- Samsung Electronics Co. Ltd. / Samsung Electronics America, Inc. v. Maxell, Ltd.All claims unpatentablePTAB · Oct 30, 2025 · IPR2024-00828 · APJ Terrence W Mcmillin · IPR · Final written decision
Claims 1, 2, 4–7, and 9–14 are unpatentable as obvious over the Rogers-based combinations with Rosenberg, Rekimoto, and, for claims 9–14, Miyazawa.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“13 The Court was very critical of Dr. Wobbrock’s testimony in the related district court case. See generally Ex. 1026 (September 18, 2025 Order). With regard to the ’086 patent, the Court found that Dr. Wobbrock’s testimony was not based on any record evidence (id. at 7, 9), arbitrary (id.), contrary to the evidence (id. at 7–8), unjustified (id. at 8), ipse dixit (id. at 9), conclusory (three times) (id.), insufficient to support a jury verdict (three times) (id. at 9, 27), untethered from the Specification (three times) (id. at 28, 30, 31), inconsistent (id. at 29), insufficient to support his opinion (id. at 29–30), unsupported (id. at 30), and not to be credited by a reasonable jury (id. at 31). We have considered this criticism of Dr. Wobbrock’s testimony in view of the September 16, 2025, Memorandum to the Members of the Patent Trial and Appeal Board on the subject of “PTAB consideration of prior findings of fact and conclusions of law” (available at: https://www.uspto.gov/sites/default/files/documents/Memo_re_prior_finding s_of_fact_and_conclusions_of_law_9_16_25.pdf?utm_campaign=subscripti oncenter&utm_content=&utm_medium=email&utm_name=&utm_source=g ovdelivery&utm_term=) and in light of the case law (see, e.g., N.L.R.B. v. Pittsburgh S.S. Co., 337 U.S. 656, 659 (1949) (“[I]n the determination of litigated facts, the testimony of one who has been found unreliable as to one issue may properly be accorded little weight as to the next.”). We have similarly found Dr. Wobbrock’s testimony to be contrary to the plain and ordinary meaning of the claims, untethered from the Specification, unsupported by the evidence, inconsistent, arbitrary, and conclusory. We accord the testimony of Dr. Wobbrock little or no weight. We view the testimony of Petitioner’s expert, Dr. Nielson, as more credible and persuasive as it tracks more closely with the ’086 patent and the cited art. EcoFactor, Inc. v. Google LLC, 137 F.4th 1333, 1339 (Fed. Cir. 2025) (quoting Daubert v. Merrell Dow Parms., Inc., 509 U.S. 579, 597, 589 (1993) (“The Supreme Court has explained ‘that the trial judge plays a “gatekeeping role,’” ‘through which it must “ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable.’”)).” slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“with touch interfaces.” PO Resp. 8 (citing Ex. 2005 ¶¶ 76–77). Although there are minor differences in these definitions of the level of ordinary skill in the art, the parties agree that this issue is not disputed. Tr. 11:24–26 (Petitioner’s counsel); 43:16–22 (Patent Owner’s counsel indicating agreement with Petitioner’s definition); see also Pet. Reply 1 (“The experts agree on the definition of ordinary skill in the art (‘POSITA’).” Determining the level of ordinary skill in the art involves various factors, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citation omitted). The prior art of record also reflects the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). We adopt the assessment offered by Petitioner as it is not disputed and is consistent with the ’086 patent and the asserted prior art.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“We find no support in the language of claim 1 for construing the “first registering mode” and the “second registering mode” as “operating modes,” or as “different operational states,” or “sub-operating modes of the ‘said registering mode’” as contended by Patent Owner. There is no express statement in claim 1 that the “first registering mode” and the “second registering mode” are “operating modes,” or are “different operational states,” or are “sub-operating modes of the ‘said registering mode.’” The language of claim 1 is clear that the only two “operating modes” explicitly recited in claim 1 are the “identification mode” and the “registration mode.” Claim 1 recites that these two “modes” are “operating modes,” but does not recite that the “first registering mode” and the “second registering mode” are “operating modes.” The language of claim 1 cannot be read to include the requirements that the “first registering mode” and the “second registering mode” are “operating modes,” or are “different operational states,” or are “sub-operating modes of the ‘said registering mode.’” Rather, we agree with Petitioner that the language of limitation 1c that specifically refers to the “registering mode” as an “operating mode” and the language of limitation 1f that refers to the “first registering mode” and the “second registering mode” as “mode[s] for inputting input information” that are “provided in said registering mode” contradicts Patent Owner’s proposed construction that would require the “first” and “second registering mode[s]” to be “different operational states.” The plain and ordinary meaning of the language of claim 1 provides that the “first registering mode” and the “second registering mode” are “mode[s] for inputting input information” that are “provided in said registering mode” which is one of the two delineated “operating modes.” Both “first” and “second” “registering mode[s]” ”for inputting input information” are recited as “provided in said registering mode,” a single “operating mode.”17” slip op. at 17
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“Both references are directed to allowing users to input information via touchsurface technology and are analogous art to the ’086 patent. . . . [A] POSITA would have found Rogers and Rosenberg to be compatible because of the technical similarity of their teachings, and a POSITA would have further recognized that Rosenberg’s finger orientation disclosures, applied to Rogers’ graphical passcode disclosures, would facilitate a “natural and intuitive” means of implementing the teachings of Rogers. A POSITA therefore would have been motivated to look to Rosenberg to improve Rogers, and vice-versa. . . . A POSITA . . . would have considered the disclosures in Rosenberg and been motivated to modify Rogers’ “large fingertip and a small stylus tip” example so that it instead used the “natural and intuitive” finger pad versus finger end distinction discussed in Rosenberg. A POSITA would have found this modification to be a simple substitution of elements well known in the art and would have had a reasonable expectation of success in achieving the benefits disclosed in Rosenberg by making the modification, which involved only routine skill. . . . [A]dding finger end and finger pad touch detection to Rogers would involve no more than applying a known technique (i.e., finger end and finger pad touch detection/distinction as taught by Rosenberg) to a known device ready for improvement (Rogers’ apparatus having “large fingertip and a small stylus tip” capabilities) to yield predictable results (simple to use touch screen interface with multipoint targeting and multi-finger gesturing). . . . It also would have been obvious to combine Rogers with Rosenberg because both references disclose touch screen interfaces that detect a contact area of a finger. . . . A POSITA would have considered Rosenberg’s disclosures and been motivated to modify the “graphical passcode” features of Rogers so that the disclosed device is capable of detecting information input by a pad or end of a finger, because it would provide a “generally easily distinguishable” basis upon which to program the device disclosed in Rogers to detect a “measurable parameter” based on “contact area.” A POSITA would have further recognized that these features of Rogers and Rosenberg could be successfully combined because both references teach a “calibration” mode in which the user trains the device to recognize a specific range of input parameters that allows for some variation in input while remaining within acceptable tolerances. . . . A POSITA would have had a reasonable expectation of success in modifying Rogers in this manner for at least the same reasons.” slip op. at 60
Patent outcomesUS 8,982,086 unpatentableClaim construction§ 103 obviousnesscites GrahamPatents in suitUS 8,982,086 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,934,356 - Valve Corporation v. Immersion CorporationAll claims unpatentablePTAB · Oct 24, 2025 · IPR2024-00714 · APJ Christopher L Ogden · IPR · Final written decision
Claims 1–20 are unpatentable: Goldenberg anticipates or renders claims 1–6, 8–13, and 15–19 obvious, and Goldenberg with Cruz-Hernandez renders claims 7, 14, and 20 obvious.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“The parties’ proposed levels of ordinary skill are substantially similar, supported by testimonial evidence, and consistent with the asserted prior art and the types of problems and solutions in the ’907 patent. See, e.g., Ex. 1001, 1:14–62. Because we discern no dispositive difference between the parties’ proposals, and neither party has argued that the choice between the two would affect the outcome,6 we adopt Petitioner’s proposed level of skill for this decision. We note, however, that our decision would be the same under Patent Owner’s proposal.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“to,” as recited in each of claims 1, 8, and 15, to “require[] a cause-and-effect relationship between a secondary event (e.g., a haptic effect) that occurs in reaction to a first event (e.g., entry of the user input element to one or more positions within the boundary range of positions).” PO Resp. 26–27 (citing Ex. 2004 ¶ 44). Patent Owner argues that “in response to” refers to more than just a coincidence and involves at least some degree of causality. Id. at 27 (citing American Calcar, Inc. v. American Honda Motor Co., 651 F.3d 1318, 1339–40 (Fed. Cir. 2011); Ex. 2007, 12–14 (dictionary definition); Ex. 2008, 7 (dictionary definition); Ex. 2006, 30:13–31:2, 32:8–11, 32:17– 21 (testimony by Mr. Ward)); PO Sur-reply 8–9 (citing Ex. 2009, 34:8–19, 36:5–21 (testimony by Mr. Ward)).” slip op. at 17
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner
“to,” as recited in each of claims 1, 8, and 15, to “require[] a cause-and-effect relationship between a secondary event (e.g., a haptic effect) that occurs in reaction to a first event (e.g., entry of the user input element to one or more positions within the boundary range of positions).” PO Resp. 26–27 (citing Ex. 2004 ¶ 44). Patent Owner argues that “in response to” refers to more than just a coincidence and involves at least some degree of causality. Id. at 27 (citing American Calcar, Inc. v. American Honda Motor Co., 651 F.3d 1318, 1339–40 (Fed. Cir. 2011); Ex. 2007, 12–14 (dictionary definition); Ex. 2008, 7 (dictionary definition); Ex. 2006, 30:13–31:2, 32:8–11, 32:17– 21 (testimony by Mr. Ward)); PO Sur-reply 8–9 (citing Ex. 2009, 34:8–19, 36:5–21 (testimony by Mr. Ward)).” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“To show anticipation under § 102, a petitioner must locate every element in a claim, arranged as recited in the claim, in a single prior art reference. See Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). The limitations may be present in the reference “either explicitly or inherently.” In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). In making this determination, we consider the reference “together with the knowledge of one of ordinary skill in the pertinent art.” In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994) (citing In re Samour, 571 F.2d 559, 562 (CCPA 1978)).” slip op. at 18
Patent outcomesUS 10,627,907 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,627,907 - Google LLC v. Dialect, LLCAll claims unpatentablePTAB · Oct 17, 2025 · IPR2024-00753 · APJ Jon M Jurgovan · IPR · Final written decision
Claim 12 is unpatentable as obvious over Kennewick and Ross because their combination teaches each limitation and a skilled artisan would have had reason to combine them with a reasonable expectation of success.
RulingsFinal written decision- BurdenUnpatentable
“A. Legal Principles “In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to the patent owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). The burden of production, however, may shift between the petitioner and patent owner as arguments and evidence are presented during the proceeding. Id. A patent claim is unpatentable under 35 U.S.C. § 103 if the differences between the claimed subject matter and the prior art are such that the subject matter, as a whole, would have been obvious at the time the invention was made to a person having ordinary skill in the art (“POSITA”) to which said subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence of nonobviousness.2 See Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).” slip op. at 8
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner contends a POSITA pertaining to the ’160 patent “would have possessed a bachelor’s degree in electrical engineering or computer science, and two years of work experience in the field of speech and natural language-interfaces for interacting with and directing computer systems and software, including speech recognition and processing (and more experience could substitute for less formal education, and vice versa).” Pet. 10; Ex. 1002 ¶¶ 11–15. Patent Owner does not respond to Petitioner’s formulation of the level of ordinary skill in the art. See PO Resp. generally. We determine that Petitioner’s proposed skill level is consistent with the problems and solutions identified in the ’160 patent and the prior art references asserted by Petitioner. In addition, we find the skill level consistent with the education and experience that a POSITA would have had. See In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citing Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986)) (citing factors to consider when determining level of ordinary skill in the art). Accordingly, we adopt Petitioner’s proposed skill level to apply in this proceeding.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“After review of the evidence, we determine that the record does not support Patent Owner’s construction of “expected contexts” as “a subset of the contexts in a context stack.” PO Resp. 16–17. The sole mention of “expected contexts” in the ’160 patent’s description is the following: “The knowledge-enhanced speech recognition may access a set of expected contexts that are stored in a context stack to determine a most likely context.” Ex. 1001, 13:66–14:2. This statement does not provide any definition for “expected contexts.” Although the ’160 patent’s description mentions a “set,” this is not the same as a “subset” as Patent Owner proposes in its construction. Similarly, claims 1, 12, 13, and 15 of the ’160 patent recite “one or more expected contexts” but do not elaborate further on what an “expected context” is. Likewise, “expected contexts” were mentioned but not discussed or defined in the prosecution history of the ’160 patent. Ex. 1012, 281, 305, 382. Consequently, we decline to restrict the construction of “one or more expected contexts” as Patent Owner proposes. To the extent that Patent Owner so argues, we do not consider “expected contexts” to require the use of “context specific matchers.” In this regard, the ’160 patent states that “knowledge-enhanced speech recognition may use context specific matchers that are able to identify context such as time, location, numbers, dates, categories (e.g., music, movies, television, addresses, etc.) and other context.” Ex. 1001, 14:2–6 (emphasis added). Hence, the ’160 patent states that “contexts” may be identified using “context specific matchers” but this is not required. We further decline to interpret “one or more expected contexts” to exclude “possible contexts” as Patent Owner argues. Simply put, we find no support in the ’160 patent or elsewhere that “expected contexts” cannot be “possible contexts” or that the two terms are mutually exclusive of one another. Although the ’160 patent mentions scoring “possible contexts” (Ex. 1001, 21:7–9), we find no reason why these “possible contexts” cannot also be “expected contexts.” Although we agree with Petitioner that “expected contexts” are ones” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“motivations to combine with reasonable expectation of success. However, in its Sur-reply, Patent Owner argues that Petitioner’s combination “makes no sense” because Ross’s contexts are arranged in order by recency of access such that no scoring is required to find a selected context, whereas Kennewick scores every context in the context stack to select a context. PO Sur-reply 9–10. Patent Owner further argues that Ross’s context grammars are fixed whereas Kennewick’s are dynamic according to prior utterances, and that Ross’s search ends upon finding a match whereas Kennewick scores the entire context stack. Id. at 10. Patent Owner’s late arguments, to which Petitioner has not had an opportunity to respond, do not undermine Petitioner’s proposed motivations to combine with reasonable expectation of success. See 37 C.F.R. § 42.23(b). Patent Owner’s arguments hinge on its assertion that “expected contexts” are not scored and are dynamic, but the ’160 patent does not define “expected contexts” in this way. See § III.C, supra. Furthermore, we do not agree that Ross’s search necessarily ends upon finding a match or that Kennewick and Ross are otherwise incompatible. See Inst. Dec. 19–22. Thus, we find that Petitioner has demonstrated by a preponderance of the evidence that a POSITA would have been motivated to combine Kennewick and Ross with a reasonable expectation of success to arrive at the claimed invention. 4.” slip op. at 22
Patent outcomesUS 7,640,160 unpatentableClaim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 7,640,160 - Prime Time Toys LLC / Prime Time Toys Ltd. et al. v. Spin Master, Inc.No claims unpatentablePTAB · Oct 10, 2025 · IPR2023-01339 · APJ Brent M Dougal · IPR · Final written decision
Claims 4–9, 12, and 14 were not shown unpatentable because Petitioner failed to establish a reason to combine Peev and Spitballs.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedOther
“We agree that the three definitions are similar. The parties do not advocate for any particular definition. We also determine that no distinction between the definitions is material to this Decision. As such, we do not repeat all three definitions and accept Patent Owner’s definition as most closely fitting the legal requirements: a bachelor’s degree in mechanical engineering, industrial design, or equivalent, with at least one year of relevant experience designing projectile launching systems but would also be a member of a team, which would include a person with a bachelor’s in materials science, chemistry, or equivalent (e.g., chemical engineering), or has at least one year experience working with materials for use in consumer products equivalent work experience may substitute for educational experience, and vice versa” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither Petitioner or Patent Owner advocate for the construction of any particular claim term. Pet. 20–21; see generally PO Resp. We determine that no terms require express construction. 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 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“conducting this kind of basic muzzle energy analysis—a conventional, even industry standard technique at the time—would not have concluded that the polymer balls that Spitballs teaches are a safer form of ammunition simply because they are softer than lightweight airsoft rounds,” because the record supports it. Ex. 2015 ¶ 59. slip op. at 12
- Obviousness (§103) › Objective indicia / secondary considerationsNot reached
“that softer ammunition was a possible solution and that Vat19 shows Spitballs exploding on contact with a person without harm. Reply 28–30 (citing Paper 12, 16–17; PO Resp. 63). However, we agree with Patent Owner, that Kim and Vat19 do not disclose all of the limitations of the claims. PO Resp. 61–62; PO Sur-reply 26; Ex. 1004, 302:7–22; Ex. 1022, 8, 9; Ex. 1024; Ex. 2007, 100 (ALJ concluding “there is no disclosure that [Kim’s] gel material is a SAP”); Ex. 2015 ¶¶ 236–239. Petitioner makes no assertions to the contrary. See Pet. 57–60; Reply 28–30. As discussed above, the full record does not support that one of ordinary skill in the art would have combined Peev and Spitballs for the reasons asserted by Petitioner. Petitioner’s insufficient evidence of simultaneous invention does not overcome that deficiency.” slip op. at 21
Patent outcomesUS 8,640,683 not shown unpatentableClaim construction§ 103 obviousnesscites GrahamPatents in suitUS 8,640,683 - Prime Time Toys LLC / Prime Time Toys Ltd. et al. v. Spin Master, Inc.No claims unpatentablePTAB · Oct 10, 2025 · IPR2023-01348 · APJ Neil T Powell · IPR · Final written decision
The Board held claims 2, 3, 5–15, 17, and 19–21 not shown unpatentable over Spitballs and Peev because the evidence did not establish an obvious reason to use the SAP ammunition in Peev’s airsoft gun.
RulingsFinal written decision- Adverse judgmentAdverse judgmentOther
“After the Petition was filed, Patent Owner disclaimed independent claim 1 and dependent claim 4 of the ’282 patent. Prelim. Resp. 26; Ex. 2013. Accordingly, we need not reach Petitioner’s challenges to claims 1 and 4. E.g., 37 C.F.R. § 42.107(e). Thus, the remaining challenged claims are claims 2, 3, 5–15, 17, and 19–21.” slip op. at 2
- Skill levelSkill level board ownOther
“that were proposed in the ITC proceeding as “similar” and noting the ITC ALJ’s determination that “all of the proposals are appropriate,” Petitioner does not argue for the application of any particular level of skill in the art in this proceeding. Pet. 20 (citing Ex. 1015, 8). We too find the definitions advanced in the ITC proceeding similar. Indeed, any differences between the definitions do not rise to a level that would affect our analysis of whether the Petition and associated evidence are sufficiently persuasive for purposes of institution. In our view, the foregoing level of ordinary skill in the art proposed by Patent Owner in the ITC proceeding best fits the legal requirements. Accordingly, we adopt and apply that level of ordinary skill in the art in our analysis of the merits.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties’ arguments and evidence do not raise any issues that necessitate an express claim construction in order to determine whether Petitioner has demonstrated by a preponderance of the evidence the unpatentability of at least one of the challenged claims. Accordingly, we need not and do not expressly construe any claim language. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (holding that only claim terms in controversy need to be construed, and only to the extent necessary to resolve the controversy (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 11
- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“success in an airsoft gun such as Peev, including rubber, cork, foam, and soft plastics, such as SAPs.” Ex. 1016 ¶ 78; Pet. 37. For multiple reasons, this testimony fails to support Petitioner’s suggestion that using SAP ammunition in Peev’s airsoft gun was among a finite number of identified, predictable solutions. For example, because Mr. Delman does not support this testimony with objective supporting evidence, it is not entitled to persuasive weight in Petitioner’s favor. Ex. 1016 ¶ 78; 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Additionally, even if Mr. Delman substantiated his view that an ordinarily skilled artisan “could have considered” SAPs as airsoft ammunition, that would not persuade us that SAPs were identified, predictable solutions for airsoft ammunition.” slip op. at 17
Patent outcomesUS 8,371,282 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,371,282 - Prime Time Toys LLC / Prime Time Toys Ltd. et al. v. Spin Master, Inc.No claims unpatentablePTAB · Oct 10, 2025 · IPR2023-01461 · APJ Hyun J Jung · IPR · Final written decision
Claims 1, 2, 13, and 15–20 were not shown unpatentable because Petitioner failed to establish a sufficient motivation to combine Peev and Spitballs, including with Moorhouse.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“The parties do not address the adopted level of ordinary skill in the art. See PO Resp.; Pet. Reply; PO Sur-reply. Based on the full record, we maintain and affirm that one of ordinary skill in the art would have had: a bachelor’s degree in mechanical engineering, industrial design, or equivalent, with at least one year of relevant experience designing projectile launching systems but would also be a member of a team, which would include a person with a chemical engineering), or has at least one year experience working with materials for use in consumer products and that “equivalent work experience may substitute for educational experience, and vice versa.” Pet. 21–22 (quoting Ex. 1015, 7–8); see also Ex. 1016 ¶ 55 (stating that “Patent Owner’s and Petitioner’s definitions of the [person of ordinary skill in the art] are similar, and my opinions in this Declaration would not change if I used Patent Owner’s definition of the [person of ordinary skill in the art] rather than Petitioner’s definition”). We find that the proposed level of ordinary skill in the art is consistent with the ’255 patent and the asserted prior art.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither Petitioner nor Patent Owner proposes any interpretation for any claim term. Pet. 23; see PO Resp. Petitioner notes that the ALJ in the ITC proceeding construed two terms used in the ’282 and ’683 patents, specifically “super absorbent polymer” and “a firing mechanism that directly applies a force to the ammunition.” Pet. 23 (citing Ex. 1015, 12, 14). Based on the full record, we determine that no term requires express construction to resolve the parties’ dispute. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to 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 8
- Expert testimonyPetitioner expert discountedMixed
“we give little weight to the opinion of Dr. Courtney on whether Spitballs would have been considered liquid filled by one of ordinary skill in the art. Pet. Reply 15–16; PO Sur-reply 18; Ex. 1037 ¶ 55; Ex. 2121, 61:12–13; see also PO Sur-reply 14–15 (arguing that Dr. Courtney does not meet the adopted level of ordinary skill in the art). We agree with Patent Owner that Petitioner’s list of “rubber, cork, foam, and soft plastics, such as SAPs” “does not exclude all of the other types of materials Petitioner failed to address—e.g., the gelatin materials used to make paintballs.” PO Resp. 24 (citing Ex. 2117, 1). The “openended” list “has no meaningful evidentiary support” because the cited paragraphs from its declaration “make no reference at all to potential airsoft ammunition.” Pet. 38; PO Resp. 24; Ex. 1016 ¶ 77; Ex. 1017 ¶¶ 36–39, 46– 48. Petitioner’s declarant Dr. Reitman also “acknowledged that airsoft considerations are beyond the scope of her testimony.” Ex. 2030, 117:17– 118:20. We agree with Patent Owner that Petitioner’s list would include “countless distinct polymers.” PO Resp. 25; Ex. 2120, 27–28.” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“In other words, Petitioner does not squarely address the testimonial evidence that the softness of Spitballs would not have been equated with safety, because of its higher weight and kinetic energy. Ex. 2015 ¶¶ 44–55. We agree with Patent Owner that Petitioner does not assert fragmentation and deformation would have overcome the greater kinetic energy of the heavier Spitballs, and that Petitioner’s declarant admitted such calculation was not done. PO Sur-reply 7 (citing Ex. 2121, 48:11–49:7); Ex. 2121, 48:11–49:7 (Petitioner’s declarant testifying that calculations of how much kinetic energy is absorbed when Spitballs bounce or explode were not done). Petitioner’s declarant also identified that back splatter can create an additional safety concern. Ex. 2121, 101:14–104:4. We agree with Patent Owner that Petitioner failed to discuss the deformation and fragmentation of Spitballs in its Petition and declarations. PO Sur-reply 6 (citing Pet. Reply 10–11; Ex. 1037 ¶ 43). We also agree that Petitioner did not explain how one of ordinary skill in the art could have reliably assessed the safety of Spitballs and airsoft rounds. Id.; see also Ex. 2121, 47:1–48:10 (Petitioner’s declarant testifying that experimentation would be the best way to quantify how much kinetic energy is absorbed through deformation and fragmentation of a given projectile). focused on the mass and diameter calculations provided by Petitioner’s declarant, and Petitioner has the burden to analyze a projectile other than the one disclosed in Spitballs, not Patent Owner. PO Sur-reply 10–11 (citing Pet. Reply 13; Ex. 1017 ¶ 67; Ex. 2015 ¶ 59). Petitioner failed to do such an analysis of a 6mm Spitball or SAP projectile. Regarding Petitioner’s reliance on deposition testimony from the ITC proceedings, as argued by Patent Owner, its declarant agreed that making ammunition softer would make injury less likely, if all other parameters were equal, not larger and heavier like a substitution with Spitballs. PO Resp. 16–17 (citing Pet. 37; Ex. 1004, 531:25–532:9; Ex. 2015 ¶¶ 60–61); Ex. 1017 ¶ 67 (Petitioner’s declarant opining that Spitballs can “grow up to 200 times their original size” to reach a mass of 1.844g); Ex. 1037 ¶ 39 (Petitioner’s declarant agreeing that “when all other variables are held constant, heavier is less safe, meaning injury potential is increased”); Ex. 2015 ¶¶ 54–59 (Patent Owner’s declarant opining that heavier and softer ammunition can pose more injury risk); Ex. 2016, 11 (indicating that airsoft ammunition typically comes in weights from 0.12g to 0.25g). We, thus, agree with Patent Owner that Petitioner fails to prove that” slip op. at 16
Patent outcomesUS 8,596,255 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 8,596,255 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,629,187 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,649,287 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,634,491
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.