Guest Post: Centocor, the Antibody Exception, and Claiming Only What was Invented

By Oskar Liivak
Assistant Professor, Cornell Law School

As Jason Rantanen’s post describes, Centocor claimed but failed to disclose any fully humanized antibodies.  Abbott consistently pushed this argument and they won.  It was the simplest and most direct way to dispose of the case.  This approach necessarily left other important issues undecided, however.  Both Eli Lilly and I separately filed amicus briefs in favor of Abbott and we both argued for a decidedly more aggressive, alternative argument for written description invalidity.  As the Court in Centocor disposed of this case by simpler means, clear judicial resolution of our arguments will have to wait for another day.

This post highlights those remaining issues, why we should still care about them, and how they are tied to a much larger ongoing struggle in patent law – can a patent claim cover more than what was actually invented (i.e. conceived and disclosed) by the inventor?  I think the answer is clear – it cannot – but not every patent attorney or CAFC judge agrees.  I think this is perhaps the most important ongoing debate in patent law.  § 112 as applied to antibodies is but one battlefront in this larger fight. 

ABANDONING THE ANTIBODY EXCEPTION
The arguments in both of our briefs would have resolved the case in favor of Abbott but would have also resolved a very problematic ambiguity relating to the written description for antibodies generally – the so-called ‘antibody exception.’  The PTO’s written description guidelines seem to suggest that disclosure of an antigen alone can provide § 112 support for any antibody that binds to that antigen.  See U.S.P.T.O., Written Description Training Materials Revision 1 March 25, 2008 at 45-46.  Cases like Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004), have cited these guidelines but the guidelines have yet to be really at the center of a case – even here in Centocor the CAFC distinguishes them.  The trouble is that those PTO guidelines are in tension if not complete conflict with written description as described in Ariad v. Eli Lilly, 598 F.3d 1336, 1354 (Fed. Cir. 2010) (en banc).  With the rapid growth of and enormous revenues associated with antibody related therapies, patent law must clarify this issue.

The crux of the argument is simple.  I believe that the disclosure requirements of § 112 limit claims to the subject matter actually invented by the inventor and disclosed by the specification.  Ariad at 1351.  If we consistently applied this rule for disclosure in light of today’s understanding of protein structure, disclosure of a well characterized antigen alone would not provide support for an antibody that binds to that antigen.  And disclosure of one actual antibody provides § 112 support only for that antibody—not the entire genus of antibodies that binds to the antigen.  This view is in direct conflict with the antibody exception.  Here is the argument.    

Ariad reaffirmed that § 112 “requires … that the specification must … show that the inventor actually invented the invention claimed.” Id.  As best I can surmise, to invent something a person must conceive it.  Conception is how patent law decides when something is invented; conception is how patent law decides who invents something; and it should be the way patent law determines what the something is that was invented.  From the perspective of conception (namely a “definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice”) the antibody exception and the broad claims it would allow start to look totally absurd. 

The problem is, as put by Eli Lilly in their amicus brief, “[e]ven with today's most advanced scientific tools, it is impossible to predict the actual structure … of a not-yet-known antibody based on the structure of an antigen or even the structure of another antibody that binds that same antigen.”  Though my own scientific background was not in immunology (it was in the more general field of three dimensional protein structure determination) I agree with Eli Lilly.  Even given the three dimensional structure of an antigen, no person today can conceive (without actually going into the lab and making one) an antibody that will bind to that antigen.  Furthermore, even once we make one antibody that does bind to an antigen, that alone does not allow for the conception of any other antibodies (much less every antibody) that will also bind to that antigen.

As the Federal Circuit determined, Centocor’s “application only provides amino acid sequence information … for a single mouse variable region.”  Slip Op. at 14.  That meager though still useful (see http://en.wikipedia.org/wiki/Infliximab) disclosure pales in comparison to the broad genus of variable regions that were claimed.  Asserted claims 2 and 3 covered any antibody with a human constant region and a human variable region that binds and neutralizes TNFα in a similar location as the deposited antibody.  There is nothing in the specification that evidences conception of any other variable regions beyond the one deposited variable region.  That disparity between the solutions disclosed versus the solutions claimed is why I viewed this case as being nearly identical to the over-reaching patentees in The Incandescent Lamp case, 159 U.S. 465 (1895).  Where a solution to a technical problem is found through trial and error (even sophisticated, elegant trial and error like for antibodies) without further discovering how to extrapolate to other solutions from the one found solution, then claims cannot exceed that one particular solution.  See id. at 472.  As a result I argued that the asserted claims are invalid under § 112 because they claim variable regions (whether humanized or not) that Centocor certainly did not invent or disclose.

From a policy perspective some might worry that this will provide incredibly narrow and worthless claims in a rapidly growing and important field.  I am not so sure.  It will certainly allow others to produce their own antibodies to the same antigen as the other antibodies will likely differ in actual variable region structure.  The narrow claims still prevent outright piracy and copying of your particular antibody but they also leave room for competition.  With tens of thousands of dollars a year for treatment for these drugs, a little fair competition doesn’t sound bad.  Lastly, the big question is the ability for generic biologic producers to piggy back on the testing data for the initial biologic.  I don’t see a problem from narrow claim scope in this regard either.  Though it depends on the details of the generic approval process for biologics, roughly speaking I wouldn’t want safety and efficacy data from one antibody to be used to confirm the safety and efficacy of structurally different antibodies even if they bind to the same antigen.

When § 112 and its usage of ‘the invention’ is rightfully tied to the subject matter actually invented (i.e. conceived and disclosed), then the shortcomings of the antibody exception become quite apparent.  In fact, when viewed in that light (which I think is the only way to interpret the statute) I cannot fathom a scenario by which the PTO could have possibly drafted the antibody related written description guidelines that have led to the antibody exception.

THE INVENTION AS THE EMBODIMENTS CONCEIVED AND DISCLOSED
But therein lies the problem: not everyone in patent law thinks about the statutory appearances of the invention in § 102, § 112, and more importantly § 271, as tied to the subject matter actually invented (i.e. conceived and disclosed).  For some the invention is just a short-hand reference for whatever subject matter the applicant claims because “the claims … define the invention….”  Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004).  The difference between these two views is critically important yet patent law has never confronted this confusion directly.  In fact, ask yourself, how do you conceptually and practically define the ‘invention’ in 35 U.S.C.?  I think some of our most pressing debates are fueled by talking past each other.  We are often thinking differently about the invention without actually being aware of the disagreement. 

The fight over the disclosure requirements evidenced in Ariad and Centocor is just one visible battle between these two world views.  Another important flashpoint is claim interpretation.  Just a month ago on Jan. 24 (as noted here on Patently-O) in IP Frontline, Hal Wegner described the ongoing problems with claim interpretation.  Discussing Arlington Indus. v. Bridgeport Fittings he pointed to the “festering sore” in Federal Circuit jurisprudence over the proper conceptual relationship between the claims and the specification.  He noted that “[u]ntil there is a final resolution of this debate there will never be clarity in claim construction at the Federal Circuit.”  That festering sore is another important instance of this broader fight over the proper conceptual relationship between claims, the invention, and the specification.  In a recent article, I further detail this controversy and its proper resolution.  For those interested in that broader discussion see Oskar Liivak, Rescuing the Invention from the Cult of the Claim (http://ssrn.com/abstract=1769270).

I thank Kevin E. Collins and Jason Rantanen for very helpful and insightful comments.

69 thoughts on “Guest Post: Centocor, the Antibody Exception, and Claiming Only What was Invented

  1. The crux of the argument is simple. I believe that the disclosure requirements of § 112 limit claims to the subject matter actually invented by the inventor and disclosed by the specification. Ariad at 1351. If we consistently applied this rule for disclosure in light of today’s understanding of protein structure, disclosure of a well characterized antigen alone would not provide support for an antibody that binds to that antigen. And disclosure of one actual antibody provides § 112 support only for that antibody—not the entire genus of antibodies that binds to the antigen. This view is in direct conflict with the antibody exception. Here is the argument

  2. Great, now all we needs is some ijutioc reference to House and the Nazgul takeover will be complete.

    sigh – let me post the “Nazgul feeding signs”.

  3. The problem is that the identifiable class has to be defined functionally in predictable arts like software, and the numbers and variations of embodiments are literally infinite.

    Yes, that is a very real problem. Not only are the variations infinite, they’re arbitrary. Literally any sequence of bits could perform any function, depending on how you program the computer that parses the software.

    That means you can’t possibly conceive of the entire genus, if the genus is defined in functional terms. Unless you conceive of all possible bit sequences, but if your genus is that broad it’s anticipated.

    None of this addresses the real problem, which is that the software isn’t your invention in the first place. Your invention is a series of steps (the “function”), and not the program that causes the steps to happen. Software is a method claim recited as “whatever code makes the steps happen”.

  4. “What I mean is that the inventor should show an understanding that the entire claimed genus (however broadly or narrowly it is claimed) is a well-defined and identifiable class of embodiments and forms part of the invention.”

    The problem is that the identifiable class has to be defined functionally in predictable arts like software, and the numbers and variations of embodiments are literally infinite.

    “And I still don’t see what this has to do with equivalents. Surely the written description and enablement requirements can only apply to the literal scope of the claim.”

    Do I have to lay it out for you? Did you read Lizardtech?

    Originally, filed claim 21 described a generic method of creating a seamless DWT. The specification, however, only disclosed one method for creating a seamless DWT, which is to “maintain updated sums” of DWT coefficients.

    At the time the application was filed, maintining updated sums was the only known way to create the seamless DWT. They enabled and described every possible way known to man to create a seamless DWT. They got their first, and deserved a dominant patent against late comers doing the same thing with trivial changes.

    However, when they tried to enforce the claim against a future alternative way of creating a seamless DWT, not only did they not get their well-deserved dominant patent, the Court actually invalidated their claim for failing to enable and describe the apparent future equivalent.

    Was the alternative way of creating a seamless DWT a “substantially different way” of achieving a seamless DWT, such that the reverse Doctrine of Equivalents would apply? We’ll never know, because the Court never addressed this point. Rather, the Court apparently required that the patent specifiaction enable and describe a future equivalent, where there is no evidence or discussion that the future equivalent was even forseeable.

    Ridiculous and unfair result? I say so.

  5. (AKA my claim is super broad and covers all uses of my invention!)

    Wishing you could claim whatever works is not what I mean by “contemplating”. What I mean is that the inventor should show an understanding that the entire claimed genus (however broadly or narrowly it is claimed) is a well-defined and identifiable class of embodiments and forms part of the invention.

    And I still don’t see what this has to do with equivalents. Surely the written description and enablement requirements can only apply to the literal scope of the claim.

  6. The latter questions were moot in view of your first answer.

    In response to your first answer, do you not see a problem with, in addition to requiring that the disclsoure enable the full scope of the claim and describe the preferred embodiment, also having to demonstrate that the inventor had within his possession every embodiment falling within the full scope of the claim. Here, I see a big difference between requiring evidence that the inventor contemplated the full scope of the claims (AKA my claim is super broad and covers all uses of my invention!), and that the inventor had every embodiment within his or her possession. The latter requirement, on its face, would requires that the claim enable and describe future equivalents. Lizardtech is an exemplary case that I have in mind.

  7. Ugh!

    The problem in a nutshell.

    Strictly viewing the US Supreme Court cases, they would prefer claims be limited to what is described and enabled. If an infringer is not infringing literally, they would prefer the use of the DOE to determine infringement.

    As I said before, practicioners always seek to extend the scope of their claims to cover all possible equivalents. This can be done in a number of ways, but typically by use of fuctional language or terms.

    Again and again and again, the Supreme Court has either declared such claims invalid or has limited them to the disclosed embodiments and equivalents.

    We have to be clear here that when a claim element is descibing the prior art, the details of which are irrelevant to the invention, that prior art element can generally be described generically without vice. The problem of generic claim language generally occurs only when the language occurs at the exact point of novelty.

    Regarding Section 112, p.6, the Federal Circuit precedent is being developed whole cloth, totally ingoring history. That history is as I have described it above. When the functional element is describing a prior art element, it is given wide scope. Equivalents should similarly be given a broad scope. But when the element is at the point of novelty, it must be limited to cover only the disclosed embodiments and equivalents. But what equivalents?

    Equivalents of the novel “structure” should be the conventional DOE that looks to see whether the infringer made insubtantial substitutions. It should not be limited to exisiting technology alone. That does violence to the historical roots of the doctrine: Westinghouse v. Boyden Power Brake.

    (As a parenthetical, let me just reiterate that the Feds made a fundamental error in Donaldson. That case permitted claim language at the point of novelty to literally read on the prior art. What a joke.)

  8. G.Kevin.T. The claims define possession and description of the scope of the claimed invention by providing the characteristics that would be used to select suitable antibodies.

    That’s a wish list and/or a future plan, not possession.

    The result of the interpretation given would mean that all potential variable region sequences would have to be provided in the specification, which would be at the least in the thousands, if not in the millions, and would require discovery of thousands of suitable antibodies instead or one or a few that are to be commercialized. The result is that such patents are entitled to only one or a few antibody sequences that were to be potentially commercialized. Thus any competitor could easily design around such patents and would be free to copy the invention without fear of infringement, indeed why patent such an invention at all.

    In the non-antibody biomolecule technologies, we’ve been dealing with this paradigm for years. They sky has not fallen and patentees continue to obtain claims that are not so easily designed around. In addition, there are additional practical and legal hurdles to marketing “design-around” drugs or therapeutics based on a patented composition.

  9. Is that correct?

    No, that’s not correct. I don’t think every possible embodiment needs to be described, but I do think the spec should give some indication that the inventor actually contemplated the full scope of the claim, and that indication should be commensurate with the level of skill and predictability in the art.

    Is a claim valid if it covers only equivalanets under DOE of those embodiments disclosed, and there is no PHE? If so, and if there is PHE, does does the claim become invalid if it is still literally broad enough to cover some embodiments not disclosed but that would have been equivalents under DOE?

    I don’t understand those questions. How can a claim literally cover equivalents? And why would you ever expect to find written description support for anything outside the literal scope of the claim?

    Do you think claims should never extend to cover future equivalents, even under 35 USC section 112 paragraph 6?

    I think the opposite of that. DOE should cover future equivalents, because they couldn’t possibly have been literally claimed and they might provide a trivial design-around. That’s a much more meaningful doctrine than DOE for contemporary equivalents, which the patentee should have had the presence of mind to literally claim in the first place.

  10. So it appears that you don’t think the requirement for actual written description of every possible embodiment encompassed by the scope of the claim should be different in the predictable arts versus the unpredictable arts. Is that correct?

    Is a claim valid if it covers only equivalanets under DOE of those embodiments disclosed, and there is no PHE? If so, and if there is PHE, does does the claim become invalid if it is still literally broad enough to cover some embodiments not disclosed but that would have been equivalents under DOE?

    Do you think claims should never extend to cover future equivalents, even under 35 USC section 112 paragraph 6?

  11. Yet more games and unwarrented assumptions…

    How typical when you lack an actual answer and have no more goal posts to move.

    Are you quite finished yet playing games Malcolm?

  12. Is the “identity of “Anon”, with a professed view and capitalization different in any substantial way even from your currently moved goalpost of “non-anonymous commenter”?

    Why not just call yourself Cavedweeb or SmallPeeingGuy like the previous semi-pro sockpuppeteers did?

  13. who called a non-anonymous commenter a “child”

    So your contention is that “Malcolm Mooney” is a “non-anonymous commenter”?

    Is this a weasel effort to distinguish from a pseudonym (nice goal post moving there – yet so childish)?

    Is the “identity of “Anon”, with a professed view and capitalization different in any substantial way even from your currently moved goalpost of “non-anonymous commenter”? – I think not. So even in your effort to cloud the issue (yet another childish game) – you FAIL.

    So feel free to try again, or better yet, just stay on topic and lose the games.

  14. Roger, I fully agree that whether there is written description support for the claimed invention is an issue that should be resolvable on based on the specification as filed. But you did raise a good point in that the specification is addressed to one of ordinary skill in the art, and it is important to consider what it is such a person would understand the specification to mean.

    But was expert testimony addressing this issue critical in this case? Obviously not.

  15. “For some the invention is just a short-hand reference for whatever subject matter the applicant claims because “the claims … define the invention….” Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004). ”

    I.e. some tards that have a hard time reading. The fence around a yard does not a yard make.

  16. an ego too big for oneself

    This from a too-important-to-be-named anonymous wanker who called a regular commenter a “child” after said regular commenter made a perfectly valid point.

    LOL. Have a lollipop, dude.

  17. an ego too big for oneself

    This from a too-important-to-be-named anonymous wanker who called a non-anonymous commenter a “child” after said non-anonymous commenter made a perfectly point.

    LOL. Have a lollipop, dude.

  18. My point is that juries are repeatedly finding written descriptions sufficient, and the Federal Circuit is repeatedly reversing denial of JMOL. That is a symptom of a bad jury instruction. Or perhaps there should be more summary judgments of no written description. One way or another, trial judges and juries seem to think that inventors are in possession of more things than the Federal Circuit seems to think. It appears to me that the Federal Circuit provides the general “possession test” but then sub silentio rules on the basis of some sort of heightened standard that varies depending upon the technological context.

    In the next case like this one, will defendant ask the jury to be instructed that a fully human antibody cannot be described absent examples of such antibodies in the specification? And if that’s the rule, what’s the point of sending it to a jury? The judge can read the patent for himself.

  19. Because a well-characterized antigen is sufficient to put the skilled person in possession of a generically recited “antibody” to that antigen

    But written description requires a showing that the patentee was in possession of the new composition at the time of filing…no? Do they discuss a requirement that the antibody was deposited in a public biologicals depository as of the filing date ..?

  20. PP, yeah, it’s tough goin’ without.

    Like when Chevy stopped making the Corvair. Like when Muhammad Ali hung up his gloves. Like the day the music died.

    He’s sure got his knickers in a wad.

    What you could do is set up Patent Prospector shadow site just for comments. It would cost you $5.95 for the URL and $60/yr for the web host.

    Moonbeams will front you the $$ for the first year.

  21. Here, TNF-a was known in the prior art, so they could not just claim the antigen to protect the antibody. Also, a key contribution was providing an antibody with features that make it suitable for therapeutic use.

    I thought the Fed Cir decision did a decent job of explaining why the “antibody exception” to the Written Description requirement is valid when the patent describes a new antigen. (Because a well-characterized antigen is sufficient to put the skilled person in possession of a generically recited “antibody” to that antigen.) On the other hand, once you are characterizing the antibody more specifically, you need to provide more written description.

    I wrote briefly about that here:

    link to pharmapatentsblog.com

  22. Yes, that is what I meant.

    Applicant discloses embodiment with elements A,B,C,D,E

    As far as Applicant knows the embodiment is novel.

    He is aware of one piece of art — A,B

    What is the scope of what he conceived and entitled to patent protection for?

    Depends on what other prior art is out there.

  23. Hint: it has to do with (1) consistency and (2) imaginary friends …

    As much, pray tell, as it has to do with unwarrented assumptions and an ego too big for oneself?

    Grow up Malcolm.

  24. Off topic- but I miss the ability to post at the Paent Hawk.

    He has a couple of dosers lately that just scream for comment, and the effect of muting that scream serves no one.

    Hawk, You have at least one fan wanting you to switch back.

  25. As if “Malcolm Mooney” somehow is any different – or any less – of a Cowardly pseudonym.

    It’s certainly different, Sockie, and certainly less “cowardly.” Ask your mom to explain why. If she can’t, then I will. Just let me know.

    Hint: it has to do with (1) consistency and (2) imaginary friends …

  26. Malcolm,

    It was you, not I that started down this road.

    Please return to your gxrbxge patent fluffing and keep your paranoid fantasies to yourself.

    is apt advice for you to follow.

    As if “Malcolm Mooney” somehow is any different – or any less – of a Cowardly pseudonym. Don’t be such a hypocrate. It is so childish.

  27. IBP The shortcoming is not the analytical paradigm and the definitions essential for its functioning—the shortcoming is the PTO’s sloped-foreheaded misunderstanding of technologies in art units upon which it purports to pontificate.

    I don’t think the antibody exception is a “misunderstanding” but rather a rule that has become out of date. I think at one point many years ago it was believed that the exception was warranted because while obtaining an antibody (any antibody, not necessarily a humanized monoclonal antibody) against a new antigen was not difficult (and rather obvious), it was difficult (but not impossible) to structurally identify (i.e., obtain the amino acid sequence of) the antibody.

  28. BB Another thing I don’t get: why claim Abs or methods of making the Abs? Why not claim the Ag, and disclose in the spec that Abs to that Ag can be made according to known methods X through Z. Your application then becomes PA against others who would try to patent the method of making the Abs to your Ag.

    You owe me a coke, Babel Boy.

  29. “Anon” the Cowardly Sockpuppet: I also know that you would be only too willing to troll with IANAE, for various reasons – including taking the spotlight off of the art field under scrutiny.

    Huh? Keep the spotlight on the “art field.” As I noted immiedately above, I agree with the holding.

    You’ll also note that the “antibody exception” is referred to as an “exception” in this art field for a reason. And note that there are very few chicken littles whining and complaining about this case, and those few that do are being rebutted by others in the “art field” including myself.

    Sheesh, even Noonan appears to be swallowing this pill without bitterness.

    Please return to your gxrbxge patent fluffing and keep your paranoid fantasies to yourself.

  30. Being a mammal, I make and use Abs all the time. Should I be worried about Section 271? I mean, if I am sitting here at my desk pumping out polyclonal Abs to some bacteria Ag I inadvertently acquired, and one of those Abs is one that Merck has patented, am I infringing? Does an infringer have to also “conceive” the invention in order to infringe?

    Another thing I don’t get: why claim Abs or methods of making the Abs? Why not claim the Ag, and disclose in the spec that Abs to that Ag can be made according to known methods X through Z. Your application then becomes PA against others who would try to patent the method of making the Abs to your Ag.

    Your claims to the Ag would be asserted against anyone who makes, uses or sells the Ag — including those using the Ag to make Abs. How does one make an Ab against an Ag without USING the Ag?

    If your Ag is an epitope of a large protein, and the competitor makes Abs to the large protein and selects out the Ab’s to your Ag, he is still “using” your Ag to make the Abs, is he not?

    Not being facetious. Just don’t understand the strategies.

  31. Compared to Beauregard claims, improperly issued antibody claims are really a drop in the proverbial bucket.

    Cite please.

    I know what we are talking about Malcolm. I also know that you would be only too willing to troll with IANAE, for various reasons – including taking the spotlight off of the art field under scrutiny.

    I also know that your “windmill quest” against Beauregard claims is not the topic here. Stay on topic if you can.

    Changing topic is exactly one of those “children running amuck” games. Just as accusing those who point out the children as being children. You think that your posts of accusations are somehow not stale and trite? Please stick to the topic and stay away from the trolling and thread hijacks.

  32. Well Oskar,

    Your analysis of a suggested conflict as to how to characterize “the invention”–what is “actually conceived and disclosed” vs what is described in the claims–presents a distinction without a difference, when you are talking about granted claims.

    When an application is filed, the claims describe NOT the invention, but what “the applicant REGARDS as his invention”, “particularly pointed out and distinctly claimed”. (112p2)

    However, after grant–that is, after examination for, among other things, disclosure, which is the evidence of conception–the claims DO in fact define the subject-matter of the patent grant, by definition.

    A claim defines the scope of subject-matter upon which a patentee can exercise exclusionary rights after they are granted thereto by the PTO.

    Post-grant, the scope of the claims is arbitrarily and pragmatically made synonymous with “the invention”. This enables a rational analytical paradigm to be applied to the patent document.

    The post-grant claims should already incorporate an assessment of the sufficiency of the disclosure, and evidence of conception and scope; if they do not, that is the fault of ineffective examination by the PTO, and not a deficiency in the pragmatic paradigm that defines “the invention” as the scope of the subject-matter described in the granted claims.

    This discussion recalls an exchange I had with Paul Cole a while back regarding use and meaning of the term “the invention”.

    Look at 102, for instance, and try this exercise: anywhere the term “the invention” appears, replace it with “the scope of the subject-matter particularly pointed out in the claims”. Now does it make sense?

    You seem to place special importance on 271, so let’s look at it. In 271, there are 8 appearances of the word “invention”. Of these 8, 6 appear directly as “patented invention”; the 8th use refers directly to, and has as its antecedent basis, the 7th use, which appears in the same sentence directly as “patented invention”, thus “patented” is implicit in the 8th use; and in the 3rd use, “invention” is a condensation of “patented machine, manufacture, combination, or composition” and “patented process”, also appearing earlier in the same sentence, and thus also implicitly incorporates the modifier “patented” by reference.

    So, all 8 discussions of “the invention” in 271 refer to “the patented invention”.

    Now, as with 102, substitute for “the patented invention” the phrase “the scope of the subject-matter particularly pointed out in the claims”, and you will have a more coherent understanding of the logic both underlying and following the pragmatic decision to DEFINE “the invention” thereas.

    I’ve got to tell you that in discourse with other patent professionals, NEVER is the term “the invention” used when referring to anything to do with patents–it is only when discussing things with clients that the term is ever used.

    In the broader context, your so-called “large ongoing struggle in patent law” amounts to nothing more than a bunch of hand-wringing.

    In the narrower context, Mooney is right—abolish the exception.

    You have mis-identified the “source of the problem”, which is in fact, once again, the PTO.

    What you should be focussed on is the text appearing on page 46 of the guidelines, and the “logic” contained therein.

    You said it yourself:

    “When § 112 and its usage of ‘the invention’ is rightfully tied to the subject matter actually invented (i.e. conceived and disclosed), then the shortcomings of the antibody exception become quite apparent. In fact, when viewed in that light (which I think is the only way to interpret the statute) I cannot fathom a scenario by which the PTO could have possibly drafted the antibody related written description guidelines that have led to the antibody exception.”

    The shortcoming is not the analytical paradigm and the definitions essential for its functioning—the shortcoming is the PTO’s sloped-foreheaded misunderstanding of technologies in art units upon which it purports to pontificate.

    You don’t actually practice, do you? Whatever position is taken by a particular attorney at a particular time is whatever will advance the interests of his client in the particular matter under discussion. The fact that we are “talking past each other” is not only natural, but is obvious—because we are NOT talking “to” each other, we are in fact talking “to” judges, juries, and arbitrators.

    “The PTO” is the problem—more specifically, it is constraints on the management of the PTO that is the problem.

  33. some of the caselaw seems to require that the specification describe the full scope of the claims, such that any claim of scope fully enabled by the spec, but reading on an embodient that is not an exact copy of an embodiment described in the spec, is invalid under 112’s written description requirement.

    If the inventor can’t even say how the inventive concept might be so generalized beyond the embodiments he describes in detail, I would not credit him with written description support for anything beyond those embodiments. In any art.

    I don’t see this as a general requirement that the claims be limited to an “exact copy” of what’s in the spec. The problem I see is that inventors want to claim more generally than they can or will describe. Which is odd, considering how many specs are full of mindless generalizations and weasel words to desperately avoid limiting the spec to a single embodiment when the inventor clearly thought of only that one.

  34. The children run amuck here.

    And you are among them, apparently. We are talking about the written description requirement and its proper application to determining the validity of composition claims. The inconsistent application of the written description requirement by the PTO and the courts is a problem. Compared to Beauregard claims, improperly issued antibody claims are really a drop in the proverbial bucket.

  35. even if it is only described at some high level of generality” – “Unless the “structure” is software, of course.

    Still looking for your trolling expedition, IANAE? Your taunts are more childish than Ping’s.

    The children run amuck here.

  36. An inventor should not need to know or disclose the molecular structure on an invention to claim it if knowing the molecular structure is not needed to make the invention.

    One cannot legally conceive of a composition without being able to describe it in a non-functional (structural) manner in such a way that the composition is distinguishable from the prior art.

    The solution for the “inventor” with a new antigen is to claim the antigen and describe/claim all the art-recognized methods for making antibodies against the antigen.

  37. That’s why claiming “whatever structure does what my invention does” is problematic. Unless the “structure” is software, of course.

    Heh.

  38. I don’t see the tension (because I don’t know what “caselaw” you have in your mind) but I do see a problem.

    If claims are for anything at all, they are to protect against those who, without licence, would realise the protected inventive concept with an embodiment that is different from any of those described in the patent application as filed. It cannot be the will of the CAFC to deny that function of a duly issued claim, can it?

  39. I perceive a debate as to what the disclosure requirements of 112 actually require.

    I read the PTO’s proposed guidelines, and it seems like they are proposing to interpret the case law such that 112 requires that the disclosure enable the full scope of the claims, but that only the preferred embodiment and method of use need be described.

    However, some of the caselaw seems to require that the specification describe the full scope of the claims, such that any claim of scope fully enabled by the spec, but reading on an embodient that is not an exact copy of an embodiment described in the spec, is invalid under 112’s written description requirement. Does anyone else see this tension, or the problem with applying 112 in this fashion?

  40. Of course the inventor knows the exact scope of what he conceived.

    What he doesn’t know, and what is limited by the PA, is the scope of protection that may be afforded him pursuant to patent law and regulation, if any.

  41. How do you bind a jury to this statement:

    Even if you do manage to bind a jury to that statement, you still don’t have any idea how to assemble any other jury (much less all of them) that could be bound to that statement.

    That’s the question, really. If the entire genus is claimed, the entire genus must be described, even if it is only described at some high level of generality that will communicate that genus to a person skilled in the art.

    If you can’t describe the genus other than by saying “whatever works”, you might not have actually invented the whole genus. That’s why claiming “whatever structure does what my invention does” is problematic. Unless the “structure” is software, of course.

  42. Robert, I am not a chemist so excuse, but may I ask whether the invention has anything to do with generic R groups?

    The reason I ask is this: In describing novel apparatus, it was deem no vice to generically describe well known structures that were no the invention. For example, if the invention had nothing to do with a particular element, that old element could be described as a “means for doing x.” The Supreme Court in Halliburton had no problem with such means claims. They did have a problem though with functional claiming at the point of novelty.

    Thus the question: are the R groups the invention?

  43. Roger, you somewhat equate enablement with description. “What did he desribe,” is the question. The answer, of course, depends on the audience — to a degree.

    Again, I think the problem in this case is claiming all antibodies that bind to a described antigen when the invention descibed is a particular antibody. The entire genus of antibodies is not described or enabled.

    This same claiming problem repeatedly presents itself in all arts; and the uniform answer from the Supreme Court is that there is a fundamental vice in such claiming. You claim beyond what you describe and beyond what you enable. By doing so, you claim subject matter that you did not invent.

  44. The Written Description requirement is an important safeguard against overclaiming, but a proposal to limit antibody claims to antibodies actually made is too restrictive. An inventor should not need to know or disclose the molecular structure on an invention to claim it if knowing the molecular structure is not needed to make the invention.

    No cook knows the structure of a pancake, but by mixing 2 cups of mix with 1.5 cups of water and heating on a griddle, an ordinarily skilled cook can make a pancake. Not knowing the pattern of gas bubbles in the pancake does not prevent the ordinarily skilled cook from understanding that Aunt Jemima had conceived of the pancake before you bought the mix.

    Biologists do not build antibodies in the same way as chemists, and it is inappropriate to hold them to a molecular standard.

    The court in Centocor was correct, however, Centocor did not provide an adequate disclosure for the ordinarily skilled artisan to make fully human antibodies. That said, access to human TNF-alpha would provide any competent biologist with a seemingly infinite number of mouse antibodies directed against the human protein because a mouse’s immune system uses a predictable, but random, process to make those antibodies.

  45. Following this line or reasoning then how do we interpret generic claims to chemical compounds having a disclosed utility.
    The average generic claim to chemical compositions are typically scoped by the prior art and not by what has been made (or even is capable of being made) or what has been tested for activity. Typically R groups are defined broadly and exemplars of each potential subgenus are not made, only a limited number of representative species are. Such claims always cover material that cannot be made as well as material that will not be active as claimed for other members of the genus.
    Is such a claim invalid following this reasoning?

  46. fish bones, there is something fundamentally flawed in your premise. I have studied enough philosophy to know your that if you accept the faulty premise, you can prove anything.

  47. Biotech Worries, assuming one could only claim the disclosed molecules or a common genus, can the docrtrine of equivalence give biotech inventions a fair scope?

  48. Let’s just nail the coffin of biotech innovation shut. If we can only claim the molecular structure we define, no one will license the patent. That way China can take over all innovative science and investment; and we will be relieved of the burdens of supporting science and creating wealth. Abs of many flavors are simple to make once you have a good Ag.

  49. it is difficult/impossible for him to know exact the scope of what he conceived.

    Is that what the softy-wofty’s think?

    Guess what – if ya depending on the prior art, then that aint your invention.

    No wonder this art unit has the most errors per application (not my observation – that be the Big D’s from awhile back – ya remember that Sunshine? Ya know the one wherein your “perfection” drives down the reported results even lower?

    He got plenty O windmills to tilt at in his own backyard.

  50. The guidelines you mention here seem at first blush to be one more example of claiming subject matter by what it does and not by what it is. They clearly were a mistake, and should be corrected.

    Well Ned (and Sunshine) clearly I am shocked to see such happenings in such a grown-up art field. Who woulda thunk it possible that grown-up art field practicioners would behave so poorly?

    Shockers, I tell yous.

  51. You are just now getting the sarcasm?

    Check all those sharp stick marks about your body. What did you think they were, love taps?

    Ya big softy wofty guy you.

  52. Question though. How do you bind a jury to this statement:

    “Even given the three dimensional structure of an antigen, no person today can conceive (without actually going into the lab and making one) an antibody that will bind to that antigen.”

    If WD is a question of fact, then an expert or who knows what sort of evidence could be introduced to contradict your assertion, at which point it’s up to the jury under current law. Are you suggesting that WD should be a question of law, or perhaps that for antibody cases, a special instruction should be given along the lines you suggest?

  53. I agree with the thoughtful remarks above.

    As a profession we are tempted down the path of unreasonably broad claims. If we do not put such claims forward our colleagues in the next office or in our competitor law firm will do so. The outcome is to ratchet claim breadth outwards, and the efforts of the USPTO and other examining patent offices to restrain unreasonable claim scope are not always availing.

    The boundary between reasonable prediction and irrationally exuberant speculation should always be kept in mind. Patent attorneys are legal advocates on behalf of their clients, but before that they were scientists and the ethics and disciplines of both science and law should be borne in mind. We would all do well to re-read the late Richard Feynman’s paper “Cargo-Cult Science” at intervals throughout our career and ask ourselves what our clients have truly created and can control

  54. Since the “invention” is defined by the prior art, and the applicant likely does not know all of the prior art when he files his application, it is difficult/impossible for him to know exact the scope of what he conceived.

  55. Oskar, what you describe here is not a new problem, but a very old one. It was the issue, to a degree, in Winans v. Denmead, the first doctrine of equivalents case. It was the issue in O’Rielly v. Morse. Ditto Westinghouse v. Boyden Power Brake; Perkins Glue; Halliburton and Muncie Gear.

    While the Supreme Court recognizes a doctrine of equivalents, it otherwise confines the inventor to what disclosed in his specification, resisting at every instance any attempt to claim subject matter not disclosed or described by claiming what it does and not what it is.

    And why?

    As explained in Morse and Halliburton, the inventor (normally) has not invented all ways of achieving the claimed result, and more certainly has not described all ways of achieving the result. To allow such a claim is to retard, not promote, the progress of the useful arts by making infringement of the future independent inventions of others.

    To go beyond the disclosed subject matter, one must rely on the doctrine of equivalents, which operates so that the infringer cannot capture the essence of the invention by insubstantial substitutions.

    In the 1898 Westinghouse case, the Supremes were presented with a claim to how a valve operated, not to what the valve was. They limited the claim to the corresponding structure described in the specification and equivalents. This rule saved functional claims until Halliburton, which simply invalidated functional claiming of apparatus. But the rule of Westinghouse was restored by Section 112, p. 6.

    Today practitioners are wont to claim an invention by what it does, and not what it is; and now, since Section 112, p. 6 has been strictly interpreted, they do so by using functional, generic terms or other such tricks to avoid that statute. Some courts and some on the Federal Circuit do no seem to understand the issues or the history I described above and are quite willing to allow broad claims with virtually no disclosure, claims literally covering subject matter well beyond any equivalents of what is disclosed. Lourie recognizes the problem.

    The guidelines you mention here seem at first blush to be one more example of claiming subject matter by what it does and not by what it is. They clearly were a mistake, and should be corrected.

    Back to claim constuction. It seems to me that we have come full circle on peripheral claiming. The practice of the bar is to set the claimed periphery well beyond the disclosure. The Supremes in Halliburton would have non of it because of the in terrorem effect this has on others even with the Westinghouse claim construction that effectively narrowed such claims. I have come to believe that this is the right answer.

    But, if there is any doubt, every claim, it seems, should be interpreted in the manner specified by Section 112, p. 6. You get what you claim, but what you claim is limited in scope to what you describe in your specification and equivalents, but no more.

  56. From Oskar’s abstract:

    Correctly viewed, invention is a substantive concept. The invention is simply the inventor’s own solution to some technical problem.

    Sounds rather … European.

    Me likey!

  57. Adding: abolishing the exception, of course, doesn’t mean that every new antibody meets the 101 utility requirement or is otherwise non-obvious …

  58. The crux of the argument is simple. I believe that the disclosure requirements of § 112 limit claims to the subject matter actually invented by the inventor and disclosed by the specification. Ariad at 1351. If we consistently applied this rule for disclosure in light of today’s understanding of protein structure, disclosure of a well characterized antigen alone would not provide support for an antibody that binds to that antigen. And disclosure of one actual antibody provides § 112 support only for that antibody—not the entire genus of antibodies that binds to the antigen. This view is in direct conflict with the antibody exception.

    Abolish the exception.

  59. “[C]an a patent claim cover more than
    what was actually invented
    (i.e. conceived and disclosed) by the inventor? I think the answer is clear – it cannot – but not every patent attorney or CAFC judge agrees. I think this is
    perhaps the most important ongoing debate in patent law.”

    Definitely the most important debate in patent law.

  60. Antibodies are typically made of basic structural units each with two large heavy chains and two small light chains. There are several different types of antibody heavy chains, which are grouped into different isotypes based on which heavy chain they possess. Thanks…

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