After Granting Certiorari In Enablement Case, Supreme Court Declines Opportunity To Address Written Description

by Chris Holman

As reported in posts by Dennis and Jason, the Supreme Court recently granted certiorari in Amgen v. Sanofi, marking the first time that the Court has taken up patent law’s enablement requirement since enactment of the Patent Act of 1952. The claims at issue are directed to a genus of functionally-defined molecules having therapeutic utility, i.e., monoclonal antibodies defined in terms of binding specificity. For the sake of brevity, I will refer to claims of this type as “chemical genus claims.”

A few days later, on November 7, the Supreme Court denied certiorari in Juno v. Kite, a case challenging the Federal Circuit’s interpretation of the written description requirement. The claims struck down for lack of adequate written description in Juno are strikingly similar to the claims that were invalidated under the enablement requirement in Amgen, being directed towards nucleic acids encoding chimeric T cell receptors (for use in Car T-cell therapy), comprising, inter alia, a functionally defined “binding element,” as exemplified by a single-chain antibody variable fragment (‘‘scFv’’).

The scope afforded to chemical genus claims under 35 USC § 112(a)’s enablement and written description requirements has been hot topic recently (at least in certain quarters). Professors Lemley, Seymore, and Karshtedt (it is so sad that he is no longer with us) published an article in 2020 entitled The Death of the Genus Claim, which asserts that “the law has changed dramatically in the last thirty years, to the point where it is nearly impossible to maintain a valid genus claim.” Amgen’s successful petition for certiorari relies heavily on Death, and its authors filed an amici curiae brief in support of Amgen’s petition.

While Death clearly raises some valid concerns regarding the challenges inventors face in trying to secure effective patent scope for inventions of this type, in my view it is an overstatement to say that chemical genus claims are “dead.” I responded to Death in a two-part article arguing, for example, that the case law identified in Death provides scant support for its assertion that the standard for compliance with the enablement and written description requirements has become significantly more stringent in recent years. Christopher M. Holman, Is the Chemical Genus Claim Really “Dead” at the Federal Circuit?: Part II, 41 Biotechnology Law Report 58 (2022); Christopher M. Holman, Is the Chemical Genus Claim Really “Dead” at the Federal Circuit?: Part I, 41 Biotechnology Law Report 4 (2022).

I also point out that relatively broad chemical genus claims continue to survive § 112(a) challenges in the district courts and at the Federal Circuit.  See, for example, Ajinomoto Co. v. Int’l Trade Comm’n, 932 F.3d 1342 (Fed. Cir. 2019); Bayer Healthcare LLC v. Baxalta Inc., 989 F.3d 964 (Fed. Cir. 2021); Plexxikon Inc. v. Novartis Pharmaceuticals Corp., Case No. 17-cv-04405-HSG, Document 565, July 22,2021 (N.D. Cal.).

Section 112(a)’s enablement and written description requirements, sometimes referred to as the “adequate disclosure requirements,” constitute U. S. patent law’s primary non-prior art-based limitations on claim scope. Although Supreme Court has in the past indicated that it views the patent eligibility doctrine as playing an important role in preventing patent claims from broadly “preempting” abstract ideas and natural phenomena, more recently the Court’s patent eligibility decisions have focused on the sufficiency of “inventive concept,” as opposed to claim breadth per se.  Absent such limitations, under a regime in which claim scope would only be limited by the prior art, an inventor could potentially secure patent claims encompassing huge swaths of yet-to-be invented technologies.

Hypothetically, for example, the inventor of the first practical method for communicating at a distance using electricity, e.g., the telegraph, might have ended up with a patent claim encompassing all means of communicating at a distance using electricity, e.g., the internet. The inventor of a rudimentary, barely functional electric light bulb could, assuming it was the first lightbulb, potentially have obtained a patent claim encompassing all lightbulbs, including far superior lightbulbs produced by subsequent inventors. While I have simplified the facts quite a bit, the gist of these examples have been the subject of actual Supreme Court decisions. O’Reilly v. Morse and Consol. Elec. Light Co. v. McKeesport Light Co..  Not surprisingly, in both cases the Supreme Court struck down the patent claims as overly broad, invoking what we would today refer to as the enablement requirement.

More pertinent to the facts of Amgen v. Sanofi, the inventor of the first antibody capable of recognizing a particular antigen could potentially obtain a patent encompassing all antibodies capable of recognizing that antigen. For example, an inventor who has succeeded in producing a mouse monoclonal antibody that binds to a particular human protein (useless as a human therapeutic) could in principle obtain a patent claim encompassing all monoclonal antibodies that bind to that particular human protein, even a fully humanized antibody that functions as a safe and effective biologic drug, e.g., AbbVie’s blockbuster Humira, or the accused product in Amgen, Praluent.  Again, the gist of this example comes from an actual Federal Circuit decision, Noelle v. Lederman, wherein the claims at issue were struck down under the written description requirement.

The Federal Circuit has invoked both the written description and enablement requirements as doctrinal tools for policing claim scope. Although as a formal matter the written description requirement focuses on whether the inventor has demonstrated “possession” of the full scope of the claim, while the enablement requirement asks whether the scope of the claim is “commensurate” with the scope of disclosure, as a practical matter the two requirements have been applied in a manner that is largely redundant, albeit with a few distinctions of arguable significance discussed later in this post. In my article responding to Death, for example, I point out that the Ariad factors that the Federal Circuit has identified as relevant to assessing compliance with the written description requirement are, in substance, virtually identical to the Wands factors used in the enablement inquiry. If anything, the written description requirement has been seen as the more stringent of the two, particularly in the context of biotechnology – the written description requirement has often been referred to as a  “super-enablement” requirement.

And in fact, prior to Amgen, the Federal Circuit has tended to invoke the written description requirement, rather than the enablement requirement, in striking down monoclonal antibody genus claims. See, for example, Noelle v. Lederman, 355 F.3d 1343, 1349 (Fed. Cir. 2004)(disclosure of mouse monoclonal antibody specific for mouse antigen (CD40CR) did not provide adequate written description for claim encompassing any monoclonal antibody capable of binding the human analog of the CD40CR antigen); Centocor Ortho Biotech v. Abbott Laboratories, 636 F.3d 1341(Fed. Cir. 2011)(disclosure of previously characterized antigen (human TNF-alpha) and mouse antibodies to the antigen did not provide adequate written description for claim encompassing fully human monoclonal antibodies capable of binding to a specific neutralizing epitope of the antigen); AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285 (Fed. Cir. 2014)(disclosure of about 300 antibodies falling within the scope of the claim did not provide adequate written description for a claim reciting neutralizing human antibodies capable of specifically binding human interleukin-12 (IL-12)).

Of course, given the redundancy of the doctrines, a claim struck down as overly broad for lack of enablement is highly likely to be invalid for lack of adequate written description, and vice versa. In Amgen, for example, the jury found Amgen’s claims not invalid under the enablement and written description requirements, but on a motion for JMOL the district court overruled the jury and found that, as a matter of law, the claims are invalid under both the enablement and written description requirements. In Amgen, the Federal Circuit decided the issue based on a failure to comply with the written description requirement, rendering the enablement issue moot, but in the past the Federal Circuit has been more inclined to find claims of this type invalid for failure to comply with the written description requirement.  See the examples provided above, as well as the Juno decision.

Thus, one of the big elephants in the room with respect to the grant of certiorari in Amgen is that the question for review appears to focus solely on the enablement requirement. Even if the Supreme Court lowers the bar for compliance with the enablement requirement, the ruling would presumably have no direct impact on the written description requirement, which has conventionally been thought of as imposing an even higher bar for the sort of claim at issue in the case, e.g., functionally defined chemical genus claims.

Sanofi raised this point in its Opposition brief, arguing that any ruling by the Supreme Court would not be dispositive of the case because, if the Supreme Court overturns the enablement verdict, the Federal Circuit would likely still find the claims invalid for lack of adequate written description. Sanofi points out that Amgen’s own amici, i.e., Professors Lemley, Seymore and Karstedt, concluded in Death that the Federal Circuit had “strongly suggested” that the claims were not only invalid under the enablement requirement, but also the written description requirement.

Indeed, the Federal Circuit has on occasion explicitly noted that a claim’s compliance with the written description and enablement requirements generally rise and fall together. For example, in Idenix v. Gilead, a recent case involving claims analogous to those at issue in Amgen, the jury also found the claims to be not invalid under the enablement and written description requirements. The district court overturned the jury verdict with respect to enablement, but denied a motion for JMOL with respect to written description. On appeal, the Federal Circuit affirmed the district court’s holding that the claims were invalid for lack of enablement, but reversed its denial of JMOL for failure to meet the written description requirement, finding the claims invalid under both doctrines.

Under the Federal Circuit’s current interpretation of the written description and enablement requirements, I think it would be highly unusual for the court to find claims of the type at issue in Amgen invalid for lack of enablement but not for lack of adequate written description. In fact, when the district court decision in Idenix v. Gilead initially came out, finding the claims invalid under the enablement requirement but not under the written description requirement, I thought it was so striking that I wrote an article about it.   Christopher M. Holman, Enablement Invoked as a ‘‘Super-Written Description Requirement’’ to Overturn $2.5 Billion Jury Verdict, 37 Biotechnology Law Report 63 (2018). So I was not at all surprised when the Federal Circuit reversed and explicitly found the claims invalid under both the enablement and written description requirements, even though the Federal Circuit could have chosen not to address the written description issue as moot in light of the enablement ruling, as it did in Amgen.

In retrospect, I wonder if it might have been better for the Supreme Court to take up the issue of adequate disclosure in a case like Idenix, where the Federal Circuit explicitly addressed both the enablement and written description requirements in the context of the same chemical genus claims. As Jason intimated in his blog post, while it is relatively easy to point out the shortcomings in the Federal Circuit’s current § 112(a) jurisprudence, it is much harder to come up with an effective alternative. I have to think that it will be particularly difficult for the Supreme Court to make a positive contribution to the law of adequate disclosure without also taking into account the written description requirement.

Although the written description requirement has long been used to police the claiming of new matter, it only took on the role of policing claim scope as what is in essence an alternate enablement requirement in 1997 when the Federal Circuit decided UC Regents v. Eli Lily, creating what I refer to as the “Lilly written description requirement” (so as to distinguish it from the “traditional written description requirement” used prevent the claiming of new matter). Early on, the Lilly written description requirement seemed to impose a much higher threshold than enablement, particular for biotechnology inventions, hence its characterization as a “super-enablement requirement.” But it seems to me that at this point in time the standards for compliance with the written description and enablement requirements have become for the most part indistinguishable, as illustrated by the redundancy of the Ariad and Wands factors, and the paucity (or, to my knowledge, the absence) of any judicial decisions (upheld on appeal) explicitly finding a claim invalid under the Lilly written description requirement but not invalid for lack of enablement, or vice versa.

Nonetheless, Federal Circuit precedent has carved out some clear differences between the written description requirement and enablement, although as a practical matter it is not clear to me how significant those differences are.  For example, the Federal Circuit treats the written description requirement as a question of fact, and the enablement requirement as a question of law based on underlying factual findings.  In its petition for certiorari, Amgen also asked the Court to rule that enablement, like written description, is a question of fact, but the Court declined to take up that question. In principle, a decision by a jury (or judge in a bench trial) should be afforded more deference with respect to a question of fact, which might explain why in Amgen and Idenix the district courts overturned the juries’ enablement decisions, but not their written description decisions. However, it seems to me that when case reaches the Federal Circuit the formal distinction between question of fact and “question of law based on underlying factual findings” has little practical effect.  See, for example, Centocor Ortho Biotech v. Abbott Laboratories, 636 F.3d 1341(Fed. Cir. 2011)(overturning jury decision finding claim encompassing fully human monoclonal antibodies not invalid for failure to comply with the written description requirement).

Another difference between the two doctrines has to do with the admissibility of evidence.  In the Federal Circuit’s first decision in Amgen v. Sanofi (the grant of certiorari is with respect to the Federal Circuit second decision in the case), the court held that the district court had committed legal error by improperly excluding post-priority date evidence of antibodies falling within the scope of the claim, including the accused product (Praluent). The district court based its decision to exclude the evidence on a 1977 decision of the Court of Customs and Patent Appeals, In re Hogan, which the Federal Circuit has interpreted as prohibiting, in the context of the enablement inquiry, admission of “post-priority-date evidence proffered to illuminate the post-priority-date state of the art.”  Without questioning the continuing vitality of Hogan, the Federal Circuit held that, in the context of the written description inquiry, post-priority-date evidence is admissible to show that a patent fails to disclose a representative number of species, explaining that Hogan is silent with respect to evidence of this type. Thus, it seems that under some circumstances post-priority-date evidence illustrating the structural and functional breadth of a chemical genus claim could be admissible for purposes of a written description challenge but not a challenge for lack of enablement.

56 thoughts on “After Granting Certiorari In Enablement Case, Supreme Court Declines Opportunity To Address Written Description

  1. 8

    Totally off-topic, but NW’s predictions that “Elon is going to fix Twitter and then expand Twitter into FB and Google’s spaces” is not looking so hot right now.

    1. 8.1

      Turns out twitter was not profitable without corporate gibs that it was being given on the sly by corpos to control the “narrative” of the country. That’s the bigger story, reported elsewhere.

      1. 8.1.1

        “Pay no attention to the 13 billion dollars in debt used to buy a company that was only ever profitable in two years (2018, 2019), this other factor is what’s hurting twitter!”

        1. 8.1.1.1

          What does debt used to buy a company have to do with whether it is profitable or not?

          1. 8.1.1.1.1

            Plenty 6 — but in a forward going sense (and not in the present context).

            He just does not agree with the narrative that you are presenting.

          2. 8.1.1.1.2

            Do you not understand that it is Twitter which owes this debt? Or that due to the interest on that debt, Twitter needs to make about a billion extra dollars a year in order to be profitable?

            1. 8.1.1.1.2.1

              The old debt was obtained at very low rates. Renewal at current rates is an ouchie. Bankruptcy will cure twitter’s ills. Any day now I expect the announcement….. 🙂

              1. 8.1.1.1.2.1.2

                Bankruptcy will cure twitter’s ills. Any day now I expect the announcement.

                Same here, which is why I think that NW’s predictions look pretty lame. Does bankruptcy really count as “success” for Musk’s tenure?

                I do not expect that a bankruptcy court will leave Musk in charge of a going-concern post-bankruptcy. The creditors will insist on a change of leadership and a return to the previous moderation practices.

                It is, however, exactly Musk’s repudiation of those previous moderation practices that NW thought would supercharge Twitter’s new success. The fact that the change in moderation practices, instead, will have driven Twitter into bankruptcy. In other words, if the bankruptcy that we both expect arrives, that will be the complete refutation of NW’s prediction.

                1. E.M. has limitations, we saw already the EU and current US administration mentioning things like security concerns, speech regulation, etc. He has less power over things as may seem. But he will be the head honcho internally post -bkpcy.
                  Short term , bkptcy can be a success but of course must be only a part of much larger timeline. Somehow twtr will eventually become part of the CBDC schema is what I’d guess. Followin these sorts of rate increases, we always see increased bkptcy’s anyhow, so in a way its an abnormal business practice becomes normal in abnormal times !

                2. “The creditors will insist on a change of leadership

                  Nah. It won’t be doable.

                  “and a return to the previous moderation practices.”

                  No moderation practices even changed as of yet. Derp.

                3. 6,

                  Both you and Greg are in error here (Greg more so).

                  There has been a definite change in moderation practices (as noted by the likes of US Senators and even Joe Rogan).

                  That being said, Greg is suffering from confirmation bias (for his Far Left views), and is actively looking ONLY for negative news.

                  He just does not understand that an initial drop is fully expected by market players in the know.

            2. 8.1.1.1.2.2

              ^^^ lol, and Ben somehow thinks my posts are not accurate.

            3. 8.1.1.1.2.3

              Twitter doesn’t owe debt that was used to purchase itself, Musk and the other people that went in with him, if any, owe that debt. Derp.

              If you’re talking about Twitter’s debt itself, then that is not debt that was used to buy Twitter. Derp.

              Unless you’re talking about some sub-company bought by twitter itself which nobody has mentioned anything about.

              Further, I doubt that the debt twitter owes has creates a 1 billy req in income to pay the interest just to be profitable. That would be an absurd amount.

              Frankly I don’t think you know what you’re talking about.

              1. 8.1.1.1.2.3.1

                Paper for paper, obligations discharge. Weaponry is oft in media involving iron, but, the most damaging weapons in history I ponder if its true…. are made of… paper. Except for my paper doll 🙂

              2. 8.1.1.1.2.3.2

                Well, I don’t think you know what you’re talking about.

                How about we let the Wall Street Journal break this deadlock?

                “Elon Musk’s deal to take Twitter Inc. private will nearly triple the social-media company’s leverage and saddle it with hundreds of millions of dollars in interest payable on the more than $25 billion used to fund the leveraged buyout.”

                “Analysts estimate that Twitter’s interest burden will increase to $845 million annually from $51 million in 2021″

                “Moody’s Investors Service also put the company’s credit rating on review for downgrade because of the planned increase in leverage.”

                link to wsj.com

    2. 8.2

      When I read about Big Dog Musk’s “strong leader” decision and its consequences I can’t help thinking also about the consequences for China of Strongman Xi’s Canute-like decision to refuse COVID entry to China and Emperor Putin’s tragic decision to invade Ukraine. I might use the term “ill-advised” except that I am not sure these so-called strongmen are ever inclined to receive or heed advice.

      I await with interest the well-trailed announcement tomorrow of the latest decision from the USA’s entry to the World’s Strongest Man competition.

    3. 8.3

      I feel like I am the only one on patentlyo that is held accountable for what I write.

      But I stick with what I said. Even more so now. This is the rocky period as Elon figures out what to do and dumps all the old Twitter employees and gets efficient hardworking people in there.

      The time period is in the range of 1-5 years before we see tremendous growth.

      1. 8.3.1

        I feel like I am the only one on patentlyo that is held accountable for what I write.

        If other people are making egregious mistakes around these parts, you are welcome to point it out. You do not have to wait for my permission, nor anyone else’s.

        1. 8.3.1.1

          Really…?

          Your comment is awaiting moderation.

          November 14, 2022 at 5:11 pm

          Lol — and Greg “Dozens-I-Use-My-Real-Name-Except-When-I-Don’t” DeLassus won’t take his fa1se umbrage at your pointing such things out.

          and /S.

        2. 8.3.1.2

          “egregious mistakes”

          For example, Greg?

          You are telling me that you can tell the outcome of the Twitter purchase already after less than six months?

          And the other prediction you like to give me a hard time about is the layoffs. OK. I admitted I was wrong about that but the only reason is that I underestimated the effects of the Chinese applications. The US originated applications have been falling in number. If it were not for the Chinese, there may have been layoffs.

          I am 100 percent in on my prediction with Twitter. It will just take some time for Elon to get the company in shape so he can easily make product changes and develop new products. Probably he’ll have to fire like 90 percent of the developers.

          1. 8.3.1.2.1

            “The US originated applications have been falling in number. ”

            Evidently all those special programs the pto launched and burned resources on, encouraging innovation, etc. yada yada yada yada yada yada yada, were ineffective.

            Unpredictability introduced by the likes of Alice’s rabbit hole, a definite factor.

            Reduced aggregate demand, inflationary effects and higher cost of credit make businesses too, re-think priorities of value of R&D vs. imminent survival, for some.

            At any rate, the greatest engine of ingenuity from historical perspective, the independent inventor(s), have little motivation to make contributions.

            We can look too, to decreasing avg. iq, for example since NEA creation the us went from #1 to about #17 academically.

            There’s so many factors. What’s most important maybe, is the trends.

            1. 8.3.1.2.1.1

              Evidently all those special programs the pto launched and burned resources on, encouraging innovation, etc. yada yada yada yada yada yada yada, were ineffective.

              How would we ever know whether they were effective or not? USPTO initiatives do not create incentives only in the U.S. CN, EP, JP (etc) innovators are motivated by U.S. patents, just like US innovators. One should not really expect USPTO initiatives to have effects only (or even disproportionately) in the USA.

              [T]he greatest engine of ingenuity from historical perspective, the independent inventor(s), have little motivation to make contributions.

              What does “greatest engine of ingenuity from a historical perspective” mean, exactly? How would one either verify or falsify this assertion?

              1. 8.3.1.2.1.1.1

                “How would we ever know whether they were effective or not? ”

                Well, they’ve been peckin’ at it for a lonnnnnggg time, so if positive results exist, I’d reckon the positve output is near nilly compared to the expenditures, that’s just the nature of excess.

                If the efforts of an exec agency have empowered foreign actors to be better innovators than us-domiciled ones, hahaha, that brings a million questions. Ultra-vires, its out of the charge of the exec agencies, to empower foreign actors to be better inventors, haha. Why do we have export laws on tech then ? Would such policy negate the security provisions of why I can’t farm out certain tech patent searches to providers in country X ? Why haven’t the pto policies which (your theory) caused foreigners to invent more than the US-based folk, also caused the US-based folk to invent more ? 🙂

                “How would one either verify or falsify this assertion?”

                Verification inherently requires a direct object, the person who claims upon being presented with whatever data, that they’re “satisfied” to some extent above some “bar” level. Different individuals of course will be less satisfied with the same, slightly satisfied by a whole bunch more, and never satisfied even if it smacked em upside a temporal. All we have are little indicia, but we have thousands and milllions of them. Borrow from calculus to sum them up, all the indicia.

                One of the indicia which cannot be denied, is the rapid progress and immense beneficial changes to the world and its posterity, by the US patent system and the way it was formerly administered.

                Another indicia I have is a Commerce Dept. issued document from 1967, which flat out states that the biggest driver of American Innovation was the independent inventor.

                Collect the indicia, integrate them. It is a huge job, not one which many have much time to be concerned with !! And to be fair one must do both sides.

                But its really frkn simple…. provide an environment for innovation, and it will happen. The world needs it more now than ever, and these ppl seem to be going the wrong way. Reference Isybery’s “Why bad projects are so hard to kill”, nice article.

                1. The patent system has been crippled. US filings are down.

                  Greg is to my mind a Socialist at best. He thinks that other filings around the world are just as good and doesn’t care if innovation occurs in the USA. He also doesn’t care about the little inventor. He works for a huge corporation and their goal is to squash any small inventors and steal the fruits of their labors or have them not exist.

                  Greg will play word salad games with you all day. Bottom line. Innovation is down. Patent filings are down. The patent system and innovation system are broken and the ones that benefit from this are huge corporations. There are some Marxists in academia that want to kill the patent system but all the people that advocate for weakening patents or eliminating patents are people that are being paid by large corporations. Lemley is probably the top person in killing off patents and he has made many millions from Google whose main purpose is to eliminate intellectual property rights so they can make money on ads as you view/take the intellectual property for free.

                2. Nice post Chrissy.

                  Night Writer, I hear you and will disagree in (minor) parts.

                  Greg does not work for a “huge corporation,” but he does work in Pharma and has a definite Big Pharma bias.

                  He certainly does NOT understand US-Sovereign-centric viewpoint of patents.

                3. Greg is to my mind a Socialist at best… He works for a huge corporation and their goal is to squash any small inventors and steal the fruits of their labors or have them not exist.

                  I work for IGM Biosciences. Anyone who cares to know where I work can look this up with a 10 sec. LinkedIn search.

                  IGM has a market cap of $1.14 billion (check your favorite stock counter to verify that assertion). By contrast, ModeRNA has $71 billion market cap, and Pfizer $271 billion market cap. I doubt many analysts would characterize my company as “huge” in view of those numbers.

                  Nor do we have any desire to “squash” any small inventors, nor to “steal” anyone else’s innovations. I favor robust and enforceable patent protections—for my company and all other innovators. I really do not know where you come up with nonsense like the above, especially because it would take no more than 30 sec. to see that some of it is just outright balderdash.

                4. Greg, picking on a minor point is not ” it is just outright balderdash.”

                  You still work for a large corporation that is not qualitatively different from the very large corporations in their patent policies.

                5. Night Writer,

                  It is not just any “Large Corp,” it is Big Pharma.

                  That’s a special kind of bias (witness Greg’s personal animosity to the Biden equity-driven COVID pledge, and the general past views on nation-to-nation price differentials vis a vis exhaustion discussions).

                6. You still work for a large corporation…

                  IGM BioSci qualifies as a small business under the SBA definitions. Once again, to the extent that you cared to know what you were talking about, you could easily have looked on PatentCenter to see that we qualify as a small entity.

                  Face it, you really know nothing about me or my employer. Why should you? And yet, you will insist on saying things about me and my employer that are demonstrably false because you cannot be troubled to look up these relevant details.

                  The interesting question is why you are so determined to ascribe to me predicates that you have no warrant to ascribe. I know why. You, however, might learn something interesting by contemplating that question.

              2. 8.3.1.2.1.1.2

                Oooh – Greg takes time from his posts of meaningless Tweets to demand from someone else a level of “proof” that he does not bother with.

                One should not really expect USPTO initiatives to have effects only (or even disproportionately) in the USA.

                Spoken like a mindless Big Pharma biased individual.

                Greg being Greg…

                1. Debbie, There’s some truth to that statement about expectations, since US policy has led in many areas for quite a spell of time, so it can be expected that some of US policy will be exported. I’ve worked pharma cases myself, they’re quite stimulating. Can’t talk about client’s but here’s one of mine US7300957. Pharma chemists rock !!

            1. 8.3.1.2.2.1

              I can’t tell you how many articles and new stories there were about what a joke Musk was 10 to 15 years ago for starting Space X and Tesla.

              We’ll see how it plays out Greg. Stop trying to take a victory lap before the race is over.

              1. 8.3.1.2.2.1.1

                And scene…

                link to twitter.com

                There you have it. Approximately three weeks from “free speech paradise” to “shadow banning is the new moderation.” Exactly as predicted.

                So much for the theory that “people want a level playing field… [where the mods do not] hid[e] items from my searches.” Musk has now tried that approach and had to abandon it because it does not work.

                1. I tried twtr once for about 15 mins. Just as it was about to suckme in, like a maelstrom, I snapped out of it and never went back. Havn’t the social scientists showed, an endorphin-reward-loop-emotional syndrome is initiated by all that drama provided by these online interactions ? Personally I think its destructive, more harm than good.

                2. I agree with you directionally about twitter’s progress and likely ultimate resolution, but I don’t believe this is the victory condition you appear to think it is.

                  Musk’s tweet directly says that you can find an objectionable tweet if you’re looking for it.

                  That sort of “censorship” does not comport with the spirit of what NW has been talking about, but it expressly doesn’t allow for “[moderators] hid[ing] items from [] searches.”

  2. 7

    Its because enablement, is a secondary feature of the description. A good description is inherently enabling and if the claims are congruent with the disclosure, problems are minimised. What is being judged is actually the adequacy of the description, and the high court is acknowledging my and others’ position, that separating the two concepts might be academic fun, but the fictious mental separation of WD from E is not necessary. E is a feature, that either ya gots it or ya don’t, and it turns basis of what’s written. Simple.

    1. 7.1

      Nope. Because you have the skills and knowledge of a person of ordinary skill to use to enable the claims, you need the WD to police new matter.

      WD should really only come into play for new matter.

      1. 7.1.1

        The only descriptions I ever wrote, were written ones. So even the word “written” in WD is a redundancy. Even un-written disclosure (pics, drwgs.) require at least some writing in the spec, unless its a design case. Claims themselves are part of the description. Since they’re written, I’d say claims are part of the WD. Weren’t there cases opining that original claims are original disclosure ? Yep. All this talk about WD, is certainly entertaining. It will be interesting to see what the high court says. Your spec defines “new matter” by what it fails to teach*. If the lexicographer / inventors are possessed of something, they need to decide whether or not to include it, being mindful that the claims may be judged on the public’s perception of what the inventor was possessed of on the filing date ! But, don’t put too much in, because that which is disclosed but not claimed… may…be….considered….. dedicated to the public. 🙂

        (my earlier post on “The Teaching Requirement” as yet another possible construct)

        1. 7.1.1.1

          I think it comes down to thinking about the scope of claims you could add because a person of ordinary skill is included in the enablement.

          You can put in the elements of the invention but add new inventions by the combination of known elements that are not only not in your specification but the combination of the elements are not in your specification.

          Takes some thinking. And one need to think about the scope of claims in terms of enablement as they should be thought about.

  3. 6

    Wondering about the daylight, if any, between this and 101, especially as to “functional” claims. I suppose there are cases where the spec can be enabling (though perhaps it isn’t in this case), but the claims still run afoul of 101. Where the spec doesn’t solve the problem, then you also have 112(f/6) in combination with 112(b/2) (in addition to enablement 112(a/1)), and indeed, straight 112(b/2). I still think 101 is used a lot where the issue is really under some aspect of 112 (not to mention 102/103). Life sciences cases have been talking about a range of 112 issues (plus 101 utility) for a long time, computer/Internet cases less so (though there was the enablement decision in McRO, cited by Judge Lurie in the Fed. Cir. decision here).

  4. 5

    > The inventor of a rudimentary, barely functional electric light bulb could, assuming it was the first lightbulb, potentially have obtained a patent claim encompassing all lightbulbs, including far superior lightbulbs produced by subsequent inventors.

    A couple of thoughts:

    1) As compared to the old first-to-invent system, we’re now telling the first-to-file inventor that they need to file ASAP i.e., before they can really work out the follow-on improvements that would make a pioneering invention more commercially viable. Put differently, I’m not sure the old first-to-invent precedents *should* be valid anymore.

    I guess the answer is a string of provisionals/CIPs…if you correctly/fully recognize the breakthrough and have lots of money.

    2) More generally, I’m also not so sure that the inventor of a pioneering advance shouldn’t be in the dominant position wrt those subsequent improvements/applications. Once someone shows something ‘impossible’ can be done, applying/improving it is more straightforward.

    1. 5.1

      fake edit:

      As a concrete example, under F2F, would/should Shockley have been limited to the tabletop-sized transistor embodiment in the famous picture?

  5. 4

    Will this enablement test involve the explicit determination of the level of ordinary skill in the art?

  6. 3

    I predict the decision will include a 2 step test for enablement, any suggestions?

    1. 3.2

      However many steps there are, the next USPTO director will unilaterally insert an additional step.

  7. 2

    It seems like, as long as enablement is a question of law and written description is a question of fact, the Federal Circuit would be more likely to address enablement than written description.

  8. 1

    Excellent article.

    1. 1.1

      +1

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