- Fresenius Kabi USA, LLC / Fresenius Kabi Swissbiosim GmbH v. Coherus Biosciences, Inc.Rehearing deniedPTAB · Jan 27, 2021 · PGR2019-00064 · APJ Christopher G Paulraj · PGR · Rehearing
The Board denied Petitioner’s rehearing requests, leaving in place denial of institution based on the merits of the written-description and enablement challenges.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. DISCUSSION A party requesting rehearing has the burden to show a decision should be modified by specifically identifying all matters the party believes were misapprehended or overlooked, and the place where each matter was addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“Petitioner’s arguments are unpersuasive because our construction of “stable” does not exclude the preferred embodiments. As Petitioner acknowledges, “[t]he Board did not construe ‘stable’ to be limited to formulations that are as stable as Humira or lose 20% of activity upon storage.” Id. at 3. Although our construction encompasses the “most” preferred embodiment (e.g., those that do not lose more than 5% of their activity during two years of long-term storage), it also encompasses other embodiments that are considered less preferred but nonetheless within the scope of what is defined to be “stable” in the specification, i.e., compositions that do “not lose more than 20%, or more preferably 15%, or even more preferably 10%” of activity. Ex. 1001, 9:28–33. Furthermore, consistent with the specification, our construction of “stable” encompasses embodiments in which stability is determined by comparison to the commercial formulation of adalimumab known in the prior art, i.e., Humira. Decision 8–9. We find no basis to construe “stable” to be limited to the only most preferred embodiment by requiring a loss of no more than 5% activity. See Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (stating “a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment”).” slip op. at 3
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not shown unpatentable
“These arguments are also unpersuasive. As stated in the Decision: [W]e find that the specification provides a detailed disclosure of the testing used to assess stability (using Humira as the control), and identifies specific ingredients to be included and excluded from the claimed composition, and further identifies the pH that is necessary to achieve the claimed stability. Although there may be certain concentrations of adalimumab or certain types of buffers and sugars that may render the compositions more difficult to stabilize, Petitioner does not explain sufficiently why a POSA would not have known how to adjust or select those ingredients in order to achieve the claimed stable aqueous pharmaceutical composition. Decision 17. As further stated in the Decision: Moreover, even if a POSA would have needed to test whether a particular composition was stable, “[t]he fact that some experimentation is necessary does not preclude enablement; what is required is that the amount of experimentation ‘must not be unduly extensive.” PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564 (Fed. Cir. 1996) (citing Atlas Powder Co. v. E.I. DuPont De Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984)). Indeed, even “a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the invention claimed.” Id. (citing Ex parte Jackson, 217 USPQ 804, 807 (BPAI 1982)). Id. at 17–18. Petitioner’s arguments do not persuade us that we committed legal or factual error in making the foregoing determinations. Accordingly, we are not persuaded that we abused our discretion in determining that Petitioner did not satisfy its burden with respect to the lack of enablement ground for claims 1–12.” slip op. at 5
- Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable
“the specification identifies with sufficient clarity each of the ingredients that must be included as part of the claimed composition (i.e., adalimumab, a buffer, polysorbate 80, and a sugar) and further provides a reason to exclude the ingredients that must not be included in theclaimed composition (i.e., mannitol, a citrate/phosphate buffer combination, and sodium chloride). Id. at 13–14. The Decision also explained how one of ordinary skill in the art would recognize that the inventors possessed the claimed invention: Patent Owner identifies teachings in the specification indicating the structural features required for achieving a stable adalimumab composition, which include: 1) avoiding the citrate/phosphate buffer combination in favor of another more stable buffer (such as an acetate buffer); 2) including polysorbate 80 as a stabilizer; 3) removing sodium chloride (NaCl) from the formulation; 4) using a sugar or polyol as the tonicity modifier in place of mannitol/NaCl; and 5) maintaining a pH of at least 5 (with an optimal pH near 5.2). Id. at 60 (citing Ex. 1001, 5:42–44, 21:40–47, 37:25–38:4, 38:1–7, 61:24–25). Patent Owner further asserts, and we agree, that the specification “provides working examples that demonstrate comparable or superior stability to the commercial Humira® formulation” and that Petitioner fails to demonstrate why a POSA would doubt that the formulations that demonstrated improved stability relative to Humira would be stable. Id. at 60–61. Id. at 14. Petitioner’s arguments do not persuade us that we committed legal or factual error in making the foregoing determinations. Accordingly, we are not persuaded that we abused our discretion in determining that Petitioner did not satisfy its burden with respect to the lack of written description ground for claims 1–12.” slip op. at 7
Claim construction§ 112 disclosurePatents in suitUS 10,155,039 - Genome & Company v. The University Of ChicagoAll claims unpatentablePTAB · Apr 14, 2020 · PGR2019-00002 · APJ John E Schneider · PGR · Final written decision
Claims 1–29 are unpatentable: claims 1–17 and 19–28 for lack of enablement and obviousness; claims 18 and 29 for obviousness.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Dr. Braun, Petitioner’s proffered expert, defines a person of ordinary skill in the art as having an advanced degree or its substantial equivalent in the biological sciences, including specifically in the fields of immunology, microbiology and the microbiome, and oncology, coupled with research experience in those fields. Ex. 1002 ¶ 40. Patent Owner does not contest Petitioner’s definition of a person of ordinary skill in the art. See generally, PO Resp. We determine that Petitioner’s description of the level of ordinary skill in the art is supported by the current record. For purposes of this Decision, therefore, we adopt Petitioner’s description. We also note that the applied prior art reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“interprets claim terms in an unexpired patent according to the broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R. § 100(b) (2018);3 Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (affirming applicability of broadest reasonable construction standard to trial proceeding before the USPTO.). Under that standard, and absent any special definitions, we generally give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definitions for claim terms must be set forth with reasonable clarity, deliberateness, and precision. See In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). We determine that it is unnecessary to expressly construe any claim terms for purposes of this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 9
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“We have considered the arguments presented by the parties and the evidence of record and conclude that the unpredictability of the art weighs in favor of finding non-enablement with respect to CPIs in general. While we agree with Patent Owner that CPIs can be effective in treating some cancers, the Specification and the evidence of record show that all of the effective CPIs are antibodies. For example, all of the CPIs listed in the chart of page 10 of Patent Owner’s Response are antibodies. Tr. 39. We find nothing in the record, other than attorney argument that one skilled in the art would know how to make of use other CPIs, such as an interfering nucleic acid molecule, in the claimed method. For example, as Petitioner points out, Patent Owner’s expert did not consider CPIs other than antibodies, in reaching his conclusions regarding enablement. Pet. Reply, 4; Ex. 1042, 19–29. The record also does not support the contention that one skilled in the art could predict the action of non-antibody CPIs based on the action of an antibody CPI. The art and the Specification identify one non-antibody CPI, and the Fe region of human IgG. Ex. 1001, col. 5, ll. 20–23; Ex. 2034, 206. At the time the ’302 patent was filed, studies of this potential CPI indicated that it acted differently than antibody CPIs and that efficacy was lacking compared to other CPIs. Id. This evidence supports Petitioner’s contention that the use of CPIs, especially non-antibody CPIs, was unpredictable at the time the ’302 patent was filed. We also agree with Petitioner that the selection of Bifidobacterium was unpredictable. The evidence of record supports Petitioner’s contention that the immunostimulatory activity of Bifidobacterium varies from strain to strain, even within the same species. Pet. 44–45. O’Mahony teaches that Bifidobacterium longum strain AH1714 is immunosuppressive while another stain of B. longum exhibits immunostimulatory activity. Ex. 1017 ¶¶ 103– 109. Similarly, Lopez evaluated 12 strains of four different species of Bifidobacterium and concluded that the properties exhibited by Bifidobacterium varied among the strains. Ex. 1038, Abstr. Patent Owner’s arguments regarding the credibility of O’Mahony and Lopez are unpersuasive. Patent Owner made specific representations to the Examiner on several occasions that strain AH1714 disclosed in O’Mahony was immunosuppressive to support Patent Owner’s argument that one would not combine an immunosuppressive agent with an immunostimulatory agent. See, e.g. Ex. 1014, 8–9. Patent Owner suggests that it was not asserting that the statements in O’Mahony were accurate, but merely argues that those statements would have led away from making the combination proposed by the Examiner. PO Sur-Reply 10. This argument fails in its logic. If one skilled in the art upon reading O’Mahony would have recognized the alleged errors in O’Mahony’s teachings and disregarded them as Patent Owner now combination advanced by the Examiner in prosecution as Patent Owner argued. With respect to Lopez, Lopez states unambiguously that the immune effects of Bifidobacteria are species and strain specific. Petitioner has advanced evidence that those skilled in the art accepted these conclusions, citing Lopez in subsequent articles. Pet. Reply 10–11 (citing Ex. 1044). Moreover, the present inventors found Lopez to be sufficiently credible to incorporate the teachings of Lopez in their entirety into the instant Specification of the ’302 patent. Ex. 1001, col. 37, l. 62–col. 38, l. 4.” slip op. at 23
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledEnabledMixed
“evidence of record and conclude that applying the all the Wands factors, Petitioner has demonstrated by a preponderance of the evidence that claims 1–17 and 19–28 are not enabled. In reviewing the evidence of record, we find that the nature of the invention that involves very broad claims, the high level of skill required in such an unpredictable art, and the dearth of working examples and lack of specific guidance on the full range of CPIs and cancers challenged claims are not enabled. Because claims 18 and 29 require known CPIs, however, we find that Petitioner has failed to show that these claims are not enabled.” slip op. at 26
Patent outcomesUS 9,855,302 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 9,855,302 - Genome & Company v. The University Of ChicagoRehearing deniedPTAB · Jan 9, 2020 · PGR2019-00002 · APJ John E Schneider · PGR · Rehearing
The Board denied the Patent Owner’s rehearing request, leaving institution in place for claims 1–29 because the Board found no abuse of discretion.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“decision should be modified. Under 37 C.F.R. § 42.71(d), the request for rehearing must identify, specifically, all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. When rehearing a decision on a petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Owner’s argument. As we noted in our Decision, the issue of whether undue experimentation is required to practice the claimed invention is evaluated using the factors outlined in In re Wands, a fact based inquiry. Dec. 8. Our conclusion for purposes of institution that undue experimentation would be required to practice the claimed invention was based, not only on Dr. Braun’s statement to that effect, but on the detailed analysis presented by Petitioner and Dr. Braun of all of the Wands factors as supported by the evidence of record. Dec. 14–15. show that the experimentation required was other than routine and found it unpersuasive at the institution stage of the proceeding. Id. Patent Owner’s argument was based on the premise that Dr. Braun’s opinion regarding nonenablement was based on the number of experiments and not whether the experiments were routine. Prelim. Resp. 2–4. This argument ignores the fact that our consideration of Dr. Braun’s opinion was based on an analysis of all of the Wands factors, a fact based inquiry that includes analyzing the minimal guidance presented in the Specification and the unpredictability of cancer treatments and unpredictable nature of CPIS, and not merely the number of experiments required. Id. at 15; Ex. 1002 ¶ 166; In re Morsa, 713 F.3d 104, 109 (Fed. Cir. 2013) (“Enablement is a question of law based on underlying factual findings.”). Although we acknowledge Patent Owner’s argument in support of its position that the claimed subject matter is enabled, we remind Patent Owner that, for purposes of deciding whether to institute a post-grant review, we view a genuine issue of material fact in the light most favorable to the petitioner. 37 C.F.R. § 42.208(c). As Patent Owner offered attorney argument concerning enablement based on the current record, we resolved the parties’ dispute regarding enablement for which Petitioner offered Dr. Braun’s opinion as supported by evidence of record in favor of Petitioner.” slip op. at 3
- Strike new argumentNew argument disregardedDecided for petitioner
“Patent Owner contends that we should reconsider our decision to institute to avoid having Patent Owner address Petitioner’s legally insufficient enablement challenge. Reh’g. Req. 6–9. Patent Owner further contends that we should exercise our discretion and deny the Petition to help maintain the integrity of the patent system and promote fairness. Id. We have considered Patent Owner’s new arguments and are not persuaded. Those arguments were not previously raised in the Preliminary Response, and a request for rehearing is not the proper vehicle to set forth new argument.” slip op. at 5
NonePatents in suitUS 9,855,302
Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.