- PTAB · Jul 3, 2023 · PGR2023-00014 · APJ Georgianna W Braden · PGR · Institution
The Board instituted PGR on claims 1–5 and all asserted challenges, finding written description and enablement challenges met the threshold but the Harris–Xing obviousness challenge did not.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“Patent Owner’s argument is unpersuasive because the combination of Harris with Xing is not cumulative of Pavlakis, Harris-2015, and Damsky. Here the combination of Harris with Xing is argued in different ways compared to what was made to the Examiner. Additionally, we agree with Petitioner that Xing discloses information the Examiner indicated were absent from the prior art. See Ex. 1010, 14–15. For example, Xing teaches administering a therapeutically effective amount of an inhibitor of IL-15 or the IL-15 receptor is administered to the subject. Compare id. at 15, with Ex. 1007, 3. Xing also teaches that TM-β1-mediated blockade of CD122 prevented disease development and progression and that inhibiting IFN-γ production downstream of IL-15 through topical administration of JAK inhibitors effectively eliminated existing lesions. Thus, we do not find that the same or substantially the same arguments were presented previously to the Office, nor do we find that the same or substantially the same art was previously presented to the Office. Thus, the first part of the Advanced Bionics framework is not satisfied for Petitioner’s § 103 challenge, and we decline to exercise our discretion under 35 U.S.C. § 325(d) to deny institution of a trial proceeding on this challenge.” slip op. at 12
- Skill levelSkill level petitioner adoptedOther
“At this stage of the proceeding, Patent Owner does not assert a different level of skill in the art at the time of the alleged invention and uses Petitioner’s proposed level of skill. Prelim. Resp. 16. For the purposes of this Decision, we too adopt Petitioner’s level of ordinary skill in the art because it appears consistent with the problems addressed in the ’505 patent and the prior art of record.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningOther
“Both parties state that express claim construction is unnecessary at this stage of the proceeding and that all terms are to given their plain and ordinary meaning. Pet. 23; Prelim. Resp. 17. We agree. Construction is needed only for those terms “that are in controversy, and only to the extent necessary to resolve the controversy.” See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 terms for purposes of institution.” slip op. at 7
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review under 35 U.S.C. § 324 and 37 C.F.R. § 42.4. A post-grant review may not be instituted unless it is determined that “the information presented in the petition filed under section 321, 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.” 35 U.S.C. § 324 (2018); see also 37 C.F.R § 42.4(a) (2022) (“The Board institutes the trial on behalf of the Director.”). The “more likely than not” standard requires greater than 50% chance of prevailing. Consolidated Trial Practice Guide 58 (Nov. 2019), available at https://www.uspto.gov/TrialPracticeGuideConsolidated. For the reasons provided below and based on the record before us, we determine Petitioner has demonstrated that it is more likely than not that it would prevail in showing the unpatentability of at least one of the challenged claims. We decline to deny the Petition on a discretionary basis as requested by Patent Owner. Accordingly, we institute a post-grant review of the ’505 patent and all of the asserted challenges to patentability.” slip op. at 2
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,278,505 - PTAB · Jun 13, 2023 · IPR2023-00224 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–19 on all three asserted § 103 grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In an IPR, 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”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). slip op. at 13
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Contrary to Patent Owner’s assertion that Petitioner seeks to describe “a person of exceptional skill,” Petitioner’s proposed definition merely indicates that one of ordinary skill in the art would have “an understanding” of relevant techniques and methods in the art. See id. at 12; Pet. 8. In particular, we read the “understanding” language of Petitioner’s proposed definition to take into account the level of skill in the art as reflected in the prior art of record—including the asserted art and that cited on pages 12–14 of Patent Owner’s Preliminary Response. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). In addition to an understanding of the relevant art, the parties are, nonetheless, welcome to address at trial whether one of ordinary skill in the art would have had actual experience with next generation sequencing techniques, the analysis of NGS data, and/or some level of specialization in the field of bioinformatics.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“In considering the scope of “whole genome sequencing” we take particular note of the Specification’s distinction between whole genome sequencing and targeted sequencing of the exome or other sub-genomic regions (e.g., Ex. 1001, 5:38–59, 24:35–58), as well as the Specification’s acknowledgement that whole genome sequencing may encompass “low mean coverage regions” and “zero mean coverage regions,” (id. at 24:59–62, 28:33–42). In this respect, we find it pertinent that Leary’s PARE studies began with sheared genomic DNA, and presumably resulted in non-targeted, randomly-distributed sequencing reads throughout the genome.10 We also find it pertinent that Forshew, a contemporary of Leary, described the matepaired technique as employed in Leary’s PARE approach as whole genome sequencing. Ex. 1030, 10. In light of the evidence and argument presently of record, we preliminarily interpret “whole genome sequencing,” as used in claim step 1(b), to mean “a non-targeted approach to sequencing all or almost all of a genome.” The panel may reconsider on the more complete record developed at trial, whether one of ordinary skill in the art would have understood that Leary’s mate-paired / PARE approach to detecting genomic rearrangements to teach or suggest sequencing all or almost all of the genome. See Ex. 1020” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“More importantly, in determining obviousness, “a reference . . . is prior art for all that it teaches.” Beckman Instruments, Inc. v. LKB Produkter AB, 892 F.2d 1547, 1551 (Fed. Cir. 1989). Considering the comparison of serial tumor samples illustrated in Ley’s Figure 3, and the related testimony of Dr. Quackenbush (Ex. 1020 ¶¶ 81–82), we presently agree with Petitioner that one of ordinary skill in the art reading Ley, “would have been motivated to include known mutations (such as those derived from a database of known cancer mutations) in a panel of polymorphisms for serial monitoring at multiple time points; and (ii) that a POSA would have had a reasonable expectation of success in successfully monitoring such polymorphisms.” See Pet. 56–57. And to be clear, at this stage of the proceeding, Patent Owner presents no credible evidence of teaching away. For the reasons set forth with respect to Leary in Ground 1, and having further considered the arguments and evidence with respect to the combination of Leary and Ley in Ground 2, we determine that Petitioner has demonstrated a reasonable likelihood that claims 1–11 and 13–19 are unpatentable in view of Leary and Ley.” slip op. at 36
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,384,394 - PTAB · Jun 13, 2023 · IPR2023-00317 · APJ Robert A Pollock · IPR · Institution
The Board instituted inter partes review of claims 1–23 on all petitioned grounds after finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“record, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one challenged claim of the ’033 patent is unpatentable. We therefore institute trial on all challenged claims under the grounds raised in the Petition. See PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (indicating that a decision whether to institute an inter partes review “require[s] a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition.”); Guidance, 2–3; 37 C.F.R. § 42.108. At this stage of the proceeding, we have not made a final determination with respect to the patentability of any of the challenged claims.” slip op. at 40
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Contrary to Patent Owner’s assertion that Petitioner seeks to describe “a person of exceptional skill,” Petitioner’s proposed definition merely indicates that one of ordinary skill in the art would have “an understanding” of relevant techniques and methods in the art. See id. at 10; Pet. 6. In particular, we read the “understanding” language of Petitioner’s proposed definition to take into account the level of skill in the art as reflected in the prior art of record—including the asserted art and that cited on pages 10–12 of Patent Owner’s Preliminary Response. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). In addition to an understanding of the relevant art, the parties are, nonetheless, welcome to address at trial whether one of ordinary skill in the art would have had actual experience with next generation sequencing techniques, the analysis of NGS data, and/or some level of specialization in the field of bioinformatics.” slip op. at 16
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“In view of the above, we preliminarily conclude that one of ordinary skill reading the ’033 patent would understand that there is no discernable physical distinction between capture probes and amplification primers, and that Patent Owner’s functional distinction—hybridizing to target DNA so as to form subsets of molecules that are/are not hybridized—is a commonly desired trait for nucleotides used as in hybridization-based methods including PCR. Considering the argument and evidence presently of record, we agree with Petitioner that the claimed “capture probes” encompass, at a minimum,10 PCR primer capture probes and solution-based hybridization capture probes (e.g., biotinylated oligonucleotide baits).” slip op. at 24
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Forshew’s capture probes hybridize to a plurality of polymorphisms because, upon replication, its PCR primers hybridize to DNA fragments containing a plurality of polymorphisms, for example, known point mutations in cancer-related genes. Patent owner, by contrast, more narrowly interprets claim step 1a as requiring that, absent replication, the nucleotide sequence of Forshew’s PCR primers must, encompass and hybridize to, polymorphic target sites. This issue may benefit from further exploration at trial. For the purpose of institution, however, we rely on Dr. Quackenbush’s testimony that one of ordinary skill in the art would have “understood that Forshew’s PCR primer capture probes are the claimed ‘capture probes’ because they are nucleic acid sequences that ‘hybridize to’ the complementary sequences on the nucleic acid harboring the polymorphic gene.” Ex. 2020 ¶ 121; see also id. ¶¶ 119–120, 122–123.” slip op. at 26
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,408,033 - PTAB · Apr 19, 2023 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted review on all challenged claims and the sole anticipation ground: claims 1–4, 8–14, and 18–26, with a reasonable likelihood of unpatentability except claim 19.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denialInstitutedDenied
“This case differs from other situations where the Board has exercised discretion under § 314(a) to deny institution. For example, we are not presented with a later-filed petition after having considered an earlier-filed petition challenging the same patent. See, e.g., General Plastic Indus. Co., Ltd. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19, 6–11, 15–22 (PTAB Sept. 6, 2017) (precedential)). This is the first petition filed against this patent and contains only a single ground. Also, as Petitioner asserts, and Patent Owner does not contest, the Fintiv factors are neutral or favor institution. See Pet. 61–63. Instead, Patent Owner asks us to deny institution because Petitioner” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 6 and 35 U.S.C. § 314, which provides that an inter partes review may not be instituted unless the information presented in the Petition “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.” A decision to institute under § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). In addition, if the Board institutes trial, it will “institute on all grounds in the petition.” PTAB Consolidated Trial Practice Guide, 5–6 (Nov. 2019); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). Having considered the arguments and evidence presented in the Petition and the Preliminary Response, for the reasons described below, we institute inter partes review.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“VIII. LEVEL OF ORDINARY SKILL IN THE ART Petitioner asserts A person of ordinary skill in the art (“POSA”) in the field of the patent between 2012 and 2021 would have held an MD with experience in clinical oncology or pharmacology; a PhD in pharmacology, pharmaceutical chemistry, cancer biology, or a related discipline; or a PharmD with experience in clinical oncology. Ex. 1020 ¶ 29. A POSA would also have practical working knowledge of oncology (Ex. 1020 ¶ 29) and experience with the design of studies necessary for drug development. This description is approximate, and additional experience could make up for less education and vice versa. Ex. 1020 ¶ 29. Pet. 15–16. Patent Owner asserts “that a POSA for purposes of the ’087 Patent would have had at least an M.D. and several years of experience treating patients with hematological malignancies (i.e., blood cancers).” Prelim. Resp. 13. Patent Owner asserts “Petitioner’s definition fails to require experience specific to hematological malignancies or blood cancers. Patent Owners’ definition of a POSA, on the other hand, accounts for the claims’ focus on lymphoma and leukemia.” Id. at 14. At this stage in the proceeding, we find that Patent Owner’s analysis more precisely establishes the level of ordinary skill in the art as it directly relates to those deciding prescribing information based on the prior art reference. See Ex. 1011, 2. The level of ordinary skill in the art usually is evidenced by the prior art references themselves. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995).” slip op. at 5
- Disclosure Requirements (§112) › Written description (Ariad)Entitled to earlier dateNot entitled to earlier dateMixed
“reasonable likelihood that claims 1 and 9 are not entitled benefit of priority to the ’087 or earlier priority Specifications prior to the publication of the November 2018 Venclexta label. Claim 1, for example, recites a GDC-0199 dosing regimen “compris[ing] a dose of 100 mg of GDC-0199 per day, followed by orally administering to the patient a dose of 200 mg of GDC- 0199 per day, followed by orally administering to the patient a dose of 400 mg of GDC-0199 per day.” This disclosure is not found in a single example, but must be selected from disparate parts of the Specification. “The written description requirement is not met when, as here, the specification provides at best disparate disclosures that an artisan might have been able to combine in order to make the claimed invention.” Flash-Control, LLC v. Intel Corp., 2021 WL 2944592 4 (Fed Cir. 2021) (citing Ariad, 598 F.3d at 1352.)” slip op. at 22
§ 102 anticipation§ 112 disclosureDiscretionary denialPatents in suitUS 11,110,087 - PTAB · Mar 22, 2023 · IPR2023-00566 · APJ John G New · IPR · Institution
The Board instituted review of claims 1–9, 34–39, 41–43, and 45 on seven grounds and granted Samsung Bioepis’s motion to join the Mylan IPR.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Samsung’s Petition is substantially identical to Mylan’s Petition, challenging the same patent and claims, based on the same grounds of unpatentability, and relying upon the same evidence (including the same prior art combinations supported by the same expert declaration) as the Mylan IPR. See Mot. 1. Petitioner seeks only institution of the same claims and grounds for which the Board instituted in the Mylan IPR. Id.” slip op. at 4
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“institution of the Mylan IPR, as required by 37 C.F.R. § 42.122(b). In the motion, Petitioner explains that: Samsung Bioepis further stipulates herein that if joinder is granted, it will take a limited “understudy” role in the same manner previously found to support joinder so long as Mylan remains an active party. Joinder thus creates no additional burden for the Patent Trial and Appeal Board (the “Board”), Mylan, or Patent Owner. Nor will it impact the schedule of the Mylan IPR.” slip op. at 6
NonePatents in suitUS 10,888,601 - PTAB · Mar 22, 2023 · IPR2023-00533 · APJ John G New · IPR · Institution
The Board instituted inter partes review of claims 1–9, 34–39, 41–43, and 45 on the seven grounds instituted in the Mylan IPR, and granted Celltrion’s motion for joinder.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In view of these representations by Petitioner, and having reviewed the Celltrion Petition, we determine that, under the current circumstances, it is appropriate to exercise our discretion to institute inter partes review of the challenged claims based upon the same grounds authorized and for the same reasons discussed in our Institution Decision in the Mylan IPR. See Mylan IPR, Paper 21.” slip op. at 5
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Having considered the unopposed motion for joinder, and our decision to institute the same grounds in the Mylan IPR, we determine that Petitioner Celltrion has established persuasively that joinder is appropriate and will have little to no impact on the timing, cost, or presentation of the trial on the instituted ground. Thus, in consideration of the foregoing, and in the manner set forth in the following Order, the Motion for Joinder is GRANTED.” slip op. at 6
NonePatents in suitUS 10,888,601 - PTAB · Mar 22, 2023 · IPR2023-00532 · APJ John G New · IPR · Institution
The Board instituted review of claims 1, 3–11, 13, 14, 16–24, and 26 on six anticipation and obviousness grounds, and granted Celltrion’s motion to join the Mylan IPR.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In view of these representations by Petitioner, and having reviewed the Celltrion Petition, we determine that, under the current circumstances, it is appropriate to exercise our discretion to institute inter partes review of the challenged claims based upon the same grounds authorized and for the same reasons discussed in our Institution Decision in the Mylan IPR. See Mylan IPR, Paper 21.” slip op. at 5
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“(c) JOINDER. — If the Director institutes an inter partes review, the Director, in his or her discretion, may join as a party to that inter partes review any person who properly files a petition under section 311 that the Director, after receiving a preliminary response under section 313 or the expiration of the time for filing such a response, determines warrants the institution of an inter partes review under section 314. As the moving party, Petitioner bears the burden of proving that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). A motion for joinder should: Set forth the reasons joinder is appropriate; identify any new grounds of unpatentability asserted in the petition; and explain what impact (if any) joinder would have on the trial schedule for the existing review. See Kyocera Corp. v. Softview, LLC, IPR2013-00004, Paper 15 at 4 (PTAB” slip op. at 5
NonePatents in suitUS 10,130,681 - PTAB · Feb 10, 2023 · IPR2022-01440 · APJ Erica A Franklin · IPR · Institution
The Board instituted IPR on claims 1–19 based on all asserted grounds, finding a reasonable likelihood that the petitioner would prevail on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted unless there is a reasonable likelihood that the petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314(a). Upon considering the parties’ arguments and evidence, we determine that Petitioner has demonstrated a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of claims 1–19 of the ’133 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art (“POSA” or “POSITA”) would have had: a Masters or a Ph.D. degree in nutritional science, chemistry, biology, biochemistry, or a related discipline or an M.D. or doctor of optometry (“O.D.”), and a few years of practical experience in the nutritional supplement area, including an understanding of formulations that could be considered for promoting eye health, including preventing or treating eye disorders such as macular degeneration. Alternatively, such a person could have been a person with a Bachelor’s degree with a greater number of years of experience. The POSITA would have, or would have access to, general information regarding eye health and eye disorders, the convenience and needs of patients who suffer from eye disorders[,] such as macular 5 Lang, WO 01/19383 A1, published Mar. 22, 2001 (Ex. 1009, “Lang”). 6 Brown et al., Nutrition Supplements and the Eye, 12 EYE 127–33 (1998) (Ex. 1014, “Brown”). degeneration, and background information. To the extent needed, the POSITA would have collaborated with others having ordinary skill in the areas pertinent to the subject matter of the ’133 Patent. Pet. 8–9 (citing Ex. 1024 ¶¶ 15–16) (citations omitted). This definition by Petitioner is uncontested on the current record. See Prelim. Resp. 7–8. Because we find Petitioner’s definition to be reasonable and consistent with the ’133 patent and the cited art, we adopt it for purposes of this Decision.” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“1. “substantially free of meso-zeaxanthin stereoisomers” Independent claims 1, 14, and 19 recite that the zeaxanthin is “present in the 3R-3R' stereoisomer form and is substantially free of meso-zeaxanthin stereoisomers.” Claims 1, 14, 19 (emphasis added). Petitioner contend that the term “substantially free of meso-zeaxanthin stereoisomers” should have its plain and ordinary meaning, and a POSA would have understood the term to mean that the zeaxanthin that is present in the 3R-3R' stereoisomer form is “largely but not wholly free of meso-zeaxanthin stereoisomers.” Pet. 25– 26 (emphasis removed) (citing Ex. 1024 ¶ 70; Ex. 1031, 3). The Board adopted, preliminarily, this construction by Petitioner in the Institution Decisions in the -0089 IPR and -1029 IPR. -0089 IPR, Paper 7 at 9–10; -1029 IPR, Paper 6 at 8–9. At this stage of the proceeding, we adopt Petitioner’s proposed construction as consistent with the plain and ordinary meaning of the term and the prior decisions in the -0089 IPR and -1029 IPR.” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“We begin by noting that the challenged claims do not recite that the nutritional supplements are “free of Vitamin A” or “free of all sources of Vitamin A.” Rather, independent claim 1 expressly recites that the supplement is “free of beta-carotene.” See Claim 1. Patent Owner urges us to expand the exclusion of beta-carotene to all forms of Vitamin A. That argument, however, lacks support on the current record. In particular, the support asserted by Patent Owner and its expert, Dr. Dorey, that “nutritional supplements include beta-carotene as Vitamin A equivalent,” see Prelim. Resp. 9–10 (citing Ex. 2001 ¶ 19), establishes little, on its own. Barker does not require the use of beta-carotene as its source of Vitamin A, nor does it limit the source or form of Vitamin A used. Rather, Barker discloses that several “[e]xamples of compounds having vitamin Aactivity or precursors thereof are retinol and esters thereof, such as retinyl palmitate; α- and β-carotene, β-cryptoxanthin, and lycopene.” Ex. 1011, 2:11–13. Thus, Barker discloses a number of exemplary compounds to supply Vitamin A to its nutritional supplement that are not beta-carotene. Accordingly, based on the current record, we disagree with Patent Owner’s argument that the challenged claims exclude all forms of Vitamin A and that Barker, therefore fails to anticipate those claims. Having considered the arguments and evidence at this stage in the proceeding, we are persuaded that Petitioner has shown sufficiently for institution that Barker discloses a nutritional supplement that is “free of beta-carotene.” Therefore, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing in showing that claims 1, 2, 5, and 9–12 are anticipated by Barker.” slip op. at 11
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,173,133 - Apple Inc. v. Masimo CorporationInstitutedPTAB · Feb 1, 2023 · IPR2022-01299 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–30 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Because Petitioner has demonstrated a reasonable likelihood that at least one claim of the ’127 patent is unpatentable, we institute an inter partes review of all challenged claims on each of the Grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”); see also Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018).1 A.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not address the above definitions in its Preliminary Response but its expert, Mr. Goldberg, disagrees with Petitioner’s first definition insofar as it requires an academic discipline emphasizing both electrical and thermal technologies. Ex. 2051 ¶ 16. In this respect, Mr. Goldberg states that “he is unaware of such an academic discipline being available, whereas, Petitioner’s expert, Dr. Anthony, appears to assert that he has worked with “many such persons.” Cf. Ex. 2051 ¶ 16 with Ex. 1003 ¶ 21. Mr. Goldberg states that one of ordinary skill in the art would have had a Bachelor of Science degree in an academic discipline emphasizing the design of electrical systems, in combination with training or at least one to two years of related work experience with thermal management of electrical systems and capture and processing of data or information, including physiological monitoring technologies. Alternatively, the person could have had a Master of Science degree in a relevant academic discipline with less than a year of related work experience in the same discipline. Ex. 2051 ¶ 16. Despite providing an alternative definition of one of ordinary skill in the art, Mr. Goldberg indicates that his opinions with respect to the applied. Id. On the current record, we accept Petitioner’s proposed definitions, as” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“At this stage of the proceeding, we find the language “to reliably estimate LED wavelengths” and “used to estimate wavelengths of multiple LEDs” descriptive of intended use of the underlying terms rather than descriptive of what they are. Although Patent Owner points to evidence that certain embodiments of the ’127 patent use “thermal mass” and “bulk temperature” in the manner described in Patent Owner’s proposed constructions, we decline to import these use limitations into the claim terms. See In re Prater, 415 F.2d 1393, 1404–05 (CCPA 1969) Reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from reading limitations of the specification into a claim, to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim. We further note that Patent Owner fails to evidence the meets and bounds of “reliably estimate[ing] LED wavelengths,” such that the construction appears indefinite. In this respect, we note the Specification’s teaching that some embodiments include “a relatively significant thermal mass, which stabilizes and normalizes the bulk temperature so that the thermistor measurement of bulk temperature is meaningful.” Ex. 1001, 10:62–11:4. Considering the intrinsic evidence, we understand a “meaningful” temperature reading in the context of the ’127 patent to be one on a scale relevant to estimating LED wavelengths. aspects of construction upon which the parties appear to agree (see e.g., Prelim. Resp. 24 (citing Ex. 1012, 213)), we provisionally construe “thermal mass” as a mass having resistance to temperature change on a scale relevant to estimating LED wavelengths, and “bulk temperature” as a temperature representative of all or substantially all of a thermal mass.” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“With respect to motivation to combine, Petitioner posits that one of ordinary skill in the art would have been motivated “to implement a thermal core as suggested by Chadwick in Yamada’s board/substrate 15” to achieve various benefits, such as to “reduc[e] the amount of heat transmitted to the patient and increasing the ‘exposure time’ by which the patient can don the sensor without discomfort or heat-related safety concerns,” and/or “mitigate heat-induced spectral shifts in the wavelengths of light emitted by LEDs” Pet. 15–18; Ex. 1003 ¶¶ 42–48. With respect to the first of these, Patent Owner argues that motivation is lacking because Chadwick’s metal core heat (citing Ex. Parte Burns, Appeal No. 2016-00351, 2017 WL 2132361, *2 (PTAB Apr. 28, 2017)). This would appear contrary to Patent Owner’s assertions that “Yamada provides no discussion regarding the purpose, function, or use of substrate 15,” whereas the purpose of Chadwick’s metal core is to dissipate heat and act “as a heat sink to cool the electronics.” Prelim. Resp. 35, 37 (citations omitted). As such, we do not find Patent Owner’s argument availing. With respect to Petitioner’s argument that one of ordinary skill in the art would have been motivated to combine Chadwick and Yamada to “mitigate heat-induced spectral shifts in the wavelengths of light emitted by LEDs,” Patent Owner argues that “the claimed invention does not reduce wavelength shift; in fact, the ’127 patent accepts wavelength shift and provides a solution to compensate for it.” Prelim. Resp. 42. Accordingly, Patent Owner asserts, motivation is lacking because “[r]educing wavelength shift points in a different direction from the invention.” Id. at 43 (citing Ex. 2051 ¶ 80. This argument is also unavailing because, on the current record, claim 7 does require a solution to compensate for wavelength shift. See Section II.C.2, above. Accordingly, Petitioner’s proposed motivation does not “point[] in a different direction,” as Patent Owner contends. Patent Owner similarly argues that Petitioner has not shown a reasonable expectation of success because “[t]here is no evidence anyone before the inventors would have expected that a thermal mass could be designed to provide a bulk temperature to reliably estimate multiple LED wavelengths.” Again, Patent Owner’s argument is predicated on Patent Owner’s interpretation of claim 7, which we disagree with on the current record for the reasons provided above. See Section II.C.1–2. We do not read Moreover, as explained more fully above, LED wavelength has a known relationship to temperature and Petitioner has reasonably shown that LEDs of the Yamada/Chadwick combination would be thermally coupled to the thermal core, and thus dependent on the bulk temperature of the thermal core.” slip op. at 28
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 7,761,127 - PTAB · Jan 11, 2023 · IPR2022-01225 · APJ John G New · IPR · Institution
The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood that claim 1 is anticipated by Dixon because the exclusion criteria likely lack patentable weight.
RulingsInstitution decision- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Decision. See Ex. 3001, 12–23. In the -00881 Decision, challenged claim 1 of US 9,254,338 B2 (the “’338 patent”) recited preamble language identical to that recited in claim 1 of the ’681 patent, viz., “a method for treating an angiogenic eye disorder in a patient.” See Ex. 1001 col. 21, ll. 40–41; Ex. 3001, 7. The Board found that this preamble was limiting upon the remainder of the claim. Ex. 3001, 18. Specifically, the Board found that: Here, the claims are directed to methods of administering, i.e., using, a VEGF antagonist for an intended purpose of “treating an angiogenic eye disorder in a patient.” The Specification repeatedly characterizes the method as one for treating angiogenic eye disorders in patients. Apart from the preamble, the independent claims do not elsewhere recite or indicate any other use for the method steps comprising the administration of a VEGF antagonist. Thus, we determine that the preamble sets forth the essence of the invention—treating an angiogenic eye disorder in a patient. Additionally, we find that the preamble provides antecedent basis for claim terms “the patient” recited in the body of each independent claim, and “angiogenic eye disorders” recited in dependent claims 6, 7, 18, and 20. Indeed, without the preamble, it would be unclear to whom the doses of VEGF are administered. Thus, … in view of the evidence of record, namely, the claim language and the written description of the ’338 patent, we find that the preambles of method claims 1 and 14 are limiting insofar as they require “treating an angiogenic eye disorder in a patient.” Id. at 17–18 (citations omitted). We adopt this same reasoning here and find, for the purposes of this Decision, that the preamble of claim 1 reciting “[a] method for treating an angiogenic eye disorder in a patient” is limiting upon the claims.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“[W]hen the Specification explains that “[t]he amount of VEGF antagonist administered to the patient in each dose is, in most cases, a therapeutically effective amount,” and discloses that “a therapeutically effective amount can be from about 0.05 mg to about 5 mg,” we find that a POSA would have understood that any dosage amount within that range administered according to the invention may, in some cases, result in a detectable improvement in “one or more symptoms or indicia of an angiogenic eye disorder,” or be one that “inhibits, prevents, lessens or delays the progression of an angiogenic eye disorder,” or it may not. In either event, the VEGF antagonist would have been administered for the purpose of treating the eye disorder. In other words, the method of treating the patient with the eye disorder is performed upon administration of the VEGF antagonist to the patient for the purpose of achieving an improvement or beneficial effect in the eye disorder, regardless whether the dosage amount administered actually achieves that intended result. Id. at 21–22 (citation omitted). Furthermore, the Board found that: Patent Owner’s proposes that the claims require not only achieving a therapeutically effective result, but more specifically, achieving a “high level of efficacy that was noninferior to the standard of care by the time the patent was filed in 2011.” In the Sur-reply, Patent Owner describes a “highly effective treatment for angiogenic eye disorders” as “one that is on par to Lucentis or off-label Avastin and can produce visual acuity gains, not just slow vision losses.” The Specification refers to “a high level of efficacy” in one instance, i.e., in the “Background” section. The Specification does not describe there, or elsewhere that “treating,” in the context of the claims or in the art, requires achieving a “high level of efficacy” or providing results “on par to Lucentis or off-label Avastin.” Id. at 22 (citations omitted). We adopt the same reasoning here, and find that, for the purposes of this Decision, the evidence of record and the Specification 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 such patient for the purpose of improving or providing a beneficial effect in their angiogenic eye disorder, but does not require a “high level of efficacy,” as proposed by Patent Owner. See Ex. 3001, 22.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“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 “secondary doses” 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. We do not find persuasive Patent Owner’s argument that the definition of these terms require a high, or otherwise defined, degree of efficacy. As we stated in the -00881 Decision: 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.” Ex. 3001, 25 (emphasis added). We see no need or reason to upend this construction now and, for the purposes of this Decision, we adopt Petitioner’s proposed definition of the claim terms “initial dose,” “secondary doses,” and “tertiary doses” as the express definition provided by the ’681 Specification.” slip op. at 13
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted
“Claim(s) 35 U.S.C. § Reference(s)/Basis Challenged 4 1, 3–11, 13, 14, 103 Dixon alone or in view of 16–24, 26 Papadopoulos5 and/or Wiegand6 5 1, 3–11, 13, 14, 103 Dixon in combination 16–24, 26 with Rosenfeld-20067, and if necessary, Papadopoulos patent and/or Wiegand 6 1, 3–11, 13, 14, 103 Dixon in combination 16–24, 26 with Heimann-2007, and if necessary, Papadopoulos and/or Wiegand” slip op. at 5
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents 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.