- PTAB · Oct 23, 2025 · IPR2025-00989 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on all challenged claims based on the asserted grounds, finding a reasonable likelihood of success on the Schaffer-Hartley and Schaffer-Eller combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’291 patent’s challenged claims. We institute inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63 (2018); 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”). Findings and conclusions at this stage are preliminary and based on the current record. Any final decision will be based on a full trial record.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“We agree with Patent Owner that Petitioner’s proposed POSA definition lacks specificity. That definition, if interpreted generically, could mean that a person may qualify as a POSA if they had, for example, a B.S. in mechanical engineering and only two years of experience designing or engineering any type of product in any field. That is too broad. We find that a POSA would have had the agreed-upon educational credentials—an undergraduate degree in mechanical engineering or a related engineering discipline. Ex. 1003 ¶ 36; Ex. 2001 ¶ 73. We find that a POSA would also have had 2–4 years of design or engineering experience related to products in the field of the invention, which involves endovascular devices and the surgical procedures that use such devices. Ex. 1001, 1:24–60 (background of the invention). Such devices include, but are not necessarily limited to, hemostasis valves and catheters for minimally-invasive vascular surgeries. Id. And, consistent with the testimony of the parties’ experts, the POSA need not have had firsthand experience designing hemostasis valves. See, e.g., Ex. 1029 (Zalesky Tr.), 72:11–73:7 (testifying direct experience “designing” hemostasis valves or aspiration catheters is not necessary, but “general experience with vascular devices and procedures” is required); Ex. 2006 (Thornton Tr.), 180:13–19. Further, as Dr. Zalesky testified, the POSA’s experience related to developing such devices “could be as simple as bench testing and looking at clinical data.” Ex. 1029, 74:5–75:1. Lastly, a POSA would have had an” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“As noted above, the challenged claims require a “filament formed in a loop around the tubular sidewall” where, when a portion of the filament is pulled away from the loop, the loop’s diameter reduces, thereby reducing the diameter of the lumen formed by the tubular sidewall to seal the valve. See supra Section II.D. Every embodiment in the ’291 patent where the filament is described as forming a “loop” in the manner claimed involves a filament that is necessarily flexible. See, e.g., Ex. 1001, 13:17–29, Figs. 6–7. The valve would not work if the looped filament were somehow inflexible— pulling an end of the filament would not change the diameter of the loop, and the valve would not seal. Ex. 2001 ¶ 65 (testifying “a loop in a rigid component would necessarily be fixed in size” and the “inherent property of flexibility is essential to the loop structure of the claims”); Ex. 1023, 16–17” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We are unpersuaded that Schaffer describes a valve with a filament as claimed. If, as construed above (supra Section III.C), the filament requires flexibility, Petitioner has not demonstrated that Schaffer describes such a feature in its valves. Instead, we agree with Patent Owner that a POSA would more likely understand Schaffer’s two U-shaped actuating members as being rigid features. Prelim. Resp. 33–36. We agree with Patent Owner that Petitioner implicitly admits that Schaffer’s actuating members are rigid leakage around tools inserted through the central lumen when in use and compared to the use of a flexible string or wire (of Hartley or Eller). Prelim. Resp. 34 (citing Pet. 51). We also find Dr. Zalesky’s interpretation of Schaffer more plausible than Mr. Thornton’s on the question of whether a POSA would have regarded Schaffer’s actuating members as being rigid structures. Ex. 2001 ¶¶ 78–85 (testifying, inter alia, that a POSA would have understood from Schaffer’s disclosure about making the actuator and actuating members from machining pre-existing amounts of metals and/or plastics, and further explaining that flexible parts would deform and be difficult to machine through conventional techniques); Ex. 1005 ¶¶ 81–82. Mr. Thornton opines that Schaffer’s disclosed manufacturing techniques for the actuator/actuating members are only examples and “a person of ordinary skill in the art could have simply purchased pre-made [flexible] flat wire or plastic tapes or ribbons.” Ex. 1003 ¶ 96. Such opinion invokes, at best, obviousness-based reasoning. This does not establish that Schaffer alone describes a filament sufficient to anticipate the claims. Furthermore, Mr. Thornton’s opinion that a POSA “would have understood that Schaffer’s U-shaped actuating members would have preferably been formed from a thin, flexible material” finds no support in Schaffer itself. Ex. 1003 ¶ 95. This opinion is also at odds with his testimony in related cases about an alleged formation of gaps with Schaffer’s actuating members, which suggested those members had a set “size” and lacked flexibility. See IPR2025-01157 (Ex. 1003 ¶ 81 (testifying a POSA “would have recognized that Hartley’s flexible string may better seal the valve than Schaffer’s metallic/plastic actuating members” because, “if a tool did not fit the size of” slip op. at 31
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,865,291 - PTAB · Oct 10, 2025 · IPR2025-00728 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on all challenged claims and all five grounds, finding a reasonable likelihood of success based on at least one claim, including claim 1 over Hartley and Eller.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’921 patent’s challenged claims.1 We institute inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63 (2018); 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”). Findings and conclusions at this stage are preliminary and based on the current record. Any final decision will be based on a full trial record.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“We agree with Patent Owner that Petitioner’s proposed POSA definition lacks specificity. That definition, if interpreted generically, could mean that a person may qualify as a POSA if they had, for example, a B.S. in mechanical engineering and only two years of experience designing or engineering any type of product in any field. That is too broad. We find that a POSA would have had the agreed-upon educational credentials—an undergraduate degree in mechanical engineering or a related engineering discipline. Ex. 1003 ¶ 35; Ex. 2024 ¶ 61. We find that a POSA would also have had 2–4 years of design or engineering experience related to products in the field of the invention, such devices. Ex. 1001, 1:16–54 (background of the invention). Such devices include, but are not necessarily limited to, hemostasis valves and catheters for minimally-invasive vascular surgeries. Id. And, consistent with the testimony of the parties’ experts, the POSA need not have had firsthand experience designing hemostasis valves. See, e.g., Ex. 1037 (Zalesky Tr.), 72:11–73:7 (testifying direct experience “designing” hemostasis valves or aspiration catheters is not necessary, but “general experience with vascular devices and procedures” is required); Ex. 2030 (Thornton Tr.), 180:13–19. Further, as Dr. Zalesky testified, the POSA’s experience related to developing such devices “could be as simple as bench testing and looking at clinical data.” Ex. 1037, 74:5–75:1. Lastly, a POSA would have had an understanding of such devices’ design requirements as determined by the needs of the physician, patient, and procedure, which understanding may be informed by work experience and/or study. Ex. 2030, 24:5–21.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“That does not, however, address the dispute about “flexibility.” On that issue, the argument and evidence at this stage tends to favor Patent Owner’s position that a “filament” as claimed is flexible. which include claim 1’s recitation of an “active tensioning mechanism” comprising the filament and the Specification’s description of a filament that can be both “loosened” and “tightened.” Prelim. Resp. 14–16 (citing, e.g., Ex. 1001, 9:36–37, 9:53–56 (teaching “the filament 150 is tightened” when the actuator buttons are released and “the filament 150 is loosened” when the buttons are pressed to open the valve)); see also Ex. 2025, 1288 (defining “tension” as to “tighten to a desired or appropriate degree”). These descriptions from the patent appear at this stage more consistent with the view that the filament is characteristically flexible, not rigid. So too, as we explained in related matters, the ’921 patent’s loop embodiments (where the filament forms one or more loops like depicted and described in Figures 6–7) require a flexible structure. See, e.g., Ex. 2032, 15–16 (explaining that the device would not work to constrict the tubular sidewall and lumen (analogous to the elongate member defining a lumen of the claims here) if the filament forming the loop(s) was inflexible); Ex. 1001, Figs. 6–7 (filament 150, with sub-filaments 150-A and 150-B). Although flexibility of the filament in the patent’s “bight” embodiments (e.g., as shown in Figures 8 and 9) is not manifestly clear, there is a dearth of evidence from Petitioner—either intrinsic or extrinsic to the patent— showing why a POSA would have understood the bights as embracing rigid structures. See Ex. 1001, Figs. 8–9 (similar to the loop embodiments, depicting structures 150-A and 150-B forming sub-filaments of the bight(s)). Moreover, as admitted by Petitioner’s expert, that a filament may be made from various materials described in the patent (e.g., synthetics or metals) does not, absent more information, lead to a conclusion that a filament is “rigid.” Ex. 2030, 125:2–126:4 (testifying “the relative stiffness or rigidity” slip op. at 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“Based on the current record, we are unpersuaded that Schaffer describes a valve with a filament as claimed. If, as construed above (supra Section III.C), a filament requires flexibility, Petitioner has not demonstrated that Schaffer describes such a feature in its valves. Instead we agree with Patent Owner that Petitioner “implicitly admits” that Schaffer’s actuating members are rigid insofar as Petitioner argues those members would form gaps for fluid leakage around tools inserted through the central lumen when in use and compared to the use of a flexible string or wire (of Hartley or Eller). Prelim. Resp. 29 (citing Pet. 36). Moreover, we find Dr. Zalesky’s interpretation of Schaffer more plausible than Mr. Thornton’s on the question of whether a POSA would have regarded Schaffer’s actuating members as being substantially rigid structures. Ex. 2024 ¶¶ 92–100 (testifying, inter alia, that a POSA would have understood from Schaffer’s disclosure about making the actuator and actuating members from machining pre-existing amounts of metals and/or plastics, and further explaining that flexible parts would deform and be difficult to machine through conventional techniques); Ex. 1005 ¶¶ 81–82. Mr. Thornton testifies that Schaffer’s disclosed manufacturing techniques for the actuator/actuating members are only examples and “a [and flexible] flat wire or plastic tapes or ribbons.” Ex. 1003 ¶ 79. Such testimony invokes, at best, obviousness-based reasoning. This does not establish that Schaffer alone describes a filament sufficient to anticipate the claims. Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1296 (Fed. Cir. 2002) (explaining that the “test for novelty” requires “strict identity”); Jamesbury Corp. v. Litton Indus. Prods., Inc., 756 F.2d 1556, 1560 (Fed. Cir. 1985) (holding “anticipation is not shown by a prior art disclosure which is only ‘substantially the same’ as the claimed invention”), overruled on other grounds, A.C. Aukerman Co. v. R.L. Chaides Constr. Co., 960 F.2d 1020 (Fed. Cir. 1992) (en banc). Because we determine on this preliminary record that Schaffer does not describe a valve comprising a “filament” as claimed, Schaffer cannot anticipate the challenged claims.” slip op. at 26
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,844,921 - Ajinomoto Co., Inc. v. Abtis Co., Ltd.InstitutedPTAB · Aug 8, 2025 · IPR2025-00283 · APJ Lilan Ren · IPR · Institution
The Board instituted IPR on claim 11, finding a reasonable likelihood it would be shown unpatentable under § 102 over CA959 and under § 103 over the listed combinations.
RulingsInstitution decision- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther
“In this case, claim 11, as it is currently written, depends from claim 1 and therefore requires that all of the limitations of claim 1, including the negative limitation of claim element 1.d, have written description support in negative limitation must be supported through an “express disclaimer or independent lexicography in the written description.” Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314, 1323 (Fed. Cir. 2003). The parties agree that “the applications underlying the ’675 Patent are entirely silent regarding terminal aldehyde groups.” Pet. 17; see Prelim Resp. 9–10. Patent Owner’s argument that these underlying applications reasonably convey possession to a POSA does not cite to evidence in the record as support. See Prelim Resp. 9. Patent Owner argues that the specific structures recited in claim element 11.a “necessarily exclude[] the terminal groups contained in the negative limitation” (id. at 9–10) but does not sufficiently explain why there is the requisite “express disclaimer or independent lexicography” (Omega Eng’g, 334 F.3d at 1323) to exclude only these particular terminal functional groups but not others. Although the scope of claim 11 is limited to those structures specifically recited, the record before us does not sufficiently show why the inclusion of these structures in element 11.a excludes only the particular terminal functional groups in the negative limitation but not others. We preliminarily determine, based on the record before us, that Petitioner has adequately established that the provisional application does not provide written description support for claim 11 as it is currently written. Accordingly, at this stage of the proceeding, Petitioner has sufficiently 11 We note that Patent Owner represents that, “[t]o the extent the Board is inclined to hold that current Claim 11 is not adequately supported by the specification due to the negative limitation recited in disclaimed Claim 1, Patent Owner intends to amend Claim 11 into independent form and remove the reference to the negative limitation.” Prelim. Resp. 11 n.4. 2023, which is the filing date of the application that issued as the ’675 patent, for purposes of institution.” slip op. at 14
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedDecided for petitioner
“In this case, claim 11, as it is currently written, depends from claim 1 and therefore requires that all of the limitations of claim 1, including the negative limitation of claim element 1.d, have written description support in negative limitation must be supported through an “express disclaimer or independent lexicography in the written description.” Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314, 1323 (Fed. Cir. 2003). The parties agree that “the applications underlying the ’675 Patent are entirely silent regarding terminal aldehyde groups.” Pet. 17; see Prelim Resp. 9–10. Patent Owner’s argument that these underlying applications reasonably convey possession to a POSA does not cite to evidence in the record as support. See Prelim Resp. 9. Patent Owner argues that the specific structures recited in claim element 11.a “necessarily exclude[] the terminal groups contained in the negative limitation” (id. at 9–10) but does not sufficiently explain why there is the requisite “express disclaimer or independent lexicography” (Omega Eng’g, 334 F.3d at 1323) to exclude only these particular terminal functional groups but not others. Although the scope of claim 11 is limited to those structures specifically recited, the record before us does not sufficiently show why the inclusion of these structures in element 11.a excludes only the particular terminal functional groups in the negative limitation but not others. We preliminarily determine, based on the record before us, that Petitioner has adequately established that the provisional application does not provide written description support for claim 11 as it is currently written. Accordingly, at this stage of the proceeding, Petitioner has sufficiently 11 We note that Patent Owner represents that, “[t]o the extent the Board is inclined to hold that current Claim 11 is not adequately supported by the specification due to the negative limitation recited in disclaimed Claim 1, Patent Owner intends to amend Claim 11 into independent form and remove the reference to the negative limitation.” Prelim. Resp. 11 n.4. 2023, which is the filing date of the application that issued as the ’675 patent, for purposes of institution.” slip op. at 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Reference is prior artInstituted
“1. CA959 The parties agree that CA959 is entitled to the same priority date as the provisional application, filed on March 8, 2019. Pet. 22; Prelim. Resp. 5. The parties agree that CA959 and ’675 patent contain essentially identical disclosures. Pet. 16; see Prelim. Resp. 9. 2. Analysis of Ground 1 At this stage of the proceeding, Patent Owner does not address Petitioner’s specific contentions with respect to the limitations of claim 11 (Pet. 31–34, 37). See generally Prelim. Resp. Based on our determination supra that claim 11 of the ’675 patent is entitled to the January 16, 2023 priority date and based on our review and consideration of the current record with regard to the alleged anticipation by CA959, we determine that Petitioner has sufficiently shown that CA959 discloses all elements of claim 11 for purposes of institution. See Pet. 31–34, 37 (and evidence cited therein). Based on the reasons provided supra, we determine that the information presented in the Petition demonstrates a reasonable likelihood of showing that claim 11 is anticipated under 35 U.S.C. § 102 by CA959.” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Patent Owner does not cite any authority stating that in a proper obviousness analysis under 35 U.S.C. § 103, there is a bright line test for the frequency at which the phrase “motivation to combine” (or similar phrases) is repeated in the petition and/or testimony. Patent Owner’s argument regarding the purportedly low frequency in which Petitioner and/or Dr. Tumey uses such phrases (see Prelim. Resp. 12) does not rebut Petitioner’s testimonial and other evidence in support of Petitioner’s arguments regarding motivation. For example, Dr. Tumey testifies that as of 2019, “there was an expectation that site-specific conjugation would decrease off-target toxicity and improve the pharmacokinetic properties of the ADC, and thus there was a clear motivation in the art to pursue technologies that allowed site-specific conjugation.” Ex. 1002 ¶ 60. Dr. Tumey cites as support Exhibit 1027, which is an article titled “Antibody-Drug Conjugate-Based Therapeutics: State of the Science” in the Journal of the National Cancer Institute. Ex. 1002 ¶ 60 (citing Ex. 1027, pg. 538); Ex. 1027.” slip op. at 21
§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 11,896,675 - PTAB · May 23, 2025 · IPR2025-00195 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on all challenged claims based on the petition’s grounds, finding a reasonable likelihood of success on at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Inter partes review may not be instituted unless there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. See 35 U.S.C. § 314(a). For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’998 patent’s challenged claims. We institute inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63 (2018).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“(“POSA”) at the relevant time “would have had a bachelor’s degree in Electrical Engineering, Mechanical Engineering, or a similar discipline with at least one year of experience with portable electronic devices,” and that “[m]ore education can substitute for practical experience and vice versa.” Pet. 6 (citing Ex. 1003 ¶¶ 23–25). Patent Owner does not at this time dispute Petitioner’s definition of the POSA’s skill level. Prelim. Resp. 14. We apply Petitioner’s proposed POSA level, which appears to be generally consistent with the cited prior art.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“At this time, express claim interpretation is not needed to resolve the controversy. According to Patent Owner, “claim construction is unnecessary at this stage because the prior art fails to invalidate under any reasonable construction of the claims.” Prelim. Resp. 14. Patent Owner does not, however, challenge Petitioner’s contentions under any of Grounds 1–5 that the asserted prior art teaches or suggests the claimed subject matter. Patent Owner’s counterargument at this time is limited to whether the asserted references qualify as prior art. See, e.g., id. at 510 (arguing most of Petitioner’s references (e.g., Downey) “fail to qualify as prior art due to their 9 Unless otherwise stated, emphases appear in the cited paper or evidence. 10 Patent Owner’s Preliminary Response includes an initial unnumbered page and the second page is numbered page “6.” The unnumbered page is, therefore, cited herein as page “5.” according to Patent Owner) or “due to insufficient evidence of public availability (in the case of Ohgi).”). We address this counterargument, which does not turn on a dispute about the meaning of any claim terms, below. See infra Sections III.D and III.G.11 Regarding Petitioner’s contention of “ambiguity” in the phrase “each of the measurements” in claims 1 and 8, Patent Owner states only that “there is no ambiguity.” Prelim. Resp. 14. If Patent Owner believes that either of Petitioner’s suggested “broader” or “narrower” interpretations of the phrase is incorrect, or if Patent Owner wants to propose another interpretation altogether, Patent Owner may address such issues in its Response during trial. And, should it elect to do so, Patent Owner will have the opportunity at trial to explain why the claims do not read on the asserted art under any interpretation advanced by Petitioner or proposed by Patent Owner.” slip op. at 12
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“sufficient written description support in either the ’315 PCT Application or the ’422 Provisional for a sensing unit that comprises a compass. The ’315 PCT Application (and similarly the ’422 Provisional) describes the sensing unit as “includ[ing] accelerometer means and gyroscope means” and that a processor is adapted to receive from a sensing unit having those features (i.e., an accelerometer and gyroscope) measurements from which data indicative of a training activity can be calculated. See, e.g., Ex. 1005, 5:13–19, 5:30–33; Ex. 1004, 5:2–28, 12:2–31. Patent Owner identifies no express or inherent disclosure of a compass in the priority applications filed before March 11, 2009. It seems all “compass” disclosures were added only when the CIP application that issued as the ’998 patent was filed. Compare, e.g., Ex. 1001, 10:23–29, 50– 59 (new or revised paragraphs adding references to a compass), with Ex. 1005, 14 (no corresponding paragraphs or descriptions of a compass). That a compass might be “compatible” with devices described in the ancestral applications or even provide alleged benefits (e.g., mitigating a swimmer’s “drift” compared to a fixed external reference, as argued by Patent Owner) misses the point. Prelim. Resp. 12–13; Paper 9, 1–2. To obtain the priority benefit of the ancestral applications’ filing dates, those applications must describe the invention of the challenged claims. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1571 (Fed. Cir. 1997) (explaining that, to claim “the benefit of the filing date of an earlier application under 35 U.S.C. § 120, each application in the chain leading back to the earlier application must comply with the written description requirement of 35 U.S.C. § 112”). And whether it might have been obvious to add a compass is not the proper inquiry. Ariad Pharm., Inc. v. Eli Lilly description that merely renders the invention obvious does not satisfy the [written description] requirement”).” slip op. at 17
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 7,980,998 - PTAB · Apr 22, 2025 · IPR2025-00156 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–9 under all seven grounds, finding a reasonable likelihood of success on at least one claim based on the Schaffer–Hartley and Schaffer–Eller combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’012 patent’s challenged claims. We institute inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63 (2018).” slip op. at 2
- Skill levelSkill level petitioner adoptedOther
“B. Level of Ordinary Skill in the Art Petitioner proposes that the person of ordinary skill in the art (“POSA”) in September 2017 “would have had an undergraduate degree in mechanical engineering or a related engineering discipline and 2–4 years of product design or engineering experience.” Pet. 15 (citing Ex. 1003 ¶ 35). Patent Owner provides no alternative definition of the POSA’s qualifications and, instead, applies Petitioner’s definition in its Response. Prelim. Resp. 21. obviousness precedents cited herein remain applicable despite this change in the timing of the obviousness inquiry. 9 Petitioner states that it is not aware of any objective indicia of nonobviousness (Pet. 94) and Patent Owner’s Preliminary Response does not provide argument about any objective indicia. level appears to be reasonable and consistent with the cited prior art.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“several threads, lines, cords, robes, ribbons, flat wires, sheets, or tapes. The Specification supports such interpretation. Ex. 1001, 9:21–23. Nevertheless, as Patent Owner argues, Petitioner’s interpretation is incomplete and does not address persuasively the dispute raised here— whether the “filament,” as recited in claim 1, requires flexibility. Based on the parties’ arguments at this preliminary stage, we agree with Patent Owner that flexibility is necessary. The claims, as understood by the POSA, suggest that the filament must be flexible. Claim 1 “recites that ‘the first filament [is] formed into a loop around the collapsible tubular sidewall” and that the “diameter of the valve lumen decreases in response to reducing a diameter of the loop.” See supra Section II.D. As Dr. Zalesky credibly explains “[t]o ‘reduc[e] a diameter of the loop,’ the filament must be ‘flexible’ because if it were rigid or inflexible the loop would retain the same diameter when acted on by the first actuator.” Ex. 2001 ¶ 58 (“This inherent property of flexibility is essential to the loop structure of the claims.”). We observed essentially the same principle in the related 1157 IPR for embodiments where the filament forms a “loop” around the collapsible tubular member, such as shown in Figure 6 of the patent. IPR2024-01157, Paper 7 at 16 (“Thus, in the above embodiment [(shown in Fig. 6)] a flexible filament is required (i.e., a the loop to constrict and seal the valve).”).11” slip op. at 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“22:10. Petitioner contends that, as a general rule, a preamble does not limit the scope of a claim, and that the preamble term “aspiration” here merely describes a non-limiting “intended use” of an otherwise structurally-complete invention defined by the body of the claim. Pet. 18–19. Patent Owner responds that whether the term “aspiration” limits claim 1 is “not germane to Patent Owner’s arguments here.” Prelim. Resp. 21. We need not decide at present if “aspiration” in the preamble phrase “aspiration catheter” is limiting. No dispute at this stage turns on whether “aspiration” is limiting, or on that term’s meaning. Realtime Data, 912 F.3d necessary to resolve matters in dispute).” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,697,012 - PTAB · Apr 17, 2025 · IPR2024-01473 · APJ Michael A Valek · IPR · Institution
The Board instituted IPR on claims 1–4, 6, 7, 17, and 22–25 because Petitioner showed a reasonable likelihood of prevailing on at least one challenged claim, including its Cai-based grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Considering the arguments and evidence currently of record, we determine the Petition demonstrates “a reasonable likelihood that [P]etitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Accordingly, we institute inter partes review of claims 1–4, 6, 7, 17, and 22–25 of the ’360 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“At this stage, we find Petitioner’s description of the level of ordinary skill in the art to be sufficient. According to the ’360 patent, “[t]he field of the invention is related to sensor arrays for the detection and diagnosis of disease states.” Ex. 1001, 1:28–29. The Specification describes accomplishing such by analysis of protein coronas using techniques such as LC-MS/MS. See id. at 4:43–5:2 (describing Figure 1). The prior art cited by Petitioner also describes the analysis of protein coronas using similar analytical techniques. See, e.g., Ex. 1005, 584; Ex. 1007, 1870; Ex. 1008, 355–356. Accordingly, the present record supports that a POSA would have an understanding of both proteins and the analytical techniques, e.g., mass spectrometry, that can be used to characterize them. We understand Petitioner’s definition of a POSA to encompass these elements. It requires a formal degree in chemistry,5 which itself entails some knowledge of proteins and related analytical techniques, along with several years’ additional experience in proteomics, protein analysis, or mass spectrometry. Moreover, Petitioner’s definition is flexible in that it allows higher education or skill with, e.g., mass spectrometry, to make up for a lack of specific experience with proteomics assay and protein coronas. This explanation is reasonable and supported on the current record.” slip op. at 8
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Third, and perhaps most importantly, there is “no requirement for perfect match between an expert’s experience and the relevant field.” See Consolidated Trial Practice Guide (Nov. 2019) 34, available at https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf (“CTPG”). (citing SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010)). A person need not be a person of ordinary skill in the art to testify as an expert under Federal Rule of Evidence 702, but rather must be “qualified in the pertinent art.” Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1363–64 (Fed. Cir. 2008). Here, there is no dispute that Dr. Vargas is qualified in the art of mass spectrometry and, on the current record, we discern no reason why she is not qualified to offer the testimony in her declaration. At most, Patent Owner’s argument that Dr. Vargas lacks experience “perform[ing] mass spectrometry techniques specifically for protein analysis,” goes to the weight we should afford her testimony at trial. See Prelim. Resp. 28–29. It is not a sufficient reason to deny institution, particularly given that Dr. Vargas’s testimony is only part of the showing offered in support of the Petition. 6 Patent Owner’s narrow characterization of Dr. Vargas’s experience (see Prelim. Resp. 28–29) is arguably inconsistent with the description in her CV (Ex. 1004). In any event, Patent Owner will have an opportunity to examine Dr. Vargas regarding her qualifications.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner “submits that no express construction of terms is necessary.” Pet. 15. Patent Owner agrees no construction is needed at this stage. See Prelim. Resp. 26. We agree that no formal claim construction is necessary for this decision. 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)). To the extent we have concerns regarding the parties’ apparent interpretation of the claim language, or in some instances Patent Owner’s attempt to read-in unrecited limitations, we address those arguments below.” slip op. at 11
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,435,360 - PTAB · Jan 23, 2025 · IPR2024-01157 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–9 across all petition grounds, finding a reasonable likelihood of success on at least one claim, including anticipation of claim 1 by Schaffer.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’011 patent’s challenged claims. We institute inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355 (2018).” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“We need not at this time expressly construe the term “filament” in the manner urged by Petitioner. We agree with Petitioner that a filament as claimed encompasses one or more threads, lines, cords, ropes, ribbons, flat wires, sheets, or tapes. The ’011 patent lists those structures explicitly, but suggests those are only examples and, thus, the term “filament” may be broader than those structures. Ex. 1001, 9:18–20 (“In some embodiments, the filament 150 can comprise one or several threads, lines cords, rope, ribbon, flat wire, sheet, or tape.”) (emphasis added). As noted above, Patent Owner also does not disagree that the claimed “filament” encompasses the listed structures. We need only construe terms to the extent necessary to resolve the controversy. Realtime Data, 912 F.3d at 1375.” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“[T]he dispositive question regarding anticipation [i]s whether 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)) (emphasis omitted). “Because the hallmark of anticipation is prior invention, the prior art reference—in order to anticipate under 35 U.S.C. § 102—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, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008) (internal quotation marks omitted). slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“have been motivated to combine Schaffer and Hartley with a reasonable expectation of success. Pet. 35–40. For example, according to Petitioner, a POSA would have regarded a substitution of Schaffer’s U-shaped members for Hartley’s string as little more than a substitution of known hemostasis-valve features with known (and similar) functions to yield a predictable result. Pet. 35–36. Petitioner’s position is supported by Mr. Thornton’s testimony (unrebutted at present) that, in the field of fluid stasis valves, “[t]here were a finite number of ways to compress the resilient material in a stasis valve to create a seal in September 2017” and “Hartley and Schaffer disclose two such methods” that operate in similar and predictable ways to constrict the central lumen to form a seal. Ex. 1003 ¶¶ 82–83. We agree at this time that the proposed technique for coupling Hartley’s string to Schaffer’s actuator buttons would have been a “simple modification” within the ordinary capabilities of the skilled artisan. Id. ¶ 84 (noting a “simple” knotting attachment); see also Ex. 1007, 14:37–54 (suggesting skilled flexible wire to an actuator or housing of a fluid stasis valve). We also agree with Petitioner at this time that the POSA would have considered a more flexible filament (e.g., Hartley’s string or Eller’s wire) as providing expected benefits insofar as such a filament may more precisely and uniformly constrict the lumen against inserted tools of different sizes and shapes. Ex. 1006 ¶ 37 (Hartley’s string can “close over a range of diameters of devices passed through the valve or can close completely down and be self sealing”); Ex. 1003 ¶¶ 80–81.” slip op. at 36
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,697,011 - PTAB · Jan 13, 2025 · IPR2024-01156 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted inter partes review of claims 1–30 on all grounds, finding it more likely than not that the claims are unpatentable.
RulingsInstitution decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“On the current record, there is no controversy over the meaning of any of the claim terms and neither party identifies a claim construction that would impact our analysis. We therefore find that, at this stage of the proceeding, there are no terms that need claim construction. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 7
- Skill levelSkill level petitioner adoptedDecided for petitioner
“VIII. LEVEL OF ORDINARY SKILL IN THE ART Petitioner asserts (without opposition): A person of ordinary skill in the art (“POSA”) at the time of invention would have a working knowledge of microbiology and would have been involved in developing testing methodologies for analysis of samples such as food products (“validation methodologies”). The POSA would most likely have an advanced degree in microbiology, food science, or animal science and at least two years of work experience but may alternatively have a bachelor’s degree in those areas and at least four years of experience with validation methodologies. The POSA would have been familiar with relevant scientific literature and industry regulations, directives, and guidelines relating to validation methodologies.” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Determining whether claims are anticipated involves a two-step analysis. The first step involves construction of the claims of the patent at issue. Claim construction is a question of law reviewed de novo.” In re Aoyama, 656 F.3d 1293, 1296 (Fed.Cir.2011). “The second step [of an anticipation analysis] involves comparing the claims to the prior art. Anticipation is a question of fact reviewed for substantial evidence.” In re Aoyama, 656 F.3d at 1296. “A prior art reference anticipates a patent claim under 35 U.S.C. § 102(b) if it discloses every claim limitation.” In re Montgomery, 677 F.3d 1375, 1379 (Fed. Cir. 2012). A reference may anticipate inherently if a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010). slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“The motivation-to-combine analysis is a flexible one. “[A]ny need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed,” [but the] “analysis ‘need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.’” Intel Corp. v. PACT XXP Schweiz AG, 61 F.4th 1373, 1379–80 (Fed. Cir. 2023) (quoting KSR, 550 U.S. at 418, 420 (emphasis added)). “[I]f there’s a known technique to address a known problem using ‘prior art elements according to their established functions,’ then there is a motivation to combine,” because KSR explains that “if a technique has been used to improve one device [or method], and a person of ordinary skill in the art would recognize that it would improve similar devices [or methods] in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” Id. at 1380 (quoting KSR, 550 U.S. at 417; and Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 797 (Fed. Cir. 2021)). If addressing a known problem, the prior art combination need not be “the best option, only . . . a suitable option.” Id. (quoting Intel, 21 F.4th at 800 (emphasis original)).” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,845,486 - 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 - 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
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.