• Resmed Corp. v. Cleveland Medical Devices, Inc.Institution denied
  PTAB · Jun 24, 2024 · PGR2024-00012 · APJ Ulrike W Jenks · PGR · Institution

  The Board denied institution of PGR on claims 1–20 because Petitioner did not show the patent was PGR-eligible, having failed to show inadequate written-description support or lack of enablement in the pre-AIA priority applications.

  RulingsInstitution decision

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

    “Petitioner has the burden of establishing eligibility for post-grant review. See Mylan Pharms. Inc. v. Yeda Res. & Dev. Co., PGR2016-00010, Paper 9 at 10 (PTAB Aug. 15, 2016). To show that the ’284 patent is eligible for post-grant review, Petitioner bears the burden of proving that the challenged claims lack the priority benefit of the filing date of an earlier 7 The ’284 patent issued from a transition application. A “transition application” is a patent application filed on or after March 16, 2013 (the effective date of the AIA), but which claims priority to an application that was filed prior to the effective date of the AIA. See, e.g., MPEP § 2159.04. challenged claims, or a claim pending during examination of the ’266 application, “was not disclosed in compliance with the written description and enablement requirements of § 112(a) in the earlier application for which the benefit of an earlier filing date prior to March 16, 2013 was sought.” Inguran, LLC v. Premium Genetics (UK) Ltd., PGR2015-00017, Paper 8 at 11 (PTAB Dec. 22, 2015).” slip op. at 9

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable

    “Thus, the ’284 patent specification explains that the system can adjust the positive airway pressure supplied to the subject without human intervention. The system gathers information from the sensors and uses it to “monitor the condition of the subject” and “determine a level of severity of the subject’s sleeping disorder.” Ex. 1001, 23:20–41. Based on this the subject,” for example by adjusting the positive airway pressure provided to the subject. See id. at 19:3–17, 3:37–55. In this way, the ’284 patent specification discloses generating “an index of treatment efficacy” where “the index [is] based in part on data of severity of sleep disorder symptoms of the subject and data of usage of the PAP device by the subject,” because the system uses data collected from the sensors to evaluate the severity of the subject’s sleeping disorder and efficacy of the current treatment, and can adjust the treatment without human intervention as needed. Accordingly, Petitioner has not demonstrated that it is more likely than not that the ’284 patent claims lack written description support in the pre-AIA priority applications for “an index of treatment efficacy” claim term.” slip op. at 13

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledNot shown unpatentable

    “’284 patent claims are not enabled. Prelim. Resp. 24–30. We find that Petitioner has failed to demonstrate, more likely than not, that any experimentation would have been undue in view of the Wands factors. Prelim. Resp. 25 (citing Wands, 858 F.2d at 737). On this record, Petitioner has not demonstrated that the claimed subject matter is unpredictable or would require undue experimentation. Petitioner argues that “the challenged claims are not enabled regarding the ‘index of treatment efficacy’ claim elements.” Pet. 24. But as Patent Owner establishes, Petitioner acknowledges that determining treatment efficacies was merely applying a known technique. See Prelim. Resp. 26 (citing Pet. 36 (determining treatment efficacy “would amount to merely applying a known technique (i.e., determining treatment efficacy based on multiple factors) to a known device ready for improvement (e.g., CPAP treatment system comprising multiple devices) to yield predictable results (i.e., improve operation of CPAP treatment to better treat the patient and its disorder)”). On this record, Patent Owner further demonstrates that “it was well- known in the art [] how to determine indices of treatment efficacy based on breathing metric data over a period of time.” Prelim. Resp. 26; Ex. 2001 at 175 (“Efficacy, in the context of [obstructive sleep apnea] OSA, reflects the ability of treatment to prevent the occurrence of obstructive breathing events during periods when the treatment is being physically applied.”); Ex. 2002 at 1–2 (based on the apnea-hypopnea index (AHI) the severity of obstructive sleep apnea (OSA) can be calculated); Ex. 2003 at 1 (“ResLink presents this efficacy information along with integrated oximetry data for simultaneous onscreen viewing and analysis.”)). index of treatment efficacy on a cell phone or transmitting it to a remote internet site.” Pet. 25. Petitioner, however, has not demonstrated, more likely than not, that it would take undue experimentation to carry out such display or transmission. The Petition merely suggests that the specification lacks enablement of these claim limitations, but fails to provide any analysis of pertinent factors, such as the state of the prior art, the level of ordinary skill, or the level of predictability in the art with regard to displaying and transmitting data on a cell phone at the time of the invention. In sum, we conclude that Petitioner has failed to show that it is more likely than not that the challenged claims are not enabled.” slip op. at 23

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

    “In this post-grant review, we construe the claims of the ’284 patent “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. § 42.200(b) (2019). Under that standard, the words of a claim are generally given their “ordinary and customary meaning,” which is the meaning the term would have to a person of ordinary skill at the time of the invention, in the context of the entire patent including the specification. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner contends that “[n]o claim term needs formal construction for purposes of evaluating the prior art in this Petition.” Pet. 16. Patent Owner also does not construe any claim terms. See generally Prelim. Resp. For purposes of this Decision, and based on the record before us, we determine that none of the claim terms requires an explicit construction to determine whether to institute post-grant review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 8

  Claim construction§ 112 disclosure
  Patents in suitUS 11,602,284
• Atea Pharmaceuticals, Inc. v. Gilead Sciences, Inc.Institution denied
  PTAB · Feb 21, 2024 · PGR2023-00046 · APJ Susan L C Mitchell · PGR · Institution

  The Board denied institution because Atea did not show claim 1 was more likely than not unpatentable for lack of written description, lack of enablement, or anticipation.

  RulingsInstitution decision

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

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

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “The major differences between Petitioner’s and Patent Owner’s definitions of a skilled artisan include the number of years of drug discovery experience that is necessary and the breadth of the fields of endeavor with which a POSA should be familiar. We agree with Patent Owner that a POSA includes a team of skilled artisans with skill sets in the various aspects of drug development, but determine that Petitioner has addressed those necessary skill sets in its definition. We also determine on this record that Petitioner has assessed adequately the level of experience needed, and do not agree with Patent Owner that greater years of experience are necessary for a POSA in this instance. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) (“A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.”). Because Petitioner’s definition of a person of skill in the art appears commensurate with the level of skill reflected in the asserted art in this case as well as the ’361 patent itself, we apply Petitioner’s proposed level of ordinary skill in the art to determine whether it is more likely than not that Petitioner would prevail on its challenges to claim 1. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 10

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

    “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. § 42.200. 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 be understood by a person of ordinary skill in the art, 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)). Both parties agree that we need not construe any claim terms here to resolve the issues in this proceeding. See Pet. 16; Prelim. Resp. 18–19. We agree with the parties that we need not construe any claim terms in this proceeding to resolve whether to institute a post-grant review.” slip op. at 11

  • BurdenNot shown unpatentable

    “In applying the rubric set forth in Ariad to determine whether claim 1 has appropriate written description support, we can look for structural features common to the members of the subgenus of claim 1 so that one of skill in the art can “visualize or recognize” the members of the subgenus. See Ariad, 598 F.3d at 1350. To do this, we look “for blaze marks within the disclosure that guide attention to the claimed species or subgenus.” See Regents of the Univ. of Minn., 61 F.4th at 1356. In this regard, the fourteenth aspect of the third embodiment is the blaze mark that points to the subgenus of claim 1. We do not need to find blaze marks that identify the fourteenth aspect of the third embodiment as the only formula of merit or the only one that should be claimed. Rather, we look to the written description to see if it describes sufficient structural features common to the members of the subgenus of claim 1 such that a POSA can visualize or recognize the members of that subgenus, thereby demonstrating that the inventors possessed the subject matter of the claim at the time they filed their application.” slip op. at 20

  Claim construction§ 102 anticipation§ 112 disclosurecites KSR
  Patents in suitUS 11,642,361
• Adama Agan Ltd. v. Bayer Cropscience LPInstitution denied
  PTAB · Feb 13, 2023 · PGR2022-00057 · APJ Susan L C Mitchell · PGR · Institution

  The Board denied institution because Petitioner did not show it was more likely than not that claims 1–18 lacked written description or enablement, or were unpatentable over the asserted prior art.

  RulingsInstitution decision

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

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

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “According to Petitioner, a person of ordinary skill in the relevant art (“POSA”) “would have had at least a bachelor’s degree in agronomy, agricultural sciences, or a related field and at least 3-5 years of experience in the application of pesticides, including experience conducting weed science research, such as field trials to determine herbicide efficacy and safety.” Pet. 25 (citing Ex. 1002 ¶ 10). Patent Owner responds that it does not challenge Petitioner’s definition of a POSA at this stage of the proceeding. Prelim. Resp. 15. Because Petitioner’s definition of a person of skill in the art appears commensurate with the level of skill reflected in the asserted art in this case, as well as the ’463 patent itself, we apply Petitioner’s proposed level of ordinary skill in the art to determine whether it is more likely than not that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 8

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

    “When claim 1 is read in light of the Specification of the ’463 patent, we find that Petitioner’s construction is too expansive and not commensurate with the appropriate scope of claim 1 when the Specification of the ’463 patent is considered. As the Specification of the ’463 patent makes clear, indaziflam has been in use as an herbicide and is well-characterized. See Ex. 1001, 3:17–6:6. The Specification of the ’463 patent incorporates by reference U.S. Patent No. 8,114,991, which describes indaziflam, and the Specification of the ’463 patent also describes several commercially available herbicides incorporating indaziflam as their active ingredient. See id. at 3:22–27, 4:15–41. The Specification of the ’463 patent sets forth embodiments with specific ranges for the amount of indaziflam. See id. at 5:45–6:6. Finally, the Specification of the ’463 patent states: A person having ordinary skill in the art would understand how to adjust dosages and concentrations depending on whether the composition is to be applied to a desirable plant or seed, part or habitat thereof, or directly to a site in which no desirable plants are present or growing (e.g., a monoculture of unwanted annual grass).” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITANo construction needed

    “We find that Petitioner’s expansive construction of the claim phrase “a composition comprising a cellulose biosynthesis inhibitor” to be inconsistent with the meaning of the transitional phrase “comprising” within the context of the claim as a whole and also inconsistent with the teachings set forth in the Specification of the ’463 patent. The transitional phrase “comprising” is inclusive or open-ended and should be read to not exclude additional, unrecited elements or method steps. See, e.g., Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368 (Fed. Cir. 2003) (“The transition ‘comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.”); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.”) (citing In re Baxter, 656 F.2d 679, 686 (CCPA 1981). Therefore, although the term “comprising” does not exclude additional steps or elements, that does not mean that any other step or element may or should be added, such as any other chemical, as Petitioner asserts. The Specification of the ’463 patent contemplates using indaziflam as the herbicidally active ingredient, but also contemplates the addition of other active ingredients in the composition. Ex. 1001, 5:59–65; 6:7–11. The Specification of the ’463 patent also contemplates the addition of other ingredients in the composition as well. Specifically, the Specification states: These formulations are produced in any desired or known manner, for example by mixing the active compounds with extenders, such as liquid solvents, pressurized liquefied gases and/or solid carriers, optionally with the use of surface-active agents, such as emulsifiers and/or dispersants and/or foam formers. Id. at 17:6–11. This and the remainder of the Specification does not suggest the expansive interpretation of the claim limitation argued by Petitioner. For example, the Specification explains that the point of the invention is to treat vegetation that is or will be consumed by livestock animals, and, more specifically, that such animals will provide food (e.g., milk or meat) for others (e.g., people or pets) further up the food chain. Id. at 2:31–35, 2:39– 59. Reason and the evidence of record support that such goals are not commensurate with co-applying any chemical in any amount to the same area. See also Ex. 1002 ¶¶ 22–23, 30, 34–36, 38–43, 55, 59–61, 63” slip op. at 13

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 11,166,463
• Sandoz Inc. v. Biogen Ma Inc.Institution denied
  PTAB · Feb 2, 2023 · PGR2022-00054 · APJ Cynthia M Hardman · PGR · Institution

  The Board denied institution on claims 1–16 because Petitioner did not establish that the patent was eligible for post-grant review, finding adequate written-description support in the pre-AIA priority applications.

  RulingsInstitution decision

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

    “1. Legal Standard – Written Description 35 U.S.C. § 112(a) requires that a patent’s specification “contain a written description of the invention . . . in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains . . . to make and use the same.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1344 (Fed. Cir. 2010). This provision ensures that as of the filing date “the inventor actually invented the invention claimed.” Id. at 1350–51. The test “requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” Id. at 1351. Adequate description of a genus requires “disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Id. at 1350. “[F]unctional claim language can meet the written description requirement when the art has established a correlation between structure and function.” Id.” slip op. at 11

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateDecided for patent owner

    “were insufficient in view of the state of the art as of the filing date of each of these three pre-AIA applications (i.e., as of the 2006, 2007, and 2010 filing dates). Prelim. Resp. 24. “This requires [Petitioner] to establish that at each of those times, a [person of ordinary skill in the art] would not have understood, in light of the specification and the then-current state of the art, that [Patent Owner] possessed the claimed invention.” Id. (citing Ariad, 598 F.3d at 1351 (“[T]he test for sufficiency 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.”) (emphasis added); Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005) (“The descriptive text needed to meet [the written description] requirement varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence.”)). We agree with Patent Owner that Petitioner “makes no attempt to engage with this requirement, instead focusing its arguments on the state of the art as it existed in 2006 (the filing date of the ’931 Application) and 2007 (the filing date of the ’628 application), while ignoring the 2010 application.” Prelim. Resp. 24. We also agree with Patent Owner that Petitioner’s failure to address the state of the art as of the filing of the 2010 application “is fatal, specifically because the Petition and the declaration repeatedly assert and admit that the field was advancing substantially between 2006 and 2010.” Id. at 27 (citing Pet. 18–19, 23–25; Ex. 1002 ¶¶ 87, 114).” slip op. at 26

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

    “We agree with Patent Owner. The ’845 patent specification defines “seroconversion” as “the change of a serologic test from negative to positive, indicating the development of antibodies.” Ex. 1001, 9:3–5. Petitioner acknowledges this definition, but asserts that “in 2006, at the time the earliest patent application in the priority chain was filed,” “there were no established thresholds for JCV positivity . . . and without such thresholds, [serological tests to detect JCV] could produce false positives (e.g., by crossreacting with BK virus) and false negatives.” Pet. 32–33 (citing Ex. 1002 ¶¶ 29, 99–100). Thus, Petitioner asserts, a person of ordinary skill in the art would understand that “‘seroconversion . . . of JCV antibodies’ requires a test ‘indicating the development of antibodies’ that is sufficiently accurate to exclude most false positives and false negatives.” Id. at 33. We are not persuaded by Petitioner’s arguments. First, as Patent Owner points out, the claims themselves “do not require any specific serological test or degree of sensitivity or specificity,” and “are agnostic as to which of the various available methods known in the art and described in the specification for measuring JCV antibodies may be used.” Prelim. Resp. 12–13. Second, we agree with Patent Owner that Petitioner’s construction “impermissibly imports into the claims subjective requirements such as sensitivity, specificity, reliability, accuracy, or some particular rate of false positives or negatives,” none of which are “grounded in the intrinsic record.” Id. at 14, 15. For purposes of this Decision, we adopt the ’845 patent specification’s express definition of “seroconversion,” i.e., “the change of a serologic test from negative to positive, indicating the development of antibodies.” Ex. 1001, 9:3–5.” slip op. at 6

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art On this record the parties agree that a person of ordinary skill in the art “would have had (1) a Ph.D., M.D., or equivalent degree and (2) at least two years of experience with the use of natalizumab to treat patients with inflammatory or autoimmune diseases, including MS, RA, and/or CD.” Pet. 33; Prelim. Resp. 3, n.2. For purposes of this Decision we adopt this undisputed proposal.” slip op. at 7

  Claim construction§ 112 disclosure
  Patents in suitUS 11,292,845
• Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc.Institution denied
  PTAB · Sep 15, 2022 · PGR2022-00025 · APJ Susan L C Mitchell · PGR · Institution

  The Board denied institution because Petitioner did not show it was more likely than not that any of claims 1–19 was unpatentable on the asserted grounds.

  RulingsInstitution decision

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

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

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “According to Petitioner, a person of ordinary skill in the relevant art (“POSA”) “would have a medical degree or a Ph.D. in a field related to endocrinology, and would have knowledge of hormone regulation and disorders, as well as knowledge of the treatment regimens employed to treat such disorders . . . [and] would also have at least three years of experience conducting research concerning endocrine disorders, including CAH or other adrenal disorders.” Pet. 26–27 (citing Ex. 1005 ¶ 34 (Dr. Carey Declaration)). Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Preliminary Response. Because Petitioner’s definition of a person of skill in the art appears commensurate with the level of skill reflected in the asserted art in this case as well as the ’201 patent itself, see, e.g., Exs. 1024, 1025, 2003, 2004, 2005, we apply Petitioner’s proposed level of ordinary skill in the art to determine whether it is more likely than not that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 7

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

    “The Specification expressly teaches that, with respect to the clinical phase 2 trial described in Example 4, “Patients will have overnight [pharmacokinetic/pharmacodynamics] PK/PD assessments performed at baseline, which include an [sic] pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose.” Ex. 1001[,] col. 42, ll. 12–16.6 This is the same quotation and clinical trial relied upon by Dr. Barnes in his Declaration [submitted by Patent Owner during prosecution], and is the only definition of a “baseline” in the ’908 patent. See Ex. 1002, 36–37. We note that placebos were evidently not employed in the phase 2 clinical study of Example 4. Given the sole exemplary description of “baseline” in Example 4 of the Specification, we construe the claim term reciting “reduced by at least 10% from baseline” as meaning “a reduction of at least 10% in the level of ACTH (claim 1) or 17-OHP (claim 11) compared to measurements of ACTH or 17-OHP made prior to, and/or at the beginning of, administration of the drug.”” slip op. at 9

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

    “From mere disclosure of crincerfont, Petitioner asks us to find a particular treatment protocol using this drug and the outcomes of such treatment as taught by non-prior art Auchus 2021 are inherent in the drug itself. Such outcomes of such treatment as is the subject of the challenged claims here may be inherent in a particular treatment regimen using a particular drug, but it is too far of a leap to say that disclosure of the drug itself would render inherent any treatment outcome using any treatment protocol. For the reasons set forth above, we determine that Petitioner has failed to establish that it is more likely than not that Grigoriadis anticipates claim 1 of the ’201 patent. Because the remaining claims challenged in this ground depend either directly or indirectly on claim 1, we similarly conclude that Petitioner has not established a likelihood of prevailing with respect to these dependent claims, claims 2–4, 7–9, 11–15, 18.” slip op. at 19

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 11,007,201
• Guardant Health, Inc. v. University Of WashingtonInstitution denied
  PTAB · Aug 1, 2022 · IPR2022-00449 · APJ Zhenyu Yang · IPR · Institution

  The Board denied institution because the written-description priority arguments were substantially the same as those considered by the Office, and Petitioner did not show material error.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied

    “Based on this record, we find Petitioner’s arguments challenging written description support are the same or substantially the same as those considered by the examiner during the prosecution of the ’045 application. 4. Material Error Having found that the condition in the first part of the two-prong framework is satisfied, we next evaluate whether Petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, 8. Based on the current record, we determine Petitioner has not met its burden to show the examiner materially erred.” slip op. at 15

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

    “Specifically, Petitioner argues that the ’785 application lacks written description support for “converting” or “attaching” tags to “circulating DNA molecules,” as recited in independent claims 1 and 20. Id. at 17–30. Patent Owner argues that we should deny institution under § 325(d) “because the Office already found that the specification provides § 112 support for tagging circulating DNA.” Prelim. Resp. 10. For the reasons explained below, we find Patent Owner’s arguments persuasive.5 5 As another basis for its priority arguments, Petitioner contends that the ’785 application does not enable methods for “converting” or “attaching” tags to “circulating DNA molecules.” Pet. 30. Patent Owner asserts that “[t]he Petition gives enablement only cursory treatment.” Prelim. Resp. 36. We agree with Patent Owner. Petitioner disposes of the entire enablement argument in a single seven-line paragraph. See Pet. 30. It provides no meaningful analyses of the factors set forth in In re Wands, 858 F.2d 731,” slip op. at 8

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied

    “III. CONCLUSION Petitioner’s anticipation and obviousness grounds rest on the priority date of the challenged claims. Because we decline to reconsider Petitioner’s challenge of priority date based on lack of written description support, we exercise our discretion under § 325(d) and decline to institute inter partes review of the ’699 patent. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied.” slip op. at 18

  § 112 disclosureDiscretionary denialcites Phillips
  Patents in suitUS 10,689,699
• Freedom To Operate, Inc. v. Compass Pathfinder LimitedInstitution denied
  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
• Freedom To Operate, Inc. v. Compass Pathfinder LimitedInstitution denied
  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
• Dr. Reddy’S Laboratories, Ltd. / Dr. Reddy’S Laboratories, Inc. v. Monosol RX, LLCInstitution denied
  PTAB · Dec 5, 2016 · IPR2016-01112 · APJ Erica A Franklin · IPR · Institution

  The Board denied institution because the Petition did not show a reasonable likelihood of establishing that any challenged claim was unpatentable over the asserted obviousness grounds.

  RulingsInstitution decision

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

    “inter partes review may not be instituted “unless . . . 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). Upon considering the Petition and Preliminary Response, we determine that the Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing the unpatentability of at least one of the challenged claims. Accordingly, we decline to institute an inter partes review of any challenged claim.” slip op. at 2

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningDecided for patent owner

    “Patent Owner correctly notes that Petitioner does not rely on its proposed claim construction in the Petition. Prelim. Resp. 7. Nor does Petitioner provide any discussion supporting its position that the construction that it proposes represents the broadest reasonable construction in light of the specification of the patent, other than asserting that it is the same construction that was proffered in a district court proceeding. For purposes of this decision, we agree with Patent Owner that the plain and ordinary meaning of the phrases apply. Id. at 7. In any event, this Decision does not turn on the claim phrases for which Petitioner has proposed a construction.” slip op. at 6

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

    “particular, Petitioner has not explained adequately why a person of skill in the art at the time of the invention would have had a reason to combine the teachings of Chen and Shiraldi. As discussed, supra, Chen describes using a mixture of two or more types of the same hydrocolloid that differ only in molecular weights and Shiraldi describes selecting and blending various polymers. Petitioner has not shown that a person of skill in the art would have understood that Shiraldi teaches or suggests selecting various polymers based upon high and low molecular weights. Nor has Petitioner established that Chen’s teaching to combine two or more types of the same hydrocolloid having differing molecular weights involved selecting a mixture of high and low molecular weights in the manner claimed. Indeed, neither reference provides a teaching or an example of such a practice. The example in Chen relied upon by Petitioner includes only a low molecular weight polyethylene oxide. Pet. 32 (referring to Chen Example 11 using a polyethylene oxide having an average molecular weight of 100,000 Da). In contrast to Chen, Schiraldi preferred and exemplified only high molecular weight polyethylene, in a range well beyond that recited in the claims for that component. That is, Schiraldi describes the ethylene oxide useful for its invention as having “a relatively high molecular weight” and preferring molecular weights above 3,000,000, whereas the claims recite a molecular weight range of 600,000 to 900,000. See Ex. 1004, 4:25–31. Moreover, Petitioner has not shown that the cited prior art, alone or in combination, taught or suggested a film comprising both low and high molecular weight polyethylene oxide in the respective ranges recited by the claims, or with the specific percentage of the low molecular weight component required. The portions of Dr. Mumper’s declaration cited by Petitioner do not provide any further support for Petitioner’s position. We note that Dr. Mumper does not explain why the polyethylene oxides molecular weights limitation would have been obvious to a person of ordinary skill over the combined teachings of the prior art. Instead, Dr. Mumper opines only that the skilled artisan “would be highly motivated to vary the amounts of the low and high molecular weight polyethylene oxide to achieve the desired effects including, but not limited to drug solubility, mucoadhesion and drug release rate.” Ex. 1003 ¶ 30. That opinion does not address a skilled artisan’s motivation, ability, or reasonable expectation of successfully achieving a film comprising the specific ranges and proportion of low and high molecular weight polyethylene oxides required by the claims. See In re Fine, 837 F.2d at 1074 (a showing of obviousness must be supported by evidence, as shown by some objective teaching in the prior art or by knowledge generally available to one of ordinary skill in the art that would have led that individual to combine the relevant teachings of the references to arrive at the claimed invention).” slip op. at 10

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “The portions of Dr. Mumper’s declaration cited by Petitioner do not provide any further support for Petitioner’s position. We note that Dr. Mumper does not explain why the polyethylene oxides molecular weights limitation would have been obvious to a person of ordinary skill over the combined teachings of the prior art. Instead, Dr. Mumper opines only that the skilled artisan “would be highly motivated to vary the amounts of the low and high molecular weight polyethylene oxide to achieve the desired effects including, but not limited to drug solubility, mucoadhesion and drug release rate.” Ex. 1003 ¶ 30. That opinion does not address a skilled artisan’s motivation, ability, or reasonable expectation of successfully achieving a film comprising the specific ranges and proportion of low and high molecular weight polyethylene oxides required by the claims. See In re Fine, 837 F.2d at 1074 (a showing of obviousness must be supported by evidence, as shown by some objective teaching in the prior art or by knowledge generally available to one of ordinary skill in the art that would have led that individual to combine the relevant teachings of the references to arrive at the claimed invention).” slip op. at 11

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosure
  Patents in suitUS 8,017,150

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.