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  • PTAB · Dec 1, 2025 · PGR2025-00045 · APJ Debra L Dennett · PGR · Institution

    The Board denied institution because Petitioner did not show it was more likely than not that any challenged claim was unpatentable under the asserted grounds.

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

      “We have authority to determine whether to institute a post-grant review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute only when “the information presented in the petition . . . would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). The burden is on Petitioner to show that the challenged patent is eligible for postgrant review. Mylan Pharms. Inc. v. Yeda Research & Dev. Co., PGR2016- 00010, Paper 9 at 10 (PTAB Aug. 15, 2016) (holding that the ultimate burden of persuasion remains with a petitioner to demonstrate that the challenged patent is eligible for post-grant review). Upon consideration of the Petition, Preliminary Response, and the cited evidence, we determine that Petitioner has not shown that it is more likely than not that any of the challenged claims are unpatentable. We thus determine to not institute a post-grant review of the ’027 patent based on the Petition.” slip op. at 2

    • Skill levelSkill level petitioner adoptedOther

      “a Bachelor of Science degree in Agricultural or Mechanical Engineering with 2–4 years of practical, applied experience in the field of agricultural machinery, including systems integration and fluid handling and sprayer control systems, or equivalent experience. Prelim. Resp. 12 (citing Ex. 2001, ¶ 59). Patent Owner states that the differences in the asserted levels of ordinary skill should not change the outcome of the Petition. Id. For the purposes of this decision, we adopt Petitioner’s definition, which appears consistent with the level of skill shown in the prior art references of record and the ’027 patent. 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))). Our analysis, however, would not change were we to adopt Patent Owner’s definition.” slip op. at 7

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

      “Patent Owner contends that claim construction is necessary for the “seed-applied substance” term because Petitioner allegedly ignores the teaching of the specification in evaluating the term. Prelim. Resp. 12. Patent Owner points to the specification, which defines a “seed-applied substance” as “includ[ing] any composition applied to seeds prior to the seeds being planted (e.g., when the seed comes in contact with the soil in a field).” Id. at 13 (quoting Ex. 1001, 7:45-48). Patent Owner contends that the term means “a substance that is applied directly to the seed before the seed comes into contact with the soil in a field.” Id. (citing Ex. 2001, ¶ 55). According to Patent Owner, Petitioner erroneously uses a definition that “allows the ‘seedapplied substance’ to be applied to the seed (and soil) as the seed lay planted in the soil.’” Id. For the purpose of addressing Petitioner’s grounds, we use the definition of “seed-applied substance” provided in the ’027 patent, i.e., “any composition applied to seeds prior to the seeds being planted (e.g., when the seed comes in contact with the soil in a field).” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) (“[A] patentee may choose to be his own lexicographer and use terms in a manner other than their ordinary meaning, as long as the special definition of the term is clearly stated in the patent specification or file history.”).” slip op. at 7

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

      “3. Analysis Our analysis of whether Wagers discloses the limitation “individually applying the desired application amount of the selected type of the seed-applied substance to each seed as it is being delivered to the soil” is dispositive of Petitioner’s challenge to claim 1 as anticipated.” slip op. at 10

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Graham
    Patents in suitUS 12,102,027
  • PTAB · Jun 22, 2022 · PGR2022-00018 · APJ Tina E Hulse · PGR · Institution

    The Board denied institution on claims 1–23 because Petitioner did not show it was more likely than not that any challenged claim was unpatentable.

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

      “post-grant review may not be instituted “unless . . . the information presented in the petition . . ., if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon considering the arguments and evidence presented by the parties, we determine Petitioner has not demonstrated that it is more likely than not that any of the claims challenged in the Petition are unpatentable.” slip op. at 2

    • PTAB / AIA Trials › Real party in interest / privityNot reached

      “G. Remaining Arguments Patent Owner also argues we should deny the Petition for failure to identify all real parties-in-interest in the Petition. Prelim. Resp. 31–44. Because we determine that Petitioner has not sufficiently established that in this Decision.” slip op. at 24

    • Skill levelSkill level petitioner adoptedOther

      “B. Person of Ordinary Skill in the Art Petitioner asserts that a person of ordinary skill in the art “would have had an advanced degree (i.e., a Master’s degree with two or more years of experience, or a Ph.D.) in inorganic or organic chemistry, chemical engineering, pharmacology, or a related discipline” and “would be familiar with medicinal chemistry or pharmaceutical chemistry, and with analytical methods to characterize and differentiate solid forms of compounds, (‘DSC’) and thermogravimetric analysis (‘TGA’).” Pet. 27 (citing Ex. 1106 ¶ 38). Petitioner further contends that “[a]lternatively, one of ordinary skill could have less education and approximately five or more years of relevant experience.” Id. Patent Owner does not dispute Petitioner’s definition of the level of ordinary skill in the art. See generally Prelim. Resp. Absent opposition from Patent Owner, we adopt Petitioner’s definition because it is consistent with the level of ordinary skill in the art reflected by the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 6

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

      “We agree with Patent Owner’s proposed construction, as it is most consistent with the intrinsic evidence. The claim language makes clear that “Polymorph A” is “characterized by” the specific peaks set forth in the claims. Ex. 1101, claims 1, 8, 16. Thus, regardless of the alleged conventional definition of a “polymorph,” urged by Petitioner, the inventors are entitled to act as their own lexicographers to define “Polymorph A” according to the recited peaks on the XRPD diffractogram. See Honeywell Int’l, Inc. v. Universal Avionics Sys. Corp., 493 F.3d 1358, 1361 (Fed. Cir. 2007) (“When a patentee defines a claim term, the patentee’s definition governs, even if it is contrary to the conventional meaning of the term.”). That the Specification consistently refers to “Polymorph A” as a proper noun and describes Polymorph A as “characterized by” the recited peaks in an XRPD diffractogram further highlights the inventors’ clear intent to act as their own lexicographer. See, e.g., Ex. 1101, 4:4–5:36; Merck & Co. v. Teva Pharms. USA, 395 F.3d 1364, 1370 (Fed. Cir. 2005) (“When a patentee acts away from their ordinary meaning, he must clearly express that intent in the written description.”). Finally, we agree with Patent Owner that the prosecution history of the parent ’257 patent is relevant to the construction of the claims of the ’259 patent, which is a continuation of the ’257 patent. Prelim. Resp. 6 (citing Iridescent Networks, Inc. v. AT&T Mobility, LLC, 933 F.3d 1345, 1350 (Fed. Cir. 2019) (“Statements made during prosecution of a parent application are relevant to construing terms in a patent resulting from a continuation application if such statements relate to the subject matter of the claims being construed.”)). During prosecution of the parent ’257 patent application, the examiner rejected original claim 1 as indefinite because it did not define “Polymorph A,” and required one to “refer to the specification to determine what is Polymorph A.” Ex. 2133, 7. Patent Owner then amended the claims to define Polymorph A by adding the specific XRPD peaks recited in claim 1. Ex. 2134, 2; see also id. at 6. Thus, we find the intrinsic evidence supports Patent Owner’s proposed construction.” slip op. at 9

    Claim construction§ 101 eligibility§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 10,954,259
  • PTAB · Jun 22, 2022 · PGR2022-00012 · APJ Tina E Hulse · PGR · Institution

    The Board denied institution of PGR on claims 1–23 because Petitioner did not show it was more likely than not that any challenged claim was unpatentable.

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

      “We have authority under 35 U.S.C. § 324(a), which provides that a post-grant review may not be instituted “unless . . . the information presented in the petition . . ., if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon considering the arguments and evidence presented by the parties, we determine Petitioner has not demonstrated that it is more likely than not that any of the claims challenged in the Petition are unpatentable.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “had an advanced degree (i.e., a Master’s degree with two or more years of experience, or a Ph.D.) in inorganic or organic chemistry, chemical engineering, pharmacology, or a related discipline” and “would be familiar with medicinal chemistry or pharmaceutical chemistry, and with analytical methods to characterize and differentiate solid forms of compounds, particularly XRPD, but also including differential scanning calorimetry (‘DSC’) and thermogravimetric analysis (‘TGA’).” Pet. 28 (citing Ex. 1006 ¶ 35). Petitioner further contends that “[a]lternatively, one of ordinary skill could have less education and approximately five or more years of relevant experience.” Id. Patent Owner does not dispute Petitioner’s definition of the level of ordinary skill in the art. See generally Prelim. Resp. Absent opposition from Patent Owner, we adopt Petitioner’s definition because it is consistent with the level of ordinary skill in the art reflected by the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 7

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

      “We agree with Patent Owner’s proposed construction, as it is most consistent with the intrinsic evidence. The claim language makes clear that “Polymorph A” is “characterized by” the specific peaks set forth in claim 1. Ex. 1001, claim 1. Thus, regardless of the alleged conventional definition of a “polymorph,” urged by Petitioner, the inventors are entitled to act as their own lexicographers to define “Polymorph A” according to the recited peaks on the XRPD diffractogram. See Honeywell Int’l, Inc. v. Universal Avionics a claim term, the patentee’s definition governs, even if it is contrary to the conventional meaning of the term.”). That the Specification consistently refers to “Polymorph A” as a proper noun and describes Polymorph A as “characterized by” the recited peaks in an XRPD diffractogram further highlights the inventors’ clear intent to act as their own lexicographer. See, e.g., Ex. 1001, 4:4–5:36; Merck & Co. v. Teva Pharms. USA, 395 F.3d 1364, 1370 (Fed. Cir. 2005) (“When a patentee acts as his own lexicographer in redefining the meaning of particular claim terms away from their ordinary meaning, he must clearly express that intent in the written description.”). Finally, during prosecution of the ’257 patent application, the examiner rejected original claim 1 as indefinite because it did not define “Polymorph A,” and required one to “refer to the specification to determine what is Polymorph A.” Ex. 1060, 7. Patent Owner then amended the claims to define Polymorph A by adding the specific XRPD peaks recited in claim 1. Ex. 1062, 2; see also id. at 6. Thus, we find the intrinsic evidence supports Patent Owner’s proposed construction.” slip op. at 9

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner

      “Having considered the parties’ respective arguments and evidence, we find Patent Owner has the better position. Although we agree with Petitioner that some degree of experimental error should be factored into the specific peaks of a diffractogram, the claim language already does so by expressly reciting a variance of “±0.1°2θ.” See Ex. 1001, claim 1. Construing the claims to include an additional degree of variance would effectively read out the “±0.1°2θ” limitation of the claims. See Merck & Co. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1372 (Fed. Cir. 2005) (“A claim construction that gives meaning to all the terms of the claim is preferred over one that does not do so.”). Moreover, we note that the express recitation of a specific variance distinguishes the ’257 patent claims from the claims of the Astrazeneca cases cited by Petitioner, which did not recite such a variance. See Pet. 11–12. In addition, the Specification consistently refers to a variance of ±0.1°2θ whenever it refers to peaks on a diffractogram. See generally Ex. 1001, 3:58–5:24. Petitioner acknowledges that the claims recite a range of peak locations, but argues that the Specification “does not explain the basis for the claimed range.” Pet. 10. Petitioner, however, does not explain why the Specification would need to explain that basis, particularly if a person of ordinary skill in the art would understand that ±0.1°2θ is an acceptable variance for XRPD.” slip op. at 13

    Claim construction§ 101 eligibility§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 10,947,257
  • PTAB · Mar 24, 2022 · PGR2021-00116 · APJ Ken B Barrett · PGR · Institution

    The Board denied institution because eight grounds failed the threshold showing and the remaining lack-of-ornamentality ground was marginal, making trial inefficient.

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

      “Here, Petitioner advances nine challenges against the claim of the ’346 patent. Pet. 8. As discussed above, we determine that, on this record, Petitioner has not met its burden for institution under eight grounds—an on-sale bar ground, six obviousness grounds, and an indefiniteness ground. Additionally, we determine that the ninth ground— the challenge based on the alleged lack of ornamentality—is marginal, at 5 We acknowledge that SAS and Harmonic address inter partes reviews, but see no reason to interpret differently § 324(a), the statute governing post-grant reviews. 6 Available at https://www.uspto.gov/patents/ptab/trials/guidance-impact-sas-aia-trial. 7 Available at https://www.uspto.gov/sites/default/files/documents/ tpgnov.pdf best. Based on the particular facts of this proceeding, instituting a trial with respect to all grounds based on evidence and arguments directed only to the one ornamentality ground would not be an efficient use of the Board’s time and resources. Cf. Chevron Oronite Co. LLC v. Infineum USA L.P., IPR2018-00923, Paper 9, 10–11 (PTAB Nov. 7, 2018) (informative); Deeper, UAB v. Vexilar, Inc., IPR2018-01310, Paper 7 (PTAB Jan. 24, 2019) (informative). Thus, we do not institute a post-grant review.” slip op. at 26

    • Other 314aInstitution denied discretionary otherInstitution denied

      “Under the Office Guidance, “if the PTAB institutes a trial, the PTAB will institute on all challenges raised in the petition.” Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018).6 When a petition fails to satisfy the “more likely than not” institution standard as to some challenges, the Board evaluates “all the challenges and determine[s] whether, in the interests of efficient administration of the Office and integrity of the patent system, the entire petition should be denied.” Patent Trial and Appeal Board Consolidated Trial Practice Guide7 64 (Nov. 2019) (citing 37 C.F.R. §§ 316(b), 326(b)). Here, Petitioner advances nine challenges against the claim of the ’346 patent. Pet. 8. As discussed above, we determine that, on this record, Petitioner has not met its burden for institution under eight grounds—an on-sale bar ground, six obviousness grounds, and an indefiniteness ground. Additionally, we determine that the ninth ground— the challenge based on the alleged lack of ornamentality—is marginal, at 5 We acknowledge that SAS and Harmonic address inter partes reviews, but see no reason to interpret differently § 324(a), the statute governing post-grant reviews. 6 Available at https://www.uspto.gov/patents/ptab/trials/guidance-impact-sas-aia-trial. 7 Available at https://www.uspto.gov/sites/default/files/documents/ tpgnov.pdf best. Based on the particular facts of this proceeding, instituting a trial with respect to all grounds based on evidence and arguments directed only to the one ornamentality ground would not be an efficient use of the Board’s time and resources. Cf. Chevron Oronite Co. LLC v. Infineum USA L.P., IPR2018-00923, Paper 9, 10–11 (PTAB Nov. 7, 2018) (informative); Deeper, UAB v. Vexilar, Inc., IPR2018-01310, Paper 7 (PTAB Jan. 24, 2019) (informative). Thus, we do not institute a post-grant review.” slip op. at 26

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “The POSITA relating to the subject matter of the D’346 patent would possess [a] Bachelor’s degree in industrial design (or a related or equivalent field) and at least ten (10) years of research or work experience related to designing, developing, specifying, testing or analyzing multi-component consumer products (or supervising the same), with experience related to handheld consumer electronic products. Pet. 14. For purposes of this decision, we assume Petitioner is referring to the designer of ordinary skill in the art. See In re Nalbandian, 661 F.2d 1214, 1216 (CCPA 1981) (“In design cases we will consider the fictitious person identified in § 103 as ‘one of ordinary skill in the art’ to be the designer of ordinary capability who designs articles of the type presented in the application.”). Patent Owner has not filed a preliminary response and therefore, at this stage, does not disagree or propose a different definition of the designer of ordinary skill in the art. Based on the limited record in front of us, we determine that Petitioner’s definition is consistent with the level of ordinary skill reflected in the prior art references of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (recognizing that the prior art itself may reflect an appropriate level of skill in the art). For purposes of this decision, we apply Petitioner’s definition of the designer of ordinary skill in the art.” slip op. at 13

    • Expert testimonyPetitioner expert discountedDecided for patent owner

      “incorrect standard, but also lacks credibility because it is internally inconsistent with other parts of his testimony. Mr. Fletcher testifies that it is his understanding that indefiniteness is viewed through the perspective of the ordinary observer, stating the following: I understand that an ordinary observer must be able to understand the scope of an invention with reasonable certainty. If not, a design is indefinite under 35 U.S.C. § 112. It is my understanding that errors and inconsistencies between drawings of a design patent can be indefinite, and thus invalid, if an ordinary observer cannot discern the overall appearance of the claimed design without resorting to conjecture or speculation. Ex. 1003 ¶ 27 (emphasis added). However, his opinions regarding indefiniteness all are in terms of the “POSITA.” Ex. 1003 ¶¶ 32–58; see, e.g., id. ¶ 32 (“The D’346 Patent is indefinite due to the inclusion of conflicting views, which would prevent a POSITA from understanding the claimed design as drawn. . . . A POSITA cannot discern from the D’346 Patent figures what design is actually being claimed.”). Casting further doubt on the reliability of his testimony, Mr. Fletcher does not articulate any definition for the POSITA, which is a necessary foundation for his opinions.4 Mr. Fletcher does not refer to the perspective of the ordinary observer (or even one skilled in the art, viewing the design as would an ordinary observer) in his opinions regarding indefiniteness (Ex. 1003 ¶¶ 32– 58), and we decline to assume his references to the unadorned “POSITA” implicitly encompass the perspective of the ordinary observer. Thus, Mr. Fletcher’s testimony regarding indefiniteness is unhelpful because it utilizes the incorrect perspective.” slip op. at 20

    § 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips
  • PTAB · Sep 17, 2021 · IPR2021-00707 · APJ John G New · IPR · Institution

    The Board denied institution on both obviousness grounds because the cited art did not teach or suggest the claimed projecting elements extending beyond the cover and medical scoping device.

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

      “review to be instituted unless … the information presented in the petition … and any response … shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition and Preliminary Response, Petitioner’s Reply (Paper 13), Patent Owner’s Sur-Reply (Paper 14), and the evidence of record, we determine that the evidence presented fails to demonstrate a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one challenged claim of the ’142 patent.” slip op. at 2

    • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away foundNot shown unpatentable

      “In sum, Hitoshi teaches that the situation depicted in Figure 21, in which the fin-shaped projections are deflected so as to “point towards a distal end of the cover,” as recited in claim 1, is one to be avoided because “during a pulling operation the effect of the aforementioned endoscope insertion assistance tool 3 in pressing on the intestinal wall would be lost and, furthermore, even in the case of insertion by a pressing-in operation, ease of insertion would deteriorate, due to increase in diameter of the insertion portion.” Hitoshi ¶ 78. We conclude that a person of ordinary skill in the art would consequently be “discouraged from following the path set out in the reference.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). As such, we conclude that Hitoshi teaches away from the third position in which: [O]ne or more of the tips of the projecting elements of the distal ring point towards a distal end of the cover, and wherein, when coupled to the medical device shaft and in the third position, the one or more of the tips of the projecting element are sized and configured to extend distally further than the distal end of the cover and the distal end of the medical scoping device shaft,” slip op. at 23

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

      “With respect to the teachings of Reydel as supporting this limitation, we find Petitioner’s argument to be almost entirely devoid of any factual basis in the evidentiary record. Nowhere does Reydel expressly teach that the apparently hair-like protrusions of its surface film are capable of extending distally further than the distal end of the cover and the distal end of the medical scoping device to facilitate withdrawal of the medical scoping device. Indeed, Figures 15–18 appear to demonstrate that the textured coating is such that the projections imparting the directionally-dependent frictional properties are not long enough to project distally past the end of either the cover or the medical scoping device, but serve only to create a bidirectional coefficient for the device. Moreover, Patent Owner’s argument that that Reydel’s teaching that “the different bidirectional coefficient of friction which impedes the spontaneous withdrawal of the device and/or instrument is not extreme enough to traumatize the canal walls, and therefore egress is not significantly more uncomfortable than with conventionally surfaced devices and/or instruments” (see Pet. 69), somehow teaches that the projections of the bidirectional coating are capable of extending distally beyond the end of the cover or the scoping device, is similarly without factual basis. To the contrary, Reydel teaches that: The patient’s comfort is also an objective of this invention, which is enhanced by simpler and less traumatic ingress methods. The different bidirectional coefficient of friction which impedes the spontaneous withdrawal of the device and/or instrument is not extreme enough to traumatize the canal walls, and therefore egress is not significantly more uncomfortable than with conventionally surfaced devices and/or instruments. Ex. 1006, 8. The plain language of this passage states merely that, due to the properties of the instrument cover, there are different coefficients of friction for distal and proximal movement of the endoscope, but that the difference between the frictional coefficients is not so great as to damage or traumatize the walls of the colon. Petitioner’s contention that this is caused by forward deflection of the projections of the cover in the distal direction, such that they extend beyond the end of the cover or of the scoping device, is mere conjecture and attorney argument to which we accord little probative weight. See In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). In short, we conclude that Petitioner has failed to meet the burden of demonstrating a reasonable likelihood of prevailing at trial because neither Reydel nor Hitoshi teaches or suggests the limitations of claim 1 reciting “the projecting elements deflect so that the tips of the projecting elements extend distally further than the distal end of the cover and the distal end of the medical scoping device to facilitate withdrawal of the medical scoping device.”” slip op. at 33

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “A Person of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the field of the ‘142 patent would be “a physician specializing in gastroenterology or a GI surgeon having an interest in colonoscopy or bowel cancer prevention. The POSA may be such a person working with members of a development team for devices to be used with colonoscopes.” Pet. 16 (citing Ex. 1001 ¶ 17). Patent Owner does not contest this definition in its Preliminary Response, and we consequently adopt Petitioner’s definition for the purposes of this Decision.” slip op. at 10

    § 103 obviousnesscites Phillips
    Patents in suitUS 9,808,142
  • PTAB · Sep 17, 2021 · IPR2021-00706 · APJ John G New · IPR · Institution

    The Board denied institution on all grounds because Hitoshi teaches away from the claimed distal projection position, and Axon and Reydel do not overcome that teaching.

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

      “review to be instituted unless … the information presented in the petition … and any response … shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition and Preliminary Response, Petitioner’s Reply, and Patent Owner’s Sur-Reply, and the evidence of record, we determine that the evidence presented fails to demonstrate a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one challenged claim of the ’103 patent.” slip op. at 2

    • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away found

      “In sum, Hitoshi teaches that the situation depicted in Figure 21, in which the fin-shaped projections are deflected so as to “point towards a distal end of the cover,” as recited in claim 1, is one to be avoided because “during a pulling operation the effect of the aforementioned endoscope insertion assistance tool 3 in pressing on the intestinal wall would be lost and, furthermore, even in the case of insertion by a pressing-in operation, ease of insertion would deteriorate, due to increase in diameter of the insertion portion.” Hitoshi ¶ 78. We conclude that a person of ordinary skill in the art would consequently be “discouraged from following the path set out in the reference.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). As such, we conclude that Hitoshi teaches away from the third position in which: [O]ne or more of the tips of the projecting elements of the distal ring point towards a distal end of the cover, and wherein, when coupled to the medical device shaft and in the third position, the one or more of the tips of the projecting element are sized and configured to extend distally further than the distal end of the cover and the distal end of the medical scoping device shaft, as recited in claim 1.” slip op. at 23

    • Expert testimonyPetitioner expert discountedOther

      “The testimony of Petitioner’s Declarant, Dr. East, fails to squarely address this teaching away by Hitoshi. Dr. East attests merely that “Hitoshi discloses an embodiment where the tips of the projecting elements extend distally further than the distal end of the endoscope cover in Figure 21, extending past projection 26” and that: A POSA would immediately envisage that the hood of Hitoshi is adapted for one or more of the tips of the projecting elements to be sized and configured to extend distally further than the distal end of the cover and endoscope given the Figures and disclosure. … A POSA viewing Figures 7 and 8 would understand that given the disclosed length and flexibility of the projecting elements 32 of the hood, as well as the teaching of positioning the projecting elements in any position along the endoscope cover, the device of Hitoshi could readily be adapted such that at least some of the projecting elements 32 of the distal ring extend further distally than the end of hood 31 and the distal end of the medical scoping device 21. East Decl. ¶¶ 182–183. Dr. East does not mention that Hitoshi teaches that the situation depicted in Figure 21, in which the fin-like projections are deflected to point distally, is a situation that Hitoshi expressly warns is to be avoided, and to which Hitoshi teaches preventative structural elements. See Hitoshi ¶ 80. Nor does Petitioner, or Dr. East, point to any teaching in Axon that would negate this teaching away in Hitoshi.” slip op. at 24

    § 103 obviousnesscites Phillips
    Patents in suitUS 10,722,103
  • PTAB · Sep 7, 2021 · PGR2021-00060 · APJ Ryan H Flax · PGR · Institution

    The Board denied institution because the petition did not show claims 1–7 likely unpatentable, and a possible § 112(a) issue for claims 8–9 did not justify instituting on all claims and grounds.

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

      “not demonstrated with particularity that it is more likely than not that most claims challenged in the petition are unpatentable under the asserted grounds. Although there is a reasonable argument that claims 8 and 9 may be unpatentable under 35 U.S.C. § 112(a), as discussed above, this analysis is applicable to only these two dependent claims under a single ground for unpatentability, leaving Petitioner’s other ten grounds insufficient regarding independent claim 1 and dependent claims 2–7. As discussed above, instituting trial under these circumstances would not be an efficient use of the Board’s or the parties’ time and resources. See Chevron, IPR2018- 00923, Paper 9, 10–11; Deeper, UAB v. Vexilar, Inc., IPR2018-01310, Paper 7, 41–43 (PTAB Jan. 24, 2019) (informative). Our decision at this stage derives from our review of the record presented. In accordance with the Court’s decision in SAS (138 S. Ct. at 1359– 60) and Office guidance, we deny institution of a post-grant review of the challenged claims of the ’631 patent on any grounds alleged by Petitioner. This decision does not reflect a final determination on the patentability of any claim.” slip op. at 66

    • Other 314aInstitution denied discretionary otherInstitution denied

      “Even when a petitioner satisfies the minimum statutory institution standard (e.g., demonstrating a reasonable likelihood of prevailing with respect to one or more claims in an inter partes review or that it is more likely than not that at least one claim is unpatentable in a post-grant review), institution of review remains discretionary. SAS Inst. v. Iancu, 138 S. Ct. 1348, 1356 (2018); Harmonic, Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“First of all, the PTO is permitted, but never compelled, to institute an IPR proceeding.”). Under such circumstances, the Board takes into account other considerations, including efficiency and fundamental fairness for all parties. See Adaptics Limited v. Perfect Co., IPR2018-01596, Paper 20 at 17 (PTAB Mar. 6, 2019) (informative); Chevron Oronite Co. LLC v. Infineum USA L.P., IPR2018-00923, Paper 9 (PTAB Nov. 7, 2018) (informative); see also Consolidated Trial Practice Guide, 84 FR 64280, 53– 63 (2019) (addressing various considerations at institution phase, including efficiency and fundamental fairness for all parties).1 We conclude that Petitioner has not demonstrated in the petition that it is more likely than not that challenged claims 1–7 are unpatentable under any asserted grounds for unpatentability. Although it is a closer question as to whether Petitioner has demonstrated it is more likely than not that dependent claims 8 and 9 are unpatentable based on a single asserted unpatentability ground under § 112, we determine based on the record here that instituting a trial with respect to all challenged claims under all eleven asserted grounds for unpatentability is not an efficient use of the Board’s or the parties’ time and resources. Therefore, we do not institute post-grant review pursuant to 35 U.S.C. § 324. See SAS, 138 S. Ct. at 1359–60 (requiring institution on all claims, if any); see also Consolidated Trial Practice Guide, 55 (providing guidance in view of SAS).” slip op. at 2

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

      “to read the concept of “flush with” into the claims. We agree with Petitioner’s position that such an interpretation is not supported by the ’631 patent’s written description, which illustrates and describes two embodiments, each having a turbine engine and reduction gearbox configured to be flush with one another, but refers to only the configuration of Embodiment 1 as being “directly connected” and refers to the configuration of Embodiment 2 as being merely “connected.” See Ex. 1001, 5:27–28, 5:62–6:2, Figs. 2, 3; see also Ex. 2001 ¶ 63 (Patent Owner’s expert witness confirming there is a difference between merely “connected” and “directly connected”). Thus, the intrinsic record supports a conclusion that the concept of “directly connected” is not related to whether one component is “flush with” another component. This disclosure of the ’631 patent also illuminates the meaning of “directly connected.” As shown in Embodiment 2, something may be connected with another thing even if there are intervening components, e.g., a transmission shaft or coupling; however, as shown in Embodiment 1, the ’631 patent uses the term “directly connected” only where no such intervening components are disclosed. Ex. 1001, 5:15– 6:19, Figs. 2, 3. Besides the guidance provided with respect to the embodiments discussed above, the ’631 patent does not otherwise expressly define the term “directly connected.” See generally Ex. 1001. Thus, we consider what the ordinarily skilled artisan would consider to be its ordinary and customary meaning. In this respect, Patent Owner also uses the word “uninterrupted” to describe “directly connected.” See Prelim. Resp. 6; see also Ex. 2001 ¶¶ 61–71. We conclude based on this record that the concept of “uninterrupted” is more apt than the concept of “flush with,” and find it to be a better description for the ordinary and customary meaning of “directly connected.” For example, the ’631 patent describes, in Embodiment 1, “the turbine engine 19 is connected to the plunger pump 18.” Ex. 1001, 5:26–27 (emphasis added). However, it is without question that Embodiment 1 positions a reduction gearbox between the turbine engine and plunger pump; thus, the engine and pump may be connected, but they are not directly connected. See, e.g., Fig. 2. On the other hand, regarding this same Embodiment 1, the ’631 patent describes that “the turbine engine 19 is directly connected to an input end of the reduction gearbox 24,” and there are no components illustrated or described as being between the turbine engine and reduction gearbox. Id. at 5:28–30 (emphasis added), Fig. 3. The connection between the turbine engine and reduction gearbox shown in Embodiment 1 is more aptly described as being uninterrupted. Thus, this illuminates the meaning of “directly connected.” In view of the above, we ascribe to the term “directly connected” its ordinary and customary meaning as it would have been understood by a person of ordinary skill in the art, and we find that ordinary and customary meaning to require that the turbine engine and reduction gearbox are connected with nothing intervening there-between so that their connection is uninterrupted.” slip op. at 29

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

      “Petitioner’s evidence shows that the Apollo 1 apparatus has two gearboxes and a clutch between its turbine engine and plunger pump, thus the Apollo 1 does not meet the claim limitation “the plunger pump is a plunger pump integrated with a reduction gearbox, the turbine engine is directly connected to an input end of the reduction gearbox integrated on the plunger pump.” Ex. 1001, 6:51–54. Petitioner’s Exhibit 1017 is explained by Mr. Zhang11 as having these two gearboxes and clutch, where at least one of the gearboxes and the clutch forecloses the system from having a single reduction gearbox that is both integrated on a pump and directly connected to a turbine engine. Ex. 2010 ¶¶ 8–12. Petitioner presents no evidence contradicting Mr. Zhang’s understanding of the Apollo 1 configuration and, notably never attempted to explain exactly what is shown in the above-reproduced photograph from its own Exhibit 1017, even when given the opportunity to address Mr. Zhang’s testimony in its Reply. See generally Reply.” slip op. at 50

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · Graham · Nautilus
    Patents in suitUS 10,865,631
  • PTAB · May 14, 2021 · IPR2021-00132 · APJ Sheridan K Snedden · IPR · Institution

    The Board denied institution because Hindson was not prior art; claims 1–26 were entitled to priority and were not shown likely unpatentable.

    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). 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 at least 1 claim of the ’115 patent is unpatentable.” slip op. at 2

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedNot shown unpatentable

      “We have considered the parties’ arguments, summarized above, but determine that Patent Owner has the better position. In particular, we are not persuaded by Petitioner’s contentions that the claims fail the written description requirement for the claimed “partitions” because the term “gel beads” are not adequately described. Pet. 19–20. The claims do not recite the term “gel beads”. Ex. 1001, 49:2–50:41. Rather, the claims of the ’115 patent are directed to compositions (claim 1–13) and devices (clam 14–26) having a plurality of second partitions containing first partitions, wherein the second partitions may be droplets (claims 4–6 and 18–20). Id. To the extent that Petitioner contends that the ’115 patent does not provide adequate written description support for those elements of the challenged claims, we disagree. For example, claim 1 recites a composition “comprising a plurality of second partitions containing first partitions” where “first partitions are contained within the second partitions.” Support for those elements is found, for example, in the following portions of the ’115 patent:” slip op. at 10

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artNot shown unpatentable

      “Accordingly, in view of the above, we are not persuaded by Petitioner’s arguments that the claims of the ’115 patent lack written description support and, thus, are not entitled to claim the benefit of priority to the ’121 application. Consequently, we determine that Hindson does not qualify as prior art to the ’115 patent and therefore cannot anticipate the claims of the ’115 patent.” slip op. at 12

    § 102 anticipation
    Patents in suitUS 10,190,115
  • PTAB · May 12, 2021 · IPR2021-00202 · APJ Elizabeth M Roesel · IPR · Institution

    The Board denied institution because Petitioner did not show a reasonable likelihood of proving claims 1, 2, 5, 7, 9, and 18 obvious over the asserted combinations.

    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) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)); see also 37 C.F.R. § 42.104(b) (requiring a petition for inter partes review to identify how the challenged claim is to be construed and where each element of the claim is found in the prior art patents or printed publications relied upon). slip op. at 7

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Relying on Dr. Osswald’s testimony, Petitioner contends that a person of ordinary skill in the art (“POSA”) would have had a Bachelor of Science degree in mechanical engineering, chemical engineering, fluid mechanics, and/or polymer processing or equivalent, and at least two years of practical experience working with dies and other equipment used in polymer processing, such as meltblowing dies, or in lieu of work experience, additional education and/or coursework exposing them to polymer processing and equipment, including meltblowing dies. Pet. 11; Ex. 1002” slip op. at 8

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

      “For purposes of this proceeding, the parties do not dispute the meaning of any claim term. See Pet. 11–15 (for purposes of this proceeding, Petitioner adopts Patent Owner’s claim construction positions from the related district court litigation); Prelim. Resp. 11–14 (discussing claim construction and not disputing constructions on which Petition is based). Accordingly, we do not need to resolve any claim construction disputes for purposes of this Decision. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in the context of inter partes review).” slip op. at 9

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner

      “passages formed by the first side of the die tip and the first air plate, and (ii) a series of passages are formed by the second side of the die tip and the second air plate. For purposes of this proceeding, the parties agree that “series” means “two or more.” Pet. 14–15 (adopting Patent Owner’s claim construction positions from the related district court litigation, including Patent Owner’s contention that a “series” is “two or more” things); Prelim. Resp. 14.6 6 Patent Owner states: “For the purposes of this IPR proceeding, both parties have agreed that ‘series’ means ‘two or more.’” Prelim. Resp. 14. (citing Pet. 15). Patent Owner directs us to the district court’s claim construction order, which construes “series” as meaning “two or more.” Prelim. Resp. 14; Ex. 2009, 27, 37. The district court relied on dictionary definitions and “normal usage,” for example, in the context of baseball. Ex. 2009, 26–27. We note that the parties’ agreed construction is consistent with the claims of the ’104 Patent, which recite the word “series” in various contexts, including a “series of passages,” a “series of raised portions,” a “series of channels,” a “series of polymer ports,” and a “series of capillaries.” Ex. 1001, 12:19, 12:23, 12:31, 12:33, 12:42, 12:44, 12:64–65, 13:2–3, 13:20–14:1, 14:6, 14:11–13. In each case, the meaning “two or more” is consistent with the claim language. The parties’ agreed construction is also supported by the Specification, which shows and” slip op. at 13

    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 6,972,104
  • PTAB · Jan 27, 2021 · PGR2019-00064 · APJ Christopher G Paulraj · PGR · Rehearing

    The Board denied Petitioner’s rehearing requests, leaving in place denial of institution based on the merits of the written-description and enablement challenges.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “II. DISCUSSION A party requesting rehearing has the burden to show a decision should be modified by specifically identifying all matters the party believes were misapprehended or overlooked, and the place where each matter was addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2

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

      “Petitioner’s arguments are unpersuasive because our construction of “stable” does not exclude the preferred embodiments. As Petitioner acknowledges, “[t]he Board did not construe ‘stable’ to be limited to formulations that are as stable as Humira or lose 20% of activity upon storage.” Id. at 3. Although our construction encompasses the “most” preferred embodiment (e.g., those that do not lose more than 5% of their activity during two years of long-term storage), it also encompasses other embodiments that are considered less preferred but nonetheless within the scope of what is defined to be “stable” in the specification, i.e., compositions that do “not lose more than 20%, or more preferably 15%, or even more preferably 10%” of activity. Ex. 1001, 9:28–33. Furthermore, consistent with the specification, our construction of “stable” encompasses embodiments in which stability is determined by comparison to the commercial formulation of adalimumab known in the prior art, i.e., Humira. Decision 8–9. We find no basis to construe “stable” to be limited to the only most preferred embodiment by requiring a loss of no more than 5% activity. See Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (stating “a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment”).” slip op. at 3

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

      “These arguments are also unpersuasive. As stated in the Decision: [W]e find that the specification provides a detailed disclosure of the testing used to assess stability (using Humira as the control), and identifies specific ingredients to be included and excluded from the claimed composition, and further identifies the pH that is necessary to achieve the claimed stability. Although there may be certain concentrations of adalimumab or certain types of buffers and sugars that may render the compositions more difficult to stabilize, Petitioner does not explain sufficiently why a POSA would not have known how to adjust or select those ingredients in order to achieve the claimed stable aqueous pharmaceutical composition. Decision 17. As further stated in the Decision: Moreover, even if a POSA would have needed to test whether a particular composition was stable, “[t]he fact that some experimentation is necessary does not preclude enablement; what is required is that the amount of experimentation ‘must not be unduly extensive.” PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564 (Fed. Cir. 1996) (citing Atlas Powder Co. v. E.I. DuPont De Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984)). Indeed, even “a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the invention claimed.” Id. (citing Ex parte Jackson, 217 USPQ 804, 807 (BPAI 1982)). Id. at 17–18. Petitioner’s arguments do not persuade us that we committed legal or factual error in making the foregoing determinations. Accordingly, we are not persuaded that we abused our discretion in determining that Petitioner did not satisfy its burden with respect to the lack of enablement ground for claims 1–12.” slip op. at 5

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

      “the specification identifies with sufficient clarity each of the ingredients that must be included as part of the claimed composition (i.e., adalimumab, a buffer, polysorbate 80, and a sugar) and further provides a reason to exclude the ingredients that must not be included in theclaimed composition (i.e., mannitol, a citrate/phosphate buffer combination, and sodium chloride). Id. at 13–14. The Decision also explained how one of ordinary skill in the art would recognize that the inventors possessed the claimed invention: Patent Owner identifies teachings in the specification indicating the structural features required for achieving a stable adalimumab composition, which include: 1) avoiding the citrate/phosphate buffer combination in favor of another more stable buffer (such as an acetate buffer); 2) including polysorbate 80 as a stabilizer; 3) removing sodium chloride (NaCl) from the formulation; 4) using a sugar or polyol as the tonicity modifier in place of mannitol/NaCl; and 5) maintaining a pH of at least 5 (with an optimal pH near 5.2). Id. at 60 (citing Ex. 1001, 5:42–44, 21:40–47, 37:25–38:4, 38:1–7, 61:24–25). Patent Owner further asserts, and we agree, that the specification “provides working examples that demonstrate comparable or superior stability to the commercial Humira® formulation” and that Petitioner fails to demonstrate why a POSA would doubt that the formulations that demonstrated improved stability relative to Humira would be stable. Id. at 60–61. Id. at 14. Petitioner’s arguments do not persuade us that we committed legal or factual error in making the foregoing determinations. Accordingly, we are not persuaded that we abused our discretion in determining that Petitioner did not satisfy its burden with respect to the lack of written description ground for claims 1–12.” slip op. at 7

    Claim construction§ 112 disclosure
    Patents in suitUS 10,155,039
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