Substantial Evidence on Appeal

by Dennis Crouch

In re Hyon (Fed Cir. 2012)

Hyon’s patent covers a method for producing a high molecular weight polyethylene to be used as a prosthesis.  In a broadening reissue application, Hyon added several claims.  Those claims were rejected as obvious by the examiner and the Board of Patent Appeals (BPAI). In a split opinion, the Federal Circuit has now affirmed those rejections. 

The question on appeal was whether the PTO properly combined the two identified prior art references in forming an obviousness rejection.  Because this issue is considered a factual question, the PTO decision making is given deference and only overturned if the decision lacks substantial evidentiary support.  This "substantial evidence" standard is quite low and requires the Federal Circuit to affirm even when the panel might have reached a different conclusion in a de novo review.

The “existence of a reason for a person of ordinary skill to combine references” is a question of fact that we review for substantial evidence. Because the Board’s findings concerning motivation to combine are supported by substantial evidence, we affirm.

The dissent by Judge Newman argues that the one skilled in the art would not have been motivated to combine the two references as suggested by the PTO. Interestingly, Judge Newman does not mention the substantial evidence standard while the Bryson majority repeats the standard six times in the ten page opinion.

Appellate attorneys understand the importance of the standard of review.  This case highlights this reality and suggests that applicants may be better served to include arguments directed to the ultimate question of obviousness (de novo review) rather than merely challenging the PTO's factual findings.  Although perhaps cost prohibitive, challenging PTO factual findings are best pursued in a civil action.

40 thoughts on “Substantial Evidence on Appeal

  1. Will read with interest. Many thanks. Rader CJ is often in Munich. When I see in his Decision that the District Court sinned when it used knowledge of the invention to define the objective problem, it leaves me even more convinced that Rader gathers obviousness insights when in Munich.

  2. Good point on Affidavit-delivered ex post facto secondary factor evidence which, since KSR, is even more significant to the outcome.

    On 3), whether the person of ordinary skill would or would not have included together in his hypothetical contemplated machine or method, as a matter of routine, the two technical features of the claim is more a question of fact than of law, I would say. I see this as distinct from the ultimate Y/N question of law, obvious or not.

    I’m still uneasy that the presumption of validity is built on statements of fact from witnesses that go without challenge.

  3. I go back to my original statement, which was that I agree that an expert giving his/her opinion on the legal conclusion of obviousness is (or should be) worthless in PTO proceedings.

    we argue about whether (as a fact) the person of ordinary skill would have come across and then devoted attention to both of the two references relied upon, and then whether he would have selected and fused elements of them together.

    I agree as to parts 1 and 2 of your statement, and “expert” evidence may be somewhat useful in establishing whether the references are in the same or related fields. I think part 3 is the legal conclusion of obviousness, however. Obviously you can find someone to swear that it would have been obvious, but I don’t need someone to argue non-obviousness – I can do that. Now, if you’re going to rely on secondary factors (which I almost never do), you need some way to get the evidence in the record. Again, an affidavit from an informed person is the right way.

    Nevertheless, the way I see it, there’s another side to the story which doesn’t come out till the proceedings go inter Partes.

    Of course.

  4. Thanks for that. When debating what’s obvious though, we argue about whether (as a fact) the person of ordinary skill would have come across and then devoted attention to both of the two references relied upon, and then whether he would have selected and fused elements of them together. The Examiner cannot opine on that, but the expert can, and will not hesitate to do so, sincerely according to his lights. No need to tell anything approaching an untruth.

    Nevertheless, the way I see it, there’s another side to the story which doesn’t come out till the proceedings go inter Partes.

    Or do I still see it wrong?

  5. And if what the “expert” for the prosecution writes counts as fact while what the examiner writes does not, how come ex parte prosecution delivers a presumption of validity that is overturnable only with evidence clear and convincing?

    We’re talking about two different things here. Ex parte prosecution delivers a presumption of validity because it is ostensibly based on findings of facts,where those findings are based on evidence resulting from a thorough search/examination. Examiner assertions unsupported by documentation are not evidence of facts; neither are unsupported attorney assertions.

    As a matter of fact (!), an examiner can introduce evidence from his personal knowledge, but he has to file an affidavit, just as the applicant’s “expert” must.

    Why is what the Examiner writes a mere assertion while what the “expert” writes is an irrefutable statement of fact?

    Nobody said that what the expert writes is “irrefutable.” I said that it is some evidence, which is to be weighed against or with any other evidence. If the examiner has not provided any evidence, but instead relies on bald assertions, then some evidence wins.

  6. not say that Declarations by Experts often contain utterances that amount to flat out lies. But without telling any lies

    No.

    I don’t know how you were raised son, but all those other things (spin, etc) are classified as lies. A lie is anything that is not the truth, the whole truth and nothing but the truth. A half-truth is half lie and thus is classified as a lie.

  7. Thanks Paul. I do not say that Declarations by Experts often contain utterances that amount to flat out lies. But without telling any lies one can spin, and be economical with the truth, and deliberately bring the reader to a false assessment of the facts. Most people spend their lives deluding their own selves, and only find out under cross-examination. Read Heffernan on Wilful Blindness to find out that it’s everywhere, once you start looking.

    And some in public life are sincerely proud of their ability to dissemble, supposing it to be very much in the public interest. They might be right. But what about dissembling advocates in courts of law? How much of a public interest defence is there for that?

    So I still think that cross-examination makes a vital difference, in bringing out the facts for the fact-finder to recognise. Compare the PCC with Leveson, for example. One is effective, the other not. Why that then?

  8. The glare from Malcolm’s own tinfoil hat makes it too difficult to read his post above.

    I can make out enough to see the “stain” of his usual vacuous contribution, and need not fight the blinding glare any further.

  9. Leopold, so is it assertions of fact from the “expert” to combat assertions of fact from the Examiner? Yes it is. No it isn’t. Tis. Tisnt. Tis. Tisnt.

    Why is what the Examiner writes a mere assertion while what the “expert” writes is an irrefutable statement of fact? Still haven’t got it yet. Sorry.

    And if what the “expert” for the prosecution writes counts as fact while what the examiner writes does not, how come ex parte prosecution delivers a presumption of validity that is overturnable only with evidence clear and convincing? Something does not smell right here.

  10. what was the reason for their disagreement?

    That’s the crux of the matter, isn’t it?

    At first glance, you feel that the applicant did not argue well enough. In the second glance, you appear to feel that there is no under-current of anti-patent sentiment.

    While I grant that the first may very well be true in any particular case, including this one, I also grant that to ignore the second is worse than foolhardy, worse than naive, and can (and does) overwhelm the first glance even if the applicant does prepare an otherwise winning argument. There is a philosophical war in progress.

  11. Magna Carta? No person shall be deprived of life, liberty or property except by the lawful judgement of his Peers or the law of the land, i.e., the common law or statutes enacted with the consent of the governed?

    But, you say, the Kings word is the law of the land?

    Humm….

    Now we begin to understand “substantial evidence.”

  12. Paul’s continuing inarticulation leaves me wondering if it is the CAFC as a group that he considers impressive, or if it is each individual judge.

    Regardless, both the CAFC as a whole, and its individual judges, have certainly left an impression in my mind.

  13. I don’t think that the manner of argument has any impact on the review at the Federal Circuit. If anyone has ever done Social Security Appeals one will find that substantiall evidence is a defential standard. Basically, if I remember this correctly it has been some 20 years, to overturn social security decisions a District Court must find that either the wrong law was applied or that there is overwhelming evidence that would warrant reversal. What I find interesting here is that agency appeals are usually to a District Court. It seems strange that such a low standard is applied to the appellate court. In short, the appellate court does not have de novo review of the case. Seems to me that this is, you guessed it, aggrandizement of the executive branch of government to the detriment of the judiciary that in unconstitutional, But hey, does anyone really care about the Constitution any more. It seems like it is treated as nothing but a truism. Could it be that it has gone the way of the Magna Carta.

  14. MM, Ned, this is always what bothers me about claiming Molecule X per se. I always think a field of use limitation ought to be required, for non-obviousness.

  15. I agree. The applicant should have claimed some limitation about the degree of crosslinking so that the part remained moldable below the melting point.

  16. Apparently, the degree of cross linking was critical.

    It wasn’t claimed.

    It’s fascinating that Newman thinks the spec is valid over the prior art, but the claims are clearly not, and the majority clearly explained why.

    Argument: No motivation because D2 not directed to joints.

    Note to lazy patent agents: You can’t use the same arguments you used before KSR. If the two prior art processes are actually incompatible, you need to specifically argue that. Maybe even prove it.

  17. MM, see my post below at 02:49. I agree with you on the field of use problem. But, ultimately, the claimed subject matter was patentable.

    Perhaps in a continuation, they will add some limitations about the degree of radiation.

  18. When is something obvious?

    The claims:

    22.

    1. cross link
    2. heat to below melting point
    3. compression deform (mold)
    4. cool

    84. Further processing to make a component (joint.)

    D1: process of claim 22, but where cross link occurs after cooling. Molding step takes place below melting point.

    D2:

    1. cross link
    2. melt!
    3. stretch (compression)

    PTO. D2 provides cross link before compression.

    Argument: No motivation because D2 not directed to joints. (Joints element is not claimed in claim 22. It is only in claim 84.)

    Argument first made at orals on appeal:

    The D2 crosslinking could not be combined with D1 because it would inhibit molding. Apparently, the degree of cross linking was critical. If there was too much, it would not work.

    But, because the argument was not raised below, it was waived. Moreover, there was no actual EVIDENCE of record to support the argument.

    Conclusion:

    Failure of advocacy. The argument concerning “joints” clearly was inapposite claim 22 that was not limited to joints.

    IMHO, The claimed subject matter was clearly patentable on the record because the claimed process required cross linking and molding below melting. The reference required it after melting. Based on this, it was not obvious that D2 would work in D1.

  19. Paul, good post.

    However, could you summarize exactly what the “evidence” was that was found to be “substantial.” Neither your post nor Dennis clearly states just what that evidence was.

  20. Paul Cole:

    The broad claims covered making an UHMW polyethylene block without restriction to intended field of use.

    Okay. That’s a very important fact. Let’s keep that fact in mind.

    On appeal the appellants argued absence of motivation to combine because the references were directed to different products

    Hmm. I seem to recall something that renders this argument moot. What was it again? Oh yeah:

    The broad claims covered making an UHMW polyethylene block without restriction to intended field of use.

    Yup. Be careful what you ask for, folks.

    The game that Newman is playing is commonly practiced but does not accord with the law. For every alleged invention, it’s always possible to come up with a “result” that an expert can opine was “unexpected”. Perhaps the novel composition when used in a bowl in Antarctica renders the water more palatable to huskies. It does not matter, unless a method of making water in a bowl in Antarctica taste better to huskies is what is being claimed.

    The law is clear that motivation to combine references in the prior art need not be related in any way to the disclosed utility or motivations in the specification.

  21. @ Stain
    If the majority of the panel had the opportunity to read and understand Pauline Newman’s view, what was the reason for their disagreement? Obviously because they did not feel that the evidence in the case supported her view sufficiently. It may be that because of her technical training she could see further than others, and was prepared to take the facts further than they were. But that still leaves the point that if there was a case for patentability, and if there was evidence of new and unexpected result, it was not presented sufficiently clearly and compellingly that the majority could not ignore it.

    @ NWPA: This was not a software patent. It was a very hard-wearing patent.

    @ Max: It is always best to win at first instance. In the EPO both sides have a substantially equal chance on appeal, but in a court system there is an inevitable prejudice in favour of the lower tribunal. In the UK the lower tribunal is held to be the primary fact-finder, and my reading of US cases suggests that the US decision is very similar. So if you want to get a reversal you have to show that the lower instance was wrong in principle e.g. by overlooking unexpected results for which there is clear and convincing evidence.

    @ Paul F. Morgan: If evidence is needed it is needed early.

    @ Max: If your expert is a “yes-man” he/she is valueless. The cogency of the evidence is not based on the conclusion but on the underlying facts and reasoning. And in both the US and the UK, experts give evidence on oath or by similarly serious declaration, and lying on oath is not a wise thing to do.

  22. Max, I agree that an expert giving his/her opinion on the legal conclusion of obviousness is (or should be) worthless in PTO proceedings. But affidavits that include statements of fact, e.g., filling in details of how something in a reference works or discussing the inherency (or lack thereof) of a feature, can be useful, if only to rebut examiner assertions that are completely unsupported by evidence. Argument is not evidence, but an affidavit making factual statements is some evidence, which always outweighs no evidence.

  23. Up to you Simple. You decide how much or little weight to accord to what I write here. Feel free to ignore. And I’ll do the same with yours.

    What you think about it is of no consequence to anybody anywhere anyway. Or is it?

  24. any “expert” declaration, untested under cross-examination, is anything other than a person simply saying what he’s been paid to say

    And how much so for those “expert” declarations appearing on blog pages, paid or unpaid?

  25. am I to take from that that the majority (looking forward to better days ahead, and trying to make them happen) put a higher priority than Pauline Newman on the desirable public policy consideration

    See the comment above about assumptions of justice.

  26. Paul, 6, NWPA would no doubt tell me I’m hopelessly naive but still I wonder, in the USPTO, how much weight is given to the pontifications of an “expert”, when these are not subject to cross-examination? In the EPO, it’s zilch. At the EPO, they would assert that it is hopelessly naive to suppose that any “expert” declaration, untested under cross-examination, is anything other than a person simply saying what he’s been paid to say.

  27. Your views, Paul, are to say the least naive. It is probably true, though, that a lot of what happens is similar to what is described in Manufacturing Concent. A lot of the judges that have been appointed have been appointed because of the way they have formed their views, so they may not have a hidden agenda, but have beliefs that were formed long ago that are difficult to unearth.

    Nonetheless, just listening to some of the oral arguments at the Fed. Cir. makes it clear that some of the judges feel very strongly that anyway they can get rid of software patents is fair game.

  28. Filing an RCE or continuation to put 103 unobviousness supporting expert affidavits into the record is a lot faster and cheaper than filing a District Court civil action to introduce unobviousness testimony [and the former will not be be subject to cross-examinations], before or after a Board rejection.

  29. So Paul, Stain, am I to take from that that the majority (looking forward to better days ahead, and trying to make them happen) put a higher priority than Pauline Newman on the desirable public policy consideration, to be loyal to the lower instance, to stand behind it, and to eschew reversing it, unless they really really had no alternative?

  30. My father used to say that no falsehood can stand before the mirror of truth.

    I have met many of the CAFC judges at AIPLA and other similar events. They are an impressive group of people and all of them, I am certain, do their very best to fulfil their judicial oath. Misunderstanding, in my view, is more plausible than an ideological war.

    Whichever may be the answer, however, presentation is key as our former Prime Minister Tony Blair was all too aware. If you are dealing with a panel prone to misunderstanding and having difficulty understanding technical facts and (more plausible) putting them correctly into context, the more effort is needed to create a straightfoward and convincing presentation of the case. Not everything that people are told gets into their minds with sufficient effectiveness to form the basis for future action, and while this is true of oral argument it is even more so in the case of written documentswritten argument.

  31. I think otherwise.

    Do you not think that the panel exchanges their views with each pther prior to a final decision?

    The majority had every opportunity to read and understand the minority view.

    They chose otherwise.

    This is simply far less about “technology” than it is about how the law is applied. Ignoring the ideological war raging about you will not make it go away.

  32. The whole point is that the new result did NOT find its way into the minds of the majority. I suspect that the issue is less pro-patent/anti-patent than technically savvy/technically challenged.

    It would be good to see some judges in the Federal Circuit who have (a) started in the USPTO and (b) worked their way up through an industrial department or patent specialist firm.

  33. Moral(s):

    Paul’s morals failed in the instant application, therefore, all the morals in the world will not help if you have a panel with a mindset geared towards limiting patents.

  34. The medical problems of wear in implants, especially in components of hip joints, is well documented. Anything that improves performance in such an implant therefore deserves to be taken very seriously.

    The majority decision takes the position that the disclosed improvements were no more than the predictable result of the disclosures ot the two cited references.

    The broad claims covered making an UHMW polyethylene block without restriction to intended field of use. The method involved starting with a polyethylene block of MW > 5 million and then irradiating it with high energy radiation. The crosslinked block was then heted and compression deformed.

    One reference called Zachariades disclosed each limitation except crosslinking the UHMWPE prior to compression. The second reference called Kitamaru taught that crosslinking before compression resulted in a product that had a higher melting or softening point, improved transparency, and excellent dimensional stability.

    On appeal the appellants argued absence of motivation to combine because the references were directed to different products (artificial joints; films and sheets). The Board concluded that the two references both taught processes directed to making the same class of products and on appeal that conclusion was held to be supported by substantial evidence. The majority opinion refers to no unexpected result flowing from the combination, and in these circumstances it would have been nore difficult for the appellants to reute an attack based on this combination of references.

    In contrast Newman’s opinion is centered on improved results. She pointed to what was said in the patent itself:

    [T]he present inventors tried to obtain a molded ar-ticle of a low friction and to improve an abrasion re-sistance by introducing molecular orientation or crystal orientation into a finished product by means of, not a chemical modification method, but a physi-cal modification method.

    This approach has never been attempted, not only in Japan, but also in other countries. The idea to endow the polyethylene molded article for artifi-cial joints with molecular orientation or crystal ori-entation is the very creative, and it is sure that this invention, if actually carried out, will be applied to artificial joints all over the world.

    She then gave the following explanation as to improved results:

    When the technologic field is mature, apparently small changes that produce unexpected results or improved prop-erties are of heightened significance. Nothing in the record suggests that a person of ordinary skill would have foreseen that Hyon’s method of slight radiation cross-linking followed by heating and compression deformation would produce the described benefits. See In re Gartside, 203 F.3d 1305, 1314 (Fed. Cir. 2000) (“the Board’s decision must be justified within the four corners of th[e] record”).

    The Board cited no reason to expect that the Hyon method would produce a superior polyethylene artificial joint. Zachariades, like Hyon, recognized the problem, and stated that “the fabrication of ultra-high-molecular-weight polyethylene products to achieve enhanced mechanical properties and good dimensional stability is a challenging task.” …

    It is only after Hyon demonstrated how to achieve this improved result that the Board was able to plug the prior art steps into the template of the Hyon method. However, as explained in Interconnect, 774 F.2d at 1143, “[w]hen prior art references require selective combina-tion by the court to render obvious a subsequent invention, there must be some reason for the combination other than the hindsight gleaned from the invention itself.”

    MORAL(S)

    1. Unexpected new results provide evidence for patentability.

    2. Especially if the panel is composed of judges not having science degrees, the new result and its unexpectedness need to be pointed out with the utmost clarity.

    3. First explain the positive things that the invention achieves, and only then nit-pick the legitimacy of combining the prior art references. It is interesting that that sequence of reasoning is built into the technical problem approach adopted by the EPO.

  35. Just wondering: if you were to add up all the obviousness decisions that the PTO fact-finders in this case had written, and then compare that aggregate number with the number that Judge MNewman has written, which would be the larger number.

    BTW, what exactly is typical “evidence”, that the notional PHOSITA “would” have combined the references? And how, here, did the PTO prove it?

    Another 2:1 split decision. I can’t shrug off the thought that the CAFC does it deliberately. Two to do justice, and one to start the hare running.

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