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Prosecution Strategies for Avoiding Patent Eligibility Rejections for Diagnostics

November 19, 2018 | Blog | By Ken Jenkins, Jeff Giering

Under the Mayo/Alice test for patent eligibility, answering the questions of whether any particular claim is “directed to” a “judicial exception” without “significantly more” remains in many ways a substantial and unpredictable challenge for U.S. patent applicants in the diagnostic space.  In cases where the detection processes are typically deemed “routine and conventional” (e.g., PCR) and the targets are known (e.g., expression of a known gene), claims must be crafted in ways that avoid rejections for both patent eligibility and anticipation and/or obviousness over the prior art.  The recent PTAB decision in In re Srivastava et al. expressly addresses obviousness in this context, while highlighting a possible strategy for dealing with patent eligibility challenges as well (Appeal 2017-1981, Application 13/974,007, decided October 22, 2018; hereafter “In re Srivastava”).
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European Patent Office Issues New Guidelines on Artificial Intelligence and Machine Learning

November 7, 2018 | Blog | By Michael Renaud, Marguerite McConihe

On November 1, 2018, the European Patent Office (“EPO”) issued new guidelines for the patentability of artificial intelligence (“AI”) and machine learning (“ML”) inventions which indicate that applications within this subject matter may be treated as largely unpatentable. The new guidelines, G-II 3.3.1, provide that AI and ML are “based on computational models and algorithms for classification, clustering, regression and dimensionality reduction, such as neural networks, genetic algorithms, support vector machines, k-means, kernel regression and discriminant analysis.” These “computational models and algorithms” are, according to the guidelines, “per se of an abstract mathematical nature.”
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§102(b) Printed Publication: Unrestricted Distribution at a Trade Show

November 5, 2018 | Blog | By Andrew DeVoogd, Serge Subach

The U.S. Court of Appeals for the Federal Circuit opinion issued on November 1, 2018 clarifies the standard for a document to qualify as a “printed publication” under pre-AIA 35 U.S.C. §102(b) and reversed an earlier Patent Trial and Appeal Board (“PTAB”) decision.1 Specifically, the requirement that a reference be “publicly available” is not as narrow as the PTAB had interpreted. The Court held that “the standard for public accessibility [of an alleged prior art reference] is one of reasonable diligence, to locate the information by interested members of the relevant public.”
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“A New Day” for Amending Claims in Post-Grant Proceedings

October 29, 2018 | Blog | By William Meunier, Daniel Weinger, Matthew Galica

U.S. Patent and Trademark Office Director, Andrei Iancu, recently gave a speech to the American Intellectual Property Law Association where he discussed a new rule proposal aimed at improving the patent amendment process during post-grant proceedings.  Specifically, he informed the audience—and patent practitioners, generally—that the USPTO “will formally publish a notice seeking comments on a new claim amendment process for post grant proceedings.”  The stated purpose of the proposed rule change is to “ensure balance” in post-grant proceedings by making the amendment process “feasible and meaningful” for the owners of challenged patents.  
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Continuing our coverage of the Federal Circuit’s Applications in Internet Time, LLC v. RPX Corp. (“Internet Time”) decision, on Tuesday, October 23, 2018, the Federal Circuit denied RPX’s request to rehear the case en banc.  Internet Time held that the Patent Trial and Appeal Board (“PTAB”) must use a flexible approach when determining what entities constitute real parties in interest for the purpose of inter partes review (“IPR”). See Applications in Internet Time, LLC v. RPX Corp., 897 F.3d 1336 (July 9, 2018) (“Internet Time”). Petitioners for IPR challenging a patent must identify all real parties in interest in their petition. 35 U.S.C. § 312(a)(2). The Director is not authorized to institute trial on the petition if the petitioner, real party in interest, or privy of the petitioner, was served with an infringement complaint for the patent in question more than one year before the petition’s filing. See 35 U.S.C. § 315(b).
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District of Delaware Dismisses ANDA Applicant for Lack of Venue under TC Heartland

October 24, 2018 | Blog | By Adam Samansky, Peter Cuomo, Joe Rutkowski

On October 18, 2018, the United States District Court for the District of Delaware, in Bristol-Myers Squibb v. Mylan Pharmaceuticals Inc., No. 17-00379, held that venue was not proper in Delaware over Mylan Pharmaceuticals Inc. (“MPI”) in connection with a claim for patent infringement arising from Mylan’s submission of an Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of the drug, apixaban.
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ALJ Cheney Holds that IPR Estoppel Does Not Apply to ITC Investigative Staff

October 18, 2018 | Blog | By Aarti Shah, Andrew DeVoogd, Daniel Weinger, Chris Duerden

In an Initial Determination finding that Fujifilm violated Section 337 by infringing two patents held by Sony, ALJ Cheney found another patent invalid after ruling that inter partes review (“IPR”) estoppel does not apply to the International Trade Commission’s (“ITC”) Office of Unfair Imports Investigations (“OUII”) Staff.  In Magnetic Tape Cartridges and Components Thereof, Investigation 337-TA-1058, ALJ Cheney remarked that even if IPR estoppel prevents a respondent from raising certain references during an investigation before the ITC, IPR estoppel does not prevent Staff from raising those same references to invalidate a patent where Staff was not a party to the IPR.  Id. at 106-07.
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A recent opinion from the Northern District of Texas is a reminder to all patent practitioners to heed pleading standards when drafting a complaint for patent infringement.  In Lexington Luminance LLC v. Service Lighting and Electrical Supplies, Inc. d/b/a 1000bulbs.com, 3-18-cv-01074 (TXND October 9, 2018, Order), the court denied the defendant, Service Lighting and Electrical Supplies, Inc. d/b/a 1000bulbs.com’s (“1000bulbs”) request to dismiss the case for failure to meet the pleading standard, but granted its alternative request for a more definite statement. The plaintiff, Lexington Luminance LLC (“Lexington Luminance”), is now required to provide a more detailed complaint. 
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As in any technology area, it is important to consider patent protection early in the development of an AI-related invention. However, AI inventions raise a number of particular issues that, if not addressed fully or at the right time, could be fatal to securing U.S. patent protection that would otherwise be available to prevent others from making, using, selling, or importing the invention. This article identifies common pitfalls in getting a patent for AI inventions and provides insights on how to avoid them. These principles apply not only to AI-related inventions, but also to digital health inventions more broadly.
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PTAB Adopts the Phillips Claim Construction Standard in AIA Proceedings

October 11, 2018 | Blog | By Brad M Scheller, Daniel Weinger, Courtney Herndon

Today the Patent Trial and Appeal Board announced a final rule changing the claim construction standard for interpreting claims in inter partes review (“IPR”), post-grant review (“PGR”), and covered business method patent (“CBM”) proceedings.  The Board retired the broadest reasonable interpretation (“BRI”) standard in favor of the standard used to construe patent claims in federal court and the International Trade Commission (“ITC”) as articulated in Phillips v. AWH Corp.  In doing so, the Board announced that it will now consider prior constructions, either from a federal district court or the ITC, in construing a claim term in an IPR, PGR, or CBM, where such prior constructions are timely made of record.  This rule change is another positive development for patent owners and should provide for consistent construction of the same term across multiple tribunals going forward.
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Recently in Nobel Biocare Services AG v. Instradent USA, Inc., the Federal Circuit affirmed a decision of the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (“the Board”) in an inter partes review (“IPR”) finding certain claims of U.S. Patent No. 8,714,977 (“the ’977 Patent”), directed to dental implants, unpatentable as anticipated.  The Nobel decision is the latest in a recent line of Federal Circuit cases holding that materials distributed at conferences, trade shows, and meetings are publically available “printed publications” within the meaning of pre-AIA 35 U.S.C. § 102(b).
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PTAB Finds Recycled Art and Advanced State of Parallel District Proceeding Warrant Denial of IPR Trial

September 17, 2018 | Blog | By Peter Snell, Daniel Weinger, Vincent Ferraro, Chris Duerden

Last week the Patent Trial and Appeal Board (“PTAB”) provided yet another arrow in the patent owner’s quiver for defending against institution of IPRs.  In NHK International Corp. v. Intri-Plex Technologies, Inc., IPR2018-00752, the PTAB exercised its discretion under 35 U.S.C. § 325(d) and denied institution because the asserted art was already considered during the original examination of the patent.  The PTAB also found that denial was warranted under 35 U.S.C. § 314(a) in light of the additional factor that a district court trial on the same patent was imminent. 
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RPX Requests en banc Review in Applications in Internet Time v. RPX

September 13, 2018 | Blog | By Peter Snell, Daniel Weinger, Kara E. Grogan

On September 7, 2018, RPX Corporation (“RPX”) requested a rehearing en banc of the Federal Circuit’s July 2018 Applications in Internet Time, LLC v. RPX Corp. decision, which held that the Patent Trial and Appeal Board (“PTAB”) must use a flexible approach when determining what entities constitute real parties in interest for the purpose of inter partes review (“IPR”).
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PTAB Denies Institution of IPR after Successive Petitions by Unrelated Co-Defendants

September 11, 2018 | Blog | By Brad M Scheller, Daniel Weinger, Courtney Herndon

Last week, the Patent Trial and Appeal Board (the “Board”) denied a second challenge to a patent where the petitioners were co-respondents in an ITC investigation. 
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Six months later, and more than 2.5 years after service of the complaint on Activision, Bungie filed IPRs challenging Worlds’ patents.
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Massachusetts Adopts Uniform Trade Secrets Act

September 6, 2018 | Blog | By Michael Renaud, Nicholas Armington

On October 1, 2018, Massachusetts will become the 49th state to adopt a version of the Uniform Trade Secrets Act. The version of the UTSA that Massachusetts will adopt bears notable similarities to the Defend Trade Secrets Act, the two year old federal trade secrets statute.
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Not just for crypto – How blockchain technology will affect medical devices

September 4, 2018 | Blog | By Lisa Adams, Linda Azrin, Derek Constantine

Most people are familiar with blockchain technology because of its use in cryptocurrency, but its use is going to be far more widespread than just as a ledger for digital currency. 
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A Sales Agent’s Home Office May Qualify as a Regular and Established Place of Business

August 20, 2018 | Blog | By Andrew DeVoogd, Daniel Weinger, Anthony Faillaci

In our continued post-TC Heartland coverage, the Southern District of New York recently held that an employee’s home office in New York constituted a “regular and established place of business” in the state as required by the patent venue statute, 28 U.S.C. § 1400(b).
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The Patent Trial and Appeal Board (PTAB) issued an August 2018 update to the American Invents Act Trial Practice Guide (the “Updated TPG”).  The Updated TPG incorporates the PTAB’s current practices and provides further explanation of certain aspects of the PTAB’s standard practices to the public. 
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In our continued post-TC Heartland coverage, Judge Gilstrap in the Eastern District of Texas recently held that venue was proper because Google exercises exclusive control over physical servers implicated by the litigation, as well as the physical space within which the server is located and maintained.
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