- 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 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 - 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 - Smaxtec Inc. / Smaxtec Animal Care GmbH v. St Reproductive Technologies, LLCAll claims unpatentablePTAB · Nov 20, 2025 · IPR2024-00875 · APJ Andreas Baltatzis · IPR · Final written decision
Claims 1–4, 6, and 17–20 are unpatentable under the Trevarthen and Laitinen-based obviousness grounds; claim 6 was not shown unpatentable over Trevarthen alone.
RulingsFinal written decision- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“statistics in the absence of evidence of unique downloads or individuals. Even if the download numbers do not exactly represent unique downloads by unique individuals, the evidence shows that Trevarthen was downloaded to some extent, and therefore distributed, prior to the filing date of the ’206 patent. Accordingly, we find this evidence weighs in favor of Trevarthen’s public accessibility.” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner
“construction issues: (1) the interpretation of limitations 1[E] and 17[F] relating to entering sensed and stored information into “at least one logical expression,” and (2) “implanted in an animal.” Inst. Dec. 19. We are persuaded by Petitioner’s argument that it would have been obvious to combine sensed and stored information into the same “at least one logical expression,” for the reasons set forth below. Accordingly, we need not construe limitations 1[E] and 17[F], relating to “at least one logical expression.”4 We discuss our construction of “implanted in an animal” below.” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundNot shown unpatentableMixed
“would have viewed Trevarthen as a cohesive disclosure of specific improvements to existing dairy farms, as opposed to disparate teachings of unrelated systems. Trevarthen itself proposes “a framework for the use of RFID on dairy farms” including “enhancements and ideas which could be considered as future additions to further add value” for utilizing RFIDs in farm management beyond the Cochrane farm ear-tag RFIDs. Ex. 1005, 99. The enhancements include RFID boluses (id.), milk meters to detect illness (id. at 115), and temperature monitoring by RFID (id. at 121–122). Considering the entire record, Trevarthen itself describes improvements that apply “the predictable use of prior art elements according to their established functions.” See KSR, 550 U.S. at 417. Accordingly, we find that Petitioner has shown a that one skilled in the art would have been motivated to” slip op. at 33
- ExcludeNot reached
“IV. EVIDENTIARY ISSUES Patent Owner moves to exclude Exhibits 1040, 1041, and 1044.” slip op. at 81
Patent outcomesUS 9,844,206 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,844,206 - Smaxtec Inc. / Smaxtec Animal Care GmbH v. St Reproductive Technologies, LLCAll claims unpatentablePTAB · Nov 20, 2025 · IPR2024-00885 · APJ Jamie T Wisz · IPR · Final written decision
Claims 1–4 and 15–25 are unpatentable: claims 1–2 are anticipated by Trevarthen, and the challenged claims are also obvious over the listed combinations.
RulingsFinal written decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Petitioner”) filed a Petition requesting an inter partes review of claims 1–4 and 15–25 (the “challenged claims”) of U.S. Patent No. 8,823,515 B2 (Ex. 1001, “the ’515 patent”). Paper 1 (“Pet.”). ST Reproductive Technologies, LLC (“Patent Owner”) filed a Preliminary Response. Paper 6 (“Prelim. Resp.”). With our authorization, Petitioner filed a Preliminary Reply (Paper 10, “Prelim. Reply”) and Patent Owner filed a Preliminary Sur-Reply (Paper 13, “Prelim. Sur-Reply”). Upon consideration of these filings and the preliminary evidence of record, we determined that Petitioner had demonstrated a reasonable likelihood that it would prevail with respect to at least one of the challenged claims of the ’515 patent (Paper 16, “Institution Decision” or “Inst. Dec.”). Thus, we instituted review with respect to all of the challenged claims. slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“statistics in the absence of evidence of unique downloads or individuals. Even if the download numbers do not exactly represent unique downloads by unique individuals, the evidence shows that Trevarthen was downloaded, and therefore distributed, prior to the filing date of the ’515 patent. Accordingly, we find this evidence weighs in favor of Trevarthen’s public accessibility.” slip op. at 20
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“retrieves sensed animal temperature information from the RFID device” and “further teaches that these temperature measurements are analyzed to detect ‘fluctuations,’ ‘a rise,’ and/or ‘anomalies’ that might indicate illness or oestrus.” Id. at 16 (citing Ex. 1005, 121–122). Accordingly, Petitioner asserts that a “POSA would understand that to perform such analysis, the animal temperature information for each animal is necessarily stored in the” slip op. at 36
- ExcludeMotion to exclude, deniedOther
“Patent Owner moves to exclude Exhibits 1040, 1041, and 1044. Paper 36. We do not rely on any of Exhibits 1040, 1041, and 1044 to decide this matter. Thus we dismiss Patent Owner’s motion to exclude as moot.” slip op. at 82
Patent outcomesUS 8,823,515 unpatentable§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,823,515 - 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 - Intas Pharmaceuticals Ltd. v. Atossa Therapeutics, Inc.All claims unpatentablePTAB · Jan 29, 2025 · PGR2023-00043 · APJ Tina E Hulse · PGR · Final written decision
Claims 1, 2, 4, 15, and 20–22 are anticipated by Ahmad; claims 3, 5–14, and 16–19 are obvious over the cited prior art.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“As explained in our Institution Decision, we adopted Patent Owner’s definition because we do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art—both definitions provide for a highly skilled POSA with experience in formulating drugs. Dec. Inst. 8. Petitioner’s counsel confirmed during the hearing that there was no substantive difference between the parties’ definitions. Tr. 7:25–8:5. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). We, therefore, adopt Patent Owner’s definition of a POSA. Moreover, we find that Dr. McConville, Dr. Bihovsky, and Dr. Davies are all qualified to opine from the perspective of a skilled artisan as all are persons of at least ordinary skill in the art, based on either party’s definition.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“When read as a whole, however, we find compelling that the Specification consistently identifies (Z)-endoxifen salts as separate from (Z)- endoxifen. Throughout the Specification—including in the Abstract and the Summary of the Invention—the ’334 Patent refers to “(Z)-endoxifen and salts thereof,” suggesting that references to “(Z)-endoxifen” alone do not include the salt forms unless expressly identified as such. See, e.g., id. at Abstract (“The present disclosure provides . . . methods of making (Z)- endoxifen or a salt thereof”), 2:60–62 (Summary of the Invention stating same); 6:4–6 (Summary of the Invention stating “process for manufacturing (Z)-endoxifen or salts thereof”). Moreover, the Specification states that although endoxifen is available commercially as an (E)/(Z) isomer free base mixture, as well as ≥98% (Z)- endoxifen HCL and (Z)-endoxifen citrate salts, “[t]here remains a need for (Z)-endoxifen free base preparations that are sufficiently stable for preparation of pharmaceutical compositions.” Id. at 82:3–5, 82:37–39. Accordingly, the Specification states, “[p]rovided herein in the present disclosure are preparations of endoxifen free base that are . . . at least 90% (Z)-endoxifen free base.” Id. at 82:43–45. Taking the language of the claims and the Specification as a whole, we determine that the intrinsic evidence supports construing the limitation “the compound of Formula (III) is (Z)-endoxifen” to be limited to the (Z)- endoxifen free base form and excludes the salt and solvate forms.” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“presumption of enablement, and the patentee/applicant has the burden to prove nonenablement for such prior art”). As such, Apple instructs us that a petitioner need not provide evidence in its petition to show a prior art patent is enabling as part of its burden to prove anticipation. Id. at 449–50 (finding the Board erred in shifting the burden to the petitioner to provide evidence in its petition to show prior art patent publication was enabling). Thus, it is Patent Owner’s burden to establish by a preponderance of the evidence that Ahmad is not enabling. Before we turn to the substantive grounds, we must first resolve the parties’ disputes over several legal issues regarding enablement. First, Patent Owner asserts that “[w]hile the claims of a prior art patent are presumed enabled, . . . [t]here is no presumption that every prophetic example in the specification is enabled, especially where that prophetic example is not explicitly claimed.” PO Resp. 32 (citations omitted). This is an incorrect statement of the law. The Federal Circuit has clearly stated that “a presumption arises that both the claimed and unclaimed disclosures in a prior art patent are enabled.” Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1354–55 (Fed. Cir. 2003). Patent Owner may rebut that presumption, but that presumption of enablement exists nonetheless for both the claimed and unclaimed disclosures.” slip op. at 17
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“We find Petitioner has the better position. Ahmad itself provides the reason to combine Ahmad’s formulation with Cole’s enteric coating, stating in the stomach” and to “prevent release of medication before it reaches the small intestine.” Ex. 1003, 18:19–24. It was known that endoxifen could be susceptible to degradation in the acidic conditions of the stomach, and a POSA would have been motivated to use an enteric capsule to avoid acidic degradation and improve bioavailability. Ex. 1031 ¶ 6 (citing Ex. 1019, 1353). We credit Dr. McConville’s testimony that applying enteric coatings would have been routine (Ex. 1020 ¶ 71; Ex. 1031 ¶ 5), which is consistent with Ahmad’s disclosure that the enteric coating “can be done as methods known in the art.” Ex. 1003, 18:27–29. Similarly, the ’334 Patent states that “enteric tablets, enteric caplets, or enteric capsules of the present disclosure may be prepared by techniques known in the art.” Ex. 1001, 39:28–30. Moreover, the fact that Cole uses paracetamol as a model drug and not endoxifen is of no concern to our obviousness analysis. We credit the formulation expertise of Dr. McConville, who explains that “[i]n the case of an enteric coated capsule, it is the degradation of the enteric coating and the capsule that will control the release of the drug, not the nature of the drug itself.” Ex. 1031 ¶ 7 (citing Ex. 1008, 84). Thus, a POSA would have understood that the capsule in Cole would have the same benefits for use with other drugs, such as endoxifen. Id. Patent Owner and Dr. Davies identify certain complications that may plague enteric-coated endoxifen formulations and HPMC capsules, such as “potential interactions between enteric coatings and pharmaceutical compositions” and “variations in release profiles.” PO Resp. 63–64; Ex. 2020 ¶¶ 164, 166. But we are not persuaded by that argument, because we agree with Dr. McConville that Patent Owner and Dr. Davies fail to cite any credible evidence of such complications between enteric coatings and interactions. Ex. 1031 ¶¶ 8, 10. Having considered the arguments and evidence presented by the parties, we find that the combination of Ahmad and Cole teaches each limitation of claims 5–8, 16, and 17 and that a POSA would have had a reason to use the enteric coating and HPMC capsules of Cole with the (Z)- endoxifen formulation of Ahmad to reach the claimed invention with a reasonable expectation of success. See Ex. 1020 ¶¶ 84–97; Ex. 1031 ¶¶ 5–16.” slip op. at 34
Patent outcomesUS 11,572,334 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,572,334 - Spectrum Solutions, L.L.C. v. Dna Genotek Inc.All claims unpatentablePTAB · Feb 7, 2024 · IPR2022-01347 · APJ Donna M Praiss · IPR · Final written decision
Claims 1, 3–8, 11, and 12 are unpatentable as obvious over each of four grounds: Plante and Cho, with or without Maples, and Plante and Patterson, with or without Maples.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“(POSITA or POSA) “would have had at least a Bachelor’s degree in mechanical engineering, biomedical engineering, or similar technical degree and at least 3 years of experience in the medical device industry, including experience with containers and valves used in disposable medical devices.” Pet. 16 (citing Ex. 1002 ¶ 49). Petitioner further asserts that such a person would have collaborated with a team member with training and experience in the chemical/biological aspects of the invention, having a Ph.D. in microbiology, molecular biology, biochemistry, or related discipline and “at least two years of post-graduate experience in the area of biological sample preservation and nucleic acid extraction, preservation, and analysis.” Id. at 16–17 (citing Ex. 1011 ¶¶ 24–26). Patent Owner does not dispute using Petitioner’s proposed definition. PO Resp. 6.8 We apply Petitioner’s proposed definition because it is consistent with the problems addressed in the ’646 patent and the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings on 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, 162 (Fed. Cir. 1985))).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989)). “In general, a preamble limits the invention if it recites essential structure or steps, or if it is ‘necessary to give life, meaning, and vitality’ to the claim.” Id. (quoting Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999)). “Conversely, a preamble is not limiting ‘where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.’” Id. (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997)). The court in Catalina noted that although no litmus test exists for determining whether to treat a preamble as a limitation, several “guideposts” have emerged from the case law in this area. Id. In particular, guideposts tending to show that the preamble is a claim limitation include: Jepson claiming, dependence on a particular disputed preamble phrase for antecedent basis, when the preamble is essential to understand limitations or terms in the claim body, and when the preamble recites additional structure or steps underscored as important by the specification. Id. On the other hand, the preamble might not constitute a claim limitation when the claim body describes such a structurally complete invention that deleting the preamble phrase does not affect the structure or steps of the claimed invention. Id. at 809. Also, “preambles describing the use of an invention generally do not limit claims because the patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of the structure.” Id.” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“the claim must be given their plain meaning unless the plain meaning is inconsistent with the Specification. In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989). Additionally, ordinary, simple English words whose meaning is clear and unquestionable are to be construed to mean exactly what they say–– absent, of course, any indication that their use in a particular context changes their meaning. Chef America, Inc. v. Lamb-Weston, Inc., 358 F.3d 1371, 1372 (Fed. Cir. 2004). The abstract of the ’646 patent describes isolating and preserving cells from bodily fluids “for cellular analysis” and “genomic studies.” Ex. 1001, code (57). In the field of the disclosure portion of the ’646 patent, cells isolated from bodily fluids are preserved “for studies in any of: functional genomic and epigenetic studies, and biomarker discovery.” Id. at 1:25–29. In the background section, the ’646 patent describes the interest in “large-scale epigenetic research” for the purpose of “understanding the mechanisms of gene-environment interactions” suggesting that “epigenetic mechanisms may provide a molecular memory of environmental experiences.” Id. at 1:60–67. The background section further describes the challenges of collecting bodily fluids, such as saliva, is that it is a digestive fluid that can be rich in proteases and that existing solutions used to stabilize cells from blood, which is a transporter fluid, “will not protect cells from proteases found in some bodily fluids, such as saliva.” Id. at 3:24–36, 4:43–47. The detailed description section of the ’646 patent discloses “a solution for preserving cells in one or more bodily fluids, such as saliva and urine” that “may be beneficial for further separation into cell types and downstream molecular analysis” and “allows for storage of cells in the bodily fluid to retain their antigenicity and cellular architecture.” Id. at 16:9–15. The Specification describes some embodiments of solutions for preserving cells in one or more bodily fluids where the solutions contain a chemical fixing agent, a protease inhibitor, an antimicrobial agent, serum proteins, and are buffered to preferred pH ranges. Id. at 16:15–22. Thus, the plain meaning of “preserving a biological sample,” consistent with the ’646 patent disclosure focused on maintaining the architecture of cells contained in a bodily fluid that may include digestive proteases for further study downstream, is “preserving the integrity of a cell contained in a bodily fluid sample.”” slip op. at 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“We agree that it is not necessary for us to construe these claim terms because neither party asserts that they are material to the asserted grounds in the Petition. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe 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 18
Patent outcomesUS 11,002,646 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,002,646
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.