in importance is the prosecution history, which is also part of the "intrinsic evidence" that directly reflects how the patentee has characterized the invention. Extrinsic evidence—testimony, dictionaries, learned treatises, or other material not part of the public record associated with the patent—may be helpful but is "less significant than the intrinsic record in determining the legally operative meaning of claim language."

Essential Feature: Several of the asserted claims include a preamble precluding needlestick injury “immediately and positively.”  Interpreting the term “immediately,” the CAFC determined that an “essential feature” of the invention is ensure a safe needle immediately “upon removal from the patient.” (rather than immediately after some other event). 

The patentee here has clearly indicated via the specification and the prosecution history that the invention provides, as an essential feature, immediate needle safety upon removal from the patient. It is therefore appropriate to construe the claims so as to ensure that they, too, require that feature.

Interestingly, two of the claims did not include the ‘immediate’ language. For those claims, the court could find no textual hook for inserting the essential feature and thus did not burden those claims with the immediacy requirement.  Between the lines, the court implied that it could have found a textual hook through other claim terms, but stated that it “lack[ed] the power to construe other terms not disputed by the parties.”

Impermissible Recapture: Claim scope which has been surrendered in order to obtain issuance of a patent cannot be later reclaimed through a reissue proceeding.  The district court found that MBO’s patent had improperly expanded the scope of a term and thus construed the terms meaning narrowly.

On appeal, the CAFC held that the recapture rule should not be used to rewrite claim language. Although claim construction should be applied with an eye toward validity, that maxim should only be applied at last resort. Rather, the court should first construe the claims and then later determine if the broadened claims are valid .

Whether those broadened claims are invalidated by the recapture rule is an issue separate from construction.

Affirmed-in-part, reversed-in-part, vacated, and remanded.

Comments

[anthony palazzolo]

Uhhh ... I know I'm not the sharpest tack in the box, but ...

how can "claim construction ... applied with an eye toward validity ..." if "the court should first construe the claims and then later determine if the broadened claims are valid?"

[John Whitaker]

Yes, I have the same question as Mr. Palazzolo. That last paragraph seems to be logically inconsistent. In fact, it seems to offer two diametrically opposed and mutually exclusive approaches to claim construction.
Guess I'll have to actually go read this case...

[Edward D. Manzo]

Under current law, validity does not properly come into play in claim construction absent ambiguity in the claim, whereupon the court may seek to preserve validity if one resolution of the ambiguity makes the claim valid and others do not. See, e.g., Pfizer v. Ranbaxy (2006) and SRAM v. AD-II (2006), Phillips (en banc), SmithKline Beecham v. Apotex (2005), and Seachange v. C-Cor (2005).

[Dennis Crouch]

From the opinion:

"We believe that the district court erred in the first instance by applying the recapture rule to rewrite the claims, essentially unmaking the change that the PTO had permitted. Claim construction should not, of course, be blind to validity issues: “claims should be so construed, if possible, as to sustain their validity.” Rhine v. Casio, Inc., 183 F.3d 1342, 1345 (Fed. Cir. 1999). A claim that is interpreted too broadly will run into validity issues, providing motivation for the construing court to choose a narrower interpretation if possible. However, validity construction should be used as a last resort, not a first principle: “we have limited the maxim [that claims are to be construed to preserve validity] to cases in which the court concludes, after applying all the available tools of claim construction, that the claim is still ambiguous.” Phillips, 415 F.3d at 1327 (quotation marks omitted). Construction of the claims here is not so difficult a problem as to require resort to the validity maxim."

[russ schultz]

does this entire "essential feature" idea bother anybody but me?-- also not being the sharpest tack in the box --but it still looks like we are steadily heading to claim construction based on subjective interpretation of the "main idea" of the invention and not the "claimed invention" -- difficult to explain to clients...

[MaxDrei]

Claim construction is always going to be "Difficult to explain to clients" who are not US patent attorneys. But, as patents are addressed to engineers, not lawyers, we (I mean the judges as well) should make the effort. I suggest "Construe the claim in the context of the disclosure" and then ask "What was the Inventor using the language of the claim to mean". That way, we avoid burnt dough embarrassment and we are not subjective. Best of all, we re-connect with our technical reader customer base.

And maybe that is where the CAFC is headed.

[Luke Ueda-Sarson]

"But, as patents are addressed to engineers, not lawyers"...

Are they though?

I thought they were addressed, at least in the US, to the PHOSITA. So who is that?

In some fields, patents are clearly part of the (real, not the legal construct) skilled person's common general knowledge, and such patents are thus indeed likely to be addressed to "engineers", since engineers will be reading them.

But in other fields/arts, patents are definitely not part of the working knowledge of those working "out there in the field". When I first moved into the patent area from being a research chemist a friend and former colleague of mine in New Zealand contacted me in Japan asking for help because one of his colleagues wanted the experimental section of a Japanese patent translated: to which he affixed the illuminating comment "I have absolutely no idea why he would want to do that", or words to that effect. As a research chemist (natural products), looking to a patent for information was simply a foreign notion to him. To him, patents were simply legal documents of no use to his research activities.

Now, I don't know enough about US practice defining a PHOSITA to say whether the CAFC considers the notional reader of a patent to be something along the lines of "an engineer but not a lawyer".

If it does, it is contrary to the position for instance in the UK, where the patent addressee is assumed to understand patent law, or, at least, basic patent law (as per Lord Hoffman's statement in Kirin-Amgen at 78). So while they are clearly something like an engineer - they are *also* something like a lawyer.

I wonder if this has something to do with who the *patentee* is? Note how Lord Hiffman in Kirin-Amgen at 34 says "As a number of judges have pointed out, the specification is a unilateral document in words of the patentee's own choosing. Furthermore, the words will usually have been chosen upon skilled advice". As is clear from the subsequent passage, the "patentee", bearing in mind this is UK practice, is the company, and in particular the company's patent agent: the inventor is just the person giving the "skilled advice" (contrast this with the US where the patentee *is* the inventor. So a UK patent is written by a patent agent with advice from the inventor as to the meaning of certain words, whereas in the States it is, at least notionally, written by the inventors themselves. Does this have a bearing on who the PHOSITA is assumed to be?

Regards, Luke

PS.

One may note that Chemical Abstracts defines any structure mentioned in a patent as merely "hypothetical" unless it has actually been produced in a working example; and this is entirely rational - I myself find nothing more frustrating than hearing my benrishi colleagues call a compound "known" simply because it's (paper) structure has been drawn or described somewhere. That is ridiculous - a chemical is only "known" when it has been shown to exist.

One day, some enterprising chemist with a mischevious mind (possibly someone in India who does't like biopiracy) is going to take their ChemDraw programme or equivalent, use a high-performance machine (or better, yet, a cluster of such machines) to get it to generate random chemical structures, and post the resulting random strctures on the web somewhere. Now, it won't take much server space to store say, 100 million (or even 100 billion) chemical structures, nor computer time to generate them, and they will thus be "published" rendering them as novelty-destroying prior art (there are of course automated naming prgrammes for structures, meaning they will be automatically indexed too, and thus accessible). I am actually rather surprised nobody has done this already - there must be plenty of "anti-patent" groups out there who can see no good in the system. Particularly in India, where in the last 3 decades of the 20th century, you couldn't even get a patent on a chemical substance itself, just the method for making.

[David Jaglowski]

Luke,

Computer generating the structure of every possible chemical isn't going to get you anywhere, at least in the United States.

http://www.uspto.gov/web/offices/pac/mpep/documents/2100_2121_02.htm#sect2121.02

1. Where a process for making the compound is not developed until after the date of invention, the mere naming of a compound in a reference, without more, cannot constitute a description of the compound. In re Hoeksema, 399 F.2d 269, 158 USPQ 596 (CCPA 1968).

2. When a prior art reference merely discloses the structure of the claimed compound, evidence showing that attempts to prepare that compound were unsuccessful before the date of invention will be adequate to show inoperability. In re Wiggins, 488 F.2d 538, 179 USPQ 421 (CCPA 1971).

Anticipatory art must be operable. Thus, the caselaw suggests that unless there is a known synthesis process for the genus or for a homolog, the applicant will be able to defeat that sort of claim rejection. See In re Donohue, 766 F.2d 531, 226 USPQ 619 (Fed. Cir. 1985).

[MaxDrei]

Oh bliss. Thank you Luke and David for your contributions following mine. Here my thoughts. By "engineer" I meant PHOSITA. I'm not a chemist. Apologies to PHOS In The chemical Arts. Not sure basic knowledge of patent law disqualifies a person from being a PHOSITA. These days, my PHOSITA inventors also know the basics of patent law, but they still think like technical professionals, not like professional lawyers. In UK, we have always had peripheral claiming. If the claim ain't wide enough, it's the patent attorney's fault. Hence the Hoffmann musings on "professional help". Contrast that with Germany's former "central claiming", where the patent attorney is absolved of responsibility for drafting errors. Maybe USA has a Doctrine of Equivalents because the lawyer lobby is stronger than the "legal certainty" lobby from industry? Next: your Chem Abs point was new to me, and very tasty. We will see it emerging in the current TAXOL stent tussle in EPO, Netherlands and England, where the prior art recited the drug class"anti-mitotic" but not the members of the class, whereas the asserted Angiotech patent also postulated "anti-mitotic" as the drug the stent should elute, but did recite the class members, including TAXOL. That was enough to get them in NL 20 years of protection for a TAXOL stent, but the English High Court found the same claim to be bad because, at the filing date, the inventor had not yet distinguished Taxol, on technical effects, from the rest of the class, so he had not advanced the art beyond the prior disclosure. And, David, thanks for the case references from USA. Our European "First to File" system is criticised by USA with the argument that it encourages speculative filings, before the invention has been reduced to practice. Legitimate concern, but now seen off by Angiotech in the English CAFC. Combined with European liberal ideas about how little disclosure is enabling, I would say that First to File can meet all the criticisms that the small inventor lobby in USA can throw against it.

[Luke Ueda-Sarson]

David, it would be nice if what you say was put into practice, but it in my experience it isn't.

"1. Where a process for making the compound is not developed until after the date of invention, the mere naming of a compound in a reference, without more, cannot constitute a description of the compound. In re Hoeksema, 399 F.2d 269, 158 USPQ 596 (CCPA 1968)"

The problem with this is that chemistry has moved on since then. It is now accepted that pretty well much any compound can be synthesized, given enough effort. This the naming of a compund is to describe it - the issue is one now of enablement only - can you turn it into something in the hand, and make it "known" in the chemist's sense of the word.

Certainly an examiner will never stop to consider whether a reference is enabling - you will have to prove to them it is non-enabling. Which if nobody has ever attempted to synthesize said compound, is going to be a mite difficult.

Furthermore, the CAFC has ruled that naming the structure of a compound is a description thereof (if not necessarily enabling though) - In re Crish, No. 04-1075 (Fed Cir. December 21, 2004) - by affirming that the structure of a compound is its identity. I fail to see how something can be identified but not described.

"2. When a prior art reference merely discloses the structure of the claimed compound, evidence showing that attempts to prepare that compound were unsuccessful before the date of invention will be adequate to show inoperability. In re Wiggins, 488 F.2d 538, 179 USPQ 421 (CCPA 1971)".

Again, this requires you to show evidence of non-enablement. No good for an unknown (in the chemist's sense) compound.

"Anticipatory art must be operable. Thus, the caselaw suggests that unless there is a known synthesis process for the genus or for a homolog, the applicant will be able to defeat that sort of claim rejection. See In re Donohue, 766 F.2d 531, 226 USPQ 619 (Fed. Cir. 1985)".

Note that it says caselaw "suggests" this. In my reading of the caselaw, there is no such suggestion; the presumption of enablement is exactly the opposite - unless it is known that there are problems with synthesizing the compound, or it is widely held by the PHOSITAs that such is likely to be difficult (and you'll need evidence for this), there will be a rather hefty presumption that a reference is enabling.

Now if somebody actually goes ahead and does what I suggest may happen one day, I suspect a court may try and turn things around, but as things stand now, if somebody does this, you are going to have a hard time getting such an "anticipated" application past an examiner.

Regards, Luke

[David Jaglowski]

Luke,

I don't intend to nitpick, but you're placing far to much emphasis on the exact wording of what was quoted from the MPEP and ignoring the historic policy concerning anticipation, obviousness, and enablement. You need to review the standards of practice for chemical cases, because there is a limit to how much time I will invest in defending myself from these types of arguments, and I've reached it with this post.

"The problem with this is that chemistry has moved on since then. It is now accepted that pretty well much any compound can be synthesized, given enough effort. This the naming of a compund is to describe it.... I fail to see how something can be identified but not described."

Qualitative descriptions of unknown structures such as proteins identify but do not describe. Purified, naturally occurring complex chemicals are routinely named but not structurally described. This does not apply to the computer generated structure database that you hypothesized, but it does apply to actual practice in the chemical arts.

Also, the section 112 standard works both ways. Remember the key phrases "ordinary skill in the art" and "undue experimentation." Enablement and operability can certainly be shown to be absent from your hypothetical database in non-trivial cases. See http://www.uspto.gov/web/offices/pac/mpep/documents/2100_2164_01_a.htm

Further, you're improperly shifting the burden to the applicants. In re Donahue was decided over evidence that others had synthesized the general class of compounds even through the prior art did not show synthesis of the particular compound. If the applicant is attempting to claim something so related, fine. However, you've speculated that someone creates a computer generated database of structures, many of which will have no disclosed method of synthesis, and in that case the rejection can be overcome simply by pointing to the absence of information concerning a synthesis process. Saying that something can be synthesized given enough effort doesn't come close to enabling someone of ordinary skill in the art to follow and modify an actual teaching of a related method without undue experimentation.

"Certainly an examiner will never stop to consider whether a reference is enabling - you will have to prove to them it is non-enabling."

The examiner certainly will if you make the argument and push the case into appeal. If the reference does not describe a method of synthesis, the applicant satisfies their burden simply by identifying that fact (in a non-trivial case). The Examiner bears the burden of presenting a complete case for rejection. The burden only shifts to the applicant when there is sufficient evidence to make a prima facie case for anticipation or obviousness. See http://www.uspto.gov/web/offices/pac/mpep/documents/2100_2121_01.htm