- PTAB · Sep 27, 2024 · IPR2024-00650 · APJ Deborah Katz · IPR · Institution
The Board instituted IPR of claims 1–38 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
“Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 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). We determine whether to institute an inter partes review on behalf of the Director. See 37 C.F.R. § 42.4(a).” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“determined to be microsatellite instability high or DNA mismatch repair deficient were placed into a study arm and then treated with pembrolizumab. (See Ex. 1005, Ex. 1003 ¶¶ 60–73.) Because treatment of the patients was performed only after MSI-H status was determined, the MSI-H Study Record teaches treating the patients “in response to” determining their MSI- H status.” slip op. at 15
- Obviousness (§103) › Motivation to combine / reasonable expectation of successInstituted
“have been expected, Petitioner cites to Brown as teaching that PD-1 inhibitors are inherently more effective when treating tumors comprised of cells that are easy for immune cells to recognize. (See Pet. 41 (citing Ex. 1034, 747).) Petitioner argues further that Duval teaches that MSI-H cancers have cells that are easy for immune cells to recognize. (See Pet. 41 (citing Ex. 1087, 5002).) Dr. Neugut’s testimony supports Petitioner’s argument that the cited teachings of Brown and Duval, as well as other references, would have motivated a person of ordinary skill in the art to obtain the results of the MSI-H Study Record. (See Ex. 1003 ¶¶ 124, 130, 132; see Pet. 41.) Petitioner argues further that Brown and Duval would have motivated one of ordinary skill in the art to obtain the results of the MSI-H Study Record by treating patients with common types of MSI-H cancers, including endometrial, small bowel, and gastric cancers. (See Pet. 41 (citing Ex. 1003 ¶ 130).) Petitioner argues further that the state of the art, as demonstrated by Brown and Duval, as well as other references, would have provided one of ordinary skill in the art with a reasonable expectation of success because physicians were successfully treating patients with cancers that were known to be MSI-H with PD-1 inhibitors. (See Pet. 42 (citing Ex. 1003 ¶¶ 131, 132).)” slip op. at 18
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner argues that one of ordinary skill in the art relevant to the ’219 patent would have been a medical doctor or a professional in a related field with at least five years of experience with treating cancer. (See Pet. 11 (citing Neugut Decl., Ex. 1003 ¶19).) Petitioner argues further that the ordinarily skilled artisan would have experience in or access to a person with knowledge of clinical studies for therapeutics and how they work and to a pathologist with comparable experience. (See id.) Dr. Neugut’s testimony supports Petitioner’s arguments regarding the level of skill that an ordinarily skilled artisan in the relevant field would have. (See Ex. 1003 ¶ 19.) Accordingly, in the analysis below, and in the absence of argument by Patent Owner to the contrary, we apply the level of skill set forth by Petitioner and refer to Dr. Neugut’s testimony of what one of ordinary skill in the art would have understood at the time the application that became the ’491 patent was filed, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 8
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,634,491 - PTAB · Sep 10, 2024 · IPR2024-00563 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on claims 1, 12, and 28 because Petitioner showed a reasonable likelihood of prevailing on obviousness over Gil, Norden, Dean, Alphagan, and Federal Register.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“partes review, “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Our § 325(d) analysis employs a two-prong framework: (1) whether the arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential). “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.” Id. at 8–9. “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9.” slip op. at 17
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“the District of New Jersey is more than three years, argues that “a trial may not be held until 2026—well after a FWD would be expected in this proceeding.” Pet. 15 (citing Ex. 1027, 2); Reply 8. Based on this evidence of the median time to trial in the district, we find factor 2 weighs in favor of institution. See Fintiv Memo 3 (“[W]hen considering the proximity of the district court’s trial date to the date when the PTAB final written decision will be due, the PTAB will consider the median time from filing to disposition of the civil trial for the district in which the parallel litigation resides.”)” slip op. at 22
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingOther
“guidance as to the meaning of particular claim terms.” Phillips, 415 F.3d 1314. Claim 1 is directed to “[a] method for reducing eye redness in a human subject having ocular hyperemia.” The preamble is limiting because (1) it provides the antecedent bases for “said human” and “said reduction of eye redness” recited in the body of the claim; and (2) “it is a statement of the intentional purpose for which the method must be performed.” See Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1341–43 (Fed. Cir. 2021). The preamble, however, does not require that eye redness is actually reduced. Id. Nor does the body of the claim recite any efficacy requirement.” slip op. at 24
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITADecided for petitioner
“In claim construction, “the claims themselves provide substantial guidance as to the meaning of particular claim terms.” Phillips, 415 F.3d 1314. Claim 1 is directed to “[a] method for reducing eye redness in a human subject having ocular hyperemia.” The preamble is limiting because (1) it provides the antecedent bases for “said human” and “said reduction of eye redness” recited in the body of the claim; and (2) “it is a statement of the intentional purpose for which the method must be performed.” See Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1341–43 (Fed. Cir. 2021). The preamble, however, does not require that eye redness is actually reduced. Id. Nor does the body of the claim recite any efficacy requirement.” slip op. at 24
Claim construction§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 11,596,600 - Microsoft Corporation / HP Inc. et al. v. Litl LLCInstitution deniedPTAB · Sep 4, 2024 · IPR2024-00457 · APJ Brian D Range · IPR · Institution
The Board denied institution on all challenged claims because Petitioner did not show a reasonable likelihood that any claim was unpatentable under the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner
“The parties agreed that resolution of this time bar issue would be resolved in the same manner as in IPR2024-00456. In particular, the parties stipulated: The parties stipulate with respect to the privity time bar issue that the facts and issues in IPR2024-00457 are the same as in IPR2024-00456, so that any decision the Board reaches resolving the privity time bar issue in IPR2024-00456 will apply and resolve the privity time bar issue in IPR2024-00457 in the same manner. Notice of Stipulation, Paper 14, 1. In the decision on institution for IPR2024-00456, the Board determined that “Lenovo is not a privity of Microsoft [in this context] and the Petition is not time-barred under § 315(b).” IPR2024-00456, Paper 22, 10 (July 31, 2024). Thus, pursuant to the parties’ stipulation, the instant petition is also not time-barred.” slip op. at 16
- Prior constructionPrior construction adoptedDecided for petitioner
“For this decision, we again construe “plurality of views of a plurality of visual representations of computer content” as “referring to a plurality of ways of organizing visual representations of computer content.” We again note that this limitation is distinct from merely providing a plurality of ways of displaying content (by, for example, changing display orientation, color, resolution, etc.). Petitioner assumes this construction for the Petition, and Patent Owner assumes this construction for Patent Owner’s Preliminary Response. Moreover, the construction is well supported by the ’715 patent’s claims and specification for reasons similar to those stated in the prior decision cited by Petitioner. IPR2021-00786, Paper 6, 13–16 (construing this term for the ’715 patent). For this decision, we do not discern a need to construe explicitly any other claim language because doing so would have no effect on our analysis below and will not assist in resolving the present controversy between the parties.7 See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in” slip op. at 15
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“Below, we explain that we deny institution based on the merits: Petitioner has not shown, with respect to at least one of the challenged claims, a reasonable likelihood of prevailing at trial. In the interest of judicial efficiency, we therefore do not need to consider discretionary denial. Cf. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (explaining that the Board is not required to reach issues unnecessary to “resolve the controversy”); see also, e.g., Aylo Freesites Ltd. v. Dish Techs. LLC, IPR 2024-00512, Paper 12, 12, n. 3 (declining to reach the 35 U.S.C. § 325(d) issues when denying based on 35 U.S.C. § 314(a)).” slip op. at 17
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art (POSITA), would have had a bachelor’s degree in electrical engineering, computer engineering, computer science, or a similar field, plus two years of work experience in designing GUIs for computing devices. Ex-1003, ¶ 21. More education could substitute for experience and vice versa. Id. Pet. 15. Patent Owner does not dispute the level of ordinary skill in the art. See Prelim. Resp. For purposes of this Decision, we adopt Petitioner’s proposal as reasonable and consistent with the level of skill reflected in the prior art and the ’715 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 13
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 9,880,715 - Microsoft Corporation / HP Inc. et al. v. Litl LLCInstitution deniedPTAB · Aug 23, 2024 · IPR2024-00458 · APJ Brian D Range · IPR · Institution
The Board denied institution on both §103 grounds because neither combination showed a reasonable likelihood that claims 1–4 and 11–14 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(a), 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.” Upon consideration of the Petition in view of the present record and for the reasons explained below, we determine that Petitioner has not shown a reasonable likelihood of prevailing with respect to at least one of the challenged claims. Accordingly, we do not institute an inter partes review on the grounds set forth in the Petition. See 37 C.F.R. § 42.108(a).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art (POSITA): would have had a bachelor’s degree in electrical engineering, computer engineering, computer science, or a similar field, plus two years of work experience in designing [graphical user interfaces (GUIs)] for computing devices. [Ex. 1003] ¶ 20–22. More education could substitute for experience and vice versa. Id. Pet. 14; see also Ex. 1003 ¶ 21 (Dr. Houh testifying that this level of skill is appropriate). Patent Owner does not dispute the level of ordinary skill in the art. See Prelim. Resp. For purposes of this Decision, we adopt Petitioner’s proposal as reasonable and consistent with the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“Petitioner argues that in IPR2021-00786, the Board construed “plurality of views of a plurality of visual representations of computer content” as “referring to a plurality of ways of organizing visual representations of computer content.” Pet. 14–15 (citing IPR2021-00786, Paper 6, 13–16). IPR2021-00786 involved U.S. Patent No. 9,880,715 B2 (“the ’715 patent”). Petitioner further notes that “the Board found [this] limitation ‘is distinct from merely providing a plurality of ways of displaying content (by, for example, changing display orientation, color, resolution, etc.).” Id. Petitioner further argues that during a reexamination proceeding of the ’715 patent, “the Examiner also clarified that the ‘plurality of views’ limitation does not encompass merely changing to entirely different content.” Id. (citing Ex. 1005 (90/014,958 Ex Parte Reexamination)). Petitioner’s witness, Dr. Houh, applied this construction when forming opinions and Petitioner proposes that we adopt this construction in this proceeding. Ex. 1003 ¶ 53; Pet. 15.” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Here, claim 1 requires the functionality of, for example, “selecting one of the plurality of views for display on the computer system in response to the detected current computer system configuration.” Ex. 1001, 71:34–36. As in Arendi and DSS, this functionality plays a major role in the subject matter claimed; this selection as at the heart of the ’818 patent. See, e.g., Ex. 1001, 2:49–62 (explaining that patent is directed to providing different views). We also determine that the limitation is not “unusually simple.” The cited art understood that display orientation could be modified based on a change in configuration (Pröll) and understood that a view could be selected based on a user’s active choice (the user shaking the device as in Martinez6), but the cited art did not recognize selecting a view based on a change of configuration. Prelim. Resp. 41. The evidence of record does not indicate that recognition of this function would be “unusually simple.”” slip op. at 18
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,564,818 - PTAB · Aug 22, 2024 · IPR2024-00580 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted review of claims 1, 3–6, and 8 on all asserted grounds, finding a reasonable likelihood that at least claim 1 would be shown obvious over the ’772 Publication and Snowdy.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Beginning with independent claim 1, we determine that Petitioner has met its burden for institution. Based on the current record, Petitioner has shown a reasonable likelihood of succeeding in establishing that the combination of the ’772 Publication and Snowdy renders at least claim 1 obvious.” slip op. at 18
- Skill levelSkill level petitioner adoptedOther
“Pet. 12 (citing Ex. 1005 ¶¶ 111–115). Patent Owner states that it does not dispute this definition for purposes of the Preliminary Response. Prelim. Resp. 16. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’462 Patent. See 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)).” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our decision. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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)); Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., 200 F.3d at 803)).” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundOther
“We agree with Patent Owner on the record before us that Petitioner does not appear to offer sufficient evidence and reasoning as to why a POSA would have modified AAVrh.10 at position 665 as described as opposed to other modifications based solely on the disclosure of the ’772 Publication. We do agree with Petitioner, however, that on the record before us, Snowdy provides such sufficient evidence and reasoning. See Pet. 47–52.” slip op. at 26
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,680,274 - PTAB · Aug 13, 2024 · IPR2024-00467 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on all challenged claims based on the asserted obviousness ground over Gil, Norden, Dean, Alphagan, and Federal Register.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Advanced Bionics, 8. As explained above, during prosecution of the ’245 patent, the examiner issued a nonstatutory double patenting rejection because the claims were “not patentably distinct from” the ’742 patent claims.13 See supra Section I.H (citing Ex. 1010, 96). Petitioner argues that “[i]t was material error for the Examiner to both acknowledge that the ’245 claims were patentably indistinct from the ’742 claims and yet ignore the FWD and allow the claims despite the Board’s prior findings.” We find Petitioner’s argument persuasive. To determine whether Petitioner has sufficiently shown material error, we look at, for example, “the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection.” Advanced Bionics, 9 (citing Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8, 10–11 (Dec. 15, 2017)). Petitioner asserts Gil, Norden, Dean, Alphagan, and Federal Register in this” slip op. at 18
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“previously denied its motion to stay. Ex. 2029. Thus, factor 1 weighs in favor of denying institution.” slip op. at 21
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We agree with Patent Owner. 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 expressly construe any claim term. Patent Owner appears to suggest, although it does not explicitly argue, that the claims require “a single drop of [0].025% brimonidine.” See Prelim. Resp. 6; see also id. at 27 (arguing Gil is “with multi-dosed 0.03% brimonidine”); id. at 28 (arguing Dean is with “multi-dosed concentrations”). To the extent our understanding is correct, Patent Owner should expressly discuss at trial any construction that would so limit the claim. Such discussion should be set forth in a separate section of a response, if filed, designated for claim construction; claim construction positions should not be merely included in arguments over the merits on patentability.” slip op. at 24
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Level of Ordinary Skill in the Art Petitioner asserts that: A person of ordinary skill in the art (“POSA”) would have been a composite person (or team) that included a medical doctor and pharmaceutical formulator. EX-1014, ¶¶60-61; EX-1013, ¶¶16, 22-24. The medical doctor would be an ophthalmologist with at least three to four years of experience in clinical trials and FDA regulation of eye products and would have experience in the use of topical brimonidine and apraclonidine and topical vasoconstrictors such as naphazoline and tetrahydrozoline. EX-1014, ¶60. The pharmaceutical formulator would have a doctorate in pharmaceutics or a related degree and at least three to five years of experience developing eye drop formulations for clinical trial and regulatory approval. EX-1013, ¶16. Pet. 16–17. Patent Owner does not, at this point, dispute this proposed definition of the ordinarily skilled artisan. See generally Prelim. Resp. For purposes of this Decision, we adopt Petitioner’s definition of the person of ordinary skill in the art as it appears consistent with the skill level reflected in the prior art of record and the disclosure of the ’245 patent.” slip op. at 24
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 11,833,245 - PTAB · Jul 26, 2024 · IPR2024-00459 · APJ Tina E Hulse · IPR · Institution
The Board instituted IPR on claims 1–20 over all six asserted obviousness grounds, finding a reasonable likelihood of success and declining discretionary denial under §§ 325(d) and 314(a).
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the arguments and evidence presented in the papers, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition and we decline to exercise our discretion to deny institution under 35 U.S.C. §§ 314(a) and 325(d). Accordingly, we institute an inter partes review of the challenged claims of the ’781 Patent.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“Owner, a POSA would have had “a doctoral degree in medicine, chemistry, biochemistry, biology, or a related field and 1–2 years of experience in the processing and analysis of biological samples, including fecal samples.” Id. at 47 (citing Ex. 2001 ¶ 43). Patent Owner also indicates that such a person could have been an individual or a member of a team of scientists addressing fecal sample processing and analysis. Id. Patent Owner notes that Petitioner’s proposal in the Petition is significantly different from the proposal in its ex parte reexamination request, which merely required a bachelor’s degree and several years of experience processing biological samples. Id. at 46; Ex. 1021, 7.8 Patent Owner also contends that the level of skill set forth in the Petition requires an extraordinary level of skill within an overly narrow focus. Prelim. Resp. 47. Regardless, Patent Owner states that its expert, Dr. Backman, is a person of at least ordinary skill and the claims of the ’781 Patent would not have been obvious under any of the parties’ proposed definitions of the level of ordinary skill in the art.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“At this stage of the proceeding, we agree with the parties that no construction of any claim term is necessary for purposes of our Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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))). C.” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“shown sufficiently that a POSA would have had a reason to modify the assay of Lenhard to combine Vilkin’s iFOBT and Itzkowitz’s collection process and DNA stabilization buffer with a reasonable expectation of success. Lenhard expressly states that “[t]he combination of [HIC1 methylation analysis with gFOBT] resulted in increased detection rates for CRCs” and includes data that supports this statement. See Ex. 1004, 147, 146 (Table 4); see also id. at 143 (“The combination of HIC1 methylation analysis with FOBT allowed for the detection of two thirds of CRCs.”). We find these positive statements and supporting data in Lenhard are sufficient to provide a “rational underpinning” to combine the gFOBT and DNA test at this stage of the proceeding. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Moreover, we are persuaded on this record that Vilkin’s explanation of the benefits of iFOBT over gFOBT provide a reason to replace Lenhard’s gFOBT with Vilkin’s iFOBT assay. See Ex. 1005, 2519. And we agree at improve Lenhard’s assay by requiring a patient to directly defecate into a sealable container and add a stabilization buffer to the sample so it could be shipped to a laboratory without freezing, as described in Itzkowitz. See Ex. 1002 ¶¶ 148–158.” slip op. at 17
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 11,634,781 - Apple Inc. v. Masimo CorporationInstitutedPTAB · Jul 9, 2024 · IPR2024-00244 · APJ Richard H Marschall · IPR · Institution
The Board instituted IPR on claims 1–5, 7–14, and 16–25 on all asserted grounds, finding a reasonable likelihood of prevailing on the Sarantos-based obviousness challenges.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“based on the Delaware Litigation. Prelim. Resp. 17–34; see Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 at 11–12 (PTAB Mar. 20, 2020) (precedential) (holding that PTAB has discretion to deny institution in certain circumstances where there is a parallel district court proceeding). Our analysis under Fintiv is guided by the USPTO Director’s Memorandum issued on June 21, 2022, titled “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation” (“Director’s Memo”).8 Pursuant to the Director’s Memo, we “will not discretionarily deny institution . . . where a petitioner presents a [Sotera] stipulation.” Director’s Memo 3 (citing Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) (precedential as to § II.A)). Because Petitioner has offered a stipulation like that in Sotera, i.e., a stipulation to “not pursue for the instituted claims, in [the Delaware 7 US 8,446,275 B2, issued May 21, 2013 (Ex. 1006, “Utter”). 8 Available at https://www.uspto.gov/sites/default/files/documents/ interim_proc_discretionary_denials_aia_parallel_district_court_litigation_m emo_20220621_.pdf. Litigation], the same grounds as in the IPR2024-00244 petition or any grounds that could have reasonably been raised in that Petition” (Ex. 1078, 1), we do not discretionarily deny institution under Fintiv. Patent Owner argues that Petitioner’s stipulation “does not carry the benefits underlying the Director’s Guidance” because it was filed “only after the parties and the court conducted extensive and costly fact and expert discovery, and fully briefed and argued dispositive motions.” Prelim. Sur-reply, 2. This argument is not persuasive because the Director’s Guidance does not afford discretion to discount a Sotera stipulation based on how far a parallel district court litigation has progressed when the stipulation was made. Director’s Memo, 7 (explaining, without qualification, that “the PTAB will not discretionarily deny institution of an IPR or PGR in view of parallel district court litigation where a petitioner stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition”); see also NXP USA, Inc. v. Impinj, Inc., IPR2021-01556, Paper 13 (Vidal Sept. 7, 2022) (precedential) (explaining that the only appropriate time for a petitioner to offer a stipulation related to Fintiv factor 4 is prior to the Board’s decision on institution). Accordingly, we decline to deny institution based on the Delaware” slip op. at 10
- Parallel petitionsDecided for petitioner
“First, we agree with Petitioner that the two petitions are not redundant and contain material differences that, in this case, support Petitioner’s argument that two petitions challenging the ’159 patent are warranted. The -243 IPR presents three grounds, all built on a combination of Iwamiya and Sarantos. -243 IPR, Paper 2, 1. In that case, Petitioner relies on Iwamiya as the primary reference that discloses a number of limitations, including the light shaping aspect of claim 1. See id. at 13–27. In this case, Petitioner relies on Sarantos alone for all of the limitations in claim 1, including the light shaping limitation, or a combination of Sarantos and Shie, with Shie allegedly disclosing the light shaping limitation. See Pet. 1, 7–14, 35–38. Petitioner also seeks to add the dark colored coating of Sarantos to Iwamiya in the -243 IPR, but relies on Sarantos alone for that limitation in this case. See Notice 2. In addition, because the combinations are different, they are supported by different motivations to combine and different underlying expert testimony. See, e.g., Pet. 30–35, 44–46; -243 IPR, Paper 2, 7–13. The material differences between the challenges presented in the two cases are readily apparent, and are underscored by Patent Owner’s arguments in its Preliminary Responses. For example, in the -243 IPR, Patent Owner does not contest Petitioner’s assertion that Iwamiya discloses the light shaping functionality (upon which Petitioner relies on Sarantos, here), but argues (for claim 1) that the combination fails to disclose the “opening” and “pass through the surface” limitations, and argues against the motivation to combine Iwamiya and Sarantos. See -243 IPR, Paper 6, 34– 48. Patent Owner raises none of those arguments in this case, and instead focuses on the alleged failure of Petitioner to establish that Sarantos alone, or Sarantos and Shie, disclose the claimed light shaping functionality, and that Petitioner fails to establish an adequate reason to combine Sarantos and Shie. See Prelim. Resp. 34–50. The arguments made by Patent Owner highlight the differences in the challenges in a manner that suggests the outcome of each case will turn on independent issues related to the application of the different prior art to different claim limitations, as presented in each case. We disagree with Patent Owner’s argument that the two petitions “are redundant” merely because Petitioner relies on Sarantos for some of the same limitations in both cases—here, despite some overlap in assertions regarding Sarantos, we determine that these petitions are not redundant of another, for the reasons discussed above. See Notice Response 2. Under these circumstances, we find the second petition at issue here to be non-redundant and materially different than that in the -243 IPR, which weighs in favor of considering the second petition here. Second, we are persuaded by Petitioner’s contention that it could not fit its arguments into a single petition due to word count restraints, and that the number and nature of claims challenged (25 claims in the -243 IPR and 23 claims here) supports the need for two petitions. See Notice 5; Pet. 88 (certifying word count of 13,991 words, just under 14,000 word limit); -243, Paper 2, 91 (certifying word count of 13,970 words). Patent Owner does not dispute Petitioner’s contention, but argues instead that Petitioner need not have challenged so many claims in its IPRs, when only five claims were asserted against it in the Delaware Litigation. Notice Response 5. We do not agree with that argument because petitioners are not required to challenge only those claims that are currently asserted against it in co-pending litigation. Third, we disagree with Patent Owner’s argument that consideration of the 23 challenged claims here is unnecessary given that Petitioner challenged all 25 claims of the ’159 patent in the -243 IPR. Id. at 5. That argument puts form over substance. Petitioner could have split up its two petitions differently such that a first petition could have addressed one subset of claims, e.g., claims 1–13, and the second petition could have addressed a different subset of claims, e.g., claims 14–25, with all prior art challenges directed to each set of claims appearing in both petitions. The end result would be the same as presented here, i.e., the number of claims challenged and the challenges raised against them would remain the same, even though it would more closely align with Patent Owner’s logic that a second petition must challenge claims not challenged in a first petition. We do not view the manner in which Petitioner divided its argument across these two petitions as a sound basis to deny institution of the second petition here. Fourth, we agree with Petitioner that the additional burden to the Board and Patent Owner, necessary to address the issues raised in this second proceeding, are minimized by the overlap with the -243 IPR and other proceedings. See Notice 3–4. For example, Sarantos, the primary reference in this proceeding, is used as a secondary reference (to teach the light shaping functionality of the claims) in the -243 IPR and has been at issue in several other IPRs. See id.; -243 IPR, Paper 2, 1. As such, the Board and Patent Owner are familiar already with Sarantos and its contents, mitigating against the burden of considering it here.” slip op. at 16
- Skill levelSkill level petitioner adoptedOther
“On the present record, Petitioner’s definition of a POSITA is consistent with the level of skill reflected in the ’159 patent and the asserted prior art. Accordingly, for purposes of this Decision, we adopt Petitioner’s description. See 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)). We note that we would reach the same outcome in this Decision under either definition of a POSITA. If the parties continue to propose differing levels of ordinary skill in the art during trial, they should state whether any issue in the case turns on those differences.” slip op. at 22
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningOther
“Based on the current record, we agree with Patent Owner that this claim limitation in claims 1 and 19 refers to different shapes rather than merely different sizes of the same shape. See Prelim. Resp. 14–16. At this stage of the proceeding, we determine that the language of the claim and the plain and ordinary meaning of “shape” seems to compel this result. As Patent Owner notes, two circles of different size still have the same circular shape. See id. at 14. We disagree, however, with Patent Owner’s argument that we should deny institution because Petitioner failed to apply this construction to the claims or intentionally withheld the parties’ district court agreement on this issue. Prelim. Resp. 12–13. Patent Owner does not point to any portion of the Petition that contends that different sizes amount to different shapes. See id. Patent Owner also seems to assume that Petitioner must have applied a construction that encompasses different sizes rather than different shapes when alleging that the prior art discloses the limitation, but Petitioner makes no such allegation in the Petition. See id. at 13, 16–17; Pet. 9–10. Patent Owner may ultimately prevail on this limitation. But, on the present record, we see no support for the argument that Petitioner implicitly used an incorrect construction and that the failure to expressly disclose the proper construction warrants denial of institution.” slip op. at 24
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,722,159 - Apple Inc. v. Masimo CorporationInstitutedPTAB · Jul 9, 2024 · IPR2024-00243 · APJ Richard H Marschall · IPR · Institution
The Board instituted IPR on claims 1–25 on all asserted obviousness grounds, finding a reasonable likelihood that Apple would prevail on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“based on the Delaware Litigation. Prelim. Resp. 16–33; see Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 at 11–12 (PTAB Mar. 20, 2020) (precedential) (holding that PTAB has discretion to deny institution in certain circumstances where there is a parallel district court proceeding). Our analysis under Fintiv is guided by the USPTO Director’s Memorandum, issued on June 21, 2022, titled “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation” (“Director’s Memo”).6 Pursuant to the Director’s Memo, we “will not discretionarily deny institution . . . where a petitioner presents a [Sotera] stipulation.” Director’s Memo 3 (citing Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) (precedential as to § II.A)). Because Petitioner has offered a stipulation like that in Sotera, i.e., a stipulation to “not pursue for the instituted claims, in [the Delaware Litigation], the same grounds as in the IPR2024-00243 petition or any grounds that could have reasonably been raised in that Petition” (Ex. 1078, 1), we do not discretionarily deny institution under Fintiv.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“At this point in the proceeding, we do not find it necessary, to expressly construe the term “opening” in order to reach a decision on institution and, under the circumstances, we do not find a basis for denying institution in Petitioner’s application of the claim language requiring an “opening.” But see infra Section F.3.b (identifying a potential issue that may benefit from record development on claim construction). Neither party offers an express construction of the term “opening” to the prior art. Pet. 5; Prelim. Resp. 12–15 (arguing inconsistency but declining to offer an express claim construction). On the present record, we are persuaded that the plain and ordinary meaning of “opening” encompasses Iwamiya’s optical filter 17 as mounted within light shielding frame 18. See Pet. 23–24; see infra at Section F.3.b. This is consistent with Patent Owner’s position, in the Delaware Litigation, that a solid material can provide an opening, and with the finding of the panel in the Final Written Decision in IPR2022-01291. Ex. 2035, 26 (Final Written Decision in IPR2022-01291); Ex. 2037 ¶¶ 463–465 (report by Petitioner’s expert, Dr. Sarrafzadeh in the Delaware Litigation, regarding non-infringement, reproducing an image that Petitioner represents is from Patent Owner’s expert, Dr. Madisetti, in which Dr. Madisetti labeled transparent material an “Opening in Dark-Colored Coating,” and in which Dr. Sarrafzadeh asserts that “every space that Dr. Madisetti . . . identified is” slip op. at 16
- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalTerm construed patent owner constructionDecided for patent owner
“prosecution history of a parent application, this language should be construed to exclude “arrangements of two or three detectors.” Prelim. Resp. 15 (citing Ex. 2057, 322 (prosecution history of U.S. Patent Application No. 15/195,199 (“the ’199 Application”))). Patent Owner notes that the panel in IPR2022-01291 adopted this construction for “a nearly identical limitation in Claim 15 of the related ’745 Patent.” Id. at 15–16 (citing Ex. 2035, 109–112). On this preliminary record, we agree with Patent Owner that, due to statements made during prosecution of a parent application, this claim language should be construed to exclude arrangements of two or three detectors. During prosecution of the ’199 Application, application claim 1 was amended to recite: a “tissue measurement site . . . having an at least partially circular shape bounded by a light block”; the light block comprising “an annular ring having a circular shape”; and a “plurality of detectors . . . arranged in an array having a spatial configuration corresponding to the shape of the irradiated portion of the tissue measurement site.” Ex. 2057, 311. Patent Owner argued to the Examiner that the “array” limitation had support in the ’199 Application specification because: The ordinary meaning of the claim term “correspond” means to “have a close similarity; match or agree almost exactly” or “be analogous or equivalent in character, form, or function” or “represent.” New Oxford American Dictionary, 390 (3rd Edition 2010). Consistent with this exemplary definition and the originally-filed application, the phrase “arranged in an array having a spatial configuration corresponding to the shape of the irradiated portion of the tissue measurement site” . . . would be understood by a person having ordinary skill in the art as requiring a sufficient number of detectors such that, when arranged together in an array, can “match,” “have a close similarity,” or “represent” the “at least partially circular shape” of the irradiated portion of the tissue measurement site. . . . In order for the claimed “plurality of detectors” to “match” or “represent” an “at least partially circular shape” or an “annular shape,” the “plurality of detectors” must include sufficient detectors to represent such shapes. For example, six or more detectors could be arranged in an annular shape and meet the recited limitation. However, two detectors, for example, can only be arranged in a spatial configuration representing a line and three detectors, for example, can only be arranged in a spatial configuration representing a line or a triangle. Thus, when read in view of the originally-filed application, the recited “plurality of detectors” would be understood by a person having ordinary skill in the art as including a sufficient number of detectors to represent the desired geometric shape.” slip op. at 18
- Skill levelSkill level petitioner adoptedDecided for petitioner
“On the present record, Petitioner’s definition of a POSITA is consistent with the level of skill reflected in the ’159 patent and the asserted prior art. Accordingly, for purposes of this Decision, we adopt Petitioner’s description. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining “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))). We note that we would reach the same outcome in this Decision under either definition of a POSITA. If the parties continue to propose differing levels of ordinary skill in the art during trial, they should state whether any issue in the case turns on those differences.” slip op. at 14
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,722,159 - Apple Inc. v. Masimo CorporationInstitutedPTAB · Jul 9, 2024 · IPR2024-00241 · APJ David Cotta · IPR · Institution
Instituted IPR on all grounds for claims 1–25, finding a reasonable likelihood that Apple would prevail on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), inter partes review may not be instituted unless 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.” Petitioner has established a reasonable likelihood of prevailing on its assertion that at least one of the challenged claims is unpatentable based on the grounds advanced here. We decline to deny the Petition on a discretionary basis as requested by Patent Owner. Thus, for reasons explained below, we institute inter partes review of claims 1–25 of the ’743 patent.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“Fintiv, Inc., IPR2020-00019, Paper 11 at 11–12 (PTAB Mar. 20, 2020) (precedential) (holding that PTAB has discretion to deny institution in certain circumstances where there is a parallel district court proceeding). Our analysis under Fintiv is guided by the USPTO Director’s Memorandum issued on June 21, 2022, titled “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation” (“Director’s Memo”).6 Pursuant to the Director’s Memo, we “will not discretionarily deny institution . . . where a petitioner presents a [Sotera] stipulation.” Director’s Memo 3 (citing Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) (precedential as to § II.A)). Because Petitioner has offered a stipulation like that in Sotera, i.e., a stipulation to “not pursue for the instituted claims, in [the Delaware Litigation], the same grounds as in the IPR2024-00241 petition or any grounds that could reasonably have been raised in that petition” (Ex. 1078, 1), we do not discretionarily deny institution under Fintiv. Patent Owner argues that Petitioner’s stipulation “does not carry the benefits underlying the Director’s Guidance” because it was filed “only after the parties and the court conducted extensive and costly fact and expert discovery, and fully briefed and argued dispositive motions.” Prelim. Sur-reply 2. This argument is not persuasive because the Director’s Guidance does not afford discretion to discount a Sotera stipulation based on how far a parallel district court litigation has progressed when the stipulation was made. Director’s Memo 7 (explaining, without qualification, that “the” slip op. at 11
- Parallel petitionsNot reached
“B. Discretionary Denial in View of Multiple Petitions Petitioner filed two petitions for inter partes review of the ’743 patent, this Petition challenging claims 1–25 and the petition filed in IPR2024- 00242 challenging claims 1, 3–14, and 16–25. See Apple Inc. v. Masimo Corp., IPR2024-00242, Paper 3 (PTAB, filed Dec. 12, 2023). Patent Owner argues that Petitioner “fails to establish that two petitions on the ’743 Patent are necessary” and that “if the Board institutes one of the Petitions, it should deny the other.” Paper 9, 1. Petitioner requests that we consider this Petition before we consider the Petition in IPR2024-00242. Paper 2, 1. Accordingly, we reserve consideration of whether multiple petitions are merited for our decision in IPR2024-00242. III.” slip op. at 12
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner contends that “[Petitioner’s] asserted level of ordinary skill in the art is relatively low” which “supports the patentability of the 7 The current record in this proceeding does not include any argument or evidence directed to objective indicia of nonobviousness. claims,” and further “notifies the Board that in the Delaware Litigation, [Patent Owner’s] expert presented a slightly different definition of the level of ordinary skill which includes education and/or experience with optical technologies.” Prelim. Resp. 11–12 (citing Ex. 2002 ¶¶ 48–51). Patent Owner asserts that the difference between the parties’ definitions “does not impact [Petitioner’s] patentability challenges here.” Id. On the present record, Petitioner’s definition of the POSA is consistent with the level of skill reflected in the ’743 patent and the asserted prior art. Accordingly, for purposes of this Decision, we adopt Petitioner’s description. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining “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))).” slip op. at 13
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,687,743
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.