- 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 · May 28, 2024 · IPR2024-00170 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR of claims 1–13 on all five asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). slip op. at 14
- Skill levelSkill level petitioner adoptedDecided for petitioner
“According to Patent Owner, Petitioner’s proposed definition “attempts to imbue the POSA with an array of different skills and competencies that do not accurately reflect the state of the field at the time of the October 2014 priority date.” Prelim. Resp. 10. Patent Owner does not offer a competing definition in the Preliminary Response, but notes that we adopted the above definition in the 00224, 00317, 00545, and 00546 IPRs. Insofar as the prior art of record appears to support Petitioner’s definition, we apply our earlier definition here as Petitioner urges. 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)). Patent Owner is, nevertheless, welcome to provide argument and evidence for an alternative definition at trial.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“In general, a preamble limits the invention if it recites essential structure or steps, or if it is necessary to give life, meaning, and vitality to the claim.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quotation marks omitted). On its face, the preamble of claim 1 includes a “wherein” clause requiring that the biological sample be obtained “from a non-fetal source.” Because Petitioner does not explain how this limitation is either understood from the body of the claim, or severable from the remainder of the preamble, we do not find Petitioner’s argument persuasive. See Cochlear Bone Anchored Sols. AB v. Oticon Med. AB, 958 F.3d 1348, 1355 (Fed. Cir. 2020) (“A conclusion that some preamble language is limiting does not imply that other preamble language, or the entire preamble, is limiting.”). Absent further argument and evidence, and solely for the purpose of this Decision, we construe the preamble as limiting. slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Specification provides little guidance regarding how much of the genome must be sequenced under Patent Owner’s construction. See generally 00224 IPR, Paper 11 at 19–23. As discussed in detail on pages 15–16 of the Preliminary Response, however, the instant Specification does make a clear distinction between “untargeted sequencing (e.g., whole genome sequencing)” as compared to targeted sequencing approaches such as “whole exome sequencing,” or “deep sequencing over a fraction of the genome.” See e.g., Ex. 1001, 17:36–49, 25:64–34, 27:16–19, 43–46; cf. 00224 IPR, Paper 11 at 22 (“tak[ing] particular note of the [’394] Specification’s distinction between whole genome sequencing and targeted sequencing of the exome or other sub-genomic regions (e.g., Ex. 1001, 5:38–59, 24:35– 58), as well as the Specification’s acknowledgement that whole genome sequencing may encompass “low mean coverage regions” and “zero mean coverage regions,” (id. at 24:59–62, 28:33–42)”). As we read the Specification, the phrase “sequencing all or almost all of a genome,” speaks more tot the untargeted nature of the process rather than to an end result of the sequencing effort. In this respect, the instant Specification’s references to “high coverage whole genome sequencing,” “low coverage whole genome sequencing,” and “low” and “zero mean coverage regions from WGS,” indicate that whole genome sequencing does not mean that all or almost all of the nucleotide bases in a genome must be determined, but that “all or almost all” of the genome is available for sequencing.12 See e.g., id. at 25:64–67, 26:6–14, 27:16–19, 28:57–60; 32:37–45; see also 00224 IPR, Paper 11 at 19–23 (preliminarily determining that Leary disclosed whole genome sequencing despite evidence that the authors sequenced only about half of the genome). With the above explanation, we provisionally construe “whole genome sequencing as “a non-targeted approach to sequencing all or almost all of a genome.” We leave for later, and to the extent necessary, any 12 Consistent with Owner’s argument that “WGS has taken on many different flavors of meaning,” we presently understand the Specification’s recognition of “high” and “low” coverage whole genome sequencing as species of the generic term. See Prelim Resp. 12–13 (citing Ex. 2018, 155:15–20, 161:21–162:1, 156:20–157:22). determination of the lower limit (if any) one of ordinary skill would attach to the number sequencing reads, extent of genomic coverage, or nucleotide bases that must be determined to qualify as whole genome sequencing, and whether any particular experimental approach would have been understood to comprise whole genome sequencing.” slip op. at 22
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,584,968 - 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 - Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.No claims unpatentablePTAB · Apr 16, 2024 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Final written decision
The Board held claims 1–4, 8–14, and 18–26 not shown unpatentable because they were entitled to priority before the November 2018 Venclexta Label, which therefore was not prior art.
RulingsFinal written decision- Skill levelSkill level board ownOther
“We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology, which would encompass the blood cancers recited in the claims. Neither party identifies a difference in the analysis or conclusions that would be based on differences in the ordinary skill in the art analysis. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties do not identify any issue relating to the preamble that would impact our analysis. We recognize that Patent Owner is suggesting that Petitioner’s expert, at least, is reading the word “clinical” into the treatment language of claim 1. However, the plain language of the claim 1 preamble states “treating lymphoma or leukemia in a human patient” and is supported by a straightforward definition in the Specification of the ’087 patent, expressly limiting the invention to treatment of human patients. See Ex. 1001, 16:25–38. We therefore find that the preamble terms do not need claim construction because there is no actual dispute suggesting that, for example, claim 1 implicitly recites the term “clinical.” 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 5
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledEntitled to earlier dateDecided for patent owner
“d. Analysis Considering the Wands factors as a whole, we find that the limited breadth of the claims, presence of several working examples, significant amount of direction and guidance provided by the ’087 patent, predictability in treating blood cancers with Bcl-2 inhibitors like GDC-0199, and high level of skill in the art are balanced against a large quantity of experimentation. Based on our consideration of the entirety of the evidence, we find that a preponderance of the evidence supports the conclusion that undue experimentation would not have been required to make and use the invention commensurate in scope with the claims of the ’087 patent. One underlying theme of Petitioner’s contentions and Petitioner’s expert testimony is the repeated contention that clinical trials were not completed by Patent Owner. See, e.g., Pet. 48 (“venetoclax (GDC-0199) was not FDA-approved”); Ex. 1020 ¶ 193. We find these arguments unpersuasive as we agree with Patent Owner that “[i]t is well established that a patent may be secured, and typically is secured, before the conclusion of clinical trials.” In re Montgomery, 67 F.3d 1375, 1382 (Fed. Cir. 2012). Particularly as to the dependent claims, a preponderance of the evidence of record does not support a finding that undue experimentation would have been required to administer three different doses of GDC-0199 starting with 100 mg, to use multiple daily dosing cycles of one day, to continue until disease progression occurs, or to combine with other treatment compounds. We find that a preponderance of the evidence does not support Petitioner’s position that any of the dependent claims fail to comply with the enablement requirement.” slip op. at 23
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner
“Applying Rai and Wertheim to the instant facts, we agree with Patent Owner that, factually and legally, in the ’087 patent “the claimed dosages of 100 mg, 200 mg, and/or 400 mg of GDC-0199 are adequately supported.” PO Second Suppl. Brief 2 (citing PO Resp. 11, 27–29; PO Sur-reply 19, 21– 22; Ex. 1001, 24:20–29.) In particular, the ’087 patent describes all three specific dosage values 100 mg, 200 mg, and 400 mg in the context of an escalating drug dosage series and Petitioner points to no persuasive statements in the specification that dispute either the effectiveness or the operability of GDC-0199 at any of these dosages.” slip op. at 32
Patent outcomesUS 11,110,087 not shown unpatentableClaim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 11,110,087 - PTAB · Apr 15, 2024 · IPR2023-01409 · APJ Cynthia M Hardman · IPR · Institution
The Board instituted IPR on claims 1–30 and all eight asserted obviousness grounds, finding a reasonable likelihood that Stafford and Cote render at least one challenged claim obvious.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“that if “the record of the Office’s previous consideration of the art is not well developed or silent, then a petitioner may show the Office erred by overlooking something persuasive.” Advanced Bionics, IPR2019-01469, Paper 6 at 10. Although Petitioner did not specifically state that the Examiner erred in not rejecting the claims over the prior art asserted here, under the second part of the Advanced Bionics framework, based on our analysis of the current record as a whole, we find that Petitioner has “ma[d]e a showing of material error,” in fact, the Petition is premised on it. Advanced Bionics, IPR2019-01469, Paper 6 at 8–9. In particular, Petitioner shows that the Office erred by overlooking something persuasive, namely, the teachings of at least Stafford and Cote, as highlighted in Petitioner’s unpatentability grounds. See Pet. 5 (arguing that each of Cote and Brenneman “provides express teachings on inserters for on-body units that were not considered by the Examiner”), 20–84 (Ground 1). In the Reasons for Allowance, the Examiner stated that “[w]hile Brister (US 2006/0016700) teaches the bulk of the claimed limitations, it fails to teach a housing . . . and an inserter with a sharp” that extends through the housing as claimed. Ex. 1002, 977. Petitioner, however, sufficiently demonstrates for purposes of institution that Stafford and Cote disclose these limitations. See Pet. 33–84 (explaining why Stafford and Cote teach or suggest the limitations of the challenged claims); see also infra Section III.E (determining that, on the current record, Petitioner establishes a reasonable likelihood that the claims challenged in Ground 1 are unpatentable as obvious over Stafford and Cote). Based on the circumstances elucidated by the current record, we find that Petitioner adequately shows that the Examiner “misapprehend[ed] or overlook[ed] specific teachings” of at least Stafford and Cote that “impact patentability of the challenged claims.” Advanced Bionics, IPR2019-01469, Paper 6 at 8 n.9. That is, Petitioner shows that the Examiner materially erred by not applying at least Stafford and Cote in the manner Petitioner argues and as supported by Dr. Fletcher.” slip op. at 13
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“After considering the arguments and cited evidence of record, we find that for purposes of institution, Petitioner has demonstrated a reasonable likelihood that Stafford and Cote would have rendered claim 1 obvious. We have reviewed the arguments and evidence of record for claims 2–6, 9–14, 16–24, 27, 29, and 30 in Ground 1, and similarly find that for purposes of institution, Petitioner has demonstrated a reasonable likelihood that Stafford and Cote would have rendered these claims obvious. See Pet. 20–84; Ex. 1003 (Fletcher Decl.) ¶¶ 44–155. On this basis, we institute inter partes review of all challenged claims on all grounds in the Petition. See SAS Institute Inc., 138 S. Ct. at 1358; 37 C.F.R. § 42.108(a).” slip op. at 30
- Skill levelSkill level petitioner adoptedOther
“understanding of a person of ordinary skill in the art at the time the invention was made.11 See Graham, 383 U.S. at 17–18. Petitioner contends that a person of ordinary skill in the art would have had: a bachelor’s degree in bioengineering, mechanical engineering, electrical engineering, or a related subject, and one or more years of experience researching, developing, and/or designing insertable medical devices, including, e.g., systems for implanting wearable medical devices such as cannulas, infusion sets, and analyte sensors, or equivalent experience. Less work experience may be compensated by a higher level of education, such as a master’s degree, and vice versa. Pet. 10–11 (citing Ex. 1003 (Fletcher Decl.) ¶ 28). Patent Owner does not presently dispute Petitioner’s proposal or offer an alternative definition. See generally Prelim. Resp. 10 The record does not presently include any objective indicia of obviousness or nonobviousness. See generally Pet.; Prelim. Resp. 11 For purposes of this Decision, we apply a priority date of February 3, 2009. See supra 8 n.2. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 17
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither party proposes that any claim term requires an express construction. See Pet. 19; see generally Prelim. Resp. We find it unnecessary to construe any claim term to decide whether Petitioner satisfies the “reasonable likelihood” standard for instituting trial. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). Any final written decision entered in this case may include express claim constructions, or may include discussion of claim scope that differs from that provided in our analysis below. Any final claim constructions will be based on the full trial record.” slip op. at 18
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,202,591 - PTAB · Mar 29, 2024 · IPR2023-01439 · APJ Tina E Hulse · IPR · Institution
The Board instituted IPR on claims 1–7, 9–11, 24–26, 28, 29, 35, and 36 on all asserted §103 grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the argument and evidence presented in the Petition, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of the challenged claims of the ’803 Patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“of the invention (“POSITA”) would have had “a bachelor’s degree and two or more years of experience or a master’s degree in organic synthesis or chemical engineering, with education substituting for experience and vice versa.” Pet. 17 (citing Ex. 1002 ¶¶ 15–16). We adopt Petitioner’s definition as it appears to be consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 6
- Expert testimonyPetitioner expert creditedDecided for petitioner
- Claim Construction › Intrinsic evidence (Phillips canons) › Conventional terms ('about', 'substantially', 'a'/'an', 'configured to')Term construed petitioner constructionDecided for petitioner
“At this stage of the proceeding—and without a substantive response from Patent Owner—we determine Petitioner’s construction is consistent with the plain ordinary meaning of “about” and the intrinsic evidence. The claim recites that the carbon chain length of the bio-alkene is “about 5 to about 20 carbons atoms.” Ex. 1001, claim 1 (emphasis added). We agree with respect to the claimed range. See Cohesive Techs., Inc. v. Waters. Corp., 543 F.3d 1351, 1368 (Fed. Cir. 2008) (“When ‘about’ is used as part of a numeric range, the use of the word ‘about,’ avoids a strict numeric boundary to the specified parameter.”) (internal quotations omitted). In other words, the claim term “about 5 to about 20 carbon atoms” does not require precisely 5 to 20 carbon atoms. Moreover, we agree that a carbon atom in a compound is not divisible. Keeping these principles in mind, we find “about 5” at the lower end of the range encompasses a carbon chain length of 4 carbon atoms, and “about 20” at the upper end of the range encompasses a carbon chain length of 21. We also agree with Petitioner that the prosecution history of the related ’902 Application—which also claims the benefit of the ’985 Provisional and shares a virtually identical specification as the ’803 Patent— supports construing “about” to encompass one additional carbon atom, as evidenced by the amendment after allowance amending the term “carbon chain length of about 8 to about 20” to “carbon chain length of 7 to 20.” See Ex. 1006, 335 see also id. at 16, 23–63. Thus, the intrinsic evidence supports Petitioner’s construction and the plain ordinary meaning of “about.”” slip op. at 7
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,882,803 - 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.