- PTAB · May 31, 2022 · IPR2022-00402 · APJ Michael A Valek · IPR · Institution
The Board instituted IPR on claims 1–30, finding a reasonable likelihood of success on the anticipation challenge and all asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Petitioner has shown that Pioneer Hi-Bred discloses examples of synthetic guide RNA and crRNA molecules having the recited modifications at their 3’ and 5’ ends. See Pet. 20–24 (referring to Table 8 of Ex. 1006). That disclosure undermines the Applicant’s arguments during prosecution that: (1) “a skilled person would not modify a CRISPR guide RNA or crRNA at the particularly claimed positions,” and (2) the reference to “‘securing or steadying the structure’ of RNA in [Zhang] relates to secondary structure” as opposed to “modifications at the claimed positions,” i.e. within five nucleotides from one or both of the ends. Ex. 1002, 783. Both of these arguments were credited by the Examiner as reasons for withdrawing the rejection over Zhang. Id. at 783–784. Thus, Petitioner has sufficiently shown that the Examiner materially erred by not recognizing the relevance of Pioneer Hi-Bred’s disclosure and in particular the crRNA examples in Table 8.” slip op. at 10
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied
“On the current record, we determine that the merits of Petitioner’s anticipation ground appear to be particularly strong for the independent claims and for those dependent claims where Petitioner’s arguments are similarly premised on the crRNA examples in Table 8 being anticipatory without any further modification. See infra § V.E (explaining that, on the current record, Petitioner has shown that Pioneer Hi-Bred Table 8 discloses presumptively-enabled examples that read on claims 1 and 12 as well as a number of the dependent claims). Accordingly, we find that this factor weighs strongly against exercising discretion to deny institution. G. Weighing of Fintiv Factors Considering the Fintiv factors as part of a holistic analysis of the factors discussed above, we are not persuaded that the interests of the efficiency and integrity of the system would be served by invoking our authority under 35 U.S.C. § 314(a) to deny institution of a potentially meritorious Petition. Accordingly, we do not exercise our discretion to deny institution under § 314(a).” slip op. at 18
- Skill levelSkill level board ownOther
“B. Level of Ordinary Skill in the Art Relying on the testimony of its declarant, Dr. Furneaux, Petitioner contends that a POSA “as of December 3, 2014 (the earliest possible priority date of the ’001 Patent) would have had a Ph.D. in molecular biology, biochemistry, or a related discipline.” Pet. 12 (citing Ex. 1003 ¶ 60). Patent Owner’s declarant, Dr. Marshall, applies the same definition for his analysis. Ex. 2003 ¶ 85. At this stage in the proceeding, we find this description of the level of ordinary skill in the art to be sufficiently supported by the record. Thus, for purposes of this decision, we adopt the description of a POSA noted above.” slip op. at 19
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction Neither party identifies any claim term for construction. Pet. 17; Prelim. Resp. 35. We agree that no formal claim construction is necessary at this stage of the proceeding. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that it is only necessary to “construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 21
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,337,001 - Streck, Inc. v. Ravgen, Inc.InstitutedPTAB · Apr 22, 2022 · IPR2021-01577 · APJ Timothy G Majors · IPR · Institution
The Board instituted inter partes review of claims 55–61, 68, 69, 80–86, 89–92, 94, 126–130, 132, and 133 on all asserted grounds.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Institution denied general plasticDenied
“We do not agree that General Plastic Factor 1 favors discretionary denial on this record. To be sure, Streck’s tubes feature prominently in Patent Owner’s infringement allegations against Quest, Natera, and other customers. See Exs. 2065, 2178, 2179, and 2196 (identifying, collectively, Streck’s tubes dozens of times). And, as evidenced by the filing of its own petition, Streck is also interested in seeing claims of the ’277 patent held unpatentable. But Streck is not a defendant in any action brought by Patent Owner related to the ’277 patent. Nor is there any assertion or indication that Streck’s blood collection tubes infringe the methods claimed in the ’277 patent. These facts, at minimum, distinguish this case from Valve. Valve at 9–10 (explaining that Valve and HTC were co-defendants sued at the same time in the same case, based on the same allegedly infringing devices that HTC and Valve co-developed).” slip op. at 17
- PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner
“each case, taking account of equitable and practical considerations. CTPG 13; RPX Corp. v. Applications in Internet Time, LLC, IPR2015-01750, Paper 128 at 7–8 (PTAB Oct. 2, 2020) (precedential) (hereafter “RPX”) (asking “whether the non-party is a clear beneficiary that has a preexisting, established relationship with the petitioner”) (quoting Applications in Internet Time, LLC v. RPX Corp., 897 F.3d 1336, 1351 (Fed. Cir. 2018)). Two questions are at the heart of the RPI inquiry: whether the non-party desires review of the patent and whether the petition has been filed at the non-party’s behest. RPX at 7–8; see also CTPG at 16 (explaining that a “common consideration” is “whether the non-party exercised or could have exercised control over a party’s participation in proceeding”). Privity is a more expansive concept because a privy need not be an RPI. RPX at 37; CTPG at 13.” slip op. at 59
- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner
“each case, taking account of equitable and practical considerations. CTPG 13; RPX Corp. v. Applications in Internet Time, LLC, IPR2015-01750, Paper 128 at 7–8 (PTAB Oct. 2, 2020) (precedential) (hereafter “RPX”) (asking “whether the non-party is a clear beneficiary that has a preexisting, established relationship with the petitioner”) (quoting Applications in Internet Time, LLC v. RPX Corp., 897 F.3d 1336, 1351 (Fed. Cir. 2018)). Two questions are at the heart of the RPI inquiry: whether the non-party desires review of the patent and whether the petition has been filed at the non-party’s behest. RPX at 7–8; see also CTPG at 16 (explaining that a “common consideration” is “whether the non-party exercised or could have exercised control over a party’s participation in proceeding”). Privity is a more expansive concept because a privy need not be an RPI. RPX at 37; CTPG at 13.” slip op. at 59
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Altogether, we determine that Petitioner has met its threshold burden and established to a reasonable likelihood that at least claim 55 would have been obvious over Pertl and Granger. Petitioner cites evidence to support its assertions on the other challenged claims, none of which are separately argued by Patent Owner at this stage. Pet. 32–42. Considering Petitioner’s argument and evidence, Petitioner is reasonably likely to prevail in establishing that one or more of those additional claims are unpatentable over Pertl and Granger.” slip op. at 51
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 7,332,277 - New World Medical, Inc. v. The Regents Of The University Of CaliforniaAll claims unpatentablePTAB · Mar 11, 2022 · IPR2021-00066 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–11 are unpatentable: claims 1–11 are anticipated by Quintana and obvious over Quintana; the Board did not reach the Jacobi ground.
RulingsFinal written decision- ExcludeMotion to exclude, deniedDenied
“Patent Owner filed a motion to exclude evidence (Paper 38); Petitioner opposed (Paper 41); and Patent Owner filed a reply in support of its motion (Paper 43). Petitioner also filed a motion to exclude evidence (Paper 39); Patent Owner opposed (Paper 40); and Petitioner filed a reply in support of its motion (Paper 42). We addressed (and denied) the parties’ motions to exclude in Paper 49.” slip op. at 3
- Expert testimonyPetitioner expert creditedPatent owner expert discountedOther
“We “conclude[d] that the better course is to have a complete record of the evidence,” and, therefore, denied Petitioner’s Motion, but also explained that “to the extent that Dr. Condon’s testimony and Patent Owner’s reliance thereon ventures into areas the witness has conceded he either does not understand or has inadequately analyzed,” we would accord it little weight, as distinguished “from that relating to Dr. Condon’s technical expertise in, for example, anatomy, eye surgery, and his own reading of evidence.” Order 13. Therefore, it is through this lens that we consider and analyze Dr. Condon’s testimony here.” slip op. at 14
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 22 (citing Ex. 1003 ¶ 24). On page 18 of our Institution Decision, we provisionally accepted Petitioner’s proposed definition, which was not opposed by Patent Owner, and is consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’544 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)). As Patent Owner expressly agrees with our analysis, we apply Petitioner’s proposed definition here. See PO Resp. 11, n.4. C.” slip op. at 25
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“1. “A device useable to create an opening in the trabecular meshwork of the eye” Independent claim 1 is directed to “[a] device useable to create an opening in the trabecular meshwork of the eye” and having a “foot member . . . advanceable, tip first, through Schlemm’s Canal to facilitate performance of a surgical procedure using the surgical instrument.” Ex. 1001, 23:4–5, 23:18–20. As an initial matter, we consider the preamble of claim 1 limiting here because a device that “create[s] an opening in the trabecular meshwork” recites or, at a minimum, implies, “essential structure or steps” required for the insertion and advancement of the instrument through Schlemm’s Canal as set forth in [1.d]. See Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002).8” slip op. at 26
Patent outcomesUS 9,999,544 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,999,544 - Janssen Biotech, Inc. v. The United States Of America, As Represented By The Secretary, Department Of Health & Human ServicesInstitution deniedPTAB · Mar 2, 2022 · IPR2021-01484 · APJ Robert A Pollock · IPR · Institution
The Board denied institution of IPR challenging claims 1–9, 13, 17, and 19 as obvious over Milone and Kalled under § 103, exercising discretion under § 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 at 8–10 (Feb. 13, 2020) (“Advanced Bionics”) (precedential), the Board addresses § 325(d) applying a “two-part framework.” In the first part of the framework, we ask whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments 8 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated. 22 previously were presented to the Office. Advanced Bionics at 8. Factors (a), (b), and (d) of Becton, Dickinson come into play under this first part of the framework. Id. at 8–10. If either condition of the framework’s first part is met (e.g., substantially the same art is presented), we move to part two of the framework, asking “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of [the] challenged claims.” Id. at 8. Factors (c), (e), and (f) of Becton, Dickinson fall within part two of the framework. Id. at 10 (“[F]actors (c), (e), and (f) relate to whether the petitioner has demonstrated material error by the Office.”). Only if the same or substantially the same art or arguments were previously presented to the Office do we then consider whether petitioner has demonstrated error. Advanced Bionics at 8–10. “If the petitioner fails to show that the Office erred, the Director may exercise his discretion not to institute inter partes review.” Id. at 8–9. “At bottom, this [§ 325(d)] framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9 (“If reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.”). B.” slip op. at 22
- Skill levelSkill level patent owner adoptedOther
“Patent Owner does not dispute Petitioner’s proposed definition, but states that the person of ordinary skill in the art would “[t]ypically” . . . have had an M.D. or a Ph.D. in immunology, biochemistry, cell biology, molecular biology, or a related discipline, with at least two years of experience in conducting laboratory research on chimeric T cell receptors.” Prelim. Resp. 44 (citing Ex. 2001 ¶ 20). According to Patent Owner, the ordinarily skilled artisan “would have had knowledge of the scientific literature and have skills relating to chimeric T cell receptors and methods of using such receptors” and “may have worked as part of a multidisciplinary team” and been able to draw on the specialized skills of, for example, an immunologist, and/or a clinical oncologist. See id. at 43–44. Considering the record before us, both parties present reasonable definitions of one of ordinary skill in the art. For the purpose of this proceeding, we consider one of ordinary skill in the art as having had an M.D. or a Ph.D. in immunology, biochemistry, cell biology, molecular biology, or a related discipline, with at least two years of experience in conducting laboratory research on chimeric T cell receptors and/or the use of CAR-T immunotherapy. Consistent with Patent Owner’s proposed definition, the ordinarily skilled artisan may have worked as part of a 20 multidisciplinary team and been able to draw on the specialized skills of, for example, an immunologist, and/or a clinical oncologist.” slip op. at 20
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for patent owner
“We do not find Petitioner’s argument persuasive for the reasons set forth on pages 34–40 of the Preliminary Response. Most particularly, we note that the phrase “[a] chimeric antigen receptor (CAR)” occurs solely in the preamble of independent claim 24. Terms in a preamble, however, are not generally construed as limiting. See Allen Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). More specifically, “when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention,” the preamble is not considered a limitation. Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). In the present case, we find it plausible—if not likely—that the Examiner gave no weight to the terms in the preamble of claim 24 such that the remaining language did not expressly or implicitly require either a 32 transmembrane domain, or a “T-cell activation moiety” specific to CAR constructs. The Examiner appears to have recognized, however, that CAR constructs differ from Kalled’s antibodies at least in having a transmembrane domain as expressly recited in claims 29 and 30. See Ex. 2005, 605, 745–749 (allowing amended claims). This view is underscored by the Examiner’s decision not to reject claims 34 and 38 as anticipated by Kalled. See Ex. 2005, 604. Notably, claims 34 and 38 recite SEQ ID Nos 4–12, each of which encodes a complete CAR construct and, thus, implicitly includes a transmembrane domain. See id. at 589 (claiming a CAR comprising the amino acid sequence of SEQ ID Nos: 4–12 (claim 34) or a nucleic acid encoding the same (claim 38)); Ex. 1001, 9:49–53; Ex. 2001 ¶ 92.12” slip op. at 32
Claim constructionDiscretionary denialcites GrahamPatents in suitUS 9,765,342 - PTAB · Feb 9, 2022 · IPR2021-01340 · APJ David Cotta · IPR · Institution
The Board instituted IPR on claims 1–17 because Petitioner showed a reasonable likelihood that Coronel and Fox render the claims obvious.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“G. Balancing the Fintiv Factors We have considered the circumstances before us in light of the Fintiv factors. Except for the second factor, the proximity of trial dates, all other factors are either neutral of weigh against exercising discretion. Altogether, balancing the factors, we decline to invoke our authority to deny the Petition on a discretionary basis under § 314(a).” slip op. at 13
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“6. Conclusion For the reasons discussed above, we find that the record sufficiently supports Petitioner’s contention that Coronel and Fox render obvious claims 1–17 of the ’402 patent. 29 IV. CONCLUSION On this preliminary record, Petitioner has established a reasonable likelihood of prevailing in showing that at least one of the challenged claims is unpatentable based on the grounds advanced in the Petition. V. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is granted, and we institute inter partes review of claims 1–17 based on the grounds asserted in this Petition;” slip op. at 29
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“On the present record, we do not find Patent Owner’s argument persuasive because Petitioner does not propose to add Fox’s computer and data processing equipment to Coronol’s system. Rather, Petitioner contends that it would have been obvious to implement Fox’s teachings regarding multivariate T2 analysis in Coronel’s computer. Petitioner explains: A POSA thus would have been motivated to adopt the teachings of Fox of using the data storage memory, data processing, and memory components in the computer or supervisor of Coronel to calculate a T2 value for the operational state data received from each tool in the system for use in fault detection by the Coronel system. (Ex. 1002, ¶ 81.) By converting operational state data into the multivariate T2 value in view of the teachings of Fox, a POSA would have further advanced the teachings of Coronel to improve the system’s ability to detect various tool state deviations during wafer processing. 22 Pet. 40; see also id. at 39 (“Applying the techniques in Fox to improve the system in Coronel would have yielded the predictable result of utilizing the Coronel computer, which already receives process parameter data from the tools (including RF parameters) via data bus 13, to store the data and apply Hotelling’s T2 multivariate technique.”); 37 (“[B]ecause the techniques in Fox are implemented through a computer, they are readily adapted to the Coronel computer, database, and supervisor.”). Moreover, on this record, Petitioner articulates sufficient reason to apply the teachings of Fox to Coronel. For example, Petitioner, relying on the testimony of Dr. Hatalis, contends that the POSA would have been motivated to apply Fox’s methodologies to Coronel “to improve process yield and remain competitive in an industry where profits are driven by reducing manufacturing defects.” Pet. 34 (citing Ex. 1002 ¶ 71). Petitioner also explains, with reference to Fox and to the testimony of Dr. Hatalis that “[m]ultivariate analysis of the RF measurement is particularly effective because it can indicate the process is out of acceptable range even when individual components are within range, and vice versa.” Id. at 36 (citing Ex. 1005, 3:45–67, 4:28–40; Ex. 1002 ¶ 74). Accordingly, we are not persuaded that the fact that Coronel already” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“current record, Petitioner has articulated sufficient reason why the POSA would seek to apply the teachings of Fox to Coronel. The current record also supports that a POSA seeking to apply the teachings of Fox to Coronel would recognize that transmitting data from the computer to the supervisor using Coronel’s bidirectional data bus would require “translat[ing] the data from ASCII format or T2 values from numeric data to the SECS II communications protocol.” Ex. 1002 ¶ 90 (presently unrebutted testimony of Dr. Hatalis). The present record further supports that it was “well-known 26 in the art how to transmit data in ASCII format or as numeric data via the SECS II communications protocol.” Id. (citing Ex. 1018, 172). Patent Owner’s argument that this would render Coronel inoperable may have merit, but, at this point in the proceeding, we credit the presently unrebutted testimony of Dr. Hatalis over Patent Owner’s attorney argument. See Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989) (“Attorneys’ argument is no substitute for evidence.”); In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974). As to Patent Owner’s argument that the use of a single protocol in Coronel and Fox teaches away from translation between protocols, Patent Owner does not identify any specific teaching in Coronel or Fox which discourages translation between protocols. Accordingly, the present record does not support that Coronel or Fox teaches away from translation. See, DyStar Textilfarben GmbH & Co. Deutsch/and Kg v. CH Patrick Co., 464 F.3d 1356, 1364 (Fed. Cir. 2006) (“[M]ere failure to discuss immediate use of his leuco indigo solution for dyeing is not the same thing as Brochet stating in his article that ... his leuco indigo solution may only be concentrated in paste form. We will not read into a reference a teaching away from a process where no such language exists.”)” slip op. at 26
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 6,725,402 - PTAB · Feb 9, 2022 · IPR2021-01342 · APJ Miriam L Quinn · IPR · Institution
The Board instituted IPR on claims 1–22 because Applied Materials showed a reasonable likelihood of prevailing on obviousness over Schulze and Gupta.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“The standard for institution is set forth in 35 U.S.C. § 314, which provides that an inter partes review may not be instituted unless the information presented in the Petition and the Preliminary Response shows that “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314 (2018); see also 37 C.F.R § 42.4(a) (“The Board institutes the trial on behalf of the Director.”). Upon consideration of the parties’ contentions and the evidence of record, we conclude that Petitioner has established a reasonable likelihood of prevailing in demonstrating the unpatentability of at least one challenged claim of the ’248 patent. Accordingly, we grant Petitioner’s request and institute an inter partes review of the challenged claims.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“teachings of Schulze and Gupta. Pet. 3541. We point out for instance Petitioner’s argument that a person of ordinary skill in the art “would have appreciated that the distributed and localized nature of the software scheduler taught in Gupta would reduce the computational complexity involved in each scheduling decision.” Id. at 36 (citing Shanfield Decl. ¶ 118; Ex. 1021, 207; Ex. 1013, 566). Additionally, Petitioner argues that Gupta provides the advantage of avoiding the need to reconfigure the scheduling strategy for the entire process flow upon adding a new type of machine to the process flow because Gupta’s local scheduler can be adjusted for the new machine. Id. at 3637 (citing Shanfield Decl. ¶ 119; Ex. 1008, 14:6061, 30:3234; Ex. 1024, 46).” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“In its opposition, Patent Owner contrasts Schulze’s “all tools” monitoring with Gupta’s individual machine focus to argue that Gupta teaches away from implementing the local scheduler with Schulze’s teachings. Prelim. Resp. 3640. For instance, Patent Owner posits that Gupta avoids taking actions that would involve the entire factory because Gupta teaches “local optimization.” Id. at 3940. Patent Owner further argues that Gupta “counsels against attempts to scale up its scheduling method to the entire fab,” because Gupta seeks to conserve processing power. Id. at 4142. Specifically, Patent Owner focuses on Gupta’s disclosure that [d]ecisions which consider many factors, such as those made for the entire facility at once, tend to require prohibitive computational resources,” and, therefore, a person of ordinary skill in the art would have been “actively discouraged” from adding “scheduling to Schulze’s fab-wide MES.” Id. at 41 (emphasis omitted). We are not persuaded by Patent Owner’s argument. Gupta describes “global planning” and “local optimization” for the entire fab. Ex. 1008, 8:469:21, 13:4114:26. Thus, arguing that Gupta’s scheduler would not be focused on an entire fab is belied by Gupta’s disclosure. Further, the portions of Gupta that Patent Owner relies on do not support what Patent Owner asserts—that Gupta’s scheduler is expressly designed to not work for the entire factory. We understand Gupta to teach a system design that makes a large number of simple computational decisions for each machine of the entire factory, rather than a computation heavy design that requires recalculating the global parameters for the entire factory each time a decision is made. Id. at 13:6714:11. This is different from how Patent Owner characterizes Gupta—i.e., as “implicitly counsel[ing] against attempts to scale up its scheduling method to the entire fab.” Prelim. Resp. 41 (see also Prelim. Resp. 39, arguing unpersuasively that Gupta expressly teaches that its local optimization should not be applied to an entire factory and likely would not work if it were so applied). Furthermore, emphasizing Gupta’s local optimization as limiting the number of tools or number of actions is also unpersuasive. First, Gupta describes that the “range of actions which can be taken is fairly limited” in the context of explaining that the machine actions are rather simple: load a lot from its queue immediately, wait for a full load, or proceed with a partial load. Ex. 1008, 13:6166. Gupta is not saying that its scheduler is somehow limited in actions—rather, the machine’s actions are simple, thus the number of options for the scheduler to decide are simple. Second, Gupta’s scheduler makes a decision for all the machines in the system by local prediction, regardless of the computational resources available. For instance, if the scheduler resources are tight, “such as a very large facility using a small computer system for scheduling and planning,” the more critical machines will have first call on the resources and the other machines employ simpler decision strategies or a default strategy, such as round-robin mode. Id. at 14:4359. But if the scheduler knows how long it will take “for each machine,” it will need to begin making decisions ahead of time, such as six minutes in advance, so that when the machines unload, the results of the prediction are available to the machine. Id. at 14:2742. Thus Gupta explains that its scheduler takes into account each machine and performs the expected decisions for each machine, regardless of the computational strain. Therefore, the argument that Gupta teaches away from applying its scheduler to an entire facility, such as that of Schulze, because of its local optimization scheme, is untenable on the present record. Consequently, we are not persuaded that Gupta teaches away from combining its teachings with those of Schulze as presented in the Petition.” slip op. at 17
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightMotivation foundDecided for petitioner
“(c) Patent Owner’s Hindsight Allegation In connection with the reasons to combine, Patent Owner alleges that Petitioner proffers conclusory arguments with insufficient factual support, and, therefore, Petitioner’s theory relies on improper hindsight. Prelim. Resp. 4243. We do not agree. Patent Owner takes issue with one of several reasons to combine proffered by Petitioner in which Dr. Shanfield states that a person of ordinary skill in the art would have recognized that the distributed and localized approach of Gupta’s scheduler would reduce the computational resources and time needed. Id. at 42 (citing Shanfield Decl. ¶ 118). According to Patent Owner, Dr. Shanfield does not explain the connection between Gupta and a distributed and localized approach, and the missing link is found in secondary references, one of which is dated after the ’248 patent’s priority date. Id. Even if Patent Owner’s argument had merit, which does not at this juncture appear to be the case given that Dr. Shanfield’s testimony is unrebutted and appears reasonable on its face, Petitioner proffers several other explanations bearing on the analysis of reasons to combine. This additional explanation provides rational underpinning sufficient to meet the requirements of KSR Int’l v. Teleflex, 550 U.S. 398, 418 (2007). For instance, as stated earlier, one such explanation is that incorporating Gupta’s scheduler implementation into Schulze provides a benefit of avoiding the need to reconfigure the scheduling strategy for the entire process flow upon adding a new type of machine because Gupta’s local scheduler can be adjusted for the new machine. Pet. 3637 (citing Shanfield Decl. ¶ 119; Ex. 1008, 14:6061, 30:3234; Ex. 1024, 46). Consequently, Patent Owner’s arguments that Petitioner’s reasons to combine fail for inadequate support or because Petitioner relies on hindsight are unpersuasive.” slip op. at 19
§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 6,968,248 - Illumina, Inc. v. Ravgen, Inc.InstitutedPTAB · Jan 26, 2022 · IPR2021-01271 · APJ David Cotta · IPR · Institution
The Board instituted review of claims 1, 3–9, 21, 22, and 24–30 after finding a reasonable likelihood of unpatentability on the asserted grounds.
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 the challenged claims are 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, 3–9, 21, 22, and 24–30 of the ’720 patent.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Denied
“For the reasons above, we find that Factor 1 weighs against denial of Illumina’s Petition.” slip op. at 20
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“Overall, we consider Fintiv factor 6 to be neutral. 7. Balancing the Fintiv Factors We consider the above factors and take “a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Fintiv at 6. In our view, the facts weighing against exercising discretion to deny institution collectively outweigh those favoring denial and concerns about potential inefficiency or integrity of the system. For these reasons, we decline to exercise our discretion to deny institution under § 314(a).” slip op. at 35
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner proposes the following POSA definition: [A POSA] would have had “a M.D. and/or Ph.D. in a related area such as genetics, biochemistry, molecular biology, cell biology, 36 or microbiology and at least one to two years of work in one of those related areas, [or] a Bachelor’s degree in one of the foregoing areas and at least three to four years of work in that area.” Pet. 12 (quoting Ex. 1020 ¶ 15). Petitioner additionally asserts that “[b]ased on this asserted level of skill, the POSA . . . would have had academic or industry experience collecting and analyzing cell-free nucleic acid, such as DNA, from blood samples.” Id. Patent Owner proposes substantially the same definition. Prelim. Resp. 11 (citing Ex. 2001 ¶ 32). To the extent there are minor differences in the proposals, Patent Owner’s declarant testifies that such differences are not material and his “opinions . . . would not change if Dr. Levy’s [i.e., Petitioner’s] proposed level of ordinary skill were adopted.” Ex. 2001 ¶ 34. The parties are in substantial agreement on the POSA level, and we adopt Petitioner’s proposal for this Decision. Our determinations below would not change if we adopted Patent Owner’s minimally different level.13” slip op. at 36
Claim construction§ 102 anticipationDiscretionary denialcites GrahamPatents in suitUS 7,727,720 - Illumina, Inc. v. Ravgen, Inc.InstitutedPTAB · Jan 26, 2022 · IPR2021-01272 · APJ Timothy G Majors · IPR · Institution
The Board instituted review of claims 55–63, 66–69, 80–91, 94–96, 126–130, 132, and 133 on all asserted grounds.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Institution denied general plasticDenied
“We do not agree with Patent Owner that Factor 1 weighs in favor of discretionary denial here. To the extent there is any relationship between Illumina and the earlier challengers, we find that such relationship is not a “significant” one, such as contemplated by Valve. First, although Illumina, Natera, Quest, and Labcorp are each defendants accused of infringing the ’277 patent, unlike Valve, they are not co-defendants in the same case. Valve at 9–10. Nor were Illumina and the other parties sued at the same time—Patent Owner instead sued those parties in seriatim district court complaints filed over approximately six months starting in mid-2020. Exs. 2086, 2087, 2088, and 2089. Thus, the staggered nature of the alleged follow-on challenges by those parties can be reasonably explained by Patent Owner’s elected timetable for suing the defendants.” slip op. at 19
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied
“7. Balancing the Fintiv Factors Altogether, considering and balancing the Fintiv factors holistically, we decline to invoke our authority to deny the Petition on a discretionary basis under § 314(a).” slip op. at 38
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“IV. CONCLUSION On this preliminary record, Petitioner has established a reasonable likelihood of prevailing in showing that at least one of the challenged claims is unpatentable based on grounds advanced in the Petition. V. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is granted, and we institute inter partes review of claims 55–63, 66–69, 80–91, 94–96, 126–130, 132, and 133 based on the grounds asserted in this Petition;” slip op. at 66
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artDecided for petitioner
“Based on the current record, we find that Petitioner has met its institution burden in establishing that Landes is entitled to claim the priority benefit of the Landes Provisional and, thus, is prior art to the ’277 patent. On the matter of written description support under § 112, the claims of Landes (claims 1–4) appear unchanged in the Landes Provisional (claims 1– 4). Compare Ex. 1003, 22–23, with Ex. 1006, 21–22. Petitioner also provides citations to the specification of the Landes Provisional that, while broad, correspond to several disclosed alternative embodiments, and the various working examples (Materials and Methods and Experimental Examples 1–5) that describe and explain how to carry out the methods claimed. Pet. 17–19 (citing, e.g., Ex. 1006, 8:7–9:27, and 10:1–20:12). Patent Owner cites precedents for the proposition that, in some circumstances, the presence of the same claim language in an original disclosure may not be enough to satisfy the description requirement. Prelim. 49 Resp. 23–24. But Patent Owner provides neither specific argument nor evidence that this is one of those circumstances. If Patent Owner believes there is some particular deficiency with respect to Landes’s claims and the written description requirement, Patent Owner leaves it unsaid.” slip op. at 49
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 7,332,277 - Apple, Inc. v. Alivecor, Inc.InstitutedPTAB · Dec 8, 2021 · IPR2021-00972 · APJ David Cotta · IPR · Institution
Instituted IPR of claims 1–23 on all three asserted §103 grounds; Apple showed a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“We typically take courts’ trial schedules at “face value,” and decline Petitioner’s invitation to speculate that the target date for completion of the ITC Investigation will slip as a result of the COVID-19 pandemic. Fintiv, IPR2020-00019, Paper 15 at 13 (informative). Accordingly, for purposes of analyzing this factor, we assume that the ITC Investigation will conclude on October 26, 2022. We also decline Petitioner’s invitation to assume an earlier date for issuance of our FWD. Although we appreciate Petitioner’s willingness to expedite resolution of this case, Patent Owner raises valid concerns that compressing the reply period will also compress the window for taking depositions. Moreover, the statutory due date for our FWD is triggered by the date of our institution decision and is unaffected by the date on which Petitioner files its reply. See 35 U.S.C. § 316(a)(11). Given that our FWD in this case is due seven weeks after the targeted completion of the ITC Investigation, we determine that this factor weighs marginally in favor of exercising our discretion to deny institution.” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Petitioner shows, based on this preliminary record, where each of the limitations of the challenged claims is taught or suggested by the combination of Shmueli and Osorio. Pet. 11–64. Petitioner’s assertions above are backed by the cited prior art and by the testimony of its declarant, Dr. Chaitman. Id.; see also Ex. 1003 ¶¶ 68–150. On this preliminary record, we determine that Petitioner’s arguments and evidence are sufficient for purposes of institution. We focus our discussion on Patent Owner’s arguments that Petitioner has not sufficiently supported a motivation to combine Shmueli and Osorio and that Shmueli and Osorio do not disclose “key elements” of the independent claims. Prelim. Resp. 30–42.” slip op. at 36
- Skill levelSkill level board ownOther
“As such, Dr. Chaitman would appear to qualify as one of ordinary skill in the art under Patent Owner’s proposed definition. Given Patent Owner’s focus on “specialized engineering skills necessary for the design, configuration, and operation of portable computing devices,” however, we note that we consider the weight of his, or any other expert’s opinions, in light of the strengths and weaknesses of their background. We further note that the research and development of medical devices is often the work of a multidisciplinary team, and courts and tribunals have frequently identified the hypothetical person of ordinary skill as a composite or team of individuals with complementary backgrounds and skills. See, e.g., AstraZeneca Pharm. LP v. Anchen Pharm., Inc., No. 10-CV-1835 JAP TJB, 2012 WL 1065458, at *19, *22 (D.N.J. Mar. 29, 2012), aff'd, 498 F. App’x 999 (Fed. Cir. 2013) (collecting cases); Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 at 10–11 (PTAB July 11, 2018) (collecting cases). In the present case, such a team might include specialists in electrical engineering, mechanical engineering, biomedical engineering, computer science, and cardiology. In this respect, Patent Owner’s expert does not discount the benefit of a background in cardiology. In particular, Dr. Efimov testifies that although a cardiologist may or may not possess the specialized engineering skills to understand the design, configuration, and operation of the subject technology, “a degree in biomedical or electrical engineering (or an equivalent), and/or extensive experience working with arrhythmia detection tools would also be necessary” Ex. 2001 ¶¶ 52–53 (emphasis added).9 Indeed, considering that the claims of the ’941 patent relate to, e.g., “method[s] of cardiac monitoring” to “confirm a presence of the arrhythmia,” we find it reasonable that one of ordinary skill in the art would encompass a multidisciplinary team including a cardiologist. Ex. 1001, 17:1–18. In view of the above, we provisionally define one of ordinary skill in the art as a multidisciplinary team comprising persons with advanced degrees in electrical engineering, mechanical engineering, biomedical engineering, computer science, and/or cardiology. The parties are welcome to further address the level of ordinary skill in the art at trial. C. Claim Construction” slip op. at 25
- Expert testimonyPetitioner expert creditedOther
“cardiac arrhythmia as opposed some other heart condition. Id. at 31–32. In this respect Patent Owner’s declarant, Dr. Efimov, testifies that Shmueli makes no attempt to define “irregular heart condition” with any specificity, and “one can only speculate” as to its meaning because “numerous conditions can be considered heart irregularities: normal autonomic nervous system control, autonomic dysfunction, heart failure, ischemia, myocardial infarction, heart block, etc.” Ex. 2001 ¶ 69. At this stage of the proceeding, however, we credit Dr. Chaitman’s testimony that Shmueli discloses “both detecting the ‘irregular heart condition’ based on PPG data and confirming the diagnosis with an ECG measurement.” Ex. 1003 ¶ 54 (citing Ex. 1004, Abstract, Fig. 8; 8:23–28). And although Shmueli “offers an expansive definition of the ‘irregular heart condition,’” one of ordinary skill in the art would have understood this term as referring to arrhythmia, which is “one of the most obvious (if not the most obvious) types of ‘irregular heart condition[s]’ that can be determined using PPG and ECG data.” Id. Considering the present record, Petitioner has established sufficiently that one of ordinary skill in the art would have understood Shmueli’s use of “irregular heart condition” as referring to—or at a minimum, encompassing—arrhythmia, and, thus, disclosing the detection of arrhythmia. See Pet. 13–14 (citing, e.g., Ex. 1003 ¶ 54).” slip op. at 37
§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,638,941 - Apple, Inc. v. Alivecor, Inc.InstitutedPTAB · Dec 8, 2021 · IPR2021-00971 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–30 on all grounds in the Petition, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“and Appeal Board Consolidated Trial Practice Guide (Nov. 2019), 58 & n.2, (“Trial Practice Guide”).6 We consider the following factors to assess “whether efficiency, fairness, and the merits support the exercise of authority to deny institution in view of an earlier trial date in the parallel proceeding”: 1. whether the court granted a stay or evidence exists that one may be granted if a proceeding is instituted; 2. proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision; 3. investment in the parallel proceeding by the court and the parties; 4. overlap between issues raised in the petition and in the parallel proceeding; 5. whether the petitioner and the defendant in the parallel proceeding are the same party; and 6. other circumstances that impact the Board’s exercise of discretion, including the merits. Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 at 5–6 (PTAB Mar. 20, 2020) (precedential) (“Fintiv”). In evaluating these factors, we “take[] a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Id. at 6. Upon consideration of these factors, we decline to exercise our discretion to deny the Petition. A. Whether the Court Granted a Stay or Evidence Exists That One May Be Granted if a Proceeding is Instituted” slip op. at 10
- Skill levelSkill level board ownOther
“skill in the art under Patent Owner’s proposed definition. Given Patent Owner’s focus on “specialized engineering skills necessary for the design, configuration, and operation of portable computing devices,” however, we consider the weight of his, or any other expert’s opinions, in light of the strengths and weaknesses of their background. We further note that the research and development of medical devices is often the work of a multidisciplinary team, and courts and tribunals have frequently identified the hypothetical person of ordinary skill as a composite or team of individuals with complementary backgrounds and skills. See, e.g., AstraZeneca Pharm. LP v. Anchen Pharm., Inc., 2012 WL 1065458, at *19, *22 (D.N.J. Mar. 29, 2012), aff'd, 498 F. App’x 999 (Fed. Cir. 2013) (collecting cases); Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 at 10–11 (PTAB July 11, 2018) (collecting cases). In the present case, such a team might include specialists in electrical engineering, mechanical engineering, biomedical engineering, computer science, and cardiology. In this respect, Patent Owner’s expert does not discount the benefit of a background in cardiology. In particular, Dr. Efimov testifies that although a cardiologist may or may not possess the specialized engineering skills to understand the design, configuration, and operation of the subject technology, “a degree in biomedical or electrical engineering (or an equivalent), and/or extensive experience working with arrhythmia detection tools would also be necessary.” Ex. 2001 ¶¶ 52–53 (emphasis added).10 Indeed, considering that the ’731 patent “relates to methods and systems for managing health and disease such as cardiac diseases including arrhythmia and atrial fibrillation,” we find it reasonable that one of ordinary skill in the art would encompass a multidisciplinary team including a cardiologist. In view of the above, we provisionally define one of ordinary skill in the art as a multidisciplinary team comprising persons with advanced degrees in electrical engineering, mechanical engineering, biomedical engineering, computer science, and/or cardiology. The parties are welcome to further address the level of ordinary skill in the art at trial.” slip op. at 27
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We interpret a claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Furthermore, at this stage in the proceeding, we need only construe the claims to the extent necessary to determine whether to institute inter partes review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). At this stage of the proceeding, no term requires construction. See Vivid Techs., 200 F.3d at 803 (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”). The parties are, of course, welcome to address the meaning of any relevant claim term at trial. D. Ground 1: Obviousness over Shmueli” slip op. at 29
- Expert testimonyPetitioner expert creditedDecided for petitioner
“At this stage of the proceeding, however, we credit Dr. Chaitman’s testimony that, “Shmueli discloses both detecting the ‘irregular heart condition’ based on PPG data and confirming the diagnosis with an ECG measurement.” Ex. 1003 ¶ 48 (citing Ex. 1004, Abstract, Fig. 8; 8:23–28). And although Shmueli “offers an expansive definition of ‘irregular heart condition,’” one of ordinary skill in the art would have understood this term as referring to arrhythmia, “which is one of the most obvious (if not the most obvious) types of ‘irregular heart condition[s]’ that can be determined using PPG and ECG data.” Id. (citing, Ex. 1016, 6081; Ex. 1020, Abstract, 44:29– 32; Ex. 1011, Abstract; Ex. 1023, 2; Ex. 1047, 320–321; Ex. 1001, 1:40–42; Ex. 1004, 8:11–13, 15:3–5) (alteration in original). Considering the present record, Petitioner has established sufficiently that one of ordinary skill in the art would have understood Shmueli’s use of “irregular heart condition” as referring to—or at a minimum, encompassing—arrhythmia, and, thus, disclosing the detection of arrhythmia. See Pet. 10–12 (citing, e.g., Ex. 1003 ¶ 48).” slip op. at 33
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,595,731
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.