- Parse Biosciences, Inc. v. 10x Genomics, Inc.All claims unpatentablePTAB · Feb 3, 2025 · IPR2023-00958 · APJ Michael J Fitzpatrick · IPR · Final written decision
Claims 1–28 are unpatentable as obvious: claims 1–12 and 19–28 over Linnarsson, McCloskey, and ordinary skill; claims 13–18 over those references plus McCloskey II.
RulingsFinal written decision- ExcludeMotion to exclude, grantedMotion to exclude, deniedGranted in part
“Clearly, the second Hall-Ellis declaration is offered to prove that McCloskey is a prior art printed publication. See, e.g., Ex. 1085 ¶50 (“In view of the foregoing, it is my opinion that [McCloskey] was publicly available no later than [January 3, 2008].”). Thus, the second Hall-Ellis declaration should have been served within ten business days of Patent Owner’s February 15, 2024, objection to the admissibility of McCloskey. See 37 C.F.R. § 42.64(b)(2) (“The party relying on evidence to which an objection is timely served may respond to the objection by serving supplemental evidence within ten business days of service of the objection.”). In its Opposition to the Motion to Exclude, Petitioner argues that, under Hulu LLC v. Sound View Innovations, LLC, No. IPR2018-01039, Paper 29 (Dec. 20, 2019) (precedential), it was allowed to wait until its Reply to file the second Hall-Ellis declaration. Paper 37, 2. The Board in Hulu does state that, “if the patent owner challenges a reference’s status as a printed publication, a petitioner may submit a supporting declaration with its reply to further support its argument that a reference qualifies as a printed publication.” Hulu, at 15 (37 C.F.R. § 42.23). However, the Board’s statement was referring to the scope of permissible reply arguments under 37 C.F.R. § 42.23(b). See Hulu at 14 (quoting 37 C.F.R. § 42.23(b)’s requirement that “[a] reply may only respond to arguments raised in the corresponding opposition, patent owner preliminary response, or patent owner response”). The Board in Hulu does not purport to interpret 37 C.F.R. § 42.64 or even discuss supplemental evidence. Petitioner clearly missed the deadline imposed by 37 C.F.R. § 42.64(b)(2), which was triggered by Patent Owner’s February 15, 2024, objection to McCloskey (i.e., Ex. 1004). Patent Owner’s Motion to Exclude is granted with respect to the second Hall-Ellis declaration (i.e., Ex. 1085).” slip op. at 18
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“Patent Owner is correct that, under Sanofi-Aventis, a petitioner bears the burden of persuasion to establish that an asserted prior art reference is analogous art to the claimed invention. See Sanofi-Aventis, 66 F.4th at 1377 (“We agree with [the patent owner] that [the petitioner] did not carry its burden to argue that de Gennes is analogous to the [challenged] patent.”); id. (“In evaluating whether a reference is analogous, we have consistently held that a patent challenger must compare the reference to the challenged patent.”); id. at 1378–79 (“We have routinely held that the petitioner has the burden of proving unpatentability.”). However, as we noted when instituting this proceeding, “Sanofi-Aventis further held: ‘A petitioner is not required to anticipate and raise analogous art arguments in its petition; instead a petitioner can use its reply to “respond to arguments raised in the corresponding opposition, patent owner preliminary response, patent owner response, or decision on institution.”’” Dec. on Reh’g 16 (quoting Sanofi- Aventis, 66 F.4th at 1379 (quoting 37 C.F.R. § 42.23)).” slip op. at 15
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Clearly, the second Hall-Ellis declaration is offered to prove that McCloskey is a prior art printed publication. See, e.g., Ex. 1085 ¶50 (“In view of the foregoing, it is my opinion that [McCloskey] was publicly available no later than [January 3, 2008].”). Thus, the second Hall-Ellis declaration should have been served within ten business days of Patent Owner’s February 15, 2024, objection to the admissibility of McCloskey. See 37 C.F.R. § 42.64(b)(2) (“The party relying on evidence to which an objection is timely served may respond to the objection by serving supplemental evidence within ten business days of service of the objection.”). In its Opposition to the Motion to Exclude, Petitioner argues that, under Hulu LLC v. Sound View Innovations, LLC, No. IPR2018-01039, Paper 29 (Dec. 20, 2019) (precedential), it was allowed to wait until its Reply to file the second Hall-Ellis declaration. Paper 37, 2. The Board in Hulu does state that, “if the patent owner challenges a reference’s status as a printed publication, a petitioner may submit a supporting declaration with its reply to further support its argument that a reference qualifies as a printed publication.” Hulu, at 15 (37 C.F.R. § 42.23). However, the Board’s statement was referring to the scope of permissible reply arguments under 37 C.F.R. § 42.23(b). See Hulu at 14 (quoting 37 C.F.R. § 42.23(b)’s requirement that “[a] reply may only respond to arguments raised in the corresponding opposition, patent owner preliminary response, or patent owner response”). The Board in Hulu does not purport to interpret 37 C.F.R. § 42.64 or even discuss supplemental evidence. Petitioner clearly missed the deadline imposed by 37 C.F.R. § 42.64(b)(2), which was triggered by Patent Owner’s February 15, 2024, objection to McCloskey (i.e., Ex. 1004). Patent Owner’s Motion to Exclude is granted with respect to the second Hall-Ellis declaration (i.e., Ex. 1085). Despite the exclusion of the second Hall-Ellis declaration, there is ample evidence in the record demonstrating that McCloskey is a prior art printed publication. McCloskey itself states: “Received: 31 January 2007 / Accepted: 29 May 2007 / Published online: 23 October 2007.” Ex. 1004, 1. McCloskey additionally states that it was published in a 2007 print issue of “Biochem Genet,” with Petitioner adding that the full name of the journal is BIOCHEMICAL GENETICS and that McCloskey was published in a December 2007 volume of the journal. Id.; Pet. 22. McCloskey also includes a copyright notice by “Springer Science+Business Media, LLC” with a date of 2007. Ex. 1004, 1. Patent Owner argues that this is unreliable hearsay that should be excluded. PO Mot. To Exclude 4 (citing Neste Oil Oyj v. REG Synthetic Fuels, LLC, No. IPR2013-00578, Paper 53 at 5–7 (Mar. 12, 2015); Standard Innovation Corp. v. Lelo, Inc., No. IPR2014-00148, Paper 429 at 13–18, 21–22 (Apr. 23, 2015)). We are not persuaded by Patent Owner’s argument or its reliance on these cases. The facts before us are different.” slip op. at 18
- Skill levelSkill level patent owner adoptedDecided for patent owner
“Patent Owner does not directly dispute Petitioner’s proposal but does offer its own proposal. PO Resp. 21. Patent Owner proposes that the skilled artisan “would have had a Ph.D. in molecular biology, molecular genetics, biochemistry, physics, mechanical engineering, or a related discipline, with 7 Exhibit 1002 is a declaration by Petitioner’s witness, Gregory Cooper, Ph.D. two years of academic, research, or industry experience in the field of genomic or transcriptome sequencing.” Id. (citing Ex. 2013 ¶¶25–268). Both of the parties’ proposals as to the level of ordinary skill in the art are consistent with the disclosure of the ’013 patent and the asserted prior art. The distinction between the parties’ proposals would not change the outcome of this Decision. Thus, we adopt and apply Patent Owner’s proposal.” slip op. at 9
Patent outcomesUS 10,697,013 unpatentable§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,697,013 - Parse Biosciences, Inc. v. 10x Genomics, Inc.All claims unpatentablePTAB · Jan 31, 2025 · IPR2023-00955 · APJ Michael J Fitzpatrick · IPR · Final written decision
Claims 1–26 are unpatentable as obvious: claims 1–4, 6–11, 20, and 23–25 over Linnarsson and McCloskey; claims 5, 12, 21, 22, and 26 with ordinary-skill knowledge; claims 13–19 with McCloskey II.
RulingsFinal written decision- ExcludeMotion to exclude, grantedGranted in part
“Clearly, the second Hall-Ellis declaration is offered to prove that McCloskey is a prior art printed publication. See, e.g., Ex. 1085 ¶50 (“In view of the foregoing, it is my opinion that [McCloskey] was publicly available no later than [January 3, 2008].”). Thus, the second Hall-Ellis declaration should have been served within ten business days of Patent Owner’s February 15, 2024, objection to the admissibility of McCloskey. See 37 C.F.R. § 42.64(b)(2) (“The party relying on evidence to which an objection is timely served may respond to the objection by serving supplemental evidence within ten business days of service of the objection.”). In its Opposition to the Motion to Exclude, Petitioner argues that, under Hulu LLC v. Sound View Innovations, LLC, No. IPR2018-01039, Paper 29 (Dec. 20, 2019) (precedential), it was allowed to wait until its Reply to file the second Hall-Ellis declaration. Paper 37, 2. The Board in Hulu does state that, “if the patent owner challenges a reference’s status as a printed publication, a petitioner may submit a supporting declaration with its reply to further support its argument that a reference qualifies as a printed publication.” Hulu at 15 (37 C.F.R. § 42.23). However, the Board’s statement was referring to the scope of permissible reply arguments under 37 C.F.R. § 42.23(b). See Hulu at 14 (quoting 37 C.F.R. § 42.23(b)’s in the prior sentence and in the subtitle to the relevant portion of its Objection. Id. requirement that “[a] reply may only respond to arguments raised in the corresponding opposition, patent owner preliminary response, or patent owner response”). The Board in Hulu does not purport to interpret 37 C.F.R. § 42.64 or even discuss supplemental evidence. Petitioner clearly missed the deadline imposed by 37 C.F.R. § 42.64(b)(2), which was triggered by Patent Owner’s February 15, 2024, objection to McCloskey. Patent Owner’s Motion to Exclude is granted with respect to the second Hall-Ellis declaration (i.e., Ex. 1085). Despite the exclusion of the second Hall-Ellis declaration, there is ample evidence in the record demonstrating that McCloskey is a prior art printed publication. McCloskey itself states: “Received: 31 January 2007 / Accepted: 29 May 2007 / Published online: 23 October 2007.” Ex. 1004, 1. McCloskey additionally states that it was published in a 2007 print issue of “Biochem Genet,” with Petitioner adding that the full name of the journal is BIOCHEMICAL GENETICS and that McCloskey was published in a December 2007 volume of the journal. Id.; Pet. 29. McCloskey also includes a copyright notice by “Springer Science+Business Media, LLC” with a date of date of 2007. Ex. 1004, 1. Patent Owner argues that this is unreliable hearsay that should be excluded. PO Mot. To Exclude 4 (citing Neste Oil Oyj v. REG Synthetic Fuels, LLC, No. IPR2013-00578, Paper 53 at 5–7 (Mar. 12, 2015); Standard Innovation Corp. v. Lelo, Inc., No. IPR2014- 00148, Paper 4210 at 13–18, 21–22 (Apr. 23, 2015)). We are not persuaded 10 Patent Owner actually cited to “Pap.41” of Standard Innovation. PO Mot. To Exclude 4. There is no Paper 41 in the record of that case. We presume Patent Owner intended to cite Paper 42, which is the final written decision in that case. by Patent Owner’s argument or its reliance on these cases. The facts before us are different. In Neste Oil, the Board “note[d] that the alleged ‘stamps’ of Exhibits 1125 and 1132 are actually handwritten dates, added to the documents by an unknown person at an unknown time.” Neste Oil, Paper 53 at 6. In contrast, the dates relied upon by Petitioner are printed, appear to have been included at the time of printing, and appear to have been printed by, or at the direction of, the journal and/or copyright holder, both of which are identified by McCloskey. Ex. 1004, 1. In Standard Innovation, the alleged prior art exhibits were “printouts of … webpages” bearing a copyright indication of “© 2003-2013,” which the petitioner argued was proof of subset of the webpages being disseminated publicly in 2003. Standard Innovation, Paper 42 at 13. This is a far cry from McCloskey, which is a journal article and which includes specific date information, not only of publishing, but also of when the journal received and accepted the article for publication as well as when it was copyrighted. Ex. 1004, 1.” slip op. at 18
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“Patent Owner is correct that, under Sanofi-Aventis, a petitioner bears the burden of persuasion to establish that an asserted prior art reference is analogous art to the claimed invention. See Sanofi-Aventis, 66 F.4th at 1377 (“We agree with [the patent owner] that [the petitioner] did not carry its burden to argue that de Gennes is analogous to the [challenged] patent.”); id. (“In evaluating whether a reference is analogous, we have consistently held that a patent challenger must compare the reference to the challenged patent.”); id. at 1378–79 (“We have routinely held that the petitioner has the burden of proving unpatentability.”). However, as we noted when instituting this proceeding, “Sanofi-Aventis further held: ‘A petitioner is not required to anticipate and raise analogous art arguments in its petition; instead a petitioner can use its reply to “respond to arguments raised in the corresponding opposition, patent owner preliminary response, patent owner response, or decision on institution.”’” Dec. on Reh’g 15 (quoting Sanofi- Aventis, 66 F.4th at 1379 (quoting 37 C.F.R. § 42.23)).” slip op. at 14
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“by Patent Owner’s argument or its reliance on these cases. The facts before us are different. In Neste Oil, the Board “note[d] that the alleged ‘stamps’ of Exhibits 1125 and 1132 are actually handwritten dates, added to the documents by an unknown person at an unknown time.” Neste Oil, Paper 53 at 6. In contrast, the dates relied upon by Petitioner are printed, appear to have been included at the time of printing, and appear to have been printed by, or at the direction of, the journal and/or copyright holder, both of which are identified by McCloskey. Ex. 1004, 1. In Standard Innovation, the alleged prior art exhibits were “printouts of … webpages” bearing a copyright indication of “© 2003-2013,” which the petitioner argued was proof of subset of the webpages being disseminated publicly in 2003. Standard Innovation, Paper 42 at 13. This is a far cry from McCloskey, which is a journal article and which includes specific date information, not only of publishing, but also of when the journal received and accepted the article for publication as well as when it was copyrighted. Ex. 1004, 1. That McCloskey is what it purports to be (a journal article) and that it was published in 2007 are corroborated by multiple pieces of evidence.” slip op. at 20
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“In sum, we find Petitioner’s rationale that a skilled artisan would have made the proposed combination to solve the problem of amplification bias persuasive.” slip op. at 44
Patent outcomesUS 10,240,197 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,240,197 - Parse Biosciences, Inc. v. 10x Genomics, Inc.All claims unpatentablePTAB · Sep 17, 2024 · IPR2023-00876 · APJ Michael J Fitzpatrick · IPR · Final written decision
Claims 1–6 are unpatentable: claims 1–4 and 6 as obvious over Linnarsson and McCloskey, and claim 5 as obvious over those references and ordinary skill.
RulingsFinal written decision- ExcludeMotion to exclude, grantedMotion to exclude, deniedGranted in part
“Clearly, the second Hall-Ellis declaration is offered to prove that McCloskey is a prior art printed publication. See, e.g., Ex. 1065 ¶50 (“In view of the foregoing, it is my opinion that [McCloskey] was publicly available no later than [January 3, 2008].”). Thus, the second Hall-Ellis declaration should have been served within ten business days of Patent Owner’s October, 27, 2023, objection to the admissibility of McCloskey. See 37 C.F.R. § 42.64(b)(2) (“The party relying on evidence to which an objection is timely served may respond to the objection by serving supplemental evidence within ten business days of service of the objection.”). Because it was not filed until March 29, 2024, Patent Owner’s Motion to Exclude is granted with respect to the second Hall-Ellis declaration. In its Opposition to the Motion to Exclude, Petitioner argues that, under Hulu LLC v. Sound View Innovations, LLC, No. IPR2018-01039, Paper 29 (Dec. 20, 2019) (precedential), it was allowed to wait until its Reply to file the second Hall-Ellis declaration. Paper 37, 1–2. The Board in Hulu does state that, “if the patent owner challenges a reference’s status as a printed publication, a petitioner may submit a supporting declaration with its reply to further support its argument that a reference qualifies as a printed publication.” Hulu, at 15 (37 C.F.R. § 42.23). However, the Board’s statement was referring to the scope of permissible reply arguments under 37 C.F.R. § 42.23(b). See Hulu at 14 (quoting 37 C.F.R. § 42.23(b)’s requirement that “[a] reply may only respond to arguments raised in the corresponding opposition, patent owner preliminary response, or patent owner response”). The Board in Hulu does not purport to interpret 37 C.F.R. § 42.64 or even discuss supplemental evidence. Petitioner clearly missed the deadline imposed by 37 C.F.R. § 42.64(b)(2), which was triggered by Patent Owner’s October 27, 2023, objection to McCloskey. Patent Owner’s Motion to Exclude is granted with respect to the second Hall-Ellis declaration (i.e., Ex. 1065).” slip op. at 16
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“We find that both references are analogous art to the ’981 patent, as there is ample supporting evidence in the record, including that to which the Reply cites (citations identified in the immediately preceding paragraph). Indeed, Patent Owner does not dispute the merits of either argument. PO Sur-Reply 27–28. Rather, Patent Owner, argues that we “should not now permit Petitioner to rewrite its clearly-deficient Petition.” Id. at 28. Petitioner’s Reply does not re-write its Petition. What Petitioner’s Reply does, in response to Patent Owner’s arguments, is precisely what Sanofi-Aventis contemplates as being proper in a reply brief. Indeed, in ruling against the petitioner in Sanofi-Aventis, the Federal Circuit specifically noted that the petitioner could have used its reply brief “to explain how [the prior art reference] is analogous to the [challenged] patent” but did not do so. 66 F.4th at 1379–1380. Here, in contrast, Petitioner used its Reply brief to explain how Linnarsson and McCloskey are analogous to the ’981 patent. Petitioner’s explanation in its Reply brief was both proper and persuasive.” slip op. at 14
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedReference is prior artDecided for petitioner
“That McCloskey is what it purports to be (a journal article) and that it was published in 2007 are corroborated by multiple pieces of evidence. McCloskey names four authors, all four of whom are named inventors of US 2007/0020640 A1, published Jan. 25, 2007 (“McCloskey ’640”). Ex. 1004, 1, Ex. 2001, code (76). Patent Owner concedes that McCloskey and McCloskey ’640 involve the same subject matter, having argued that the consideration of McCloskey ’640 supported discretionary denial of the Petition based on McCloskey. See, e.g., Prelim. Resp. 22 (“Petitioner’s secondary reference, an article by McCloskey, is at best cumulative of the far more detailed McCloskey ’640, which was raised by the Office and substantively discussed as the basis for a potential rejection using its asserted disclosure of a polynucleotide-specific tag—the same purported teaching for which Petitioner relies on McCloskey here.”). Notably, McCloskey ’640 was published on January 25, 2007. Ex. 2001, code (43). That is just days before McCloskey was received by BIOCHEMICAL GENETICS on January 31, 2007. See EX. 1004, 1 (“Received: 31 January 2007 / Accepted: 29 May 2007 / Published online: 23 October 2007”). In other words, it appears that the authors sought to have their research published in a scientific journal promptly after the subject matter of their research had been published by the Office. Further, the existence of McCloskey and its publication year of 2007 is confirmed by other sources in the record. See Ex. 1029, code (56) (United States Patent identifying as a cited reference: “McCloskey, et al. Encoding Pcr products with batch-stamps and barcodes. Biochem Genet. Dec. 2007;45(11-12):761-7. Epub Oct. 23, 2007.”); Ex. 1053, code (56) (same); Ex. 1060 (article’s bibliography citing “McCloskey ML, Stöger R, Hansen RS, Laird CD. Encoding PCR products with batch-stamps and barcodes. Biochem. Genet 2007;45:761–767. [PubMed: 17955361]”). Patent Owner’s Motion to Exclude is denied with respect to” slip op. at 19
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“The Petition states that “Petitioner does not believe that any terms require explicit construction in view of the prior art being presented.” Pet. 36. Despite this stated position, Petitioner proposed constructions for “multiplex-identifier (MID)” and “providing a sample.” Id. Patent Owner, in its Preliminary Response, stated that it “agrees that at this time, solely for purposes of an institution decision on the Petition, no terms require explicit construction.” Prelim. Resp. 45. In instituting the IPR, we found no need to provide an express construction of any claim term. Inst. Dec. 6. In the Patent Owner Response, Patent Owner repeats that it “does not believe any term needs construction,” but nonetheless “applies the Petition’s definitions for ‘MID’ and ‘sample.’” PO Resp. 19. The Petition defines MID as “‘a tag or combination of tags associated with a polynucleotide whose identity (e.g., the tag DNA sequence) can be used to differentiate polynucleotides in a sample.’” Pet. 36 (quoting Ex. 1001, 6:33–38). The Petition defines sample as “‘a quantity of material from a biological, environmental medical, or patient source in which detection, measurement, or labeling of target nucleic acids is sought.’” Id. (quoting Ex. 1001, 12:7– 10). We apply these same definitions in our analysis.” slip op. at 6
Patent outcomesUS 10,155,981 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,155,981 - PTAB · Oct 31, 2023 · PGR2022-00040 · APJ Cynthia M Hardman · PGR · Final written decision
The Board cancelled claims 1–17 and denied substitute claims 18–30 for lack of written-description support; it did not reach the remaining grounds against the substitute claims.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“For the reasons discussed below, on the full trial record, we find that Patent Owner has not carried its burden of showing by a preponderance of the evidence that the proposed substitute claims introduce no new matter relative to the original disclosure. 35 U.S.C. § 326(d)(3); 37 C.F.R. § 42.221(d)(1); see also Paper 58, 2 (Patent Owner acknowledging that it “bears the burden to meet the regulatory and statutory requirements” for a motion to amend, including demonstrating that the substitute claims do not “introduce new matter”). Importantly, we note that Patent Owner fails to explain how the material cited in the claim chart supports the claims. See Mot. 15–16. Instead, Patent Owner provides only a claim chart with bare citations, leaving it to the panel to discern how the cited material supports the claim limitations. See id. Patent Owner’s failure to explain the citations constitutes a fatal error, as we have reviewed the passages cited by Patent Owner and are unable to discern where support is found for several of the substitute claim limitations. Where, as here, “the Board is unable to determine how the specification and drawings support the proposed substitute claims, the motion to amend may be denied.” Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019) (“TPG”),6 71.” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“Petitioner persuades us that the ’418 Application lacks adequate written description support for the formulation limitations of proposed substitute claim 18 [limitations 18a–8c]. As outlined by Petitioner and its declarants, the ’418 Application, including the Abstract, Field of the Invention, Summary of the Invention, and Detailed Description of the Invention sections, uniformly focuses on phosphate prodrugs of levodopa and carbidopa. See, e.g., Ex. 1004 (Sloan Decl.) ¶¶ 38–55, 64–69; Ex. 1003 (LeWitt Decl.) ¶¶ 89–97; Ex. 1047 (Forrest Decl.) ¶¶ 40–74, 80–92; Opp. 6– 10; Pet. 23–26, 49–55. We agree with Petitioner that “nothing in the specification suggests that the invention includes methods of subcutaneous infusion with anything other than the carbidopa prodrugs and L-dopa prodrugs of Formulas (I) and (II), respectively, or teaches how to get sufficient amounts of either L-dopa or carbidopa into solution, or achieve particular L-dopa plasma levels, without those particular prodrugs.” Pet. 27. Petitioner persuades us that the ’418 Application fails to contain “[so] much as a single generic sentence, anywhere in the application, suggesting the inventors possessed the claimed formulations.” Sur-reply 3. Additionally, the ’418 Application contains no example teaching administration of an aqueous formulation comprising carbidopa itself with levodopa itself or one of the three claimed levodopa prodrugs, let alone one that is suitable for continuous subcutaneous administration. See Ex. 1047 (Forrest Decl.) ¶¶ 61–72, 82–92. Patent Owner is correct that to establish written description support, neither “an actual reduction to practice,” nor a verbatim recitation of the claims is required. Sur-reply 4. Nevertheless, “[a]lthough examples are not always required to satisfy the written description requirement, the lack of any disclosure of examples may be considered when determining whether the claimed invention is adequately described.” Bos. Sci. Corp. v. Johnson & Johnson, 647 F.3d 1353, 1364 (Fed. Cir. 2011). Here, the lack of an actual reduction to practice or verbatim description of a formulation that falls within the scope of the claims is relevant, because we also see no other description or material in the ’418 Application that suggests the claimed methods extend to continuous subcutaneous administration of a composition comprising levodopa or one of the three claimed levodopa prodrugs, together with carbidopa, in an aqueous carrier.” slip op. at 28
- ExcludeMotion to exclude, deniedDenied
“All of the exhibits that are the subject of Patent Owner’s motion to exclude relate to the prior-art status and/or authenticity of Yacoby-Zeevi and ancillary related documents underlying Petitioner’s prior art-based challenges to the proposed substitute claims. See generally MTE. Because we deny Patent Owner’s request to enter proposed substitute claims 18–30 based on lack of written description support and do not reach Petitioner’s prior-art based challenges to the patentability of these claims, we do not rely on Exhibits 1005, 1007, 1040–1044, 1046, or 1048–1050 in this Decision. Accordingly we dismiss Patent Owner’s Motion to Exclude as moot.” slip op. at 49
- Strike new argumentNew argument consideredDenied
“On the other hand, Petitioner shows that Patent Owner took positions in its Motion to Amend that it only later sought to support with technical declarations. For example, in the Motion to Amend, Patent Owner elected to assert “that levodopa and carbidopa could be ‘interchanged’ in a formulation with their prodrugs, and that a skilled artisan could ‘perform a pharmacokinetic analysis to predict steady state levodopa plasma levels’ using the ‘parent compounds’ based on Example 24.” MTS 2 (citing Mot. 12–13). Patent Owner, however, “chose to forgo any expert support” on these issues at the time it filed its Motion to Amend, and instead waited until the Reply to submit technical declarations in support of these arguments. Id. We agree with Petitioner that although Patent Owner “was not required to anticipate the arguments that [Petitioner] would make in its Opposition” to the Motion to Amend, if Patent Owner “wanted to provide expert testimony to support the positions it actually took” in that Motion, “the TPG required [Patent Owner] to do so at that time, instead of waiting until [Petitioner] had limited ability to respond.” Id. at 5. Accordingly, we agree with Petitioner that in this respect at least some portions of Patent Owner’s Declarations are untimely, because it is “improper for a reply to present new evidence (including new expert testimony) that could have been presented in a prior filing.” TPG 74. Nevertheless, an order striking arguments and evidence in their entirety is an “exceptional remedy,” particularly under the circumstances here, where some portions of the Declarations are proper, while other portions are untimely. TPG 80. Moreover, “there is a strong public policy for making all information filed in an administrative proceeding available to the public.” Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012- 00010, Paper 59 at 40 (PTAB Feb. 24, 2014). Under the facts of this case, Patent Owner was permitted to file evidence to respond to Petitioner’s unpatentability claims, but also belatedly supported positions it made in earlier attorney argument. Petitioner’s Motion to Strike, however, challenges all of Patent Owner’s evidence, without acknowledging that some portions constitute proper reply. Although “[t]he Board is not required to attempt to sort proper from improper portions of the reply” (TPG 74, emphasis added), under the circumstances here, we agree with Patent Owner that Petitioner’s lack of specificity as to what it seeks to strike is fatal to Petitioner’s motion. Accordingly, we decline to strike the Declarations in their entirety as untimely.” slip op. at 46
§ 112 disclosurePatents in suitUS 11,091,507 - Applied Materials, Inc. v. Ocean Semiconductor LLCAll claims unpatentablePTAB · Feb 7, 2023 · IPR2022-00680 · APJ Miriam L Quinn · IPR · Final written decision
Claims 1–22 of the ’248 patent and claims 1–25 and 33–53 of the ’305 patent are unpatentable as obvious over Schulze and Gupta.
RulingsFinal written decision- Strike new argumentNew argument disregardedNew argument consideredGranted in part
“Petitioner an opportunity to respond raises concerns as to whether we should consider it. The issue of enablement is a mixed issue of law and fact, where underlying facts may be necessary to support such a conclusion. Minn. Mining & Mfg. Co. v. Chemque, Inc., 303 F.3d 1294, 1301 (Fed. Cir. 2002). The lack of evidence for the proposition that the art is not enabled and the further lack of an opportunity for rebuttal argument make this issue one that is not fully developed on the full record before us, and particularly because it was raised too late. Thus, we agree with Petitioner that this is an issue on” slip op. at 98
- Skill levelOther
“E. Level of Ordinary Skill in the Art Petitioner contends that a person having ordinary skill in the art” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“A. Whether the preamble is limiting The standard that governs the significance of the “preamble” in claim” slip op. at 15
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“monitoring and assessment system that is suitable for implementing the local scheduler and related data structures disclosed in Gupta, which is implemented in software. Id. ¶ 125. The need for a scheduler that works as a local optimizer is evidenced by the recognition in Gupta’s disclosure of real-time scheduling decisions, which are advantageous for dealing with unexpected or unplanned events in a manufacturing process. Id. ¶ 121 (citing Ex. 1008, 30:19−20). Further, the local optimization scheme would have been desirable for devising scheduling strategies for specific machines, resulting in a reduction of re-engineering efforts each time a new machine is added to the process flow. Id. ¶ 119. Because Gupta focuses on a specific machine and the strategy devised for each machine, the decision-making is simplified as it focuses on optimizing each machine and not re-programming the entire process flow for the factory. Id. ¶¶ 116−118. As stated above, the enhancement of using Gupta’s local optimizer stems from the recognition that global process flow scheduling was an NP-hard program of extensive computing costs; yet, Gupta solved for it by reducing the computational costs of scheduling through optimizing local machines, rather than performing global factory calculations each time an event occurs. Id. ¶¶ 114−116; Ex. 1008, 8:48−55, 13:22−34; 13:43−48; 14:6−11. The testimony of Dr. Shanfield is persuasive and supported by the facts, and we credit it accordingly. Dr. Shanfield regarding the expectation of success is supported by the facts and we credit it accordingly. Dr. Shanfield opines that Schulze’s system is specifically designed to monitor the state of the equipment and to provide notification of events like machine operation status transitions. 1342 Shanfield Decl. ¶ 123. Gupta’s local optimization scheme is driven by events like those that Schulze captures. Id. Gupta provides additional events that are useful for Schulze’s factory, such as machine loads and unloads. Id. Thus, we agree that Schulze’s system is particularly suitable for Gupta’s local optimization scheme. And according to Dr. Shanfield, the implementation of Gupta’s scheduler (together with its database and its related data structures) would be suitable for implementation in the computer of Schulze (automated monitoring and assessment system 107) because they are both software compatible. Id. ¶¶ 124−125. Once Gupta’s scheduler is implemented in Schulze’s computer, there are no changes to the functions performed by Schulze’s semiconductor fabrication system or Gupta’s local optimization scheme. Id. ¶ 127. The implementation would require adjustments to the local scheduler program, so that it can interpret and interact with the messages generated by the equipment and MES of Schulze. Id. However, Dr. Shanfield testifies that, “[b]ased on my industry experience, such routine adjustments to the local scheduler software involve tasks like making one-time inputs identifying status flags for each equipment module being characterized, and are well within the ordinary skill of a POSA.” Id. None of these tasks would have required special techniques or extraordinary skill given the well-known components and standards used in the Schulze and Gupta implementations. Id. ¶ 128.” slip op. at 57
Patent outcomesUS 6,907,305 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 6,907,305 - Applied Materials, Inc. v. Ocean Semiconductor LLCAll claims unpatentablePTAB · Feb 7, 2023 · IPR2021-01344 · APJ Miriam L Quinn · IPR · Final written decision
Claims 1–22 of the ’248 patent and claims 1–25 and 33–53 of the ’305 patent are unpatentable as obvious over Schulze and Gupta.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“A. Whether the preamble is limiting The standard that governs the significance of the “preamble” in claim” slip op. at 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“the “software scheduling agent” broadly as being “capable of reactively scheduling appointments for activities in the process flow responsive to an automatic detection and notification of a plurality of predetermined events.” Ex. 1001, 32:7−11; Ex. 1001, 43:48−50, 44:54−58 (claim 44 of the ’305 patent recites similar language except it requires scheduling appointments for processing the work pieces through the process stations, instead of for activities in the process flow). Again, this language is agnostic as to which manufacturing domain entity the software scheduling agent is monitoring and scheduling for. For instance, an MSA receives any changes that occur to a particular machine. Ex. 1001, 7:61−62. If the availability of the machine changes, the MSA subscribed to monitor for notifications from that specific machine receives an alert and reacts appropriately. Id. at 7:62−67. Likewise, the change of an appointment for processing a lot causes a notification for the corresponding lot scheduling agent, which will then change its calendar accordingly. Id. at 9:51−59. Regardless of whether it is a machine or a lot, the claimed software scheduling agent is notified of an event, and then reactively schedules an appointment for a corresponding manufacturing entity domain in response to the event. It is therefore” slip op. at 29
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“monitoring and assessment system that is suitable for implementing the local scheduler and related data structures disclosed in Gupta, which is implemented in software. Id. ¶ 125. The need for a scheduler that works as a local optimizer is evidenced by the recognition in Gupta’s disclosure of real-time scheduling decisions, which are advantageous for dealing with unexpected or unplanned events in a manufacturing process. Id. ¶ 121 (citing Ex. 1008, 30:19−20). Further, the local optimization scheme would have been desirable for devising scheduling strategies for specific machines, resulting in a reduction of re-engineering efforts each time a new machine is added to the process flow. Id. ¶ 119. Because Gupta focuses on a specific machine and the strategy devised for each machine, the decision-making is simplified as it focuses on optimizing each machine and not re-programming the entire process flow for the factory. Id. ¶¶ 116−118. As stated above, the enhancement of using Gupta’s local optimizer stems from the recognition that global process flow scheduling was an NP-hard program of extensive computing costs; yet, Gupta solved for it by reducing the computational costs of scheduling through optimizing local machines, rather than performing global factory calculations each time an event occurs. Id. ¶¶ 114−116; Ex. 1008, 8:48−55, 13:22−34; 13:43−48; 14:6−11. The testimony of Dr. Shanfield is persuasive and supported by the facts, and we credit it accordingly. Dr. Shanfield regarding the expectation of success is supported by the facts and we credit it accordingly. Dr. Shanfield opines that Schulze’s system is specifically designed to monitor the state of the equipment and to provide notification of events like machine operation status transitions. 1342 Shanfield Decl. ¶ 123. Gupta’s local optimization scheme is driven by events like those that Schulze captures. Id. Gupta provides additional events that are useful for Schulze’s factory, such as machine loads and unloads. Id. Thus, we agree that Schulze’s system is particularly suitable for Gupta’s local optimization scheme. And according to Dr. Shanfield, the implementation of Gupta’s scheduler (together with its database and its related data structures) would be suitable for implementation in the computer of Schulze (automated monitoring and assessment system 107) because they are both software compatible. Id. ¶¶ 124−125. Once Gupta’s scheduler is implemented in Schulze’s computer, there are no changes to the functions performed by Schulze’s semiconductor fabrication system or Gupta’s local optimization scheme. Id. ¶ 127. The implementation would require adjustments to the local scheduler program, so that it can interpret and interact with the messages generated by the equipment and MES of Schulze. Id. However, Dr. Shanfield testifies that, “[b]ased on my industry experience, such routine adjustments to the local scheduler software involve tasks like making one-time inputs identifying status flags for each equipment module being characterized, and are well within the ordinary skill of a POSA.” Id. None of these tasks would have required special techniques or extraordinary skill given the well-known components and standards used in the Schulze and Gupta implementations. Id. ¶ 128.” slip op. at 57
- Strike new argumentNew argument disregardedNew argument consideredGranted in part
“Petitioner an opportunity to respond raises concerns as to whether we should consider it. The issue of enablement is a mixed issue of law and fact, where underlying facts may be necessary to support such a conclusion. Minn. Mining & Mfg. Co. v. Chemque, Inc., 303 F.3d 1294, 1301 (Fed. Cir. 2002). The lack of evidence for the proposition that the art is not enabled and the further lack of an opportunity for rebuttal argument make this issue one that is not fully developed on the full record before us, and particularly because it was raised too late. Thus, we agree with Petitioner that this is an issue on” slip op. at 98
Patent outcomesUS 6,907,305 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 6,907,305 - Applied Materials, Inc. v. Ocean Semiconductor LLCAll claims unpatentablePTAB · Feb 7, 2023 · IPR2021-01342 · APJ Miriam L Quinn · IPR · Final written decision
Claims 1–22 of the ’248 patent and claims 1–25 and 33–53 of the ’305 patent are unpatentable as obvious over Schulze and Gupta.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedDecided for petitioner
“monitoring and assessment system that is suitable for implementing the local scheduler and related data structures disclosed in Gupta, which is implemented in software. Id. ¶ 125. The need for a scheduler that works as a local optimizer is evidenced by the recognition in Gupta’s disclosure of real-time scheduling decisions, which are advantageous for dealing with unexpected or unplanned events in a manufacturing process. Id. ¶ 121 (citing Ex. 1008, 30:19−20). Further, the local optimization scheme would have been desirable for devising scheduling strategies for specific machines, resulting in a reduction of re-engineering efforts each time a new machine is added to the process flow. Id. ¶ 119. Because Gupta focuses on a specific machine and the strategy devised for each machine, the decision-making is simplified as it focuses on optimizing each machine and not re-programming the entire process flow for the factory. Id. ¶¶ 116−118. As stated above, the enhancement of using Gupta’s local optimizer stems from the recognition that global process flow scheduling was an NP-hard program of extensive computing costs; yet, Gupta solved for it by reducing the computational costs of scheduling through optimizing local machines, rather than performing global factory calculations each time an event occurs. Id. ¶¶ 114−116; Ex. 1008, 8:48−55, 13:22−34; 13:43−48; 14:6−11. The testimony of Dr. Shanfield is persuasive and supported by the facts, and we credit it accordingly. Dr. Shanfield regarding the expectation of success is supported by the facts and we credit it accordingly. Dr. Shanfield opines that Schulze’s system is specifically designed to monitor the state of the equipment and to provide notification of events like machine operation status transitions. 1342 Shanfield Decl. ¶ 123. Gupta’s local optimization scheme is driven by events like those that Schulze captures. Id. Gupta provides additional events that are useful for Schulze’s factory, such as machine loads and unloads. Id. Thus, we agree that Schulze’s system is particularly suitable for Gupta’s local optimization scheme. And according to Dr. Shanfield, the implementation of Gupta’s scheduler (together with its database and its related data structures) would be suitable for implementation in the computer of Schulze (automated monitoring and assessment system 107) because they are both software compatible. Id. ¶¶ 124−125. Once Gupta’s scheduler is implemented in Schulze’s computer, there are no changes to the functions performed by Schulze’s semiconductor fabrication system or Gupta’s local optimization scheme. Id. ¶ 127. The implementation would require adjustments to the local scheduler program, so that it can interpret and interact with the messages generated by the equipment and MES of Schulze. Id. However, Dr. Shanfield testifies that, “[b]ased on my industry experience, such routine adjustments to the local scheduler software involve tasks like making one-time inputs identifying status flags for each equipment module being characterized, and are well within the ordinary skill of a POSA.” Id. None of these tasks would have required special techniques or extraordinary skill given the well-known components and standards used in the Schulze and Gupta implementations. Id. ¶ 128.” slip op. at 57
- Strike new argumentNew argument disregardedNew argument consideredGranted in part
“Petitioner an opportunity to respond raises concerns as to whether we should consider it. The issue of enablement is a mixed issue of law and fact, where underlying facts may be necessary to support such a conclusion. Minn. Mining & Mfg. Co. v. Chemque, Inc., 303 F.3d 1294, 1301 (Fed. Cir. 2002). The lack of evidence for the proposition that the art is not enabled and the further lack of an opportunity for rebuttal argument make this issue one that is not fully developed on the full record before us, and particularly because it was raised too late. Thus, we agree with Petitioner that this is an issue on” slip op. at 98
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“A. Whether the preamble is limiting The standard that governs the significance of the “preamble” in claim” slip op. at 15
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“monitoring and assessment system that is suitable for implementing the local scheduler and related data structures disclosed in Gupta, which is implemented in software. Id. ¶ 125. The need for a scheduler that works as a local optimizer is evidenced by the recognition in Gupta’s disclosure of real-time scheduling decisions, which are advantageous for dealing with unexpected or unplanned events in a manufacturing process. Id. ¶ 121 (citing Ex. 1008, 30:19−20). Further, the local optimization scheme would have been desirable for devising scheduling strategies for specific machines, resulting in a reduction of re-engineering efforts each time a new machine is added to the process flow. Id. ¶ 119. Because Gupta focuses on a specific machine and the strategy devised for each machine, the decision-making is simplified as it focuses on optimizing each machine and not re-programming the entire process flow for the factory. Id. ¶¶ 116−118. As stated above, the enhancement of using Gupta’s local optimizer stems from the recognition that global process flow scheduling was an NP-hard program of extensive computing costs; yet, Gupta solved for it by reducing the computational costs of scheduling through optimizing local machines, rather than performing global factory calculations each time an event occurs. Id. ¶¶ 114−116; Ex. 1008, 8:48−55, 13:22−34; 13:43−48; 14:6−11. The testimony of Dr. Shanfield is persuasive and supported by the facts, and we credit it accordingly. Dr. Shanfield regarding the expectation of success is supported by the facts and we credit it accordingly. Dr. Shanfield opines that Schulze’s system is specifically designed to monitor the state of the equipment and to provide notification of events like machine operation status transitions. 1342 Shanfield Decl. ¶ 123. Gupta’s local optimization scheme is driven by events like those that Schulze captures. Id. Gupta provides additional events that are useful for Schulze’s factory, such as machine loads and unloads. Id. Thus, we agree that Schulze’s system is particularly suitable for Gupta’s local optimization scheme. And according to Dr. Shanfield, the implementation of Gupta’s scheduler (together with its database and its related data structures) would be suitable for implementation in the computer of Schulze (automated monitoring and assessment system 107) because they are both software compatible. Id. ¶¶ 124−125. Once Gupta’s scheduler is implemented in Schulze’s computer, there are no changes to the functions performed by Schulze’s semiconductor fabrication system or Gupta’s local optimization scheme. Id. ¶ 127. The implementation would require adjustments to the local scheduler program, so that it can interpret and interact with the messages generated by the equipment and MES of Schulze. Id. However, Dr. Shanfield testifies that, “[b]ased on my industry experience, such routine adjustments to the local scheduler software involve tasks like making one-time inputs identifying status flags for each equipment module being characterized, and are well within the ordinary skill of a POSA.” Id. None of these tasks would have required special techniques or extraordinary skill given the well-known components and standards used in the Schulze and Gupta implementations. Id. ¶ 128.” slip op. at 57
Patent outcomesUS 6,968,248 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 6,968,248 - Applied Materials, Inc. v. Ocean Semiconductor LLCAll claims unpatentablePTAB · Feb 7, 2023 · IPR2021-01339 · APJ David Cotta · IPR · Final written decision
Claims 1–16, 18–26, and 28–31 are unpatentable: claims 1, 2, 6, 9–13, 18, 19, 21–23, 28, and 29 are anticipated by Brcka; the remaining challenged claims are obvious over Brcka.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner’s proposal is generally consistent with the level of skill reflected in the specification and the cited prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) 6 Patent Owner does not present objective indicia of nonobviousness in this case. See generally, PO Resp. 9 (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). And we agree with Patent Owner that “additional education can compensate for less work experience and vice versa.” Accordingly, we adopt Petitioner’s proposed definition of the POSA level with the additional clarification proposed by Patent Owner.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner does not identify any claim terms that require construction. Pet. 18. Patent Owner does not dispute Petitioner’s assertion that no claim terms require construction. PO Resp. 16–17. We do not find it necessary to construe the claims in order to resolve this case. 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))); 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’”).” slip op. at 10
- Expert testimonyPetitioner expert creditedDecided for petitioner
“The implicit premise of Patent Owner’s argument is that Brcka discloses only failures and thus does not disclose “fault detection.” However, we credit the testimony of Dr. Shanfield that “[g]enerally you always need a fault to have a failure occur. So when there is a failure, a fault has occurred.” Ex. 2003, 74:6–11; see also Ex. 1003 ¶ 37 (“A fault is an abnormal tool condition, such as when a parameter strays beyond its acceptable boundary. Faults may lead to failure, which is the ‘termination of the ability of an item to perform a required function.’”) (internal citation omitted), 81 (“Machine failure, though, means that a fault condition existed requiring termination of the machine function upon the wafer.”). Thus, Brcka’s disclosure of analyzing machine failures is also, necessarily, a disclosure of a analyzing a fault. Accordingly, we find that Petitioner has established, by a preponderance of the evidence, that Brcka discloses “performing in a computer a fault detection analysis relating to processing of a workpiece.”” slip op. at 20
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Petitioner cites to the embodiment depicted in Brcka’s Figure 4 as illustrating Brcka’s “fault detection analysis.” Pet. 32–33; see also Ex. 1003 ¶¶ 72–73. Figure 4 is a “flow diagram demonstrating operation of a learning system and [a] neural network model designed in accordance with at least one embodiment of [Brcka’s] invention.” Ex. 1005 ¶ 44. In step 415 of the operation disclosed in Figure 4, “a determination is made whether maintenance has been performed or a machine failure has occurred.” Id. ¶ 44, Fig. 4. If either of these things has happened, “a new reward value is calculated.” Id. In step 440, “a determination is made whether maintenance is needed.” Id. ¶ 45, Fig. 4. Thus, Brcka determines whether a failure has occurred, accounts for this determination by assigning a “reward value” (Fig. 4, step 425), and then decides whether maintenance is needed. On this record, the analysis reflected in these steps qualifies as a “fault detection analysis.” We recognize that Brcka’s fault detection analysis is used in a method that includes a predictive component. But, we do not find anything in the language of claim 1 that precludes performing the fault detection analysis as part of a predictive model. Indeed, the claim language requires only “performing . . . a fault detection analysis.” Moreover, the “fault detection” itself (i.e., Brcka’s step 415), as opposed to the analysis of the detected fault, is backward-looking, not predictive; it determines “whether . . . a machine failure has occurred.” Id. ¶ 44 (emphasis added).” slip op. at 16
Patent outcomesUS 8,676,538 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,676,538 - PTAB · Aug 12, 2020 · PGR2019-00032 · APJ David Cotta · PGR · Final written decision
The Board granted cancellation of claim 8 and denied entry of substitute claim 11 because Petitioner showed it would have been obvious over Omura, Tsuji, and the knowledge of a person of ordinary skill.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“In our Institution Decision, we agreed with the position Patent Owners took in their Preliminary Response – i.e, that the focus of the challenged claims was enzyme-based biosensors and thus the POSA would have more than just a familiarity with enzyme-based biosensors and protein chemistry. Inst. Dec. 8–9. Accordingly, based on the record before us at the time, we accepted the definition provided in Patent Owners’ Preliminary Response, which was consistent with the level of skill reflected in the asserted prior art references and in the specification of the ‘987 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art). Neither party challenges the identification of the POSA set forth in our Institution Decision. See generally, R. Mot.; Opp.; Reply; Sur-reply. Additionally, we find that the fully developed trial record supports the POSA identification we made in our Institution Decision. Accordingly, in this decision, we apply the identification of the POSA set forth in our Institution Decision. Inst. Dec. 9.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). For purposes of this decision, we need not expressly construe any claim terms.” slip op. at 10
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“first, substitute claim 11 would have been obvious over Omura in view of the knowledge of the POSA, and second, substitute claim 11 would have been obvious over the combination of Omura and Tsuji in view of the knowledge of the POSA. Opp. 7–24. We have considered the question of patentability in view of all the evidence and arguments presented in this proceeding. Based on the record developed during this proceeding, we determine that Petitioner has shown by a preponderance of the evidence that substitute claim 11 would have been obvious over the combination of Omura, Tsuji, and the knowledge of the POSA. Because Petitioner has proven that substitute claim 11 would have been obvious, as discussed in detail below, we do not consider whether Patent Owners’ motion otherwise complies with the statutory and regulatory requirements for a motion to amend. See, 35 U.S.C. § 326(d)(1)(B) (requiring that the amendment propose a “reasonable number of substitute claims” and requiring that the substitute claims do “not enlarge the scope of the claims of the patent or introduce new matter”); 37 C.F.R. § 42.221 (additionally providing, inter alia, that a motion to amend “may be denied where . . . [t]he amendment does not respond to a ground of unpatentability involved in the trial”). Similarly, because we have determined that substitute claim 11 would have been obvious over the combination of Omura, Tsuji, and the knowledge of the POSA, as discussed in detail below, we do not reach the question of whether substitute claim 11 would also have been obvious over only Omura in view of knowledge of the POSA.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“includes “research experience and/or knowledge in enzymology . . . and biosensors,” we agree with Petitioner that it would have been obvious to a POSA to substitute FAD-conjugated glucose dehydrogenase derived from the claimed strain of Aspergillus oryzae for FAD-conjugated glucose dehydrogenase derived from Aspergillus terreus as disclosed in Omura.” slip op. at 18
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,976,125
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.