In re Kao: Important Decision Controlling BPAI Obviousness Holdings

In re Kao, ___ F.3d ___ (Fed. Cir. 2011)

In an important decision for patent prosecutors, the Court of Appeals for the Federal Circuit has partially overturned a PTO obviousness decision. The question on appeal for all three related patent applications was whether the Board of Patent Appeals & Interferences (BPAI) had properly held the pending claims obvious.

Background: Endo Pharmaceuticals has three pending patent applications that were all rejected on obviousness grounds and those rejections were affirmed by the BPAI. The applications relate to controlled-release oxymorphone tablets and were all found obvious as compared to Patent Cooperation Treaty (PCT) Pub. No. WO 01/08661 (“Maloney”).

Obviousness: The Section 103(a) of the patent act states that a claimed invention is unpatentable “if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art.” In Graham v. John Deere, the Supreme Court outlined a set of factual inquiries that should serve as the basis for the ultimate legal question of obviousness. When a BPAI decision is appealed directly to the Federal Circuit, the appellate court affirms factual findings so long as they are supported by “substantial evidence,” but reviews ultimate obviousness conclusion de novo. Theh substantial evidence requirement offers substantial deference to the BPAI and will be accepted so long “as a reasonable mind might accept [the evidence as] adequate to support [the] conclusion [being drawn].” Quoting In re Kumar, 418 F.3d 1361 (Fed. Cir. 2005).

BPAI Factual Findings Lack Substantial Evidence for the ’432 application: The parties all recognized that controlled-release oxycodone was within the Maloney prior art. The Board made the further factual conclusion that the claimed invention, including a claimed dissolution rate, would be realized by taking a chemical formula provided by Maloney and replacing the known oxycodone with the claimed oxymorphone. On appeal, the Federal Circuit held that this factual finding was not supported by substantial evidence.

Accepting that it would be obvious to substitute oxymorphone in Maloney’s Formula 6, the Board’s reasoning nonetheless does not pass the substantial evidence threshold as to whether such a substitution would indeed fall within the dissolution profile of pending claim 1.

The problem was that the dissolution rate reported in Maloney was measured in a different way than that claimed by Endo, and the USPTO provided no “direct factual support in the record for the view that the claimed range of dissolution rates actually over-laps with the dissolution rate disclosed in Maloney.” In this case, testimony before the board (from Endo’s expert) was that “there is no general correlation” between the two measurement methods. The expert also “cited prior art literature that supported this conclusion.” On remand, the claim may still be held obvious, but the USPTO will need to do a better job linking the prior art to the patent as claimed. However, the Federal Circuit was clear that: “the Board should neither rely upon conclusory reasoning nor its own conjecture in assessing the weight of evidence.”

Secondary Considerations Nexus: The court also held that, when presented, the BPAI must consider secondary considerations of nonobviousness. The doctrine requires a nexus between the claim scope and the secondary consideration. The nexus requirement has seemingly been more and more strictly applied over the years. In the recent Tokai decision, the court held that “if commercial success is due to an element in the prior art, no nexus exists.” In this case, the court wrote “Where the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention.” (emphasis added) (I would inquire what the court means by “novel in the claim.”)

The nexus requirement is a two-way requirement in the secondary consideration will be rejected if either (1) overbroad so as to be a result of prior art aspects of the claim or (2) overly narrow so that only small number of potential embodiments exhibit the asserted secondary benefits. However, the court here (and elsewhere) have held that the applicant need not provide hard evidence that every embodiment covered by the claim has that nexus.

[A]n applicant ‘need not sell every conceivable embodiment of the claims in order to rely upon evidence of commercial success, so long as what was sold was within the scope of the claims.’

Quoting In re DBC, 545 F.3d 1373 (Fed. Cir. 2008).

Obviousness and its Interplay with Patentable Subject Matter of Section 101: Endo’s ’740 application claimed a method of treatment that included the step of “providing information” about a correlation between renal failure and bioavailablity of oxymorphone. Citing King Pharma, the Federal Circuit held that, even if novel, the informing step “cannot confer patentability absent a functional relationship between the informing and administering steps.” Here, the court distinguished from “transformative” and therefore patentable information delivery – such as a method of adjusting dosage based upon the informing step.

Waiving Rights to Appeal Particular Claim Issue: In its BPAI brief, Endo had grouped together all twenty claims of one of the pending applications under representative claim 1. On appeal, the Federal Circuit held that Endo had therefore waived its right to separately argue any of the other claims.

56 thoughts on “In re Kao: Important Decision Controlling BPAI Obviousness Holdings

  1. I beg to differ . . .they did let it slip by.

    As to Claim 1 of the ’432 appl. that was remanded, neither the examiner, nor BAPI, nor Linn picked up on the fatal point that the claim claims nothing but a result.

    Wasn’t Linn an examiner?? Does he not see the HUGE 101 issue with this claim?

    What is wrong with these people? Answer: brain-ded.

    Max?? Where are you? The EPO guys would have been all over this piece of cxap. Anything I give them that slightly smells of claiming a result gets thrown right back in my face, which my paralegal considers to be an improvement, BTW. Surely our EP expert spotted this nonsense, or is it just American applications that get spanked for claiming results in EU?

    Also, whoever drafted this claim wasted everybody’s time, including Linn’s. To avoid it, all an infringer has to do is include 10 mg of aspirin in the tablet. Or, even better, 5 mg dried and ground eye of Gingrich.

  2. “…it’s way more efficient to respond to specific requests for evidence or support than it is to provide it for every single word in a claim.”

    In other words, it’s way more efficient not to do your job right the first time around, and only do it right if the applicant requests that you do it right.

    Where’s ping when I need him?!

  3. “Reasonable people understand that there is a gray area in which it is debatable whether or not evidence, or support, must be provided by an examiner.”

    There is no gray area. Substantial evidence is required for every finding of fact. Just because a lot of lazy practitioners don’t hold you to that doesn’t mean it’s not required.

    Keep being lazy and taking shortcuts. You’ll get away with it frequently. Just not with me.

  4. As I actually have a job, unlike “view” I can’t post all day long, every day.

    Reasonable people understand that there is a gray area in which it is debatable whether or not evidence, or support, must be provided by an examiner.

    If we think that the answer to a particular question in the gray area is “no”, we don’t provide it, and the applicant is then free to ask for it.

    If they agree and don’t ask for anything, so much the better for everybody.

    Sometimes our judgment is not upheld, but it IS ours to make in the first instance. And the system works well overall–it’s way more efficient to respond to specific requests for evidence or support than it is to provide it for every single word in a claim.

    Like I said, everybody except “view” seems to understand this, and the system seems to work well enough–unless you want to pay more for us analyzing and justifying every single word we use.

    How lame would that be.

  5. “‘Lazy’ was in providing that case to begin with, rather than providing a case on point that had proper citations.”

    Huh?

    That case is right on point for Rockhead. Admittedly, I just came across it on a site that reports BPAI decisions daily, so I didn’t spend any time looking for it, but I’m not exactly getting paid for my posts on this site.

    Lazy? What’s lazy is examiners like Rockhead who fall back on “common knowledge” and “reasonably held belief” and “say so” rather than making the effort to produce actual substantial evidence. That’s lazy.

    Take some of your own advice.

  6. what’s,

    Your attempt at confusing the issue avails you not.

    “Lazy” was not in not citing (obviously the one who wrote the case did not cite) – “Lazy” was in providing that case to begin with, rather than providing a case on point that had proper citations.

    Once again:

    Being lazy is one thing, snapping at those who point out your laziness is another.

    Don’t be a prcck.

  7. So all this time I was spot on. And Policy is whatever they decide it is.
    And now I know the reason for the Policy decisions. And how they effect what they want the Constitution to be about, and what they did to a citizen.
    GEE no GWB

  8. Well Malcolm, I must say, I’m glad Europe is managing so well, to keep you ever more amused. It would be so unfair, when Europe is laughing so much, that you don’t also get a laugh from time to time.

    And they do say, laughing is very good for your health

  9. “Did you even read what I posted?”

    Lulz. Did you read what I posted? Calling me lazy for leaving out case cites when I explained to that other rockhead that I was not the one who omitted the case cites.

    You have the reading comprehension of an examiner, when you bother to read the response at all.

    Good representatives makes sure the examiner meets his/her evidentiary burden and don’t let them get away with lame resorts to “common knowledge.” Poor representatives let rockheads like you think you’re doing the job correctly even though you don’t have a clue.

    But your latest review was excellent. So the rockhead who supervises you is as clueless as you are.

    Gee, there’s something you don’t see at the PTO every day.

  10. Big deal.

    One time in a thousand an applicant disagrees. The system works well.

    Did you even read what I posted? I guess not, as your response makes no sense at all.

    Good representatives are not argumentative like you. You just want to argue for the sake of arguing, where there is clearly no issue.

  11. “Me and other examiners know where to draw the line, and reasonable applicants agree. It saves everybody time and money.”

    Right. Like that reasonable examiner in that BPAI decision I provided the link to. Saved everybody time and money, didn’t he? He really knew where to draw the line. It’s “common knowledge” that helium and argon are suppressants, amirite?

    Unfortunately my clients get stuck with “reasonable” rockhead examiners like you all too often. Unfortunately, rockheads like you never take your own advice and get over themselves.

  12. Your laziness is typical of what I see daily from applicants.

    I said “common knowledge”, NOT “technical facts in the areas of esoteric technology”, etc.

    Get over yourself, and get a life. Me and other examiners know where to draw the line, and reasonable applicants agree. It saves everybody time and money.

    Except for your clients, of course.

  13. I thought that there was an interesting discussion on page 17 of this opinion regarding claims being “commensurate in scope” with unexpected results evidence. The court states to the effect that if applicant shows unexpected results and then provides an adequate basis to show that other embodiments, beyond those tested, would behave similarly, then the evidence is commensurate in scope. The court then cites In re Greenfield and In re Cescon from the 70’s. I looked at those opinions and they don’t seem to say that quite as succinctly. To my knowledge, the MPEP only talks about the claims being commensurate in scope with the evidence. There is generally little to stop examiners from applying the “commensurate in scope” rule very strictly, and they often only allow only those embodiments actually tested. I think the court gives us a nice little quote on page 17 to counter with in these situations to argue for broader claim scope, and which is very nicely and succinctly stated. It is definitely going in my bag of quotes.

  14. I didn’t omit the cites to the case law. The APJ who wrote the decision that I provided the link to omitted the case cites. He omitted them because nobody needs a cite to a case that stands for the proposition that inherency cannot be established by possibilities or probabilities. And he wasn’t being lazy for omitting those case cites any more than I was being lazy by providing a link to the decision.

    You must be in Rockhead’s art unit.

  15. As you know Europe has them only because claims to methods of medical treatment are forbidden.

    Claims that prevent treating patients with old compositions are only “forbidden” when the claim begins with the word “method.”

    That’s what’s funny.

  16. What’s,

    Maybe it shouldn’t take a blog comment to ask you for the “well known” cases if you had provided them in your first comment.

    Being lazy is one thing, snapping at those who point out your laziness is another.

    Don’t be a prcck.

  17. Do you not see that I cited Zurko and Gartside? Do you not understand the difference between failing to provide substantial evidence in support of “findings of fact” and APJ’s, and blog commenters, omitting cites to well known case law?

    W

    T

    F

  18. Why do you need a case where citations are provided?

    cf

    and can be supported by no more than the Examiner’s reasonably held belief, or notice.

    W

    T

    F

    Do you not see the hypocrisy? Do you always do what you are complaining others of doing?

  19. Why do you need a case where citations are provided? I posted that decision so Rockhead might learn that the examiner’s “reasonably held belief” or “notice” or “say so” is not a substitute for substantial evidence. But if you really need a case cite, see Zurko, or Gartside, etc.

  20. The Examiner proffers no evidence to support the assertion. The Examiner does not substantiate how the filling of a void space in a fuel tank with an inert gas for explosion protection necessarily leads to the inert gas acting as a suppressant.

    Inherency cannot be established by possibilities or probabilities (citations omitted).

    While the inherent characteristic does not have to be readily known to a person having ordinary skill in the art (citations omitted),

    the Examiner, to support a finding of inherency, must then establish through technical reasoning and/or evidence that helium or argon gas necessarily possess a suppressant characteristic (citations omitted).

    We agree with Appellant that assertions of technical facts in the areas of esoteric technology or specific knowledge of an art must be supported by citation to some reference work recognized as a standard in the pertinent art.

    Could we have a case where the citations are provided?

  21. But, in the real world of patent owners and infringers, Malcolm, do “use” claims do the business? I think they do. As you know Europe has them only because claims to methods of medical treatment are forbidden. I prefer the accused embodiments to be packets of pills than doctors who prescribe.

    Like the concept of the PHOSITA,the concept of a use claim is hard at first to grasp accurately but, once grasped, its aptitude becomes obvious.

  22. Why, this case of course.

    My thoughts exactly … except that the PTO didn’t let this one slip through. ;)

  23. Why, this case of course. Claim 1 of the ’432 patent. It claims an old compound and a controlled release delivery system. Now this is where it gets interesting. The claim does not define what the release delivery system is. It just claims that whatever it is, it releases a specified amount of the compound at 1 hour according to a defined test.

    What this claim does is define the delivery system by result. The true invention is in the delivery system formulations as described in the opinion of the court. However, the claim covers every delivery system that achieves the result. Is there anything at all wrong with this claim?

    Yes indeed there is. See, Perkins Glue. link to supreme.justia.com

    One cannot claim a compound by describing the results it achieves because the claim literally covers compounds that acheive the same results but are different. As described by the Supreme Court, such claims retard rather than advance the progress of the useful arts and are condemned in the strongest terms.

  24. Honestly, MD, I think that the King Pharma case is incomprehensible bullhockey.

    A proper claim to protect your invention would be a method claim reciting the sequential administration of the specified doses (using ranges where appropriate) which were demonstrated by the inventors to benefit patients in a manner not expressly taught or expected by others.

    Use claims still crack me up. Is there a better example of an utterly phony baloney but universally smiled upon end-around the written law, anywhere? In any context?

  25. instructions to follow

    Are those instructions functionally related to the medium?

  26. Actually, the PTO just needs to do a better job at their budgeting process.

    After all, it is only that money over budget (considered in excess) that is skimmed back to the treasury).

    Yet another example of how non-real-world minded the PTO is.

  27. Sure, the PTO just needs to hire their own experts using all that extra money they were handed by the government.

  28. Malcolm, my patentable invention is embodied in a pack which comprises the medicament in dosage form, and instructions to follow a new and not obvious dosage regime that realises the correlation between eating and pill-swallowing that (as such)the CAFC just acknowledged as new and not obvious. The claim would probably be a European “Use” claim, for the medication as such is old and presentations of information (as such) are not patent-eligible in Europe

    Thus it is, that the kidneys of the world benefit from a better dosage regime, and so (proportionately) does the discoverer of the better dosage regime.

  29. isn’t it surprising they do not more often ask

    What makes you think that they currently do not ask often enough, as may be rightfully justified?

  30. Since the PTO has no capability for factually challenging applicant-argued comparisons, isn’t it surprising they do not more often ask applicants for supporting data for their argued distinctions under 37 CFR 1.105?

  31. “Since the examiner could not find the measurement in the art, they usually allowed the claim, creating havoc and concern among the competition who really knew what was going on.”

    Example please.

  32. Malcolm, years ago I had a discussion with a wise old head, a graduate of Harvard Law and no dummy, who told me about the common practice of some practitioners to dress up old subject matter with a new measurement of some property that was not measured before but was inherent in the prior art. Since the examiner could not find the measurement in the art, they usually allowed the claim, creating havoc and concern among the competition who really knew what was going on.

    Having not read the case, I share your concern that one should not be able to reclaim old subject matter by adding a new measurement of it, the criticality of the ranges having nothing to do with effectiveness.

  33. You are correct: ignorance is bliss.

    Enjoy the ignorance, sucka.

  34. Ignorant?

    I know that I get paid well, and that my latest review was excellent.

    Enjoy the private sector, sucka.

  35. I said common “knowledge”, not common “sense”.

    How much client money have you wasted with your overcompensatory arguing with the examiner corps?

  36. You don’t expect us to have to prove EVERYTHING, like the meaning of the word “the”, do you?

    When something’s common knowledge, all we have to do is say so.

  37. Actually, it’s an even better argument for the Office to actually do its job.

  38. As I understand it, the US patent system exists to nurture those who discover things that are new, useful and not obvious.

    Yes, things = new compositions and new processes, not new facts.

    What would an allowable claim look like?

    What’s the invention?

  39. Malcolm, as I read page 26, the correlation between renal impairment and bioavailability was not known. As I understand it, the US patent system exists to nurture those who discover things that are new, useful and not obvious. Here, the “informing” claim failed. What would an allowable claim look like?

  40. “Findings of fact by the Examiner and Board CAN be ‘evidence’, and can be supported by no more than the Examiner’s reasonably held belief, or notice.”

    Lulz. Another examiner who doesn’t understand evidence and facts. Do they not teach that in the Patent Academy?

  41. It’s worth reading the whole decision. On most of the issues raised in this case, the applicant was vigorously kicking up dust but failed miserably. Overall, a pathetic performance and a rather crxxpy “invention”.

    The problem was that the dissolution rate reported in Maloney was measured in a different way than that claimed by Endo, and the USPTO provided no “direct factual support in the record for the view that the claimed range of dissolution rates actually over-laps with the dissolution rate disclosed in Maloney.” In this case, testimony before the board (from Endo’s expert) was that “there is no general correlation” between the two measurement methods. The expert also “cited prior art literature that supported this conclusion.”

    Why is the dissolution rate even relevant here? Unless it’s some strikingly improved rate of dissolution that was unexpected or taught away from, the structural composition being claimed should still be found obvious. It seems the applicant is just appending some non-patentable functional measurement to their claim to turn an otherwise obvious composition into a non-obvious composition. In other words, a loophole is being created whereby you can render an obvious composition non-obvious simply be performing a measurement on the composition that has not been performed before and is not readily correlated to measurements on similar compositions disclosed in the prior art.

    Citing King Pharma, the Federal Circuit held that, even if novel, the informing step “cannot confer patentability absent a functional relationship between the informing and administering steps.” Here, the court distinguished from “transformative” and therefore patentable information delivery – such as a method of adjusting dosage based upon the informing step.

    This is why Prometheus’ claims which do not recite a step of administering an adjusted dosage are anticipated. The step wherein a “need” to increase the dosage is “indicated” by a measured value of drug metabolite “in no way transforms” the the claimed process of determining the level of the metabolite in the blood.

    Thank you, Federal Circuit.

    And yes they ARE dissecting the claims. And of course there’s nothing wrong with doing that in certain contexts.

  42. Examiner and Board ARGUMENTS are of course not “evidence”.

    Findings of fact by the Examiner and Board CAN be “evidence”, and can be supported by no more than the Examiner’s reasonably held belief, or notice.

  43. This is an interesting case that points up how KSR obviousness plays out quite differently in the PTO and in a district court. In a court, the parties put up expert witnesses who are sworn, are subject to cross-examination, who must disclose the facts and data underlying their opinions, and whose testimony is entered in evidence under Fed.R.Ev. 702 and 703.

    In contrast, 5 USC 706, Dickinson v Zurko, and In re Gartside tell us that examiner and Board argument is not itself evidence. The examiner and Board can (and must) explain evidence, but they can’t create evidence merely “because I said so.”

    Will this end “it’s obvious because I said so?” Of course not. That would require the PTO to honor procedural law.

  44. With regard to the unexpected results analysis, I have seen the BPAI often dismiss unexpected results by saying that the claimed and prior art compounds/structures are sufficiently close that the prior art would have exhibited the same unexpected results, even though there is no evidence of the prior art doing so. That is, the BPAI treats the results as inherent in close prior art. Based on this opinion, it appears that the Applicant need only indicate that the unexpected results owe to a difference between the claims and prior art, and the BPAI must actually find evidence of the result in the prior art to maintain the rejection.

    Of course, the BPAI has several other tricks to dismiss unexpected results, including that the results weren’t different enough in magnitude or kind. And when unexpected results occur when the claims are not close to prior art structures, the BPAI will dismiss the results for not using the “closest prior art.”

  45. A “must read” decision for anybody in Europe, where the interplay between 103 and 101 has raged for years.

    I will be keen to read the thread, and hope it will be of high quality. Thanks Dennis for the provocation.

    BTW, Rader CJ is in Germany this week, yet again.

  46. Dennis, claims can have points of novelty for numbers of purposes, including it seems, secondary considerations. Obviousness and patentable subject matter are considered on claims considered as a whole.

  47. what is both claimed and novel in the claim

    Why, my goodness – it’s a utility patent “points of novelty” test!

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