Written Description Requirement: Disclosed but Not Described

by Dennis Crouch

Biogen Int’l v. Mylan Pharmaceuticals (Fed. Cir. 2022) (en banc denial)

Back in December 2021, the Federal Circuit invalidated Biogen’s U.S. patent 8,399,514–affirming the lower court’s ruling of invalidity for lack of written description. 35 U.S.C. §112(a).

  • The claimed method has one step: administering “a therapeutically effective amount [of] about 480 mg” of DMF per day along with an excipient for treatment of multiple sclerosis.
  • The specification’s only reference to that dosage is in a prophetic example reciting “an effective dose of DMF … can be from … about 480 mg to about 720 mg per day; or about 720 mg per day.”

The appellate majority noted that this was the “sole reference,” the “one and only reference”, a “single passing reference” to 480 mg/day and that it appeared “at the end of one range among a series of ranges.”  The court  also 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.  Although the patentee’s prophetic example recited effectiveness, at the time the patentee did not actually have evidence that the 480 mg/day dosage was effective.  Thus, the Federal Circuit concluded 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.”  We know now that 480 mg/day is effective —  but that knowledge is based upon post-filing research that cannot be added back into the written description.

The original opinion was penned by Judge Reyna and joined by Judge Hughes.  Judge O’Malley (now retired) wrote in dissent.

After losing, the patentee then petitioned for en banc rehearing with two written description questions (paraphrased below):

  1. Must a “written description” prove the invention’s efficacy?
  2. Is there a need to repeatedly emphasize elements of the invention in order to satisfy the written description requirement?

The Federal Circuit has now released its 6-3 decision denying the en banc petition.  Since Judge O’Malley is retired, she did not participate in the rehearing petition. Judges Stoll and Cunningham also did not participate.

Judge Lourie wrote in dissent, joined by Chief Judge Moore and Judge Newman. The trio argued that this case is a true outlier.

[I]n all [the] history [of the written description requirement], this case, in which every claim limitation is expressly described in the disclosure of the patent specification, is at the farthest end of the spectrum of cases where written description has not been found. It is an outlier.

Judge Lourie dissenting from the en banc denial.  The dissent particularly argues that the decision “blurs the boundaries between the written description requirement and the other statutory requirements for patentability. In doing so, the court has contributed to the muddying of the written description requirement.”

From my point of view, the majority was wrong to place so much emphasis on the fact that 480 mg/day was only mentioned once in the specification.  A single reference is certainly sufficient to satisfy written description.

However, I am also drawn-in by claim language that expressly requires that the 480 mg/day dosage be “therapeutically effective.”  The patentee expressly claimed the therapeutic effectiveness, but did not include enough in the specification to demonstrate that it actually was effective at the 480 mg/day dosage.

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

= = = =

Today, the Federal Circuit also denied an en banc petition in another written description case focusing on claimed ranges, Indivior UK v. Dr. Reddy’s Labs (Fed. Cir. 2022).  In my post on the case, I wrote “Four points are not A range.” The basic holding: although the specification described several embodiments covered by the claims, it did not describe the full-scope of the claimed invention. No dissent in the Indivior denial.  Judge Lourie dissented in Biogen in favor of the patentee, but wrote the majority opinion invaliding the claims in Indivior.

Written Description: Four Points Are Not A Range

 

61 thoughts on “Written Description Requirement: Disclosed but Not Described

  1. 9

    MPEP 2121 Prior art is presumed enabling. “When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable.” Not just what is claimed, but whatever is written into the specification. It is per se enabled. It is up to the applicant to show the prior art is non-enabling, i.e., to prove a negative.

    Moreover, “proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation.” Impax Labs. Inc. v. Aventis Pharm . Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006). See also MPEP § 2122.

    In this instance, Biogen’s patent with support in the specification claiming the specific dose of DMF to treat MS is enabled for prior art purposes, but not sufficiently enabled to be claimed.

    This case also raises further questions:

    Why wasn’t post filing data allowed to rebut the rejection? See Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed. Cir. 2003).

    Finally, how does this decision affect prophetic examples?

    The litigators should just thank the Fed Cir. for their part in ensuring their job security.

    1. 9.1

      The “presumption of enablement” is only for “what it teaches,” and does not reach what it does not teach.

      Further, this is not absolute, but is merely a presumption,

      Further still, the case law on this matter constrains such a presumption to examined and allowed patent material. All too often this is improperly stretched to mere published patent applications (which lack the basis for the presumption), as well as NPL (which can be — and I have personally seen to be) merely science fiction.

      1. 9.1.1

        “matter constrains such a presumption to examined and allowed patent material” – Flat out wrong.

        “Consistent with the statutory framework and our precedent, we therefore hold that, during patent prosecution, an examiner is entitled to reject claims as anticipated by a prior art publication or patent without conducting an inquiry into whether or not that prior art reference is enabling. As long as an examiner makes a proper prima facie case of anticipation by giving adequate notice under § 132, the burden shifts to the applicant to submit rebuttal evidence of nonenablement.”

        In re Antor Media Corp., 689 F.3d at 1289, 103 USPQ2d at 1559. As quoted in MPEP 2121.

        The level of disclosure required within a reference to make it an “enabling disclosure” is the same no matter what type of prior art is at issue. It does not matter whether the prior art reference is a U.S. patent, foreign patent, a printed publication or other. There is no basis in the statute (35 U.S.C. 102 or 103) for discriminating either in favor of or against prior art references on the basis of nationality. In re Moreton, 288 F.2d 708, 129 USPQ 227 (CCPA 1961)

        1. 9.1.1.1

          Just one more…..

          “Even if a reference discloses an inoperative device, it is prior art for all that it teaches.” Beckman Instrumentsv.LKB Produkter AB, 892 F.2d 1547, 1551, 13 USPQ2d 1301, 1304 (Fed. Cir. 1989). Therefore, “a non-enabling reference may qualify as prior art for the purpose of determining obviousness under 35 U.S.C. 103.” Symbol Techs. Inc. v. Opticon Inc., 935 F.2d 1569, 1578, 19 USPQ2d 1241, 1247 (Fed. Cir. 1991).

          So what you get during prosecution is not a 102, but a 103 “obvious to try” rejection.

          What gets my goat is the disparate treatment of the disclosure during prosecution versus when that same disclosure becomes prior art. So what I am trying to point out with this ruling is that something magical happens when Biogen’s application publishes. The specification sections that Greg sites to in 9.2 still doesn’t enable a claim to that subject matter, but for prior art purposes, that same specification enjoys the presumption that it is enabled.

              1. 9.1.1.1.1.1.1

                I agree with you Anon – read the entire case. BUT…i copied and pasted from the MPEP because this is what examiners spit out at practitioners….

                Have you ever been successful convincing an examiner that a cited case in the MPEP doesn’t stand for what it is cited for?

                1. Thanks xtian,

                  Your post provides an excellent customer service and reminder that those who wrote the MPEP have included more than just a few plain errors, and that practitioners should never except at face value the MPEP citations presented in their Cut and Paste form paragraphs.

                  As to you second question, ALL THE TIME.

                  To do this though often takes about a page and a half of set-up and reminder how to PROPERLY read a case with the correct interpretation drawing parallel to actual holding and explaining how reasoning of the new set of facts must result in a decision FOR the patentee.

                  At a second “go,” I also set up for Appeal with case law citations (as prominent, with the MPEP reference “for convenience,” and make it clear to point out the MPEP’s own weasel words that it is case law that is superior, and that the MPEP does NOT have the force of law.

    2. 9.2

      In this instance, Biogen’s patent with support in the specification claiming the specific dose of DMF to treat MS is enabled for prior art purposes, but not sufficiently enabled to be claimed.

      I think that you are giving Biogen too much credit here. There is a Monty Python skit where John Cleese pretends to be a Shakespearean actor giving an interview to the BBC. When the interviewer asks what is the most challenging role he has ever played, Cleese answers “I think the answer must be Hamlet… I found the role a very taxing one. I mean, er, Hamlet has eight thousand two hundred and sixty-two words, you see… But…, I don’t want you to get the impression it’s just a question of the number of words… um… I mean, getting them in the right order is just as important.”

      Biogen’s patent recited “480 mg/day” only in paragraph [0171]. Meanwhile, the nearest mention of “multiple sclerosis” to that dosage occurs in [0159]. There are a variety of drugs mentioned in this disclosure, offered as therapeutics for a variety of diseases at a variety of dosages, but Biogen tried here to pick one dosage of one drug for treatment of one disease, cobbling the claim together from disparate and far-flung parts of the disclosure.

      It is not, in other words, a quibble about whether the claim language is present in the written description, but whether the words occur in the right order. This is not enough to amount to anticipation. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1370 (Fed. Cir. 2008) (“[A] reference that discloses all of the claimed ingredients, but not in the order claimed, would not anticipate, because the reference would be missing any disclosure of the limitations of the claimed invention ‘arranged as in the claim'”).

      1. 9.2.1

        Nice cite, Greg. One can perhaps look forward to the time when the enquiry “WD Y/N” uses the same approach as the enquiry “Novelty destroying Y/N”. Later, that common approach would serve for the enquiry into whether the claim enjoys the priority of the filing date of an earlier patent application, a predecessor of the application in view.

        It seems to me that for fairness between rival Applicants under any First Inventor to File system, there HAS to be a common approach. At the EPO, it’s caled the “Gold Standard”.

        Otherwise, the rights are liable to be enjoyed by an Inventor who was not the First.

        And at the EPO they have an expression for cobbling together in a claim amendment features drawn from disparate parts of the specification, to create a feature combination not evident from the application as originally filed. It’s called “cherry picking”.

        1. 9.2.1.1

          One can perhaps look forward to the time when the enquiry “WD Y/N” uses the same approach as the enquiry “Novelty destroying Y/N”.

          Look forward? Brother, that day is here. A lot of folks do not wish to believe as much, which is why there is grumbling about this decision. In reality, however, we are nearly 10 years on by now from when the CAFC started requiring the same showing for written description as for anticipation.

        2. 9.2.1.2

          And in the US Sovereign, any decent attorney “defeats” this “can not pick and choose” mindset.

      2. 9.2.2

        Your comment is a counter-argument as to why it is not an enabling prior art disclosure. However, the law as it stands provides the presumption that it is enabling. My beef is why is a published patent application presumed enabled, but that same patent application is not presumed enabled when that subject matter is attempted to be claimed?

        Open question to any on this board (any particularly the Examiners) whether you think biogen patent’s specification is not an enabling prior art reference that teach treatment of MS with the 480 mg/day..

        1. 9.2.2.1

          Three quick responses:

          (1) I am definitely not arguing that Biogen’s spec—if asserted as prior art—would not be enabling. I agree with what you write in 9.1.1 and 9.1.1.1 above, that all prior art is presumed enabling.

          (2) Biogen did not lose this one on enablement grounds. They lost on written description grounds.

          (3) What I am really saying is that if Biogen’s spec had been asserted as prior art against Biogen’s claims, the anticipation argument (and maybe even the obviousness argument) would have failed. In order for a spec to supply adequate written description for a claim, the spec must contain a disclosure that would constitute anticipating prior art against the claim if it had come before the claim’s effective filing date. Biogen’s spec did not do this.

          To achieve the claim at issue, Biogen had to pull this limitation from paragraph [0159], and that limitation from [0171], and the next limitation from [0245] (etc), with nothing in the spec actually tying those various teachings together. That just is not adequate written description. Biogen deserved to lose this one.

          1. 9.2.2.1.1

            Yes – biogen lost on written description. As the dissent argues, the majority blurred the lines, and I am interpreting this decision to inject an injected an enablement requirement in the written description analysis. Hence my comments on enablement.

            To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003).

            It should be undeniable that a PHOSITA can take 480 mg of the drug and administer it to an MS patent. Written description satisfied.

            HOWEVER, I am taking issue where the majority took the “possession of the claimed invention” in the written description requirement and, in my opinion, interpreted that to mean “efficacy.” There is no efficacy requirement in patent law,. The closest we have is enablement. hence my comments RE enablement.

        2. 9.2.2.2

          My beef is why is a published patent application… not presumed enabled when that subject matter is attempted to be claimed?

          An application is presumed enabling for the claims as filed. Remember, “[t]he word ‘presumption’ properly used refers only to a device for allocating the production burden.” Texas Dept. of Community Affairs v. Burdine, 450 U.S. 248, 254 n.8 (1981). In other words, all that it means to say that the spec is “presumed” enabling is that the examiner has the burden of creating a prima facie rejection, which is exactly the case.

          1. 9.2.2.2.1

            …and again (as is typical), Greg launches into “presumption” with only half the story.

            Presence AND level — that’s the full story

            (just ask i4i)

  2. 8

    “the decision ‘blurs the boundaries between the written description requirement and the other statutory requirements for patentability.'”

    Gee. Where have we seen this before. (Hint: 101)

    1. 8.1

      Relatedly, both places where the court seems to ignore the statutory presumption of validity, Chevron deference, etc.

      For 102/103 challenges, you can normally point to ‘new facts’ as the rationale for overcoming the presumption. But for 101/112….the USPTO had the exact same evidence in front of it. Can you actually have ‘clear and convincing evidence’ when unbiased experts in the technology and the statutory language thought it was adequately described??

  3. 7

    I look forward to the “treat technologies equal crowd” demanding for this standard to be applied to the software arts.

    1. 7.1

      I definitely believe that the standard used here should also be used in software—and machine tools, and materials science, and metal alloys, etc.

  4. 6

    OT, but I was thinking about the venue VW case and I think I finally figured out how to characterize it.

    The dealership is like an employee of the manufacturer. So they get away with various things by abstracting up a level the relationship of employer/employee.

    1. 6.1

      Your “like” would require a clear view of “follow the money,” one in which it is only too readily obscured with games of the Efficient Infringer and the (somewhat analogous) “it’ not really a sale, it’s a lease” type of semantics.

      Agency relationship should NOT require a level of control over the fact of whether or not the business relationship is meant to achieve a certain flow of goods in one direction and money in the opposite.

      1. 6.1.1

        I think you are right anon in framing the issue that way. I agree. But I also think even under the CAFC framing that they are wrong and played a little game (as it there wont) of analyzing the wrong relationship.

    2. 6.2

      I don’t think this framing helps your cause. While I would agree that the level of control the CAFC seems to be looking for is analogous to an “employee” relationship, I think it’s less defensible to call the dealerships the “employees” of the manufacturer than it is to call the dealerships the “agents” of the manufacturers (which is the issue the court was considering). So this framing seems to lower the bar for the manufacturers to get away from the dealership’s venue.

      1. 6.2.1

        Ben, the issue the CAFC looked at was the Google issue of whether VW had daily control of the employees of the dealership.

        My point is that the dealership as an entity (like an employee) is controlled in their daily behavior by VW every bit as much as an employee is.

        But it is like the dealership is the manager and VW controls the manager. And the CAFC is looking at the employee of the manager. Get it?

        1. 6.2.1.1

          “My point is that the dealership as an entity (like an employee) is controlled in their daily behavior by VW every bit as much as an employee is.”

          I get that you think this. My point was that “employee” implies more control than “agent”. So making this about an “employee” relationship rather than an “agent” relationship is bad for your side.

          Say Bob personally believes 5.0 units of control is sufficient to be an agent, while 8.0 units of control is necessary to be an employee. Bob looks at the VW-dealership relationship and personally concludes that there’s 6.0 units of control in that relationship. If you argue agent-level of control is necessary, you’ll win Bob over. If you argue employee-level of control is necesssry you won’t persuade Bob.

          In other words, don’t make it harder than necessary for your audience to buy your argument.

          1. 6.2.1.1.1

            The use of “like” is expressly differentiating in degree.

            What you think should be there is already there, Ben.

    3. 6.3

      Took you awhile bruh. But truthfully they’re not that much like an employee as the “employer”/would be employer (the manufacturer) doesn’t have much control at all (sometimes contractual but those can be broken breach of contract style).

      1. 6.3.1

        6, not really. The firing is to lose your right to sell/buy VW cars.

        And the contracts are onerous that include more details for controlling the dealership than you work under.

        1. 6.3.1.1

          “The firing is to lose your right to sell/buy VW cars.”

          Yeah but that doesn’t happen, because the sellers voluntarily go along with the terms.

          “And the contracts are onerous that include more details for controlling the dealership than you work under.”

          I hear you on that one, but truthfully the people doing the dealerships are working hand in glove with the overall franchise/brand though nominally “on their ownlol” as they do actually make their own everyday decisions. As noted above, they just voluntarily go along with the conditions. Freedom to contract and all that.

          1. 6.3.1.1.1

            6, what you wrote is wrong.

            The dealership is no more control of their daily activities than you are. The contracts specify everything from what signs have to be displayed to a level of customer satisfaction. The maintenance that has to be performed and for what cost. The size of the lobby.

            Everything. As I said there are more constraints on a dealership in their daily activities than you have for your daily activities under the USPTO.

            Just like you they have sales goals to meet. Quality goals. And so forth.

            The firing as I said is to lose the right to buy VWs from the manufacturer.

            The fact is that the dealership works for VW.

            1. 6.3.1.1.1.1

              “The dealership is no more control of their daily activities than you are.”

              Thats just not true tho bruh. They could be an indie dealership at any time. I have an uncle that had one (finally shut it down a couple years ago) that was in his fam going back back. He was daewoo and other brand affiliates but he never contracted with them so much so as to to curtail his divine authority. The ones that do such a contract are doing so voluntarily to get the branding/franchise status. They 100% can buy the cars and then sell them at their own “John Doe car lot” dealership and “be their own boss entirely”. Mine on the other hand is a straight employment contract.

              “Everything.”

              Yes but that’s all just so they can plaster the brand/franchise all over their dealership. They can choose to not do so at any time.

              “The fact is that the dealership works for VW.”

              I happen to disagree with you, and you’ll need to convince a court that the franchise/branding agreements are basically employment contracts. Tough sell.

              “The firing as I said is to lose the right to buy VWs from the manufacturer.”

              That’s not usually the stakes tho, usually it’s just the right to put branding/franchise stuff up and say you’re an authorized dealership and get some inside info on stuff. You can still try to contract to buy a big shipment of cars from them. If they decline, I mean, tough titties, but I doubt they would for enough money. As long as you don’t have your dealership sporting their branding they don’t care if you want to buy some cars from them. Tho franchisees might get to go to the front of the line when it comes to receiving new shipments.

              1. 6.3.1.1.1.1.1

                You keep on missing the point, 6.

                The ones that do such a contract are doing so voluntarily to get the branding/franchise status.

                And therein is the LOSS of your “freedom” and the point being advanced by Night Writer.

                Sure, one MAY want to be completely independent and with NO controls (and as cars – like books [see Kirtsaeng] may lose rights according to a First Sale doctrine), such IS possible.

                But such is just present in the facts of THIS case.

                1. “And therein is the LOSS of your “freedom” and the point being advanced by Night Writer.”

                  Um, they’re free to ditch the brand/franchisee status at any time. Derp derp.

                  “But such is just present in the facts of THIS case.”

                  Such was never established in evidence. All we can presume is that they are a standard dealership with a standard dealership arrangement for branding etc. One which courts have not recognized as being as controlling as you want to portray it to be, and one which the court did not here. And which courts will continue to not most likely. Again, you don’t need to fight me on this, go fight the courts. Show your big time evidenciaries to them and get them to rule for you.

                2. Again 6 — you miss.

                  IF they “choose to ditch,” that in itself is a change in facts of the case.

                  Your desire to IGNORE the facts simply defeats your posts.

                3. They don’t have to actually ditch out to still have the capability to ditch out at any time ta rd.

                4. Once again, 6, your use of “ta rd” reflects immediately back at you.

                  I chuckled at your “lofty” “still have the capability to ditch out at any time” – as of you were making some important legal point (hint: you were not).

                  You do know of course that slavery has been outlawed and that EVERYONE has this “still have the capability to ditch out at any time” – BUT still must face legal repercussions of such.

                  You break a contract (which IS in the fact pattern here), you have repercussions.

                  Maybe stop and think a bit before your next inane reply, eh?

                5. I need do NO such thing, “bro.”

                  I am not in a court, making the legal case there.

                  I am on a blog, having a legal discussion with you here.

                  And in OUR discussion, I have eviscerated your attempted points.

                  What YOU need to do is recognize that, “bro.”

                  (so yet again, your attempted denigration fits you)

                6. “I have eviscerated your attempted points.”

                  Lol, I’m going to sit and lol at you and wait for you to take this loser argument to court. And then laugh at you more.

                  “What YOU need to do is recognize that, “bro.””

                  No.

                7. Yes.

                  Again, we are not in court, we are here.

                  You can “wait” all you want to 6, but that f001s no one. You “wait” because you have nothing intelligent to come back with in our discussion.

                  Hey, it is perfectly within your rights to sit there being wrong and “wait” for whatever, but you ARE sitting there, waiting, in the wrong.

                  Or, you can decide to try to engage on the merits and attempt to improve your current condition.

                  As always, up to you.

  5. 4

    The question presented of “Must a “written description” prove the invention’s efficacy?” is misleading. The proper decision is about whether or not what is required by the [presumably amended] claim language is supported in the spec or the original claims.

    1. 4.1

      I don’t think D and MM think that it has to “prove” the efficacy. That can happen in the background. What MM and D means is that when using the claim language that was used, the WD must have at least set it forth as efficacious. And then have sworn to it (in the oath). At least I think is what they mean.

      1. 4.1.1

        Yes it’s not about “proving.” It’s about having *some* evidence (or some legit reasoning) that supports the asserted claim. This is especially true if the patentee is trying to thread the needle between the art with a very specific numerical limitation. The specification isn’t just a playground for picking out numbers that get you past the prior art (especially in an unpredictable art).

  6. 3

    I should add, it seems like at this point (considering the cases hinging on this sort of things) it should be borderline malpractice for the drafter to not include the end point points separately or explicitly, as well as any other points that seem important. Unless the patentee genuinely didn’t think about it and even the patent attorney holding their hand in an interview didn’t get it specified.

  7. 2

    Tis a tough situation as you don’t want to ding the patentee for what could just be the way the draftsman chose to word things rather than the patentee genuinely not having possession of that amount etc.

  8. 1

    I think the majority got it right, and for the right reasons. The patentee did not have written description sufficient to show possession as of the filing date. They had not shown that 480 was efficacious.

    It makes sense legally and reasonably that if you show just one example of dosage effectiveness, highlight that example repeatedly, then drop in ten pages where you recite 10,000 other dosage levels (with no evidence of effective’s) that you can’t later avoid the prior art and grab one dosage level out of that 10,000.

    1. 1.1

      Given the EPO’s gruesomely strict prohibition on adding to the disclosure after filing, I find it interesting that the only attack on validity with which the ten Opponents succeeded in knocking out family member EP 2137537 was obviousness.

      My impression is that judges in Europe have no apprehensions about revoking a patent for obviousness whereas in the USA there is no limit to the lengths courts will go to, to find a way to revoke without having to get to what is nearly always the decisive issue, namely obviousness. Here we see WD used in that way, but in other technical fields it is often the eligibility requirement.

      I wonder who disagrees.

    2. 1.2

      Presumably, everyone’s response will be to cut-and-paste a really(!) long sentence a few dozen(!) times in each spec, stating something like “the effective dose can be from … about 480 mg to about 720 mg per day; specifically including without limitation 450 mg and 451 mg and 452 mg……….and 719 mg and 720 mg”

      The resulting specs are now 5x longer and effectively unreadable to an actual POSITA. Worse, a simple macro will write that banal sentence, so the whole thing becomes the proverbial “exercise in draftsmanship.”

      1. 1.2.1

        Well indeed. Yes, OC, I go along with you, that exactly that is the (absurd) consequence.

        What’s wrong with the alternative adopted in Europe, namely, to enquire whether the disclosure in the application as filed has rendered it “plausible” that the disclosure enables that which is claimed, and that claimed subject matter i) has utility and ii) has the technical effect on which its patentability is predicated.

        Or is the European “plausible” solution workable only for civil law (inquisitorial) jurisdictions and not workable for adversarial English law jurisdictions?

        1. 1.2.1.1

          Where in our law would you put this “plausible” thing?

          Here – in this Sovereign – our Constitution dictates which branch of the government has the (sole) authority to write what you seem to want to imply being made up (whole cloth) for a different branch of the government.

        2. 1.2.1.2

          See 4.1.1 which mentions the notion of “legit reasoning” (as well as the notion of being able to adduce some non-zero something that has the attributes of “evidence”). It seems to me that “plausible” is nothing more than a requirement for some degree of credible argument and evidence.

          To answer the question “Obvious Y/N?” is challenging. Compared with that degree of difficulty, answering the question “What they are currently contending: did they in their specification as filed already establish it as plausible?” is not difficult at all.

          Does it not happen all the time, that in the application as filed, Applicant has it that you can choose any of alternatives A-Z and that they will all do the trick whereas later, in prosecution, the line is that only P,Q and R deliver some perfomance attribute, one not attainable with any of A-Z now lying outside the newly claimed narrower range? That (A-Z) which on Monday was the solution to the problem turns out on Tuesday to be no solution at all. Instead, Applicant advances a different invention (P-R) as the solution to a different problem altogether. Such behaviour is not in accordance with a First to File patent system.

          1. 1.2.1.2.1

            Such behaviour is not in accordance with a First to File patent system.

            And I call Bovine Excrement on that.

            Certainly in the US Sovereign in which scriveners are well trained to write robust applications that take into account the vagaries of examiners and the unknowable manner of how examiners will attempt to piece together disparate prior art.

            MaxDrei, you are making the mistake of inserting your mere “desired” practice, based on your decades going around the same little block of your own foreign practice.

            This is not the first time that you have made this mistake, nor the first time you have been corrected for making this mistake.

            It is rude to insist on making that mistake as if you have not been corrected.

          2. 1.2.1.2.2

            I see that not all readers grasp immediately that ANY First to File system (that grants rights to the party who really was the first amongst the rival inventors of the subject matter to file on the contested invention) must necessarily include a way to render ineffective the filing of a patent application based on nothing more substantial than pure speculation. To grant the rights to that party is to fail to grant them to the First Inventor.

            This was the mischief that so distressed all the headless chickens and “Sky is Falling” merchants while the AIA was going through the Congress. Forty years of development of the case law at the EPO has consolidated it around the notion of “plausibility”. Other solutions are of course imaginable, to deal with the situation of parties jumping the gun, filing first, making their inventions while their applications are pending at the PTO. The poster anon is troubled by this behaviour in the field of pharmaceuticals but it is everywhere in the “unpredictable arts” and has to be curbed somehow. Or not?

            1. 1.2.1.2.2.1

              What lenses are you using MaxDre?

              Your first paragraph is a strawman that no one has taken such a position.

              Your first sentence of your second paragraph is simply false – you pulled that out of your arse.

              At that point, I simply tossed the rest of your post.

              For someone who spends so much of their time on US patent law blogs, you STILL spend an inordinate amount of your effort shilling for EPO Uber Alles.

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