- Stryker Corporation / Wright Medical Technology, Inc. v. Osteomed LLCAll claims unpatentablePTAB · May 4, 2026 · IPR2022-00189 · APJ Sheridan K Snedden · IPR · Remand
Claim 16 is unpatentable because Slater anticipates it.
RulingsRemand decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“undisputed limitations of claim 16 and find that Petitioner establishes that Slater discloses each limitation of claim 16 for the reasons provided by Petitioner. Specifically, Petitioner shows, and Patent Owner does not dispute, that Slater describes a plate with “flared hips” comprising opposing “generally parabolic wings” as recited in dependent claim 16. Pet. 28–30; Ex. 1005, Fig. 2; Ex. 1002 ¶ 106. We adopt Petitioner’s arguments and evidence as to these limitations as our own. See Pet. 28–30. Based on the foregoing, Petitioner proves by a preponderance of the evidence that Slater anticipates claim 16.” slip op. at 12
Patent outcomesUS 8,529,608 unpatentable§ 102 anticipationPatents in suitUS 8,529,608 - Stryker Corporation / Wright Medical Technology, Inc v. Osteomed LLCSome claims unpatentablePTAB · May 4, 2026 · IPR2021-01452 · APJ Sheridan K Snedden · IPR · Remand
On remand, claims 6, 8, 9, 13, and 19 are unpatentable; claims 2–5, 11, 12, 17, and 18 were not shown unpatentable over Slater or Slater and Weaver.
RulingsRemand decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“Accordingly, for the same reasons expressed by our previous decision addressing claim 8 of the ’085 patent, and the court’s analysis in Stryker, we conclude that Slater does not anticipate claims 2–5, 11, 12, 17, and 18 of the ’716 patent because Slater deliberately describes a variable angle hole that lacks a single predetermined angle—that is, Slater describes a transfixation screw hole that does not have a central axis defining the trajectory.” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable
“In its Petition, Petitioner contends that Weaver discloses the limitations in claim 6 and that it would have been obvious to add Weaver’s features to Slater’s plate to provide a more secure fixation between the screws and the plate. Pet. 36–39; Ex. 1002 ¶¶ 188–196. Specifically, Petitioner contends that configuring Slater’s transfixation screw hole (claim 6) or at least one of Slater’s attachment points (claim 8) as a threaded screw hole to lockably engage the head of a locking screw would have been an obvious design choice “because locking screws ‘provide a high resistance to shear or torsional forces’ and reduce the incidence of screw loosening.” Pet. 39 (quoting Ex. 1009, 1:57–58); Ex. 1009, 1:46–48; Ex. 1002 ¶¶ 191– 196. Petitioner otherwise relies on its anticipation analysis for claim 1 discussed above. Pet. 36.” slip op. at 18
Patent outcomesUS 9,763,716 mixed§ 102 anticipation§ 103 obviousnessPatents in suitUS 9,763,716 - Stryker Corporation / Wright Medical Technology, Inc v. Osteomed LLCAll claims unpatentablePTAB · May 4, 2026 · IPR2022-00191 · APJ Sheridan K Snedden · IPR · Remand
On remand, the Board held claims 15 and 21 unpatentable as anticipated by Slater.
RulingsRemand decision- RemandOther
“Appeals for the Federal Circuit. The court issued its decision in Stryker Corp. v. OsteoMed LLC, No. 2023-1925, 2025 WL 2814019 (Fed. Cir. Oct. 3, 2025) (“Stryker”) (Paper 381), affirming-in-part, reversing-in-part, vacating and remanding-in-part our Final Written Decision (Paper 35) for further proceedings. In its opinion, the Federal Circuit reversed our finding of no anticipation as to independent claims 1, 10, and 16 of U.S. Patent No. 9,763,716 B2 (“the ’716 patent,” Ex. 1001), and vacated and remanded for further proceedings to evaluate whether either of dependent claims 15 and 21 is unpatentable. Stryker, slip op. at 17.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“We have reviewed Petitioner’s arguments and evidence as to the undisputed limitations of claims 15 and 21 and find that Petitioner establishes that Slater discloses each limitation of claims 15 and 21 for the reasons provided by Petitioner. Specifically, Petitioner shows, and Patent Owner does not dispute, that Slater describes a plate with “flared hips” comprising opposing “generally parabolic wings” as recited in dependent claims 15 and 21. Pet. 31–33; Ex. 1005, Fig. 2; Ex. 1002 ¶ 124. We adopt Petitioner’s arguments and evidence as to these limitations as our own. See Pet. 31–33. Based on the foregoing, Petitioner proves by a preponderance of the evidence that Slater anticipates claims 15 and 21.” slip op. at 13
Patent outcomesUS 9,763,716 unpatentable§ 102 anticipationPatents in suitUS 9,763,716 - Stryker Corporation / Wright Medical Technology, Inc. v. Osteomed LLCAll claims unpatentablePTAB · May 4, 2026 · IPR2022-00190 · APJ Sheridan K Snedden · IPR · Remand
On remand, the Board determined claim 15 unpatentable as anticipated by Slater because Slater discloses every limitation, including the flared hips and opposing generally parabolic wings.
RulingsRemand decision- BurdenUnpatentable
“We have reviewed Petitioner’s arguments and evidence as to the undisputed limitations of claim 15 and find that Petitioner establishes that Slater discloses each limitation of claim 15 for the reasons provided by Petitioner. Specifically, Petitioner shows, and Patent Owner does not dispute, that Slater describes a plate with “flared hips” comprising opposing “generally parabolic wings” as recited in dependent claim 15. Pet. 30–32; Ex. 1005, Fig. 2; Ex. 1002 ¶ 119. We adopt Petitioner’s arguments and evidence as to these limitations as our own. See Pet. 28–30. Based on the foregoing, Petitioner proves by a preponderance of the evidence that Slater anticipates claim 15.” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“We have reviewed Petitioner’s arguments and evidence as to the undisputed limitations of claim 15 and find that Petitioner establishes that Slater discloses each limitation of claim 15 for the reasons provided by Petitioner. Specifically, Petitioner shows, and Patent Owner does not dispute, that Slater describes a plate with “flared hips” comprising opposing “generally parabolic wings” as recited in dependent claim 15. Pet. 30–32; Ex. 1005, Fig. 2; Ex. 1002 ¶ 119. We adopt Petitioner’s arguments and evidence as to these limitations as our own. See Pet. 28–30. Based on the foregoing, Petitioner proves by a preponderance of the evidence that Slater anticipates claim 15.” slip op. at 13
Patent outcomesUS 9,351,776 unpatentable§ 102 anticipationPatents in suitUS 9,351,776 - Stryker Corporation / Wright Medical Technology, Inc. v. Osteomed LLCSome claims unpatentablePTAB · May 4, 2026 · IPR2021-01450 · APJ Sheridan K Snedden · IPR · Remand
On remand, claims 6, 8–10, 14, and 17 are unpatentable; claims 2–5, 12, and 13 were not shown unpatentable, based on anticipation by Slater and obviousness over Slater and Weaver.
RulingsRemand decision- RemandMixed
“Appeals for the Federal Circuit. The court issued its decision in Stryker Corp. v. OsteoMed LLC, No. 2023-1925, 2025 WL 2814019 (Fed. Cir. Oct. 3, 2025) (“Stryker”) (Paper 49),1 affirming-in-part, reversing-in-part, vacating and remanding-in-part our Final Written Decision (Paper 46) for further proceedings. In its opinion, the Federal Circuit reversed our finding of no anticipation as to independent claims 1 and 11 of U.S. Patent No. 8,529,608 B2 (“the ’608 patent,” Ex. 1001), and vacated and remanded for further proceedings to evaluate whether dependent claims 2–6, 8–10, 12–14, and 17 (the “Remanded Claims”) are similarly unpatentable in view of Petitioner’s challenges relying on the Slater reference. Stryker, slip op. at 14–15. We have jurisdiction under 35 U.S.C. § 6. We issue this Final Written Decision on Remand pursuant to 35 U.S.C. §§ 144, 318 and 37 C.F.R. § 42.73 in an inter partes review involving Stryker Corporation and Wright Medical Technology, Inc. (collectively, “Petitioner”) and OsteoMed LLC (“Patent Owner”). For the reasons discussed below, after considering the entirety of the record in light of the Federal Circuit’s directives in Stryker, we find by a preponderance of the evidence that claims 6, 8–10, 14, and 17 are unpatentable. We also conclude that Petitioner has not demonstrated, by a preponderance of the evidence, that claims 2–5, 12, and 13 are unpatentable.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“Accordingly, for the same reasons expressed by our previous decision addressing claim 8 of the ’085 patent, and the court’s analysis in Stryker, we conclude that Slater does not anticipate claims 2–5, 12, and 13 of the ’608 patent because Slater deliberately describes a variable angle hole that lacks a single predetermined angle—that is, Slater describes a transfixation screw hole that does not have a central axis defining the trajectory.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable
“limitations in claim 6 and that it would have been obvious to add Weaver’s features to Slater’s plate to provide a more secure fixation between the screws and the plate. Pet. 37–39; Ex. 1002 ¶¶ 161–169. Specifically, Petitioner contends that configuring Slater’s transfixation screw hole (claim 6) or at least one of Slater’s attachment points (claim 8) as a threaded screw hole to lockably engage the head of a locking screw would have been an obvious design choice “because locking screws ‘provide a high resistance to shear or torsional forces’ and reduce the incidence of screw loosening.” Pet. 39 (quoting Ex. 1009, 1:57–58); Ex. 1009, 1:46–48; Ex. 1002 ¶¶ 162– 163. Petitioner otherwise relies on its anticipation analysis for claim 1 discussed above. Pet. 37. Patent Owner raised no separate argument regarding the patentability of claims 6 and 8, instead relying solely on its argument that Slater does not anticipate independent claim 1, on which claims 6 and 8 depend. PO Resp. 46; Reply 4 (“Patent Owner does not challenge the combination of Slater and Weaver for claims 6 and 8.”). We have reviewed Petitioner’s arguments and evidence as to the undisputed limitations of claims 6 and 8 and find that Petitioner establishes that the combination of Slater and Weaver discloses all of the limitations of claims 6 and 8, and that one of ordinary skill in the art would have been motivated to combine Slater and Weaver for the reasons provided by Petitioner. We adopt Petitioner’s arguments and evidence as to these limitations as our own. See Pet. 37–39.” slip op. at 19
Patent outcomesUS 8,529,608 mixed§ 102 anticipation§ 103 obviousnessPatents in suitUS 8,529,608 - Stryker Corporation / Wright Medical Technology, Inc. v. Osteomed LLCSome claims unpatentablePTAB · May 4, 2026 · IPR2021-01451 · APJ Sheridan K Snedden · IPR · Remand
On remand, claims 6, 8, 9, and 13 were held unpatentable; claims 2–5, 11, and 12 were not shown unpatentable because Slater lacks the claimed central axis.
RulingsRemand decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableUnpatentableMixed
“addressing the ’085 patent and by the court’s analysis in Stryker, we conclude that Slater does not anticipate claims 2–5, 11, and 12 of the ’776 patent because Slater deliberately describes a variable angle hole that lacks a single predetermined angle—that is, Slater describes a transfixation screw hole that does not have a central axis defining the trajectory.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable
“In its Petition, Petitioner contends that Weaver discloses the limitations in claim 6 and that it would have been obvious to add Weaver’s features to Slater’s plate to provide a more secure fixation between the screws and the plate. Pet. 36–39; Ex. 1002 ¶¶ 169–74. Specifically, Petitioner contends that configuring Slater’s transfixation screw hole (claim 6) or at least one of Slater’s attachment points (claim 8) as a threaded screw hole to lockably engage the head of a locking screw would have been an obvious design choice “because locking screws ‘provide a high resistance to shear or torsional forces’ and reduce the incidence of screw loosening.” Pet. 39 (quoting Ex. 1009, 1:57–58); Ex. 1009, 1:46–48; Ex. 1002 ¶¶ 169– 74. Petitioner otherwise relies on its anticipation analysis for claim 1 discussed above. Pet. 36.” slip op. at 17
- RemandOther
“Appeals for the Federal Circuit. The court issued its decision in Stryker Corp. v. OsteoMed LLC, No. 2023-1925, 2025 WL 2814019 (Fed. Cir. Oct. 3, 2025) (“Stryker”) (Paper 49),1 affirming-in-part, reversing-in-part, vacating and remanding-in-part our Final Written Decision (Paper 46, “FWD”) for further proceedings. In its opinion, the Federal Circuit reversed our finding of no anticipation as to independent claims 1 and 10 of U.S. Patent 9,351,776 B2 (“the ’776 patent,” Ex. 1001), and vacated and remanded for further proceedings to evaluate whether dependent claims 2–6 and 8, 9 and 11–13 (the “Remanded Claims”) are unpatentable in view of Petitioner’s challenges relying on the Slater reference. Stryker, slip op. 14– 15.” slip op. at 2
Patent outcomesUS 9,351,776 mixed§ 102 anticipation§ 103 obviousnessPatents in suitUS 9,351,776 - Preomics GmbH / Biognosys AG. v. The Brigham And Women’S Hospital, Inc.Some claims unpatentablePTAB · Mar 23, 2026 · IPR2024-01473 · APJ Michael A Valek · IPR · Final written decision
Claims 1, 4, 6, 17, 22, and 25 are unpatentable as anticipated by and obvious over Cai; claims 2, 3, 7, 23, and 24 were not shown unpatentable.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We disagree with Patent Owner and again find Petitioner’s description of the level of ordinary skill in the art sufficient for the reasons explained in the Decision on institution. See Dec. 8–10. As explained before, the formal training required by Petitioner’s description of a POSA includes understanding of both proteins and analytical techniques for studying them. See Dec. 9. Neither Patent Owner, nor its declarant, Dr. Cimas, clearly articulates a competing POSA description at trial, but both suggest more formal training, e.g., a graduate degree, is required. See Resp. 65–66; Ex. 2023 ¶ 8 (agreeing with our observation that the educational backgrounds of the inventors and authors of Cai, Zaccaria, and Hu “suggests that a graduate degree is more typical for a POSA”) (quoting Dec. 9, n. 5). Even if we were to accept that modification, it would not change our findings herein. Nor does it suggest that Dr. Vargas, who holds a Ph.D. in chemistry from Stanford University and has substantial experience with mass spectrometry and other analytical techniques, is unqualified to testify from the perspective of one of ordinary skill in the art. See Ex. 1004 (Vargas CV). Accordingly, our findings and conclusions would be the same, even assuming the perspective of a POSA possessing the higher level of formal training and specific proteomics experience that Patent Owner suggests is appropriate here.5” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“Ex. 1001, 20:33–39. As Petitioner points out, the first sentence in this passage does not define the term “biological sample,” but rather the term “sample.” Id. According to that sentence, the term “sample” refers to either “a biological sample or a complex biological sample obtained from a subject.” Id. (emphasis added). Patent Owner’s argument assumes, without explanation, that the phrase “obtained from a subject” modifies both instances of “biological sample” in the first sentence. Id. But it need not be read that way. Indeed, that sentence is more naturally read to define “sample” as one of two things––either a “biological sample” or a “complex biological sample” with only the latter being “obtained from a subject.” Id. In addition, the second sentence in the passage above supports Petitioner’s view that the term “biological sample” is not limited to a sample obtained directly from a subject. It provides a broad, non-exhaustive list of “[s]uitable biological samples” that specifically includes the types of biological samples, i.e., “cell lysates,” “systemic blood,” “plasma,” assayed in Petitioner’s cited references. Ex. 1001, 20:36–39. It also lists as an example “processed tissue samples,” which would include samples that have been modified (i.e., “processed”) from the form in which they were originally obtained. Id.; see also Ex. 1001, 20:52–57 (describing tissue processing). Given this broad description, we agree with Petitioner that there is no basis in the cited intrinsic evidence for reading in the “negative limitations” Patent Owner seeks to try to distinguish the particular biological samples assayed in Cai, Hu, and Zaccaria. See Reply 3–4.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“We agree with Petitioner. Step 1(a) recites forming coronas around a plurality of particles of “different particle types.” Ex. 1001, 86:53–60. Step 1(b) recites separating a “subset of the plurality of the particles comprising the coronas.” Id. at 86:61–65. As Petitioner correctly observes, as a matter of ordinary English parlance, “there is no requirement whatsoever that the ‘subset’ have all of the same characteristics as the set from which it is separated.” Reply 10. By way of analogy, consider a jar containing a plurality of coins of different coin types, e.g., nickels and dimes. One can separate out a “subset” of that plurality of coins (plural) by removing any two coins from the jar—this is true even if the two coins are both nickels or both dimes. In the same way, nothing in the ordinary meaning of the claim language requires the subset in step 1(b) to include particles with coronas representative of each of the different particle types in step 1(a). Nor has Patent Owner identified any other evidence that supports its attempt to read such a requirement into the claims. See Resp. 16, 18 (citing expert testimony that is not inconsistent with the broader, ordinary meaning of the claim language and, even if it was, would not be a proper basis for limiting the same). For these reasons, we reject Patent Owner’s interpretation of “a subset of the plurality of particles comprising the coronas” in step 1(b) as limited to a subset of each type of particle comprising the coronas formed in step 1(a).” slip op. at 15
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“We credit Petitioner’s showing above and agree that Cai discloses a method comprising all of the steps in claim 1. Beginning with step 1(a), Cai discloses contacting two different particle types, i.e., MWCNT and CB, with HeLa cell lysate (i.e., a biological sample) to form protein coronas around those particles. Ex. 1003 ¶¶ 199–206; Ex. 1005, Abstr. (describing MWCNT and CB as distinct “forms of carbon nanoparticles” that bind “vastly different sets of proteins”). Cai’s results show the coronas formed around the MWCNT and CB particles comprise overlapping and distinct proteins as recited in step 1(a). Ex. 1003 ¶¶ 216–222; Ex. 1005, 587 (“a small number of CB-binding proteins also bind to MWCNTs”). A subset of the proteins from the coronas on these particles is then prepared by eluting the bound proteins and analyzing them with SDS-PAGE in a MWCNT and CB “pull-down,” which reads on step 1(b). Ex. 1005, 586 (Fig. 1A–B depicting scheme for “pull-down experiment” and describing other “pull-down experiments” used with SILAC media in Fig. 3), 588 (Fig. 3). Regarding step 1(c), Cai discloses assaying the proteins in those subsets using LC-MS/MS with SILAC encoding to characterize and quantify the relative abundance of the proteins that bind to each type of particle.11 Ex. 1003 ¶¶ 225–229; Ex. 1005, 586–587 (describing “systemic characterization of carbon nanoparticle-protein corona”), 588 (Fig. 3). Cai’s results show “the relative abundance of the MWCNT-binding proteins spread over 8 orders of magnitude” and that “some of the proteins with the highest binding efficiencies” are actually “low abundance proteins” in the lysate, meaning that that Cai’s method selectively enriches such proteins for detection. Ex. 1005, 587. We credit Dr. Vargas’s testimony that these results demonstrate that Cai’s method achieves the “dynamic range” recited in step 1(c). Ex. 1003 ¶¶ 225–229.” slip op. at 23
Patent outcomesUS 11,435,360 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,435,360 - Penumbra, Inc. v. Rapidpulse, Inc.No claims unpatentablePTAB · Feb 17, 2026 · IPR2024-01261 · APJ Jamie T Wisz · IPR · Final written decision
Claims 1–20 were not shown unpatentable because the asserted combinations did not teach the claimed predetermined cycle for controlling distal fluid flow.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“(1) a person with a B.S. in engineering or an equivalent field, with two-four years of academic or industry experience in aspiration embolectomy and thrombectomy or comparable industry experience who would, where appropriate, work or consult with others, including a physician, to develop embolectomy or thrombectomy devices; or (2) an interventional neurosurgeon with at least three years of experience developing and/or using medical devices in embolectomy or thrombectomy procedures, and who would, where appropriate, work or consult with others, including an engineer, to develop such a medical device. Pet. 11 (citing Ex. 1005 ¶ 48). Petitioner also contends that, “[a] person with less education but more relevant practical experience, or more relevant education but less practical experience, may also meet this standard.” Id. Patent Owner states that for purposes of its PO Response, it “accepts ¶ 44). We adopt Petitioner’s characterization because it is consistent with the level of skill in the art at the time of the invention as reflected by the ’402 patent and the cited prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“specification explicitly includes sensors similar to those in the prior art in support of their argument that the claimed “predetermined cycle” must not exclude the use of such sensors. Pet. Reply 15 (citing Ex. 1001, 32:55–33:7, 40:66–41:5, 44:9–29). We reviewed the portions of the specification cited by Petitioner. We agree with Patent Owner that one excerpt discussing sensor use appears to be directed to triggering the predetermined cycle rather than causing timing changes during the cycle itself (Ex. 1001, 32:55–66) (describing use of a pressure sensor to “determine when the vacuum channel 3 is clogged by a thrombus and automatically perform the unclogging procedures described herein”), while another excerpt discusses a sensor that Petitioner that the ’402 patent discusses the use of sensors to “tune” the system and that such “tuning” can be done statically (setting the cycle timing in advance) or dynamically (adjusting the timing during the cycle itself). See Ex. 1001, 48:19–49:50. Overall, we find that these disclosures involving sensors demonstrate that sensors may be used in various ways in different embodiments. However, none of these disclosures explicitly discuss the use of sensors in conjunction with a “pre-determined cycle.” Therefore, we find that the ’402 patent specification’s discussion of “sensors” are not particularly informative as to the appropriate construction of a “predetermined cycle” and do not outweigh the other explicit disclosures of “predetermined cycle” in the patent. We next turn to the other intrinsic evidence discussed by the parties — the prosecution history. As discussed by Patent Owner, in the Notice of Allowance, the Examiner found that Garrison did not teach or suggest a “predetermined cycle” because Garrison’s controller “changed the cycle of opening and closing the valves based on feedback from sensors.” Ex. 1004, 86. We acknowledge that the patent applicant filed subsequent comments during prosecution in which they stated that they “do[] not concede that the Examiner’s characterizations of the terms of the claims and the prior art are correct.” Id. at 29. However, we agree with Patent Owner that the importance of the Examiner’s statement in the Notice of Allowance does not rely on it being an express disclaimer (a standard which it does not meet). PO Sur-reply 8. We also considered Petitioner’s contention that the Examiner’s interpretation of Garrison may have been in error (PO Resp. 16); however, even if this were true, the Examiner’s statement still provides helpful insight into how the Examiner was interpreting the term sensors to change the opening and closing of valves during a cycle was not a “predetermined cycle.” Id. at 86. In sum, we find that Patent Owner’s proposed construction is consistent with the usage of the term “predetermined cycle” in the ’402 patent specification and prosecution history. Thus, after considering all of the cited evidence, we construe “predetermined cycle” to mean that “the timing of the sequence of valve operations in the cycle is determined beforehand, i.e., fixed, rather than varying based on feedback after operation begins.”” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“2. Other Terms The parties also provided proposed constructions for the limitations of “[limited/limiting] to a positive amount of exit flow” and “control[ling] fluid flow in and out from the distal end of the catheter.” See Pet. 15–16; Pet. Reply 1–8; PO Resp. 22–24; PO Sur-Reply 2–6. However, having evaluated the arguments and evidence before us, we determine that construction of these terms is not necessary for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable
“We agree with Patent Owner that neither Petitioner nor Mr. Brown propose any combination of Yang and Mullins that does not include Mullins’s pressure sensor in order “to control fluid flow in and out from the distal end of the catheter.” Indeed, in addressing the “predetermined cycle” limitation, Mr. Brown contends that Mullins discloses a “cycling controller that ‘varies aspiration pressure according to sensed pressure within the catheter lumen.’” Ex.1005 ¶¶ 131–32 (citing, e.g., Ex.1008, 27:40–28:20 (“[a] novel aspect of this pump system is the incorporation of feedback into the pump algorithm in order to produce more effective pressure cycling”)). This use of a sensor to change pressure during a cycle, is not a “predetermined cycle” under our construction. combinations is its discussion of distal end flow control, not for its sensors.” Pet. Reply 17 (citing Ex. 1035 ¶ 83). However, Petitioner’s obviousness grounds rely on the combination of Yang and Mullins, especially with regard to Mullins’s disclosure of “a controller” in order “to control fluid flow in and out.” As discussed above, Mullins relies on the sensor-feedback approach in order to control flow and we find that Petitioner has not presented persuasive evidence of how the combined disclosures of Yang and Mullins would control flow without using Mullins’s sensor feedback approach. See W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1550 (Fed. Cir. 1983) (error to “consider[] … references in less than their entireties, i.e., in disregarding disclosures in [them] … that diverge from and teach away from the invention”). Therefore, we determine that Petitioner has not sufficiently shown that the combination of Yang and Mullins discloses or renders obvious “a controller configured to open and close the vacuum valve and the vent valve in a predetermined cycle to change a level of vacuum at the distal end of the catheter and to control fluid flow in and out from the distal end of the catheter.” Accordingly, having considered the parties’ respective evidence and arguments, we find that Petitioner has not shown by a preponderance of the evidence that claim 1 of the ’402 patent would have been unpatentable as obvious over the combination of Yang and Mullins.” slip op. at 27
Patent outcomesUS 11,406,402 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,406,402 - Geneoscopy, Inc. v. Exact Sciences CorporationAll claims unpatentablePTAB · Feb 5, 2026 · IPR2024-01330 · APJ Ryan H Flax · IPR · Final written decision
Claims 3, 4, and 12–19 are unpatentable as obvious under each asserted ground.
RulingsFinal written decision- Skill levelOther
- Expert testimonyOther
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“embody claims of the ’746 patent, the product has features not covered by the ’746 patent’s claims, some of which are critical unclaimed elements according to Patent Owner. Accordingly, Cologuard is not coextensive with the challenged claims, and no nexus between the product and the challenged claims is shown on this record.” slip op. at 35
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“developed where the patient need not manipulate their fecal sample to portion it, but the law of obviousness does not require an option to be the best option to be obvious. For these reasons, bearing in mind that the ultimate burden here is always on Petitioner, we are not persuaded by Patent Owner’s argument. We also reject Patent Owner’s argument that only impermissible” slip op. at 60
Patent outcomesUS 11,970,746 unpatentable§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,970,746 - Smaxtec Inc. / Smaxtec Animal Care GmbH v. St Reproductive Technologies, LLCAll claims unpatentablePTAB · Jan 16, 2026 · IPR2024-01067 · APJ Andreas Baltatzis · IPR · Final written decision
Claims 5–7, 9, and 10 are unpatentable: claims 5 and 6 are anticipated by Harvey and Riskey, claim 7 is obvious over Harvey and Rettedal, and claims 9 and 10 are obvious over Harvey and …
RulingsFinal written decision- BurdenNot shown unpatentable
“Considering the entire record, we determine that Petitioner “did not make out its obviousness case in its petition” and its arguments on reply “effectively abandoned its petition in favor of a new argument.” Wasica at 1286. To the extent Petitioner asserts the claims would have been obvious over Harvey and Riskey in the Petition, it does so using a merely conclusory statement that “[t]o the extent Patent Owner alleges that either Harvey or Riskey fails to teach any claim element, that element is provided by the other reference.” See Pet. 42; Wasica at 1286. And, as discussed in our Institution Decision, the Petition at a minimum does not explain what reference is the primary versus second reference, and what elements should be combined to reach the claimed invention. See Sisvel, 82 F.4th at 1364. reference to be modified with Riskey’s bolus and data compression. See Pet. Reply 15–17. Rather than explaining how its original petition was correct, Petitioner’s subsequent arguments amount to an entirely new theory of prima facie obviousness absent from the Petition. See Wasica, 853 F.3d at 1286; see also Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (“the expedited nature of IPRs bring with it an obligation for petitioners to make their case in their petition to institute”). We decline to engage in this new argument. Accordingly, we determine that Petitioner has not met is burden to show that claims 5 and 6 would have been obvious over Harvey and Riskey. G. Asserted Obviousness of Claim 7 over Harvey and Rettedal” slip op. at 54
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Riskey discloses “said sensor signal varies based on a corresponding change in one or more physiological parameters of said ruminant animal” (limitation 5[B]). We find Riskey’s description of temperature sensors to be persuasive evidence on this issue. Riskey discloses sensors for measuring changing animal characteristics, e.g., temperature, over time. Ex. 1005 ¶¶ 35, 44; see also id. ¶¶ 75, 76 (detecting temperature changes). We further credit Dr. Young’s testimony that one skilled in the art would understand that generated sensor signals, e.g., temperature, would change over time, whereby the sensor signal varies based on any corresponding change in the ruminant physiological parameter that the signal represents. Ex. 1002 ¶¶ 84, 85; see Cont’l Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1269 (Fed. Cir. 1991) (“This modest flexibility in the rule that ‘anticipation’ requires that every element of the claims appear in a single reference accommodates the reference; that is, where technological facts are known to those in the field of the invention.”). We consider Dr. Kan’s testimony that Riskey is silent as to details about the sensor signal, but are not persuaded because the testimony appears to contradict Riskey’s disclosure of a bolus including sensors for monitoring changes in animal characteristics, generating animal characteristic messages, i.e., signals, and wirelessly transmitting data corresponding to the monitored characteristics. See Ex. 2006 ¶¶ 170–174; Ex. 1005 ¶¶ 25, 63, 67, 68, 75–78, 101. Given Riskey’s express description of monitoring animal characteristics over time, we agree with Petitioner’s argument that Riskey discloses that said sensor signal varies based on changes to the animal’s physiological parameters.” slip op. at 16
- Skill levelSkill level board ownOther
“Petitioner asserts that a person of ordinary skill in the art (“POSA”) as of the claimed priority date would have “had at least a bachelor’s degree in electrical engineering or a related or equivalent field, and three or more years of experience researching, developing, designing and/or evaluating sensor systems for humans or other animals.” Pet. 5 (citing Ex. 1002 ¶ 35) (emphasis added). Patent Owner does not contest Petitioner’s characterization of the level of skill in the art. See PO Resp. 12 (citing Ex. 2006 ¶¶ 19–20). On the entire record, we determine this level of skill, with the exception of the open-ended phrases “at least” and “or more,” which we remove from Petitioner’s proposal, comports with the qualifications a person 5 In the present record, neither party presents arguments or evidence relating to secondary considerations.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We construe claim terms according to the standard set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–17 (Fed. Cir. 2005) (en banc), i.e., as construed in a civil action under 35 U.S.C. § 282(b). See 37 C.F.R. § 42.100(b). Under Phillips, claim terms are afforded “their ordinary and customary meaning.” Id. at 1312. “[T]he ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.” Id. at 1313. “Importantly, the person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification.” Id. Neither party expressly seeks a specific claim construction or definition for any claim term. See Pet. 10; PO Resp. 12. To the extent Patent Owner seeks to interpret claim 7 in view of the Specification, we address that argument in our discussion of claim 7, below. See infra, § III.G.3. For purposes of this Decision, we determine that no claim terms require express construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)). D. Asserted Anticipation of Claims 5 and 6 by Riskey” slip op. at 11
Patent outcomesUS 10,231,644 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,231,644
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