• Neuroderm Ltd. v. Abbvie Inc.Instituted
  PTAB · Nov 14, 2022 · PGR2022-00040 · APJ Cynthia M Hardman · PGR · Institution

  The Board instituted PGR on claims 1–17 based on all asserted grounds, finding the petition showed they more likely than not lacked written description support and enablement.

  RulingsInstitution decision

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

    “For the reasons explained below, we find that Petitioner has met the threshold showing for post-grant review of claims 1–17 with respect to the first challenge (written description support for the claimed genus). On that basis, we institute post-grant review of all challenged claims. See SAS Institute Inc. v. Iancu, 138 S. Ct. 1348, 1358 (2018); 37 C.F.R. § 42.208(a) (“When instituting post-grant review, the Board will authorize the review to proceed on all of the challenged claims . . . .”). We address this challenge first, then provide the parties guidance on Petitioner’s second written description challenge (support for carbidopa itself).” slip op. at 19

  • Skill levelSkill level board ownOther

    “Ex. 1006, 1 (citations omitted). Accordingly, when considering the ’507 patent’s purpose, the type of problems encountered in the art, and prior art solutions to those problems, it is clear that with respect to levodopa/carbidopa treatments for Parkinson’s Disease, the pharmaceutical formulation and its resulting pharmacokinetics and patient experience are intertwined, thus supporting a requirement that a person of ordinary skill in the art have knowledge or experience in each of these areas. See, e.g., Indivior Inc. v. Dr. Reddy’s Labs., S.A., 930 F.3d 1325, 1345 (Fed. Cir. 2019) (finding no clear error in district court’s compromise measure of level of ordinary skill in the art as a team comprising different skill sets). In view of the above considerations, we preliminarily find that a person of ordinary skill in the art would be a member of a team that includes person(s) with (a) a Ph.D. in a field related to the development of pharmaceuticals (for example, pharmacology, pharmacokinetics, pharmaceutics, pharmaceutical chemistry, organic chemistry, biochemistry, molecular biology, medicinal chemistry, formulation development, or a related field), or equivalent degree, and 2–4 years of experience in the analysis of pharmacokinetic data, pharmaceutical formulation development, and/or drug discovery or development, or a B.S. or M.S. degree in a field related to the development of pharmaceuticals, or equivalent degree, and 4–6 years of experience in the analysis of pharmacokinetic data, pharmaceutical formulation development, and/or drug discovery or development, and (b) a medical degree or equivalent degree with experience in treating patients with Parkinson’s disease. In subsequent briefing, should the parties propose any differences from the team approach articulated above, they should support their proposal and address the impact, if any, of the differences on the pertinent disputes in this proceeding. Any final determination on the level of ordinary skill in the art will be made on the full trial record.” slip op. at 15

  • Expert testimonyPetitioner expert creditedOther

    “Additionally, based on their statements of qualifications and curricula vitae, for purposes of this Decision we find Drs. LeWitt and Sloan qualified to provide technical opinions from the perspective of a person of ordinary skill in the art. Ex. 1003 ¶¶ 1–10, pp. 87–119 (Dr. LeWitt’s statement of qualifications and curriculum vitae); Ex. 1004 ¶¶ 1–11, pp. 45–71 (Dr. Sloan’s statement of qualifications).” slip op. at 16

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

    “We agree with the parties that the express definition provided during prosecution should be adopted. See, e.g., Biotec Biologische Naturverpackungen GmbH v. Biocorp, Inc., 249 F.3d 1341, 1346–47 (Fed. Cir. 2001) (construing claims in accordance with definition provided in declarations submitted during prosecution). Accordingly, we preliminarily construe the term “a compound comprising levodopa” in accordance with the full definition Dr. Okun provided during prosecution, i.e., “any molecule with a levodopa core moiety including levodopa itself, as well as prodrugs, salts, and hydrates of levodopa.”” slip op. at 17

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · Graham
  Patents in suitUS 11,091,507
• Sandoz Inc. v. Boehringer Ingelheim International GmbHInstitution denied
  PTAB · Nov 7, 2022 · PGR2022-00037 · APJ Devon Zastrow Newman · PGR · Institution

  The Board denied institution because Petitioner did not show that the patent was eligible for post-grant review; the challenged claims were entitled to the pre-AIA priority date.

  RulingsInstitution decision

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

    “Accordingly, we find that Petitioner has not identified any challenged claim that has an effective filing date on or after March 16, 2013. For this reason, we find that Petitioner has not shown sufficiently that the ’265 patent is eligible for post-grant review. IV. CONCLUSION After considering the evidence and arguments presently before us, we determine Petitioner has not shown that the ’265 patent is eligible for post-grant review. Accordingly, we do not institute a post-grant review. V. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(d), the Petition is denied.” slip op. at 29

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner

    “To interpret “stable,” we begin with how the term is used in independent claims 7 and 19. Both terms recite “stable” in relation to the pharmaceutical formulation as a whole by reciting “wherein the formulation is stable.” Ex. 1001, 189:62–190:27. From this, we conclude that the ordinary artisan, as defined above to have a relevant advanced degree and at least two years of experience in development or manufacture of therapeutic protein formulations, would have understood that the components of a “stable” formulation would maintain their integrity and desired function following preparation, including when stored as described. This meaning is supported by the following language in the specification pertaining to the disclosed pharmaceutical compositions: Pharmaceutical compositions according to the present invention are described in further details hereinbelow. In one aspect, the pharmaceutical compositions disclosed herein are physico-chemically stable and maintain the integrity of an antibody comprised in said pharmaceutical composition, for example when stored for 8 weeks at 40° C. as shown hereinbelow. Ex. 1001, 84:20–26. We also note, as Petitioner argued, that the prosecution history supports that the formulation components needed to remain functional during storage, and that Patent Owner cited to formulation integrity after a storage period of 8 weeks at 40° C as evidence of such integrity. Ex. 1004, 7380. As disclosed in the ’265 patent, Examples 9 and 12 measure function and identity of the components following storage to confirm formulation stability.” slip op. at 11

  • Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable

    “burden of showing that claim 7 or 14 lacks written description support in the priority application, which Petitioner has conceded provides the same support as the ’265 patent specification. In this regard, we agree that the reasoning in Fresenius likewise applies: there is no legal requirement that a patent specification must include test results or working examples demonstrating stability for every possible composition that is covered by the claims. Fresenius at 13, citing Ariad Pharms., 598 F.3d at 1352 (stating that “the written description requirement does not demand either examples or an actual reduction to practice”). Formulations 2 and 3, disclosed in the ’265 patent specification, which Petitioner acknowledges falls within the scope of claims 7 and 14 (Pet. 26–27 (citing Ex. 1002 ¶¶ 134, 135)), were shown to be stable for 8 weeks in a syringe. Moreover, the ordinary artisan was provided with guidance in making such formulations from the teachings of the specification and has additional knowledge from the art. See Ex. 1001, 85:32–94:35. Claims 7 and 14 identify specific structures (risankizumab) and required excipients within a defined pH range, which are stable as confirmed by testing results presented in the specification. Prelim. Resp. 33; Ex. 1001, 94:14–36. On this record, we conclude that the evidence presented does not establish that it is more likely than not that an ordinarily skilled artisan would not have reasonably believed that the inventors of the ’265 patent possessed the claimed subject matter, each limitation of which is demonstrated as supported in the specification. As we have interpreted the claim term “wherein the formulation is stable” to mean “wherein the formulation maintains the functional integrity of the antibody and other components, for example when stored for 8 weeks at 40° C,” the specification supports maintenance of functional integrity as shown by the stability of Formulations 2 and 3, including when stored for a period of time. For this reason, we find that Petitioner has not shown that the ordinary artisan would not have understood the inventors of the ’265 patent possessed the subject matter of claims 7 and 14 as of the filing date of the priority application.” slip op. at 23

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not shown unpatentable

    “We acknowledge that in the Fresenius case, the extensive testing disclosed in that specification supported the ordinary artisan’s ability to formulate stable compounds using such guidance, and that the specification here discloses less testing. See, e.g., Sur-Reply. 8–9. Nevertheless, it is Petitioner’s burden on this issue, and we are not persuaded that the concerns raised by Dr. Klibanov provide sufficient evidence of actual instability to justify institution on this record. See, e.g., Atlas Powder Co. v. E.I. du Pont De Nemours & Co., 750 F.2d 1569, 1577 (Fed. Cir. 1984) (finding lack of evidence that district court erred in upholding claims as enabled where defendant did not identify inoperable embodiments despite extensive testing). In particular, we are persuaded that, on this record, Petitioner’s lack of evidence of instability of any formulation falling within the limitations of claim 14 indicates that Petitioner has not established sufficiently, for purposes of trial institution, that it is more likely than not that an ordinarily skilled artisan would not have been able to practice the full scope of claim 14 invention based on the teachings of the specification.” slip op. at 28

  Claim construction§ 112 disclosurecites Phillips
  Patents in suitUS 11,078,265
• Markforged Inc. v. Continuous Composites, Inc.Institution denied
  PTAB · Sep 9, 2022 · IPR2022-00652 · APJ Jo-Anne M Kokoski · IPR · Institution

  The Board denied institution because the Petition did not show a reasonable likelihood that claims 1–15 and 17–41 were unpatentable over the asserted obviousness combinations.

  RulingsInstitution decision

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

    “Institution of an inter partes review is authorized by statute when “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 (2018); see also 37 C.F.R. § 42.4 (2021). For the reasons discussed below, we deny the Petition and do not institute an inter partes review.” slip op. at 2

  • Skill levelSkill level board ownOther

    “Petitioner contends that a person having ordinary skill in the art (“POSITA”) would have had “a master’s degree in mechanical engineering, materials science, or a related degree, and at least 3–5 years of experience in composite materials or additive manufacturing,” or a bachelor’s degree in the same fields and at least 5–6 years of experience. Pet. 9 (citing Ex. 1002 ¶ 36). Patent Owner states that it “does not agree that Petitioner’s proposed level of skill in the art accurately reflects the level of ordinary skill in the art as of the priority date . . . . But regardless of what level of skill is applied, the Petition does not show a reasonable likelihood to prevail.” Prelim. Resp. 10. Patent Owner does not propose a different level of skill in the art at this stage of the proceeding. See id. (“Patent Owner reserves the right to propose a level of ordinary skill in the art in this proceeding should it be instituted, or in other proceedings.”). On this record, we determine that the level of ordinary skill is reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (specific findings on the ordinary skill” slip op. at 6

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

    “We construe each 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.” 37 C.F.R. § 42.100(b) (2019). Under this standard, claim terms are generally given their plain and ordinary meaning as would have been understood by a person of ordinary skill in the art at the time of the invention and in the context of the entire patent disclosure. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). Only those terms in controversy need to be construed, and only to the extent necessary to resolve the controversy. Realtime Data LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019).” slip op. at 7

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

    “teachings of multiple references, an articulated reason with some rational underpinning to combine the known elements in the fashion claimed must be provided. See KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007); see also In re Magnum Oil Tools, Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (It is the petitioner’s “burden to demonstrate both that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention[s], and that the skilled artisan would have had a reasonable expectation of success in doing so.”) (citation and internal quotation omitted). Having reviewed the parties’ arguments and evidence of record, we are not persuaded that Petitioner provides sufficient articulated reasoning with a rational underpinning as to why one of ordinary skill in the art would have combined the teachings of Lipsker and Wohrl in the manner recited in the challenged claims.” slip op. at 12

  Claim construction§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 9,511,543
• Markforged Inc. v. Continuous Composites, Inc.Institution denied
  PTAB · Sep 9, 2022 · IPR2022-00548 · APJ Jo-Anne M Kokoski · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–15 and 17–41 were unpatentable over the asserted obviousness grounds.

  RulingsInstitution decision

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

    “Institution of an inter partes review is authorized by statute when “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 (2018); see also 37 C.F.R. § 42.4 (2021). For the reasons discussed below, we deny the Petition and do not institute an inter partes review.” slip op. at 2

  • Skill levelOther

    “(“POSITA”) would have had “a master’s degree in mechanical engineering, materials science, or a related degree, and at least 3–5 years of experience in composite materials or additive manufacturing,” or a bachelor’s degree in the same fields and at least 5–6 years of experience. Pet. 9–10 (citing Ex. 1002 ¶ 36). Patent Owner states that it “does not agree that Petitioner’s proposed level of skill in the art accurately reflects the level of ordinary skill in the art as of the priority date . . . . But regardless of what level of skill is applied, the Petition does not show a reasonable likelihood to prevail.” Prelim. Resp. 10. Patent Owner does not propose a different level of skill in the art at this stage of the proceeding. See id. (“Patent Owner reserves the right to propose a level of ordinary skill in the art in this proceeding should it be instituted, or in other proceedings.”).” slip op. at 6

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

    “customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” 37 C.F.R. § 42.100(b) (2019). Under this standard, claim terms are generally given their plain and ordinary meaning as would have been understood by a person of ordinary skill in the art at the time of the invention and in the context of the entire patent disclosure. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). Only those terms in controversy need to be construed, and only to the extent necessary to resolve the controversy. Realtime Data LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019).” slip op. at 7

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

    “Thus, as we understand it, Petitioner is arguing that a POSITA would have understood Wohrl’s teaching of laying fiber strands on a core and precuring the fibers so that the fibers dry and stick to the core is “coupling a portion of the at least one path to an anchor point” as recited in claims 1 and 38. Petitioner’s argument appears to be premised on the understanding that any point at which the path contacts a “surface suitable for anchoring the part” is the claimed “anchor point.” The ’543 patent, however, describes an “anchor point” as something more than just any point to which a part of the path is affixed.” slip op. at 11

  Claim construction§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 9,511,543
• Markforged Inc. v. Continuous Composites, Inc.Institution denied
  PTAB · Sep 9, 2022 · IPR2022-00732 · APJ Sheldon M Mcgee · IPR · Institution

  The Board denied institution for claims 1–9 because Petitioner did not show a reasonable likelihood of prevailing on any asserted obviousness ground.

  RulingsInstitution decision

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

    “III. ANALYSIS We have authority to institute an inter partes review only where “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). Our findings and conclusions set forth in this Decision are provided for the exclusive purpose of explaining our determination that Petitioner has not met that standard on this record.” slip op. at 5

  • Skill levelSkill level board ownOther

    “On this record, we determine that the level of ordinary skill is reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (specific findings on the ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). A more specific definition is not necessary for purposes of deciding whether to institute review. To the extent a more specific definition is required, however, we adopt Petitioner’s proposed definition because, on this record, it is consistent with the disclosures of the asserted prior art references. In any event, for the reasons explained below, even under Petitioner’s definition, Petitioner fails to establish a reasonable likelihood of prevailing at trial with respect to any challenged claim based on the grounds of unpatentability advanced in the Petition.” slip op. at 12

  • Expert testimonyPetitioner expert discountedOther

    “Finally, we determine that Dr. Rosen’s testimony supporting Petitioner’s proffered motivations to combine is entitled to little or no weight. Prelim. Resp. 30 (citing 37 C.F.R. § 42.65(a)). Here, the relied-upon portions of Dr. Rosen’s Declaration simply parrot Petitioner’s conclusory assertions. Compare Pet. 35–36, 86, with Ex. 1002 ¶¶ 169–174, 280.” slip op. at 20

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

    “The question of whether the prior art references are in the same field of endeavor is merely a threshold issue that must be satisfied before an obviousness determination can be made. See K-Tec, Inc. v. Vita-Mix, Corp., 696 F.3d 1364, 1375 (Fed. Cir. 2012) (to qualify as prior art in an obviousness analysis, references must be analogous art—either in the same field of endeavor, or reasonably pertinent to the problem with which the inventor is involved). In other words, once it is determined that the prior art is analogous to the claimed invention, it is then necessary to show that it would have been obvious for the skilled artisan to select and combine the teachings of the prior art in the manner claimed. Thus, we agree with Patent Owner that the Petition needs to set forth specific reasoning as to why an ordinarily skilled artisan would have been motivated to combine these references even if they are in the same or similar fields. Prelim. Resp. 31. Petitioner fails to do so on this record. The absence of such reasoning is particularly noteworthy here in view of Ma’s numerous teachings against the “passive” method of pulling the composite strand from the extruder as claimed. Patent Owner identifies no fewer than eight disclosures within Ma that seemingly disparage the passive “pulling” method and discuss benefits of the active “pushing” method. Prelim. Resp. 17–19 (citing Ex. 1007, 53, 95–96, 98–107, 143–147, 149, 167–168). In the absence of any explanation from Petitioner on this point, we are not persuaded that the skilled artisan would have ignored those teachings and selected Ma’s pulling method. Petitioner’s second reason to combine these references fares no better than the first because it lacks an explanation as to what specific disclosures in Lipsker and Ma would have been combined and for what reason(s). Instead, Petitioner provides little more than a conclusory assertion that Ma contains complementary teachings that would illuminate the skilled artisan’s understanding of Lipsker. Pet. 36. Petitioner, however, fails to provide a single citation to Ma in support of its position, much less an explanation regarding how Ma’s teachings would have enlightened the skilled artisan’s understanding of Lipsker such that it would have been obvious to arrive at the claimed subject matter. Bare assertions such as these fall far short of providing the requisite rationale sufficient to support a conclusion of obviousness. In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (cited with approval in KSR, 550 US at 418). Petitioner’s third reason to combine is similarly deficient because it fails to address the teachings of Lipsker and Ma with any degree of specificity and again does not elaborate on how or why the ordinarily skilled artisan would have combined the teachings of these references to arrive at the claimed subject matter.” slip op. at 18

  § 103 obviousnesscites Phillips · KSR
  Patents in suitUS 10,759,109
• Arkema Inc. / Arkema France v. Honeywell International Inc.All claims unpatentable
  PTAB · Aug 25, 2022 · PGR2016-00012 · APJ Sheldon M Mcgee · PGR · Remand

  Claims 1–20 are unpatentable under § 102(a) for prior public use; the Board did not reach the remaining anticipation, obviousness, and enablement grounds.

  RulingsRemand decision

  • RemandOther

    “On October 1, 2019, the Federal Circuit held that we “abused [our] discretion by assuming the authority that 35 U.S.C. § 255 expressly delegates to the Director: to determine when a Certificate of Correction is appropriate,” and vacated our Final Written Decision. Honeywell Int’l Inc. v. Arkema Inc., 939 F.3d 1345 (Fed. Cir. 2019). The Federal Circuit instructed us to “authorize Honeywell to file a motion seeking leave to petition the Director for a Certificate of Correction.” Id. at 1351. Pursuant to the Federal Circuit’s mandate, we gave our authorization, and Patent Owner filed its Motion for Leave to Request a Certificate of Correction. PGR11 Paper 61; PGR12 Paper 41. After additional briefing from the parties was complete, we granted Patent Owner’s Motion. PGR11 Paper 77; PGR12 Paper 57. Patent Owner filed its Request for a Certificate of Correction, as well as a Petition to Accept [Unintentionally] Delayed Claim to Priority under 35 U.S.C. § 120 and 37 C.F.R. § 1.78. PGR11 Ex. 2174; PGR12 Ex. 2172.” slip op. at 3

  • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

    “Synthes USA, LLC v. Spinal Kinetics, Inc., 734 F.3d 1332, 1344 (Fed. Cir. 2013). And, although there are no bright-line rules for the amount of disclosure needed in an unpredictable art, that amount “necessarily changes with each invention” and “changes with progress in the field.” Ariad, 598 F.3d at 1351. Here, we find that the art of AAC was unpredictable and that a heat-transfer composition for AAC required specific technical features that were unpredictable and unexpected. Thus, we conclude that the ’525 application requires a more-detailed disclosure than would be required in a predictable field to adequately demonstrate possession of a heat-transfer composition consisting essentially of HFO-1234yf and PAG for use in AAC. (iii) Disclosure in the ’525 Application With these background findings in mind, we now turn to the four corners of the ’525 application—and we find that the ’525 application does not contain the detailed disclosure needed in this case to reasonably convey possession of a heat-transfer composition consisting essentially of HFO- 1234yf and PAG for use in AAC.” slip op. at 37

  • Skill levelSkill level board ownDecided for patent owner

    “develops new refrigerants for use as heat transfer fluids. Ex. 1002 ¶ 149. Such a person would have had a Ph.D. in Chemistry, Chemical Engineering, Mechanical Engineering, Material Science, or a related field or discipline and at least 3 to 5 years of experience, or alternatively an M.S. degree and 5 to 10 years of experience. Id. Patent Owner’s Declarant, Dr. Bivens, provides a similar description of the person of ordinary skill in the art, stating that such a person would have a B.S. degree in Chemical Engineering or Chemistry, and five years of work experience, or a Ph.D. or M.S. degree and 2–3 years of experience. Ex. 2001 ¶ 23. Based on these descriptions, we find that the parties’ definitions of ordinary skill in the art are substantially the same, and agree with the parties that an ordinarily skilled artisan would be educated in the Chemical and Chemical Engineering arts or related disciplines. We also agree with the parties that a person having less formal education, such as a B.S. or M.S. degree, would require more years of experience than a person with more formal education, such as a Ph.D., to qualify as an ordinarily skilled artisan. We also find that neither party states how any difference in the parties’ articulated levels of skill impacts this proceeding. Thus, our analysis would be the same regardless of any minor differences between the parties’ respective articulations. Finally, we note that the level of ordinary skill in the art is reflected by the prior art of record. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 20

  • Novelty / Anticipation (§102) › Prior-art status of a reference › On-sale bar (Pfaff, Helsinn)UnpatentableUnpatentable

    “Tr. 114:15–115:18 (emphases added). Thus, we find that Patent Owner does not contest that a heat-transfer composition consisting essentially of HFO- 1234yf and PAG for AAC was in public commercial use before the March 26, 2014, filing date of the ’017 patent. Accordingly, we find that Petitioner’s evidence, together with Patent Owner’s concessions, demonstrates by a preponderance of evidence that the claimed subject matter of the ’017 patent was in commercial use before its March 26, 2014, effective filing date. See Ex. 1002 ¶¶ 399–409. In particular, as to claims 1, 3–10, 12, 13, and 15–20, we credit Dr. Brown’s uncontested testimony that the refrigerant-lubricant AAC composition of the Ford Transit Custom Bus, the Mazda CX 5 (2.0i and 2.2D), and the Opel Mocca used HFO-1234yf and a PAG lubricant as early as 2012. Ex. 1002 ¶ 399 (citing Ex. 101324, 2, 38, 55, 70). We also credit Dr. Brown’s 24 Behr Hella Services, Refrigerant and Oil Filling Quantities Passenger Cars & Commercial Vehicles 2014–15. PGR12 Ex. 1013. (“Service Guide”). PGR12 Ex. 1013. The Service Guide provides tables setting forth specifications for refrigerant type, refrigerant quantity, vehicle manufacturers’ original equipment compressor oil type, and oil filling quantity for the air-conditioning system of each vehicle listed in the tables. Id. at 2–3. Petitioner and Dr. Brown direct us to the Sevice Guide’s entries calculations, which show that the Ford Transit Custom Bus had an AAC refrigerant-lubricant composition of 26.7% of PAG lubricant and 73.3% of HFO-1234yf (Ex. 1002 ¶ 401 (citing Ex. 1013, 38)); the Mazda CX 5 2.0i had 16.7% PAG lubricant and 83.3% HFO-1234yf (Ex. 1002 ¶ 402 (citing Ex. 1013, 55)); the Mazda CX 5 2.2D had a 17.5% PAG lubricant and 82.5% HFO-1234yf (id.); and the Opal Mocca had 11.6% PAG lubricant and 88.4% HFO-1234yf (Ex. 1002 ¶ 402 (citing Ex. 1013, 70)). As to dependent claims 2, 11, and 14, which all require that the lubricant is present “in an amount from about 30% to about 50% weight,” we credit Dr. Brown’s uncontested testimony that the refrigerant-lubricant composition of the Ford Transit Custom Bus recited lubricant amount. Ex. 1002 ¶ 403. In particular, we agree with Dr. Brown that, because the lubricant accounts for 26.7% of the AAC refrigerant-lubricant composition in the Ford Transit Custom Bus, the lubricant makes up “about 30%” of the refrigerant-lubricant composition as claimed. Id. For these reasons, we find that Petitioner has met its burden to show that claims 1–20 are unpatentable for anticipation under § 102(a)(1).” slip op. at 55

  Patent outcomesUS 9,157,017 unpatentable
  § 102 anticipation§ 112 disclosure
  Patents in suitUS 9,157,017
• Arkema Inc. / Arkema France v. Honeywell International Inc.All claims unpatentable
  PTAB · Aug 25, 2022 · PGR2016-00011 · APJ Grace Karaffa Obermann · PGR · Remand

  Claims 1–20 are unpatentable under § 102(a) for prior public use; the Board did not reach the other anticipation, obviousness, and enablement grounds.

  RulingsRemand decision

  • RemandOther

    “On October 1, 2019, the Federal Circuit held that we “abused [our] discretion by assuming the authority that 35 U.S.C. § 255 expressly delegates to the Director: to determine when a Certificate of Correction is appropriate,” and vacated our Final Written Decision. Honeywell Int’l Inc. v. Arkema Inc., 939 F.3d 1345 (Fed. Cir. 2019). The Federal Circuit instructed us to “authorize Honeywell to file a motion seeking leave to petition the Director for a Certificate of Correction.” Id. at 1351. Pursuant to the Federal Circuit’s mandate, we gave our authorization, and Patent Owner filed its Motion for Leave to Request a Certificate of Correction. PGR11 Paper 61; PGR12 Paper 41. After additional briefing from the parties was complete, we granted Patent Owner’s Motion. PGR11 Paper 77; PGR12 Paper 57. Patent Owner filed its Request for a Certificate of Correction, as well as a Petition to Accept [Unintentionally] Delayed Claim to Priority under 35 U.S.C. § 120 and 37 C.F.R. § 1.78. PGR11 Ex. 2174; PGR12 Ex. 2172.” slip op. at 3

  • Skill levelSkill level board ownDecided for petitioner

    “develops new refrigerants for use as heat transfer fluids. Ex. 1002 ¶ 149. Such a person would have had a Ph.D. in Chemistry, Chemical Engineering, Mechanical Engineering, Material Science, or a related field or discipline and at least 3 to 5 years of experience, or alternatively an M.S. degree and 5 to 10 years of experience. Id. Patent Owner’s Declarant, Dr. Bivens, provides a similar description of the person of ordinary skill in the art, stating that such a person would have a B.S. degree in Chemical Engineering or Chemistry, and five years of work experience, or a Ph.D. or M.S. degree and 2–3 years of experience. Ex. 2001 ¶ 23. Based on these descriptions, we find that the parties’ definitions of ordinary skill in the art are substantially the same, and agree with the parties that an ordinarily skilled artisan would be educated in the Chemical and Chemical Engineering arts or related disciplines. We also agree with the parties that a person having less formal education, such as a B.S. or M.S. degree, would require more years of experience than a person with more formal education, such as a Ph.D., to qualify as an ordinarily skilled artisan. We also find that neither party states how any difference in the parties’ articulated levels of skill impacts this proceeding. Thus, our analysis would be the same regardless of any minor differences between the parties’ respective articulations. Finally, we note that the level of ordinary skill in the art is reflected by the prior art of record. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 20

  • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateNot shown unpatentable

    “We agree with Petitioner that the ’525 application’s statement that the compounds are “adaptable for use” weighs against a finding of adequate written description. First, “adaptable for use” is vague, as Dr. Bivens acknowledges. See Ex. 1177, 151:15 (testifying that “adaptable for use can have a wide range of meaning”). Second, the ’525 application gives no direction on how a skilled artisan would need to adapt any particular composition for use in AAC, or even if any “adaptation” was necessary. We find that such a teaching is important in this case to show that the inventors had possession of the claimed invention, given our findings above that the art of AAC was unpredictable and that a heat-transfer composition for AAC required specific technical features that were unpredictable and unexpected. For completeness, we again reject Patent Owner’s argument that “[t]o show the inventors possessed claim 1 requires no more” than the statement in the written description that “‘the compositions of the present invention are believed to be adaptable . . . with or without system modification.’” PGR12 Resp. 27–28 (quoting Ex. 1001, 7:4–8). Regardless of the exact wording of claim 1, the inventors “still [had to have] describe[d] some way of performing the claimed methods.” Ariad, 598 F.3d at 1355. And here, with merely a passing reference to AAC, the ’525 application fails to provide any credible “technologic knowledge” to demonstrate to an ordinarily skilled artisan that Patent Owner “was in possession of the invention that is claimed.” Id.” slip op. at 43

  • Novelty / Anticipation (§102) › Prior-art status of a reference › On-sale bar (Pfaff, Helsinn)UnpatentableUnpatentable

    “unless . . . the claimed invention was . . . in public use . . . before the effective filing date of the claimed invention.” 35 U.S.C. § 102(a)(1). “The proper test for the public use prong . . . is whether the purported use was accessible to the public or was commercially exploited.” Delano Farms Co. v. Cal. Table Grape Comm’n, 778 F.3d 1243, 1247 (Fed. Cir. 2015) (quotation omitted). “Commercial exploitation is a clear indication of public use . . . .” Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1380 (Fed. Cir. 2005).” slip op. at 53

  Patent outcomesUS 9,157,017 unpatentable
  § 102 anticipation§ 112 disclosure
  Patents in suitUS 9,157,017
• Agrofresh Solutions, Inc. v. Lytone Enterprise, Inc.All claims unpatentable
  PTAB · Jul 25, 2022 · IPR2021-00451 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 3 and 11 are unpatentable as obvious over Hisano and Daly, and over Daly and Hisano, because the skilled artisan would have been motivated to combine the teachings with a reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “definition focuses on chemistry and materials science without a specific focus to the application of that knowledge to the subject matter of the invention, while Patent Owner’s proposal permits the artisan’s degree to be in horticulture or plant science, requires at least 2–4 years of experience in the area of postharvest biology and technology, and specifically requires “working with encapsulated gaseous agents such as the 1-MCP encapsulation complex.” PO Resp. 14. It is not clear on the record before us nor does Patent Owner’s expert explain why the additional, specific expertise in postharvest biology and technology would have been required to understand the teachings of the ’185 patent in a manner necessary to apply them. Moreover, the proposed additional skill level does not appear to be necessary in light of the skill level reflected by the asserted prior art. See specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163–64 (Fed. Cir. 1985)). For instance, Hisano measures preservation visually, by ascertaining whether the flowers looked fresh or appeared to have been harmed by effects of the chemicals added, and whether the water the flowers were stored in was cloudy. Ex. 1004 ¶ 24. This observation does not require specific expertise in postharvest biology and technology. Petitioner’s assessment appears consistent with the level of ordinary skill in the art at the time of the invention as reflected in the prior art in this proceeding, although we agree with Patent Owner that a degree in plant physiology, horticulture, plant science or the like along with work experience, or a master’s degree in exchange for such work experience, in the area of controlled release of compounds would provide sufficient expertise to understand the teachings of the ’185 patent in a manner necessary to apply them. Accordingly, we adopt the following definition of the skilled artisan for purposes of this Decision: a bachelor’s degree in chemistry, chemical engineering, materials science, plant physiology, horticulture, plant science or the like, and 1–2 years of work experience, or a master’s degree in exchange for such work experience, in the area of controlled release of compounds, such as those used to inhibit ethylene response in plants.” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningNo construction neededDecided for petitioner

    “Neither party advances any claim terms for construction. Pet. 20; PO Resp. 15. We find that no express construction is necessary for purposes of rendering this Decision and apply the plain meaning of all terms. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 13

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “It is not necessary for an expert’s experience or expertise to precisely match the art at issue. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). However, one offering expert testimony must at least have ordinary skill in the art to provide relevant and reliable testimony that is helpful to the factfinder. Kyocera Senco Indus. Tools, Inc. v. ITC, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022). “The Board has broad discretion to assign weight to be accorded expert testimony.” Consolidated Trial Practice Guide 35 (available at https://www.uspto.gov/TrialPracticeGuide Consolidated).” slip op. at 7

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable

    “We find that the ordinarily skilled artisan would have looked at Hisano as an analogous reference and would have been motivated to try scaling up its smaller-scale solution of effervescent tablets for delivery on a larger scale than single flower vases. We further find that the artisan would not have been deterred by Hisano’s lack of embodiments including gas agents and disclosing local use only that would have prevented use of 1- MCP directly with plants. Ex. 2013 ¶¶ 52–54. In particular, because Daly suggested the molecularly encapsulated 1-MCP could be made in powder form (Ex. 1005, 11:1–11), which is the form Petitioner suggested for use in the proposed obviousness combination (e.g., Pet 36–37), we are not persuaded by Patent Owner’s arguments regarding concerns the skilled artisan would have had about working with 1-MCP gas that is released into the atmosphere where the atmosphere becomes the treatment medium as opposed to a liquid medium. agent, along with Daly’s teachings that 1-MCP is a known substitute for STS without STS’s toxic waste byproduct would have motivated the artisan to explore use of 1-MCP. Daly’s teaching of using a cyclodextrin cage-stabilized and powdered version of 1-MCP to inhibit ethylene binding in plants would have motivated the skilled artisan to try this stabilized version in Hisano’s effervescent tablet preparation because of the benefits of effervescent ingredients for dissolution and dispersion, to treat plants on a larger scale. See Ex. 1005 11:1–20; Ex. 1006 ¶¶ 29, 110–115; Ex. 1035 ¶¶ 11–18. Hisano instructs the artisan about optimization by creating tablets with a proper “effervescence component: freshness preserving component to a weight ratio of between 6.5:3.5 and 5.0:5.0 to create a large, compact tablet agent that can secure some degree of the freshness preserving component” while also stabilizing the tablet for transportation and adjusting the ratios of components to affect the “target quality, effervescence effects, and dissolution time, etc. of the final product.” Ex. 1004 ¶¶ 12, 14. These additional teachings would have led the skilled artisan to understand that an effervescent tablet dosage made with cyclodextrin-stabilized 1-MCP could be made for larger scale production and use. In particular, we find that the artisan would have been motivated to combine the teachings of Hisano and Daly because of 1) Daly’s teaching that STS is problematic for use in inhibiting ethylene in plants due to difficulties in silver waste byproduct disposal, leading to “a great desire among postharvest physiologists to find alternatives to STS” (Ex. 1005, 2:42–64); 2) Daly’s teachings that cyclopropene and its derivatives, including 1-MCP, are “commercially acceptable replacement[s] for STS”) (id. at 1005) and that powder complexes provided advantages over 3) Hisano’s teaching that an ethylene suppressing agent could be delivered via an effervescent tablet, which when dissolved in water, creates “generated carbonic acid gas [that] will promote assimilation action, which will be effective for cultivating, and preserving the freshness of, the cut flowers (plants).” Ex. 1004 ¶ 25; see also Ex. 1006 ¶¶ 113–115 (opining that the skilled artisan would have understood encapsulated 1-MCP, a powder-based form, to be one of a finite number of safer substitutes for STS that could be incorporated into an effervescent tablet using methods known to the skilled artisan at the time); Ex. 1013 at 9 (identifying 1-MCP as a newly discovered “ethylene inhibitor [that acts] as a binding site competitor and is very promising as a postharvest treatment for both potted plants and fresh cut flowers [giving] ethylene protection equal to that obtained from STS, but without silver” and noting that a “company plans to sell the product in a powder form that will release MCP gas when mixed with water”). The art suggested finding substitutes for STS, meaning that the skilled artisan would have looked for likely substitutes such as this stable form of 1-MCP for use in various delivery methods. See, e.g., In re Kerkhoven, 626 F.2d 846, 850 (“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose.”).” slip op. at 25

  Patent outcomesUS 6,897,185 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 6,897,185
• Human Power Of N Company v. Heartbeet LtdInstitution denied
  PTAB · May 16, 2022 · PGR2022-00004 · APJ Devon Zastrow Newman · PGR · Institution

  The Board denied institution on all challenged claims because Petitioner did not show the patent was eligible for post-grant review.

  RulingsInstitution decision

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

    “Determining whether a patent is subject to the first-inventor-to-file provisions of the AIA, and therefore eligible for post-grant review, is straightforward when the patentee filed the application from which the patent issued before March 16, 2013, or when the patentee filed the application on or after March 16, 2013, without any priority claim. The determination is more complex, however, for a patent that issues from a “transition application,” that is, an application filed on or after March 16, 2013, that claims the benefit of an earlier filing date. See MPEP § 2159.04 (9th ed. Rev. 10.2019, June 2020). Entitlement to the benefit of an earlier date under 35 U.S.C. §§ 119, 120, 121, or 365 is premised on disclosure of the claimed invention “in the manner provided by § 112(a) (other than the requirement to disclose the best mode)” in the earlier application. See 35 U.S.C. §§ 119(e), 120. Thus, a patent that issues from a transition application is not available for post-grant review if the claimed subject matter complies with the written description and enablement requirements of § 112(a) for an ancestor application filed prior to March 16, 2013.” slip op. at 9

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “B. Legal Standard The test for written description support is “whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date” based on an “objective inquiry into the four corners of the specification.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). If this test fails, the application is not entitled to the benefit of the earlier filing date.” slip op. at 11

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledDecided for patent owner

    “[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)). Undue experimentation is analyzed by applying the factors set forth in In re Wands, 858 F.2d 731 (Fed. Cir. 1988).5 Nothing more than objective enablement is required, and therefore it is irrelevant whether this teaching is provided through broad terminology or illustrative examples. In re Marzocchi, 439 F.2d 220, 223 (CCPA 1971); see also In re Howarth, 654 F.2d 103, 105 (CCPA 1981) (“An inventor need not, however, explain every detail since he is speaking to those skilled in the art.”). slip op. at 13

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “F. Person of Ordinary Skill in the Art Petitioner proposes that one of ordinary skill in the art would have had “an M.D. degree or a Ph.D. degree in biochemistry, pharmacology, nutrition chemistry, exercise physiology, or kinesiology, and at least two years of 2 This chart repeats the grounds as presented in Petitioner’s chart at Pet. 4. 3 Brunton, An Address on Blood Pressure in Man: Its estimation and indications for treatment, The British Medical Journal, pp. 64-67 (July 10, 1909) (Ex. 1032 “Brunton”). 4 Brunton et al., An Address on Longevity and the Means of Attaining It, The Lancet, Vol. 168, Issue 4342, pp. 1330–1355 (Nov. 17, 1906) (Ex. 1033 “Brunton 2”). post-doctoral research or clinical experience with physiology, biochemistry, or dietary supplements and formulation.” Pet. 13 (citing Ex. 1003 ¶ 21). Patent Owner does not challenge this definition at this time. Prelim. Resp. 7. For purposes of this decision, we apply Petitioner’s proposed definition as it is consistent with the level of skill presented in the ’747 patent and applied art. We also note that the level of ordinary skill in the art at the time of the invention may be reflected in the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 6

  Claim construction§ 112 disclosurecites Phillips
  Patents in suitUS 11,083,747
• Incyte Corporation v. Concert Pharmaceuticals, Inc.No claims unpatentable
  PTAB · May 11, 2022 · PGR2021-00006 · APJ Devon Zastrow Newman · PGR · Final written decision

  The Board held claims 1–7 and 9–21 not shown unpatentable over either obviousness ground because Petitioner did not establish motivation to select Compound (I) from Silverman’s genus.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedOther

    “It is not necessary for an expert’s experience or expertise to precisely match the art at issue. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). However, one offering expert testimony must at least have ordinary skill in the art to provide relevant and reliable testimony that is helpful to the factfinder. Kyocera Senco Indus. Tools, Inc. v. ITC, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022). “The Board has broad discretion to assign weight to be accorded expert testimony.” Consolidated Trial Practice Guide 35 (available at https://www.uspto.gov/sites/default/files/documents/ tpgnov.pdf?MURL=). Dr. Patterson has a Ph.D. in Chemistry and over 30 years of experience in drug design, drug administration, evaluation of drug effectiveness, and participated in drug design for over 20 years. Ex. 1007 ¶¶ 4–10; Ex. 1008, 1–2. He is author or co-author on over eight peer-reviewed journal articles involving medicinal chemistry. Ex. 1007 ¶ 5. We find this level of skill to meet the qualifications for the level of skill in the art under the training and experience portion of the definition we have adopted for purposes of this opinion (see § II.B.), reproduced below: a Ph.D. in chemistry, pharmaceutical sciences, molecular biology, or a similar field, or an M.D. with similar background. A POSA would also have had at least several years of experience with drug design, drug development, clinical trials, or access to other individuals with that knowledge and experience. Likewise, a POSA would have had knowledge and experience in treating hair loss disorders, or access to a person with that knowledge and experience. We note that Dr. Patterson himself also proposes this definition. Id. ¶ 102. However, Dr. Patterson does not have “knowledge and experience in treating hair loss disorders” and did not opine that, in regards to his testimony, he had access to a person with that knowledge and experience, as is proposed in the definition. See generally, Ex. 1007. Accordingly, we find Dr. Patterson qualified to opine on the level of ordinary skill with regard to issues of drug design, evaluation of effectiveness, and drug administration, but we find he is not adequately qualified to opine on the level of ordinary skill with regard to issues of treating hair loss disorders.” slip op. at 7

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner proposes the same definition as Petitioner, but adds that the skilled artisan “would also have had experience in JAK inhibition, deuteration, and AA [alopecia areata] formulations, or access to a person with that knowledge and experience.” Resp. 15 (citing Ex. 2059 ¶ 14). Patent Owner’s expert Dr. Ko critiques Petitioner’s proposed definition as “incomplete, because it lacks any requirement for experience, or access to individuals with experience, in JAK inhibition, deuteration, and AA formulations.” Ex. 2059 ¶ 16. However, neither Dr. Ko nor Patent Owner explains what difference this additional direct experience would have provided to an artisan with the skill level proposed by Petitioner, particularly when Petitioner’s definition includes “experience in treating hair loss disorders,” and for which the record contains evidence that existing JAK inhibitors such as ruxolitinib had been identified as causing reversal of hair loss caused by AA. Ex. 1003, 1043. Accordingly, we adopt Petitioner’s proposed definition as consistent with the level of skill apparent in the cited prior art. In any event, as Patent Owner does not explain why its alternative definition would have any bearing on the outcome of the present case, and as we discern no appreciable difference in the parties’ definitions, we note our findings and conclusions would be the same regardless of which definition were adopted. We further note that the prior art itself demonstrates the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 11

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

    “C. Claim Construction We construe claims 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. Therefore, we construe the challenged claims under the framework set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would have been understood by a person of ordinary skill in the art (“POSA”), at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id. Only those terms that are in controversy need be construed and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We have considered Petitioner’s claim construction proposals (see Pet. 21–23), which are uncontested (see generally Resp., not addressing construction), and find that it is not necessary to expressly construe any claim term for purposes of rendering this Decision.” slip op. at 13

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artReference not prior artDecided for patent owner

    “Section 102(b)(1) provides two exceptions to § 102(a)(1) for disclosures made within one year of the effective filing date. Specifically, 35 U.S.C. § 102(b)(1) provides that a disclosure made one year or less before the effective filing date of a claimed invention shall not be prior art under 35 U.S.C. § 102(a)(1) with respect to the claimed invention if: (A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or (B) the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor. 35 U.S.C. § 102(b)(1).” slip op. at 16

  Patent outcomesUS 10,561,659 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,561,659

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.