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:
Illumina, Inc. v. Trustees of Columbia University, No. IPR2018-00797 (Decision Entered September 18, 2018). In ground 1 of the petition, Petitioner challenged claim 1 of U.S. Patent No. 9,868,985 (“the ’985 patent”) as obvious based on references by Tsien and Prober. IPR2018-00797, Paper 20 at 8. In ground 2, Petitioner challenged claim 2 of the ’985 patent as obvious based on references by Tsien, Prober, and Pallas. Id. And in ground 3, Petitioner challenged claims 1 and 2 as obvious based on references by Dower, Prober, and Metzker. Id.
The ’985 patent “relates to a system for DNA sequencing by the synthesis approach which employs a stable DNA template, which is able to self prime for the polymerase reaction, covalently linked to a solid surface such as a chip, and 4 unique nucleotides [sic] analogues.” IPR2018-00797, Paper 20 at 4 (internal quotation marks omitted). With respect to ground 1, the Board found that Petitioner’s arguments were likely to be successful. The Board stated that “[i]n particular, Tsien teaches, for example, that the key to its nucleotides is direct identification as they are incorporated into the growing complementary DNA chain.” Id. at 34 (internal quotation marks omitted). The Board also credited Petitioner’s expert who stated that “[a] person of ordinary skill in the art would recognize that Prober’s statement that DNA polymerase maintains ‘fidelity’ means that during a DNA polymerase reaction Prober’s nucleoside triphosphate analogues base pair with their complementary nucleotide according to standard Watson-Crick base paring.” Id. at 35 (alteration in original).
Patent Owner argued that the references of Tsien and Prober did not disclose a small capping group as required by claim 1, and that Petitioner should be precluded from arguing otherwise because during reexamination for one of Petitioner’s patents, “Petitioner overcame obviousness and novelty rejections by admitting that ‘Tsien does not disclose a nucleotide analogue with the allyl capping group.’” Id. at 20-21. The Board, however, declined to exercise its discretion to preclude and “invite[d] the parties to further address whether judicial estoppel is applicable to this inter partes review proceeding.” Id. at 21 (citing Athena Automation, Ltd. v. Husky Injection Molding Sys. Ltd., Case IPR2013-00290, slip op. at 13 (PTAB Oct. 25, 2013) (Paper 18)). The Board concluded that Petitioner made an adequate showing to institute inter partes review on ground 1. Id. at 34.
Regarding ground 2, the Board found Petitioner made a sufficient showing to institute because (1) “Pallas teaches simultaneously sequencing different nucleic acids” and (2) “Pallas encourages use of its simultaneous sequencing combined with Tsien’s approach.” Id. at 36.
With respect to ground 3, the Board stated that Petitioner’s argument likewise supported institution. It stated that “Dower discloses adding a blocking agent onto the 3’-hydroxyl group of the nucleotide, and Prober discloses attaching a fluorescent label to the 5 position of 5-substituted pyrimidines[,]” and “Dower refers to the label described in Prober.” Id. at 38 (citations omitted). The Board concluded that, at this stage of the proceeding, Petitioner made an adequate showing that one of skill in the art “performing the method of Dower would have incorporated the label Prober teaches, e.g., based on the express disclosure of Dower.” Id. Moreover, the Board concluded that Petitioner adequately demonstrated that one of skill in the art “would have had a reasonable expectation of success in using an allyl blocking group and would have a reasonable expectation of success in that group being chemically cleavable” because (1) “Dower discloses blocking the 3’ hydroxyl group”; (2) “Metzker indicates that 3’-O-allyl ethers are recognized by Vent DNA polymerase”; and (3) “the ’985 patent indicates that there were ‘well-established synthetic procedures’ for using allyl blocking groups.” Id. at 40-41. The Board also credited Petitioner’s argument “that Dower suggests that it is desirable for a fluorescent label to be removable” as required by the claim. Id. at 42. Overall, the Board determined that Petitioner demonstrated a reasonable likelihood of success in ground 3. Id. at 46.
The Board further stated that it would not deny institution based on Patent Owner’s argument that the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d) because the references by Tsien and Prober were considered during prosecution. Id. at 46-47
Finally, Petitioner argued that Patent Owner should “be barred from participating in the present proceeding under the Board’s patent owner estoppel regulation.” Id. at 47 (citing 37 C.F.R. § 42.73(d)(3)(i)). That regulation provides that “[a] patent applicant or owner is precluded from taking action inconsistent with the adverse judgment, including obtaining in any patent: (i) A claim that is not patentably distinct from a finally refused or cancelled claim.” 37 C.F.R. § 42.73(d)(3)(i). The Board did not apply the rule because Petitioner failed to point to any authority supporting the rule’s application in inter partes review proceedings challenging existing claims. Id. at 47. The Board stated, however, that even if the rule applied, Petitioner failed to adequately establish that claim 1 “is not patentably distinct from a claim canceled in any previous final written decision of the Board” because Petitioner did not account for or evaluate the difference between the presently challenged claims and those cancelled previously. Id. Petitioner only pointed to a terminal disclaimer filed by Patent Owner during prosecution. Id. But “the filing of a terminal disclaimer does not constitute an admission of a rejection or of double patenting.” Id. (citing MPEP § 804.02; Quad Evntl. Techs. Corp. v. Union Sanitary Dist., 946 F.2d 870, 874 (Fed. Cir. 1991). Accordingly, Patent Owner was not barred from participating in the proceeding. Id. at 48.
Argentum Pharm. LLC v. Alcon Research, Ltd., No. IPR2017-01053 (Decision Entered Sept. 20, 2018). In its petition, Petitioner challenged claims 1-28 of U.S. Patent No. 8,268,299 (“the ’299 patent”). IPR2017-01053, Paper 52 at 1. The ’299 patent relates to “multi-dose, self-preserved ophthalmic compositions.” Id. at 4. The claimed ophthalmic composition can “satisfy the USP preservative efficacy requirements . . . without employing any conventional antimicrobial preservatives.” Id. at 5. “The specification identifies prostaglandin analogs (including ‘travoprost’) as therapeutic agents suitable for use with the zinc-based preservation system of the invention.” Id.
Petitioner challenged claim 1 as obvious in grounds 1 and 2. Ground 1 asserts that claim 1 is obvious based on references by Schneider, Xia, and Chowhan. Id. at 8. Ground 2 added a reference by Gadd to the references in ground 1. Due to their similarity, the Board addressed grounds 1 and 2 together. Id. Petitioner argued “that a person of ordinary skill in the art would have selected Schneider’s Formulation A as the starting point for modification.” Id. Petitioner’s expert, Dr. Xia, testified that a skilled artisan would have selected Formulation A because it was “already in the marketplace” and was shown to be safe and effective. Id. The Board found it significant that “Petitioner acknowledge[d] that one undertaking to improve Formulation A ‘would have retained as much of’ the original composition ‘as feasible.’” Id. (quoting Pet. at 14-15). Petitioner’s challenge depended “on at least six modifications to Formulation A—which, in unmodified form, bears little resemblance to the composition specified in claim 1.” Id. at 8. These six modifications included: “(1) replacing [the preservative] BAC [i.e., benzalkonium chloride] with zinc ions; (2) replacing mannitol with sorbitol; (3) adding propylene glycol; (4) adjusting the amounts of zinc ions, sorbitol, and propylene glycol to fall within specific concentration ranges required by claim 1; (5) removing EDTA; and (6) limiting anionic species present in the modified composition to a concentration that is less than 15 mM.” Id. at 9. The Board addressed each proposed modification in turn:
- First, Petitioner asserted that one skilled in the art would have replaced BAC with zinc ions to improve Formulation A because BAC was “a known source of toxicity, discomfort, and irritation to the eye.” Id. at 10. Patent Owner countered that making the proposed replacement “would have been [a] more complicated and less obvious route than selecting one of many conventional BAC alternatives known and available in the art at the time of the invention.” Id. (internal quotation marks omitted). Patent Owner relied on testimony of its expert, who noted that zinc is “‘an unconventional’ preservative in a field rife with ‘conventional’ BAC alternatives.” Id. (citation omitted). Further, this was the first time zinc was used as the only preservative in an ophthalmic drug on the market. Id. The Board remarked that “[a]lready, with this first modification, a glimmer of doubt creeps in, regarding whether Petitioner’s selection of zinc is driven by disclosures in the prior art or impermissible hindsight reconstruction.” Id.
- Second, Petitioner asserted that one skilled in the art would have replaced mannitol with sorbitol without articulating a reason for the substitution, save for observing that “mannitol and sorbitol are sugars . . . differing only in their stereochemistry at a single carbon and therefore share many similar physical properties.” Id. at 10-11 (alterations in original) (quoting Pet. at 17). The Board rejected Petitioner’s argument as an unpersuasive conclusory opinion. Id. at 11.
- Third, relying on the reference by Chowhan, Petitioner proposed adding propylene glycol to Formulation A as required by claim 1. Petitioner asserted “that Chowhan would have supplied ‘a reason to optimize’ the polyol selection in Formulation A and, in so doing, would have prompted an ordinarily skilled artisan to arrive at a polyol mixture of ‘propylene glycol and sorbitol’ to improve the antimicrobial efficacy of zinc ions in the modified composition of Formulation A.” Id. at 12 (quoting Pet. at 17). The Board found it unclear on the record why one skilled in the art, “seeking to improve the preservative efficacy of zinc, would have turned to Chowhan, which does not mention zinc.” Id. at 13.
- Fourth, Petitioner proposed removing EDTA from Formulation A to meet the “self-preserved” limitation in claim 1. Petitioner asserted that one skilled in the art would have been motivated to remove EDTA “to avoid chelation of the zinc and interference with its antimicrobial properties.” Id. (quoting Petition at 19). But this modification ran counter to the teachings of Xia, the reference Petitioner relied on for the proposed modification. Id. The Board concluded that Petitioner was using hindsight, “picking and choosing ingredients in Xia’s formulation to include those required, and remove those precluded, by the terms of claim 1.” Id. at 14.
- Fifth, the Board stated that “[e]ven if we accept that an ordinarily skilled artisan would have replaced BAC with zinc, substituted sorbitol for mannitol, added propylene glycol, and removed EDTA from Formulation A, we are not persuaded that the artisan also would have recognized the necessity of maintaining the zinc ions, sorbitol, and propylene glycol within the specific concentration ranges required for each component in claim 1.” Id. The Board again rejected Petitioner’s argument as conclusory. Id. at 15.
- Sixth, Petitioner asserted that Xia and Chowhan “would have led an ordinarily skilled artisan to limit the amount of anionic species in the modified composition of Formulation A to fall below a concentration of 15mM as required by claim 1.” Id. at 16. Petitioner again used opinion testimony to support its assertion that was “not tethered adequately to disclosures in the prior art or other objective proof.” Id. at 17. The Board rejected this proposed modification as “based on impermissible hindsight rather than … the prior art or the understanding of an ordinarily skilled artisan.” Id.
- Last, Petitioner argued that a composition that had been modified in the six ways above “would have inherently satisfied. . . USP 27 preservative efficacy requirements” as required by claim 1. Id. at 20 (citations omitted). Alternatively, Petitioner argued that to one of skill in the art, it would have been a matter of routine optimization to adjust the proposed composition to satisfy USP 27 requirements. Id. To demonstrate inherency in an obviousness challenge, a Petitioner “must show sufficiently that ‘the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.’” Id. at 20-21 (quoting Par Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1195 (Fed. Cir. 2014)). The Board found that the Petitioner failed to present persuasive evidence that the USP 27 limitation was “‘necessarily’ present or the ‘natural result’ of combining ‘elements explicitly disclosed by the prior art.’” Id. at 21 (citations omitted). Accordingly, the Board rejected Petitioner’s argument. The Board was similarly unpersuaded by Petitioner’s optimization argument. Id. at 21-22.
In addition to the above analysis, the Board reviewed Patent Owner’s arguments directed to secondary considerations of nonobviousness. Id. at 22. Patent Owner asserted that commercial success of its TRAVATAN Z product and long-felt need supported a finding of nonobviousness. Id. at 22-25. Petitioner countered that Patent Owner’s long-felt need evidence was not commensurate with the scope of some of the challenged claims. Id. at 24. The Board concluded that the evidence was entitled to “some weight” and that, on balance, “[t]he objective indicia of nonobviousness, when weighed against Petitioner’s relatively weak evidence of obviousness, tip the scales farther in favor of Patent Owner.” Id. at 25. As such, the Board concluded that Petitioner failed to demonstrate that claim 1 would have been obvious. Further, because the remaining challenged claims depend from claim 1, the Board found Petitioner failed to demonstrate claims 2-28 were invalid as obvious by a preponderance of the evidence. Id. at 27.