- PTAB · Nov 19, 2025 · IPR2025-00947 · APJ Christopher G Paulraj · IPR · Institution
The Board instituted review of all challenged claims and grounds, finding a reasonable likelihood that claim 1 would have been obvious over Herrstedt and Bös.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denialDenied
“II. DISCUSSION A. Discretionary Denial Patent Owner filed a request for discretionary denial of institution. Paper 8. Petitioner opposed. Paper 9. The Acting Director denied the discretionary denial request. Paper 12 (September 19, 2025). Accordingly, we proceed with our analysis of the merits of Petitioner’s patentability” slip op. at 8
- Skill levelOther
“At this stage, we need not resolve the parties’ dispute with regard to the requisite level of skill in the art, as our analysis would be the same under either party’s definition of a POSA. We note, however, that Petitioner’s definition seems to be overly broad insofar as it would only require the POSA to be skilled in one of several broad fields, including “statistics” and “medical policy and decision making,” that do not directly relate to the claimed subject matter. At the same time, we do not agree with Patent Owner that the POSA needs specific clinical experience in the field of oncology. The claimed subject matter relates to the treatment of a side-effect associated with cancer therapy (CINV), and not the cancer itself. We also recognize that the prior art and the ’357 patent itself reflect the level of skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he absence of specific findings on the level of skill in the art does not give rise to reversible error where the prior art itself reflects an appropriate level and a need for testimony is not shown.”).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2019). This standard requires that we construe claims “in accordance with the ordinary and customary meaning of such claim[s] as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Petitioner contends no terms need to be construed to find the claims unpatentable in view of the prior art. Pet. 9. Patent Owner also contends that no claim construction is necessary to resolve the parties’ disputes. Prelim Resp. 14. At this stage, we do not perceive a need to construe expressly any claim terms of the ’357 patent for purposes of determining whether to institute trial.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Herrstedt taught the use of aprepitant as an NK1 receptor antagonist that could be combined with dexamethasone and palonosetron to treat emesis. Nonetheless, based on Bös’s identification of netupitant (compound Ib) as a “potent and selective” NK1 antagonist with “valuable therapeutic properties,” the present record supports Petitioner’s argument that the POSA would have been motivated to replace aprepitant with netupitant in the combination therapy. Ex, 1014, 14:31–34. Bös indicates that the compounds disclosed therein have utility in the treatment of emesis, and that neutpitant in particular “is a potent antagonist of NK1 induced behaviors in Gerbil and blocks emesis in Ferrets and suncus murinus with similar potency.” Id. at 19:26–30. Bös further indicates that netupitant has a high affinity for the NK1 receptor and a prolonged half-life. Id. at 18:44–48, 19:31–38. In view of these properties, we find a POSA would have had good reason to consider netupitant as a potential replacement for aprepitant in the treatment of CINV.” slip op. at 28
Claim construction§ 103 obviousnessDiscretionary denialcites KSRPatents in suitUS 9,186,357 - Mim Software Inc. v. Progenics Pharmaceuticals, Inc.Institution deniedPTAB · Oct 10, 2025 · IPR2025-00726 · APJ Annette R Reimers · IPR · Institution
The Board denied institution because the Petition did not adequately explain which of its three alternative constructions of “risk indices” applied to the asserted grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2024). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon consideration of the Petition and the evidence of record, we determine that Petitioner has not demonstrated a reasonable likelihood of success in proving that at least 1 claim of the ’141 patent is unpatentable. 1” slip op. at 2
- BurdenDenied
“risk index” differ in several “particular details,” but those details matter and can make a difference in our patentability analysis, especially given Petitioner’s acknowledgment that there is no well-established ordinary and customary meaning for the term. In taking this “choose-your-own-adventure” approach to claim construction, Petitioner fails to satisfy the requirements of 37 C.F.R. § 42.104(b)(3)–(4), which specify the content of the petition. In particular, Rule 42.104(b)(3) requires the petition to identify “[h]ow the challenged claim is to be construed,” while Rule 42.104(b)(4) requires the petition to identify “[h]ow the construed claim is unpatentable” under either 35 U.S.C. § 102 or § 103. Moreover, by proposing these “choose-your-own-adventure” constructions, Petitioner obfuscates which circumstances each proposed construction should be applied. The Board does not find that alternative claim constructions are per se improper. Nonetheless, there must be reasoning to explain the circumstances under which each alternative construction should be applied. For example, Petitioner may assert one construction on the basis that a claim term should be construed as a means-plus-function term under 35 U.S.C. § 112(f), but also propose an alternative construction to be applied if the term is not found to be a means-plus-function term. However, Petitioner does not provide any rationale here for including three alternative constructions. Rather, Petitioner indicates there is no well-established ordinary and customary meaning for the term(s), and incorrectly contends that the three alternative constructions are not significantly different without explaining why three different constructions are being proposed or under what circumstances one construction should be applied over the other two constructions. slip op. at 7
Discretionary denialPatents in suitUS 11,894,141 - Mim Software Inc. v. Progenics Pharmaceuticals, Inc.Institution deniedPTAB · Oct 8, 2025 · IPR2025-00725 · APJ Christopher G Paulraj · IPR · Institution
The Board denied institution because the Petition failed to explain how the challenged claims should be construed or how the prior art rendered them unpatentable under the proposed constructions.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied
“III.CONCLUSION For the foregoing reasons, we determine that the Petition fails to satisfy the requirement of 37 C.F.R. § 42.104(b) to set forth how the challenged claims are to be construed. Accordingly, we decline to institute an inter partes review. IV.ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 314, the Petition for an inter partes review is denied and no inter partes review is instituted.” slip op. at 10
- BurdenDenied
“particular details,” but those details matter and can make a difference in our patentability analysis, especially given Petitioner’s acknowledgment that there is no well-established ordinary and customary meaning for the term. In taking this “choose-your-own-adventure” approach to claim construction, Petitioner fails to satisfy the requirements of 37 C.F.R. § 42.104(b)(3)–(4), which specify the content of the petition. In particular, Rule 42.104(b)(3) requires the petition to identify “[h]ow the challenged claim is to be construed,” while Rule 42.104(b)(4) requires the petition to identify “[h]ow the construed claim is unpatentable” under either 35 U.S.C. § 102 or § 103. Moreover, by proposing these “choose-your-own-adventure” constructions, Petitioner obfuscates which claim construction the Board is being asked to apply, and under what circumstances each proposed construction should be applied. To be sure, we do not find that alternative claim constructions are per se improper. Nonetheless, there must be reasoning to explain the circumstances under which each alternative construction should be applied or an explanation of how the prior art renders the claims unpatentable under alternative constructions. For instance, Petitioner may assert one construction on the basis that a claim term should be construed as a meansplus-function term under 35 U.S.C. § 112(f), but also propose an alternative construction to be applied if the term is not found to be a means-plus- any rationale here for including three alternative constructions. Instead, Petitioner indicates there is no well-established ordinary and customary meaning for the term, and incorrectly contends that the three alternative constructions are not significantly different without explaining why three different constructions are being proposed or under what circumstances one construction should be applied over the other two constructions. slip op. at 7
Discretionary denialPatents in suitUS 11,424,035 - Mim Software Inc. v. Progenics Pharmaceuticals, Inc.Institution deniedPTAB · Oct 8, 2025 · IPR2025-00630 · APJ Christopher G Paulraj · IPR · Institution
The Board denied institution because the Petition failed to explain which of three alternative constructions of “risk map” applied or how the prior art met the claims under those constructions.
RulingsInstitution decision- BurdenDenied
“particular details,” but those details matter and can make a difference in our patentability analysis, especially given that Petitioner acknowledges there is no well-established ordinary and customary meaning for the term. In taking this “choose-your-own-adventure” approach to claim construction, Petitioner fails to satisfy the requirements of 37 C.F.R. § 42.104(b)(3)–(4), which specify the content of the petition. In particular, Rule 42.104(b)(3) requires the petition to identify “[h]ow the challenged claim is to be construed,” while Rule 42.104(b)(4) requires the petition to identify “[h]ow the construed claim is unpatentable” under either 35 U.S.C. § 102 or § 103. Moreover, by proposing these “choose-your-own-adventure” constructions, Petitioner obfuscates which claim construction the Board is being asked to apply, and under what circumstances each proposed construction should be applied. To be sure, we do not find that alternative claim constructions are per se improper. Nonetheless, there must be reasoning to explain the circumstances under which each alternative construction should be applied or an explanation of how the prior art renders the claims unpatentable under alternative constructions. For instance, Petitioner may assert one construction on the basis that a claim term should be construed as a means- construction assuming the term is not found to be a means-plus-function term. Unlike this example, however, Petitioner does not provide any rationale here for including three alternative constructions. Instead, Petitioner indicates there is no well-established ordinary and customary meaning for the term, and summarily contends that the three alternative constructions are not significantly different without explaining why three different constructions are being proposed or under what circumstances one construction should be applied over the other two constructions. slip op. at 7
Discretionary denialPatents in suitUS 10,665,346 - Restem, LLC. v. Jadi Cell, LLCNo claims unpatentablePTAB · Apr 18, 2023 · IPR2021-01535 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–15 were not proven unpatentable: Majore did not anticipate claims 1–13 and 15, and the asserted obviousness combinations did not establish the claimed limitations.
RulingsFinal written decision- Expert testimonyPetitioner expert discountedDecided for patent owner
“Ex. 1007 ¶¶ 132, 133. Importantly, however, Dr. Olson does not cite anything to support his opinion that the ordinary artisan would have known that MSCs could be cultured to be renewable from subepithelial UC tissue. Nor does Dr. Olson explain why the artisan would have had this understanding aside from simply stating it. Majore uses the word “subepithelial” only once to explain that primitive stem cells are “distributed in subepithelial and intervascular regions,” but this does not teach what Dr. Olson asserts. Accordingly, Dr. Olson’s testimony is entitled to little weight. Xerox Corp., IPR2022-00624, Paper 9 at 15–16 (finding that an expert’s conclusory assertions that repeat the proposition for which they are offered without “any additional supporting evidence or provide any technical reasoning” in support are “conclusory and unsupported, add[] little to the conclusory assertion[s] for which [they are] offered to support, and is” slip op. at 52
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“21 The parties do not dispute that the preamble’s recitation of “isolated cell” serves as a limitation to claim 1 as it provides antecedent basis for its recitation later in the body of the claim. Accordingly, we treat the preamble as limiting. “When limitations in the body of the claim rely upon and derive antecedent basis from the preamble, then the preamble may act as a necessary component of the claimed invention.” See Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003).” slip op. at 31
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“[JUDGE NEWMAN:] So if -- if the comparison is possible, why did you not present evidence of that comparison? MR. FITZPATRICK: We --we’ve had the -- we had this discussion with our -- with our expert, and our conclusion was that it’s just not -- it wasn’t necessary. The conclusion was that the -- the evidence that’s in the -- in the prior art references, including the fact that it clearly practices the exact same steps as the claims, that was sufficient to -- and would anticipate or render obvious the claims. That’s the only reason we didn’t present evidence -- our own evidence.” slip op. at 38
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Ex. 1007 ¶ 168 (alteration in original). We agree that an ordinary artisan would be motivated to look to the teachings of analogous references for information, but to establish obviousness, a party must show that “there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness”)). Petitioner has not provided sufficient rationale to explain why the ordinary artisan would have been motivated to make the isolated cell with the specific marker profile or why the artisan would have looked to the cited references themselves out of the wide range of references available in the art.” slip op. at 64
Patent outcomesUS 9,803,176 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,803,176 - PTAB · Jun 16, 2022 · PGR2022-00014 · APJ Christopher G Paulraj · PGR · Institution
The Board instituted PGR on claim 13, finding it more likely than not unpatentable as obvious over Silvestre or over Du, Choi, and Zitvogel.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute a post-grant review, we must determine whether 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.” 35 U.S.C. § 324(a). Upon consideration of the Petition and the Preliminary Response, for the reasons set forth below, we determine that the evidence and arguments presented in the Petition are sufficient to satisfy the “more likely than not” standard regarding the asserted unpatentability of claim 13 in the ’513 patent. Therefore, we authorize a post-grant review to be instituted as to claim 13.” slip op. at 3
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“1. Legal Framework Pursuant to 35 U.S.C. § 325(d), in determining whether to institute an post-grant 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.” The Board evaluates two issues in addressing 35 U.S.C. § 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, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). With respect to the first issue, previously “presented” art includes, among other things, “art provided to the Office by an applicant, such as on an Information Disclosure Statement (IDS), in the prosecution history of the challenged patent.” Id. at 7–8. With respect to the second issue, institution generally will be denied if a “petitioner fails to make a showing of material error,” and “[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 8–9. “[T]his 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 21
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner proposes that a person of ordinary skill in the art (“POSA”) “would have had a Ph.D. in molecular biology, or a related field, with expertise in virology (including expertise growing, isolating, and rescuing viruses), immunology, and cancer biology with at least four years of post- Ph.D. experience in those areas.” Pet. 6 (citing Ex. 1007 ¶¶ 35, 96). Patent Owner does not argue otherwise. See Prelim. Resp. 16–17. At this stage of the proceeding and for purposes of our analysis in this Decision, we adopt Petitioner’s uncontested definition as that definition is consistent with the level of skill in the art reflected by the 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))). It is from the perspective of such a person of ordinary skill that we consider the claims and prior art.” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Based on the present record, we find that Petitioner has shown that it is more likely than not that inserting the GM-CSF gene and the CTLA-4 inhibitor encoding gene in a back-to-back orientation in relation to each other would have been known to a person of ordinary skill in the art. Petitioner’s expert Dr. Bell states that “[w]hen inserting two genes into a given locus, the simplest and most common way to do so is to insert them in a back-to-back orientation under control of separate regulatory elements.” Ex. 1007 ¶ 230. While Patent Owner is correct in stating that no sources are cited in paragraph 230, Dr. Bell does cite back to paragraphs 73–81 and 87– 88 of his own declaration. See id. In those paragraphs, Dr. Bell explains that the “deletion of endogenous nucleotides requires either pre-existing knowledge of the effect of disrupting the particular gene at the insertion site or requires a difficult and time-consuming trial-and-error process to gain such knowledge.” Id. ¶ 73 (citing Ex. 1035). Exhibit 1035 is a review article entitled “Unconventional viral gene expression mechanisms as therapeutic targets.” See Ex. 1035. Dr. Bell points to Figure 1 of this article as showing that certain viral genomes include genes that are overlapping and/or that encode polyproteins, which can add to a further level of difficulty in identifying a suitable insertion locus. Ex. 1007 ¶ 74 (citing Ex. 1035, 364, Fig. 1). Dr. Bell further explains that “inactivation of the neurovirulence factor ICP34.5 in HSV1 has been well-known to direct tumor-specific cell lysis, making HSV1 ICP34.5 knock-outs useful oncolytic virus vectors,” but also notes that “unless such a well-known insertion site is used, determining whether insertion of a heterologous gene at any particular site will be successful requires a difficult and time-consuming trial-and-error process.” Id. ¶ 77 (citing Ex. 1039, 292, Ex. 1040, 4–7, Ex. 1041, 575). Accordingly, within paragraphs 73–81 and 87–88, Dr. Bell provides evidentiary support for his conclusions in paragraph 230. See Ex. 1007 ¶¶ 73-81, 87-88. We are not persuaded by Patent Owner’s reliance upon the Arendi case to argue that Petitioner improperly relies upon common sense to supply a missing limitation. In Arendi, the court noted that “the Board’s presumption that adding a search for phone numbers to [the prior art refence] would be ‘common sense’ was conclusory and unsupported by substantial evidence, the missing limitation is not a ‘peripheral’ one, and there [was] nothing in the record to support the Board’s conclusion that supplying the missing limitation would be obvious to one of skill in the art.” 832 F.3d at 1366–67. But here, as noted above, Dr. Bell cites to several references in support of his rationale that one of ordinary skill in the art seeking to insert both the genes would have started with the known ICP34.5 locus rather than undertaking a rigorous trial-and-error process to find an altogether new insertion locus. We do not find the concern stated in Arendi about using common sense “as a wholesale substitute for reasoned analysis and evidentiary support” to be present in this case. See id. at 1362. Here, the “common sense” challenged by Patent Owner refers to the “common knowledge” of the ordinarily skilled artisan as of the invention referenced in the Petition and by Dr. Bell, and it is from such a person’s perspective that we must read Silvestre. Thus, based on the current record, we determine that Petitioner has provided sufficient evidence beyond merely a conclusory assertion of “common sense” to show that inserting the genes at issue in a back-to-back orientation would have been known in the art.7” slip op. at 14
§ 103 obviousnessDiscretionary denialPatents in suitUS 10,947,513 - PTAB · Apr 1, 2022 · IPR2022-00034 · APJ John G New · IPR · Institution
The Board instituted IPR on all extant claims and grounds, finding a reasonable likelihood that claim 6 would have been obvious over Levi combined with Walther or Spenser II.
RulingsInstitution decision- Adverse judgmentAdverse judgmentOther
“Patent Owner’s Statutory Disclaimer On January 26, 2022, Patent Owner filed a statutory disclaimer of claims 1–5 and 7–12 of the ’846 patent with the U.S. Patent and Trademark Office. See Ex. 2011. In view of Patent Owner’s statutory disclaimer, we treat claims 1–5 and 7–12 as having never been part of the ’846 patent, such that Petitioner cannot seek inter partes review of those claims. See Vectra Fitness, Inc. v. TNWK Corp., 162 F.3d 1379, 1383 (Fed. Cir. 1998) (holding that “[t]his court has interpreted the term ‘considered as part of the original patent’ in section 253 to mean that the patent is treated as though the disclaimed claims never existed”) (citing Guinn v. Kopf, 96 F.3d 1419, 1422 (Fed. Cir. 1996)); 37 C.F.R. § 42.107(e) (“No inter partes review will be instituted based on disclaimed claims”). Grounds 8–10 set forth in the Petition, which are directed solely to disclaimed claim 10, are also hereby deemed moot. And because no inter partes review will be instituted based on disclaimed claims, we do not consider claims 1–5 and 7–12 to be within the scope of this proceeding. Cf. General Elec. Co. v. United Techs. Corp., IPR2017-00491, Paper 9 (PTAB July 6, 2017) (precedential) (denying institution of inter partes review in view of a statutory disclaimer of all challenged claims). We base our decision to institute on the remaining challenged claim 6 that has not been disclaimed.” slip op. at 2
- PTAB / AIA Trials › Real party in interest / privityOther
“Real Parties in Interest Petitioner identifies Edwards Lifesciences Corp. and Edwards Lifesciences LLC, as the real parties-in-interest. Pet. 111. Patent Owner identifies Aortic Innovations, LLC as the real party-in-interest. Paper 4, 1.” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review to be instituted unless … the information presented in the petition … and any response … shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition, Preliminary Response, Reply, Sur-Reply, and the evidence of record, we determine that the evidence presented demonstrates a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one challenged claim of the ’846 patent.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Claim Construction 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). See 37 C.F.R. § 100(b) (2020). 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). “In determining the meaning of the disputed claim limitation, we look principally to the intrinsic evidence of record, examining the claim language itself, the written description, and the prosecution history, if in evidence.” DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 469 F.3d 1005, 1014 (Fed. Cir. 2006) (citing Phillips, 415 F.3d at 1312–17). Extrinsic evidence is “less significant than the intrinsic record in determining ‘the legally operative meaning of claim language.’” Phillips, 415 F.3d at 1317 (quoting C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 862 (Fed. Cir. 2004)). Neither Petitioner nor Patent Owner proposes a construction for any claim terms apart from their plain and customary meaning. Pet. 23; see generally Prelim. Resp. Nor do we perceive a need to construe any claim terms of the ’846 patent for purposes of determining whether to institute trial. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 295, 803 (Fed. Cir. 1999) (holding that “only those terms need to be construed that are in controversy, and only to the extent necessary to resolve the controversy”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in the context of an inter partes review).” slip op. at 11
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 10,966,846 - Penumbra, Inc. v. Rapidpulse, Inc.InstitutedPTAB · Mar 14, 2022 · IPR2021-01466 · APJ Jamie T Wisz · IPR · Institution
The Board instituted IPR on claims 1–18 and all four § 103 grounds, finding a reasonable likelihood that at least one challenged claim would have been obvious.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review under 35 U.S.C. § 314, which provides that an inter partes review may be instituted only upon a showing that “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). After considering the Petition, the Preliminary Response, and the evidence of record, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing with respect to at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of all challenged claims of the ’883 patent, based on all of the grounds identified in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner, relying on the testimony of Mr. Brown, contends that a person of ordinary skill in the art (“POSA” or “POSITA”) as of the relevant date would be either: (1) a person with a B.S. in engineering or an equivalent field, with two to four years of academic or industry experience in aspiration embolectomy and thrombectomy or comparable industry experience who would, where necessary or desired, work or consult with others, including a physician, to develop embolectomy or thrombectomy devices; or (2) an interventional neurosurgeon with at least three years of experience developing and/or using medical devices in embolectomy or thrombectomy procedures, and who would, where necessary, work or consult with others, including an engineer, to develop such a medical device. Pet. 15 (citing Ex. 1005 ¶ 48). Petitioner also contends that, “[a] person with less education but more relevant practical experience, or more relevant education but less practical experience, may also meet this standard.” Id. Patent Owner does not address the definition of a POSA in its Preliminary Response.6 See Prelim. Resp. Because Petitioner’s proposed definition is unopposed at this stage and is consistent with the level of skill reflected in the cited prior art, we adopt it for the purposes of this Decision.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner provides proposed constructions for the terms, “the change in the level of vacuum at the distal end is greater than approximately [15]/[20]/[25] in Hg and no greater than approximately [50]/[30]/[20] ms.” Pet. 21–23. Patent Owner does not address claim construction in its Preliminary Response.7 See Prelim. Resp. Upon review of the parties’ arguments and the evidence of record, we determine that the terms provided by Petitioner do not require express 6 The Declaration of Dr. Finol expresses some disagreement with Petitioner’s definition of a POSA; however, the Preliminary Response does not address the definition nor does it cite to the discussion of a POSA in the Finol Declaration. See Ex. 2001 ¶¶ 38–39. 7 The Declaration of Dr. Finol does not dispute the constructions proposed by Petitioner, but Patent Owner does not cite this testimony or otherwise address claim construction in the Preliminary Response. See Ex. 2001 ¶¶ 34–36. construction for purposes of this Decision. We do, however, construe the term “forward flow” in the analysis below. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“Next, in analyzing whether Teigen and Grey disclose limitation [1i], we find it useful to construe the term, “forward flow,” as recited in claim 1 of the ’833 patent. The ’833 patent defines forward flow as “an amount of liquid in the lumen . . . that exits the distal end . . . in the distal direction” and “is defined as greater than 6 microliters of fluid.” Ex. 1001, 36:18–22. With this definition in mind, we turn to the disclosures from Teigen and Grey relied on by Petitioner to show obviousness of “prevent[ing] forward flow of the distal portion out from the distal end during each cycle.”10 Claim 1 of Teigen recites that “the controller [is] configured to cyclically open and close the vacuum valve and the vent valve to: . . . control flow of the distal portion in and out from the distal end during each cycle.” Ex. 1007, 23:28–33. Further, Teigen discloses a controller configured to cyclically open and close its vacuum and fluid injection valves to change a level of vacuum at the distal end of the catheter during each extraction cycle in order to more effectively digest blood clots at the distal end of the” slip op. at 26
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,531,883 - Apotex Inc. / Apotex Corp. v. Auspex Pharmaceuticals, Inc.Institution deniedPTAB · Mar 9, 2022 · IPR2021-01507 · APJ Grace Karaffa Obermann · IPR · Institution
The Board denied institution of review of claims 1–3 under § 325(d), finding the petition relied on substantially the same art or arguments previously presented and did not show material Examiner error.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Becton, Dickinson factors (a), (b), and (d) relate to 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 the prior art or arguments. Id. In general, only if the same, or substantially the same, art or arguments previously were presented to the Office, do we turn to whether Petitioner has established a material error. Id. “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 24
Discretionary denialPatents in suitUS 8,524,733 - Medtronic, Inc. And Medtronic Vascular, Inc. v. Teleflex Life Sciences LimitedSome claims unpatentablePTAB · Feb 23, 2022 · IPR2020-01343 · APJ James A Tartal · IPR · Final written decision
Claims 52 and 53 are unpatentable as anticipated by Ressemann; the other challenged claims were not shown unpatentable because Itou is not prior art.
RulingsFinal written decision- ExcludeMotion to exclude, deniedDenied
“Documents are authenticated by evidence “sufficient to support a finding that the item is what the proponent claims it is.” Fed. R. Evid. 901(a); see Fox Factory v. SRAM, LLC, IPR2016-01876, Paper 59 at 63 (PTAB Apr. 2, 2018) (quoting same). “Authenticity is, therefore, not an especially high hurdle for a party to overcome.” Fox Factory, Paper 59 at 63 (citing United States v. Patterson, 277 F.3d 709, 713 (4th Cir. 2002)). We determine that Exhibit 2024 has been authenticated under the low bar required under Federal Rule of Evidence 901 based on the evidence provided by Petitioner. See Mot. Opp. 2–11. In addition, Petitioner’s arguments go to the weight of the evidence and not its admissibility. Accordingly, we deny Petitioner’s Motion to Exclude. We note, however, that even if we were to exclude Exhibit 2024, it would not change the outcome or our general analysis of this case.” slip op. at 13
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art at the time of the invention would have been either: (1) a medical doctor who would have had “(a) a medical degree; (b) completed a coronary intervention cardiologist;” or (2) an engineer who would have had “(a) an undergraduate degree in engineering, such as mechanical or biomedical engineering; and (b) at least three years of experience designing medical devices, including catheters or catheter-deployable devices.” Pet. 13–14. Additionally, Petitioner contends “[e]xtensive experience and technical training might substitute for education, and advanced degrees might substitute for experience.” Id. at 14. Further, according to Petitioner, a person of ordinary skill in the art “with a medical degree” and a person of ordinary skill in the art “with an engineering degree” may have had access to each other. Id. (citing Ex. 1005 ¶ 31; Ex. 1042 ¶¶ 18–19). Patent Owner does not dispute Petitioner’s proposed level of ordinary skill. PO Resp. 5. We adopt Petitioner’s proposed level of ordinary skill in the art as it is undisputed and consistent with the level of skill reflected in the prior art and the specification of the ’116 patent. 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 17
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Not reached
“Petitioner proposes the following constructions: (1) “substantially rigid” as “rigid enough to allow the device to be advanced within the guide catheter,” (2) “side opening” needs no construction and should be given its plain and ordinary meaning, (3) “lumen” as “the cavity of a tube,” and (4) “flexural modulus” as “[a] measure of resistance . . . to bending.” 7 Patent Owner argues that Dr. Hillstead does not meet the definition of a person of ordinary skill in the art because he lacks a four-year undergraduate degree in engineering. PO Resp. 5 n.1 (citing, e.g., Ex. 2137, 462:8–13). As noted above, however, it is undisputed that “[e]xtensive experience and technical training might substitute for education.” Pet. 14. Patent Owner does not address Dr. Hillstead’s significant professional experience, which we find sufficient to show he is qualified to opine on the issues in this proceeding from the perspective of a person of ordinary skill in the art. See Ex. 1043 (curriculum vitae of Dr. Hillstead). does not dispute at this stage of the proceeding Petitioner’s proposed construction of these terms. See generally PO Resp. In view of the issues we address below, we determine it is not necessary to address the express interpretation of any claim term. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017); Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”).” slip op. at 19
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Ressemann. Pet. 23–31. Petitioner provides a detailed explanation of how it contends Ressemann discloses each of the limitations of claims 52 and 53. Id. In particular, Petitioner explains how Ressemann’s disclosures of the use of features including guide catheter 160, evacuation sheath assembly 100, intermediate shaft portion 120, distal shaft portion 130, lumen 140, and stent delivery system 194 correspond to the recited methods of claims 52 and 53. Id. Petitioner’s contentions are supported by Dr. Brecker and Dr. Hillstead. Ex. 1005 ¶¶ 164–174; Ex. 1042 ¶¶ 36–39, 58–62. Patent Owner does not dispute that claims 52 and 53 are anticipated by Ressemann. See generally PO Resp; PO Sur-reply; see also Pet. Reply 2 (Petitioner arguing that Patent Owner did not dispute that Ressemann anticipates claims 52 and 53). After reviewing the record, we find Petitioner shows by a preponderance of the evidence that Ressemann discloses each limitations (Pet. 23–31) as our own findings. Accordingly, Petitioner shows by a preponderance of the evidence that Ressemann anticipates claims 52 and 53 of the ’116 patent.” slip op. at 26
Patent outcomesUS RE46,116 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
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.