- 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 - Gene Company Pty Ltd v. The Trustees Of Columbia University In The City Of New YorkNo claims unpatentablePTAB · Jun 23, 2025 · IPR2024-00313 · APJ Tawen Chang · IPR · Final written decision
Claims 1–54 were not shown unpatentable because Petitioner failed to establish a reasonable expectation of success for the proposed combinations; objective indicia also supported non-obviousness.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“As to the first issue, we agree with Patent Owner that defining the level of skill in view of the solution described in the patent risks improper hindsight. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) 18 (“[T]he level of skill in the art is a . . . lens through which . . . the Board views the prior art and the claimed invention,” which “prevents . . . factfinders from using their own insight or . . . hindsight[] to gauge obviousness.”). We therefore do not include “practical knowledge about . . . the deuterium isotope effect, including the patents and publications discussed [in the Petition],” as part of our definition of a person of ordinary skill in the art.” slip op. at 18
- Expert testimonyPetitioner expert creditedMixed
“person of ordinary skill in the art would employ” in an obviousness analysis, we give some weight to Dr. Guengerich’s testimony. KSR, 550 U.S. at 418; Plantronics, Inc. v. Aliph, Inc., 724 F.3d 1343, 1354 (Fed. Cir. 2013) (explaining that “motivation to combine may be found. . . in . . . the background knowledge, creativity, and common sense of the person of ordinary skill”). Nevertheless, even if we were to agree that an ordinarily skilled artisan would have seen the 1,5-shift in NRPE in Mata’s A2E biosynthetic pathway as a particularly desirable location for intervention, we are not persuaded that such a person would have been motivated to substitute C20 deuterated vitamin A for the vitamin A in Ortho Pharma’s composition and method, because Petitioner has not shown, by a preponderance of evidence, that such an artisan would have reasonably expected the substitution to retard the accumulation of A2E or to treat macular degeneration.” slip op. at 42
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“In our Institution Decision, we preliminarily construed the preamble of claim 28 as limiting. Inst. Dec. 30–31. Petitioner did not take issue with our construction, or dispute Patent Owner’s construction of the preambles of claims 1 and 29 as also limiting. After consideration of the full trial record, we maintain our construction of the preamble of claim 28 as limiting for the reasons set forth in our Institution Decision. For similar reasons and the reasons set forth in Patent Owner’s Response, we further construe the preambles of claims 1 and 29 as limiting. See PO Resp. 12–14. We further determine that we do not need to construe any other claim term in order to resolve the controversy between the parties. See 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 26
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would be understood by a person of ordinary skill in the art, at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id.” slip op. at 25
Patent outcomesUS RE47,045 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · Graham - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Jun 9, 2025 · IPR2024-00240 · APJ Deborah Katz · IPR · Final written decision
Claims 1–42 are unpatentable: claims 1–42 are anticipated by the MSR, and the Board also finds the challenged claims obvious over the MSR and cited combinations.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“claims a method of treating a human patient with colorectal cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner discloses testing pembrolizumab to treat human patients. (See Ex. 1001, 25:40–50, Ex. 1005; see Decision 8–9.) Accordingly, the relevant field of Patent Owner’s claims is treating human patients, as well as testing existing compounds. Neither party directs us to evidence of the level of skill in the art beyond what we considered for institution of trial. In the Decision to institute trial, we determined that the level of skill in the art relevant to the claims of the ’393 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials. (See Dec. 8–9.) We determined that the level of skill also includes knowledge of and experience with treating colorectal cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy. (See id.) Because the parties do not present additional evidence or argument, we maintain that determination.” slip op. at 9
- Expert testimonyPetitioner expert creditedDecided for petitioner
“what one of ordinary skill in the art would have known and understood at the relevant time. Specifically, Petitioner relies on the testimony of Alfred L. Neugut, M.D., Ph.D., M.P.H.3 (Ex. 1003) and Paul E. Oberstein, M.D. (Ex. 1150). Patent Owner relies on the testimony of Nils Lonberg, Ph.D. (Ex. 2001) and Richard Goldberg, M.D. (Ex. 2090).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“1 requires a causal relationship wherein the patient must be tested for MSI-H and, if he or she is determined to be MSI-H or dMMR, then the patient is treated with 10 mg/kg of pembrolizumab every 14 days. We further agree that this relationship is different than the use of the term “after” in claims 7, 20, and 27, wherein patients must be treated with a different cancer therapy, and wherein the cancer must have later progressed for the treatment to be within the scope of these claims. (Ex. 1001, 25:66–7, 26:44–46, 26:63–64.) In claim 1, a biological sample from the patient must be tested to determine if the cancer is MSI-H and, if so, the patient is treated with a therapeutically effective amount of pembrolizumab. For this reason, if the prior art teaches the limitations of 1) testing a biological sample obtained from a patient having colorectal cancer to determine that the patient’s colorectal cancer is microsatellite instability high or mismatch repair deficient, and 2) treating the patient with a therapeutically effective amount of pembrolizumab if the patient’s colorectal cancer is determined to be microsatellite instability high or DNA mismatch repair deficient, the art anticipates claim 1. We are not persuaded that claim 1 requires or excludes anything else because nothing else is recited in the claim.” slip op. at 12
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Microsatellite Unstable (MSI) Tumors.” (Ex. 1005, 2.) The parties’ witnesses agree that MK-3475 is pembrolizumab, the compound recited in claim 1. (See Neugut Decl., Ex. 1003 ¶ 37; see Lonberg Decl., Ex. 2001, ¶ 65.) Patent Owner does not dispute Petitioner’s assertion that the MSR was published on a government web site on June 10, 2013, more than two years before the priority date of the ’393 patent on July 10, 2015. (See Pet. 7 (citing Ex. 1005, 3, Ex. 1003 ¶ 35).)” slip op. at 17
Patent outcomesUS 11,591,393 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,591,393 - 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
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.