Generic Industry Skepticism Irrelevant to Non-Obviousness

by Dennis Crouch

In a divided opinion, the Federal Circuit rejected a PTAB non-obviousness decision–holding that “generic industry skepticism” is irrelevant to the question of obviousness.  Auris Health, Inc. v. Intuitive Surgical Operations, Inc., 2021-1732, — F.4th —, 2022 WL 1275241 (Fed. Cir. Apr. 29, 2022).  I suggest the Auris Health majority departs from KSR by again drawing sharp lines rather than allowing for a functional, flexible analysis. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007). The opinion was penned by Judge Prost and joined by Judge Dyk. Judge Reyna wrote in dissent.

The Intuitive Surgical patent is directed to a “method for performing robotic surgery.”   The improvement is a servo-pulley mechanism for swapping surgical tools (e.g., scissors to scalpel to graspers).  In 2018, Intuitive Surgical sued Auris Health for patent infringement. Intuitive Surgical Operations, Inc. v. Auris Health, Inc., No. 1:18-cv-01359 (D. Del.).  In response, Auris petitioned for inter partes review. The PTAB instituted the IPR, but ultimately concluded in its final written decision that the claims had not been proven obvious.  On appeal, the Federal Circuit has vacated and remanded.

The IPR focused on the combination of two prior art references: Smith and Faraz (US5624398 and US5824007) that collectively teach all of the claim limitations. Smith is directed to a robotic surgical system; and Faraz is directed to stand for holding surgical instruments. In its analysis, the PTAB considered evidence presented that (1) combining the two references would create some complications and (2) conventional wisdom established substantial skepticism regarding the use of robotic systems during surgery.  Based upon this evidence, the PTAB concluded that a person of skill in the art would not have been motivated to combine the references in order to arrive at the claimed invention.  On appeal, the Federal Circuit altered course–holding that “generic industry skepticism cannot, standing alone, preclude a finding of motivation to combine.”

There are two areas where skepticism might come into play: (1) as part of the KSR obviousness analysis considering reasons to combine references; and (2) as a secondary consideration of non-obviousness (aka objective indicia).  In the second use-case (objective indicia), the Federal Circuit has previously tightened scope of relevant evidence to only those shown to have a tight nexus with the claimed invention.  Here, however, the skepticism was tied to the particular claim elements, but rather was general skepticism shown to be held by persons of skill in the art “about performing robotic surgery in the first place.”

Here, the Federal Circuit has taken the nexus requirement used for secondary indicia and brought it forward to also apply when considering motivation-to-combine.

[W]hile specific evidence of industry skepticism related to a specific combination of references might contribute to finding a lack of motivation to combine, that’s not what we have here.

Auris Health. It seems to me that this approach is unduly restrictive and in tension with KSR’s rejection of “[r]igid preventative rules that deny factfinders recourse to common sense.”  Rather, in KSR, the Supreme Court held that the question of whether a person of skill would combine references is a broad and flexible inquiry.  Here, it appears that the Federal Circuit is asking for evidence relating to motivation-to-combine to be tied directly to the problem being solved. But KSR rejected that approach as well.

The Court of Appeals failed to recognize that the problem motivating the patentee may be only one of many addressed by the patent’s subject matter. . . . Under the correct analysis, any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.

KSR. One question to consider here is whether the Supreme Court intended its analysis to by symmetrical or balanced. The Supreme Court talked about “reasons for combining” involving substantial flexibility, but did not discuss whether “reasons for not combining” should receive the same treatment. It seems obvious that this should be a balanced inquiry.

In his dissent, Judge Reyna agreed that “general skepticism toward robotic surgery” should ordinarily not be enough–by itself–to negate a motivation to combine.  However, he argues that it should still may be relevant to the analysis.  Here, Judge Reyna found that the Board had included this reason as one among many, and that substantial evidence thus supported the Board’s conclusion of no motivation to combine.  (For example, the Board noted that the combination would restrict physician movement and would reduce surgical precision).

Judge Reyna also commented on the seeming rigid new rule:

I am also concerned that the majority opinion may reasonably be understood to announce an inflexible and rigid rule, namely that it is “impermissible” for the Board to consider evidence of artisans’ skepticism toward robotic surgery in determining motivation to combine. I find no authority for this assertion, and indeed it appears in tension, at a minimum, with the central thrust of KSR. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007) (rejecting the “rigid approach of the Court of Appeals” and articulating an “expansive and flexible approach” of determining obviousness). This is particularly true when considering art in fields of endeavor that are inherently dangerous or risky. Indeed, in past cases, this court has accounted for the attitudes of medical professionals toward certain types of procedures when determining whether a motivation to combine has been adequately demonstrated. See, e.g., Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1369 (Fed. Cir. 2012) (finding no motivation to combine where “doctors were not using the disclosed devices and methods to heal wounds with negative pressure because they did not believe that these devices were capable of such healing”).

Reyna in dissent.

= = =

What’s really happening here.  In my view, the problem in this case comes down to the reality that the patentee’s evidence against combining the references is quite weak, and the majority disagreed with the PTAB’s conclusion giving it weight.  However, since the court must give deference to PTAB factual findings, it would have been much harder challenge the decision on that ground, especially because the obviousness analysis depends upon so many factors. So, instead of challenging the factual findings, the majority decided to create a bright rule of law barring the evidence from even being considered as relevant to the inquiry.

20 thoughts on “Generic Industry Skepticism Irrelevant to Non-Obviousness

  1. 5

    What comes to mind on reading this piece is the case law in England on “prejudice” in an industry and its relevance to obviousness. See the Dyson bag-less vacuum cleaner cases, in which Dyson proved such prejudice to see off the obviousness attacks. The court did NOT say that such prejudice is irrelevant to obviousness.

    The obviousness determination has to be objective but should be as “real world” as possible, to maintain confidence in the patent system. If an industry was, in fact, truly and generally sceptical about the value of Smith ‘398 as a realistic starting point for any further R&D efforts, then motivation to combine Smith with any other of the million disclosures in the state of the art would surely have been diminished, even perhaps down to zero.

    But actually, here, it is not really feasible, is it, to contend that the scepticism is so sky-high that nobody in the field would waste a moment mulling over what Smith teaches? Or is it?

    1. 5.1

      As to the Dyson v Hoover litigation and the relevance to obviousness of industry prejudice/aversion, for anybody interested here is a Link to the Court of Appeal decision in England. The obviousness reasoning starts at para 50.

      link to bailii.org

  2. 4

    This skepticism argument can be silly.
    If there is general skepticism toward robotic surgery, doesn’t that prove that robotic surgery is known and obvious? If something is so well-known that it has generated “general skepticism”, it must be well-known.
    And isn’t there be general skepticism toward all commercially new (not patent-wise new) medical procedures? That is why we have an FDA.
    There was no specific skepticism toward the claimed invention, was there? For example, if you invent something truly novel, and industry experts tell you it won’t work and that is not based on past experience. U.S. v. Adams (initial disbelief in the efficasy of the specific invention by government experts) comes to mind.

    1. 4.1

      This.

      It’s no different than “general skepticism” about computers picking your “perfect mate” being used to obtain a patent on “do date matching on a computer.”

      Nuance is difficult for those who inhale patent maximalism straight from the spray can.

      1. 4.1.1

        LOL – you do realize that the essence of nuance is the opposite of your tendency to “one-bucket” anything that you do not like – INCLUDING the differences effected by programming a computer?

        Your “This.” is actually opposite of your intended (and usual) screed.

    2. 4.2

      Good catch on U.S. v. Adams on the government infringement of the Adams battery, for initial disbelief in the efficacy of the specific invention. Also for good lawyering. It lit a lightbulb when dropped in a glass of plain tap water right in front of the Justices.

  3. 3

    “What’s really happening here. . . .”

    Bingo.

  4. 2

    First, thanks for listing the judges on the panel at the beginning of the write-up.

    Second, I agree with Wt at 1 below: with Prost and Dyk ont the panel, it was a foregone conclusion that the patentee would lose. But this decision is remarkable even for those two in its wholesale discounting of evidence of motivation to NOT combine something. If these two were looking for yet another way to weaken patents, they found it.

    I’m wondering when a patent attorney is going to get sued by a client for not disclosing that, thanks to the case law, most patents are worthless, no matter how well-written and how innovative the claimed invention, and therefore the attorney should have advised his client to save money and not bother seeking a US patent.

    1. 2.1

      >attorney should have advised his client to save money and not bother seeking a US patent.

      I’m more-or-less doing that already wrt the small inventor community.

      1. 2.1.1

        Sadly, while not overt advice, current advice does include a rather frank portrayal that the Efficient Infringers have largely been winning (and one of their tactics is to make patenting the Sport of Kings).

      2. 2.1.2

        I’ve ran across a couple of independent inventors who just wanted the proverbial “beribboned document to hand on the wall” (ref Firgueroa v. U.S., CAFC 2006, 5-5144, Newman concurring).

        1. 2.1.2.1

          They may be a little disappointed with the electronic versions then.

          1. 2.1.2.1.1

            The ‘patent plaque’ companies have got it covered. They sell all kinds of ego wall stuff based off the PTO e-file.

      3. 2.1.3

        I’m more-or-less doing that already wrt the small inventor community.
        I’m no different. Patent law does not work for the small inventor community. It hasn’t worked in over a decade. Patents owned by the small inventor community are essentially worthless, which was the (unstated) intent of the America Invents Act (AIA)

        When was the last time anyone can remember someone from the small inventor community publicly praising the AIA?

        1. 2.1.3.1

          “ Patent law does not work for the small inventor community. It hasn’t worked in over a decade. ”

          That “community” revealed itself to be mostly a collection of pathetic reactionary glibertarian cranks and worse. And yes I’m being generous here.

          Maybe going “all in” on the stillborn idea that a claim to “any process” or “any machine” is eligible for patenting was unwise? Maybe it made you and your cohorts look like infantile dooooshbags … because that’s what you are?

          1. 2.1.3.1.1

            Please Pardon Potential rePeat (due to George Carlin filter):

            Your comment is awaiting moderation.

            May 5, 2022 at 12:45 pm

            mostly a collection of [p@ the t1c] reactionary glibertarian cranks and worse. And yes I’m being generous here.

            No, you are being Malcolm here.

            And everyone knows what that means.

  5. 1

    The opinion was penned by Judge Prost and joined by Judge Dyk.
    LOL. If there ever was a time when a patentee was going to get screwed, it would be with those two at the helm. Seriously, one would hard-pressed to identify two judges holding more anti-patent views than those two.

    In my view, the problem in this case comes down to the reality that the patentee [ran up against a bad panel].
    Fixed it for you. Again, seriously, there is no need to overthink this. A different panel brings a different result — the result has little to do with the law.

    Reading who wrote the opinion if oftentimes more instructive as to the result than the actual opinion itself.

    1. 1.1

      Note the ‘rebuttal’ (surfeit with caveats) from Prof. Crouch on the next thread.

      Of course, that “study” is flawed as noted on that thread.

      If one removes the bulk of the “well, no duh” type of cases from the poll, and instead focus on those that would be clearly contested by knowledgeable practitioners, there could be no doubt that the level of differences do — in fact — have a high degree of statistical significance — directly TO your point.

      1. 1.1.1

        If one removes the bulk of the “well, no duh” type of cases from the poll, and instead focus on those that would be clearly contested by knowledgeable practitioners, there could be no doubt that the level of differences do — in fact — have a high degree of statistical significance — directly TO your point.
        Agree.

        For example, one cannot lump a bunch of Rule 36 affirmances on appeals that should have never been taken with substantive/precedential rulings that impact the law. The stakes matter and the issues matter.

        1. 1.1.1.1

          Yes – context (especially as concerns patent practitioners) matters.

          This (and the next thread) appear more to be fig leaves of “it doesn’t really matter to list the judges on the decisions.”

Leave a Reply

Your email address will not be published. Required fields are marked *

You can click here to Subscribe without commenting

Add a picture