- Gene Company Pty Ltd v. The Trustees Of Columbia University In The City Of New YorkNo claims unpatentablePTAB · Jun 23, 2025 · IPR2024-00313 · APJ Tawen Chang · IPR · Final written decision
Claims 1–54 were not shown unpatentable because Petitioner failed to establish a reasonable expectation of success for the proposed combinations; objective indicia also supported non-obviousness.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“As to the first issue, we agree with Patent Owner that defining the level of skill in view of the solution described in the patent risks improper hindsight. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) 18 (“[T]he level of skill in the art is a . . . lens through which . . . the Board views the prior art and the claimed invention,” which “prevents . . . factfinders from using their own insight or . . . hindsight[] to gauge obviousness.”). We therefore do not include “practical knowledge about . . . the deuterium isotope effect, including the patents and publications discussed [in the Petition],” as part of our definition of a person of ordinary skill in the art.” slip op. at 18
- Expert testimonyPetitioner expert creditedMixed
“person of ordinary skill in the art would employ” in an obviousness analysis, we give some weight to Dr. Guengerich’s testimony. KSR, 550 U.S. at 418; Plantronics, Inc. v. Aliph, Inc., 724 F.3d 1343, 1354 (Fed. Cir. 2013) (explaining that “motivation to combine may be found. . . in . . . the background knowledge, creativity, and common sense of the person of ordinary skill”). Nevertheless, even if we were to agree that an ordinarily skilled artisan would have seen the 1,5-shift in NRPE in Mata’s A2E biosynthetic pathway as a particularly desirable location for intervention, we are not persuaded that such a person would have been motivated to substitute C20 deuterated vitamin A for the vitamin A in Ortho Pharma’s composition and method, because Petitioner has not shown, by a preponderance of evidence, that such an artisan would have reasonably expected the substitution to retard the accumulation of A2E or to treat macular degeneration.” slip op. at 42
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“In our Institution Decision, we preliminarily construed the preamble of claim 28 as limiting. Inst. Dec. 30–31. Petitioner did not take issue with our construction, or dispute Patent Owner’s construction of the preambles of claims 1 and 29 as also limiting. After consideration of the full trial record, we maintain our construction of the preamble of claim 28 as limiting for the reasons set forth in our Institution Decision. For similar reasons and the reasons set forth in Patent Owner’s Response, we further construe the preambles of claims 1 and 29 as limiting. See PO Resp. 12–14. We further determine that we do not need to construe any other claim term in order to resolve the controversy between the parties. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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 26
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would be understood by a person of ordinary skill in the art, at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id.” slip op. at 25
Patent outcomesUS RE47,045 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · Graham - PTAB · Jun 18, 2025 · IPR2025-00321 · APJ Christopher M Kaiser · IPR · Institution
The Board instituted IPR on claims 1, 2, 5–7, 9, 16, and 17, finding a reasonable likelihood that claim 1 is anticipated by Boyer.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“approximately two weeks before the statutory deadline for a final written decision, but the most recent median time-to-trial statistics for Judge Gilstrap in the Eastern District of Texas indicate that the actual trial date will likely be in July 2026, which is later than the statutory deadline to issue a final written decision in this proceeding in mid-June 2026. See Ex. 2001, 7 (median time from filing to trial of 23.2 months); Prelim. Resp. 10. Thus, we find this factor is neutral or weighs slightly against discretionary denial.” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“At this preliminary stage, we determine whether the information presented shows a reasonable likelihood that Petitioner would prevail in establishing that at least one of the challenged claims would have been unpatentable over the proposed prior art. We analyze the asserted grounds with the above-noted principles in mind.” slip op. at 7
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that one of ordinary skill in the art “would have had (1) at least a bachelor’s degree in Mechanical Engineering, Computer Engineering, Chemical Engineering, Materials Science, or a related field, and (2) at least two years of research or industry experience in 3D printing or materials used for 3D printing.” Pet. 5 (citing Ex. 1003 ¶¶ 14–16). Petitioner also argues that “[a]dditional experience could substitute for a formal degree or formal training (and vice versa).” Id. Patent Owner proposes a slightly different level of skill, arguing that a person of ordinary skill in the art “would have had a bachelor’s degree in Mechanical Engineering, Computer Engineering, Chemical Engineering, Materials Science, or a comparable field and at least two years of experience related to 3D printing, with additional experience potentially being a substitute for a formal degree or training (and vice versa).” Prelim. Resp. 24. Neither party explains why the outcome of this case would be affected by the adoption of any of the proffered definitions of a person of ordinary skill in the art. For purposes of this Decision, we adopt Petitioner’s assessment of the level of ordinary skill in the art, as it appears to be consistent with the ’713 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 16
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“We note that, as discussed below, we are able to determine whether to institute inter partes review of the ’713 patent without expressly construing the term “from multiple print heads or deposition lines.” See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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))). As for Patent Owner’s argument that Petitioner has failed to carry its burden to identify how the claims are to be construed, we disagree on the present record. Although Petitioner does not provide a preferred construction for the single term it proposes requires construction, Petitioner does identify which of its two alternative constructions applies to each of its asserted grounds of unpatentability. Pet. 6 (“Under the first construction, [the obviousness grounds] are applicable, and [the anticipation ground] would be excluded from the claim scope. Under the alternative construction, all of [the asserted grounds] are applicable.”). In our view, this approach does not fail to satisfy Petitioner’s burden under 37 U.S.C. § 42.104(b)(3).” slip op. at 17
Claim construction§ 102 anticipationDiscretionary denialcites PhillipsPatents in suitUS 9,421,713 - PTAB · Jun 18, 2025 · IPR2025-00311 · APJ Christopher M Kaiser · IPR · Institution
The Board instituted IPR of claims 1, 3–11, and 17–22 on all asserted grounds because Petitioner showed a reasonable likelihood of prevailing on claim 1 over Mazumder and Mori.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“based on Petitioner’s first stipulation filed on December 18, 2024.15 Prelim. Resp. 13–15. Patent Owner does not address Petitioner’s updated second stipulation filed on April 8, 2025. This updated second stipulation mitigates any concerns of duplicative efforts between the district court and the Board, as well as concerns of any potentially conflicting decisions. See Sand at 12. We therefore find that this factor weighs against exercising discretion to deny institution. See id., n.5. 5. Whether Petitioner and the Defendant in the Parallel Proceeding are the Same Party Whereas Petitioner does not address factor 5, Patent Owner argues that the parties to this proceeding are both in the related district court litigation. Pet. 98–99; Prelim. Resp. 15. While it is common in IPR proceedings for the petitioner and patent owner to also be parties in a related district court proceeding, this factor weighs slightly in favor of discretionary denial. Fintiv, Paper 11 at 13–14.” slip op. at 15
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“c) Conclusion Regarding Claim 1 Based on the current record, we determine that there is a reasonable likelihood that Petitioner will prevail in demonstrating that claim 1 is unpatentable as obvious over the combination of Mazumder and Mori. Accordingly, we institute inter partes review with respect to all claims and all grounds asserted in the Petition. 5. Claims 3, 5–7, 9, 10, and 19–22 Because Petitioner demonstrates a reasonable likelihood of success in proving that at least one claim of the ’324 patent is unpatentable, we institute on all grounds and all claims raised in the Petition. See 37 C.F.R. § 42.108(a). Therefore, at this stage of the proceeding, it is not necessary for us to provide an assessment of every challenge raised by Petitioner, especially, as in this case, when Patent Owner does not separately argue those claims. See Prelim. Resp. 28–46. Those challenges, in our view, are best left for trial after full development of the record.” slip op. at 27
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“reference must be analogous art to the claimed invention. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). For a reference to be analogous art, it must be “either in the field of the applicant's endeavor or [be] reasonably pertinent to the problem with which the inventor was concerned.” In re Kahn, 441 F.3d 977, 986-87 (Fed. Cir. 2006) (citing In re Oetiker, 977 F.2d 1443, 1447 (Fed. Cir. 1992)). “A reference is reasonably pertinent if, even though it may be in a different field from that of the inventor's endeavor, it is one which, because of the matter with which it deals, logically would have commended itself to an inventor's attention in considering his problem.” In re Clay, 966 F.2d 656, 659 (Fed. Cir. 1992).” slip op. at 20
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“Mazumder because “the presentation of both image types would have beneficially aided the remote user to more easily visually compare the actual image and virtual image to quickly identify any defects or problems with the fabrication process.” Pet. 23–24 (citing Ex. 1003 ¶ 113). Patent Owner argues that “it is hindsight to use ‘the invention to define the problem the invention solves.’” Prelim. Resp. 43 (quoting Mintz v. Dietz & Watson, Inc., 679 F.3d 1372, 1377 (Fed. Cir. 2012); citing AT&T Services Inc. et. al. v. Innovative Sonic Ltd., IPR2024-001143 (PTAB Feb. 11, 2025)). According to Patent Owner, because neither Mazumder nor Mori teaches visual comparison of image types, the idea to improve the Mazumder-Mori combination by simultaneously displaying different image types and thus permitting visual comparison must be driven by hindsight. Id. at 44–45. But Petitioner cites evidence other than the ’324 patent to support the person of ordinary skill in the art having a desire to visually compare the different images presented in the Mazumder-Mori combination. Pet. 23–24 (citing Ex. 1003 ¶ 113). Specifically, Dr. Wolfe testifies that “the presentation of the actual images captured by the camera and the virtual images simultaneously within the user interface would have beneficially aided the remote user to more easily visually compare the actual image and virtual image to quickly identify any defects or problems with the fabrication process” and that a person of ordinary skill in the art would have recognized this. Ex. 1003 ¶ 113. Thus, Petitioner has shown sufficiently for the purpose of the present decision that Mori teaches or suggests the disputed limitation of claim 1. We encourage the parties to develop the arguments and the record surrounding this issue further during the trial.” slip op. at 26
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 8,562,324 - PTAB · Jun 11, 2025 · PGR2025-00004 · APJ Susan L C Mitchell · PGR · Institution
The Board instituted PGR on claims 1–4, 7–19, and 22; it found written-description and enablement challenges likely to succeed, but the obviousness ground insufficient.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner’s contentions are, at this stage, unavailing because Patent Owner’s proffered definition of a POSA is too restrictive. Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’298 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not be an expert in hyaluronidases. See Pet. 16. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases. See id. Moreover, Patent Owner fails to persuasively explain why Petitioner’s definition that includes a person with expertise in other enzymes is insufficient. Even if we were to apply Patent Owner’s POSA definition, it is not clear on the record before us that Petitioner’s experts lack relevant expertise or qualifications of at least a POSA. Patent Owner will have the chance to cross-examine Dr. Hecht and Dr. Park in this proceeding to develop a full record for us to determine the weight that each expert’s testimony should be given. Patent Owner will have further opportunity on a full record to assert that we should discount either experts’ testimony due to lack of appropriate qualifications. At this stage of the proceeding and on the record before us now, we apply Petitioner’s proposed POSA level, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner
“posttranslational modifications and those that do not contain chemical or posttranslational modifications.” Id. at 44:59–62. The ’298 patent provides an express definition of the term “modified PH20 polypeptide” which refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 47:15–30 (emphasis added).” slip op. at 14
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Under the second step of the Advanced Bionics framework, we must determine whether Petitioner has demonstrated Examiner error in a manner material to the patentability of the challenged claims. Advanced Bionics, at 10. Becton, Dickinson Factors (c), (e), and (f) inform our analysis at this step. Id. at 8.” slip op. at 21
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority to determine whether to institute a post-grant review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . 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). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition, Preliminary Response, Reply, Sur-Reply, and the cited evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 1–4, 7–19, and 22 of the ’298 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 12,018,298 - Njoy, LLC / Njoy Holdings, Inc. v. Juul Labs, Inc.No claims unpatentablePTAB · Jun 10, 2025 · IPR2024-00231 · APJ Avelyn M Ross · IPR · Final written decision
Claims 14–16, 18, 27–29, 31, and 32 were not proven unpatentable because the asserted references failed to establish the claimed airflow path or a reason to make the proposed combinations.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner’s and Patent Owner’s proposed levels of skill are similar and differ in that Petitioner’s relevant degrees and corresponding two years of experience additionally includes “industrial design” and “product design” and familiarity with “electrically powered vaporizing articles, their components or the underlying technologies” where Patent Owner requires two years of experience “designing electro-mechanical consumer products or an advanced degree.” Compare Pet. 7, with PO Resp. 2. Patent Owner alleges that “Petitioner has failed to establish unpatentability under either standard,” indicating that the level of skill in the art is not a dispositive issue. PO Resp. 3. In light of the record before us, we adopt Petitioner’s proposal regarding the level of ordinary skill in the art. Based on our review of the ’123 patent and the prior art of record, we determine that the definition offered by Petitioner comports with the qualifications a person would have needed to understand the ’123 patent and the prior art. We note that the outcome of this Decision would be the same under Patent Owner’s proposed definition.” slip op. at 11
- Expert testimonyPetitioner expert creditedOther
“In this case, Mr. McAlexander meets both Petitioner’s and Patent Owner’s proposed level of skill in the art. As a result, we are persuaded Mr. McAlexander has the requisite skill and relevant expertise to offer testimony in this matter. For example, Mr. McAlexander has a Bachelor’s Degree in Electrical Engineering and far more than 2 years of experience in the electrical engineering field. Ex. 1027, 3–6, 7. In addition, Mr. McAlexander has provided expert consulting services in a wide range of technology areas involving the process and design of electro-mechanical consumer products. Ex. 1003 ¶ 5. Through one of Mr. McAlexander’s business ventures, his laboratory has “performed detailed airflow analyses, designing and constructing specialized apparatuses to emulate human breath, allowing for precise activation testing of ENDS devices.” Ex. 1043 ¶ 16. That said, a declarant’s expertise, even clothed as a skilled artisan, does not entitle a naked opinion persuasive weight. Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985). Here, Patent Owner had the opportunity to, and in fact did, thoroughly cross examine Mr. McAlexander about the purported deficiencies in his testimony. See, e.g., Exs. 2052, 2054; Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 595 (1993) (“Vigorous cross examination [and] presentation of contrary evidence . . . are the traditional and appropriate means of attacking shaky but admissible evidence.”). Therefore, to the extent Patent Owner credibly identifies deficiencies in Mr. McAlexander’s testimony or that testimony lacks factual support or is based on broad, conclusory assertions, we will assign appropriate weight. See Velander v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003) (explaining that it is within the Board’s discretion, as the trier of fact, to accord appropriate weight to the evidence presented).” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Petitioner contends that the parties proposed a construction for “pressure valve,” a limitation appearing in claims 18 and 31, during the ITC investigation. Pet. 7 (citing Ex. 1001, 41:58–65). Patent Owner contends that the terms of the ’123 patent should be given their plain and ordinary meaning. PO Resp. 4. Because resolution of the issues presented in this case do not require construction of the term “pressure valve,” we do not expressly construe this claim term. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that “only those terms need 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) (citing Vivid Techs. in the context of an inter partes review).” slip op. at 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We agree with Patent Owner. To anticipate a claim, a reference “must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements ‘arranged as in the claim.’” Net MoneyIN, 545 F.3d at 1369. “The requirement that the prior art elements themselves be arranged as in the claim means that the claims cannot be treated . . . as mere catalogs of separate parts, in disregard of the part-to-part relationships set forth in the claims.” Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1325, 1332 (Fed. Cir. 2010). Indeed, the prior art reference “must clearly and unequivocally disclose the claimed [invention] or direct those skilled in the art to the [invention] without any need for picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference.” Net MoneyIN, 545 F.3d at 1371 (citation omitted). “[D]ifferences between the prior art reference and the claimed invention, however slight, invoke the question of obviousness, not anticipation.” Id.” slip op. at 20
Patent outcomesUS 10,130,123 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,130,123 - Formycon AG v. Regeneron Pharmaceuticals, Inc.Institution deniedPTAB · Jun 2, 2025 · IPR2025-00233 · APJ Michael A Valek · IPR · Institution
The Board denied institution under § 314(a) based on the Fintiv factors and denied joinder; it did not reach the merits of the asserted grounds.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivInstitution denied
“B. The Fintiv Factors and Related Guidance The Board’s precedential decision in Fintiv outlines factors that balance considerations of system efficiency, fairness, and patent quality when a patent owner raises an argument for discretionary denial due to the advanced state of a parallel proceeding, such as the MDL proceeding here. Fintiv 5–6. These factors are: 1. whether the court granted a stay or evidence exists that one may be granted if a proceeding is instituted; 2. proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision; 3. investment in the parallel proceeding by the court and the parties; 4. overlap between issues raised in the petition and in the parallel proceeding; 5. whether the petitioner and the defendant in the parallel proceeding are the same party; and 6. other circumstances that impact the Board’s exercise of discretion, including the merits. Id. “[I]n evaluating the factors, the Board takes a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Id. at 6.” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied
“III. DISCRETION UNDER 35 U.S.C. § 314(A) We begin by addressing Patent Owner’s arguments for discretionary denial. As explained below, we find those arguments persuasive. Thus, we exercise discretion to deny institution of the Petition under 35 U.S.C. § 314(a) without reaching the merits of Petitioner’s asserted grounds of unpatentability.” slip op. at 8
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, deniedDenied
“35 U.S.C. § 314(a) to deny institution of the Petition and deny the Joinder Motion.” slip op. at 2
Discretionary denialPatents in suitUS 11,084,865 - Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.Institution deniedPTAB · Jun 2, 2025 · IPR2025-00176 · APJ Michael A Valek · IPR · Institution
The Board denied institution of IPR on all challenged claims under § 314(a), finding the Fintiv factors—particularly investment, overlap, and merits—weighed against review.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“raised by this overlap, but given the circumstances, it does not effectively mitigate them. First, the disputed issues for Petitioner’s ODP defense are the same or substantially similar to those for the obviousness grounds in the Petition, but the Sotera stipulation does not prevent Petitioner from litigating those issues before both the district court (as part of its ODP defense) and here in the event an IPR is instituted.19 Second, the MDL proceeding 19 ODP or nonstatutory double patenting is, as the name implies, not premised on any statute. See, e.g., Ostuka Pharm. Co., Ltd. v. Sandoz, Inc., 678 F.3d 1280, 1297 (Fed. Cir. 2012) (“Nonstatutory double patenting is a judicially created doctrine grounded in public policy.”). Accordingly, it is not a ground Petitioner reasonably could have raised in this IPR. See 35 U.S.C. § 311(b) (inter partes review may be requested “only on a ground that could be raised under section 102 or 103”). includes other biosimilar applicant defendants who are similarly motivated to try to invalidate the ’865 patent claims, but who are not subject to any Sotera stipulation. Even if we institute review on Petitioner’s grounds here, those other defendants remain free to litigate the same grounds in the consolidated MDL proceeding. For these reasons and given the particular circumstances of this case, Petitioner’s Sotera stipulation does not sufficiently mitigate the risks of duplicated efforts or inconsistent decisions by making this IPR a “true alternative” to resolution of these issues by the district court. See Motorola Solutions, Inc. v. Stellar, LLC, IPR2024-01205, Paper 19, 3–4 (PTAB Mar. 28, 2005) (determining on Director Review that a Sotera stipulation did not ensure IPR would be a “true alternative” because Petitioner’s invalidity arguments “include combinations of the prior art asserted in these proceedings with unpublished system prior art, which Petitioner’s stipulation is not likely to moot” and thus the same or similar issues would remain in the parallel proceeding); SAP America, Inc. v. Cyandia, Inc., IPR2024-01496, Paper 13, 8–9 (PTAB Apr. 7, 2025) (similar).” slip op. at 19
Discretionary denialPatents in suitUS 11,084,865 - PTAB · Jun 2, 2025 · PGR2025-00003 · APJ Jeffrey N Fredman · PGR · Institution
Instituted PGR on claims 1–4 and 8–21 because the Board found a more-likely-than-not showing of written description and enablement failures; the obviousness ground did not meet that threshold.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner’s contentions are, at this stage, unavailing because Patent Owner’s proffered definition of a POSA is too restrictive. Petitioner’s proposal is sufficiently comprehensive to encompass the prior art relevant to the ’600 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not be an expert in hyaluronidases. See Pet. 16. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner
“refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 48:38–53 (emphasis added). Based on this express definition, the current record does not support the interpretation of Dr. Triggs-Raine that the “term ‘modified PH20 polypeptide,’ therefore, has a purely structural meaning in the context of the specification.” Ex. 2001 ¶ 68.4 Indeed, when reproducing the definition from this column of the ’600 patent, Dr. Triggs-Raine does not include any text after the first period, but the ’600 patent text continues to detail specific elements required including a requirement that replacements in the PH20 polypeptide are permitted “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 48:44‒46. On this” slip op. at 13
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“on the ’429 patent, and there is no evidence of record that the Examiner meaningfully considered the relevant disclosures of the ’429 patent. We find unpersuasive Patent Owner’s reliance on the Examiner’s issuance of an office action with a written description rejection over a different issue that also included some double patenting rejections. As to Becton, Dickinson Factor (e), “whether Petitioner has pointed out sufficiently how the [E]xaminer erred in its evaluation of the asserted prior art,” Petitioner provides persuasive evidence of Examiner error. See Pet. 36–39 (citing Ex. 1009, 21–27). We agree with Petitioner that the Examiner overlooked the written description requirement with regard to claim 1. As discussed below, we find that, on the current record, the evidence sufficiently shows that it is more likely than not that the claims fail to comply with the written description requirement. See Section X. We, thus, find that the Examiner erred by either overlooking, or failing to appreciate, the factual underpinning necessary to support a written description for the breadth of an enormous genus claim such as claim 1 of the ’600 patent.” slip op. at 22
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“XIII. CONCLUSION Petitioner has, at this stage, established that it will more likely than not prevail in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. XIV. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a) post grant review of claims 1–4 and 8–21 of the ’600 patent is hereby instituted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 324(d) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; and” slip op. at 60
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,952,600 - Juul Labs, Inc. v. Njoy, LLCNo claims unpatentablePTAB · May 21, 2025 · IPR2024-00160 · APJ Kimberly Mcgraw · IPR · Final written decision
The Board held claims 1–48 not shown unpatentable on any of six § 103 grounds because the asserted references did not teach the required housing aperture and the proposed combinations lacked adequate support.
RulingsFinal written decision- Skill levelDecided for patent owner
“time it was made, we consider the level of ordinary skill in the pertinent art at the time of invention. Graham, 383 U.S. at 17. Petitioner does not provide its own definition of the level of ordinary skill in the art. Instead, Petitioner asserts: In previous litigation involving the ’881 patent – the parent patent to the ’864 patent (Fuma International LLC v. R.J. Reynolds Vapor Company, Case No. 1:19-cv-260 (M.D.N.C. 2019)) with an identical specification – Patent Owner’s predecessor-in-interest asserted that a person of ordinary skill in the art (“POSITA”) at the time of the purported invention would have had a mechanical or electrical engineering degree, industrial design degree, or a similar technical degree, or equivalent work experience, and 5 to 10 years of experience in electromechanical devices. Ex. 1007, ¶¶14-17. Pet. 11–12; see also Ex. 1007 ¶ 16 (Mr. Sturges testifying that he meets “that qualification” without affirmatively providing a definition for a POSITA). Before institution, Patent Owner stated it did not challenge this definition (Prelim. Resp. 9), and we adopted Petitioner’s proposed definition in our Decision granting institution. During trial, Patent Owner also adopted this definition. PO Resp. 10–11. Upon a complete record, we see no reason to change and we maintain the agreed upon definition of a POSITA.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Patent Owner argues, and Petitioner does not dispute, that an aperture is a “hole” or an “opening.” See, e.g., id. at 21; see generally Reply. Patent Owner asserts that, in the proper context, the plain and ordinary meaning of a housing having an aperture is that the aperture is a hole, or an opening, on the housing structure itself. Id. at 21–22. We agree. In order for an object to have an “aperture” or an “opening,” the aperture or opening must be on the structure itself and not on a separate object that is located in the structure. This construction is in accord with the Specification of the ’864 patent, which refers to apertures in context of the structure on which they are located. See, e.g., Ex. 1001, 6:12–18 (referring to a first end comprising a first aperture), 7:11–12, 7:65–67 (stating that the wall of an airflow passageway may have apertures).” slip op. at 18
- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalTerm construed patent owner constructionDecided for patent owner
“large obstructions that force the air flow to near the peripheral surface of the housing, render the passageway non-central. During prosecution of the ’864 patent, the Examiner rejected certain claims (i.e., dependent claims 49, 63, and 75) over Han. To overcome this rejection, the applicant argued that Han cannot meet the limitation “wherein the airflow passageway extends centrally and axially from the first aperture to the second aperture.” Ex. 1002, 273. The applicant explained that Han does not meet this limitation because Han’s shell (b) does not include a central airflow passageway and instead places the perforated component for liquid storage (9) in the middle of shell (b), thereby forcing the airflow around the peripheral surface of the perforated component for liquid storage (9). Id. at 273–274. The examiner relied on this argument in determining that the applicant had overcome an earlier rejection. Id. at 195. Thus, some obstructions of a passageway render the passageway non-central; in particular those obstructions that force air to flow near the peripheral surface of the housing are large enough to render the passageway non-central.” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“lacks motivation and is plagued by improper hindsight.” Sur-reply 15–17. On the record developed during trial, we agree with Patent Owner that Petitioner has not shown by a preponderance of the evidence that a person of ordinary skill in the art would have had a reason to combine the teachings of Xia with those of Wang to arrive at the claimed limitations. Relying on the testimony of Patent Owner’s declarant Dr. Singhose, Petitioner argues that a person of ordinary skill in the art “would have known a central straight path has less airflow resistance than a circuitous one.” Reply 22 (citing Ex. 1035, 127:15–128:9). But the same witness also testified that higher airflow resistance might be desirable and explained that providing more resistance to airflow might result in improved mixing. Ex. 1035, 21:21–22:12, 127:20–24, 170:10–14. In addition, Dr. Singhose testifies that the complicated design of the airflow passageway in Xia “serves important functions,” including “allow[ing] large droplets to be reabsorbed by the liquid-guiding mechanism,” allowing “excessive liquid in the airflow [to] condense,” and “prevent[ing] the chemical liquid from being sucked into the mouth.” Ex. 2022 ¶ 190 (citing Ex. 1004, 11, 13–14, 16). Although Petitioner’s declarant Dr. Sturges testifies that a straight airflow passageway “would provide improved, smoother air flow,” he does not provide any evidence supporting the view that the air flow would be improved. Ex. 1007 ¶ 144. We credit the testimony of Dr. Singhose that using a straight passageway in Xia would have been detrimental rather than beneficial. Ex. 2022 ¶ 190. slip op. at 40
Patent outcomesUS 11,497,864 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,497,864 - Juul Labs, Inc. v. Njoy, LLCNo claims unpatentablePTAB · May 21, 2025 · IPR2024-00161 · APJ Christopher M Kaiser · IPR · Final written decision
Claims 1–27 were not shown unpatentable because the asserted obviousness grounds failed to establish the claimed central airflow passageway or a reason to combine the references.
RulingsFinal written decision- Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner
“Relying on the testimony of Patent Owner’s declarant Dr. Singhose, Petitioner argues that a person of ordinary skill in the art “would have known a central straight path has less airflow resistance than a circuitous one.” Reply 22–23 (citing Ex. 1035, 127:15–128:9). But the same witness also testified that higher airflow resistance might be desirable and explained that providing more resistance to airflow might result in improved mixing. Ex. 1035, 21:21–22:12, 127:20–24, 170:10–14. In addition, Dr. Singhose testifies that the complicated design of the airflow passageway in Xia “serves important functions,” including “allow[ing] large droplets to be reabsorbed by the liquid-guiding mechanism,” allowing “excessive liquid in the airflow [to] condense,” and “prevent[ing] the chemical liquid from being sucked into the mouth.” Ex. 2022 ¶ 183 (citing Ex. 1004, 11, 13–14, 16). Although Petitioner’s declarant Dr. Sturges testifies that a straight airflow passageway “would provide improved, smoother air flow,” he does not provide any evidence supporting the view that the air flow would be improved. Ex. 1007 ¶ 118. We credit the testimony of Dr. Singhose that using a straight passageway in Xia would have been detrimental rather than beneficial. Ex. 2022 ¶ 183. Petitioner also argues that the inventors’ use of a straight path is evidence that the use of a straight passageway was “merely common-sense obviousness.” Reply 22–23. This is hindsight. Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280, 1296 (Fed. Cir. 2012) (“The inventor’s own path itself never leads to a conclusion of obviousness; that is hindsight.”). Moreover, it does not address the testimony of Dr. Singhose that the use of a complicated passageway like that in Xia had benefits not present in a straight central passageway.” slip op. at 29
- Skill levelSkill level petitioner adoptedOther
“B. Level of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art (“POSITA”) “would have had a mechanical or electrical engineering degree, industrial design degree, or a similar technical degree, or equivalent work experience, and 5 to 10 years of experience in electromechanical devices.” Pet. 10 (citing Ex. 1007 ¶ 16). Prior to institution, Patent Owner stated that, for “the limited purpose of this Preliminary Response,” it “does not challenge the definition of a POSITA set forth in the Petition.” Prelim. Resp. 9. We adopted Petitioner’s proposed definition in our Decision granting institution. During trial, neither party disputed this definition. Upon a complete record, we see no reason to change the adopted definition.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Patent Owner argues, however, that this presumption is overcome in the present case, and we agree. PO Resp. 28–32. We note that, although the claims require the first aperture to be “on the first end,” the claims still require that the “housing hav[e] a first aperture.” Thus, the issue is whether the aperture must be on the housing itself or part of the housing, as well as whether the aperture is on the first end of the housing. Although “having” and “includes” are used with respect to the solution holding medium to refer to elements located inside the housing, the specification of the ’881 patent suggests that the ends of the housing are part of the housing itself, rather than located inside the housing. First, “the first end . . . can be integrated into a single assembly as part of the housing.” Ex. 1001, 6:16–17. Second, “the housing . . . may comprise the cylindrical wall and two end-caps,” or “the housing . . . may comprise the cartridge wall and a single end-cap.” Id. at 3:55–59. The only figures of the ’881 patent that depict first end 206 show it at the end of the housing rather than located within the interior of housing 202. Id. at Figs. 2, 3. Moreover, there is no requirement to construe a claim term uniformly across multiple uses in the claims when doing so would be nonsensical. Microprocessor Enhancement Corp. v. Texas Instruments, Inc., 520 F.3d 1367, 1375 (Fed. Cir. 2008). Here, construing a first element that is recited as “having” or “includ[ing]” a second element always as encompassing not only second elements that are part of the first element, but also second elements that are located within the interior of the first element, would lead to nonsensical results. Claim 2 recites an airflow passageway “having a length having a circular cross section.” Ex. 1001, 17:59–60. It would be nonsensical to interpret this claim as encompassing an airflow passageway of non-circular cross section that contains another object that has a circular cross section, and neither party argues in favor of such a reading. Similarly, claim 16 recites an “airflow passageway having an interior having a uniform cross-sectional area,” and there is no reason to interpret this claim as encompassing an airflow passageway of non-uniform cross-sectional area that contains another object that itself has uniform cross-sectional area. Id. at 19:47–48. Thus, the claims do not use “having” or “includes” consistently to refer to elements located within the interior of an object; instead, they sometimes use these terms to refer to elements that are a part of an object. See Epcon Gas Sys., Inc. v. Bauer Compressors, Inc., 279 F.3d 1022, 1030–31 (Fed. Cir. 2002) (terms should be construed based on the context of how the terms are used in the claims).” slip op. at 13
- Prior constructionPrior construction not adoptedDecided for patent owner
“When we instituted trial, we preliminarily construed this phrase to encompass apertures that are located within the first end of the housing, determining on the record available at that time that “[t]he term does not require that the first aperture be located in the housing itself.” Inst. Dec. 16. We invited the parties to “address [the] construction of this term during trial,” id., and, on the full record developed during trial, we reach a different conclusion.” slip op. at 10
Patent outcomesUS 10,334,881 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,334,881
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.