- Apple Inc. v. Resonant Systems, Inc.All claims unpatentablePTAB · Oct 9, 2025 · IPR2025-00680 · APJ Karl D Easthom · IPR · Final written decision
Claims 2 and 3 are unpatentable under § 103 over Gregorio, Ramsay, Tierling, Rossi, and Aldrich; claim 2 is also unpatentable over Gregorio, Ramsay, Wakuda, Rossi, and Aldrich.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have had a degree in mechanical engineering, electrical engineering, physics, or a related technical field, and at least 2–3 years of experience related to the design or development of systems incorporating linear actuators; additional years of experience could substitute for the advanced-level degree. Ex. 1003 ¶ 30. Patent Owner offers “a similar level of ordinary skill in the art.” See PO Resp. 4. Based on a review of the record, we adopt Petitioner’s proposed level of ordinary skill in the art because it is consistent with the evidence of record, including the asserted prior art and ’337 patent specification.” slip op. at 9
- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for petitioner
“An element in a claim for a combination may be expressed as a means . . . for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. 35 U.S.C. § 112 ¶ 6. In particular, the parties agree that the “driving component” and “control component” requirements of independent claim 2 are means-plus-function limitations. Pet. 2–6; PO Resp. 7. Construing a means-plus-function limitation under 35 U.S.C. § 112 ¶ 6 involves two steps: 1) identifying the claimed function and 2) identifying in the specification the corresponding structure that performs the claimed function. Med. Instrumentation & Diagnostics Corp. v. Elekta AB, 344 F.3d 1205, 1210 (Fed. Cir. 2003); Cardiac Pacemakers, Inc. v. St. Jude Med., Inc., 296 F.3d 1106, 1119 (Fed. Cir. 2002).” slip op. at 10
- Claim Construction › Functional claiming / §112(f) means-plus-function › Corresponding structure / algorithm (indefinite if none)Term construed petitioner constructionTerm construed board ownMixed
“supply of power from the power supply to . . . cause the moveable component to oscillate at a frequency . . . specified by one or more stored values” to portions of steps 706 and 708 of the flow diagram algorithm of Figure 7A, as described above. Thus, the control component requires a microprocessor and memory with algorithmic structure including a timing algorithm or similar coding for creating a control output signal that flips to control the direction of current flow through a coil (e.g., coil 514, Fig. 5, coil 626, Fig. 6), where the coil is structure that corresponds to the recited “driving component,” as noted above.10 We adopt the District Court’s conclusion in the Apple litigation that the “control component” structure itself does not require an H-bridge switch, but only requires that the processor generates the “d” inputs configured to operate a switch or other circuit; and further that the structure does not require does not require computing initial default values as specified in step 702 of Figure 7A (i.e., values not specified by a user). Ex. 3001, 30–33, 35. This is in accord with settled law that limits the structure to that necessary to 10 “Rather than using a formal timer mechanism, certain implementations may simply employ counted loops or other simple programming techniques for periodically carrying out tasks.” Ex. 1001, 7:7–10. perform the claimed function. 11 By the same token, we modify the District Court’s construction to the extent it would require, based on such steps as 706, 710, and 716, a specific order of the steps of generating the “p” and “d” values. The claims only require the control component to control the power supply to cause oscillation at a specified frequency and amplitude, but do not require the frequency value to be generated before the amplitude value, or vice versa.” slip op. at 17
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“The record, including testimony by Dr. Hannaford (Ex. 1003; Ex. 1049), supports Petitioner’s rationale, and shows that one of ordinary skill would have been motivated to combine Gregorio, Ramsay, and Wakuda in the manner proposed. Patent Owner does not address Petitioner’s showing for combining these references with any particularity. See generally PO Resp. We discuss below Patent Owner’s argument that Petitioner’s showing as to limitation 2.f based on the combination of Gregorio and Ramsay is conclusory.” slip op. at 34
Patent outcomesUS 8,860,337 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,860,337 - Apple Inc. v. Resonant Systems, Inc.All claims unpatentablePTAB · Oct 9, 2025 · IPR2024-00807 · APJ Karl D Easthom · IPR · Final written decision
Claims 2 and 3 are unpatentable under § 103 over Gregorio, Ramsay, Tierling, Rossi, and Aldrich; claim 2 is also unpatentable over Gregorio, Ramsay, Wakuda, Rossi, and Aldrich.
RulingsFinal written decision- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for petitioner
“The parties agree that independent claim 2 includes means-plus- function limitations under 35 U.S.C. § 112 ¶ 6.8 Pet. 2–6; PO Resp. 7–15. An element in a claim for a combination may be expressed as a means . . . for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. 35 U.S.C. § 112 ¶ 6. In particular, the parties agree that the “driving component” and “control component” requirements of independent claim 2 are means-plus-function limitations. Pet. 2–6; PO Resp. 7. Construing a means-plus-function limitation under 35 U.S.C. § 112 ¶ 6 involves two steps: 1) identifying the claimed function and 2) identifying in the specification the corresponding structure that performs the claimed function. Med. Instrumentation & Diagnostics Corp. v. Elekta AB, 344 F.3d 1205, 1210 (Fed. Cir. 2003); Cardiac Pacemakers, Inc. v. St. Jude Med., Inc., 296 F.3d 1106, 1119 (Fed. Cir. 2002).” slip op. at 10
- Claim Construction › Functional claiming / §112(f) means-plus-function › Corresponding structure / algorithm (indefinite if none)Term construed petitioner constructionDecided for petitioner
“1. Construction of “Driving Component” Petitioner contends that the claimed function of “driving component” is “drives the moveable component to oscillate within the housing.” Pet. 5; Ex. 2002, 2. Petitioner asserts that the corresponding structure is a coil of conductive wire 420” (Figures 4A–4G); “coil 514” (Figures 5A–5B); “coil 626” (Figure 6); “electromagnet” (Figures 10-11); “additional coils 1202 and 1204” (Figure 12); “coils 1302 and 1304” (Figure 13); “driving coils 1412 and 1414” (Figure 14); “coil 1510” (Figures 15–17); “stator coils” (Figures 24A-25). Pet. 5–6 (citing Ex. 1001, 5:2–34, 5:54–59, 6:32–35, 9:11–52, 9:64–10:22, 14:59); Ex. 2002, 2.). Patent Owner states that it “does not believe that the phrase involving a ‘driving component’ needs to be construed in order to resolve any issue in this proceeding.” PO Resp. 7. Patent Owner agreed to the above construction in the Apple Litigation, and the court adopted this construction. Ex. 2002, 2. The record supports Petitioner’s position and we adopt it.” slip op. at 11
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner’s expert declarant contends that a person of ordinary skill in the art (POSITA) would have had a degree in mechanical engineering, electrical engineering, physics, or a related technical field, and at least 2–3 years of experience related to the design or development of systems incorporating linear actuators; additional years of experience could substitute for the advanced-level degree. Ex. 1003 ¶ 30. Patent Owner offers “a similar level of ordinary skill in the art.” See PO Resp. 4. Based on a review of the record, we adopt Petitioner’s proposed level of ordinary skill in the art because it is consistent with the evidence of record, including the asserted prior art and ’337 patent specification.” slip op. at 9
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“In contrast to Petitioner’s showing, at the passage cited by Patent Owner, Dr. Goossen, Patent Owner’s expert, does not provide a basis for his opinion that “the combined system of Gregorio-Ramsay-Rossi-Aldrich does not teach the claimed output to the power supply.” Ex. 2009 ¶ 156; PO Resp. 21 (citing Ex. 2009 ¶ 156). To the extent Dr. Goossen addresses the issue, like Patent Owner, Dr. Goossen concedes that “a POSITA would recognize in the [annotated drawing of Gregorio supplied by Petitioner] that a power supply is required that is not shown.” Ex. 2009 ¶ 116. And also like Patent Owner, Dr. Goossen concludes that Petitioner’s rationale that an “unshown power supply receives a signal from the processor is a sweeping conclusion that does not follow.” Id. For the reasons discussed above in connection with Patent Owner’s parallel arguments, this testimony is conclusory and unsupported. Primarily, it does not adequately address Petitioner’s showing and Dr. Hannaford’s testimony, discussed above, which relies on Gregorio’s statement that “[p]rocessor 12 outputs the control signals to drive circuit 26 which includes electronic components and circuitry used to supply LRA 18 with the required electrical current and voltage to cause the desired haptic effects.” Ex. 1004, 2:36–39 (emphases added). Dr. Goossen and Patent Owner also do not address the initial finding in the Institution Decision that “[t]he ’337 patent does not disclose any detail or structure for the controllable power supply, indicating that such a controllable power supply was well-known.” Inst. Dec. 30 (citing Ex. 1001, 6:33–35 (“The power supply 612 receives a control input 624 from the CPU to control the current supplied to the H-bridge switch for transfer to the coil 626.”)).16 And while Dr. Goossen contends that Dr. Hannaford’s reliance on Ramsay to further suggest control of the power supply is conclusory because “Dr. Hannaford’s statement about ‘the current provided from a power supply to the driving component’ has nothing to do with Ramsay’s disclosure,’” Dr. Goossen addresses Ramsay and Gregorio in isolation, without adequately addressing the combination, specifically where Gregorio teaches or suggests controlling a power supply in order to provide desired LRA amplitude and frequency haptic effects, which is in line with Ramsay’s teaching of user-customizable parameters to control amplitude and frequency for the same purpose. See Ex. 2009 ¶ 126; Pet. 53–54 (summarized above). Therefore, the Petition shows persuasively that Gregorio’s processor controls Gregorio’s power supply to provide power to its haptic unit or that such power supply control would have been obvious in view of Ramsay in order to allow a user to control the desired haptic effect.” slip op. at 41
Patent outcomesUS 8,860,337 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,860,337 - 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 - PTAB · Oct 1, 2025 · PGR2025-00033 · APJ Michael A Valek · PGR · Institution
The Board instituted PGR on claims 1, 2, and 6–29 based on the written-description and enablement grounds; it found the obviousness ground did not meet the institution threshold.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority to determine whether to institute a post-grant review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). Applying that standard in view of the current record, we determine that Petitioner has shown it is more likely than not that claims 1, 2 and 6–29 of the ’652 patent are unpatentable and therefore institute post-grant review for the reasons articulated below.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner’s contentions are, at this stage, unavailing because Patent Owner’s proffered definition of a POSA is too restrictive. Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’652 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not have expertise specifically in hyaluronidases. See Pet. 15–16. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases. See id. Moreover, Patent Owner fails to persuasively explain why Petitioner’s definition that includes a person with expertise in other enzymes is insufficient. Even if we were to apply Patent Owner’s POSA definition, it is not clear on the record before us that Petitioner’s experts lack relevant expertise or qualifications of at least a POSA.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 48:41–54 (emphasis added). Based on this express definition, the current record does not support the interpretation proffered by Patent Owner and Dr. Triggs-Raine that the “term ‘modified PH20 polypeptide,’. . . has a purely structural meaning in the context of the specification.” Prelim Resp. 21 (citing Ex. 2055 ¶ 68). Patent Owner and its declarant rely on a truncated version of the definition above that omits the text after the first period because, in their view, that text “is not part of the express definition of ‘modified PH20 polypeptide’” and “merely describes an upper limit for the number of modifications possibly allowing a modified PH20 polypeptide to exhibit enzymatic activity.” Ex. 2055 ¶¶ 67, 77–78 (emphasis in original). On this record, we disagree. We find that this text is part of the definition of “modified PH20 polypeptide” because it continues to detail specific elements required of that term, i.e., a requirement that modifications in the PH20 polypeptide are permitted “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 48:47–49 (emphasis added); see Ex. 2055 ¶ 67 (acknowledging that a “patent’s definition controls,” but referring, without adequate explanation, to the second sentence of the definition paragraph as “a non-limiting example”). Indeed, while some of the language in the definitional paragraph is permissive in nature, i.e.., describing the number of amino acid replacements a modified PH20 polypeptide “can have” or “[t]ypically . . . contains” or the other modifications the polypeptide “can include,” the phrase “so long as” is not. See Ex. 1001, 48:41–56. This distinction demonstrates that hyaluronidase activity is not an optional feature of a non-limiting example as Patent Owner posits, but a requirement of the “modified PH20 polypeptide” defined and claimed in the ’652 patent. See Alynylam Pharms., Inc. v. Moderna, Inc., 138 F.4th 1326, 1333 (Fed. Cir. 2025) (explaining that the “contrast” between “non-limiting terms” and more definitive statements may indicate that the latter is definitional).” slip op. at 16
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateInstituted
“On the current record, the evidence shows it is more likely than not that the claims of the ’652 patent fail to satisfy the written description requirement because they “recite a description of the problem to be solved while claiming all solutions to it and . . . cover any compound later actually invented and determined to fall within the claim’s functional boundaries— leaving it to the pharmaceutical industry to complete an unfinished invention.” Ariad, 598 F.3d at 1353. Accordingly, Petitioner has demonstrated that it is more likely than not that there is insufficient written description for the challenged claims. Similarly, the current record does not appear to provide evidence of possession of the full scope of the claims of the ’652 patent in the ’731 application or any of the subsequent divisional or continuation applications leading to the ’652 patent that claim priority to the ’731 application (which appear to all have similar specifications) for the reasons given above.11 Therefore, the challenged claims of the ’652 patent do not receive the benefit of priority from the earlier filed applications, and based on this preliminary determination, the ’652 patent is eligible for post-grant review because the 11 We do not agree with Patent Owner that Petitioner only evaluates description and enablement as of 2011, rather than as of the 2012 filing date of the ’731 application. See, e.g., Prelim. Resp. 1, 11–12, 32. Instead, we agree with Petitioner that it “did not restrict the § 112(a) analysis to December 2011;” rather Petitioner stated that “the claims are not entitled to the ‘December 28, 2012’ benefit date of the ’731 Application, while ‘the obviousness grounds use’ the December 2011 priority date being claimed.” Prelim. Reply 5–6 (citing Pet. 5–6, 15–16). effective filing date is no earlier than the ’652 patent’s actual filing date of December 12, 2022. See Ex. 1001, code (22).” slip op. at 32
Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,049,652 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Sep 18, 2025 · IPR2024-00625 · APJ Deborah Katz · IPR · Final written decision
Claims 1–8 are unpatentable: claims 1–4 and 6–8 are anticipated by MSR, and claim 5 is obvious over MSR with the additional marker-testing teachings of Chapelle.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“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). Although Patent Owner argues that a missing element cannot be filled by what an ordinarily skilled artisan would have envisioned, Petitioner’s argument is based on what one of ordinary skill in the art would have understood from what the MSR expressly teaches. (See Pet. 20 (“Indeed, prior art concerning the MSI-H Study indicates that the physicians understood postings on clinicaltrials.gov indicated that patients had ‘metastatic tumors.’ (EX1049, 444; see also EX1050, S4; EX1003, ¶62.)”).) Unlike the facts of Nidec, where a missing signal could have been envisioned but was not present, we are persuaded by the evidence Petitioner presents that those of ordinary skill in the art understood the MSR express disclosure to include patients with unresectable or metastatic tumors because references referring to the study underlying the MSR discuss the inclusion of patients with metastatic tumors in the study. Even if Dr. Neugut’s reasoning that the reference to “measurable” disease in the MSR would have indicated patients having metastatic cancer is flawed, we are persuaded by Petitioner’s evidence of publications referring to the MSR as a study of metastatic colorectal cancer, and we are further persuaded that one of ordinary skill in the art would have understood the MSR to disclose treating patients having metastatic colorectal cancer with pembrolizumab. (See Ex. 1049, 444, Ex. 1050, S4.) Patent Owner does not address this evidence. Instead, Patent Owner acknowledges that “the MSR discloses treating cancer patients that could be within the claimed subset,” but argues that the MSR does not inherently anticipate results later obtained by treating only patients within the claimed subset. (See Pet. Sur- Reply 5–6.) We are persuaded, though, that Petitioner’s challenge is based on what one of ordinary skill in the art would have understood from the MSR (that patients who had an unresectable or metastatic tumor were selected), not on what is inherent to the disclosure of the MSR. We are persuaded that one of ordinary skill in the art at the time would have understood the MSR to teach selecting a patient “who has an unresectable or metastatic,” as required in claim 1. c) Element 1.2: “microsatellite instability-high (MSI-H) or mismatch slip op. at 14
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Patent Owner argues further that the MSR discloses an experimental use that does not qualify as prior art. (See PO Resp. 16–23.) Patent Owner argues that an inventor can be granted latitude to experiment in the public eye until her invention is ready for patenting. (See id. at 16 (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 Eng'g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1353 (Fed. Cir. 2002). (See PO Resp. 17–23.) 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. (See PO Resp. 18–20.) 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. (See id. at 19–20.) 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 21.) In City of Elizabeth, the Supreme Court was concerned that “[i]t is 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). After considering the parties’ arguments and evidence, we are” slip op. at 24
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“In order to show that objective evidence renders the method of claim 5 non-obvious, Patent Owner must show a nexus between the subject matter recited in claim 5 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 argues that there is a nexus between the development and commercialization of pembrolizumab and the patented method of treatment recited in the challenged claims, citing, inter alia, the package insert for Keytruda® (pembrolizumab), but Patent Owner does not direct us to evidence of a nexus to MSI-H or MMR deficient tumors that exhibit instability in the microsatellite markers recited in claim 5 and the unexpected results, commercial success, or other objective measures of non-obviousness flowing from these additional limitations. (See PO Resp. 50–63 (citing Ex. 2129, Ex. 2072 ¶ 190, Ex. 2090 ¶¶ 82–92).) Patent Owner directs us only to evidence regarding determining MSI-H status and then using Keytruda® to treat MSI-H cancer patients, which we determine to be anticipated by the MSR. (See PO Resp. 60.) When evidence of a “secondary consideration [] is exclusively related” slip op. at 34
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“(Ex. 1001, 26:19–28.) In Grounds 3 and 5, Petitioner argues, relying on Dr. Neugut’s testimony, that Chapelle teaches standard methods of testing whether a tumor is MSI-H, including determining whether the patient’s tumor exhibits instability in a microsatellite marker, such as BAT-25 or BAT-26. (See Pet. 42 (citing Ex. 1007, 3380, 3383; Ex. 1003 ¶ 107).) For example, Chapelle states that “‘a standard test’ using a ‘[p]anel consisting of … BAT26, BAT25’ has ‘stood the test of time.’” (Ex. 1007 at 3382.) Dr. Neugut testifies that one of ordinary skill in the art would have been motivated to treat a patient with an unresectable or metastatic MSI-H dMMR tumor, wherein the tumor exhibits instability in the BAT-25 and BAT-26 microsatellite marker, and would have expected success in doing so, in light of the teachings of Chapelle. (See Ex. 1003 ¶¶ 105–108.) We find that the record as recounted above supports Petitioner’s challenges of claim 5 in Grounds 3 and 5.” slip op. at 31
Patent outcomesUS 11,339,219 unpatentable§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,339,219 - PTAB · Sep 15, 2025 · IPR2025-00632 · APJ Mitchell G Weatherly · IPR · Institution
The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood that claims 1, 2, 7–9, 11, 12, and 20–24 are obvious over Yamaguchi-727.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Cerebrum Sensor Technologies, Inc. (“Patent Owner”) timely filed a Preliminary Response. Paper 9 (“Prelim. Resp.”).1 Institution of an inter partes review is authorized by statute when “the information presented in the petition filed under section 311 and any response filed under section 313 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). Based on our review of the record, we conclude that Petitioner is reasonably likely to prevail with respect to at least one of the challenged claims.” slip op. at 2
- BurdenInstituted
“We disagree. Positioning module 6 to face a “predetermined direction” is a form of preventing movement that falls within the scope of limitation 1b. Moreover, Yamaguchi-727 uses a method for preventing movement of its module 6 in its housing 20, silicone potting material, that is expressly recognized by the Specification of the ’421 patent when it states: “A common technique used to assist in fixturing the electrical sensor device 40 known within the automotive industry is to fill the internal cavity with a coating material such as a neutral silicone or the like for purposes of retaining placement position.” Ex. 1001, 13:56–60. Although the Specification also asserts that the sensor assemblies disclosed in the 421 patent “do not use or require the use of any such coating or filing agents or materials for any fixturing of the electrical sensor device 40,” id. at 13:61–64, limitation 1b merely requires that the “sensor device . . . is disposed within the internal cavity and attached therein to prevent movement of the device within the internal cavity,” id. at 30:25–27. Absent a persuasive argument to the contrary, we preliminarily conclude that Yamaguchi-727’s use of potting material to hold its module 6 in place within its housing 20 meets the requirements of limitation 1b. Both parties are encouraged to adduce intrinsic evidence relating to the meaning of limitation 1b at trial. For all the reasons set forth above, we find that Petitioner has established a reasonable likelihood of proving the Yamaguchi-727 renders claim 1 unpatentable as obvious. 2. Dependent Claims 2, 7–9, 11, 12, and 20–24 Petitioner identifies the portions of Yamaguchi-727 that teach the limitations introduced in dependent claims 2, 7–9, 11, 12, and 20–24, all of which ultimately depend from claim 1. Pet. 32–40. Patent Owner relies upon its argument that Petitioner’s showing for claim 1 is deficient as the reason why Petitioner’s challenge to dependent claims 2, 7–9, 11, 12, and 20–24 fails. We reject this argument for the reasons stated in Part II.C.1 above. Based on our review of Petitioner’s otherwise uncontested argument and evidence cited in support, we find that Petitioner also establishes a reasonable likelihood of proving that Yamaguchi-727 renders dependent claims 2, 7–9, 11, 12, and 20–24 unpatentable as obvious. D. Remaining Challenges” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“Petitioner complies with the requirement of identifying “[h]ow the claim language is to be construed” by setting forth proposed interpretations of various claim terms in the table above.7 Both cases cited by Patent Owner relate to an issue presented by a petitioner’s alleged inconsistent handling of whether a claim term is subject to interpretation as a means-plus-function element under 35 U.S.C. § 112(f). Orthopediatrics Corp. v. K2M, Inc., IPR2018-01546, Paper 10 at 11 (PTAB Feb. 14, 2019); 10x Genomics, Inc. v. President and Fellows of Harvard College, IPR2023- 7 Neither party has identified any claim language that might invoke interpretation as a means-plus-function limitation, and we discern no such claim language. Additionally, we do not imply that a petitioner must always propose express interpretations for specific claim language to comply with Rule 42.104(b)(3). Rather, we only note that Petitioner has, by any measure, complied by expressly proposing interpretations for identified claim language.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“We disagree. Positioning module 6 to face a “predetermined direction” is a form of preventing movement that falls within the scope of limitation 1b. Moreover, Yamaguchi-727 uses a method for preventing movement of its module 6 in its housing 20, silicone potting material, that is expressly recognized by the Specification of the ’421 patent when it states: “A common technique used to assist in fixturing the electrical sensor device 40 known within the automotive industry is to fill the internal cavity with a coating material such as a neutral silicone or the like for purposes of retaining placement position.” Ex. 1001, 13:56–60. Although the Specification also asserts that the sensor assemblies disclosed in the 421 patent “do not use or require the use of any such coating or filing agents or materials for any fixturing of the electrical sensor device 40,” id. at 13:61–64, limitation 1b merely requires that the “sensor device . . . is disposed within the internal cavity and attached therein to prevent movement of the device within the internal cavity,” id. at 30:25–27. Absent a persuasive argument to the contrary, we preliminarily conclude that Yamaguchi-727’s use of potting material to hold its module 6 in place within its housing 20 meets the requirements of limitation 1b. Both parties are encouraged to adduce intrinsic evidence relating to the meaning of limitation 1b at trial. For all the reasons set forth above, we find that Petitioner has established a reasonable likelihood of proving the Yamaguchi-727 renders claim 1 unpatentable as obvious. 2. Dependent Claims 2, 7–9, 11, 12, and 20–24 Petitioner identifies the portions of Yamaguchi-727 that teach the limitations introduced in dependent claims 2, 7–9, 11, 12, and 20–24, all of which ultimately depend from claim 1. Pet. 32–40. Patent Owner relies upon its argument that Petitioner’s showing for claim 1 is deficient as the reason why Petitioner’s challenge to dependent claims 2, 7–9, 11, 12, and 20–24 fails. We reject this argument for the reasons stated in Part II.C.1 above. Based on our review of Petitioner’s otherwise uncontested argument and evidence cited in support, we find that Petitioner also establishes a reasonable likelihood of proving that Yamaguchi-727 renders dependent claims 2, 7–9, 11, 12, and 20–24 unpatentable as obvious. D. Remaining Challenges” slip op. at 11
Claim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,835,421 - PTAB · Sep 8, 2025 · PGR2025-00017 · APJ Jeffrey N Fredman · PGR · Institution
The Board instituted PGR on claims 1, 2, 6–15, and 17–30 based on written-description and enablement challenges; it found the obviousness challenge insufficient at this stage.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority to determine whether to institute a post-grant review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition, Preliminary Response, Reply, Sur-Reply, and the cited evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 1, 2, 6–15, and 17–30 of the ’520 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner’s contentions are, at this stage, unavailing because Patent Owner’s proffered definition of a POSA is too restrictive. Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’520 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not be an expert in hyaluronidases. See Pet. 15–16. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases. See id. Moreover, Patent Owner fails to persuasively explain why Petitioner’s definition that includes a person with expertise in other enzymes is insufficient. Even if we were to apply Patent Owner’s POSA definition, it is not clear on the record before us that Petitioner’s experts lack relevant expertise or qualifications of at least a POSA.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 48:38–53 (emphasis added). Based on this express definition, the current record does not support the interpretation of Dr. Triggs-Raine that the “term ‘modified PH20 polypeptide,’ therefore, has a purely structural meaning in the context of the specification.” Ex. 2055 ¶ 68. Indeed, when reproducing the definition from this column of the ’520 patent, Dr. Triggs-Raine does not include any text after the first period, stating that “is not part of the express definition of ‘modified PH20 polypeptide’” and “merely describes an upper limit for the number of modifications possibly allowing a modified PH20 polypeptide to exhibit enzymatic activity.” Ex. 2055 ¶¶ 67, 77–78. On this record, however, we find that this text is part of the definition of “modified PH20 polypeptide” because it continues to detail specific elements required including a requirement that replacements in the PH20 polypeptide are permitted “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 48:44–47; see Ex. 2055 ¶ 67 (stating a “patent’s definition controls”). And Dr. Triggs-Raine states “the modified PH20 polypeptides have multiple credible uses, including ‘therapeutic uses of modified PH20 polypeptides that have the ability to degrade hyaluronan.’” Ex. 2055 ¶ 115.7 That is, Dr. Triggs-Raine recognizes hyaluronidase as the primary utility for the modified PH20 polypeptides recited in claim 1.” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateInstituted
“Thus, the ’520 patent evidences that even when only a single mutation is made in the PH20 polypeptide, that single mutation is more likely than not to alter the structure in such a way as to inactivate the hyaluronidase activity found in the native PH20 polypeptide. On this record, Dr. Hecht persuasively demonstrates that when the full scope of claim 1 is addressed, which includes not just single mutations in the PH20 polypeptide, but also multiple mutations, there is no expectation of structural homogeneity, stating that “[i]ntroducing multiple amino acid changes simultaneously . . . could prevent the folding of sequences into secondary structures and structural motifs and can destabilize those structures if they do form.” Ex. 1003 ¶ 59. Dr. Hecht notes that claim 1 allows “21-42 changes, with each additional change (except at position 324) being to 1 of 19 other amino acids. But the up to 21-42 changes also can be at any of between 430 and 465 (or, in the case of the broadest claims, 474) different positions depending on which unmodified PH20 sequence is used.” Id. ¶ 120. Dr. Park calculates that “95% sequence identity to PH201-465 means that the protein can have 23 total changes,” and that where one of those changes is one of five choices at position 324 as required by claim 1, the number of possible PH20 polypeptides with twenty-two additional changes is “extremely large by all accounts, ranging from 1059 to 10112.” See” slip op. at 27
Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,110,520 - PTAB · Aug 25, 2025 · IPR2025-00631 · APJ Kevin W Cherry · IPR · Institution
The Board instituted IPR on claims 1–3, 5, 7–9, 11–13, and 15–22 on all five asserted § 103 grounds, finding a reasonable likelihood of success on at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“institute an inter partes review. The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted unless “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” The Supreme Court has held that the Board, in a decision to institute under 35 U.S.C. § 314(b), may not institute review on less than all claims challenged in the petition. SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355–56 (2018). Moreover, in accordance with our rules, “[w]hen instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.” 37 C.F.R. § 42.108(a) (2020); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). Applying those standards, and upon considering the Petition, the Preliminary Response, and the evidence of record, we determine the information presented shows a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one of the challenged claims of the ’027 patent. Accordingly, we institute an inter partes review of all challenged claims (i.e., 1–3, 5, 7–9, 11–13, and 15–22) of the ’027 patent, based on the grounds asserted in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art would have “possessed an undergraduate degree in chemistry, polymers, materials science, chemical engineering (or related field) and one to two years of experience with constructing and manufacturing tires, tire patches, tire decals/stickers and/or the like.” Pet. 8 (citing Ex. 1003 ¶¶ 6–11). According to Petitioner, “Additional education could compensate for less practical experience. Conversely, additional practical experience could compensate for less education.” Id. Patent Owner does not provide an alternate definition, but, “Patent Owner does not acquiesce to, and reserves the right to address, [Petitioner’s] definition of a POSA.” Prelim. Resp. 6 n.6. Petitioner’s proposed definition appears to be consistent with the disclosure of the ’027 patent, and we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that the prior art itself may “reflect[] an appropriate level” of ordinary skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“Having considered the record, we determine that no express claim construction is necessary for any claim terms. 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 10
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted
“We disagree with Patent Owner’s contentions that these disclosures indicate that Wilson’s patch would not meet the construction of “barrier material composition.” None of these disclosures even suggests that the base of Wilson’s patch is rigid as Patent Owner suggests. To begin with, the fact that the housing is “more rigid” provides no information about the absolute rigidness of the patch. See Ex. 1009, 9:16–21. As for the disclosure that the patch is contoured (id. at 3:35–67), Patent Owner provides only attorney argument to support its contention that the contour demonstrates that Wilson’s patch must be so rigid that it cannot be meet the claim limitation. In contrast, Petitioner demonstrates that Wilson discloses using the exact same materials described in the challenged patent (see Ex. 1001, 6:33–58 (noting “[e]lastomeric materials useful for forming the intermediate layer 24 include but are not limited to gum rubber, vulcanized natural rubber SBR . . . or comparable materials”); Ex. 1009, 3:49–55 (noting the patch may be constructed from natural rubber (NR), a preferred mixture of chlorobutyl rubber and natural rubber (CR/NR), or a preferred mixture of SBR and natural rubber (SBR/NR)), and provides detailed testimony from its expert to support its contentions (see Ex. 1003 ¶¶ 114–119). On the current record, we find Petitioner’s reasoning and evidence to be persuasive, and find that Petitioner has shown sufficiently that Willson discloses or teaches this limitation.” slip op. at 20
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,124,027 - Sarepta Therapeutics, Inc. v. The Trustees Of The University Of PennsylvaniaNo claims unpatentablePTAB · Aug 20, 2025 · IPR2024-00580 · APJ Susan L C Mitchell · IPR · Final written decision
The Board held claim 8 not shown unpatentable under each of three §103 grounds because Petitioner failed to establish motivation to combine the references with a reasonable expectation of success.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In addressing the level of ordinary skill in the art, Petitioner contends that a person of ordinary skill in the art (“POSA” or “POSITA”) would have had at least a Ph.D. in biochemistry, molecular biology, or a related field and between one and four years of post-doctoral experience in the field of gene therapy. Alternatively, a POSA would have had at least a Master’s or Bachelor’s Degree in biochemistry, molecular biology, or a related field, with a corresponding number of additional years of experience in the field of gene therapy. Pet. 12 (citing Ex. 1005 ¶¶ 111–115). Patent Owner states that it does not challenge Petitioner’s definition. PO Resp. 10. On this complete record, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’274 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts that the ’274 patent “does not specify a particular program or set of program parameters that should be used to align sequences and calculate percent identity for purposes of determining whether a particular test sequence falls within the scope of the claims.” Pet. 21. Petitioner asserts that it analyzed the percent identity claim elements, as Patent Owner did in the parallel District Court litigation, Penn-II, “using the Clustal program at default settings to generate amino acid sequence alignments and calculate percent identity values.” Id. at 21–22. Petitioner, however, does not ask for any particular construction of any claim term. See id. Patent Owner states that it “does not challenge Petitioner’s articulation of the lack of a need for claim construction.” PO Resp. 10. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our decision. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms that . . . are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)); Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd. v. Matal, 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., 200 F.3d at 803)).” slip op. at 12
- Expert testimonyPatent owner expert creditedDecided for patent owner
“According to the import of the complete recitation of paragraph 250 of the ’772 Publication set forth above that Petitioner relies upon for the motivation to improve efficient gene transfer in liver, AAV8 already fulfills this need. See Tr. 28:15–18. We do not read the ’772 Publication as calling for a search for a more efficient variant to improve efficient gene transfer in liver. We credit Dr. Samulski’s testimony that supports this view of the teachings of the ’772 Publication. Dr. Samulski testifies: Additionally, when the inventors compared AAV8’s expression in the liver against new serotypes AAVrh2, AAVrh10, AAVrh13, and AAVrh21, they found that AAV8 remained superior: EX1007, ¶ 253. Notably, AAV8 was shown to have over fifty percent (50%) greater expression in liver than AAVrh10. As I discuss more below, a skilled artisan in 2005 would not have expected a single amino acid substitution to significantly alter tropism in order to target to a different tissue. Thus, in my opinion, in 2005, a skilled artisan with the goal of targeting the liver would have selected the best known vector for delivery to liver at that time—AAV8. Ex. 2027 ¶ 42. We also agree with Dr. Samulski’s opinion that a POSA would have selected the best vector for liver, AAV8, instead of modifying another vector to increase tropism to liver. Dr. Samulski testifies: In my opinion, a skilled artisan in 2005 would not have looked solely to modify a vector to try to improve tropism to a particular tissue. As discussed throughout this declaration, changing tropism is difficult to predict, and a skilled artisan would not have had a reasonable expectation that changes could be made to improve or alter tropism. A skilled artisan would also have been concerned that changes, even small ones, could negatively impact other properties of the capsid protein. Therefore, rather than seek to modify a vector, a skilled artisan” slip op. at 29
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“The ’772 Publication, however, does not indicate as Petitioner asserts that a new variant is necessary to improve the efficiency of gene transfer to liver; the ’772 Publication indicates that AAV8 fulfills that need. See Ex. 1007 ¶ 250. In the paragraph that Petitioner relies upon for the alleged need to improve the efficiency of gene transfer to the liver, the ’772 Publication states in full: The tropism of each new vector is favorable for in vivo applications. AAV2/7 vectors appear to transduce skeletal muscle as efficiently as AAV2/1, which is the serotype that confers the highest level of transduction in skeletal muscle of the primate AAVs tested to date. Importantly, AAV2/8 provides a substantial advantage over the other serotypes in terms of efficiency of gene transfer to liver that until now has been relatively disappointing in terms of the numbers of hapatocytes stably transduced. AAV2/8 consistently achieved a 10 to 100-fold improvement in gene transfer efficiency as compared to the other vectors. The basis for the improved efficiency of AAV2/8 is unclear, although it presumably is due to uptake via a different receptor that is more active on the basolateral surface of hepatocytes. This improved efficiency will be quite useful in the development of liver-directed gene transfer where the number of transduced cells is critical, such as in urea cycle disorders and familial hypercholesterolemia. Id. (citations omitted) (emphasis added). According to the import of the complete recitation of paragraph 250 of the ’772 Publication set forth above that Petitioner relies upon for the motivation to improve efficient gene transfer in liver, AAV8 already fulfills this need. See Tr. 28:15–18. We do not read the ’772 Publication as calling for a search for a more efficient variant to improve efficient gene transfer in liver. We credit Dr. Samulski’s testimony that supports this view of the teachings of the ’772 Publication. Dr. Samulski testifies: Additionally, when the inventors compared AAV8’s expression in the liver against new serotypes AAVrh2, AAVrh10, AAVrh13, and AAVrh21, they found that AAV8 remained superior:” slip op. at 28
Patent outcomesUS 11,680,274 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,680,274 - 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.