- Pfizer, Inc. v. Uniqure Biopharma B.V.All claims unpatentablePTAB · Nov 15, 2022 · IPR2021-00925 · APJ Julia Heaney · IPR · Final written decision
Claims 1, 3, 7–10, 14–16, 19, and 20 are unpatentable as obvious over Stafford and Manno, and Stafford, Manno, and Schuettrumpf.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In our Decision on Institution, although we agreed with Patent Owner that the ordinarily skilled artisan would have experience in the treatment of coagulopathy, we applied a broader definition of a person of ordinary skill in the art, as articulated by Drs. Wang and Pedersen. Dec. Inst. 22; see Ex. 1003 ¶ 48; Ex. 1094 ¶ 19. We determined a person of ordinary skill in the art would have the skill of a research team working to develop factor IX variants and gene therapies, where that team would include (1) one or more researchers with experience in the fields of molecular biology and virology and the use of gene therapy for treatment of coagulopathies, working together with (2) one or more individuals with experience in protein structure or engineering; and where the individuals working on the team have an advanced degree and several years of experience in a relevant discipline. See id. Patent Owner states its positions on patentability of the challenged claims “would not change under that construction or Petitioner’s proposed definition ....” PO Resp. 13. Accordingly, we apply the definition of a person of ordinary skill in the art set forth supra and in our Decision on Institution.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“We agree with Petitioner that the ’248 patent provides an express definition of “treat” and “treatment.” The Specification states, “[i]n the present text the term ‘treat’ or ‘treatment’ of a pathology means the prophylaxis and/or therapy and/or cure of this pathology.” Ex. 1001, 5:19– 21. This definition includes “cure” as a separate concept from therapy, and further provides that therapy includes “partial or total” alleviation of symptoms. Id. at 5:21–24. The ’248 patent does not define or otherwise describe “treating a coagulopathy” as requiring any specific duration of therapeutic efficacy; therefore, a person of ordinary skill in the art would understand that partial alleviation of symptoms and a shorter duration of therapeutic efficacy is encompassed in “treating a coagulopathy” as recited in claim 1. Claim 16, which depends from claim 1, supports a construction of “treating a coagulopathy” that does not require complete alleviation of symptoms or permanent therapeutic efficacy. Claim 16 recites the “modified FIX polypeptide is expressed at a level that reduces and/or prevents hemorrhages.” Ex. 1001, 46:34–36. Because claim 16 depends from claim 1, this means that “treating a coagulopathy” as recited in claim 1 encompasses merely reducing hemorrhages, i.e., partial alleviation of symptoms. Accordingly, based on the intrinsic evidence, including the express definition of the terms “treat” and “treatment,” we construe “treating a coagulopathy” as prophylaxis and/or therapy and/or cure of this coagulopathy which includes partial alleviation of symptoms, for any duration of therapeutic efficacy. We determine that we need not explicitly construe any other claim terms.” slip op. at 10
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“Accordingly, Patent Owner has failed to show that it is entitled to a presumption of a nexus between the objective evidence and the claimed invention. Patent Owner argues that it “need not rely on such presumption [of nexus]” under the Polaris and Fox Factory analysis. PO Resp. 67. Although Patent Owner does not fully explain its position, we note that Fox Factory provides, “[a] finding that a presumption of nexus is inappropriate does not end the inquiry into secondary considerations”; rather, “the patent owner is still afforded an opportunity to prove nexus by showing that the evidence of secondary considerations is the ‘direct result of the unique characteristics of the claimed invention.’” Fox Factory, 994 F.3d at 1374 (quoting In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996)). Here, we find that Patent Owner presents insufficient evidence to establish a nexus by this alternative route. Patent Owner does not present argument as to the “unique characteristics” of the claimed invention, or provide evidence to support such an analysis. See PO Resp. 66–67; PO Sur-reply 26–28. In addition, as discussed above, Patent Owner’s evidence is broadly directed to FIX- R338L, which was in the prior art and does not suggest non-obviousness of the claimed invention as a whole. In summary, Patent Owner does not meet its burden to show a presumption of nexus or show a nexus to the alleged long-felt need for an effective gene therapy for hemophilia B, industry praise, and unexpectedly superior efficacy of AAV-FIX-R338L. Weighing the evidence and arguments presented, we determine that even if there is some nexus, it is weak. See Merck & Cie, 808 F.3d at 837 (Where objective indicia “result[ ] from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention.”). The failure to show a nexus is fatal to Patent Owner’s contentions regarding objective indicia.” slip op. at 26
- Expert testimonyPatent owner expert discountedDecided for petitioner
“We also find Dr. Pedersen’s opinion with regard to a leucine substitution in FIX-R338 more credible than Dr. Spiegel’s, who states “there is no such thing as ‘conservative amino acid substitutions’ in the sense Dr. Pedersen asserts.” Ex. 2101 ¶ 72. The ’248 patent itself refers to “conservative amino acid substitutions” and states “[i]t is expected that substitutions between these homologous amino acids [including alanine and leucine] would not change the phenotype of the proteins.” Ex. 1001, 4:48– 61. Although Dr. Spiegel notes that substitution is context dependent and “the specification recognizes ... various properties of each unique amino acid all contribute to the amino acid’s interactions” (Ex. 2101 ¶ 75, citing Ex. 1001, 4:48–61; Ex. 1002, 4:45–58; Ex. 1039, 51), his opinions do not account for the knowledge of a person of ordinary skill in the art as to the properties of alanine and leucine and the structure of FIX. See Ex. 1101 ¶¶ 36–39. Further, Dr. Spiegel’s surface-exposure opinion (see, e.g., Ex. 2101 ¶ 99) is undercut by Stafford’s teaching that the 330–338 region of wild-type FIX contains two solvent-exposed leucines. Ex. 1101 ¶ 41 (citing Ex. 1004, 34). Dr. Spiegel’s opinion that a leucine substitution would reduce solubility or increase susceptibility to aggregation also lacks credibility because it is based on the protein hemoglobin S, and not on a modification to FIX positions 330–338. Ex. 2101 ¶ 62; Ex. 1103, 78:15–18; see Ex. 1101 ¶ 60. We also do not find persuasive Patent Owner’s argument that a person of ordinary skill in the art would have had serious concerns whether R338L would be expressed, based on Stafford. As discussed above, Stafford discloses successful expression of R338A in vitro, and as Dr. Wang explains, the understanding of a person of ordinary skill of similarities between R338A and R338L would have supported the understanding that R338L would express at a similar level to R338A, given Stafford’s disclosure that only R338P showed reduced expression, and unlike leucine, “proline is a known ‘helix breaker.’” Ex. 1004, 14–15; Ex. 1100 ¶¶ 113– 116. Stafford’s disclosure that mutations at 330–337 cause severe hemophilia due to loss of FIX activity (Ex. 1004, 19:16–20) does not support Patent Owner’s argument, because Patent Owner’s experts do not persuasively explain why the risk of severe hemophilia from single amino acid substitutions at positions 330–337 would be predictive of a similar risk at position 338. See Ex. 1100 ¶¶ 115–119; Ex. 1101 ¶¶ 48–51. As such, we agree with Dr. Wang that a person of ordinary skill in the art would not have expected difficulties in expression of R338L.” slip op. at 38
Patent outcomesUS 9,982,248 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,982,248 - Miltenyi Biomedicine GmbH / Miltenyi Biotec Inc. v. The Trustees Of The University Of PennsylvaniaInstitution deniedPTAB · Oct 11, 2022 · IPR2022-00853 · APJ Robert A Pollock · IPR · Institution
The Board denied institution on all challenged claims under § 325(d), finding substantially the same art had been presented to the Office and no material examination error was shown.
RulingsInstitution decision- Skill levelSkill level board ownOther
“In addressing the level of ordinary skill in the art, Petitioner contends that: A POSA is a person skilled in the art of administering CAR T-cell therapies. The person would possess a relatively high level of skill and have at least an MD, together with several years of experience in administering CAR T-cell therapies. The person would also have experience designing CARs. The POSA would have knowledge of the scientific literature pertaining to immunology, including CARs and methods for utilizing CARs before the priority date. A POSA would also be knowledgeable about laboratory techniques related to engineering and testing the function of CAR T-cells. A POSA would also be knowledgeable about designing clinical trials, including selecting dose ranges, that evaluate CAR T-cell therapies. Pet. 10. Patent Owner does not presently contest this definition. Although Petitioner’s definition generally comports with our understanding of the high level of skill in the art, we are not persuaded all of the asserted qualifications must be embodied in a single person. For example, it seems unduly limiting to require that the person of ordinary skill in the art have “at least an MD” degree, and “be knowledgeable about laboratory techniques related to engineering and testing the function of CAR T-cells,” as Petitioner suggests. Accordingly, we provisionally adopt Petitioner’s definition with the caveat that the asserted qualifications may be shared among multiple individuals working as part of a multidisciplinary team. C. Claim Construction” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notNot reached
“Patent Owner points out that the structure of independent claim 1 here is similar to those addressed in Eli Lilly. Prelim. Resp. 18. And, as in Eli Lilly, the Specification of the ’140 patent underscores the centrality of the method recited in the preamble. Id. (citing Ex. 1001, codes (54), (57), 1:55– 57). Unlike in Eli Lilly, however, the body of independent claim 1 does not recite merely “an effective amount” but “an anti-tumor effective amount” of the composition administered. Petitioner argues that whereas the preambles in Eli Lilly “provide the only metric by which one practicing the claim could determine whether the amount administered is an ‘effective amount,’” the term “anti-tumor effective amount” in independent claim 1 “is well-defined by the specification and provides sufficient guidance for determining effectiveness.” Prelim. Reply 3 (citing Eli Lilly at 1342). On balance, Petitioner appears to have the better argument. Nonetheless, even if we were to construe the treatment language of the preamble to mean “reducing the frequency or severity of at least one sign or symptom of cancer” as Patent Owner proposes, this definition is coextensive with, if not subsumed by, the term “anti-tumor effective amount,” discussed below. As such, the outcome of this proceeding does not turn on whether the preamble is limiting.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“As we understand it response, Patent Owner does not appear to contest that “anti-tumor effect” can comprise a decrease in the number of tumor cells, but argues that the claim term requires “a palpable therapeutic effect,” which is more than “just the death of a single cancer cell or handful of cells.” Prelim. Resp. 19–23; Prelim. Sur-reply 4–5. In support, Patent Owner points to the ’140 patent’s express definition of “[a]n ‘effective amount’” as meaning “an amount which provides a therapeutic or prophylactic benefit.” Pet. 20 (citing Ex. 1001, 13:53–54). Relatedly, we note that the Specification also teaches that a “‘therapeutically effective amount’ includes that amount of a compound that, when administered, is sufficient to prevent development of, or alleviate to some extent, one or more of the signs or symptoms of the disorder or disease being treated.” Ex. 1001, 18:12–15. Patent Owner further contends that “[t]he specification teaches that ‘an antitumor effective amount’ is an amount to be administered that is “determined by a physician” as part of determining ‘[t]he optimal dosage and treatment regime for a particular patient . . . by monitoring the patient for signs of disease and adjusting the treatment accordingly.’” Prelim. Resp. 22 (citing Ex. 1001, 37:53–38:5). Considering the argument and evidence of record, we agree with Patent Owner that one of ordinary skill in the art would understand an “anti- tumor effective amount” as used in claim 1 to require more than the killing of a single tumor cell. Accordingly, we provisionally construe “anti-tumor effective amount” as any amount of CAR T-cells administered to a patient in need of cancer treatment that reduces the frequency or severity of at least one clinically relevant sign or symptom of the disease. To the extent this functional limitation is satisfied, claim 2 indicates that an “anti-tumor effective amount” may be limited to between 104 to 109 CAR T-cells/kg body weight. At this stage of the proceeding, no other term requires construction.” slip op. at 19
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“reasonable expectation of success in light of the unpredictability of cancer therapy and the “uninspiring” results and failures of earlier CAR-T clinical trials. Prelim. Resp. 23–28 (citing e.g., Ex. 2037, 1036; Ex. 2010, 1824– 1825; Ex. 2032, 1250–1251). In support, Patent Owner points to OSI Pharms. as “directly on-point.” Id. at 24 (citing OSI Pharms., LLC v. Apotex Inc., 939 F.3d 1375 (Fed. Cir. 2019)). The claims at issue in OSI Pharms., were structurally similar to those at issue here and directed to a method of treating non-small cell lung cancer (“NSCLC”) in a mammal using a therapeutically effective amount of erlotinib, which had previously been shown to inhibit the epidermal growth factor receptor (“EGFR”) in vitro. 939 F.3d at 1378–79. The court stated: Cancer treatment is highly unpredictable. Even though the EGFR was identified in some cancers as a drug target, the in vitro (i.e., in a test tube) effectiveness of a drug in inhibiting the EGFR turned out to be a poor proxy for how effective that drug actually was in treating cancer in vivo (i.e., in the body). Numerous EGFR inhibitors that showed promising in vitro activity failed for a variety of reasons. Id. at 1377; see also id. at 1386 (“1,630 other new drug compounds that, like erlotinib, targeted NSCLC and were studied in Phase II trials. The failure rate for these compounds was 99.5%”). Against this backdrop, the court reversed the Board over its unsupported reading of the two cited references, finding that: the asserted references do not disclose any data or other information about erlotinib’s efficacy in treating NSCLC. The record does not contain any clinical (human) data or preclinical (animal) data. It does not even include in vitro (test tube) data regarding erlotinib’s effect on NSCLC. Id. at 1384. Considering the promising in vitro data presented in Campana and Jensen, Petitioner here has a somewhat better position than the Appellees in OSI Pharms. At core, Grounds 1 and 2, require us to find a reasonable expectation of success in treating a human cancer based on in vitro experiments, the mere existence of a clinical trial, and absent any of the “clinical (human) data or preclinical (animal) data,” highlighted by the court. See id. Considering the inherent unpredictability of the field and the history of failures of similar technology documented by Patent Owner, we do not find Petitioner’s arguments persuasive. As such, Petitioner has not demonstrated a reasonable likelihood of success in proving that any claim of the ’140 patent is unpatentable under Grounds 1 and 2.” slip op. at 40
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,464,140 - PTAB · Aug 9, 2022 · IPR2022-00517 · APJ Tina E Hulse · IPR · Institution
The Board instituted IPR on claims 1–8, finding a reasonable likelihood of success on the asserted grounds, including anticipation by EMA.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)InstitutedDecided for petitioner
“The Board has set forth certain factors (“the Fintiv factors”) that may be considered in determining whether to exercise its discretion to deny institution based on the advanced stage of a parallel proceeding: 1. whether the court granted a stay or evidence exists that one may be granted if a proceeding is instituted; 2. proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision; 3. investment in the parallel proceeding by the court and the parties; 4. overlap between issues raised in the petition and in the parallel proceeding; 5. whether the petitioner and the defendant in the parallel proceeding are the same party; and 6. other circumstances that impact the Board’s exercise of discretion, including the merits. Fintiv, IPR2020-00019, Paper 11, at 5–6. On June 21, 2022, the Director of the Office issued a Memorandum to clarify how the Board should apply certain Fintiv factors when determining whether to exercise its discretion to deny institution under § 314(a).4 The 4 Memorandum Re: Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (June 21, 2022), available at https://www.uspto.gov/sites/default/files/documents/ interim_proc_discretionary_denials_aia_parallel_district_court_litigation_memo_2 0220621_.pdf. (“Memo”). Memorandum explains that the Board should decline to exercise its discretion to deny institution where: (1) a petition presents compelling evidence of unpatentability; (2) a request for denial under Fintiv is based on a parallel ITC proceeding; or (3) a petitioner stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition. Memo 2–3. Moreover, when analyzing Fintiv’s second factor, the Board will consider the published median time to trial in the district court in which the parallel litigation resides. Id. at 3. B. Analysis of the Relevant Fintiv Factors As explained further below, we find the Petition presents compelling evidence of unpatentability with respect to the challenges over the EMA reference, which precludes us from exercising our discretion to deny institution under Fintiv. Memo 4–5. Although that factor alone is sufficient to end our analysis, we further note that several other factors support declining to exercise our discretion, as well.” slip op. at 7
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitutedDecided for petitioner
“In performing an analysis under § 325(d), the Board uses a two-part framework: (1) We consider whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) If either condition of the first part of the framework is satisfied, we consider whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019- 01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential).” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the argument and evidence presented in the papers, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of claims 1–8 (all claims) of the ’310 Patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“invention would have had “the equivalent of an M.D. degree, knowledge, and experience regarding the diagnosis and treatment of patients with CAD and PAD, including administering antiplatelet and anticoagulant agents to such patients.” Pet. 10 (citing Ex. 1002 ¶¶ 50–52, 89–95). Patent Owner does not contest Petitioner’s definition of the level of ordinary skill in the art for purposes of its Preliminary Response. Prelim. Resp. 10. We adopt Petitioner’s definition as it appears to be consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,828,310 - Boehringer Ingelheim Animal Health USA Inc. v. Kansas State University Research FoundationInstitution deniedPTAB · Jul 15, 2022 · PGR2022-00021 · APJ Sheridan K Snedden · PGR · Institution
The Board denied institution on Grounds 1–5 under § 325(d) and found Ground 6 had not shown any challenged claim more likely than not unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“met (e.g., substantially the same art is presented), we move to part two of the framework, asking “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of [the] challenged claims.” Id. at 8. Factors (c), (e), and (f) of Becton, Dickinson fall within part two of the framework. Id. at 10 (“[F]actors (c), (e), and (f) relate to whether the petitioner has demonstrated material error by the Office.”). Only if the same or substantially the same art or arguments were previously presented to the Office do we then consider whether petitioner has demonstrated error. Id. at 8–10. “If the petitioner fails to show that the Office erred, the Director may exercise his discretion not to institute.” Id. at 8–9. “At bottom, this [§ 325(d)] framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9 (“If reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.”).” slip op. at 15
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“specific citations to evaluate its assertions, Petitioner does not direct our attention to any portion of the Nordgren Declaration providing information on why the partial sequences disclosed by the references teach or suggest the claimed 90% sequence homology. Pet. 76, 79 (citing Ex. 1026 at VII.C, ¶¶ 247–269). For example, Dr. Nordgren’s assertion “a POSITA would anticipate natural genetic variation of PorkNW2/USA/2009 ORF2 would bring it within the scope of the Claim 1 genera” is not supported by substantial evidence. Ex. 1026 ¶ 256. Claim 1, for example, recites a PCV3 protein and does not recite partial proteins. Without knowing what portion of complete proteins are disclosed by the references, we are not persuaded that a person of ordinary skill in the art would have been able to predict the variation expected among a group of complete proteins to arrive at the claimed subject matter as is implied by Petitioner. Petitioner’s conclusory statements are insufficient to support a legal conclusion of obviousness. And while we agree with Petitioner that the protein sequences disclosed in the cited references do not necessarily have to be designated as PCV3 sequences, we determine that Petitioner has failed to meet its burden to demonstrate that any of the PCV3 deposit references teach or suggest the recited sequences within the claimed range. Pet. 79. Therefore, Petitioner has not met its burden in showing that every claimed element is taught by its cited references, and we need not reach Petitioner’s argument on motivation to combine. Accordingly, we determine that Petitioner fails to carry its burden to show that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable based on Petitioner’s Ground 6.” slip op. at 25
- Skill levelSkill level petitioner adoptedOther
“A person of ordinary skill in the art (or “POSITA”) in the field of the ’274 Patent in the October 2015 to October 2019 timeframe would have held a Doctorate in Veterinary Medicine (D.V.M.) or equivalent, or a Ph.D. or equivalent in immunology, vaccinology, virology, molecular biology, animal science, and/or husbandry, or a closely related field. A POSITA would also have practical knowledge of immunology, including how vaccine candidates are first identified and then subsequently developed. The knowledge may come from the POSITA’s own experience, or it may come through research or work collaborations with other experienced individuals in the medical, pharmaceutical, or biotech industry, e.g., as members of a research team or group. Pet. 16 (citing Ex. 1026 ¶ 34). Absent opposition from Patent Owner, we adopt Petitioner’s definition because it is consistent with the level of ordinary skill in the art reflected by the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The Board applies the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.200(b) (2019). Under that standard, claim terms “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner contends that it “does not believe any term of the ’274 Patent needs to be construed in this proceeding.” Pet. 29. We agree and independently determine that it is unnecessary to expressly construe any claim term for purposes of rendering 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 11
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 10,954,274 - Restem, LLC. v. Jadi Cell, LLCInstitutedPTAB · Apr 20, 2022 · IPR2021-01535 · APJ Devon Zastrow Newman · IPR · Institution
The Board instituted IPR on claims 1–15 over all asserted grounds, finding a reasonable likelihood that Petitioner would show at least one challenged claim unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority to determine whether to institute an inter partes review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2019). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon consideration of the Petition, the Preliminary Response, and the evidence of record, we conclude that the information presented shows a reasonable likelihood that Petitioner would prevail in showing the unpatentability of at least one of the Challenged Claims. Accordingly, we authorize an inter partes review to be instituted as to the Challenged Claims of the ’176 patent on the grounds raised in the Petition. Our factual findings and conclusions at this stage of the proceeding are based on the evidentiary record developed thus far (prior to Patent Owner’s Response). This is not a final decision as to patentability of claims for which inter partes review is instituted. Any final decision will be based on the record, as fully developed during trial.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 15 (citing Ex. 1007 ¶¶ 19–24). Patent Owner does not comment on the characterization offered by Petitioner or offer one of its own. See generally Prelim. Resp. For purposes of this Decision, we adopt Petitioner’s characterization as it is consistent with the level of skill in the art at the time of the invention as reflected by the ’176 patent and the cited prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionOther
“Prelim. Resp. 16. Patent Owner cites Ex. 1001 6:32–34, noting that the patent specification “expressly defines ‘isolated cell’ as ‘[referring] to a cell that has been isolated from the subepithelial layer of a mammalian umbilical cord.’” Id. As neither party references any prosecution history related to interpretation of this claim term, we look only to the claim itself and the specification as intrinsic evidence. DePuy Spine, 469 F.3d at 1014. Claim 1 recites “an isolated cell prepared by a process comprising . . . ” Ex. 1001 at 19:6. As Patent Owner notes, the patent specification states “the term ‘isolated cell’ refers to a cell that has been isolated from the subepithelial layer of a mammalian umbilical cord.” Id. at 6:32–34. The remainder of the citations Petitioner cites relate to additional steps for isolating the cell, or characteristics of the cell, such as the markers expressed or not expressed, but do not further elucidate the meaning of “an isolated cell” itself. Dr. Olsen’s testimony reiterates the content of these citations but does not add any additional information or explanation. Ex. 1007 ¶¶ 67–68. Given the definition provided in the specification, we interpret “an isolated cell,” consistent with Patent Owner’s definition, to mean “one or more cells isolated from the subepithelial layer of a mammalian umbilical cord.”” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInstituted
“the Wharton’s Jelly, epithelium, etc.” and that, without evidence that the recited markers are expressed/not expressed as recited, there is no inherent disclosure. Prelim. Resp. 22, 25, 28–29 (citing Ex. 2022 ¶ 162). Patent Owner is correct that an ultimate finding of anticipation requires such confirmation, but, for purposes of institution, our standard is a reasonable likelihood. 35 U.S.C. § 314(a). Due to the breadth of claim 1, Majore’s method must produce only one cell having the recited limitations to anticipate. Petitioner’s expert testifies that production of such cells would be inherent by Majore. See Ex. 1007 ¶ 97 (“Majore’s protocol would produce a population of adherent cells that necessarily and inevitably comprise the cells of the subepithelial layer.”). And, although we recognize that the burden of persuasion does not rest on Patent Owner, Dr. Burger’s testimony, which focuses heavily on the differences in methodology between Majore and the ’176 patent disclosure and Petitioner’s alleged failure of proof, is not persuasive at this stage to overcome the evidence presented by Petitioner. See Ex. 2002 ¶¶ 137–163. Indeed, both Majore and the ’176 patent disclose umbilical cord tissue cut into sections and placed into environments fostering cell culture and replication. Ex. 1011 at 18, Ex. 1001 at 13:57–14:5. Both methods encourage and result in adherent cells growing on a plastic growth surface awash in culture media. Id. On this record, Petitioner has provided sufficient factual basis to establish a reasonable likelihood that Majore’s explant method of dissecting umbilical cord, culturing cells, and growing adherent cells would have produced (or did produce) at least one cell with the recited limitations. In this regard, we credit the testimony of Dr. Olsen that the isolated cells disclosed in Majore are MSCs cultured from umbilical cord tissues including the subepithelial layer, which have migrated to the periphery of the cut tissue and adhered to the tissue culture vessel. Ex. 1007 ¶¶ 95–97. That Majore discloses genetic markers with similar expression/non-expression to the markers recited in claim 1 is further evidence that at least some cells were cultured from the subepithelial layer. Id. ¶ 99. Moreover, even if we gave weight to the process limitations construed as requested by Patent Owner (Prelim. Resp. 13–20), the limitations are sufficiently broad as to read on Majore with the exception of the express/non-expressed markers. With regard to markers not examined by Majore, we credit Dr. Olson’s statement that “the cells obtained by Majore’s protocol necessarily and inevitably comprise the same cells produced by the process steps of claim 1[A] and 1[B]” and that the skilled artisan would have understood that the marker expression pattern would be identical for those cells. Id. ¶ 101.16 The evidence on this issue is subject to final determination on a more complete record developed through trial.” slip op. at 21
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,803,176 - New World Medical, Inc. v. The Regents Of The University Of CaliforniaAll claims unpatentablePTAB · Mar 11, 2022 · IPR2021-00066 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–11 are unpatentable: claims 1–11 are anticipated by Quintana and obvious over Quintana; the Board did not reach the Jacobi ground.
RulingsFinal written decision- ExcludeMotion to exclude, deniedDenied
“Patent Owner filed a motion to exclude evidence (Paper 38); Petitioner opposed (Paper 41); and Patent Owner filed a reply in support of its motion (Paper 43). Petitioner also filed a motion to exclude evidence (Paper 39); Patent Owner opposed (Paper 40); and Petitioner filed a reply in support of its motion (Paper 42). We addressed (and denied) the parties’ motions to exclude in Paper 49.” slip op. at 3
- Expert testimonyPetitioner expert creditedPatent owner expert discountedOther
“We “conclude[d] that the better course is to have a complete record of the evidence,” and, therefore, denied Petitioner’s Motion, but also explained that “to the extent that Dr. Condon’s testimony and Patent Owner’s reliance thereon ventures into areas the witness has conceded he either does not understand or has inadequately analyzed,” we would accord it little weight, as distinguished “from that relating to Dr. Condon’s technical expertise in, for example, anatomy, eye surgery, and his own reading of evidence.” Order 13. Therefore, it is through this lens that we consider and analyze Dr. Condon’s testimony here.” slip op. at 14
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 22 (citing Ex. 1003 ¶ 24). On page 18 of our Institution Decision, we provisionally accepted Petitioner’s proposed definition, which was not opposed by Patent Owner, and is consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’544 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). As Patent Owner expressly agrees with our analysis, we apply Petitioner’s proposed definition here. See PO Resp. 11, n.4. C.” slip op. at 25
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“1. “A device useable to create an opening in the trabecular meshwork of the eye” Independent claim 1 is directed to “[a] device useable to create an opening in the trabecular meshwork of the eye” and having a “foot member . . . advanceable, tip first, through Schlemm’s Canal to facilitate performance of a surgical procedure using the surgical instrument.” Ex. 1001, 23:4–5, 23:18–20. As an initial matter, we consider the preamble of claim 1 limiting here because a device that “create[s] an opening in the trabecular meshwork” recites or, at a minimum, implies, “essential structure or steps” required for the insertion and advancement of the instrument through Schlemm’s Canal as set forth in [1.d]. See Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002).8” slip op. at 26
Patent outcomesUS 9,999,544 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,999,544 - PTAB · Jan 13, 2022 · IPR2021-01136 · APJ Ulrike W Jenks · IPR · Institution
The Board instituted review of claims 1 and 2 on the § 103 ground over Popplewell and Sazani, finding a reasonable likelihood that the claims would have been obvious.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“We determine that the Popplewell article relied upon by Petitioner in this proceeding is the same or substantially the same as the art previously presented to the Office. As noted by Patent Owner, Popplewell was cited in an IDS and indicated as being considered by the Examiner during prosecution. Prelim. Resp. 1, 16; Ex. 2012, 2; Ex. 2007, 15. Moreover, Popplewell is discussed in the Specification of the ’461 patent as prior art in which “a technique for skipping exon 53 with a high efficiency has not yet been established.” Ex. 1001, 2:55–56, 3:5–6. This is sufficient under the under the first part of the Advanced Bionics framework. As explained in Advanced Bionics, “[p]reviously presented art includes art made of record . . . such as on an [IDS].” Advanced Bionics at 7–8. We further note that the Popplewell ’212 reference that formed the basis of the Examiner’s rejection during prosecution appears to include substantially similar disclosures as Popplewell, including with regard to the 25-mer PMO-A, which form the primary basis for Petitioner’s unpatentability arguments in this proceeding. See, e.g., Ex. 1023 ¶ 87 (“When tested and compared directly at 300 nM doses by nucleofection, PMO-G, PMO-H and PMO-A were most active producing in the order of 60% exon skipping”). To be sure, we recognize that the Examiner does not appear to have specifically considered, nor did Patent Owner otherwise highlight during prosecution, Popplewell’s or Popplewell ’212’s teachings regarding the viability of PMO-A. We address this failure under the second part of the Advanced Bionics framework.” slip op. at 23
- Other 314aInstitution denied discretionary otherDenied
“2. 35 U.S.C. § 314(a). Patent Owner contends that we should exercise our discretion to deny institution under § 314(a) because of a Mutual Confidentiality Agreement between the parties. Prelim. Resp. 65–73. Patent Owner argues that filing a petition for inter partes review violates the Agreement’s forum selection clause, which requires all potential actions to be filed in the United States District Court for the District of Delaware. Id. at 66–68 (citing Ex. 2026 § 1). Patent Owner acknowledges that the District of Delaware has already denied Patent Owner’s Motion for Preliminary Injunction seeking withdrawal of this and related Petitions due to the Agreement. See id. at 67– 68. Nevertheless, Patent Owner argues that the Board should deny this Petition so that the Federal Circuit can address the issue on appeal. Id. at 74. Finally, Patent Owner argues that considerations of efficiency, fairness, and the merits favor discretionary denial. Id. at 71–73. Petitioner responds that “[t]he Board has consistently refused to interpret and enforce contractual forum-selection clauses in deciding whether to institute post-grant proceedings.” Reply 6–7 (citing Samsung Elecs. Co. v. NuCurrent, Inc., IPR2019-00861, Paper 15, 20 (PTAB Feb. 7, 2020); Bally Gaming, Inc. v. New Vision Gaming & Dev., Inc., CBM2018- 00006, Paper 47, 7–8 (PTAB June 19, 2019); Dot Hill Sys. Corp. v. Crossroads Sys., Inc., IPR2015-00822, Paper 18, 6–10 (PTAB Sept. 17, 2015)). Petitioner further contends that the District of Delaware has already denied Patent Owner’s request for preliminary injunction on this issue, finding that the Agreement indicates that the parties intended to allow IPRs to proceed. Id. at 7 (citing Ex. 1103, 5). We have considered Patent Owner’s arguments related to the forum selection clause in the parties’ Agreement. We determine, however, that the particular facts of this case, including the District of Delaware’s denial of a preliminary injunction, do not warrant exercise our discretion to deny institution on this basis.” slip op. at 28
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“III. CONCLUSION After considering the evidence and arguments presented in the current record, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that the challenged claims of the ’461 patent are unpatentable. We therefore institute trial on all challenged claims under the ground raised in the Petition. See PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (Indicating that a decision whether to institute an inter partes review “require[s] a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition.”); 37 C.F.R. § 42.108(a). At this stage of the proceeding, we have not made a final determination with respect to the patentability of any of the challenged claims.” slip op. at 46
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art would have a Ph.D. in chemistry, biochemistry, cell biology, genetics, molecular biology, or an equivalent, and several years of experience with AOs for inducing exon skipping. A POSA would also have familiarity with methods for making and testing the safety and efficacy of such AOs, both in vitro and in vivo, and the use of AOs for inducing exon skipping in the context of medical conditions, such as DMD, that may be treated by administering such AOs. Further, a POSA would have knowledge of and experience with chemical modifications that may be incorporated into AOs, such as modifications to the backbone and/or nucleobases of the AOs, and the potential impact of those modifications on the utility of the AOs. Pet. 28–29 (citing Ex. 1097 ¶¶ 91, 92). Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill. Prelim. Resp. 14. Because Petitioner’s proposed definition is unopposed and appears consistent with the Specification and art of record, we apply it here.” slip op. at 14
§ 103 obviousnessDiscretionary denialcites KSRPatents in suitUS 10,407,461 - PTAB · Jan 13, 2022 · IPR2021-01138 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1–12 based on the §103 ground combining Popplewell and Sazani.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). A claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which that subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence of nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). In analyzing the obviousness of a combination of prior art elements, it can be important to identify a reason that would have prompted one of skill in the art “to combine . . . known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418. A precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. Id. Rather, “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Id. at 420. Accordingly, a party that petitions the Board for a determination of unpatentability based on obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (internal quotations and citations omitted). slip op. at 10
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“325(d), the Board applies a two-part framework: (1) first, we determine whether the same or substantially the same art previously was presented to the Office, or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, we examine whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, 8.” slip op. at 39
- Other 314aInstitution denied discretionary otherDenied
“institution under § 314(a) because of a Mutual Confidentiality Agreement between the parties. Prelim. Resp. 71. Patent Owner argues that filing a petition for inter partes review violates the Agreement’s forum selection clause, which requires all potential actions to be filed in the United States District Court for the District of Delaware. Id. at 66–67 (citing Ex. 2026 § 1). Patent Owner acknowledges that the District of Delaware has already denied Patent Owner’s Motion for Preliminary Injunction seeking withdrawal of this and related Petitions due to the Agreement. See id. at 68. Nevertheless, Patent Owner argues that the Board should deny this Petition so that the Federal Circuit can address the issue on appeal. Id. at 73. Finally, Patent Owner argues that considerations of efficiency, fairness, and the merits favor discretionary denial. Id. at 70–72. Petitioner responds that “[t]he Board has consistently refused to interpret and enforce contractual forum-selection clauses in deciding whether to institute post-grant proceedings.” Reply 6–7 (citing Samsung Elecs. Co. v. NuCurrent, Inc., IPR2019-00861, Paper 15, 20 (PTAB Feb. 7, 2020); Bally Gaming, Inc. v. New Vision Gaming & Dev., Inc., CBM2018- 00006, Paper 47, 7–8 (PTAB June 19, 2019); Dot Hill Sys. Corp. v. Crossroads Sys., Inc., IPR2015-00822, Paper 18, 6–10 (PTAB Sept. 17, 2015)). Petitioner further contends that the District of Delaware has already denied Patent Owner’s request for preliminary injunction on this issue, finding that the Agreement indicates that the parties intended to allow IPRs to proceed. Id. at 7 (citing Ex. 1103, 5). We have considered Patent Owner’s arguments related to the forum selection clause in the parties’ Agreement. We determine, however, that the particular facts of this case, including the District of Delaware’s denial of a preliminary injunction, do not warrant exercise our discretion to deny institution on this basis.” slip op. at 46
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner proposes that a person of ordinary skill in the art would have had “a Ph.D. in chemistry, biochemistry, cell biology, genetics, molecular biology, or an equivalent, and several years of experience with AOs for inducing exon skipping” and would “have familiarity with methods for making and testing the safety and efficacy of such AOs, both in vitro and in vivo, and the use of AOs for inducing exon skipping in the context of medical conditions, such as DMD, that may be treated by administering such AOs.” Pet. 31–32 (citing Ex. 1099 ¶ 98). Petitioner also proposes that a person of ordinary skill in the art “would have knowledge of and experience with chemical modifications that may be incorporated into AOs, such as modifications to the backbone and/or nucleobases of the AOs, and the potential impact of those modifications on the utility of the AOs.” Id. at 32 (citing Ex. 1099 ¶ 99). Patent Owner states, “[s]olely for purposes of this IPR, Patent Owner does not dispute Petitioner’s definition of a POSA. To the extent the Board decides to institute this Petition, Patent Owner reserves the right to present a different definition post-institution.” Prelim. Resp. 14. Because Petitioner’s proposed definition is unopposed at this stage of the proceeding and appears consistent with the Specification and art of record, we apply it here.” slip op. at 13
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,647,741 - PTAB · Nov 18, 2021 · IPR2021-00854 · APJ Wesley B Derrick · IPR · Institution
The Board instituted IPR on claims 1–35 and all asserted grounds, finding a reasonable likelihood that claim 1 is anticipated by Birnboim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. See 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a). To institute an inter partes review, we must determine that the information presented in the Petition shows that there is “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). The Federal Circuit has interpreted the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition.” PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Thus, based on the information presented, we institute an inter partes review of claims 1–35 of the ’240 patent on all grounds.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that A person of ordinary skill in the art . . . would have had (1) a Ph.D. in microbiology, molecular biology, biochemistry, or related discipline; (2) at least two years of post-graduate experience in the area of nucleic acid extraction and analysis; and (3) experience with the development or use of nucleic acid 10 Koller, WO 91/02740, published Mar. 7, 1991. Ex. 1016. 11 Robert E. Farrell, Jr., Ph.D., “RNA Methodologies: A Laboratory Guide for Isolation and Characterization,” (3rd Ed., 2005). Ex. 1026. extraction formulations, and the literature concerning nucleic acid extraction and analysis. Pet. 7 (citing Ex. 1002 ¶ 38). Patent Owner does not dispute Petitioner’s proposed definition at this stage. Prelim. Resp. 7. For purposes of this Decision, at this stage of the proceeding, we accept Petitioner’s proposed definition of the person of ordinary skill in the art, which is not substantively opposed by Patent Owner and appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’240 patent. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). B. Claim Construction” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Neither Petitioner nor Patent Owner offer any position on the construction of any claim term. See Pet.; Prelim. Resp. 7. On this record, and for purposes of this Decision, we decline to construe any claim terms beyond the limited extent we do so below in our analysis, because it is not necessary to do so in reaching our decision on institution. C. Principles of Law” slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“and particularly claim 1. Petitioner provides a detailed analysis of where each element of claim 1 is found in Birnboim. Pet. 13–19. Specifically, Petitioner asserts that Birnboim’s Example 3 discloses an aqueous composition comprising the one or more chaotropes, one or more detergents, one or more reducing agents, one or more chelators, and one or more buffers, as recited in the claim. Id. at 13–18. Petitioner also asserts that “Birnboim’s reagents are present in an amount sufficient to perform the claimed functions.” Id. at 18–23 (heading capitalization normalized and underlining omitted).” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,669,240 - PTAB · Nov 12, 2021 · IPR2021-00860 · APJ Robert A Pollock · IPR · Institution
The Board instituted inter partes review of claims 1–20 on all petitioned grounds because Petitioner showed a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Birnboim, Mori, and Farrell, Petitioner provides a detailed analysis of where each claim element is found in the cited references and discusses why one of ordinary skill in the art would have been motivated to combine those elements with a reasonable expectation of success. See e.g., Pet. 34–42 (discussing motivation to combine and reasonable expectation of success with respect to claim 1). For the purpose of institution, we focus on independent claim 1.” slip op. at 17
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Relying on the testimony of Dr. Taylor, Petitioner asserts that A person of ordinary skill in the art (“POSA”) would have had (1) a Ph.D. in microbiology, molecular biology, biochemistry, or related discipline; (2) at least two years of post-graduate experience in the area of nucleic acid extraction and analysis; and (3) experience with the development or use of nucleic acid extraction formulations, and the literature concerning nucleic acid extraction and analysis. Pet. 10 citing Ex. 1002, ¶¶34–35. Patent Owner presently does not dispute Petitioner’s proposed definition. Prelim. Resp. 6. For purposes of this Decision, at this stage of the proceeding, we accept Petitioner’s proposed definition of the person of ordinary skill in the art, which is not substantively opposed by Patent Owner and appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’256 patent. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C. Claim Construction” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionPlain and ordinary meaningDecided for petitioner
“According to Petitioner, we should apply the plain and ordinary meaning of “stock solution” as meaning “a formulated supply of solution for future use,” which, in the context of the instant claims, refers to “the aqueous composition before it is mixed with a sample.” Pet. 8 (citing Ex. 1029; Ex. 1002 ¶ 38). Patent Owner neither contests Petitioner’s definition of “stock solution” nor requests that we construe any other claim term, but reserves its right to do so. Prelim. Resp. 7. At this stage of the proceeding, we apply the plain and ordinary meaning of “stock” solution as Petitioner proposes. In section II.D.4, below, we note that Patent Owner implicitly relies on narrow constructions of “kills pathogens” and “without degrading nucleic acids.” As these terms may be critical to our final determination but have not been briefed by either party, we provisionally apply their plain and ordinary meaning. D. Ground 1: Obviousness in View of Birnboim, Mori, and Farrell” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Petitioner provides reasoned bases for why one of ordinary skill in the art would have combined the cited references to arrive at the claimed invention. See Pet. 34–42 (citations omitted). Summarizing its arguments, Petitioner concludes that one of ordinary skill in the art would have been motivated to prepare solutions comprising a chaotrope, a detergent, a reducing agent, a chelator, a shortchain alkanol, and a buffer (with the associated acid and base) at a pH of 5–7 with a reasonable expectation that, when combined with a biological sample, the solution would denature proteins, inactivate nucleases, and kill pathogens, all without degrading nucleic acids of the sample. Ex. 1002, ¶151. The POSA would have been motivated to use Mori’s surfactants or defoaming agents along with Farrell’s nuclease-free water in Birnboim’s stock solution and would have had a reasonable expectation of success in doing so. Ex. 1002, ¶¶137–152.” slip op. at 19
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,683,256
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.