- PTAB · Oct 26, 2022 · IPR2022-00886 · APJ John G New · IPR · Institution
The Board instituted review of claims 1–4 on all petition grounds, finding a reasonable likelihood that Mutz anticipates the claims.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“of claims 1–4 of the ’816 patent. Patent Owner argues, however, that Mutz cannot anticipate claims 1–4 because the reference is not enabled. See Gleave, 560 F.3d at 1334 (holding that, to anticipate, “the reference must “enable one of ordinary skill in the art to make the invention without undue experimentation.” (citing Impax Labs., Inc. v. Aventis Pharms. Inc., 545 F.3d 1312, 1314 (Fed. Cir. 2008))). Specifically, Patent Owner contends that, because Mutz does not disclose a method for making fingolimod HCl, it is not enabled and therefore cannot anticipate the claims of the ’816 patent. We disagree.” slip op. at 25
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“Procedure for Discretionary Denials in AIA Postgrant Proceedings with Parallel District Court Litigation, June 21, 2022 available at: https://www.uspto.gov/sites/default/files/documents/interim_proc_discretion ary_denials_aia_parallel_district_court_litigation_memo_20220621_.pdf (last visited October 11, 222) (the “Guidance”). As stated by the Guidance, the Board will not rely on the Fintiv factors to discretionarily deny institution in view of parallel district court litigation when: (1) a petition presents compelling evidence of unpatentability; (2) a petitioner presents a stipulation (a “Sotera stipulation”) not to pursue in a parallel proceeding the same grounds or any grounds that could have reasonably been raised before the PTAB9; and (3) if all other Fintiv factors weighing against exercising discretion to deny institution, or are neutral, the proximity to trial should not alone outweigh all of those other factors.10 Guidance at 1–8.” slip op. at 40
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“In performing an analysis under § 325(d): [T]he Board uses the following two-part framework: (1) 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 first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.… If, after review of [Becton, Dickinson] factors (a), (b), and (d), it is determined that the same or substantially the same art or arguments previously were presented to the Office, then factors (c), (e), and (f) relate to whether the petitioner has demonstrated a material error by the Office. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential).” slip op. at 45
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“of claims 1–4 of the ’816 patent. Patent Owner argues, however, that Mutz cannot anticipate claims 1–4 because the reference is not enabled. See Gleave, 560 F.3d at 1334 (holding that, to anticipate, “the reference must “enable one of ordinary skill in the art to make the invention without undue experimentation.” (citing Impax Labs., Inc. v. Aventis Pharms. Inc., 545 F.3d 1312, 1314 (Fed. Cir. 2008))). Specifically, Patent Owner contends that, because Mutz does not disclose a method for making fingolimod HCl, it is not enabled and therefore cannot anticipate the claims of the ’816 patent. We disagree.” slip op. at 25
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 9,266,816 - PTAB · Oct 19, 2022 · IPR2022-01513 · APJ Tina E Hulse · IPR · Institution
The Board instituted IPR on claims 1–8 on all five grounds previously instituted in IPR2022-00517 and granted Teva’s motion to join that proceeding.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Teva’s Petition here is substantively identical to Mylan’s Petition in the -517 IPR, challenging the same claims based on the same art and the same grounds. Compare IPR2022-00517, Paper 1 with IPR2022-01513, Paper 2. For the same 1 European Medicines Agency, Assessment Report, Xarelto, EMA/CHMP/794349/2012 (2013). Ex. 1005 (“EMA”). 2 Foley et al., Antithrombotic therapy in peripheral artery disease, 21 VASCULAR MED. 156–69 (2016). Ex. 1006 (“Foley”). 3 Plosker, Rivaroxaban: A Review of Its Use in Acute Coronary Syndromes, 74 DRUGS 451–64 (2014). Ex 1007 (“Plosker”). reasons stated in our Decision Granting Institution of Inter Partes Review in IPR2022-00517, we institute trial in this proceeding on the same five grounds. See IPR2022-00517, Paper 15.” slip op. at 3
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Motion for Joinder. Based on authority delegated to us by the Director, we have discretion to join an inter partes review to a previously instituted inter partes review. 35 U.S.C. § 315(c). Section 315(c) provides, in relevant part, that “[i]f the Director institutes an inter partes review, the Director, in his or her discretion, may join as a party to that inter partes review any person who properly files a petition under section 311.” Id. When determining whether to grant a motion for joinder, we consider factors such as timing and impact of joinder on the trial schedule, cost, discovery, and potential simplification of briefing. Kyocera Corp. v. SoftView, LLC, IPR2013-00004, Paper 15 at 4 (PTAB Apr. 24, 2013).” slip op. at 4
NonePatents in suitUS 10,828,310 - 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 · Sep 21, 2022 · IPR2022-00684 · APJ James A Tartal · IPR · Institution
The Board instituted IPR on claims 1–18 across all petitioned grounds, finding 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
“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 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 ’460 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
“have had either “a medical degree and at least two years’ experience with treating glaucoma and performing glaucoma surgery,” or “an undergraduate or graduate degree in biomedical or mechanical engineering and at least five years of work experience in the area of ophthalmology, including familiarity with ophthalmic anatomy and glaucoma surgery.” Pet. 22–23 (citing Ex.1003, ¶ 26). In the absence of any preliminary response, Patent Owner, at this stage of the proceeding, takes no position on the definition of the person of ordinary skill in the art. 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, or skilled artisan, which is not 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 ’460 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)” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“Petitioner suggests, generally, that “all terms should be given their plain and ordinary meaning” and notes that in the related proceedings the Board “gave the term ‘dual blade device’ its ordinary meaning, noting ‘dual refers to two, and blade, in context, refers to a cutting part,” and construed “ab interno” as generally meaning “from the inside or from within the eye.” Pet. 23, 27, 30–31 (citing Ex. 1056, 22–23). We find that an express construction of any claim term is not necessary 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 10
Claim constructioncites Phillips · KSR · GrahamPatents in suitUS 10,888,460 - Nextremity Solutions, Inc. / Zimmer Biomet Holdings, Inc. et al. v. Extremity Medical, LLCInstitutedPTAB · Aug 16, 2022 · IPR2022-00802 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted IPR of claim 59 on all three asserted § 102(b) anticipation grounds: Brumfield, Marcus, and Chandran.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“XI. CONCLUSION Petitioner has, at this stage, established a reasonable likelihood of prevailing in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. XII. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 314(a) an inter partes review of claim 59 of the ’802 patent is hereby instituted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 314(c) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial.” slip op. at 34
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Determining whether claims are anticipated involves a two-step analysis. The first step involves construction of the claims of the patent at issue. Claim construction is a question of law reviewed de novo.” In re Aoyama, 656 F.3d 1293, 1296 (Fed.Cir.2011). “The second step [of an anticipation analysis] involves comparing the claims to the prior art. Anticipation is a question of fact reviewed for substantial evidence.” In re Aoyama, 656 F.3d at 1296. “A prior art reference anticipates a patent claim under 35 U.S.C. § 102(b) if it discloses every claim limitation.” In re Montgomery, 677 F.3d 1375, 1379 (Fed. Cir. 2012). A reference may anticipate inherently if a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010). We analyze the asserted grounds of unpatentability in accordance with these principles to determine whether Petitioner has met its burden to establish a reasonable likelihood of success at trial. slip op. at 10
§ 102 anticipationcites PhillipsPatents in suitUS 8,303,589 - 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 - PTAB · May 31, 2022 · IPR2022-00403 · APJ Michael A Valek · IPR · Institution
The Board instituted IPR on claims 1–33, finding a reasonable likelihood of success on the Pioneer Hi-Bred anticipation ground and the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“Advanced Bionics9 sets out a two-part framework for analyzing these factors. In the first part, we consider factors (a), (b), and (d) to determine whether the art and arguments presented in the petition are the same or substantially the same as those previously presented to the Office. Advanced Bionics, 8–10. “If, after review of factors (a), (b), and (d), it is determined that the same or substantially the same art or arguments previously were presented to the Office,” then we move on to the second part of the analysis to determine “whether the petitioner has demonstrated a material error by the Office” in view of factors (c), (e), and (f). Id.” slip op. at 8
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“On balance, the record before us does not support either party’s view as to the proximity of the district court’s trial date to the projected deadline for our final written decision. Accordingly, this factor is neutral.” slip op. at 16
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Beginning with independent claims 1 and 19, we determine that Petitioner has met its burden for institution. Based on the current record, Petitioner has shown that Table 8 of Pioneer Hi-Bred discloses a synthetic CRISPR crRNA molecule having one or more 2’-O-methyl modifications in its guide sequence (i.e., SEQ ID No: 66 and SEQ ID No: 68). See, e.g., Pet. 26–30. Petitioner also demonstrates sufficiently for institution that Pioneer Hi-Bred discloses a tracrRNA segment complementary to a stem sequence of the crRNA. Id. at 19–25. Petitioner points to Pioneer Hi-Bred’s disclosure that “the modified gRNAs such as those described in [] Tables 7 and 8 can be used to edit cells, e.g., maize cells,” (see id. at 26) thus demonstrating sufficiently for institution that Pioneer Hi-Bred discloses that the modified crRNAs in Table 8 have guide RNA functionality in a CRIPSR-Cas system.” slip op. at 25
- Skill levelSkill level board ownOther
“B. Level of Ordinary Skill in the Art Relying on the testimony of its declarant, Dr. Furneaux, Petitioner contends that a POSA “as of December 3, 2014 (the earliest possible priority date of the ’034 Patent) would have had a Ph.D. in molecular biology, biochemistry, or a related discipline.” Pet. 11 (citing Ex. 1003 ¶ 60). Patent Owner’s declarant, Dr. Marshall, applies the same definition for his analysis. Ex. 2003 ¶ 85. At this stage in the proceeding, we find this description of the level of ordinary skill in the art to be sufficiently supported by the record. Thus, for purposes of this decision, we adopt the description of a POSA noted above.” slip op. at 20
Claim constructionDiscretionary denialcites KSR · GrahamPatents in suitUS 10,900,034 - PTAB · May 31, 2022 · IPR2022-00402 · APJ Michael A Valek · IPR · Institution
The Board instituted IPR on claims 1–30, finding a reasonable likelihood of success on the anticipation challenge and all asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Petitioner has shown that Pioneer Hi-Bred discloses examples of synthetic guide RNA and crRNA molecules having the recited modifications at their 3’ and 5’ ends. See Pet. 20–24 (referring to Table 8 of Ex. 1006). That disclosure undermines the Applicant’s arguments during prosecution that: (1) “a skilled person would not modify a CRISPR guide RNA or crRNA at the particularly claimed positions,” and (2) the reference to “‘securing or steadying the structure’ of RNA in [Zhang] relates to secondary structure” as opposed to “modifications at the claimed positions,” i.e. within five nucleotides from one or both of the ends. Ex. 1002, 783. Both of these arguments were credited by the Examiner as reasons for withdrawing the rejection over Zhang. Id. at 783–784. Thus, Petitioner has sufficiently shown that the Examiner materially erred by not recognizing the relevance of Pioneer Hi-Bred’s disclosure and in particular the crRNA examples in Table 8.” slip op. at 10
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied
“On the current record, we determine that the merits of Petitioner’s anticipation ground appear to be particularly strong for the independent claims and for those dependent claims where Petitioner’s arguments are similarly premised on the crRNA examples in Table 8 being anticipatory without any further modification. See infra § V.E (explaining that, on the current record, Petitioner has shown that Pioneer Hi-Bred Table 8 discloses presumptively-enabled examples that read on claims 1 and 12 as well as a number of the dependent claims). Accordingly, we find that this factor weighs strongly against exercising discretion to deny institution. G. Weighing of Fintiv Factors Considering the Fintiv factors as part of a holistic analysis of the factors discussed above, we are not persuaded that the interests of the efficiency and integrity of the system would be served by invoking our authority under 35 U.S.C. § 314(a) to deny institution of a potentially meritorious Petition. Accordingly, we do not exercise our discretion to deny institution under § 314(a).” slip op. at 18
- Skill levelSkill level board ownOther
“B. Level of Ordinary Skill in the Art Relying on the testimony of its declarant, Dr. Furneaux, Petitioner contends that a POSA “as of December 3, 2014 (the earliest possible priority date of the ’001 Patent) would have had a Ph.D. in molecular biology, biochemistry, or a related discipline.” Pet. 12 (citing Ex. 1003 ¶ 60). Patent Owner’s declarant, Dr. Marshall, applies the same definition for his analysis. Ex. 2003 ¶ 85. At this stage in the proceeding, we find this description of the level of ordinary skill in the art to be sufficiently supported by the record. Thus, for purposes of this decision, we adopt the description of a POSA noted above.” slip op. at 19
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction Neither party identifies any claim term for construction. Pet. 17; Prelim. Resp. 35. We agree that no formal claim construction is necessary at this stage of the proceeding. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that it is only necessary to “construe terms ‘that are in controversy, and only 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 21
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,337,001 - PTAB · May 18, 2022 · IPR2022-00142 · APJ John G New · IPR · Institution
The Board instituted IPR of claims 1–6 on all petitioned grounds, finding a reasonable likelihood that claim 1 is anticipated by Gil and claims 1–6 are obvious over the cited combination.
RulingsInstitution decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“When ‘about’ is used as part of a numeric range, the use of the word “‘about’” avoids a strict numerical boundary to the specified parameter.” Cohesive, 543 F.3d at 1368 (internal quotations omitted). When “about” is used to define the limit of a numerical range, the extension beyond the stated number depends on what “a person having ordinary skill in the art … would reasonably consider ‘about …’ to encompass.” Monsanto Tech. LLC v. E.I. DuPont de Nemours & Co., 878 F.3d 1336, 1342 (Fed. Cir. 2018). Furthermore, when determining how far beyond the claimed range the term “about” extends the claim, “[w]e must focus ... on the criticality of the [numerical limitation] to the invention.” Ortho–McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1327 (Fed. Cir. 2007). “Extrinsic evidence of meaning and usage in the art may be helpful in determining the criticality of the parameter.” Id. at 1326 (quoting Pall Corp. v. Micron Separations, Inc., 66, F.3d 1211, 1217 (Fed. Cir. 1995)). At this stage of the proceeding, and on this record, we find Petitioner’s reasoning that the claim term “about 0.025%” includes 0.03% to be more persuasive. As Petitioner points out, the Specification discloses a number of embodiments with concentration ranges of brimonidine that include both values. Furthermore, Patent Owner has not persuasively pointed to any disclosures of the ’742 patent that expressly support the criticality of 0.025% brimonidine as the upper end of the concentration range. Indeed, the passage pointed to in this respect by Patent Owner states: FIG. 6 depicts a graphical representation of a finding of the present invention that an increased rebound hyperemia begins at around 0.03% for brimonidine. It thus demonstrates that the net effectiveness of brimonidine as a decongestant is greatest between about 0.01% and about 0.03%; preferably, between about 0.012% and about 0.02%. Ex. 1001, col. 19, ll. 52–57. This passage does not expressly or implicitly disclose the criticality of “about 0.025%” as the upper limit of the effective range of brimonidine concentration. slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“2. “ocular condition” Petitioner argues that the ’742 patent defines “ocular condition” broadly and without limitation. Pet. 31 (citing Ex. 1001, col. 12, ll. 14–49). Petitioner therefore urges us to construe “ocular condition” as including, without limitation eye redness, glaucoma (including open-angle glaucoma); elevated intraocular pressure, also known as ocular hypertension, postoperative reduction of subconjunctival hemorrhage and hyperemia after refractive surgery such as LASIK and radial keratotomy, subconjunctival hemorrhage and hyperemia prophylaxis prior to refractive surgery such as LASIK and radial keratotomy, and redness in the eye following LASIK or radial keratotomy. Id. (citing Ex. 1001, col. 12, ll. 14–49; Ex. 1002 ¶ 47). Patent Owner makes no argument with respect to construction of this claim term, other than to note that the phrase would be understood by a skilled artisan to have its ordinary meaning consistent with the Specification. Given the capacious disclosures of the Specification of the ’742 patent in this respect, we find Petitioner’s proposed construction to be reasonable. See Ex. 1001, col. 12, ll. 14–52. We consequently construe, for the purposes of this Decision, the claim term “ocular condition” as including, without limitation, “eye redness, glaucoma (including open-angle glaucoma); elevated intraocular pressure, also known as ocular hypertension, postoperative reduction of subconjunctival hemorrhage and hyperemia after refractive surgery such as LASIK and radial keratotomy, subconjunctival hemorrhage and hyperemia prophylaxis prior to refractive surgery such as LASIK and radial keratotomy, and redness in the eye following LASIK or radial keratotomy.” 3. Additional claim construction Reviewing the present record, the panel the panel concludes that no other claim term needs express construction for the purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (per curiam) (claim terms need to be construed “only 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 12
- Skill levelSkill level petitioner adoptedDecided for petitioner
“have been a composite person (or team) that included a medical doctor and a pharmaceutical formulator. Pet. 15 (citing Ex. 1002 ¶ 26; Ex. 1003 ¶ 29). Petitioner asserts that the medical doctor would have been an ophthalmologist with at least three to four years of experience in LASIK surgery, clinical trials, and U.S. FDA regulation of eye products, and had experience in the use of topical brimonidine, apraclonidine; and topical vasoconstrictors such as naphazoline and tetrahydrozoline. Id. (citing Ex. 1002 ¶ 26). Petitioner contends that the pharmaceutical formulator would have had a doctoral degree in pharmaceutics, or a related degree, and at least three to five years of experience developing eye drop formulations for clinical trial and regulatory approval. Id. (citing Ex. 1003 ¶ 29). Patent Owner does not contest this definition in its Preliminary Response, stating it does not take a position at this time regarding the qualifications of the person of ordinary skill in the art. Prelim. Resp. 29. Patent Owner further notes that Petitioner’s characterization of a person of ordinary skill in the art goes beyond that of ordinary skill. Id. We find Petitioner’s proposed characterization to be reasonable and consequently adopt Petitioner’s definition for the purposes of this Decision.” slip op. at 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundInstituted
“A claim is unpatentable under 35 U.S.C. § 102 only when “every element and limitation of the claim was previously described in a single prior art reference, either expressly or inherently, so as to place a person of ordinary skill in possession of the invention.” Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1082 (Fed. Cir. 2008). With respect to Petitioner’s argument that Gil inherently discloses the preambular limitation reciting a “method for reducing eye redness,” we agree that, although Gil teaches that “[o]cular responses characteristic of neurogenic inflammation, including redness and pupillary constriction, are also observed in rabbits following external stimuli,” Example 1 of Gil does not expressly teach that administration of 0.03% brimonidine reduces redness in the subject patients. See Ex. 1004, col. 5, ll. 38–40. Nevertheless, we do not agree with Patent Owner that Gil teaches only the reduction of ocular pain via administration of brimonidine in the claimed concentrations. Gil discloses that a person of skill in the art would understand that inflammation of the eye is accompanied by both redness and pain, and expressly discloses that its invention is directed to “the topical application of brimonidine for treating ocular pain and neurogenic inflammation.” Id. at col. 1, ll. 11–13. Gil also discloses that “neuropeptides enhance inflammatory reactions in the injured tissue, contributing to vasodilation, edema, and increased vascular permeability, this phenomenon is called ‘neurogenic inflammation.’” Id. at col. 1, ll. 40– 43. We find that a skilled artisan would understand that “neurogenic inflammation,” and particularly “vasodilation, edema, and increased vascular permeability” are proximal causes of eye redness. See id. at col. 5, ll. 38–40. Furthermore, and as Petitioner argues, the ’742 Specification also expressly teaches that administration of doses of brimonidine of 0.02– 0.033% resulted in redness reduction. See Ex. 1001, cols. 19–20, ll. 65–25. Although Gil is generally silent with respect to redness reduction, using pain as an indicator of neurogenic inflammation, the ’742 Specification demonstrates that application of 0.03% brimonidine would also necessarily reduce redness when administered to patients with an ocular condition. See also Ex. 1025. We therefore conclude that Petitioner has established a reasonable likelihood of success in prevailing at trial with respect to at least one claim upon Ground 1.” slip op. at 19
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 8,293,742
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.