Category Archives: Obviousness

The Board May Consider Non-Prior Art Evidence in Considering the Knowledge, Motivations, and Expectations of a PHOSITA Regarding the Prior Art.

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In Yeda Research and Development Co., Ltd. v. Mylan Pharmaceuticals Inc., [2017-1594, 2017-1595, 2017-1596] (October 12, 2018) the Federal Circuit affirmed the Board’s determination that U.S. Patent Nos. 8,232,250, 8,399,413, and 8,969,302 unpatentable as obvious.

Yeda contends that its due process rights and the APA were violated because it did not have notice of, and an opportunity to respond to, Khan 2009. The Board relied on Khan 2009 in deciding whether a POSITA would have had a reasonable expectation of  success of a thrice-weekly regimen.  Yeda received notice of Khan 2009 in Petitioners’ expert reply declaration, attached to Petitioners’ reply. Yeda deposed Dr. Green after receiving his reply declaration; he discussed Khan 2009 in that deposition and was questioned about it.  Yeda also moved to exclude Khan 2009 as irrelevant, which the Board denied. Yeda could have, but did not, address Khan 2009 at the oral hearing or
seek leave to file a surreply to substantively respond to Khan 2009.

Based on this record, the Federal Circuit received proper notice of and an opportunity to respond to Khan 2009—an opportunity Yeda took advantage of when it moved to  exclude the study. But Yeda contends that it had no notice that the Board “might rely extensively” on Khan 2009 and make it “an essential part of its obviousness analysis.” The Federal Circuit said that although Yeda framed its argument as being about due process, it really only challenges the Board’s use of Khan 2009.  The Board acknowledged that Khan 2009 does not qualify as statutory prior art, but because the study began two years before the priority date of the patents, the Board concluded that Khan 2009 is “probative of the fact that those skilled in the art were motivated to
investigate dosing regimens of GA with fewer injections to improve patient compliance.”

The real question before the Federal Circuit was whether the Board may consider non-prior art evidence, such as Khan 2009, in considering the knowledge, motivations, and
expectations of a POSITA regarding the prior art.  The Federal Circuit noted that the statute permits IPR petitioners to rely on evidence beyond the asserted prior art. Section 312(a)(3) of Title 35 specifies that a petition should include both “copies of
patents and printed publications that the petitioner relies upon,” and “affidavits or declarations of supporting evidence and opinions.” As do the regulations.  See 37 C.F.R. § 42.104(b).

The Federal Circuit said that the Board has recognized that non-prior art evidence of what was known “cannot be applied, independently, as teachings separately combinable” with other prior art, but “can be relied on for their proper supporting roles, e.g., indicating the level of ordinary skill in the art, what certain terms would mean to one with ordinary skill in the art, and how one with ordinary skill in the art would have understood a prior art disclosure.” The Federal Circuit said that the expert’s reliance on Khan 2009 is permissible, as it supports and explains his position that a POSITA would have thought less frequent dosing worthy of investigation as of the priority date. The Federal Circuit found the reliance proper, but to the extent that this reliance was error,
it concluded that it was harmless error, because substantial evidence otherwise
supports the Board’s conclusion.

 

District Court Did Not Rely on Flawed Obvious to Try Rational

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In Teva Pharmaceuticals USA, Inc., v. Sandoz Inc., [2017-1575] (October 12, 2018), the Federal Circuit affirmed the district court decision invalidating for obviousness all asserted claims of patents directed to COPAXONE® 40mg/mL, a product marketed for treatment of patients with relapsing forms of multiple sclerosis.

On appeal, Teva argued the district court improperly discounted the “sufficiency” terms in its claims, construing these terms to be nonlimiting statements of intended effect.  The Federal Circuit said that “the regimen being sufficient to reduce the frequency of relapses in the patient” does not change the express dosing amount or method already disclosed in the claims, or otherwise result in a manipulative difference in the steps
of the claims.” The Federal Circuit further found that Teva’s argument that the  sufficiency terms were added during prosecution to overcome rejections overstated the intrinsic record. Accordingly the Federal Circuit found no error in the district court’s construction.

As to obviousness, Teva argued for the patentability of its claimed dosing regimen,  the improved tolerability, reduced frequency of adverse effects, and the reduced severity of injection site reactions.

The Federal Circuit rejected Teva’s argument that the district court engaged in an improper obvious to try analysis.  An “obvious to try” analysis is improper if it suggests varying all parameters or try every available option until one succeeds, where the prior art gave no indication of critical parameters and no direction as to which of many possibilities is likely to be successful.   An “obvious to try” analysis is involves a new technology or general approach in a seemingly promising field of experimentation, but the prior art gives only general guidance as to the particular form or method of
achieving the claimed invention. The Federal Circuit said that neither of these was what the district court did — the prior art focused on two critical variables, dose size and injection frequency, and provided clear direction as to choices likely to be successful in
reducing adverse side effects and increasing patient adherence.

Teva contends that the unpredictable nature of the compound categorically precludes the obvious-to-try analysis employed by the district court.  Again the Federal Circuit disagreed, noting obviousness was proven through human clinical studies establishing the safety, efficacy, and tolerability at doses and dose frequencies similar to the claimed regimen.

Regarding improved tolerability and reduced frequency, Teva argued that the prior art did not lead POSITAs to expect improved tolerability and reduced frequency of
injection reactions from the claimed regimen compared to the prior art, but the Federal Circuit disagreed.  Teva found fault with the district court’s reference to “common sense” in its reliance on expert testimony, and argued that the expert testimony was conclusory and unsupported by the prior art.  The Federal Circuit found no error in what is essentially a credibility determination.

On reduced severity, the Federal Circuit again agreed with the district court that the evidence provided a reasonable expectation to those skilled in the art that reducing the number of injections per week may also reduce the severity of injection site reactions.

 

 

 

 

“Capable of” Construction (Rather than “Configured to” Construction) Dooms Apparatus, but Not Method Claims

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In Parkervision, Inc. v. Qualcomm Incorporated, [2017-2012, 2017-2013, 2017-2014, 2017-2074] (September 13, 2018), the Federal Circuit affirmed the PTAB’s determination in related inter partes review proceedings, The certain apparatus claims of U.S. Patent No. 6,091,940, generally related to telecommunications devices,  were unpatentable as obvious under 35 U.S.C. § 103(a), and that certain method claims were not unpatentable.

The Federal Circuit rejected the argument that the Board erred by basing its
patentability decisions on theories and evidence regarding the phrase “plurality of harmonics” that Qualcomm did not present in its petitions.  The case came down to whether the claim language required the production of the “plurality of harmonics,” or simply the capability of producing the “plurality of harmonics” —  The Federal Circuit found the claim language merely required the capability of producing the plurality of harmonics, which was met by the prior art that was similarly capable.

The method claims presented a different story —  while Qualcomm was only required to identify a prior art reference that discloses an apparatus “capable of” performing
the recited functions to prove that the apparatus claims would have been obvious, more was required with respect to the method claims. Specifically, Qualcomm needed to present evidence and argument that a person of ordinary skill would have been motivated to operate the prior art in a manner that satisfied the “plurality of harmonics”
limitation, which Qualcomm failed to do.

Blocking Patent Can Explain Long-Felt But Unmet Need, Reducing Importance of Objective Indicia of Nonobviousness

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In Acorda therapeutics, Inc. v. Roxane Laboratories, Inc., [2017-2078, 2017-2134] (September 10, 2018), the Federal Circuit affirmed the judgment that the asserted claims of U.S. Patent Nos. 8,007,826; No. 8,663,685; No. 8,354,437; and No. 8,440,703, were invalid, and dismissed the cross-appeal regarding U.S. Patent No. 5,540,938, which expired while the appeal was pending, as moot.  The patents all relate to improvement of the gait of persons with multiple sclerosis.

Acorda made three arguments on appeal against the determination of obviousness:
First, that the district court erred in finding that a person of skill would have had a
motivation to combine the prior art to arrive at the Acorda invention and a reasonable expectation of success in doing so. Second, that the district court erred in findng that the limitations relating to pharmacokinetics are inherent in the claimed invention and therefore obvious. Third, that the court improperly applied a categorical rule that a blocking patent negates any findings in favor of Acorda on the objective indicia of commercial success, failure of others, and long felt but unmet need.

Regarding the motivation to combine, Acorda argued that the prior art teaches away from the invention, but the Federal Circuit found that the prior art supported a motivation to combine with a reasonable expectation of success, and that the district did not clearly err in finding that a person of skill would look to the claimed lower doses rather than
higher ones.  Regarding Accorda’s arguments against the inherency of the pharmokinetic limitations, the Federal Circuit said that the court invoked the principle that an obvious formulation cannot become nonobvious simply by administering it to a patient and claiming the resulting serum concentrations, and concluded that the pharmacokinetic limitation could not alter the obviousness analysis.   The Federal Circuit found that the Acorda had not pointed to any evidence to contradict the district court’s assumption.

Finally, regarding the argument that the district court improperly applied a categorical rule that the existence of a blocking negated objective evidence of non-obviousness, the Federal Circuit explained that a blocking patent can diminish the possible rewards from a non-owner’s or non-licensee’s investment activity aimed at an invention whose commercial exploitation would be infringing, therefore reducing incentives for
innovations in the blocked space by non-owners and nonlicensees of the blocking patent. The Federal Circuit said that such a blocking patent therefore can be evidence that can discount the significance of evidence that nobody but the blocking patent’s
owners or licensees arrived at, developed, and marketed the invention covered by the later patent at issue in litigation. However, the the magnitude of the diminution in incentive in any context—in particular, whether it was great enough to have actually deterred activity that otherwise would have occurred—is “a fact-specific inquiry.”  The Federal Circuit concluded that in a particular case, a court may ultimately be left, for its evaluation, with the solid premise of diminished incentives, plus some evidence  (possibly weak or ambiguous) about the significance of the deterrence, together with a background sense of the general realities in the area at issue that can affect the
weight to be given to the evidence in the specific case.  Against this background, the Federal Circuit examined the district court’s consideration of objective indicia.  The Federal Circuit found no clear error in the district court’s discounting evidence of long-felt, unmet need, in view of the evidence of blocking.

Just Because Seldom was Heard a Discouraging Word Did Not Mean The Invention Was Obvious

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In Orexo AB v. Actavis Elizabeth LLC [2017-1333](September 10, 2018), the Federal Circuit reversed the district court’s determination that the challenged claims of U.S. Patent No. 8,940,330 were invalid for obviousness.

The invention related to pills for treating opiod addition, that were less susceptible to misuse, where the active ingredient, buprenorphine, was adhered to carrier particles of citric acid.  The district court relied upon a patent disclosing the use of citric acid to reduce the pH of an orally dissolvable film.  However the Federal Circuit found taht the claimed structure was achieved solely upon the hindsight knowledge of the
structure and benefits described in the ’330 Patent.

Orexo argued that citric acid is nowhere used or listed or suggested as a carrier particle in the prior art, and at oral argument Actavis conceded that no reference teaches using citric acid as a carrier particle, or that citric acid should be used as a carrier particle.  The district court finding that a person of ordinary skill in the art would not have excluded citric acid, was not the same as a teaching or suggestion to use citric acid. The Federal Circuit observed that the mere fact that the prior art could be so modified would not have made the modification obvious unless the prior art suggested the desirability of the modification. The Federal Circuit said that the record does not contain clear and convincing evidence of a teaching or suggestion to use citric acid particles as a carrier for this opioid product in substitution therapy, or that the actual beneficial results would be obtained.

In response to the district court’s observation that “there is nothing in the prior art which would have discouraged a person of ordinary skill from following the path set out in the various references,” the Federal Circuit said that “no reference or combination of references proposes the path of the ’330 Patent.”

The district court erred in discounting objective indicia of nonobviousness, and concluded that obviousness had not been established by clear and convincing evidence.

What’s Zup? Water Board Patent Obvious; Secondary Considerations Too Weak to Show Otherwise

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In Zup, LLC v. Nash Manufacturing, Inc., [2017-1601] (July 25, 2018), the Federal Circuit affirmed the district court’s judgment that claims 1 and 9 of U.S. Patent No. 8,292,681 on a water recreational board and a method of riding such a board were invalid for obviousness.

Zup and Nash had discussions about a potential joint manufacturing venture for the ZUP Board, and when they fell through, and Nash
brought the accused product to market.  Zup sued Nash, and the district court granted Nash’s motion for summary judgment of invalidity.  The parties agreed on the content of the prior art, and level of skill, but disagreed on whether a person of ordinary skill in the art would have been motivated to combine the prior art references in the way claimed in the patent, and whether the district court properly evaluated Zup’s
evidence of secondary considerations.

The Federal Circuit said that a “motivation to combine may be found explicitly or implicitly in market forces; design incentives; the ‘interrelated teachings of multiple patents’; ‘any need or problem
known in the field of endeavor at the time of invention and addressed by the patent’; and the background knowledge, creativity, and common sense of the person of ordinary skill.”  The district court explained that the ’681 patent identified known elements in the prior art that aided in rider stability while engaging a water recreational device and simply combined them in one apparatus and method.  The district court said that one of ordinary skill in the art would have been motivated to combine the various elements from the prior art references, noting that such motivation would have stemmed from a desire to aid in rider stability, to allow a wide variety of users to enjoy the device, and to aid users in maneuvering between positions on a water board — all
motivations that were “a driving force throughout the prior art and have been shared by many inventors in the water recreational device industry.

The Federal Circuit found that the record supported the district court’s analysis.  The Federal Circuit observed that helping riders switch between riding positions had long been a goal of the prior art, citing various portions of the references of record.  The Federal Circuit pointed out that Zup admitted that achieving rider stability is an “age-old motivation in this field,” and found that such stability was enhanced in the prior art through the same components employed in the ’681 patent: tow hooks, handles, foot bindings, and other similar features.

In the face of significant evidence regarding the consistent desire for riders to change positions while riding water recreational boards (and the need to maintain stability while doing so), and given that the elements of the ’681 patent were used in the prior art for this very purpose, the Federal Circuit said there was no genuine dispute as to the existence of a motivation to combine the references.

The Federal Circuit further found that Zup’s minimal evidence of secondary considerations does not create a genuine dispute of fact
sufficient to withstand summary judgment on the question of obviousness.  The Federal Circuit rejected ZUP’s contention that the district court improperly shifted the burden to prove non-obviousness to Zup because Nash introduced no evidence as to secondary
considerations, yet Zup still lost, noting that “any concerns regarding improper burden allocation can be quickly dismissed. The Federal Circuit said that the burden of persuasion remains with the challenger during litigation because every issued patent is entitled to a  presumption of validity. However, while the burden of persuasion remains with the challenger, a patentee bears the burden of production with respect to evidence of secondary considerations of nonobviousness.  The Federal Circuit said that it is clear that the district
court kept the ultimate burden of persuasion on the patent challenger throughout the obviousness analysis. Any argument that the district court improperly shifted the burden is therefore without merit.

On the issue of secondary considerations the Federal Circuit said that where the differences between the prior art and the claimed invention are minimal, it cannot be said that any long-felt need was unsolved.  The Federal Circuit further found that the record evidence indicates that the claimed invention was not the first to achieve the goal of helping users maneuver between positions on a water recreational board.

The Federal Circuit rejected the arguments of copying, noting that Nash’s instructions suggest a configuration that is different from Zup’s product, dispelling any inference of copying.

The Federal Circuit concluded that the weak evidence of secondary
considerations presented here simply cannot overcome the strong showing of obviousness, quoting “a claimed invention represents no more than the predictable use of prior art elements according to
established functions, as here, evidence of secondary indicia are frequently deemed inadequate to establish non-obviousness.”

Federal Circuit Finds No Error in District Court Determination the Claimed Invention was not Obvious

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In Endo Pharmaceutical Solutions, Inc. v. Custopharm Inc., [2017-1719] (July 13, 2018), the Federal Circuit affirmed the determination that the claims of U.S. Patent Nos. 7,718,640 and 8,338,395 on a long-acting injectable testosterone replacement therapy were not invalid for obviousness.

the district court found that the prior art did not disclose the 750 mg TU injection dosage, and that Custopharm had not shown, by clear and convincing evidence, that a skilled artisan would have been motivated to lower the dosage of TU from 1000 mg to 750 mg.  The district court
found that articles about studies do not inherently disclose the particular co-solvent or the particular ratio of solvent to co-solvent claimed by the patents-in-suit simply because this formulation was what had been used in the studies forming the basis of the articles.

The claims required a 750 mg dosage, which the parties agreed was not disclosed by the prior art.  However, Custompharm argued the district court erred in finding no motivation for a skilled artisan to lower the dose of TU from the 1000 mg disclosed in the prior art to 750 mg.   After discussing the evidence, the Federal Circuit said the district court
reasonably rejected Custopharm’s argument that a skilled artisan would consider 1000 mg of TU to be an overdose and would have been motivated to lower the dosage to the patented 750 mg.

Custopharm also argued that the district court erred in finding that the
claimed formulation was not inherently described by prior art articles Articles.  Although the formulation was not disclosed is the articles,  Custopharm argues that the vehicle formulation was “necessarily present” in the articles because it was later revealed to be the actual formulation the authors of the Articles used in their reported clinical studies, but the Federal Circuit disagreed.  The Federal Circuit noted that Custopharm has not demonstrated that a skilled artisan could extrapolate the vehicle formulation used in the Articles from pharmacokinetic performance data.  It was Custopharm’s burden to present clear and convincing evidence that the Articles necessarily disclosed the vehicle formulation to one of skill in the art, and  Custopharm’s expert’s testimony and briefing fall short of meeting this burden.  The Federal Circuit said that under the circumstances
of this case, the incomplete description of the injection composition elements denied skilled artisans from having access to that composition, thereby precluding use of the inherency doctrine to fill in disclosure about the product missing from the articles.

Regarding the motivation to combine, the Federal Circuit said that the district court thus did not err in considering the obviousness inquiry from the perspective of a skilled artisan “confronted with the same problems as the inventor,” which in the present case is developing a commercially
viable long-acting testosterone therapy.  Doing so, the district court properly found that Custopharm failed to meet its burden of showing that a skilled artisan would combine the lowered dose with the injection schedule in the manner claimed.

Federal Circuit Affirms Non-obvious Holding in “Close” Case, Declining to Disturb Factual Findings on Motiviation

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In Impax Laboratories Inc. v. Lannett Holdings Inc., [2017-2020] (June 28, 2018), the Federal Circuit affirmed the district court decision that claims 4, 11, 12, and 14 of U.S. Patent 6,760,237 and claims 6 and 14–
16 of U.S. Patent 7,220,767 were not shown to be invalid and entering an injunction.

The claims at issue are directed to pharmaceutical formulations, intranasal administration devices, or aqueous solutions, of zolmitriptan.  The Federal Circuit noted that all of the claims at issue rise and fall together with the issue of whether it would have been obvious to make zolmitriptan into a nasal spray.

In considering the asserted obviousness of the claimed invention, the Federal Circuit noted that while the reference mentioned the possible nasal administration of zolmitriptan (just once, and not in a claim or an example), the reference was not about administering zolmitriptan, but about the nasal administration of active ingredients generally.  The Federal Circuit also noted evidence in the record that a skilled artisan would have expected delayed or lower therapeutic effectiveness from
zolmitriptan if administered nasally because it would have been “absolutely counterintuitive to make a nasal spray when you have an active metabolite which is more potent . . . than the drug itself.”

The Federal Circuit said that:

In view of the totality of the record evidence of the state of the prior art, we cannot find that the district court clearly erred in its findings. Far from disregarding the prior art’s discussion of zolmitriptan, the court specifically considered and acknowledged that zolmitriptan was mentioned in connection with nasal formulations and
sprays. However, the court also properly considered additional record evidence to make findings on the state of the prior art as a whole.

The Federal Circuit noted that the presence or absence of a motivation to combine references in an obviousness determination is a pure  question of fact, as is what a reference teaches and whether it teaches toward or away from the claimed invention.  Based on the record before it, the Federal Circuit could not find that the court clearly erred in concluding that at the time, zolmitriptan’s known significant reliance on its active metabolite would have, on balance, dissuaded a person of
skill in the art from making nasal formulations of zolmitriptan.  The Federal Circuit said that it does not and should not reweigh evidence or make factual findings anew on appeal.

Board Failed to Properly Consider Circumstances of Disclosure When It Determined They Were Not Printed Publications

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In Medtronic, Inc. v. Barry, [2017-1169, 2017-1170] (June 11, 2018) the Federal Circuit affirmed-in-part and vacated-in-part two PTAB Decisions finding that the Board erroneously concluded that asserted videos and slides were were not prior art because
the Board did not fully consider all the factors for determining whether the video and slides were publicly accessible.

The patents in suit, U.S. Patent Nos. 7,670,358 and 7,776,072 are directed to methods and systems for ameliorating aberrant spinal column deviation conditions.  After being sued for infringement, Medtronic instituted two IPRs relying in part on a video demonstration and a related slide presentation to spinal surgeons at various industry meetings and conferences in 2003.  The Board found that the video and slides, although presented at three different meetings in 2003, were not publicly accessible and therefore were not “printed publications,” in accordance with 35 U.S.C. § 102.

The determination of whether a document is a “printed publication” under 35 U.S.C. § 102(b) “involves a case-by-case inquiry into the facts and circumstances surrounding
the reference’s disclosure to members of the public. There are many ways in which a reference may be disseminated to the interested public, so public accessibility is the touchstone in determining whether a reference constitutes a ‘printed publication’
bar under 35 U.S.C. § 102(b).  A reference will be considered publicly accessible if it was ‘disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence could locate it.

The Federal Circuit noted that the distribution of certain materials to groups of people at one or more meetings presents a slightly different question than references stored in libraries, and that in the former, the publication need not be easily searchable after publication if it was sufficiently disseminated at the time of its publication.  The Federal Circuit identified several relevant factors from the case law, including (1) whether the copies were freely distributed to interested members of the public; (2) any expectations of confidentiality; (3) the length of time the display was exhibited, (4) the expertise of the target audience (to determine how easily those who viewed the material could
retain the information), (5) the existence (or lack thereof) of reasonable expectations that the material displayed would not be copied,” and (6) “the simplicity or ease with
which the material displayed could have been copied.”

The Federal Circuit said the record does not show that the Board fully considered
all of the relevant factors, including effect of the differences in the various disclosures.  The Federal Circuit said that the nature of those meetings, as well as any restrictions on
public disclosures, expectations of confidentiality, or, alternatively, expectations of sharing the information gained, can bear important weight in the overall inquiry.  For these reasons, the Federal Circuit vacated the Board’s finding that the video and slides are not printed publications and remand for further proceedings.

One of Ordinary Skill Would not Blindly Incorporate One Reference’s Exact Methodology into the Other

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In PGS Geophysical AS v. Iancu, [2016-2470, 2016-2472, 2016-2474] (June 7, 2018), the Federal Circuit affirmed the Board’s decisions finding certain claims of U.S. Patent No. 6,906,981 invalid.  After the Board issued its final written decisions, PGS settled with the Petitioner, leaving the Director to defend the final Written decision on appeal.

The Federal Circuit first considered its jurisdiction, concluding the Board’s decisions were final (and thus appealable) even though the decision not to institute as to some grounds is known after SAS to be erroneous, it was nonetheless final.

As to obviousness, the Federal Circuit noted that the obviousness inquiry entails
consideration of whether a person of ordinary skill in the art would have been motivated to combine the teachings of the prior art references to achieve the claimed invention,
and would have had a reasonable expectation of success in doing so.  Such a motivation and reasonable expectation may be present where the claimed invention
is the combination of familiar elements according to known methods that does no more than yield predictable results.

On appeal PGS could not dispute that the references disclosed all of the elements of the claims, but argued that the Board erred regarding the needed motivation.  The Federal Circuit noted that w it may not supply a reasoned basis for the agency’s action that the agency itself has not given, it will uphold a decision of less than ideal clarity if the agency’s path may reasonably be discerned.

PGS argued,with the support of expert testimony, that the combination of the references would result in an eight-fold loss of spatial resolution.  However the Federal Circuit noted that this argument relies on the presumption that one of ordinary skill would blindly incorporate one reference’s exact methodology into the other.  The Federal Circuit found that the Board properly did not view the proposed combination to be so limited.