Trees for the Forest: Claiming Endpoints of a Range and Written Description

by Dennis Crouch

In his 1967 Ruschig decision, Judge Rich applied a colorful woodsman metaphor to the written description requirement:

It is an old custom in the woods to mark trails by making blaze marks on the trees. It is no help in finding a trail or in finding one’s way through the woods where the trails have disappeared—or have not yet been made, which is more like the case here—to be confronted simply by a large number of unmarked trees. Appellants are pointing to trees. We are looking for blaze marks which single out particular trees. We see none.

In re Ruschig, 379 F.2d 990, 994–995 (C.C.P.A. 1967).

In Biogen Int’l GMBH v. Mylan Pharma Inc. (Fed. Cir. November 30, 2021), the Federal Circuit has extended that metaphor and found Biogen’s patents invalid for lack of written description.  In the case, Judge Keeley (N.D.W.Va.) held a bench trial and concluded that the asserted claims Biogen’s MS treatment-method patent invalid for lack of written description.  On appeal, a divided Federal Circuit then affirmed, with Judge Reyna penning the majority opinion joined by Judge Hughes, and Judge O’Malley writing in dissent.

Biogen’s U.S. Patent 8,399,514 covers a method of treating multiple sclerosis using the drug dimethyl fumarate (DMF). The claimed method has one step: administering about 480 mg of DMF per day along with an excipient.  Claim 1 is reprinted below:

1. A method of treating a subject in need of treatment for multiple sclerosis comprising orally administering to the subject in need thereof a pharmaceutical composition consisting essentially of (a) a therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof, and (b) one or more pharmaceutically acceptable excipients, wherein the therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof is about 480 mg per day.

‘514 patent.

The question in the case is whether the dosage requirement (~480 mg/day) was sufficiently disclosed in the original specification so that it can be specifically claimed.  For this type of analysis, the courts look to the Written Description requirement as one way to ensure that a patent’s exclusive rights are commensurate with what was actually invented.  The doctrine requires that the patent application show “possession of the invention” as judged from the perspective of a person of skill in the art considering the entire original specification, including “words, structures, figures, diagrams, formulas, etc.”  Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997).  Originally filed claims are seen as part of the specification, and so most often it is sufficient to show that claim limitations were found in the original application.  But seeAriad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc) (original claims can still fail). Despite Ariad, we most often see the power of written description in situations where the claims have been amended to add some limitation that is not clearly expressed in the original specification.

Here, for prior art purposes, the patentee needs to claim priority back to its original provisional application filed back in 2007.  That original application is focused on use of DMF for a variety of neurological conditions, including MS and did not include the ~480 mg/day limitation within any of the included claims.

The ~480 mg/day dosage is listed once in the original specification, describing an effective dose of DMF without particularly specifying that the dosage is for MS.

For example, an effective dose of DMF … can be from about 0.1 g to 1 g per pay, 200 mg to about 800 mg per day (e.g., from about 240 mg to about 720 mg per day; or from about 480 mg to about 720 mg per day; or about 720 mg per day). For example, the 720 mg per day may be administered in separate administrations of 2, 3, 4, or 6 equal doses.

On appeal, the majority classified the disclosure of 480 mg/day as a “sole reference . . appear[ing] at the end of one range among a series of ranges.”  The court contrasted the 480 mg/day disclosure with the specification’s disclosure of 720 mg/day that was specifically identified and elsewhere in the patent shown to be effective.  The inventor also provided testimony that those ranges in the specification could not be extrapolated to a clinical dose.  Based upon all of this, the court affirmed that “a skilled artisan would not have recognized, based on the single passing reference to a DMF480 dose in the disclosure, that DMF480 would have been efficacious in the treatment of MS, particularly because the specification’s only reference to DMF480 was part of a wide DMF dosage range and not listed as an independent therapeutically efficacious dose.”

Biogen later established that the 480 mg/day was effective, but by then prior art was already available and so a new application would have been ineffective.

In a recent decision, the Federal Circuit ruled that written description failed for a claim covering a range of values since the specification only disclosed several points within the range. Indivior UK v. Dr. Reddy’s Labs (Fed. Cir. 2021).  This case is a flip-side — the specification discloses a range, and the court rules that, without more, written description also fails for a claim directed to an endpoint of the disclosed range.

Writing in dissent, Judge O’Malley focused on a separate district court error that, she concludes, tainted its written description analysis.  In particular, the district court applied the doctrine of judicial estoppel to bar the patentee from distinguishing from clinical efficacy (required for FDA approval) and therapeutic effect (as claimed in the patent).   O’Malley concludes that the district court’s analysis erroneously focused on requiring a showing that 480 mg/day was clinically effective and that improperly resulted in invalidity.

53 thoughts on “Trees for the Forest: Claiming Endpoints of a Range and Written Description

  1. 9

    Largely off-topic, but if you are not connected to Dr. Kevin Noonan of MBHB on LinkedIn, you really should look him up. His work on that network is very entertaining of late.

  2. 8

    Every so often something happens here that prompts an astonished laugh out loud.

    It happened today.

    Who would have predicted that the usually verbose and opaque poster “sarah mcpherson” would deal with anon’s 3122111 “reply caught in filter” by posting the incomparably short and pithy one liner “you need to be caught in the filter”.

  3. 7

    Was trying to cover treatments for several different diseases in the same single patent application being “penny wise and pound foolish” in a business like pharmaceuticals in which patents can be unusually lucrative?

  4. 6

    This patent has a sordid history. It survived a Kyle Bass IPR…

    On March 21, 2017, the PTAB refused to cancel claims of a Biogen MA Inc. (Biogen) patent covering multiple sclerosis drug Tecfidera® during IPR2015-01993.

  5. 5

    As someone who does not work in Chemistry but does in computers, this opinion is wild stuff inasmuch as I have the impression its par for the course.

    The specification casts a wide net for a myriad of neurological disorders, including neurodegenerative diseases such as amyotrophic lateral sclerosis
    (ALS), Parkinson’s disease, Alzheimer’s disease, and Huntington’s disease; demyelinating neurological diseases, such as various forms of MS and at least twenty-eight other disorders related to demyelination; polyneuritis; and mitochondrial disorders with demyelination.

    Because the claims at issue concern methods to treat
    MS, we must look to methods 4 and 5 as disclosed in the
    specification. Method 5 is largely irrelevant…
    But method 4 is instructive, as it discloses “methods of treating a neurological disease by administering to the subject in need thereof at least one compound that is at least partially structurally similar to DMF and/or [monomethyl
    fumarate (MMF)],” as well as “a method of treating a mammal who has or is at risk for a neurological disease . . . [by] administering to the mammal a therapeutically effective amount of at least one neuroprotective compound” such as DMF or MMF,

    That column 18 of the ’514 Patent specification recites several DMF doses in the 100–1,000 mg/day range as “effective” without even identifying a target disease is further indicative that the inventors were not in possession of a
    complete and final invention as of February 2007.

    Between 2004 and 2006, Biogen conducted a Phase II, clinical, dose-ranging study to test the efficacy of DMF at 120, 360, and 720 mg/day concentrations (DMF120, DMF360, and DMF720, respectively) for the treatment of MS. J.A. 2184–91. The May 2006 results of this study showed that DMF720 was efficacious in treating MS, but DMF120 and DMF360 were not. J.A. 7. In August 2006, the FDA recommended that Biogen add a DMF480 dosing regimen in the Phase III study because the lower dose “might improve patient compliance and/or minimize dropouts from adverse effects during the study.” J.A. 1724–25.
    According to Biogen, the Phase II lead scientist, Dr. O’Neill, had conceived the idea of using DMF480 as early as 2003 and advocated testing the DMF480 dose as part of the trial in February 2004. J.A. 7. At the time, Biogen had decided not to include the DMF480 dose in the study for commercial reasons. See J.A. 1364. Although Biogen told the FDA that DMF720 was the best option, it eventually
    included DMF480 in the Phase III clinical testing. See J.A. 1726. The Phase III results showed efficacy for the DMF480 and DMF720 doses. J.A. 2060.

    I’m just amazed that this claim issues. The specification says that a wide range of a drug is “effective” with respect to a range of diseases, it turns out that in fact that the lower end of the range is not effective, the FDA suggests using the actual value claimed, and conveniently the company declares that they had posited it beforehand, and had not done so for commercial reasons.

    That’s like saying that “we know flour is used in baking, so you’d want to some effective amount of flour into [list all known baked goods] and bake it in oven somewhere between 100-600 degrees, optionally 200-500, optionally 300-450, perhaps 300, maybe 325, also 350 is good, maybe 400 and yeah 450 too for some length of time between 5 and 30 minutes, checking in half minute intervals” and then coming back and claiming a cookie recipe with two cups in a 350degree over for 11.5 minutes. That’s just wild “claim first invent later” vibes.

    The rule ought to be that they should lose the entire range because they told one of skill that the range included 120 and 360 and the 120 and 360 were ineffective. Since that paragraph expresses that 360 is effective (it’s right inside the 240-720 range) the only thing to conclude is that the entire paragraph is either (a) directed to the effectiveness with respect to some other disease or (b) just legal patent bs. I suspect it is actually b.

    Is this what commonly happens? Are there are truly invented bio/chem claims or are they all p*ssing to mark your territory and actually inventing once you have the patent?

    1. 5.1

      Just so I can be clear of what I think actually happened here: It sure sounds like the applicant knew 720 worked, and hoped 120 and 360 would work. When they did not, the public suggested the 480 value because that was an entirely obvious thing to do with the prior disclosure of the 720 value working.

      In other words, there is a valid claim to only the 720 dosage, and the other dosages are obvious routine optimizations that could have, and in fact were discovered/discoverable by anyone of skill, as evidenced by the FDA suggesting it. The correct patent result here is a claim to 720, and the other dosages being dedicated to the public, because that’s what’s supposed to happen, and there is just a massive amount of money trying to privatize that public benefit – that’s why the second application was filed, that’s why the second application claims the benefit of the first (when the author of the first explicitly says it was not for treatment), and that’s why this whole case happened: It’s the culmination of a largely successful improper chilling campaign to prevent the public from taking what was their benefit of the bargain.

    2. 5.2

      The rule ought to be that they should lose the entire range…

      Right, and for all intents and purposes, that is the outcome here. Biogen’s suit failed, so Mylan’s ANDA will be approved and the MS community will have generic drug competition in the market.

      Are there are truly invented bio/chem claims or are they all… actually inventing once you have the patent?

      Everyone in the industry knows that the IP around new chemical entities (“NCEs”) tends to be stronger than the IP around second medical uses. This is a second medical use patent, and it failed like so many of its confrères do. Most NCE patents tend to stand up when asserted. Does that answer your question.

      1. 5.2.1

        Right, and for all intents and purposes, that is the outcome here. Biogen’s suit failed, so Mylan’s ANDA will be approved and the MS community will have generic drug competition in the market.

        Presumably there is a claim to the 720 dosage that did have support to the parent. I suggest the rule should be that the attempted unjust enrichment (with the spec disclosing the range when part of it was in fact unenabled in an effort to get an overly broad scope) should taint the otherwise valid 720 claim under an unclean hands theory. In other words, if you throw everything at the wall hoping to claim what sticks and you get caught, you should lose the good with the bad.

        1. 5.2.1.1

          And yet, that is exactly what examiners do.

          Would you be willing to be constrained by the limitations that you would impose on others?

        2. 5.2.1.2

          Presumably there is a claim to the 720 dosage that did have support to the parent.

          Maybe. Who cares? There is no practical effect that would derive from rendering such a claim unenforceable. The FDA considered the side effects of 720 mg/day intolerable, so that dosage is not approved. You are not denying the public anything by failing to strike down such a claim, because the FDA will still stand as a barrier even if one extends inequitable conduct doctrine as you propose.

          I do not take strong exception to your ideas about inequitable conduct above. They are without practical effect, however. It is generally best for courts not to go charging into areas of commerce where there are no actual practical stakes, and thus no interested parties briefing those stakes.

      2. 5.2.2

        Everyone in the industry knows that the IP around new chemical entities (“NCEs”) tends to be stronger than the IP around second medical uses. This is a second medical use patent, and it failed like so many of its confrères do.

        What makes this a second medical use? I thought the original specification was the first time that there was a linkage between “some amount” of di or mono fumerate and MS? Is a first use a functional claim on using it to treat, while the second use is a claim on a particular dosage?

        1. 5.2.2.2

          What makes this a second medical use?

          This patent (US 8,399,514) claims dimethyl fumarate (DMF) for treating multiple sclerosis. US 6,359,003 discloses DMF for preventing host-vs-graft reactions in transplant medicine. In other words, DMF is an old drug, and this patent is claiming a new medical use for the old drug. That is what is meant by “second medical use” claim.

          1. 5.2.2.2.1

            Just FYI, ‘003 published in 2002 (assigned to Fumapharm, Biogen’s predecessor in interest). Biogen filed the priority app for ‘514 in 2007.

            In other words, the pharmacological efficacy of DMF (including dosage) was already part of the state of the art at the time of ‘514’s priority filing. The patentability of ‘514 turns entirely on the discovery of a second utility for DMF that is not obvious in view of its previous, known utility.

    3. 5.3

      [T]hey told one of skill that the range included 120 and 360 and the 120 and 360 were ineffective.

      Just so that we are clear what “ineffective” means here, please know that 21 U.S.C. §355(b)(1) provides that “[a]ny person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application… full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use…” (emphasis added). “Effective” is a statutory term, and has a particular legal meaning in the FDA context that is not exactly the colloquial sense of the word. More particularly, when there is already an approved drug on the market, the FDA considers that a new drug must be at least as good as the existing approved drug in order for the new one to count as “effective.”

      In other words, when the opinion here recounts that “[t]he May 2006 results of this study showed that… DMF120 and DMF360 were not [efficacious],” it does not mean that these dosages did not work at all. Rather, it means that DMF at these dosages did not work as well as the already approved drug at the already approved dosage. The 120 mg/day and 360 mg/day dosages are probably enough to satisfy the §112(a) enablement standard (c.f., In re Anthony, 414 F.2d 1383, 1395 (C.C.P.A 1969)), which is not set so high as 21 U.S.C. §355(b).

      1. 5.3.1

        This is important, thanks! What were the 120 and 360 being compared to when it was said they were not efficacious? The 720?

        1. 5.3.1.1

          The currently approved standard of care therapy for MS is interferon β-1a at 66 μg/week (3 injections of 22 μg each).

    4. 5.4

      That’s just wild “claim first invent later” vibes.

      As I have long noted as a Pharma “gee, it’s medical, so let’s bend the rules” card…

    5. 5.5

      “this opinion is wild stuff inasmuch as I have the impression its par for the course.”

      Have you got a SPE who’ll defend 112(a) rejections for when applicants decide 3 years after filing to combine a function in paragraph 17 with an unrelated function in paragraph 78?

      I can understand if you’re saying this is theoretically par-for-the-case, but I don’t see Management standing behind you if you put that theory into practice.

      1. 5.5.1

        Is your own tale of woe a hypothetical or perhaps you are omitting important context in one of your own ‘bad’ 112 rejections?

    6. 5.6

      I wonder what happens if they say 200 to 800, such as about 210, 220, 230, 240… all the way to 800. And then maybe name a couple preferred embodiments. OK because about 480 is named? This stuff always seemed silly to me. They don’t know what works best within the range, but it’s all somewhat effective. Unless there is data in the patent showing around 480 is special or preferred, there should be no claim granted. What am I missing?

  6. 4

    “For example, an effective dose of DMF … can be from about 0.1 g to 1 g per pay, 200 mg to about 800 mg per day (e.g., from about 240 mg to about 720 mg per day; or from about 480 mg to about 720 mg per day; or about 720 mg per day). For example, the 720 mg per day may be administered in separate administrations of 2, 3, 4, or 6 equal doses.”

    Hmmmm. Looks to me like the applicant here in effect disclosed one DMF dose range, 0.1-1g at most. That’s not actually a very big range as such applications go. And the included “blazes” are at least: 0.1g (100mg), 200mg, 240mg, 480mg, 720mg, 800mg, and 1g (1000mg) of DMF, respectively. The 480mg dose was later claimed. That doesn’t look like plucking isolated statements from the spec and stippling them together into a configuration that was never described.

    It also makes me wonder, if 480mg isn’t sufficiently described, what dose is? 720mg? None?

    1. 4.1

      Or make it a pure cut-and-paste job e.g., “…is between about 480 mg and about 720 mg per day”??

      I’ll admit I’m not a chemical guy, though.

      1. 4.1.1

        I am a chem guy, and I think that if one were guided by WD precedent, O’Malley is correct to think that the mention of MS in one part of the spec and 480 mg/day dose in another part of the spec is good enough to satisfy WD. Evidently, the N.D.W. Va. (and the CAFC majority) is trying to raise the bar here.

        In Europe, one would not be allowed to pull “treat MS” from one part of the spec and “480 mg/day” dose from another. Under their “directly and unambiguously derivable” standard, if you mean to claim a 480 mg/day dose for treating MS, then you need to put those two concepts together in the same thought.

        The CAFC is evidently turning to enforce the same degree of rigor under §112(a) as the EPO enforces under Art. 123(2).

        1. 4.1.1.1

          Just to be clear about the EPO WD test “directly and unambiguously derivable” it is these days routinely referred to as the “Gold Standard” because i) it is so exacting and ii) it is necessarily applied identically, with the same rigour, to the determination whether to acknowledge Paris Convention priority and whether any given prior disclosure is or is not a novelty-destroyer. In ech case, the enquiry is into what a PHOSITA derives from the content of any given document (the appln as filed, the priority document, or prior publication D1).

          I can imagine that the degree of legal certainty which the Gold Standard delivers, on most every enquiry into the validity of any given claim, must by now be quite seductive for hard-presed patent judges everywhere else in the First to File world.

        2. 4.1.1.2

          > if you mean to claim a 480 mg/day dose for treating MS, then you need to put those two concepts together in the same thought.

          Routinely, I’ll draft cases with a ‘use’ or ‘structure’ figure and several supporting paragraphs. Later, I’ll introduce a ‘method of making’ figure and several supporting paragraphs. Effectively, this separates those two concepts. Is that now an error?

          In fairness, I’ll also add a boilerplate linkage (e.g., FIG. 4 illustrates one embodiment of a method of making the structure of FIG. 1). But…I’m assuming this patent also had similar boilerplate linkage.

          I guess the answer is to copy the Euros i.e., write multiple dependent claims, then use a macro to cut-and-paste that into the spec, then rewrite the claims in US style.

          1. 4.1.1.2.1

            [T]he answer is to copy the Euros…

            +1

            The best practice has always been to draft your U.S. written description as if it needs to survive EPO examination standards.

      2. 4.1.2

        “Or make it a pure cut-and-paste job e.g., “…is between about 480 mg and about 720 mg per day”??”

        Okaaay… so if they’d written the claim this way, claiming the range, then a skilled person would suddenly agree they had possession of the 480 mg dose?

    2. 4.2

      [I]f 480mg isn’t sufficiently described, what dose is? 720mg?

      The majority opinion (slip op. at 16) appears to suggest that 720 mg/day is adequately supported (“The DMF480 dose is listed only once in the entire specification… [This] constitutes a significant fact that cuts against Biogen’s case, particularly because it… is in stark contrast to DMF720, which is referenced… as one dose… known to be effective as of the February 2007 priority date,” emphasis added).

  7. 3

    I think that Judge O’Malley’s dissent had slightly the better of this dispute, but it does not matter because this case is not going to attract enough attention to go en banc or up to SCOTUS. The real take away here is that we are edging closer to a world where the U.S.’s §112(a) grows ever closer in application to the EPC’s “directly and unambiguously derivable” standard. That is all for the best.

    1. 3.1

      Ha! Greg, prompted by your remark, I went back to the new thread on Patent Docs for the Indivior case, to find there your reference to the EPO’s standard.

      Good thing? I wonder. There are many who argue vociferously that “directly and unambiguously derivable” is counter-productive because of the impossibly high standards it requires of patent drafters. For that reason alone, I find it hard to imagine that it will take root in the USA.

      1. 3.1.1

        MaxDrei,

        As you may have surmised by now, Greg’s Big Pharma tendencies reflect more of a (non-existent) One World Order view of patent rights.

        He certainly does not reflect a general view of the US Sovereign’s take on patent law, and his wishful thinking (here and elsewhere) should be taken with a rather large grain of salt.

        1. 3.1.1.1

          anon,

          You always seem to rail against a one-world patent view. I am a realist.
          So, when a PCT is filed, how do you draft your claims and spec so that it comports with EP law and US law? Wouldn’t you have to draft to the most strict standard? While I agree each country is sovereign, the PCT has blurred those lines?

          1. 3.1.1.1.1

            Meh, IF one is aiming for multinational coverage with one specification, then certainly the specification likely should be adapted.

            Claims though are not woodenly held to be the same, and in our practice, we OFTEN defer to local counsel who know (and respect) the differences in the Sovereigns.

            1. 3.1.1.1.1.1

              The interesting question, xtian, is whether drafting in compliance with the PCT and its Implementing Regulations is the right thing to do, when writing a specification for filing under the PCT. It is for everywhere in the world outside the USA but is it the right thing to do when you want to enforce in the USA patents based on your PCT filing?

              Perhaps, given adequate funding, anon would advise that one should write one specification for PCT filing but not rely on it for your patent rights inside the USA, and for the USA rely instead on some other specification filed only at the USPTO? I don’t fully understand what anon has in mind with his suggestion to “adapt” the drafted specification but I guess he means that you should start at the USPTO and then “adapt” that specification to bring it into line with the PCT and its Rules, for filing outside the USA, if you want patents outside the USA. Whether that advice is useful for inventors resident outside the USA and filing under the PCT is another interesting question.

      2. 3.1.2

        Good thing? I wonder. There are many who argue vociferously that “directly and unambiguously derivable” is counter-productive…

        “What is the law?” and “what should the law be?” are analytically separate questions. Whether the U.S. law on written description is moving closer to the EP standard really is not a debatable point by now. No one needs to take my word on that point—they can read Amgen v. Sanofi for themselves, read Juno v. Kite for themselves, and now Biogen v. Mylan for themselves. The case law is what it is, and the trend here is unmistakable.

        Whether this should the trend is, of course, a different question. I say that the trend is a good thing because this more demanding standard is easier for non-technical experts (like your average district judge or juror) to apply. Less room for a battle of Ph.D.s to baffle the fact finder with a lot of waffle about what the person of skill will understand from a notably dense and technical lot of prose. If the invention really is described, one should be able to point to a single paragraph or single drawing that discloses it. If one cannot, then the claims are not adequately supported—clean and simple.

        Clearly, the claims here were cobbled together (like Frankenstein’s monster) post-filing from disparate pieces of the spec (a bit of paragraph 3 stitched together to a bit of paragraph 78, with a dollop of fig. 2N). This was done because post-filing data suggested that this was the best course of treatment, but the ability to introduce a new claim post-filing based on post-filing discoveries is precisely the sort of thing that the WD requirement exists to prevent. A WD standard that prevents this is furthering the ends that Congress intended, even if it will make a number of patentees (and their attorneys) squeal.

        1. 3.1.2.1

          Greg’s squealing is interesting, as his “ but the ability to introduce a new claim post-filing based on post-filing discoveries is precisely the sort of thing that the WD requirement exists to prevent” sounds in my past criticisms of Pharma and its practice of filing claims prior to possession as shown by successfully passing FDA (especially in view of claim terms such as “an effective amount”).

          Of course, my missive was directed at more of a 101 view of NOT having the claimed utility at time of filing, but in this case, that “not having the utility” does appear to be reflected in also violating the 112 requirements.

        2. 3.1.2.2

          Greg, now that the USA is a First to File jurisdiction, the notion of “possession” at the filing date assumes decisive importance. And so, inevitably, WD gets to occupy centre stage. Here in Europe, the notion of “utility” is found in our doctrine of “plausibility” which is creeping ever more unstoppably towards centre stage. In short, the utility that you announce in your application as filed has to be at least plausible to the PHOSITA, and the technical effect on which you rely for your inventive step also has to be at least plausible.

          You are probably aware of the impending referral to the EPO’s “supreme court”, its EBA, of the question about how much evidence is needed to support plausibility and how late you can adduce that evidence. But when it comes to issues of evidence handling, fact-finding, common law jurisdictions do it rather more expensively than civil law jurisdictions of mainland Europe so I look forward with great interest to the forthcoming time when the US courts start to weigh up issues of plausibility. It is coming: that to me seems inevitable, given that the same questions of patentability between rival applicants arise, sooner or later, in every patent jurisdiction. You would agree, I’m sure.

          1. 3.1.2.2.1

            My emphasis added…

            now that the USA is a First to File jurisdiction, the notion of “possession” at the filing date assumes decisive importance

            No.

            I realize that you want to apply your EPO Uber Alles glasses, but your supposition is simply not so. Possession at time of filing has always been a paramount factor.

            1. 3.1.2.2.1.1

              In priority competitions between rival applicants under First to Invent, possession at the time of filing was just one hurdle to jump, amongst many others. Diligence, for example. Now, with First to File, conception and diligence are no longer of interest. Instead, possession at the filing date assumes a level of importance that is decisive to the issue who wins amongst the rivals.

        3. 3.1.2.3

          This is not directly on point, I know, but it might be interesting to some that way back in the day, MPEP 1302.02 (since revised) was understood by some to *require* cancellation from the specification of “matter … extraneous to the claimed invention,” no matter how “valuable for reference purposes” that matter may have been been. Applications were then maintained in secret until they issued as patents. Patent file wrappers were publicly available, but “online” had not been invented yet. Under that regime, if an applicant was prevented, perhaps “rigorously,” from claiming subject matter that was described somewhere in the specification, that subject matter would have been canceled from the specification, and would have been hard for the public to notice, regardless of its informational value.

  8. 2

    Pity the computing arts don’t get this level of Written Drscription rigor.

    “You have a single, vague mention of a function in isolation from all the other features of the claim? Then there’s no Written description issue here!”

    1. 2.1

      I have notice more rigorous Examiner pushback on claims like that or where the limitation was a passing sentence in the specification. I think its a ripe area when analyzing asserted software claims were it is obvious that invention took place after the 3rd continuation was filed (suddenly the claims cover subject matter that is, at best, tangential to the specification as originally filed).

    2. 2.2

      Who says it does not?

      Of course, the particulars of each art may make application of the same rigor appear differently, but that is no more than the typical whine about ‘how easy’ it may be to innovate in the computing arts — as opposed to any rigor of the Rule of Law itself.

  9. 1

    Marking every tree in the forest is also not trailblazing but it’s a heck of a way to generate prior art and keep others from getting a patent.

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