- Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc.All claims unpatentablePTAB · Nov 27, 2024 · PGR2022-00025 · APJ Susan L C Mitchell · PGR · Final written decision
Claims 1–19 are unpatentable because the ’201 patent lacks written description support for the claimed genus of CRF1 receptor antagonists under § 112(a).
RulingsFinal written decision- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“[A] sufficient description of a genus instead requires the 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 (citing Regents, 119 F.3d at 1568–69). Moreover, “an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials.” Id. (citing Regents, 119 F.3d at 1568 (quoting Fiers, 984 F.2d at 1171)). Furthermore, “functional claim language can meet the written description requirement when the art has established a correlation between structure and function.” Id. (citing Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 964 (Fed. Cir. 2002) (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001))). “[M]erely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.” Id.” slip op. at 42
- 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 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. 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). C.” slip op. at 22
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“For these reasons, we do not find persuasive the testimony of Patent Owner’s expert, Dr. Dobs, that: By describing adjustments of dosing protocols to achieve an A4 reduction from baseline, and describing this use of tildacerfont as just one embodiment of the claimed use of the entire well-known, well-characterized, and discrete class, the specification reasonably conveyed to a POSA that the invention extended to the particularly claimed use of the entire recited class. Ex. 2014 ¶ 82. On the contrary, far from being a “well-known, well-characterized, and discrete class” the prior art teaches a heterogeneous assembly of different classes of small molecule CRF1 receptor antagonists (Type I, Type II, and “atypical”) displaying a very considerable variety of structures, both in terms of the core pharmacophore (e.g., monocyclic, bicyclic, tricyclic, phenolic, cyclohexyl amide, etc.) as well as in the various side groups. Moreover, the challenged claims recite only “a CRF1 receptor antagonist or a pharmaceutically acceptable salt thereof,” the scope of which also encompasses the much larger (and, according to Williams) much more effective large-molecule (peptide) CRF1 receptor antagonists, about which the Specification is entirely silent. See Ex. 1029, Abstr., 1065. Furthermore, despite Dr. Dobs’ testimony that “[t]he [prior art] references explain the typical CRF1 antagonist consists of a core nitrogen heterocycle with an aryl substituent adjacent to the core nitrogen atom and a branched alkyl group attached at the opposite end of the core,” Dr. Dobs also acknowledged that the “atypical CRF1 receptors depicted in Figures 11 and 12 of Williams had different structures, and lacked the nitrogen heterocyclic core.” Ex. 1042, 127:9–14, 130:13–131:16; see also Ex. 2014 ¶ 83. Additionally, Petitioner’s expert, Dr. Cutler, testified, by way of example, in his Reply Declaration that two of the ‘“first-generation CRF1 antagonists’ identified in Figure 1 of the Williams article do not fall within the Figure 2 structure Dr. Dobs relies upon.” Ex. 1047 ¶ 93. Indeed, with respect to the alleged core pharmacophore that Dr. Dobs” slip op. at 54
- ExcludeMotion to exclude, deniedMixed
“with chemical terminology”; “could not answer questions regarding the chemical structures in the prior art articles”; “did not know whether CRF1 receptor antagonists contained the structural features she deemed ‘essential’ in her Declaration”; and “agreed that tildacerfont has structurally unique features” (see Ex. 1042, 52–53, 125–126, 126–128, 128–130) goes to the weight that we assign to such testimony, but we do not find that such testimony, in light of Dr. Dobs’ extensive qualifications as an endocrinologist set forth above, deems Dr. Dobs unqualified to testify concerning the written description issue in this proceeding. For these reasons explained above, Petitioner’s Motion to Exclude Dr. Dobs’ written description opinions in paragraphs 20 and 75–87 of Exhibit 2014 is denied.” slip op. at 11
Patent outcomesUS 11,007,201 unpatentable§ 112 disclosurecites PhillipsPatents in suitUS 11,007,201 - Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc.All claims unpatentablePTAB · Nov 26, 2024 · PGR2021-00088 · APJ John G New · PGR · Final written decision
Claims 1–25 are unpatentable because the ’908 patent lacks written description support under § 112(a); the Board did not reach Grounds 1–3 or 5.
RulingsFinal written decision- ExcludeMotion to exclude, deniedMixed
“To the extent that Dr. Dobs has admitted that she is “not comfortable with chemical terminology”; “could not answer questions regarding the chemical structures in the prior art articles”; “did not know whether CRF1 receptor antagonists contained the structural features she deemed ‘essential’ in her Declaration”; and “agreed that tildacerfont has structurally unique features” (see Ex. 1038, 52–53, 125–126, 126–128, 128–130), we will weigh her testimony regarding those matters accordingly. However, for the reasons explained above, Petitioner’s Motion to Exclude Dr. Dobs’ written description opinions in paragraphs 19 and 80–91 of Exhibit 2014 is denied.” slip op. at 10
- Strike new argumentOther
“Analysis Patent Owner’s Exhibits 2020–2026 play no part in our reasoning and were not relied upon by the Board in reaching our Decision. Petitioner’s Motion to strike Exhibits 2020–2026 is therefore dismissed as moot.” slip op. at 23
- Skill levelSkill level petitioner adoptedDecided for petitioner
“typically possess 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. Pet. 60 (citing Ex. 1005 ¶ 34). Petitioner argues that such a person of ordinary skill would also have at least three years of experience conducting research concerning endocrine disorders, including CAH or other adrenal disorders. Id. Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. Because we find Petitioner’s definition to be consistent with the demonstrable level of skill in the art (see, e.g., Exs. 1009, 1025, 2003, 2004, 2005), and in the absence of a different proposed definition of the level of skill in the art by Patent Owner, we adopt Petitioner’s definition.” slip op. at 26
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“For these reasons, we do not find persuasive the testimony of Patent Owner’s expert, Dr. Dobs, that: By describing adjustments of dosing protocols to achieve at least a 10% reduction from baseline, and describing this use of tildacerfont as just one embodiment of the claimed use of the entire well-known, well-characterized, and discrete class, the specification reasonably conveyed to a POSA that the invention extended to the particularly claimed use of the entire recited class. Ex. 2014 ¶ 87. On the contrary, far from being a “well-known, well-characterized, and discrete class” the prior art teaches a heterogeneous assembly of different classes of small molecule CRF1 receptor antagonists (Type I, Type II, and “atypical”) displaying a very considerable variety of structures, both in terms of the core pharmacophore (e.g., monocyclic, bicyclic, tricyclic, phenolic, cyclohexyl amide, etc.) as well as in the various side groups. Moreover, the challenged claims recite only “a CRF1 receptor antagonist or a pharmaceutically acceptable salt thereof,” the scope of which also encompasses the much larger (and, according to Williams) much more effective large-molecule (peptide) CRF1 receptor antagonists, about which the Specification is entirely silent. See Ex. 1029, Abstr., 1065.” slip op. at 56
Patent outcomesUS 10,849,908 unpatentable§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,849,908 - Dexcom, Inc. v. Abbott Diabetes Care Inc.Institution deniedPTAB · Aug 8, 2024 · IPR2024-00520 · APJ John G New · IPR · Institution
The Board denied institution because Dexcom did not show a reasonable likelihood that claims 5–7 were unpatentable under either Stafford–Raymond ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Burden of Proof “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”)). Therefore, in an inter partes review, the burden of proof is on the Petitioner to show that the challenged claims are unpatentable; that burden never shifts to the patentee. See 35 U.S.C. § 316(e); In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016) (citing Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015)). At the institution stage, Petitioner must show a reasonable likelihood that it would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314.” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“We do not find these arguments persuasive. It may be so that Turner teaches that its recesses 77 receive rotation-restricting protrusions 71, which “extend[] into each recess 77 such that the recess side walls interfere with the protrusions to prevent rotation of the insertion device relative to body 20.” Ex. 1011 ¶ 69. And, it may also be so that Turner teaches this assembly as an advantage in that it prevents rotation of body 20. Id. However, Petitioner did not present this “design choice” theory of obviousness in the Petition. Petitioner first raises its “obvious design choice” argument with respect to Turner and Ground 2 in its Reply Brief; it is not to be found in its Petition.12 Petitioner cannot raise an argument in its” slip op. at 32
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“In each of the ’335 Specification, Stafford, Raymond, and Turner, the OBU is universally depicted as having a circular perimeter oriented around a longitudinal axis, and possessing either a cylindrical shape (’335 patent, Stafford, Raymond) or a roughly domed shape, with a circular, circumferential collar. See, e.g., Ex. 1001, Figs. 8, 17, 52, 54; Ex. 1009, Figs 3A–C, 4A; Ex. 1010, Figs. 14–16, Ex. 1011, Figs. 2A–B, 5G, 7A-B, 9, 11, 13A–B, 14, 15, 19, 20, 21, 25, 29, 30, 37, 38. Moreover, in each description of the location of recesses 3766 in the ’335 Specification, the recesses are described as being located “on the side walls” of the OBU. See Ex. 1001, col. 44, ll. 8–12; col. 45, ll. 61–64. Given the circular perimeter of all of these embodiments of the disclosures of the ’335 Specification, the teachings of Petitioner’s cited references, the dictionary definition of “periphery” as being “the perimeter of a circle or other closed curve,” and the ordinary meaning that the terms would have had to a skilled artisan at the time of the invention, in view of the ’335 Specification and file history” (Phillips, 415 F.3d at 1312–13), we conclude that a person of ordinary skill in the art would understand that the “plurality of recesses disposed on a periphery of the on body electronics unit housing” would be located “on the circumference of the on-body housing,” as we concluded in the ’01396 IPR Decision. See Dec. 48; see also Ex. 1001, col. 44, ll. 9–14 (stating that “gripping arms 3762 [of medical device carrier 3730] are provided with engagement boss 3764 which are configured to engage with corresponding recesses 3766 provided on the side walls of the on body housing 322”).” slip op. at 38
- Strike new argumentNew argument disregardedDecided for patent owner
“However, Petitioner did not present this “design choice” theory of obviousness in the Petition. Petitioner first raises its “obvious design choice” argument with respect to Turner and Ground 2 in its Reply Brief; it is not to be found in its Petition.12 Petitioner cannot raise an argument in its 12 The Petition makes a design choice argument with respect to the teachings of Raymond on Ground 1, contending that “it would have been an obvious design choice to implement two spaced-apart plural recesses on the housing—one to engage the protrusions on each of the two arms taught by Raymond.” Pet. 38. However, Petitioner adduced no prior art teaching or evidence of record of “spaced-apart plural recesses on the housing” that Reply Brief if that argument could first have been raised in its Petition. 37 C.F.R. § 42.23(b); see also L’Oréal USA, Inc. v. Univ. of Massachusetts, 2018 WL 4278992, *5 n.4 (PTAB Sept. 7, 2018); Matterport, Inc. v. Appliance Comp. III, Inc., 2021 WL 6340164, *9–10 (PTAB Nov. 19, 2021).” slip op. at 32
Claim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,266,335 - Shanghai Hongene Biotech Corp. v. Chemgenes Corp.All claims unpatentablePTAB · Jul 18, 2024 · IPR2023-00490 · APJ John G New · IPR · Final written decision
Claims 1–5 are unpatentable: claim 1 is anticipated by Reddy; claims 2–4 are obvious over the stated combinations; claim 5 is anticipated by Gaur.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“However, we prefer Patent Owner’s definition of the required 2–3 years of experience in “the development and syntheses of nucleosides, nucleotides, and nucleic acids, including, but not limited to, the syntheses of oligonucleotides through solid phase oligonucleotide synthesis (‘SPOS’)” to Petitioner’s more generalized requirement of having experience in “medicinal chemistry, synthetic organic chemistry, and nucleic acid chemistry, including the development of oligonucleotide therapeutics, diagnostics, or building blocks.” Both parties acknowledge that the level of skill in the art is very high. See, e.g., Resp. 17; Reply 2. We find that, to achieve a level of ordinary skill in the art, a person with the requisite educational background would require 2–3 years of experience for one possessing a doctorate in the relevant field, or 3–5 years for one with a lesser degree (to compensate for the additional educational experience gained by achieving a doctorate) in the specific techniques recited by Patent Owner. We reject the terminal clause “pursuant to P(III) chemistry” proposed by Patent Owner as redundant in that a person engaged for a number of years in “the development and syntheses of nucleosides, nucleotides, and nucleic acids” including SPOS, would likely have an operant knowledge of P(III) chemistry. Consequently we adopt the following definition of a person of ordinary skill in the art: “A person of ordinary skill in the art having a Ph.D. (or equivalent degree) in organic or medicinal chemistry, and 2 to 3 years of post-graduate work experience in the development and syntheses of nucleosides, nucleotides, and nucleic acids, including, but not limited to, the syntheses of oligonucleotides through solid phase oligonucleotide synthesis (‘SPOS’)” and, alternatively, “a person of ordinary skill in the art would have a Bachelor’s or Master’s degree in organic or medicinal chemistry who had at least 5 years of extensive work experience in these fields.”” slip op. at 12
- Expert testimonyPetitioner expert creditedDecided for petitioner
“As for Dr. Baran, we are not persuaded by Patent Owner’s argument that Dr. Baran is not sufficiently experienced or qualified to opine with respect to the claimed subject matter. A review of Dr. Baran’s extensive curriculum vitae (Ex. 1003, 79–137), indicates that he is deeply experienced and extensively published in the field of oligonucleotide synthesis. Patent Owner’s argument that Dr. Baran is principally experienced in P(V) techniques presupposes that experience in that technique indicates an ignorance of P(III) methodologies. We do not find this position consistent with the breadth of Dr. Baran’s C.V. We will weigh Dr. Baran’s testimony, and that of Dr. Hrdlicka, against the cumulative weight of the evidence of record in this inter partes review in assessing the credibility and probative value of their respective testimonies.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“Both parties agree that the terms of the challenged claims should be given the ordinary and customary meaning of such terms as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent. Pet. 17; PO Resp. 15 (both citing 37 C.F.R. § 42.100). Accordingly we see no need for explicitly construing any of the terms of the challenged claims beyond that standard.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Furthermore, both Petitioner and Patent Owner agree that clear errors exist in the wording of challenged claims 3–5. Both parties agree that a person of ordinary skill in the art would have recognized that the limitation reciting “where M is selected from the group consisting of succinyl, oxalyl, and hydroquinolynyl” should properly read “where M is selected from the group consisting of ethyl, oxalyl, and hydroquinolynyl.” Pet. 18–20; PO Resp. 15. Both parties further agree that the language of claim 5 mistakenly omits the italicized portions of the limitation reciting “NH is capable of being attached to a solid support with a spacer selected from the group consisting of C1–C20 alkyl, ethyloxyglycol, and a combination of alkyl and ethyleneglycoxy,” as is expressly recited in claims 3 and 4. Pet. 21–22 (citing Ex. 1003 ¶ 158); PO Resp. 15. We agree with both parties’ reasoning with respect to these errors, and we construe the claims as reciting the corrected language, such that claims 3–5 read, in relevant part “where M is selected from the group consisting of ethyl, oxalyl, and hydroquinolynyl” and claim 5 additionally reads “NH is capable of being attached to a solid support with a spacer selected from the group consisting of C1–C20 alkyl, ethyloxyglycol, and a combination of alkyl and ethyleneglycoxy.” See Fitbit, Inc. v. Valencell, Inc., 964 F.3d 1112, 1119–20 (Fed. Cir. 2020) (holding that the Board erred in not correcting a “conspicuous” and undisputed error in claim).” slip op. at 8
Patent outcomesUS 9,884,885 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,884,885 - Cala Health, Inc. v. Emkinetics Inc.All claims unpatentablePTAB · Jul 1, 2024 · IPR2023-00511 · APJ Jason W Melvin · IPR · Final written decision
Claims 1–8 are unpatentable: claims 1–3 and 6 based on Govier anticipation and Govier-Williams obviousness; claims 4, 5, 7, and 8 based on obviousness over Govier-Mumford and Govier-Williams-Mumford.
RulingsFinal written decision- BurdenFwd all claims unpatentableUnpatentable
“We conclude that Petitioner has proven by a preponderance of the evidence that the challenged claims are unpatentable.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS A. LEVEL OF ORDINARY SKILL IN THE ART Petitioner contends that a person of ordinary skill in the art “would have had an undergraduate degree in the field of biomedical engineering, or a related discipline, and at least two years of experience in the design and/or analysis of biomedical devices” and that “[a]dditional work experience could serve as a substitute for a formal degree and vice versa.” Pet. 10 (citing Ex. 1002 ¶ 23). Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the challenged patent and prior art, and we adopt it here.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“B. CLAIM CONSTRUCTION Petitioner argues that “no claim terms require express construction to resolve the challenges in this Petition.” Pet. 10. We agree and do not expressly construe any terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we 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 6
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Govier describes a study in which patients with overactive bladders were given “percutaneous electrical stimulations via a 34 gauge needle placed near the tibial nerve 3 finger breadths above the ankle.” Ex. 1005, 1193. Specifically, “[a] 34 gauge, solid stainless steel needle was advanced through the skin” and “the needle was advanced approximately 3 to 4 cm. posterior to the tibia and, if advanced further, would traverse anterior to the fibula.” Id. at 1194. Govier further explains that “[a]n electrocardiogram ground pad was placed over the medial aspect of the calcaneus” and “[a] stimulator was then connected to the needle and the ipsilateral ground pad.” Id. This arrangement is depicted in Govier’s Figure 3, which is reproduced below.” slip op. at 6
Patent outcomesUS 9,387,338 unpatentableClaim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 9,387,338 - Cala Health, Inc. v. Emkinetics Inc.All claims unpatentablePTAB · Jul 1, 2024 · IPR2023-00508 · APJ Jason W Melvin · IPR · Final written decision
Claims 1–8 are unpatentable as anticipated by Govier and obvious over Govier and Williams; the Board did not reach the additional grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS A. LEVEL OF ORDINARY SKILL IN THE ART Petitioner contends that a person of ordinary skill in the art “would have had an undergraduate degree in the field of biomedical engineering, or a related engineering discipline, and at least two years of experience in the design and/or analysis of biomedical devices” and that “[a]dditional work experience could serve as a substitute for an engineering degree.” Pet. 9–10 (citing Ex. 1002 ¶ 23). Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the challenged patent and prior art, and we adopt it here.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“B. CLAIM CONSTRUCTION Petitioner argues that “no claim terms require express construction to resolve the challenges in this Petition.” Pet. 10. We agree and do not expressly construe any terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we 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 6
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“We have reviewed Petitioner’s contentions and evidence and conclude that they prove anticipation of the challenged claims by Govier for the reasons given by Petitioner. Pet. 19–55.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableUnpatentable
“For claim 1, Petitioner asserts that, if Govier does not disclose applying an electrode patch to the outer surface of the skin, skilled artisans would have had reason to substitute Williams’s known electrode patch for Govier’s ground pad as a simple substitution of one known structure for another performing the same function—“creating a current path along the tibial nerve”—and yielding the same results—“ability to stimulate the tibial nerve to treat overactive bladder.” Id. at 21–24. Petitioner contends also that, if Govier does not disclose a controller including a pulse generator, skilled artisans would have had reason “to substitute Williams’s pulse generator for Govier’s stimulator.” Id. at 27–29. Petitioner reasons that skilled artisans would have found it obvious to try Williams’s pulse generator because of its similarities with Govier’s stimulator—“each create current pulses between 1–10 mA.” Id. at 28. Petitioner reasons further that using Williams’s pulse generator would have been a simple substitution. Id.” slip op. at 9
Patent outcomesUS 9,757,584 unpatentableClaim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 9,757,584 - Samsung Bioepis Co. Ltd. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jun 14, 2024 · IPR2023-00442 · APJ John G New · IPR · Final written decision
Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as obvious over Dixon because Dixon anticipates them.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“We adopt the same reasoning here, and conclude that the evidence of record and the Specification of the ’681 patent support construing the preamble’s recitation of a “method for treating a patient with an angiogenic eye disorder” as meaning administering a compound, i.e., the recited VEGF antagonist, to a patient for the purpose of improving or providing a beneficial effect in their angiogenic eye disorder. We find that, as in Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, although the claims “encompass a clinical result, they do not require such a result.” (emphasis added). 8 F.4th 1331, 1343 (Fed. Cir. 2021). We consequently reject Patent Owner’s proposed construction that the language of the preamble reciting a “method for treating an angiogenic eye disorder” requires not only an intent to treat, but, additionally, a high degree of efficacy on par with monthly Lucentis. See PO Resp. 9–10.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We adopt Petitioner’s proposed construction of the claim terms “initial dose,” “secondary dose,” and “tertiary dose.” Petitioner proposes adoption of the definitions expressly set forth in the Specification of the ’681 patent, viz., that the initial dose is the dose “administered at the beginning of the treatment regimen,” and is followed by the secondary doses that are “administered after the initial dose,” and the tertiary doses are “administered after the secondary doses” and may be distinguished from the secondary doses “in terms of frequency of administration.” Ex. 1001, col. 3, ll. 36–44. Patent Owner does not expressly dispute Petitioner’s construction, other than to argue that, by 2011, a person of ordinary skill in the art would have understood “initial” and “secondary” doses to correspond to loading doses and “tertiary” doses to correspond to maintenance doses. PO Resp. 13 (citing Ex. 2056 ¶ 66; Ex. 2349, 6–11. Patent Owner contends that the purpose (and expected effect) of loading doses was to achieve visual acuity gains and retina drying, and the goal of less frequent maintenance doses was to maintain the efficacy achieved with loading doses. Id. at 14 (citing Ex. 2056 ¶ 66). As we have explained above, we do not find persuasive Patent Owner’s argument that the definition of these terms requires a high, or otherwise defined, degree of efficacy. As we stated in the -00881 and -01225 Decisions: Based on those express definitions in the Specification, we do not find cause to construe the terms differently. In particular, we do not find that the Specification requires the “tertiary doses” to maintain any efficacy gain achieved after the initial and secondary doses, or that the term suggests any specific level of efficacy. The Specification unequivocally states that “[t]he terms ‘initial dose,’ ‘secondary doses,’ and ‘tertiary doses,’ refer to the temporal sequence of administration of the VEGF antagonist.”” slip op. at 18
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“If a claim limitation is directed to printed matter, the second step of the Praxair analysis is to determine whether the printed matter is functionally related to its “substrate.” Praxair, 890 F.3d at 1032. Printed matter that is functionally related to its substrate is given patentable weight. Id. (citing DiStefano, 808 F.3d at 850). However, “[w]here the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.” Id. (quoting In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004)). More specifically, printed matter is functionally related to its substrate when the language changes not mere thoughts or outcomes, but provides action steps that the method requires. See C R Bard Inc. v. AngioDynamics, Inc., 979 F.3d 1372, 1381 (Fed. Cir. 2020) (holding that the test for printed matter is whether it “merely informs people of the claimed information, or whether it instead interacts with the other elements of the claim to … cause a specific action in a claimed process.”); see also Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) (stating that language “is only a statement of purpose and intended result” where its “expression does not result in a manipulative difference in the steps of the claim”) (emphasis added).” slip op. at 21
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A Person of Ordinary Skill in the Art Petitioner notes that the Petitioner in the ’00881 IPR proposed that a person of ordinary skill in the art would have: (1) knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders; and (2) the ability to understand results and findings presented or published by others in the field. Pet. 17–18 (quoting -00881 IPR, Paper 94 at 9–10). Furthermore, it was asserted that such a person would typically have an advanced degree, such as an M.D. or Ph.D. (or equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field), with practical academic or medical experience in (i) developing treatments for angiogenic eye disorders, including through the use of VEGF antagonists, or (ii) treating of same, including through the use of VEGF antagonists. Id. at 18 (citing -00881 IPR Paper 94 at 10). Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. In the -01225 IPR, we adopted the same definition of a person of ordinary skill in the art for the challenged claims of the ’681 patent, concluding that that definition was consistent with the level of skill in the art. See -01225 IPR, Paper 96 at 52–53. Having previously adopted this definition of the level of skill in the art for the claims of the ’681 patent, we do so again in the present proceeding.” slip op. at 25
Patent outcomesUS 10,130,681 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,130,681 - Dexcom, Inc. v. Abbott Diabetes Care Inc.Institution deniedPTAB · Apr 16, 2024 · IPR2023-01397 · APJ John G New · IPR · Institution
The Board denied institution on all grounds because Dexcom did not show a reasonable likelihood that claims 1–4, 8, 9, and 11–27 were unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“We do not find Petitioner’s argument persuasive. Figure 29 is a “cross-sectional view,… of the insertion device” disclosed by Raymond. Ex. 1110 ¶ 55. Another view of base 122 is depicted in Raymond’s Figure 18, a detail of which is reproduced below: Detail of Figure 18 of Raymond showing base 122 As depicted in Figure 18, base 122 of Raymond’s device comprises a circular disk, with an annular ring on the proximal side. This view is consistent with the cross-sectional view of base 122 in Raymond’s Figure 29, reproduced below: Detail of Raymond’s Figure 29 depicting a cross-sectional view of base 122 The annular ring of base 122, as depicted in Raymond’s Figures 18 and 29 thus comprises, at most, a single recess encircling base 122 beneath the annular ring at the periphery of the base. As such, it neither teaches nor suggests “a plurality of recesses disposed on a periphery of the on-body electronics unit housing, wherein the plurality of recesses comprises a first recess in a spaced relation to a second recess,” as required by challenged claim 1 of the ’335 patent. Petitioner’s argument that Figures 20 and 30 of Raymond depict” slip op. at 29
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“Detail of Raymond’s Figure 29 depicting a cross-sectional view of base 122 The annular ring of base 122, as depicted in Raymond’s Figures 18 and 29 thus comprises, at most, a single recess encircling base 122 beneath the annular ring at the periphery of the base. As such, it neither teaches nor suggests “a plurality of recesses disposed on a periphery of the on-body electronics unit housing, wherein the plurality of recesses comprises a first recess in a spaced relation to a second recess,” as required by challenged claim 1 of the ’335 patent. Petitioner’s argument that Figures 20 and 30 of Raymond depict plural recesses in Raymond’s base 122 is based upon a false premise. See Pet. 37–38. The depiction of base 122 in these Figures is entirely consistent with the depiction of base 122 in Raymond’s Figure 18 as having an annular ring with a single recess situated beneath its rim. With respect to Petitioner’s argument that it would have been an obvious design choice to implement two spaced-apart plural recesses on the housing (see Pet. 38), neither Petitioner nor its Declarant, Dr. Fletcher, adduces any evidence beyond that conclusory statement. Id. at 38 (citing Ex. 1103 ¶ 70; Ex. 1110, Figs. 18, 25–27); Ex. 1003, 77. Petitioner makes no persuasive argument as to why a skilled artisan would substitute multiple recesses for a single annular ring, which seemingly serves the purpose of allowing base 122 to be held in position by base-retaining arms 1226. To the contrary, substituting multiple recesses in base 122 to engage retaining arms 1226, and ensuring that each retaining arm 1226 suitably engages each recess, would seem only to add needless complexity to the design, without producing a substantial benefit or improvement.” slip op. at 30
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Turner’s rotation-resisting recesses 77 are not located on the periphery of its body 20. Instead, they are disclosed as being located upon the upper surface of body 20, between its central axis and its edge, and are configured to receive rotation-resisting protrusions 71 of insertion device 70. This placement of rotation-resisting recesses 77 is depicted in Figure 9 of Turner, which is reproduced again below: Figure 9 of Turner is a perspective, exploded view of its fluid delivery system including body 20 and rotation-restricting recesses 77 We therefore find that Turner does not teach or suggest the limitation of challenged claim 1 (and all claims by their dependency) reciting “an on body electronics unit housing comprising a plurality of recesses disposed on a periphery of the on body electronics unit housing.” We further conclude that Petitioner provides no persuasive reason why a person of ordinary skill in the art would have been motivated to alter the location of Turner’s rotation-resisting recesses 77 from the upper surface to the circumferential periphery of body 20, because Turner and the ’335 patent teach that their respective recesses serve different functions. Turner teaches that:” slip op. at 47
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“Because we deny institution of inter partes review on the merits, we need not reach the parties’ arguments with respect to whether we should exercise our discretion and deny institution of inter partes review under Section 325(d). As we conclude in Sections IV.B.2.d and IV.C.2.c above, Petitioner has failed to meet its burden of showing a reasonable likelihood of demonstrating at trial that the challenged claims are unpatentable over the combination of Thomas and Raymond, or of Thomas, Raymond, and Turner. That remains true even if, arguendo, the Examiner materially erred in concluding that Thomas is not prior art to the ’335 patent, an issue upon 13 Thomas et al. (US 2010/0198034 A1, August 5, 2010) (“Thomas ’034”), Ex. 2101. 14 The publication date of the Thomas reference that is a basis of Grounds 1 and 2 in this inter partes review is August 12, 2010, one week after the publication of Thomas ’034. which we express no view. We consequently deny as moot Patent Owner’s request that we exercise our discretion under Section 325(d).” slip op. at 51
§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 11,266,335 - Dexcom, Inc. v. Abbott Diabetes Care Inc.Institution deniedPTAB · Apr 16, 2024 · IPR2023-01396 · APJ John G New · IPR · Institution
The Board denied institution on all grounds because Petitioner did not show a reasonable likelihood that claims 1–4, 8, 9, and 11–27 were unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Under 35 U.S.C. § 314, the Board “may not authorize an inter partes review to be instituted unless … the information presented in the petition … and any response … shows that there is a reasonable likelihood that the 1 The other Petition seeking inter partes review of challenged claims 1–4, 8, 9, and 11–27 of the ’335 patent is in Dexcom, Inc. v. Abbott Diabetes Care Inc., IPR2023-01397 (filed October 6, 2023). 2 Available at: https://www.uspto.gov/TrialPracticeGuideConsolidated. petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition, Patent Owner’s Preliminary Response, the Explanation, the Explanation Response, and the evidence of record as presently developed, we determine that the evidence presented fails to demonstrate a reasonable likelihood that Petitioner would ultimately prevail at trial in establishing the unpatentability of the challenged claims of the ’335 patent. We consequently deny institution of inter partes review.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“We further conclude that Petitioner provides no persuasive reason why a person of ordinary skill in the art would have been motivated to alter the location of Turner’s rotation-resisting recesses 77 from the upper surface of body 20 to the periphery of body 20, because Turner and the ’335 patent teach that their respective recesses serve different functions. Turner teaches that: Body 20 and insertion device 70 may be configured such that insertion device 70 cannot rotate with respect to body 20 when fully inserted in body 20. One manner of achieving this configuration comprises providing hub 74 with rotation-restricting protrusions 71, which extend in a downstream or downward direction from the main portion of insertion device hub 74, and by providing cap element 24 of body 20 with rotation-restricting recesses 77. When insertion device 70 is fully inserted in body 20, as shown in FIG. 3, at least a portion of each protrusion 71 extends into each recess 77 such that the recess side walls interfere with the protrusions to prevent rotation of the insertion device relative to body 20.” slip op. at 49
§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,266,335 - PTAB · Apr 15, 2024 · IPR2023-01409 · APJ Cynthia M Hardman · IPR · Institution
The Board instituted IPR on claims 1–30 and all eight asserted obviousness grounds, finding a reasonable likelihood that Stafford and Cote render at least one challenged claim obvious.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“that if “the record of the Office’s previous consideration of the art is not well developed or silent, then a petitioner may show the Office erred by overlooking something persuasive.” Advanced Bionics, IPR2019-01469, Paper 6 at 10. Although Petitioner did not specifically state that the Examiner erred in not rejecting the claims over the prior art asserted here, under the second part of the Advanced Bionics framework, based on our analysis of the current record as a whole, we find that Petitioner has “ma[d]e a showing of material error,” in fact, the Petition is premised on it. Advanced Bionics, IPR2019-01469, Paper 6 at 8–9. In particular, Petitioner shows that the Office erred by overlooking something persuasive, namely, the teachings of at least Stafford and Cote, as highlighted in Petitioner’s unpatentability grounds. See Pet. 5 (arguing that each of Cote and Brenneman “provides express teachings on inserters for on-body units that were not considered by the Examiner”), 20–84 (Ground 1). In the Reasons for Allowance, the Examiner stated that “[w]hile Brister (US 2006/0016700) teaches the bulk of the claimed limitations, it fails to teach a housing . . . and an inserter with a sharp” that extends through the housing as claimed. Ex. 1002, 977. Petitioner, however, sufficiently demonstrates for purposes of institution that Stafford and Cote disclose these limitations. See Pet. 33–84 (explaining why Stafford and Cote teach or suggest the limitations of the challenged claims); see also infra Section III.E (determining that, on the current record, Petitioner establishes a reasonable likelihood that the claims challenged in Ground 1 are unpatentable as obvious over Stafford and Cote). Based on the circumstances elucidated by the current record, we find that Petitioner adequately shows that the Examiner “misapprehend[ed] or overlook[ed] specific teachings” of at least Stafford and Cote that “impact patentability of the challenged claims.” Advanced Bionics, IPR2019-01469, Paper 6 at 8 n.9. That is, Petitioner shows that the Examiner materially erred by not applying at least Stafford and Cote in the manner Petitioner argues and as supported by Dr. Fletcher.” slip op. at 13
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“After considering the arguments and cited evidence of record, we find that for purposes of institution, Petitioner has demonstrated a reasonable likelihood that Stafford and Cote would have rendered claim 1 obvious. We have reviewed the arguments and evidence of record for claims 2–6, 9–14, 16–24, 27, 29, and 30 in Ground 1, and similarly find that for purposes of institution, Petitioner has demonstrated a reasonable likelihood that Stafford and Cote would have rendered these claims obvious. See Pet. 20–84; Ex. 1003 (Fletcher Decl.) ¶¶ 44–155. On this basis, we institute inter partes review of all challenged claims on all grounds in the Petition. See SAS Institute Inc., 138 S. Ct. at 1358; 37 C.F.R. § 42.108(a).” slip op. at 30
- Skill levelSkill level petitioner adoptedOther
“understanding of a person of ordinary skill in the art at the time the invention was made.11 See Graham, 383 U.S. at 17–18. Petitioner contends that a person of ordinary skill in the art would have had: a bachelor’s degree in bioengineering, mechanical engineering, electrical engineering, or a related subject, and one or more years of experience researching, developing, and/or designing insertable medical devices, including, e.g., systems for implanting wearable medical devices such as cannulas, infusion sets, and analyte sensors, or equivalent experience. Less work experience may be compensated by a higher level of education, such as a master’s degree, and vice versa. Pet. 10–11 (citing Ex. 1003 (Fletcher Decl.) ¶ 28). Patent Owner does not presently dispute Petitioner’s proposal or offer an alternative definition. See generally Prelim. Resp. 10 The record does not presently include any objective indicia of obviousness or nonobviousness. See generally Pet.; Prelim. Resp. 11 For purposes of this Decision, we apply a priority date of February 3, 2009. See supra 8 n.2. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 17
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither party proposes that any claim term requires an express construction. See Pet. 19; see generally Prelim. Resp. We find it unnecessary to construe any claim term to decide whether Petitioner satisfies the “reasonable likelihood” standard for instituting trial. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we 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))). Any final written decision entered in this case may include express claim constructions, or may include discussion of claim scope that differs from that provided in our analysis below. Any final claim constructions will be based on the full trial record.” slip op. at 18
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,202,591
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.