- 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 - Dr. Squatch, LLC v. The Procter & Gamble CompanyAll claims unpatentablePTAB · Mar 25, 2026 · IPR2024-01498 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–19 are unpatentable as obvious over the Lesniak- and Native-based grounds; the Squatch and Sturgis ground fails because Squatch was not shown to be a printed publication.
RulingsFinal written decision- BurdenDecided for patent owner
“We agree with Patent Owner that Petitioner has not shown sufficiently that Squatch is a printed publication. As described above, Petitioner relies on Squatch as a “website excerpt” placed on its site at the relevant time, but has not produced a screen shot of the website to show that it ever existed. See Ex. 1059. Petitioner provides internal documents that purport to describe what would have been on Dr. Squatch’s website at the relevant time, but falls short of establishing what was on the website for the interested consumer to view. Thus, we determine that this ground fails.” slip op. at 55
- Skill levelSkill level petitioner adoptedDecided for petitioner
“or “POSITA”) at the time of the invention “would have (1) at least a B.S. or equivalent degree; and (2) at least two years of experience in cosmetics formulations.” Pet. 17 (citing Ex. 1002 ¶¶ 26–28). Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications at this stage of the proceeding. PO Resp. 10. We adopt and apply Petitioner’s proposed definition of a POSA, which is consistent with the level of skill reflected in the asserted prior art. See e.g., Exs. 1003, 1004.” slip op. at 8
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“compositions with the relevant ingredients and achieves stable compositions through the use of a second wax having a melting point of 73 to 90° C. Pet. Reply 6–7 (citing Ex. 1003, 1:39–54). For example, Lesniak’s compositions (nos. 8 and 11) that used such a secondary wax, namely CastorWax MP80, are disclosed as sufficiently stable. Ex. 1003, Table 2. Here, we further credit the testimony of Dr. Michniak-Kohn that Lesniak teaches how to make stable compositions by including a secondary wax, such as castor wax, with a sufficiently high melting point. Ex. 1003, 1:39-54, 5:23-32, Table 2. Both of the compositions (nos. 8 and 11) tested by Lesniak that had such a wax passed the stability tests. Id. Ex. 1086 ¶ 7; see also Pet. Reply 6 (“Lesniak overcame any stability issues, as it expressly discloses compositions that are ‘physically stable at high and low temperatures.’”) (citing Ex. 1003, 5:23–32). Having considered the parties’ positions and evidence of record, summarized above, we determine that Lesniak provides sufficient disclosure to enable a person of ordinary skill in the art to formulate deodorant stick within the parameters of claim 1.” slip op. at 25
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Patent Owner asserts that the preamble of independent claims 1, 16, and 19 reciting “a deodorant stick” is limiting as it provides antecedent basis for the recitation of “said deodorant stick being free of an aluminum salt” for each independent claim. PO Resp. 7–10. Patent Owner also points to dependent claims 6–9 as relying on the preamble reciting “a deodorant stick” as antecedent basis for claim elements. Id. at 9. We agree. Petitioner does not argue to the contrary. See, e.g., Pet. 19 (arguing that Lesniak discloses a deodorant stick in the form of an antiperspirant stick).” slip op. at 8
Patent outcomesUS 11,844,752 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,844,752 - Dr. Squatch, LLC v. The Procter & Gamble CompanyAll claims unpatentablePTAB · Jan 28, 2026 · IPR2024-01174 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–8 and 10–23 are unpatentable: the Board found claims 1–15 anticipated or obvious over the asserted grounds and claims 16–23 obvious over the Native combination.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedPatent owner expert discountedOther
“argument that the prior art fails to enable a stable deodorant stick. Rather, we are persuaded by Petitioner that Lesniak sufficiently teaches compositions with the relevant ingredients and achieves stable compositions through the use of a second wax having a melting point of 73 to 90° C. Reply 6–7 (citing Ex. 1003, 1:39–54). For example, Lesniak’s compositions (nos. 8 and 11) that used such a second wax, namely CastorWax MP80, are disclosed as sufficiently stable. Ex. 1003, Table 2. Here, we further credit the testimony of Dr. Michniak-Kohn that Lesniak teaches how to make stable compositions by including a secondary wax, such as castor wax, with a sufficiently high melting point. Ex. 1003, 1:39-54, 5:23-32, Table 2. Both of the compositions (nos. 8 and 11) tested by Lesniak that had such a wax passed the stability tests. Id. Ex. 1086 ¶ 7; see also Reply 6 (“Lesniak overcame any stability issues, as it expressly discloses compositions that are ‘physically stable at high and low temperatures.’”) (citing Ex. 1003, 5:23–32).” slip op. at 22
- Skill levelSkill level petitioner adoptedOther
“Petitioner proposes that a person of ordinary skill in the art (“POSA” or “POSITA”) at the time of the invention “would have (1) at least a B.S. or equivalent degree; and (2) at least two years of experience in cosmetics formulations.” Pet. 17 (citing Ex. 1002 ¶¶ 27–29). Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications at this stage of the proceeding. PO Resp. 10. For this Decision, we adopt and apply Petitioner’s proposal above, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Patent Owner asserts that the preamble of independent claim 1, 16, and 20 reciting “a deodorant stick” is limiting” as it provides antecedent basis for the recitation of “said deodorant stick being free of an aluminum salt” for each independent claim. PO Resp. 7–10. Patent Owner also points to dependent claims 6–9 as relying on the preamble reciting “a deodorant stick” as antecedent basis for claim elements. Id. at 9. We agree. Petitioner does not provide argument to the contrary. See, e.g., Pet. 19 (arguing that Lesniak discloses a deodorant stick in the form of an antiperspirant stick). We determine that no express construction of any claim term is necessary to determine whether to institute inter partes review. 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))). To the extent further discussion of the meaning any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“We find that the evidence of record fails to support Patent Owner’s argument that the prior art fails to enable a stable deodorant stick. Rather, we are persuaded by Petitioner that Lesniak sufficiently teaches compositions with the relevant ingredients and achieves stable compositions through the use of a second wax having a melting point of 73 to 90° C. Reply 6–7 (citing Ex. 1003, 1:39–54). For example, Lesniak’s compositions (nos. 8 and 11) that used such a second wax, namely CastorWax MP80, are disclosed as sufficiently stable. Ex. 1003, Table 2. Here, we further credit the testimony of Dr. Michniak-Kohn that Lesniak teaches how to make stable compositions by including a secondary wax, such as castor wax, with a sufficiently high melting point. Ex. 1003, 1:39-54, 5:23-32, Table 2. Both of the compositions (nos. 8 and 11) tested by Lesniak that had such a wax passed the stability tests. Id. Ex. 1086 ¶ 7; see also Reply 6 (“Lesniak overcame any stability issues, as it expressly discloses compositions that are ‘physically stable at high and low temperatures.’”) (citing Ex. 1003, 5:23–32). Having considered the parties’ positions and evidence of record, summarized above, we determine that Lesniak provides sufficient disclosure to enable a person of ordinary skill in the art to formulate deodorant stick within the parameters of claim 1. Therefore, for the reasons discussed above, we conclude that Petitioner has proved by a preponderance of evidence that Lesniak anticipates claim 1.” slip op. at 22
Patent outcomesUS 11,497,706 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,497,706 - Dr. Squatch, LLC v. The Procter & Gamble CompanyAll claims unpatentablePTAB · Jan 28, 2026 · IPR2024-01173 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–7, 9–13, and 16–19 are unpatentable: claims 16–17 are anticipated by Lesniak, and the remaining challenged claims are obvious over the stated combinations.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“argument that the Lesniak fails to enable a stable deodorant stick. Rather, we are persuaded by Petitioner that Lesniak sufficiently teaches compositions with the relevant ingredients and achieves stable compositions through the use of a second wax having a melting point of 73 to 90° C. Pet. Reply 8 (citing Ex. 1003, 1:39–54). For example, Lesniak’s compositions (nos. 8 and 11) that used such a second wax, namely CastorWax MP80, are disclosed as sufficiently stable. Ex. 1003, Table 2. Here, we further credit the testimony of Dr. Michniak-Kohn that secondary wax, such as castor wax, with a sufficiently high melting point. Ex. 1003, 1:39-54, 5:23-32, Table 2. Both of the compositions (nos. 8 and 11) tested by Lesniak that had such a wax passed the stability tests. Ex. 1086 ¶ 7; see also Reply 8 (“Lesniak overcame any stability issues, as it expressly discloses compositions that are ‘physically stable at high and low temperatures.’”) (citing Ex. 1003, 5:23–32).” slip op. at 22
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Level of Ordinary Skill in the Art Petitioner proposes that a person of ordinary skill in the art (“POSA” or “POSITA”) at the time of the invention “would have (1) at least a B.S. or equivalent degree; and (2) at least two years of experience in cosmetics formulations.” Pet. 24 (citing Ex. 1002 ¶¶ 27–28). Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications. See generally PO Resp. We adopt and apply Petitioner’s proposed definition of a POSA, which is consistent with the level of skill reflected in the asserted prior art.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Patent Owner asserts that the preamble of independent claim 1 reciting “a deodorant stick” is limiting” as it provides antecedent basis for certain other claim elements, specifically, for the recitation of “said deodorant stick being free of an aluminum salt” and “said deodorant stick” having a particular hardness range. PO Resp. 8–9. Patent Owner also points to dependent claims 5–8 as relying on the preamble reciting “a deodorant stick” as antecedent basis for claim elements. Id. at 10. We agree.” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“We find that the evidence of record fails to support Patent Owner’s argument that the Lesniak fails to enable a stable deodorant stick. Rather, we are persuaded by Petitioner that Lesniak sufficiently teaches compositions with the relevant ingredients and achieves stable compositions through the use of a second wax having a melting point of 73 to 90° C. Pet. Reply 8 (citing Ex. 1003, 1:39–54). For example, Lesniak’s compositions (nos. 8 and 11) that used such a second wax, namely CastorWax MP80, are disclosed as sufficiently stable. Ex. 1003, Table 2. Here, we further credit the testimony of Dr. Michniak-Kohn that secondary wax, such as castor wax, with a sufficiently high melting point. Ex. 1003, 1:39-54, 5:23-32, Table 2. Both of the compositions (nos. 8 and 11) tested by Lesniak that had such a wax passed the stability tests. Ex. 1086 ¶ 7; see also Reply 8 (“Lesniak overcame any stability issues, as it expressly discloses compositions that are ‘physically stable at high and low temperatures.’”) (citing Ex. 1003, 5:23–32). Having considered the parties’ positions and evidence of record, summarized above, we determine that Lesniak provides sufficient disclosure to enable a person of ordinary skill in the art to formulate a deodorant stick within the parameters of claims 16 and 17. e) Conclusion as to Claims 16 and 17 We agree with Petitioner that “the challenged claims recite nothing more than well-known deodorant ingredients performing their conventional functions.” Pet. Reply 2. Therefore, for the reasons discussed above, we conclude that Petitioner has proved by a preponderance of evidence that Lesniak anticipates claims 16 and 17.” slip op. at 22
Patent outcomesUS 10,905,647 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,905,647 - Dr. Squatch, LLC v. The Procter & Gamble CompanyAll claims unpatentablePTAB · Jan 26, 2026 · IPR2024-01105 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–15 are unpatentable: claims 1, 3–8, and 11–14 as anticipated by Lesniak; claims 2, 9, 10, and 15 as obvious over the respective asserted combinations.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner proposes that a person of ordinary skill in the art (“POSA” or “POSITA”) at the time of the invention “would have (1) at least a B.S. or equivalent degree; and (2) at least two years of experience in cosmetics formulations.” Pet. 27 (citing Ex. 1002 ¶¶ 26–28). Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications. PO Resp. 7– 8. We adopt and apply Petitioner’s proposed definition of a POSA, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Patent Owner asserts that the preamble of independent claim 1 reciting “a deodorant stick” is limiting” as it provides antecedent basis for certain other claim elements, specifically, for the recitation of “said stick range. PO Resp. 8–10. We agree. Petitioner does not provide argument to the contrary. See, e.g., Pet. 27 (arguing that Lesniak discloses a deodorant stick in the form of an antiperspirant stick).” slip op. at 6
- Expert testimonyPetitioner expert creditedDecided for petitioner
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“disclosure to enable a person of ordinary skill in the art to formulate deodorant stick within the parameters of claim 1. d) Conclusion as to claim 1 Having considered the parties’ positions and evidence of record, summarized above, we are persuaded by Petitioner’s analysis that Lesniak discloses all elements of claim 1. We are not persuaded to Patent Owner’s arguments to the contrary. Accordingly, we determine that Lesniak anticipates claim 1.” slip op. at 20
Patent outcomesUS 10,966,915 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,966,915 - Salvacion USA, Inc. v. Trutek CorpAll claims unpatentablePTAB · Dec 2, 2025 · IPR2024-00711 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–3 and 8 are unpatentable as anticipated by Chen, Baker, Wahi ’005, and, for claims 1, 2, and 8, Rolf; the Board also finds them obvious over the asserted grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In our Institution Decision, we adopted Petitioner’s definition of a person of ordinary skill in the art (“POSITA”) as it was undisputed at the time and consistent with the evidence of record. Inst. Dec. 7–8. Based on our consideration of the full record, we maintain our determination that a POSITA at the time the application for the ’802 patent was filed “would have had at least an undergraduate degree in pharmacy, chemistry, biochemistry, biomedical engineering or a closely related field, such that the POSITA generally understand[s] pharmaceutical formulation.” Pet. 12. Additionally, we agree with Petitioner that “[a] POSITA would be familiar with the chemical ingredients in the [’802] Patent, biocidic agents, and cationic agents, have knowledge of airborne particles including viruses and bacteria, and understand electrostatic fields, electrostatic attraction and repulsion, adhesion and cohesion.” Id. (citing Ex. 1002 ¶¶ 38–39).” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“of independent claims 1, 2, and 8 as limiting. Inst. Dec. 7–8. The parties do not dispute our construction of the preambles of claims 1, 2, and 8 as limiting. See generally PO Resp.; Pet. Reply 2–4. After consideration of the full trial record, we maintain our construction of the preamble of claims 1, 2, and 8 as limiting for the reasons set forth in our Institution Decision. Id. Briefly, the preamble of independent claims 1, 2, and 8 limits the challenged claims as both the preamble and the body are used to define the subject matter claimed. See Allen Engineering Corp., v. Bartell Industries, Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). In particular, the preamble is “necessary to give life, meaning and vitality” to the claim, see id., because it provides the only description in the claim for the application site of the formulation, i.e., “to skin or tissue of nasal passages,” and how the formulation is applied, i.e., “in a thin film.”” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner
“After consideration of the full trial record, we maintain our construction. From our perspective, the claims themselves support this construction as the claims expand upon the term “electrostatically inhibiting” with specific means for achieving such inhibition. Specifically, claims 1 and 2 recite electrostatically attracting the particulate matter, holding the matter in place, and inactivating the matter. Additionally, the Specification supports our construction as it describes the use of “an electrostatic field such that oppositely charged airborne particulates (including microorganisms) in the vicinity of the surface are electrostatically trapped, held thereto and one or more of the microorganisms so captured is neutralized, killed, inactivated, and rendered harmless.” Ex. 1001, 3:36–40; PO Resp. 10 n.6.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for petitioner
“We adopt the parties’ construction of “adequate impermeability” that has been accepted in the related district court litigation: “Adequate impermeability” refers to the “thin film holding harmful particles in place and inhibiting them from penetrating the thin film and contacting the skin or tissue of an individual’s nasal passages. This is done by varying the concentration of ingredients . . .[,] thereby adjusting the adhesion and cohesion of the thin film.” Pet. Reply 3 (quoting Ex. 1010, 17). Furthermore, as stated in our Institution Decision, along with that term, the claim language explains that the thin film is meant to stick to the skin or tissue and to hold the particulate matter in place. Inst. Dec. 9–10. The claim language also explains that the cohesion of the formulation is adjusted to provide adequate impermeability to the thin film. Thus, it is reasonable to consider the recited impermeability is a function of the cohesive properties of the thin film, and that such impermeability refers to a property of the thin film, i.e., inhibiting the penetration or passage of matter through it onto the skin or tissue at the application site.” slip op. at 10
Patent outcomesUS 8,163,802 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,163,802 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Nov 17, 2025 · IPR2024-00648 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–30 are unpatentable: claims 1–2, 4–7, 9–12, 14–17, and 19–30 are anticipated by the MSI-H Study Record; claims 3, 8, 13, and 18 are obvious over the cited combinations.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“We agree with Patent Owner that the phrase “in response to” in claim 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. 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 cancer to determine that the patient’s 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 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 10
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference is prior artDecided for petitioner
“Patent Owner does not direct us to evidence that it attempted to file any patent application before the publication date of the MSI-H clinical study and was denied an earlier filing date. Contrary to Patent Owner’s argument that it could not file a patent application without results from the MSI-H clinical study, we note that the inventors filed a provisional patent application on November 13, 2014, which, although also filed more than a year after the publication of the MSI-H clinical study, disclosed no clinical results or data. Ex. 1001, cover; Ex. 1030, 1. After considering the parties’ arguments, we are not persuaded by Patent Owner’s assertion that the inventors could not have filed an earlier application to at least attempt to secure a priority date before the MSI-H clinical study was publicly available. an earlier filing date. Instead, we are persuaded by Petitioner’s argument that because the MSI-H clinical study was published before the inventors filed an application to protect their patent rights the MSI-H clinical study is prior art for the information it discloses. Accordingly, we proceed to analyze Petitioner’s contentions in Ground 1.” slip op. at 24
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“the genus disclosed in the MSI Study Record and does not argue or provide evidence to show that one of ordinary skill in the art could have envisaged each species within that genus. PO Resp. 11–14. We are not persuaded that either the size of the genus in the MSI Study Record or whether one of ordinary skill in the art would have been able to envisage every species within it is dispositive of whether the MSI Study Record anticipates claim 1, where one of ordinary skill in the art would have known that specific cancers recited in claim 1 would be included in the MSI Study Record. As Petitioner argues, claim 1 requires that “a patient…selected from the group consisting of [the listed cancers]” be tested and treated. Pet. Reply 10 (emphasis original). Claim 1 does not require that the patient have each and every one of the sixteen listed cancers to anticipate the claim. Rather, claim 1 requires testing a sample from “a patient” with one of the recited types of cancer and treating the patient. See Brown v. 3M, 265 F.3d 1349, 1351 (Fed. Cir. 2001) (“When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art.”).” slip op. at 31
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“In contrast, the testimony of Patent Owner’s witness, Dr. Goldberg, supports Petitioner’s argument of the knowledge in the art at the time, wherein Dr. Goldberg testifies that “[w]hile many clinical oncologists were aware that patients with Lynch Syndrome had a defect in DNA mismatch repair, they associated MSI testing with young onset colorectal and endometrial cancer and patients with a family history of colorectal and/or endometrial cancer.” Ex. 2090 ¶ 79. Similarly, during his deposition, Dr. Goldberg also agreed that endometrial, gastric, and small-bowel cancers would come to mind when he saw a reference to MSI-high non-colorectal cancer. See Ex. 1243, 115:5–116:22 (Q. And so does endometrial cancer come to mind when you see reference to MSI-high non-colorectal cancers? . . . A. Yes. Q. As . . . a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does gastric cancer come to mind? . . . A. comes to mind. So the answer is yes. Q. As a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does small bowel cancer come to mind? . . . A. Yes.”). Patent Owner does not direct us to other evidence contradicting Petitioner’s argument that MSI-H was known to occur in endometrial, small bowel, and gastric cancer. Pet. 18.” slip op. at 30
Patent outcomesUS 11,643,462 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,643,462 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Nov 6, 2025 · IPR2024-00623 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–7 are unpatentable: claims 1–3 and 5–7 are anticipated by the MSI-H Study Record, and claim 4 is obvious over the MSI-H Study Record and other cited references.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedDecided for petitioner
“On balance, we find Petitioner’s evidence more persuasive of what one of ordinary skill in the art would have understood from the MSI-H Study Record. We find Dr. Neugut’s and Dr. Oberstein’s testimony, and Dr. Lonberg’s lack of clear testimony to the contrary, persuasive as to this issue. In addition, we are not persuaded by the case law cited by Patent Owner regarding inherent anticipation. See PO Resp. 6–7. Rather, we agree with Petitioner that the correct inquiry is whether the skilled artisan would have understood that all limitations are disclosed in the prior art. See Pet. 34–35; Pet. Reply 12–13. In light of the cited testimony, we are persuaded that Petitioner has met its burden of proving that a skilled artisan would reasonably have understood or inferred that the limitation for a patient having received a prior cancer therapy drug to treat the tumor was disclosed in the MSI-Study Record. Petitioner demonstrates what one of ordinary skill in the art would have understood from the MSI-H Study Record, not what it inherently discloses. Contra PO Resp. 6–9.” slip op. at 22
- Skill levelSkill level board ownDecided for petitioner
“In light of the extent of the relevant field, we determine that the level of skill in the art relevant to the claims of the ’974 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating 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.” slip op. at 9
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
Patent outcomesUS 11,325,974 unpatentable§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,325,974
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.