- Shenzhen Tuozhu Technology Co., Ltd. v. Stratasys, Inc.All claims unpatentablePTAB · Sep 28, 2026 · IPR2025-00611 · APJ Christopher L Ogden · IPR · Final written decision
Claims 1–10, 12, 13, 19, and 20 are unpatentable under § 103 over the stated Douglas–Mark and Hamilton-based grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“The parties agree that experience could substitute for a degree, and vice versa. Pet. 3; PO Resp. 10. The parties’ proposed levels of ordinary skill are substantially similar. For this decision, as in the Institution Decision, we adopt Petitioner’s proposed level, which is supported by credible testimonial evidence and is consistent with the problems addressed in the ’774 patent. See Ex. 1001, 1:16–52. Our decision would be the same, however, if we were to adopt Patent Owner’s proposal.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other
“Neither Petitioner nor Patent Owner argues that we need to construe any claim terms explicitly. See Pet. 2–3; PO Resp. 10. However, the parties contest two material claim-construction issues which we address below. To the extent that the parties’ positions depend on interpreting other claim language in a particular way, we discuss the relevant claim language below in the context of the parties’ arguments regarding the prior art.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“We disagree with Patent Owner that a person of ordinary skill in the art would have understood that limitation 1.2 must be performed before limitations 1.3 or 1.4. See Ex. 1001, 35:21–24. See Interactive Gift Exp., Inc. v. Compuserve Inc., 256 F.3d 1323, 1342 (Fed. Cir. 2001) (“Unless the steps of a method actually recite an order, the steps are not ordinarily construed to require one.” (citing Loral Fairchild Corp. v. Sony Corp., 181 F.3d 1313, 1322 (Fed. Cir. 1999)). The evidence suggests that a “target printer” is any printer that is ultimately selected for fabricating the object, and such a printer could send its configuration information either before or after that determination is made in limitation 1.2. This interpretation does not render the word “target” meaningless. At some point, a printer must be determined to be the target printer, which is the one intended to ultimately fabricate the three-dimensional object. But the target printer still exists, and is capable of being queried, before that determination is made. We find the examples in the ’774 patent pertinent to this question. The ’774 patent states that “the target printer may include more than one printer.” Ex. 1001, 18:66–67. In discussing the step of “query target printer for properties 306” (Fig. 3A), the ’774 patent states that “[i]n one aspect, numerous queries are sent to numerous printers, e.g., for use in selecting one or more of the printers as the target printer.” Id. at 19:8–10. Alternatively, “the query is sent to a printer that is not necessarily the target printer as described herein, e.g., when the query or information received from a response to the query is used for the selection of the target printer.” Id. at 19:11–14. Importantly, the second embodiment states that the queried printer “is not necessarily the target printer,” suggesting that the queried printer could be the target printer even before it is determined to be such. Id. at 19:11–12 (emphasis added). Based on the evidence of record, a person of ordinary skill in the art would have understood that the “target printer” can be determined after the query recited in limitation 1.3 or the reception of configuration information recited in limitation 1.4. Thus, the evidence does not impose an ordering between limitations 1.2 and 1.3 or between limitations 1.2 and 1.4. The evidence also does not support Patent Owner’s argument that the two reverse-order examples in the ’774 patent are unclaimed embodiments.” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightMotivation foundDecided for petitioner
“We disagree that Petitioner’s arguments are based on impermissible hindsight, because they are based on the disclosures in Douglas and Mark, and Petitioner has articulated a persuasive reason to combine those references without referring to the ’774 patent itself, as we discuss below. See In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971) (an obvious rationale is not improper hindsight if it “takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure”).” slip op. at 29
Patent outcomesUS 11,886,774 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,886,774 - Arashi Vision (U.S.) LLC (D/B/A Insta360) v. Gopro, Inc.Some claims unpatentablePTAB · Nov 26, 2025 · IPR2024-00984 · APJ Nabeel U Khan · IPR · Final written decision
Claims 6 and 7 are unpatentable as obvious over Meulen and Chao; claim 1 was not shown unpatentable because Meulen does not disclose transforming an image captured by its camera.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner argues that a person of ordinary skill in the art in the relevant field “would have a bachelor’s degree in engineering or computer science, or equivalent field, and two years of experience working on image or video processing, or digital cameras,” or alternatively “would have four years of experience working on image or video processing, or digital cameras.” Pet. 6. Petitioner further argues that an “advanced graduate degree” may “make up for the work experience.” Id. (citing Ex. 1002 ¶¶ 33–34). “Patent Owner applies Petitioner’s proposed level of skill.” PO Resp. 4–5 (citing Ex. 2027 ¶¶ 19–20). We adopt Petitioner’s proposed level of ordinary skill because it is consistent with the level of skill in the art at the time of the invention as reflected by the ’413 patent and the cited prior art.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“From the outset we note that the words of the claim recite “non- uniformly shift[ing] the pixels” and do not recite a “non-linear” transformation. This favors Petitioner’s position, which is based directly off the definition of “non-uniform,” over Patent Owner’s position, which substitutes “non-linear” for “non-uniform.” Generally, then, we would determine the ordinary and customary meaning of the claim term in the context of the entire Specification. Here, however, the ʼ413 patent does not mention “uniform” or “non-uniform” shifting of pixels anywhere except in the claims. The Specification, therefore, provides limited guidance, by itself, as to the ordinary and customary meaning of the term. Nonetheless, even reviewing the portions of the Specification cited by the parties, we see no clear or unambiguous effort to limit the challenged claims to require only non-linear transformations in which the pixels to which a transformation is applied do not have the same amount of shift. is not non-linear. Pet. Reply 1. Specifically, Petitioner argues that the center circle of Figure 2B maintains the original circular shape after the transformation is applied to the image which contradicts Patent Owner’s argument that no two pixels will have the same amount of shift. Pet. Reply 1–2. We agree. In Figure 2B of the ʼ413 patent, the center of the image is chosen to be the region of interest. Ex. 1001, 4:19–21. After the input image goes through linear scaling (step 204) and then non-linear warping (step 206) the circles become more vertically compressed as they approach the top and bottom edges and more horizontally stretched as they approach the left and right edges. Id. at 4:22–30. But “the center circle is fully corrected so that it maintains the original circular shape of the corresponding circle in the input image 212.” Id. at 4:23–25. This means that at least some pixels, such as those of the center circle, undergo the same amount of shift after being transformed.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“readable instructions” of claims 1 and 2 must occur in a particular order. Specifically, Patent Owner argues that the step of “determine a portion within the input image” must occur after “obtain[ing] an image” and before “apply[ing] a transformation to the input image.” PO Resp. 17 (citing Ex. 2027 ¶ 59). Petitioner argues, on the other hand, that the specification does not require such an order and, in fact, describes an embodiment where such an order is not followed. Pet. 3. We determine that the “determine a portion within the input image” step does not need to occur after the “obtain an image” step and before the “apply a transformation to the input image” step. As Patent Owner itself points out, claims 1 and 2 are apparatus and system claims respectively, and an ordering of the limitations of such claims is not necessary. PO Resp. 17. Even if we were to treat the apparatus and system claims as reciting the steps of a method, “as a general rule the claim is not limited to performance of the steps in the order recited, unless the claim explicitly or implicitly requires a specific order.” Baldwin Graphic Systems, Inc. v. Siebert, Inc., 512 F.3d 1338, 1345 (Fed. Cir. 2008) (citing Interactive Gift Express, Inc. v. Compuserve Inc., 256 F.3d 1323, 1342–43 (Fed. Cir. 2001)). We see nothing in the claims that would cause us to break this general rule. Patent Owner argues that the claims imply a “specific order because the ‘determine a portion’ requirement operates on ‘the [obtained] input image’ and defines the ‘portion’ that is necessary for the 23; Ex. 2027 ¶ 59). Although the steps are recited in a specific order in the claim, as they necessarily must be, the claim does not expressly specify that the certain steps must occur before or after other instructions, nor does logic imply such a requirement. For example, if certain characteristics of the image are known before the image is obtained (e.g. the size, dimensions, resolution, aspect ratio, or content etc.) the determination of the portion of the image could be made before the image is obtained. These characteristics may be based on the specific device taking the image or the subject matter of the image, both of which may be known before the image is captured or obtained. It is, therefore, not necessary that the image be obtained in order for a portion of the image to be determined. Similarly, we do not find the written description to expressly or implicitly specify an order the claimed step of “determine a portion of the input image.” For example, the written description of the ʼ413 patent states that in Figure 2B “the center of the image is chosen to be the region of interest that is most fully corrected and the distortion increases in each direction as the frame boundary is approached.” Ex. 1001, 4:19–22. Patent Owner emphasizes that this disclosure implies that an input image is obtained before the center portion is chosen. PO Resp. 19 (citing Ex. 1001, 3:63–64, 4:19–22). But the description of this embodiment does not expressly recite an order. For example, the description of Figure 2A explains that “an input image is obtained” in step 202, “the image is then scaled” in step 204, and a “non-linear warping is then applied” in step 206. Ex. 1001, 3:63–4:3. This description does not mention “determin[ing] of a portion of the image” as a separate step or as part of the listed steps, and therefore, does not specify an order in which this step must occur. is configured so that some areas of the image are fully corrected geometrically, while some other areas are distorted. . . . [T]he center of the image is chosen to be the region of interest that is most fully corrected and the distortion increases in each direction.” Id. at 4:17–19. This excerpt from the ʼ413 patent, which the Patent Owner specifically relies on (PO Resp. 19), also does not specify an order in which the determination step (choosing of the region of interest) takes place. Moreover, because the ʼ413 patent states that the warp module is configured so that some areas are fully corrected while others are not, the determination step could take place at the time the warp module was configured, presumably before the image was obtained. Finally, the ʼ413 patent states that “in the case, of video, the area may dynamically change between images (e.g. to follow a moving object).” Ex. 1001, 4:34–36. Patent Owner argues that this description “requires first obtaining the image in order to locate the object that is being followed.” PO Resp. 19–20. This embodiment is related to the case of video or a moving object, which the challenged claims do not mention. We, therefore, decline to limit the scope of the claim based on this embodiment. Phillips v. AWH Corp., 415 F.3d 1303, 1323 (Fed. Cir. 2005) (en banc) (“[A]lthough the specification often describes very specific embodiments of the invention, we have repeatedly warned against confining the claims to those embodiments.”).” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“Having reviewed the parties’ arguments and cited evidence we determine Petitioner has established, by a preponderance of the evidence, that a POSITA would have been motivated to combine Meulen and Chao. For example, Petitioner argues that “[i]t would have been obvious that when performing image scaling, pixels from the input to output positions are shifted based on a scaling factor.” Pet. 91. Meulen teaches scaling but does not provide the details regarding scaling. E.g., Ex. 1007, 1:55–56, 4:37–49. We agree that in light of Meulen’s disclosure of scaling, a POSITA would have looked to other references, such as Chao, for further details on how to perform scaling. Dr. Katsaggelos provides credible support, testifying that “Meulen mentions ‘compression and/or scaling,’ and provides details on how to perform compression. But Meulen does not disclose the details of how to perform scaling. A POSITA when faced with Meulen and having the knowledge about scaling would have been motivated to turn to a prior art reference that discloses the details of scaling.” Ex. 1002 ¶ 262. Patent Owner argues that Petitioner provides no motivation to combine other than asserting that it involves combining prior art elements. PO Resp. 35 (quoting Pet. 92). As explained above, however, Petitioner does more than just assert that the motivation involves combining prior art elements. Instead, Petitioner explains that Meulen discusses both compression and scaling, and provides details regarding compression but does not provide details on how to scale. Pet. 91–92; Ex. 1002 ¶¶ 262–262. Thus, Meulen teaches that scaling was a known technique. See Hybritech, (“a patent need not teach, and preferably omits, what is well known in the art”). Dr. Katsaggelos testifies that, in this situation, a POSITA would have looked to Chao for details regarding scaling. Ex. 1002 ¶¶ 262–263. We determine this establishes, by a preponderance of the evidence, that a POSITA would have had reason to combine Meulen’s teachings with Chao. Patent Owner draws a distinction between Meulen and Chao, arguing that “Meulen is concerned with modifying content from a media source to be displayed on a device’s screen while Chao, by contrast, is directed to changing the aspect ratio of a document intended for printing.” Id. at 36 (citing Ex. 2027 ¶¶ 89–90). Patent Owner’s argument is contradicted, however, by Chao’s disclosure which states that “after all the background and foreground elements in the image have been resized . . . [t]he image may be output by displaying the image on or as part of: a display screen such as a computer monitor, camera screen, printer screen, printed page, projected image, or the like.” Ex. 1008 ¶ 32. Patent Owner argues that Meulen’s system avoids distortion near the middle where the user’s focus is more likely to be, while Chao, on the other hand, is directed to avoiding distortion of stylized borders on differently sized pages. PO Resp. 36–37 (citing Ex. 1006, 1:26–29; Ex. 1008 ¶¶ 1, 25; Ex. 2027 ¶¶ 91–92). This argument reads the prior art too narrowly and does not address Petitioner’s combination. Petitioner does not rely on Chao for its teaching of avoiding distortion near the borders of the image, but rather on its teaching of scaling the image while maintaining the design intent of the original image. Ex. 1008 ¶ 22; Ex. 1014 ¶ 67. Thus, Petitioner is applying Chao’s techniques of scaling (regardless of where the area of 92. Finally, Patent Owner argues that Chao’s approach of stretching/shrinking only the background and uniformly scaling entire foreground objects is suitable for graphic design but incompatible with Meulen which is concerned with adapting externally derived media source content for display on a fixed size screen. PO Resp. 37–38 (citing Ex. 2027 ¶ 93). We disagree with Patent Owner’s argument because it does not address Petitioner’s combination. Petitioner relies on Chao’s teaching of stretching/shrinking of background elements and applies that stretching/shrinking to Meulen’s images displayed on its screen. Pet. 91–92 (citing Ex. 1008 ¶¶ 28, 63; Ex. 1002 ¶ 263). The fact that Chao applies its teaching to graphic design does not prevent a POSITA from applying those teachings to Meulen’s media content displayed on its screen.” slip op. at 20
Patent outcomesUS 10,015,413 mixedClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,015,413 - Arashi Vision (U.S.) LLC (D/B/A Insta360) v. Gopro, IncNo claims unpatentablePTAB · Nov 25, 2025 · IPR2024-01165 · APJ William V Saindon · IPR · Final written decision
Claims 1–21 were not shown unpatentable because Zhou does not teach the claimed low-light high-pass or stickiness parameter limitations.
RulingsFinal written decision- BurdenFwd all claims patentableNot shown unpatentable
“4. Conclusion for the Prior Art Analysis In sum, we find that Zhou does not disclose the low-light high-pass parameter or the stickiness parameter. Petitioner’s grounds for both independent claims 1 and 16 rely on Zhou for teaching a low-light high-pass parameter or a stickiness parameter. Pet. 23–28, 64. Because we find Zhou does not teach these limitations, all of Petitioner’s grounds fall for this reason. III. CONCLUSION For the reasons given above, we determine that Petitioner has not established by a preponderance of the evidence that any claim of the ’840 patent would have been obvious in view of the prior art cited.” slip op. at 18
- Skill levelSkill level petitioner adoptedOther
“A person of ordinary skill in the art (POSITA) in the field of the ’840 patent would have a bachelor’s degree in engineering or computer science, or equivalent field, and two years of experience working on image or video processing, or digital cameras. Alternatively, a POSITA would have four years of experience working on image or video processing, or digital cameras. An advanced graduate degree in the disciplines cited above may make up for the work experience indicated above. Pet. 6 (citing Ex. 1002 ¶ 32). Patent Owner applies the same standard. PO Resp. 26–27. We use this agreed-upon standard for purposes of this Decision.” slip op. at 7
- Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner
“We review this testimony based on the strength of the underlying factual basis. 37 C.F.R. § 42.65(a); Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (“Lack of factual support for expert opinion going to factual determinations, however, may render the testimony of little probative value . . ..”). Here, the underlying factual basis is not very strong for either witness. That said, we find that Dr. Foroosh’s testimony is more logically sound and consistent with the ’840 patent disclosure. Based on our reading of the specification, we find a clear indication that “stickiness” has to do with the past. In order to control “the extent by which preceding portion(s) . . . impacts determination of the smoothed trajectory” (emphasis added), one must control the degree by which the past frames impact determination. And to control the degree of the past’s influence, one must, as a consequence, favor the past over the future. That is, the frame of reference of the stickiness parameter is the past. The specification could have used a time-agnostic term, like a “nearness” or “adjacency” parameter, but it did not. Thus, the fact that “stickiness” is used in conjunction with “preceding” indicates that it deals with a preference for preceding frames. On this basis, we find Dr. Katsaggelos’s testimony less persuasive than Dr. Foroosh’s.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“That said, we do not construe a stickiness parameter as prohibiting consideration of future frames. Instead, we determine that the stickiness parameter’s value determines the impact of the preceding portions, versus the following portions. The ’840 patent recognizes this, when it says that a stickiness parameter value of “1,” representing a “lazy” stabilizer that maximally favors the past, would not override a violation of the margin constraint based on the look-ahead (i.e., would not allow the viewing window to fall out of bounds in the event of large future motion). See Ex. 1001, 22:26–30; see also id. at 12:61–13:29 (acknowledging that favoring the past may lead to a conflict with the viewing window determination), 15:39–60 (adjusting the viewing window to ensure it does not violate a margin constraint). Thus, while a past-favoring parameter by necessity favors the past over the future, it does not prohibit consideration of the future. In view of the above, we construe the claimed “stickiness parameter” as a parameter that controls the extent by which preceding portions of the trajectory impacts determination of the smoothed trajectory, with an understanding that in order to favor preceding portions, to some extent, the parameter must relatively disfavor following portions.” slip op. at 10
Patent outcomesUS 10,958,840 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,958,840 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Nov 17, 2025 · IPR2024-00648 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–30 are unpatentable: claims 1–2, 4–7, 9–12, 14–17, and 19–30 are anticipated by the MSI-H Study Record; claims 3, 8, 13, and 18 are obvious over the cited combinations.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“We agree with Patent Owner that the phrase “in response to” in claim 1 requires a causal relationship wherein the patient must be tested for MSI-H and, if he or she is determined to be MSI-H or dMMR, then the patient is treated with 10 mg/kg of pembrolizumab every 14 days. In claim 1, a biological sample from the patient must be tested to determine if the cancer is MSI-H and, if so, the patient is treated with a therapeutically effective amount of pembrolizumab. For this reason, if the prior art teaches the limitations of 1) testing a biological sample obtained from a patient having cancer to determine that the patient’s cancer is microsatellite instability high or mismatch repair deficient, and 2) treating the patient with a therapeutically effective amount of pembrolizumab if the patient’s cancer is determined to be microsatellite instability high or DNA mismatch repair deficient, the art anticipates claim 1. We are not persuaded that claim 1 requires or excludes anything else because nothing else is recited in the claim.” slip op. at 10
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference is prior artDecided for petitioner
“Patent Owner does not direct us to evidence that it attempted to file any patent application before the publication date of the MSI-H clinical study and was denied an earlier filing date. Contrary to Patent Owner’s argument that it could not file a patent application without results from the MSI-H clinical study, we note that the inventors filed a provisional patent application on November 13, 2014, which, although also filed more than a year after the publication of the MSI-H clinical study, disclosed no clinical results or data. Ex. 1001, cover; Ex. 1030, 1. After considering the parties’ arguments, we are not persuaded by Patent Owner’s assertion that the inventors could not have filed an earlier application to at least attempt to secure a priority date before the MSI-H clinical study was publicly available. an earlier filing date. Instead, we are persuaded by Petitioner’s argument that because the MSI-H clinical study was published before the inventors filed an application to protect their patent rights the MSI-H clinical study is prior art for the information it discloses. Accordingly, we proceed to analyze Petitioner’s contentions in Ground 1.” slip op. at 24
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“the genus disclosed in the MSI Study Record and does not argue or provide evidence to show that one of ordinary skill in the art could have envisaged each species within that genus. PO Resp. 11–14. We are not persuaded that either the size of the genus in the MSI Study Record or whether one of ordinary skill in the art would have been able to envisage every species within it is dispositive of whether the MSI Study Record anticipates claim 1, where one of ordinary skill in the art would have known that specific cancers recited in claim 1 would be included in the MSI Study Record. As Petitioner argues, claim 1 requires that “a patient…selected from the group consisting of [the listed cancers]” be tested and treated. Pet. Reply 10 (emphasis original). Claim 1 does not require that the patient have each and every one of the sixteen listed cancers to anticipate the claim. Rather, claim 1 requires testing a sample from “a patient” with one of the recited types of cancer and treating the patient. See Brown v. 3M, 265 F.3d 1349, 1351 (Fed. Cir. 2001) (“When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art.”).” slip op. at 31
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“In contrast, the testimony of Patent Owner’s witness, Dr. Goldberg, supports Petitioner’s argument of the knowledge in the art at the time, wherein Dr. Goldberg testifies that “[w]hile many clinical oncologists were aware that patients with Lynch Syndrome had a defect in DNA mismatch repair, they associated MSI testing with young onset colorectal and endometrial cancer and patients with a family history of colorectal and/or endometrial cancer.” Ex. 2090 ¶ 79. Similarly, during his deposition, Dr. Goldberg also agreed that endometrial, gastric, and small-bowel cancers would come to mind when he saw a reference to MSI-high non-colorectal cancer. See Ex. 1243, 115:5–116:22 (Q. And so does endometrial cancer come to mind when you see reference to MSI-high non-colorectal cancers? . . . A. Yes. Q. As . . . a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does gastric cancer come to mind? . . . A. comes to mind. So the answer is yes. Q. As a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does small bowel cancer come to mind? . . . A. Yes.”). Patent Owner does not direct us to other evidence contradicting Petitioner’s argument that MSI-H was known to occur in endometrial, small bowel, and gastric cancer. Pet. 18.” slip op. at 30
Patent outcomesUS 11,643,462 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,643,462 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Nov 4, 2025 · IPR2024-00624 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–4, 6–10, and 12–15 are unpatentable, principally because the MSI-H Study Record anticipates them.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“Pet. 12 (citing Ex. 1003 ¶ 19). To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. PO Resp. 6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Thus, Petitioner and Patent Owner characterize one of ordinary skill in the art differently. Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties do not assert constructions of any terms recited in the challenged claims other than that their ordinary and customary meanings should apply. Pet. 11–12; PO Resp. 6. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We construe” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’975 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not inherently anticipate where it failed to mention specific vitamin deficiencies, instead merely inviting further experimentation to find associations with metabolic perturbations). requirement, efficacy is inherent in carrying out the claim steps,” referring to a claimed method of treating or preventing stroke, which was held to be anticipated by the publication of a proposed study. 677 F.3d at 1381. Patent Owner attempts to distinguish the size and apparent surety of the study in Montgomery from the MSR. PO Resp. 15. But because we find that the MSR teaches performing the steps recited in claim 1 for the purpose of determining and treating MSI-H cancer, we are persuaded that the MSR inherently discloses the results of selection of patients and administration of the drug treatment recited in those steps. See Bristol-Myers, 246 F.3d at 1376. Whether or not the MSR could have provided results or was sufficient for full regulatory approval does not change that the MSR teaches Patent Owner’s claimed steps. We have no reason to doubt that the disclosure in the MSR of the steps recited in claim 1 produces the efficacy element required in claim 1, whether or not this efficacy was disclosed in the MSR or was known when it was published. See Mehl/Biophile, 192 F.3d at 1366 (“Where, as here, the result is a necessary consequence of what was deliberately intended, it is of no import that the article’s authors did not appreciate the results.”).” slip op. at 21
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“use that does not qualify as prior art. PO Resp. 18–25. Patent Owner argues that an inventor can be granted latitude to experiment in the public eye until her invention is ready for patenting. Id. at 18 (citing Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 64 (1998). According to Patent Owner, the experimental use negation applies to the MSR under a 13-factor analysis provided in Allen Engineering Corp. v. Bartell Industries, Inc., 299 F.3d 1336, 1353 (Fed. Cir. 2002). PO Resp. 19–25. For example, Patent Owner argues that to establish that treatment of MSI-H cancers was effective, the inventors had to test treatment in humans, there being no animal models, and had to publish the MSR on the government website under federal law. Id. at 20–22. Patent Owner argues further that the inventors had control over the MSI-H clinical study and that the field of cancer treatment was highly unpredictable, among other facts. Id. at 21. Patent Owner argues that “[a]t the time of the MSR’s posting, the claimed invention was not, nor could it have been, ready for patenting. The clinical study that ultimately collected the data reported in the patent specification and supporting the patent claims had not and could not have commenced before the MSR was posted.” Id. at 23. sometimes said that an inventor acquires an undue advantage over the public by delaying to take out a patent, inasmuch as he thereby preserves the monopoly to himself for a longer period than is allowed by the policy of the law,” but held that “when the delay is occasioned by a bona fide effort to bring his invention to perfection, or to ascertain whether it will answer the purpose intended,” the experiment use exception can preserve the inventor’s rights. City of Elizabeth v. Am. Nicholson Pavement Co., 97 U.S. 126, 137 (1877). Because we are not persuaded that Patent Owner could not have filed an earlier application, we are not persuaded that the experimental use doctrine is properly applied in this case. Given that clinical trial protocols published on the ClinicalTrials.gov website have been successfully asserted as prior art in other cases, we are not persuaded by Patent Owner’s arguments that the MSR is not available as prior art against the challenged claims. See, e.g., Salix Pharms., Ltd. v. Norwich Pharms. Inc., 98 F.4th 1056, 1061 (Fed. Cir.), cert. denied, 145 S. Ct. 567 (2024), and cert. denied, 145 S. Ct. 983 (2024).” slip op. at 24
Patent outcomesUS 11,325,975 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,325,975 - 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 - PTAB · Oct 6, 2025 · IPR2025-00611 · APJ Christopher L Ogden · IPR · Institution
The Board instituted IPR of claims 1–10, 12, 13, 19, and 20 on all petition grounds after finding a reasonable likelihood that claim 1 was obvious over Douglas and Mark.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“A claim is unpatentable under § 103 “if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C. § 103; see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). When a ground in a petition is based on a combination of references, we consider “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)).” slip op. at 8
- Skill levelSkill level petitioner adoptedDecided for petitioner
“The parties agree that experience could substitute for a degree, and vice versa. Pet. 3 (citing Ex. 1003 ¶¶ 19–21); Prelim. Resp. 9. The parties’ proposed levels of ordinary skill are substantially similar. Although we discern no difference in the outcome of this decision from choosing one over the other, we adopt Petitioner’s proposal for this decision. Only Petitioner’s proposed level is supported by testimonial evidence on the preliminary record, and it appears to be consistent with the problems addressed in the ’774 patent. See Ex. 1001, 1:16–52. Therefore, we adopt Petitioner’s proposal for this decision.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“CLAIM CONSTRUCTION B. In an IPR, we construe a patent claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b). This generally includes “construing the claim in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. The ordinary and customary meaning of a claim term “is its meaning to the ordinary artisan after reading the entire patent,” and “as of the effective filing date of the patent application.” Phillips, 415 F.3d at 1313, 1321. Neither Petitioner nor Patent Owner argues that we need to construe any claim terms explicitly. See Pet. 2–3; Prelim. Resp. 9. However, the parties’ positions depend on interpreting the claim language in a particular way, and we discuss the relevant claim language below in the context of the parties’ arguments regarding the prior art. 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 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“At this stage, we find Petitioner’s arguments persuasive and disagree with Patent Owner. Patent Owner appears to equate a “fabrication profile” with a toolpath description, but nothing in the plain language of claim 1 supports that narrow interpretation. The ’774 patent describes a “fabrication profile” broadly and states that the profile can simply “include the dictionary [of configuration information],” or be “used to determine which machineready representation is available or suitable for a target printer.” Ex. 1001, 23:49–52. The preliminary evidence suggests that Douglas’s “operational parameters” would count as a “fabrication profile” because it is “the basis for generation of a machine-ready representation of the three-dimensional model that is executable on the target printer.” Id. at 23:37–39; see infra Section III.C.8. We also disagree that Petitioner’s argument is impermissible hindsight, because it is based on the disclosures in Douglas and Mark, and Petitioner has articulated a sufficiently persuasive reason to combine those references without referring to the ’774 patent itself. See In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971) (an obvious rationale is not improper hindsight if it “takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure”). Finally, Petitioner appears to rely on Mark for providing a particular example of a fabrication profile, not to replace Douglas’s overall system in which the 3D printer can receive “operational parameters” rather than just G-code. See Pet. 8–10, 17–23; see also Ex. 1005 ¶ 41 (the print queue, which stores tool instructions, may be maintained locally on printers 204 or on print servers 208); see In re Mouttet, 686 F.3d 1322, 1332 (Fed. Cir. 2012) (“[A] determination of obviousness based on teachings from multiple references does not require an actual, physical substitution of elements.” (citing In re Etter, 756 F.2d 852, 859 (Fed. Cir. 1985) (en banc))).” slip op. at 19
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,886,774 - 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 - 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 - Posco Co., Ltd. v. ArcelormittalInstitutedPTAB · Jul 23, 2025 · IPR2025-00371 · APJ Brian D Range · IPR · Institution
The Board instituted IPR on claims 1–25 based on all petitioned grounds, finding a reasonable likelihood that POSCO would prevail.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the petition “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.” The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioner meets the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Any arguments not raised by Patent Owner in a timely-filed response may be deemed waived. For the reasons stated below, we determine that Petitioner has established a reasonable likelihood that it would prevail with respect to at least one claim. We hereby institute an inter partes review as to claims 1–25 of the ’227 patent based upon Petitioner’s asserted grounds of unpatentability.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art (POSITA) “would have had an undergraduate degree in materials science, manufacturing engineering, mechanical engineering, or equivalent knowledge, training, or experience, with two years of experience working in metallurgy.” Pet. 6 (citing Ex. 1003 ¶ 15). For purposes of this Decision, we adopt Petitioner’s proposal as reasonable and consistent with the ’227 patent specification and the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner does not propose any claim constructions. Pet. 3. We do not discern a need to construe explicitly any claim language at this juncture because doing so would have no effect on our analyses below of Petitioner’s asserted grounds and will not assist in resolving the present controversy between the parties. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“35 U.S.C. § 103(a) as obvious over Takagi and Cornette, citing the Declaration of Dr. Miles for support. Pet. 1, 6–49 (citing Ex. 1003) (Petitioner’s Ground 1A). a. Claim 1 Petitioner argues that Takagi and Cornette teach or suggest each recitation of claim 1. Pet. 6–31. Petitioner argues, for example, that the preamble of claim 1 is not limiting or, alternatively, imparts no structural distinction from Takagi. Id. at 20–23 (citing, e.g., Ex. 1003 ¶ 48). Petitioner further argues that Takagi and Cornette teach forming or hot stamping to arrive at their products. Id. at 23 (citing, e.g., Ex. 1016 ¶ 36 (Takagi referring to “form[ing]” its products shape); Ex. 1014, 9–11 (Cornette referring to “hot stamping”); Ex. 1003 ¶ 48. Petitioner argues that Takagi teaches a strip of base steel having a first and second side. Id. at 23–24 (citing, e.g., Ex. 1003 ¶ 49; Ex. 1016 ¶¶ 13, 36. Petitioner argues that Takagi teaches a coating that is a “diffusion layer” having five phases as depicted by Takagi Figure 2A and explained by Takagi Table 1 (Takagi Fig. 4). Id. at 24–30 (citing, e.g., Ex. 1003 ¶¶ 50–59; Ex. 1016 ¶ 20, Fig. 2A). Petitioner argues that Takagi alone or as modified by Cornette teaches a coating thickness greater than than 30 µm. Id. at 30–31; Ex. 1014, 9; Ex. 1016 ¶ 35; Ex. 1003 ¶¶ 60–61. Petitioner explains why a person having ordinary skill in the art would have had reason to combine teachings of Takagi and Cornette with a reasonable expectation of success. Pet. 11–20 (citing, e.g., Ex. 1003 ¶¶ 31–47; Ex. 1016 ¶¶ 19–37, 47; Ex. 1014, 9; Ex. 1025, 5:17–20; Ex. 1026, 7; Ex. 1034 ¶ 13; Ex. 1055 ¶¶ 2, 7, 14–15, 18, Fig. 3). Based on our review and consideration of the current record, we determine that the information presented sufficiently supports, for purposes of institution, Petitioner’s assertions that Takagi and Cornette teach or suggest each limitation of claim 1. See Pet. 6–31. We therefore determine Petitioner has met its burden to show a reasonable likelihood it would prevail in demonstrating that claim 1 would have been obvious over Takagi and Cornette.” slip op. at 12
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,326,227
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.