During the week of February 25, 2019, the Board issued six decisions in Technology Center 1600: five instituting inter partes review (IPR) and one instituting post-grant review (PGR). The decisions are summarized as follows:
Eli Lilly and Company v. Teva Pharmaceuticals International GmbH, IPR2018-01425 (Decision—Institution of Inter Partes Review Feb. 25, 2019); Eli Lilly and Company v. Teva Pharmaceuticals International GmbH, IPR2018-01426 (Decision—Institution of Inter Partes Review Feb. 25, 2019); Eli Lilly and Company v. Teva Pharmaceuticals International GmbH, IPR2018-01427 (Decision—Institution of Inter Partes Review Feb. 25, 2019). Petitioner Eli Lilly challenged the patentability of claims 1-15 of U.S. Patent No. 9,890,210 (“the ’210 patent”), claims 1-15 of U.S. Patent No. 9,890,211 (“the ’211 patent”), and claims 1-9 of U.S. Patent 8,597,649 (“the ’649 patent”) as being obvious over prior art references Tan, Wimalawansa, and Queen. IPR2018-01425, Paper 14 at 2, 7; IPR2018-01426, Paper 14 at 2, 7; IPR2018-01427, Paper 14 at 1, 6. The ’210, ’211, and ’649 patents claim priority to the same provisional application and are related to humanized monoclonal anti-Calcitonin Gene-Related Peptide (CGRP) antagonist antibodies, which can be used to treat CGRP-related headaches (e.g., migraines) and hot flushes. IPR2018-01425, Paper 14 at 4-6.
Petitioner argued that skilled artisans would be motivated to combine the asserted prior art because “the prior art—replete with exemplary disclosures of anti-CGRP antagonist antibodies, including humanized antibodies, to treat human diseases and conditions—provided express motivation to prepare a humanized anti-CGRP antagonist antibody against human CGRP suitable for administration to humans.” Id. at 18 (emphasis in original). Petitioner further asserted that skilled artisans would have a reasonable expectation of success in making the claimed humanized anti-CGRP antibody and “would have expected such an antibody to specifically bind to human α or βCGRP, at least because such binding was reported throughout the art describing anti-CGRP antagonist antibodies.” Id. at 19. In all three IPRs, the Board found that Petitioner demonstrated that there is a reasonable likelihood that the challenged claims are unpatentable based on the combined teachings of Tan, Wimalawansa, and Queen. Id. at 26.
Patent Owner argued in its preliminary response that the petitions should be denied under 35 U.S.C. § 325(d) because Tan, Wimalawansa, and Queen were considered by the Examiner during prosecution and/or were cumulative to references considered. Id. at 33. The Board granted Petitioner’s request to address the issue and allowed Petitioner a reply and Patent Owner a sur-reply. Id. at 2.
The Board analyzed Patent Owner’s arguments under the factors set forth in Becton, Dickinson & Co. v. B. Braun Melsungen AG, Case IPR2017-01586, slip op. at 17-18 (Paper 8) (PTAB Dec. 15, 2017) (informative): (a) the similarities and material differences between the asserted art and the prior art involved during examination; (b) the cumulative nature of the asserted art and the prior art evaluated during examination; (c) the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection; (d) the extent of the overlap between the arguments made during examination and the manner in which Petitioner relies on the prior art or Patent Owner distinguishes the prior art; (e) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art; and (f) the extent to which additional evidence and facts presented in the Petition warrant reconsideration of prior art or arguments. Id. at 31-32.
The Board found that Tan was already considered or was cumulative and that it was unclear whether Queen was cumulative. However, the Board found Wimalawansa to be “materially different” than prior art considered during prosecution. Id. at 32. Although Wimalawansa was cited in an IDS, the Board found “the extent to which Examiner considered Wimalawansa is not clear” and “the information presented in Wimalawansa was otherwise not addressed during examination, at least not in a meaningful way.” Id. at 33. As a result, the Board did not deny the Petition under § 325(d) and instituted IPR of the challenged claims with respect to the obviousness ground. Id.
Reactive Surfaces Ltd., LLP v. LG Chem Ltd., IPR2018-01520 (Decision—Institution of Inter Partes Review Feb. 26, 2019). Petitioner Reactive Surfaces Ltd., LLP challenged claims 1-8 of U.S. Patent No. 8,932,717 (“the ’717 patent”) as being obvious under four grounds relying on Wang and three grounds relying on Ho and Pegg. IPR2018-01520, Paper 8 at 7-9. The claims relate to a method of forming an anti-fingerprint coating on plastic or glass using a lipolytic enzyme. Id. at 7. The ’717 patent discloses that the coating has a self-cleaning function that decomposes the lipid components of a fingerprint. Id. at 4, 5, and 7. The ’717 patent explains that the technology solves the problem of having to remove fingerprints by hiding or wiping. Id. at 4.
During claim construction, Petitioner argued that the construction of the claim term “anti-fingerprint coating” should include that the lipolytic enzyme is “capable of actively reducing transfer of” or “decomposing” fingerprints. Id. at 14-15. In contrast, Patent Owner argued that “anti-fingerprint coating” should not be limited to any particular mechanism of action and that fingerprint should not be limited to only lipid stains but can include any type of residue from a fingerprint, including lipid-free. Id. at 15-16. The Board did not entirely agree with either construction but found Petitioner’s construction to be closest to the broadest reasonable interpretation. Id. at 16-17. The Board adopted a modified construction that included “a coating that is capable of providing a self-cleaning function . . . of actively reducing transfer of a fingerprint or decomposing a fingerprint transferred to a surface of the coated substrate.” Id. at 19. Additionally, the Board concluded that “normal fingerprints” have lipids as their main component and could not encompass stains that are lipid-free. Id. at 25.
The obviousness analysis turned on whether Wang, Ho, and Pegg inherently disclose an anti-fingerprint coating. Wang expressly teaches how to make a lipase-coated plastic substrate and discloses that lipases have a self-cleaning function against fat and lipid stains on treated surfaces. Id. at 34. Ho teaches immobilizing lipase-based compositions onto porous glass and that lipases decompose lipids. Id. at 44. Pegg discloses plastic substrates that could be used to immobilize the Ho lipid-based compositions. Id. Neither Wang, Ho, nor Pegg mentions fingerprints. Nevertheless, the Board found that the references teach glass or plastic substrates coated with enzymatically active lipases that decompose lipids, and therefore, such coated substrates would inherently decompose fingerprints, which are composed primarily of lipids. Id. at 45. The Board’s reasoning was heavily dependent on its claim construction for “anti-fingerprint coating.” In conclusion, the Board found that the Petitioner established a reasonable likelihood of unpatentability of one or more of the challenged claims. Id. at 45.
Becton, Dickinson and Co. v. bioMérieux S.A., IPR2018-01566 (Decision—Institution of Inter Partes Review Feb. 22, 2019). Petitioner Becton, Dickinson and Co. challenged claim 15 of U.S. Patent No. 8,367,337 (“the ’337 patent”) as being anticipated by Oberdorfer as evidenced by Huletsky and Warren, and claims 15 and 29-31 as being obvious over Huletsky in view of Oberdorfer and Sinsimer. IPR2018-01566, Paper 6 at 6. The challenged claims relate to a method of detecting a methicillin-resistant Staphylococcus aureus (MRSA) using multiplex amplification to amplify and detect both an insertion of a staphylococcal cassette chromosome mec (SCCmec) cassette within Staphylococcus aureus chromosomal DNA and a region of the mecA gene. Id. The ’337 patent discloses that MRSA is an infectious pathogen and resistance to methicillin is conferred by the mecA gene in the SCCmec cassette. Id. at 3. The ’337 patent explains that the claimed method is an improvement over prior art tests because it reduces the number of false positives that can result from the presence of methicillin-sensitive S. aureus or other Staphylococcus strains. Id. at 4. Figure 1 of the ’337 patent, below, shows a region of the MRSA chromosome with an inserted SSCmec cassette containing the mecA gene. Id. at 3.
First, the Board found Petitioner established a reasonable likelihood that it would prevail on the anticipation ground of Oberdorfer as evidenced by Huletsky and Warren. Id. at 13. Specifically, Oberdorfer teaches an IDI-MRSA assay that uses multiplex amplification and Huletsky and Warren evidence that the IDI-MRSA assay of Oberdorfer amplifies and detects the claimed junction of the SCCmec cassette with S. aureus chromosomal DNA. Id. at 14-16. Although the Board found that Oberdorfer only suggests adding amplification and detection of the mecA gene into the IDI-MRSA test, “anticipation does not require actual performance of suggestions in a disclosure.” Id. at 17 (quoting Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1379 (Fed. Cir. 2001)).
Second, the Board found Petitioner established a reasonable likelihood that it would prevail on at least one claim on its asserted ground of obviousness over Huletsky in view of Oberdorfer and Sinsimer. Id. at 18. The Board found skilled artisans would be motivated to combine, with a reasonable expectation of success, Huletsky’s teaching of an IDI-MRSA assay to detect the junction of the SCCmec cassette and S. aureus chromosomal DNA with Oberdorfer’s suggestion to add amplification and detection of a mecA region to the assay, which is supported by Sinsimer. Id. at 17-18. The Board instituted IPR of claims 29-31 on the same ground in view of SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1355–56 (2018), and USPTO guidance (see Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018) (available at https://www.uspto.gov/patents-application-process/patent-trial-and-appealboard/trials/guidance-impact-sas-aia-trial). Id. at 23.
Grünenthal GmbH v. Antecip Bioventures II LLC, PGR2018-00092 (Decision—Institution of Post Grant Review Feb. 25, 2019). Petitioner Grünenthal GmbH challenged various claims of U.S. Patent No. 9,820,999 (“the ’999 patent”) as anticipated under three grounds, obvious under three grounds, and for lack of enablement under one ground. PGR2018-00092, Paper 7 at 8. Representative claim 1 recites: “A method of treating pain associated with complex regional pain syndrome (CRPS) comprising selecting a human having CRPS triggered by bone fracture and administering neridronic acid or a pharmaceutically acceptable salt thereof, wherein the treatment is effective in reducing pain.” Id. at 5.
The Board agreed with Petitioner that the ’999 patent was not entitled to the May 14, 2012 filing date of the earliest-filed provisional application because that application does not provide support for the claimed limitation “CRPS triggered by bone fracture.” Id. at 13. The Board found, however, that Petitioner did not show adequately that the ’999 patent was not entitled to claim the benefit of a later-filed application and assigned the ’999 patent an effective filing date of May 14, 2013. Id. at 14-15.
Petitioner sufficiently showed that Varenna, published in 2012, anticipated claims 1-4, 9, 10, 12, 14, 16-18, 23-25, and 27-29 of the ’999 patent. Id. at 18, 22. However, Petitioner failed to show that it is more likely than not that the challenged claims are unpatentable based on the other two anticipation grounds and all three obviousness grounds because Petitioner failed to show the asserted references, all published after May 14, 2013, are prior art against the ’999 patent. Id. at 18-19.
Finally, Petitioner failed to demonstrate that the challenged claims are more likely than not unpatentable for lack of an enabling disclosure. The Board found that the state of the art provided by Varenna 2012, which Petitioner asserted anticipated the claims, in combination with the disclosure of the specification of the ’999 patent, sufficiently enabled the claims. Id. at 21.
Although Petitioner only met the institution threshold for one ground of anticipation of claims 1-4, 9, 10, 12, 14, 16-18, 23-25, and 27-29 of the ’999 patent, the Board instituted post-grant review of all challenged claims based on all grounds set forth in the Petition. Id. at 22 (citing SAS).