- Nexus Pharmaceuticals, LLC v. Exela Pharma Sciences, LLCInstitution deniedPTAB · Aug 8, 2024 · PGR2024-00016 · APJ Ulrike W Jenks · PGR · Institution
The Board denied institution of PGR on claims 1–30 under § 325(d), finding substantially the same art or arguments had been presented to the Office and no material error was shown.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied
“Under 35 U.S.C. § 324(a), a post-grant review may be instituted only if “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Post-grant review is available for patents that issue from applications that at one point contained at least one claim with an effective filing date on or after March 16, 2013. See Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), §§ 3(n)(1), 6(f)(2)(A). After considering the briefing and the evidence of record, for the reasons set forth below, we exercise discretion to deny institution under § 325(d). Accordingly, we do not institute a post-grant review of the challenged claims of the ’370 patent.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“review, “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.”3 Our § 325(d) analysis employs a two-prong framework: (1) whether the arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential). We consider several non-exclusive factors as set forth in Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 (Dec. 15, 2017) (precedential as to § III.C.5, first paragraph) (“Becton, Dickinson”), which “provide useful insight into how to apply the 3 The Board institutes trial on behalf of the Director. 37 C.F.R. § 42.4(a). framework” under § 325(d). Advanced Bionics, 9. These non-exclusive factors include: (a) the similarities and material differences between the asserted art and the prior art involved during examination; (b) the cumulative nature of the asserted art and the prior art evaluated during examination; (c) the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection; (d) the extent of the overlap between the arguments made during examination and the manner in which Petitioner relies on the prior art or Patent Owner distinguishes the prior art; (e) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art; and (f) the extent to which additional evidence and facts presented in the Petition warrant reconsideration of the prior art or arguments. Becton, Dickinson, 17–18 (formatting added). “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 factors (c), (e), and (f) relate to whether the petitioner has demonstrated a material error by the Office.” Advanced Bionics, 10.” slip op. at 10
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art: would have had an advanced degree like a Ph.D. or equivalent in chemistry, biochemistry, pharmaceutics, pharmacy, or a related pharmaceutical field, with at least two years of experience in pharmaceutical formulation development, analysis, optimization and manufacturing, including experiences with processes and techniques for minimizing impurities in, and improving the stability of, pharmaceutical drug products during manufacture and storage. Pet. 27 (citing Ex. 1003 ¶ 24). Petitioner also states that one of ordinary skill in the art “may also have lesser levels of education but more years of experience” and “[a] multi-disciplinary team consisting of individuals with different skills and experience could also suffice.” Id. Patent Owner argues that: A person of ordinary skill in the art has attained a Pharm. D., or M.S. or Ph.D. in chemistry, chemical engineering, or a related field; has three or more years of experience in developing aqueous drug formulations; and has access to other scientists to collaborate and consult with on, for example, characterizing the drug formulation, manufacture of the drug formulation, and clinical use and effect of the drug formulation.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Because this Decision declining to institute trial does not necessitate the application of any express claim construction, we need not construe any terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only 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 8
Claim constructionDiscretionary denialPatents in suitUS 11,642,370 - 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 - Hugel, Inc. v. Medytox Inc.Institution deniedPTAB · Aug 28, 2023 · IPR2023-00604 · APJ Jo-Anne M Kokoski · IPR · Institution
The Board denied institution: Ground 1 did not show claims 1–9 likely obvious over Jung and Ton; it denied Ground 2 under § 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Petitioner “has the burden from the outset to show with particularity why the patent it challenges is unpatentable.” Harmonic, Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016); see also SAS Inst., Inc. v. Iancu, 138 S.Ct. 1348, 1355 (2018) (“in an inter partes review, the petitioner is the master of its complaint”). A petition for inter partes review must identify how the challenged claims are unpatentable, and must specify where each element of the claim is found in the relied-upon prior art. 37 C.F.R. § 42.104(b); see also 35 U.S.C. § 312(a)(3) (a petition must identify, “with particularity, each claim challenged, the grounds on which the challenge to each claim is based, and the evidence that supports the grounds for the challenge to each claim”). A petition must also include “a detailed explanation of the significance of the evidence including material facts, and the governing laws, rules, and precedent.” 37 C.F.R. § 42.22(a)(2). What is missing from both the Petition and the supporting testimony is an adequate explanation of how or why a POSA would have understood that Jung teaches the isolation of a botulinum toxin type A macro complex in particular, when Jung is silent as to the form of the toxin being produced. In this case, it is not enough to simply cite evidence; an explanation of the significance of that evidence is necessary. Based on our review of the record, we find that there is insufficient explanation and insufficient supporting evidence that Jung teaches isolating a botulinum toxin type A macro complex. Petitioner’s statements, and Dr. Bates’s testimony, that Jung teaches isolating a botulinum toxin, and that botulinum toxins “naturally comprise[] a complex with a variety of non-toxic proteins bound thereto” that can be intermediate, large, or macro in size, are conclusory because they do not explain why the form of toxin ultimately isolated in Jung is a macro complex. Therefore, Petitioner does not sufficiently show that the combination of Jung and Ton discloses “[a] method of isolating a botulinum toxin type A macro complex from a botulinum containing solution” or “separating the botulinum toxin type A macro complex from the cation exchange chromatography medium” as required by claim 1 of the ’598 patent.” slip op. at 13
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” The Board uses a two-part framework for evaluating arguments under § 325(d): (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. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). In applying this framework, we consider the Becton, Dickinson10 factors that address discretion to deny institution when a petition presents the same or substantially the same prior art or arguments previously presented to the Office, including:” slip op. at 17
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“To support a conclusion of obviousness when combining the teachings of multiple references, an articulated reason with some rational underpinning to combine the known elements in the fashion claimed must be provided. See KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007); see also In re Magnum Oil Tools, Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (It is the petitioner’s “burden to demonstrate both that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention[s], and that the skilled artisan would have had a reasonable expectation of success in doing so.” (citation and internal quotation marks omitted)). Here, the Petition lacks an adequate explanation as to why a POSA reading Kim ’741 would have looked to Jung for its teachings regarding anion exchange chromatography, and how a POSA would have combined the teachings of Kim ’741 and Jung in the manner claimed. Because we are not persuaded that Petitioner sufficiently establishes a motivation to combine Kim ’741 and Jung with respect to the anion exchange chromatography limitation of claim 1, we are not persuaded that Petitioner’s alternative assertion of Jung for this limitation warrants reconsideration of the prior art and arguments previously considered by the Office. Accordingly, we find that the Examiner’s failure to consider Jung in combination with Kim ’741 with respect to the anion exchange chromatography limitation of claim 1 is not an error that weighs in favor of institution.” slip op. at 29
- Skill levelSkill level petitioner adoptedDecided for petitioner
“the graduate degree.” Pet. 17 (citing Ex. 1021 ¶ 22). Patent Owner states that, for purposes of its Preliminary Response, it does not challenge Petitioner’s proposed definition of a POSA. Prelim. Resp. 20. For purposes of this Decision, and based on the current record, we adopt the uncontested assessment offered by Petitioner.” slip op. at 6
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 11,331,598 - 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 - Alarm.Com, Inc. v. Vivint, Inc.Institution deniedPTAB · Nov 1, 2022 · IPR2022-00728 · APJ Charles J Boudreau · IPR · Institution
The Board denied institution on all challenged claims under § 325(d), finding substantially the same art had been presented during prosecution and no material Office error was shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“GMBH, IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”), the Board applied a two-part framework in considering whether to exercise discretion to deny institution under § 325(d): “(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.” Advanced Bionics, Paper 6 at 8.” slip op. at 17
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied
“After considering the Petition and associated evidence, we exercise” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Based on our review of the record at this stage, we find that Petitioner’s proposal is consistent with the level of skill reflected in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007) (listing the type of problems encountered in the art, prior art solutions to those problems, and the sophistication of the technology as factors that may be considered in determining the level of ordinary skill in the art). See also 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”). Accordingly, for purposes of this decision and to the extent necessary, we adopt Petitioner’s definition of the person of ordinary skill in the art.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner does not propose constructions for any claim terms. See Pet. 6 (citing 37 C.F.R. § 42.100(b)). On this record, we determine that no terms or phrases in the claims require express construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 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 12
Claim constructionDiscretionary denialPatents in suitUS 9,349,262 - Nespresso USA, Inc. v. K-Fee System GMHBInstitution deniedPTAB · Jan 18, 2022 · IPR2021-01222 · APJ James J Mayberry · IPR · Institution
The Board denied institution under § 325(d), finding substantially the same prior art or arguments had been presented to the Office and no material examiner error was shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“stated in the Petition, standing alone, supports a finding of material examiner error, that argument is not developed adequately and, therefore, is unpersuasive on this record. Pet. 84–85. Petitioner bears the burden of showing that the Office erred, for example, by “misapprehending or overlooking specific teachings of the relevant prior art whose teachings impact patentability of the challenged claims.” Advanced Bionics, Paper 6 at 8. Where “the record of the Office’s previous consideration of the art is not well developed or silent, then a petitioner may show the Office erred by overlooking something persuasive under” Becton, Dickinson factors (e) and (f). Advanced Bionics, Paper 6 at 10. As explained above, when assessing factor (e), we consider whether Petitioner “point[s] out sufficiently how the examiner erred in its evaluation of the asserted prior art.” Supra 8. When assessing factor (f), in turn, we look for some explanation of how or why “the extent to which additional evidence and facts presented in the petition warrant reconsideration of the prior art or arguments.” Id. Petitioner addresses neither of those issues adequately, if at all. Pet. 81–85; Prelim. Reply 5–10. The closest Petitioner comes to addressing those issues is by observing, “the obviousness analysis” in the Petition “is supported by expert testimony, which the Examiner did not have.” Pet. 85. That observation is undeveloped by further analysis and, therefore, is ineffective to show that the Examiner materially erred by failing to discuss the same prior art combinations advanced in the Petition, or that “additional evidence and facts presented in the Petition warrant reconsideration of the prior art” previously presented to the Office. Becton, Dickinson, Paper 8 at 18.” slip op. at 26
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied
“institute review. See also 37 C.F.R. § 42.4(a) (2021) (permitting the Board to institute trial on behalf of the Director). To institute an inter partes review, we must determine that the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least [one] of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). For the reasons set forth below, upon considering the Petition, Preliminary Response, Preliminary Reply, Preliminary Sur-reply, and evidence of record, we exercise discretion under 35 U.S.C. § 325(d) and do not institute an inter partes review.” slip op. at 2
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedDecided for patent owner
“namely, whether the claimed invention is entitled to a priority date of July 22, 2010, based on certain German priority documents, thereby disqualifying Jarisch as prior art under 35 U.S.C. § 102(e). See Pet. 15–18 (discussing priority to the German applications), 22–23 (asserting Jarisch as prior art under § 102(e)), 85 (arguing that the examiner did not consider Jarisch because of an error in priority); Ex. 1002–176, Part 1, 278. Pet. 15–18 (arguing that the challenged claims are not entitled to priority based on the German priority documents), 85 (arguing the examiner applied an incorrect priority date, based on the German priority documents, to antedate Jarisch); Prelim. Resp. 4–6, 16–22; Prelim. Reply 8–10; Prelim. Sur-reply 7–10. Petitioner focuses only on whether the examiner erred in assessing that argument. Pet. 85. Petitioner does not, and cannot, submit that the Office never considered the issue during patent prosecution, at least with respect to applications in the priority chain of the ’177 patent. The Office, in fact, expressly considered whether “Jarisch is not prior art” because the challenged claims are “entitled to a priority date of 22 July 2010” based on the German priority documents. Ex. 1002–176, Part 1, 278 (prosecution history for the grandparent application). The Office also expressly responded to Patent Owner’s argument on that point as follows: “This urging is not deemed persuasive.” Id. This issue represents a second, significant argument previously presented to the Office.” slip op. at 20
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Not reached
“B. Discretionary Denial under 35 U.S.C. § 314(a) Patent Owner also argues that we should exercise our discretion under 35 U.S.C. § 314(a) in light of parallel district court litigation involving the parties and the ’177 patent. Prelim. Resp. 36–44; Prelim. Sur-reply 1–4. Because we exercise our discretion under § 325(d) and deny the Petition, we do not reach this issue.” slip op. at 28
§ 102 anticipationDiscretionary denialPatents in suitUS 10,858,177 - PTAB · Dec 8, 2021 · IPR2021-00608 · APJ Thu A Dang · IPR · Rehearing
The Board denied Samsung’s rehearing request, leaving institution denied under § 325(d) because the same or substantially the same arguments were previously presented and examiner error was not shown.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party requesting rehearing bears the burden of showing that the decision should be modified. 37 C.F.R. § 42.71(d). The party must identify specifically all matters we misapprehended or overlooked, and the place where each matter was previously addressed in its petition. Id. When reconsidering a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be determined if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“Advanced Bionics, we exercised our discretion under 35 U.S.C. § 325(d) and determined not to institute inter partes review. Dec. 7−26 (citing Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte Gmbh, IPR2019- 01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential)). As to Part 1 of the Advanced Bionics framework, we determined that the same or substantially the same arguments were presented previously to the Office. Id. at 10−13. Under Part 2 of the Advanced Bionics framework, we determined that Petitioner failed to show that the Examiner erred by not realizing that Chu ’330 and Chu ’886 qualify as 35 U.S.C. § 102(b) prior art and are material to the patentability of the claims in the ’654 patent. Id. at 14−26.” slip op. at 3
- Strike new argumentNew argument disregardedDecided for patent owner
“Petitioner’s arguments are new arguments raised for the first time in its Rehearing Request. Petitioner acknowledges that “NRG and Hollmer were not cited in the Petition.” Req. Reh’g 10. Nevertheless, Petitioner alleges that it “could not have anticipated the Patent Owner’s mischaracterization of the Droplets decision, nor the Board’s reliance on this mischaracterization,” and that Petitioner was not authorized to file a reply to the Patent Owner Preliminary Response. Id.; see also id. at 2−3, fn.1. Petitioner’s new arguments in connection with Hollmer and NRG are improper. As we discussed above, Patent Owner did not mischaracterize and we did not misapprehend Droplets. It was not necessary to authorize Petitioner to file a reply, as we were capable of determining whether Patent Owner mischaracterizes Droplets. As discussed above, Petitioner fails to recognize that the language relied upon by Patent Owner in Droplets is consistent with 37 C.F.R. § 1.57 and MPEP § 608.01(p). Although Petitioner relies on MPEP § 608.01(p) in its Petition, Petitioner now in its Rehearing Request for the first time suggests that we should ignore MPEP § 608.01(p) and the case law cited in MPEP § 608.01(p). Pet. 11–12; Req. Reh’g 6−7. A request for rehearing is not an opportunity to submit new arguments, after the decision has noted the deficiencies in the petitioner’s original analysis. 37 C.F.R. § 42.71(d). It is Petitioner’s burden to identify specifically all matters we misapprehended or overlooked in our Decision to Institute. We could not have misapprehended or overlooked the new arguments that were not presented in the record until after the Decision.” slip op. at 15
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner
“Contrary to Petitioner’s contentions, section 1.57 of Title 37 of the Code of Federal Regulations is not a “statute,” but a regulation that became effective on September 21, 2004. See 69 Fed. Reg. 56,482. The ’882 application, which incorporated Chu ’886 by reference, was filed on September 8, 1998, and issued as Chu ’330 on February 5, 2002. Ex. 1005, codes (21), (22), (45), (60), 6:1–7. The ’654 patent, which incorporated the ’882 application by reference, is a reissue of Application No. 09/312,199 (“the ’199 application”) filed on May 14, 1999, now U.S. Patent No. 6,634,777 (“the ’777 patent”), issued on November 4, 2003. Ex. 1001, codes (63), (64); 5:63–67. Both the ’882 application (issued as Chu ’330) and the ’199 application (reissued as the ’654 patent) were filed and issued as patents prior to the effective date, September 21, 2004, of 37 C.F.R. § 1.57. Petitioner does not explain why the applicant should have complied with 37 C.F.R. § 1.57, which did not exist at the time of filing of those applications or issuance of those patents that incorporated by reference Chu ’886 and the ’882 application. Pet. 7–8, 10−17; Req. Reh’g 1−12. We decline to apply 37 C.F.R. § 1.57 retroactively to the incorporation by reference statements submitted in the ’882 application and the ’199 application.” slip op. at 6
§ 102 anticipationDiscretionary denial - Intel Corporation v. Acqis LLCInstitution deniedPTAB · Dec 6, 2021 · IPR2021-01108 · APJ Thu A Dang · IPR · Institution
The Board denied institution for claims 1–3, 7–9, 13–17, 19, 20, 25, and 33–35 under § 325(d), finding the same arguments were previously presented and no material examiner error was shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“review], the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” We determine whether to exercise our discretion to deny institution under 35 U.S.C. § 325(d) based on the framework set forth in Advanced Bionics, LLC v. Med-El Elektromedizinische Geräte GMBH, IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) (precedential). In Advanced Bionics, the Board applied a two-part framework in considering whether to exercise discretion to deny institution under § 325(d): “(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 at 8. 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. Id. 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.” Id. at 9.” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied
“review], the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” We determine whether to exercise our discretion to deny institution under 35 U.S.C. § 325(d) based on the framework set forth in Advanced Bionics, LLC v. Med-El Elektromedizinische Geräte GMBH, IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) (precedential). In Advanced Bionics, the Board applied a two-part framework in considering whether to exercise discretion to deny institution under § 325(d): “(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 at 8. 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. Id. 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.” Id. at 9.” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“II. ANALYSIS 35 U.S.C. § 325(d) Petitioner relies upon Chu ’330 in both of the asserted grounds.” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Decided for patent owner
“As such, we find that Petitioner has failed to show (1) the ’768 patent is not entitled to a priority date before April 15, 2011, (2) the ’436 patent’s parent applications in the’768 patent family did not properly incorporate by reference the ’886 provisional, and (3) the amendments adding the subject matter from the ’886 provisional improperly introduced new matter. Pet. 18−30.” slip op. at 23
§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialPatents in suitUS 9,529,768 - PTAB · Dec 6, 2021 · IPR2021-00605 · APJ Thu A Dang · IPR · Rehearing
The Board denied Samsung’s rehearing request, leaving institution denied under § 325(d) because the same or substantially the same arguments were previously presented and material Examiner error was not shown.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party requesting rehearing bears the burden of showing that the decision should be modified. 37 C.F.R. § 42.71(d). The party must identify specifically all matters we misapprehended or overlooked, and the place where each matter was previously addressed in its petition. Id. When reconsidering a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be determined if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“Under Part 2 of the Advanced Bionics framework, Petitioner has the burden to show that “[t]he Examiner erred by not realizing that Chu ’330, Chu ’185, and Chu ’886 qualify as 35 U.S.C. § 102(b) prior art and are material to the patentability of the ’768 Patent claims,” as Petitioner alleges in its § 325(d) analysis. Pet. 7, 9−18. Upon consideration of Petitioner’s Request for Rehearing, we are not persuaded by Petitioner’s arguments of Examiner error.” slip op. at 4
- Strike new argumentNew argument disregardedDecided for patent owner
“Petitioner’s arguments are new arguments raised for the first time in its Rehearing Request. Petitioner acknowledges that “Hollmer and NRG were not cited in the Petition.” Req. Reh’g 10. Nevertheless, Petitioner alleges that it “could not have anticipated the Patent Owner’s mischaracterization of the Droplets decision, nor the Board’s reliance on this mischaracterization,” and that Petitioner was not authorized to file a reply to the Patent Owner Preliminary Response. Id.; see also id. at 2−3, fn.1. Petitioner’s new arguments in connection with Hollmer and NRG are improper. As we discussed above, Patent Owner did not mischaracterize and we did not misapprehend Droplets. It was not necessary to authorize Petitioner to file a reply, as we were capable of determining whether Patent Owner mischaracterizes Droplets. As discussed above, Petitioner fails to recognize that the language relied upon by Patent Owner in Droplets is consistent with 37 C.F.R. § 1.57 and MPEP § 608.01(p). Although Petitioner relies on MPEP § 608.01(p) in its Petition, Petitioner now in its Rehearing Request for the first time suggests that we should ignore MPEP § 608.01(p) and the case law cited in MPEP § 608.01(p). Pet. 11; Req. Reh’g 6−7. A request for rehearing is not an opportunity to submit new arguments, after the decision has noted the deficiencies in the petitioner’s original analysis. 37 C.F.R. § 42.71(d). It is Petitioner’s burden to identify specifically all matters we misapprehended or overlooked in our Decision to Institute. We could not have misapprehended or overlooked the new arguments that were not presented in the record until after the Decision.” slip op. at 15
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner
“codes (21), (22), (45), (60), 6:1–7. The initial parent application in the ’768 patent’s priority chain, U.S. Application No. 09/569,758 (“the ’758 application”), which incorporated the ’882 application by reference, was filed on May 12, 2000, and issued as U.S. Patent No. 6,718,415 B1 (“the ’415 patent”) on April 6, 2004. See Ex. 1001, code (63); Ex. 1008, code (45), 4:50–53. Both the ’882 application (issued as Chu ’330) and the ’758 application (issued as the ’415 patent) were filed and issued as patents prior to the effective date, September 21, 2004, of 37 C.F.R. § 1.57. Petitioner does not explain why the applicant should have complied with 37 C.F.R. § 1.57, which did not exist at the time of filing of those applications or issuance of those patents that incorporated by reference Chu ’886 and the ’882. Pet. 7, 9−18; Req. Reh’g 1−13. We decline to apply 37 C.F.R. § 1.57 retroactively to the incorporation by reference statements submitted in the ’882 application and the ’758 application.” slip op. at 7
§ 102 anticipationDiscretionary denialPatents in suitUS 9,529,768
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.