Dissenting on Obviousness

In re Efthymiopoulos (Fed. Cir. 2016)

In a split opinion, the Federal Circuit has affirmed the PTAB’s determination of obviousness.  Biota’s patent claims influenza treatment through oral inhalation of zanamivir while the prior art teaches the identical treatment by nasal inhalation.   A second prior art reference also suggests that similar compound can be taken via “inhalation” (without the nasal or oral modifier).  On appeal, the Federal Circuit affirmed that the general inhalation disclosure “is reasonably understood to disclose inhalation by either the nose alone, mouth alone, or both.”

Judge Newman writes in dissent:

The PTAB and now this court rule that it was obvious to administer this drug by oral inhalation, although there is no reference, no prior art, no suggestion, proposing that this mode of application might succeed, or that it should be tried. There was evidence of skepticism even as oral inhalation was evaluated. There was no contrary evidence. The evidence on which the Board and now this court rely is the evidence in the patent application itself, describing oral inhalation, its benefits, and its effectiveness. Upon learning this information from this inventor’s disclosure, the Board found that it was obvious, and my colleagues agree that it is obvious to them.

 

 

In its brief, the PTO wrote:

Efthymiopoulos seeks to capture as his exclusive property right a particular (but not particularly new) way of delivering an old compound to treat a well-known disease. Specifically, Efthymiopoulos claims a method for treating influenza, an infectious disease of the respiratory tract caused by influenza (flu) viruses, by administering zanamivir, a compound known in the prior art as an inhibitor of influenza virus production, by inhalation of zanamivir through the mouth alone. Efthymiopoulos contends that his contribution to the art is the route of inhalation – treating influenza solely by oral inhalation.
But the evidence of record shows that oral inhalation would have been obvious. Specifically, as of the effective filing date, skilled artisans understood inhalation to mean oral, nasal, or both. The prior art was replete with available oral inhaler devices for use with well-known micronized dry powder formulations. Skilled artisans also knew that oral inhalation delivers more drug to the lungs and that nasal inhalation delivers more drug to the nasal cavity. Skilled artisans further knew that some strains of influenza infect the lungs, and that young children are more susceptible to lung infections.

The case here is an example of the difficulty with the flexible obviousness analysis — it allows for well supported arguments on both sides.

135 thoughts on “Dissenting on Obviousness

  1. 14

    I have had a quick look at the Decision and the Dissent and the wrapper of EP-B-764023 which I take to be the EPO family member. Decisive seems to be how successful is a drug administration regimen that is exclusively oral, compared with effectiveness when administered nasally.

    I am left puzzled by what the proprietor means by a drug administration regimen which is “effective”. Can anybody help?

    I mean, suppose we are prior to the date of the claim, and you the PHOSITA have a patient with pneumonia and needing this medication. Now, for some reason (which we do not need to go into) nasal delivery is not possible. Would you i) try oral delivery, or ii) give up and throw away the drug dispenser unused?

    If you were to try oral delivery, would that be because you assess as greater than zero the chances that it will have some useful “effect” against the disease?

    Judge Newman tells us the claimed subject matter is inventive because on the relevant date oral administration would not have been “obvious to try”. Why was that? Because, the judge tells us, nowhere in the prior art was there any teaching that oral administration “would have a reasonable likelihood of success”. What does she mean, here, by “success”? As effective as nasal? More effective than nasal? Effective enough to help the patient in his/her fight against the disease?

      1. 14.1.1

        You set me thinking.

        If you were to claim”…..through the left nostril alone” and I argue to Judge Newman that your claim is obvious, would she uphold your patent because I had failed to provide her with evidence of prior art suggestions to adopt this administration route?

          1. 14.1.1.1.1

            There is a real albeit subtle difference here Ben.

            As I indicated, this may have more to do with the procedural aspects than with the factual aspects (per se), and is certainly not indicative of any larger “truth” as to any type of end result of someone else (easily) following the proper procedural path to obtain the legal decision of the claim being found obvious.

    1. 14.2

      Well, what if the reasoning goes, oral administration does not work because it cannot reach the sinuses and as long as there is infection in the sinuses, the infection in the lungs will be re-established almost immediately after the orally administered dosage dissipates? Moreover, the sinus colony may receive a reduced exposure to the medicine only sufficient to kill off the weakest members of the infecting colony, thereby selecting for drug resistant bugs.

      Mightn’t it be non-obvious to do oral administration in that scenario?

      1. 14.2.1

        As Malcolm pointed out, the issue here is very factually intensive (he even added “b0ring”).

        As I pointed out, Newman’s dissent seems more on the procedural aspects that those same (b0ring) extensive factual predicates were not stepped through adequately enough in this case and by the Office or PTAB below.

        She disagrees with the Majority who seems to take a “maybe the below did not do what they needed to do, but we’ll just fill in the blanks and -wink- and say ‘good enough’ hand wave.”

        Regardless of any view of the claims themselves, Newman’s focus appears to be on the Means used to get to the Ends (and merely saying the Ends are good – or even inevitable – is simply not enough for our system of law).

        In that view, she is correct. See eBay.

        1. 14.2.1.1

          merely saying the Ends are good – or even inevitable – is simply not enough for our system of law

          People who pretend to be born yesterday in service of a Kafka-esque game are miserable excuses for human beings. And, yes, that applies to Judge Newman’s dissent in this case.

          And please try to get off your high horse, “anon.” You only care about “means” when your peculiar interests are being served. We all know that. We’ve seen it. You’re a hypocrite of unbelievable proportions. Stop the inane preaching.

          1. 14.2.1.1.2

            And please try to get off your high horse, “anon.” You only care about “means” when your peculiar interests are being served. We all know that

            First – it is disingenuous to accuse me of riding a high horse when I have the correct grasp of the law and you do not. the only horse I ride here is the one you provide by taking the incorrect course.

            Second – it is duplicitous to accuse me of using an “Ends justify the Means” approach when I have done no such thing. Do more than just lay out an empty accusation. Do not cloak your L I E in a banal “we all” – your sockpuppets do not count in your prevarications here. You merely employ the very thing that you accuse me of in the immediate instance.

    2. 14.3

      If you look to my comment at 10, I suggest that the claim itself is anticipated by your hypothetical if any doctor, in fact, used the product off-label in the manner you describe.

      I understand that this is an ex partes case, but there is no reason to pursue this case as in any real suit the defendant can win the case with a simple affidavit from a doctor.

  2. 13

    ‘A method for transporting a human being to jupiter by chemical rocket’ is clearly non-obvious as the prior art only discloses transporting humans to the moon, and there is a paid schill who said that people were skeptical about using chemical rockets to get to jupiter.

    1. 13.1

      That’s lovely Ben.

      But if in the case below, that “paid shill” was not rebutted, and his testimony is taken as fact, can the reviewing court simply chose to ig nore that fact because it wants to and with only a hand wave?

      I think that you are learning the wrong lesson here (of being glib).

      1. 13.1.1

        that “paid shill” was not rebutted

        Secondary considerations absent invention are not patentable. They’re called secondary for a reason. You’re confusing insufficiency with chosen ig norance.

            1. 13.1.1.1.1.1

              I just noticed that it wasnt you who posted the reply.

              Big Whoop.

              I am still not confused about anything that I have said, Ben.

              As for Random – he is way off.

              1. 13.1.1.1.1.1.1

                Your argument doesn’t rebut the weak (but extant) evidence of your confusion. Better get a paid shill.

                1. Do you even know what the words you use mean, Ben?

                  I have no need of any rebuttal. There is no confusion in my statements.

                  YOU may be confused – but as evident here, that confusion more than likely merely comes from you not understanding the law under discussion.

                  Further, “getting a paid shill” means nothing in a discussion of law. Why would you even offer such advice?

                  You only demonstrate that you are truly c1ueless, Ben.

                  Not a great tactic to take when trying to hold a legal conversation with anyone, let alone with me.

    2. 13.2

      Ben –

      Notfanuttin, but it would not be obvious to transport a human to Jupiter by chemical rocket.

      It took 3 days to get to the moon by chemical rocket. The moon is about 238,900 miles away.

      On a good day, and good days are not very common, Jupiter is 1527 times further away (365,000,000 miles). So, it would take 4,583 days, or about 12.5 years to get to Jupiter by chemical rocket, and that assumes you could make a rocket big enough to carry enough groceries to last a guy 12. 5 years. Oh, and that’s just for a one way trip. The groceries would have to last over 25 years if ya wanted to get her home again.

  3. 12

    I read Newman’s dissent not so much as “THIS claim” must be non-obvious, but more in the way of the eBay directive of “don’t hand wave the analysis”-and-the-Office-and-the-majority-did-just-that.

    Yes, it would be exceptionally easy to make the case (even perhaps b0ringly so), but if you don’t actually make that case, you shouldn’t expect to end up at the Ends you want “just because.”

  4. 11

    Clearly this is not in the record but an interesting thought I had is that this patent may also be anticipated under 102 by off-label use of zanamivir by doctors in the intervening years.

    It is actually one of the cases where the PHOSITA may have less incentive to try the alternative methods of administration than laypeople or doctors who know that people don’t like having crap up their noses. So a doctor might recommend oral instead without even really thinking about it.

  5. 10

    Also not to start too much of a firestorm here but the non-obviousness argument ultimately hinges on the fact that:

    It was undisputed that, at the time of this invention, it was believed that the influenza virus infected primarily the upper respiratory tract, that is, the nasal passages.

    Someone want to explain how this claim isn’t barred under 101 for the same reason that the “fetal DNA is located in a previously unknown place” natural phoenomina case was? It’s a conventional treatment for a disease that the art was mistaken about the location of. It’s even less inventive, because there was no change at all from the previous act save moving the location. At least the DNA case had an additional test step (albeit a conventional test) to ferret out the DNA.

    1. 10.1

      RG: Someone want to explain how this claim isn’t barred under 101 for the same reason that the “fetal DNA is located in a previously unknown place” natural phoenomina case was? It’s a conventional treatment for a disease that the art was mistaken about the location of.

      For starters, remember that Sequenom’s claims didn’t treat anybody for anything. The claims recited a method for detecting a detectable molecule using conventional molecule detection technology. Information-gathering technologies (as well as information storage, processing and disseminating technologies) are treated differently by our patent system, for great reasons.

      It’s even less inventive

      I’m not sure about that.

      In any event, the claim here was properly deemed obvious following a straightforward application of the law. Note that the right result was reached here at the initial stage of examination, and similarly deficient pharma claims to these are deemed obvious all the time, and yet somehow there isn’t an army of trained m0nkeys flying around the Internets complaining that “nothing is patentable” and nobody is going to develop better drug delivery methods because “Prost is senile.”

      Please wake me up when a claim to a method of treating a headache with aspirin “wherein the headache is caused by watching a scrolling advertisement requesting a political donation” sails through the PTO and is asserted against 200 defendants in East Texas. Then we’ll know we have a 101 problem.

      1. 10.1.1

        For starters, remember that Sequenom’s claims didn’t treat anybody for anything. The claims recited a method for detecting a detectable molecule using conventional molecule detection technology. Information-gathering technologies (as well as information storage, processing and disseminating technologies) are treated differently by our patent system, for great reasons.

        Does that matter though? Mayo *did* treat people and it was insignificant post-solution activity because the treatment was conventional. The inventiveness of this claim can’t come in the treating, because they’re not suggesting that they discovered the treating aspect. The only argument is that the method of delivery is new, but the method of delivery flows directly from the natural fact.

          1. 10.1.1.1.1

            (there is a reflection of the rather undefined notion of “directed to” or the leading edge of the sword in “Gisting” that can be seen in Random’s words)

        1. 10.1.1.2

          Mayo *did* treat people and it was insignificant post-solution activity because the treatment was conventional.

          Not sure what you’re driving at. It was Prometheus’ claims that were at issue. The first step of detection of metabolite levels was old in the art and the second (and final step) only required a “new understanding” of what the data meant. There wasn’t a new treatment protocol described by the claims at issue, nor was any new treatment required for infringement.

          The only argument is that the method of delivery is new,

          In fact, they’re arguing that their “new” delivery method results in a transformation of matter that was nobody expected. Their problem is that this transformation of matter was expected and the delivery method was suggested in the art.

          1. 10.1.1.2.1

            In fact, they’re arguing that their “new” delivery method results in a transformation of matter that was nobody expected.

            But that “unexpectedness” is due solely to a discovery about a natural phoenomina.

            To use an example we used in that fetal DNA case – Everyone knows how to drill for oil. If we allowed for a patent on “drilling for oil at location X” purely because nobody knew there was oil under the ground at position X, we would essentially be patenting the natural phoenomina discovery that “there is oil in this location” because the drilling steps are entirely conventional. I believe you agreed with me that that claim would be ineligible.

            This is the same thing, it’s just that instead of “the public did not know there was oil at location X” instead we’re saying “the public did not know that influenza was present in the lower respiratory tract.” The remaining steps – administering a dose of a drug to the affected location, is conventional. Given that the solution preexisted and the discovery of the “problem” is not a discovery about a man-made machine but a fact of nature, aren’t we allowing for a patent on a natural thing.

            If the spec said “The public didn’t know that influenza affected the lower respiratory tract, therefore I claim any treating of influenza in the lower respiratory tract” you would have no problem calling this a 101, right? So why does it change when there is a wherein clause that limits the treatment to a conventional treatment – “I claim treating influenza in the lower respiratory tract, wherein the treatment is known treatment drug X and the treatment delivery method is a known method of getting a drug to that location Y” aren’t you just appending insignificant conventional action and knowledge onto the ineligible discovery?

            1. 10.1.1.2.1.1

              aren’t we allowing for a patent on a natural thing.

              No patent was allowed here.

              You do understand why that’s important, right?

              1. 10.1.1.2.1.1.1

                No patent was allowed here.

                That’s not what we’re discussing. Whether the facts also support a 103 is not the same test as to whether it is a 101. I’m asking you to distinguish it from the fetal DNA and the oil drilling hypothetical, because I don’t see a distinction.

                1. Random,

                  You are correct – welcome to the moving goalposts of Malcolm land.

                  But you did not answer his question of “You do understand why that’s important, right?

                2. No patent was allowed here.

                  That’s not what we’re discussing.

                  It’s absolutely what we’re discussing. We’re discussing how facts about the world and facts about conventional detection methods relate to determinations of eligibility and obviousness. In this case, the claims were correctly deemed obvious.

                  Note that the fetal DNA detection methods can even be distinguished from the oil drilling methods, although the result (ineligibility) is the same. Finding an old disease in a “new location” and using conventional methods to treat that disease are more like the simple oil drilling hypo, for sure. But these latter two scenarios can also be distinguished depending on the specific facts, e.g., perhaps there are reasons to expect that the conventional method would not work at the particular location.

                  If the spec said

                  Ultimately it doesn’t matter at all “what the spec says” (patent-adverse admissions excepted). What matters are the facts.

                  If your hypothetical is that you discover the non-obvious fact that influenza is in the hair and you claim “Treating flu in the hair by applying anti-flu drugs to the hair”, then I agree with you that the claim should be ineligible. Note that there is still plenty of room for patentability, however, and note also that this analysis doesn’t mean that “no treatment methods are eligible.”

            2. 10.1.1.2.1.2

              1) Who ever invents of DISCOVERS….may obtain a patent therefor.

              2) There is nothing to DISCOVER but laws of nature and natural phenomenons.

              3) We do allow claims to drill a location X. Either through a lease or via filing a prospecting claim. See Treasure of the Sierra Madre. link to imdb.com

              4) “It’s even less inventive, because there was no change at all from the previous act save moving the location.”

              Yeah, no change at all except for the change that allowed the treatment to work. Surely THAT sort of change is not the sort of progress in the sciences that we want patents to promote.

              sigh…..

              1. 10.1.1.2.1.2.1

                Les, “There is nothing to DISCOVER but laws of nature and natural phenomenon[].”

                Agreed.

                A principle, in the abstract, is a fundamental truth; an original cause; a motive; these cannot be patented, as no one can claim in either of them an exclusive right. Nor can an exclusive right exist to a new power, should one be discovered in addition to those already known. Through the agency of machinery a new steam power may be said to have been generated. But no one can appropriate this power exclusively to himself, under the patent laws. The same may be said of electricity, and of any other power in nature, which is alike open to all, and may be applied to useful purposes by the use of machinery.

                In all such cases, the processes used to extract, modify, and concentrate natural agencies, constitute the invention. The elements of the power exist; the invention is not in discovering them, but in applying them to useful objects. Whether the machinery used be novel, or consist of a new combination of parts known, the right of the inventor is secured against all who use the same mechanical power, or one that shall be substantially the same.

                A patent is not good for an effect, or the result of a certain process, as that would prohibit all other persons from making the same thing by any means whatsoever. This, by creating monopolies, would discourage arts and manufactures, against the avowed policy of the patent laws.

                A new property discovered in matter, when practically applied, in the construction of a useful article of commerce or manufacture, is patentable; but the process through which the new property is developed and applied, must be stated, with such precision as to enable an ordinary mechanic to construct and apply the necessary process. This is required by the patent laws of England and of the United States, in order that when the patent shall run out, the public may know how to profit by the invention. It is said, in the case of the Househill Company v. Neilson, Webster’s Patent Cases, 683, “A patent will be good, though the subject of the patent consists in the discovery of a great, general, and most comprehensive principle in science or law of nature, if that principle is by the specification applied to any special purpose, so as thereby to effectuate a practical result and benefit not previously attained.”

                LE ROY ET AL. v. TATHAM ET AL., 55 US 156, 174-175 (1852)

                link to scholar.google.com

                1. I’m not sure what your point is here Ned.

                  You say you agree and then you paste in this contrary edict.

                  The edict is wrong, is my point.

                2. Les, I agreed with what you said about discovery being of laws of phenomena of nature. But that does not mean you have a right to patent laws of nature or phenomena of nature just because you discover them. I posted the Supreme Court case that explained why. Patents are for inventions, not for discoveries.

                3. As well as ignore what Congress explicitly stated (35 USC 100)…

                  But since when is the scrivening of the Court “bound” by the explicit words of Congress… ;-)

  6. 9

    If only there was some sort of well-known machine that one could place into their mouth for the purpose of delivering an aerosol to the lungs, so that people wouldn’t make silly statements questioning whether the art might understand that “oral inhalation might succeed.” We could call it “an inverse exhaler machine.” I bet it would work great for asthma.

    As anyone who has ever, you know, done anything strenuous can tell you, one can breathe both through their nose and their mouth. Is it the same thing in every case? No. Does it *suggest* that a nasal intake could lead to an oral intake? Of course it does. Does obvious-to-try apply to a two-option setup? Of course it does. You don’t have to know something will succeed for it to be obvious, you just have to be motivated to make the attempt. You don’t need an expert opinion on this – the town moe-ron could tell you its worth a try.

    Also – lol at the suggestions that there lacks a reasonable likelihood of success or that it is unexpected results when a treatment for influenza is delivered to an area with influenza, it treats the influenza. The study applicants cited didn’t find a statistical difference in the results due to intake, and were directed to prevention rather than treatment anyway. Unexpected results could have saved this claim, but there weren’t any.

    1. 9.1

      RG You don’t need an expert opinion on this – the town moe-ron could tell you its worth a try.

      But the town patent attorney will gently take his super serious pipe from his mouth and ask you “Then why didn’t anybody try it before, hmmm? Now, check out these smoke rings.”

  7. 8

    Unless the SCOTUS intervenes to address Patlex, the PTAB will forever be her legacy – no matter how many times she dissents.

            1. 8.1.1.1.1.1

              gotcha – you mean the transition from the courts into the executive branch based on “patents are not property” (even though Congress explicitly says otherwise)….

              Have a feeling that that will not be her legacy – but I catch your drift.

    1. 8.2

      anony, not only did she write Patlex, but her reasoning has been sustained.

      Patent rights are public rights because they are created by statute.

      I have read many a law review article that have concluded that that is exactly where the Supreme Court is on the public rights doctrine. The only exception to this general rule is where a legal remedy is provided for the newly created statutory right. That legal remedy is accorded a right to a trial by jury and the right to be heard in a court of law.*

      What many in this conversation do not fully appreciate is that a action to revoke a patent is, in point of fact, a legal remedy (writ scire facias), and it was used at common law to revoke patents.

      Thus, even if patents are public rights, the remedy to revoke a patent has a right to a trial by jury in a court of law.

      *

      Petitioner nevertheless argues that the Amendment is inapplicable to new causes of action created by congressional enactment. As the Court of Appeals observed, however, we have considered the applicability of the constitutional right to jury trial in actions enforcing statutory rights “as a matter too obvious to be doubted.” 467 F. 2d, at 1114. Although the Court has apparently never discussed the issue at any length, we have often found the Seventh Amendment applicable to causes of action based on statutes. See, e. g., Dairy Queen, Inc. v. Wood, 369 U. S. 469, 477 (1962) (trademark laws); Hepner v. United States, 213 U. S. 103, 115 (1909) (immigration laws); cf. Fleitmann v. Welsbach Street Lighting Co., 240 U. S. 27 (1916) (antitrust laws), and the *194 discussion of Fleitmann in Ross v. Bernhard, 396 U. S. 531, 535-536 (1970).[7] Whatever doubt may have existed should now be dispelled. The Seventh Amendment does apply to actions enforcing statutory rights, and requires a jury trial upon demand, if the statute creates legal rights and remedies, enforceable in an action for damages in the ordinary courts of law.

      Curtis v. Loether, 415 US 189, 193 (1974)

      1. 8.2.1

        Ned – correct. The reasoning of Patlex cannot be limited to a single administrative tribunal. Newman created the Article I “slippery slope,” and the PTAB (and whatever comes next) is her legacy.

        As for the statutory issue, the question is whether the statute displaces a traditional cause of action that existed at law, equity, or admiralty. If no, then an administrative claim (i.e. public right). If yes, then an Article III claim (i.e. private right).

        If merely “at statute,” what would exist of Article III?

        Hint: nothing.

        1. 8.2.1.1

          That’s pretty scary – and I cannot see the Supreme Court taking that path (as that would remove even them from the loop).

  8. 7

    This case is a rare instance where I am totally unconvinced by Judge Newman. Usually, if she writes an opinion, I find myself nodding along saying “if only the rest of the CAFC were just like her…” Here, however, I really I cannot see what she is trying to defend. Even if Von Itzstein does not name mouth inhalation in the list of ways to administer zanamivir, surely the PHOSITA knows that patients have mouths and that they can inhale things through the mouths. Once one also knows from elsewhere in the record (the opinion does not give the precise citation) that “young children… [a]re more susceptible to lower respiratory tract infections from the virus,” and that “oral inhalation delivers more drugs to the lower respiratory tract…,” it seems to me that obviousness is the only logical outcome here.

    Based on the facts as they are summarized in the opinion (and neither the majority or the dissent seem to disagree really on the facts), the PTAB clearly got this one right. Judge Newman’s dissent seems to me as nothing more than the occasional instance of “even Homer nods.”

    1. 7.1

      Greg, I can agree with everything but the word “occasional” in your last line.
      Judge Newman is now 89 years old – born on June 20, 1927. Not surprisingly, like many really old patent attorneys, she is not fond of all the new-fangled patent law from the Sup. Ct. and Congress.

      1. 7.1.1

        Judge Newman is now 89 years old – born on June 20, 1927.

        But totally not senile! Unlike, say, Judge Mayer (whose age-related dementia is perfectly evident, at least according to all the super serious armchair doctors over at the Junk Patent Luvvers Club).

        1. 7.1.1.1

          Although I don’t agree with her in this case, may she go on forever! We need a Pauline Newman preservation society to keep her active indefinitely. And prior to her judicial appointment she had much relevant experience in our profession.

      2. 7.1.2

        Well, I really will insist on that “occasional.” This particular Newman opinion seems to me to sail wide of the mark, but it is very much the exception. Usually, she runs circles around her colleagues in terms of her clear, lucid, and accurate exposition of the law. Nor do I see any decline in the quality of her written work today compared to 10, 20, or even 30 years ago.

        I will understand if she decides to take a well deserved retirement, but I certainly do not see any evidence that she needs to do so. If she qualifies as “senile,” we should all be so lucky to experience such “senility.”

        1. 7.1.2.1

          Greg, I made no suggestion at all of any senility – merely that [in several prior opinions] she has expressed her dislikes for some new-fangled patent law, like the decisions of IPRs, as here. That may logically influence her enthusiasm for reversing them, as here.

          1. 7.1.2.1.1

            It was MM that made the “senile” remark. Because he likes to put people down, particularly those with which he disagrees.

          2. 7.1.2.1.2

            I made no suggestion at all of any senility

            Fair enough. I still stand behind my earlier “occasional.”

        2. 7.1.2.2

          Usually, she runs circles around her colleagues in terms of her clear, lucid, and accurate exposition of the law

          The idea that Newman was some sort of goddess of legal clarity and logic crashed and burned around the time — pretty much at the peak of the bubble expansion — that she insisted we needed product-by-process claims to protect all those awesome “new” compositions that nobody could describe except by their manufacture. That’s when the cheerleading for Newman was revealed to be little more than just the usual cheerleading by the usual people for More Patents, All the Time, Easier to Enforce.

          Heck, even Judge Rader managed to figure his way through that “controversy.”

          1. 7.1.2.2.1

            Because anyone who does not agree with Malcolm is an obvious p00pyhead, duh.

            (Translated from the Malcolm fretting)

      3. 7.1.3

        “Judge Newman is now 89 years old”

        Jesus. I thought she was 70’s. Love the old bird but its time for a long vaca before the reaper man comes.

        1. 7.1.3.1

          Judge Stevens was great in Bilski at 89. Then he retired at 90.

          Appears to be having a great retirement still at 96.

    2. 7.3

      “Once one also knows from elsewhere in the record (the opinion does not give the precise citation) that “young children… [a]re more susceptible to lower respiratory tract infections from the virus,” and that “oral inhalation delivers more drugs to the lower respiratory tract…,” it seems to me that obviousness is the only logical outcome here.”

      Yes this is true, but how good is mere ordinary skilled artisan (no factual finding here who that is that I saw) at putting that 2+2 together?

      1. 7.3.1

        That is a really good point. I have pulled all of the PTAB decisions (this case went three times to the PTAB and once to the ED Va before this CAFC appeal), and I do not see where they ever make a fact finding about who is the person of ordinary skill. That really is reversible error. If Efthymiopolous had argued that point, he might have gotten somewhere.

        Mind you, the most that could have come from that is a remand to make fact findings on that point, at which point I would still be on an ultimate holding of obviousness. At least that way, however, Efthymiopoulos would have won his CAFC appeal, so that he would get the (C) time PTA back if he was ever able to squeeze a patentable claim out this application.

        1. 7.3.1.2

          “and I do not see where they ever make a fact finding about who is the person of ordinary skill”

          Obviously not.

          “If Efthymiopolous had argued that point, he might have gotten somewhere.”

          I think that’s what they were trying to argue, they just probably didn’t make it explicit. Their evidence that they presented as to the skepticism of those in the art as to whether it would work even while it was being tested (or whatever I can’t remember off hand specifically what it was) is evidence that tends to bear on that factor if I’m not mistaken. But you’re probably right that they neglected to make this all explicit. Bad lawlyering all the time. I still say we’d avoid this kind of nonsense if we spelled out all the volumes of caselaw on 103 in the fraking statute itself so that everyone could see specifically all the nooks and crannies everytime they read 103.

      2. 7.3.2

        how good is mere ordinary skilled artisan (no factual finding here who that is that I saw) at putting that 2+2 together?

        Fantastically good.

        Most kindergartners can add 2+2, after all.

        But leave it to a patent attorney to argue that unless we have some “fact finding” about what an “ordinary artisan” would think, then we should all pretend we were born yesterday.

        I have to say that these super serious concerns about the need for an express identification of the “skilled artisan” in every obviousness situation seems to be a hot new obsession for bulldog patent procurers. If you got nothing else, I suppose, might as well run with that.

        1. 7.3.2.2

          “Fantastically good.”

          I would be inclined to believe you MM except for the evidence the contrary that’s literally on the record here iirc.

        2. 7.3.2.3

          “But leave it to a patent attorney to argue that unless we have some “fact finding” about what an “ordinary artisan” would think”

          It’s not a fact finding about what they would think, it’s a fact finding about who they are. Though evidence of what actual people in the field think may bear on the question of who they are and fundamentally how good they would be at putting that 2+2 together. Esp as we cannot cross the line into “expert” territory wherein we surely have people that are “fantastically good” at putting 2+2 together.

          1. 7.3.2.3.1

            In my life before I became a patent attorney I used to be a research virologist. I worked with John Maassab, so I feel entirely qualified to say that the person of ordinary skill in this art would know to put the 2 and 2 in this record to get 4.

            That said, that is no excuse for the PTAB not to make findings on the ordinary level of skill in the art. That is the PTAB’s job, for pity’s sake. It is not good enough just to say “well, the CAFC can just fill the in the blank here.” It is not the CAFC’s role to make fact findings in the first instance, and the level of ordinary skill in virology is hardly the sort of everyone-knows-it fact of which the CAFC can take judicial notice. I definitely agree that, had this issue been raised, the CAFC should have vacated the PTAB decision and remanded for more fact finding.

            However, as I said above, I know (from personal experience) what the level of ordinary skill was for this case. Even if they had remanded it, the applicant was not going to reach allowance on these claims. Once the appropriate fact finding was made, these claims deserved to be rejected as obvious.

            1. 7.3.2.3.1.1

              So what would you say the level of ordinary skill is? Is it Mr. Maassab’s skill level or is it your lab partner’s skill level (who never invented squat, let’s presume)?

              1. 7.3.2.3.1.1.1

                Dr Maassab was an inventor, which means by definition that he was not a person of ordinary skill. The person of ordinary skill, of course, does not exist. This person is a legal fiction, like the “reasonable man” of tort law.

                Still and all, those of us who worked in virology back in the aughts know what “ordinary” virologists knew back then and how they thought. The idea that if some strains of flu set up their active infection in the lower respiratory tract, then that is where you will want to deliver the drug would not have escaped the “ordinary” among us.

                1. “The idea that if some strains of flu set up their active infection in the lower respiratory tract, then that is where you will want to deliver the drug would not have escaped the “ordinary” among us.”

                  Would love to believe you, but why the evidence of skepticism that it would work then? Perhaps even though they might know where the drug needs delivering to, they don’t think ordinary inhalation directly to the lungs orally would have worked?

                2. The “evidence for skepticism” reported in the case was that it was known that influenza typically infects the upper respiratory tract. But that “typically” reflects the fact that most studies are done in adults, and in adults the infection is usually localized to the upper respiratory tract. In children, it was known that many strains actually proliferate in the lower respiratory tract. Therefore, it would have been obvious to employ oral inhalation to children. Seeing as Efthymiopoulos did not limit his claimed method to adults, his claims read on obvious subject matter.

                3. The more that I think about this, the more I am inclined to believe that you are right to be skeptical of my earlier assertions about what the person of ordinary skill knew back then. As I think about it, the relevant art is medicine, not virology, and the PHOSITA was an MD, not a research virologist. I am not an MD and never have been, so what would I know about the level of skill of the ordinary artisan at the time of invention?

                4. Greg, wouldn’t it be nice to have actual people of ordinary skill in the art to decide obviousness?

            2. 7.3.2.3.1.2

              Greg, courts all the time make findings on what the level of skill is, then that is the last time this question even matters. It is irrelevant, because the question of obviousness depends not on a person’s education and work, but on what that what the relevant art teaches, which is the same as saying, what one of ordinary skill knows or should know.

              But the trier of fact is every time presented with the opinion of an expert that the person of ordinary skill would find x or y obvious. How are they going to decide this question? The question they need to decide is what an a person of ordinary skill knows — and would he or she know this or that.

              Here, it seems highly relevant that the worker would know that oral inhalation was a known alternative. However, Newman disputed this factual finding, finding the evidence lacking in the record.

            3. 7.3.2.3.1.3

              “once…
              If…”

              Like I said – I think this is the posture that Newman was taking here.

  9. 6

    From a case which I have been prosecuting:

    The compound of claim X or Y for parenteral, subcutaneous, intramuscular, intravenous, intrarticular, intrabronchial, intraabdominal, intracapsular, intracartilaginous, intracavitary, intracelial, intracerebellar, intracerebroventricular, intracolic, intracervical, intragastric, intrahepatic, intramyocardial, intraosteal, intrapelvic, intrapericardiac, intraperitoneal, intrapleural, intraprostatic, intrapulmonary, intrarectal, intrarenal, intraretinal, intraspinal, intrasynovial, intrathoracic, intrauterine, intravesical, bolus, vaginal, rectal, buccal, sublingual, intranasal, or transdermal administration.

    If anyone asks me how I take my coffee, my first reply is “by mouth”.

    Interestingly the application was published under the PCT and there is a granted EP0764023 which we can all read. The specification is sparse and there is no clinical data to demonstrate any problem in administering the compound by mouth, any special advantages in the oral route or any unusual difficulties to be overcome. The evidence pointed to by Judge Newman is post facto evidence, and is less convincing than data recorded in the specification itself. If I were to vote, I would follow Judge Prost in this case.

    1. 6.1

      Paul on the EPO file, did you read through Frank B. Dehn’s letter of 23 June 2000? I gather from it that inhaling through the mouth de-viruses the nose too, and that this is totally unexpected and totally awesome.

      I guess this surprising(?) technical effect is what got the Australian’s case to issue in Europe.

  10. 4

    DC: The case here is an example of the difficulty with the flexible obviousness analysis — it allows for well supported arguments on both sides.

    I’m not sure if I would refer to this case as an example of the “difficulty” of the “flexible” 103 analysis. The input of well supported arguments from both sides is a feature of any flexible test. The “difficulty” arises from the time required to wade through not only the well-supported arguments but all the poorly supported, self-serving, and/or irrelevant arguments that inevitably make up a large part of the proceedings.

    I only skimmed this case yesterday as it seemed very fact intensive and, well, b0 ring. But the core (and, I believe, undisputed) facts present a very difficult situation for the patentee here. Specifically, we have a prior art situation where the drug is old, it’s been administered nasally for the flu (with success), and at least one reference generically suggests this specific drug can be administered by “inhalation” (which would seem to include the mouth and nose, and why not?). On top of that we have an extensive and long history of successfully formulating all kinds of drugs for oral inhalation.

    Those facts set up a really tough prima facie case. Absent some really strong and specific teaching away from the oral inhalation of this particular drug, or some striking synergy arising from a very specifically tailored and claimed inhalation formulation, the patentee/applicant is fighting a losing battle. A hired expert opining about “some evidence of skepticism” just isn’t going to cut it.

    This is a great example of the PTO doing its job right.

    1. 4.1

      I think your analysis is accurate – in view of a strong prima facie case, the patentee needs fairly strong teaching-away evidence to carry the day. The argument regarding the “inhalation” (generally) establishes that the prior art taught the genus of which there are a very limited number of species – only 2! This limited number makes it difficult for the patentee to argue that selecting 1 of 2 possibilities is unreasonable, unpredictable, etc. for the phosita absent some very strong evidence to the contrary – i.e., it was dangerous or entirely ineffective to administer this class of drug through the mouth.

  11. 3

    DC: The case here is an example of the difficulty with the flexible obviousness analysis — it allows for well supported arguments on both sides.

    I’m not sure if I would refer to this case as an example of the “difficulty” of the “flexible” 103 analysis. The input of well supported arguments from both sides is a feature of any flexible test. The “difficulty” arises from the time required to wade through not only the well-supported arguments but all the poorly supported, self-serving, and/or irrelevant arguments that inevitably make up a large part of the proceedings.

    I only skimmed this case yesterday as it seemed very fact intensive and, well, boring. But the core (and, I believe, undisputed) facts present a very difficult situation for the patentee here. Specifically, we have a prior art situation where the drug is old, it’s been administered nasally for the flu (with success), and at least one reference generically suggests this specific drug can be administered by “inhalation” (which would seem to include the mouth and nose, and why not?). On top of that we have an extensive and long history of successfully formulating all kinds of drugs for oral inhalation.

    Those facts set up a really tough prima facie case. Absent some really strong and specific teaching away from the oral inhalation of this particular drug, or some striking synergy arising from a very specifically tailored and claimed inhalation formulation, the patentee/applicant is fighting a losing battle. A hired expert opining about “some evidence of skepticism” just isn’t going to cut it.

    This is a great example of the PTO doing its job right.

  12. 2

    If this is true: “There was evidence of skepticism even as oral inhalation was evaluated, ” then the prior art taught away and the method was not obvious.

    Its not a close call. The court is just wrong.

        1. 2.1.1.1

          Teaching away is where the prior art, considered as a whole, says “You can’t do X because Y.” And then you solve the problem.

          It’s not where the art says “X is a great way to do Y”, but you’ve dug up some paper or some “expert” who says “It doesn’t always work” or “Z is preferred.”

          1. 2.1.1.1.1

            Well, your quote marks not withstanding, if the “expert” is at least one of ordinary skill in the art and its not obvious to her to do it that way….maybe its not obvious to do it even though some poly sci majors think they can clip words out of 3 different documents and paste them together and make a sentence like the one in the claim, like some kind of ransom note in a 60’s cop movie.

            1. 2.1.1.1.1.1

              Les,

              You hit upon an important factor: PHOSITA.

              There tends to be an (anti-patent) tendency to not understand that just because some “art” may be prior, said art is not automatically “prior art” in the 103 legal sense.

              1. 2.1.1.1.1.1.1

                There tends to be an (anti-patent) tendency to not understand that just because some “art” may be prior, said art is not automatically “prior art” in the 103 legal sense.

                I have a long list of patent maximalist “tendencies”. I guess now would be the time to run through them since “anon” appears to be reaching for any excuse to fling his usual p00 around.

            2. 2.1.1.1.1.2

              Obviousness is the legal conclusion. The existence of teaching away in the art is a factor to be considered in reaching that conclusion.

              some poly sci majors think they can clip words out of 3 different documents and paste them together and make a sentence like the one in the claim

              I’m not sure why you want to bring software patent drafting into this discussion.

          2. 2.1.1.1.2

            You offer a false dichotomy.

            Your version of teaching away is more like “teaching against” (as in, ALL teachings say “such” is impossible (while your option is a bit of a strawman).

            Impossibility is not necessarily a part of teaching away.

            1. 2.1.1.1.2.1

              You offer a false dichotomy.

              LOL.

              I corrected Les (something that you never would have done) and I answered your question.

              By the way, John McCain called: he appreciates your vehement support of his Supreme Court strategy, whatever it happens to be this minute.

              1. 2.1.1.1.2.1.1

                My comment is in direct relation to you answering the question I put to you – it has nothing to do with Les’s comment, or your reply to Les’s comment.

    1. 2.2

      I wonder if you mean what you just wrote? Is any amount of skepticism among those in the field is enough to establish non-obviousness?

      Imagine that Dr. A writes in 2007 “technique K will not work.” Dr. B responds in 2008 “I disagree with Dr. A. There is no reason in principle that technique K cannot work in certain circumstances.” Does this establish non-obviousness?

      Certainly Dr. A’s remarks constitute “evidence of skepticism,” but from where I am standing I could not say that this alone is enough to convince me that a claim to modified-K is non-obvious by 2009.

      1. 2.2.1

        Look at the meaning of obvious. It means you walk right into it, trip over it. If Dr. A is one of at least ordinary skill and it is not obvious to him to use that technique, then it would not be obvious to one of ordinary skill. How can you say otherwise?

        If your saying, but here are 50 other Doctors that say K would work, then maybe your argument is Dr. A is not one of ordinary skill….but that’s a different argument.

        1. 2.2.1.1

          Got it. So you don’t mean “if… [t]here was evidence of skepticism… then the prior art taught away and the method was not obvious.”

          You meant to write “if… [t]here was evidence of skepticism among PHOSITAs at the time of invention… then the prior art taught away and the method was not obvious.” I suppose that this is fair enough.

          There will almost always be evidence of skepticism among some group, but if that group is composed of people with less than ordinary skill, the skepticism does not bespeak nonobviousness.

        2. 2.2.1.2

          Got it. So you don’t mean “if… [t]here was evidence of skepticism… then the prior art taught away and the method was not obvious.”

          You meant to write “if… [t]here was evidence of skepticism among PHOSITAs at the time of invention… then the prior art taught away and the method was not obvious.” I suppose that this is fair enough.

          There will almost always be evidence of skepticism among some group, but if that group is composed of people with less than ordinary skill, the skepticism does not bespeak nonobviousness.

    2. 2.3

      I tend to agree with your if-then, that if there is actually evidence of skepticism, then you may not have a reasonable expectation of success in combination (of course, this also depends on the prior art as a whole, and not just the reference expressing skepticism).

      However, it appears that, from the declaration, this skepticism seems to be only from the declaration of the inventor, who notes “uncertainties” about using oral inhalation. I guess Newman equates uncertainties to skepticism?

      Moreover, the prior art suggests inhalation and insufflation; Newman argues that the omission of “oral inhalation” suggests it was not a predictable solution and thus not obvious to try. Silly.

      Of course, because the above is not true, the court is not wrong, but correct.

    3. 2.4

      Both the nose and mouth connect to the rest of the respiratory system when inhaling with the mouth open. Was there any prior evidence that you only caught flu through your nose, or only got flu in your nose, and thus needed inhalation only through your nose [even if the nose was plugged up]? [I doubt it, or even breathing chicken soup vapor through your nose would be required.]

    4. 2.5

      The fact that it was tried meant that the PHOSITA expected it was more likely than not to work. The reality of clinical research is that you don’t put things into people unless you have a reasonable belief that it do what you want it to, without harming them.

      1. 2.5.1

        The reality of clinical research is that you don’t put things into people unless you have a reasonable belief that it do what you want it to, without harming them.

        Er, o.k., but when were the clinical trials done—before or after the date of invention? The fact that one had a reasonable expectation of success at the time of the human trials is not particularly informative as to whether one would have had a reasonable expectation of success at the time of invention (which is the relevant consideration), unless the human trials came before or roughly contemporaneous with the invention.

        1. 2.5.1.1

          Don’t EVEN get me started on pharma filing before they actually have possession of an invention….

      2. 2.5.2

        will –

        In the PHOSITA analysis the inventor is assumed to have beyond ordinary skill. By that I mean, if the fact that anyone made any invention meant that the invention was obvious to one of ordinary skill, then noting would be worthy of a patent. If it was obvious to PH merely oridinay SITA, then someone would would have done it sooner.

        1. 2.5.2.2

          Good point. Just because the inventor expected it to work does not mean that the person of ordinary skill would have expected it to work. An inventor is, by definition, not a person of ordinary skill.

        2. 2.5.2.3

          beware the “would have done it sooner” line of thought as that is NOT what the law of obviousness means.

          You are conflating 102 art and 103 art.

              1. 2.5.2.3.1.1.1

                If as you assert the “law of obviousness” means something other than what would logically follow from the meaning of obvious…i.e. If the Office can assert that something that was obvious to do but, was nevertheless not done by anyone, without any explanation as to why it was not done, though it was obvious to do….

                Then the statute is missing clothes….

                1. “Not done” is just not the same as “obvious to do.”

                  “Not done” is a 102 style argument.

                  The statute is not missing clothes, Les. Leastwise not in this regard.

                2. If the Office can assert that something that was obvious to do but, was nevertheless not done by anyone, without any explanation as to why it was not done, though it was obvious to do….

                  Then the statute is missing clothes….

                  If it was obvious to do for even those of merely ordinary skill, then why wasn’t it done? Seems to me that explaining that has to be an element to a prima facie showing.

                  Saying the King has clothes doesn’t make it so.

                3. I am not ignoring anything Les.

                  Maybe you want to realize that the term is a term of art and has a meaning in law that you may be missing out on.

                4. Maybe you are missing out on something.

                  If someone alleges that something is obvious, but no one has ever done the allegedly obvious thing or made the allegedly obvious combination then that someone needs to back up the assertion with some further explanation as to why the allegedly obvious thing or combination has never been made or done; else the assertion is merely conclusory drivel.

                5. Your addition here (the added explanation) is something that distinguishes have done (which would be a 102 rejection) and could do (a 103 rejection).

                  You STILL do not seem to appreciate exactly what the difference is between 102 and 103, and the mere reliance on “not done before” is simply legal error.

  13. 1

    A finding of non-obviousness often requires the person making the determination to be without ego or self purpose, since that person believes, based on the historical record, that “I wouldn’t have made that connection without hindsight” (even though the phosita is the proper target). It requires a fair amount of self reflection and the ability to resist human nature by admitting to a personal lack of capability. Hindsight reconstruction is tempting because it bolsters the ego, and because it provides the roadmap to a well supported argument.

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