- PTAB · Mar 13, 2024 · IPR2023-01347 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted review of claim 16 on both asserted obviousness grounds, finding a reasonable likelihood that Petitioner would show the claim unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented in the Petition, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that claim 16 of the ’344 patent is unpatentable.” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
“Based on the preliminary record, we are persuaded by Petitioner’s contention that claim 16 does not comply with the written description requirement for the reasons set forth in the Petition (Pet. 11–17), summarized above. More specifically, on the current record, we do not recognize the ’344 patent to disclose a representative number of API, solvent and co-former combinations having the necessary recited features. We do not understand the ’344 patent to disclose structural features common to the recited solvents and co-formers such that a POSA could “visualize or recognize” the members of the claimed genus. Ariad, 598 F.3d at 1350. We recognize that a POSA’s perspective is key to the written description inquiry and many factors may inform the adequacy of a specification’s disclosure, including existing knowledge in the field and the content of the prior art. See Ariad, 598 F.3d at 1351. On the current record, however, we do not find evidence that a POSA would have considered the recited mechanisms to form supramolecular synthons via non-covalent hydrogen bonding by pairing solvents and co-formers having certain functionalities a concept that was well-known in the art. effective filing date for claim 16 is February 13, 2014, the filing date of the ’344 patent.2” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“Petitioner contends that a POSA would have been motivated to combine Ueto with Li, Martindale, Zaworotko, and Remington “to improve physicochemical properties of the co-crystal components.” Id. at 49. In particular, furosemide was known as of 2014 to have low water solubility (Ex. 1506, Martindale at 1421; Ex. 1503, Appel ¶ 58; Ex. 1502, Rogers ¶¶ 232–34, 236), and water solubility, along with bioavailability, were properties that co-crystals had the potential to improve. Ex. 1507, Ueto at 485; Ex. 1503, Appel ¶ 59; Ex. 1502, Rogers ¶¶ 234, 236. As such, a POSA would have been motivated to pursue studies with the Ueto co-crystals, including the furosemide/nicotinamide/water co-crystal. Pet. 49. In view of the foregoing, we determine that Petitioner has established a reasonable likelihood of showing that the combination of Ueto, Li, Martindale, Zaworotko, and Remington renders obvious claim 16 for the purposes of our preliminary findings. Patent Owner at this stage does not offer any arguments addressing Petitioner’s substantive showing. Accordingly, we institute a inter partes review of claim 16 of the ’344 patent.” slip op. at 17
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“Petitioner proposes constructions for the terms “active pharmaceutical ingredient (API)”, “API homosynthons”, “carbonyl”, “carboxamide”, “co-former”, and “supramolecular synthon.” Pet. 9–10. According to Petitioner, “[t]he parties agree that co-former is used synonymously with cocrystal former and that a co-former is a component of a co-crystal.” Id. at 9. Petitioner represents that the proposed constructions have been agreed to between the parties in parallel litigation, or agreed upon such that “the disputed portions are not relevant to [the] issues raised in this Petition.” Id. at 8. We have reviewed each of these constructions and adopt Petitioner’s proposed construction for the purposes of this Decision. Petitioner’s construction aligns with the plain words of the claim, is consistent with the prosecution history of the ’344 patent, and finds support in the uncontroverted testimony of Dr. Rogers. Ex. 1502 ¶¶ 52–63; Ex. 1516, 256–58, 261–63. Petitioner construes the term “co-crystal” to mean “a multiple- component, single crystalline phase, having a fixed stoichiometry of its component compounds.” Id. at 10. Petitioner states that the proposed construction of the term “co-crystal” is “currently disputed in parallel litigation between the parties; however, because claim 16 is unpatentable under Patent Owners’ constructions, Petitioner adopts those constructions solely for the purpose of this Petition.” Id. at 8–9. We adopt Petitioner’s proposed construction of “co-crystal” for the purposes of this Decision. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (per curiam) (claim terms need to be construed “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))). To the extent further discussion of the meaning of any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 13
Claim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 10,633,344 - PTAB · Mar 13, 2024 · IPR2023-01346 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 10, 11, and 18 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“priority to the filing date of a prior application only “for an invention disclosed [in the prior application] in the manner provided by” 35 U.S.C. § 112. This requires that the earlier application provides written description support for the invention claimed by the later application. See Paice LLC v. Ford Motor Co., 881 F.3d 894, 906 (Fed. Cir. 2018); PowerOasis, Inc. v. T- Mobile USA, Inc., 522 F.3d 1299, 1306–11 (Fed. Cir. 2008); Augustine Medical, Inc. v. Gaymar Indus., Inc., 181 F.3d 1291, 1302–03 (Fed. Cir. 1999). The test for sufficiency of a written description under 35 U.S.C. § 112, ¶ 1, is whether the earlier application’s disclosure “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The written description “test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” Id. As articulated in Ariad, “an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials.” Ariad, 598 F.3d at 1350 (citations omitted). One test of whether a claimed genus finds adequate support involves identifying in the specification “either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (citing Regents of the Univ. of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997)).” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented in the Petition, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least 1 of the challenged claims of the ’344 patent is unpatentable.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“To anticipate a claim under 35 U.S.C. § 102, “a single prior art reference must expressly or inherently disclose each claim limitation.” Finisar Corp. v. DirecTV Group, Inc., 523 F.3d 1323, 1334 (Fed. Cir. 2008). 2 We note that Petitioner additionally challenges the Priority Applications for lack of enablement. Having found that the ’344 patent lacks written description support for all Challenged Claims, however, we need not address Petitioner’s enablement challenge in order to decide whether to institute. one skilled in the art would reasonably understand or infer from the [prior art reference’s] teaching’ that every claim element was disclosed in that single reference.” Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 1368 (Fed. Cir. 2003) (quoting In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991)).” slip op. at 11
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Because Petitioner’s presently unopposed definition is consistent with the ’344 patent and the prior art of record, we adopt that definition in deciding whether to institute trial. See Okajima v. Bourdeau, 261 F.3d 1350, 1354–55 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579–80 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 15
§ 102 anticipation§ 112 disclosurecites KSR · GrahamPatents in suitUS 10,633,344 - PTAB · Feb 5, 2024 · IPR2023-01251 · APJ Cynthia M Hardman · IPR · Institution
The Board instituted IPR on all asserted grounds challenging claims 1–12, 14–28, and 30, finding a reasonable likelihood that Petitioner would prevail on at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“III. CONCLUSION For the foregoing reasons, we determine that the information presented establishes a reasonable likelihood that Petitioner would prevail in showing that at least one of the challenged claims of the ’056 patent is unpatentable. At this preliminary stage, we have not made a final determination regarding the patentability of any challenged claim or any underlying factual and legal issues. See TriVascular, Inc. v. Samuels, 812 F.3d 1056, 1068 (Fed. Cir. 2016) (noting that “there is a significant difference between a petitioner’s burden to establish a ‘reasonable likelihood of success’ at institution, and actually proving invalidity by a preponderance of the evidence at trial”). Any final decision in this proceeding will be based on the full trial record.” slip op. at 48
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 13 (citing Ex. 1008 (Gross Decl.) ¶ 51). Patent Owner indicates that it does not dispute this portion of Petitioner’s proposal. See Prelim. Resp. 24. Petitioner also posits that “[t]he POSITA may be part of an interdisciplinary team with others having relevant experience and/or with clinicians involved in diagnosis, treatment, and patient management relevant to the use of medical devices for monitoring physiological signals” and “would have been aware of commercially available glucose monitoring systems (e.g., the Medtronic Paradigm® REAL-Time) through scientific journals and magazines,” “would have known the importance of data reliability to glucose monitoring, including anticipating that errors (e.g., communication or calibration failures) would result in missing or inaccurate glucose data,” and would have accounted for missing data using technical concepts known at the time, including programming glucose monitoring systems to detect failures that result in data being unavailable for display (e.g., due to a calibration error or loss of communication), preserving this data in memory, regenerating it once the system recovered, and displaying regenerated data. Pet. 13–14 (citing Ex. 1008 (Gross Decl.) ¶¶ 52, 54–61). Patent Owner does not specifically comment on or dispute this portion of Petitioner’s proposal. See generally Prelim. Resp. Because Petitioner’s full proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither party proposes that any claim term requires an express construction. See Pet. 14; Prelim. Resp. 24. We find it unnecessary to construe any claim term to decide whether Petitioner satisfies the “reasonable likelihood” standard for instituting trial. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we 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))). Any final written decision entered in this case may include express claim constructions, or may include discussion of claim scope that differs from that provided in our analysis below. Any final claim constructions will be based on the full trial record.” slip op. at 15
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“We determine that Petitioner’s proffered reason to combine is sufficient for purposes of institution. Petitioner does not merely rely on the fact that Patel-2008, Mastrototaro, Shahmirian, and Causey are from same field of study or address the same problem. Instead, Petitioner points to Patel-2008’s express discussion of the utility of Mastrototaro, Shahmirian, and Causey’s teachings, together with the fact that all of the references apparently discuss different components of the same system (i.e., the Medtronic MiniMed continuous glucose monitoring system). See, e.g., Pet. 83–84; Ex. 1008 (Gross Decl.) ¶¶ 55, 70–71. On this record, we find for purposes of institution that Dr. Gross sufficiently establishes that “POSITAs would have been motivated to combine the sensor and transmitter of Mastrototaro, the communications of Shahmirian, and the monitor control programs of Causey to effectuate a diabetes management system with the monitoring, communication, and display functionalities disclosed in Patel-2008,” and “to convey as much accurate glucose information to a user as possible without providing inaccurate information.” Ex. 1008 (Gross Decl.) ¶¶ 190–93. Patent Owner’s argument that “nothing in Patel-2008 teaches or suggests incorporating these disparate teachings into a single system” (Prelim. Resp. 47–48) is unavailing. First, as noted above, Patel-2008 expressly teaches using in its system components described in Mastrototaro, Shahmirian, and Causey. Second, even if Patent Owner were correct that Patel-2008 lacks a teaching or suggestion to incorporate Mastrototaro, Shahmirian, and Causey’s teachings into Patel-2008’s system, Patel-2008 itself need not express a reason to combine. Rather, “[a]ny motivation to combine references, whether articulated in the references themselves or supported by evidence of the knowledge of a skilled artisan, is sufficient to combine those references to arrive at the claimed [invention].” Outdry Techs. Corp. v. Geox S.p.A., 859 F.3d 1364, 1370–71 (Fed. Cir. 2017). As noted above, we find that Petitioner’s rationales are sufficiently supported by Dr. Gross and the cited references for purposes of institution.” slip op. at 43
Claim construction§ 103 obviousnesscites KSRPatents in suitUS 11,298,056 - Novartis Gene Therapies, Inc. / Novartis Pharmaceuticals Corporation v. Genzyme CorporationInstitutedPTAB · Jan 17, 2024 · IPR2023-01045 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted review of claims 5–9, 15, and 16 on all grounds in the Petition, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- Parallel petitionsInstitutedInstituted
“Upon consideration of the specific circumstances under which Petitioner filed two petitions, we decline to exercise our discretion to deny institution in this proceeding. We agree with Petitioner that a large number of claims have been asserted against it in district court and that addressing those 34 claims may necessitate filing two separate petitions.2 See TPG at 59 (“[T]he Board recognizes that there may be circumstances in which more than one petition may be necessary, including, for example, when the patent owner has asserted a large number of claims in litigation.”) The fact that the same claims are not challenged between the two petitions weighs in favor of declining to exercise our discretion to deny institution. See Gen. Plastic Co., Ltd. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19 at 16–17 (PTAB 2 We recognize that Patent Owner has now disclaimed claim 4 and 10–14, however, that disclaimer was entered after the filing date of the Petition. Ex. 2010. dismissed one petition or the other, some claims of the [’288] patent would be left uncovered by any ground alleged by Petitioner.” Marvell Semiconductor, Inc. v. Uniloc 2017 LLC, IPR2019-01349, Paper 9 at 14 (PTAB Feb. 4, 2020) (instituting review); Paper 2, 2.” slip op. at 4
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“III. CONCLUSION Petitioner has, at this stage, established a reasonable likelihood of prevailing in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record. 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. See In re NuVasive, 842 F.3d 1376, 1380–81(Fed. Cir. 2016) (noting in the context of an inter partes review that “there is a significant difference between a petitioner’s burden to establish a ‘reasonable likelihood of success’ at institution, and actually proving invalidity by a preponderance of the evidence at trial”) (quoting 35 U.S.C. § 314(a) and comparing § 316(e)).” slip op. at 27
- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have possessed at least a B.S. in biology, chemistry, chemical engineering, biochemistry, biophysics, pharmaceutical science, or a related discipline, with two or more years of industry, laboratory, and/or clinical experience in analyzing or characterizing biomolecules, including viruses or viral vectors. Such a person may be familiar with, or consult with someone familiar with, the development, formulation, and/or administration of viral vectors for gene therapy and quality Pet. 17 (citing Ex. 1020 ¶ 58). We do not find a proposal by Patent Owner for a different level of skill in the preliminary response. See PO Resp. generally. For this Decision, we adopt and apply Petitioner’s proposal for the person of ordinary skill in the art level, which appears to be consistent with the level of skill reflected in the’288 patent and the asserted prior art.” slip op. at 8
- Expert testimonyPetitioner expert creditedDecided for petitioner
“In particular, we are persuaded on the current record by the testimony of Dr. Berkowitz that “Le Bec teaches a method for characterizing a viral preparation of rAAV particles that can analytically separate, detect, and quantify the presence of empty capsids, full capsids, and aggregates based on sedimentation coefficients.” Ex. 1020 ¶ 72 (citing Ex. 1003, 16:25–29; 15:17–23; 18:1–6). Here, we note that Le Bec teaches that the “distribution profile of the species allows the identification of two categories of populations,” which include species identified as 60S, 90S, and 105S, for example. Ex. 1003, 18:11–27; see also Figs. 2 and 3. We have considered Patent Owner’s arguments and the testimony of Dr. Hansen, and are not persuaded on the current record to deny institution. Prelim. Resp. 31–45; Ex. 2001 ¶¶ 96–113. For example, we recognize Patent Owner’s contention that Petitioner “fails to identify where Le Bec discloses integrating and determining the area of specific peaks in its species, for example at 77S and 90S.” Prelim Resp. 33 (citing Ex. 2001 ¶ 104; see also id. at 33 (The “Petition is understandably silent on Le Bec’s lack of disclosure of concentrations for each peak in its C(s) distributions that correlate to, for example, partial or fragmented genomes.”). We recognize also Dr. Hansen’s testimony that, even accepting Petitioner’s argument that the SEDFIT software was available and could have been used to “calculate[] relative concentrations by integrating the area under the peaks of a sedimentation coefficient distribution profile,” “the POSA would not have considered Le Bec to have provided any indication that the area under each peak was determined nor that the area under each peak was converted to concentrations by applying the extinction coefficients for the rAAV species corresponding to each peak.” Ex. 2001 ¶ 97 (citing Ex. 1020 ¶ 83; Pet. 27); see also id. at ¶ 100 (“Neither the Petition nor the Berkowitz Declaration address Le Bec’s omissions of concentration values for each peak in its C(s) distributions in Figures 2 and 3”). Having considered that information presented by Patent Owner, however, we determine that the information presented by Patent Owner creates genuine issues of material fact about whether a person of ordinary skill in the art would have interpreted Le Bec to disclose “integrating the area under each peak in the C(s) distribution to determine the relative concentration of each peak, wherein each peak represents a species of recombinant AAV particle.”5 See 5 We note also that, while the parties’ dispute centers on whether Le Bec discloses “integrating the area under each peak,” as required by the claims, neither party has offered a claim construction of that phrase. We understand that phrase to refer to a known standard technique for determining relative concentrations in a sample by calculating the area under the curve. Here, we credit the testimony of Dr. Berkowitz that “the SEDFIT software referenced [Patent Owner’s] testimonial evidence will be viewed in the light most favorable to the petitioner solely for purposes of deciding whether to institute an inter partes review.”). Those issues may be further briefed and developed during trial, and the parties are encouraged to do so.” slip op. at 16
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 10,429,288 - Novartis Gene Therapies, Inc. / Novartis Pharmaceuticals Corporation v. Genzyme CorporationInstitutedPTAB · Jan 9, 2024 · IPR2023-01044 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted review of claims 1–3 and 17–34 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
- PTAB / AIA Trials › Real party in interest / privityOther
“Petitioner asserts that Novartis Gene Therapies, Inc. and Novartis Pharmaceuticals Corporation are the real parties in interest. Pet. 68. Patent Owner asserts that “Sanofi, the ultimate parent company of Genzyme Corporation, Genzyme Corporation, and Aventis, Inc. are the real parties-ininterest.” Paper 8, 2.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts that the claim terms require no express construction. Pet. 21. Patent Owner does not challenge Petitioner’s position. Prelim. Resp. 30. Having considered the parties’ positions and evidence of record, we determine that no express construction of any claim term is necessary to determine whether to institute inter partes review. 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))). To the extent further discussion of the meaning of any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 7
Claim construction§ 102 anticipation§ 103 obviousnesscites GrahamPatents in suitUS 10,429,288 - PTAB · Nov 17, 2023 · IPR2023-00894 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–15 on all petitioned grounds, finding a reasonable likelihood of prevailing and declining discretionary denial under Fintiv and § 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Legal Standards “In an [inter partes review], the petitioner has the burden from the onset 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) (citing 35 U.S.C. § 312(a)(3) (2012) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review).” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownNo construction neededOther
“to be construed.” 37 C.F.R. § 42.104(b)(3). But only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); 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 AIA trial proceeding). For the purpose of this Decision, we need address only the terms “bore” and “at a terminal end.”” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Contrary to Patent Owner’s analysis, we preliminarily construe a “bore” as “a hole or passage made by or as if by the turning or twisting movement of a tool such that its interior walls have a cylindrical cross-section, and which do not exclude and may include holes or passages having tapered or stepped longitudinal cross-sections.” See supra Section II.C.1. As such, and on the limited record before us, Cognet discloses a bore and further satisfies all elements of claim phrase 1[c][iii]. c) Conclusion as to Ground 1 In view of the above preliminary construction, Petitioner establishes sufficiently that Cognet discloses claim element 1[c][iii]. Patent Owner does not dispute any other element of Ground 1 in its Preliminary Response. Having considered the evidence of record, we determine that Petitioner has established sufficiently that these remaining elements are also disclosed in Cognet. According, and solely for the purpose of institution, Petitioner has demonstrated a reasonable likelihood that Cognet anticipates claim 1.” slip op. at 19
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“On the present record, we decline to speculate whether the pending motion to stay might be successful. Accordingly, Fintiv Factor 1 is neutral.” slip op. at 29
Claim construction§ 102 anticipationDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,298,166 - PTAB · Aug 17, 2023 · PGR2023-00020 · APJ Jeffrey N Fredman · PGR · Institution
Instituted PGR on claims 22 and 25–31; the Board found a reasonable likelihood of success on anticipation over Zhang and obviousness grounds for claim 22.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Feb. 13, 2020) (“Advanced Bionics”) (precedential), we further apply the following two-step framework in determining whether discretionary denial under § 325(d) is appropriate: (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. Becton, Dickinson Factors (a), (b), and (d) relate to the first step, and Becton, Dickinson Factors (c), (e), and (f) relate to the second step. Id. Only if the same or substantially the same art or arguments were previously presented to the Office do we then consider whether petitioner has demonstrated error. Advanced Bionics, at 8–10. “If the petitioner fails to show that the Office erred, the Director may exercise [her] discretion not to institute inter partes review.” Id. at 8–9 (“If a condition in the first part of the framework [i.e., substantially same art or arguments] is satisfied and the petitioner fails to make a showing of material error, the Director generally will exercise discretion not to institute inter partes review.”). “At bottom, this [§ 325(d)] framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9. An “example of a material error” could be “misapprehending or overlooking specific teachings of the relevant prior art where those teachings impact patentability of the challenged claims.” Id. at 8 n.9” slip op. at 13
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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) (2018). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition, Preliminary Response, and the 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 22 and 25–31 of the ’817 patent.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“We find that on the present record, the evidence more likely than not supports Petitioner’s claim interpretation which is based on the express definition of the term “patient” in the ’817 patent specification. That express definition states: “‘Patient’ and ‘subject’ are used interchangeably herein and include, but not limited to, primates such as humans, canines, porcine, ungulates, rodents, poultry, and avian.” Ex. 1001, 32:65–67.” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundInstituted
“We appreciate Patent Owner’s point that for a reference to anticipate without disclosing the relevant feature of the claimed invention, it is required that the “missing characteristic is necessarily present . . . in the single anticipating reference.” Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003). In this case, Zhang demonstrates that ganaxolone continues to improve status epilepticus in rats for 5+ hours, supporting the inherency position. Moreover, the ’817 patent’s Specification shows that 10 and 20 mg/kg ganaxolone doses that bracket the 12 and 15 mg/kg ganaxolone doses tested by Zhang, result in improved 24-hour survival relative to lower doses. See Ex. 1001, Fig. 4; Ex. 1009, 21 ¶ 117. This evidence further supports Petitioner’s inherency position because it shows that doses bracketing those recited in Zhang provide continued improvement to patients for periods exceeding 8 hours. “Extrinsic evidence can be used to demonstrate what is ‘necessarily present’ in a prior art embodiment even if the extrinsic evidence is not itself prior art.” Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322, 1329 (Fed. Cir. 2020). As to the issue of whether Zhang’s teaching to treat with multiple doses also teaches “improvement to the patient after administration for more than 8 hours” as required by claim 22, on this record we find that Petitioner’s position is more persuasive. Claim 22 does not distinguish between a single administration event or multiple administrations, and therefore is reasonably interpreted as broadly open to both single administration and multiple administrations. This understanding is consistent with the ’817 patent, which teaches that “[g]anaxolone or a pharmaceutically acceptable salt thereof can be administered, e.g., once daily, twice daily, three times daily, or four times daily.” Ex. 1001, 8:35–37. Zhang teaches “[d]osing schedules in which the substituted β-cyclodextrin-ganaxolone injectable formulation is injected every 1 hr, 2 hrs, 4 hrs, 6 hrs, 8 hrs, 12 hrs, or 24 hours are included herein.” Ex. 1009, 13 ¶ 74. We agree with Petitioner that, on this record, Zhang directly demonstrates that where doses are administered every 1, 2, or 4 hours, the ganaxolone would have been expected to necessarily result in improvement in status epilepticus treatment over more than 8 hours based on the five hour efficacy results reported in Zhang. See Ex. 1009, 25 ¶ 135.9” slip op. at 27
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 11,395,817 - PTAB · Apr 19, 2023 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted review on all challenged claims and the sole anticipation ground: claims 1–4, 8–14, and 18–26, with a reasonable likelihood of unpatentability except claim 19.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denialInstitutedDenied
“This case differs from other situations where the Board has exercised discretion under § 314(a) to deny institution. For example, we are not presented with a later-filed petition after having considered an earlier-filed petition challenging the same patent. See, e.g., General Plastic Indus. Co., Ltd. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19, 6–11, 15–22 (PTAB Sept. 6, 2017) (precedential)). This is the first petition filed against this patent and contains only a single ground. Also, as Petitioner asserts, and Patent Owner does not contest, the Fintiv factors are neutral or favor institution. See Pet. 61–63. Instead, Patent Owner asks us to deny institution because Petitioner” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 6 and 35 U.S.C. § 314, which provides that 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.” A decision to institute under § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). In addition, if the Board institutes trial, it will “institute on all grounds in the petition.” PTAB Consolidated Trial Practice Guide, 5–6 (Nov. 2019); see also 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”). Having considered the arguments and evidence presented in the Petition and the Preliminary Response, for the reasons described below, we institute inter partes review.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“VIII. LEVEL OF ORDINARY SKILL IN THE ART Petitioner asserts A person of ordinary skill in the art (“POSA”) in the field of the patent between 2012 and 2021 would have held an MD with experience in clinical oncology or pharmacology; a PhD in pharmacology, pharmaceutical chemistry, cancer biology, or a related discipline; or a PharmD with experience in clinical oncology. Ex. 1020 ¶ 29. A POSA would also have practical working knowledge of oncology (Ex. 1020 ¶ 29) and experience with the design of studies necessary for drug development. This description is approximate, and additional experience could make up for less education and vice versa. Ex. 1020 ¶ 29. Pet. 15–16. Patent Owner asserts “that a POSA for purposes of the ’087 Patent would have had at least an M.D. and several years of experience treating patients with hematological malignancies (i.e., blood cancers).” Prelim. Resp. 13. Patent Owner asserts “Petitioner’s definition fails to require experience specific to hematological malignancies or blood cancers. Patent Owners’ definition of a POSA, on the other hand, accounts for the claims’ focus on lymphoma and leukemia.” Id. at 14. At this stage in the proceeding, we find that Patent Owner’s analysis more precisely establishes the level of ordinary skill in the art as it directly relates to those deciding prescribing information based on the prior art reference. See Ex. 1011, 2. The level of ordinary skill in the art usually is evidenced by the prior art references themselves. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995).” slip op. at 5
- Disclosure Requirements (§112) › Written description (Ariad)Entitled to earlier dateNot entitled to earlier dateMixed
“reasonable likelihood that claims 1 and 9 are not entitled benefit of priority to the ’087 or earlier priority Specifications prior to the publication of the November 2018 Venclexta label. Claim 1, for example, recites a GDC-0199 dosing regimen “compris[ing] a dose of 100 mg of GDC-0199 per day, followed by orally administering to the patient a dose of 200 mg of GDC- 0199 per day, followed by orally administering to the patient a dose of 400 mg of GDC-0199 per day.” This disclosure is not found in a single example, but must be selected from disparate parts of the Specification. “The written description requirement is not met when, as here, the specification provides at best disparate disclosures that an artisan might have been able to combine in order to make the claimed invention.” Flash-Control, LLC v. Intel Corp., 2021 WL 2944592 4 (Fed Cir. 2021) (citing Ariad, 598 F.3d at 1352.)” slip op. at 22
§ 102 anticipation§ 112 disclosureDiscretionary denialPatents in suitUS 11,110,087 - Apple Inc. v. Alivecor, Inc.InstitutedPTAB · Apr 11, 2023 · IPR2022-01562 · APJ David Cotta · IPR · Institution
The Board instituted IPR of claims 1–20 based on three §103 grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- Other 314aDenied
“deny institution. This case is readily distinguishable from OpenSky. In OpenSky, the Director determined that petitioner was formed for no purpose other than to capitalize on a jury verdict awarding significant damages in a patent litigation by extracting payment from one of the parties to that litigation. OpenSky, Paper 102 at 39. The Director also determined that the petitioner was “seeking compensation from both the patent owner and another petitioner in exchange for advocacy against whichever party does not pay,” which the Director characterized as “double-dealing,” suggesting that the “petition was filed purely to extract rents, in either direction, rather than for legitimate purposes.” Id. at 40. Finally, the Director determined that petitioner in the OpenSky case was not “meaningfully pursuing unpatentability grounds.” Id. at 29. Here, there is no evidence remotely paralleling that in OpenSky. Petitioner is a practicing entity with an interest in the subject matter covered by the patent at issue. Patent Owner has not provided any evidence of double-dealing. And the evidence to date suggests that Petitioner fully intends to meaningfully pursue the unpatentability grounds set forth in the Petition.” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“unless 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.” Petitioner has established a reasonable likelihood of prevailing on its assertion that the challenged claims are unpatentable based on the grounds advanced here. We decline to deny the Petition on a discretionary basis as requested by Patent Owner. Thus, for reasons explained below, we institute inter partes review of claims 1–20 of the ’415 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“For purposes of this decision, and consistent with Petitioner’s proposal, we find that a POSA may be a member of an interdisciplinary team including persons with backgrounds in electrical engineering, mechanical engineering, biomedical engineering, computer science, and/or cardiology, and having at least two years of relevant work experience designing, using, or analyzing data from, cardiac monitoring devices.8 This definition is generally consistent with the level of skill reflected in the specification and in 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)). 8 This definition is identical to the definition we applied in the inter partes review challenging U.S. Patent No. 9,572,499, which claims similar subject matter. See IPR2021-00970, Paper 43, 25 (PTAB, Dec. 6, 2022) (Final Written Decision).” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We have considered Petitioner’s arguments with respect to these limitations and do not find them deficient for failure to provide a claim construction. We address these limitations infra § III.E.2 and, for purposes of this Decision, do not find it necessary to expressly construe these claim limitations. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 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))); Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy’”). Nor do we find it necessary to construe any other claim terms. Id. To the extent Patent Owner contends an express claim construction of these limitations, or any other claim limitations, would be helpful, Patent Owner is invited to brief the issue in its Response.” slip op. at 14
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,159,415 - Apple Inc. v. Alivecor, Inc.InstitutedPTAB · Apr 11, 2023 · IPR2022-01560 · APJ David Cotta · IPR · Institution
The Board instituted IPR on claims 1–21, finding a reasonable likelihood that the challenged claims would have been obvious over the asserted combinations.
RulingsInstitution decision- Other 314aDenied
“We decline to exercise our discretion under 35 U.S.C. § 314(a) to deny institution. This case is readily distinguishable from OpenSky. In OpenSky, the Director determined that petitioner was formed for no purpose other than to capitalize on a jury verdict awarding significant damages in a patent litigation by extracting payment from one of the parties to that litigation. OpenSky, Paper 102 at 39. The Director also determined that the petitioner was “seeking compensation from both the patent owner and another petitioner in exchange for advocacy against whichever party does not pay,” which the Director characterized as “double-dealing,” suggesting that the “petition was filed purely to extract rents, in either direction, rather than for legitimate purposes.” Id. at 40. Finally, the Director determined that petitioner in the OpenSky case was not “meaningfully pursuing unpatentability grounds.” Id. at 29. Here, there is no evidence remotely paralleling that in OpenSky. Petitioner is a practicing entity with an interest in the subject matter covered by the patent at issue. Patent Owner has not provided any evidence of double-dealing. And the evidence to date suggests that Petitioner fully intends to meaningfully pursue the unpatentability grounds set forth in the Petition.” slip op. at 11
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“unless 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.” Petitioner has established a reasonable likelihood of prevailing on its assertion that the challenged claims are unpatentable based on the grounds advanced here. We decline to deny the Petition on a discretionary basis as requested by Patent Owner. Thus, for reasons explained below, we institute inter partes review of claims 1–21 of the ’956 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“For purposes of this decision, and consistent with Petitioner’s proposal, we find that a POSA may be a member of an interdisciplinary team including persons with backgrounds in electrical engineering, mechanical engineering, biomedical engineering, computer science, and/or cardiology, and having at least two years of relevant work experience designing, using, or analyzing data from, cardiac monitoring devices.10 This definition is generally consistent with the level of skill reflected in the specification and in 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 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We have considered Petitioner’s arguments with respect to the “receiving heart rate . . .” limitations of claims 1 and 12 and do not find them deficient for failure to provide a claim construction. We address these limitations infra § III.E.2 and, for purposes of this Decision, do not find it necessary to expressly construe these claim limitations. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 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))); Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy’”). Nor do we find it necessary to construe any other claim terms. Id. To the extent Patent Owner contends an express claim construction of the “receiving the heart rate . . .” limitations, or any other claim limitations, would be helpful, Patent Owner is invited to brief the issue in its Response.” slip op. at 15
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 9,420,956
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.