Federal Circuit: No Deference to PTO Factual Findings from Prosecution

By Dennis Crouch

Novo Nordisk v. Caraco Pharma (Fed. Cir. 2013)

In a divided opinion, the Federal Circuit has affirmed a lower court trial ruling that Novo’s diabetes treatment patent is invalid as obvious. The patent covers the use of a combination of repaglinide and metformin to stabilize a patient’s glucose level. U.S. Patent No. 6,677,358. (Branded as PrandiMet)

At the time of Novo’s application filing in 1997, it was known that both repaglinide and metformin were useful for treating unstable glucose levels. Repaglinide is a secretagogue and combination drug therapies using metformin other secretogogues were already known to be successful. With those factual findings, the district court made the legal conclusion that the combination would have been obvious to one skilled in the art at the time of the invention. On appeal, the Federal circuit affirmed and rejected

We have an interesting setup in that Novo did not challenge the proposition that the combination was obvious to try. Still, the patentee argued that the synergy of the combination was unexpected and that, therefore, the combination was nonobvious. That argument has the potential of winning. However, in this case the Federal Circuit agreed with the lower court that Caraco had established “that the results of the claimed combination therapy said by Novo to be unexpected and unexplainable were, to the contrary, expected and explainable in light of the state of the art as of the critical date.”

A key element of the Federal Circuit’s decision is that the result flows from the findings-of-fact and findings-of-fact are reviewed for clear error on appeal. Thus, although Novo provided credible evidence that a skilled artisan would have been surprised by the synergistic effect of the proposed combination of drugs, that evidence was insufficient to overcome the clear-error standard.

Of course, this lawsuit is occurring long after the patent issued. However, one quirky element of the case is that the examiner stated in the prosecution history that the evidence of synergy presented during prosecution was the basis of the decision on allowance. In the later lawsuit, Novo argued that the examiner’s factual findings (based upon the same studies presented in court) should be given administrative deference. On appeal, the Federal Circuit rejected that argument and flatly concluded that the PTO findings should be given no deference during later litigation.

The initial determinations by the PTO in determining to grant the application are entitled to no deference as they would be in an appeal to this court under 28 U.S.C. § 1295(4)(A) or (absent new evidence) in a district court proceeding under 35 U.S.C. § 145. Rather, we treat the issued patent as having a presumption of validity that must be overcome by clear and convincing evidence. No decision of the Supreme Court or this court has ever suggested that there is an added burden to overcome PTO findings in district court infringement proceedings, and we reject Novo’s contrary assertion. Neither are we persuaded that the presence or absence of PTO findings on particular issues affects the basic presumption of validity.

This administrative deference issue is one that is ripening for further Supreme Court review and follows in the wake of the Supreme Court’s decision in Kappos v. Hyatt, 132 S. Ct. 1690 (2012).

The majority opinion was written by Judge Prost and signed by Judge Dyk.

Writing in dissent, Judge Newman argued that Novo’s “discovery of the synergistic combination of metformin and repaglinide meets the criteria of patentability, and was incorrectly held to be unpatentable on the ground of obviousness, 35 U.S.C. §103.”

The combination described and claimed in the patent in suit, U.S. Patent No. 6,677,358 (“the ’358 patent”), is eight-fold more effective than the additive properties, and is now apparently a treatment of choice for persons whose Type II diabetes had previously been untreatable. It is a lifesaving combination for such persons, and is valuable to other diabetics, for it permits a more flexible treatment regimen than prior products. The Novo inventors pursued this combination despite the advice of other “experts” that they were wasting time and money. Nonetheless the district court, and now my colleagues on this panel, find the combination obvious to them, and invalidate the patent. I respectfully dissent.

One of Judge Newman’s major points here is that – if anything – patents should offer legal protection for practical advances in science and medicine that actually save lives. That patent guarantee in turn would serve to encourage investment in achieving those advances.

= = = = =

The case is interesting to read for the legal-technical arguments made by the patentee against a finding of obviousness. After KSR and the fall of the teaching-suggestion-motivation test it appeared that obviousness had moved to a much more flexible analysis guided by common sense rather than bright line rules. Although unsuccessful here, the patentees arguments are interesting because they show ways in which that flexibility can be corralled.

121 thoughts on “Federal Circuit: No Deference to PTO Factual Findings from Prosecution

  1. AAA JJ,

    Thanks, I’m aware of 6′s utter ignorance of the law generally and patent law specifically. But I do enjoy pointing out his ignorance whenever I can!

  2. Have you read the case, arbitrage789 ?

    The case makes clear that the synergy of the combination was expected.

    Don’t be lulled with the word ‘synergy’ in and of itself.

    To the world of addition, multiplication looks like magical ‘synergy.’ But when you have one multiplication in the prior art, and the mystery is gone, then another multiplication can be, well, obvious.

  3. “The combination described and claimed in…US Patent No. 6,677,358…is eight-fold more effective than the additive properties”

    ________________

    If that’s really true, I don’t see how any judge can say that the combination is obvious.

  4. “You realize of course that the DC did not bother with ANY construction, right 6?”

    That is not what the decision said. The decision said that the court, in trying to “bother with ANY construction” could not find one that would make the claim eligible, and the patent owner wouldn’t provide one. I presume that the challenger wasn’t able to provide one either.

    That makes all 3 entities involved in the proceedings unable to find a construction that would make the claim valid.

    If you really really really want to bs with a Markman, then it is fine with me, I have no problem requiring a Markman, or giving the patent owner the construction he desires or giving them the one the court deems to be most beneficial to him, especially in this procedural posture.

  5. If the application itself is abstract

    How do you have an application itself that is abstract?

    Where in the claim as a whole are you trying to insert your canard of point of novelty?

  6. And you do not understand the plain fact that software is equivalent to firmware is equivalent to hardware.

    Components of a machine. Unassailable.

  7. Regarding Myriad – I have explained to you why what you think is itself wrong. I cannot force you to understand law, but you are simply being pedantic and far too literal with the phrase product of nature. The phrase is not ‘items producED by nature.

    If you refuse to understand why I was right in that case and why you are wrong, you will be stuck forever wrong.

    Not the place to be, son.

  8. You have not agreed with the quote because you constantly try to add additional conditions that are not there.

    And that is why you disappear EVERY time I ask for you to provide such citations.

  9. Anon, I am sorry but I have quoted authority to you. Benson was an example of using a general purpose digital computer and it was not approved by the Supreme Court. There is a difference between using a computer and modifying a computer so that it is a new machine. I don't think you understand that there is a difference.
     

  10. Anon, Judge Rich's position in Benson was that a programmed computer was machine and that a process of using a programmed computer was eligible. I hope you can see the this position has never been adopted by the Supreme Court.

    Regarding Myriad, I think the result in a case is wrong because isolated DNA is a product of man regardless of the structure is identical with that found in nature.
     
     

  11. You add qualifications that are not there in law. And you refuse to give any legal citation for your additions.

    Component parts are themselves patent eligible while having no utility sitting alone. Rivets, tires, and bullets. Software is equivalent to firmware is equivalent to hardware.

    Another ride on the Ned ignore the points raised merry-go-round.

  12. Ned,

    Saying” it is a strawman and avoiding any discussion on it paints your words as shallow and meaningless.

    Just as in the Myriad pre-decision discussion when I asked you to provide SOME (any) legal authority for the contrary view on products of nature – and you did not because you could not.

    When will you realize that I know this stuff way better than you?

  13.   Anon, I agree with the quote and have explained why I think a programmed computer can be eligible.  I just don't agree that a programmed computer, without more, is eligible.  That was the position of judge Rich in Benson.  That position was rejected

     
     
     

  14. Rich continued with that line even after Benson – and we both know why he could do so without censure.

    Because the anti-software rant in the Supreme’s Benson case was meaningless dicta.

    C’mon Ned – you were the one who provided the source explaining how bad it was to rely on dicta to make law, and yet you are the one way too eager to do EXACTLY that when that dicta serves your agenda. You are also the one to ignore the words of the Supreme Court when you think those words go against your agenda (re: Myriad).

    Your inability to evaluate law on an objective basis is why I always get the better of you in our discussions of the law of 101, or any law for that matter.

    You are too invested in your agenda, and cannot wield the law appropriately.

  15. Anon, I have answered this question many times. I have agreed in principle that a programmed computer can be eligible provided that the programming is permanent and modifies the operation machine.

    But your post is response to something I said which is quite different. I was talking about Judge Rich’s position. His position assumes that if a machine as recited in the claim, the method or process is eligible without more, a presumption that has been flatly rejected by the Supreme Court.

  16. a hack, who will do and say anything to achieve the pre-ordained result.

    LOL – Malcolm is at it again with his accuse-others-of-that-which-he-is.

    When faced with the definition of poor blogging being the spin of fact, law and what other people say, all Malcolm could do was stand by and [shrug].

    If anyone will do anything and say anything to further their agenda, that anyone is Malcolm (or Keeping It Real, or Robert, or Francis, or Shrivan, or Vivika M., or…)

    But let’s see another attempt at a crybaby’s veto…

    LOL

  17. The problem here is determining before novelty is assessed is whether the claimed process claims a new machine process or whether the process claimed is an old machine process that varies from the old machine process only in its application. If the application itself is abstract, then what really is claimed is unpatentable per Prometheus.

    I think in handling these matters that if the patent owner attempts to distinguish the prior art based upon the abstract subject matter that is not otherwise integrated into a patentable process per Diehr, then it should be open to the defendant to again raised 101 issue.

  18. Funny that you call “what I set up” a strawman, yet never (and I do mean NEVER) have actually addressed that quote in Benson. That quote – and not your added words and conditions absent from that quote.

    We both know why.

  19. Ned,

    You interjected several extemporaneous conditions that are found nowhere in law.

    I have REPEATEDLY asked you to provide legal citations for your ad hoc changes and requirements.

    You have never done so.

    Couple this with your blatant disregard for those words of the Supreme Court that you do not want to pay attention to (immediate example being the Myriad case and what I impressed upon you from Chakrabarty and Funk), and it is obvious just who is trying to serve a different agenda than what is current law.

    Hey – I have no problem discussing changes that anyone might want to suggest for the law – I do have a MAJOR problem with those that would misrepresent, spin and dissemble the facts and the current law to serve an agenda.

    Be honest – it will set you free (of course, you may have to decline service to your third party benefactors).

  20. Do your questions have any meaning? At all?

    Why do you persist in avoiding my post at 9:09?

    You are the one that is stalling and refusing to engage.

    Why is that?

    (and yes, you and I both know it is due to your third party interests)

  21. And, EG, I did not say that Benson flatly proscribed the patenting of program computers. Why don’t you read what I actually said to compare with what anon said I said. The two are different. Anon has again erected a straw man and knocked it down.

    The formalism I was speaking of was that if a machine, a programmed machine, is recited, in the view of Rich, as stated in the lower court opinion in Benson, the claim passes 101 and so does a method claim involving a programmed computer.

    This formalism was flatly rejected by the Supreme Court in Benson.

  22. EG, perhaps if you have been following discussions of anon myself for while you may have noticed that I a agree that if a programmed computer is claimed in a fashion so that the program is permanent and modifies the operation of the computer that the claim may be eligible.

    But there are no such limitations in most programmed computer claims. So a machine is not modified, but used. That is why the recitation of a computer in most of these cases is not claim to a modified computer, but rather a claim to using a computer to do its ordinary and normal function.

    I do not disagree with Diamond v. Diehr. They are the programmed computer was used to modify a process.

    I do not disagree with Alappat. There a programmed computer was used to modify the operation of a larger machine which was claimed.

    I have more to say on this particular issue in a few moments with respect to this case.

  23. Malcolm, I’m not sure Myriad is all Clarence Thomas’s fault. But the fact that he never even discussed cases like Parke-Davis, or the aspirin case, or the B12 case is remarkable. He seemed to pull the answer to Prometheus right out of thin air, that he simply followed the ill considered position of the US government.

    But Rader is a revolutionary. He will never willingly follow the Supreme Court because he disagrees with it on 101 matters, particularly with Benson, having been an acolyte of you know who. If a machine or process using a machine is claimed, it passes 101. That is the thinking of Judge Rich as he expressed in In re Benson.

  24. Ned: “One has to, has to, determine what is new, and whether that new subject matter modifies the old in a functional way."

    Anon: You are misstating the exception to the printed matter doctrine Ned

    Really?  Haven't you at least heard of the 101 integration test?  Haven't you read Diehr?  Haven't you read Prometheus?
     
     

  25. Rader throws the gauntlet in Ultramercial before SCOTUS to be clearer than the “fuzzy” Bilski decision

    That’s pretty much all he did. Not a very creative fellow, is he? He likes his kindergarten-level tests for eligibility and beyond that it’s all just oh so complicated. It’s safe to say that Rader is to computer “technology” what Clarence Thomas is to molecular biology: a hack, who will do and say anything to achieve the pre-ordained result.

  26. Maybe a substantive attempt (for the first time) will create an even bigger bonfire of Ned’s agenda than Malcolm’s pet theory suffered when he ventured forth for the first time trying to square Prometheus with the case most on point…

    Or maybe Ned will stonewall (again) and run away (again), and return on some other post and throw his CRP against the wall (again).

    Why do we (the royal we) allow such obvious poor blogging? Shouldn’t those (especially those that repeat this nonsense) be held accountable to answer valid questions and valid points raised against their soapbox views?

    C’est La Vie

  27. anon is correct.

    I agree, EG.

    You should have stopped right there.

    And yet, you cannot help yourself, can you?

    Have you ever wondered why not?

  28. LOL – some of ‘us’…?

    Who is ‘us?’

    And why again the purposeful misrepresentation?

    OPEN YOUR EYES, Leopold.

  29. Sorry Ned, anon is correct.

    I agree, EG. But what do you think – is anon (or “Honest Abe,” as some of us like to call him) correct that there are only eight-and-three-fifths robes on the Supreme Court?

  30. Sorry Ned, anon is correct. Gottschalk v. Benson doesn’t forbid patenting of computer programs (software). And Diamond v. Diehr is even clearer on that point. That Rader throws the gauntlet in Ultramercial before SCOTUS to be clearer than the “fuzzy” Bilski decision is SCOTUS’ problem to deal with.

  31. One has to, has to, determine what is new, and whether that new subject matter modifies the old in a functional way.

    You are misstating the exception to the printed matter doctrine Ned.

    You do have an ETHICAL responsibility for acknowledging controlling law and not trying to misrepresent that law.

    That ethical responsibility over-rides your duty to the third party for whom you post. You should be clear on that.

  32. And you Ned, continue yours.

    Tell me again, (and for the first time) why you have NEVER addressed one particular quote from Benson:

      “It is said that the decision precludes a patent for any program servicing a computer. We do not so hold”

    Your silence speaks volumes. When you choose to be silent screams so loud that I cannot hear your attempted subversion of the law.

  33. Ned,

    Try this: address the points I HAVE ALREADY RAISED and answer the questions I HAVE ALREADY ASKED before you embark on your hydra of more questions and ASININE hypotheticals.

    It is YOU that is stonewalling and avoiding.

    And leave the CRP analogies out of the discussion of law. Religion, like music is not recognized as belonging to the useful arts. Your briar patch will not be jumped into.

  34. anon,
     
    OK
     
    Try this.
     
    You go to church and encounter two boxes.   One says, “Insert nickel.”   The other says, “Insert $100.”   The sign in the first says that it forgives one venal sin per nickel. The second says that it forgives one mortal sin per $100.  The boxes are the same.  They are made of wood and have a slot in them for receiving he money.  Their power to forgive depends on the blessing given the boxes by a priest.
     
    Are these boxes patentable over other boxes with slots?
     
      

     
     

  35. Night, convey to me, slowly that even I can understand, the technological difference between the following two interactive systems:
     
    System with copyrighted works.System with uncopyrighted works.
     
    Rader is saying nothing more in 5000 words here than this:  If a machine (system) is claimed, it passes 101.  He fails to even acknowledge that Benson forbids this formalism.
     
    One has to, has to, determine what is new, and whether that new subject matter modifies the old in a functional way. 
     
    Rader will not give up.  He continues his revolution.
     
     
     
     

  36. with music

    AARRRGGGGHHHH.

    Stop with the canards already Ned. I just got done explaining this to you on the product of nature thread. Not only do you NOT address my point there, you turn around on the very next subject and repeat your gross error in legal logic AGAIN.

    For the love of GOD – stop.

    The claim here is not claiming the copyrighted works. But you DO have to take the claim as a whole, remember?

  37. NWPA,

    You can always count on Ned Heller to get Alappat wrong.

    The words “we hold” do not mean the court is announcing a holding to him. The fact that more than one issue can decide a case and that thus there can be more than holding in a case is lost on him.

    Ned posts to advance the agenda of a third party.

    This has been established beyond doubt. It takes some serious effort to bring Ned near to any type of intellectually honest exchange that encroaches on what his benefactor wants to push. Get close, and Ned either disappears or purposefully trainwrecks the conversation.

    This has happened only like a bajizillion times now. It’s the merry-go-round effect.

  38. Do I need to post yet another dictionary quote to show that I am using the word correctly and that it is you that is trying (too hard) to spin something?

    I have done this on a number of times, Malcolm.

    Go back to your corner and shine that metal helmet of yours.

  39. the DC did their best to magic them up a construction

    You realize of course that the DC did not bother with ANY construction, right 6?

    Absolutely clueless.

  40. Ned, you do not even ask questions that are relevant to patent law. You ask questions that are meant to intentionally deceive. Why don’t you go figure out the meaning of 1 + 1 with Bertrand and then come back and tell us.

  41. Night, we have an interactive system. It is a machine. It operates to confirm transactions with a user.

    Can we repent that machine if we use it sell copyrighted works as opposed to uncopyrighted works.

    Night, as long as we have been at this, you do not seem ever to be able to grasp the fundamentals of what is going on.

  42. We still need a doctrine, it appears, so that one cannot distinguish the prior art based on the abstract. In other words, if the prior art shows the interactive method claimed, the one should not be able to distinguish the prior art based on the abstract.

    Thus, a claim to a novel player piano with music is different from claiming an old player piano with new music.

    The old interactive system does not become patentable because it is applied to copyrighted works as opposed to uncopyrighted works.

  43. You see Ned a bit conveys structure to one skilled in the art. But, you know that, don’t you? You know that the question that is supposed to asked don’t you?

    The only ones taken in by your filth are the ignorant ones. And, the only type that appeals to the ignorant ones is the type that should be flushed.

  44. Your little games fool no one that understands patent law and science. They are nothing more than a pretext for not applying the law.

  45. Ned, this is not a philosophy exercise. It is does it enable any one skilled in the art to build it? YES. Does it clearly define the boundaries–YES.

    But, ole Neddie pooh would like to try to turn this into a conversation with Bertrand Russell.

    There is a machine. It works. The application tells others what it is and how to build and use it. Done.

  46. The best thing I can say about Rader’s opinion is that he is now at least quoting the holding of Alappat in addition to the dicta, and seems to understand Morse. But he says so many things that are flat out wrong or irrelevant that as a whole, he does not seem to get it yet.

  47. Good opinion by Lourie, and I agree with it.

    Rader also attempts to define abstract:

    “An abstract idea is one that has no reference to material objects or specific examples—i.e., it is not concrete.”

    Close.

    Recently I asked, “What is a bit?” I got various answers, but a “bit” is a number, a value. It is abstract. In contrast, a circuit to implement a bit typically has two states, one of which we call a “one.” the other of which we call a “zero.” Ones and zeros are abstract values.

    But a bit is abstract. The hardware implementation is not.

    Here we have an example of a system claim that calls for specific interactions between computers and an a user. I think the system thus specified is not abstract.

  48. The Dudas “Just Say No” era never happened

    The endless non-sequitur machine just keeps pumping ‘em out. Will Tr0llboy ever run out of nickels? Highly doubtful as long as he keeps working nights behind the 7-11.

  49. Not at all, the DC did their best to magic them up a construction that would be eligible, there’s nothing they can do if none such construction exists.

  50. Sure, under his “analysis” where he simply evaluates the abstract idea presented by the parties, the claim survives np. The abstract idea that was put forth by the parties is not preempt, and so the claim would stand regardless of the field of use limitations he buttresses with, and regardless of Alappat. That is because the abstract idea which is preempt by the claim is more complex than the one put forth by the challenger.

    The challenger just put forth a sound byte, as was put forth by the court in Bilski. The particular hedging method in Bilski is a bit more narrow than all of hedging, but it is still an abstract hedging idea. In the just the same manner, the abstract idea at issue here is a bit narrower than the sound byte put forth by the challenger.

    Of course, this shouldn’t matter, as the court has a responsibility to resolve this question of law in its entirety, not merely looking to what the parties are arguing about. Just as the USSC does, every single time.

  51. I’m also confident that the number of overzealous examiners is dwarfed by the number of underzealous examiners.

    The Dudas “Just Say No” era never happened either.

    /sarcasm off.

    Love that shiny hat you have Malcolm. Buff it yourself?

  52. every invention is directed to an abstract idea if you ignore all the concrete and practical aspects of the claim, as overzealous examiners have been wont to do.

    Actually, some inventions aren’t “directed” toward anything if you ignore the concrete and practical aspects. That said, I’m know some Examiners have been “overzealous”. I’ve seen some bizarre 101 rejections. I’m also confident that the number of overzealous examiners is dwarfed by the number of underzealous examiners.

    Having read Rader’s opinion in Ultramercial, I’m rather stunned at the combination of hubris and cluelessness therein. The whole thing is rather odd. He begins by downplaying the role that the prior art must play in 101 determinations, and ends by trumpetting the alleged “invention” in Ultramercial as some sort of awesome improvement in computer “technology”. There’s enough intellectually dishonesty in the opinion to choke even Clarence Thomas’ horse.

  53. “It’s how people in the real world who haven’t been polluted by patent crack think about this stuff.”

    Right, but not imaginary men :(

  54. MM, is you main objection here to the post-filing evidence?

    I think post-filing evidence to support non-obviousness shouldn’t be allowed unless the Examiner has doubts about the experiments and wants them repeated or wants to see better controls. And generally speaking “unexpected synergy” should not be sufficient to rebut a strong prima facie case of obviousness of a new mixture (e.g., where there is teaching in the art that the components of the mixture are each useful and where there is no teaching that combining them would be harmful; some expert saying it would be a “waste of money” for a business to develop and patent the drug is not “teaching away” from the combination — that’s just “teaching away” from commercialization).

    You seem to think it is always concocted in some way.

    It often is. Read this opinion. Whether or not you believe there was inequitable conduct, there was certainly a lot of “concocting”. That’s because the declarant refused to sign his name to a declaration that said that the synergy was apparent from the data in the original application!

  55. Yes… Thus, not fact finding as is the case here. I presume it’d be some Mead sort of deference… lower than Chevron to be sure.

  56. I don’t think that is what I said.

    No, that isn’t what you said. It’s what I said. It’s how people in the real world who haven’t been polluted by patent crack think about this stuff.

  57. In their subjective opinion, it was. Or else there was some other reason, as yet unknown to this record.

    Gosh, what could those reasons be?

  58. Hey!!! Perhaps 6 letters is too much. Too convoluted. Too willing to speak in abstractions. Too, well, too long.

  59. “Too bad you 1 number people are too small to understand the reasoning. ”

    I got all of his reasoning just fyi. I disagree with some of it, but not all of it. He puts just enough in that is counter to the law to save these claims. Np, if the supremes take it all will be set straight. And he’s teed up several subjects for appeal.

    The procedure for adopting claim constructions at the DC. (which he gets right) But then his part about what happens in the event that there are none presented or made up by the court that allow for the claims to be eligible he manages to boink up.

    He tees up whether the court needs to try to find the abstract idea being preempt or whether it should rely on the parties.

    He tees up alappat for destruction, by invoking it, even though he didn’t need to because of his earlier mess ups.

    To name at least 3.

  60. ” Rader gets it. Too ”

    Rader gets what? That the challenger boinked up his argument? Yeah we knew that already, a long time ago.

  61. Apparently I lost the rest of my rather lengthy comment and I’ll likely have to end up typing it up again at some point.

    Suffice to say, I agree with Rader in so far as the challenger boinked up on the abstract idea at issue.

    I disagree with him on the ultimate holding because the court has a responsibility to resolve this issue of law properly, and not merely in conjunction with what was being argued by the challenger as being the abstract idea. And the court could easily have figured out the abstract idea preempt here. I have posted it several times myself, and it didn’t take more than 15 minutes or so.

    I likewise disagree with his proposal to presume a magical claim construction that the DC couldn’t even dream up that would make the claim eligible. If the challenger presents one that makes the claim ineligible and if there appear to be no other claim constructions as here, or if the court determines that there are none that it can think of that would make the claim eligible then that should be sufficient to proceed. Even under this procedural posture.

    Mostly though I disagree with his assertion (/misreading of the caselaw) that they’re not to go hunting for abstract ideas to compare against the preemptive effect of the claim. That is in fact what the USSC does in every 101 case, so I’m pretty da m sure that’s what is supposed to be done. It should not be up to the challenger to figure it out on his own since this is a question of law reviewed de novo. And it sure as the world is to be done at the office when determining this question of law.

    Also, his attempts to bring in field of use limitations to buttress his holding is rather hilarious. He should have quit while he was ahead and not teed up Alappat for destruction quite as much as he did. Because we already know the supremes have their eye on this case. If they take the case, the claim will be invalidated without a doubt regardless of what the challenger has argued, because the supremes will go on a hunt as is proper.

  62. Great opinion isn’t it, 6? Rader gets it. Too bad you 1 number people are too small to understand the reasoning. Perhaps you should broaden yourself and take on some more digits.

  63. I have to say he sure went through a lot of trouble to get himself vacated again.

    I mean, really? It isn’t that hard to spot the abstract idea at play in this case. If I can do it, Rader can do it.

    Just reading this farce is about hilarious. Rader seems to think that the DC “erred” in requiring a claim construction that would make the claim eligible from the patent owner. I’m afraid that is not an error if the court cannot come up with one itself, which was the case here. It is far from “presumed” that such a magical construction exists if nobody can produce such. That is a preposterous way to conduct claim constructions and it sure as f will not happen in my office where there is no presumption of validity for them to fall back on. And yes, it is preposterous even in that ridiculous procedural posture. Indeed, the district court did (or attempted to do) exactly what Rader suggested, adopted the construction most favorable to the patent owner. The fact that construction most favorable to the patent owner that the DC could think of turned out to not be up to snuff anyway is quite irrelevant.

    “Because the parties here focus only on the second step, we do as well. ”

    However, at the end of the day, that is acceptable since the parties messed it up themselves. Rader rightfully puts the blame for this messed up 101 analysis at the feet of the challenger who did a bad job.

  64. Maybe this will be the great software case that goes to the SCOTUS.

    Rader has it right. I am surprised that Lourie went along. O’Malley is pretty solid.

    Although I am guess the two lettered people will disagree. Us four letter people think 4 letters and not just 2 so we get it right.

  65. To elaborate a little, it appears that Judge Rader thinks the 101 nonsense has gone on long enough – he spent quite a bit of time talking about the narrowness of the judicial exceptions, and also correctly noted that every invention is directed to an abstract idea if you ignore all the concrete and practical aspects of the claim, as overzealous examiners have been wont to do.

    The summary of the Supreme Court case law seems pretty good, though I sense some discomfort with the facts of Benson. (I could be sensing my own discomfort – my personal opinion is that the law in Benson is fine, but the Court applied it incorrectly to the facts.)

  66. Off topic: The new Ultramercial case is out: link to cafc.uscourts.gov .

    I’ve only skimmed it, but it looks like Judge Rader has done a nice job (even if he did ignore “Integration Analysis”), and reached the right conclusion.

  67. A. Y. Mous, In the PTO, no sweat. In the DC, they were held to have committed IC for failing to inform the PTO that a rat experiment was not on humans and that the researcher has changed his protocols after he started.

  68. The patented product was “eight-fold more effective than the additive properties”! How does that evidence fail to overcome the prima facie case of obviousness?

  69. What? No Chevron-deference given the administrative agency? Wouldn’t the APA apply in this matter? No mention of Chevron in the opinion.

  70. They did not need to say that. That’s called a first action on the merits, and luckily applicants still have the right to fight that at the Office.

  71. No deference to the examiner? I wonder if that’s a backhanded comment about the overall quality of the examination process. Could be worse. They could have said there is a presumption the examiner is wrong.

  72. She say that “difference” between patent disclosure and what “skillfull person” know can be really small. Hence she would strenghen patents, and weaken possibilities of invalidation.

    And skillfull person do not need to have EXACT knowlege, as disclosed in patent. Just that given settup could be used to acheaved means described in patent.

    Because just finding what is best is not magically making “invention” patentable.

  73. Tom asks: How can a test that is used 90% of the time be characterized as a test that has experienced any “fall”???

    Tom answers: KSR did have an impact on the TSM test during litigation.

    In any case, I’m pretty sure all Dennis meant was that the legal requirement for explicit TSM in the prior art was removed by KSR. The best obviousness rejections will always be the rejections with the best express teaching towards the claimed combination/improvement.

  74. “An ordinary person hearing that two drugs, X is Y, are good for Z would think that a combination of X and Y is a non-obvious way of treating Z? ”

    I don’t think that is what I said. In fact, I’m pretty much sure that I didn’t. What I said, if written out long hand, was something more along the lines of that an ordinary person hearing that two drugs, X and Y, are good for Z would think that a combination of X and Y is a non-obvious way of treating Z AFTER IT WORKS AND THEIR BUDDIES TOLD THEM THAT EVEN TRYING WAS A WASTE OF TIME TO BEGIN WITH AND AFTER NOTING THAT THEY HAD MUAH RESULTS. Underlined there at the end.

  75. “Uh … so?”

    So… they told him not to waste his time?

    “That’s not a “waste of time or money.” ”

    In your subjective opinion. In their subjective opinion, it was. Or else there was some other reason, as yet unknown to this record.

  76. there is something to be said for a patent on a combination that shows a real technical advance

    Right, something should be said like “maybe you should have claimed a method of administering a very specific dosage of a specifically defined mixture to a particular group of patients and put that claim in your original filing.” You know, give people patents on what they actually invented, rather than patents on obvious mixtures just because the demonstrated some “synergy” years after they filed the application.

    The good news is the Federal Circuit got it right here.

  77. “Why would it be a “waste of time” to see what happens when both are administered?”

    Presumably because they figured that the results would simply be additive?

    Uh … so? People do combinations of things all the time without expecting or obtaining a synergistic effect. That’s not a “waste of time or money.”

    all I’m saying is that from my somewhat layman’s perspective, my invisible ordinary skilled man would probably find this not to be obvious

    Hmm. An ordinary person hearing that two drugs, X is Y, are good for Z would think that a combination of X and Y is a non-obvious way of treating Z? I don’t know about you but where I’m from the ordinary people don’t think like that. Has the PTO granted a patent on a chocolate bar with pomengranate seeds and peanuts yet?

  78. The statement by Prof. Crouch refers to the “fall of the TSM test.” This is an incorrect statement. It is not correct to state that the TSM test experienced any “fall.” Please see my article in JPTOS, where I provide data that demonstrates that the TSM test is alive and well in the USPTO. The complete statement of Prof. Crouch is as follows: “After KSR and the fall of the teaching-suggestion-motivation test it appeared that obviousness had moved to a much more flexible analysis guided by common sense rather than bright line rules.” My article in JPTOS demonstrates that, in the year or so after the KSR holding, it was the case that about 90% of the obviousness rejections by examiners in a variety of technologies, were based on the TSM test. (How can a test that is used 90% of the time be characterized as a test that has experienced any “fall”???) In contrast to the situation in the USPTO, as demonstrated in my article, the KSR did have an impact on the TSM test during litigation. The notion that rejections for obviousness “moved to a much more flexible analysis guided by common sense” is an incorrect notion. THIS IS NOT LEGAL ADVICE

  79. “MM, there is something to be said for a patent on a combination that shows a real technical advance rather that the fluff coming out of the some branches of the patent office.”

    Amen to that.

    And a further glory be and hallelujah! Lulz.

    Call me old fashioned, but this seems to be more or less the entire point of the patent system.

  80. “Why?”

    Because that is what they subjectively believed? Perhaps this is because real humans are somewhat more tar ded than the invisible man that you have constructed for your own use in the obviousness analysis.

    “Why would it be a “waste of time” to see what happens when both are administered?”

    Presumably because they figured that the results would simply be additive? Then it turned out they were synergistic and produced a multiplicative effect and everyone thought it was super awesomez?

    “Prior to the filing of the application, dabetics who knew how to read might well have self-administered both drugs to themselves if they were struggling to keep their glucose levels down.”

    And depending on whether or not they are prescriptions with serious side effects they may have suffered some severe reactions.

    Look bro, I’m not equipped to sit and argue with you about all this, all I’m saying is that from my somewhat layman’s perspective, my invisible ordinary skilled man would probably find this not to be obvious based simply on just the facts as I know them (I have not looked deep into them).

  81. “And just in case you were wondering, the admission of post-filing evidence to rebut a prima facie case of obviousness is allowed in some jurisdictions but in most jurisdictions the evidence that can be presented is limited depending on the nature of the evidence and its relationship to the the problems and advantages disclosed in the original filing. In other words, the other jurisdictions are generally intellectually honest enough to admit that there is, in fact, some logic for the proposition that the unexpected results relied on for a patent be put in the specification upon filing. ”

    That just sounds like a requirement for a nexus under a different name. At least in so far as its ultimate effect.

  82. “Moreover, given that some such “unexpected” synergy can nearly always be found, where is the quid pro quo in allowing applicants to first claim the obvious mixture with no demonstration of synergy and then LATER demonstrate the buried “synergy”? ”

    The disclosure for a patent? At least that was what I thought the quid pro quo was.

    “The composition was obvious at the time of filing.”

    Not necessarily. There simply existed grounds for concluding that it would have been obvious. In this case though especially there were extra grounds for concluding otherwise, his buddies. Here you have two secondary considerations, not just the one. Frankly I see the synergism as the lesser of the two factors, and would weight it accordingly when the evidence is being weighted.

    And yes, I understand what you’re saying about there always being “some” unexpected result. But that unexpected result has to have a nexus with the combo being made, and a not-insubstantial one at that. Otherwise, that sht gets ignored or weighted so lightly that you may as well consider it ignored.

    But even if you’re right, and that there is always some unexpected something then that’s just tantamount to saying that the bio field is wide open for patenting. Frankly I don’t see a lot wrong with this. My art is wide open. It is trivially easy for me to invent something at my desk, right now, that is conceivably as valuable as the majority of the things I work on. And it would be trivially easy to obtain a patent for the same depending on whether or not I get one of the few newbies examining or one or two of the old ta rds whose allowance pen is always out of ink.

    “(almost always more specific than the originally disclosed mixture)”

    In other words, no real nexus. No nexus, no secondary consideration. It’s that simple.

    “LOL. Let’s face it: nobody could wank like Judge Rich. The guy was a master.”

    This is true.

  83. So how do we reconcile the years of deference in the context of administrative law and federal agencies with how CAFC essentially disregards agency decision making here by flatly saying the Examiner was wrong and that the synergy was in fact obvious?

    Evidence provided to the Examiner and CAFC was credible and that one skilled in the art would hav ebeen surprised. If it’s credible according to the agency meaning the obviousness determination is not clearly erroneous, doesn’t administrative law suggest that’s the end of the analysis?

  84. MM, there is something to be said for a patent on a combination that shows a real technical advance rather that the fluff coming out of the some branches of the patent office.

    I think the real question here remains “obvious to try.” If there are twenty known candidates to investigate and no expectation of consistent success, I have a hard time seeing that it was obvious to try all of them.

    A captain sails the Atlantic and looks for the Northwest passage to the Pacific. He has a choice of 20 possible points of access to the interior. He knows from prior attempts that many lead to dead ends. Some lead to passages that freeze over most of the year.

    He, by chance or persistence, eventually finds one that allows clear sailing most of the year, Atlantic to Pacific.

    If we deny the captain his patent, do we undercut his enthusiasm for publishing his map?

  85. It’s like a requirement

    The only “requirement”, Tr0lb0y, is that you keep fluffin’ those patents, no matter how clueless you are about the technology. That’s what Judge Rich wants you to do. He loves you, Tr0lb0y. He really does.

  86. Newman seems to make a good point that not all combinations exhibited any synergy at all.

    No synergy was detected, at least, under the specific experiments that were conducted and using the specific assays that were used. That doesn’t mean that there wasn’t any synergy arising from those other combinations.

    Let’s say that someone else reads the decision and repeats those same experiments and uses a different assay and finds that that there was some synergy in one of those tested combinations. Should they get a patent on that combination? Of course not. But from Newman’s policy perspective of handing out composition patents to people just because they show some “practical advance” that “saves lives” or otherwise makes your mom/kid/turtle a bit healthier, that’s the wrong result.

  87. LOL. Let’s face it: nobody could wank like Judge Rich. The guy was a master.

    It’s like a requirement that Malcolm must accuse others of what he does.

    He is this site’s biggest W@nker, bar none.

  88. And just in case you were wondering, the admission of post-filing evidence to rebut a prima facie case of obviousness is allowed in some jurisdictions but in most jurisdictions the evidence that can be presented is limited depending on the nature of the evidence and its relationship to the the problems and advantages disclosed in the original filing. In other words, the other jurisdictions are generally intellectually honest enough to admit that there is, in fact, some logic for the proposition that the unexpected results relied on for a patent be put in the specification upon filing.

    Would anyone like to argue that the “best practice” is to worry about gathering such evidence after the application is filed?

  89. 6: Inherent synergism or whatever you want to call it, is either present or it isn’t, just because it was discovered after they put in an application doesn’t really seem to change that one way or the other.

    It’s true (and trivially so) that the date on which the synergy is discovered does not change the fact that the synergy is inherent to the administration of the drug. I’m glad we can all agree on that. Basic science lives!

    But we’re talking about under what circumstances a patent should be granted on an otherwise obvious combination of drugs — a composition of matter. There’s some issues that arise with post-filing showings of synergistic effects to prove non-obviousness. First, given the complexity of biology, it’s almost always going to be the case that some “unexpected” synergy can be found somewhere. It’s also true that the harder you need to look, the more likely that the relied-upon synergy is going to be something that is specific to the dosage regime and to the pecularities of the patient. Those latter aspects are certainly not “inherent” to the mixture that is claimed.

    Moreover, given that some such “unexpected” synergy can nearly always be found, where is the quid pro quo in allowing applicants to first claim the obvious mixture with no demonstration of synergy and then LATER demonstrate the buried “synergy”? The composition was obvious at the time of filing. That didn’t change. What changed is that the applicant later “invented” a method of administering a specific mixture (almost always more specific than the originally disclosed mixture) to certain patients under certain conditions to achieve a certain result. That’s indicative of a possible invention of a method of treatment, not the patent-worthy invention of an otherwise obvious composition of matter.

    In re Chu is a classic example of the Federal Circuit just putting the patent pedal to the metal because the panel was so high on patent crack that they couldn’t find a reason not to. Who were the judges? Rich, Newman and Skelton. Here’s their deep-thinking analysis of the issue:

    We have found no cases supporting the position that a patent applicant’s evidence and/or arguments traversing a Sec. 103 rejection must be contained within the specification. There is no logical support for such a proposition as well

    link to bulk.resource.org

    LOL. Let’s face it: nobody could wank like Judge Rich. The guy was a master.

  90. Synergy there was. Even if Synergy was expected, was it expected to the degree it actually exhibited? I think not.

    Newman seems to make a good point that not all combinations exhibited any synergy at all.

    Obvious to try: There were 20 known secretagogue. That seems to be a large number, especially if it known that some show no synergy. What is the motivation to try so many different combinations?

    Obvious to try seems to suggest that one has a range of alternatives all of which are expected to work. Picking one is simply a design choice. But if the range is large, and some are known not to work, what then?

  91. AAA JJ: There is no requirement that applicants for patents present “compelling” evidence (whatever standard that may fall under, care to enlighten us?) that the prior art “taught away” from their claim(s).

    That’s nice. I never said there was such a requirement. Maybe you can learn to read? It’s a good skill if you are a patent attorney, which you clearly aren’t [< -- a page from your Book of Lame Logic Leading to Incorrect Results. Enjoy!].

    On the other hand, if you are presented with a prima facie case of obviousness, as in this case, it sure is nice to be able to show that the art teaches away from the combination. I’ve definitely relied on that to get cases allowed, although it’s the rare case where the facts are squarely aligned like that.

    6 opines thusly: she means that they were saying that they were wasting their time even trying out the combo

    Why? Both drugs were known to be effective. Both were known for treating unstable glucose levels. There was no evidence suggesting that the combination would be bad for patients. Why would it be a “waste of time” to see what happens when both are administered? Prior to the filing of the application, dabetics who knew how to read might well have self-administered both drugs to themselves if they were struggling to keep their glucose levels down. Would those patients have been “wasting their time and money” as well?

  92. “Unless I missed it, there was no compelling evidence that the prior art ‘taught away’ from the claimed combination.”

    There is no requirement that applicants for patents present “compelling” evidence (whatever standard that may fall under, care to enlighten us?) that the prior art “taught away” from their claim(s). You seem to be confused on the whole burden of persuasion thing. Hint: it remains on the PTO throughout the prosecution and is never on the applicant.

    Do you still insist that you are an actual practitioner?

  93. “I’m not really sure that should matter all that much. Inherent synergism or whatever you want to call it, is either present or it isn’t, just because it was discovered after they put in an application doesn’t really seem to change that one way or the other.”

    This is correct. See In re Chu.

    “Idk bro. But I think she means that they were saying that they were wasting their time even trying out the combo, not that they were wasting their time because they wouldn’t make bank.”

    This is also correct. But it’s nice to see an examiner reminding Mooney on the law of secondary considerations. Why anybody who claims to be a practitioner would be against the consideration of any and all evidence relevant to patentability remains a mystery. Much like the mystery of Dennis’s stooge Malcolm continues to insist that he actually is a practitioner.

  94. “There was evidence and teaching in the prior art that the combination could have synergistic effects.”

    Then why did their buddies say they were wasting their time? Someone here is not being forthright.

    “If worse comes to worst, as it did in this case, you put some post-filing data in front of the Examiner, via a declaration, “proving” that the synergy is even more awesome than you suggested in your specification. That post-filing data was key here because the declarant who provided it admitted that the data in the specification was insufficient to show synergy (top paragraph of page 16 of the opinion). ”

    I’m not really sure that should matter all that much. Inherent synergism or whatever you want to call it, is either present or it isn’t, just because it was discovered after they put in an application doesn’t really seem to change that one way or the other.

    “The Novo inventors pursued this combination despite the advice of other “experts” that they were wasting time and money.

    I wonder how much of that “advice” was predicated on the belief that the invention was unlikely to be deemed patentable? Unless I missed it, there was no compelling evidence that the prior art “taught away” from the claimed combination.”

    Idk bro. But I think she means that they were saying that they were wasting their time even trying out the combo, not that they were wasting their time because they wouldn’t make bank.

  95. One of Judge Newman’s major points here is that – if anything – patents should offer legal protection for practical advances in science and medicine that actually save lives. That patent guarantee in turn would serve to encourage investment in achieving those advances.

    Right, and why do patents “encourage” certain types of “investors” to put their money behind patent-backed ventures? Because they can maximize the amount of money they get back. Where does that money come from? It comes from people who don’t own patents and who never will and who, in many cases, would appreciate paying quite a bit less for an “advance” that wasn’t really an “advance” at all.

    patents should offer legal protection for practical advances in science and medicine that actually save lives

    Perhaps the law should be changed, then, to should remove obviousness as a consideration when granting patents on “practical” medical treatments. Than all “practical advances” will be patent-worthy. I think that would be bad idea.

    Newman here seems to arguing that the combination of these drugs was non-obvious because the results were unexpected. That issue was litigated. It’s one thing for Newman to explain why, in her view, the majority reached the wrong conclusion on non-obviousness. The ad copy bal-ney regarding “life saving” this-and-that is beside the point. Both of the drugs in the mixture were known to be useful for diabetics prior to the filing of the application. There was evidence and teaching in the prior art that the combination could have synergistic effects.

    The prosecution of this case is a classic example of how obvious drug combinations become granted patents at the USPTO. With the help of the in-house counsel or the application drafting attorney, the clinical data is combed over for ANY and all indications that some observed result of the drug administration, no matter how obscure or trivial, is “synergistic”. Then you ask the “inventors” to come up with a situation where that observed fact might actually matter. Then you hammer the Examiner on how nobody could have predicted the awesomeness of the combination. If worse comes to worst, as it did in this case, you put some post-filing data in front of the Examiner, via a declaration, “proving” that the synergy is even more awesome than you suggested in your specification. That post-filing data was key here because the declarant who provided it admitted that the data in the specification was insufficient to show synergy (top paragraph of page 16 of the opinion).

    As for this Newman quote:

    The Novo inventors pursued this combination despite the advice of other “experts” that they were wasting time and money.

    I wonder how much of that “advice” was predicated on the belief that the invention was unlikely to be deemed patentable? Unless I missed it, there was no compelling evidence that the prior art “taught away” from the claimed combination.

  96. One of Judge Newman’s major points here is that – if anything – patents should offer legal protection for practical advances in science and medicine that actually save lives. That patent guarantee in turn would serve to encourage investment in achieving those advances.

    Right, and why do patents “encourage” certain types of “investors” to put their money behind patent-backed ventures? Because they can maximize the amount of money they get back. Where does that money come from? It comes from people who don’t own patents and who never will and who, in many cases, would appreciate paying quite a bit less for an “advance” that wasn’t really an “advance” at all.

    patents should offer legal protection for practical advances in science and medicine that actually save lives

    Even obvious “advances”?? Perhaps we should remove obviousness as a consideration when granting patents on “practical” medical treatments. Then we can really “promote progress”! We’ll all be healthier as a direct result, and our “job creators” will become even richer, which makes them happy, which is really all that matters.

    Seriously, Newman here seems to arguing that the combination of these drugs was non-obvious because the results were unexpected. That issue was litigated. It’s one thing for Newman to explain why, in her view, the majority reached the wrong conclusion on non-obviousness. The ad copy baloney regarding “life saving” this and that is beside the point. Both of the drugs in the mixture were known to be useful for diabetics prior to the filing of the application. There was evidence and teaching in the prior art that the combination could have synergistic effects.

    The prosecution of this case is a classic example of how obvious drug combinations become granted patents at the USPTO. With the help of the in-house counsel or the application drafting attorney, the clinical data is combed over for ANY and all indications that some observed result of the drug administration, no matter how obscure or trivial, is “synergistic”. Then you ask the “inventors” to come up with a situation where that observed fact might actually matter. Then you hammer the Examiner on how nobody could have predicted the awesomeness of the combination. If worse comes to worst, as it did in this case, you put some post-filing data in front of the Examiner, via a declaration, “proving” that the synergy is even more awesome than you suggested in your specification. That post-filing data was key here because the declarant who provided it admitted that the data in the specification was insufficient to show synergy (top paragraph of page 16 of the opinion).

    As for this Newman quote:

    The Novo inventors pursued this combination despite the advice of other “experts” that they were wasting time and money.

    I wonder how much of that “advice” was predicated on the belief that the invention was unlikely to be deemed patentable? Unless I missed it, there was no compelling evidence that the prior art “taught away” from the claimed combination.

  97. A rare occasion where I may well agree with Newman, if, IF what she says is in fact the case. Which it rarely is. I don’t have time to dig into this today to find out.

Comments are closed.