- Apple Inc. v. Ferid AllaniInstitution deniedPTAB · Nov 4, 2025 · IPR2025-00856 · APJ Jameson Lee · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–19 were obvious over the asserted prior-art combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review. See 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a). An inter partes review may not be instituted unless the information presented in the Petition “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). The “reasonable likelihood” standard is “a higher standard than mere notice pleading” but “lower than the ‘preponderance’ standard to prevail in a final written decision.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 at 13 (PTAB Dec. 20, 2019) (precedential). We determine Petitioner has not demonstrated a reasonable likelihood that it would prevail in establishing the unpatentability of at least one of challenged claims 1–19 of the ’877 patent. Accordingly, the Petition is denied, and no trial is instituted.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner asserts that a person of ordinary skill at the pertinent time “would be a person with a bachelor’s degree in computer science, computer engineering, or a closely related discipline and two years of relevant professional experience in software engineering or a similar field.” Prelim. Resp. 10. We adopt Petitioner’s statement of the level of ordinary skill in the art. It is supported by the testimony of Dr. Bederson. Ex. 1003 ¶¶ 32–33, 37–39. Although Patent Owner has proposed a slightly different statement for the level of ordinary skill in the art, Patent Owner does not explain why Petitioner’s proposal is incorrect. We find Petitioner’s proposed level presents a better statement of the level of ordinary skill in the art because it requires experience with web-based information systems and Patent Owner’s proposal does not. As noted above, the ’877 patent relates to a method for accessing information sources and services on the Web. Ex. 1001, 2:4–12. Further, Petitioner’s proposal appears consistent with what is reflected by the content of the applied prior art. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1354–55 (Fed. Cir. 2001) (the applied prior art may reflect an appropriate level of skill). B.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“We need not resolve the above-identified dispute, because a different aspect of “beforehand locally stored” is determinative. Read in context, “beforehand locally stored” in both limitations 1(a)(2) and 12(a) refer back to the “preliminary search” action recited in limitation 1(a)(1) and in limitation 12(a) itself, respectively. Thus, we construe “beforehand locally stored” to mean that the selection pages must already be stored within the communication device when the user begins the preliminary search, regardless of whether it was the user or an automated process that downloaded the selection pages to the communication device. This understanding stems from a plain reading of the claim language and does not leave room for reasonable doubt otherwise. Petitioner does not present any reason why the claims do not require the selection pages to have already been stored in the communication device when a user begins the preliminary search. C.” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“of the language in these limitations is that the selection pages must be beforehand locally stored, where beforehand is assessed at the time of starting a preliminary search. Based on this construction, Petitioner has not sufficiently shown that Rossman discloses limitation 1(a)(2) and limitation 12(a), even for institution purposes. Petitioner identifies Rossmann’s cards as the claimed selection pages of claims 1 and 12. Pet. 18–19. Rossmann’s cards, however, are not beforehand locally stored on the communication device at the time a user begins a preliminary search for information. Rather, on the record before us, at the time of starting a search for information, the user must request a connection to a server device at a desired host site, which request results in the server device at the host site sending one or more decks each including a plurality of cards to the user’s mobile device. Ex. 1004, 6:26–29; 7:22–27; 7:56–66. Thus, Rossmann’s cards are not beforehand locally stored at the time the user commences a preliminary search. Petitioner’s reliance on Himmel and on King do not make up for this deficiency.” slip op. at 14
Claim construction§ 103 obviousnessPatents in suitUS 8,271,877 - Comcast Cable Communications, LLC v. Entropic Communications, LLCInstitution deniedPTAB · Apr 29, 2025 · IPR2025-00182 · APJ Scott B Howard · IPR · Institution
The Board denied institution of IPR on claims 1–20, exercising § 314(a) discretion because this was an unnecessary third parallel petition.
RulingsInstitution decision- Parallel petitionsInstitution denied discretionary otherDenied
“Our Practice Guide provides guidance on handling situations involving multiple petitions by a single petitioner challenging the same patent claims: Based on the Board’s experience, one petition should be sufficient to challenge the claims of a patent in most situations . . . . In addition, multiple petitions by a petitioner are not necessary in the vast majority of cases. To date, a substantial Practice Guide 59 (emphasis added). The Practice Guide provides examples of “circumstances in which more than one petition may be necessary.” Id. None of these examples are pertinent here.” slip op. at 7
Discretionary denialPatents in suitUS 11,785,275 - Comcast Cable Communications, LLC v. Entropic Communications, LLCInstitution deniedPTAB · Apr 29, 2025 · IPR2025-00181 · APJ Scott B Howard · IPR · Institution
The Board denied institution on claims 1–20, exercising § 314(a) discretion because Petitioner’s second parallel petition was unnecessary.
RulingsInstitution decision- Parallel petitionsDenied
“Our Practice Guide provides guidance on handling situations involving multiple petitions by a single petitioner challenging the same patent claims: Based on the Board’s experience, one petition should be sufficient to challenge the claims of a patent in most situations . . . . In addition, multiple petitions by a petitioner are not necessary in the vast majority of cases. To date, a substantial majority of patents have been challenged with a single petition. Practice Guide 59 (emphasis added). The Practice Guide provides examples of “circumstances in which more than one petition may be necessary.” Id. None of these examples are pertinent here.” slip op. at 7
Discretionary denialPatents in suitUS 11,785,275 - SAP America, Inc. v. Cyandia, Inc.Institution deniedPTAB · Apr 7, 2025 · IPR2024-01496 · APJ Mitchell G Weatherly · IPR · Institution
The Board denied institution of inter partes review of claims 1–11, 13, 16, 18, and 31–34 under § 314(a), after weighing the Fintiv factors.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“Although Petitioner has filed a Sotera stipulation, we agree with Patent Owner that the stipulation has limited practical effect in reducing the overlapping efforts here and in the Litigation. Petitioner contends in the district court that the system described in the WebSphere materials renders at least some of the challenged claims invalid. Because Petitioner cannot challenge claims in this proceeding based on a public use or sale of the WebSphere system, Petitioner’s Sotera stipulation would not prevent Petitioner from asserting an invalidity defense in the district court based on the public use or sale of the WebSphere system. We understand that, in the Litigation, Petitioner has relied upon the WebSphere publications as prior art, presumably as evidence describing the WebSphere system that was publicly used and on sale. Regardless of any decision rendered in this proceeding on the patentability of the challenged claims based on the WebSphere printed publications, Petitioner may continue to press an invalidity defense based on the same evidence presented here. Additionally, it appears that all claims being contested as invalid in the Litigation are also subject to a challenge in the Petition. The narrowing of asserted claims in the Litigation, if it occurs, will streamline the parties’ overall dispute on invalidity if we decide to discretionarily deny institution. So, a majority of the parties’ work that would be done here will also be required in the Litigation regardless of whether we institute review. Accordingly, we do not consider the presence of the Sotera stipulation in our case to ensure that inter partes review would be a “true alternative” to the Litigation. On balance, we find that Fintiv Factor 4 weighs in favor of discretionarily denying institution. E. Fintiv Factor 5: Whether Petitioner Is Defendant in District Court” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied fintivInstitution denied
“We decline to characterize the merits as sufficiently strong to overcome the other factors. That is not to say we view Petitioner’s case as marginal or close. Rather we determine that the other factors are more persuasive here. Although Petitioner’s challenge is straightforward and definitely meets the standard for institution, even when balanced against Patent Owner’s counterarguments, we do not find the challenge to be sufficiently strong to outweigh the evidence discussed above in connection with Fintiv Factors 1–5. When reviewing all other circumstances, we find that Fintiv Factor 6 is neutral. G. Conclusion” slip op. at 10
Discretionary denialPatents in suitUS 8,595,641 - SAP America, Inc. v. Cyandia, Inc.Institution deniedPTAB · Apr 7, 2025 · IPR2024-01495 · APJ Mitchell G Weatherly · IPR · Institution
The Board denied institution on claims 1–10, 13, 17, 18, and 36–42 under § 314(a), finding the Fintiv factors holistically favored discretionary denial.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied
“Although Petitioner has filed a Sotera stipulation, we agree with Patent Owner that the stipulation has limited practical effect in reducing the overlapping efforts here and in the Litigation. Petitioner contends in the district court that the system described in the WebSphere materials renders at least some of the challenged claims invalid. Because Petitioner cannot challenge claims in this proceeding based on a public use or sale of the WebSphere system, Petitioner’s Sotera stipulation would not prevent Petitioner from asserting an invalidity defense in the district court based on the public use or sale of the WebSphere system. We understand that, in the Litigation, Petitioner has relied upon the WebSphere publications as prior art, presumably as evidence describing the WebSphere system that was publicly used and on sale. Regardless of any decision rendered in this proceeding on the patentability of the challenged claims based on the WebSphere printed publications, Petitioner may continue to press an invalidity defense based on the same evidence presented here. Additionally, it appears that all claims being contested as invalid in the Litigation are also subject to a challenge in the Petition. The narrowing of asserted claims in the Litigation, if it occurs, will streamline the parties’ overall dispute on invalidity if we decide to discretionarily deny institution. So, a majority of the parties’ work that would be done here will also be required in the Litigation regardless of whether we institute review. Accordingly, we do not consider the presence of the Sotera stipulation in our case to ensure that inter partes review would be a “true alternative” to the Litigation. On balance, we find that Fintiv Factor 4 weighs in favor of discretionarily denying institution. E. Fintiv Factor 5: Whether Petitioner Is Defendant in District Court” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied discretionary otherInstitution denied
“Institution of an inter partes review is authorized by statute when “the information presented in the petition filed under section 311 and any response filed under section 313 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.” 35 U.S.C. § 314(a).” slip op. at 2
Discretionary denialPatents in suitUS 8,578,285 - SAP America, Inc. v. Cyandia, Inc.Institution deniedPTAB · Apr 7, 2025 · IPR2024-01432 · APJ Jason W Melvin · IPR · Institution
The Board denied institution of review of claims 1–7, 10, 11, 13, 18, 19, 23, 29, 35, and 36 under § 314(a) based on the Fintiv factors and copending district-court litigation.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivInstitution denied
“overcome the other factors. That is not to say we view Petitioner’s case as marginal or close, rather we determine that the other factors are more persuasive here. Although Petitioner’s challenge is straightforward and definitely satisfies the institution standard, even when balanced against Patent Owner’s counterarguments, we do not find the challenge to be sufficiently strong to outweigh the evidence discussed above in connection with Fintiv factors 1–5. When reviewing all other circumstances, we find that factor 6 is neutral.” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“An inter partes review may not be instituted unless “the information presented in the petition . . . and any 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.” 35 U.S.C. § 314(a) (2018). “When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.” 37 C.F.R. § 42.108(a) (2021).” slip op. at 2
Discretionary denialPatents in suitUS 8,751,948 - Biofrontera Inc. / Biofrontera Bioscience GmbH et al. v. Sun Pharmaceutical Industries, Inc.Institution deniedPTAB · Nov 12, 2024 · IPR2024-00874 · APJ Erica A Franklin · IPR · Institution
The Board denied institution because the petition did not show a reasonable likelihood that any challenged claim was unpatentable, failing to show Bansal's claimed light intensity arrangement.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“An obviousness determination requires finding both ‘that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.’” CRFD Research, Inc. v. Matal, 876 F.3d 1330, 1340 (Fed. Cir. 2017) (quoting Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367– 68 (Fed. Cir. 2016)). Obviousness grounds must be supported with “articulated reasoning with some rational underpinning” and not by “mere conclusory statements.” See KSR Int’l Co., 550 U.S at 418. slip op. at 11
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“agree with Patent Owner that Petitioner has not sufficiently shown for institution that Bansal teaches or suggests arranging light sources “such that a higher intensity of light is emitted proximate the second edges compared to the intensity of light emitted not proximate the second edges,” as required by the challenged claims. Instead, Petitioner demonstrates how Bansal describes varying the density of light source distribution throughout the array to provide a higher density of light in the entire peripheral area of the array, which includes the areas proximal to both the first and second edges, as compared to the central area of the array. See Pet. 36–37; Ex. 1005 ¶ 25. In this regard, Petitioner relies on Bansal’s Figure 9b, asserting that it “shows one embodiment where more light sources are placed near the edges of the panel compared to the light sources in the center.” Pet. 36–37. The comparison of Bansal’s light density between the entire periphery and the central area of the array is insufficient. What is missing from Petitioner’s argument and discussion of Bansal is how Bansal teaches or suggests a configuration that provides a higher density of light proximate to the second shorter edges of the periphery in comparison to the remaining areas of the array, which includes the first longer edges of the periphery. Without that discussion, we find that Petitioner has not shown sufficient for institution that Bansal is persuasively relied upon for the light source arrangement limitation of the challenged claims. likelihood of prevailing in its obviousness challenge of independent claims 1, 5, 16, 20, or 21, or dependent claims 2, 4, 6–8, and 17–19 over Larsen, Bansal, and Jones.” slip op. at 17
- Skill levelOther
“would have had at least a Bachelor of Science in electrical engineering, physics, biomedical engineering, computer engineering, chemical engineering, material science, or a related scientific or engineering field, and at least one year of work or research experience in optics, optoelectronics, radiometry, photometry, photodynamic diagnosis (PD), photodynamic therapy (PDT), phototherapy (PT), or a related field. Pet. 8. Petitioner asserts that, alternatively, a “POSITA in the relevant time frame would have had at least four years of industry or academic experience in optics, optoelectronics, radiometry, photometry, PD, PDT, PT, or a related field.” Id. (citing Ex. 1003 ¶ 37). According to Patent Owner, a person of ordinary skill in the art at the time the application for the ’028 patent was filed, “would have had a M.D. and/or a Ph.D. in an electrical engineering, physics, optical sciences, optical engineering, or a related scientific or engineering field, and at least one to two years of work or research experience in optical engineering, optics, optoelectronics, phototherapy (‘PT’), PDT, or a related field.” Prelim. Resp. 16. Patent Owner asserts that, “[a]lternatively, a POSITA could have a Bachelor’s degree in one of the above areas and at least three to four years of work or research experience in that area.” Id. (citing Ex. 2001 ¶¶ 30–31). We note that the parties’ proposed definitions are largely similar. To the extent that the proposed definitions differ, we do not need to resolve those differences as our findings and conclusion in this Decision would be the same under any of the proposed definitions.” slip op. at 9
§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,697,028 - Lenovo (United States) Inc. / Motorola Mobility LLC v. Theta IP, LLCInstitution deniedPTAB · Oct 23, 2023 · IPR2023-00694 · APJ Thomas L Giannetti · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood of proving claims 1, 23, 29, or 30 obvious over the asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the petition “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons stated below, we determine that Petitioner has not established a reasonable likelihood that it would prevail with respect to at least one claim. We, therefore, deny the Petition and do not institute inter partes review.” slip op. at 2
- Skill levelSkill level petitioner adoptedOther
“The two proposals are materially similar in the education requirement, but differ marginally in professional experience required (three versus five years). See supra. While we are persuaded, on the present record, that both Petitioner’s and Patent Owner’s proposals are consistent with the problems and solutions in the ’330 patent and the prior art of record, on balance, Petitioner’s proposal is a better reflection of the level of skill in the prior art, and we, therefore, adopt it for this decision. Our decision would not change, however, if we had applied Patent Owner’s proposed level of ordinary skill.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We construe claim terms only as relevant to the parties’ contentions and only to the extent necessary to resolve the issues in dispute. See Vivid Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017). Having considered the positions of the parties, we find that for the purpose of this decision, we do not need to construe this term to resolve a dispute.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITANot reached
“In light of the analysis of the patentability of the claims that follows, and having considered the positions of the parties, we find that for the dispute. See Vivid Techs., 200 F.3d at 803, supra. C. Other Terms We determine there are no other claim terms that need to be construed for this decision.” slip op. at 9
Claim construction§ 103 obviousnesscites GrahamPatents in suitUS 7,010,330 - Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution deniedPTAB · Oct 2, 2023 · IPR2023-00723 · APJ Robert A Pollock · IPR · Institution
The Board denied institution on claims 1–6 because Petitioner did not show a reasonable likelihood that any challenged claim was unpatentable under the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (2012) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). A claim is unpatentable under 35 U.S.C. § 103 if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence (1966). In analyzing the obviousness of a combination of prior art elements, it can be important to identify a reason that would have prompted one of skill in the art “to combine . . . known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418. A precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. Id. Rather, “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Id. at 420. Accordingly, a party that petitions the Board for a determination of unpatentability based on obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (internal quotations omitted). slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“In determining the level of skill in the art, we consider the type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. See Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 955, 962 (Fed. Cir. 1986); see also Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983). In addressing the level of ordinary skill in the art, Petitioner contends that “[t]he claimed subject matter falls within the medicinal chemical and pharmacological arts and encompasses the skills, education, and expertise of a team of individuals working together to develop and formulate GLP-1 analogs to treat patients having type-2 diabetes or related conditions.” Pet. 7. The persons of ordinary skill in the art (“POSA”) making up the team would have an M.D., Pharm.D., or doctoral degree(s) in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, chemical engineering, biochemical engineering or related fields, peptides or proteins, and experience with the development, design, manufacture, formulation, or administration of therapeutic peptides or proteins, and the literature concerning protein or peptide formulation and design or diabetes treatments. Id. at 7–8 (citing Ex. 1020 ¶ 27; Ex. 1022 ¶ 27; Ex. 1024 ¶ 21; Ex. 1026 ¶¶ 25–26). 13 Patent Owner does not offer a different level of ordinary skill in the art. See generally Prelim. Resp. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’343 Patent. 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. Claim Construction” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We interpret a claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2020). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Moreover, “the specification ‘is always highly relevant to the claim construction analysis. Usually it is dispositive; it is the single best guide to the meaning of a disputed term.’” In re Abbott 13 We need not consider Petitioner’s similar alternative definitions. See id. at 8–9. v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc)). The parties contend that no claim term requires construction. Pet. 13. Prelim. Resp. 15. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). D. Overview of Asserted References” slip op. at 12
- Expert testimonyPetitioner expert discountedDecided for patent owner
“On the record before us, however, Dr. Flatt’s assessment of the relative benefit one of ordinary skill in the art would have accorded the higher Ki of mono-substituted compound 3 as compared to the “much longer plasma half-life” of Dong’s bi-substituted compounds is at odds with Dong’s selection of bi-substituted compound 4 for clinical trials. See Ex. 1013, 670– 671 (Table 1). We are also skeptical of Dr. Flatt’s assertion that one of ordinary skill in the art would have recognized that Dong’s substitution of Aib for alanine at position 8 “would complement and work synergistically with liraglutide’s [other] properties,” including the fatty acylation of Lys26. See Ex. 1020 ¶ 181. In this respect, Patent Owner notes that, unlike liraglutide, Dong’s GLP-1 analogs were not acylated, whereas Knudsen 2001 counseled against N-terminal modifications in the context of acylation. Prelim. Resp. 28–30, 46 (citing Ex. 1011, 680–681). In addressing such combinations, Knudsen 2001 states, for example, that “Desamino His7 represents one of the more potent suggestions to a modification giving metabolic stability (81 ). Nevertheless, as seen when comparing 19 (687 pM) to 5 [liraglutide] (68 pM), considerably more potent compounds could be obtained by not modifying the N-terminus when a combination with acylation was desired.” Id. at 680. As such, we are unpersuaded on the record before us that one of ordinary skill in the art would have had a reasonable expectation that the Aib8 modification would be beneficial or otherwise “complement and work synergistically with” the acylated Lys26 of liraglutide or semaglutide. See Ex. 1020 ¶ 181.” slip op. at 30
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 8,129,343 - Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution deniedPTAB · Oct 2, 2023 · IPR2023-00722 · APJ Robert A Pollock · IPR · Institution
Institution was denied for claims 1, 2, 4–11, 13, and 15 because Petitioner did not show a reasonable likelihood of proving them obvious under any of the three grounds.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In addressing the level of ordinary skill in the art, Petitioner contends that “[t]he claimed subject matter falls within the medicinal chemical and pharmacological arts and encompasses the skills, education, and expertise of a team of individuals working together to develop and formulate GLP-1 analogs to treat patients having type-2 diabetes or related conditions.” Pet. 7. The persons of ordinary skill in the art (“POSA”) making up the team would have an M.D., Pharm.D., or doctoral degree(s) in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, chemical engineering, biochemical engineering or related fields, with at least two years of experience in developing therapeutic peptides or proteins, and experience with the development, design, manufacture, formulation, or administration of therapeutic peptides or proteins, and the literature concerning protein or peptide formulation and design or diabetes treatments. ¶ 24).14 Patent Owner does not offer a different level of ordinary skill in the art. See generally Prelim. Resp. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’122 Patent. 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)).” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties contend that no claim term requires construction. Pet. 16. Prelim. Resp. 16. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our 14 We need not consider Petitioner’s similar, but alternative, definitions. See id. at 8–9. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 15
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“For the reasons provided below, we determine Petitioner has not satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Because Petitioner has not demonstrated a reasonable likelihood that at least one claim of the ’122 patent is unpatentable, we do not institute an inter partes review on the Grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yesor-no institution choice respecting a petition, embracing all challenges included in the petition”); see also Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018).1” slip op. at 2
- BurdenNot shown unpatentable
“Considering the record before us, Petitioner has not shown sufficiently that one of ordinary skill in the art would be motivated to make the required modification with a reasonable expectation of success. (4) Hindsight and Reasonable Expectation of Success One of ordinary skill in the art seeking to modify liraglutide would need undertake at least four discrete steps to arrive at semaglutide—some of which entail multiple options and decision points (e.g., the selection and placement of di-AEEA, and whether to replace, or add to, the existing γ-glu linker). As discussed above, we find Petitioner’s justification for these individual steps problematic. Taken as whole, and considering the vast number of modifications suggested in the art—and indeed, the large number of amino acids suggested as cites for modification—Petitioner has failed to meet its burden of demonstrating why a skilled artisan would have been motivated to make all of the identified substitutions and no others. See e.g., Ex. 1010, 4130 (Figure 3) (identifying amino acids available for derivatization (Ser18, Gln23, Lys26, Glu27, Lys34, and Arg36) or modification (Ala8)); Ex. 1011, 680–681 (identifying desamino His7 as “one of the more potent suggestions to a modification giving metabolic stability,”); Ex. 1012 at, e.g., 9:21-19:59; 192:30–60 (Table 1), 193:35–46 (disclosing numerous GLP-1 analogs, including those with greater half-lives or potency than liraglutide, and teaching that each could be further modified, including with amino acid substitutions and/or acylation at multiple positions, numerous the fatty and amino acids); Ex. 1013, 670–671 (disclosing that GLP-1 analogs bearing modifications at both positions 8 and 35 maintain efficacy but “have much longer plasma half-life than mono-substituted compounds”).” slip op. at 43
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 8,536,122
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.