United States: Spotlight On Upcoming Oral Arguments – October 2019

Evolved Wireless LLC v. ZTE (USA) Inc.., No. 18-2008, Dallas, Texas

The Court has been asked to consider whether the PTAB has the discretion to properly disregard evidence that is deficient in certain technical requirements.  Evolved is the owner of U.S. Patent No. 7,881,236 (“the ’236 patent”), which discloses an invention that improves upon prior art mobile telephone systems.  In an IPR challenging the validity of the ’236 patent, Evolved submitted an expert declaration to support the validity of its patent.  The Board declined to give any weight to Evolved’s expert declaration because it failed to include language that the statements were submitted “under the penalty of perjury.” The Board reasoned that to give the declaration any weight would “thwart the purpose” of the rules regarding affidavit or declaration evidence, and ultimately found the ’236 patent invalid as obvious.

On appeal, Evolved argues that the Board’s refusal to consider the declaration, indeed, thwarts the purpose of its rule requiring a timely motion to exclude any submitted evidence so that the technical defect in the declaration can be corrected.  According to Evolved, the petitioners never filed a motion to exclude as required by the Board’s rules, but instead stated untimely objections to the technical deficiency of the declaration.  Evolved further argues that it was not given an opportunity to correct the defect due to the regulations and scheduling orders governing the IPR procedures.  In response, ZTE points out that the Board did not exclude the declaration from the record, but simply exercised its broad discretion to regulate the presentation of evidence and give the unsworn declaration no weight for failing to comply with the Board’s regulations.  ZTE contends that Evolved nonetheless had the opportunity to cure the defective declaration earlier as ZTE’s reply brief put Evolved on notice of the defect.

Apple Inc. v. Andrea Electronics Corporation, No. 18-2382, Courtroom 203

In two related IPR proceedings, Apple challenged the claims of U.S. Patent No. 6,363,345 (“the ’345 patent”) as obvious in view of certain prior art references.  The ’345 patent claims methods and systems for processing sound to remove ambient noise based on a technique known as “spectral subtraction.” Importantly, Apple relied on a reference that discloses an algorithm for tracking noise floor using any number of sub-windows.  In its decision, the Board did not consider an expert declaration and certain arguments in Apple’s reply brief.  The Board explained that Apple improperly advanced a new theory of unpatentability based on multiple sub-windows for the first time in the reply.  Apple appealed the Board’s decision.

Apple argues that it raised the same obviousness rationale in both its petition and reply.  Specifically, Apple argued that its reply merely provided additional explanations of its obviousness argument and responded to arguments raised in the patent owner response using identical passages of the prior art references, which are not bound to a specific number of sub-windows.  Moreover, Apple argues that disregarding its rebuttal evidence and arguments contravenes the procedural requirements of the Administrative Procedure Act (“APA”) because the APA requires the Board to consider the whole record and entitles a party to submit rebuttal evidence.  Andrea argues that Apple’s petition relied solely upon a scenario with one sub-window and that Apple’s reply addressed a configuration of four sub-windows.  Andrea further contends that at trial, Apple could not demonstrate to the Board, despite multiple opportunities, where Apple raised the “multiple sub-windows theory” in its petition.  

Arthrex, Inc. v. Smith & Nephew, Inc., No. 18-2140, Courtroom 402

Arthrex appeals from a PTAB decision finding the challenged claims of U.S. Patent No. 9,179,907 (“the ’907 patent”) invalid as anticipated.  The ’907 patent claims a suture securing assembly using a rigid eyelet that enables surgeons to repair soft tissue damage without having to tie a single knot.  On its face, the ’907 patent claims priority to U.S. Application No. 09/886,280 (“the ’280 application”), which discloses a flexible eyelet assembly.  The ’907 patent also claims priority to several intervening patent applications, each of which incorporates the ’280 application by reference.  The PTAB did not accord the ’907 patent the priority date of the ’280 application because the intervening patent applications only supported claims to the rigid eyelet, not the flexible eyelet.  In doing so, the PTAB specifically recognized that the later intervening applications described the flexible eyelet as a “problematic background technique.”  The PTAB then held that the challenged claims were invalid as anticipated by the ’280 application. 

On appeal, Arthrex argues that the incorporation by reference of the ’280 application throughout the intervening applications is broad and unambiguous because the ’280 application was referenced and incorporated without qualification.  Thus, Arthrex argues that the incorporation by reference must be considered when determining whether there is adequate written description support.  Moreover, Arthrex argues that the statements in the intervening applications are not commentary on prior art because they involve the inventors’ own earlier work to which priority is claimed.  In response, Smith & Nephew argues that the inquiry does not end with a finding of incorporation and that the Court must consider whether the incorporated application supplies the requisite written description support, a highly factual inquiry.  Smith & Nephew contends that the description of the ’280 application in later applications as problematic prior art is instructive to this inquiry and that there is substantial evidence—in the applications themselves, expert and inventor testimony, and original claims of the patent—that the ’280 application fails to support the intervening applications that became the ’907 patent. 

Amgen Inc. v. Amneal Pharmaceuticals LLC, No. 18-2414, Courtroom 201

The question on appeal in Amgen is whether the specific patent language in this case claiming “at least one” listed element in a particular Markush group, excludes particular products in this case that contain a listed element and other unlisted elements.  Amgen appealed a decision from the District of Delaware finding non-infringement of U.S. Patent No. 9,375,405 (“the ’405 patent”) covering Amgen’s FDA-approved Sensipar® drug product.  The ’405 patent claims a pharmaceutical composition containing the active ingredient cinacalcet hydrochloride and specific amounts of “at least one” of particular listed binders and “at least one” of the particular listed disintegrants to achieve a specific therapeutic amount of the active ingredient in patients in this particular case.  The district court construed the claims to require at least one of the specifically listed binders and disintegrants in this particular case and to exclude any unlisted binders or disintegrants.  The generic cinacalcet hydrochloride products at issue in this particular case contained the binder and disintegrants listed in the Markush groups, but also contained binders and disintegrants that were not specifically recited in the claims in this case.  Thus, the district court held that the generic cinacalcet hydrochloride products at issue in this case did not infringe.

Amgen argues on appeal that the Markush groups must be read to permit additional unnamed or unlisted elements because the claim language starts with a “pharmaceutical composition comprising.”  Amgen argues that “comprising” is an open-ended term making the listed elements essential while allowing for the inclusion of additional binders and disintegrants.  Amneal argues that the Markush group in this case sets forth an exclusive list of binders and disintegrants elements that forecloses the inclusion of any unlisted binders and disintegrants.  Amneal further argues that Amgen tried and failed during prosecution in this case to secure claims without employing Markush groups, and thus is estopped in this case from arguing that the claims in this case cover pharmaceutical compositions containing binders and disintegrants not identified in the specific claims.

Wednesday, October 2, 2019

23andMe, Inc. v. Ancestry.com DNA, LLC, No. 19-1222, Fort Worth, Texas

23andMe appeals a decision from the Northern District of California granting a motion to dismiss after finding that certain claims of U.S. Patent No. 8,463,554 (“the ’554 patent”) are patent-ineligible under 35 U.S.C. § 101.  The ’554 patent claims a system and method for finding unknown relatives in a database containing certain DNA sequence information—identical by descent or “IBD” regions—of its users to predict whether two users are related.  In determining that certain claims were patent-ineligible, the district court concluded that the claims: (1) are directed to a law of nature because the focus of the claims is a correlation existing in nature, i.e. the more recombinable DNA information that is shared between two people, the closer the degree of relationship, and (2) lack inventive concept because, inter alia, undertaking a simple comparison of recombinable DNA information is not an unconventional, inventive application sufficient to make a claim patent-eligible.

On appeal, 23andMe argues that the district court erred in finding the asserted claims are directed to a law of nature because the invention selects the IBD regions using man-defined measurements, then alters and manipulates that information to predict a probability of relative relatedness to find unknown relatives.  23andMe argues that the district court fundamentally misapprehended the invention, which applies a natural law, but uses man-made constructs to identify the IBD regions and manipulate that information in a unique way to predict relatedness.  In response, Ancestry.com argues that the asserted claims determine relative relationship by focusing on a correlation that exists in nature because both the existence of the IBD regions and relative relationship by that existence are naturally occurring phenomena, and are thus directed to determining relations that exist apart from any human action.

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