- 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 - Google LLC v. Metarail, Inc.Rehearing deniedPTAB · Aug 25, 2025 · IPR2024-01271 · APJ Frances L Ippolito · IPR · Rehearing
The Board denied Google’s rehearing request, leaving institution denied for claims 1–21 because the petition did not show a reasonable likelihood that Belanger-Halevy taught limitation [1B].
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. ANALYSIS A request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, a reply or sur-reply.” 37 C.F.R. § 42.71(d). The party challenging a decision bears the burden of showing the decision should be modified. Id. We address Petitioner’s rehearing arguments below.” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“variable data database’ as required by claim 1.” Dec. 22. We discussed and quoted extensively from Petitioner’s expert declaration of Dr. Fox and Patent Owner’s expert declaration of Dr. Malek. Id. at 22–26 (citing Ex. 1003 ¶ 94; Ex. 2001 ¶¶ 68, 70). In reviewing the parties’ submissions, we found that: Halevy’s disclosures are consistent with Patent Owner’s arguments and Dr. Malek’s testimony that Halevy does not teach mapping fields to one another or mapping of fields to one another through SO-properties. For example, as described, in Figure 6 and Halevy as a whole, Halevy does not teach or suggest mapping or linking different keywords to one another, rather the keywords are mapped to SO-properties.” slip op. at 5
- Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner
“Dr. Fox states that “Halevy’s disclosure of a form database in which corresponding fields from different forms on different websites map to the same SO-properties based on the SO-class identified for the form would have been recognized by a POSA as what the ’342 patent refers to as a universal variable map.” Ex. 1003 ¶ 98 (citing Ex. 1001, 17:48– 52). Based on this conclusory opinion, Dr. Fox reasons that Halevy’s form database is a “universal variable map” that must also link computer-readable field identifiers from multiple different websites to each other in the form database, because field identifiers are mapped to the same SO-properties associated with an SO-class.” Id. (emphasis omitted). We observe first that Dr. Fox’s conclusion is not supported by the cited portions of the ’342 patent. In column 17, lines 48–52, the ’342 patent explains that fields or variables may be part of forms, and variations of the data fields or variables “may include a source form, a destination form, a single source to many destination form, many sources to one destination form, cascading forms (e.g., a first form links to a second form which links to a third form, etc.) and so on.” Ex. 1001, 17:48–52. While this portion of the ’342 patent indicates that forms may include variations on fields or variables, it does not describe linking or mapping variables to one another. Ex. 2001 ¶ 75 (“[T]hat portion of the specification does not have anything to do with the definition of a “universal variable map.” Rather, it merely discusses different types of variables and fields that might appear in different types of forms.”). Dec. 28–29. We again referred to the disclosure of the ’342 patent to address evidence in the Petition relied upon by Dr. Fox to support Petitioner’s position. Id. We credited Dr. Malek’s testimony over Dr. Fox’s testimony because Dr. Malek underlined the distinctions between the asserted Belanger-Halevy prior art combination and limitation [1B]. Dec. 28–31. In short, any confusion applying the prior art Belanger-Halevy references to the claim limitation is rooted in the Petition. The Board denied the Petition because the Petition did not demonstrate a reasonable likelihood of showing that Belanger-Halevy discloses or teaches limitation [1B] of the ’342 patent.” slip op. at 5
NonePatents in suitUS 10,262,342 - Google LLC v. Metarail, Inc.Rehearing deniedPTAB · Aug 25, 2025 · IPR2024-01270 · APJ Frances L Ippolito · IPR · Rehearing
The Board denied Google’s rehearing request, leaving in place the denial of institution because the Petition did not show a reasonable likelihood that Belanger-Halevy teaches limitation [1C] of claims 1–26.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. ANALYSIS A request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, a reply or sur-reply.” 37 C.F.R. § 42.71(d). The party challenging a decision bears the burden of showing the decision should be modified. Id. We address Petitioner’s rehearing arguments below.” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“[m]issing, however, from Halevy’s disclosure is any teaching or suggestion that a ‘plurality of computer-readable field identifiers’ are mapped ‘to one another’ as required by claim 1.” Dec. 22. We discussed and quoted extensively from Petitioner’s expert declaration of Dr. Fox and Patent Owner’s expert declaration of Dr. Malek. Id. at 22–26 (citing Ex. 1003 ¶ 104; Ex. 2001 ¶¶ 69, 71). In reviewing the parties’ submissions, we found that: Halevy’s disclosures are consistent with Patent Owner’s arguments and Dr. Malek’s testimony that Halevy does not teach mapping fields to one another or mapping of fields to one another through SO-properties. For example, as described, in Figure 6 and Halevy as a whole, Halevy does not teach or suggest mapping or linking different keywords to one another, rather the keywords are mapped to SO-properties. slip op. at 5
- Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner
“Dr. Fox states that “Halevy’s disclosure of a form database in which corresponding fields from different forms on different websites map to the same SO-properties would have been recognized by a POSA as what the ’378 patent refers to as a universal variable map.” Ex. 1003 ¶ 108 (citing Ex. 1001, 17:42–46). Based on this conclusory opinion, Dr. Fox reasons that Halevy’s form database is a “universal variable map” that must also link computer-readable field identifiers (including parameter names) from multiple different websites to each other in the form database, because the field identifiers are mapped to the same SO-properties associated with an SO-class. Id. We observe first that Dr. Fox’s conclusion is not supported by the cited portions of the ’378 patent. In column 17, lines 42–46, the ’378 patent explains that fields or variables may be part of forms and variations of these data fields or variables “may include a source form, a destination form, a single source to many destination form, many sources to one destination form, cascading forms (e.g., a first form links to a second form which links to a third form, etc.) and so on.” Ex. 1001, 17:42–46. While this portion of the ’378 patent indicates that forms may include variations on fields or variables, it does not describe any linking or mapping of variables to one another. Ex. 2001 ¶ 76 (“[T]hat portion of the specification does not have anything to do with the definition of a “universal variable map.” Rather, it merely discusses different types of variables and fields that might appear in different types of forms.”). Dec. 28–29. We again referred to the disclosure of the ’378 patent to address evidence in the Petition relied upon by Dr. Fox to support Petitioner’s position. Id. We credited Dr. Malek’s testimony over Dr. Fox’s testimony because Dr. Malek underlined the distinctions between the asserted Belanger-Halevy prior art combination and limitation [1C]. Dec. 28–31. In short, any confusion applying the prior art Belanger-Halevy references to the claim limitation is rooted in the Petition. The Board denied the Petition because the Petition did not demonstrate a reasonable likelihood of showing that Belanger-Halevy discloses or teaches limitation [1C] of the ’378 patent.” slip op. at 5
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“Finally, with regard to the Reply and Sur-Reply submitted by the parties (Req. 9), we note that our Decision on Institution reviewed the parties’ discussion of claim construction, but ultimately determined that “[b]ased on our review of the preliminary record, we do not need to construe any terms expressly to reach our decision.” Dec. 11. Thus, we disagree with Petitioner that we misconstrued the mapping limitation where we did not find it necessary to construe any claim term for the purposes of our institution decision because we determined the Petition deficient for failing to meet our threshold requirements as discussed above and in detail in the Decision on Institution. See Req. 1–11.” slip op. at 7
Claim constructionPatents in suitUS 9,633,378 - 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 - PTAB · Aug 13, 2025 · IPR2025-00068 · APJ Neil T Powell · IPR · Remand
On remand, the Board denied institution of IPR challenging claims 1–21, applying the construction of “association” used in the parallel petition.
RulingsRemand decision- RemandOther
“The Director Review Decision determined that we should not have instituted inter partes review in both proceedings. DR 1. Instead, we “should have construed [‘association’] and instituted review of, at most, one of the petitions.” Id. at 3. Given this, the Director Review Decision vacated this proceeding’s Institution Decision and the 70 Institution Decision, remanding “to the Board panel to determine which of the two proceedings, if Board should construe the term ‘association,’” the Director Review Decision instructed us to “consider the parties’ claim construction arguments in making [our] determination.” Id. at 4. As we explain in a concurrently issued decision in IPR2025-00070, the parties have persuaded us that the correct construction of the ’872 patent claims’ recitation of “association” is the construction advanced and applied in the 70 Petition, not the narrower, possible construction addressed in this proceeding’s Petition. IPR2025-00070, Paper 28. Accordingly, we deny institution of inter partes review in this proceeding.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“As we explain in a concurrently issued decision in IPR2025-00070, the parties have persuaded us that the correct construction of the ’872 patent claims’ recitation of “association” is the construction advanced and applied in the 70 Petition, not the narrower, possible construction addressed in this proceeding’s Petition. IPR2025-00070, Paper 28. Accordingly, we deny institution of inter partes review in this proceeding.” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied
“As we explain in a concurrently issued decision in IPR2025-00070, the parties have persuaded us that the correct construction of the ’872 patent claims’ recitation of “association” is the construction advanced and applied in the 70 Petition, not the narrower, possible construction addressed in this proceeding’s Petition. IPR2025-00070, Paper 28. Accordingly, we deny institution of inter partes review in this proceeding. II. ORDER It is: ORDERED that, pursuant to 35 U.S.C. § 314(a), the petitioned institution of inter partes review of the ’872 patent is denied.” slip op. at 3
Claim constructionPatents in suitUS 9,954,872 - PTAB · Aug 13, 2025 · IPR2025-00070 · APJ Neil T Powell · IPR · Remand
The Board instituted inter partes review of claims 1–21 on all asserted grounds, finding a reasonable likelihood that at least claim 1 is unpatentable over Capalik.
RulingsRemand decision- Director reviewOther
“Patent Owner then filed a Request for Director Review, arguing that Petitioner did not need two petitions to challenge the ’872 patent’s claims. Paper 19. Acting Director Coke Morgan Stewart granted Director Review. Paper 25 (“Director Review Decision” or “DR Dec.”); IPR2025-00068, Paper 25. The Director Review Decision vacated this proceeding’s Institution Decision and the 68 Institution Decision, remanding “to the Board panel to Authorizing the parties to brief “how the Board should construe the term ‘association,’” the Director Review Decision instructed us to “consider the parties’ claim construction arguments in making [our] determination.” Id.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Thus, the parties agree on the correct construction of “association.” And the parties persuade us to adopt their construction: “association” does not require any classification as authorized or unauthorized. Pet. 4–8; PO Remand Br. 1–3; Pet. Resp. Br. 1–2. This construction of “association” is the one applied in this Petition’s claim challenges, which comports with (1) our earlier determination that the Petition demonstrates a reasonable likelihood of prevailing and (2) Petitioner’s preference for this Petition over the 68 Petition. Pet. 4–8, 13–74; Dec. 10–22; Paper 3, 2; Pet. Resp. Br. 2, 5.” slip op. at 13
- BurdenDecided for petitioner
“D. The Merits of Petitioner’s Claim Challenges In our Institution Decision, after weighing the parties’ arguments and evidence, we determined that the Petition demonstrates a reasonable likelihood of establishing unpatentability of at least claim 1 of the ’872 patent as obvious over Capalik. E.g., Dec. 16–22. Based on all of the arguments and evidence currently of record, we remain persuaded that the Petition demonstrates a reasonable likelihood of prevailing on at least claim 1 of the ’872 patent. Indeed, as discussed above in Section II.A, the parties’ agreement on the correct construction of “association” reinforces this determination. III. CONCLUSION In view of the foregoing, having determined that Petitioner has demonstrated a reasonable likelihood of establishing at least claim 1 of the ’872 patent is unpatentable, we institute trial as to all challenged claims on all grounds stated in the Petition IV. ORDER It is: ORDERED that inter partes review of claims 1–21 of the ’872 patent is instituted on all grounds presented in the Petition; and” slip op. at 18
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“institution under § 325(d). Prior to our Institution Decision, Patent Owner did not argue we should deny under § 325(d). See generally Prelim. Resp.; Pet. Resp. Br. 4. Patent Owner first raised § 325(d) while its Request for Director Review was pending, emailing the Office with a request to brief § 325(d) in view of Ecto World. Ex. 3101, 4–5. The Office did not grant that request. Id. at 1. Nor did the Director Review Decision authorize Patent Owner to brief § 325(d). It only authorized Patent Owner “to file a ten-page brief explaining how the Board should construe the term ‘association.’” DR Dec. 4. In sum, Patent Owner’s unauthorized § 325(d) arguments are waived. Moreover, even if Patent Owner had not waived its § 325(d) arguments, we find Petitioner’s § 325(d) arguments more persuasive.” slip op. at 16
Claim constructionDiscretionary denialPatents in suitUS 9,954,872 - Neurent Medical Inc. / Neurent Medical Ltd. v. The Foundry, LLCAll claims unpatentablePTAB · Jul 21, 2025 · IPR2024-00669 · APJ Timothy G Majors · IPR · Final written decision
Claims 1–8 and 11 are unpatentable as obvious over Makower, Fang, and Edwards, with claim 4 also obvious over those references and Stern; the Board did not reach Grounds 1–4.
RulingsFinal written decision- Skill levelSkill level board ownOther
“Based on the record before us, including the types of problems and solutions described in the ’077 patent and the cited prior art, we find a POSA would have had (1) a Doctor of Medicine (M.D.) or at least a bachelor of science degree in biomedical engineering or a related discipline, (2) at least three years of experience in the clinical use, design, development, and/or testing of medical devices that deliver energy to tissue, and 3) knowledge and experience in treating nasal conditions, or access to a person with that knowledge and experience. Less work experience may be compensated by a higher level of education, and vice versa. 11 Patent Owner suggests a POSA’s ability to “learn about” the nasal anatomy invokes the wrong standard because a POSA “must have the necessary background at the time of the invention.” PO Sur-reply 27. We agree in part with Patent Owner; the hypothetical POSA is presumed to possess the requisite skill at the time of the invention. Nevertheless, as it concerns an engineer with extensive experience designing and developing RF ablation devices (like Dr. Martin), we see no basis to conclude that such person may not become familiar with the features of the nose through review of the literature and/or consultation with clinicians. Ex. 1098 ¶ 44 (testifying a person with device design experience could learn about the relevant nasal anatomy and apply their skill to problems or solutions for that area by reviewing the relevant literature). Moreover, that Dr. Martin may not have had personal experience designing devices for the nose prior to 2006 does not mean that he cannot testify from a POSA’s perspective. Osseo Imaging, LLC v. Planmeca USA, Inc., 116 F.4th 1335, 1341 (Fed. Cir. 2024) (“An expert need not have acquired the skill level prior to the time of the invention to be able to testify from the vantage point of a person of ordinary skill in the art” because “an expert can acquire the necessary skill level later and develop an understanding of what a [POSA] knew at the time of the invention”) (emphasis omitted). Petitioner that the ’077 patent discloses delivering neurotoxins to any target, and not just the nose, the claims of the ’077 patent are directed to methods of treating a nasal condition by delivering energy to the nasal cavity. Pet. Reply 32. Thus, to fill a gap between Petitioner’s POSA definition and the scope of the challenged claims, we add to Petitioner’s definition the requirement for knowledge and experience in treating nasal conditions, or access to a person with that knowledge and experience. We additionally add that a POSA’s educational background may include a bachelor of science degree in biomedical engineering or related discipline to reflect the nature of the field of invention. Nonetheless, we also note that our analysis and conclusions herein would not change even under Petitioner’s proposed skill level for a POSA. We do not agree with Patent Owner that prior experience designing or developing nasal medical devices is required for a POSA. PO Resp. 19–20. A definition inclusive of the clinical use, design, development, and/or testing of nasal medical devices that deliver energy to tissue is consistent with the skill level reflected in the disclosures of the ’077 patent and prior art. Consequently, we disagree with Patent Owner that Dr. Bu-Saba fails to qualify as a POSA because he lacks experience specific to designing medical devices. PO Resp. 19 n.4. We also disagree that Dr. Martin’s testimony should be discounted for a lack of first-hand experience designing RF ablation devices specific for the nose (which experience Patent Owner’s engineer expert also lacks). Id. As Dr. Martin’s testimony concerns certain issues in dispute (i.e., use of bipolar electrodes), we find Dr. Martin is qualified and his testimony helpful in resolving those disputes. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010) (explaining And, even if there may be gaps in Dr. Martin’s experience or knowledge about the nasal anatomy, such gaps are filled by Dr. Bu-Saba’s extensive clinical expertise and testimony of record. Accordingly, we do not agree with Patent Owner that we should discount the testimony of Dr. Bu-Saba or Dr. Martin; we give their testimony appropriate weight in reaching our conclusions here.” slip op. at 15
- Expert testimonyPetitioner expert creditedOther
“We do not agree with Patent Owner that prior experience designing or developing nasal medical devices is required for a POSA. PO Resp. 19–20. A definition inclusive of the clinical use, design, development, and/or testing of nasal medical devices that deliver energy to tissue is consistent with the skill level reflected in the disclosures of the ’077 patent and prior art. Consequently, we disagree with Patent Owner that Dr. Bu-Saba fails to qualify as a POSA because he lacks experience specific to designing medical devices. PO Resp. 19 n.4. We also disagree that Dr. Martin’s testimony should be discounted for a lack of first-hand experience designing RF ablation devices specific for the nose (which experience Patent Owner’s engineer expert also lacks). Id. As Dr. Martin’s testimony concerns certain issues in dispute (i.e., use of bipolar electrodes), we find Dr. Martin is qualified and his testimony helpful in resolving those disputes. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010) (explaining And, even if there may be gaps in Dr. Martin’s experience or knowledge about the nasal anatomy, such gaps are filled by Dr. Bu-Saba’s extensive clinical expertise and testimony of record. Accordingly, we do not agree with Patent Owner that we should discount the testimony of Dr. Bu-Saba or Dr. Martin; we give their testimony appropriate weight in reaching our conclusions here.” slip op. at 16
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“construction standard used to construe claims in a civil action before the courts under 35 U.S.C. § 282(b), including construing claims’ language in accordance with its ordinary and customary meaning as understood by the POSA, in view of the patent’s specification and considering the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only construe terms that are in controversy and only to the extent needed to resolve the dispute. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019); U.S. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed. Cir. 1997) (holding claim construction is for “resolution of disputed meanings”). Petitioner contends that, “[f]or purposes of this IPR, the Board need not construe any terms.” Pet. 18. Patent Owner responds that “the Board need not construe any terms to determine Petitioners have failed to carry their burden in this proceeding.” PO Resp. 20. On the record before us, we conclude that the claims need not be expressly construed to resolve the dispute before us. Insofar as the parties dispute the mapping of the prior art to dependent claims 4 and 7, we address that dispute below including, to the extent necessary, any implicit disagreement about the subject matter encompassed by those claims.” slip op. at 17
- BurdenFwd all claims unpatentableUnpatentable
“For all the reasons above, we determine that the evidence supports Petitioner’s contention that a POSA would have reasonably expected success in combining the prior art to arrive at the subject matter of claim 1.” slip op. at 44
Patent outcomesUS 11,679,077 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,679,077 - Neurent Medical Inc. / Neurent Medical Ltd. v. The Foundry, LLCAll claims unpatentablePTAB · Jul 21, 2025 · IPR2024-00280 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1, 2, 5, 8–10, 12, and 14 are unpatentable as obvious over Makower, Fang, and Edwards; the Board did not reach Grounds 1–3.
RulingsFinal written decision- Skill levelSkill level board ownOther
“Based on the record before us, including the types of problems and solutions described in the ’011 patent and the cited prior art, we find a POSA would have had (1) a Doctor of Medicine (M.D.) or at least a bachelor of science degree in biomedical engineering or a related discipline, (2) at least three years of experience in the clinical use, design, development, and/or testing of medical devices that deliver energy to tissue, and 3) knowledge and experience in treating nasal conditions, or access to a person with that knowledge and experience. Less work experience may be compensated by a higher level of education, and vice versa.” slip op. at 12
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We do not agree with Patent Owner that prior experience designing or developing nasal medical devices is required for a POSA. PO Resp. 19–20. A definition inclusive of the clinical use, design, development, and/or testing of nasal medical devices that deliver energy to tissue is consistent with the skill level reflected in the disclosures of the ’011 patent and prior art. Consequently, we disagree with Patent Owner that Dr. Bu-Saba fails to qualify as a POSA because he lacks experience specific to designing medical devices. PO Resp. 19 n.4. Accordingly, we do not agree with Patent Owner that we should discount the testimony of Dr. Bu-Saba and we give Dr. Bu-Saba’s testimony appropriate weight in reaching our conclusions here.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“On the record before us, we conclude that the claims need not be expressly construed to resolve the dispute before us. Insofar as the parties dispute the mapping of the prior art to dependent claim 9, we address that dispute below including, to the extent necessary, any implicit disagreement about the subject matter encompassed by claim 9.” slip op. at 14
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“Petitioner contends that Makower and Fang7 are analogous art to the challenged claims. Pet. 77 (arguing Makower and Fang “are in the same field” and are “reasonably pertinent” to solving problems addressed by the claimed invention); Ex. 1002 ¶ 178. According to Petitioner, Makower and 7 Petitioner argues a POSA had reasons for combining Edwards with Makower and Fang with a reasonable expectation of success (see, e.g., Pet. 74–76, 81–85). We find persuasive Petitioner’s reasoning and evidence on the addition of Edwards, and Patent Owner provides no rebuttal about Edwards. energy to tissue and “each uses RF energy to treat tissue.” Pet. 77 (citing, e.g., Ex. 1005 ¶¶ 1, 43, 132, 164, 187; Ex. 1006, 876–877).” slip op. at 25
Patent outcomesUS 10,894,011 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,894,011 - Neurent Medical Inc. / Neurent Medical Ltd. v. The Foundry, LLCAll claims unpatentablePTAB · Jul 21, 2025 · IPR2024-00279 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–3, 7, 9, 10, and 17–25 are unpatentable as obvious over Makower and Fang; the Board did not reach the other grounds.
RulingsFinal written decision- Skill levelSkill level board ownPetitioner expert creditedDecided for petitioner
“Based on the record before us, including the types of problems and solutions described in the ’675 patent and the cited prior art, we find a POSA would have had (1) a Doctor of Medicine (M.D.) or at least a bachelor of three years of experience in the clinical use, design, development, and/or testing of medical devices that deliver energy to tissue, and 3) knowledge and experience in treating nasal conditions, or access to a person with that knowledge and experience. Less work experience may be compensated by a higher level of education, and vice versa. In reaching our finding, we note that, although we agree with Petitioner that the ’675 patent discloses delivering neurotoxins to any target, and not just the nose, the claims of the ’675 patent are directed to methods of treating a nasal condition by delivering energy to the nasal cavity. Pet. Reply 30. Thus, to fill a gap between Petitioner’s POSA definition and the scope of the challenged claims, we add to Petitioner’s definition the requirement for knowledge and experience in treating nasal conditions, or access to a person with that knowledge and experience. We additionally add that a POSA’s educational background may include a bachelor of science degree in biomedical engineering or related discipline to reflect the nature of the field of invention. Nonetheless, we also note that our analysis and conclusions herein would not change even under Petitioner’s proposed skill level for a POSA. We do not agree with Patent Owner that prior experience designing or developing nasal medical devices is required for a POSA. PO Resp. 19. A definition inclusive of the clinical use, design, development, and/or testing of nasal medical devices that deliver energy to tissue is consistent with the skill level reflected in the disclosures of the ’675 patent and prior art. Consequently, we disagree with Patent Owner that Dr. Bu-Saba fails to qualify as a POSA because he lacks experience specific to designing medical devices. PO Resp. 19 n.4. Accordingly, we do not agree with Patent Owner” slip op. at 12
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Second, we credit the testimony of the experts that, on balance, further confirms that skilled clinicians knew how to manage and remove fluids to the extent necessary. Dr. Bu-Saba testifies that typical steps for RF ablation procedures (even before 2006) included positioning the patient in a seated or slightly reclined position to facilitate the flow of any mucus or fluids away from the nasal cavity, application of topical decongestants, and “[i]n some circumstances,” if mucus or blood was still in the treatment area, “a 11 Nor does Patent Owner identify any disclosure in any other technical literature (either before or after 2006) expressing concerns that electrolytic fluids at the operative site could not be managed and/or would prevent targeted application of RF ablation energy to tissues at that site. See, e.g., Ex. 2003 ¶¶ 91–97 (testifying about the hypothetical “fluid” problem, but identifying no independent recognition of such a problem in any corroborating reference); Ex. 2005 ¶¶ 66–76 (same). visualization of the surgical site.” Ex. 1098 ¶¶ 81–89; Pet. Reply 14–15. Patent Owner’s expert, Dr. Levine, concurs that skilled clinicians knew how to remove mucus and other fluids, testifying that “[i]f [mucus] was obstructing my view” and “[i]f it was this thick . . . I might have to mechanically remove it with forceps, I might have to suction it, I might have to irrigate the nose with a saline solution to wash out the nose.” Ex. 1089 (Levine Tr.), 83:3–84:6 (admitting residual saline could either be swallowed or suctioned out); see also id. at 86:1–16 (testifying a patient may be positioned such that by “[v]irtue of gravity . . . fluid would fall to the bottom”).” slip op. at 33
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner contends that, “[f]or purposes of this IPR, the Board need not construe any terms.” Pet. 18. Patent Owner responds that “the Board need not construe any terms to determine Petitioners have failed to carry their burden in this proceeding.” PO Resp. 20. On the record before us, we conclude that the claims need not be expressly construed to resolve the dispute before us. Insofar as the parties dispute the mapping of the prior art to dependent claim 22, we address that dispute below including, to the extent necessary, any implicit disagreement about the subject matter encompassed by claim 22.” slip op. at 14
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
Patent outcomesUS 10,610,675 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,610,675 - Palo Alto Networks, Inc. v. Centripetal Networks, Inc.No claims unpatentablePTAB · Jul 21, 2025 · IPR2021-01150 · APJ Stacey G White · IPR · Remand
On remand, the Board held that Petitioner had not shown claims 1–18 unpatentable under § 103 over Paxton, Sutton, and Ivershen because the combination did not teach or motivate transmission responsive to correlation.
RulingsRemand decision- RemandOther
“the Final Written Decision for “not clearly explaining its holding or rationale regarding motivation to combine and whether the proposed combination teaches the final limitation of claim 1: transmitting an indication of the first host responsive to the correlating.” Palo Alto Networks, 122 F.4th at 1384. In the opinion, the Federal Circuit explained that the Final Written Decision “never made a clear finding on whether a person of ordinary skill in the art would have been motivated to modify Paxton by adding Sutton’s step of transmitting a notification of malicious activity after Paxton’s correlation step,” as proposed by Petitioner. Id. at 1385. The Federal Circuit stated that the Board “failed to explain why a person of ordinary skill in the art would not have been motivated to modify Paxton to provide the recited notification as taught by Sutton in response to the correlation disclosed in Paxton.” Id. The Federal Circuit concluded that “[b]y reading Paxton and Sutton in isolation, the Board erred,” and that we vacate and remand for the Board to clarify and explain its holding on whether a person of ordinary skill in the art would have been motivated to transmit the identity of the first host (e.g., to an administrator) as taught by Sutton, responsive to the correlating disclosed by Paxton to improve network security.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“the alleged invention of the ’903 patent “had a bachelor’s degree in electrical engineering, computer engineering, computer science, or a related field, and approximately 2–3 years of experience in the design or development of telecommunication systems, or the equivalent.” Pet. 13 (citing Ex. 1003 ¶¶ 18–20). Petitioner further notes that “[a]dditional graduate education could substitute for professional experience, or significant experience in the field could substitute for formal education.” Id. Patent Owner’s proposed level of ordinary skill is similar, with Patent Owner contending that the ordinary skilled artisan “would be someone with a bachelor’s degree in computer science, electrical engineering, or related field, and either (1) two or more years of industry experience and/or (2) an advanced degree in computer science or related field.” PO Resp. 12–13 (citing Ex. 2019 ¶¶ 27– 31). Similar to Petitioner, Patent Owner also states that a person of ordinary skill in the art “may have additional industry experience in lieu of a formal degree.” Id. at 13.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“After review of the current record, we conclude that no express claim construction is necessary for the purposes of this Decision. See, e.g., Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng'g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’”).” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“responsive to the correlation, we are not persuaded that one of ordinary skill in the art would have been motivated to combine the teachings of these references in the manner advocated by Petitioner. Petitioner contends that this combination would only involve “[t]he application of known techniques (e.g., Sutton’s implementation of rules and data to define security policies, disallowed websites, etc.) to improve similar devices (e.g., servers, gateways, firewalls, etc. in Sutton’s and Paxton’s systems) to provide predictable results in the same way (e.g., to provide packet-filtering functions preventing communications with potentially malicious hosts).” Id. at 22–23.” slip op. at 25
Patent outcomesUS 10,530,903 not shown unpatentableClaim construction§ 103 obviousnesscites GrahamPatents in suitUS 10,530,903
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.