- Bright Data Ltd. v. Oxylabs, UabNo claims unpatentablePTAB · Jul 15, 2024 · IPR2023-00186 · APJ Iftikhar Ahmed · IPR · Final written decision
Claims 1–20 were not shown unpatentable because Scoda did not disclose the claimed interception limitation and Hallak did not disclose execution of the removed script after removal.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“the invention of the ’091 patent would have had master’s degree or higher in the field of electrical engineering, computer engineering, or computer science, or would have had a bachelor’s degree in the same fields and two or more years of experience in internet communications. Pet. 15–16 (citing Ex. 1007 ¶¶ 30–31). Patent Owner does not dispute Petitioner’s definition for a person of ordinary skill in the art. See generally PO Resp. We adopt the level of ordinary skill as articulated by Petitioner because, based on the current record, this proposal appears to be consistent with the ’091 patent and the prior art of record and is supported by the testimony of Dr. Williams.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We find that the parties’ agreed upon construction is supported by the record before us and apply it in our patentability analysis below, requiring the embedded script to be removed before that script is executed. We determine that no other claim terms require express construction.” slip op. at 12
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“during trial, we determine that Petitioner has not shown by a preponderance of the evidence that Scoda discloses intercepting a web page sent from a We agree with Patent Owner that portions of Scoda cited in the Petition do not disclose a web page, let alone one sent from a server and addressed to a client browser. See PO Resp. 17; Tr. 73:10–23. Scoda discloses that “[t]he core module 21 is executed by the web content proxy server 12 to determine where to provide the response with the executed JavaScript functionality in the exemplary environment 10, such as to a web browser on one of the client devices 14(1)–14(n).” Ex. 1016 ¶ 55. But this functionality does not refer to a web page from a server. Instead, this discussion is about a HTTP request that comes from a client device and may include one or more hidden JavaScript identifiers. See id. ¶¶ 50–55. The discussion about providing a response to a web browser on a client device refers to a response to the client device’s HTTP request, in the form of an error message, that is sent from the proxy server to client device. Id. ¶ 58. As Patent Owner points out, this is one of the two scenarios presented in Scoda, the other one being that HTTP request is sent to the server. Id.; PO Resp. 36; see also Ex. 2009 ¶ 70. We agree with Patent Owner and Dr. Almeroth that these communications between the client and proxy server or the proxy server and the content server do not disclose the “intercepting” limitation.” slip op. at 19
- Strike new argumentNew argument disregardedDenied
“deficient, Petitioner attempts to change the focus of its argument. Pet. Reply 2–3. Petitioner instead relies on Figure 8 and related discussion as “Scoda’s disclosure of proxy server 12 processing a web page that was sent from a web server.” Id. Scoda, and Petitioner’s argument based on this disclosure is, therefore, an untimely new argument presented in the Reply. See 37 C.F.R. § 42.23(b); see also Intelligent Bio-Sys., 821 F.3d at 1369 (“It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the grounds for the challenge to each claim.’”) (citing 35 U.S.C. § 312(a)(3)).” slip op. at 20
Patent outcomesUS 9,516,091 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Enfish · Phillips · KSR · GrahamPatents in suitUS 9,516,091 - Bright Data Ltd. v. Oxylabs, UabNo claims unpatentablePTAB · Jul 11, 2024 · IPR2023-00187 · APJ Thomas L Giannetti · IPR · Final written decision
Claims 1–5 were not proven unpatentable: Athas does not show the same packets are received, modified, and forwarded; neither obviousness combination teaches execution in response to the client’s execution of the second script.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art of the ’457 patent would have had “a Master’s Degree or higher in the field of electrical engineering, computer engineering, or computer science, or as of that time had a Bachelor’s Degree in the same fields and two or more years of experience in Internet Communications.” Pet. 14 (citing Williams Decl. ¶¶ 30–31). For our Institution Decision, we adopted Petitioner’s formulation. Institution Dec. 11. Patent Owner has not provided a description of the ordinarily skilled artisan. However, Dr. Almeroth testifies that although he “do[es] not necessarily agree with every aspect of Dr. Williams’s explanation,” he bases his opinions on Dr. Williams’s description of the person of ordinary skill in the art. Almeroth Decl. ¶ 36. For this Final Written Decision, therefore, we adopt the description of the person of ordinary skill articulated by Petitioner 6 Neither party has presented evidence or arguments regarding objective evidence of non-obviousness. and used previously in our Institution Decision. We find that this formulation is consistent with the ’457 patent, the prior art of record, and is supported by the testimony of Dr. Williams. Williams Decl. ¶¶ 30–31.” slip op. at 11
- Expert testimonyPetitioner expert discountedDecided for patent owner
“The citations to Dr. Williams’s testimony do not help Petitioner meet its burden of showing that the “same packets” feature is met by a preponderance of the evidence. Pet. Reply 11. The testimony of Dr. Williams cited by Petitioner relates to whether a hypothetical request for a web page forwarded from a conventional proxy to a server would use the same packets as the original request from a client to the proxy. See Ex. 2011, 115:7–21. The testimony does not address the issue raised by limitations 1b–1d, which is whether Athas discloses using the same packets for the receiving, modifying, and forwarding operations performed by the network appliance. In any event, we find Dr. Williams’s testimony on this issue to be equivocal and unconvincing. Several times he avoids answering questions by stating “it depends on how the software is written” or “it depends on the details of the code.” See id. at 117:8–17; 118:10–12.” slip op. at 23
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“as “the number of packets” intercepted in limitation 1a (see PO Resp. 6–7). Petitioner responds that resolving this argument is not necessary. Pet. Reply 1. We find that whether claim 1 requires the packets intercepted by the network appliance in limitation 1a to be the same packets involved in limitations 1b–1d, Petitioner has not persuasively shown that any same number of packets in Athas that are received at proxy platform 101 are then modified and forwarded as required by limitations 1b–1d, for the reasons discussed below. We agree with Patent Owner that the number of packets in limitations 1b-1d are the same, and, therefore, we find that Petitioner’s citations to Athas do not disclose the sequence of operations recited in claim limitations 1b–1d. Petitioner, therefore, does not demonstrate that Athas anticipates the claim. Specifically, we are not persuaded either by Petitioner’s assertions or Dr. Williams’s testimony that in Athas, the same “number of packets” that are received and modified by Athas’s proxy platform 101 are then forwarded to Athas’s proxy client 107, as required by limitations 1b–1d. PO Resp. 6– 7; 15–20; Almeroth Decl. ¶¶ 76–77. Petitioner does not persuasively address this issue the Petition or in its Reply (see Pet. Reply 2–11, asserting, in a footnote, only that “Patent Owner mischaracterizes Dr. Williams’s testimony regarding same versus different packets,” and that “Dr. Williams’s testimony does not support Patent Owner’s arguments.”). Id. at 11 n.4 (citing Ex. 2011, 115:22–117:20, 118:5–12). The citations to Dr. Williams’s testimony do not help Petitioner meet its burden of showing that the “same packets” feature is met by a preponderance of the evidence. Pet. Reply 11. The testimony of Dr. Williams cited by Petitioner relates to whether a hypothetical request for a web page forwarded from a conventional proxy to a server would use the same packets as the original request from a client to the proxy. See Ex. 2011, 115:7–21. The testimony does not address the issue raised by limitations 1b–1d, which is whether Athas discloses using the same packets for the receiving, modifying, and forwarding operations performed by the network appliance. In any event, we find Dr. Williams’s testimony on this issue to be equivocal and unconvincing. Several times he avoids answering questions by stating “it depends on how the software is written” or “it depends on the details of the code.” See id. at 117:8–17; 118:10–12. There is, therefore, no persuasive evidence of record demonstrating that Athas discloses that the same “number of packets” received at proxy platform 101 are, in a modified form, forwarded to proxy client 107. For example, there is no support in the record for a finding that once the content of packets sent from service platform 109 to proxy platform 101 in Athas is extracted and manipulated to replace non-MWL scripts with MWL scripts and the DOM is generated, modified versions of the same received packets are forwarded to provide the web page to proxy client 107, as opposed to completely new packets. We find no sufficient support for this contention in Dr. Williams’s testimony:” slip op. at 23
- BurdenNot shown unpatentable
“1b-1d are the same, and, therefore, we find that Petitioner’s citations to Athas do not disclose the sequence of operations recited in claim limitations 1b–1d. Petitioner, therefore, does not demonstrate that Athas anticipates the claim. Specifically, we are not persuaded either by Petitioner’s assertions or Dr. Williams’s testimony that in Athas, the same “number of packets” that are received and modified by Athas’s proxy platform 101 are then forwarded to Athas’s proxy client 107, as required by limitations 1b–1d. PO Resp. 6– 7; 15–20; Almeroth Decl. ¶¶ 76–77. Petitioner does not persuasively address this issue the Petition or in its Reply (see Pet. Reply 2–11, asserting, in a footnote, only that “Patent Owner mischaracterizes Dr. Williams’s testimony regarding same versus different packets,” and that “Dr. Williams’s testimony does not support Patent Owner’s arguments.”). Id. at 11 n.4 (citing Ex. 2011, 115:22–117:20, 118:5–12). The citations to Dr. Williams’s testimony do not help Petitioner meet its burden of showing that the “same packets” feature is met by a preponderance of the evidence. Pet. Reply 11. The testimony of Dr. Williams cited by Petitioner relates to whether a hypothetical request for a web page forwarded from a conventional proxy to a server would use the same packets as the original request from a client to the proxy. See Ex. 2011, 115:7–21. The testimony does not address the issue raised by limitations 1b–1d, which is whether Athas discloses using the same packets for the receiving, modifying, and forwarding operations performed by the network appliance. In any event, we find Dr. Williams’s testimony on this issue to be equivocal and unconvincing. Several times he avoids answering questions by stating “it depends on how the software is written” or “it depends on the details of the code.” See id. at 117:8–17; 118:10–12. There is, therefore, no persuasive evidence of record demonstrating that Athas discloses that the same “number of packets” received at proxy platform 101 are, in a modified form, forwarded to proxy client 107. For example, there is no support in the record for a finding that once the content of packets sent from service platform 109 to proxy platform 101 in Athas is extracted and manipulated to replace non-MWL scripts with MWL scripts and the DOM is generated, modified versions of the same received packets are forwarded to provide the web page to proxy client 107, as opposed to completely new packets. We find no sufficient support for this contention in Dr. Williams’s testimony:” slip op. at 23
Patent outcomesUS 8,924,457 not shown unpatentable§ 102 anticipation§ 103 obviousnesscites GrahamPatents in suitUS 8,924,457 - Bright Data Ltd. v. Oxylabs, UabNo claims unpatentablePTAB · Jul 11, 2024 · IPR2023-00185 · APJ Thomas L Giannetti · IPR · Final written decision
Claims 1–19 were not proven unpatentable; the Board found the asserted WebShield and Hallak grounds failed on script-removal and execution sequencing, and the Kothari combination lacked motivation.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Post-institution, Patent Owner proposes two claim constructions. PO Resp. 7–8. Patent Owner proposes that we construe the term “embedded script,” as defined in the ’498 patent, as “a script that is included or incorporated by reference into a markup language description of a web page and executable by a browser rendering that web page.” Id. at 8 (citing Ex. 1001, 3:23–26). According to Patent Owner, a “script” is “a sequence of machine-readable instructions.” Id. (citing Ex. 1001, 3:21–23). Patent Owner proposes that we construe “executing . . . the removed embedded script” as requiring the removal of the script embedded in the web page to take place before the script is executed. Id. This limitation is recited in claim 1 and in each of the other independent claims. Ex. 1001, 11:43–46 (claim 1), 12:17–20 (claim 10); 12:58–63 (claim 19). Petitioner responds that “[t]hese claim terms have already been construed by the district court and those constructions are not disputed in this proceeding.” Pet. Reply 2. We find that these undisputed constructions are supported by the record before us. We, therefore, adopt them for this Decision. We do not find it necessary to expressly construe any other terms for this Decision.” slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner has not provided a description of the ordinarily skilled artisan. However, Dr. Almeroth testifies that although he “do[es] not necessarily agree with every aspect of Dr. Williams’ explanation,” he bases 7 Neither party has presented evidence or arguments regarding objective evidence of non-obviousness. his opinions on Dr. Williams’s description of the person of ordinary skill in the art. Almeroth Decl. ¶ 36. For this Decision, therefore, we adopt the description of the person of ordinary skill articulated by Petitioner and used previously in our Institution Decision. In light of our review of the complete record, we find that this formulation is consistent with the ’498 patent, the prior art of record, and is supported by the testimony of Dr. Williams. See Williams Decl. ¶¶ 30–31.” slip op. at 11
- Expert testimonyPetitioner expert discountedDecided for patent owner
“We are not persuaded by Dr. Williams’s testimony that WebShield teaches or suggests this limitation. See Williams Decl. ¶¶ 132–137. His testimony does not address the claimed sequence required by the claims and, in fact, quotes WebShield’s description of parsing and executing the embedded JavaScript files to create the DOM data structures relied on by Patent Owner and Dr. Almeroth. See id. at ¶ 136 (quoting Ex. 1008, 5).” slip op. at 21
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We agree that Petitioner’s citations to WebShield do not disclose the sequence of operations called for by the claims. WebShield expressly states that “the HTML page, embedded JavaScript files and embedded CSS files will be parsed and executed to create the DOM data structures of the webpage.” Ex. 1008, 5 (emphasis added). As Dr. Almeroth explains, “WebShield does not remove an embedded script and then subsequently execute the removed embedded script. . . . WebShield . . . executes the embedded JavaScript without first removing that JavaScript from the web page, and only subsequently generates ‘the new HTML page [that WebShield] transfers to the client browser T(R).’” Almeroth Decl. ¶ 78 (quoting Ex. 1008, 6) (final alteration in original). We are not persuaded by Dr. Williams’s testimony that WebShield teaches or suggests this limitation. See Williams Decl. ¶¶ 132–137. His testimony does not address the claimed sequence required by the claims and, in fact, quotes WebShield’s description of parsing and executing the embedded JavaScript files to create the DOM data structures relied on by Patent Owner and Dr. Almeroth. See id. at ¶ 136 (quoting Ex. 1008, 5).” slip op. at 21
Patent outcomesUS 9,503,498 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites GrahamPatents in suitUS 9,503,498 - Forte Biosciences, Inc. v. University Of MassachusettsAll claims unpatentablePTAB · Jun 24, 2024 · PGR2023-00014 · APJ Georgianna W Braden · PGR · Final written decision
Claims 1–5 are unpatentable for lack of written description and enablement under § 112(a); the Board did not reach the § 103 challenge.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not contest Petitioner’s proposed definition, except to modify the level such that an ordinarily skilled artisan “would have been familiar with well-known inhibitors of IL-15 and IL-15R as described in the ’505 patent and recognized in the art as of April 2017.” Resp. 26–27 (citing Ex. 2005 ¶ 94). We adopt Petitioner’s level of ordinary skill in the art with Patent Owner’s proposed modification because it appears consistent with the problems addressed in the ’505 patent and the prior art of record.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“this stage of the proceeding and that all terms are to given their plain and ordinary meaning. Pet. 23; Resp. 38. We agree. Construction is needed only for those terms “that are in controversy, and only to the extent necessary to resolve the controversy.” See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Here, we determine that no claim construction is necessary.” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“Finally, we are reminded that “a sufficient description of the genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350. “[F]unctional claim language can meet the written description requirement when the art has established a correlation between structure and function.” Id. Here, however, the challenged claims are directed to methods using a wide range of different types of compounds purported to be “IL-15/IL-15R inhibitors” that are not part of a known or readily identifiable class, do not target the same biological pathway, do not have any common structural features, and do not appear to always function as inhibitors. See Ex. 1018, Abstr., 1575–77, 1579; Ex. 1046, 189:4–19, 191:15–192:15, 193:18–196:22, 198:21–199:21, 197:12–198:19, 200:1–8, 207:11–14, 203:3–10, 207:15–21, 236:12–24; Ex. 1047 ¶¶ 19–23, 56, 63–64, 80–85. Therefore, we find there is neither a representative number of species disclosed, nor a sufficient” slip op. at 21
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“598 U.S. at 610. A “specification may call for a reasonable amount of experimentation to make and use a patented invention. What is reasonable in any case will depend on the nature of the invention and the underlying art.” Id. at 613. But the person of ordinary skill in the art cannot be left with merely “a hunting license” or obligated to engage in “painstaking experimentation” or “trial and error” to “see what works.” Id. at 614. Patent Owner argues that “the IL-15/IL-15R inhibitors disclosed in the specification were known in the art and “share the common ‘general quality’ of inhibiting a pathway known to be relevant to and having ‘particular fitness for the particular purposes’ of (id.) treating certain autoimmune diseases by blocking IL-15 signaling.” Sur-reply 14 (citing Ex. 1011, 22; Ex. 2013, 3; Ex. 2017, Abstr.; Ex. 2024, 17; Ex. 2025, 2–3, 6; Ex. 2027, 4; Ex. 2028, 9; Ex. 2029, 4; Ex. 2031, 23; Ex. 2118, 53:22–54:9; Ex. 1018, 1; Ex. 2005, ¶¶ 52–63, 80–83, 130; Ex. 1046, 231:20–25). Patent Owner’s argument is unavailing, however, because the record shows that different IL-15-specific inhibitors may operate in different ways that may result in differential effects, some of which may not include inhibition at all. See Ex. 1047 ¶¶21, 23, 40, 71; Ex. 1018, Abstr., 1576, 1579; Ex. 2013, 4:1– 8; Ex. 2014, 4:9–15; Ex. 2015 ¶ 22; Ex. 2025, 4:34–5:2; Ex. 1046, 166:21– 24, 168:25–169:5, 207:23–209:22, 210:4–17, 210:24–211:6; Ex. 1011, 1:67–2:4; Ex. 2005 ¶¶ 116, 134. Thus, we find that the record supports Drs. Abbas and Plott’s testimony, which we credit, that a person of ordinary skill in the art would be forced to hunt down and test every compound through painstaking Ex. 1002 ¶¶ 85–90, 92; Ex. 1047 ¶ 53 (Dr. Plott’s testimony that the “specification of the ’505 patent is essentially a black box (so far as which aspects of IL-15 signaling it inhibits and how it operates), leaving the reader to guess through trial and error which molecules might operate similarly to ChMBC7 and which do not.”); Ex. 1004 ¶ 61 (Dr. Plott’s testimony that “from the perspective of a clinician, the amount of experimentation required would be extremely burdensome and success would be speculative.”); Ex. 2007, 93:16–97:25, 38:208; Ex. 1046, 234:20–236:11. This is due to the fact that the claims (without limit) encompass any inhibition of any one of the various types of IL-15 signaling and various versions of the receptor, and even implicate other compounds that act on different targets but which inhibit the IL-15 signaling pathway. See Ex. 1047 ¶¶ 10, 53, 68; Ex. 2005 ¶ 71; Ex. 1046, 254:4–255:11, 158:12–160:20. The evidence has shown that IL-15/IL-15R inhibition is complicated and unpredictable, with some inhibitors also capable of enhancing forms of IL-15 signaling rather than preventing it. See Ex. 1047 ¶¶ 10, 25–26, 53; Ex. 2013, 2:10–18; Ex. 2014, 2:12–20; Ex. 2015 ¶ 3; Ex. 2025, 2:10–18; Ex. 2078, 267.” slip op. at 32
Patent outcomesUS 11,278,505 unpatentableClaim construction§ 112 disclosurecites PhillipsPatents in suitUS 11,278,505 - PTAB · Jun 13, 2024 · IPR2024-00240 · APJ Deborah Katz · IPR · Institution
The Board instituted inter partes review of claims 1–42 on all asserted grounds, finding a reasonable likelihood of success and declining discretionary denial under §§ 314(a) and 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“The Director may not authorize an inter partes review “unless the Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). We determine whether to institute a post grant review on behalf of the Director. See 37 C.F.R. § 42.4(a). The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioner meets the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Upon considering the Petition, the Preliminary Response, and the evidence of record, we determine that Petitioner has demonstrated there is a reasonable likelihood that the petition would prevail in showing that at least one challenged is unpatentable. Accordingly, we institute inter partes review of all challenged claims on all asserted grounds. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1354, 1359–60 (2018); 37 C.F.R. § 42.108(a).” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“patient is MSI-H after enrollment in a study in which pembrolizumab is to be administered is not within the scope of the claim step “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating the patient with a therapeutically effective amount of pembrolizumab.” At this point in the proceeding, though, we do not interpret the claim step as meaning anything other than the treatment of colorectal cancer patients after they have been determined to be microsatellite instability high or DNA mismatch repair deficient. Although the term “in response to” in claim 1 requires that treatment of the patient occur after the determination that the colorectal cancer is MSI-H, we do not interpret the term to mean that other patients are not treated or that the recruitment and enrollment of patients for a clinical trial has any bearing on the steps recited in claim 1. 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) (2019). 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. Patent Owner has not directed us to evidence that one of ordinary skill in the art would have understood treating a patient “in response to” the determination that the patient has a condition excludes treatment of other patients without the condition, although it does require that treatment of the patient occur after the determination that the colorectal cancer is MSI-H. The language of claim 1 refers only to patients that are determined to have microsatellite instability high or DNA mismatch repair deficient colorectal cancer, not to other patients. (See Ex. 1001, 25:40–50.) At this point in the proceeding, the record does not indicate that the treatment of patients determined not to be MSI-H is be factored into whether the teaching of treating patients determined to be MSI-H anticipates the method of claim 1. At this point in the proceeding, we construe the “in response to” limitation of claim 1 to mean that pembrolizumab is administered to a patient after the patient has been determined to be microsatellite instability high or DNA mismatch repair deficient, regardless of whether pembrolizumab is also administered to other patients.” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“H Study Record teaches treating colorectal cancer patients after they were determined to be microsatellite instability high or DNA mismatch repair deficient with pembrolizumab. (See MSI-H Study Record, Ex, 1005, 4 (Arms and Interventions); see also id., 2 (Study Identification), 3 (Study Description), 4–5 (Outcome Measures), 5–6 (Eligibility); see Neugut Decl., Ex. 1003, ¶¶ 58–62.) At this point in the proceeding, Petitioner has sufficiently shown that there is a reasonable likelihood of a causal relationship in the MSI-H Study Record between treatment of colorectal cancer patients and the determination of their MSI status — all colorectal cancer patients determined to be microsatellite instability high or DNA mismatch repair deficient were treated. Whether or not other patients were treated or enrolled in the study does not detract from this teaching.” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Furthermore, to the extent the MSI-H Study Record does not disclose the limitation of “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating the patient with a therapeutically effective amount of pembrolizumab,” the record before us supports this limitation being rendered obvious by Pernot and the MSI-H Study Record. Specifically, because Pernot teaches that colorectal cancer patients are good candidates for immunotherapy, the evidence of the current record shows that one of ordinary skill in the art would have had a reason to use to PD-1 inhibitors to treat colorectal cancers. (See Ex. 1006, 3741.) Additionally, the focus in the MSI-H Study Record on a clinical study treating colorectal cancer patients who had been determined to be MSI-H with prembrolizumab indicates that it would have been obvious to test for this condition before treatment. The additional references discussed by Petitioner contribute further to a reasonable likelihood that Petitioner will prevail. For example, Libson reports the successful treatment of a colorectal cancer patient having MSI-H status with a PD- 1 inhibitor (see Ex. 1057, 463-64) and Champiat discusses evaluating the clinical activity of PD-1 agents in DNA mismatch repair, such as MSI+, colorectal cancer (see Ex. 1032, e27817-5). (See Pet. 44.) Thus, based on the entire record before us, Petitioner presents a reasonable likelihood that the method of claim 1 would have been considered obvious by one of ordinary skill in the art.” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,591,393 - Foresight Diagnostics, Inc. v. Personalis, Inc.All claims unpatentablePTAB · Jun 12, 2024 · IPR2023-00317 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–23 are unpatentable: claims 1–7 and 10–23 as anticipated by Forshew, and claims 1–23 and 1–9 and 11–23 as obvious over Forshew with Wagle and Wagle with Chan, respectively.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner has not subsequently challenged the above definition. See Ex. 2031 ¶ 48 (Dr. Furneaux applying the above definition). For the reasons set forth in our Institution Decision, and because Petitioner’s proposed level is commensurate with the level of skill reflected in the prior art of record, we apply the same definition here. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978). C. Claim Construction” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“adopt Petitioner’s proposed definition of “capture probes” as encompassing at least, “PCR primer capture probes and solution-based hybridization capture probes (e.g., biotinylated oligonucleotide baits).” See DI 18–24. For the reasons set forth in our Institution Decision, and as further addressed below, we apply that definition here—albeit with a minor modification in wording. In particular, we credit Patent Owner’s argument that the phrase “PCR primer capture probe” is not a recognized term of art and its use in our construction “would improperly inject ambiguity into the claim.” POR 58– 59 (citing, e.g., Ex. 2018, 166:10–169:1, 171:16–175:2; Liquid Dynamics Corp. v. Vaughan Co., 355 F.3d 1361, 1367 (Fed. Cir. 2004)). Although we recognize Petitioner’s use of “PCR primer capture probe” as a shorthand for its position that, as read in light of the Specification, PCR primers are a species of, and/or indistinguishable from, the genus of capture probes, Patent Owner’s point is well taken. Accordingly, we clarify the meaning of “capture probes,” as used in the instant Specification, to encompass PCR primers and solution-based hybridization capture probes (e.g., biotinylated oligonucleotide baits). We do not view this modification as altering the substance of our provisional construction or the analysis in our Institution Decision.” slip op. at 11
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedReference is prior artDecided for petitioner
“Ex2112, slide 5 for the ‘plurality of capture probes’ limitation of step 1(a),” Petitioner contends that its “bare reference to ‘pullout’” suggests at most, “that by May 2012, Mr. West contemplated that a particular type of capture probe would be among many other ‘lab solutions’ for addressing accuracy.” Reply 7–8; see Ex. 1225 ¶¶ 123–126. In this respect we note Mr. West’s testimony that he understood “pullout” in Slide 5, as a reference to Agilent SureSelect biotinylated probe system. See Ex. 1222, 83:8–85:22, 88:7–16. We, nevertheless, find persuasive Dr. Quackenbush’s testimony that “a POSA reviewing Slide 5 in light of the overall record on conception would have insufficient information to determine how, specifically, Personalis intended to use the ‘Pullout,’ other than that their purpose was to provide a laboratory solution to improve the accuracy of 2012 sequencing technology in some way.” Ex. 1225 ¶ 125. Considering the evidence of record, we credit Dr. Quackenbush’s testimony that a person of ordinary skill in the art reading Personalis’ conception exhibits, including Exhibit 2112, “would have found, at most, an incipient research project for improving the accuracy of sequencing technology that would involve the use of an undefined combination of various conventional techniques.” Ex. 1225 ¶ 128. In addition to Dr. Quackenbush’s testimony as to claim steps involving capture probes (elements 1(a)–1(c)), we further find persuasive his testimony that Patent Owner provides no corroboration of the conception of steps 1(d)–1(f), which require assaying samples obtained from the same individual obtained at different time points. See id. ¶¶ 120–121, 126–127; Reply 9–10; Sur-Reply 6–8 (citing, e.g., Ex. 2032 ¶¶ 91–134; Ex. 2109; Ex. 2112; Ex. 2036). In sum, we find that Personalis’ exhibits and related testimony do not evidence sufficient conception of the invention set forth in the challenged claims. See, e.g., Ex. 1225 ¶¶ 120–128 (Dr. Quackenbush’s testimony about missing aspects of the claims in Patent Owner’s proofs, such that the “completed thought” is not shown).15 Considering the above, we find that Patent Owner has not satisfied the burden of establishing that its claimed invention is entitled to a priority date that precedes either of the respective publication dates of Forshew and Chan. Accordingly, Forshew and Chan qualify as prior art to the ’033 patent.” slip op. at 31
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“In Section II.C. above, we construe “capture probes,” as used in the instant Specification, to encompass PCR primers and solution-based hybridization capture probes (e.g., biotinylated oligonucleotide baits). Accordingly, in disclosing the use of PCR primers, Forshew discloses “capture probes,” as would have been understood by one of ordinary skill reading the ’033 Specification. See Pet. 29–33 (citing Ex. 1020 ¶¶ 117–122; Ex. 1030, 2–3). Forshew further satisfies the “plurality of capture probes” “COSMIC: mining complete cancer genomes in the Catalogue of Somatic Mutations in Cancer,” 39 NAR D945-950 (2011)). limitation in disclosing the use of PCR primers for the detection and monitoring of cancer-associated alleles. See, e.g, id.; Ex. 1020, 3 (“We designed 48 primer pairs to amplify 5995 bases of genomic sequence covering coding regions (exons and exon junctions) of TP53 and PTEN, and selected regions in EGFR, BRAF, KRAS, and PIK3CA (table S1) by overlapping short amplicons (Fig. 1A).”). For the reasons set forth above, Petitioner has sufficiently shown that Forshew discloses “capture probes” and “a plurality of capture probes,” as would have been understood by one of ordinary skill reading the ’033 Specification.” slip op. at 36
Patent outcomesUS 11,408,033 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,408,033 - PTAB · May 28, 2024 · IPR2024-00170 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR of claims 1–13 on all five asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). slip op. at 14
- Skill levelSkill level petitioner adoptedDecided for petitioner
“According to Patent Owner, Petitioner’s proposed definition “attempts to imbue the POSA with an array of different skills and competencies that do not accurately reflect the state of the field at the time of the October 2014 priority date.” Prelim. Resp. 10. Patent Owner does not offer a competing definition in the Preliminary Response, but notes that we adopted the above definition in the 00224, 00317, 00545, and 00546 IPRs. Insofar as the prior art of record appears to support Petitioner’s definition, we apply our earlier definition here as Petitioner urges. 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)). Patent Owner is, nevertheless, welcome to provide argument and evidence for an alternative definition at trial.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“In general, a preamble limits the invention if it recites essential structure or steps, or if it is necessary to give life, meaning, and vitality to the claim.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quotation marks omitted). On its face, the preamble of claim 1 includes a “wherein” clause requiring that the biological sample be obtained “from a non-fetal source.” Because Petitioner does not explain how this limitation is either understood from the body of the claim, or severable from the remainder of the preamble, we do not find Petitioner’s argument persuasive. See Cochlear Bone Anchored Sols. AB v. Oticon Med. AB, 958 F.3d 1348, 1355 (Fed. Cir. 2020) (“A conclusion that some preamble language is limiting does not imply that other preamble language, or the entire preamble, is limiting.”). Absent further argument and evidence, and solely for the purpose of this Decision, we construe the preamble as limiting. slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Specification provides little guidance regarding how much of the genome must be sequenced under Patent Owner’s construction. See generally 00224 IPR, Paper 11 at 19–23. As discussed in detail on pages 15–16 of the Preliminary Response, however, the instant Specification does make a clear distinction between “untargeted sequencing (e.g., whole genome sequencing)” as compared to targeted sequencing approaches such as “whole exome sequencing,” or “deep sequencing over a fraction of the genome.” See e.g., Ex. 1001, 17:36–49, 25:64–34, 27:16–19, 43–46; cf. 00224 IPR, Paper 11 at 22 (“tak[ing] particular note of the [’394] Specification’s distinction between whole genome sequencing and targeted sequencing of the exome or other sub-genomic regions (e.g., Ex. 1001, 5:38–59, 24:35– 58), as well as the Specification’s acknowledgement that whole genome sequencing may encompass “low mean coverage regions” and “zero mean coverage regions,” (id. at 24:59–62, 28:33–42)”). As we read the Specification, the phrase “sequencing all or almost all of a genome,” speaks more tot the untargeted nature of the process rather than to an end result of the sequencing effort. In this respect, the instant Specification’s references to “high coverage whole genome sequencing,” “low coverage whole genome sequencing,” and “low” and “zero mean coverage regions from WGS,” indicate that whole genome sequencing does not mean that all or almost all of the nucleotide bases in a genome must be determined, but that “all or almost all” of the genome is available for sequencing.12 See e.g., id. at 25:64–67, 26:6–14, 27:16–19, 28:57–60; 32:37–45; see also 00224 IPR, Paper 11 at 19–23 (preliminarily determining that Leary disclosed whole genome sequencing despite evidence that the authors sequenced only about half of the genome). With the above explanation, we provisionally construe “whole genome sequencing as “a non-targeted approach to sequencing all or almost all of a genome.” We leave for later, and to the extent necessary, any 12 Consistent with Owner’s argument that “WGS has taken on many different flavors of meaning,” we presently understand the Specification’s recognition of “high” and “low” coverage whole genome sequencing as species of the generic term. See Prelim Resp. 12–13 (citing Ex. 2018, 155:15–20, 161:21–162:1, 156:20–157:22). determination of the lower limit (if any) one of ordinary skill would attach to the number sequencing reads, extent of genomic coverage, or nucleotide bases that must be determined to qualify as whole genome sequencing, and whether any particular experimental approach would have been understood to comprise whole genome sequencing.” slip op. at 22
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,584,968 - PTAB · May 23, 2024 · IPR2024-00215 · APJ Jason M Repko · IPR · Institution
The Board instituted IPR of claims 1–10 on all grounds, finding a reasonable likelihood that claim 1 would be obvious over Foster and Hayhurst.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute an inter partes review, we must determine “that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). For the reasons discussed below, Petitioner has shown a reasonable likelihood that it would prevail with respect to all claims challenged in the Petition. Thus, we institute an inter partes review.” slip op. at 2
- BurdenDecided for petitioner
“The record at this stage sufficiently supports Petitioner’s argument that Foster’s receiver 430 stores content that it receives. Pet. 65 (citing Ex. 1006 ¶¶ 4, 8, Fig. 8). According to Dr. Rubin’s annotations, receiver 430 can be a personal computer (PC) or set-top box. Ex. 2003 ¶ 83 (labeling the receiver in Figure 16 as such). This is consistent with Foster. Ex. 1006 ¶¶ 49, 51 (describing PC 18 and a set-top box). Foster describes how the receiver stores encrypted content. See id. ¶¶ 8, 79. For example, Foster explains, “Once received, recipient 430 can then synchronously store the encrypted content.” Id. ¶ 79, cited in Pet. 68–69. According to Foster, “The encrypted title key is then attached to the content packet and the header for synchronized transmission to, or storage by a receiver.” Id. ¶ 8 (emphasis added), quoted in Pet. 65. For at least the reason that Foster teaches a PC or at this stage that Foster’s data set is “for storage.” See Pet. 65–66, 80–82. At this stage, we credit Dr. Bhattacharjee’s testimony (Ex. 1003 ¶¶ 221–222) over Dr. Rubin’s (Ex. 2003 ¶¶ 108–109) because it is better supported by the current record. In particular, we see no support for Dr. Rubin’s testimony that Foster’s receiver cannot provide long-term storage or is unlike the ’854 patent’s storage devices. See Ex. 2003 ¶¶ 108– 109. For instance, we see little difference between Foster’s PC 18 and the magnetic or optical disk, USB key drive, or other devices that Dr. Rubin claims are long-term storage devices. Ex. 1001, 67:16–19, cited in Ex. 2003 ¶¶ 108–109. PC 18 has “data storage.” Ex. 1006 ¶ 75. Foster explains “optical media” or “magnetic media” are types of data storage. Id. Foster also states that the receiver stores data. Id. ¶ 8. In view of these parts of Foster, we credit Dr. Bhattacharjee’s testimony that Foster’s receiver has data storage (Ex. 1003 ¶¶ 221–222) over Dr. Rubin’s testimony that Foster’s devices are unlike those described in the ’854 patent (Ex. 2003 ¶¶ 108–109), at this stage.” slip op. at 17
- Skill levelSkill level petitioner adoptedDecided for petitioner
“had at least a bachelor’s degree in computer science, computer engineering, or a related field, with three years of experience in the area of securing data from unauthorized access or use.” Pet. 6 (citing Ex. 10032 ¶¶ 37–38). Petitioner also asserts that a “higher level of education may substitute for less experience.” Id. Patent Owner does not respond to Petitioner’s assertions or argue for a definition of a person of ordinary skill in the art. See Prelim. Resp. Here, we apply the skill level proposed by Petitioner. Pet. 6.” slip op. at 4
- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“key (the encryption operation Petitioner contends would be reordered/repeated).” Id. at 16. Dr. Rubin explains why reordering the steps in the way that Petitioner proposes would have been pointless: Indeed, a [person of ordinary skill in the art] would recognize that encryption with the alleged external key would not be an appropriate step to repeat or reorder because it is parsed along with the data set into portions and those portions are then encrypted. Consequently, encrypting the shares with the alleged external key (i.e., the session master key) would render the splitting and encryption of the alleged external key pointless. Ex. 2003 ¶¶ 52–53. Dr. Bhattacharjee does not fully explain why the key that is parsed and encrypted is then used to further secure the data. Ex. 1003 ¶¶ 110–111. Thus, we credit Dr. Rubin’s testimony (Ex. 2003 ¶¶ 52–53) over Dr. Bhattacharjee’s (Ex. 1003 ¶¶ 110–111) on this issue. For this additional reason, Petitioner has not shown that Orsini discloses the Different-Order Version. See Pet. 33–35.” slip op. at 29
Claim construction§ 102 anticipation§ 103 obviousnesscites KSRPatents in suitUS 10,452,854 - PTAB · May 23, 2024 · IPR2024-00214 · APJ Stephen E Belisle · IPR · Institution
The Board instituted IPR on claims 1–10 and all petition grounds, finding a reasonable likelihood of success on Foster grounds for claims 1–3, 7, and 8 and claims 4–6, 9, and 10.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2023). We may not institute an inter partes review “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). The “reasonable likelihood” standard is “a higher standard than mere notice pleading” but “lower than the ‘preponderance’ standard to prevail in a final written decision.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 at 13 (PTAB Dec. 20, 2019) (precedential). When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim. 37 C.F.R. § 42.108(a). Applying those standards, and upon consideration of the information presented in the Petition and Preliminary Response, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one claim of the ’609 patent is unpatentable. See 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). Accordingly, we institute an inter partes review as to all Challenged Claims of the ’609 patent on all grounds raised in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citation omitted). The level of ordinary skill in the art also may be reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Neither party argues, at least at this stage of the proceeding, that the outcome of this case would differ based on our adoption of any particular definition of the level of ordinary skill in the art. Considering the subject matter of the ’609 patent, the background technical field, the prior art, and Petitioner’s proposed and unopposed definition of the skilled artisan, we apply the level of skill set forth above, which is consistent with the testimony of Dr. Bhattacharjee (Ex. 1003 ¶¶ 37–38).” slip op. at 9
- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“repeated, would not necessarily indicate that the chunks, each encrypted with a separate share key, would be again encrypted using the session master key (the cryptographic operation Petitioner contends would be reordered/repeated).” Prelim. Resp. 16. Dr. Rubin explains why reordering the steps in the way that Petitioner proposes would have been “pointless:” Indeed, [the skilled artisan] would recognize that encryption with the alleged first key would not be an appropriate step to repeat or reorder because it is parsed along with the data set into portions and those portions are then encrypted. Consequently, encrypting the shares with the alleged first key (i.e., the session master key) would render the splitting and encryption of the alleged first key pointless. Ex. 2003 ¶¶ 52–53. Dr. Bhattacharjee does not fully explain why the key that is parsed and encrypted is then used to further secure the data. Ex. 1003 ¶¶ 101–105. Thus, we find Dr. Rubin’s testimony (Ex. 2003 ¶¶ 52–53) more persuasive than Dr. Bhattacharjee’s (Ex. 1003 ¶¶ 101–105) on this issue. For this additional reason, Petitioner has not shown that Orsini discloses the Different-Order Versions.” slip op. at 39
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Decided for petitioner
“Here, however, Petitioner does not insist any construction is incorrect. Rather, Petitioner presents alternative rationales for why the claims are unpatentable, stating that the Petition demonstrates “unpatentability regardless of which proposed construction is correct.” Pet. 9. Even though some stated rationales are based on Patent Owner’s constructions in the District Court Case, the Petition complies with the rule because it explains how the Challenged Claims are to be construed under the alternative challenges. See 37 C.F.R. § 42.104(b)(3). The rule “does not require Petitioner to express its subjective agreement regarding correctness of its proffered claim constructions or to take ownership of those constructions.” Western Digital Corp. v. SPEX Techs., Inc., IPR2018-00084, Paper 14 at 11 (PTAB Apr. 25, 2018).” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,068,609 - Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.No claims unpatentablePTAB · Apr 16, 2024 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Final written decision
The Board held claims 1–4, 8–14, and 18–26 not shown unpatentable because they were entitled to priority before the November 2018 Venclexta Label, which therefore was not prior art.
RulingsFinal written decision- Skill levelSkill level board ownOther
“We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology, which would encompass the blood cancers recited in the claims. Neither party identifies a difference in the analysis or conclusions that would be based on differences in the ordinary skill in the art analysis. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. 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” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties do not identify any issue relating to the preamble that would impact our analysis. We recognize that Patent Owner is suggesting that Petitioner’s expert, at least, is reading the word “clinical” into the treatment language of claim 1. However, the plain language of the claim 1 preamble states “treating lymphoma or leukemia in a human patient” and is supported by a straightforward definition in the Specification of the ’087 patent, expressly limiting the invention to treatment of human patients. See Ex. 1001, 16:25–38. We therefore find that the preamble terms do not need claim construction because there is no actual dispute suggesting that, for example, claim 1 implicitly recites the term “clinical.” See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 5
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledEntitled to earlier dateDecided for patent owner
“d. Analysis Considering the Wands factors as a whole, we find that the limited breadth of the claims, presence of several working examples, significant amount of direction and guidance provided by the ’087 patent, predictability in treating blood cancers with Bcl-2 inhibitors like GDC-0199, and high level of skill in the art are balanced against a large quantity of experimentation. Based on our consideration of the entirety of the evidence, we find that a preponderance of the evidence supports the conclusion that undue experimentation would not have been required to make and use the invention commensurate in scope with the claims of the ’087 patent. One underlying theme of Petitioner’s contentions and Petitioner’s expert testimony is the repeated contention that clinical trials were not completed by Patent Owner. See, e.g., Pet. 48 (“venetoclax (GDC-0199) was not FDA-approved”); Ex. 1020 ¶ 193. We find these arguments unpersuasive as we agree with Patent Owner that “[i]t is well established that a patent may be secured, and typically is secured, before the conclusion of clinical trials.” In re Montgomery, 67 F.3d 1375, 1382 (Fed. Cir. 2012). Particularly as to the dependent claims, a preponderance of the evidence of record does not support a finding that undue experimentation would have been required to administer three different doses of GDC-0199 starting with 100 mg, to use multiple daily dosing cycles of one day, to continue until disease progression occurs, or to combine with other treatment compounds. We find that a preponderance of the evidence does not support Petitioner’s position that any of the dependent claims fail to comply with the enablement requirement.” slip op. at 23
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner
“Applying Rai and Wertheim to the instant facts, we agree with Patent Owner that, factually and legally, in the ’087 patent “the claimed dosages of 100 mg, 200 mg, and/or 400 mg of GDC-0199 are adequately supported.” PO Second Suppl. Brief 2 (citing PO Resp. 11, 27–29; PO Sur-reply 19, 21– 22; Ex. 1001, 24:20–29.) In particular, the ’087 patent describes all three specific dosage values 100 mg, 200 mg, and 400 mg in the context of an escalating drug dosage series and Petitioner points to no persuasive statements in the specification that dispute either the effectiveness or the operability of GDC-0199 at any of these dosages.” slip op. at 32
Patent outcomesUS 11,110,087 not shown unpatentableClaim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 11,110,087
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.