- Shanghai Hongene Biotech Corp. v. Chemgenes Corp.All claims unpatentablePTAB · Oct 17, 2024 · IPR2023-00862 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1 and 2 are unpatentable because Aerschot anticipates them.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedDecided for petitioner
“Patent Owner’s argument that Dr. Baran is principally experienced in P(V) chemistry presupposes that experience indicates an ignorance of P(III) chemistry. We do not find this position consistent with the breadth of Dr. Baran’s experience as indicated by his Curriculum Vitae. See Ex. 1003, 47–102. We weigh the testimonies of both Dr. Baran and Dr. Hrdlicka, against the cumulative weight of the evidence of record in assessing their credibility and probative value.” slip op. at 8
- Skill levelSkill level board ownOther
“The parties’ proposed definitions of the level of ordinary skill, although different facially, are similar substantively. For example, both parties argue that a POSA would have high levels of skill, with advanced degrees and/or extensive work experience in organic chemistry.3 See Pet. 12; PO Resp. 20–21. In addition, Petitioner contends that a POSA would have had experience in the development of oligonucleotide building blocks. Pet. 16. Similarly, Patent Owner asserts that a POSA would have had education and/or experience in “the development and syntheses of nucleosides, nucleotides, and nucleic acids.” PO Resp. 20–21. After considering the parties’ arguments and the prior art, we determine that a POSA would have had a Ph.D. (or equivalent degree) in organic chemistry or medicinal chemistry, with at least two to three 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. In addition, an individual with a Bachelor’s or Master’s degree and at least five years of work experience in these fields also would qualify as a POSA.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to address the construction of any claim term.” slip op. at 6
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“To show anticipation under 35 U.S.C. § 102, each and every claim element, arranged as in the claim, must be disclosed in a single piece of prior art. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359 (Fed. Cir. 2008). For a claim directed to a genus, if a prior art reference discloses a species falling within the claimed genus, the species anticipates the genus. In re Slayter, 276 F.2d 408, 411 (CCPA 1960); see also Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288, 1298 (Fed. Cir. 2009) (stating that when a claim element is written in Markush form, “the entire element is disclosed by the prior art if one alternative in the Markush group is in the prior art”).” slip op. at 5
Patent outcomesUS 8,541,569 unpatentableClaim construction§ 102 anticipationcites PhillipsPatents in suitUS 8,541,569 - 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 - PTAB · Jul 24, 2024 · IPR2024-00465 · APJ Bart A Gerstenblith · IPR · Institution
The Board instituted IPR on claims 1–24 on all petition grounds, finding a reasonable likelihood that Irwin renders at least one challenged claim obvious.
RulingsInstitution decision- Other 314aInstitution denied discretionary otherDenied
“Even assuming Linq3 is a real party in interest to Petitioner and assuming we may exercise our discretion to deny institution based on unclean hands (see Kavo Dental Techs, LLC v. Osseo Imaging, Inc., IPR2020-00659, Paper 10 at 19 (PTAB June 10, 2020)), Patent Owner essentially asks us to resolve multiple factual issues related to its contract dispute with Linq3 to justify denial of institution. See, e.g., Prelim. Resp. 1– 26. Many, if not all, of these issues appear to be involved in the contract dispute, which will be resolved by the Arizona state court. We are not in a good position to make determinations about these particular issues at this stage of the proceeding, on the limited record before us. Rather, we find that the state court is better suited to address the conduct of Linq3 of which Patent Owner complains. Accordingly, we leave these matters for the state court. To the extent Patent Owner seeks to pursue its argument that Linq3 is a real party in interest to Petitioner, even though no time bar under 35 U.S.C. § 315(b) has been asserted, Patent Owner may raise the issue of real party in interest again in its Patent Owner Response, and the parties may brief and argue the issue during trial.” slip op. at 10
- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Institution denied general plasticDenied
“We disagree. First, we agree with Patent Owner that the fact pattern presented here is not the typical situation in which the factors from General Plastic are considered. In particular, this proceeding challenges claims of a different patent than the patents at issue in PGR2020-00084 and IPR2023- 01235. Challenging claims of different patents significantly distinguishes the facts here from those in General Plastic, and we decline Patent Owner’s invitation to extend General Plastic in this regard. Accordingly, we do not exercise our discretion to deny institution.” slip op. at 11
- PTAB / AIA Trials › Real party in interest / privityNot reached
“Even assuming Linq3 is a real party in interest to Petitioner and assuming we may exercise our discretion to deny institution based on unclean hands (see Kavo Dental Techs, LLC v. Osseo Imaging, Inc., IPR2020-00659, Paper 10 at 19 (PTAB June 10, 2020)), Patent Owner essentially asks us to resolve multiple factual issues related to its contract dispute with Linq3 to justify denial of institution. See, e.g., Prelim. Resp. 1– 26. Many, if not all, of these issues appear to be involved in the contract dispute, which will be resolved by the Arizona state court. We are not in a good position to make determinations about these particular issues at this stage of the proceeding, on the limited record before us. Rather, we find that the state court is better suited to address the conduct of Linq3 of which Patent Owner complains. Accordingly, we leave these matters for the state court. To the extent Patent Owner seeks to pursue its argument that Linq3 is a real party in interest to Petitioner, even though no time bar under 35 U.S.C. § 315(b) has been asserted, Patent Owner may raise the issue of real party in interest again in its Patent Owner Response, and the parties may brief and argue the issue during trial.” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“5. Weighing the Graham Factors “Once all relevant facts are found, the ultimate legal determination [of obviousness] involves the weighing of the fact findings to conclude whether the claimed combination would have been obvious to an ordinary artisan.” Arctic Cat, 876 F.3d at 1361. On balance, considering the record presently before us, Petitioner has established a reasonable likelihood that it would prevail in showing that Irwin would have rendered the subject matter of claims 1–9 and 11–24 of the ’451 patent obvious to one of ordinary skill in the art at the time of the invention.” slip op. at 38
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,488,451 - PTAB · Jul 22, 2024 · IPR2024-00374 · APJ Jason M Repko · IPR · Institution
The Board instituted IPR on claims 1–10 and all asserted grounds because the petition showed a reasonable likelihood of prevailing on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“petition for inter partes review. Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2140 (2016). In determining whether to exercise that discretion on behalf of the Director, the Board considers an early trial date in related litigation, among other factors, as part of an assessment of all relevant circumstances of the case—including the merits—to balance considerations such as system efficiency, fairness, and patent quality. Fintiv, Paper 11 at 5. When the same prior art is submitted in district court and to the Board, there are “concerns of inefficiency and the possibility of conflicting decisions.” Id. at 12. Petitioner can mitigate those concerns by presenting a stipulation not to pursue in a parallel proceeding the same grounds or any grounds that” slip op. at 7
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“(2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. If a condition in the first part of the framework is satisfied and the petitioner fails to make a showing of material error, the Director generally will exercise discretion not to institute inter partes review.” slip op. at 9
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute an inter partes review, we must determine “that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). For the reasons discussed below, Petitioner has shown a reasonable likelihood that it would prevail with respect to at least one claim challenged in the Petition. Thus, we institute an inter partes review.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“engineering, electrical engineering, or a related field, and (2) at least two years of industry experience in digital video processing, or a related field.” Pet. 3 (citing Ex. 10035 ¶¶ 76–78). Petitioner also asserts that “[a]dditional graduate education could substitute for professional experience, and vice versa.” Id. Patent Owner uses the same skill level in its Preliminary Response. Prelim. Resp. 21. We also apply Petitioner’s proposed skill level in this Decision. Pet. 3.” slip op. at 13
Claim construction§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 8,090,025 - 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 - PTAB · Jul 18, 2024 · IPR2024-00327 · APJ Nathan A Engels · IPR · Institution
The Board instituted review of claims 1 and 2 on all petitioned grounds, finding a reasonable likelihood that Demircin renders claim 1 obvious.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a); see 37 C.F.R. § 42.108. Upon consideration of the evidence currently of record, we conclude that the information presented shows that there is a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one challenged claim of the ’303 patent.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“III. DISCRETIONARY DENIAL Patent Owner argues that we should exercise our discretion to deny the Petition based on the parallel district court litigation. Prelim. Resp. 33– 39 (citing Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 at 6 (PTAB Mar. 20, 2020) (precedential)). Petitioner, however, presented a Sotera stipulation.8 Pet. 76 (citing Ex. 1029). Thus, we do not exercise our discretion to deny institution here. See Katherine K. Vidal, Interim” slip op. at 17
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“3. Preliminary Analysis Regarding Claim 1 At this stage, we are persuaded by Petitioner’s contentions that the teachings of Demircin satisfy each limitation of claim 1. On the current record, we do not agree with Patent Owner’s arguments that Demircin does not satisfy the parties’ agreed construction. As cited by Petitioner (see, e.g., Pet. 33, 43), Demircin teaches that when additional bandwidth becomes available, NAL units that were previously discarded or only partially transmitted may be transmitted in a delayed manner (Ex. 1005 ¶¶ 34, 104– 128, Fig. 13, 14). We are currently persuaded that Demircin teaches or reasonably suggests that such delayed NAL units could be received out of order and would be rearranged, as claimed.” slip op. at 16
§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,986,303 - PTAB · Jul 18, 2024 · IPR2024-00372 · APJ Jason M Repko · IPR · Institution
The Board instituted review of claims 2–4 and 11 on all petition grounds, finding a reasonable likelihood that Samsung would show them unpatentable as obvious over Phek, Segall, Martins, and He.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“such as system efficiency, fairness, and patent quality. Fintiv, Paper 11 at 5. When the same prior art is submitted in district court and to the Board, there are “concerns of inefficiency and the possibility of conflicting decisions.” Id. at 12. Petitioner can mitigate those concerns by presenting a stipulation not to pursue in a parallel proceeding the same grounds or any grounds that could have reasonably been raised before the Board. Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 at 19 (PTAB Dec. 1, 2020) (precedential). Here, Petitioner has presented such a stipulation: if the Board grants institution, Petitioner “agrees not to pursue any grounds raised in the petition, or any grounds [Petitioner] could have reasonably raised in the petition, in [the] district court litigation or any parallel proceeding” Ex. 1028, 1. “Consistent with [Sotera], the PTAB will not discretionarily deny institution in view of parallel district court litigation where a petitioner presents a stipulation not to pursue in a parallel proceeding the same grounds or any grounds that could have reasonably been raised before the PTAB.” Katherine K. Vidal, Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (USPTO June 21, 2022).5 Thus, we decline to exercise our discretion to deny the Petition.” slip op. at 7
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“present arguments specifically directed to the subject matter recited in the rest of the claim. See Prelim. Resp. Even so, Petitioner has the burden to show that the challenged claims are unpatentable. Thus, we have reviewed Petitioner’s arguments and evidence submitted in connection with the remaining limitations and find them to be sufficient at this stage and on this record. From the current record, Petitioner has established a reasonable likelihood that it will prevail in demonstrating that claim 2 is unpatentable.” slip op. at 25
- Skill levelSkill level petitioner adoptedDecided for petitioner
“digital video processing, or a related field.” Pet. 3–4 (citing Ex. 10036 ¶¶ 123–125). Petitioner also asserts that “[a]dditional graduate education could substitute for professional experience, and vice versa.” Id. at 4. Patent Owner uses the same skill level in its Preliminary Response. Prelim. Resp. 13. We also apply Petitioner’s proposed skill level in this Decision.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Patent Owner’s arguments, however, are based on an implicit construction for the second resolution converter. See § II.D.5.c supra. For the reasons discussed below, we disagree with Patent Owner’s arguments and the implicit construction. See id. Apart from rejecting the implicit construction of the second resolution converter, we agree with the parties that no claim term needs to be construed in this Decision.” slip op. at 9
Claim construction§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 10,218,995 - 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
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.