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.

 

 

 

 

Primers and the Use of Naturally Occurring Position-Specific Signature Nucleotides are Patent Ineligible

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In Roche Molecular Systems, Inc., v. Cepheid, [2017-1690] (October 9, 2018), the Federal Circuit affirmed summary judgment of invalidity of claims of U.S. Patent No. 5,643,723 as directed to patent ineligible subject matter.

The ’723 patent is directed to methods for detecting the pathogenic bacterium Mycobacterium tuberculosis.  The ’723 patent provides two types of claims: (1) composition-of-matter claims for the primers used in the PCR, which could hybridize to the rpoB gene of MTB at a site that includes at least one of the eleven signature nucleotides (“the primer claims”); and (2) process claims for methods for detecting MTB that include amplifying target sequences by PCR and detecting amplification products,
which, if present, indicate the presence of MTB (“the method claims”).

As to the primer claims, the Federal Circuit held that In re BRCA1 foreclosed Roche’s arguments for patentability. There, the Federal Circuit examined the subject matter eligibility of similar primer claims and held that those primers were not distinguishable
from the isolated DNA found patentineligible in Myriad” and thus are not patent-eligible.  Primers necessarily contain the identical sequence of the nucleotide sequence directly opposite to the DNA strand to which they are designed to bind.  The subject matter eligibility inquiry of primer claims hinges on comparing a claimed primer to its corresponding DNA segment on the chromosome—not the whole chromosome.

As to the method claims, the Federal Circuit said that the claims disclose a diagnostic test based on the observation that the presence of the eleven position-specific signature nucleotides of the naturally occurring MTB rpoB gene indicates the presence
of MTB in a biological sample.  The method claims are directed to a relationship between the eleven naturally occurring position-specific signature nucleotides and the
presence of MTB in a sample. In other words, the method claims assert that if an investigator detects a signature nucleotide from a sample, she knows the sample contains MTB. This relationship between the signature nucleotides and MTB is a phenomenon that exists in nature apart from any human action, meaning the method claims are directed to a natural phenomenon, which itself is ineligible for patenting.

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Details Save Claims from Invalidity Under Section 101

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In Data Engine Technologies LLC v. Google LLC, [2017-1135] (October 9, 2018), the Federal Circuit affirmed in part, reversed in part, and remanded, entry of judgment on the pleadings holding that the asserted claims of DET’s U.S. Patent Nos. 5,590,259; 5,784,545; 6,282,551; and 5,303,146 are ineligible under 35 U.S.C. § 101.

The Federal Circuit concluded that with the exception of claim 1 of the ’551 patent, the asserted claims of the ’259, ’545, and ’551 patents are directed to patent-eligible subject matter, finding that these claims claims are not abstract, but rather are directed to a
specific improved method for navigating through complex three-dimensional electronic spreadsheets. The Federal Circuit agreed that the asserted claims of the ’146 patent,
reciting methods for tracking changes to data in spreadsheets, were directed to the abstract idea of collecting, recognizing, and storing changed information.

Regarding the ’259, ’545, and ’551 patents, the Federal Circuit said that the claimed method does not recite the idea of navigating through spreadsheet pages using buttons or a generic method of labeling and organizing spreadsheets. Rather, the claims require a specific interface and implementation for navigating complex three-dimensional spreadsheets using techniques unique to computers.

 

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(Prior) Art Masterpieces

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“Prior art” is virtually anything before the inventor invention (pre-AIA) or filing date (post-AIA), and there are some amazing examples of the extent patent challengers, and even patent examiners will go in the pursuit of prior art.

One of the most well know instances is from Sakraida v. Ag Pro, 425 U.S. 273 (1976), where the Supreme Court invalidated U.S. Patent No. 3,223,070, entitled “Dairy  Establishment,” covering a water flush system to remove cow manure from the floor of a dairy barn, citing the Legends of Hercules from Witt, Classic Mythology (1883).  The Supreme Court noted in a footnote that Heracles cleansed the stables of Augeas, King of Elis, in a single day.

 

 

 

 

Another instance is in Karl Kroyer’s Netherlands application for a patent on his Method of Raising Sunken or Stranded Vessels.  Mr. Kroyer successfully raised the sunken freighter Al Kuwaita from the bottom of Kuwait harbor by pumping 27 million expanded polystyrene balls to raise the sunken freighter.  He then filed patent applications in Denmark, Great Britain, and the Netherlands.  Things were going well until the Netherlands patent examiner found a Donald Duck cartoon in which Huey, Dewey, and Louie helped to raise Scrooge McDuck’s yacht by filling it with ping pong balls.

 

 

Apparently, patent examiner’s spend a lot of time reading comics, comics played an important part in the examination of Great Britain patent application 2117179 on an Entry System for Pets, which the Examiner rejected over a Beano comic strip:

When they are not reading comics, examiners are apparently watching movies because an examiner relied on the movie Borat to reject Patent Application 2009/0216171:

 

It not just patent examiners who rely upon movies, in defending a suit brought by Apple on its iPad patents, Samsung pointed to tablet devices used by the astronauts in Stanley Kubrick’s 1968 classic 2001 Space Odyssey:

“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.

Do Over — Different Evidence and Different Evidentiary Standard Allow IPR to Reach Different Conclusion of Validity than ITC

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in Nobel Biocare Services AG v. Instradent USA, Inc., [2017-2256] (September 13, 2018), the Federal Circuit affirmed the PTAB’s determination that claims 1-5 and 19 of U. S. Patent No. 8,714,977,directed to dental implants, were anticipated.

The undisputed critical date of the ‘977 patent was May 23, 2003, and Instradent alleged that the claims were anticipated by an ABT “Product Catalog” with the date
“March 2003” on the cover.  The ITC, applying a clear and convincing evidentiary standard, had previously determined that the claims were not anticipated, and the Federal Circuit affirmed.

Meanwhile, Instradent petitioned for IPR.  While the Board adopted the same claim construction as the ITC, and considered the same evidence presented to the ITC, the Board also considered new evidence not considered by the ITC, including the declarations and deposition testimony of Hantman and Chakir that the catalog was available to the industry in March 2003.  The Board determined that a preponderance of the evidence establishes that the ABT Catalog qualifies as a prior art printed publication under 35 U.S.C. § 102(b).

On appeal, the parties disputed whether the ABT Catalog qualifies
as a “printed publication” under § 102(b).  The Federal Circuit said that whether a reference qualifies as a “printed publication” is a legal conclusion based on underlying factual findings, including The parties dispute whether the ABT Catalog qualifies
as a “printed publication” under pre-AIA § 102(b). Whether a reference qualifies as a “printed publication” is a legal conclusion based on underlying factual findings, including whether a reference was publicly accessible. Public accessibility has been called the touchstone in determining whether a reference constitutes a “printed publication.”  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 can locate it.

The Federal Circuit noted that it was not bound by its prior affirmance of the ITC’s holding that there was insufficient evidence to find pre-critical date public accessibility, observing that the evidentiary standard in IPRs, “preponderance of the evidence” is different from the higher standard applicable in ITC proceedings.  The Federal Circuit further noted that the Board also had more evidence on this issue than what was before the ITC.  Finally the Federal Circuit said that under the substantial evidence standard, the inconsistent conclusions from the evidence does not prevent an administrative agency’s finding from being supported by substantial evidence.

The Federal Circuit agreed with Instradent that substantial evidence supported the Board’s finding that the ABT Catalog was publicly accessible prior to the critical date. The Board credited Chakir and Hantman’s testimony that Chakir obtained a copy of the ABT Catalog at the March 2003 IDS Conference and that Hantman retained that copy in
his records thereafter. Furthermore, Hantman’s declaration included excerpts of his copy of the ABT Catalog taken from his files. The Board found that Hantman’s copy of the ABT Catalog and the copy offered as prior art by Instradent in the IPR had identical pages except for some handwriting on the cover of Hantman’s copy.

The Federal Circuit noted that corroboration is required of any witness whose testimony alone is asserted to invalidate a patent, regardless of his or her level of interest.  Corroborating evidence may include documentary or testimonial evidence, and circumstantial evidence can be sufficient corroboration.  The Federal Circuit listed eight factors to be considered in evaluating corroboration:

(1) the relationship between the corroborating witness and the alleged prior user,
(2) the time period between the event and trial,
(3) the interest of the corroborating witness in the subject matter in suit,
(4) contradiction or impeachment of the witness’ testimony,
(5) the extent and details of the corroborating testimony,
(6) the witness’ familiarity with the subject matter of the patented invention and the prior use,
(7) probability that a prior use could occur considering the state of the art at the time,
(8) impact of the invention on the industry, and the commercial value of its practice.

Applying a “rule of reason” analysis to the corroboration requirement, which “involves an assessment of the totality of the circumstances including an evaluation of all pertinent evidence, the Federal Circuit held the corroboration to be sufficient, noting “there are no hard and fast rules as to what constitutes sufficient corroboration, and each case must be decided on its own facts.”

The Federal Circuit rejected the challenges to the claim construction, and affirmed the Board.

 

 

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.

Expert Testimony Critical to Determining Meaning of Prior Art to a PHOSITA

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In IXI IP, LLC v. Samsung Electronics Co.. Ltd., [2017-1665] (September 10, 2018), the Federal Circuit affirmed the PTAB’s determination that the challenged claims of U.S. Patent No. 7,039,033 were unpatentable.  The ’033 patent is directed to a system that accesses information from a wide area network (WAN), such as the Internet, and local wireless devices in response to short-range radio signals.

The Federal Circuit noted that issues relating to a motivation to combine prior art references and a reasonable expectation of success are both questions of fact, reviewed for substantial evidence.  Substantial evidence is “such relevant evidence as a
reasonable mind might accept as adequate to support a conclusion.”

The single issue on appeal is whether a PHOSITA would read the prior art as implicitly
describing an implementation in which the JINI LUS, which identifies services provided on the network, is located on the gateway device, i.e., the cellphone.  Samsung acknowledged that the reference does not expressly state that the JINI LUS is located on a mobile phone, but nonetheless, contended, and the Board agreed, that a PHOSITA would read the reference to understand that JINI LUS may be located on the cellphone.

After examining the evidence, the Federal Circuit held that the Board’s determination
that a POSITA reading the reference would understand that the cellphone is the master of the ad-hoc network and contains the LUS is reasonable and was supported by substantial evidence.  The determination of how a PHOSITA would understand the references was based on the weighing expert testimony from both parties, with Samsung’s expert being credited by the Board.