During the week of April 15–19, 2019, the Patent Trial and Appeal Board (“Board”) issued two IPR non-institution decisions (on the same patent), two PGR institution decisions, and one IPR final written decision in TC 1600.

Intervet Inc. a/k/a Merck Animal Health v. Boehringer Ingelheim Vetmedica, Inc., IPR2018-01788 and IPR2018-01789 (Decision Denying Institution Entered Apr. 16, 2019).  The Board denied institution of Intervet Inc. a/k/a Merck Animal Health’s (“Intervet”) petition, which challenged as unpatentable all claims of U.S. Patent No. 9,011,872 B2 (“’872 patent”), assigned to Boehringer Ingelheim Vetmedica, Inc. (“Boehringer”). The challenged claims are directed to an “improved method of producing” or “recovering” recombinant PCV2 ORF2 protein. Production of recombinant PCV ORF2 protein (sometimes called rORF2) generally involves the steps of transfecting recombinant virus containing open reading frame 2 coding sequences into cells contained in growth media, causing the virus to express open reading frame 2, and recovering the expressed protein in the supernate.

Petitioner Intervet argued that a limitation in the ’872 patent directed to a protective effect broadly encompassed a protective effect of any magnitude, duration, or type, against any clinical symptom associated with a PCV2 infection or against PCV2 infection itself. The Board disagreed, finding that Intervet advanced an incorrect construction of the protective effect limitation; that fact, standing alone, warranted denial of the Petition because without Intervet’s proposed construction there is not a reasonable likelihood that it would prevail with respect to at least one of the challenged claims.

Alternatively, the Board rejected Intervet’s anticipation and obviousness grounds. Intervet failed to show sufficiently that the prior art discloses an immunological composition that satisfies the protective effect limitation of the challenged claims, which require an amount of recombinant PCV2 ORF2 protein sufficient to provide a protective effect against the symptoms of PCV2 infection in a single dose.

Genome & Co. v. Univ. of Chicago, PGR2019-00002 (Decision Granting Institution Entered Apr. 15, 2019).  The Board granted institution on all eleven grounds of Genome & Company’s (“Genome”) petition, which challenged as unpatentable all claims of U.S. Patent No. 9,855,302 B2 (“’302 patent”), assigned to The University of Chicago. The challenged claims are directed to the treatment or prevention of cancer through the use of commensal microflora—specifically bacteria from the genus Bifidobacterium—in combination with an immune checkpoint inhibitor (“CPI”). Genome asserted that all claims lack enablement and certain claims are obvious. The Board declined to deny the petition under 35 U.S.C. § 325(d).

The claims of the ’302 patent are not limited to a specific form of cancer nor to a specific species of Bifidobacterium, and that the broader claims do not specify the CPI to be used. Thus, Genome contended that because the claims can cover “thousands of different combinations of cancers, immune checkpoint inhibitors and genera of Bifidobacterium,” the guidance given in the ’302 patent is inadequate given the scope of the claims and the unpredictable nature of the technology. The Board agreed, finding that: the working examples are markedly limited and only address two types of cancer using only one CPI and 4 species of Bifidobacterium; the specification gives no guidance as to how to select CPIs and Bifidobacterium that will work in the claimed method without resorting to trial and error; and the specification lists 36 different species of Bifidobacterium and gives a broad definition of a CPI. Thus, the Board found Genome was reasonably likely to succeed in its argument that the Wands factors show that the claims are not enabled for the full scope of the claims.

Genome also contended that prior art teaches a method for treating cancer in humans by administering CPIs such as anti-PD-1 and anti-CTLA-4 antibodies that bind to their respective immune checkpoint proteins; that oral administration of Bifidobacterium longum exerts strong antitumor activity; and that that Bifidobacterium longum is immunostimulatory, thus one skilled in the art would have been motivated to combine the teachings of the references as the CPIs and the Bifidobacterium are both shown to be effective in treating colon cancer and are both immunostimulatory. The University of Chicago responded that one skilled in the art would not use an immunosuppressive agent in combination with an immunostimulatory agent, and, therefore, would not have combined the prior art’s purportedly immunosuppressive bifidobacterium with its immunostimulatory CPIs. The Board again found Genome demonstrated a reasonable likelihood of success and instituted trial as to all challenged claims on all grounds asserted.

Adello Biologics LLC, Apotex Inc., and Apotex Corp. v. Amgen Inc. and Amgen Mfg. Ltd., PGR2019-00001 (Decision Granting Institution Entered Apr. 19, 2019). The Board granted institution on all grounds of Adello Biologics LLC, Apotex Inc., and Apotex Corp.’s (collectively “Petitioners”) petition, which challenged as unpatentable all claims of U.S. Patent No. 9,856,287 B2 (“’287 patent”), assigned to Amgen Inc. and Amgen Manufacturing Ltd. (“Amgen”). The challenged claims are generally directed to a method of refolding proteins expressed in non-mammalian cells. Petitioners asserted unpatentability based on lack of adequate written description, lack of enablement, anticipation, obviousness, and indefiniteness. The Board declined to deny the petition under 35 U.S.C. § 325(d) or for delayed identification of a real party in interest.

With respect to the prior-art grounds, Amgen argued in response to Petitioner’s anticipation and obviousness assertions that the prior art discloses the ratio of the concentration of reductant to the concentration of oxidant, not the actual concentrations of reductant and oxidant used, and without the actual concentration one cannot deduce the concentrations of the oxidant and reductant or the thiol-pair ratio. While the Board tended to agree that Petitioner had demonstrated a reasonable likelihood of success at this stage, it noted that the parties may more fully develop the record during trial before it resolves this dispute.

With respect to the written-description ground, the Board was persuaded, based upon the current record, that there was a reasonable likelihood that certain claims may be unpatentable under 35 U.S.C. § 112(a) based upon the argument that the specification of the ’287 patent does not provide adequate written description support for “at least about 25% of the proteins are properly refolded.”

The Board was also persuaded on the current record that Petitioner demonstrated a reasonable likelihood of success on lack of enablement based on the argument that the claims do not place any limitation on the proteins to be refolded and recite that the thiol-pair ratio is in the range of 0.001-100, resulting in a large number of possible redox conditions. Each of independent claims 1 and 16 recites “at least about 25% of the proteins are properly refolded,” and each of independent claims 10 and 26 recites “about 30–80% of the proteins are properly refolded.”
The claims also recite “wherein the thiol-pair buffer strength maintains the solubility of the preparation.” The Board was persuaded, at this stage, that this term may be indefinite because if the solubility is of the preparation itself and not that of proteins, it may be unclear which ingredients of the preparation are the solvent and which are the solute or how the thiol-pair buffer strength maintains such solubility. The Board, however, did not conclusively construe that claim term and noted the parties will fully develop the record during trial before resolving this dispute.

Accordingly, the Board granted institution on all grounds of the petition.

ModernaTX, Inc. v. CureVac AG, IPR2017-02194 (Final Written Decision Entered Apr. 16, 2019). The Board issued a final written decision on a patent challenged by ModernaTX, Inc., U.S. Patent No. 8,383,340 B2 (“’340 patent”), and assigned to CureVac AG, finding all claims (1–26) unpatentable. The patent at issue claimed a method for purifying RNA on a preparative scale by high-performance liquid chromatography (“HPLC”) using a porous reversed phase—namely, porous non-alkylated polystyrenedivinylbenzene (“PSDVB”)—as the stationary phase. ModernaTX asserted that certain claims are anticipated and all claims are obvious.

After denying both ModernaTX’s and CureVac’s motions to exclude, the Board determined that ModernaTX has shown by a preponderance of the evidence that all claims of the ’340 patent as challenged are unpatentable under 35 U.S.C. § 103(a) for obviousness as entailing an improvement that is no “more than the predictable use of prior art elements according to their established functions.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).

Claim 1 is illustrative:

1. A method for purifying RNA on a preparative scale,
wherein the RNA is purified by HPLC or low or normal pressure liquid chromatography using a porous reversed phase as stationary phase and a mobile phase, wherein the porous reversed phase is a porous non-alkylated polystyrenedivinylbenzene.

ModernaTX explicitly premised its ground of unpatentability for anticipation on its view that the preamble is not limiting. Unfortunately for ModernaTX, the Board rejected its argument that the preamble is not limiting because it “does not result in a manipulative difference in the steps of the claim.” Because the Board held that the preamble is limiting, the ’340 patent was not anticipated. But ModernaTX prevailed in its obviousness challenge. The Board held that there was motivation to combine the asserted prior art references and an ordinarily skilled artisan would have had a reasonable expectation of success.