As we have reported in several recent posts, the PTAB often rigorously evaluates public accessibility when considering non-patent prior art.  Disputes over accessibility are often pivotal because insufficient evidence of accessibility can disqualify a reference as a “printed publication” under § 102.  The Federal Circuit recently expanded on the applicable standard for online publications in a case rooted in computer technology, but the decision provides relevant insights for life science practitioners as well. Continue Reading Federal Circuit Upholds PTAB Decision Finding Library Website’s Indexing and Search Capabilities Insufficient to Establish Public Accessibility

In the chemical and biological arts, it is common for patent challengers to allege obviousness based upon prior art disclosures of ranges combined with “routine optimization” by one skilled in the art.  In E.I. du Pont de Nemours & Co. v. Synvina C.V., No. 17-1977 (Fed. Cir. Sept. 17, 2018), the Federal Circuit reversed the PTAB’s (“Board”) final written decision upholding Synvina’s U.S. Patent No. 8,865,921 (“’921 patent”) as non-obvious, in response to du Pont’s inter partes review (“IPR”) challenge on such grounds.  In particular, in E.I. du Pont, the Court found that the patentee failed to demonstrate that 1) the claimed range produced a new and unexpected result, different in kind and not merely in degree from the prior art, 2) the optimized parameter was not recognized as a result-effective variable, 3) the disclosure of broad ranges did not invite more than routine optimization, or 4) that the prior art taught away from the range.

The claims of the ’921 patent are generally directed to methods of preparing 2,5-furan dicarboxylic acid (“FDCA”), a compound useful in certain “green” chemicals.  Claim 1 requires that a substrate is “contact[ed] … in the presence of an oxidation catalyst . . .  at a temperature between 140°C and 200°C[, and] an oxygen partial pressure of 1 to 10 bar.”  While methods for preparing FDCA were already well-known, the prior art disclosed methods using at least different temperatures and pressures from those recited in the ’921 patent claims.

In its final written decision, the Board found that the ’921 patent claims were not obvious despite prior art references disclosing oxidation of substrates using overlapping conditions to create FDCA.  The Board reasoned that none of the applied references expressly taught the claimed combination of conditions recited in the ’921 patent’s methods and rejected DuPont’s argument that the burden-shifting framework applies to overlapping prior art ranges.

According to the Federal Circuit, the Board misconstrued In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016), and Dynamic Drinkware, LLC v. Nat’l Graphics, Inc. 800 F.3d 1375, 1378 (Fed. Cir. 2015), as prohibiting application of burden-shifting framework to IPRs and further erred by applying the wrong legal standards for obviousness.  In overruling the Board’s final written decision, the Federal Circuit explained that the burden-shifting framework applies to IPRs in the same manner as it applies in the district courts and at the USPTO.  The Federal Circuit cited In re Aller, 220 F.2d 454, 456 (CCPA 1955), and others, to support the asserted rationale for obviousness: “For decades, this Federal Circuit and its predecessor have recognized that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” (Internal quotation marks omitted.)  Because the claimed ranges recited in the ’921 patent’s methods are within those ranges described in the prior art, the Federal Circuit also found that a presumption of obviousness applies.  The presumption of obviousness provides that a prima facie case of obviousness has been met when prior art ranges overlap with those recited in the claims.  In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003).  When such a presumption is proper, as it was here, the burden shifts to the patentee to rebut the presumption by demonstrating that (1) the claimed process parameter “produce[s] a new and unexpected result which is different in kind and not merely in degree from the results of the prior art,” (2) the prior art taught away from the claimed range, (3) the parameter was not recognized as “result-effective,” and/or (4) the prior art disclosed “very broad ranges” which “may not invite routine optimization.”  See In re Aller, 220 F.2d 454, 456 (CCPA 1955); In re Applied Materials, Inc., 692 F.3d 1289 (Fed. Cir. 2012); Genetics Inst., LLC v. Novartis Vaccines & Diagnostics, Inc., 655 F.3d 1291 (Fed. Cir. 2011).  Synvina failed to rebut the presumption using any of these four approaches.  As such, the Federal Circuit held that the Board erred in its analysis and should have held that the ’921 patent is obvious.

 

During the week of October 15-19, the Board issued one decision in Technology Center 1600, instituting inter partes review. The decision is as follows:

Mylan Pharmaceuticals Inc. v. Bristol-Meyers Squibb Co., No. IPR2018-00892 (Decision Entered October 15, 2018). In ground 1 of the Petition, Mylan Pharmaceuticals Inc. (“Petitioner”) challenged claims 1–38 of U.S. Patent No. 9,326,945 (“the ’945 patent”) as obvious over the references of Carreiro, Wei, and the FDA Dissolution Guidance. IPR2018-00892, Paper 24 at 5. In ground 2, Petitioner challenged claims 1–38 as obvious over the references of Carreiro, Wei, Rudnic, and the FDA Dissolution Guidance. Id. In ground 3, Petitioner challenged claims 1–38 as obvious over the references of Pinto, Wei, and the FDA Dissolution Guidance. Id. at 6. In ground 4, Petitioner challenged claims 1–38 as obvious over the references of Pinto, Wei, Rudnic, and the FDA Dissolution Guidance. Id. Bristol-Meyers Squibb Company and Pfizer, Inc. (“Patent Owner”) filed a Preliminary Response. Id. at 2. Continue Reading PTAB Tech Center 1600 Round-Up: Week of October 15–19

During the week of October 8, 2018, the Patent Trial and Appeal Board (“the Board”) issued five decisions in Tech Center 1600.  One decision denied institution of post-grant review (“PGR”), and the other four—which were related inter partes review (“IPR”) petitions—instituted the IPR petitions and granted the requests for joinder.  The decisions are summarized below. Continue Reading PTAB Tech Center 1600 Round-Up: Week of October 8-12, 2018

This morning, the US Patent and Trademark Office issued its final rule implementing district court-style claim construction at the PTAB, replacing the “broadest reasonable interpretation” standard.  The official text of the rule will publish in the Federal Register on October 11, 2018, in final form.  The new rule is not retroactive and will apply to petitions filed on or after the effective date of the final rule, which is Nov. 13, 2018 (i.e., the first federal business day after 30 days from publication). [Note: 30 days from an October 11, 2018 publication falls on Saturday, November 10, 2018, but the PTO’s press release [PDF] reports the effective date as November 13, 2018.]

Continue Reading USPTO Issues Claim Construction Final Rule for Patent Office Trials – In with Phillips, Out with BRI

During the week of October 1, 2018, the Board issued seven Final Written Decisions and two institution decisions in Technology Center 1600.  The decisions are summarized as follows: Continue Reading PTAB Tech Center 1600 Round-Up: Week of October 1-5, 2018

During the week of September 24, 2018, the Patent Trial and Appeal Board (“the Board”) issued two decisions in TC 1600, both denying institution of inter partes review.  A summary of the decisions follows: Continue Reading PTAB Tech Center 1600 Round-Up: Week of September 24 – 28, 2018

During the week of September 17-21, 2018, the Board issued two decisions in Technology Center 1600, one instituting inter partes review and one final written decision finding the challenged claims had not been proven unpatentable.  The decisions are as follows: Continue Reading PTAB Tech Center 1600 Round-Up: Week of September 17-21, 2018