- PTAB · Aug 22, 2024 · IPR2024-00521 · APJ Cynthia M Hardman · IPR · Institution
The Board instituted IPR on all grounds challenging claims 13 and 29, finding a reasonable likelihood that both claims would be shown unpatentable as obvious.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Denied
“the prior art asserted in Petition 3 at the time it filed Petition 1, and had in hand both Patent Owner’s preliminary response to Petition 1 and the Board’s institution decision on Petition 1. See, e.g., Pet. 9; Prelim. Resp. 7–8. Nevertheless, we find that factors 2 and 3, considered in combination with factor 1, do not favor discretionary denial. See Code200, Paper 18, 5 (“General Plastic factor 1 must be read in conjunction with factors 2 and 3.”). We agree with Petitioner that the grounds and arguments presented by Petition 3 are not informed by the Board decisions or Patent Owner arguments in the first two IPRs. Petitioner’s arguments are unchanged as to the overlapping claim elements found in claim 1, from which challenged claims 13 and 29 depend. As to those overlapping elements, Petitioner repeats without substantive modification the mapping from Ground 1 of Petition 1 and is using neither the Petition 1 POPR [Patent Owner Preliminary Response] nor the institution decision to modify arguments that were previously unsuccessful, nor shifting its prior art arguments for this petition. Pet. 11. Stated differently, we find no “road-mapping” concerns or “shifts in the prior art asserted and the related arguments” in the later petition, like those found in General Plastic. See General Plastic at 17.” slip op. at 15
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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”)). Petitioner ultimately bears the burden of persuasion to prove unpatentability of each challenged claim by a preponderance of the evidence. 35 U.S.C. § 316(e). This burden never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). The Board may authorize an inter partes review if we determine that the information presented in the Petition and Patent Owner’s Preliminary Response shows a reasonable likelihood that Petitioner will prevail with respect to at least one of the challenged claims. 35 U.S.C. § 314(a).” slip op. at 19
- Skill levelSkill level petitioner adoptedDecided for petitioner
“a Bachelor of Science degree in biomedical engineering, or a similar field, such as electrical, or software, or computer engineering, and two years of industry experience or research working with medical devices and systems for measuring biomedical signals. Such systems might include those for determining levels of blood analytes, such as glucose, in a 9 See infra Section III.B. 10 Patent Owner does not presently assert any objective indicia of nonobviousness. See generally Prelim. Resp. 11 For purposes of this Decision, we apply a priority date in the 2009–2010 timeframe. See supra page 3 n.1. On the present record, it does not appear that the level of ordinary skill changed during this timeframe. patient and transmitting indications of such levels to a receiving device for reporting the measurements. Additional education, such as a Master’s degree could substitute for the industry experience, or vice versa. Pet. 23 (citing Ex. 1208 (Gross Decl.) ¶ 51).” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Having reviewed the arguments and evidence of record, we determine that no construction of any claim term is needed to decide whether to institute this Petition. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). 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. Should the parties argue for any specific claim interpretations at trial, they should do so in a separately designated section of their briefing to highlight their proposed claim interpretations. See, e.g., Consolidated Trial Practice Guide (Nov. 21, 2019), 44–49.12 Claim construction arguments should not be merely asserted within arguments over the merits of patentability challenges.” slip op. at 23
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,298,056 - 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 - Dexcom, Inc. v. Abbott Diabetes Care Inc.Institution deniedPTAB · Aug 8, 2024 · IPR2024-00520 · APJ John G New · IPR · Institution
The Board denied institution because Dexcom did not show a reasonable likelihood that claims 5–7 were unpatentable under either Stafford–Raymond ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Burden of Proof “In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016 (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity … the evidence that supports the grounds for the challenge to each claim”)). Therefore, in an inter partes review, the burden of proof is on the Petitioner to show that the challenged claims are unpatentable; that burden never shifts to the patentee. See 35 U.S.C. § 316(e); In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016) (citing Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015)). At the institution stage, Petitioner must show a reasonable likelihood that it would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314.” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“We do not find these arguments persuasive. It may be so that Turner teaches that its recesses 77 receive rotation-restricting protrusions 71, which “extend[] into each recess 77 such that the recess side walls interfere with the protrusions to prevent rotation of the insertion device relative to body 20.” Ex. 1011 ¶ 69. And, it may also be so that Turner teaches this assembly as an advantage in that it prevents rotation of body 20. Id. However, Petitioner did not present this “design choice” theory of obviousness in the Petition. Petitioner first raises its “obvious design choice” argument with respect to Turner and Ground 2 in its Reply Brief; it is not to be found in its Petition.12 Petitioner cannot raise an argument in its” slip op. at 32
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“In each of the ’335 Specification, Stafford, Raymond, and Turner, the OBU is universally depicted as having a circular perimeter oriented around a longitudinal axis, and possessing either a cylindrical shape (’335 patent, Stafford, Raymond) or a roughly domed shape, with a circular, circumferential collar. See, e.g., Ex. 1001, Figs. 8, 17, 52, 54; Ex. 1009, Figs 3A–C, 4A; Ex. 1010, Figs. 14–16, Ex. 1011, Figs. 2A–B, 5G, 7A-B, 9, 11, 13A–B, 14, 15, 19, 20, 21, 25, 29, 30, 37, 38. Moreover, in each description of the location of recesses 3766 in the ’335 Specification, the recesses are described as being located “on the side walls” of the OBU. See Ex. 1001, col. 44, ll. 8–12; col. 45, ll. 61–64. Given the circular perimeter of all of these embodiments of the disclosures of the ’335 Specification, the teachings of Petitioner’s cited references, the dictionary definition of “periphery” as being “the perimeter of a circle or other closed curve,” and the ordinary meaning that the terms would have had to a skilled artisan at the time of the invention, in view of the ’335 Specification and file history” (Phillips, 415 F.3d at 1312–13), we conclude that a person of ordinary skill in the art would understand that the “plurality of recesses disposed on a periphery of the on body electronics unit housing” would be located “on the circumference of the on-body housing,” as we concluded in the ’01396 IPR Decision. See Dec. 48; see also Ex. 1001, col. 44, ll. 9–14 (stating that “gripping arms 3762 [of medical device carrier 3730] are provided with engagement boss 3764 which are configured to engage with corresponding recesses 3766 provided on the side walls of the on body housing 322”).” slip op. at 38
- Strike new argumentNew argument disregardedDecided for patent owner
“However, Petitioner did not present this “design choice” theory of obviousness in the Petition. Petitioner first raises its “obvious design choice” argument with respect to Turner and Ground 2 in its Reply Brief; it is not to be found in its Petition.12 Petitioner cannot raise an argument in its 12 The Petition makes a design choice argument with respect to the teachings of Raymond on Ground 1, contending that “it would have been an obvious design choice to implement two spaced-apart plural recesses on the housing—one to engage the protrusions on each of the two arms taught by Raymond.” Pet. 38. However, Petitioner adduced no prior art teaching or evidence of record of “spaced-apart plural recesses on the housing” that Reply Brief if that argument could first have been raised in its Petition. 37 C.F.R. § 42.23(b); see also L’Oréal USA, Inc. v. Univ. of Massachusetts, 2018 WL 4278992, *5 n.4 (PTAB Sept. 7, 2018); Matterport, Inc. v. Appliance Comp. III, Inc., 2021 WL 6340164, *9–10 (PTAB Nov. 19, 2021).” slip op. at 32
Claim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,266,335 - 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
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.