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  • PTAB · Nov 21, 2025 · IPR2024-00810 · APJ Neil T Powell · IPR · Final written decision

    Claims 1–18 are unpatentable: claims 1–6 and 10–12 over Rosenberg and Park, and claims 3, 4, 7–9, and 11–18 over Rosenberg, Park, and Geisner.

    RulingsFinal written decision
    • Prior constructionPrior construction adoptedDecided for patent owner

      “Turning to the substantive issues, we find the District Court’s “mirror tracking mode” construction to be well-reasoned and supported by the record, and we therefore adopt that construction and its reasoning. As the District Court points out, both the “double the distance” and “same size” aspects of its construction are expressly discussed in the ’109 patent, which is incorporated in the ’110 patent. See Ex. 2008, 16 (citing Ex. 1021, 2:5–27, Figs. 5A, 5B), 40 (citing “same reasons set forth regarding the term ‘it appears to mimic a reflection of a mirror’” in support of construction of “mirror tracking mode”). So, too, is “flipping” or reversing of the image disclosed. Id. at 17 (citing Ex. 1021, 14:46–51, 15:41–47), 40.” slip op. at 14

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

      “persuasively address limitation 1[f]’s “mirror tracking mode.” In particular, Petitioner does not address persuasively the requirement, as explained in Section II.B above, that mirror tracking mode involves processing camera-captured images in a way that “maintains roughly the same size regardless of the user movement.” At odds with this requirement, Petitioner founds its case on an assertion that “Haan teaches the claimed mirror tracking mode” because “if the viewer is within 35 cm of the camera, a tracking mode is entered, applying resizing transformation.” Pet. 44 (emphasis added) (citing Ex. 1005 ¶¶ 75–76, 80–82, 90–94, 97; Ex. 1003 ¶¶ 205–210). The resizing transformation Petitioner references actually involves magnifying the user’s image by an amount that changes based on the user’s position relative to the camera, quite the opposite of maintaining image size regardless of the user movement. Ex. 1005 ¶¶ 75–76, Fig. 8. Thus, Petitioner’s initial position is unpersuasive. Petitioner’s shift to Haan’s “reflective mirror mode and conventional mirror period in the dual mode” is also unavailing. Reply 8. Consistent with Patent Owner’s arguments, Petitioner does not provide persuasive evidence that these operating states of Haan’s device involve any processing of camera-captured images. Sur-reply 13–14. To the contrary, Haan suggests that anytime its device provides an unmagnified image, it comes from a reflection off a physical reflective surface. See, e.g., Ex.1005 ¶ 76 (“This can be done for instance by using the device as a simple mirror, i.e. not displaying an image on the display device, but using the device in the reflective mode.”) (emphasis added), ¶ 92 (“a simple reflective mode, to act as a mirror”), ¶ 29 (“for a first range of positions, no image is displayed, whereby the reflective layer acts as a mirror, and for a second range of positions, the recorded image is displayed.”) (emphasis added). We also find unpersuasive Petitioner’s Reply arguments based on Haan’s disclosure of smoothly transitioning from “using the device as a simple mirror” (i.e., using a physical reflecting surface) to displaying a magnified image. Reply 11 (citing Ex. 1005 ¶¶ 76, 80). To the extent this may establish a point around the transition at which Haan’s system displays an image with relatively little magnification, it does not establish that Haan teaches, suggests, or renders obvious holding the displayed size roughly constant, “regardless of the user movement.” Indeed, given Haan’s focus on helping the user see things more clearly with image magnification, Petitioner’s argument that it would have been obvious to hold the size of the image constant is not persuasive. See, e.g., Ex. 1005 ¶ 4. Thus, on the whole, Petitioner’s shifting, scattered arguments do not persuasively address limitation 1[f]. Accordingly, Petitioner has not shown by a preponderance of the evidence that claim 1 would have been obvious over Haan and Francois. And Petitioner’s arguments and evidence addressing claims 2–6, 10–12, 16, and 17 do not cure the foregoing deficiencies in the challenge of claim 1. Pet. 46–52. Accordingly, Petitioner has not shown by a preponderance of the evidence that any of claims 1–6, 10–12, 16, and 17 would have been obvious over Haan and Francois.” slip op. at 23

    • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

      “We do not agree. Petitioner demonstrates persuasively that a person of ordinary skill would have combined these references “to correct image distortions and provide a more realistic mirror image.” Pet. 52–55; Ex. 1003 ¶¶ 242–249. We are not persuaded by Patent Owner that by specifically disclosing “flipping” the image, Rosenberg is discouraging or teaching away from performing other transformations to achieve its objective of “replicat[ing] the performance of a standard household mirror.” See PO Resp. 35, 38–39 (Patent Owner asserting lack of motivation to combine the references). A reference may be said to “teach away” “when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.” Galderma Lab'ys, L.P. v. Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013) (quoting DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed.Cir.2009)). “A reference does not teach away, however, if it merely expresses a general preference for an alternative invention but does not criticize, discredit, or otherwise discourage investigation into the invention claimed.” Id. Further, when conducting an obviousness analysis, the Board must consider a prior art reference “not only for what it expressly teaches, but also for what it fairly suggests.” Bradium Techs. LLC v. Iancu, 923 F.3d 1032, 1049 (Fed. Cir. 2019) (quoting In re Baird, 16 F.3d 380, 383 (Fed. Cir. 1994)). We are not convinced that the references before us “teach away” from performing the other transformations. In sum, we find for the reasons given that Petitioner has demonstrated by a preponderance of evidence that to a person of ordinary skill, Rosenberg alone or with Park teaches or suggests limitation 1[f].” slip op. at 44

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

      “shows by a preponderance of the evidence that limitations 1[c] and 1[e] are taught or suggested by Rosenberg and Park, in combination. Pet. 58–64; PO Resp. 39–40; Reply 19–20; Sur-reply 19. Petitioner persuades us that limitations 1[c] and 1[e], would have been obvious over Rosenberg and Park, in combination. Pet. 58–64; Reply 19–20. Patent Owner’s counter arguments are unavailing for multiple reasons. Patent Owner’s arguments fail because they improperly attack Rosenberg’s teachings individually, rather than addressing Petitioner’s combination of the references. PO Resp. 39–40; Sur-reply 19. This is fatal to Patent Owner’s arguments. In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Moreover, Petitioner presents persuasive arguments and evidence that the references, in combination, teach limitations 1[c] and 1[e], including persuasive evidence that the references’ tilting, resizing, and zooming meet the claim limitations’ “adaptive transformation mapping . . . to generate modified images that appear to be captured from a different point of view” that “corresponds to an image taken from a different angle and a different distance.” Pet. 58–64 (citing Ex. 1001, 3:26–28; Ex. 1003 ¶¶ 65–67, 253–268; Ex. 1006 ¶¶ 26–28, 50, 52, 61, 75 ; Ex. 1011 ¶¶ 50–51, 59, Figs. 6A–6B, 7, 8, 14, 15; Ex. 1019, 16–20; Ex. 1021, 2:19–27, 17:19–24, 21:60, 23:65–24:9, 25:46–48, 30:4–11, Fig. 11); Reply 19–20 (citing Ex. 1003 ¶¶ 253–268; Ex. 1021, 17:17–23; Ex. 2012, 63:13–22, 111:13–21). Regarding tilting, after noting the ’110 patent’s disclosure (incorporated from the ’109 patent) of performing tilt transformations (Pet. 10–11), Petitioner advances persuasive evidence that Park discloses such a tilting transformation, thereby teaching the claimed “different angle” (id. at 61–63). Regarding resizing and zooming, citing extensive discussion in the ’110 patent (incorporated from the ’109 patent) of resizing and/or zooming to address the effects of varying distance between an object and a camera, Petitioner and Dr. Karam explain that the prior art’s zooming and resizing meet the claimed “different distance.” Pet. 63 (Ex. 1001, 3:26–28; Ex. 1021, 17:19–23, 21:57–60, 23:65–24:9, 25:46–48, 30:4–11, Fig. 11); Ex. 1003 ¶ 265 (citing Ex. 1001, 3:26–28; Ex. 1021, 17:19–23, 21:57–60, 23:65–24:9, 25:46–48, 30:4–11, Fig. 11). In its counterarguments, Patent Owner suggests that zooming and resizing do not account for “occlusion effects,” but Patent Owner does not persuasively tie this argument to the ’110 patent, failing to cite any portion of the ’110 patent that evinces its invention addresses such effects. PO Resp. 23–25, 39–40.” slip op. at 39

    Patent outcomesUS 8,982,110 unpatentable
    Claim construction§ 103 obviousnesscites Phillips
    Patents in suitUS 8,982,110
  • 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
  • PTAB · Sep 23, 2025 · IPR2024-00647 · APJ Sheridan K Snedden · IPR · Final written decision

    Claims 1–36 are unpatentable: claims 1–2, 4–8, 11–12, 14–18, and 21–36 as anticipated, and claims 3, 9, 10, 13, 19, and 20 as obvious.

    RulingsFinal written decision
    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided 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 colorectal cancer to determine that the patient’s colorectal cancer is microsatellite instability high or mismatch repair deficient, and 2) treating the patient with a therapeutically effective amount of pembrolizumab if the patient’s colorectal cancer is determined to be microsatellite instability high or DNA mismatch repair deficient, the art anticipates claim 1. We are not persuaded that claim 1 requires or excludes anything else because nothing else is recited in the claim.” slip op. at 9

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “The ’287 patent claims a method of treating a human patient with colorectal cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner discloses testing pembrolizumab to treat human patients. See Ex. 1001, 24:42–52; Ex. 1005. Accordingly, the relevant field of Patent Owner’s claims is treating human patients, as well as testing existing compounds. In the Decision to institute trial, we adopted Petitioner’s uncontested proposal defining that the level of skill in the art, presented above. Dec. 7– 8. 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 14

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “In an anticipation analysis, the dispositive question is whether a skilled artisan would ‘reasonably understand or infer’ from a prior art reference that every claim limitation is disclosed in that single reference.” Acoustic Tech., Inc. v. Itron Networked Sols., Inc., 949 F.3d 1366, 1373 (Fed. Cir. 2020). Extrinsic evidence, such as declarations and depositions may be considered when it is used to explain, but not expand, the meaning of a reference. See In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991) (holding that the depositions and declarations of skilled workers were properly used to show what those skilled in the art would have known about the prior art). We credit Dr. Neugut’s and Dr. Oberstein’s testimony about what one of ordinary skill in the art would have understood after reviewing the MSR. slip op. at 34

    Patent outcomesUS 11,649,287 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,649,287
  • PTAB · Sep 19, 2025 · IPR2024-00650 · APJ Deborah Katz · IPR · Final written decision

    Claims 1–38 are unpatentable: claims 1, 2, 4–7, 11–17, 19–22, and 26–38 are anticipated by the MSR; the remaining claims are obvious over the MSR and cited references.

    RulingsFinal written decision
    • 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 be 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. (See 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. (See PO Resp. 5–6 (citing Ex. 2072 ¶¶ 31–32, 91–99).) Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects. The ’491 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 discloses testing pembrolizumab to treat human patients. (See Ex. 1001, 25:36–52, 26:24–41, Ex. 1005; see Decision 8–9.) Accordingly, the relevant field of Patent Owner’s claims is treating human patients, as well as testing existing compounds. 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 ’491 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. C. Claim Construction” slip op. at 8

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “Dr. Lonberg, Patent Owner’s witness, does not dispute any of Dr. Neugut’s or Dr. Oberstein’s testimony, but asserts only that Dr. Neugut’s testimony relies only on what was generally done, not on what is expressly disclosed in the MSR. (See Ex. 2072 ¶¶ 105–107.) On cross-examination, Dr. Lonberg agreed with Dr. Oberstein that patients who had received prior cancer therapy were not excluded from the study described in the MSR. (See Ex. 1245, 57:5–58:2, 40:5–14, 49:2–12.) Thus, after considering the evidence cited by each party, we find Dr. Neugut’s and Dr. Oberstein’s testimony to be the most directly relevant and persuasive about what one of ordinary skill in the art would have understood from the MSR itself. We are also persuaded by the lack of a specific contradiction regarding the understanding of one of ordinarily skill in the art by Dr. Lonberg. Even if some patients who had been previously treated with specific drugs were excluded from the study described in the MSR, we are persuaded that one of ordinary skill in the art would have understood the MSR as including other patients who have been treated with a prior cancer therapy drug. We are persuaded that Petitioner has met its burden of proving whether a skilled artisan would reasonably understand or infer that the limitations of claims 13, 28, 32, and 36 were disclosed in the MSR. Petitioner demonstrates what one of ordinary skill in the art would have understood from the MSR, not what it inherently discloses. (Contra PO Resp. 19–22.)” slip op. at 38

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner

      “Patent Owner argues that the “in response to” limitation of claim 1 describes administering the claimed treatment only to patients determined to have an MSI-H tumor. (See PO Resp. 6.) But neither claim 1 nor claim 16 includes a limitation excluding the treatment of any patient, such as specifically excluding treatment of any patient who has a tumor that is not MSI-H or dMMR. Neither claim 1 nor claim 16 recites any language differentiating between patients or identifying a patient population to be excluded from treatment. Instead, claims 1 and 16 provide that if the colorectal cancer patient is tested and the cancer is determined to be MSI-H or dMMR, the patient is treated with a therapeutically effective amount of pembrolizumab. We note that the methods of claims 1 and 16 use the open-ended transitional phrase “comprising” that is generally interpreted to not exclude additional, unrecited elements. See Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368 (Fed. Cir. 2003) (“The transition ‘comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.”); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997) (“‘Comprising’ is a term of art used in claim language that means that the named elements are essential, but that other elements may be added and still form a construct within the scope of the claim.”). The use of the open-ended transitional phrase “comprising” in claims 1 and 16 further suggests to us that any additional steps taken in conjunction with expressly recited method steps, such as the treatment of patients who are not MSI-H or dMMR, are not excluded from the scope of the claim.” slip op. at 13

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

      “discloses species that fall within the scope of claim 1. (See Ex. 2090 ¶ 79; Ex. 1243, 115:5–116:22; Ex. 1085, 673–75; Ex. 1086, 14; Ex. 1003 ¶¶ 25, 67; 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. d) Element [1.3]: “thereby determining that the patient’s cancer is” slip op. at 26

    Patent outcomesUS 11,634,491 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,634,491
  • PTAB · Jul 1, 2025 · IPR2024-00287 · APJ Norman H Beamer · IPR · Final written decision

    Claims 9–12, 14–16, and 22–24 are unpatentable under § 103 over Riepling and Meisels, or Riepling, Manzano, and Meisels; claim 13 was disclaimed.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner’s proposal is consistent with the level of ordinary skill in the art as reflected by the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); GPAC, 57 F.3d at 1579. We apply Petitioner’s articulation.” slip op. at 20

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner

      “construction of “representation of the at least one file.” Petitioner is correct that a representation of a file is not the file itself, but (in keeping with the ordinary meaning of “representation”) is rather some sign or symbol that stands for the folder. Reply 2. This is confirmed by the explicit example of a representation of a folder in the ʼ906 application, illustrated in the portion of Figure 6B reproduced below (highlighted here for purposes of explanation). This portion of Figure 6B depicts representations of two files: “FamilyHistory.docx” and “XmasLetter-2012.pdf.” The ’906 application specifically states: [A] located data resources dialog UI element 630b . . . includes a presentation space 632b for presenting a user detectable representation of some or all of the data objects identified in the received data object identification response from . . . second node 504. Ex. 2004 ¶ 147 (emphasis added). The entries in the above figure are representations of the files, not the files themselves. The actual files are stored in the file system storage associated with the user’s node, and only retrieved if the user selects the “Access” or “Access All” elements. Id. ¶ 148. Patent Owner misconstrues the claim 22 language, “a first representation of the at least one file, in a location among one or more folders, that is stored at the at least one server” and “a second representation of the at least one file, in a location among one or more folders, that is stored at the first node.” Patent Owner infers from this language that the representation is itself a file that is “in a location among one or more folders” and is stored on a server or at a node. PO Resp. 17. Not so — the representation of a file, such as “FamilyHistory.docx” in the above figure, is not stored at a server or node, but rather is simply displayed on a screen. As the ’906 application states: A representation of a program entity may be stored and/or otherwise maintained in a presentation space. As used in this document, the term “presentation space” refers to a storage region allocated and/or otherwise provided for storing presentation information . . . . A screen of a display, for example, is a presentation space.” slip op. at 22

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner

      “because (i) Riepling and Meisels are from the same field of endeavor, directed to sharing files over a network; (ii) the combination would have yielded expected, predictable results, using known and routine computer programming principles, to modify Riepling’s system to generate an electronic message that includes a link pointing to an uploaded file; (iii) the combination would have been readily implemented given Meisels’ teachings of inserting, in an electronic message, a link to a shared location where a file is uploaded; and (iv) the combination was suggested because Meisels expressly disclosed a benefit of sending an email message with a link, to avoid multiple copies of a file from existing at multiple locations, and sending links to one file to multiple recipients and managing permissions on an individual recipient basis. Pet. 67–70 (citing Ex. 1107, Fig. 1, ¶¶ 2, 4, 19; Ex. 1108, Fig. 4, ¶¶ 1, 3, 41–45, 56; Mowry Decl. ¶¶ 194–198). In addition, for reasons similar to the motivation basis, Petitioner argues that a person of ordinary skill in the art would have had a reasonable expectation of success in making the combination. Id. at 70–71 (citing Mowry Decl. ¶¶ 199–200). Other than its arguments directed to ’520 claim requirement 9[l], discussed below in Section III.D.4.d), Patent Owner does not further address Petitioner’s arguments regarding the combination of Riepling and Meisels. As discussed in that section, we are persuaded by Petitioner’s expert’s testimony that one of ordinary skill would have applied the document link teachings of Meisels to modify Riepling. Accordingly, we determine that Petitioner has proved by a preponderance of the evidence that one of ordinary skill in the art would have been motivated to combine Riepling and Meisels in the manner argued by Petitioner.” slip op. at 32

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

      “We agree with Petitioner that set content field 325 of Riepling teaches or suggests claim requirement 9[b]. As Petitioner’s expert explains, the fact that field 325 has an appearance identical to that of fields 321–324 in Figure 3, which fields are specifically stated to be “text field[s],” strongly suggests that field 325 is also a text field. Mowry Decl. ¶ 70; see also Reply 10–11. Patent Owner’s suggestion that field 325 could be a dropdown list or other type of field is contradicted by the fact that it does not show the typical dropdown arrow associated with a dropdown box, or other typical non-textbox appearance such as the checkbox appearance of field 320. Moreover, in the example of Figure 3, the “Set Content” entry is “audio,” which is a file description. Reply 10. The fact that “JPEG” is checked in field 320 is not inconsistent with the “audio” entry in field 325, given that, as Riepling explains, “it may be possible for audio files such as MP3 files to contain non-MP3 data, such as JPEG data embedded within the MP3 files.” Id. at 11 (citing Ex. 1107 ¶ 32; Mowry 2nd Decl. ¶ ¶ 101–104). Also, there is no reason why the Figure 5 response that gives the uploader the ability to provide additional description of the file being uploaded is inconsistent with the ability of the requester first describing what type of file is being requested via field 325 in Figure 3. Id. at 11–12. Accordingly, for the reasons discussed above, we are persuaded that the record supports Petitioner’s arguments regarding claim requirement 9[b].” slip op. at 37

    Patent outcomesUS 11,611,520 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,611,520
  • PTAB · Jun 30, 2025 · IPR2024-00286 · APJ Norman H Beamer · IPR · Final written decision

    Claims 17–21 are unpatentable under § 103 over Houston and Garcia; the Board did not reach the alternative grounds.

    RulingsFinal written decision
    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

      “We conclude that there is no basis for Patent Owner’s proposed construction of “representation of the at least one folder.” Petitioner is correct that a representation of a folder is not the folder itself, but (in keeping with the ordinary meaning of “representation”) is rather some sign or symbol that stands for the folder. Reply 2. This is confirmed by the explicit example of a representation of a folder in the ’635 application, illustrated in the portion of Figure 6D reproduced below (highlighted here for purposes of explanation). This portion of Figure 6D depicts representations of several folders, including the highlighted “Music” folder. The ’635 application specifically states: A folder content pane UI element 648d in navigation window UI element 646d is presented including representations of one or more data objects[11] at a location, identified in a path UI element 650d. A pointer UI element 652d illustrates a drag and drop operation of a “Music” folder represented in contents pane UI element 648d, dropped on edit window UI element 602d. Ex. 2004 ¶ 123 (emphasis added). The word “Music” in the above figure is a representation of a folder, not the folder itself. The actual folder is an entity in a file system that stores files (in the case of a “Music” folder, presumably MP3 or WAV files, or the like).” slip op. at 17

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

      “Patent Owner’s arguments are not pertinent to Petitioner’s proffered combination of Houston with Garcia as applied to the remaining challenged claims 17–21. As discussed further below, Petitioner relies on Garcia as supplementing Houston for details regarding the requirements of generating and sending an email with a link to a folder but without a file attachment, and for synchronizing folders and providing interfaces for display of shared folders. Pet. 26–27, 36–39, 57–60. For the challenged claims, Petitioner does not need to rely on the combination to modify Houston’s system such that, when an icon for a shared folder is created in Houston’s interface at an invited user’s client, the client does not store a file in the shared folder — 14 For this argument and others, Patent Owner cites for additional support portions of U.S. Provisional Patent Application No. 61/233,787. PO Resp. 18, 42, 46; Sur-Reply 9–12. This application is designated in Houston as a related application, and incorporated by reference therein. Ex. 1003, code (60), 1:6–10. We denied as untimely Patent Owner’s request to belatedly add this application to the record. Ex. 3002; Paper 39. Even accepting Patent Owner’s representations of the relied-on disclosures in that application, those disclosures are cumulative to Houston’s criticisms of systems that store documents remotely, and are irrelevant for the same reasons as discussed herein with respect to those Houston disclosures. that aspect of the Houston/Garcia combination is only relevant to claims 1–8, which have been disclaimed. Id. at 40–41; Ex. 2045.15 Thus, Patent Owner’s argument that Houston teaches away from combining with Garcia to delay storing a file when a folder is shared is not applicable to Petitioner’s challenges of claim 17–21, in light of our conclusion set forth above in Section III.C rejecting Patent Owner’s proposed construction of claim 17. The fact that the Houston system ensures the availability of synchronized local copies of files at each user’s local system and criticizes systems that store documents remotely, such as in Garcia, is irrelevant to those claims. On this record, there is nothing about that particular difference in the approaches of Houston and Garcia that would support a finding that one of ordinary skill in the art would have been discouraged from adopting Houston to take advantage of the teachings in Garcia regarding use of email and folder interfaces. In sum, Patent Owner focuses on a specific irrelevant detail of Houston regarding local storage of files, whereas Petitioner relies on other features of the combination of Houston and Garcia. In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986); In re Keller, 642 F.2d 413, 425 (CCPA 1981). “The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary” slip op. at 41

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

      “To give substantial weight to objective indicia of nonobviousness such as commercial success, a proponent must establish a nexus between the evidence and the merits of the claimed invention. ClassCo, Inc. v. Apple, Inc., 838 F.3d 1214, 1220 (Fed. Cir. 2016). Nexus is a legally and factually sufficient connection between the objective evidence and the claimed invention, such that the objective evidence should be considered in determining nonobviousness. Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988). “[T]here is no nexus unless the evidence presented is ‘reasonably commensurate with the scope of the claims.’” ClassCo, 838 F.3d at 1220 (quoting Rambus Inc. v. Rea, 731 F.3d 1248, 1257 (Fed. Cir. 2013)). A patentee is entitled to a presumption of nexus “when the patentee shows that the asserted objective evidence is tied to a specific product and that product ‘embodies the claimed features, and is coextensive with them.’” Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019) (quoting Polaris Indus., Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1072 (Fed. Cir. 2018)). “[T]he patentee retains the burden of proving the degree to which evidence of secondary considerations tied to a product is attributable to a particular claimed invention.” Fox Factory, 944 F.3d at 1378. The Federal Circuit has held that “if the marketed product embodies the claimed features, and is coextensive with them, then a nexus is presumed and the burden shifts to the party asserting obviousness to present evidence to rebut the presumed nexus.” Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1130 (Fed. Cir. 2000). “A finding that a presumption of nexus is inappropriate does not end the inquiry into secondary considerations”; rather, “the patent owner is still afforded an opportunity to prove nexus by showing that the evidence of secondary considerations is the ‘direct result of the unique characteristics of the claimed invention.’” Fox Factory, 994 F.3d at 1373–74 (quoting In re Huang, 100 F.3d 125, 140 (Fed. Cir. 1996)). “Ultimately, the fact finder must weigh the [objective indicia] evidence presented in the context of whether the claimed invention as a whole would have been obvious to a skilled artisan.” See Lectrosonics, Inc. v. Zaxcom, Inc., IPR2018-01129, Paper 33, 33 (PTAB Jan. 24, 2020) (precedential) (citing WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1331–32 (Fed. Cir. 2016)).” slip op. at 23

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

      “However, as Petitioner argues above, Houston discloses that a client can provide an email to the server to invite others to share a folder, and Houston explains that “attaching files [to emails is] cumbersome for many computer users.” Pet. 25–26 (citing Ex. 1003, Fig. 4, 1:41–42, 3:40–43, 7:50–51). From this, Petitioner argues that it would have been obvious for the email invitation to notify how to access the folder, rather than sending the folder contents itself. Id. Petitioner further argues that the claim 17[d] requirement would have been obvious over the combination of Houston and Garcia given the disclosure in Garcia of sharing a folder by sending an email with a link to the folder, instead of an attachment. Id. at 27, 57 (citing Ex. 1004, Figs. 9, 11–12, 10:32–34, 10:38–40, 11:39–43, cl. 3). We are persuaded that the record supports Petitioner’s arguments regarding this claim requirement. Both Houston alone, and the combination of Houston and Garcia, teach or suggest sending an email with a link to a folder to be shared, rather than the folder contents. Only if the recipient clicks on the link are the contents of the folder shared. Ex. 1004, 11:29–31. The act of clicking on the link in the email after the email is received is the required “initiation of the communication” that must occur separately from the email itself, as required by claim 17[d]: “causing generation of at least one email [that] does not include a file attachment, for permitting avoidance of at least one file from being communicated to and stored at the second node until an initiation of the communication of the at least one file by a user of the second node is detected and the communication commences via at least one server that stores the at least one file” (emphasis added). It does not matter if Houston or Garcia automatically downloads local copies of files when a recipient clicks on the email link, because that is a separate step following the step of claim 17[d].” slip op. at 46

    Patent outcomesUS 11,611,520 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,611,520
  • PTAB · Jun 9, 2025 · IPR2024-00240 · APJ Deborah Katz · IPR · Final written decision

    Claims 1–42 are unpatentable: claims 1–42 are anticipated by the MSR, and the Board also finds the challenged claims obvious over the MSR and cited combinations.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for petitioner

      “claims a method of treating a human patient with colorectal cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner discloses testing pembrolizumab to treat human patients. (See Ex. 1001, 25:40–50, Ex. 1005; see Decision 8–9.) Accordingly, the relevant field of Patent Owner’s claims is treating human patients, as well as testing existing compounds. Neither party directs us to evidence of the level of skill in the art beyond what we considered for institution of trial. In the Decision to institute trial, we determined that the level of skill in the art relevant to the claims of the ’393 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials. (See Dec. 8–9.) We determined that the level of skill also includes knowledge of and experience with treating colorectal cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy. (See id.) Because the parties do not present additional evidence or argument, we maintain that determination.” slip op. at 9

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “what one of ordinary skill in the art would have known and understood at the relevant time. Specifically, Petitioner relies on the testimony of Alfred L. Neugut, M.D., Ph.D., M.P.H.3 (Ex. 1003) and Paul E. Oberstein, M.D. (Ex. 1150). Patent Owner relies on the testimony of Nils Lonberg, Ph.D. (Ex. 2001) and Richard Goldberg, M.D. (Ex. 2090).” slip op. at 8

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner

      “1 requires a causal relationship wherein the patient must be tested for MSI-H and, if he or she is determined to be MSI-H or dMMR, then the patient is treated with 10 mg/kg of pembrolizumab every 14 days. We further agree that this relationship is different than the use of the term “after” in claims 7, 20, and 27, wherein patients must be treated with a different cancer therapy, and wherein the cancer must have later progressed for the treatment to be within the scope of these claims. (Ex. 1001, 25:66–7, 26:44–46, 26:63–64.) In claim 1, a biological sample from the patient must be tested to determine if the cancer is MSI-H and, if so, the patient is treated with a therapeutically effective amount of pembrolizumab. For this reason, if the prior art teaches the limitations of 1) testing a biological sample obtained from a patient having colorectal cancer to determine that the patient’s colorectal cancer is microsatellite instability high or mismatch repair deficient, and 2) treating the patient with a therapeutically effective amount of pembrolizumab if the patient’s colorectal cancer is determined to be microsatellite instability high or DNA mismatch repair deficient, the art anticipates claim 1. We are not persuaded that claim 1 requires or excludes anything else because nothing else is recited in the claim.” slip op. at 12

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

      “Microsatellite Unstable (MSI) Tumors.” (Ex. 1005, 2.) The parties’ witnesses agree that MK-3475 is pembrolizumab, the compound recited in claim 1. (See Neugut Decl., Ex. 1003 ¶ 37; see Lonberg Decl., Ex. 2001, ¶ 65.) Patent Owner does not dispute Petitioner’s assertion that the MSR was published on a government web site on June 10, 2013, more than two years before the priority date of the ’393 patent on July 10, 2015. (See Pet. 7 (citing Ex. 1005, 3, Ex. 1003 ¶ 35).)” slip op. at 17

    Patent outcomesUS 11,591,393 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,591,393
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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.