- Advance Medical Designs, Inc. v. Corbin Clinical Resources, LLCInstitution deniedPTAB · Jan 23, 2024 · PGR2023-00041 · APJ Jamie T Wisz · PGR · Institution
The Board denied institution of PGR on claims 1, 4–6, 11–13, 16–18, 23, 24, 28, and 29 under § 325(d), finding substantially the same art was previously presented and no material Office error was shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Section 325(d), the Board uses the following two-part framework: (1) determining 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, determining whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, Paper 6 at 8.” slip op. at 20
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“are defined by the claims themselves. For example, claim 1 recites “coupling the access needle to one of the plurality of needle receiving ports of the displacement member of the transperineal biopsy guide such that a position and angle of the access needle relative to the displacement member is retained.” Ex. 1001, 36:1–5 (emphasis added). Similarly, claim 13 recites “securing the access needle to the displacement member such that a position and angle of the access needle relative to the displacement member is maintained.” Id. at 36:59–61 (emphasis added).” slip op. at 13
- Expert testimonyPetitioner expert discountedDecided for patent owner
“Further, although Petitioner contends that BK Medical’s needle guide “maintains and stabilizes” the needle position, they provide no explanation as to how it does so and do not appear to account for forces that would move the position of the needle during insertion. Petitioner cites to testimony from their declarant, Dr. Yun, to provide support for this argument; however, Dr. Yun’s testimony is essentially a verbatim repetition of Petitioner’s argument without a discussion of how BK Medical’s needle guide provides such stability. Compare Pet. 59–60 with Ex. 1003 ¶ 107. Thus, we accord little weight to Dr. Yun’s testimony on this topic. 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”); see also Xerox Corp. et al., v. Bytemark, IPR2022-00624, Paper No. 9 at 15 (PTAB Aug. 24, 2022) (precedential) (“Conclusory expert testimony “is particularly problematic in cases where, like here, expert testimony is offered not simply to provide a motivation to combine prior-art teachings, but rather to supply a limitation missing from the prior art.”).” slip op. at 31
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Not reached
“V. 35 U.S.C. § 324(a) Patent Owner also contends that the Board should discretionarily deny institution of the post-grant review under 35 U.S.C. § 314(a) in view of the co-pending Maryland District Court litigation, pursuant to Fintiv. Prelim. Resp. 21–32; see Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB 20 Although we do not specifically discuss the “securing” limitation of claims 13 and 24, the same analysis would apply. 21 We also do not find the testimony of Dr. Záťura or Ex. 1009 to be relevant to the question of whether the Examiner materially erred in finding that the prior art does not teach the “coupling” limitation. Mar. 20, 2020) (precedential). Because we deny the petition under 35 U.S.C. § 325(d), this argument is moot. Further, we note that Petitioner has filed a stipulation under Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 at 19 (PTAB Dec. 1, 2020) (precedential as to § II.A). Pet. 112. Our analysis under Fintiv is guided by the USPTO Director’s Memorandum issued on June 21, 2022, titled “Interim Procedure for Discretionary Denials in AIA Post Grant Proceedings with Parallel District Court Litigation” (“Director’s Memorandum”).22 Pursuant to the Director’s Memorandum, we “will not discretionarily deny institution of an IPR or PGR in view of parallel district court litigation where 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.” Director’s Memorandum, 7.” slip op. at 38
Claim constructionDiscretionary denialPatents in suitUS 11,547,436 - Padagis Israel Pharmaceuticals Limited / Padagis US LLC et al. v. Bausch Health Ireland LimitedInstitution deniedPTAB · Jan 12, 2024 · IPR2023-01114 · APJ Michael A Valek · IPR · Institution
The Board denied institution of IPR challenging claims 1–11 because substantially the same art and arguments were previously considered, and Petitioner did not show material error.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“factors. In the first part, we consider factors (a), (b), and (d) to determine whether the art or 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 advance 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. Advanced Bionics instructs that “[i]f 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.” Id. at 9.” slip op. at 12
Discretionary denialPatents in suitUS 11,311,482 - Parse Biosciences, Inc. v. 10x Genomics, Inc.Institution deniedPTAB · Dec 19, 2023 · IPR2023-01033 · APJ Sheridan K Snedden · IPR · Institution
The Board denied institution of IPR challenging claims 1–30, finding substantially the same art had been presented to the Office and no material error was shown under § 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“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 [the] 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. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6, 8 (PTAB Feb. 13, 2020) (precedential). The Becton, Dickinson factors provide useful insight into how to apply the framework under 35 U.S.C. § 325(d). Id. at 9 (referencing Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8, 17– 18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first paragraph)).” slip op. at 12
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Not reached
“presented to the Office, and (2) Petitioner has not demonstrated that the Office erred. We therefore conclude that it is appropriate to exercise discretion under 35 U.S.C. § 325(d) to deny the Petition. III. CONCLUSION For the foregoing reasons, we exercise discretion under 35 U.S.C. § 325(d) to deny institution of an inter partes review. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied, and no trial is instituted.” slip op. at 21
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“enzyme complex” and “nucleic acid insert element.” Pet. 21. Patent Owner, for its part, states that “[n]o terms require construction for considering institution.” Prelim. Resp. 18. We determine that neither of the two limitations identified by Petitioner requires an express construction for purposes of this Decision. It bears mentioning, however, that the ’357 patent states that “[t]he insertional enzyme can be a transposase.” Ex. 1001, 3:47–48. There is no dispute that Grunenwald discloses the use of a transposase and, thus, an insertional enzyme complex. See Pet. 16 (citing Ex. 1003 ¶¶ 17, 93–94, 162); Prelim. Resp. 13 (“Grunenwald further defines ‘transposase’ to mean ‘an enzyme that is capable of forming a functional complex . . . and catalyzing insertion or transposition of the transposon end-containing composition into the double-stranded target DNA with which it is incubated in an in vitro transposition reaction.” (citing Ex. 1003 ¶ 93)).” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner
“express construction of the term “chromatin.” The ’357 patent itself provides a definition, stating: The term “chromatin,” as used herein, refers to a complex of molecules including proteins and polynucleotides (e.g. DNA, RNA), as found in a nucleus of a eukaryotic cell. Chromatin is composed in part of histone proteins that form nucleosomes, genomic DNA, and other DNA binding proteins (e.g., transcription factors) that are generally bound to the genomic DNA. Ex. 1001, 12:61–67. This is the meaning that we apply in this Decision.” slip op. at 6
Claim constructionDiscretionary denialPatents in suitUS 10,738,357 - Risen (Suzhou) Pharma Tech. Co. Ltd. v. Alzheon, Inc.Institution deniedPTAB · Jan 13, 2023 · PGR2022-00051 · APJ Jamie T Wisz · PGR · Institution
The Board denied institution on all challenged claims, finding no reasonable likelihood of unpatentability under §§ 101 and 112(a), and denying Grounds 4–6 under § 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“unless . . . the information presented in the petition . . . , if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon considering the arguments and evidence, we determine that the information presented fails to demonstrate it is more likely than not that at least one of the challenged claims of the ’742 patent is unpatentable for ineligibility, lack of written description, or non-enablement. We also exercise our discretion to deny institution of post-grant review under 35 U.S.C. § 325(d). slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“tramiprosate “showed a significant overall treatment effect” in “an APOE4+ sub-group,” including APOE4 homozygotes; “therapeutic interventions applied earlier in the course of AD more likely might achieve the goal of disease modification;” and that “AD would be optimally treated before significant cognitive impairment, during its pre-symptomatic or pre-clinical stages …”) (emphases removed). Accordingly, Caltagirone was previously presented to the Office and we also find that Caltagirone’s disclosures are substantially similar to, or cumulative of, other references previously considered by the Examiner.” slip op. at 49
- Adverse judgmentAdverse judgmentOther
“D. Statutory Disclaimer After the filing of the Petition in this proceeding, Patent Owner filed a statutory disclaimer, disclaiming claims 9 and 11–15 of the ’742 patent, effective October 7, 2022. Prelim. Resp. 12; Ex. 2001, 1. “No post-grant review will be instituted based on disclaimed claims.” 37 C.F.R. § 42.207(e). We do not analyze the validity of claims 9 and 11–15 based on Petitioner’s challenges (e.g., Grounds 2 and 3) because these claims have been statutorily disclaimed.” slip op. at 5
- Skill levelSkill level petitioner adoptedDecided for petitioner
“at least an M.D. or Ph.D. degree in a biomedical science or equivalent field. They would also have several years of clinical experience treating and/or conducting clinical trials of drugs for AD patients, or professional experience working in clinical trial design and execution related to drugs for AD or supervising such work. Pet. 14–15 (citing Ex. 1003 ¶ 62) (internal citation omitted). Patent Owner does not contest the characterization offered by Petitioner. Prelim. Resp. 12–13. For purposes of this Decision, we adopt Petitioner’s characterization as it is consistent with the level of skill in the art at the time of the invention as reflected by the ’742 patent and the cited prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 9
Claim construction§ 101 eligibility§ 112 disclosureDiscretionary denialcites Alice · Mayo · GrahamPatents in suitUS 11,191,742 - Risen (Suzhou) Pharma Tech. Co. Ltd. v. Alzheon, Inc.Institution deniedPTAB · Jan 9, 2023 · IPR2022-01200 · APJ Devon Zastrow Newman · IPR · Institution
The Board denied institution for claims 1–14 under § 325(d), finding the petition relied on substantially the same art and arguments previously presented and did not show material examiner error.
RulingsInstitution decision- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer foundDecided for patent owner
“ApoE4+ patient with AD using tramiprosate over the Caltagirone reference, which disclosed treatment of ApoE4+ “all-comers” (containing at least one ApoE4 allele, either heterozygous or homozygous) with tramiprosate. See, e.g., Ex. 1002, 204–208. When Patent Owner responded to the Examiner by highlighting data (i.e., Figure 8 of the specification giving rise to the ’029 patent) showing a notable increase in cognitive function in patients with two ApoE4 alleles (homozygous) who were administered tramiprosate as compared to the ApoE4 “all-comers” (mixed homozygous/heterozygous population), the Examiner suggested narrowing the pending claims to treatment of ApoE4 homozygotes. Ex. 1002, 342. Patent Owner submitted amended claims requiring selection of patients for treatment who were homozygous for ApoE4, and argued: The presently amended claims . . . select only ApoE4 homozygotes for treatment with tramiprosate or a prodrug thereof, necessarily omitting ApoE4 heterozygotes from such treatment. . . . Caltagirone fails to teach or suggest a patient selection strategy that would limit tramiprosate treatment to patients having two ApoE4 alleles and, in fact, teaches away from such selection. Kong fails to contradict or overcome these deficiencies in Caltagirone. Kong does not refer to any patient selection strategy, much less one that would limit tramiprosate prodrug treatment to ApoE4 homozygotes. The Office's reliance on Kong is solely for its teaching of a tramiprosate prodrug. Thus, the combination of Caltagirone and Kong, taken under the Office’s interpretation, suggests treatment of all ApoE4+ patients with a prodrug of tramiprosate. This falls far short of suggesting the presently claimed patient selection and treatment strategy which selects only ApoE4 homozygotes for treatment and does not treat ApoE4 heterozygotes. Id. at 338–39 (emphasis added). The Examiner acknowledged the” slip op. at 16
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art (“skilled artisan”) at the time of the invention would have had at least an M.D. or Ph.D. degree in a biomedical science or equivalent field. They would also have several years of clinical experience treating and/or conducting clinical trials of drugs for AD patients, or professional experience working in clinical trial design and execution related to drugs for AD or supervising such work. Pet. 19 (citing Ex. 1003 ¶¶ 52–53). Patent Owner does not contest the characterization offered by Petitioner. Prelim. Resp. 14–15. For purposes of this Decision, we adopt Petitioner’s characterization as it is consistent with the level of skill in the art at the time of the invention as reflected by the ’029 patent and the cited prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 12
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“whether the art or arguments presented in the Petition are the same or substantially the same as those previously presented to the Office (Advanced Bionics, Paper 6 at 10). Factors (c), (e), and (f) “relate to whether the petitioner has demonstrated a material error by the Office” in its prior consideration of that art or arguments (Advanced Bionics, Paper 6 at 10). 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 a material error by the Office (Advanced Bionics, Paper 6 at 10). “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown” (Advanced Bionics, Paper 6 at 9).” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot reached
“Babic ascertained that “different effects of a drug could be observed in different subpopulations of patients based on ApoE4 carrier status”” and that “drug effects in homozygous carriers could be greater than those in the heterozygous carriers and non-carriers who did not respond to the drug.” Ex. 1003 ¶ 107. As stated, this testimony does not support Petitioner’s contention that an ordinary artisan would have been motivated “to select homozygous ApoE4 carriers for treatment with any drug for which response has been correlated to ApoE4 carrier status.” See Pet. 41 (emphasis added). In particular, we find an insufficient factual basis for Petitioner’s contention that results obtained for galantamine, an acetylcholinesterase inhibitor (Ex. 1003 ¶ 105) would have motivated an ordinary artisan to replace the galantamine taught in Babic with tramiprosate (homotaurine), a GABA receptor agonist that works by a different mechanism (Ex. 1007, 582). We have also considered Dr. Ruffalo’s testimony that the ordinary artisan would have been motivated to replace Babic’s galantamine with tramiprosate as taught in Caltagirone or Val-APS as taught in Kong. Ex. 1003 ¶¶ 276–277. Dr. Ruffalo posits that Babic’s disclosures would have motivated the ordinary artisan to analyze Caltagirone’s data to ascertain if tramiprosate is more effective in homozygotes, and to replace galantamine with tramiprosate or Val-APS as taught in Kong because of their improved safety profiles as compared to galantamine, and because the replacement drugs target the underlying disease and not symptom amelioration as does galantamine. Id. Dr. Ruffalo also posits that the prior art would have imparted the following knowledge to the ordinary artisan: because the effect of tramiprosate was dependent on the required ApoE4 allele, homozygotes having the highest number of ApoE4 allele copies would derive, at the very least, as much benefit as from the drug as the heterozygotes having only one copy of the allele, and most likely the homozygotes would have the greatest therapeutic response to tramiprosate since they have the maximum number of copies of the required allele. Having done this simple assessment, A POSA would conclude that tramiprosate would be expected to exhibit a greater therapeutic effect in homozygotes and thus would have been motivated to treat homozygotes with tramiprosate, including in an oral dosage form as taught by Aisen. Id. Dr. Ruffalo further posits that the skilled artisan would have had a reasonable expectation of success in administering tramiprosate to treat homozygous ApoE4 patients because they “would almost certainly have the greatest response to the drug.” Id. ¶ 286. Patent Owner argues that the Examiner previously examined the issue of whether ApoE4 genotypes in treatment decisions should be considered during prosecution, with respect to Caltagirone, where ApoE4 genotypes were included, and Sleegers (Ex. 1002, 685, 1137), where studies led away from such inclusion. Prelim. Resp. 30–31. We find Sleegers’ disclosure” slip op. at 29
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 10,471,029 - Eyenovia, Inc. v. Sydnexis.Institution deniedPTAB · Nov 8, 2022 · IPR2022-00963 · APJ Susan L C Mitchell · IPR · Institution
The Board denied institution of IPR on claims 1–27 under § 325(d), finding substantially the same art and arguments had been presented to the Office and no material error was shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“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 advance 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. Advanced Bionics instructs that “[i]f 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.” Id. at 9–10.” slip op. at 10
Discretionary denialPatents in suitUS 9,421,199 - Eyenovia, Inc. v. Sydnexis.Institution deniedPTAB · Nov 7, 2022 · IPR2022-00965 · APJ Michael A Valek · IPR · Institution
The Board denied institution on claims 1–20 under § 325(d), finding substantially the same art and arguments had been considered during prosecution and no material Office error was shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“For these reasons, we determine that both the art and the arguments presented in the Petition are substantially the same as those previously presented to the Examiner.” slip op. at 21
Discretionary denialPatents in suitUS 10,076,515 - Eyenovia, Inc. v. Sydnexis.Institution deniedPTAB · Nov 7, 2022 · IPR2022-00964 · APJ Michael A Valek · IPR · Institution
The Board denied institution of inter partes review of claims 1–19 under § 325(d), finding the art and arguments substantially similar to those previously presented and no material Office error.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“We again determine that Patent Owner has the better position. As explained above, the Examiner considered substantially the same art during prosecution. Although there was no rejection issued over the particular references cited in the Petition, those references were either before the Examiner (Siegel) or are cumulative of references (Chua & Tan and Lund) before the Examiner. There is no evidence that suggests the Examiner overlooked the most pertinent teachings in the art presented during prosecution. Indeed, the Teva rejection presented substantially the same arguments as the grounds in the Petition, including Patent Owner’s argument that there was “insufficient rationale to combine Teva and other references to produce a D2O-based formulation in which atropine is the monotherapeutic agent because atropine and its derivatives are specifically recognized as stable in ordinary water.” Ex. 2003, 69, 87–88. The Examiner credited this argument by withdrawing the Teva rejection and allowing the ’447 patent. Thus, we do not agree with Petitioner’s argument that the Examiner failed to consider whether it would have been “obvious to improve low-concentration atropine with D2O as a monotherapy for treating myopia.” See Pet. 63.” slip op. at 22
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied
“D. Conclusion Based on the foregoing, we determine that the circumstances of this case warrant the exercise of discretion under 35 U.S.C. § 325(d) and therefore deny institution. ORDER After due consideration of the record before us, and for the foregoing reasons, it is: ORDERED that the Petition is denied, and no inter partes review is instituted.” slip op. at 25
Discretionary denialPatents in suitUS 9,770,447 - Eyenovia, Inc. v. Sydnexis.Institution deniedPTAB · Nov 7, 2022 · IPR2022-00966 · APJ Jamie T Wisz · IPR · Institution
The Board denied institution of inter partes review of claims 1–13, 15–27, and 29–30 under § 325(d), finding substantially the same art and arguments had been presented to the Office and no material error shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“For these reasons, we determine that both the art and the arguments presented in the Petition are substantially the same as those previously presented to the Examiner.” slip op. at 20
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied
“D. Conclusion Based on the foregoing, we determine that the circumstances of this case warrant the exercise of discretion under 35 U.S.C. § 325(d) and therefore deny institution. ORDER After due consideration of the record before us, and for the foregoing reasons, it is: ORDERED that the Petition is denied, and no inter partes review is instituted.” slip op. at 26
Discretionary denialPatents in suitUS 10,201,534 - 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
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.