- Tanklogix, LLC v. Sitepro, Inc.Institution deniedPTAB · Oct 10, 2025 · IPR2025-00652 · APJ Bart A Gerstenblith · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–23 and 25–30 were unpatentable over the asserted grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“presented in the petition . . . and any [preliminary] response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2024). For the reasons given below, on this record Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of any of the Challenged Claims. Accordingly, we do not institute an inter partes review.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“The parties’ proposed levels of ordinary skill in the art are similar, although Patent Owner proposes two years of experience along with a bachelor’s degree whereas Petitioner proposes “significant” experience. Patent Owner also proposes an alternative with more extensive experience in lieu of a bachelor’s degree. Although we find Petitioner’s proposed qualifications acceptable, we adopt Patent Owner’s proposed qualifications for the purposes of this Decision because they offer a wider range of qualifications that nonetheless comport with the level of ordinary skill necessary to understand and implement the teachings of the ’403 patent and the asserted prior art. 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). Our analysis and findings herein, however, do not turn on any differences in the parties’ proposed qualifications.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties assert that each claim term should be construed in accordance with its plain and ordinary meaning. Pet. 10; Prelim. Resp. 4 (citing Ex. 2009 ¶ 73); see Ex. 1002 ¶ 22 (opining the same). And, in the respective claim construction sections of their briefs, the parties do not propose any claim terms for express construction. We agree with the parties that no claim terms require express construction to resolve the controversy before us. See Realtime Data, 912 F.3d at 1375.” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We agree with Patent Owner that the Petition fails to demonstrate that Kahn discloses element [1.2] because the evidence cited does not disclose a “first computer system being configured to provide remote control of the first pump or first valve” (i.e., a fluid-handling device). Kahn is directed to providing access to fluid sensing data and analyzing and providing visual information on that data, but Petitioner has not identified any disclosure of the capability to remotely control fluid-handling devices. See, e.g., Ex. 1005, code (54), 1:27–36, 2:50–3:2. More specifically, Kahn’s disclosures that Petitioner relies on for allegedly teaching remote control are deficient. We discuss each. First, Petitioner points to the following, “[f]or instance, as illustrated in FIG. 1C, a fluid control device such as a valve 15A is located on the input side of a sen[s]or unit 110.” Ex. 1005, 8:19–21, cited in Pet. 13. This portion of Kahn, however, does not disclose remote control. Second, Petitioner cites to the following: Finally, or in addition to, the communication unit 112B can include on-site alerts such as optical (indicator lights), audible alerts (e.g., alarm sounds), tactile (e.g., vibration of the unit) or can be interfaced to an appropriate control valve for simply shutting off the supply of fluid upon the detection of emergency events, for instance. Pet. 13 (citing Ex. 1005, 10:62–67). We agree with Patent Owner that this portion of Kahn teaches on-site alerts and local control of the fluid-handling device. See Prelim. Resp. 7. This portion of Kahn does not disclose remote control.” slip op. at 18
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,294,403 - Tanklogix, LLC v. Sitepro, Inc.Institution deniedPTAB · Oct 10, 2025 · IPR2025-00651 · APJ Bart A Gerstenblith · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–3, 6, 7, and 9–20 were unpatentable over any asserted ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“presented in the petition . . . and any [preliminary] response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2024). For the reasons given below, on this record Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of any of the Challenged Claims. Accordingly, we do not institute an inter partes review.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“The parties’ proposed levels of ordinary skill in the art are similar, although Patent Owner proposes two years of experience along with a bachelor’s degree whereas Petitioner proposes “significant” experience. Patent Owner also proposes an alternative with more extensive experience in lieu of a bachelor’s degree. Although we find Petitioner’s proposed qualifications acceptable, we adopt Patent Owner’s proposed qualifications for the purposes of this Decision because they offer a wider range of qualifications that nonetheless comport with the level of ordinary skill necessary to understand and implement the teachings of the ’680 patent and the asserted prior art. 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). Our analysis and findings herein, however, do not turn on any differences in the parties’ proposed qualifications.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“target value” is part of a command that is sent from a computing device to a server and then to a controller. The controller then receives a measurement of the fluid by a sensor and determines whether the measurement satisfies the “target value.” If the measurement does not satisfy the “target value,” further operations are undertaken. The recited operation sequence makes clear that the plain and ordinary meaning of “target value” is not as Dr. Wooley opines because the particular operating condition that a device is in at a particular time is represented by the measurement taken by the sensor, 11 Some claim language less relevant to construing “target value” was omitted for ease of reference. which the controller then uses to determine whether the measurement satisfies the “target value.” Additionally, claim 1 recites that the “target value” is sent as part of a command to the controller. The “target value” is not sent to the controller from the sensor, as might be expected if the plain and ordinary meaning of “target value” were as Dr. Wooley opines. Petitioner and Dr. Wooley’s construction would also result in “target value” meaning effectively the same thing as the measurement of the fluid by the sensor, a concept that is separately recited in claim 1 and to which the “target value” is compared. The Specification of the ’680 patent does not support Petitioner’s understanding of the plain and ordinary meaning of “target value.” Although the Specification does not recite “target value,” it recites “target state,” and describes “target state” sufficiently to understand the plain and ordinary meaning of “target” as used in “target value” and “target state.” In particular, the ’680 patent explains that “[i]n some embodiments, the process 104 includes receiving, via a network interface, from a remote user device, (e.g., via a command-center server) a command to change a state of a fluid-handling device to a target state.” Ex. 1001, 11:48–51. This portion reflects that the command is seeking to change a state of a fluid-handling device to a target state. In other words, the “target value” or “target state” is not generally “the particular operating condition that a device is in at a particular time”; rather, it is a value or state that the fluid-handling device is desired to be in, as Patent Owner and Dr. Durham explain. Additionally, just as claim 1 recites a directional component for the “target value” to be sent to the controller in a command, so too does the Specification describe a “target state” as being sent in a command from a remote user device. Thus, the Specification clearly supports the plain and ordinary meaning proposed by Patent Owner and Dr. Durham and not the plain and ordinary meaning proposed by Petitioner and Dr. Wooley. slip op. at 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“time-stamped process data, report exception therein to the remote host, and extract and transmit time-stamped process data to the remote host.” Ex. 1005, Abst. (emphases added). Almadi explains that its remote field systems must include a plurality of controller units “to issue commands to, and gather and process data from a plurality of field devices, including remote systems and instruments, . . . [and] a database server for the storage of process data retrieved from the remote subsystems and instruments.” Id. at 2:22–30 (emphases added). Based on these disclosures, we agree with Patent Owner that Petitioner has not established that Almadi discloses element [1.4]. Specifically, the teachings from Almadi identified by Petitioner refer to process data, which is data retrieved from the remote subsystems/field devices. Thus, we understand that Almadi’s teaching—of using an Ethernet switch to transmit “process data”—describes transmitting data from the remote subsystems/field devices. See Ex. 1005, 3:13–17, cited in Pet. 15. But claim 1 and particularly element [1.4], recites “sending, with the server, the target value to the network address [which identifies a controller of the fluid-handling device13] via the network,” which is different than sending process data from the field devices to the remote host or database server for storage.” slip op. at 19
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,175,680 - Fusion Orthopedics, LLC v. Extremity Medical, LLCSome claims unpatentablePTAB · Nov 4, 2024 · IPR2023-00894 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–10 and 12–15 are unpatentable; claim 11 was not shown unpatentable. Substitute claims 16–25 and 27–30 are unpatentable over Mazur; claim 26 was not reached.
RulingsFinal written decision- BurdenMixed
“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.’” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (quoting 35 U.S.C. § 312(a)(3)). Here, however, not until its Reply does Petitioner belatedly suggest that Ferrante’s disclosure of bone screws with self-tapping ends equally meets the limitation of claim 10 (with respect to the first member) as with claim 11 (with respect to the second member), and that both claims are obvious in light of “evidence” from Ferrante “that it was well known to equip bone screws with self-tapping ends.” Reply 26–27. We do not discern these arguments in the Petition, and consider them waived. See Netflix, Inc. v. DivX, LLC, 84 F.4th 1371,1377 (Fed. Cir. 2023) (“While the Board should not take an overly mechanistic view of a petition and decline to address an argument because the petitioner did not present it with ideal vigor and clarity, the Board should also not have to decode a petition to locate additional arguments beyond the ones clearly made.”). In sum, Petitioner’s error in failing to first address limitations of claim 10 in the Petition specific to the Cognet/Ferrante combination indicates a failure to meet the particularity requirements for what must be in the petition and cannot be left to be filled in on reply. See 35 U.S.C. § 312(a)(3); 37 C.F.R. §§ 42.22(a)(2) (requiring, among other things, “a detailed explanation of the significance of the evidence”), 42.104(b)(4)–(5) (requiring that petition “specify where each element of the claim is found in the prior art patents or printed publication relied upon” and, regarding submitted evidence, state “the relevance of the evidence to the challenge raised, including identifying specific portions of the evidence that support the challenge”). Microsoft, 2022 WL 989403, at *6. Accordingly, Petitioner has not shown persuasively that claim 11 would have been obvious in light of Cognet and Ferrante for the reasons set forth in the Petition. slip op. at 41
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We also find persuasive Mr. Dominguez’s explanation that one of ordinary skill in the art would have understood “bore” as including stepped diameter holes, sometimes described as a bore having a counterbore. See generally Ex. 1018 ¶¶ 4–29; Reply 3–10. Three of Mr. Dominguez’s illustrative examples are reproduced in the annotated figures below. The above figures show Mr. Dominguez’s annotated illustrations from the Jackson (Ex. 1019, Fig. 3), Brånemark (Ex. 1021, Fig. 4), and Ray (Ex. 1025, Fig. 1) references as discussed at paragraphs 10, 12, and 13, respectively, of Mr. Dominguez’s Second Declaration. With reference to the above figures, Mr. Dominguez testifies that “Jackson describes a bone repair set screw in which ‘[t]he bore 27 comprises a first bore section 31, a second bore section 32,’ etc. delineated by shoulders 41, 42, etc. (Ex. 1019, 5:24– 43)” (Ex. 1018 ¶ 10); “Brånemark describes an osseous implantation device having body 1ʺ with first and second holding portions 21ʺ, 31ʺ and ‘an inner through bore with a first portion 4ʺ in the first holding portion and a second portion 5ʺ in the second holding portion.’” Ex. 1021, 4:44–46” (id. ¶ 12); and Ray discloses surgical calipers including “handle 12 having ‘stepped cylindrical bore 14,’” wherein “[c]ollar 20 of a shaft inserted in the bore ‘rests against a step of the bore 14’ (2:14–15)” (id. ¶ 13). Patent Owner responds that Mr. Dominguez’s examples “that allegedly show a single bore encompassing two or more stepped-diameter holes or a counterbore . . . . are specific to these references and divorced from the disclosures of the ’166 patent.” Sur-Reply 7. Insofar as the ’166 patent makes no mention of the term “bore” outside the claims, and Mr. Dominguez’s examples are all taken from the field of orthopedic surgery, we do not find this argument persuasive. Patent Owner further appears to contend that exemplary references to a “cylindrical stepped down bore” or a “stepped cylindrical bore” are too specific to be within the scope of the term “bore.” Sur-Reply 7–8. As these terms merely describe species within a larger genus, and Patent Owner presents no cogent reason to exclude them, we do not find this argument availing. Relatedly, we are also not persuaded by Patent Owner’s argument that “the prior art treats a ‘bore’ as an element that is distinct from a ‘counterbore.’” Id. at 8. Rather, we credit Mr. Dominguez’s testimony that “[a] counterbore is not a structure unto itself, a counterbore is part of a larger structure” as exemplified by numerous examples including Laps (Ex. 1028 ¶ 33 (sensor assembly wherein “bore 16 includes a counterbore 18”)); Martinez (Ex. 1029, 3:61 (surgical cutting instrument wherein “bore 56 has a counterbore 64”)); Zang (Ex. 1030, 2:49 (bone anchor having a “bore [that] includes a counterbore”)); Ledet (Ex. 1022, 29:3–5 (vertebral fixation plate having “through holes . . . . countersunk, or counterbored to accommodate the head of a bone screw”)); Seo (Ex. 1031, 3:45 (chair leg employing “counterbored bore 23”)); and Exner (Ex. 1032, 2:16 (extrusion press including “counterbored axial bore 6”)). Ex. 1018 ¶¶ 17–23. That a reference may refer to a figure as showing “bore 103” with “counterbore 105 . . . formed on one end” does not indicate that they are distinct structures as Patent Owner contends, but merely that the focus of each term is directed to the entire bore or to a particular aspect of the bore, i.e., its counterbore. See” slip op. at 22
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner subsequently proposed an alternative definition, as a person having “[a] Bachelor’s Degree in biomedical and/or mechanical engineering or similar training and . . . at least three years of experience with implant devices used for internal fixation of bones.” POR 5 (citing Ex. 2012 ¶¶ 32–33). According to Patent Owner, “[t]his hypothetical person would be capable of performing various design tasks and would understand the basic mechanical features and operation of orthopaedic implant devices [and] have an appreciation for orthopaedic fusion techniques and the medical issues and concerns faced by a doctor/surgeon charged when performing operations to implant orthopaedic devices.” Id. Despite some differences in wording, Patent Owner asserts (and Petitioner does not contest) that any “distinction between the parties’ proposed definitions of a POSITA does not affect the arguments set forth herein.” Id. (citing Ex. 2012 ¶ 34). Consistent with this view, we find the parties’ constructions equally applicable in light of the prior art of record and the disclosure of the ’166 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). We adopt, for convenience, Petitioner’s definition, but our analysis does not change depending on which of the two articulations are applied here. H.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“one of ordinary skill in the art would understand that “bore,” as used in the context of claims 1 and 12, encompasses a multi-diameter passage, and in particular, one having stepped longitudinal cross sections such as that shown in Cognet’s Figure 1. See generally DI 11–13. For the reasons that follow, we conclude that one of ordinary skill in the art would have understood “bore” as such. Relying on the testimony of Mr. Dominguez, Petitioner initially proposed a construction of “bore” as “a usually cylindrical hole made by or as if by the turning or twisting movement of a tool.” Pet. 16 (citing Ex. 1002 ¶ 58). Petitioner’s proposal relied on Mr. Dominguez’s testimony that “[a] bore is a cylindrical hole made by the spinning rotation of a twist drill cutting tool. It is typically made by removing material from a solid or hollow object, similar to a tunnel or orifice.” Ex. 1002 ¶ 58. Pointing to its annotation of Cognet’s Figure 1, above, Patent Owner argued that that the term “bore” excludes a tunnel made by “two adjacent bores.” See Prelim. Resp. 21–25. In view of the then-available evidence, we provisionally construed “bore” as a hole or passage made by or as if by the turning or twisting movement of a tool such that its interior walls have cylindrical lateral cross-sections, and which do not exclude holes or passages having tapered or stepped longitudinal cross-sections. DI 13.” slip op. at 19
Patent outcomesUS 11,298,166 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,298,166 - 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 · IPR2024-00085 · APJ Michael L Woods · IPR · Institution
The Board instituted IPR on claims 1, 2, 4, 5, 7–11, 13, and 15 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314 and 37 C.F.R. § 42.4(a), we have authority to institute an inter partes review if “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). After considering the Petition, the Preliminary Response, the Preliminary Reply, the Preliminary Sur-reply, and the evidence of record, we determine the information presented shows a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one of the Challenged Claims of the ’659 patent. Accordingly, we institute an inter partes review of the Challenged Claims on the grounds asserted in the Petition.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“We disagree with Patent Owner. Our analysis under Fintiv is guided by the USPTO Director’s Memorandum issued on June 21, 2022, titled “Interim Procedure for Discretionary Denials in AIA Post Grant Proceedings with Parallel District Court Litigation.”8 The Director’s Memorandum explains that, when a petitioner makes a Sotera-type stipulation, “it mitigates concerns of potentially conflicting decisions and duplicative efforts between the district court and the PTAB” and “[w]ith such a stipulation, if an IPR or PGR is instituted, the grounds the PTAB resolves will differ from those present in 8 https://www.uspto.gov/sites/default/files/documents/interim_proc_discretio nary_denials_aia_parallel_district_court_litigation_memo_20220621_.pdf (“Director’s Memorandum”). the parallel district court litigation.” Director’s Memorandum 7 (citing Sotera, IPR2020-01019, Paper 12 at 18–19). Pursuant to the Director’s Memorandum, we “will not discretionarily deny institution of an IPR or PGR in view of parallel district court litigation where a petitioner stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition.” Id. Because Petitioner provides a Sotera-type stipulation, we do not exercise our discretion to deny institution under Fintiv.” slip op. at 8
- Skill levelSkill level patent owner adoptedDecided for patent owner
“Upon review of the prior art of record and the parties’ arguments, we adopt Patent Owner’s definition of the person of ordinary skill in the art for purposes of this Decision as it appears consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (holding that the prior art itself can reflect the appropriate level of ordinary skill in the art). Petitioner’s proposed definition appears overly restrictive, as it requires a graduate degree in a narrow field of engineering or equivalent experience. We find that a bachelor’s degree with the accompanying experience proposed by Patent Owner more closely aligns with the prior art of record and the ’659 patent. We note, however, there is some overlap in the proposed levels of ordinary skill in the art because Patent Owner’s proposal includes “at least” a bachelor’s degree, which would encompass Petitioner’s master’s degree as well. Prelim. Resp. 19. Nonetheless, our determination herein would be the same under either party’s definition.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We disagree with Patent Owner’s claim construction. By using the word “or,” the plain and ordinary meaning of “prone, kneeling, or standing” is that only one must be satisfied to meet the claim. See, e.g., SkinMedica, Inc. v. Histogen Inc., 727 F.3d 1187, 1199 (Fed. Cir. 2013) (“The disjunctive ‘or’ plainly designates that a series describes alternatives.”). Furthermore, and although claims are read in light of the specification, limitations in a specification are not read into a claim. In re van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). Even if the Specification describes embodiments in which the user can begin in a prone position and then transition to a kneeling or standing position, as Patent Owner points out (see Prelim. Resp. 20), the claim does not recite the term “transitioning,” and we do not read the terms “each of” or “substantially flat surface” into this claim limitation. For example, the claim does not recite a “substantially flat” top surface and Patent Owner’s attempt to infer this structure into the claim is not supported under the law. See id. at 29–30. For purposes of this Decision, we agree with Petitioner and construe “prone, kneeling, or standing” in accordance with its plain and ordinary meaning as alternatives, and the prior art need only show one to satisfy this aspect of the claim.” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 9,586,659 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jan 9, 2024 · IPR2023-00566 · APJ John G New · IPR · Final written decision
Claims 1–9, 34–39, 41–43, and 45 are unpatentable as anticipated by Dixon; the Board did not reach the other grounds.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“Owner and its experts proposed claim construction of “effectively treating” as meaning “noninferior,” “statistically noninferior,” or “comparable.” Pet. Reply 4. Petitioner asserts that Patent Owner, and its expert, Dr. Do, advance the proposed construction of “effectively treating, ” with no explanation for what that means, or how it comports with the challenged dependent claims that recite visual acuity limitations ranging from losing less than 15 letters to gaining more than 15 letters. Id. at 4–5.” slip op. at 32
- ExcludeMotion to exclude, grantedMotion to exclude, deniedMixed
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
Patent outcomesUS 10,888,601 unpatentableClaim construction§ 102 anticipationcites PhillipsPatents in suitUS 10,888,601 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jan 9, 2024 · IPR2023-00533 · APJ John G New · IPR · Final written decision
Claims 1–9, 34–39, 41–43, and 45 are unpatentable as anticipated by Dixon; the Board did not reach the other grounds.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Id. at 18. The similar language of the challenged claims of the ’601 patent, and our reasoning in the related -00881 Decision, compel the same conclusion here, i.e., that the preamble is limiting upon the claims.” slip op. at 43
- ExcludeMotion to exclude, grantedMotion to exclude, deniedMixed
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
Patent outcomesUS 10,888,601 unpatentableClaim construction§ 102 anticipationcites PhillipsPatents in suitUS 10,888,601 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jan 9, 2024 · IPR2022-01226 · APJ John G New · IPR · Final written decision
Claims 1–9, 34–39, 41–43, and 45 are unpatentable as anticipated by Dixon; the Board did not reach the remaining grounds.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
- ExcludeMotion to exclude, grantedMotion to exclude, deniedMixed
“challenged claims are thus anticipated, we do not reach the additional Grounds 2–7 proposed in the Petition. Furthermore, Petitioner’s Motion to Exclude Evidence is granted-in-part, denied-in-part and dismissed-in-part. Patent Owner’s Motion to Exclude Evidence is denied-in-part and dismissed-in-part.” slip op. at 92
Patent outcomesUS 10,888,601 unpatentable§ 102 anticipationcites PhillipsPatents in suitUS 10,888,601 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jan 9, 2024 · IPR2023-00532 · APJ John G New · IPR · Final written decision
Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as anticipated by Dixon; the Board did not reach Grounds 2–6.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Decision. See Ex. 3001, 12–23. As an initial matter, we are not persuaded by Patent Owner’s reliance on Sanofi and Eli Lilly. See PO Resp. 9. In Sanofi, a non-precedential decision, the Federal Circuit held that the preamble to the claims at issue, reciting “[a] method of increasing survival comprising administering to a patient in need thereof” was limiting upon the claims, in conformance with the court’s prior decisions in Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333 (Fed. Cir. 2003) and Rapoport v. Dement, 254 F.3d 1053 (Fed. Cir. 2001). Sanofi, 757 F. App’x at 992–93. Furthermore, the court held that, because the preamble was limiting, and recited a “method of increasing survival” the proposed claims would now clearly require “increasing survival.” Id. at 994. The preamble to claim 1 of the ’681 patent, however, recites no such “increase” with respect to efficacy, but merely recites “A method for treating an angiogenic eye disorder in a patient,” and the remainder of the claim requires no specific efficacy requirement. Nor does Eli Lilly support Patent Owner’s position. In Eli Lilly, the court upheld the Board’s conclusion that the preamble reciting “a method for treating headache in an individual” was limiting upon the claims. Eli Lilly, 8 F.4th at 1343. However, it noted, in upholding the Board’s conclusion, the Board also “found that while the claims encompass a clinical result, they do not require such a result.” Id. (emphasis added). We also find that the similar language of the preamble to challenged claim 1 of the ’681 patent, although encompassing clinical efficacy, does not require it, let alone a “high degree of efficacy.”” slip op. at 33
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“the preamble’s recitation of a “method for treating” requires a high level of efficacy. In the -00881 Decision, the Board rejected Patent Owner’s similar argument because it required improperly importing limitations into the claims. See Ex. 3001, 22. Specifically, the Board found that: [W]hen the Specification explains that “[t]he amount of VEGF antagonist administered to the patient in each dose is, in most cases, a therapeutically effective amount,” and discloses that “a therapeutically effective amount can be from about 0.05 mg to about 5 mg,” we find that a POSA would have understood that any dosage amount within that range administered according to the invention may, in some cases, result in a detectable improvement in “one or more symptoms or indicia of an angiogenic eye disorder,” or be one that “inhibits, prevents, lessens or delays the progression of an angiogenic eye disorder,” or it may not. In either event, the VEGF antagonist would have been administered for the purpose of treating the eye disorder. In other words, the method of treating the patient with the eye disorder is performed upon administration of the VEGF antagonist to the patient for the purpose of achieving an improvement or beneficial effect in the eye disorder, regardless whether the dosage amount administered actually achieves that intended result. Id. at 21–22 (citation omitted). Furthermore, the Board found that: Patent Owner proposes that the claims require not only achieving a therapeutically effective result, but more specifically, achieving a “high level of efficacy that was noninferior to the standard of care by the time the patent was filed in 2011.” In the Sur-reply, Patent Owner describes a “highly effective treatment for angiogenic eye disorders” as “one that is on par to Lucentis or off-label Avastin and can produce visual acuity gains, not just slow vision losses.” The Specification refers to “a high level of efficacy” in one instance, i.e., in the “Background” section. The Specification does not describe there, or elsewhere that “treating,” in the context of the claims or in the art, requires achieving a “high level of efficacy” or providing results “on par to Lucentis or off-label Avastin.” Id. at 22 (citations omitted). We adopt the same reasoning here, and find that, for the purposes of this Decision, the evidence of record and the Specification support construing the preamble’s recitation of a “method for treating a patient with an angiogenic eye disorder” as meaning administering a compound, i.e., the recited VEGF antagonist, to such patient for the purpose of improving or providing a beneficial effect in their angiogenic eye disorder. We find that, as in Eli Lilly, although the claims “encompass a clinical result, they do not require such a result.” Eli Lilly, 8 F.4th at 1343. We consequently reject” slip op. at 35
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“The terms “initial dose,” “secondary doses,” and “tertiary doses,” refer to the temporal sequence of administration of the VEGF antagonist Thus, the “initial dose” is the dose which is administered at the beginning of the treatment regimen (also referred to as the “baseline dose”) ; the “secondary doses” are the doses which are administered after the initial dose; and the “tertiary doses” are the doses which are administered after the secondary doses. The initial, secondary, and tertiary doses may all contain the same amount of dosing regimens, but will generally differ from one another in terms of frequency of administration. Ex. 1001, col. 3 ll. 34–44. Petitioner also notes that the Specification further explains that “the immediately preceding dose” means “in a sequence of multiple administrations, the dose of VEGF antagonist which is administered to a patient prior to the administration of the very next dose in the sequence with no intervening doses.” Pet. 24 (citing Ex. 1001, col. 3, ll. 54–59; Ex. 1002 ¶¶ 44–45). We adopt Petitioner’s proposed construction of the claim terms “initial dose,” “secondary dose,” and “tertiary dose.” Petitioner proposes adoption of the definitions expressly set forth in the Specification of the ’681 patent, viz., that the initial dose is the dose “administered at the beginning of the treatment regimen,” and is followed by the secondary doses that are “administered after the initial dose,” and the tertiary doses are “administered after the secondary doses” and may be distinguished from the secondary doses “in terms of frequency of administration.” Ex. 1001, col. 3, ll. 36–44.” slip op. at 37
- Obviousness (§103) › Objective indicia / secondary considerationsNot reached
“As Petitioner states, Patent Owner relies upon these Exhibits as objective secondary evidence of non-obviousness. See, e.g., PO Resp. 65– 69. However, and as we explain below, because we find that the challenged claims are anticipated by Dixon, we do not reach Patent Owner’s arguments that the claims are non-obvious (Grounds 4–6) or its contentions regarding secondary considerations of non-obviousness. See Cohesive Techs., Inc. v. Waters Corp., 543 F.3d 1351, 1364 (Fed. Cir. 2008) (holding that “secondary considerations are not an element of a claim of anticipation”). Consequently, we dismiss Petitioner’s motion to dismiss the Financial Documents as moot.” slip op. at 10
Patent outcomesUS 10,130,681 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 10,130,681 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jan 9, 2024 · IPR2022-01225 · APJ John G New · IPR · Final written decision
Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as anticipated by Dixon; the Board did not reach the remaining grounds.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Here, the claims are directed to methods of administering, i.e., using, a VEGF antagonist for an intended purpose of “treating an angiogenic eye disorder in a patient.” The Specification repeatedly characterizes the method as one for treating angiogenic eye disorders in patients. Apart from the preamble, the independent claims do not elsewhere recite or indicate any other use for the method steps comprising the administration of a VEGF antagonist. Thus, we determine that the preamble sets forth the essence of the invention—treating an angiogenic eye disorder in a patient. Additionally, we find that the preamble provides antecedent basis for claim terms “the patient” recited in the body of each independent claim, and “angiogenic eye disorders” recited in dependent claims 6, 7, 18, and 20. Indeed, without the preamble, it would be unclear to whom the doses of VEGF are administered. Thus, …in view of the evidence of record, namely, the claim language and the written description of the ’338 patent, we find that the preambles of method claims 1 and 14 are limiting insofar as they require “treating an angiogenic eye disorder in a patient.” Id. at 17–18 (citations omitted). We adopt this same reasoning here and find that the preamble of claim 1 reciting “[a] method for treating an angiogenic eye disorder in a patient” is limiting.” slip op. at 34
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We adopt Petitioner’s proposed construction of the claim terms “initial dose,” “secondary dose,” and “tertiary dose.” Petitioner proposes adoption of the definitions expressly set forth in the Specification of the ’681 patent, viz., that the initial dose is the dose “administered at the beginning of the treatment regimen,” and is followed by the secondary doses that are “administered after the initial dose,” and the tertiary doses are “administered after the secondary doses” and may be distinguished from the secondary doses “in terms of frequency of administration.” Ex. 1001, col. 3, ll. 36–44.” slip op. at 37
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“If a claim limitation is directed to printed matter, the next step in the Praxair analysis is to determine whether the printed matter is functionally related to its “substrate.” Praxair, 890 F.3d at 1032. Printed matter that is functionally related to its substrate is given patentable weight. Id. (citing DiStefano, 808 F.3d at 850). However, “[w]here the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.” Id. (quoting In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004)). More specifically, printed matter is functionally related to its substrate when the language changes not mere thoughts or outcomes, but provides action steps that the method requires. See C R Bard Inc. v. AngioDynamics, Inc., 979 F.3d 1372, 1381 (Fed. Cir. 2020) (holding that the test for printed matter is whether it “merely informs people of the claimed information, or whether it instead interacts with the other elements of the claim to … cause a specific action in a claimed process.”); see also Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) (stating that language “is only a statement of purpose and intended result” where its “expression does not result in a manipulative difference in the steps of the claim”) (emphasis added).” slip op. at 46
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A Person of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art would have: (1) knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders; and (2) the ability to understand results and findings presented or published by others in the field. Pet. 28. Petitioner asserts that such a person would typically have an advanced degree, such as an M.D. or Ph.D. (or equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field), with practical academic or medical experience in (i) developing treatments for angiogenic eye disorders, including through the use of VEGF antagonists, or (ii) treating of same, including through the use of VEGF antagonists. Id. at 28–29 (citing Ex. 1002 ¶¶ 27–29; Ex. 1003 ¶¶ 21–25). Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. Because we find Petitioner’s definition to be consistent with the level of skill in the art (see, e.g., Exs. 1006, 1020), we adopt Petitioner’s definition.” slip op. at 52
Patent outcomesUS 10,130,681 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 10,130,681
Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.