- Tanklogix, LLC v. Sitepro, Inc.Institution deniedPTAB · Oct 10, 2025 · IPR2025-00651 · APJ Bart A Gerstenblith · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–3, 6, 7, and 9–20 were unpatentable over any asserted ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“presented in the petition . . . and any [preliminary] response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2024). For the reasons given below, on this record Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of any of the Challenged Claims. Accordingly, we do not institute an inter partes review.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“The parties’ proposed levels of ordinary skill in the art are similar, although Patent Owner proposes two years of experience along with a bachelor’s degree whereas Petitioner proposes “significant” experience. Patent Owner also proposes an alternative with more extensive experience in lieu of a bachelor’s degree. Although we find Petitioner’s proposed qualifications acceptable, we adopt Patent Owner’s proposed qualifications for the purposes of this Decision because they offer a wider range of qualifications that nonetheless comport with the level of ordinary skill necessary to understand and implement the teachings of the ’680 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978). Our analysis and findings herein, however, do not turn on any differences in the parties’ proposed qualifications.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“target value” is part of a command that is sent from a computing device to a server and then to a controller. The controller then receives a measurement of the fluid by a sensor and determines whether the measurement satisfies the “target value.” If the measurement does not satisfy the “target value,” further operations are undertaken. The recited operation sequence makes clear that the plain and ordinary meaning of “target value” is not as Dr. Wooley opines because the particular operating condition that a device is in at a particular time is represented by the measurement taken by the sensor, 11 Some claim language less relevant to construing “target value” was omitted for ease of reference. which the controller then uses to determine whether the measurement satisfies the “target value.” Additionally, claim 1 recites that the “target value” is sent as part of a command to the controller. The “target value” is not sent to the controller from the sensor, as might be expected if the plain and ordinary meaning of “target value” were as Dr. Wooley opines. Petitioner and Dr. Wooley’s construction would also result in “target value” meaning effectively the same thing as the measurement of the fluid by the sensor, a concept that is separately recited in claim 1 and to which the “target value” is compared. The Specification of the ’680 patent does not support Petitioner’s understanding of the plain and ordinary meaning of “target value.” Although the Specification does not recite “target value,” it recites “target state,” and describes “target state” sufficiently to understand the plain and ordinary meaning of “target” as used in “target value” and “target state.” In particular, the ’680 patent explains that “[i]n some embodiments, the process 104 includes receiving, via a network interface, from a remote user device, (e.g., via a command-center server) a command to change a state of a fluid-handling device to a target state.” Ex. 1001, 11:48–51. This portion reflects that the command is seeking to change a state of a fluid-handling device to a target state. In other words, the “target value” or “target state” is not generally “the particular operating condition that a device is in at a particular time”; rather, it is a value or state that the fluid-handling device is desired to be in, as Patent Owner and Dr. Durham explain. Additionally, just as claim 1 recites a directional component for the “target value” to be sent to the controller in a command, so too does the Specification describe a “target state” as being sent in a command from a remote user device. Thus, the Specification clearly supports the plain and ordinary meaning proposed by Patent Owner and Dr. Durham and not the plain and ordinary meaning proposed by Petitioner and Dr. Wooley. slip op. at 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“time-stamped process data, report exception therein to the remote host, and extract and transmit time-stamped process data to the remote host.” Ex. 1005, Abst. (emphases added). Almadi explains that its remote field systems must include a plurality of controller units “to issue commands to, and gather and process data from a plurality of field devices, including remote systems and instruments, . . . [and] a database server for the storage of process data retrieved from the remote subsystems and instruments.” Id. at 2:22–30 (emphases added). Based on these disclosures, we agree with Patent Owner that Petitioner has not established that Almadi discloses element [1.4]. Specifically, the teachings from Almadi identified by Petitioner refer to process data, which is data retrieved from the remote subsystems/field devices. Thus, we understand that Almadi’s teaching—of using an Ethernet switch to transmit “process data”—describes transmitting data from the remote subsystems/field devices. See Ex. 1005, 3:13–17, cited in Pet. 15. But claim 1 and particularly element [1.4], recites “sending, with the server, the target value to the network address [which identifies a controller of the fluid-handling device13] via the network,” which is different than sending process data from the field devices to the remote host or database server for storage.” slip op. at 19
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,175,680 - Tanklogix, LLC v. SiteproInstitution deniedPTAB · Oct 10, 2025 · IPR2025-00650 · APJ Sheila F Mcshane · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 18–32 and 34 were unpatentable over Kahn or Kahn and Gutierrez.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2024). Upon consideration of the Petition, the Preliminary Response, and the evidence of record, we determine that Petitioner has not established a reasonable likelihood of prevailing with respect to the unpatentability of at least one claim of the ’871 patent. Accordingly, for the reasons that follow, we decline to institute an inter partes review of claims 18–32 and 34 of the ’871 patent.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“The respective proposed levels of qualifications for a person of ordinary skill in the art are similar, with Patent Owner proposing two years of experience compared to Petitioner proposing significant experience with remotely controlling fluid-handling devices, like SCADA systems. Patent Owner also proposes more extensive experience in lieu of educational experience. While we find Petitioner’s proposed qualifications to be acceptable, we adopt Patent Owner’s proposed qualifications for the purposes of this Decision because they offer a wider range of qualifications that nonetheless comport with the level of skill necessary to understand and implement the teachings of the ’871 patent and the asserted prior art. Our analysis and findings herein, however, do not turn on any differences in the qualifications adopted.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We determine that we need not expressly construe any claim terms to resolve the parties’ disputes on the current record. See 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))).” slip op. at 10
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“actuators and the remote control of fluid handling devices, including the receipt with the user-interface module of “a user command to actuate an actuator via a presented control interface” (limitation [18.7]) and “account authorized to send commands to remotely control fluid handling devices” (limitation [18.11]). We agree with Patent Owner that the Petition fails to demonstrate that Kahn discloses or teaches these limitations because the evidence does not provide support that there is remote control of fluid handling devices or the use of a user command on a control interface to send a command to a fluid handling device, for instance. Kahn is directed to providing access to fluid sensing data and analyzing and providing visual information on that data, but we do not discern that it teaches or discloses the capability to remotely control fluid handling devices. See, e.g., Ex. 1005, code (54), 1:27–36, 2:50–3:2. More specifically, the Kahn disclosures that Petitioner repeatedly relies upon for allegedly teaching this control are deficient. See Ex. 1005, 10:62–67, 14:35– 15:2, 15:62–16:32; see also Pet. 12–14, 16–18. Kahn discloses that “the communication unit 112B can include on-site alerts such as optical (indicator lights), audible alerts (e.g., alarm sounds), tactile (e.g., vibration of the unit) or can be interfaced to an appropriate control valve for simply shutting off the supply of fluid upon the detection of emergency events, for instance.” Ex. 1005, 10:62–67. Communication unit 112B is part of the local “sensor unit,” wherein the detection conditions determined by the sensor are communicated to remote devices by communication unit 112B. See id. at 3:31–33, 5:62–6:2, 6:27–35, 7:33–37, 13:7–12, Figs. 1A–1C. Kahn discloses that the sensor units, which include communication units 112B, can be located near shut-off valves and can communicate with distant locations. See id. at 11:1–13. There are no disclosures, however, in the above passages that there is remote control of fluid handling devices, that there is a user command on a control interface that actuates an actuator, or that there is a command sent to the facility actuators via a network connection, as required in limitations [18.5]–[18.7] and [18.9]–[18.12], respectively. Rather, the disclosure indicates that the communication unit 112B includes on-site alerts and that the local (non-remote) communication unit 112B can be interfaced with the control valve.” slip op. at 18
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,488,871 - 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 - Synaffix B.V. v. Hangzhou Dac Biotech Co., Ltd.Some claims unpatentablePTAB · Aug 26, 2025 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–17, 20, 21, 24, 26, and 29–31 are unpatentable; claims 25 and 32–34 were not shown unpatentable, and the motion to exclude was dismissed as moot.
RulingsFinal written decision- RemandOther
“review of claims 1–17, 20, 21, 24–26, and 29–34 of the ’682 patent. Paper 2 (“Pet.”), 1, 3. Patent Owner, Hangzhou DAC Biotech Co., Ltd., filed a Preliminary Response (Paper 9, “Prelim. Resp.”). We initially determined that the information presented in the Petition did not establish a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims, and did not institute inter partes review. Paper 17. Petitioner requested Director review of our decision denying institution (Paper 18 (“Request”)). The Director delegated review of the decision to a Delegated Rehearing Panel (“DRP”). Paper 19. Patent Owner was granted the option to file a response to Petitioner’s Request (Paper 22 (“Request Resp.”)). The Delegated Review Panel vacated our decision and remanded the case to this panel with a revised claim construction for claim 1. Paper 23 (“DRP Dec.”). On August 30, 2024, we instituted an inter partes review after remand from the Director. Paper 25 (“Inst. Dec.”). Patent Owner subsequently filed a Patent Owner Response (Paper 31, “Resp.”), Petitioner filed a Reply (Paper 36, “Reply”), Patent Owner filed a Sur-reply (Paper 44, “Sur-reply”), and Petitioner filed a Sur-sur-reply (Paper 48, “Sur-sur-reply”).” slip op. at 2
- PTAB / AIA Trials › Motions to amend / substitute claimsOther
“I. Patent Owner’s Motion to Exclude Evidence Patent Owner moves to exclude Exhibits 1089 and 1090. Paper 50. As we did not rely on either of Exhibits 1089 or 1090 in deciding this matter, Patent Owner’s motion is dismissed as moot.” slip op. at 96
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableMixed
“For these reasons, Patent Owner’s arguments and cited evidence also” slip op. at 31
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed
“function as R2, and the ethyl group may function as R4, which can be a linear alkyl having 1–6 carbon atoms. We note that claim 3 permits R5 and R6 to be absent. For these reasons, the arguments presented in the Petition demonstrate that claim 3 would have been obvious over Singh’s Compound 3 when modified in view of Harris.” slip op. at 73
Patent outcomesUS 10,131,682 mixed§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,131,682 - Abbott Laboratories / Abbott Diabetes Care Inc. v. Altivera LLCAll claims unpatentablePTAB · Jul 15, 2025 · IPR2024-00425 · APJ Bach V Hoang · IPR · Final written decision
Claims 1–3, 5, 9, and 10 are unpatentable as obvious over Beck, Heller, and Lovejoy; the Board did not reach the alternative Bandy grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not dispute this assessment. See generally PO Resp. Having considered the record, we adopt Petitioner’s proposed level of skill, as articulated above. We are satisfied that Petitioner’s proposal comports with the level of skill necessary to understand and implement the teachings of the ’307 Patent. Accord Inst. Dec. 8–9.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“both the unique sensor ID as well as the associated unique wireless device ID is contradicted, or at least unsupported, by the claim language and the Specification. We determine that this limitation does not require authentication of both the unique sensor ID and the unique wireless device ID, or otherwise require authentication using the unique wireless ID. Rather, the limitation only requires authentication of the unique sensor ID. The language and structure of the claim itself, “the remote server authenticates said unique sensor ID associated with said unique wireless device ID,” requires authentication of the unique sensor ID but not the unique wireless device ID. See Ex. 1001, 19:51–52 (emphasis added). The portion of the limitation reciting “associated with said unique wireless device ID” is linguistically an appositive modifying the “unique sensor ID.” Indeed, Patent Owner acknowledges the “plain meaning of the claim term is that the remote server authenticates the unique sensor ID and that such unique sensor ID is associated with a unique wireless device ID.” PO Resp. 18.” slip op. at 10
- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for petitioner
“Patent Owner does not contest Petitioner’s proposed constructions of any of these other claim terms or phrases. PO Resp. 24. We agree with the parties that the identified limitations—which each recite a “means” or “means for” performing a particular function—are means-plus-function limitations that should be interpreted under pre-AIA 35 U.S.C. § 112 ¶ 6. See Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1349 (Fed. Cir. 2015) (en banc) (holding that “use of the word ‘means’ creates a presumption that § 112, ¶ 6 applies”). And we agree with Petitioner’s uncontested identification of the recited functions and corresponding structure for these limitations for the reasons explained by Petitioner. See Pet. 11–15 (citing Ex. 1001, 2:20–21, 2:24–28, 3:33–36, 17:18–30); id. at 13–15 (citing Ex. 1009, 9:4–6, 9:19–20, 9:57–65, 10:10– 11) (explaining that Lovejoy is incorporated by reference into the ’307 Patent). We adopt the uncontested constructions identified by Petitioner, as” slip op. at 15
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“We agree with Petitioner that the improvements offered by the incorporation of Heller’s teachings would have motivated one of ordinary skill in the art to combine the teachings of Beck and Heller in the manner proposed by Petitioner. Confirming Petitioner’s assertion that the combination yields improvements, Heller states that it improves the type of glucose monitor used in one of Beck’s embodiments. Beck states that its “medical device 130 includes a glucose meter” which “measure[s] blood glucose levels of blood applied to test strips.” Ex. 1007 ¶ 34. Specifically addressing such “conventional” test strip glucose monitoring, Heller states that its in vivo glucose sensor system addresses a need for continuous or automatic monitoring in a small, comfortable device. Ex. 1016, 2:1–7, 2:15–58, 3:19–25. As such, we agree that a person of ordinary skill in the art would have been motivated to combine the teachings of Beck and Heller to improve Beck’s medical device. See KSR, 550 U.S. at 401. We further agree with Petitioner that a POSITA would have been motivated to incorporate sensor implementation details described in Heller, e.g., an A/D converter and patient attachment systems, with Beck’s medical device. Pet. 44–45, 53, 55; Ex. 1003 ¶¶ 228, 234, 236–238, 259, 267, 278, which do no more than yield predictable results, e.g., converting signals or attaching a sensor to a patient. See KSR, 550 U.S. at 401 (“[A] combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”).” slip op. at 20
Patent outcomesUS 7,969,307 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 7,969,307 - Interactive Communications International, Inc. v. Blackhawk Network Inc.All claims unpatentablePTAB · Jul 14, 2025 · IPR2024-00465 · APJ Bart A Gerstenblith · IPR · Final written decision
Claims 1–24 are unpatentable: claims 1–10 and 12–24 as obvious over Szrek and Llach, and claim 11 as obvious over Szrek, Llach, and Gilmore.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner proposes that the level of ordinary skill in the art is an artisan with a working knowledge of POS activation systems and lottery systems that was gained through a mixture of training and work experience in the relevant field such as (i) having a Bachelor’s degree in computer science, computer communications, electrical engineering, or equivalent degree, coupled with at least three years of work experience; (ii) having a Master’s degree in computer science, computer communications, or electrical engineering, but having less work experience; or (iii) having no formal degree, but having experience in the relevant field of at least six years of work experience. Pet. 2–3 (citing Ex. 1003 ¶¶ 13–14).9 Patent Owner states that, “[f]or the purpose of this proceeding, Patent Owner adopts the Petition’s proposed definition of the level of ordinary skill in the art.” PO Resp. 19 (citing Pet. 2–3). We find that the parties’ agreed-upon level of ordinary skill in the art is consistent with the level of ordinary skill in the art reflected by the ’451 patent and the prior art of record. See Inst. Dec. 14; see Okajima v. 9 Petitioner proposes the same level of ordinary skill in the art that the Board adopted in PGR2020-00084 (Pet. 2–3 (citing Ex. 1008, 11)), and IPR2023- 01235 (see IPR2023-01235, Paper 34 at 12–13). Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978). Therefore, we adopt the parties’ agreed-upon level of ordinary skill in the art, as articulated above, in our consideration of the issues presently before us.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“We need not construe “transaction processor” expressly because its meaning is not in dispute and its construction is not necessary to resolve the controversy before us.” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“On balance, we find that even with the alleged disadvantages identified by Patent Owner, one of ordinary skill in the art would have been motivated to modify Szrek with Llach’s third-party transaction processor because the advantage of having a “centralized intermediary” allows Szrek’s system to support different game providers, such as different lottery companies, which would reduce some implementation costs and allow the system to be more easily and cheaply extended. Pet. 47 (citing Ex. 1003 ¶ 181); see Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) (“a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine”) (citing Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n.8 (Fed. Cir. 2000)); see also Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 795 (Fed. Cir. 2021) (stating the same). We acknowledge that the combination comes with some disadvantages, including “add[ed] delay, reduce[d] efficiency, and . . . implementation complexities by converting a simple, direct communication exchange into an exchange that traverses multiple systems.” PO Resp. 52 (citing Ex. 2052 ¶ 163). But, “[t]he fact that the motivating benefit comes at the expense of another benefit, however, should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another. Instead, the benefits, both lost and gained, should be weighed against one another.” Winner, 202 F.3d at 1349 n.8. Here, Szrek expressly teaches indirect communication as a possible implementation of its system and Petitioner’s combination—employing Llach’s third-party transaction processor as part of the indirect communication channel—offers the attractive benefit of allowing Szrek’s system to support different game providers, which would reduce some implementation costs even if it might increase other costs, e.g., by having to program certain components (e.g., the cash registers) differently. Specifically, we find that the ability to expand Szrek’s system to support different game providers provides advantages that outweigh the disadvantages discussed above in the circumstance where one desires a more robust and comprehensive system. See Pet. Reply 23 (noting three advantages of the combination— (1) “allow[ing] Szrek’s system to use ‘a centralized system for activating lottery tickets from different retailers and different locations,’” (2) “allow[ing] support for different game providers, such as different lottery companies,” “reduc[ing] implementation costs,” and (3) “allow[ing] Szrek’s system to ‘communicate with individual card” slip op. at 37
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightMotivation foundDecided for petitioner
“On balance, we find that even with the alleged disadvantages identified by Patent Owner, one of ordinary skill in the art would have been motivated to modify Szrek with Llach’s third-party transaction processor because the advantage of having a “centralized intermediary” allows Szrek’s system to support different game providers, such as different lottery companies, which would reduce some implementation costs and allow the system to be more easily and cheaply extended. Pet. 47 (citing Ex. 1003 ¶ 181); see Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) (“a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine”) (citing Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n.8 (Fed. Cir. 2000)); see also Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 795 (Fed. Cir. 2021) (stating the same). We acknowledge that the combination comes with some disadvantages, including “add[ed] delay, reduce[d] efficiency, and . . . implementation complexities by converting a simple, direct communication exchange into an exchange that traverses multiple systems.” PO Resp. 52 (citing Ex. 2052 ¶ 163). But, “[t]he fact that the motivating benefit comes at the expense of another benefit, however, should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another. Instead, the benefits, both lost and gained, should be weighed against one another.” Winner, 202 F.3d at 1349 n.8. Here, Szrek expressly teaches indirect communication as a possible implementation of its system and Petitioner’s combination—employing Llach’s third-party transaction processor as part of the indirect communication channel—offers the attractive benefit of allowing Szrek’s system to support different game providers, which would reduce some implementation costs even if it might increase other costs, e.g., by having to program certain components (e.g., the cash registers) differently. Specifically, we find that the ability to expand Szrek’s system to support different game providers provides advantages that outweigh the disadvantages discussed above in the circumstance where one desires a more robust and comprehensive system. See Pet. Reply 23 (noting three advantages of the combination— (1) “allow[ing] Szrek’s system to use ‘a centralized system for activating lottery tickets from different retailers and different locations,’” (2) “allow[ing] support for different game providers, such as different lottery companies,” “reduc[ing] implementation costs,” and (3) “allow[ing] Szrek’s system to ‘communicate with individual card” slip op. at 37
Patent outcomesUS 11,488,451 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,488,451 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Jun 9, 2025 · IPR2024-00240 · APJ Deborah Katz · IPR · Final written decision
Claims 1–42 are unpatentable: claims 1–42 are anticipated by the MSR, and the Board also finds the challenged claims obvious over the MSR and cited combinations.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“claims a method of treating a human patient with colorectal cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner discloses testing pembrolizumab to treat human patients. (See Ex. 1001, 25:40–50, Ex. 1005; see Decision 8–9.) Accordingly, the relevant field of Patent Owner’s claims is treating human patients, as well as testing existing compounds. Neither party directs us to evidence of the level of skill in the art beyond what we considered for institution of trial. In the Decision to institute trial, we determined that the level of skill in the art relevant to the claims of the ’393 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials. (See Dec. 8–9.) We determined that the level of skill also includes knowledge of and experience with treating colorectal cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy. (See id.) Because the parties do not present additional evidence or argument, we maintain that determination.” slip op. at 9
- Expert testimonyPetitioner expert creditedDecided for petitioner
“what one of ordinary skill in the art would have known and understood at the relevant time. Specifically, Petitioner relies on the testimony of Alfred L. Neugut, M.D., Ph.D., M.P.H.3 (Ex. 1003) and Paul E. Oberstein, M.D. (Ex. 1150). Patent Owner relies on the testimony of Nils Lonberg, Ph.D. (Ex. 2001) and Richard Goldberg, M.D. (Ex. 2090).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“1 requires a causal relationship wherein the patient must be tested for MSI-H and, if he or she is determined to be MSI-H or dMMR, then the patient is treated with 10 mg/kg of pembrolizumab every 14 days. We further agree that this relationship is different than the use of the term “after” in claims 7, 20, and 27, wherein patients must be treated with a different cancer therapy, and wherein the cancer must have later progressed for the treatment to be within the scope of these claims. (Ex. 1001, 25:66–7, 26:44–46, 26:63–64.) In claim 1, a biological sample from the patient must be tested to determine if the cancer is MSI-H and, if so, the patient is treated with a therapeutically effective amount of pembrolizumab. For this reason, if the prior art teaches the limitations of 1) testing a biological sample obtained from a patient having colorectal cancer to determine that the patient’s colorectal cancer is microsatellite instability high or mismatch repair deficient, and 2) treating the patient with a therapeutically effective amount of pembrolizumab if the patient’s colorectal cancer is determined to be microsatellite instability high or DNA mismatch repair deficient, the art anticipates claim 1. We are not persuaded that claim 1 requires or excludes anything else because nothing else is recited in the claim.” slip op. at 12
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Microsatellite Unstable (MSI) Tumors.” (Ex. 1005, 2.) The parties’ witnesses agree that MK-3475 is pembrolizumab, the compound recited in claim 1. (See Neugut Decl., Ex. 1003 ¶ 37; see Lonberg Decl., Ex. 2001, ¶ 65.) Patent Owner does not dispute Petitioner’s assertion that the MSR was published on a government web site on June 10, 2013, more than two years before the priority date of the ’393 patent on July 10, 2015. (See Pet. 7 (citing Ex. 1005, 3, Ex. 1003 ¶ 35).)” slip op. at 17
Patent outcomesUS 11,591,393 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,591,393 - Intel Corporation / Lenovo (United States) Inc. et al. v. Collision Communications, Inc.Institution deniedPTAB · May 28, 2025 · IPR2025-00301 · APJ Bart A Gerstenblith · IPR · Institution
The Board denied institution of review for claims 1–11, 16, and 21 under § 314(a), finding the Fintiv factors favored discretionary denial, and denied joinder.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivInstitution denied
“2026. This date is nearly five months prior to the date on which the final written decision would be due if trial were instituted in this proceeding. And, even if we assume Petitioner’s alleged February–March 2026 trial date, this date too is several months prior to the projected final written decision deadline. As such, it is unlikely that a final written decision in this proceeding would issue before trial in the district court, unless the trial was delayed or rescheduled for a later time. Thus, we find this factor weighs in favor of exercising our discretion to deny institution. See ARM Ltd. v. Daedalus Prime LLC, IPR2025-00207, Paper 10 at 2 (May 16, 2025) (Before the Office of the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office) (exercising discretion to deny institution with the same relative timing between district court trial and final written decision deadline).” slip op. at 13
- PTAB / AIA Trials › Motions to amend / substitute claimsNot reached
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, deniedDenied
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied discretionary otherInstitution denied
“presented in the petition . . . and any [preliminary] response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Institution of inter partes review, however, is discretionary. See Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“[T]he PTO is permitted, but never compelled, to institute an IPR proceeding.”). For the reasons discussed below, we exercise discretion pursuant to 35 U.S.C. § 314(a) not to institute inter partes review. Additionally, for the same reasons and because institution was denied in IPR2024-01248, we deny Petitioner’s Motion for Joinder. See 35 U.S.C. § 315(c) (“[T]he Director . . . may join as a party . . . any person who properly files a petition under section 311 that the Director . . . determines warrants the institution of an inter partes review under section 314.”).” slip op. at 3
Discretionary denialPatents in suitUS 9,814,071
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.