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  • PTAB · Jun 17, 2026 · IPR2025-00109 · APJ Bach V Hoang · IPR · Final written decision

    Claims 1–24 were not shown unpatentable because the petitioner failed to establish motivation to combine the references and failed to show the claimed different-distance image capture.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Having considered the full record at trial, we maintain the preliminary finding regarding the level of ordinary skill in the art. See Inst. Dec. 11–12. In particular, based on the teachings of the ’910 Patent and the asserted prior art, we are persuaded that an ordinarily skilled artisan would have had a work experience related to biometrics, facial authentication, computer vision, and/or optics as at least one of those fields is respectively implicated by the ’910 Patent and the asserted prior at. Moreover, our decision would be the same under either proposed level of skill.” slip op. at 10

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

      “C. Claim Construction We interpret claim terms using “the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b). Under the principles set forth by the Federal Circuit, the “words of a claim ‘are generally given their ordinary and customary meaning,’” as would be understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). The parties do not dispute any claim terms or phrases and our decision does not require construing any particular claim terms or phrases, therefore, we do not expressly construe any particular claim term or phrase. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’”” slip op. at 10

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable

      “We find that these reasons would not have adequately motivated a person having ordinary skill in the art to combine and modify the references in Petitioner’s asserted manner to reach the claimed features. Petitioner’s motivations — “substitution,” “obvious alternative . . . approaches,” “use of a known technique,” and “complimentary” techniques — are all similarly based on swapping or adding techniques for verifying three dimensionality. See Pet. 13–17; Pet. Reply 16–17. Those motivations might have been suitable had Tanii described techniques to verify three dimensionality, but Petitioner has not shown that Tanii describes any technique to verify three dimensionality. See Pet. 13–17, 25–28. Instead, as discussed above, Tanii describes the existence of the perspective distortion phenomenon and a technique for correcting it. As such, substituting the knowledge that perspective distortion exists and techniques to correct it does not correspond adequately motivate Petitioner’s combination. Put another way, because Tanii does not teach an approach for verifying three-dimensionality, Tanii’s techniques cannot be used as a substitute for approaches that do verify three dimensionality simply because Tanii discloses the concept of perspective distortion.” slip op. at 16

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

      “distance from the user. Derakhshani teaches two different approaches (1) focus-distance approach and (2) parallax approach. Petitioner acknowledges that the focus-distance approach does not expressly disclose capturing a second image at a second distance. Pet. 13 (distinguishing “focus distances” from “actual distances.”). This is because focus-distance, by definition, is not actual distance. Ex. 1005, 16:47–48 (“Focus distance is the distance from a sensor to a point in its field of view that is perfectly in focus.”) In Derakhshani’s focus-distance approach the camera stays the same distance from its subject—only the focus distance changes. Id. at 16:66–17:2 (“By comparing degree of focus for a landmark in images with different focus distances, the distance from the sensor to the landmark may be estimated.”) Derakhshani’s parallax approach also does not expressly disclose capturing a second image at a second distance. In the parallax approach the camera is rotated or slid about the user to create images with different perspectives. Ex. 1005, 17:59–64 (“In some implementations, the sensor is moved about the subject during image capture to collect image data from different orientations relative to the subject. For example, a single camera may be rotated or slid slightly or multiple cameras at different positions may be used for image capture.”). Rotating a camera around a user does not change the distance of the camera from the user. At the hearing Petitioner, indicating that Derakhshani takes a second image at a second distance. Tr. 16:9–12 (“[Petitioner’s Counsel: . . . Dr. Daft is talking about some of the terms that Derakhshani is using. For example, the term slid and shown in the images, he talks about how slid refers to the different distances between the sensor and the user.”). We determine that it is more likely that the word “slid,” as used in the relevant portion of Derakhshani, further describes the rotation of the camera about the user. Derakhshani indicates as much by describing that both rotating and sliding the camera are examples of how the camera sensor is “moved about the subject during image capture.” Ex. 1005, 17:60–61. Thus, sliding the camera does not necessarily disclose moving the camera to a second distance from the subject. Zhang also does not expressly disclose capturing a second image at a second distance. Petitioner acknowledges as much stating “[a]lthough Zhang does not expressly say that the second image is captured at a second distance different from the distance of the first image, this would have been obvious to a POSITA.” Pet. 61 (citing Ex. 1003 ¶ 1046). Because Zhang does not expressly disclose capturing a second image at a second distance, Petitioner once again relies on expert testimony to argue that the multiple images disclosed in Zhang would have been taken at different perspectives resulting from rotating or translating the position of the camera and that taking images at different distances would have enhanced Zhang’s homography-transformation procedure. Pet. 61–62 (citing Ex. 1003 ¶ 1046). From here Petitioner repeats many of the same arguments it made regarding the parallax approach from Derakhshani, except that these arguments are on even weaker footing because Zhang does not mention taking images by translating the position of the camera, nor even that the multiple images taken should be from different perspectives. Each of these assertions are made solely on the basis of Petitioner’s expert testimony, and as such are not persuasive. Pet. 61–62 (citing Ex. 1003 ¶¶ 1046). Petitioner’s argument that Zhang teaches capturing a second image at a second distance simply lacks sufficient support from Zhang’s disclosure.” slip op. at 25

    Patent outcomesUS 11,874,910 not shown unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,874,910
  • Jumio Corp. v. Facetec, Inc.No claims unpatentable
    PTAB · Jun 17, 2026 · IPR2025-00108 · APJ Nabeel U Khan · IPR · Final written decision

    Claims 1–24 were not shown unpatentable because the asserted combinations lacked adequate motivation to combine and did not teach capturing images at different distances.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner argues Petitioner’s proffered level of skill is too broad with respect to work experience. PO Resp. 27–28. Patent Owner counters that a person having ordinary skill in the art would have had a Bachelor’s degree in electrical engineering, computer engineering, computer science, physics, or a related field, and two years’ work experience related to biometric security, facial authentication, and three-dimensional computer vision such that they would have had significant academic and/or work experience in both facial biometrics and computer vision. Id. at 28–29. Having considered the full record at trial, we maintain the preliminary finding regarding the level of ordinary skill in the art. See Inst. Dec. 13–14. In particular, based on the teachings of the ’938 patent and the asserted prior art, we are persuaded that an ordinarily skilled artisan would have had a work experience related to biometrics, facial authentication, computer vision, and/or optics as at least one of those fields is respectively implicated by the ’938 patent and the asserted prior at. Moreover, our decision would be the same under either proposed level of skill.” slip op. at 9

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

      “C. Claim Construction We interpret claim terms using “the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b). Under the principles set forth by the Federal Circuit, the “words of a claim ‘are generally given their ordinary and customary meaning,’” as would be understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). The parties do not dispute any claim terms or phrases and our decision does not require construing any particular claim terms or phrases, therefore, we do not expressly construe any particular claim term or phrase. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we 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 10

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable

      “images are three dimensional—let alone a technique that captures two images at different distances, compares the images for certain differences, and verifies three dimensionality based on those differences, as recited by the claim. Instead, Tanii describes a system that “corrects warp in which the perspective is exaggerated when an image is captured with the user’s face at close range.” Ex. 1007, code (57). In particular, Tanii recognizes the physical phenomenon of perspective distortion (fish-eye distortion) where “[i]f the image of the face of a person or the like is captured from a point that is relatively nearby, an image is obtained in which the perspective appears exaggerated,” i.e., the user image is warped or distorted. Id. ¶ 6; see id. ¶ 48, Fig. 4B. Tanii corrects such warped images by enlarging peripheral areas of the user image. Id. ¶¶ 55–56.” slip op. at 17

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

      “distance from the user. Derakhshani teaches two different approaches: (1) focus-distance approach and (2) parallax approach. Petitioner acknowledges that the focus-distance approach does not expressly disclose capturing a second image at a second distance. Pet. 12 (distinguishing “focus distances” from “actual distances.”). This is because focus-distance, by definition, is not actual distance. Ex. 1005, 16:47–48 (“Focus distance is the distance from a sensor to a point in its field of view that is perfectly in focus.”) In Derakhshani’s focus-distance approach the camera stays the same distance from its subject—only the focus distance changes. Id. at 16:66–17:2 (“By comparing degree of focus for a landmark in images with different focus distances, the distance from the sensor to the landmark may be estimated.”) Derakhshani’s parallax approach also does not expressly disclose capturing a second image at a second distance. In the parallax approach the camera is rotated or slid about the user to create images with different perspectives. Derakhshani, 17:59–64 (“In some implementations, the sensor is moved about the subject during image capture to collect image data from different orientations relative to the subject. For example, a single camera may be rotated or slid slightly or multiple cameras at different positions may be used for image capture.”). Rotating a camera around a user does not change the distance of the camera from the user. At the hearing Petitioner, instead, focused specifically on the use of the word “slid” in Derakhshani as indicating that Derakhshani takes a second image at a second distance. Tr. 16:9–12 (“[Petitioner’s Counsel: . . . Dr. Daft is talking about some of the terms that Derakhshani is using. For example, the term slid and shown in the images, he talks about how slid refers to the different distances between the sensor and the user.”). We determine that it is more likely that the word “slid,” as used in the relevant portion of Derakhshani, further describes the rotation of the camera about the user. Derakhshani indicates as much by describing that both rotating and sliding the camera are examples of how the camera sensor is “moved about the subject during image capture.” Derakhshani, 17:60–61. Thus, sliding the camera does not necessarily disclose moving the camera to a second distance from the subject.” slip op. at 27

    Patent outcomesUS 11,693,938 not shown unpatentable
    Claim construction§ 103 obviousnesscites KSR
    Patents in suitUS 11,693,938
  • PTAB · Jun 17, 2026 · IPR2025-00107 · APJ Bach V Hoang · IPR · Final written decision

    Claims 1–20 were not determined unpatentable because the petition did not establish motivation to combine the references or that they taught capturing images at different distances.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for patent owner

      “Patent Owner argues Petitioner’s proffered level of skill is too broad with respect to work experience. PO Resp. 27–28. Patent Owner counters that a person having ordinary skill in the art would have had a Bachelor’s degree in electrical engineering, computer engineering, computer science, physics, or a related field, and two years’ work experience related to biometric security, facial authentication, and three-dimensional computer vision such that they would have had significant academic and/or work experience in both facial biometrics and computer vision. Id. at 28–29. Having considered the full record at trial, we maintain the preliminary finding regarding the level of ordinary skill in the art. See Inst. Dec. 8. In particular, based on the teachings of the ’606 Patent and the asserted prior art, we are persuaded that an ordinarily skilled artisan would have had a work experience related to biometrics, facial authentication, computer vision, and/or optics as at least one of those fields is respectively implicated by the ’606 Patent and the asserted prior at. Moreover, our decision would be the same under either proposed level of skill.” slip op. at 9

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

      “The parties do not dispute any claim terms or phrases and our decision does not require construing any particular claim terms or phrases, therefore, we do not expressly construe any particular claim term or phrase. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we 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 10

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable

      “We find that these reasons would not have adequately motivated a person having ordinary skill in the art to combine and modify the references in Petitioner’s asserted manner to reach the claimed features. Petitioner’s motivations—“substitution,” “obvious alternative . . . approaches,” “use of a known technique,” and “complimentary” techniques—are all similarly based on swapping or adding techniques for verifying three dimensionality. See Pet. 12–16; Pet. Reply 6–7. These motivations might have been suitable had Tanii described techniques for verifying three dimensionality, but Petitioner has not shown that Tanii describes any technique to verify three dimensionality. See Pet. 12–16, 19–23. Instead, as discussed above, Tanii describes the existence of the perspective distortion phenomenon and a technique for correcting it. As such, substituting the knowledge that perspective distortion exists and techniques to correct it does not correspond with approaches for verifying three-dimensionality, and so does not adequately motivate Petitioner’s combination. Put another way, because Tanii does not teach an approach for verifying three-dimensionality, Tanii’s techniques cannot be used as a substitute for approaches that do verify three dimensionality simply because Tanii discloses the concept of perspective distortion.” slip op. at 16

    • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia with nexusObjective indicia outweighedDecided for patent owner

      “Patent Owner has demonstrated a nexus by showing that certain objective indicia, discussed below, are the direct result of the unique characteristics of the claimed invention. As discussed above in our summary of the ’606 Patent and reflected in our discussion of Petitioner’s obviousness challenges (see §§ I.F, II.E.1, II.E.2, II.E.3), the unique characteristics of the claim relate to verification of three dimensionality by comparing two images taken at different distances for perspective distortion. Indeed, those features are what distinguish over the prior art. See id. Furthermore, Patent Owner, supported by testimony from its Chief Technology Officer, Mr. Rose, asserts the unique characteristics claimed are reflected in the “3D liveness checks” its ZoOm software product provides because ZoOm “confirms that a user is 3D by comparing images taken at different distances for expected differences in biometric data, such as the presence of appropriate perspective distortion and differences.” PO Resp. 25 (citing Ex. 2059 ¶ 49). Patent Owner’s assertion is further supported by a “FaceTec Software Explanation” stating that its software uses “near & far image data . . . to determine if the expected differences in perspective distortion are present in the image data” and, from that, “decides if there is sufficient evidence in the image data to conclude with a high degree [of] confidence that the image data contains first-generation biometric data captured in real-time from a live, physically present user.” Ex. 2067; see PO Resp. 25–26. As such, the 3D liveness checks provided by Patent Owner’s software are indicative of the unique characteristics of the claimed invention and, as we discuss below, certain objective indicia of nonobviousness have a direct nexus to the 3D liveness checks of its software.” slip op. at 30

    Patent outcomesUS 11,157,606 not shown unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,157,606
  • Jumio Corp. v. Facetec, Inc.No claims unpatentable
    PTAB · Jun 17, 2026 · IPR2025-00106 · APJ Nabeel U Khan · IPR · Final written decision

    The Board determined claims 1–20 were not unpatentable because Jumio did not show sufficient motivation to combine the references or that they taught capturing images at different distances.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner argues Petitioner’s proffered level of skill is too broad with respect to work experience. PO Resp. 28. Patent Owner counters that a person having ordinary skill in the art would have had a Bachelor’s degree in electrical engineering, computer engineering, computer science, physics, or a related field, and two years’ work experience related to biometric security, facial authentication, and three-dimensional computer vision such that they would have had significant academic and/or work experience in both facial biometrics and computer vision. Id. at 28–29. Having considered the full record at trial, we maintain the preliminary finding regarding the level of ordinary skill in the art. See Inst. Dec. 11–12. In particular, based on the teachings of the ’471 patent and the asserted prior art, we are persuaded that an ordinarily skilled artisan would have had a work experience related to biometrics, facial authentication, computer vision, and/or optics as at least one of those fields is respectively implicated by the ’471 patent and the asserted prior at. Moreover, our decision would be the same under either proposed level of skill.” slip op. at 10

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

      “that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b). Under the principles set forth by the Federal Circuit, the “words of a claim ‘are generally given their ordinary and customary meaning,’” as would be understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). The parties do not dispute any claim terms or phrases and our decision does not require construing any particular claim terms or phrases, therefore, we do not expressly construe any particular claim term or phrase. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we 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 10

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable

      “We find that these reasons would not have adequately motivated a person having ordinary skill in the art to combine and modify the references in Petitioner’s asserted manner to reach the claimed features. Petitioner’s motivations—“substitution,” “obvious alternative . . . approaches,” “use of a known technique,” and “complimentary” techniques—are all similarly based on swapping or adding techniques for verifying three dimensionality. See Pet. 12–16; Pet. Reply 6–7. These motivations might have been suitable had Tanii described techniques for verifying three dimensionality, but Petitioner has not shown that Tanii describes any technique to verify three dimensionality. See Pet. 13–17, 25–28. Instead, as discussed above, Tanii describes the existence of the perspective distortion phenomenon and a technique for correcting it. As such, substituting the knowledge that perspective distortion exists and techniques to correct it does not correspond with approaches for verifying three-dimensionality, and so does not adequately motivate Petitioner’s combination. Put another way, because Tanii does not teach an approach for verifying three-dimensionality, Tanii’s techniques cannot be used as a substitute for approaches that do verify three dimensionality simply because Tanii discloses the concept of perspective distortion.” slip op. at 18

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

      “none of the relied upon references teach capturing two images at two different distances, as required by limitations 1[d3] and 1[d4]. These limitations recite “moving the camera from a first location to a second location, the second location being a second distance from the user” and “capturing at least one second image of the user taken with the camera of the computing device at the second distance from the user, the second distance being different than the first distance.” Derakhshani does not teach capturing a second image at a second distance from the user. Derakhshani teaches two different approaches: (1) focus-distance approach and (2) parallax approach. Petitioner acknowledges that the focus-distance approach does not expressly disclose capturing a second image at a second distance. Pet. 13 (distinguishing “focus distances” from “actual distances.”). This is because focus-distance, by definition, is not actual distance. Ex. 1005, 16:47–48 (“Focus distance is the distance from a sensor to a point in its field of view that is perfectly in focus.”) In Derakhshani’s focus-distance approach the camera stays the same distance from its subject—only the focus distance changes. Id. at 16:66–17:2 (“By comparing degree of focus for a landmark in images with different focus distances, the distance from the sensor to the landmark may be estimated.”) Derakhshani’s parallax approach also does not expressly disclose capturing a second image at a second distance. In the parallax approach the camera is rotated or slid about the user to create images with different perspectives. Ex. 1005, 17:59–64 (“In some implementations, the sensor is moved about the subject during image capture to collect image data from different orientations relative to the subject. For example, a single camera may be rotated or slid slightly or multiple cameras at different positions may be used for image capture.”). Rotating a camera around a user does not change the distance of the camera from the user. At the hearing Petitioner, instead, focused specifically on the use of the word “slid” in Derakhshani as indicating that Derakhshani takes a second image at a second distance. Tr. 16:9–12 (“[Petitioner’s Counsel: . . . Dr. Daft is talking about some of the terms that Derakhshani is using. For example, the term slid and shown in the images, he talks about how slid refers to the different distances between the sensor and the user.”). We determine that it is more likely that the word “slid,” as used in the relevant portion of Derakhshani, further describes the rotation of the camera about the user. Derakhshani indicates as much by describing that both rotating and sliding the camera are examples of how the camera sensor is “moved about the subject during image capture.” Derakhshani, 17:60–61. Thus, sliding the camera does not necessarily disclose moving the camera to a second distance from the subject.” slip op. at 27

    Patent outcomesUS 10,776,471 not shown unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,776,471
  • PTAB · May 13, 2026 · IPR2025-01082 · APJ David C Mckone · IPR · Adverse judgment

    The Board granted Patent Owner’s request for adverse judgment after it disclaimed the entire patent term, entering judgment against claims 1–10.

    RulingsAdverse judgment
    • Adverse judgmentAdverse judgmentGranted

      “A party may request entry of adverse judgment against itself at any time during an inter partes review proceeding. See 37 C.F.R. § 42.73(b). In addition, “[a]ctions construed to be a request for adverse judgment include: (1) Disclaimer of the involved application or patent; [and] (2) Cancellation or disclaimer of a claim such that the party has no remaining claim in the trial.” Id. Because Patent Owner has explicitly requested adverse judgment against itself pursuant to Rule 42.73(b), and has disclaimed the entire term of the ’181 patent, Patent Owner’s request for adverse judgment is granted.” slip op. at 3

    None
    Patents in suitUS 6,888,181
  • PTAB · Jan 22, 2026 · IPR2024-01094 · APJ Grace Karaffa Obermann · IPR · Final written decision

    Claims 1, 2, 6, and 8–14 are unpatentable as obvious over Ma; claims 3 and 4 were not shown unpatentable over Werner.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends: A person of ordinary skill in the art (“POSA”) at the time of the alleged invention of the ’223 patent would have had a university degree in chemistry and additional expertise or a second university degree in the field of electrical engineering, particularly optoelectronics, or alternatively a university degree in electrical engineering and additional expertise or a second university degree in the field of chemistry. The person of ordinary skill in the art has spent several years studying the structure and function of organic optoelectronic components, in particular OLEDs, and has detailed knowledge of the chemical structure of light-emitting organic layers and the transport of charge carriers to these layers. In this respect, the person of ordinary skill in the art works at the interface between electrical engineering/physics (charge carrier transport and light emission processes in optoelectronic components) and chemistry, in particular organic chemistry (materials and layer stack combinations suitable). Pet. 14 (citing Ex. 1003 ¶¶ 46–47). Patent Owner does not dispute Petitioner’s contention. See generally Resp. Neither party indicates that the result would change depending on the definition selected. We adopt Petitioner’s uncontested proposed definition, because it is consistent with the disclosures of the asserted prior art references. See Ex. 1005, (code 57); Ex. 1007, 8107 (abstracts of the references asserted in the patentability challenges).” slip op. at 8

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

      “history pertaining to the patent.” 37 C.F.R. § 42.100(b). Under that standard, claim terms generally are given their plain and ordinary meaning as would have been understood by the ordinarily skilled artisan at the time of the invention and within the context of the entire patent disclosure. See Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). We construe claim terms only as relevant to the parties’ contentions and only to the extent necessary to resolve the issues in dispute. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017). Neither party indicates that an express construction for any claim term is necessary to resolve the disputes at hand. Pet. 15; see generally Resp. On this record, we determine that no claim term requires express construction for purposes of this Decision. In our analysis of the challenges, however, we discuss the meaning of the terms “metal complex” and “central metal atom,” which appear in claim 1 (Ex. 1001, 19:19–20) to the extent necessary to resolve Patent Owner’s contention that Petitioner fails to establish that Ma invalidates claim 1. See Resp. 53, 56–58.” slip op. at 9

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

      “Whether Ma qualifies as a “printed publication” involves an inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public. In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). A reference is considered “publicly accessible” upon a satisfactory showing that the document has been “disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence[] can locate it.” Kyocera Wireless Corp. v. ITC, 545 F.3d 1340, 1350 (Fed. Cir. 2008); see Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29, 10– 11 (PTAB Dec. 20, 2019) (precedential).” slip op. at 10

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable

      “Based on the information presented, we find Petitioner has the better position. Patent Owner admits that joint vaporization means “two materials vaporize together.” Reply 21 (quoting Resp. 54). As Petitioner argues, “This is what Ma discloses.” Id. We agree with Petitioner that Ma describes a “two-component” electron transport layer having a “thickness with one value.” Id.; see Ex. 1007, 811 (reporting a “co-deposited” application of “BPhen:LiQ” that is “50 nm thick”). Ma’s disclosure, thereby, strongly “indicates that the two components were vaporized together––as opposed to creating a ‘macroscopically homogenous form’” prepared by sequentially vaporizing the individual components as Patent Owner “hypothesizes.” Reply 21 (citing Ex. 1020 ¶¶ 42–44; Ex. 2041 ¶¶ 155–157); see Resp. 54– 55; see also Ex. 1007, 811 (Ma’s description of its device fabrication, appearing in the third paragraph of the experiments section). Petitioner further advances evidence that “[p]reparing a layer that is ‘macroscopically homogeneous’ but potentially microscopically heterogeneous,” as Patent Owner postulates, “would introduce excessive variability and render the data noncomparable and unreliable, thus undermining the experiment’s purpose.” Reply 21 (citing Ex. 1020 ¶ 44); see Resp. 54–55. Patent Owner presents no counterargument or evidence that is persuasive to undercut Petitioner’s reasoning or evidence on that point. See Sur-reply 19–22. Petitioner also argues that an ordinarily skilled artisan would have recognized “that vaporizing materials together would best achieve Ma’s objective of assessing the current density using different Liq doping percentages.” Reply 22 (citing Ex. 1007, 811; Ex. 1020 ¶ 51). Here again, Petitioner’s evidence on point stands uncontested. See Sur-reply 19–22 (declining to contest that point). On this record, therefore, we agree with Petitioner that, as to the relevant disclosure in Ma, “the most natural interpretation of ‘co-deposition’ for forming a layer, particularly when there is nothing to indicate that the materials” are “vaporized sequentially,” is that the materials are co-deposited by joint vaporization. Reply 22 (citing Ex. 1020 ¶ 46–51). We further agree that, “[u]nder a preponderance standard, Ma’s disclosures are sufficient to render joint vaporization at least obvious.” Id. For the above reasons, we determine that Petitioner demonstrates by a preponderance of the evidence that Ma discloses joint vaporization as required by the challenged claims.” slip op. at 15

    Patent outcomesUS 8,558,223 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
    Patents in suitUS 8,558,223
  • PTAB · 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 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,643,462
  • PTAB · Nov 4, 2025 · IPR2024-00624 · APJ Sheridan K Snedden · IPR · Final written decision

    Claims 1–4, 6–10, and 12–15 are unpatentable, principally because the MSI-H Study Record anticipates them.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for petitioner

      “Pet. 12 (citing Ex. 1003 ¶ 19). To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. PO Resp. 6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Thus, Petitioner and Patent Owner characterize one of ordinary skill in the art differently. Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects.” slip op. at 8

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

      “The parties do not assert constructions of any terms recited in the challenged claims other than that their ordinary and customary meanings should apply. Pet. 11–12; PO Resp. 6. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. 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)). We construe” slip op. at 7

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

      “record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’975 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not inherently anticipate where it failed to mention specific vitamin deficiencies, instead merely inviting further experimentation to find associations with metabolic perturbations). requirement, efficacy is inherent in carrying out the claim steps,” referring to a claimed method of treating or preventing stroke, which was held to be anticipated by the publication of a proposed study. 677 F.3d at 1381. Patent Owner attempts to distinguish the size and apparent surety of the study in Montgomery from the MSR. PO Resp. 15. But because we find that the MSR teaches performing the steps recited in claim 1 for the purpose of determining and treating MSI-H cancer, we are persuaded that the MSR inherently discloses the results of selection of patients and administration of the drug treatment recited in those steps. See Bristol-Myers, 246 F.3d at 1376. Whether or not the MSR could have provided results or was sufficient for full regulatory approval does not change that the MSR teaches Patent Owner’s claimed steps. We have no reason to doubt that the disclosure in the MSR of the steps recited in claim 1 produces the efficacy element required in claim 1, whether or not this efficacy was disclosed in the MSR or was known when it was published. See Mehl/Biophile, 192 F.3d at 1366 (“Where, as here, the result is a necessary consequence of what was deliberately intended, it is of no import that the article’s authors did not appreciate the results.”).” slip op. at 21

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

      “use that does not qualify as prior art. PO Resp. 18–25. Patent Owner argues that an inventor can be granted latitude to experiment in the public eye until her invention is ready for patenting. Id. at 18 (citing Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 64 (1998). According to Patent Owner, the experimental use negation applies to the MSR under a 13-factor analysis provided in Allen Engineering Corp. v. Bartell Industries, Inc., 299 F.3d 1336, 1353 (Fed. Cir. 2002). PO Resp. 19–25. For example, Patent Owner argues that to establish that treatment of MSI-H cancers was effective, the inventors had to test treatment in humans, there being no animal models, and had to publish the MSR on the government website under federal law. Id. at 20–22. Patent Owner argues further that the inventors had control over the MSI-H clinical study and that the field of cancer treatment was highly unpredictable, among other facts. Id. at 21. Patent Owner argues that “[a]t the time of the MSR’s posting, the claimed invention was not, nor could it have been, ready for patenting. The clinical study that ultimately collected the data reported in the patent specification and supporting the patent claims had not and could not have commenced before the MSR was posted.” Id. at 23. sometimes said that an inventor acquires an undue advantage over the public by delaying to take out a patent, inasmuch as he thereby preserves the monopoly to himself for a longer period than is allowed by the policy of the law,” but held that “when the delay is occasioned by a bona fide effort to bring his invention to perfection, or to ascertain whether it will answer the purpose intended,” the experiment use exception can preserve the inventor’s rights. City of Elizabeth v. Am. Nicholson Pavement Co., 97 U.S. 126, 137 (1877). Because we are not persuaded that Patent Owner could not have filed an earlier application, we are not persuaded that the experimental use doctrine is properly applied in this case. Given that clinical trial protocols published on the ClinicalTrials.gov website have been successfully asserted as prior art in other cases, we are not persuaded by Patent Owner’s arguments that the MSR is not available as prior art against the challenged claims. See, e.g., Salix Pharms., Ltd. v. Norwich Pharms. Inc., 98 F.4th 1056, 1061 (Fed. Cir.), cert. denied, 145 S. Ct. 567 (2024), and cert. denied, 145 S. Ct. 983 (2024).” slip op. at 24

    Patent outcomesUS 11,325,975 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,325,975
  • PTAB · Oct 28, 2025 · IPR2024-00622 · APJ Sheridan K Snedden · IPR · Final written decision

    Claims 1–28 are unpatentable: claims 1, 6–11, 13–20, 22–24, and 26–28 as anticipated by the MSI-H Study Record; claims 2–5, 12, 21, and 25 as obvious.

    RulingsFinal written decision
    • BurdenUnpatentable

      “(“the claimed process here is not directed to a new use; it is the same use, and it consists of the same steps as described by [the prior art]. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). After analysis of the full record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’356 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not” slip op. at 22

    • Skill levelSkill level board ownDecided for petitioner

      “Petitioner and Patent Owner characterize one of ordinary skill in the art differently. To Petitioner, the ordinarily skilled artisan would have been a medical doctor, or a professional in a related field, with experience treating cancer or access to those with experience in clinical studies of therapeutics and to a pathologist with this experience. Pet. 11 (citing Ex. 1003 ¶ 19). To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. PO Resp. 5–6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects. The ’356 patent claims a method of treating a human patient with cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner, MSR, discloses testing Ex. 1005. Accordingly, the relevant field of Patent Owner’s claims is treating human patients for cancer, as well as testing existing compounds for use in treatment modalities. 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 ’356 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

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

      “The parties do not assert constructions of any terms recited in the challenged claims other than that their ordinary and customary meanings should apply. Pet. 10–11; PO Resp. 6. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. 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)). We construe claims “in accordance with the ordinary and customary meaning of such history pertaining to the patent.” 37 C.F.R. § 42.100(b) (2020).” slip op. at 8

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundUnpatentable

      “(“the claimed process here is not directed to a new use; it is the same use, and it consists of the same steps as described by [the prior art]. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). After analysis of the full record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’356 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not” slip op. at 22

    Patent outcomesUS 10,934,356 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,934,356
  • PTAB · Sep 23, 2025 · IPR2024-00649 · APJ Sheridan K Snedden · IPR · Final written decision

    Claims 1–28 are unpatentable: claims 1, 2, 4–7, 9–12, 14–17, and 19–28 are anticipated by the MSI-H Study Record; claims 3, 8, 13, and 18 are obvious.

    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 9

    • Skill levelSkill level board ownOther

      “In the Decision to institute trial, we adopted Petitioner’s uncontested proposal defining that the level of skill in the art, presented above. Inst. Dec. 7. Neither party directs us to evidence of the level of skill in the art beyond what we considered for institution of trial. Having considered Patent Owner’s positions and evidence of record, however, we determine that the level of skill also 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 cancers and the associated conditions and immunotherapy.” slip op. at 15

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

      “holding is limited to anticipation of a claimed genus through disclosure of individual species, whereas the facts of this case involve the disclosure of a genus. PO Resp. 14. Because the facts before us, including the testimony of Patent Owner’s witness, indicate that one of ordinary skill in the art would have immediately understood that the third arm of the study described in the MSR includes patients with cancers recited in claim 1, including endometrial, gastric, and small-bowel cancers, we are persuaded that one of ordinary skill in the art would have understood that the MSR discloses species that fall within the scope of claim 1. Ex. 2090 ¶ 79; Ex. 1243, 115:5–116:22; Ex. 1085, 673–75; Ex. 1086, 14; Ex. 1003 ¶¶ 25, 63; Ex. 1005, 4. We are not persuaded that where species falling within the scope of claim 1 were previously known and disclosed in MSR, that claim 1 is patentable over the MSR. See Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (“a reference can anticipate a claim even if it ‘d[oes] not expressly spell out’ all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’” the claimed arrangement or combination.” (quoting In re Petering, 301 F.2d 676, 681 (CCPA 1962)). After considering the parties’ arguments and the evidence presented, we are persuaded that the MSR teaches “testing or having tested a biological sample obtained from a patient” having endometrial, small bowel, or gastric cancer and, thus teaches the corresponding limitation of claim 1.6” slip op. at 29

    • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

      “Regarding the dependent claims that Petitioner challenges only on obviousness grounds (claims 3, 8, 13, 18), Patent Owner must show a nexus between the claimed methods and the evidence of non-obviousness. See Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019) (“to be accorded substantial weight in the obviousness analysis, the evidence of secondary considerations must have a ‘nexus’ to the claims, i.e., there must be ‘a legally and factually sufficient connection’ between the evidence and the patented invention. . . . Ultimately, ‘[t]he patentee bears the burden of showing that a nexus exists.’” (quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988), WMS Gaming, Inc. v. Int'l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999)). Patent Owner does not direct us to evidence of a nexus to limitations recited in the dependent claims, for example to claims 3 and 13, which recite testing a biological sample that is a bodily fluid, claims 8 and 18, which recite testing that comprises assessing one or more markers selected from the group consisting of BAT-25, BAT-26, MONO-27, NR-21 and NR-24. Even if there is a nexus to the Patent Owner’s evidence of secondary considerations, the evidence addresses the methods of independent claims 1 and 11, not the limitations of the claims Petitioner challenges as being obvious. PO Resp. 55–83. Patent Owner directs us only to evidence regarding treating patients determined to have certain MSI-H cancers with pembrolizumab, which we determine to be anticipated by the MSR. Id. at 58. When evidence of a “secondary consideration is exclusively related to a single feature that is in the prior art,” our reviewing court has held the evidence is of no relevance to the obviousness inquiry. See Yita LLC v. MacNeil IP LLC, 69 F.4th 1356, 1363–65 (Fed. Cir. 2023), cert. denied, 144 S. Ct. 499 (2023) (distinguishing WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1330–31 (Fed. Cir. 2016)); see also Ethicon Endo-Surgery, Inc. v. Covidien LP, 812 F.3d 1023, 1034 (Fed. Cir. 2016) (“[I]f the feature that creates the commercial success was known in the prior art, the success is not pertinent.”). In Yita, the prior art taught close-conformance of a floor tray with the walls of a vehicle foot well, which one of ordinary skill in the art would have had reason to use in combination with other prior-art teachings to arrive at the claimed invention. See Yita, 69 F.4th at 1359–61. The court held that because the asserted evidence of secondary consideration related exclusively to close-conformity, the evidence was not persuasive of non-obviousness, even though the claimed floor tray was coextensive with the product that produced the evidence. See id. at 1364–65 (“The coextensiveness inquiry bears only on the presumption of nexus; it does not decide the overall nexus question.”). Because Patent Owner directs us only to evidence that the methods recited in claims 1 and 11 produced evidence of secondary considerations, we are not persuaded that this evidence is persuasive of the non-obviousness of the specific methods recited in the dependent claims. For example, Patent Owner fails to direct us to evidence that a method of treating MSI-H colorectal cancer in a patient “wherein the biological sample is a body fluid from the patient,” as recited in claim 3, or “wherein the at least one marker comprises BAT-25, BAT-26, MONO-27, NR-21 or NR-24,” as recited in claim 8, demonstrated unexpected results or commercial success. Accordingly, having considered the evidence of record as a whole, we determine that Petitioner has demonstrated by a preponderance of the evidence that the methods of claims 3, 8, 13, and 18 would have been obvious. We are not persuaded to the contrary by Patent Owner’s arguments or evidence of second secondary considerations.” slip op. at 47

    Patent outcomesUS 11,629,187 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,629,187
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