- 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 - 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 - 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 - Select Sires Inc. / Semex Alliance, Inc. et al. v. Abs Global, Inc.Institution deniedPTAB · Jun 28, 2022 · PGR2022-00019 · APJ Ulrike W Jenks · PGR · Institution
The Board denied the petition and instituted no post-grant review because Patent Owner disclaimed all challenged claims.
RulingsInstitution decision- Adverse judgmentAdverse judgmentDenied
“2 Exhibit numbers refer to proceeding PGR2022-00019. Corresponding Exhibits were entered in PGR2022-00020. 3 We acknowledge Petitioner’s request to treat the terminal disclaimer as a request for adverse judgment (see Ex. 3004). However, because there are no pending claims for us to consider, we decline Petitioner’s request for further briefing. See General Elec. Co. v. United Techs. Corp., IPR2019-01489, Paper 11 at 4–5 (Dec. 10, 2019) (denying institution based on disclaimer and declining authorization to file motion for adverse judgment); Google LLC v. Jenam Tech LLC, PGR2021-00082, Paper 8 at 2 n.1 (Nov. 17, 2021) (denying institution based upon disclaimer and declining petitioner’s request to file additional briefing regarding adverse judgment).” slip op. at 2
NonePatents in suitUS 10,975,351 - 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 - New World Medical, Inc. v. Microsurgical Technology, Inc.All claims unpatentablePTAB · Mar 11, 2022 · IPR2020-01573 · APJ Ryan H Flax · IPR · Final written decision
Claims 1–10 are unpatentable as obvious over Quintana and Lee; the Board did not reach the other asserted grounds.
RulingsFinal written decision- 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 Dr. Condon’s testimony here.” slip op. at 12
- Skill levelSkill level petitioner adoptedOther
“A [person of ordinary skill in the art] would have: (1) a medical degree and at least two years’ experience with treating glaucoma and performing glaucoma surgery; or (2) 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. Ex.1003, ¶27. Pet. 23–24 (citing Ex. 1003 ¶ 27). Patent Owner states that it “agrees with the Board’s preliminary acceptance in its institution decision of Petitioner’s proposed definition of a [person of ordinary skill in the art] for purposes of this IPR.” Resp. 11, n.6. We accept, as has Patent Owner, Petitioner’s proposed definition of the person of ordinary skill in the art, or ordinarily skilled artisan, which appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’729 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)). B.” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We decline to expressly adopt any proposed construction of the claim language. Vivid Techs., 200 F.3d at 803 (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”). Based on the evidence of record, the term “ab interno” is a well- understood term of art in the ophthalmological field. See, e.g., Ex. 1005, 1; Ex. 1013, 1; Ex. 1018, 1; Ex. 1020, 1. The ’729 patent does not expressly assign a special meaning to the term “ab interno.” Ex. 1001. As Patent Owner states, quoting Petitioner’s witness Dr. Netland, “[p]ersons of ordinary skill in the art would have understood the term ‘ab interno’ to generally mean from the inside . . . .” Resp. 31 (quoting Ex. 1003 ¶ 74 (emphasis in original)). We find that the record supports that the person of ordinary skill in the art would have understood this term and that it needs no special interpretation. The language “dual blade device” is readily understandable on its face; dual refers to two, and blade, in context, refers to a cutting part. The evidence of record does not indicate that this term has any special meaning different than what the plain language in context would suggest. The ’729 patent does not expressly assign a special meaning to the language “dual blade device.” Ex. 1001. We find that the record supports that the person of ordinary skill in the art would have understood this term and that it needs no special interpretation. To summarize, we find there is no need to expressly interpret the claim language in any way different from its ordinary meaning as would have been understood by the person of ordinary skill in the art. This is consistent with our preliminary determinations as set forth in our Institution Decision (at 15–17) and the parties’ understanding of the claims at trial. See generally Resp.; Reply; Sur-Reply; see also Hr’g Tr. 50:9–10 (Petitioner adopting the Board’s understanding of dual blade), 53:17–22 (Petitioner adopting the Board’s understanding of ab interno), 70:17–18 (Patent Owner adopting the Board’s understanding of dual blade). C.” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“As noted above, we do not agree with Patent Owner’s arguments and, for reasons below, we agree with Petitioner that Quintana and Lee would have been combined with a reasonable expectation of success. Quintana, Lee, and the invention claimed by the ’729 patent each are directed to the same field of endeavor, i.e., glaucoma eye surgery and tools for such procedures or, even more particularly, eye surgery tools for stripping trabecular network to treat glaucoma. See Ex. 1001, Abstract, 1:35–39, 1:66–2:3, 6:43–7:6 (claim 1); Ex. 1003 ¶¶ 91–103, 175, 181, 192; Ex. 1004, 3–3; Ex. 1006, Abstract, 3:50–57. We agree with Petitioner that the ordinarily skilled artisan would have looked to Quintana and Lee’s teachings together and would have, for example, modified Quintana’s device or procedure in view of Lee for the advantages expressed by the references themselves, such as providing sharp cutting edges to better excise tissue. Quintana’s disclosed device, a bent-tip hypodermic needle, is a simple tool, and the reference explains its use to strip delicate trabecular meshwork tissue to treat glaucoma. Ex. 1004, 3–4. Quintana is not explicit about some features of its bent-tip needle, for example, just how sharp its cutting edges are, or how exactly the device should enter the eye’s anatomy to strip the trabecular meshwork tissue. Id. Thus, if supporting information was desired, the ordinarily skilled artisan would certainly have looked to Lee for details for a trabecular meshwork stripping tool and method because that is exactly what Lee teaches designing and using a tool for. See supra Section I.F; see also Ex. 1003 ¶ 181 (discussing Lee’s ab interno goniotomy surgery with a dual blade device). “[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” KSR, 550 U.S. at 417. Here, ordinarily skilled artisans would have recognized that the advantageous structures and techniques of Lee would improve Quintana’s device and methods because Lee clarifies, for example, that ab interno techniques were well known as useful for goniectomy procedures and were established to be successful and improved patient comfort, recovery time, and safety, and because Lee also clarifies that using a sharp, dual blade device for such a procedure enables the extraction of large intact tissue samples of trabecular meshwork. See, e.g., Ex. 1003 ¶¶ 174–176, 181. These advantages of Lee’s device and technique would also have improved Quintana’s trabecular meshwork stripping goniotrabeculotomy device and technique. Id. The obviousness analysis “can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR, 550 U.S. at 418. “A person of ordinary skill is also a person of ordinary creativity, not an automaton.” Id. at 421. We do not find that it would have taken much, if any, creativity on the part of the ordinarily skilled artisan to have modified, if necessary, Quintana’s tool and its use (e.g., to have two sharp sides and to use it in an ab interno procedure) in view of Lee because each reference teaches a very simple device and explains its use. Such modification to Quintana, however, would likely not have been necessary because, as discussed herein (see infra Section II.D.1.b), Quintana teaches its device has sharp sides and is used in an ab interno procedure. The simplicity of Quintana’s device and the straightforwardness of Lee’s disclosure supports Petitioner’s position that the ordinarily skilled artisan would have had a reasonable expectation of success as “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 416; see, e.g., Ex. 1003 ¶¶ 175, 181 (testifying that modifying Quintana in view of Lee would amount to simple substitutions of known procedures or structural features and ordinarily skilled artisans would have expected success). For the reasons above and the rationale set forth in the aforementioned” slip op. at 29
Patent outcomesUS 9,107,729 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,107,729 - 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 - Janssen Biotech, Inc. v. The United States Of America, As Represented By The Secretary, Department Of Health & Human ServicesInstitution deniedPTAB · Mar 2, 2022 · IPR2021-01484 · APJ Robert A Pollock · IPR · Institution
The Board denied institution of IPR challenging claims 1–9, 13, 17, and 19 as obvious over Milone and Kalled under § 103, exercising discretion under § 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 at 8–10 (Feb. 13, 2020) (“Advanced Bionics”) (precedential), the Board addresses § 325(d) applying a “two-part framework.” In the first part of the framework, we ask whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments 8 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated. 22 previously were presented to the Office. Advanced Bionics at 8. Factors (a), (b), and (d) of Becton, Dickinson come into play under this first part of the framework. Id. at 8–10. If either condition of the framework’s first part is 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. Advanced Bionics at 8–10. “If the petitioner fails to show that the Office erred, the Director may exercise his discretion not to institute inter partes review.” 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.”). B.” slip op. at 22
- Skill levelSkill level patent owner adoptedOther
“Patent Owner does not dispute Petitioner’s proposed definition, but states that the person of ordinary skill in the art would “[t]ypically” . . . have had an M.D. or a Ph.D. in immunology, biochemistry, cell biology, molecular biology, or a related discipline, with at least two years of experience in conducting laboratory research on chimeric T cell receptors.” Prelim. Resp. 44 (citing Ex. 2001 ¶ 20). According to Patent Owner, the ordinarily skilled artisan “would have had knowledge of the scientific literature and have skills relating to chimeric T cell receptors and methods of using such receptors” and “may have worked as part of a multidisciplinary team” and been able to draw on the specialized skills of, for example, an immunologist, and/or a clinical oncologist. See id. at 43–44. Considering the record before us, both parties present reasonable definitions of one of ordinary skill in the art. For the purpose of this proceeding, we consider one of ordinary skill in the art as having had an M.D. or a Ph.D. in immunology, biochemistry, cell biology, molecular biology, or a related discipline, with at least two years of experience in conducting laboratory research on chimeric T cell receptors and/or the use of CAR-T immunotherapy. Consistent with Patent Owner’s proposed definition, the ordinarily skilled artisan may have worked as part of a 20 multidisciplinary team and been able to draw on the specialized skills of, for example, an immunologist, and/or a clinical oncologist.” slip op. at 20
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for patent owner
“We do not find Petitioner’s argument persuasive for the reasons set forth on pages 34–40 of the Preliminary Response. Most particularly, we note that the phrase “[a] chimeric antigen receptor (CAR)” occurs solely in the preamble of independent claim 24. Terms in a preamble, however, are not generally construed as limiting. See Allen Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). More specifically, “when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention,” the preamble is not considered a limitation. Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). In the present case, we find it plausible—if not likely—that the Examiner gave no weight to the terms in the preamble of claim 24 such that the remaining language did not expressly or implicitly require either a 32 transmembrane domain, or a “T-cell activation moiety” specific to CAR constructs. The Examiner appears to have recognized, however, that CAR constructs differ from Kalled’s antibodies at least in having a transmembrane domain as expressly recited in claims 29 and 30. See Ex. 2005, 605, 745–749 (allowing amended claims). This view is underscored by the Examiner’s decision not to reject claims 34 and 38 as anticipated by Kalled. See Ex. 2005, 604. Notably, claims 34 and 38 recite SEQ ID Nos 4–12, each of which encodes a complete CAR construct and, thus, implicitly includes a transmembrane domain. See id. at 589 (claiming a CAR comprising the amino acid sequence of SEQ ID Nos: 4–12 (claim 34) or a nucleic acid encoding the same (claim 38)); Ex. 1001, 9:49–53; Ex. 2001 ¶ 92.12” slip op. at 32
Claim constructionDiscretionary denialcites GrahamPatents in suitUS 9,765,342 - Boehringer Ingelheim Animal Health USA Inc. v. Kansas State University Research FoundationAll claims unpatentablePTAB · Jan 31, 2022 · PGR2020-00076 · APJ Erica A Franklin · PGR · Final written decision
Claims 1–16 are unpatentable under § 112(a) for lack of written description; the Board did not reach the remaining grounds.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“As noted by the Drs. Nordgren and HogenEsch, the differences in these descriptions are “relatively minor.” See Ex. 1038, 238:21–24; Ex. 1039 ¶ 42. Dr. Nordgren explains that even under the higher skill level required by Patent Owner’s description of a POSITA, his opinions would not change. Id. at 1039 ¶ 42. Based upon our review, the differences in Petitioner’s and Patent Owner’s proposed definitions do not impact Petitioner’s grounds for unpatentability or Patent Owner’s responsive arguments. Nor does our consideration of the issues presented turn on which proposed definition is applied. In any event, having considered the evidence and the arguments, we find Patent Owner’s rationale for its more narrow description of the level of ordinary skill in the art to be persuasive and Patent Owner’s description of a person of ordinary skill in the art, while maintaining that the prior art reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“In the Patent Owner Response, Patent Owner asserts that Petitioner’s proposed construction is actually a subject matter eligibility argument. PO Resp. 23. According to Patent Owner, “[t]he term ‘porcine circovirus type 3 recombinant protein’ has a plain and ordinary meaning of ‘genetically engineered PCV3 protein.’” Id. (citing Ex. 2052 ¶¶ 91–92). Having considered the positions of both parties, and the evidence of record, we find that for purposes of this Decision, the ordinary and customary meaning of the claim term “porcine circovirus type 3 recombinant protein,” is a PCV3 protein obtained by genetic engineering, and specifically by recombinant technology, wherein the recombinant protein may either have the same structure and same amino acid sequence as variation therein. See Ex. 1026 ¶¶ 217–218; Ex. 1038, 264:2–9, 266:13– 267:3). 2.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner
“In the Patent Owner Response, Patent Owner asserts that “[a] POSITA would have understood ‘the nucleotide sequence encoding [ORF1, ORF2 or ORF3]’ to mean ‘a nucleotide sequence having at least 90% sequence homology with SEQ ID NOS. 3, 5, or 7 or encoding a sequence having at least 90% sequence homology with SEQ ID NOS. 4, 6 or 8.’” PO Resp. 24 (citing Ex. 2052 ¶¶ 93–96). In support of that position, Patent Owner refers to the following Specification description: [a] preferred PCV3 ORF2 protein is that of SEQ ID NO. 6, but it is understood by those of skill in the art that this sequence, as well as those for ORF1 and ORF3 could vary by as much as 10% in sequence homology and still retain the antigenic characteristics that render it useful in immunogenic compositions. Patent Owner asserts, according to that Specification description, “the sequences described and identified by SEQ ID Nos. in the patent for PCV3 ORF1, ORF2 and ORF3 are representative sequences, and ‘ORF1,’ ‘ORF2’ and ‘ORF3’ in the patent also refers to those sequences with at least 90% sequence homology.” Id. (citing Ex. 2052 ¶ 95; Ex. 2006, 107:9–17). Further, Patent Owner asserts this interpretation is consistent with the language of the other claims. In particular, Patent Owner refers to the limitation in claim 1 reciting that the composition comprises a PCV3 recombinant protein selected from “ORF1, ORF2 and ORF3, wherein said protein is encoded by a nucleotide sequence having at least 90% sequence homology with a sequence selected from the group consisting of SEQ ID NO. 3, SEQ ID NO. 5, SEQ ID NO. 7.” Id. (quoting Ex. 1001, 71:14–21). Having considered the positions of the parties, and the evidence of record, we agree with Patent Owner that the Specification provides clarity and meaning for the use of the terms ORF1, ORF2, and ORF3, which are not set forth or defined in claim 4, from which claim 5 depends, or in claim 5. Petitioner, in its alternative argument regarding the construction of the phrase involving those terms in claim 5, agrees to some extent. See Pet. 26. For purposes of this Decision, and for the reasons discussed by Patent Owner, we construe the claim phrase “nucleotide sequence encoding ORF1, . . . ORF2, and . . . ORF3” recited in claim 5 as meaning “a nucleotide sequence having at least 90% sequence homology with SEQ ID NOS. 3, 5, or 7 or encoding a sequence having at least 90% sequence homology with SEQ ID NOS. 4, 6 or 8.”” slip op. at 13
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“We do not find that description to be adequate. Essentially, the Specification description that the sequences for PCV3 ORF 1, 2, and 3, could vary by as much as 10% sequence homology just rephrases what is claimed in terms of those sequences having at least 90% sequence homology, adding only that antigenic characteristics are retained that render it useful for immunogenic compositions. A claim, however, “does not become more descriptive by its repetition,” see Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568), and “a definition of a useful result rather than a definition of what achieves that result” does not sufficiently Inc. v. Gen-Probe Inc., 323 F.3d 956, 969 (Fed. Cir. 2002)). As noted by Petitioner and Dr. Nordgren, the ’351 patent discloses nucleotide and amino acid sequences corresponding only to the naturally-occurring PCV3 ORFs 1–3. PO Resp. 52; Ex. 1026 ¶ 168. While those sequences may be characterized as “reference” sequences, as they reflect sequences with 100% homology with PCV3 ORFs 1–3, Patent Owner has not demonstrated that they are “representative” sequences for the broad range of sequences claimed. We find that the Specification does not reasonably convey that the inventor made or was otherwise in possession of any of the remaining members of the genus with at least 90% sequence or amino acid homology with ORFs 1–3. PO Resp. 53; Ex. 1026 ¶ 168. We find that Dr. Nordgren credibly characterizes the Specification, as follows: [T]he ’351 Patent outlines a preliminary research plan to eventually make and use the broad range of claimed proteins. That is, the inventor provides a number of DNA and primer sequences that could be used to clone homologous DNA sequences into an expression vector, and theorizes that proteins expressed from sequences having 90% sequence homology will be antigenic. Critically, however, the ’351 Patent does not disclose which of the thousands of different claimed homologous sequences, if any, the inventor possessed, much less had discovered to be antigenic. Instead, the inventor merely proposes, without any factual support, that PCV3-derived amino acid sequences “could vary by as much as 10% in sequence homology and still retain the[ir] antigenic characteristics.” Ex. 1001 at 8:49-56. A POSITA would not credit that unsupported speculation, and therefore would not believe that the inventors possessed such a wide range of proteins.” slip op. at 33
Patent outcomesUS 10,450,351 unpatentableClaim construction§ 112 disclosurecites GrahamPatents in suitUS 10,450,351
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.