- PTAB · Nov 19, 2025 · IPR2025-00948 · APJ Michael J Fitzpatrick · IPR · Institution
The Board instituted IPR on all claims 1–23, finding a reasonable likelihood that claim 11 would have been obvious over Herrstedt, Bös, and Herrington.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Institution of an inter partes review requires that “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). Determining whether to institute has been delegated to the Board. See 37 C.F.R. § 42.4(a) (“The Board institutes the trial on behalf of the Director.”). Upon consideration of the Petition and the Preliminary Response, and for the reasons explained below, we determine that there is a reasonable likelihood that Petitioner would prevail with respect to at least one claim. Accordingly, we grant the Petition.” slip op. at 2
- Skill levelOther
“At this stage, we need not resolve the parties’ dispute with regard to the requisite level of skill in the art, as our analysis would be the same under either party’s definition of a POSA. We note, however, that Petitioner’s definition seems to be overly broad insofar as it would only require the POSA to be skilled in one of several broad fields, including “statistics” and “medical policy and decision making,” that do not directly relate to the claimed subject matter. At the same time, we do not agree with Patent Owner that the POSA needs specific clinical experience in the field of oncology. The claimed subject matter relates to the treatment of a side-effect associated with cancer therapy (CINV), and not the cancer itself. We also recognize that the prior art and the ’357 patent itself reflect the level of skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he absence of specific findings on the level of skill in the art does not give rise to reversible error where the prior art itself reflects an appropriate level and a need for testimony is not shown.”). We further find, based on the present record, that both parties’ experts are qualified to testify from the perspective of a POSA in this proceeding. See Ex. 1009 ¶¶ 1–7 (Dr. Peroutka’s qualifications); Ex. 2069 ¶¶ 8–15 (Dr. Navari’s qualifications); Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm'n, 22 F.4th 1369, 1377 (Fed. Cir. 2022) (“[T]o be qualified to offer expert testimony on issues from the vantage point of an ordinarily skilled artisan in a patent case, an expert must at a minimum possess ordinary skill in the art.”). Even if some specific experience with regard to the treatment” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“First, Petitioner proposes that “therapeutically effective amount” (recited in both independent claims) means: an amount sufficient to elicit the desired biological response. Pet. 9 (citing Ex. 1003, 8:13–15). The cited portion of the Specification clearly supports such a construction. Ex. 1003, 8:13–15 (“As used herein, ‘therapeutically effective amount’ refers to an amount sufficient to elicit the desired biological response.”). We adopt it. Second, Petitioner proposes that “the word if in claims 1 and 11 appears from context to mean ‘is’.” Id. (citing Ex parte Tanksley, 26 USPQ2d 1384, 1387 (BPAI 1991)). Both of the independent claims conclude with the following clause: “and said single dose of netupitant or pharmaceutically acceptable salt thereof if effective to treat said nausea and vomiting for said five consecutive days.” (Emphasis added). The word “if” cannot mean “is,” as Petitioner literally proposes. Pet. 9. However, we understand Petitioner to be arguing implicitly that (1) “if” was a typographical or other error in the independent claims and (2) “is” was intended in its place. Such is a reasonable position in the context of the challenged claims. On the instant record, with no argument to the contrary by Patent Owner, we construe claims 1 and 11 such that the word “is” was intended in lieu of the word “if” in the last clause of each claim. Cf. Canatex Completion Sols., Inc., v. Wellmatics, LLC, No. 2024-1466, 2025 WL 3153362, at *5 (Fed. Cir. Nov. 12, 2025) (“[W]e have ruled that a district court may correct obvious minor typographical and clerical errors in patents.”) (cleaned up; citations omitted)).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Third, Petitioner proposes a construction for “minimum effective dose of dexamethasone.” Pet. 10. That term appears nowhere in the challenged claims. Accordingly, we do not interpret the term.” slip op. at 11
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,943,515 - PTAB · Nov 19, 2025 · IPR2025-00945 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1–25 after finding a reasonable likelihood that claim 19 would have been obvious over MASCC and Hoffmann.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have the authority to determine whether to institute an inter partes review. 35 U.S.C. § 314; 37 C.F.R. §42.4(a). We may not institute an inter partes review “unless . . . 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). Upon consideration of the Petition and the Preliminary Response, and for the reasons explained below, we determine that there is a reasonable likelihood that Petitioner would prevail with respect to at least one claim. Accordingly, we grant the Petition” slip op. at 2
- PTAB / AIA Trials › Real party in interest / privityOther
“Each party identifies itself as the sole real party in interest (RPI). Pet. 69; Paper 4, at 1. There is no dispute over RPIs in this proceeding. B. Related Matters” slip op. at 2
- Skill levelOther
“At this stage, we need not resolve the parties’ dispute with regard to the requisite level of skill in the art, as our analysis would be the same under either party’s definition of a POSA. We note, however, that Petitioner’s definition seems to be overly broad insofar as it would only require the POSA to be skilled in one of several broad fields, including “statistics” and “medical policy and decision making,” that do not directly relate to the claimed subject matter. At the same time, we do not agree with Patent Owner that the POSA needs specific clinical experience in the field of oncology. The claimed subject matter relates to the treatment of a side-effect associated with cancer therapy (CINV), and not the cancer itself. We also recognize that the prior art and the ’826 patent itself reflect the level of skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he absence of specific findings on the level of skill in the art does not give rise to reversible error where the prior art itself reflects an appropriate level and a need for testimony is not shown.”). We further find, based on the present record, that both parties’ experts are qualified to testify from the perspective of a POSA in this proceeding. See Ex. 1009 ¶¶ 1–7 (Dr. Peroutka’s qualifications); Ex. 2067 ¶¶ 8–15 (Dr. Navari’s qualifications); Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm'n, 22 F.4th 1369, 1377 (Fed. Cir. 2022) (“[T]o be qualified to offer expert testimony on issues from the vantage point of an ordinarily skilled artisan in a patent case, an expert must at a minimum possess ordinary skill in the art.”). Even if some specific experience with regard to the treatment of CINV is required, Dr. Peroutka appears to have published in that field. See, e.g., Ex. 1020 at 10, (publication 16: article on “Combination antiemetics” in Cancer Treatment Reports); id. at 11 (publication 37: article on “Neurotransmitter receptor binding studies predict antiemetic efficacy and side effects” in Cancer Treatment Reports); id. at 13 (publication 51: article on “Chemotherapeutic agents do not interact with neurotransmitter receptors” in Cancer Chemotherapy and Pharmacology). B. Claim Construction” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionNo construction neededOther
“First, Petitioner proposes that “therapeutically effective amount” (recited in both independent claims) means: an amount sufficient to elicit the desired biological response. Pet. 9 (citing Ex. 1001, 7:55–57). The cited portion of the Specification clearly supports such a construction. Ex. 1001, 7:55–57 (“As used herein, ‘therapeutically effective amount’ refers to an amount sufficient to elicit the desired biological response.”). We adopt it. Second, Petitioner proposes a construction for “minimum effective dose of dexamethasone.” Pet. 9. That term appears nowhere in the challenged claims. Accordingly, we do not interpret the term. Finally, Petitioner proposes construing the following language appearing in claim 1: “administering to said patient on day one netupitant or a pharmaceutically acceptable salt thereof, in a therapeutically effective amount which enters the systemic circulation, crosses the blood brain barrier and occupies at least 70% of neurokinin-1 (NK1) receptors in the striatum seventy-two hours after said administration.” Pet. 9–10 (emphasis added). Specifically, Petitioner proposes that the italicized language, as introduced by the word “which,” denotes inherent properties (and not further limitations) resulting from the administering of the drug in a therapeutically effective amount. Id. On the instant record, with no argument to the contrary by Patent Owner, we agree with Petitioner. However, we do not explicitly address claim 1 below. Instead, the focus of our institution analysis is independent claim 19. We do not perceive a need to construe expressly any other claim term of the ’826 patent for purposes of determining whether to institute trial. C. Summary of Asserted References” slip op. at 13
Claim construction§ 103 obviousnesscites GrahamPatents in suitUS 8,623,826 - PTAB · Nov 19, 2025 · IPR2025-00947 · APJ Christopher G Paulraj · IPR · Institution
The Board instituted review of all challenged claims and grounds, finding a reasonable likelihood that claim 1 would have been obvious over Herrstedt and Bös.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denialDenied
“II. DISCUSSION A. Discretionary Denial Patent Owner filed a request for discretionary denial of institution. Paper 8. Petitioner opposed. Paper 9. The Acting Director denied the discretionary denial request. Paper 12 (September 19, 2025). Accordingly, we proceed with our analysis of the merits of Petitioner’s patentability” slip op. at 8
- Skill levelOther
“At this stage, we need not resolve the parties’ dispute with regard to the requisite level of skill in the art, as our analysis would be the same under either party’s definition of a POSA. We note, however, that Petitioner’s definition seems to be overly broad insofar as it would only require the POSA to be skilled in one of several broad fields, including “statistics” and “medical policy and decision making,” that do not directly relate to the claimed subject matter. At the same time, we do not agree with Patent Owner that the POSA needs specific clinical experience in the field of oncology. The claimed subject matter relates to the treatment of a side-effect associated with cancer therapy (CINV), and not the cancer itself. We also recognize that the prior art and the ’357 patent itself reflect the level of skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he absence of specific findings on the level of skill in the art does not give rise to reversible error where the prior art itself reflects an appropriate level and a need for testimony is not shown.”).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“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) (2019). This standard requires that we construe claims “in accordance with the ordinary and customary meaning of such claim[s] as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Petitioner contends no terms need to be construed to find the claims unpatentable in view of the prior art. Pet. 9. Patent Owner also contends that no claim construction is necessary to resolve the parties’ disputes. Prelim Resp. 14. At this stage, we do not perceive a need to construe expressly any claim terms of the ’357 patent for purposes of determining whether to institute trial.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Herrstedt taught the use of aprepitant as an NK1 receptor antagonist that could be combined with dexamethasone and palonosetron to treat emesis. Nonetheless, based on Bös’s identification of netupitant (compound Ib) as a “potent and selective” NK1 antagonist with “valuable therapeutic properties,” the present record supports Petitioner’s argument that the POSA would have been motivated to replace aprepitant with netupitant in the combination therapy. Ex, 1014, 14:31–34. Bös indicates that the compounds disclosed therein have utility in the treatment of emesis, and that neutpitant in particular “is a potent antagonist of NK1 induced behaviors in Gerbil and blocks emesis in Ferrets and suncus murinus with similar potency.” Id. at 19:26–30. Bös further indicates that netupitant has a high affinity for the NK1 receptor and a prolonged half-life. Id. at 18:44–48, 19:31–38. In view of these properties, we find a POSA would have had good reason to consider netupitant as a potential replacement for aprepitant in the treatment of CINV.” slip op. at 28
Claim construction§ 103 obviousnessDiscretionary denialcites KSRPatents in suitUS 9,186,357 - PTAB · Nov 19, 2025 · IPR2025-00946 · APJ Christopher G Paulraj · IPR · Institution
The Board instituted inter partes review on all challenged claims and grounds after finding a reasonable likelihood that claims 2 and 4 would have been obvious over Herrstedt and Bös.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314; 37 C.F.R. §42.4(a). We may not institute an inter partes review “unless . . . 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).” slip op. at 2
- PTAB / AIA Trials › Discretionary denialNot reached
“II. DISCUSSION A. Discretionary Denial Patent Owner filed a request for discretionary denial of institution. Paper 8. Petitioner opposed. Paper 9. The Acting Director denied the discretionary denial request. Paper 12 (September 19, 2025). Accordingly, we proceed with our analysis of the merits of Petitioner’s patentability challenges and do not address the discretionary denial arguments presented by the parties.” slip op. at 8
- Skill levelOther
“At this stage, we need not resolve the parties’ dispute with regard to the requisite level of skill in the art, as our analysis would be the same under either party’s definition of a POSA. We note, however, that Petitioner’s definition seems to be overly broad insofar as it would only require the POSA to be skilled in one of several broad fields, including “statistics” and “medical policy and decision making,” that do not directly relate to the Owner that the POSA needs specific clinical experience in the field of oncology. The claimed subject matter relates to the treatment of a side-effect associated with cancer therapy (CINV), and not the cancer itself. We also recognize that the prior art and the ’357 patent itself reflect the level of skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he absence of specific findings on the level of skill in the art does not give rise to reversible error where the prior art itself reflects an appropriate level and a need for testimony is not shown.”). We further find, based on the present record, that both parties’ experts are qualified to testify from the perspective of a POSA in this proceeding. See Ex. 1009 ¶¶ 1–7 (Dr. Peroutka’s qualifications); Ex. 2068 ¶¶ 8–15 (Dr. Navari’s qualifications); Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm'n, 22 F.4th 1369, 1377 (Fed. Cir. 2022) (“[T]o be qualified to offer expert testimony on issues from the vantage point of an ordinarily skilled artisan in a patent case, an expert must at a minimum possess ordinary skill in the art.”). Even if some specific experience with regard to the treatment of CINV is required, Dr. Peroutka appears to have published in that field. See, e.g., Ex. 1020 at 10, (publication 16: article on “Combination antiemetics” in Cancer Treatment Reports); id. at 11 (publication 37: article on “Neurotransmitter receptor binding studies predict antiemetic efficacy and side effects” in Cancer Treatment Reports); id. at 13 (publication 51: article on “Chemotherapeutic agents do not interact with neurotransmitter receptors” in Cancer Chemotherapy and Pharmacology).” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“that could be combined with dexamethasone and/or palonosetron to treat emesis. Nonetheless, based on Bös’s identification of netupitant (compound Ib) as a “potent and selective” NK1 antagonist with “valuable therapeutic properties,” the present record supports Petitioner’s argument that the POSA would have been motivated to replace aprepitant with netupitant in the compounds disclosed therein have utility in the treatment of emesis, and that neutpitant in particular “is a potent antagonist of NK1 induced behaviors in Gerbil and blocks emesis in Ferrets and suncus murinus with similar potency.” Id. at 19:26–30. Bös further indicates that netupitant has a high affinity for the NK1 receptor and a prolonged half-life. Id. at 18:44–48, 19:31–38. In view of these properties, we find a POSA would have had good reason to consider netupitant as a potential replacement for aprepitant in the treatment of CINV. Bös also teaches that the daily dosage can be adjusted between 10 to 1000 mg per person, or above that upper limit when necessary, and that the effective amount can be fitted to the individual requirements in each particular case. Id. at 42:5–11. As with palonosetron, given the significant half-life of netupitant, and its administration via the circulatory system, we find that a POSA would also have been motivated to adjust the dose of netupitant to an amount that induces “blood levels” effective to treat CINV.” slip op. at 28
§ 103 obviousnessDiscretionary denialcites KSRPatents in suitUS 9,186,357 - PTAB · Jul 22, 2024 · IPR2024-00278 · APJ Michael A Valek · IPR · Institution
The Board instituted inter partes review of claims 1, 4–6, 9, 10, 12, 13, and 15–17 on all grounds presented in the Petition.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Considering the arguments and evidence of record, we determine that the Petition demonstrates “a reasonable likelihood that [P]etitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Accordingly, we institute an inter partes review.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner contends a person of ordinary skill in the art (“POSITA”) would have had (1) a Doctor of Medicine (M.D.) or at least a bachelor of science degree in engineering or a related discipline and (2) at least three years of experience in the clinical use, design, development, and/or testing of medical devices, including medical devices that deliver energy to tissue. Pet. 19–20 (citing Ex. 1002 ¶¶ 24–28). Patent Owner does not respond to Petitioner’s description of a POSITA in its Preliminary Response. At this stage, we find Petitioner’s description of the level of ordinary skill in the art to be sufficiently supported by the record and apply it for purposes of this decision.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner contends “the Board need not construe any terms because the Challenged Claims are invalid under any reasonable interpretation.” Pet. 20. At this stage, Patent Owner does not respond to this contention, nor propose any express claim construction of its own. For this decision, and given that neither party seeks any express claim construction, we determine that no express claim construction is necessary. To the extent our consideration of Petitioner’s grounds touches on any implicit issues of claim construction, those are addressed in our analysis below.” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“several reasons. First, Petitioner’s reasoning for combining Edwards-535 and Stern is supported by testimony from Dr. Martin who identifies multiple, specific reasons for the combination. Ex. 1002 ¶¶ 103–122, 129–148. This testimony is not conclusory and is supported with numerous citations to other evidence of record. Id. Patent Owner does not offer any countervailing testimony with its Preliminary Response, electing instead to rely on attorney argument at this stage. Second, Patent Owner’s assertions that Petitioner’s reasoning is insufficient because Stern describes treating the endometrium and ablating different tissue, i.e., surface versus underlying tissue, are undermined by Edwards-535’s citation to Baker. As Petitioner points out, “Edwards-’535 points a POSITA” to, and incorporates teachings from, Baker. Pet. 47. This is true even though Baker, like Stern, is largely focused on treating the uterus and describes preferred embodiments for delivering RF energy to the endometrium. See, e.g., Ex. 1011, Abstr., 3:5–9, 5:50–65. Moreover, Petitioner offers evidence to show that Baker and Stern depict similar devices, including the figure from Dr. Martin’s declaration reproduced below. See Ex. 1002 ¶¶ 117–119, 144–147. Dr. Martin’s figure above is a side-by-side comparison of Figure 8 of Baker and Figure 4a of Stern, depicting devices that, at least on their face, appear to share a similar shape and configuration. See id. ¶¶ 119, 146 (testifying that the comparison above shows “Baker and Stern both depict very similar devices”). At this stage, Patent Owner does not dispute that Petitioner’s comparison is apt, nor otherwise address Petitioner’s reliance on Baker as evidence of a motivation to combine Stern. Thus, on the current record, we agree with Petitioner that Edwards-535’s express citation to Baker suggests that a POSITA would have been motivated to combine the similar teachings Petitioner identifies in Stern. Third, Stern also contradicts Patent Owner’s assertion that a POSITA would have considered its teachings to be inapplicable to treating the nasal concha as taught in Edwards-535. While Stern is primarily concerned with endometrial ablation applications, that does not mean its teachings are limited to such. Indeed, Stern explains that its “electrode partitioning structure” may be used to treat “other body organs or tissues either externally or internally” and that its “principles with respect to the delivery of controlled RF energy” can be applied “not only for controlled destruction of tissue but also for controlled heat treatment of tissue.” Id. Such teachings further support the testimony of Dr. Martin that “[a] POSITA would have known that technology from ablation devices for one part of the body would be applicable to devices used in other areas of the body.” Pet. 41 (citing Ex. 1002 ¶ 117–121; Ex. 1033, 18:27–40). We also disagree with Patent Owner’s argument that “Edwards-535 and Stern are so in conflict with one another that they rise to the level of teaching away.” Prelim. Resp. 21. A teaching away requires that the reference “criticize, discredit, or otherwise discourage the solution claimed.” In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). But Patent Owner has not shown that any of the references cited here discourage the articulated combination of Stern’s electrode configuration, i.e., multiple pairs of bipolar electrodes connected to separate radiofrequency output channels, with Edwards-535’s device. To the contrary, Stern expressly states that its “electrode partitioning structure” can be used for other applications (see Ex. 1033, 18:27–40), which on the current record would seem to include Edwards-535’s device for ablating nasal tissue.” slip op. at 22
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,033,318 - Parse Biosciences, Inc. v. 10x Genomics, Inc.Rehearing grantedPTAB · Feb 5, 2024 · IPR2023-00958 · APJ Michael J Fitzpatrick · IPR · Rehearing
Rehearing was granted and IPR instituted on claims 1–28 because the petition showed a reasonable likelihood that claim 1 was obvious over Linnarsson, McCloskey, and ordinary skill.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“III. WHETHER REHEARING IS WARRANTED Petitioner argues that we misconstrued the claims “as requiring one to add tags in a way that can provide a distinction based on a ‘polynucleotide sequence.’” Req. 6 (quoting Dec. 14 (Petitioner’s emphasis)). Petitioner is correct. More specifically, we implicitly construed the claim language reciting “a second tag sequence distinguishing said sample polynucleotide from other sample polynucleotides from said cell,” as requiring said “distinguishing” to be based on the sequences of the sample polynucleotides. See, e.g., Dec. 14 (“[E]ach strand of cDNA that is tagged in Linnarsson is tagged regardless of the polynucleotide sequence of the cDNA or its corresponding mRNA. Thus, Linnarsson’s tags do not distinguish between ‘sample polynucleotides,’ whether cDNA or mRNA, of different sequences.”). Based on that misunderstanding, we erroneously determined that the proposed modification could not achieve the claim language, stating the following: Petitioner’s proposal appears to defeat satisfaction of another portion of claim 1, namely a “second tag sequence distinguishing said sample polynucleotide from other sample polynucleotides from said cell.” Ex. 1001, 30:62–64. For if the second tag is “added to the CDS or TSO after extension,” as opposed to the sample polynucleotide, as Petitioner argues (Pet. 39 (emphasis added)), it would appear that the second tag would be incapable of distinguishing any sample polynucleotide from other sample polynucleotides. Rather, the second tag would be ligated to each and every extension product bearing a CDS or TSO without regard to the sequence of any sample polynucleotide. Dec. 16. We now reconsider whether to institute.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Cited”). Because we find that the same or substantially the same art was previously presented to the Office, we proceed to part two of the analysis. 2. Advanced Bionics Part Two Patent Owner argues that the Petition “fails to show any error in the Examiner’s application during prosecution of the prior art teachings Petitioner now purports to invoke from . . . McCloskey.” Prelim Resp. 23; see also id. at 24–25 (“Revisiting the same art and arguments already overcome during prosecution is a waste of the Board’s limited resources and would unfairly burden PO.”). However, Petitioner argued that “the Examiner committed major error in Examination by erroneously stating that the prior art fails to teach a dual tagging approach when, in fact, this approach is plainly taught in both McCloskey and McCloskey II.” Pet. 67. The record supports Petitioner’s position, and we agree that the error was material to patentability. See Ex. 1005, 131 (Notice of Allowance). Accordingly, and having considered all of the Becton, Dickinson factors, we do not exercise discretionary denial.” slip op. at 12
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We are persuaded there is a reasonable likelihood that Petitioner would prevail in demonstrating that a person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Linnarsson and McCloskey with the knowledge of a person of ordinary skill in the art to obtain the claimed subject matter. 8. Conclusion as to Claim 1 There is a reasonable likelihood that Petitioner would prevail in proving that claim 1 is unpatentable.” slip op. at 21
- Obviousness (§103) › Analogous artNot reached
“the three references is analogous art to the ’013 patent as opposed to each other. Prelim. Resp. 46 (citing Pet. 35; Sanofi-Aventis Deutschland GmbH v. Mylan Pharms. Inc., 66 F.4th 1373, 1374 (Fed. Cir. 2023)). As Sanofi- Aventis holds, a petitioner bears the burden of persuasion to establish that an asserted prior art reference is analogous art to the claimed invention. See Sanofi-Aventis, 66 F.4th at 1377 (“We agree with [the patent owner] that [the petitioner] did not carry its burden to argue that de Gennes is analogous to the [challenged] patent.”); id. (“In evaluating whether a reference is analogous, we have consistently held that a patent challenger must compare the reference to the challenged patent.”); id. at 1378–79 (“We have routinely held that the petitioner has the burden of proving unpatentability.”). However, the Petition should not be denied for failing to state explicitly that the cited prior art references are analogous art to the ’013 patent. Rather, as Sanofi-Aventis further held: “A petitioner is not required to anticipate and raise analogous art arguments in its petition; instead a petitioner can use its reply to ‘respond to arguments raised in the corresponding opposition, patent owner preliminary response, patent owner response, or decision on institution.’” Sanofi-Aventis, 66 F.4th at 1379 (quoting 37 C.F.R. § 42.23). Accordingly, we need not address this issue for purposes of deciding whether to institute trial.” slip op. at 15
§ 103 obviousnessDiscretionary denialPatents in suitUS 10,697,013 - Parse Biosciences, Inc. v. 10x Genomics, Inc.Rehearing grantedPTAB · Feb 5, 2024 · IPR2023-00955 · APJ Michael J Fitzpatrick · IPR · Rehearing
Rehearing granted and IPR instituted on claims 1–26; the Board found a reasonable likelihood that claim 1 would have been obvious over Linnarsson and McCloskey.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“III. WHETHER REHEARING IS WARRANTED Petitioner argues that we misconstrued the claims “as requiring one to add tags in a way that can ‘provide a distinction based on a polynucleotide’s sequence.’” Req. 6 (quoting Dec. 15 (Petitioner’s emphasis)). Petitioner is correct. More specifically, we implicitly construed the claim language reciting “a second tag sequence distinguishing said sample polynucleotide from other sample polynucleotides from said cell,” as requiring said “distinguishing” to be based on the sequences of the sample polynucleotides. See, e.g., Dec. 14 (“[E]ach strand of cDNA that is tagged in Linnarsson is tagged regardless of the polynucleotide sequence of the cDNA or its corresponding mRNA. Thus, Linnarsson’s tags do not distinguish between ‘sample polynucleotides,’ whether cDNA or mRNA, of different sequences.”). Based on that misunderstanding, we denied the Petition because “adding a second tag sequence to Linnarsson’s CDS and/or TSO would do nothing to achieve such a distinction,” i.e., “a distinction based on a polynucleotide’s sequence.” Id. at 15. That was error. We now reconsider whether to institute.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“the ’197 patent. See Ex. 1001, code (56) (listing McCloskey II under “References Cited”). Because we find that the same or substantially the same art was previously presented to the Office, we proceed to part two of the analysis.” slip op. at 11
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We are persuaded there is a reasonable likelihood that Petitioner would prevail in demonstrating that a person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Linnarsson and McCloskey to obtain the claimed subject matter. 6. Conclusion as to Claim 1 There is a reasonable likelihood that Petitioner would prevail in proving that claim 1 is unpatentable.” slip op. at 18
- Obviousness (§103) › Analogous artNot reached
“GmbH v. Mylan Pharms. Inc., 66 F.4th 1373, 1374 (Fed. Cir. 2023)). As Sanofi-Aventis holds, a petitioner bears the burden of persuasion to establish that an asserted prior art reference is analogous art to the claimed invention. See Sanofi-Aventis, 66 F.4th at 1377 (“We agree with [the patent owner] that [the petitioner] did not carry its burden to argue that de Gennes is analogous to the [challenged] patent.”); id. (“In evaluating whether a reference is analogous, we have consistently held that a patent challenger must compare the reference to the challenged patent.”); id. at 1378–79 (“We have routinely held that the petitioner has the burden of proving unpatentability.”). However, the Petition should not be denied for failing to state explicitly that the cited prior art references are analogous art to the ’197 patent. Rather, as Sanofi-Aventis further held: “A petitioner is not required to anticipate and raise analogous art arguments in its petition; instead a petitioner can use its reply to ‘respond to arguments raised in the corresponding opposition, patent owner preliminary response, patent owner response, or decision on institution.’” Sanofi-Aventis, 66 F.4th at 1379 (quoting 37 C.F.R. § 42.23). Accordingly, we need not address this issue for purposes of deciding whether to institute trial.” slip op. at 15
§ 103 obviousnessDiscretionary denialPatents in suitUS 10,240,197 - PTAB · Dec 19, 2023 · IPR2023-01037 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–29 and all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
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 it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. Considering the parties’ arguments and evidence, for reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’283 patent’s challenged claims. We decline to deny the Petition on the basis of discretion under § 325(d). We institute an inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355 (2018).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“35 U.S.C. § 325(d). In evaluating whether to deny institution under 325(d), the Board has considered several non-exclusive factors: (a) the similarities and material differences between the asserted art and the prior art involved during examination; (b) the cumulative nature of the asserted art and the prior art evaluated during examination; (c) the extent to which the asserted art was evaluated during examination; (d) the extent of the overlap between the arguments made during examination and the manner in which a petitioner relies on the prior art or a patent owner distinguishes the prior art; (e) whether a petitioner has pointed out sufficiently how the Office erred in evaluating the asserted prior art; and (f) the extent to which additional evidence and facts presented in the petition warrant reconsideration of the prior art or arguments. See Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first para.). Factors (a), (b), and (d) relate to whether the art or arguments in the Petition are the same or substantially the same as those previously presented to the Office. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 10 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). Factors (c), (e), and (f) “relate to whether the petitioner has demonstrated a material error by the Office” in the Office’s prior consideration of that art or arguments. Id. Under Advanced Bionics’s two-part framework, we first determine whether the same or substantially the same art or arguments previously were presented to the Office. Id. at 8, 10. If “either condition of [the] first part of Office has been shown. Id. at 8, 10.” slip op. at 68
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner’s contentions are, at this stage, unavailing. Petitioner’s proposal could have been more specific, but it is not so lacking that the institution burden is unmet. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in a “relevant discipline,” Petitioner is referring to the technical areas it cited previously, such as protein/enzyme biochemistry. Pet. 18. Petitioner’s definition does not ignore subject matter like “transgenic plants” because it states that the POSA would be able to apply key scientific concepts here (e.g., protein biochemistry, enzyme activity, and substrate selectivity) to such plants. Moreover, although Patent Owner complains about Petitioner’s POSA definition, it does not offer its own or explain why Petitioner’s challenge fails under any alternative definition. At this stage, Patent Owner’s suggestion that Dr. Hausinger lacks relevant expertise or qualifications of at least a POSA is unpersuasive. The ’283 patent relies on Dr. Hausinger’s own prior work. See, e.g., 1002, 18:44–50 (citing Hogan (Ex. 1027)), 50:51–55 (citing Fukumori (Ex. 2001)) (both references co-authored by Dr. Hausinger). Patent Owner also cites Dr. Hausinger’s work as evidencing what “skilled artisans” understood about the claimed and prior art technology, including αKGD dioxygenases, which is a focus of the parties’ arguments. See, e.g., Prelim. Resp. 8 (“Thus, as reflected in Hogan and Hotopp [(co-authored by Dr. Hausinger)], skilled artisans understood the structure-function relationships of Group II αKG-dependent dioxygenases . . . .”); Ex. 1029 (Hotopp 2002)). During prosecution, Dr. Wright’s declaration relied on Dr. Hausinger’s research. See, e.g., Ex. 1008, 462 (Wright I ¶ 13 (citing Hotopp)), 658 (Wright II artisans”)). And, Applicant’s other declarant, Dr. Nair, who testified about the POSA’s perspective at the time of the invention, appears to have academic and prior work history focused on chemistry, biochemistry, and enzymology without significant background in subjects like “controlling weeds” about which Patent Owner questions Dr. Hausinger’s qualifications. See, e.g., Ex. 1008, 590–591.17 Patent Owner will have the chance to cross-examine Dr. Hausinger in this proceeding. If Patent Owner feels we should discount Dr. Hausinger’s testimony due to lack of qualifications, it may raise such argument in trial. For now, we apply Petitioner’s proposed POSA level, with the” slip op. at 23
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“C. Claim Construction In inter partes review, we construe claims using the same claim construction standard used to construe claims in a civil action before the courts under 35 U.S.C. § 282(b), including construing claims in accordance with the ordinary and customary meaning as understood by the POSA and the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only construe terms that are in controversy and only as needed to resolve the matters in dispute. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019). 17 The closest work we see from Dr. Nair related to herbicide resistant transgenic plants is his 2019 paper co-written with the applicant’s employees (e.g., Dr. Wright), which paper appears to be a follow-on investigation into the AAD-1 proteins of the patent. Ex. 1008, 594–595; Ex. 1019, Abstr. proceeding. Pet. 17; Prelim. Resp. 20. It is not apparent at this stage that any terms need further interpretation to resolve the matters in dispute.18” slip op. at 24
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · GrahamPatents in suitUS 11,149,283 - PTAB · Dec 19, 2023 · IPR2023-01036 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–34 and all petitioned grounds, finding a reasonable likelihood of success on at least one challenged claim.
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 it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. Considering the parties’ arguments and evidence, for reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’555 patent’s challenged claims. We decline to deny the Petition on the basis of discretion under § 325(d). We institute an inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355 (2018).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“proposal could have been more specific, but it is not so lacking that the institution burden is unmet. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in a “relevant discipline,” Petitioner is referring to the technical areas it cited previously, such as protein/enzyme biochemistry. Pet. 17–18. Petitioner’s definition does not ignore subject matter like “transgenic plants” because it states that the POSA would be able to apply key scientific concepts here (e.g., protein biochemistry, enzyme activity, and substrate selectivity) to such plants. Moreover, although Patent Owner complains about Petitioner’s POSA definition, it does not offer its own or explain why Petitioner’s challenge fails under any alternative definition. At this stage, Patent Owner’s suggestion that Dr. Hausinger lacks relevant expertise or qualifications of at least a POSA is unpersuasive. The ’555 patent relies on Dr. Hausinger’s own prior work. See, e.g., 1001, 18:2– 7 (citing Hogan (Ex. 1027)), 51:6–12 (citing Fukumori (Ex. 2001)) (both references co-authored by Dr. Hausinger). Patent Owner also cites Dr. Hausinger’s work as evidencing what “skilled artisans” understood about the claimed and prior art technology, including αKGD dioxygenases, which is a focus of the parties’ arguments. See, e.g., Prelim. Resp. 7–8 (“Thus, as reflected in Hogan and Hotopp [(co-authored by Dr. Hausinger)], skilled artisans understood the structure-function relationships of Group II αKG-dependent dioxygenases . . . .”); Ex. 1029 (Hotopp 2002)). During prosecution, Dr. Wright’s declaration relied on Dr. Hausinger’s research. See, e.g., Ex. 1008, 462 (Wright I ¶ 13 (citing Hotopp)), 658 (Wright II ¶¶ 10–13 (describing the research in Hogan and Hotopp as that of “skilled artisans”)). And, Applicant’s other declarant, Dr. Nair, who testified about academic and prior work history focused on chemistry, biochemistry, and enzymology without significant background in subjects like “controlling weeds” about which Patent Owner questions Dr. Hausinger’s qualifications. See, e.g., Ex. 1008, 590–591.17 Patent Owner will have the chance to cross-examine Dr. Hausinger in this proceeding. If Patent Owner feels we should discount Dr. Hausinger’s testimony due to lack of qualifications, it may raise such argument in trial. For now, we apply Petitioner’s proposed POSA level, with the clarifications noted above, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 22
- Expert testimonyPetitioner expert creditedDecided for petitioner
“At this stage, Patent Owner’s suggestion that Dr. Hausinger lacks relevant expertise or qualifications of at least a POSA is unpersuasive. The ’555 patent relies on Dr. Hausinger’s own prior work. See, e.g., 1001, 18:2– 7 (citing Hogan (Ex. 1027)), 51:6–12 (citing Fukumori (Ex. 2001)) (both references co-authored by Dr. Hausinger). Patent Owner also cites Dr. Hausinger’s work as evidencing what “skilled artisans” understood about the claimed and prior art technology, including αKGD dioxygenases, which is a focus of the parties’ arguments. See, e.g., Prelim. Resp. 7–8 (“Thus, as reflected in Hogan and Hotopp [(co-authored by Dr. Hausinger)], skilled artisans understood the structure-function relationships of Group II αKG-dependent dioxygenases . . . .”); Ex. 1029 (Hotopp 2002)). During prosecution, Dr. Wright’s declaration relied on Dr. Hausinger’s research. See, e.g., Ex. 1008, 462 (Wright I ¶ 13 (citing Hotopp)), 658 (Wright II ¶¶ 10–13 (describing the research in Hogan and Hotopp as that of “skilled artisans”)). And, Applicant’s other declarant, Dr. Nair, who testified about academic and prior work history focused on chemistry, biochemistry, and enzymology without significant background in subjects like “controlling weeds” about which Patent Owner questions Dr. Hausinger’s qualifications. See, e.g., Ex. 1008, 590–591.17 Patent Owner will have the chance to cross-examine Dr. Hausinger in this proceeding. If Patent Owner feels we should discount Dr. Hausinger’s testimony due to lack of qualifications, it may raise such argument in trial. For now, we apply Petitioner’s proposed POSA level, with the clarifications noted above, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 22
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“We agree with Petitioner that the priority applications do not disclose sufficient representative species compared to the breadth of the claims. As Petitioner contends, SEQ ID NO: 9 and the two AAD-1 variants that differ from SEQ ID NO: 9 by just one or two amino acids do not fairly represent the diversity of proteins within genus of at least 2044 variants. Pet. 30–31; Ex. 1054 ¶¶ 81–82 (showing the minimal sequence differences in AAD-1 v2 (alanine substituted for histidine at position 2, and cysteine substituted for arginine at position 212), and v3 (alanine insertion at position 2)); Ex. 1001, Dr. Hausinger testifies persuasively that the > 99% identity shared by these three AAD-1 variants “are simply not representative of proteins having as little as 85% sequence identity to AAD-1 v1 (SEQ ID NO: 9).” Ex. 1054 ¶¶ 83–86 (testifying, e.g., that the specification “does not provide any structural information that might have allowed the POSA to make inferences about the effect of a given change” and that nothing in the disclosure “would have suggested to the POSA that changes at [the positions in which v2 and v3 differ] would be particularly informative.”). Patent Owner provides no argument or evidence to the contrary on the question whether sufficient representative species are disclosed.27” slip op. at 43
§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · GrahamPatents in suitUS 10,947,555 - PTAB · Oct 13, 2023 · IPR2023-00876 · APJ Michael J Fitzpatrick · IPR · Institution
Instituted IPR on claims 1–6; the Board found a reasonable likelihood that claim 1 would be unpatentable as obvious over Linnarsson and McCloskey.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“In sum, on the record presented, it appears that Petitioner is correct in stating that “no arguments were made during examination with respect to McCloskey or any similar reference disclosing an oligonucleotide with two tags.” Pet. 70 (underlining added).” slip op. at 16
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“4. Conclusion as to Claim 1 There is a reasonable likelihood that Petitioner would prevail in proving that claim 1 is unpatentable on this ground.” slip op. at 23
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The Petition states that “Petitioner does not believe that any terms require explicit construction in view of the prior art being presented.” Pet. 36. Despite this stated position, Petitioner proposes constructions for “multiplex-identifier (MID)” and “providing a sample.” Id. Patent Owner, for its part, states that it “agrees that at this time, solely for purposes of an institution decision on the Petition, no terms require explicit construction.” Prelim. Resp. 45. On the record before us, and for purposes of institution, we find there is no need to provide an express construction of any claim term.” slip op. at 6
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 21–22 (citations omitted). At this stage of the proceeding, Patent Owner does not dispute the level of skill proposed by Petitioner. Because Petitioner’s formulation of the level of ordinary skill in the art appears consistent with the disclosure of the ’981 patent and the asserted prior art, and because there is no argument to the contrary at this stage of the proceeding, we apply Petitioner’s formulation in our analysis below.” slip op. at 7
Claim construction§ 103 obviousnessDiscretionary denialcites GrahamPatents in suitUS 10,155,981
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.