- PTAB · Aug 13, 2024 · IPR2024-00467 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on all challenged claims based on the asserted obviousness ground over Gil, Norden, Dean, Alphagan, and Federal Register.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Advanced Bionics, 8. As explained above, during prosecution of the ’245 patent, the examiner issued a nonstatutory double patenting rejection because the claims were “not patentably distinct from” the ’742 patent claims.13 See supra Section I.H (citing Ex. 1010, 96). Petitioner argues that “[i]t was material error for the Examiner to both acknowledge that the ’245 claims were patentably indistinct from the ’742 claims and yet ignore the FWD and allow the claims despite the Board’s prior findings.” We find Petitioner’s argument persuasive. To determine whether Petitioner has sufficiently shown material error, we look at, for example, “the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection.” Advanced Bionics, 9 (citing Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8, 10–11 (Dec. 15, 2017)). Petitioner asserts Gil, Norden, Dean, Alphagan, and Federal Register in this” slip op. at 18
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“previously denied its motion to stay. Ex. 2029. Thus, factor 1 weighs in favor of denying institution.” slip op. at 21
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We agree with Patent Owner. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to expressly construe any claim term. Patent Owner appears to suggest, although it does not explicitly argue, that the claims require “a single drop of [0].025% brimonidine.” See Prelim. Resp. 6; see also id. at 27 (arguing Gil is “with multi-dosed 0.03% brimonidine”); id. at 28 (arguing Dean is with “multi-dosed concentrations”). To the extent our understanding is correct, Patent Owner should expressly discuss at trial any construction that would so limit the claim. Such discussion should be set forth in a separate section of a response, if filed, designated for claim construction; claim construction positions should not be merely included in arguments over the merits on patentability.” slip op. at 24
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Level of Ordinary Skill in the Art Petitioner asserts that: A person of ordinary skill in the art (“POSA”) would have been a composite person (or team) that included a medical doctor and pharmaceutical formulator. EX-1014, ¶¶60-61; EX-1013, ¶¶16, 22-24. The medical doctor would be an ophthalmologist with at least three to four years of experience in clinical trials and FDA regulation of eye products and would have experience in the use of topical brimonidine and apraclonidine and topical vasoconstrictors such as naphazoline and tetrahydrozoline. EX-1014, ¶60. The pharmaceutical formulator would have a doctorate in pharmaceutics or a related degree and at least three to five years of experience developing eye drop formulations for clinical trial and regulatory approval. EX-1013, ¶16. Pet. 16–17. Patent Owner does not, at this point, dispute this proposed definition of the ordinarily skilled artisan. See generally Prelim. Resp. For purposes of this Decision, we adopt Petitioner’s definition of the person of ordinary skill in the art as it appears consistent with the skill level reflected in the prior art of record and the disclosure of the ’245 patent.” slip op. at 24
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 11,833,245 - PTAB · Jun 13, 2024 · IPR2024-00269 · APJ Robert J Silverman · IPR · Institution
The Board instituted IPR on claims 1, 2, 4, 5, 7, 8, 10, 12, 17, and 18 based on both § 103 grounds, finding a reasonable likelihood of success.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Provisur proposes, and Weber does not dispute, that a person of ordinary skill in the art of the ’823 patent, at the time relevant for the analysis herein, would have possessed the following background and qualifications: (1) a bachelor’s degree (or equivalent) in mechanical engineering (or a similar field) and at least two years of experience working as an engineer (or similar role) on food processing and/or packaging systems (or in a similar field); or (2) at least seven years of experience working as an engineer (or similar role) on food processing and/or packaging systems (or in a similar field). Pet. 13–14. Provisur’s proposed definition appears to be consistent with the problems and solutions addressed in the ’823 patent and the prior art of 3 US 2016/0023370 A1, pub. Jan. 28, 2016 (Ex. 1004, “Müller”). 4 US 2019/0329438 A1, pub. Oct. 31, 2019 (Ex. 1005, “GEA438”). 5 US 2009/0159631 A1, pub. June 25, 2009 (Ex. 1006, “DePoi”). record. Therefore, for the purposes of this Decision, we adopt Provisur’s characterization of the level of ordinary skill in the art.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Weber’s Preliminary Response does not manifest any claim construction dispute that would bear upon this Decision. Therefore, we need not expressly construe any claim terms at this preliminary stage. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)” slip op. at 7
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“[I]n evaluating the factors,” set forth in Fintiv, “the Board takes a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Fintiv 6 (emphasis added). In view of the following discussion of these factors, under the circumstances as they appear from the present record, the efficiency and integrity concerns, referenced in Fintiv, are best served by not exercising our discretion to deny the Petition without considering the merits. slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. See 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). Under 35 U.S.C. § 314(a), we may not authorize an inter partes review unless the information in the petition and the preliminary response “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons that follow, and solely for the purposes of this Decision, we determine that Grounds 1 and 2 of the Petition (as identified below) satisfy this standard.” slip op. at 15
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,331,823 - PTAB · Jun 13, 2024 · IPR2024-00258 · APJ Carl M Defranco · IPR · Institution
The Board instituted IPR on claims 2, 3, 9, 10, 12, 13, and 16–20, finding a reasonable likelihood that claims 2, 17, and 19 are obvious over Müller and Waffner.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Aside from operability, Weber does not further dispute Provisur’s showing as to how the asserted combination of Müller and Waffner renders obvious the subject matter of independent claims 2, 17, and 19. See Prelim. Resp. 14–24. After analyzing Provisur’s showing, including Provisur’s mapping of the claim elements to Müller and/or Waffner and its reasoning for why one of ordinary skill in the art would have been led to combine their respective teachings (as discussed above), we find that Provisur demonstrates a reasonable likelihood that at least independent claims 2, 17, and 19 are unpatentable as obvious over the combined teachings of Müller and Waffner. See Pet. 28–38 (claim 2), 38–42 (reason to combine), 47–52 (claim 17), 53 (claim 19). Thus, Provisur meets the threshold for institution. At this stage, Weber offers no response to Provisur’s challenge of dependent claims 3, 9, 10, 12, 13, 16, 18, and 20, except presumably to rely on its argument against Provisur’s challenge of their respective base claims 2, 17, and 19. See Prelim. Resp. 14–24. Because Provisur provides an obviousness challenge that satisfies the “reasonable likelihood” threshold with respect to at least the independent claims, we do not address the dependent claims in the absence of any rebuttal from Weber. Further analysis is best left for trial after full development of the record.” slip op. at 11
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“C. Discretionary Denial Under 35 U.S.C. § 314(a) Weber requests that we exercise our discretion under 35 U.S.C. § 314(a) to deny institution due to the advanced state of the parallel Missouri action. See Prelim. Resp. 3–13. Although Provisur argues that discretionary denial is not warranted (Pet. 73–77), it nonetheless submits a Sotera style stipulation (Ex. 1029) in an effort to resolve the issue.8 In light of Provisur’s Sotera stipulation, we will not discretionarily deny institution under § 314(a). See Director Memorandum, Interim Procedure for Discretionary Denials in AIA-Post Grant Proceedings With Parallel District Court Litigation, U.S. PATENT AND TRADEMARK OFFICE (June 21, 2022), at 3, 7.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“the art reasonably would have understood the advantage of incorporating Waffner’s air-permeable contact surface and vacuum chamber into Müller’s downstream buffer 12, as opposed to its upstream buffer 8, given that both prior art references emphasize the importance of controlling the infeed speed and tension of the interleaver material adjacent the cutting region where rapid acceleration and braking of the interleaver material may result in tearing and wrinkling. See Ex. 1004 ¶¶ 26, 48; Ex. 1006, 2:58–3:4, 6:50–56; see also Ex. 1003 ¶¶ 200–210 (addressing the teachings of Müller and Waffner in view of the existing knowledge in the art). Indeed, Provisur’s expert confirms that “[l]ike many interleaver devices known in the art, Müller discloses creating a buffer loop of web material upstream of the rollers that insert the web material into the cutting area,” and that “[i]t was known in the food slicing and interleaving industry that the tension of interleaver material fed to the cutting region from a loose loop must be controlled.” Ex. 1003 ¶¶ 199, 220. And, like Waffner, Müller describes buffer 12 in terms of being a “loop” buffer for controlling the infeed speed of the interleaver material into the cutting region. See Ex. 1004 ¶ 48 (“Provided downstream of the first buffer 8 is a further buffer 12, a loop here, which . . . preferably buffers only as much interleaver material as is needed for the ejection of an interleaver.”). In contrast, Müller’s buffer 8 is used only “in the event of a[n] emergency stop” for buffering “overrun of the reel.” Id. ¶ 33. Thus, based on the current record, we reject the notion that Provisur’s proposed modification of Müller’s buffer 12, which continuously controls the length of the loop near the cutting region, would have any effect on Müller’s buffer 8, which merely stops unraveling near the reel. Aside from operability, Weber does not further dispute Provisur’s showing as to how the asserted combination of Müller and Waffner renders obvious the subject matter of independent claims 2, 17, and 19. See Prelim. Resp. 14–24. After analyzing Provisur’s showing, including Provisur’s mapping of the claim elements to Müller and/or Waffner and its reasoning for why one of ordinary skill in the art would have been led to combine their respective teachings (as discussed above), we find that Provisur demonstrates a reasonable likelihood that at least independent claims 2, 17, and 19 are unpatentable as obvious over the combined teachings of Müller and Waffner. See Pet. 28–38 (claim 2), 38–42 (reason to combine), 47–52 (claim 17), 53 (claim 19). Thus, Provisur meets the threshold for institution.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Provisur asserts that the claim terms should be construed “according to their plain and ordinary meanings as understood by [one of ordinary skill in the art] in view of the specification and prosecution history” and that “[n]o terms require an explicit construction to resolve the unpatentability controversy between the parties here.” Pet. 18. Weber appears to agree, stating in the parallel Missouri action that “most of [Weber’s] patent claims are plain and ordinary . . . [t]hey’re not difficult or complex claims or claim terms.” Ex. 1028, 5. There being no dispute, we need not expressly construe any claim terms at this stage of the proceeding, because we can decide the threshold question of institution without further construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (approving Board decision not to construe claim language where the construction is not material to the dispute).” slip op. at 6
Claim construction§ 103 obviousnessDiscretionary denialPatents in suitUS 10,647,013 - Sanofi Pasteur Inc. / SK Chemicals Co., Ltd. et al. v. Pfizer Inc.All claims unpatentablePTAB · Jun 10, 2024 · IPR2018-00187 · APJ Jeffrey N Fredman · IPR · Remand
On remand, the Board found proposed substitute claims 48 and 49 unpatentable as obvious over GSK-711, Merck-086, and Hausdorff, and denied the motion to amend as to those claims.
RulingsRemand decision- RemandOther
“I. INTRODUCTION This case was remanded to the Board by the United States Court of Appeals for the Federal Circuit with instructions that we address the patentability of Patent Owner’s proposed substitute claims 48 and 49 to U.S. Patent No. 9,492,559 B2 (Ex. 1001, “the ’559 patent”). Pfizer Inc. v. Sanofi Pasteur Inc., 94 F.4th 1341 (Fed. Cir. 2024); see Paper 15 (Patent Owner’s Motion to Amend, “Mot. Amend.”). The Court stated that: we affirm in toto the Board’s decision at issue in Appeals 2019- 1875 and 2019-1876. We further affirm the Board’s decisions at issue in Appeals 2019-1871, 2019-1873, and 2019-2224 as to claims 1–45 and proposed substitute claims 46, 47, and 50–52. Claims 1–45 are therefore unpatentable. But we vacate the Board’s denials of Pfizer’s motions to amend in those decisions as to proposed substitute claims 48 and 49 and remand for further proceedings consistent with this opinion. Pfizer, 94 F.4th at 1354.3 We therefore limit our analysis to proposed substitute claims 48 and 49 (the “Challenged Claims”) of the ’559 patent. For the reasons discussed herein, we determine that Petitioner has shown, by a preponderance of the evidence, that the Challenged Claims are unpatentable. 3 The same issues on remand in IPR2018-00187 remain for IPR2017-02131 and IPR2017-02132, and all three of these pending cases are addressed together in both the Federal Circuit’s Decision from which these proceedings are remanded, and in this consolidated Final Decision, because the issues presented are substantively identical. See Pfizer, 94 F.4th 1341, 1350–54. We generally cite to the record of the IPR2018-00187 proceeding, as it is representative, and will specifically note when we cite to the record in either of the IPR2017-02131 or IPR2017-02132 proceedings.” slip op. at 2
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied
“V. CONCLUSION We conclude on remand that Petitioner has shown by a preponderance of the evidence that proposed substitute claims 48 and 49 are unpatentable as obvious over the combination of GSK-711, Merck-086, and Hausdorff, in view of the knowledge of the ordinary artisan. Motion to Amend Outcome19 Claim(s) Original Claims Cancelled by Amendment Substitute Claims Proposed in the Amendment 48, 49 Substitute Claims: Motion to Amend Granted Substitute Claims: Motion to Amend Denied 48, 49” slip op. at 33
- Skill levelSkill level petitioner adoptedDecided for petitioner
“12 Petitioner states that the person of ordinary skill in the art at the time of the invention “would have had a Ph.D. or equivalent degree in chemistry, immunology, or other biological sciences or an MD and at least 2 years of experience in glycoconjugate vaccine research and development, or would objective indicia of obviousness or non-obviousness.13 Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). In that regard, an obviousness 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.” KSR, 550 U.S. at 418. In KSR, the Supreme Court also stated that an invention may be found obvious if trying a course of conduct would have been obvious to a person having ordinary skill: When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103. Id. at 421. “KSR affirmed the logical inverse of this statement by stating that § 103 bars patentability unless ‘the improvement is more than the predictable use of prior art elements according to their established have an M.S. degree and at least 4 years of relevant experience.” Pet. 26 (citing Ex. 1005 ¶ 77). Patent Owner “does not dispute Sanofi’s proposed level of skill for the person having ordinary skill in the art.” PO Response 8. We agree with the parties regarding the level of ordinary skill in the art. In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). We also note that the applied prior art reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). 13 Neither Petitioner nor Patent Owner presents evidence on the fourth Graham factor.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“II. ANALYSIS A. Claim Interpretation As discussed in the Final Written Decision, and left undisturbed by the Federal Circuit Decision, upon review of the parties’ arguments and the evidence before us, we maintain our conclusion that the claim term “immunogenic,” as it is used in the ’559 patent and recited by proposed substitute claims 46, 48, and 49, requires that a functional antibody be elicited against each immunogen contained in the respective composition. Paper 61, 7–9. Consequently, for proposed substitute claims 48 and 49, the term “immunogenic” requires that functional antibodies be elicited against each immunogen specifically recited and required.” slip op. at 9
Patent outcomesUS 9,492,559 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,492,559 - Sanofi Pasteur Inc. / SK Chemicals Co., Ltd. et al. v. Pfizer Inc.All claims unpatentablePTAB · Jun 10, 2024 · IPR2017-02131 · APJ Jeffrey N Fredman · IPR · Remand
On remand, the Board denied the motion to amend proposed substitute claims 48 and 49, finding them obvious over GSK-711, Merck-086, and Hausdorff in view of ordinary skill.
RulingsRemand decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“II. ANALYSIS A. Claim Interpretation As discussed in the Final Written Decision, and left undisturbed by the Federal Circuit Decision, upon review of the parties’ arguments and the evidence before us, we maintain our conclusion that the claim term “immunogenic,” as it is used in the ’559 patent and recited by proposed substitute claims 46, 48, and 49, requires that a functional antibody be elicited against each immunogen contained in the respective composition. Paper 61, 7–9. Consequently, for proposed substitute claims 48 and 49, the term “immunogenic” requires that functional antibodies be elicited against each immunogen specifically recited and required.” slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“12 Petitioner states that the person of ordinary skill in the art at the time of the invention “would have had a Ph.D. or equivalent degree in chemistry, immunology, or other biological sciences or an MD and at least 2 years of experience in glycoconjugate vaccine research and development, or would objective indicia of obviousness or non-obviousness.13 Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).” slip op. at 9
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“of success in obtaining a 2-log increase, we find Table 3 of Hausdorff shows that a composition with thirteen of the fourteen serotypes that were required by proposed substitute claim 46, conjugated with CRM197, produced an immune response with more than a 2-log increase above baseline serum IgG levels in New Zealand White Rabbits after administration of the two equal doses with or without the aluminum salt adjuvant. Ex. 2027 ¶ 231, Table 3. Thus, we find there would have been a reasonable expectation of success in the inclusion of serotypes 22F, 33F, 8, 10A, 11A, 12F, and 15B in Hausdorff’s pneumococcal vaccine composition while retaining the 2-log increased immune response of the thirteen serotypes and also retaining a 2- log increase in the immune response to the added serotypes. We note that Patent Owner does not identify any particularized evidence drawn to the seven serotypes recited in the challenged claims showing any expected difference in the behavior of these serotypes from the fourteen serotypes already included in the Hausdorff composition.” slip op. at 26
Patent outcomesUS 9,492,559 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,492,559 - Sanofi Pasteur Inc. / SK Chemicals Co., Ltd. et al. v. Pfizer Inc.All claims unpatentablePTAB · Jun 10, 2024 · IPR2017-02132 · APJ Jeffrey N Fredman · IPR · Remand
On remand, the Board denied the motion to amend because proposed substitute claims 48 and 49 were obvious over GSK-711, Merck-086, and Hausdorff.
RulingsRemand decision- RemandOther
“in which it: (1) affirmed our Final Written Decisions to the extent that claims 1–45 of the ’559 patent and proposed substitute claims 46, 47, and 50–52 were found unpatentable and (2) vacated our Final Written Decisions as to proposed substitute claims 48 and 49 of the ’559 patent and remanded for further proceedings consistent with its decision. Pfizer, 94 F.4th at 1354. The Federal Circuit determined that we abused our discretion because “[i]t does not appear that the Board considered whether, once incorporated, it would have been reasonably expected that the compositions exhibit the claimed 2-log IgG increase across all serotypes5 recited in proposed claims 48 and 49.” Id. at 1353. The Federal Circuit explained that it “is hornbook law that administrative agencies must provide a ‘reasoned basis’ for their actions that is sufficient to permit meaningful judicial review.” Id. The Federal Circuit therefore remanded for the Board to address whether the record provided sufficient evidence to support an obviousness finding for the 2-log IgG increase required by proposed substitute claims 48 and 49 of the ’559 patent. Id. at 1352–53. On May 15, 2024, we conducted a conference call with the parties where the parties agreed that no further briefing or evidence was necessary to address the remand. Paper 83.” slip op. at 4
- Skill levelSkill level board ownDecided for petitioner
“12 Petitioner states that the person of ordinary skill in the art at the time of the invention “would have had a Ph.D. or equivalent degree in chemistry, immunology, or other biological sciences or an MD and at least 2 years of experience in glycoconjugate vaccine research and development, or would objective indicia of obviousness or non-obviousness.13 Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“II. ANALYSIS A. Claim Interpretation As discussed in the Final Written Decision, and left undisturbed by the Federal Circuit Decision, upon review of the parties’ arguments and the evidence before us, we maintain our conclusion that the claim term “immunogenic,” as it is used in the ’559 patent and recited by proposed substitute claims 46, 48, and 49, requires that a functional antibody be elicited against each immunogen contained in the respective composition. Paper 61, 7–9. Consequently, for proposed substitute claims 48 and 49, the term “immunogenic” requires that functional antibodies be elicited against each immunogen specifically recited and required.” slip op. at 9
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“(1) Prior Art Teaches the Disputed Claim Limitation We agree with Petitioner that the asserted prior art teaches the claim limitations. We find Merck-086 teaches “a multivalent immunogenic composition having 15 distinct polysaccharide-protein conjugates. Each conjugate consists of a capsular polysaccharide prepared from a different serotype of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F or 33F) conjugated to a carrier protein, preferably CRM197.” Ex. 1008 ¶ 2; see also 02131 Ex. 1006, 1:7–11. That is, Merck-086 teaches a multivalent composition that lacks one of the capsular polysaccharides required by proposed substitute claim 48, i.e., serotype 15B, and that lacks the capsular polysaccharides of serotypes 12F, 10A, 11A, and 8 required by proposed substitute claim 49. We find GSK-711 teaches “the multivalent pneumococcal vaccine of the invention will be selected from the following serotypes 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15[B], 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F.” Ex. 1007, 7:1–3; see also 02131 Ex. 1007, 8:29–31. GSK 2008 also teaches conjugation of polysaccharides to the carrier protein CRM197. See Ex. 1007, 10:4–6; see also 02131 Ex. 1007, 10:12–15.” slip op. at 23
Patent outcomesUS 9,492,559 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,492,559 - PTAB · May 31, 2024 · IPR2024-00235 · APJ Carl M Defranco · IPR · Institution
The Board instituted IPR on claims 1–6, 8, 10, and 14–16 based on a reasonable likelihood that claims 1 and 14 are anticipated by Young and obvious over Young and Norrie.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Provisur proposes that one of ordinary skill in the art typically would have had: (1) a bachelor’s degree (or equivalent) in mechanical engineering (or a similar field) and at least two years of experience working as an engineer (or similar role) on food processing and/or packaging systems (or in a similar field); or (2) at least seven years of experience working as an engineer (or similar role) on food processing and/or packaging systems (or in a similar field). Pet. 12. Weber does not contest Provisur’s framing of the level of ordinary skill in the art. Because Provisur’s proposed definition is consistent with the level of skill described in the ’321 patent and the prior art of record, we adopt it here for purposes of institution.” slip op. at 5
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Provisur asserts that the claim terms should be construed “according to their plain and ordinary meanings as understood by [one of ordinary skill in the art] in view of the specification and prosecution history” and that “[n]o terms require an explicit construction to resolve the unpatentability 4 US 5,514,032, issued May 7, 1996 (Ex. 1004, “Young”). 5 US 4,979,269, issued Dec. 25, 1990 (Ex. 1005, “Norrie”). 6 US 6,929,540 B2, issued Aug. 16, 2005 (Ex. 1006, “Johnson”). 7 US 6,198,834 B1, issued Mar. 6, 2001 (Ex. 1007, “Belk”). controversy between the parties here.” Pet. 13. Weber appears to agree, its counsel stating in the parallel Missouri action that “most of [Weber’s] patent claims are plain and ordinary . . . [t]hey’re not difficult or complex claims or claim terms.” Ex. 1028, 5. There being no dispute, we need not expressly construe any claim terms at this stage, because we can decide the threshold question of institution without further construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (approving Board decision not to construe claim language where the construction is not material to the dispute).” slip op. at 5
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“Weber requests that we deny institution under 35 U.S.C. § 314(a) due to the advanced state of the parallel Missouri action. See Prelim. Resp. 6– 17. Provisur disputes that discretionary denial is warranted (Pet. 73–77), but nonetheless submits a Sotera stipulation (Ex. 1029) in an effort to resolve the issue.8 In light of Provisur’s Sotera stipulation, we will not discretionarily deny institution under § 314(a). See Director Memorandum, Interim Procedure for Discretionary Denials in AIA-Post Grant Proceedings With Parallel District Court Litigation, U.S. PATENT AND TRADEMARK OFFICE (June 21, 2022), at 3, 7.” slip op. at 6
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“We disagree with Weber’s position, at least on the current record. Instead, we find that Provisur presents sufficient evidence that Young anticipates all elements of independent claims 1 and 14, including the disputed limitation requiring “automatic determination of the thickness of the fat cover.” In particular, Young’s imaging system 190 includes multiple cameras, including top plan camera 196, end view camera 197, and fat line camera 198, as well as controller 172 and real-time image processor 194. Ex. 1004, 17:34–59, 18:46–56, Figs. 2, 13. As described by Young, top plan camera 196 is primarily used to obtain “physical dimensions and characteristics” of the meat product, end view camera 197 is primarily used to determine the “height” of meat product and “to create a clear delineation along the top edge of the end” of the meat product, whereas fat line camera 198 is primarily used to determine the fat/lean separation line of the meat product. See id. at 17:59–18:39. Those disclosures by Young clearly contemplate determining specific dimensions of the meat product, and not simply identifying the fat/lean separation line, as Weber suggests. See Prelim. Resp. 19. To determine the “thickness” of the fat cover, Young’s imaging system has image processing routine 240, which “generates a fat/lean separation line and an edge line . . . representing the outer surface of the pork side proximate the fat/lean line” and uses those lines to calculate “the height, width, and length of the [meat product].” Ex. 1004, 23:12–25, 24:10–22. As part of routine 240, controller 172 uses that information to set the cutting profile of knife assembly 100 “so that the assembly follows a fixed distance from the separation line to provide the optimum fat cover for the loin.” Id. at 18:35–39 (emphasis added). Notably, according to Young, the “fixed distance” represents the “desired” thickness of fat that remains on the meat, after cutting, and “sufficiently keeps the loin from drying out, but doesn’t make the loin look too fat.” Id. at 20:60–66; see also id. at 10:39–42 (“Through control of the knife blade along several axes, assembly 100 preferably produces an optimum separation between loin and belly, with a desired fat covering left on the loin.” (emphasis added)). Young’s disclosure that image processing routine 240 determines a “fixed distance” from the loin/fat separation line at which to cut the meat product undoubtedly corresponds to the claimed “determination of the thickness of the fat cover . . . in a contactless manner.” See Ex. 1003 ¶¶ 104–112. Indeed, Young discloses specific dimensions for the desired optimum fat cover to remain on the meat—“a fixed distance (preferably 0.1 inch) from the fat/lean separation line 6.” Ex. 1004, 20:55–63.” slip op. at 8
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 8,529,321 - PTAB · Apr 26, 2024 · IPR2024-00474 · APJ Ryan H Flax · IPR · Institution
The Board instituted IPR of claims 1 and 2 on all four asserted §103 grounds, finding a reasonable likelihood that at least one challenged claim would be shown unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We find that, on the current record, Petitioner has sufficiently mapped the limitations/steps of the claims to the disclosures of Lievestro and Schneider, identified a reason with rational underpinnings why the ordinarily skilled artisan would have combined the teachings of the references, and identified that there would have been a reasonable expectation of success. Based on the evidence presented at this stage of the proceeding, Petitioner has shown under Ground 1 that there is reasonable likelihood that at least one of the ’301 patent’s claims would have been obvious over Lievestro and Schneider.” slip op. at 26
- Skill levelSkill level petitioner adoptedDecided for petitioner
“At this stage of the proceeding, we accept and use Petitioner’s proposed and unopposed definition of the ordinarily skilled artisan. It appears that Petitioner’s proposed definition comports with the level of skill in the art reflected in the prior art of record and the ’301 patent, itself. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C.” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“We find that, on the current record, Petitioner has sufficiently mapped the limitations/steps of the claims to the disclosures of Lievestro and Schneider, identified a reason with rational underpinnings why the ordinarily skilled artisan would have combined the teachings of the references, and identified that there would have been a reasonable expectation of success. Based on the evidence presented at this stage of the proceeding, Petitioner has shown under Ground 1 that there is reasonable likelihood that at least one of the ’301 patent’s claims would have been obvious over Lievestro and Schneider.” slip op. at 26
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“At this stage of the proceeding we find this term is readily understandable on its face and do not find it necessary to expressly interpret this claim language.” slip op. at 12
Claim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 10,842,301 - Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations LLCInstitution deniedPTAB · Feb 22, 2024 · IPR2023-01325 · APJ Timothy G Majors · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 2, and 4–6 were unpatentable under any asserted obviousness ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“Under 35 U.S.C. § 314(a), inter partes review may not be instituted 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.” For reasons discussed below, we do not institute review of claims 1, 4, and 4–6 of the ’033 patent.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“concerning the ’834 patent, the intrinsic evidence is minimally helpful in revealing an affirmative meaning for the claims’ “spacing(s)” terms. IPR2023-01151, Paper 12, 39–41. The Specification does not use the term “spacings” in relation to the positioning of adjacent fibers; the drawings might be helpful, but neither party proposes a specific construction that is reliant on them. And, portions of the prosecution record are arguably confounding. For example, the applicant distinguished claimed “spacings” from “tightly knitted fibers.” Ex. 2140, 1001 (suggesting a more “loosely defined fiber structure” may be covered); see also Ex. 1002, 29–30 (asserting the claimed design has “a lesser [fiber] density construction” compared to Walther). This begs the question, at what point does a cloth of “tightly knitted fibers” convert to a cloth having a “loosely defined” fiber structure that would come within the scope of the claimed “spacings?” The record does not answer. Applicant’s suggestion during prosecution that the claimed spacings between fibers are “intentionally placed” about the frame and not simply “the spacing that may be inherent” in fibrous cloths is also unavailing on this record in clearly defining the metes and bounds of the term. Ex. 1002, 28–29. Whether the alleged absence of “objective boundaries” for the term “spacings” supports a conclusion that the claims are invalid as indefinite would be a question for the court. Paper 11, 5 (arguing There is insufficient technical detail available to determine whether the SAPIEN 3 Ultra does or does not include “spacings” as claimed and we take no position on whether such device infringes any claim of the ’033 patent. that a conclusion that the claims are indefinite is “outside the Board’s [IPR] jurisdiction”).12 Notwithstanding the lack of any express claim construction for the “spacings” term from either party, claim 1 of the ’033 patent requires something more than just “spacings.” Claim 1 requires “spacings extending through a thickness of the sealing assembly that allow fluid to pass therethrough when the prosthetic heart valve assembly is in an undeployed state.” Ex. 1001, 22:11–15 (emphasis added). In other words, the spacings must allow fluid to pass through the sealing assembly’s thickness when the valve is undeployed. For reasons discussed below, we are not persuaded on this record that Petitioner is reasonably likely to prevail in showing that this limitation is met—particularly the fluid-passing element—in the proposed combinations of Spenser or Levi with Spenser II.” slip op. at 31
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“We, thus, find Dr. Brecker’s testimony more credible that “[i]t would, accordingly, be counterintuitive for a [POSA] to look to a device designed to occlude a blood vessel when designing a TAVR.” Id. ¶¶ 119–120 (testifying “[n]o [POSA] would look to this [occluder] design when considering a TAVR valve and . . . would further have concerns about the pro-thrombotic potential of the arrangement of fibers in Chuter”). Where a proposed combination would run counter to the primary reference’s stated purpose, the POSA would not generally be motivated to make that combination. Polaris Indus., Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1069–70 (Fed. Cir. 2018).” slip op. at 43
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightDecided for patent owner
“Grounds 1 and 2 is based on the combination of either Levi and Spenser II, or Spenser and Spenser II. Yet Petitioner purports to modify Spenser II’s compressible material, or supplant it with something else, based on “porous” fabrics allegedly known elsewhere in the art, which art is not identified in the Petition itself as part of any asserted combination. Pet. 49. To see what specific modifications or combinations Petitioner might be suggesting, requires we look to three paragraphs of Dr. Buller’s Declaration, cited but not discussed by Petitioner, where eight additional references are mentioned. Ex. 1003 ¶¶ 157–159 (identifying Exs. 1106–1112, and 1129). This format is an improper incorporation-by-reference of argument and evidence that, had Petitioner wanted to pursue some other combination of asserted art beyond Levi, Spenser, and Spenser II, needed to be set forth explicitly in the Petition. 37 C.F.R. § 42.6(a)(3). Moreover, it leaves the record unclear and forces Patent Owner, the Board, and the public to guess at what combination(s) are, in fact, being urged. We also find that Petitioner’s position reveals a hindsight bias insofar as it suggests, with the aim of arriving at the claimed subject matter, removing Spenser II’s “sufficiently dense” and fluid impermeable compressible material (Ex. 2128 ¶ 222) in favor of some other sufficiently “porous” and fluid permeable material. Hindsight is further evidenced because Spenser II’s cited material is already described as being compressible and adapted to allow coagulation and tissue ingrowth—factors cited by Patent Owner as allegedly motivating a change to some other material. Ex. 1011 ¶ 145. Altogether, we find unpersuasive Petitioner’s position based on unspecified combinations of unasserted prior art to achieve benefits that Spenser II’s existing compressible material already provides.” slip op. at 36
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,491,033 - Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations LLCInstitution deniedPTAB · Feb 7, 2024 · IPR2023-01232 · APJ Timothy G Majors · IPR · Institution
The Board denied institution because Petitioner had not shown a reasonable likelihood that claims 11–13 were unpatentable on any asserted obviousness ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Under 35 U.S.C. § 314(a), inter partes review may not be instituted 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.” For reasons discussed below, we do not institute review of claims 11–13 of the ’310 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner proposes that the person of ordinary skill in the art (“POSA”) in November 2012 “would have been an interventional cardiologist with a working knowledge of heart valve designs and endovascular prostheses. This [POSA] would, where necessary, work with a medical device engineer to experiment with or manufacture a prosthetic heart valve.” Pet. 21 (citing Ex. 1003 ¶ 50). Patent Owner does not expressly contest Petitioner’s proposed definition or offer an alternative. See generally Prelim. Resp. For this Decision, we apply Petitioner’s proposed POSA level, which appears to be consistent with the level of skill shown in the prior art of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). This POSA level is also consistent with the level the Board applied in earlier decisions involving the same parties and related patents. See, e.g., Ex. 2124, 11; Ex. 1120, 11–12.” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“construction standard used to construe claims in a civil action before the courts under 35 U.S.C. § 282(b), including construing claims’ language in accordance with its ordinary and customary meaning as understood by the POSA, in view of the patent’s specification and considering the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only construe terms that are in controversy and only as needed to resolve the matters in dispute. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019). Petitioner contends that “[n]o terms of the ’310 patent require construction to resolve the patentability issues herein.” Pet. 19. Also, Petitioner contends, its “grounds are based on [Patent Owner’s] allegations that the ’310 patent covers Petitioner’s SAPIEN 3 Ultra valve and the scope of the claims asserted by [Patent Owner] in litigation.” Id. (citing Ex. 1122 (Complaint); Ex. 1123 (Infringement Contentions), 2, 262–476).11 Patent Owner does not propose any express claim construction. Instead, Patent Owner contends that the claims should be interpreted according to their ordinary and customary meaning. See, e.g., Prelim. Resp. 18–19, 35–36 (asserting that Petitioner’s mapping of the claims is, in respects, contrary to the “plain language” of the claims). 11 Petitioner identifies a claim construction order in related litigation where the district court construed an “outer frame” as a “self-expanding frame.” Pet. 19 (citing Ex. 1140, 17). We need not further construe the “outer frame” term here because Petitioner contends, without dispute, that the prior art discloses self-expanding frames. Id. at 19–20, 26. Moreover, Patent Owner states that it has disclaimed those claims reciting the term “outer frame” to reduce the number of issues before the Board. Prelim. Resp. 75. about the scope of the claims, we address those arguments below in our discussion of the mapping of claims to the asserted prior art.” slip op. at 15
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“We are unpersuaded. The language of claim 11 states the “sealing material is attached to the frame,” but also that it is the plurality of outwardly-extending “fibers” that maintain “contact with the frame along the height of the sealing material” whether the valve assembly is compressed or expanded. Supra Section II(D). Thus, according to this plain language, Petitioner must demonstrate that Spenser II’s identified fibers contact with the frame in its modification of Spenser or Levi—not just that some portion of Spenser II’s compressible material be attached to and contact the frame. On this record, we agree with Patent Owner that Petitioner’s contrary interpretation is “at-odds with the plain language of the claims.” Prelim. Resp. 18, 35. The cited excerpt from the prosecution history does not support Petitioner’s position that the “in contact” limitation is met if the sealing material—but not necessarily the fibers—contacts the frame. Petitioner cites an assertion by applicant during prosecution that modifying Levi’s valve so that the “sealing material” is in contact with the frame would not show that the claimed subject matter is obvious. Pet. 44 (citing Ex. 1002, 147–148). In its more complete context, however, applicant’s prosecution argument was made in furtherance of applicant’s repeated assertion that replacing Levi’s loosely-fit, “billowing” skirt with a tightly-held and bulky sleeve would change Levi’s principle of operation and make it too large and Resp. 35–36 (arguing applicant’s position is also “consistent” with claims’ plain language because, if Levi’s billowing skirt included outwardly-extending fibers, such fibers could not contact the frame along the skirt’s height when it billows out from the frame).15 Applicant’s argument does not rise to a concession that the “fibers in contact with the frame” limitation can be met so long as the sealing material contacts the frame. At best for Petitioner, the relevant prosecution history could be characterized as ambiguous; it does not justify rewriting claim 11’s plain language. See, e.g., Ex. 1002, 127–128 (earlier version of proposed amendment to application claim 31, reciting “the sealing material is in contact with the outer frame”), 138–139 (later version of the proposed and as-entered amendment, expressly changing the language to require “the plurality of fibers is in contact with the outer frame”).” slip op. at 28
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,389,310
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.