- PTAB · Jul 22, 2024 · IPR2024-00276 · APJ Michael J Fitzpatrick · IPR · Institution
Instituted review of claims 1–3, 6, 12, 14, 16, 18, and 19 based on a reasonable likelihood of success on the asserted anticipation and obviousness grounds.
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
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“contacting mucosal tissue of the upper airway with the treatment delivery portion, without piercing the mucosal tissue,” as recited in claim 1. Prelim. Resp. 8; see Verdegaal Bros., Inc. v. Union Oil Co., 814 F.2d 628, 631 (Fed. Cir. 1987) (“A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.”). As will become apparent from Patent Owner’s arguments, central to the dispute between the parties is Petitioner’s mapping of Baker to limitation [b] and, in particular, to the recited “treatment delivery portion” of the device. In Petitioner’s view, Baker’s inflatable chamber 28 constitutes part of the recited “treatment delivery portion.” See Pet. 28 (“An energy delivery member including an inflatable chamber 28 is located at the distal tip of insertion wand 24.” (citing Ex. 1013, 16:19–26, 17:22–32, 20:35–39, Fig. 5; Ex. 1002 ¶75)). Petitioner further points out, with supporting evidence, that the inflatable chamber contacts mucosal tissue without piercing it. Id. at 34 (citing Ex. 1013, 17:22–36, Fig. 5; Ex. 1002 ¶84). slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“underlying the mucosal tissue, and wherein delivering the energy comprises ablating the nerve tissue.” Ex. 1001, 29:64–67. In challenging claim 6 as obvious, Petitioner relies on Chen for teaching targeting of nerve tissue with radiofrequency energy and on Edwards-535 for teaching targeting of underlying tissue (including nerves) without harming the mucosal surface. Pet. 80–81 (citing 1017, 239–240; 1010, 4:60–67, 6:10–37; Ex. 1002 ¶171). Petitioner explains why a person of ordinary skill in the art would have combined the teachings of Baker, Edards-535, and Chen and had a reasonable expatiation of success in doing so. Id. at 61–68. Patent Owner does not dispute Petitioner’s reliance on Edwards-535 and Chen to reach the additional subject matter recited in claim 6. Nor does Patent Owner dispute Petitioner’s reasons for combining Edwards-535 and Chen with Baker or that a person of ordinary skill in the art would have had a reasonable expectation of success in such an endeavor. Prelim. Resp. 15– 535, and Chen fails to satisfy limitation [b] of claim 1, from which claim 6 ultimately depends. Prelim. Resp. 15. However, as discussed above, we have already determined there is a reasonable likelihood that Baker alone discloses limitation [b] of claim 1. There is a reasonable likelihood of Petitioner prevailing on Ground 3 as to both claim 1 and claim 6. We decline, at this time, to address the other claims challenged in Ground 3. SAS, 138 S. Ct. at 1356.” slip op. at 17
§ 102 anticipation§ 103 obviousnessPatents in suitUS 9,415,194 - PTAB · Jul 22, 2024 · IPR2024-00275 · APJ Michael J Fitzpatrick · IPR · Institution
The Board instituted review of claims 9, 14, 16, 18, 20, 22–24, 44, and 46 based on a reasonable likelihood of prevailing on the asserted anticipation and obviousness grounds.
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
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“argues that we “should exercise . . . discretion to deny institution of Ground 1 under 35 U.S.C. § 325(d).” Prelim. Resp. 8 (emphasis added). However, we do not institute on a ground-by-ground basis. See 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”); see also SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348, 1359 (2018) (holding that the Director’s prior “partial institution practice” was contrary to 35 U.S.C. § 314(a)). Even assuming Patent Owner requests that we exercise discretion to deny the entire Petition, its discretionary denial arguments could not support such a request because those arguments are limited to Ground 1. Patent Owner does not argue or present any basis for exercising our discretion under 35 U.S.C. § 325(d) as to any of the additional grounds. And, as discussed below, there is a reasonable likelihood that the Petitioner will prevail with respect to at least 1 of the claims challenged in at least one of those additional grounds. For this reason alone, discretionary denial under 35 U.S.C. § 325(d) is not warranted.” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“step [b], i.e., “contacting a treatment element of the treatment device with mucosal tissue in the patient’s nasal airway,” as recited in claim 9. Prelim. Resp. 17; see Verdegaal Bros., Inc. v. Union Oil Co., 814 F.2d 628, 631 (Fed. Cir. 1987) (“A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.”). As will become apparent from Patent Owner’s arguments, central to the dispute between the parties is Petitioner’s mapping of Gertner to limitation [b] and, in particular, to the recited “treatment element.” In Petitioner’s view, Gertner’s distal end 216 and expandable component 218 together form the recited “treatment element.” As Petitioner explains it, Gertner discloses that “the distal end 216 emits light from ‘within’ the expandable component 218, such that the light emitter and expandable component 218 (which together constitute distal end 216) act as a treatment element.” Pet. 30 (citing Ex. 1013 ¶¶103, 106, 107; Ex. 1002 ¶64). Petitioner further points out, with supporting evidence, that the expandable component contacts mucosal tissue. Id. (citing Ex. 1013 ¶¶37, 103).” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Edwards-535. Pet. 61–64. Claim 16 recites: “A method as in claim 9, wherein adjusting the shape comprises forming at least one bend in a shaft of the treatment device.” For this additional subject matter, Petitioner points us to the bend in the structure that is designated with reference numeral 124 in Edwards-535, as illustrated in Figure 3B. Pet. 61–62. Petitioner also argues, with supporting evidence, that, even absent this disclosure, it would have been obvious to form a bend, as it is well known in the art to provide bendable catheters to facilitate insertion of a medical device. Id. at 62–64 (citing Ex. 1002 ¶¶130–132). Patent Owner’s sole argument is Edwards-535 fails to disclose limitation [b] of claim 9, from which claim 16 depends. Prelim. Resp 31– 32. That argument is not persuasive for reasons already discussed. Although we have already held that the single-claim threshold of § 314(a) has been met with respect to independent claim 9, we nonetheless further determine that there is a reasonable likelihood of Petitioner prevailing in showing that dependent claim 16 would have been obvious over Edwards-535.” slip op. at 19
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 9,072,597 - PTAB · Jul 22, 2024 · IPR2024-00282 · APJ Zhenyu Yang · IPR · Institution
The Board instituted review of claims 1–4 and 7–9 on all asserted grounds after finding a reasonable likelihood that claims 1–3 and 7–9 are obvious over Edwards-’535 and Stern.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Accordingly, we institute inter partes review of all challenged claims based on all grounds raised in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS Level of Ordinary Skill in the Art Petitioner argues that an ordinarily skilled artisan at the relevant time 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. 17 (citing Ex. 1002 ¶¶ 24–28). Patent Owner does not address the skill level in its Preliminary Response. At this stage, we find Petitioner’s definition of the level of ordinary skill in the art sufficiently supported by the record and apply it for purposes of this Decision.” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“Under that standard, the words of a claim “are generally given their ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner argues that the preamble of claim 1 “to treat rhinitis” is not limiting. Pet. 18. According to Petitioner, the body of claim 1 recites a structurally complete apparatus, and the preamble only states an intended use for the device without limiting the claimed structure. Id. at 18–19. Patent Owner does not propose any claim construction. On this record, we find Petitioner’s argument persuasive and determine that the preamble of claim 1 “to treat rhinitis” is not limiting. On this record and for purposes of this Decision, we see no need to expressly construe any other claim term.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). We still “must further consider the factual questions of whether a person of ordinary skill in the art would be motivated to combine those references, and whether in making that combination, a person of ordinary skill would have had a reasonable expectation of success.” Dome Patent L.P. v. Lee, 799 F.3d 1372, 1380 (Fed. Cir. 2015). Based on the current record, and for purposes of this Decision, we find Petitioner has shown sufficiently that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” See In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (citations omitted). slip op. at 13
Claim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 11,766,286 - 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 - PTAB · Jul 22, 2024 · IPR2024-00277 · APJ Michael A Valek · IPR · Institution
Instituted IPR of claims 1–4, 6–12, and 16 on all asserted grounds; the Board found a reasonable likelihood of prevailing on the Edwards-535, Kong, and Stern obviousness challenge.
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
“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. 20–21 (citing Ex. 1002 ¶¶ 27–29; Ex. 1004 ¶¶ 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 9
- 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. 21. 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
“On the current record, Patent Owner’s arguments are unavailing for several reasons. First, Petitioner’s reasoning for combining Edwards-535 and Stern is supported by testimony from its declarants who identify multiple, specific reasons for the combination. Ex. 1002 ¶¶ 93–94; Ex. 1004 ¶¶ 75–97. 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 a different tissue, i.e., surface versus underlying tissue, are undermined by Edwards-535’s citation to Baker. As Petitioner points out, “Edwards-’535 instructs a POSITA to look to Baker for how to dispose electrodes on the surface of a membrane.” 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, including the figure reproduced below, to show that “Baker and Stern depict similar devices for ablating tissue.” Pet. 46. Petitioner’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. Petitioner offers a similar figure showing that both Baker and Stern teach the arrangement of “electrodes in rows.” See id. at 47 (showing side-by-side comparison of Figure 8 of Baker to Figure 19 of Stern). At this stage, Patent Owner does not dispute that Petitioner’s comparisons are 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.” slip op. at 21
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,241,271 - PTAB · Jun 13, 2024 · IPR2024-00240 · APJ Deborah Katz · IPR · Institution
The Board instituted inter partes review of claims 1–42 on all asserted grounds, finding a reasonable likelihood of success and declining discretionary denial under §§ 314(a) and 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“The Director may not authorize an inter partes review “unless the Director determines 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). We determine whether to institute a post grant review on behalf of the Director. See 37 C.F.R. § 42.4(a). The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioner meets the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Upon considering the Petition, the Preliminary Response, and the evidence of record, we determine that Petitioner has demonstrated there is a reasonable likelihood that the petition would prevail in showing that at least one challenged is unpatentable. Accordingly, we institute inter partes review of all challenged claims on all asserted grounds. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1354, 1359–60 (2018); 37 C.F.R. § 42.108(a).” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“patient is MSI-H after enrollment in a study in which pembrolizumab is to be administered is not within the scope of the claim step “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating the patient with a therapeutically effective amount of pembrolizumab.” At this point in the proceeding, though, we do not interpret the claim step as meaning anything other than the treatment of colorectal cancer patients after they have been determined to be microsatellite instability high or DNA mismatch repair deficient. Although the term “in response to” in claim 1 requires that treatment of the patient occur after the determination that the colorectal cancer is MSI-H, we do not interpret the term to mean that other patients are not treated or that the recruitment and enrollment of patients for a clinical trial has any bearing on the steps recited in claim 1. We interpret a claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2019). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Patent Owner has not directed us to evidence that one of ordinary skill in the art would have understood treating a patient “in response to” the determination that the patient has a condition excludes treatment of other patients without the condition, although it does require that treatment of the patient occur after the determination that the colorectal cancer is MSI-H. The language of claim 1 refers only to patients that are determined to have microsatellite instability high or DNA mismatch repair deficient colorectal cancer, not to other patients. (See Ex. 1001, 25:40–50.) At this point in the proceeding, the record does not indicate that the treatment of patients determined not to be MSI-H is be factored into whether the teaching of treating patients determined to be MSI-H anticipates the method of claim 1. At this point in the proceeding, we construe the “in response to” limitation of claim 1 to mean that pembrolizumab is administered to a patient after the patient has been determined to be microsatellite instability high or DNA mismatch repair deficient, regardless of whether pembrolizumab is also administered to other patients.” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“H Study Record teaches treating colorectal cancer patients after they were determined to be microsatellite instability high or DNA mismatch repair deficient with pembrolizumab. (See MSI-H Study Record, Ex, 1005, 4 (Arms and Interventions); see also id., 2 (Study Identification), 3 (Study Description), 4–5 (Outcome Measures), 5–6 (Eligibility); see Neugut Decl., Ex. 1003, ¶¶ 58–62.) At this point in the proceeding, Petitioner has sufficiently shown that there is a reasonable likelihood of a causal relationship in the MSI-H Study Record between treatment of colorectal cancer patients and the determination of their MSI status — all colorectal cancer patients determined to be microsatellite instability high or DNA mismatch repair deficient were treated. Whether or not other patients were treated or enrolled in the study does not detract from this teaching.” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Furthermore, to the extent the MSI-H Study Record does not disclose the limitation of “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating the patient with a therapeutically effective amount of pembrolizumab,” the record before us supports this limitation being rendered obvious by Pernot and the MSI-H Study Record. Specifically, because Pernot teaches that colorectal cancer patients are good candidates for immunotherapy, the evidence of the current record shows that one of ordinary skill in the art would have had a reason to use to PD-1 inhibitors to treat colorectal cancers. (See Ex. 1006, 3741.) Additionally, the focus in the MSI-H Study Record on a clinical study treating colorectal cancer patients who had been determined to be MSI-H with prembrolizumab indicates that it would have been obvious to test for this condition before treatment. The additional references discussed by Petitioner contribute further to a reasonable likelihood that Petitioner will prevail. For example, Libson reports the successful treatment of a colorectal cancer patient having MSI-H status with a PD- 1 inhibitor (see Ex. 1057, 463-64) and Champiat discusses evaluating the clinical activity of PD-1 agents in DNA mismatch repair, such as MSI+, colorectal cancer (see Ex. 1032, e27817-5). (See Pet. 44.) Thus, based on the entire record before us, Petitioner presents a reasonable likelihood that the method of claim 1 would have been considered obvious by one of ordinary skill in the art.” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,591,393 - PTAB · May 28, 2024 · IPR2024-00170 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR of claims 1–13 on all five 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
“In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). slip op. at 14
- Skill levelSkill level petitioner adoptedDecided for petitioner
“According to Patent Owner, Petitioner’s proposed definition “attempts to imbue the POSA with an array of different skills and competencies that do not accurately reflect the state of the field at the time of the October 2014 priority date.” Prelim. Resp. 10. Patent Owner does not offer a competing definition in the Preliminary Response, but notes that we adopted the above definition in the 00224, 00317, 00545, and 00546 IPRs. Insofar as the prior art of record appears to support Petitioner’s definition, we apply our earlier definition here as Petitioner urges. 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)). Patent Owner is, nevertheless, welcome to provide argument and evidence for an alternative definition at trial.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“In general, a preamble limits the invention if it recites essential structure or steps, or if it is necessary to give life, meaning, and vitality to the claim.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quotation marks omitted). On its face, the preamble of claim 1 includes a “wherein” clause requiring that the biological sample be obtained “from a non-fetal source.” Because Petitioner does not explain how this limitation is either understood from the body of the claim, or severable from the remainder of the preamble, we do not find Petitioner’s argument persuasive. See Cochlear Bone Anchored Sols. AB v. Oticon Med. AB, 958 F.3d 1348, 1355 (Fed. Cir. 2020) (“A conclusion that some preamble language is limiting does not imply that other preamble language, or the entire preamble, is limiting.”). Absent further argument and evidence, and solely for the purpose of this Decision, we construe the preamble as limiting. slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Specification provides little guidance regarding how much of the genome must be sequenced under Patent Owner’s construction. See generally 00224 IPR, Paper 11 at 19–23. As discussed in detail on pages 15–16 of the Preliminary Response, however, the instant Specification does make a clear distinction between “untargeted sequencing (e.g., whole genome sequencing)” as compared to targeted sequencing approaches such as “whole exome sequencing,” or “deep sequencing over a fraction of the genome.” See e.g., Ex. 1001, 17:36–49, 25:64–34, 27:16–19, 43–46; cf. 00224 IPR, Paper 11 at 22 (“tak[ing] particular note of the [’394] Specification’s distinction between whole genome sequencing and targeted sequencing of the exome or other sub-genomic regions (e.g., Ex. 1001, 5:38–59, 24:35– 58), as well as the Specification’s acknowledgement that whole genome sequencing may encompass “low mean coverage regions” and “zero mean coverage regions,” (id. at 24:59–62, 28:33–42)”). As we read the Specification, the phrase “sequencing all or almost all of a genome,” speaks more tot the untargeted nature of the process rather than to an end result of the sequencing effort. In this respect, the instant Specification’s references to “high coverage whole genome sequencing,” “low coverage whole genome sequencing,” and “low” and “zero mean coverage regions from WGS,” indicate that whole genome sequencing does not mean that all or almost all of the nucleotide bases in a genome must be determined, but that “all or almost all” of the genome is available for sequencing.12 See e.g., id. at 25:64–67, 26:6–14, 27:16–19, 28:57–60; 32:37–45; see also 00224 IPR, Paper 11 at 19–23 (preliminarily determining that Leary disclosed whole genome sequencing despite evidence that the authors sequenced only about half of the genome). With the above explanation, we provisionally construe “whole genome sequencing as “a non-targeted approach to sequencing all or almost all of a genome.” We leave for later, and to the extent necessary, any 12 Consistent with Owner’s argument that “WGS has taken on many different flavors of meaning,” we presently understand the Specification’s recognition of “high” and “low” coverage whole genome sequencing as species of the generic term. See Prelim Resp. 12–13 (citing Ex. 2018, 155:15–20, 161:21–162:1, 156:20–157:22). determination of the lower limit (if any) one of ordinary skill would attach to the number sequencing reads, extent of genomic coverage, or nucleotide bases that must be determined to qualify as whole genome sequencing, and whether any particular experimental approach would have been understood to comprise whole genome sequencing.” slip op. at 22
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,584,968 - Sun Pharmaceutical Industries Ltd. / Sun Pharmaceutical Industries, Inc. v. Novo Nordisk A/SInstitutedPTAB · May 28, 2024 · IPR2024-00107 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted review of claims 1–10 on all petitioned grounds, finding a reasonable likelihood of unpatentability, and granted Sun’s motion to join the Mylan IPR.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“The Director set forth in the Interim Procedure that “the PTAB will not discretionarily deny institution of an IPR or PGR in view of parallel district court litigation where a petitioner stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition.” Interim Procedure, 7, 9. This guidance does not condition or otherwise qualify the effect of a Sotera stipulation on our exercise of discretion to deny the Petition based on any remaining defendants in the parallel litigation that are not subject to the stipulation or any alleged “behind the scenes” participation by Petitioner such as paying for experts, participating in expert reports or deposition preparation “in connection with any of the stipulated grounds.” See Paper 14, 1. Petitioner has filed such a stipulation. See Ex. 1099. Therefore, we will not exercise our discretion to deny the Petition. We also find that with the change of the district court trial date to over two months after the original statutory due date for the Mylan IPR, the Mylan IPR should be completed before a trial in the district court begins. See Mylan IPR, Ex. 1098. This change in trial date, in addition to the lack of complete overlap in the claims asserted here and in the Delaware Litigation, provide further reason for us to refrain from exercising our discretion to deny the Petition under 35 U.S.C. § 314(a) regardless of remaining defendants in the Delaware Litigation that are not bound by any estoppel arising from the Mylan IPR.9” slip op. at 9
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“For the same reasons set forth in our institution decision in the Mylan IPR, we determine that Petitioner has shown a reasonable likelihood that at least one claim is unpatentable. Mylan IPR, Paper 10, 17–29 (PTAB Oct. 4, 2023). We therefore institute trial as to all challenged claims on all grounds stated in the Petition.” slip op. at 11
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“entitled to the requested relief. 37 C.F.R. § 42.20(c). A motion for joinder should: set forth the reasons joinder is appropriate; identify any new grounds of unpatentability asserted in the petition; and explain what impact (if any) joinder would have on the trial schedule for the existing review. See Kyocera Corp. v. Softview LLC, IPR2013-00004, Paper 15 at 4 (PTAB Apr. 24, 2013).” slip op. at 12
Discretionary denialPatents in suitUS 10,335,462 - PTAB · Apr 25, 2024 · IPR2024-00009 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted review of claims 1–10 on all petition grounds, declined discretionary denial, and granted joinder with IPR2023-00724.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“Director Vidal set forth in the Interim Procedure that “the PTAB will not discretionarily deny institution of an IPR or PGR in view of parallel district court litigation where a petitioner stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition.” Interim Procedure, 7, 9. This guidance does not condition or otherwise qualify the effect of a Sotera stipulation on our exercise of discretion to deny the Petition based on any remaining defendants in the parallel litigation that are not subject to the stipulation. Petitioner has filed such a stipulation. Reply 2 (“Petitioners stipulate that, if instituted, they will not pursue in the parallel district court proceeding the same grounds as in the Petition or any grounds that could have reasonably been raised therein”). Therefore, we will not exercise our discretion to deny the Petition. We also find that with the change of the district court trial date to over two months after the current statutory due date for the Mylan IPR, the Mylan IPR should be completed before a trial in the district court begins. See Ex. 1098. This change in trial date, in addition to the lack of complete overlap in the claims asserted here and in the Delaware Litigation, provide further reason for us to refrain from exercising our discretion to deny the Petition under 35 U.S.C. § 314(a) regardless of remaining defendants in the Delaware Litigation that are not bound by any estoppel arising from the Mylan IPR.10” slip op. at 9
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“For the same reasons set forth in our institution decision in the Mylan IPR, we determine that Petitioner has shown a reasonable likelihood that at least one claim is unpatentable. Mylan IPR, Paper 10, 17–29 (PTAB Oct. 4, 2023). We therefore institute trial as to all challenged claims on all grounds stated in the Petition.” slip op. at 11
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“response under section 313 or the expiration of the time for filing such a response, determines warrants the institution of an inter parties review under section 314. As the moving party, Petitioner bears the burden of proving that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). A motion for joinder should: set forth the reasons joinder is appropriate; identify any new grounds of unpatentability asserted in the petition; and explain what impact (if any) joinder would have on the trial schedule for the existing review. See Kyocera Corp. v. Softview LLC, IPR2013-00004, Paper 15 at 4 (PTAB Apr. 24, 2013).” slip op. at 12
Discretionary denialPatents in suitUS 10,335,462 - PTAB · Apr 24, 2024 · IPR2024-00028 · APJ Michael J Fitzpatrick · IPR · Institution
The Board instituted IPR on claims 1–19 because Petitioner showed a reasonable likelihood that claim 1 would have been obvious over Flusberg, Flusberg ’338, and PacBio-BAM.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“In assessing whether to exercise the Board’s authority to deny institution under § 325(d), the Board considers a two-part analysis. Advanced Bionics at 8–9. First, the Board considers whether “the same or substantially the same” art or arguments were previously presented to the Office. Id. at 8. If so, the Board then considers whether the petition demonstrates that the Office “erred in a manner material to the patentability of the challenged claims.” Id. In applying the two-part framework, the Board considers several nonexclusive factors set forth in Becton, Dickinson & Co. v. B. Braun Melsungen AG, No. IPR2017-01586, Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first paragraph).” slip op. at 13
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“G. Conclusion Regarding Claim 1 Petitioner has demonstrated a reasonable likelihood of prevailing on its challenge to claim 1 as unpatentable under 35 U.S.C. § 103 due to obviousness over Flusberg, Flusberg ’338, and PacBio-BAM. H. Remaining Claims of Ground 1 and Grounds 2–4 Patent Owner does not present any arguments specific to any claim beyond claim 1. See, e.g., Prelim. Resp. 1 (“Because all other asserted Grounds rely upon prevailing on Ground 1 for claim 1, all other grounds fail for the same reasons.”). In any event, the threshold for institution is a reasonable likelihood of Petitioner prevailing as to any single claim. 35 U.S.C. § 314(a). “Once that single claim threshold is satisfied, it doesn’t matter whether the [P]etitioner is likely to prevail on any additional claims.” SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348, 1356 (2018). Thus, because we have decided to grant review of claim 1, we do the same for all claims challenged and all grounds raised. Id.; see also 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”). III. CONCLUSION For the reasons discussed above, we are persuaded that Petitioner has demonstrated a reasonable likelihood of prevailing in establishing that at least one of the challenged claims is unpatentable. IV. ORDER In consideration of the foregoing, it is hereby ORDERED that the Petition is granted and inter partes review is hereby instituted as to claims 1–19 of U.S. Patent No. 11,091,794 B2 on the grounds presented; and” slip op. at 35
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Other
“Petitioner argues that an input data structure having the recited combination of properties would have been obvious, in part, because all such properties were identified and could be measured in the prior art. For example, according to Petitioner, “[i]n addition to encoding the identity and relative locations of each nucleotide, PacBio-BAM encodes the PW and IPD of each nucleotide as integer arrays.” Pet. 43 (citing Ex. 1011, 8). This argument is supported by the cited evidence. Under a section titled “Encoding of kinetics pulse features,” PacBio-BAM states: “Interpulse duration (IPD) and pulsewidth are measured in frames [and] . . . may be encoded in BAM read tags” and further states such information relates to “base modification detection.” Ex. 1011, 8. Petitioner also notes that Flusberg and Flusberg ’338 teach that PW and IPD are affected by nucleotide modifications. Pet. 43–44 (citing Ex. 1007, 66:46–67:4, 9:41–46; 22:49–54; Figs. 12, 13, and 15–19; Ex. 1006, 462, Fig. 3). For example, Flusberg ’338 teaches: In certain aspects, the invention provides a general-purpose approach to discriminating between Me+ and Me- using features in a real-time sequencing-by-synthesis trace comprising signals emitted during the incorporation of optically detectable nucleotides into a nascent strand by a polymerase enzyme. . . . A first stage of this approach includes the development of a classifier for distinguishing methylated from unmethylated cytosines in a nucleic acid template. A set of features is measured for every pulse (discrete event or signal) in the trace. For example, a set of measurable features might be {pulse width, pulse duration, pulse height, pulse amplitude variability}. Ex. 1007, 64:46–59 (emphasis added). Similarly, Flusberg states: Fluorescence pulses in SMRT sequencing are characterized not only by their emission spectra but also by their duration and by the interval between successive pulses. These metrics, defined here as pulse width and interpulse duration (IPD), add valuable information about DNA polymerase kinetics. Pulse width is a function of all kinetic steps after nucleotide binding and up to fluorophore release, and IPD is determined by the kinetics of nucleotide binding and polymerase translocation. We have previously demonstrated that SMRT sequencing polymerase synthesis rates are sensitive to DNA primary and secondary structure. Therefore, we hypothesized that methylated bases in a DNA template might be detected directly on the principle that their presence affects polymerase kinetics during SMRT sequencing. Ex. 1006, 462 (emphasis added; end notes omitted). Petitioner argues that “PacBio-BAM teaches creating an input data” slip op. at 19
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“4. Reason To Combine Petitioner points out that (1) each of Flusberg and Flusberg ’338 teach methods of detecting nucleotide modifications using SMRT sequencing, and (2) PacBio-BAM teaches a BAM file containing values for all claimed properties generated in the course of SMRT sequencing. Pet. 29. Petitioner argues with supporting evidence, that it would have been obvious “to use PacBio’s BAM file containing the recited properties as an input data structure, as expressly suggested in PacBio-BAM.” Id. at 29–30; see also Ex. 1002 ¶82 (Dr. Dessimoz providing his opinion in support of the combination); Pet. 30–33 (providing additional arguments and evidence to support the combination). Patent Owner argues that “Petitioner fails to provide motivation to combine Flusberg with the other two references of Ground 1 to arrive at the claimed invention.” Prelim. Resp. 45. According to Patent Owner, “Petitioner makes no argument for why Flusberg and the ’338 patent would be combined, let alone why a POSITA would selectively combine various aspects of each reference and include features not used in either reference to arrive.” Id. Patent Owner premises its argument on a purported failure by Flusberg ’338 to incorporate by reference the entire Flusberg reference as opposed to limited aspects of its. Id. at 45–46. Flusberg ’338 patent twice states that Flusberg is “incorporated herein by reference in its entirety for all purposes.” Ex. 1007, 77:30–24, 78:58–66. Patent Owner argues that what is incorporated by reference is only the specific content of Flusberg that is mentioned by Flusberg ’338. Prelim. Resp. 46. Patent Owner cites Nautilus, Inc. v. Icon Health & Fitness Inc., No. IPR2017-01407, 2018 WL 6321395, at *18–19 (PTAB Dec. 3, 2018) in support. Id. Patent Owner additionally points out that, if either incorporation by reference successfully incorporated the entire Flusberg disclosure, then the other incorporation by reference would be superfluous. Prelim. Resp. 46–47. This last point is logical, but the totality of the facts, as discussed below, better support Petitioner’s position. In Nautilus, the Board interpreted the following incorporation by reference language: “The ’088 Application provides ‘One example of customizing a work-out that may be utilized in conjunction with the exercise apparatus described herein is set forth in U.S. Patent Application No. 13/754,361, filed on Jan. 30, 2013, the disclosure of which is incorporated by reference herein in its entirety.’” Nautilus, 2018 WL 6321395, at *19. The Board found that the word “disclosure” could refer to either the example being discussed or the entire disclosure of the ’088 Application, and the Board ultimately held that what was incorporated by reference was the example of customizing a work-out only and not the entirety of the ’088 Application. Id. Nautilus is not precedential. Moreover, its facts are different. Here, we have statements that Flusberg is incorporated by reference both “in its entirety” and “for all purposes.” Ex. 1007, 77:30–24, 78:58–66. Further, the Board’s holding in Nautilus explicitly hinged on its understanding of the word “disclosure” in the following phrase: “the disclosure of which is incorporated by reference herein in its entirety.” Nautilus, 2018 WL 6321395, at *19. The Board held that, “as a matter of grammar, the antecedent of the ‘disclosure’ being incorporated could be either the application or ‘one example’ that is described in the application.” Id. Here, the rules of grammar contradict Patent Owner’s position, rather than support it. For example, the first incorporation by reference states: “Further details on the detection of N6-MeA, as well as other modifications within a template nucleic acid, are provided in Flusberg, et al. (2010) Nature Methods 7(6):461–465, incorporated herein by reference in its entirety for all purposes.” Ex. 1007, 77:30–24 (emphasis added). The word “its” can refer to only one thing, Flusberg itself, as the alternative would be plural nouns, namely “details” and “other modifications,” and thus inconsistent with the singular “its.” In sum, we find that, on the current record, Petitioner has sufficiently shown a motivation to combine Flusberg and Flusberg ’338 with PacBio- BAM.” slip op. at 25
§ 103 obviousnessDiscretionary denialcites KSRPatents in suitUS 11,091,794
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.