The Board issued four decisions denying institution of inter partes review (IPR) in TC 1600 during the week of September 3.  Summaries of the decisions follow.

L’Oréal USA, Inc. (“L’Oréal”) v. University of Massachusetts (“UMass”), IPR2018-00778 and L’Oréal v. UMass, IPR2018-00779 (Decisions Denying Institution, Entered September 7, 2018).  L’Oréal submitted two Petitions challenging claims 1-7 and 9 of U.S. Patent No. 6,423,327 (“the ’327 patent) and claims 1-7 and 9 of U.S. Patent No. 6,645,513 (“the ’513 patent).  Both of the Petitions challenged the patentability of the claims on one ground of anticipation and two grounds of obviousness based on two references: Japanese patent publication No. JP H9-157153 A (“JP ’153”) and German patent publication No. DE 195 45 107 A1 (“DE ’107”).  UMass filed a preliminary response.  Claim 1 of both the ’327 patent and the ’513 patent are directed to methods for “enhancing the condition of unbroken skin” that require a step of “topically applying to the skin a composition comprising a concentration of adenosine…wherein the adenosine concentration” is “applied to the dermal cells” (emphasis added).  In the ’327 patent, the claimed adenosine concentration is “10-4 to 10-7” while the ’513 patent claims require an adenosine concentration of “10-3 to 10-7”.

L’Oréal proposed claim constructions for the limitations recited above.  Regarding the limitation reciting “topically applying to the [unbroken] skin a composition comprising a concentration of adenosine,” the Board adopted L’Oréal’s proposed construction because there was no dispute that a “topical” application to unbroken skin requires application “directly to the outer, epidermal layer of the skin that is intact and does not have any damage, such as wounds or cuts, burns, etc., such that the inner, dermal layer of the skin is not exposed.”

Regarding the limitation relating to the layer of skin to which the claimed adenosine concentration is applied, L’Oréal argued that the limitation should be construed to require the adenosine concentration to be applied to “the unbroken, outer epidermal layer of a region of the skin containing the dermal cells,” whereas UMass argued that the claimed adenosine concentration is applied to the dermal cells themselves.  Siding with the Patent Owner, the Board pointed to the claim language that explicitly requires the claimed adenosine concentration to be “applied to the dermal cells,” not to the outer epidermal layer of a region of the skin as L’Oréal would require.

Consequently, the Board denied institution on all anticipation and obviousness grounds because L’Oréal failed to identify evidence in JP ’153 or DE ’107 reflecting a concentration of adenosine that is applied to dermal cells.

Aurobindo Pharma USA Inc. (“Aurobindo”) v. Andrx Corporation (“Andrx”) et al., IPR2018-00530 (Decision Denying Institution, Entered September 5, 2018).  In its petition, Aurobindo challenged claims 1-21 of U.S. Patent No. 6,790,459 (“the ’459 patent”) on a single obviousness ground based on six references: Cheng, Timmins, Wagner, Lewis, Gibaldi, and DeFronzo.  After considering Andrx’s preliminary response, the Board exercised its discretion under 35 U.S.C. §314(a) to decline institution of the (IPR) in this case.

Citing the factors set forth in Gen. Plastic Indus. Co. v. Canon Kabushiki Kaisha, Case IPR2016-01357 (PTAB Sept. 6, 2017) (Paper 19) (precedential) (“General Plastic”), the Board’s decision was influenced by the following facts weighing in favor of its denial:

  • Aurobindo filed a first petition for IPR (the “First Petition”) that challenged the same claims of the ’459 patent seven months prior to filing the petition in this IPR.
  • Aurobindo knew of the Cheng, Timmins, and Lewis references at the time it filed the First Petition because those references were relied upon in the First Petition. And without an explanation from Petitioner, the Board found it reasonable to assume that Petitioner could have found the Wagner, Gibaldi and DeFronzo references through reasonable diligence in its prior searches—and thus should have known of those references.
  • Aurobindo admitted that it used the Board’s decision denying institution of the first IPR as a roadmap to shift its strategy and reformulate its challenge for this IPR.

Aurobindo provided no explanation—other than to address the deficiencies cited in the Board’s denial of the first IPR—as to why they filed this IPR.

The Board emphasized that under General Plastic, Aurobindo’s use of the Board’s previous decision as a roadmap to cure the deficiencies in its first, failed petition is unfair to patent owners and an inefficient use of its resources.  Further sealing the fate of Aurobindo’s petition, the Board invited Aurobindo to request authorization to file a reply to Andrx’s Preliminary Response to address the General Plastic factors, but Aurobindo never took the opportunity to do so.  Thus, the Board found it appropriate to exercise its discretion under 35 U.S.C. §314(a) to deny institution in this IPR.

Hologic, Inc. (“Hologic”) v. bioMérieux, Inc. (“bioMérieux”), IPR2018-00567 (Decision Denying Institution, Entered September 4, 2018).  In its petition, Hologic challenged claims 1-15 of U.S. Patent No. 9,047,262 (“the ’262 patent”) on two obviousness grounds based on four references: Backus, Bell, Sooknanan, and Myers.  After considering bioMérieux’s preliminary response, the Board exercised its discretion under 35 U.S.C. § 325(d) to deny institution of both grounds.

Citing the factors set forth in Becton, Dickinson and Co. v. B. Braun Melsungen AG, IPR2017-01586 (Paper 8, Dec. 15, 2017) (informative), the Board’s decision was influenced by the following facts weighing in favor of its denial:

  • The Backus and Bell references are listed on the cover of the ’262 patent, and although Backus and Bell were not explicitly relied upon by the Examiner to reject any claims of the ’262 patent, the Backus reference was used to reject similar claims during prosecution of the’262 patent’s parent application and the Bell reference was discussed during interviews held with the Examiner during the prosecution of the’262 patent’s parent application.
  • The Examiner considered substantively the same reference as the Myers reference relied upon by Hologic during the prosecution of the ’262 patent.
  • The Sooknanan reference is cumulative to the prior art evaluated during the examination of the ’262 patent.
  • The Examiner made extensive fact findings related to the Backus, Bell, Sooknanan, and Myers references—even though those findings were taught in other references.
  • The reference the Examiner relied upon as a primary reference during examination of the ’262 patent—Montagnier—was a stronger reference than Myers, and was relied upon by the Examiner for essentially the same reason that Petitioner cites Myers for in this IPR.
  • The Sooknanan reference does not add anything material to the Examiner’s discussion of what was already known in the art.
  • The Petitioner failed to cite or discuss 35 U.S.C. § 325(d) and failed to state whether the Examiner erred in its evaluation of the prior art.
  • The Examiner allowed the claims after bioMérieux narrowed the claims and submitting a Declaration under 37 C.F.R. §1.132—and bioMérieux failed to persuade the Board that the Examiner erred in relying on that declaration or that the Board should reconsider the Examiner’s decision.

Ultimately, the Board exercised its discretion to deny institution under 35 U.S.C. § 325(d) because bioMérieux overcame rejections based on substantially similar arguments to those submitted by Hologic in this IPR, and Hologic failed to persuade the Board that the Examiner erred in its decision to allow the claims over bioMérieux’s evidence.

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.

During the week of September 10, the Board issued two decisions in Technology Center 1600, each of which instituted an inter partes review (“IPR”) proceeding.  The decisions are as follows:

Moderna Therapeutics, Inc., v. Protiva Biotherapeutics, Inc., No. IPR2018-00680 (Decision Entered September 12, 2018).  Moderna Therapeutics, Inc. (“Moderna”) challenged claims 1­–22 of U.S. Patent No. 9,404,127 (“the ’127 Patent”) as anticipated by and/or obvious in view of six references.  The ’127 Patent “relates to stable nucleic acid-lipid particles (SNALP) that have a non-lamellar structure and that comprise a nucleic acid.”  IPR2018-00680, Paper 13 at 3 (internal quotations omitted).   Both Moderna and Protiva Biotherapeutics, Inc. (“Protiva”) advanced a claim construction of the term “nucleic acid-lipid particle.”  Moderna proposed that “nucleic acid-lipid particle” means “a composition of lipids and a nucleic acid for delivering a nucleic acid to a target site of interest.”  Protiva contended such a construction is unreasonably broad, and the term should be defined as “non-lamellar particles formulated to fully encapsulate the nucleic acid component and to be stable in serum following systemic (in vivo) administration.”  Id. at 7-8 (internal citations omitted).  According to the Board, Moderna’s “proposed construction is a general restatement of the composition recited in claim 1 and a use thereof as set forth in the ’127 patent,” while Protiva’s “proposed construction is not consistent with claim 1.”  Id. at 8.  Solely for the purpose of deciding whether to institute IPR, the Board defined “nucleic acid-lipid particle” consistent with the ’127 Patent specification’s definition of lipid particle.

Ground 1: Moderna’s “anticipation challenge is based on the contention that the only limitation from claim 1 of the ’127 patent not disclosed explicitly in U.S. Patent No. 8,058,069 (“the ’069 Patent”) is 95% of the claimed particles having a non-lamellar morphology, but that [Protiva] . . . uses several of the formulations disclosed in the ’069 patent to illustrate in the later ’127 patent a greater than 95% non-lamellar morphology among such particles.”  Id. at 11 (internal citations omitted).  Moderna alleged that the final wherein clause of claim 1 is inherently anticipated by the ’069 Patent which results from “(1) the lipid composition of a SNALP formulation and (2) the formation process used to prepare the SNALP formulation”.  The particle composition and methods of making the claimed particle are disclosed in the ’069 Patent and “the ’127 Patent itself identifies these variables as resulting in the claimed property.”  Id. at 11-12 (internal citations omitted).  The Board found Protiva’s burden-shifting arguments improper despite Protiva’s argument that “Ground 1 [was] not presented with the requisite degree of particularity as it states alternate theories of challenge and lacks clarity as to the particular references on which the alternate obviousness theory rests.”  Protiva’s “arguments fail to appreciate that there is a significant difference between a petitioner’s burden to establish a reasonable likelihood of success at institution, and actually proving invalidity by a preponderance of the evidence at trial. … [T]he analysis at the institution stage is very different and made under a qualitatively different standard than the standard applicable in reaching the Final Written Decision.”  Id. at 13 (internal citations and quotations omitted).  The Board also dismissed Protiva’s allegation that Moderna left the task of evaluating the cited disclosure of the ’069 Patent as overly burdensome to the Board and to Protiva “given that the ’069 patent and the ’127 patent are commonly owned by Protiva and have overlapping named inventors.”  Id. at 14 (internal citations and quotations omitted).  Finally, Protiva argued that Moderna’s anticipation analysis suffers from “mixing and matching different embodiments” of the ’069 Patent.  Id. at 15.  The Board disagreed at least because the basis for Protiva’s arguments rested on features of the claimed particle that were not expressly recited in the claims but rather described in the specification.  Moreover, Moderna’s alleged “mixing and matching” included just one component of the claimed particle that were listed in the alternative in the ’069 Patent as examples of the component.  Id. at 16.  Moderna relied on incorporation by reference and disclosed prior art ranges to allegedly anticipate each of dependent claims 2-22.  The Board noted that possible issues may develop during trial with respect to the dependent claims, and the Board invited Moderna to submit extrinsic evidence in support of its obviousness position as an alternative to anticipation.

Grounds 2-4: Similar to Ground 1, Moderna alleged that claims 1-22 are anticipated by and/or obvious in view of five references.  Protiva asserted that Moderna failed to meet its burden with respect to articulating how claims 1-22 were anticipated by and/or obvious in view of these five references and, rather, advanced several conclusory statements in an attempt to support its position.

Despite Protiva’s complaints, the Board instituted IPR on claims 1-22 because Moderna “established a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim of the ’127 Patent.  Id. at 2.

Moderna Therapeutics, Inc., v. Protiva Biotherapeutics, Inc., No. IPR2018-00739 (Decision Entered September 12, 2018).  Moderna challenged claims 1­–20 of U.S. Patent No. 9,364,435 (“the ’435 Patent”) as anticipated by and/or obvious in view of seven references.  The ’435 Patent is directed to subject matter similar to that of the ’127 Patent.  Moderna and Protiva advanced the same claim constructions for the term “nucleic acid-lipid particle” here as in the ’680 IPR described above and the Board arrived at the same conclusion, instituting IPR.

Ground 1: Moderna alleged that claims 1-20 would have been obvious in view of two references, the combination of which disclosed “nucleic acid-lipid particles that comprise a nucleic acid, and the lipid components—a cationic lipid, a non-cationic lipid, and a conjugated lipid—in mol percentage ranges that overlap with the claimed ranges.”  Id. at 18.  Protiva responded the claimed ranges for at least the cationic lipid component were “contrary to the conventional wisdom concerning the community’s aversion to the toxicity and poor in vivo efficacy associated with formulations with a high level of cationic lipid.”  However, the Board credited Moderna’s expert who stated that “determining the optimal proportion of cationic lipid for a given lipid combination would be a simple matter of varying the proportion using prior art methodologies” in determining the explicit disclosure of overlapping ranges.  Id. at 18-19.  Protiva also relied on unexpected results and argued that 1) “the claimed formulations are well-tolerated and possess favorable in vivo transfection efficiency at far lower dosages than prior art formulations,” and 2) “the claimed formulations are well-tolerated following systemic delivery.”  Id. at 25.  The Board pointed back to its construction of the term “nucleic acid-lipid particle” as not nearly as narrow as advanced by Protiva and stated that “such a fact intensive inquiry concerning unexpected results is best vetted during trial on a full record.”  Id.  Accordingly, the Board found that “the disclosure in the prior art of the overlapping ranges to the claimed invention shows a reasonable likelihood [Moderna] will prevail in establishing that at least claim 1 of the ’435 patent would have been obvious to one of skill in the art.”  Id. at 19.

Grounds 2 and 3: Similar to Ground 1, Moderna alleged that claims 1-20 were anticipated by and/or would have been obvious in view of five references.  As pointed out by Protiva, Moderna “picks and chooses and thus, mischaracterizes the teachings” of two of these references and in particular, disclosures that teach away from Moderna’s proposed combinations.  Id. at 30.  Protiva also alleged that Moderna failed to sufficiently explain how one of ordinary skill in the art would combine the various references to arrive at the claimed invention with a reasonable expectation of success.  Id.  While the Board seemed to agree with Protiva, the Board found that the sufficiency of these grounds should be vetted during trial on the full record.  Id. at 32-33.

Accordingly, the Board instituted IPR on claims 1-20 because Moderna “established a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim of the ’435 Patent.  Id. at 3.

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:

Apotex Inc. and Apotex Corp. (“Apotex”) v. Celgene Corporation (“Celgene”), IPR2018-00685 (Decision Denying Institution entered September 27, 2018).

In its petition, Apotex challenged claims 1-4, 8, 9, 15, and 20 of U.S. Patent No. 8,741,929 (“the ’929 patent”) on anticipation and obviousness grounds.  The ’929 patent is directed to methods of treating mantle cell lymphoma (“MCL”) using the immunomodulatory compound lenalidomide, marketed by Celgene under the tradename Revlimid® (or Revimid®).

Apotex challenged the claims as anticipated and/or obvious based on references by Drach, Zeldis, Querfeld, and a Celgene press release.  In its preliminary response, Celgene argued that Apotex replaced art considered during prosecution with art containing the same disclosures and presented substantially the same arguments that had been overcome during prosecution.  The Board exercised its discretion under 35 U.S.C. § 325(d) to determine whether to institute inter partes review based on its determination of whether the same or substantially the same prior art or arguments had already been presented to and considered by the Office during prosecution.  In evaluating the prior art and arguments, the Board considered several non-exclusive factors, including:

  1. the similarities and material differences between the asserted art and the prior art involved during examination;
  2. the cumulative nature of the asserted art and the prior art evaluated during examination;
  3. the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection;
  4. 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 distinguished the prior art;
  5. whether Petitioner has pointed out sufficiently how the Examiner erred in its consideration of the asserted prior art; and
  6. the extent to which additional evidence and facts presented in the Petition warrant reconsideration of the asserted prior art or arguments.

On balance, the Board found the factors weighed in favor of Celgene.  The Board further held that Apotex failed to provide a compelling reason why the Board should adjudicate the issues based on the art and arguments presented in the Petition.  In addition, the Board relied on Celgene’s prior arguments of unexpected results, which had overcome the prima facie obviousness rejection during prosecution.  Regarding the Celgene press release, the Board determined that Apotex had failed to provide evidence that the reference was sufficiently accessible to the public prior to the critical date.

The Board concluded that for the references that qualified as printed publications, Apotex had merely cited the same or substantially the same prior art or arguments as were presented to the Office during prosecution.

As such, the Board exercised its discretion under § 325(d) and denied institution of inter partes review.

Oxford Nanopore Technologies, Inc. (“Oxford”) v. Pacific Biosciences of California, Inc. (“Pacific”), IPR2018-00789 (Decision Denying Institution entered September 25, 2018).

Oxford challenged claims 1-15 of U.S. Patent No. 9,546,400 (“the ’400 patent”) on anticipation and obviousness grounds.  The ’400 patent is directed to a method for sequencing of polymeric molecules, such as nucleic acids, including single-stranded DNA.

Oxford challenged the claims as obvious based on seven references, used alone or in various combinations.  In particular, element (d) of challenged claim 1 was disputed by the parties.  Element (d) recites “determining the sequence of the template nucleic acid using the measured property from step (c) by performing a process including comparing the measured property from step (c) to calibration information produced by measuring such property for 4 to the N sequence combinations.”  In its preliminary response, Pacific argued that certain cited references had been thoroughly considered by the Office during prosecution and that Oxford failed to show either a sufficient reason to combine or a reasonable expectation of success.  The Board agreed with Pacific and determined that Oxford had failed to provide a clear analytical path from statements regarding prior art difficulties to the calibration information recited in element (d).  As such, the Board held that Oxford had failed to show that there was a reasonable likelihood that it would prevail in establishing obviousness of claim 1.

Consequently, the Board denied institution of Oxford’s petition in IPR2018-00789 and no trial was instituted against the claims of the ’400 patent.