• Azurity Pharmaceuticals, Inc. v. Exelixis Inc.Institution denied
  PTAB · Jun 4, 2025 · IPR2025-00210 · APJ Jeffrey N Fredman · IPR · Institution

  The Board denied institution on all grounds because Petitioner did not show a reasonable likelihood of proving claims 1–3 unpatentable.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “Accordingly, we find that on the current record Petitioner has not shown that the combination of Brown, Kubo, and Remington would inherently result in less than 200 ppm impurity and Petitioner has not shown that it has a reasonable likelihood that it would prevail on the obviousness ground.” slip op. at 29

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner

    “Here, there is no dispute that the ’349 patent and Wilson, which issued from a patent application from which priority was claimed for the ’349 patent, share the identical disclosure of a pharmaceutical composition comprising Compound IA or IB; one or more fillers; one or more disintegrants; one or more glidants; and one or more lubricants. In this embodiment, the filler comprises microcrystalline cellulose. In this embodiment, the disintegrant comprises croscarmellose sodium. In this embodiment, the disintegrant comprises croscarmellose sodium and sodium starch glycolate. In this embodiment, the glidant comprises fumed silica. In this embodiment, the lubricant comprises stearic acid. Ex. 1001, 21:1–12; Ex. 1002, 20:51–62. There is express ipsis verbis disclosure of the elements recited in claim 1 of the ’349 patent.” slip op. at 13

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

    “1. Reason to reduce contaminant levels We agree with Patent Owner that Petitioner identifies no teaching in the prior art providing any reason to reduce levels of 6,7-dimethoxy-quinoline-4-ol specifically. And while Brown does teach a desire to form “substantially pure” compounds, Brown focuses on “at least about 90 wt.%” of the compound, then lists specifically “about 90, about 91, about 92, about 93, about 94, about 95, about 96, about 97, about 98, about 99 and about 100% wt. %.” Ex. 1003 ¶ 97. This permits a range of concentration for contaminants from about 0 to 10%.” slip op. at 24

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable

    “to modify Brown’s process with Kubo to eliminate the added step. See, e.g., Id. ¶ 73. But even with that combination, Dr. Dichtel states only that a “POSA would have expected there to be a decrease in the amount of 6,7- dimethoxy-quinoline-4-ol at the end of cabozantinib (L)-malate’s synthesis that was attributable to hydrolytic degradation of the 4- (nitrophenoxy)quinoline intermediate by avoiding its use in the synthesis.” Id. ¶ 78. That is not, however, the standard for inherency. It must be the necessary result, not a possible expected result. The Federal Circuit in Par explained that: Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient. If, however, the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient.” slip op. at 28

  § 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 11,298,349
• Aardevo North America, LLC v. Agventure B.V.Institution denied
  PTAB · May 1, 2025 · IPR2025-00136 · APJ Jeffrey N Fredman · IPR · Institution

  Institution of inter partes review was denied for claims 1–10 because Petitioner did not establish a reasonable likelihood of prevailing on any asserted ground.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “Accordingly, we find that on the current record Petitioner has not shown that it has a reasonable likelihood that it would prevail on these obviousness grounds. XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5. XIII. CONCLUSION After reviewing the information presented in the Petition and the Preliminary Response, we determine that, based on the evidence of record, Petitioner has not established a reasonable likelihood that claims 1–10 of the ’841 patent are unpatentable. XIV. ORDER Accordingly, it is ORDERED that, pursuant to 35 U.S.C. § 314(a), institution of an inter partes review of all challenged claims on all grounds presented in the Petition is denied.” slip op. at 35

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable

    “However, neither Petitioner nor Dr. Jansky provide specific data on the record before us showing the actual measured homozygosity of either of the inbred lines, US-W 5309 and US-W 5315. And Phumichai experimentally demonstrates that Dr. Jansky’s assumption that theoretical heterozygosity reduction of 50% per generation is not necessarily accurate, stating the “observed average percentage of reduction of heterozygosity per generation (38.4% or 38.5%) was lower than the theoretically expected value of 50%.” Ex. 1005, 982. Indeed, Phumichai disclosed that the “SOPH [Section-based observed percentage of heterozygosity] decreased steadily from the original 100% in 99H2–1 (S0) to the family means of 62.4% in 3H2 (S1), 37.9% in 3H3 (S2).” Id. at 981. That is, Phumichai experimentally shows that in an S2 generation of a potato line, the heterozygosity was 37.9%, resulting in homozygosity of about 62.1%, below the 75% theoretically expected and the 75% required by claim 1 of the ’841 patent. Therefore, the evidence of record does not show that the S2 generation of potato lines in Jong necessarily satisfies the homozygosity recitation in claim 1 of the ’841 patent, and so cannot establish on the record before us that Jong inherently teaches this limitation.” slip op. at 15

  • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedNot shown unpatentableNot shown unpatentable

    “Owner is telling. Petitioner does not refute Patent Owner’s evidence of objective indicia. On the current record, the objective indicia evidence is compelling. As to long felt need, Patent Owner cited evidence on record before the Examiner that showed a persistent need recognized by ordinarily skilled artisans. In re Gershon, 372 F.2d 535, 538 (CCPA 1967). For example, Dr. Huang states “This research is the breakthrough we have been waiting for since nearly a century . . . This is crucial for the potato breeding worldwide.” Ex. 2009, 687. There is no evidence that this long-felt need was satisfied by another before Appellant’s invention. See Newell Companies, Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988) (“[O]nce another supplied the key element, there was no long-felt need or, indeed, a problem to be solved . . . .”). Lastly, Dr. Lindhout explains that this invention satisfies the long-felt need, stating “I have discovered, and disclosed in the present application for patent, how a fertile homozygote in” slip op. at 33

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached

    “XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5.” slip op. at 35

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 11,140,841
• Imperative Care, Inc. v. Inari Medical, Inc.Institution denied
  PTAB · Feb 7, 2025 · IPR2024-01257 · APJ Timothy G Majors · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood of proving any challenged claim unpatentable, chiefly because Garrison did not disclose the claimed negative-pressure arrangement.

  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 it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. Based on the record here and for the reasons discussed below, we find that Petitioner has not demonstrated a reasonable likelihood that it will prevail in establishing that any of the challenged claims are unpatentable. We, therefore, do not institute inter partes review.” slip op. at 2

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “We need only construe the claims to the extent needed to resolve the controversy before us. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019). Patent Owner neither disputes Petitioner’s proffered construction nor disputes Petitioner’s contention that Hartley teaches a “filament” as claimed. See, e.g., Pet. 41–43; Prelim. Resp. 17. We need not expressly construe the term “filament” or any other term for this Decision.” slip op. at 12

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art Petitioner proposes that the person of ordinary skill in the art (“POSA”) in August 2018 “would have had an undergraduate degree in mechanical engineering or a related engineering discipline and 2–4 years of catheter design experience.” Pet. 20 (citing Ex. 1003 ¶¶ 35–36). Patent Owner contends that Petitioner’s proposal is “insufficient,” yet Patent Owner provides no alternative definition of the POSA’s qualifications and, instead, applies Petitioner’s proposed definition. Prelim. Resp. 17. We apply Petitioner’s proposed POSA level for the purposes of this Decision, which level does not appear to be inconsistent with the prior art of record.” slip op. at 11

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableInstitution denied

    “On this record, we agree with Patent Owner that Petitioner has not shown sufficiently that Garrison describes the subject matter of claim 1’s system with the subject matter being arranged as recited in the claim. Prelim. Resp. 44–62. Patent Owner argues, for example, that Petitioner “fails to identify any embodiment of Garrison that discloses . . . an aspiration system including an aspiration pump in which negative pressure is generated in a first chamber and a second chamber when a valve is closed.” Id. at 45. Patent Owner cites, inter alia, Petitioner’s identification of “an aspiration pump that is positioned upstream of a receptacle such that the pump delivers fluid (e.g., blood) to the receptacle via positive pressure and thus cannot generate negative pressure in the receptacle”—the alleged “first chamber” identified by Petitioner. Id. at 45–46 (emphasis added). Patent Owner persuasively supports its counterarguments with the teachings of Garrison and the testimony of Mr. Brown. See, e.g., Ex. 1006, Figs. 32–36; Ex. 2001 ¶¶ 64–76. We discuss in further detail below. whenever Garrison discloses a pump in the embodiments identified by Petitioner—whether a peristaltic pump as shown in Figures 32–34, a centrifugal pump, or the pump device 3250 shown in Figure 36—the pump is positioned to draw fluid through an inlet and expel the fluid out of an outlet via positive pressure to a downstream delivery location such as a receptacle or blood return line. Such a pump would not and could not generate negative pressure in the downstream delivery location (the receptacle the Petition alleges is the first chamber) for multiple reasons—and therefore would not generate negative pressure in any “first chamber” identified by Petitioner. Prelim. Resp. 46. We agree with Patent Owner.” slip op. at 22

  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,744,691
• Vectair Systems Inc. v. Fresh Products, Inc.Institution denied
  PTAB · Nov 12, 2024 · IPR2024-00824 · APJ Sheridan K Snedden · IPR · Institution

  The Board denied institution on all challenged claims because the Petition did not establish that the listings were prior art or provide sufficient evidence and motivation for the obviousness combinations.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). An inter partes review may be instituted only upon a showing that “there is a reasonable likelihood that the petitioner would prevail with respect to at least one of the claims challenged in the petition.” 35 U.S.C. § 314(a). After considering the Petition, Preliminary Response, and information presented by the parties, we determine that Petitioner has not demonstrated a reasonable likelihood of prevailing with respect to at least one claim challenged in the Petition. Accordingly, we decline to institute inter partes review.” slip op. at 2

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable

    “of claims under 35 U.S.C. § 102 or § 103 “only on the basis of prior art consisting of patents or printed publications.” 35 U.S.C. § 311(b). At the institution stage, the “burden is on the petitioner to identify with particularity evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent, and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29, 21 (PTAB Dec. 20, 2019) (precedential). This differs from the standard in a final written decision, at which point “the petitioner bears the burden of establishing by a preponderance of the evidence that a particular document is a printed publication.” Nobel Biocare Servs. AG v. Instradent USA, Inc., 903 F.3d 1365, 1375 (Fed. Cir. 2018) (citing Medtronic, Inc. v. Barry, 891 F.3d 1368, 1380 (Fed. Cir. 2018)).” slip op. at 13

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “c. Discussion Having considered the parties’ positions and evidence of record, summarized above, we determine that Petitioner fails to establish a reasonable likelihood that the Amazon Listings were publicly accessible before the priority date of the ’098 patent, and therefore fails to establish a reasonable likelihood that the Amazon Listings qualify as printed publications. As explained in a previous Board decision, “[t]he date that a product was listed as first available on a website . . . is not sufficient evidence that the content of the listing, including the photographs depicted therein, were published at that time.” Next Step Grp., Inc. v. Deckers Outdoor Corp., No. IPR2024-00525, 2024 WL 3678413, at *5 (P.T.A.B. Aug. 6, 2024) (citing Ex parte Basulto, Appeal 2020-00129, 2021 WL 1264902, at *2 (PTAB Apr. 2, 2021) (stating “the date [a] product was listed on Amazon.com is not compelling evidence that the content of [the] listing itself as shown in the document, and the photographs relied on within it were published at that time”). That is because product listings may be updated and photographs of the products may change over time and, therefore, a statement on a commercial website as to when a product was “first available” is insufficient evidence without additional corroborating evidence that the listing itself, or any photograph depicted therein, has not changed over time. See id. (citing Ex parte Zhang, Appeal 2021-000087, 2021 WL 633718 at *3 (PTAB Feb. 16, 2021) (stating “while the [webpage] date indicates that the product information was last updated on [date], there is no additional evidence to corroborate that the picture was publicly accessible on that date”)). In this case, Petitioner does not provide sufficient corroborating evidence that any of the information or images depicted in the Amazon Listings were available and remained unchanged on the website prior to the critical date. In contrast, Patent Owner provides evidence in the form of testimony of Mr. Smith, which we find credible, that the Amazon Listings offering the Wave 3D Urinal Screen for sale could not have existed prior to November 2014, the priority date of the ’098 patent. d. Conclusion In view of the above, we determine that, on this record, Petitioner has not established a reasonable likelihood of prevailing in demonstrating the unpatentability of claims 1, 19, and 38 with respect to Ground 1.” slip op. at 14

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable

    “b. Legal Standard “To satisfy its burden of proving obviousness, a petitioner cannot employ mere conclusory statements. The petitioner must instead articulate specific reasoning, based on evidence of record, to support the legal conclusion of obviousness.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016). Moreover, “[a] party seeking to invalidate a patent on the basis of obviousness must demonstrate by clear and convincing evidence 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.” See Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1360 (Fed. Cir. 2012) (quotation marks omitted); see also In re Nuvasive, Inc., 842 F.3d 1376, 1383 (Fed. Cir. 2016) (explaining that “conclusory statements” are “insufficient articulations of motivation to combine” prior art references). When an assertion of obviousness “fails to identify any actual reason why a skilled artisan would have combined the elements in the manner claimed,” the assertion of obviousness “is inadequate.” See In re Van Os, 844 F.3d 1359, 1361 (Fed. Cir. 2017). Furthermore, unsupported statements that a combination of elements would have been merely a design choice is insufficient to establish obviousness. See Stryker Corp. v. Karl Storz Endoscopy–America, Inc., IPR2015–00677, Paper 15 at 37 (P.T.A.B. Sept. 2, 2015) (“[t]he mere recitation of the words ‘common sense’ or ‘design choice,’ however, without any evidentiary support, adds nothing to the obviousness equation.” (citing Mintz v. Dietz & Watson, Inc., 679 F. 3d 1372, 1377 (Fed. Cir. 2012)).” slip op. at 17

  § 102 anticipation§ 103 obviousness
  Patents in suitUS 10,145,098
• Biofrontera Inc. / Biofrontera Bioscience GmbH et al. v. Sun Pharmaceutical Industries, Inc.Institution denied
  PTAB · 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 · Graham
  Patents in suitUS 11,697,028
• Microbiotica, Limited v. Board Of Regents, The University Of Texas SystemInstitution denied
  PTAB · Nov 21, 2023 · PGR2023-00026 · APJ Susan L C Mitchell · PGR · Institution

  The Board denied institution because Petitioner did not show it was more likely than not that claims 1–19 were unpatentable, including because the proposed prior-art combination lacked a sufficient reason to select Ruminococcus for skin …

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “Institution of post-grant review is authorized by statute only when “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.”1 35 U.S.C. § 324; see 37 C.F.R. § 42.4. Upon considering the Petition, Preliminary Response, and the cited evidence, we conclude that Petitioner has not satisfied its burden under 35 U.S.C. § 324 to show that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable.” slip op. at 2

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached

    “7 Patent Owner requested that we exercise our discretion to deny institution under 35 U.S.C. § 325(d). See Prelim. Resp. 11–49. Because we determine on the merits that no post-grant review should be instituted, we will not address Patent Owner’s arguments concerning Section 325(d).” slip op. at 44

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner counters that Petitioner has set the level of skill of a person of ordinary skill in the art too low. Prelim. Resp. 9–11; Ex. 2001 ¶ 25. Patent Owner asserts that a POSA would have a more advanced degree than a bachelor of science and would have more specific work experience. Id. For instance, Patent Owner asserts: A POSA for the ’838 Patent typically would have an advanced degree, such as an M.D. or a Ph.D., with experience and training in oncology, have several years of experience with administering oncology treatments to subjects and evaluating results of such treatments, and have experience or knowledge in microbiome science and its modulation, inclusive of studies that involve stool microbiome profiling, as well as experience in, or knowledge of, related research and development of bacterial-based cancer treatments. A POSA may also have worked as part of a multi-disciplinary team and drawn upon not only his or her own skills, but also taken advantage of certain specialized skills of others in the team, to solve a given problem. For example, such a team may include a clinician, an immunologist, microbiologist, bioinformatician, molecular biologist, manufacturing specialist, and/or pharmaceutical formulator. Prelim. Resp. 9–10 (citing Ex. 2001 ¶¶ 26–27). Patent Owner concludes that by applying the inappropriately low level of skill of a POSA, “Petitioner overstates the amount of guidance needed in the specification to describe and enable the claimed methods.” Prelim. Resp. 11. Patent Owner confirms, however, that all arguments on all grounds presented in the Preliminary Response “apply regardless of which party’s POSA definition is used.” Prelim. Resp. 11 n.2. We disagree with Patent Owner that a POSA is required to have a” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner

    “Patent Owner acted as its own lexicographer and expressly defined “isolated” and “purified” as follows. The term “isolated” encompasses a bacterium or other entity or substance that has been (1) separated from at least some of the components with which it was associated when initially produced (whether in nature or in an experimental 6 Available at https://www.uspto.gov/sites/default/files/documents/IndefinitenessMemo.pd f?utm_campaign=subscriptioncenter&utm_content=&utm_medium=email& utm_name=&utm_source=govdelivery&utm_term=. setting), and/or (2) produced, prepared, purified, and/or manufactured by the hand of man. Isolated bacteria may be separated from at least about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, or more of the other components with which they were initially associated. In some embodiments, isolated bacteria are more than about 80%, about 85%, about 90%, about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98%, about 99%, or more than about 99% pure. As used herein, a substance is “pure” if it is substantially free of other components. The term “purify,” “purifying” and “purified” refer to a bacterium or other material that has been separated from at least some of the components with which it was associated either when initially produced or generated (e.g., whether in nature or in an experimental setting), or during any time after its initial production. A bacterium or a bacterial population may be considered purified if it is isolated at or after production, such as from a material or environment containing the bacterium or bacteria population, and a purified bacterium or bacterial population may contain other materials up to about 10%, about 20%, about 30%, about 40%, about 50%, about 60% about, 70%, about 80%, about 90% or above about 90% and still be considered “isolated.” In some embodiments, purified bacteria and bacterial populations are more than about 80%, about 85%, about 90%, about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98%, about 99%, or more than about 99% pure. In the instance of bacterial compositions provided herein, the one or more bacterial types present in the composition can be independently purified from one or more other bacteria produced and/or present in the material or environment containing the bacterial type. Bacterial compositions and the bacterial components thereof are generally purified from residual habitat products. Ex. 1001, 28:40–29:11. In reviewing the express definitions of “isolated” and “purified,” it is not surprising that the two similar terms, “isolated” and “purified,” may have overlapping definitions. We agree with Patent Owner that such overlap does not mean the definitions lack “reasonable clarity, deliberateness, and precision” that would inform a POSA with reasonable certainty about the scope of claim 1. We also agree with Patent Owner that a POSA would understand the two parts of the definition of “isolated” set forth above.” slip op. at 30

  Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · Graham · Nautilus
  Patents in suitUS 11,395,838
• Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution denied
  PTAB · 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 · Graham
  Patents in suitUS 8,129,343
• Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution denied
  PTAB · 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 · Graham
  Patents in suitUS 8,536,122
• Novartis Gene Therapies, Inc. / Novartis Pharmaceuticals Corporation v. Genzyme CorporationInstitution denied
  PTAB · Aug 30, 2023 · IPR2023-00609 · APJ James A Tartal · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 5 or 6 were unpatentable over either asserted obviousness combination.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2021). 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); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (stating that the decision whether to institute inter partes review requires “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”).” slip op. at 2

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “show a reasonable likelihood of prevailing in its assertion that the aggregate limitations were inherently taught by the asserted art. Pet. 38–43; Prelim. Resp. 34–36. To prove inherency in the context of obviousness, a party must “meet a high standard” and establish that “the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.” PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1195–96 (Fed. Cir. 2014).” slip op. at 21

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

    “Fourth, we find insufficient and not persuasive Petitioner’s conclusory assertions that “only routine optimization” with a reasonable expectation of success in light of the asserted art would have been required to obtain a optimization would be required to obtain an average AAV Rh <20nm using the obvious variants of Liu’s Example 17 composition”) (citing Ex.1025 ¶¶ 320–322), 43 (“only routine optimization would be required to improve AAV recovery following filtration of Liu’s modified Example 17 composition through a 0.22μm filter”) (citing Ex. 1025 ¶¶ 326–329). Petitioner offers scant evidence or explanation of what “optimization” was necessary, or why it would have been obvious to do so at the time of the invention. See Pet. 40 (“To the extent modifications to Lin’s composition” would have been “required to achieve the features of claim 5,” a person of ordinary skill in the art “would have been motivated to make such changes”) (emphasis added). Petitioner then suggests “such changes” are merely “optimization of known stabilization factors.” Id. Neither the Petition nor Dr. Amiji on behalf of Petitioner adequately explains what such optimization would have entailed or whether it would have been within the ability of a person of ordinary skill in the art at the time of the invention. See Ex. 1025 ¶ 319 (referring to “known aggregation reduction tools” without citation to any supporting prior art and asserting Liu taught “reducing potential aggregation by addition of surfactants”). In regard to the alleged expectation of success, we also find persuasive the testimony of Dr. Davies who notes that a person of ordinary skill in the art would have understood that “rAAV undergoes concentration-dependent aggregation,” and that the “nature of the interparticle interactions that result in aggregation has not been well characterized.” Ex. 2004 ¶¶ 97, 100 (quoting Ex. 1007, 17, 176).” slip op. at 22

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable

    “show a reasonable likelihood of prevailing in its assertion that the aggregate limitations were inherently taught by the asserted art. Pet. 38–43; Prelim. Resp. 34–36. To prove inherency in the context of obviousness, a party must “meet a high standard” and establish that “the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.” PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1195–96 (Fed. Cir. 2014).” slip op. at 21

  § 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 9,051,542
• Novartis Gene Therapies, Inc. / Novartis Pharmaceuticals Corporation v. Genzyme CorporationInstitution denied
  PTAB · Aug 30, 2023 · IPR2023-00608 · APJ Sheridan K Snedden · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 5 or 6 were obvious over either asserted combination.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “To institute an inter partes review, we must determine that the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the evidence and arguments presented in the Petition, we determine that Petitioner has not demonstrated a reasonable likelihood of success in proving that either claim 5 or claim 6 of the ’542 patent is unpatentable.” slip op. at 2

  • PTAB / AIA Trials › Discretionary denialNot reached

    “with respect to any claim challenged in the Petition.5 Accordingly, we do not institute an inter partes review. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied as to all challenged claims, and no trial is instituted. 5 Because we deny the Petition on the merits, we do not reach Patent Owner’s argument for discretionary denial under 35 U.S.C. § 314(a) or § 325(d). Prelim. Resp. 44–50, 61–67.” slip op. at 25

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner proposes that a person of ordinary skill in the art (“POSA”) at the time of the invention would have possessed at least a BS in biology, chemistry, chemical engineering, biochemistry, pharmaceutical science, or a related discipline, with ≥4 years of industry, laboratory, and/or clinical experience in formulating or developing dispersions for therapeutic biologics, such as proteins or vectors for gene delivery. Such person may be familiar with, or consult with someone familiar with, the development and/or administration of viral vectors for gene therapy. Ex.1025, ¶82. Pet. 16–17. Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications. Prelim. Resp. 2 n.2. For this Decision, we adopt and apply Petitioner’s proposal for the person of ordinary skill in the art level, which appears to be consistent with the level of skill reflected in the asserted prior art and the ’542 patent.” slip op. at 11

  • BurdenDecided for patent owner

    “To prove inherency in the context of obviousness “[a] party must . . . meet a high standard . . . the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.” PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1195– 96 (Fed. Cir. 2014). To that point, Petitioner fails to provide sufficient evidence such as prior art or testing evidence to show that the combination of Evans, Huang, and Mingozzi would result in a composition having the recited aggregation outcomes. For example, the ’542 patent explains that compositions having ionic strength greater than 200 mM surprisingly resulted in recoveries exceeding 90%, whereas compositions having ionic strengths below 200 mM resulted in recoveries below 80%. Ex. 1001, 8:1– 10, 11:53–12:29 (Example 2); Ex. 2004 ¶ 133. Petitioner fails to submit any evidence that the particle radius and product recovery elements of claims 5 and 6, respectively, would necessarily be present, or the natural result of the combination of teachings explicitly disclosed by Evans, Huang, and Mingozzi.” slip op. at 22

  § 103 obviousnessDiscretionary denialcites KSR · Graham
  Patents in suitUS 9,051,542

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.