- Neurent Medical Inc. / Neurent Medical Ltd. v. Aerin Medical Inc.All claims unpatentablePTAB · Jul 11, 2025 · IPR2024-00282 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1–4 and 7–9 are unpatentable as obvious, principally over Edwards-’535 and Stern for claims 1–3 and 7–9, and Makower, Edwards-’535, and Stern for claims 1, 2, and 4.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“To the extent Petitioner’s definition could be interpreted to encompass someone who only has experience using or testing unrelated medical devices, we tend to agree with Patent Owner. But it does not follow that experience with the clinical use and testing of medical devices, including those that deliver energy to tissue, would not be relevant background for one of ordinary skill. See Reply 27–28 (identifying evidence that clinical experience is relevant). The devices and methods in the challenged patent and asserted prior art are designed to be used by clinicians. Accordingly, clinical experience using and testing them would inform their design and therefore be relevant experience for one of ordinary skill in the art. For these reasons, we do not adopt Patent Owner’s proposed modification of Petitioner’s definition, which would remove clinical use and testing from the list of activities in Petitioner’s POSITA definition. See PO Resp. 7 (proposing redlines). Instead, after reviewing the record, we adopt Petitioner’s definition as it is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. Regardless, Petitioner’s declarant, Dr. Martin, is qualified to offer opinions under either definition. Moreover, the parties do not argue that their respective position would be different under either POSITA definition. See PO Resp. 8 (Patent Owner arguing that the challenges fail “[r]egardless of how a POSITA is defined”); Ex. 1083 ¶ 88 (Dr. Martin testifying that his opinions “remain the same regardless of which definition applies”). Accordingly, all of the findings and conclusions herein would be the same under either side’s definition of a POSITA.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“Petitioner argues that the part of claim 1’s preamble “to treat rhinitis” is not limiting. Pet. 18. According to Petitioner, the body of claim 1 recites a structurally complete apparatus, and the preamble only states an intended use for the device without limiting the claimed structure. Id. at 18–19. Patent Owner neither addresses this issue, nor proposes any other claim construction. PO Resp. 13 (“Patent Owner believes that no claim constructions are required to resolve the issues raised [in this IPR].”). On this record, we find Petitioner’s argument persuasive and determine that the part of claim 1’s preamble “to treat rhinitis” is not limiting.” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“techniques of delivering bipolar RF ablation energy through expandable devices to the mucosal tissue of different body cavities.” Id. at 39. According to Petitioner, “combining Edwards-’535 and Stern involves applying Stern’s known bipolar pairing technique to Edwards-’535’s known device that was ready for improvement (because Edwards-’535 omits electrode wiring details) to yield predictable results.” Id. Thus, Petitioner concludes that an ordinarily skilled artisan would have had a reasonable expectation of success when modifying Edwards-’535 in view of Stern. Id. at 38–40. Patent Owner does not dispute Petitioner’s mapping for claim limitations 1[a]-1[c] and 1[f] above, nor does Patent Owner challenge Petitioner’s reasoning for combining Edwards-’535 with Stern. See PO Resp. 14. Patent Owner, however, argues that Petitioner has failed to show Stern teaches limitations 1[d] and 1[e] “because Stern teaches a device comprising only a single pair of bipolar radiofrequency electrodes and a single radiofrequency output channel.” Id. We find that a POSITA would have been motivated to combine the teachings of Edwards-’535 and Stern and would have had a reasonable expectation of success in doing so for the reasons set forth in the Petition. We also find that the articulated combination of Edwards-’535 and Stern teaches all of the limitations of claim 1. We adopt Petitioner’s undisputed analysis of claim limitations 1[a]-1[c] and [f] and reasoning for combining the references, and credit its supporting evidence. See Pet. 26–33, 43–46; Ex. 1002 ¶¶ 84–102, 159–165. Below we address the parties’ arguments regarding the disputed limitations 1[d] and 1[e].” slip op. at 17
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“In our view, nothing is missing. Stern teaches that the circuitry in Figure 15 is configured to form multiple pairs of bipolar RF electrodes. Ex. 1033, 12:61–13:2 (explaining “[a]s an example” the closing of certain switches in Figure 15 to activate a bipolar pair between electrodes 220 and 224 and a second bipolar pair between electrodes 222 and 226 and further noting that “[c]learly bipolar operation is not limited to these . . . pair couplings” because other switches could be operated to activate a bipolar pair between electrodes 220 and 222); Ex. 1002 ¶¶ 108–111, 135–138. Indeed, Stern consistently uses the word “pairs,” i.e., the plural not the singular, to describe the bipolar operation of its device. See, e.g., Ex. 1033, 2:36–40, 3:38–40, 12:20–25, 12:29–30, 13:27–44, 20:9–10 (describing the bipolar operation of “pairs” nine times). Accordingly, we disagree with Patent Owner’s argument that Stern teaches a device configured to have at most only a single pair of bipolar RF electrodes. Second, Stern teaches that the “embodiment of FIG. 15 . . . provides flexibility within the bipolar operation so that any pair or any combination of pairs may be utilized together.” Ex. 1033, 13:39–43 (emphasis added). Thus, even if claim 1 did require simultaneous activation of multiple bipolar pairs, we agree with Petitioner that such functionality is also taught by Stern. See Reply 5–6.” slip op. at 20
Patent outcomesUS 11,766,286 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,766,286 - Neurent Medical Inc. / Neurent Medical Ltd. v. Aerin Medical Inc.All claims unpatentablePTAB · Jul 11, 2025 · IPR2024-00278 · APJ Michael A Valek · IPR · Final written decision
Claims 1, 4–6, 9, 10, 12, 13, and 15–17 are unpatentable as obvious over the asserted prior-art combinations.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner disputes the second part of Petitioner’s definition “because the ‘and/or’ encompasses within the definition . . . persons who only have experience with the clinical use or testing of medical devices.” Resp. 6. According to Patent Owner, one of ordinary skill “would have had more experience than just clinically using medical devices or simply conducting tests with medical devices” Id. at 6–7. To the extent Petitioner’s definition could be interpreted to encompass someone who only has experience using or testing unrelated medical devices, we tend to agree with Patent Owner. But it does not follow that experience with the clinical use and testing of medical devices, including those that deliver energy to tissue, would not be relevant background for one of ordinary skill. See Reply 33–34 (identifying evidence that clinical experience is relevant). The devices and methods in the challenged patent and asserted prior art are designed to be used by clinicians. Accordingly, clinical experience using and testing them would inform their design and therefore be relevant experience for one of ordinary skill in the art. For these reasons, we do not adopt Patent Owner’s proposed modification of Petitioner’s definition, which would remove clinical use and testing from the list of activities in Petitioner’s POSITA definition. See Resp. 7 (proposing redlines). Instead, we apply Petitioner’s definition. Regardless, Petitioner’s declarant, Dr. Martin, is qualified to offer the opinions in his declarations under either definition. Moreover, Patent Owner does not identify any testimony it contends would be different under its POSITA definition. See Ex. 1083 ¶ 103 (Dr. Martin testifying that his opinions “remain the same regardless of which definition applies”). Accordingly, all of the findings and conclusions herein would be the same under either side’s definition of the level of ordinary skill in the art.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“Neither side proposes any terms for express construction. Petitioner contends “the Board need not construe any terms because the Challenged Claims are invalid under any reasonable interpretation.” Pet. 20. “Patent Owner believes that no claim constructions are required to resolve the issues raised” in this IPR. Resp. 13. Nevertheless, in their arguments over whether the prior art teaches certain claim elements, each side accuses the other of misinterpreting or reading requirements beyond their ordinary meaning into those terms. See Reply 3–10 (urging that Patent Owner’s arguments read requirements into elements 1[d] and 1[e]); Sur-Reply 9–15 (arguing Petitioner applies an incorrect definition of “radio frequency output channel”). To the extent the parties’ arguments raise any implicit issues of claim construction, we address those issues within the context they are raised in our analysis below. No further express claim construction is necessary for this decision.” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“We find that one of ordinary skill in the art would have been motivated to combine Edwards-535 and Stern, and had a reasonable expectation of success in doing so for the reasons set forth in the Petition. We also find that the articulated combination of Edwards-535 and Stern teaches all of the limitations of claim 1. We adopt Petitioner’s undisputed analysis of claim elements 1[a]-[c] and [f] and reasoning for combining the references, and credit its supporting evidence. See Pet. 7–14, 17–20; Ex. 1002 ¶¶ 79–103, 113–21. Below we address the parties’ arguments regarding the disputed elements 1[d] and 1[e].” slip op. at 23
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“We find that Petitioner has the more persuasive position and has demonstrated that Stern teaches element 1[e]. Petitioner demonstrates Stern’s multiple RF output channels with the annotated version of Figure 15 shown below. Pet. 42–43. As shown by Petitioner’s annotations above, the channel (highlighted in orange) connecting the output received from voltage source 228 to the first bipolar pair (circled in green on the left) is distinct from the channel connecting the output to the second bipolar electrode pair (circled in purple on the right) because depending on which switches are closed, energy travels through a separate connection between those switches and the corresponding electrodes. We agree with Petitioner, and credit Dr. Martin’s testimony, that each of the output channels highlighted in orange in Stern’s Figure 15 above “are output channels as required by the claims because the channels are separately/individually connected to the electrodes” and “control individual pairs of bipolar RF electrodes.” Id. at 43–44; Ex. 1002 ¶¶ 124–128; see also Ex. 1083 ¶ 45 (“an ‘output channel’ connects electrodes and provides the ability to independently control pairs of electrodes”). This understanding of the term “output channel” is consistent with the claim language. Claim 1 recites “multiple radiofrequency output channels” wherein “each pair” of bipolar RF electrodes “is connected with a respective one of the multiple radio frequency output channels.” Ex. 1001, 52:27–33. The RF generator itself and its connection to the output channels is not recited in claim 1. Instead, the claim language focuses on the connection between the electrode pair and its respective output channel. The description in the specification also focuses on the connection to the electrodes and further explains that having a “separate, controlled electrical channel” for “each pair of electrodes” allows for “different regions of the treatment element to be activated separately.” Ex. 1001, 24:45–52, 48:63–65; see also Ex. 1083 ¶ 33 (“[e]very time the patent mentions ‘electrical channel’ or ‘output channel,’ it is referring to connections to electrodes”). This aligns with the depiction of the output channels in the ’318 patent’s figures. See Ex. 1001, Figs. 39–44 (showing RF output channel 961 connected to electrodes). Petitioner demonstrates this in the annotated version of Figure 39 shown below. Reply 8.” slip op. at 29
Patent outcomesUS 11,033,318 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,033,318 - Neurent Medical Inc. / Neurent Medical Ltd. v. Aerin Medical Inc.All claims unpatentablePTAB · Jul 11, 2025 · IPR2024-00277 · APJ Michael A Valek · IPR · Final written decision
Claims 1–4, 6–12, and 16 are unpatentable as obvious over the Edwards-535, Kong, and Stern combinations, with Edwards-886 added for claim 4.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“To the extent Petitioner’s definition could be interpreted to encompass someone who only has experience using or testing unrelated medical devices, we tend to agree with Patent Owner. But it does not follow that experience with the clinical use and testing of medical devices, including those that deliver energy to tissue, would not be relevant background for one of ordinary skill. See Reply 29–31 (identifying evidence that clinical use and testing experience is relevant). The devices and methods in the challenged patent and asserted prior art are designed to be used by clinicians. Ex. 1083 ¶¶ 5, 14–15 (explaining that clinicians who use such devices gain extensive experience regarding how they work); see also Ex. 1084, 82:13–83:20 (Dr. Bikson testifying that a physician would perform the claimed method steps). Accordingly, clinical experience using and testing them would inform their design and be relevant experience for one of ordinary skill in the art. For these reasons, we do not adopt Patent Owner’s proposed modification of Petitioner definition, which would remove clinical use and testing from the list of activities in Petitioner’s POSITA definition. See Resp. 7 (proposing redlines). Instead, we apply Petitioner’s definition. Regardless, Petitioner’s expert, Dr. Martin, is qualified to offer the opinions in his declarations under either definition and Patent Owner does not identify any testimony it contends would be different under its POSITA definition. See Ex. 1097 ¶ 49 (Dr. Martin testifying that his opinions “remain the same regardless of which definition applies”). Moreover, as explained below, we are not persuaded by Patent Owner’s challenge to Dr. DelGaudio’s qualifications and give his testimony appropriate weight in our analysis. For these reasons, our findings and conclusions would be the same under either side’s definition of the level of ordinary skill in the art.” slip op. at 10
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Third, nothing suggests that Dr. DelGaudio is not qualified to offer opinions regarding the knowledge and skill of one of ordinary skill in the art. In addition, to his relevant clinical experience, Dr. DelGaudio has experience designing different types of medical devices and consulting with device manufacturers to provide feedback and improve devices used in nasal surgery. Ex. 1083 ¶¶ 9–11. Thus, even if we had adopted a POSITA definition requiring design and development experience, Dr. DelGaudio would qualify as one of ordinary skill in the art because he has such experience in addition to his extensive clinical background. Id. Nevertheless, Patent Owner argues he is “not an individual capable of designing and developing the medical device used in the claimed method” because “Dr. DelGaudio has no experience in designing medical devices that deliver energy to tissue.” Sur-reply 22–24 (emphasis added). That argument is unavailing because such devices and methods of using them such as those recited in the claims of the ’271 patent are often developed by a team of individuals with different backgrounds and expertise. That Dr. DelGaudio working alone may not be capable of designing and developing such a device does not disqualify him from offering testimony from the perspective of one of ordinary skill in the art, particularly as it relates to those claim elements that recite the use of the device as opposed to its technical details.8 Moreover, Dr. DelGaudio was careful not to overstep the bounds of his expertise, relying on testimony from Dr. Martin to confirm his understanding concerning some of the engineering details of the devices themselves. See Ex. 1002 ¶¶ 94, 124, 127, 130, 151; see also Ex. 1083 ¶ 12 (explaining he relied on Dr. Martin to confirm his understanding of teachings in Stern that disclose “implementation details about circuitry used to operate the bipolar electrodes, the physics of delivering energy to tissue, among other things”); Ex. 1004 ¶¶ 66–131 (Dr. Martin testifying regarding a POSITA’s understanding of the prior art as it relates to such elements). Fourth, even if Dr. DelGaudio did not himself qualify as one of ordinary skill, we could still consider his testimony on those matters on which he was qualified. See Consolidated Trial Practice Guide (Nov. 2019), 52, available at https://www.uspto.gov/sites/default/files/documents /tpgnov.pdf (“CTPG”) (“A person may not need to be a person of ordinary skill in the art in order to testify as an expert under Rule 702, but rather must be ‘qualified in the pertinent art.’”) (citing cases). We agree with Petitioner that this would include matters such as the use of the devices described in the cited references in a clinical setting. See Reply 28. 8 Indeed, by its logic, Patent Owner’s own expert would not be one of ordinary skill in the art because he is not himself capable of practicing the claimed method. See Ex. 1084, 24:13–22, 82:19–83:8 (testifying he has never used an RF device to treat a patient and would not himself perform the recited method).” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“Petitioner’s position is persuasive. Even without taking into account the reasoning based on Baker (which we address separately below), Petitioner has demonstrated a sufficient rationale for incorporating Stern’s arrangement of two rows of bipolar electrode pairs into Edwards-535’s device. Edwards-535 teaches that a plurality of electrodes may be positioned on the surface of its treatment element, but does not specify how those electrodes are arranged or controlled. Ex. 1010, 8:25–27; Ex. 1004 ¶¶ 68–69. Stern teaches a control system for selectively delivering power to bipolar electrode pairs arranged in two rows on the surface of its device that provides even heating and precise control. Ex. 1004 ¶¶ 80–85. As Dr. DelGaudio explains, one of ordinary skill in the art would have regarded these attributes to be particularly beneficial when delivering treatment to the “nasal passages . . . given the uneven morphology of nasal cavity tissue and the proximity of the RF energy delivery to a patient’s brain and other critical tissues within the head.” Ex. 1002 ¶ 94. We credit the testimony of Petitioner’s experts that one of ordinary skill would have been motivated to incorporate Stern’s teachings, including the complementary two-row surface electrode arrangement shown in Figure 19, for these reasons. See Ex. 1002 ¶¶ 93–94; Ex. 1004 ¶¶ 72–73, 75–88, 96–97 (explaining that Stern’s techniques would have been used to improve Edwards-535’s device in a similar way). Petitioner’s reasoning that “arranging electrodes in rows . . . facilitates simple spatial resolution of the applied energy” is also persuasive. See Pet. 47–48. As Dr. Martin explains, one of ordinary skill in the art would have understood that arranging bipolar electrodes in two or more rows was a “common way to arrange such electrodes” (Ex. 1004 ¶ 34) and a “simple way to direct energy to specific locations for treatment would have been to place pairs of electrodes in rows . . . along the device at the locations being treated.” Id. ¶ 95.” slip op. at 41
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“Petitioner’s position is persuasive. Stern’s Figure 15 shows bipolar electrodes 220 and 224 in a first horizontal row and electrodes 222 and 226 in a second horizontal row. Stern teaches that bipolar pairs can be formed between various combination of these electrodes resulting in both pairs within a row and pairs formed across two rows. See Ex. 1033, 12:61–13:2 (explaining that “bipolar operation is not limited to [electrode] 220-224 and 222-226 pair couplings” because pairs could also be formed across rows, e.g., between electrodes 220 and 222). Stern’s Figure 19 likewise depicts a plurality of electrodes arranged in two rows. See Ex. 1004 ¶¶ 71–74 (Dr. Martin explaining that the physical arrangement in Figure 19 is complementary to the control structure in Figure 15 and that there are two rows regardless of which electrodes are paired). In bipolar operation, each of these figures depicts “two rows of bipolar electrode pairs” as recited in element 1[a] because there are two rows comprising multiple pairs.15 Patent Owner’s narrower interpretation of the phrase “two rows of bipolar electrode pairs” is not consistent with the intrinsic record. According to Patent Owner and Dr. Bikson, it is not enough that there are two rows of electrodes comprising multiple pairs––rather each row must itself contain multiple pairs. See Resp. 23; Ex. 2001 ¶ 75 (“A row of only two electrodes is not a row of bipolar electrode pairs because a row of only two electrodes has at most a single pair (not multiple pairs).”). As Petitioner points out, Patent Owner’s interpretation assumes that the “s” in “pairs” modifies each row individually, rather than the recited “rows” collectively. But the claim 15 In reply to Patent Owner’s argument that there must be at least three electrodes in a row for that row to contain multiple pairs, Petitioner shows that Stern also discloses rows with three or more electrodes. Ex. 1083 ¶¶ 36– 40; Ex. 1097 ¶¶ 39–41 (identifying rows with three or more electrodes in Stern’s Figures 4a and 19). We need not address that showing in detail because, as explained below, element 1[a] does not require that there be more than one pair in each row. language does not specify that each row has pairs (plural). Rather, given its plain meaning, “two rows of bipolar electrode pairs” encompasses an arrangement like that shown in Stern’s Figure 15. Ex. 1097 ¶ 30 (Dr. Martin explaining that “what is required is (1) more than one bipolar electrode pair that are (2) spread across rows”). This broader understanding is confirmed by the specification of the” slip op. at 35
Patent outcomesUS 11,241,271 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,241,271 - Geneoscopy, Inc. v. Exact Sciences CorporationAll claims unpatentablePTAB · Jul 9, 2025 · IPR2024-00459 · APJ Ryan H Flax · IPR · Final written decision
Claims 1–20 are unpatentable as obvious under § 103 over each of the six asserted grounds.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Here, as in our Institution Decision, we do not discern a significant difference between the parties’ respective proposed definitions beyond the number of years of experience after obtaining a doctoral degree. Compare Pet. 12, with Prelim. Resp. 47, and Resp. 19–20; see also DI 7–8. Under either proposed definition, the ordinarily skilled artisan would have been very highly skilled and educated. For purposes of this Final Decision, we maintain that Patent Owner’s definition appears to be reasonable (and it falls between Petitioner’s two definitions asserted in the reexamination request and in the Petition). Further, Patent Owner’s proposed definition appears to comport with the level of skill in the art reflected in the prior art of record and the ’781 patent itself, for example, Vilkin’s authors are a group of medical doctors and an editor of the journal is a PhD, Joost Louwagie, the named inventor of the ’781 patent, holds a PhD in Biochemistry, and the authors of Itzkowitz are medical doctors and PhDs. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he 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)); see Ex. 1005, 3 (list of authors); Ex. 1016 (Dr. Louwagie profile); Ex. 1055; see also generally Reply (Petitioner did not contest our similar determination at Institution). Therefore, we adopt and use Patent Owner’s definition of the ordinarily skilled artisan, set forth above. C.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts that no claim construction is necessary in this proceeding. See generally Pet. Similarly, Patent Owner states that it “does not believe that claim construction is necessary to resolve patentability” in this proceeding. Resp. 21. “[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” 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)). We agree with the parties that no construction of any claim term is necessary for purposes of our Final Decision. D.” slip op. at 14
- Expert testimonyOther
“Pet. 12. In support of these grounds for unpatentability, Petitioner relies on, inter alia, the 1st and 2nd Declarations of Duncan Whitney, PhD. Ex. 1002; Ex. 1080. In support of its positions, Patent Owner relies on, inter alia, the 1st and 2nd Declarations of Vadim Backman, PhD, and the Declaration of Peter Wood. Ex. 2001; Ex. 2022; Ex. 2023.” slip op. at 10
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“We have no reasonable doubt that aspects of the Cologuard product practice the invention of the ’781 patent’s claims 1 and 3, which are most generally directed to steps of collecting two portions of a fecal sample at home, and combining a respective buffer stabilizer/preservative with each of the two portions for claim 1, and then processing those fecal samples by testing for blood and nucleic acids (e.g., DNA) for claim 3. These appear to be nearly the most basic steps for using the Cologuard kit. See generally Ex. 2032. And, these steps do illustrate a certain ease of use and consumerfriendliness that may be a contributing factor in Cologuard’s success. See, e.g., Ex. 2022 ¶¶ 140–142, 155, 158–159, 170–171.” slip op. at 25
Patent outcomesUS 11,634,781 unpatentableClaim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,634,781 - PTAB · Jun 3, 2025 · IPR2025-00054 · APJ John G New · IPR · Institution
The Board instituted inter partes review of claims 1–16 on all petitioned grounds, finding a reasonable likelihood that claim 1 is obvious over Dohil.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Analysis After considering the as-yet uncontested evidence and arguments presented in the Petition, we determine that Petitioner has demonstrated a reasonable likelihood of success at trial in proving that at least one challenged claim of the ’828 patent is unpatentable. In particular, because Petitioner has demonstrated a reasonable likelihood that at least claim 1 is rendered obvious over Dohil in view of the understanding of a person of ordinary skill in the art, as argued in Ground 1, we institute inter partes review with respect to claim 1. Furthermore, because we determine that Petitioner has demonstrated a reasonable likelihood of success at trial in showing that at least one claim is unpatentable on at least one of the stated Grounds, we institute inter partes review of all challenged claims of the ’828 patent, based on all of the grounds identified in the Petition. See 37 C.F.R. § 42.208(a); SAS Inst., Inc. v. Iancu, 584 U.S. 357, 371 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yesor-no institution choice respecting a petition, embracing all challenges included in the petition”)” slip op. at 16
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We determine that no express construction of any claim term beyond the definitions provided by the Specification and, in the absence of such definitions, the ordinary and customary meaning, as understood by a person of ordinary skill in the art at the time of the invention, is necessary for the purpose of rendering this Decision. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017); see also Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms … that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 6
- Skill levelSkill level petitioner adoptedDecided for petitioner
“appears to be consistent with the level of skill presented in the cited prior art. See, e.g., Exs. 1004–1007; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself may reflect an appropriate level of skill in the art). However, at this point we reject the portion of Petitioner’s proposed definition that includes having “access to a medical doctor with a specialty in gastroenterology, and other individuals with expertise related to the above subjects,” as not reflecting the individual level of skill of a given skilled artisan. See Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986) (holding that “[t]he person of ordinary skill is a hypothetical person who is presumed to be aware of all the pertinent prior art. The actual inventor’s skill is not determinative”) (emphasis added, footnotes omitted). For the purposes of this Decision, we adopt Petitioner’s proposed definition as defining a person of ordinary skill in the art as a person who would have had: [A] Ph.D., another advanced degree, or its equivalent, in areas related to pharmaceutics, chemistry, biology, medicine, or a related discipline, and 2–3 years of experience in formulation development. Alternatively, a POSA would have a lesser degree in those fields, with at least five or more years of experience in formulation development.” slip op. at 7
Claim constructioncites Phillips · KSRPatents in suitUS 11,246,828 - PTAB · Jun 3, 2025 · IPR2025-00052 · APJ John G New · IPR · Institution
The Board instituted inter partes review of claims 1–17 on all petitioned grounds, finding a reasonable likelihood that claim 1 is obvious over Dohil in view of ordinary skill.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Analysis After considering the as-yet uncontested evidence and arguments presented in the Petition, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving at trial that at least one challenged claim of the ’069 patent is unpatentable. In particular, because Petitioner has demonstrated a reasonable likelihood that at least claim 1 is rendered obvious over Dohil in view of the understanding of a person of ordinary skill in the art, as argued in Ground 1, we institute inter partes review with respect to claim 1. Furthermore, because we determine that Petitioner has demonstrated a reasonable likelihood of success at trial in showing that at least one claim is unpatentable on at least one of the stated Grounds, we institute inter partes review of all challenged claims of the ’069 patent, based on all of the remaining grounds identified in the Petition. See 37 C.F.R. § 42.208(a); SAS Inst., Inc. v. Iancu, 584 U.S. 357, 371 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”)” slip op. at 16
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner’s proposed definition of the level of ordinary skill in the art appears to be consistent with the level of skill presented in the cited prior art. See, e.g., Exs. 1004–1007; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself may reflect an appropriate level of skill in the art). However, at this point we reject the portion of Petitioner’s proposed definition that includes having “access to a medical doctor with a specialty in gastroenterology, and other individuals with expertise related to the above subjects,” as not reflecting the individual level of skill of a given skilled artisan. See Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986) (holding that “[t]he person of ordinary skill is a hypothetical person who is presumed to be aware of all the pertinent prior art. The actual inventor’s skill is not determinative”) (emphasis added, footnotes omitted). For the purposes of this Decision, we adopt Petitioner’s proposed definition as defining a person of ordinary skill in the art as a person who would have had: [A] Ph.D., another advanced degree, or its equivalent, in areas related to pharmaceutics, chemistry, biology, medicine, or a related discipline, and 2–3 years of experience in formulation development. Alternatively, a POSA would have a lesser degree in those fields, with at least five or more years of experience in formulation development.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We determine that no express construction of any claim term beyond the definitions provided by the Specification and, in the absence of such definitions, the ordinary and customary meaning, as understood by a person of ordinary skill in the art at the time of the invention, is necessary for the purpose of rendering this Decision. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017); see also Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms … that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 6
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“Petitioner argues that it would have been obvious to a person of ordinary skill in the art to formulate Dohil’s rapidly dissolving lozenge or tablet to disintegrate within 60 seconds when tested using the USP <701> Disintegration Test. Pet. 26. According to Petitioner, the knowledge of those of skill in the art is represented by, for example, the FDA’s Guidance for Industry on ODTs. Id. Petitioner points out that the FDA Guidance explains that ODTs “disintegrate[] rapidly, usually within a matter of seconds.” Id. (quoting Ex. 1005, 2). Petitioner also notes that the FDA recommends that ODTs have “an in-vitro disintegration time of approximately 30 seconds or less, when based on the United States Pharmacopeia (USP) disintegration test method or alternative (see section IV).” Id. (quoting Ex. 1005, 2). Petitioner argues that the FDA Guidance further “recommend[s] that applicants use the USP method for disintegration testing,” specifically “USP 29, <701> Disintegration.” Id. (citing Ex. 1005, 3 n.3). Petitioner argues that a skilled artisan would have been motivated to follow the FDA Guidance in formulating Dohil’s rapidly dissolving lozenge or tablet containing budesonide. Pet. 26. Petitioner contends that the FDA Guidance provides the agency’s thinking and recommendations on the topic of orally dissolving tablets. Id. (citing Ex. 1005, 1). Petitioner argues that the FDA regulates the use of pharmaceutical compositions in the United States, and that Dohil’s formulations were intended to “be used in therapy for human patients,” and the initial testing of its formulations was conducted within the United States. Id. at 26–27 (citing Ex. 1002 ¶¶ 28, 49). Petitioner contends that a person of ordinary skill in the art, seeking to formulate budesonide into an orally disintegrating tablet, would have been motivated to follow the FDA Guidance that such a tablet should disintegrate within 30 seconds or less when tested using the USP <701> Disintegration Test. Id. (citing Ex. 1050 ¶¶ 134–135; also citing Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286, 1291–92 (Fed. Cir. 2013) (holding that “[t]he potential for FDA approval also may properly be considered, as it was here, in determining whether one of ordinary skill would be motivated to develop a drug product”).” slip op. at 14
Claim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,632,069 - PTAB · Jun 3, 2025 · IPR2025-00055 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on claims 1–42 on all asserted grounds, finding a reasonable likelihood that Dohil renders claim 35 obvious.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“On this record and for purposes of institution, we find Petitioner’s analysis persuasive and adopt it as our own. Thus, we find Petitioner has established a reasonable likelihood of prevailing on its assertion that Dohil renders claim 35 obvious. We thus institute an inter partes review as to all challenges raised in the Petition. See SAS Institute, Inc. v. Iancu, 584 U.S. 357, 365–71 (2018); see also 37 C.F.R. § 42.108(a) (“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.”).” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“Petitioner notes that the ’407 patent defines (1) “orally disintegrating tablet,” “orally dispersing tablet,” or “ODT;” (2) “about;” and (3) “having no significant systemic glucocorticoid or mineralocorticoid activity.” Pet. 17–19 (citing Ex. 1001, 2:46–49; 2:62–3:3, 3:16–21). We adopt the express definitions of these terms as set forth in the ’407 patent Specification. See Multiform Dessicants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1478 (Fed. Cir. 1998) (“When the specification explains and defines a term used in the claims, without ambiguity or incompleteness, there is no need to search further for the meaning of the term.”).” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to expressly construe these or any other claim terms.” slip op. at 6
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Petitioner contends that a POSA would have been motivated to follow the FDA Guidance (i.e., the guidance on the matter from the U.S. regulatory agency concerned with pharmaceuticals) in formulating Dohil’s rapidly dissolving lozenge or tablet containing budesonide. Id. at 25. According to Petitioner, a POSA seeking to formulate budesonide into an orally disintegrating pharmaceutical composition would have been motivated to follow the FDA Guidance that such a composition should disintegrate within thirty seconds or less when tested using the USP <701> Disintegration Test. Id. (citing Ex. 1053 ¶ 128). Petitioner also argues that a POSA would have had a reasonable expectation of success in doing so based on Dohil’s detailed description of how to formulate budesonide into a rapidly disintegrating lozenge or tablet. Id. (citing Ex. 1002 ¶¶ 27–41). According to Petitioner, formulating orally disintegrating tablets that dissolve within “several seconds to about a minute” would have been a routine exercise by 2009, the earliest possible priority date of the ’407 patent. Id. at 26 (citing Ex. 1005, 2; Ex. 1018, 434). Petitioner contends that, at that time, there were many orally disintegrating systems and products that were commercially available, which would have bolstered a POSA’s expectation of success. Id. (citing Ex. 1017, 179–181; Ex. 1018, 436–439; Ex. 1053 ¶ 129). Thus, Petitioner concludes that Dohil would have suggested to a POSA limitation 35[iv]. Id.” slip op. at 9
Claim construction§ 103 obviousnesscites PhillipsPatents in suitUS 9,486,407 - PTAB · Jun 3, 2025 · IPR2025-00056 · APJ Ryan H Flax · IPR · Institution
The Board instituted IPR on claims 1–30 and all three grounds, finding a reasonable likelihood that at least one claim would have been obvious over Perrett.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“In determining whether to deny institution under § 325(d), we use the following two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). The Becton, Dickinson factors provide useful insight into how to apply the framework under 35 U.S.C. § 325(d). Id. at 9 (referencing Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“An inter partes review may be instituted if the information presented by a petitioner in the petition, in view of the patent owner’s preliminary response and the preliminary record, shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314.” slip op. at 19
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A person of ordinary skill in the art (“POSA”) related to the ’061 patent would have a Ph.D., another advanced degree, or its equivalent, in areas related to pharmaceutics, chemistry, biology, medicine, or a related discipline, and 2-3 years of experience in formulation development. Alternatively, a POSA would have a lesser degree in those fields, with at least five or more years of experience in formulation development. The 8 See infra Section II.C. 9 At this stage of the proceeding, there is no evidence of objective indicia of obviousness or non-obviousness. POSA would also have had access to a medical doctor with a specialty in gastroenterology, and other individuals with expertise related to the above subjects. EX1070 ¶30. Pet. 5. At this stage of the proceeding, Patent Owner neither contests Petitioner’s proposed definition of the ordinarily skilled artisan nor provides an alternative definition. See generally Prelim. Resp. For the purposes of this Decision, we accept and use Petitioner’s proposed, and unopposed, definition of the ordinarily skilled artisan. It appears that Petitioner’s proposed definition comports with the high level of skill in the art reflected in the prior art of record and the ’061 patent, itself. 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)). D.” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownNo construction neededOther
“When the specification explains and defines a term used in the claims, without ambiguity or incompleteness, there is no need to search further for the meaning of the term.” Multiform Dessicants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1478 (Fed. Cir. 1998). The Specification expressly states that “[t]he terms ‘orally disintegrating tablet’, ‘orally dispersing tablet’, or ‘ODT’ refer to a solid dosage form of the present invention, which disintegrates rapidly in the oral cavity of a patient after administration, without chewing.” Ex. 1001, 5:12–15. At this stage of the proceeding, we interpret the language “orally disintegrating tablet” / “orally dispersing tablet” / “ODT” to have the meaning as expressly set forth in the Specification, as noted above. slip op. at 23
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 11,260,061 - Provisur Technologies, Inc. v. Weber Food Technology GmbHAll claims unpatentablePTAB · May 28, 2025 · IPR2024-00235 · APJ Carl M Defranco · IPR · Final written decision
Claims 1–6, 8, 10, and 14–16 are unpatentable as anticipated by Young and obvious over Young and Norrie; the Johnson and Belk ground was not reached.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Provisur proposes that one of ordinary skill in the art would have had: (1) a bachelor’s degree (or equivalent) in mechanical engineering (or a similar field) and at least two years of experience working as an engineer (or similar role) on food processing and/or packaging systems (or in a similar field); or (2) at least seven years of experience working as an engineer (or similar role) on food processing and/or packaging systems (or in a similar field). Pet. 12. Weber does not contest Provisur’s framing of the level of ordinary skill in the art. See generally PO Resp. There being no dispute, we adopt Provisur’s definition of the level of skill in the art.” slip op. at 5
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Provisur construes the claim terms “according to their plain and ordinary meanings as understood by a [person of ordinary skill in the art] in view of the specification and prosecution history” and posits that “[n]o terms require an explicit construction to resolve the unpatentability controversy between the parties here.” Pet. 13. Weber appears to agree, stating in the related district court action that “most of [its] patent claims are plain and ordinary . . . [t]hey’re not difficult or complex claims or claim terms.” Ex. 3 US 5,514,032, issued May 7, 1996 (Ex. 1004, “Young”). 4 US 4,979,269, issued Dec. 25, 1990 (Ex. 1005, “Norrie”). 5 US 6,929,540 B2, issued Aug. 16, 2005 (Ex. 1006, “Johnson”). 6 US 6,198,834 B1, issued Mar. 6, 2001 (Ex. 1007, “Belk”). 1028, 5. This being the case, we do not find the need to expressly construe any claim terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (confirming that the Board need not construe claim terms where their construction is not material to the dispute).” slip op. at 5
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“without first determining how much fat existed to begin with, i.e., prior to the side of meat being trimmed. But, as Provisur correctly notes, Weber ignores what one skilled in the art reasonably would have understood from reading Young’s disclosure as a whole. See Pet. 30–36 (citing Ex. 1003 ¶¶ 104–106, 109–112); Pet. Reply 2–12. When that is done, one skilled in the art would have understood that a necessary premise of Young’s determination of the thickness of fat to remain on the loin is knowing the thickness of the fat to begin with, which Young’s imaging system 190 and imaging processing routine 240 determine by first analyzing a series of “fat/lean separation lines” and “edge lines” in the side of meat being trimmed. Pet. 30–32 (citing Ex. 1004, 17:34–62, 18:33–56, 22:53–24:38, Figs. 2, 13); Pet. Reply 3–7 (citing portions of same evidence). More specifically, as described in Young (and articulated by Provisur), the side of meat is placed fat side down on a product support, i.e., platen 20. See Ex. 1004, 7:16–21, Figs. 1, 2. Using several cameras—top plan camera 196, end view camera 197, and fat line camera 198—Young’s imaging system 190 acquires multiple images of the side of meat from various angles and under various lighting conditions to “provide image data regarding each side of [meat].” See id. at 17:34–18:56. That image data is then used by Young’s image processing routine 240 to generate a series of demarcation lines on the side of meat, including: (1) fat/lean separation lines (representing the interface between the loin meat and the fat layer along top, side, and end views of the meat product; and (2) edge lines (representing lines along the outer surface of the meat product). See id. at 22:53–23:67, Figs. 10, 13 (Blocks 242, 246, 250, 254). In addition, “a plurality of points (preferably 20) are generated for each of the fat/lean separation and edge lines using known pattern matching routines.” Id. at 23:28–30, Fig. 13 (Blocks 244, 248, 252, 256); see also id. at 23:61–63 (essentially same). The fat/lean separation and edge lines (and points therein) generated by Young’s image processing routine 240 are then used to calculate certain dimensions and characteristics of the side of meat, such as height, length, and width. Id. at 24:10–22, Fig. 13 (Block 258). As Provisur’s expert credibly testifies, one skilled in the art would have understood that the dimension from the fat/lean separation line to the edge line along the outer surface represents the thickness of fat cover on the side of meat, i.e., before the fat is trimmed. See Ex. 1003 ¶ 106. Insofar as how that dimension is used, Young states that controller 172 uses “dynamic (real time) image data” of the fat/lean separation and edge lines “to dynamically modify the cutting profile of the loin knife assembly 100 so that the assembly follows a fixed distance from the separation line to provide the optimum fat cover for the loin.” Ex. 1004, 18:32–45; see also id. at 17:48–52 (describing “real time processor” for “image processing routines”). Notably, according to Young, the “fixed distance” represents the “desired” thickness of fat that remains on the loin, after trimming, and “sufficiently keeps the loin from drying out, but doesn’t make the loin look too fat,” although “[o]ther fat thicknesses may be desired in the alternative.” Id. at 20:60–66; see also id. at 10:39–42 (“Through control of the knife blade along several axes, assembly 100 preferably produces an optimum separation between loin and belly, with a desired fat covering left on the loin.” (emphases added)). Because the desired thickness of fat cover is what remains on the loin” slip op. at 9
- Strike new argumentNew argument consideredDecided for patent owner
“argument that Weber considers vital to its dispute of Provisur’s showing for the claimed fat thickness determination. During oral hearing, Weber repeatedly argued that Provisur changed theories midstream, i.e., between the time of the petition and the hearing. See Hrg. Tr. 22:18–24:47; see also id. at 31:14–22, 33:8–18, 34:16–20, 49:17–50:15, 54:16–56:25 (repeating same argument). More specifically, according to Weber, Provisur originally relied only on image data from Young’s “top view” camera as processed in “block 246” of Young’s image processing routine 240 when showing how Young meets the claimed fat thickness determination, whereas now Provisur relies on image data from Young’s “end view” cameras as processed in “Block 254.” Compare PO Sur-Reply 3–6 (focusing on Young’s “top view camera” in “block 246”), with Hrg. Tr. 27:4–16 (“[Block] 246, which is what they relied on, is processing images from the top-view camera in Young’s system. It is generating lines from the top-view camera in Young’s system. What they are newly trying to rely on today, for the first time, is Block 254 that is discussed toward the bottom of column 23 in Young, and that analyzes different images from a different camera. It is the end camera. It generates different lines. It demonstrates an end fat/lean line and an end edge line. Prior to today’s hearing, neither Petitioner, nor its expert, had ever discussed Block 254. You will not find a single reference to 254 in their papers, nor have they discussed the end edge line. It is completely new today. It finds absolutely no support in the record.” (emphases added)). We disagree with Weber’s contention. As shown and described in the petition, Provisur relies on more than simply Young’s “top view” camera and “block 246.” See Pet. 29–31. Rather, in its petition, Provisur annotates Young’s Figure 2 to show that image data from all three cameras of “imaging system 190”—“top plan camera 196, end view camera 197, [and] fat line camera 198”—play a role in the determination of fat thickness.8 Id. at 30. Moreover, Provisur cites the entire process depicted in “Figure 13” and described in columns “22:53–24:38” of Young as critical to the determination. Id. at 31. Those cited portions of Young involve not only the analysis of fat/lean and edge lines from “top view” images (block 246), but also the analysis of fat/lean and edge lines from “end view” images (blocks 250 and 254). See Ex. 1004, 23:12–24:13. In other words, Provisur’s showing for the claimed fat thickness determination is based on Young’s collective analysis of all those images. Indeed, Provisur’s expert confirms as much when confronted by Weber on cross-examination— Q. How does [Young] use the other cameras to identify that fat/lean separation line? A. Again, this is a -- this is a three-dimensional product that’s not regular, and all the views basically are needed to be able to describe that complex three-dimensional shape, so that the knife will be able to cut at that -- at that line, offset by whatever desired thickness there is, on that three-dimensional shape. Ex. 2006, 25:15–27:19 (emphasis added). 8 Indeed, contrary to Weber’s assertion, Provisur highlights “fat lean separation camera 198,” not top view camera 196, as most critical to the determination of fat thickness. Pet. 31. In the end, we reject the notion that Provisur changed theories” slip op. at 12
Patent outcomesUS 8,529,321 unpatentableClaim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 8,529,321 - PTAB · May 23, 2025 · IPR2025-00196 · APJ Ryan H Flax · IPR · Institution
The Board instituted IPR on claims 1–16 under both § 103 grounds, finding a reasonable likelihood that at least one claim would have been obvious over Best-2008 and Osada.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“Under our current guidance, the filing of a Sotera-type stipulation is not conclusive, but remains “highly relevant” and will be considered “as part of [our] holistic analysis” here. See Guidance Memo. Whether Petitioner has other bases for invalidating the ’457 patent, such as the CarnoJet prior art product identified in the district court, is not a consideration here if such bases could not be asserted in this proceeding (and are not being used to argue over the asserted prior art here as a loop hole from the stipulation, of which there is no evidence).” slip op. at 15
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“satisfied that Petitioner has met its burden for institution. No argument by Patent Owner persuades us otherwise. Petitioner has shown that each limitation and element of claim 1 is taught or suggested by the combination of Best-2008 and Osada. Moreover, Petitioner’s asserted reason to combine the references is supported by the references’ disclosures: Best-2008 suggests filtration of its coolant is desirable, but provides no specific means for doing so; Osada teaches a way of filtering fluid from an open-top tank, similar to Best-2008’s.” slip op. at 42
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A POSITA[12]in the field of the ’457 patent at the time of the earliest possible effective filing date (December 14, 2012) would have had Bachelor of Science degree in mechanical or chemical engineering and at least two years of experience relating to the design and/or implementation of fluid circulation systems involving application of fluid dynamics and heat transfer principles. Additional education may serve as a substitute for a lack of experience and vice versa. (Ex-1003- Dahm at ¶¶36-41, 63-70.) Pet. 18–19. Patent Owner applies this same definition. Prelim. Resp. 6–7. At this stage of the proceeding, we accept and use Petitioner’s proposed and unopposed definition of the ordinarily skilled artisan. It appears that Petitioner’s proposed definition comports with the level of skill in the art reflected in the prior art of record and the ‘457 patent, itself. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Although either of the district court proceedings’ definitions of the term “weir” appears to accurately describe the feature, at this stage of the proceeding, we do not find it necessary to expressly interpret this claim language.” slip op. at 23
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 10,405,457
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.