Federal Circuit Affirms PTAB Decision on Obviousness, Judge Newman Dissents

Federal CircuitIn re: Ethicon, Inc., No. 2015-1696, 2017 U.S. App. LEXIS 4 (Fed. Cir. Jan. 3, 2017) (Before Newman, Lourie, and Dyk, J.) (Opinion for the court, Lourie, J.) (Dissenting opinion, Newman, J.)(The Federal Circuit rejected Ethicon’s argument that the Board’s obviousness finding impermissibly relied on hindsight. In dissent Judge Newman disagreed, saying without hindsight there would have been no motivation to combine.)

In a January 3, 2017 decision, the Federal Circuit affirmed a decision by the Patent Trial and Appeal Board (“The Board”) in an inter partes reexamination affirming the examiner’s obviousness finding.

Ethicon, Inc. (“Ethicon”) owns the ’844 patent, which relates to intraluminal medical devices for the local delivery of drugs, e.g., drug-eluting stents, and methods for maintaining drugs on those devices. The patent teaches that stent coatings themselves, and stent coatings delivering drugs locally, may be capable of reducing resentosis, the gradual re-closure of a blood vessel. Ethicon sued Boston Scientific SCIMED and Abbott Laboratories (collectively, “Requesters”) for infringement of the ’844 patent. The Requesters filed separate requests for inter partes reexamination of the ’844 patent. The PTO merged and granted the requests, and the examiner rejected claims 1-17 and 19-23 as obvious over the “Tuch,” “Tu,” and “Lo” patents. The examiner found that Ethicon’s evidence regarding objective indicia of nonobviousness was insufficient. Ethicon appealed to the Board, and the Board affirmed, and Ethicon appealed to the Federal Circuit.

The Federal Circuit rejected Ethicon’s argument that the Board’s obviousness finding impermissibly relied on hindsight and failed to provide any reason why one of ordinary skill in the art would have combined the prior art references to create the claimed invention. The Court emphasized that KSR Int’l Co v. Teleflex, Inc. does not require an explicit teaching, suggestion, or motivation in the references. The Board made sufficient factual findings from substantial evidence under the circumstances to support its obviousness conclusion. First, Tuch taught that elasticity and biocompatibility are useful polymer characteristics and that coatings with low elasticity are problematic. Second, the components of Tu and Lo supported the Board’s combination of the three references to address the elasticity problem described by Tuch. Tu and Lo disclosed an 85:15 weight ratio of VDF:HFP elastomers, which low described as “optimal” and Tu disclosed that a VDF:HFP elastomer “promotes the elasticity [and] strength” of components for medical devices.

The Court rejected Ethicon’s argument that the Board was mistaken in certain factual findings. Tuch teaches that elasticity is a useful polymer characteristic and that coatings with low elasticity are problematic. Tu teaches that its multilayer elastomer material has a “very broad application in biomedical devices, such as . . . heart valve leaflets.” The Court found no error in the Board’s reliance on Lo, applied for “teaching the properties of VDF:HFP” at different ratios of copolymer. Substantial evidence supported finding that Lo’s teachings are “reasonably pertinent to the particular problem with which the inventor is involved.” Further, “[t]he normal desire of artisans to improve upon what is already generally known can provide the motivation to optimize variables such as the percentage of a known polymer for use in a known device.” Selecting a particular elastomer ratio for use with drug-loaded stents was seen as a reasonably predictable biomedical application for a known material.

Finally, the Court rejected Ethicon’s argument that the Board erred by discounting its proffered objective indicia of nonobviousness. Ethicon argued that copying, commercial success, industry praise, and unexpected results supported the nonobviousness of the ’844 patent. The Board did not err in its review because Ethicon relied solely on its expert’s conclusory testimony to support its copying allegations.

Judge Newman dissented with the majority’s finding there was motivation to combine the references without hindsight. She argued that the references recite thousands of polymer and copolymer components for stent coating materials, but not the copolymer of the ’844 patent. To the contrary, Tu and Lo did not fill in the gaps in Tuch to render obvious the ’844 patent. She emphasized that “[t]he Board erred in its analysis, collecting elements of the ’844 Patent’s stent from assorted sources, and placing them in the template of the ’844 claim.” Judge Newman also found that the Board erred in declining to consider Ethicon’s evidence of copying, commercial success, and medical acclaim.

The Court’s opinion stresses that in an obviousness analysis, it should consider “whether the improvement is more than the predictable use of prior art elements according to their established functions.” An explicit teaching, suggestion, or motivation in the references is not necessary to support a conclusion of obviousness.




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4 comments so far.

  • [Avatar for step back]
    step back
    January 16, 2017 03:48 pm

    Totally agree Eric.

    Bilski had the hope and audacity to sue big coal/oil.
    Alice had the hope and audacity to sue big bank (CLS).

    The Supremes had to make up some sort of mumbo jumbo for explaining why the little guy loses each time. The twirling crystal shard on a string that tells them what a claim is “directed to” is the perfect mechanism. Only those who are wise and loyal can see the Emperor’s new clothes.


  • [Avatar for Eric Berend]
    Eric Berend
    January 16, 2017 02:24 pm

    It’s totally ‘f-ing’ simple. Just look at whether there is a marked disparity in the size and wealth of the legal protagonists; and if so: the larger, wealthier entity will be favored. If such a disparity exists not in a present case, then whatever will cause the most harm to individual or small entity inventors, is then applied.

    Purple-robes whim for the day satisfied, it’s time for a taxpayer-funded three-martini lunch. Topic of conversation: what easily deceived rubes inventors are, for actually believing there is any chance of lawful, equitable or fair decisions in their captive, bought-and-paid-for Courts.

    And, no amount of hand-wringing will bring back ‘Humpty Dumpty’ (e.g., inventors) – especially not, when there is still this cabal dedicated to destroying inventors in America, forever.

  • [Avatar for step back]
    step back
    January 16, 2017 11:40 am

    It has been shown experimentally that the part of the human brain that thinks it is the “me” makes ex post facto excuses for why the body did what it did rather than making the actual decision at the time. In other words, hindsight. Other parts of the brain, including emotional centers are the ones in control, not the alleged “rationalizing” part. Example: I punched you in the nose for the following list of rational reasons and not, my amygdala got triggered by an irrational fear of mine and I acted without any further thought.

    It takes many years of actual experience in the chemical arts to get a feel for what is obvious and what is not. Newman has that experience. The rest of the philosopher king gang does not. Then again, Newman is equally guilty when it comes to the computer related arts.

    Each one of us is a genius in the other guy’s field of expertise.

  • [Avatar for Charles Barton]
    Charles Barton
    January 15, 2017 01:35 pm

    I am sympathetic to Judge Newman’s position.

    I ask lawyers here whether they see contradiction with Judge Lourie’s decision ARIAD PHARMACEUTICALS, INC. v. ELI LILLY AND COMPANY, 598 F.3d 1336, 94 U.S.P.Q.2d 1161, United States Court of Appeals, Federal Circuit, No. 2008-1248, March 22, 2010.

    In that case the CAFC rejected Ariad’s assertion of rights to non-preferred embodiments in an unpredictable art.

    On page 22 of the above document, we find the following.

    Perhaps there is little difference in some fields between describing an invention and enabling one to make and use it, but that is not always true of certain inventions, including chemical and chemical-like inventions. Thus, although written description and enablement often rise and fall together, requiring a written description of the invention plays a vital role in curtailing claims that do not require undue experimentation to make and use, and thus satisfy enablement, but that have not been invented, and thus cannot be described. For example, a propyl or butyl compound may be made by a process analogous to a disclosed methyl compound, but, in the absence of a statement that the inventor invented propyl and butyl compounds, such compounds have not been described and are not entitled to a patent.

    The argument for 103 (a) unpatentability in an unpredictable art seems to have exactly the same difficulties as the argument for 112 first paragraph possession in an unpredictable art.

    Thus Judge Newman seems to have been as correct in rejecting obviousness in the case of In re: Ethicon, Inc as Judge Lourie was to find lack of possession in ARIAD PHARMACEUTICALS, INC. v. ELI LILLY AND COMPANY.

    In this case Judge Lourie seems to have no problem with defining obviousness by predictability in an unpredictable art and thus logically must be using hindsight.