• Facebook, Inc. / SAP America, Inc. et al. v. Express Mobile, Inc.All claims unpatentable
  PTAB · Jan 16, 2026 · IPR2022-00518 · APJ Jeffrey S Smith · IPR · Remand

  Claims 1–4 and 6 are unpatentable under §103 because the prior-art combinations teach limitations 1(c) and 1(g) under the proper construction of “style.”

  RulingsRemand decision

  • RemandOther

    “As directed by the Federal Circuit, we determine whether the prior art combination teaches limitations 1(c) and 1(g) under the proper construction of “style,” but otherwise do not revisit our analysis of claim 1. Remand Opinion 7, 13–14. The Federal Circuit construed “style” to mean “a collection of one or more settings that is defined separately from any single object but can be associated with one or more objects,” with the understanding that “associated with one or more” means capable of being associated with both one object and more than one object. Id. at 14.” slip op. at 4

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

    “Because the Specification discloses that data defines an object, we construe the plain meaning of the claimed “object,” read in light of the Specification of the ’168 patent, as encompassing data that defines the object. See Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (The “specification . . . is the single best guide to the meaning of a disputed term.”); Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583 (Fed. Cir. 1996); (Excluding an embodiment in the specification from “the scope of the patent claim . . . is rarely, if ever, correct.”). Further, because the Specification discloses that data defines image objects, and that objects include images, we construe the plain meaning of the claimed “image object,” read in light of the Specification, as encompassing data that defines an image, such as one of the 12 different pocket watch images of Lemay Web.” slip op. at 9

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

    “We agree with Petitioner. As discussed above, the plain meaning of an “image object” read in light of the Specification encompasses data that defines an image, such as each of the 12 different pocket watch images of Lemay Web. Ex. 1004, 89–90. Therefore, the HTML file of Lemay Web, which specifies attributes including width, height, pause value, and repeat value of the pocket watch image objects, is “capable of being applied to more than one” image object, such as each of the 12 different pocket watch image objects described by Lemay Web. Id.” slip op. at 11

  • Strike new argumentNew argument consideredDecided for petitioner

    “We agree with Petitioner. The Board and Petitioner understood the meaning of “or” in the phrase “one or more objects” in Patent Owner’s proposed construction of style as meaning that “a style . . . can be associated with just one object.” Dec. 22; see Reply 4–5. The Federal Circuit “ultimately conclude[d] that Express Mobile’s proposed construction, with ‘or’ properly interpreted,” means “that the claimed ‘style’ must be capable of being applied to both one and more than one ‘object,’” and “remand[ed] for further proceedings in view of the correct claim construction.” Remand Opinion 13. In doing so, the Federal Circuit stated that “[i]t may be that under the correct claim construction, the Board finds that Lemay Web teaches the claimed ‘style’; however, that is still an open fact question for the Board to decide in the first instance.” Id. at n.6. Given that the Federal Circuit has ordered the Board to determine whether the prior art teaches the claimed “style” under the proper construction, we find that Petitioner’s arguments on this issue are timely.” slip op. at 6

  Patent outcomesUS 7,594,168 unpatentable
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 7,594,168
• Facebook, Inc. / SAP America, Inc. et al. v. Express Mobile, Inc.All claims unpatentable
  PTAB · Jan 16, 2026 · IPR2022-00572 · APJ Jeffrey S Smith · IPR · Remand

  Claims 1–4 and 6 are unpatentable under §103 because the prior-art combinations teach the limitations at issue under the Federal Circuit’s construction of “style.”

  RulingsRemand decision

  • RemandDecided for petitioner

    “We agree with Petitioner. Lemay Web discloses that the style settings of width, height, pause, and repeat for the pocket watch images can be changed by changing the values for width, height, pause, and repeat in the HTML file. Ex. 1004, 89–90. This results in changing the size, duration, and frequency of the display of the multiple pocket watch image objects without changing the image files or the Java applet. Id. That is, the 12 image objects of Lemay Web can be uniformly formatted by applying and altering the style settings of the HTML file, which is stored separately from the image objects and the Java applet. Id. at 88– 89. In our Final Written Decision, we wrote that “Lemay Web discloses that the image files that are displayed as the animation object are separate from the HTML.” Ex. 1004, 88–89.” Dec. 22. The Federal Circuit wrote that “how the Board evaluated what constitutes separateness in the prior art software is less than clear.” Opinion, 13 n.7. To be clear, the animation of Lemay Web comprises 12 different pocket watch image objects. Ex. 1004, 89. The HTML file that contains the style settings for the 12 different pocket watch image objects is stored separately from the 12 different pocket watch image objects. Id. at 88–91. The style of the 12 different pocket watch image objects can be altered by changing the values of the style settings in the separate HTML file, thus allowing the style to be uniformly applied to each of the associated 12 pocket watch image objects when the pocket watch image objects are created on the web page. Id.; see Ex. 1030 ¶¶ 28–29; Dec. 21–22. In conclusion for issue (B), we find that Lemay Web teaches applying the style located in the separate HTML file to the pocket watch image objects when creating the pocket watch image objects on the web page. Therefore, Lemay Web’s style is “defined separately from any single object” as claimed. Because Lemay Web’s style can be applied to one object and more than one object and Lemay Web’s style is defined separately from any single object, we find that the prior art combination teaches limitations 1(c) and 1(g) under the proper construction of “style.”” slip op. at 12

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

    “As directed by the Federal Circuit, we determine whether the prior art combination teaches limitations 1(c) and 1(g) under the proper construction of “style,” but otherwise do not revisit our analysis of claim 1. Remand Opinion 7, 13–14. The Federal Circuit construed “style” to mean “a collection of one or more settings that is defined separately from any single object but can be associated with one or more objects,” with the understanding that “associated with one or more” means capable of being associated with both one object and more than one object. Id. at 14.” slip op. at 4

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

    “Because the Specification discloses that data defines an object, we construe the plain meaning of the claimed “object,” read in light of the Specification of the ’168 patent, as encompassing data that defines the object. See Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (The “specification . . . is the single best guide to the meaning of a disputed term.”); Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583 (Fed. Cir. 1996); (Excluding an embodiment in the specification from “the scope of the patent claim . . . is rarely, if ever, correct.”). Further, because the Specification discloses that data defines image objects, and that objects include images, we construe the plain meaning of the claimed “image object,” read in light of the Specification, as encompassing data that defines an image, such as one of the 12 different pocket watch images of Lemay Web.” slip op. at 9

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “What you see in the bottom right is an excerpt from the Lemay Web book . . . [y]ou can still use the Java applet just by putting this applet code into your HTML file. So this shows the animator class is going to be run within height or how big a window within the browser should be allocated in this applet. You can . . . tell the animator class how long to pause in between each image. So that’s a style that’s being applied to all of the multiple images that make up this animation. Ex. 2029, 746:23–747:7. Patent Owner then asked GoDaddy’s expert “for each unique animation you want to create with this animator class that’s shown here, you’re going to have to have a unique set of HTML code with the settings along with any of the images you’ll want to associate with the animator class, right?” Ex. 2030, 793:7–11. GoDaddy’s expert testified, with reference to Exhibit 2027, 80, that “Yeah. I’m not a hundred percent sure I understand your question, but yes, if you had six animations on a page, for example, you’d have six blocks of markup that looked like the markup at the bottom right of that slide, starting with applet.” Id. at 793:12–16. In addressing Patent Owner’s question about “each unique animation,” GoDaddy’s expert provided a hypothetical example of a web page having six animations, and explained that the six animations have six blocks of markup. Ex. 2030, 793:13–16. We find that this testimony means that if a web page has six unique animations, then for each unique animation, a corresponding HTML file contains the style settings for the image objects of that animation, such that the “six animations on a page . . . have six blocks of markup.” Id. We find that the subsequent testimony of GoDaddy’s expert cited by Patent Owner is consistent with the expert’s initial testimony that Lemay Web’s style is “applied to all of the multiple images that make up this animation.” Ex. 2029, 747:5–7. We also find that the subsequent testimony is consistent with and supported by the disclosure of Lemay Web, which teaches that an animation has a set of image files and is added to a Web page using the Animator applet. Ex. 1004, 88 (“[Y]ou’ll learn just enough about Java applets to set up animation on your Web page. . . . To create animation using Java and the Animator applet, you’ll need . . . [a] set of image files . . . that make up your animation.”); see id. at 88–91. That is, Lemay Web, consistent with the testimony of GoDaddy’s expert, discloses that the style settings for the animation of the pocket watch in the HTML file are uniformly applied to the 12 pocket watch image objects. Id. at 88–91.” slip op. at 17

  Patent outcomesUS 7,594,168 unpatentable
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 7,594,168
• Facebook, Inc. / SAP America, Inc. et al. v. Express Mobile, Inc.All claims unpatentable
  PTAB · Jan 16, 2026 · IPR2022-00597 · APJ Jeffrey S Smith · IPR · Remand

  Claims 1–4 and 6 are unpatentable under §103 over both listed prior art combinations; Lemay Web teaches the claimed style under the Federal Circuit’s construction.

  RulingsRemand decision

  • RemandOther

    “As directed by the Federal Circuit, we determine whether the prior art combination teaches limitations 1(c) and 1(g) under the proper construction of “style,” but otherwise do not revisit our analysis of claim 1. Remand Opinion 7, 13–14. The Federal Circuit construed “style” to mean “a collection of one or more settings that is defined separately from any single object but can be associated with one or more objects,” with the understanding that “associated with one or more” means capable of being associated with both one object and more than one object. Id. at 14.” slip op. at 4

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

    “We agree with Petitioner. As discussed above, the plain meaning of an “image object” read in light of the Specification encompasses data that defines an image, such as each of the 12 different pocket watch images of Lemay Web. Ex. 1004, 89–90. Therefore, the HTML file of Lemay Web, which specifies attributes including width, height, pause value, and repeat value of the pocket watch image objects, is “capable of being applied to more than one” image object, such as each of the 12 different pocket watch image objects described by Lemay Web. Id.” slip op. at 11

  • Strike new argumentNew argument consideredDecided for petitioner

    “We agree with Petitioner. The Board and Petitioner understood the meaning of “or” in the phrase “one or more objects” in Patent Owner’s proposed construction of style as meaning that “a style . . . can be associated with just one object.” Dec. 22; see Reply 4–5. The Federal Circuit “ultimately conclude[d] that Express Mobile’s proposed construction, with ‘or’ properly interpreted,” means “that the claimed ‘style’ must be capable of being applied to both one and more than one ‘object,’” and “remand[ed] for further proceedings in view of the correct claim construction.” Remand Opinion 13. In doing so, the Federal Circuit stated that “[i]t may be that under the correct claim construction, the Board finds that Lemay Web teaches the claimed ‘style’; however, that is still an open fact question for the Board to decide in the first instance.” Id. at n.6. Given that the Federal Circuit has ordered the Board to determine whether the prior art teaches the claimed “style” under the proper construction, we find that Petitioner’s arguments on this issue are timely.” slip op. at 6

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

    “Contrary to Patent Owner’s contention, the Specification discloses, “Data that defines text button, image, paragraph, or other parent objects . . . can be stored in two-dimensional arrays (by web page and by object number).” Ex. 1001, 22:11–13 (emphasis added). The Specification further discloses that “objects . . . include colors, fonts, images, audio clips, video clips, text areas, URLs and thread objects.” Id. at 2:16–17 (emphasis added); see id. at 8:40. We highlight that the Specification’s use of “object” is consistent with a definition of “object” in the computing art at the time of the invention, which is “(2) A passive entity that contains or receives data; for example, bytes, blocks, clocks fields, files . . . .” George McDaniel, IBM Dictionary of Computing, McGraw-Hill, Inc. 1994, p. 471 (Ex. 3001). Because the Specification discloses that data defines an object, we construe the plain meaning of the claimed “object,” read in light of the Specification of the ’168 patent, as encompassing data that defines the object. See Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (The “specification . . . is the single best guide to the meaning of a disputed term.”); Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583 (Fed. Cir. 1996); (Excluding an embodiment in the specification from “the scope of the patent claim . . . is rarely, if ever, correct.”). Further, because the Specification discloses that data defines image objects, and that objects include images, we construe the plain meaning of the claimed “image object,” read in light of the Specification, as encompassing data that defines an image, such as one of the 12 different pocket watch images of Lemay Web.” slip op. at 8

  Patent outcomesUS 7,594,168 unpatentable
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 7,594,168
• Facebook, Inc. / SAP America, Inc. et al. v. Express Mobile, Inc.All claims unpatentable
  PTAB · Jan 16, 2026 · IPR2021-01226 · APJ Jeffrey S Smith · IPR · Remand

  Claims 1–4 and 6 are unpatentable under § 103 over the asserted combinations because the prior art teaches the limitations under the proper construction of “style.”

  RulingsRemand decision

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

    “Contrary to Patent Owner’s contention, the Specification discloses, “Data that defines text button, image, paragraph, or other parent objects . . . can be stored in two-dimensional arrays (by web page and by object number).” Ex. 1001, 22:11–13 (emphasis added). The Specification further discloses that “objects . . . include colors, fonts, images, audio clips, video clips, text areas, URLs and thread objects.” Id. at 2:16–17 (emphasis added); see id. at 8:40. We highlight that the Specification’s use of “object” is consistent with a definition of “object” in the computing art at the time of the invention, which is “(2) A passive entity that contains or receives data; for example, bytes, blocks, clocks fields, files . . . .” George McDaniel, IBM Dictionary of Computing, McGraw-Hill, Inc. 1994, p. 471 (Ex. 3001). Because the Specification discloses that data defines an object, we construe the plain meaning of the claimed “object,” read in light of the Specification of the ’168 patent, as encompassing data that defines the object. See Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (The “specification . . . is the single best guide to the meaning of a disputed term.”); Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583 (Fed. Cir. 1996); (Excluding an embodiment in the specification from “the scope of the patent claim . . . is rarely, if ever, correct.”). Further, because the Specification discloses that data defines image objects, and that objects include images, we construe the plain meaning of the claimed “image object,” read in light of the Specification, as encompassing data that defines an image, such as one of the 12 different pocket watch images of Lemay Web.” slip op. at 8

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

    “We agree with Petitioner. As discussed above, the plain meaning of an “image object” read in light of the Specification encompasses data that defines an image, such as each of the 12 different pocket watch images of Lemay Web. Ex. 1004, 89–90. Therefore, the HTML file of Lemay Web, which specifies attributes including width, height, pause value, and repeat value of the pocket watch image objects, is “capable of being applied to more than one” image object, such as each of the 12 different pocket watch image objects described by Lemay Web. Id.” slip op. at 11

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “Ex. 2030, 793:7–11. GoDaddy’s expert testified, with reference to Exhibit 2027, 80, that “Yeah. I’m not a hundred percent sure I understand your question, but yes, if you had six animations on a page, for example, you’d have six blocks of markup that looked like the markup at the bottom right of that slide, starting with applet.” Id. at 793:12–16. In addressing Patent Owner’s question about “each unique animation,” GoDaddy’s expert provided a hypothetical example of a web page having six animations, and explained that the six animations have six blocks of markup. Ex. 2030, 793:13–16. We find that this testimony means that if a web page has six unique animations, then for each unique animation, a corresponding HTML file contains the style settings for the image objects of that animation, such that the “six animations on a page . . . have six blocks of markup.” Id. We find that the subsequent testimony of GoDaddy’s expert cited by Patent Owner is consistent with the expert’s initial testimony that Lemay Web’s style is “applied to all of the multiple images that make up this animation.” Ex. 2029, 747:5–7. We also find that the subsequent testimony is consistent with and supported by the disclosure of Lemay Web, which teaches that an animation has a set of image files and is added to a Web page using the Animator applet. Ex. 1004, 88 (“[Y]ou’ll learn just enough about Java applets to set up animation on your Web page. . . . To create animation using Java and the Animator applet, you’ll need . . . [a] set of image files . . . that make up your animation.”); see id. at 88–91. That is, Lemay Web, consistent with the testimony of GoDaddy’s expert, discloses that the style settings for the animation of the pocket watch in the HTML file are uniformly applied to the 12 pocket watch image objects. Id. at 88–91. Contrary to Patent Owner’s contention, the testimony of GoDaddy’s expert further supports our finding that the style settings in the HTML file of Lemay Web are applied to the multiple image objects that make up the animation. Patent Owner does not identify anything else from the district court trial connected to the “style” issue raised by the Federal Circuit. We conclude that the jury verdict does not change our decision here. IV. CONCLUSION” slip op. at 18

  Patent outcomesUS 7,594,168 unpatentable
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 7,594,168
• GE Healthcare Ltd. v. The Johns Hopkins UniversityInstituted
  PTAB · Jan 14, 2026 · PGR2025-00059 · APJ Devon Zastrow Newman · PGR · Institution

  The Board instituted post-grant review of claims 1–4 on all four asserted grounds, finding a sufficient preliminary showing of obviousness and lack of enablement.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “V. CONCLUSION Petitioner has, at this stage, established that it will more likely than not prevail in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a) post grant review of claims 1–4 of the ’233 patent is hereby instituted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 324(d) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; and” slip op. at 40

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not proffer a description of a POSA. See generally, Prelim. Resp. For the purposes of this decision, on the record at this time, we find that Petitioner’s definition appears consistent with the level of skill shown in the prior art references of record, and apply it herein. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). We invite the parties to further address the definition of a POSA during trial should they find it necessary.” slip op. at 7

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “In addition, the opinion stated in the Pomper Declaration that “the term of ‘low molecular weight’ is well accepted in the chemical arts” and the declarant “recognize[s] that low molecular weight compounds would have a molecular weight of typically from about 50 Daltons to about 1,500 Daltons” is offered by a co-inventor. We, as factfinder, have discretion to weigh the credibility of expert witnesses and to give each item of evidence such weight as appropriate. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”). In this case, we find that the published references on metabolites do not support the opinion. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d at 1368 (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”) US-121, of which Dr. Pomper is lead inventor, also uses the term “low molecular weight”—without further characterization of the term—and is uninformative as to the meaning of the term. See Ex. 1006, ¶ 12. In addition, Patent Owner’s definition does not appear to apply to all compounds claimed in US-121.5” slip op. at 11

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

    “limited to Patent Owner’s proposed “from about 50 Daltons to about 1,500 Daltons.” The cited evidence relied on in the Pomper Declaration to define “low molecular weight” as a term well accepted in the chemical arts relates to metabolomics and metabolites. See Ex. 1002, 169, (specifically, ¶ 17 of Dr. Pomper’s declaration). Patent Owner admits that Dr. Pomper’s testimony is about molecules that differ from the claimed imaging and radiotherapeutic agents targeting FAP-α, but argues that the testimony is still relevant for purposes of explanation. Prelim Resp. 21. While it may be relevant, the testimony is not persuasive in light of the Specification. We find the uncontested fact that several of the B moieties alone—without the A moiety or L linker—specifically identified in the ’233 patent fall outside of Patent Owner’s proposed definition persuasive, as we normally do not interpret claim terms in a way that excludes examples disclosed in the specification. See, e.g., Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1305 (Fed. Cir. 2007) (rejecting proposed claim interpretation that would exclude disclosed examples in the specification). The cases cited by Patent Owner supporting that a claim term may be construed to exclude embodiments where the prosecution history supports such construction are factually distinguishable from the instant case as they regard instances of specific prosecution history disclaimer, clear prosecution disavowal, or relate to a specific definition of the terms in the Specification for the term being construed. Here, “low molecular weight” is not defined in the Specification, but, as Petitioner argues (see Pet. 21–25) is characterized as “demonstrat[ing] faster pharmacokinetics and a higher specific signal within clinically convenient times after administration” and that it “can be synthesized in radiolabeled form more easily.” Ex.1001, 13:33–50, 14:56– 16:14, 17:9–20. We are persuaded by the testimony of Dr. Zeglis, Petitioner’s declarant, that compounds weighing over 1500 Da may share those same behaviors, along with certain identified B moieties disclosed as embodiments. See Ex. 1003 ¶ 83.” slip op. at 10

  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 12,115,233
• Toyota Motor Corp. v. Emerging Automotive LLCAll claims unpatentable
  PTAB · Nov 19, 2025 · IPR2024-00814 · APJ Frances L Ippolito · IPR · Final written decision

  Claims 1, 2, and 4–20 are unpatentable as obvious over the stated combinations of Rector, Kleve, and, for certain claims, additional references.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person of ordinary skill in the art (“POSITA” or “POSA”) at the time of the invention of the ’244 patent “would have had at least a Bachelor’s degree in electrical engineering, computer science, or closely related field, with at least two-to-four years’ experience in cloud services for settings customization” and that computer science, or equivalent) could substitute for professional experience and vice-versa.” Pet. 12 (citing Ex. 1005 ¶ 89). Patent Owner does not address the level of ordinary skill in the art. See, generally PO Resp. Patent Owner’s Declarant, Dr. Malek, adopts the definition proffered by Petitioner and its Declarant, Dr. Almeroth. Ex. 2001 ¶ 37. We adopt Petitioner’s proposal as it is reasonable and consistent with the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 8

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

    “Patent Owner asserts that the term “transferring is configured to instruct” should be construed according to its plain and ordinary meaning – the limitation.” PO Resp. 11. Patent Owner contends that the challenged claims require more than that the server is capable of the recited transferring (e.g., claims 1 and 17), and must be configured to accomplish the specific purpose of the claims. Id. at 12–17. Our analysis and the outcome of this dispute, however, would not change even if we were to adopt Patent Owner’s construction. Therefore, upon review of the entire record, including arguments by the parties and the relied upon evidence, we determine no terms require express construction to reach our decision. See Realtime Data LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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 9

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “With regard to this testimony, we note that Dr. Malek does not provide an underlying basis for these statements to support his conclusion that it is “common knowledge” that distributed software systems are less secure than local software systems. Id. In fact, when viewed with Kleve, Dr. Malek’s testimony appears to contradict Kleve’s express teaching that the “system may be further extended to facilitate the virtual key with additional security by requiring remote credential verification at the vehicle . . . by the VCS, using a server, or allowing the Owner to verify the Temporary User’s request.” Ex. 1007 ¶ 49 (emphases added). With regard to Kleve’s disclosure, Dr. Malek further testifies that [a] POSITA would understand that in Kleve credential authorization can be performed by: (1) VCS, (2) server, or (3) owner . . . . While Kleve discloses the verification can be performed by any of these entities, it states the client-side verification at the vehicle using VCS provides additional security. A POSITA would not have been motivated to modify side verification. Rector already uses the more secure client-side verification. Ex. 2003 ¶ 79 (emphases added). Dr. Malek, however, does not explain how Kleve’s express teachings limit “additional security” to client-side verification with VCS. Id. In fact, Kleve expressly discloses the opposite. Kleve teaches that the additional security may be provided by a remote credential certification that “may be done by the VCS, using a server, or allowing the Owner to verify the Temporary User’s request.” Ex. 1007 ¶ 49 (emphasis added). Kleve further teaches that the Temporary User may enter “a credential verification password at the vehicles touchscreen visual display while having the VCS, server, or owner compare and verify authorization.” Id. (emphasis added). Even Dr. Malek acknowledges that the verification can be performed by “any of these entities,” including the server. Id. We further note Dr. Almeroth testifies that “[t]he server-side verification may be done above and beyond any verification that takes place locally. The server-side verification could also be done as a check on local verification.” Ex. 1005 ¶ 122. This testimony is consistent with and supported by Kleve’s disclosure, which expressly states that “additional security” includes remote credential verification at the vehicle using a server. Ex. 1007 ¶ 49. As such, we credit Dr. Almeroth’s testimony as his testimony better supported by prior art disclosure.” slip op. at 28

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

    “With regard to this testimony, we note that Dr. Malek does not provide an underlying basis for these statements to support his conclusion that it is “common knowledge” that distributed software systems are less secure than local software systems. Id. In fact, when viewed with Kleve, Dr. Malek’s testimony appears to contradict Kleve’s express teaching that the “system may be further extended to facilitate the virtual key with additional security by requiring remote credential verification at the vehicle . . . by the VCS, using a server, or allowing the Owner to verify the Temporary User’s request.” Ex. 1007 ¶ 49 (emphases added). With regard to Kleve’s disclosure, Dr. Malek further testifies that [a] POSITA would understand that in Kleve credential authorization can be performed by: (1) VCS, (2) server, or (3) owner . . . . While Kleve discloses the verification can be performed by any of these entities, it states the client-side verification at the vehicle using VCS provides additional security. A POSITA would not have been motivated to modify side verification. Rector already uses the more secure client-side verification. Ex. 2003 ¶ 79 (emphases added). Dr. Malek, however, does not explain how Kleve’s express teachings limit “additional security” to client-side verification with VCS. Id. In fact, Kleve expressly discloses the opposite. Kleve teaches that the additional security may be provided by a remote credential certification that “may be done by the VCS, using a server, or allowing the Owner to verify the Temporary User’s request.” Ex. 1007 ¶ 49 (emphasis added). Kleve further teaches that the Temporary User may enter “a credential verification password at the vehicles touchscreen visual display while having the VCS, server, or owner compare and verify authorization.” Id. (emphasis added). Even Dr. Malek acknowledges that the verification can be performed by “any of these entities,” including the server. Id. We further note Dr. Almeroth testifies that “[t]he server-side verification may be done above and beyond any verification that takes place locally. The server-side verification could also be done as a check on local verification.” Ex. 1005 ¶ 122. This testimony is consistent with and supported by Kleve’s disclosure, which expressly states that “additional security” includes remote credential verification at the vehicle using a server. Ex. 1007 ¶ 49. As such, we credit Dr. Almeroth’s testimony as his testimony better supported by prior art disclosure.” slip op. at 28

  Patent outcomesUS 11,396,244 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,396,244
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  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
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Nov 6, 2025 · IPR2024-00623 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–7 are unpatentable: claims 1–3 and 5–7 are anticipated by the MSI-H Study Record, and claim 4 is obvious over the MSI-H Study Record and other cited references.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “On balance, we find Petitioner’s evidence more persuasive of what one of ordinary skill in the art would have understood from the MSI-H Study Record. We find Dr. Neugut’s and Dr. Oberstein’s testimony, and Dr. Lonberg’s lack of clear testimony to the contrary, persuasive as to this issue. In addition, we are not persuaded by the case law cited by Patent Owner regarding inherent anticipation. See PO Resp. 6–7. Rather, we agree with Petitioner that the correct inquiry is whether the skilled artisan would have understood that all limitations are disclosed in the prior art. See Pet. 34–35; Pet. Reply 12–13. In light of the cited testimony, we are persuaded that Petitioner has met its burden of proving that a skilled artisan would reasonably have understood or inferred that the limitation for a patient having received a prior cancer therapy drug to treat the tumor was disclosed in the MSI-Study Record. Petitioner demonstrates what one of ordinary skill in the art would have understood from the MSI-H Study Record, not what it inherently discloses. Contra PO Resp. 6–9.” slip op. at 22

  • Skill levelSkill level board ownDecided for petitioner

    “In light of the extent of the relevant field, we determine that the level of skill in the art relevant to the claims of the ’974 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy.” slip op. at 9

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

  Patent outcomesUS 11,325,974 unpatentable
  § 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,325,974
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  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
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  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

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.