- PTAB · Mar 18, 2025 · IPR2024-01375 · APJ Jason W Melvin · IPR · Institution
The Board instituted IPR of claims 1–13 based on both §103 grounds, finding a reasonable likelihood that the asserted combinations render at least one challenged claim unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“35 U.S.C. § 325(d) because Amarenco and Mann previously were presented to the Office during prosecution of the ’742 patent. See Prelim. Resp. 17–18. According to Patent Owner, Petitioner has identified additional references that “supposedly teach[] only some of what was missing—stimulation of a branch of the posterior tibial nerve but not to treat overactive bladder or incontinence.” Id. at 18. Patent Owner’s argument is flawed for two reasons. First, neither Svihra nor Ponsford were previously presented to the Office. Because Patent Owner does not argue that we should deny institution of Petitioner’s Svihra-based ground under § 325(d), and because that ground relies on a combination of art not previously presented, Patent Owner’s § 325(d) argument is unpersuasive. In that regard, we determine that even if we were to conclude the Amarenco-based ground warranted discretionary denial, the Svihra-based ground would not be subject to such denial and may alone justify institution. See USPTO, SAS Q&As (June 5, 2018) at D1.11 Additionally, for the Amarenco-based ground, Petitioner relies on a combination including prior art that was not previously presented, and Patent Owner does not show that additional prior art is cumulative to art presented during prosecution. We determine that Petitioner’s Amarenco-based ground 11 Available at: https://www.uspto.gov/sites/default/files/documents/ sas_qas_20180605.pdf is not substantially the same as one previously presented to the Office. Thus, we decline to discretionarily deny institution under § 325(d).” slip op. at 8
- Skill levelSkill level petitioner adoptedDecided for petitioner
“of filing “would have had an undergraduate degree in the field of biomedical engineering or a related discipline, such as electrical engineering, and at least two years of experience in the design and/or analysis of biomedical devices” and that “[a]dditional work experience could substitute for a formal degree and vice versa.” Pet. 21 (citing Ex. 1003 ¶¶ 20–21). Patent Owner does not dispute Petitioner’s proposal. See generally Prelim. Resp. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the challenged patent and prior art, we adopt it, and use “skilled artisans” to refer to people with such skill at the time the invention was filed.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner argues that “no terms require construction for purposes of this Petition.” Pet. 22. Patent Owner does not contest Petitioner’s position. See generally Prelim. Resp. We agree and do not expressly construe any terms at this stage. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 9
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“It has long been recognized that the touchstone as to whether an asserted reference qualifies as prior art is public accessibility. See In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986). “[A]t the institution stage, the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29, 13 (PTAB Dec. 20, 2019) (precedential).” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,224,742 - Encube Ethicals PTV. Ltd. v. Dermavant Sciences GmbHAdverse judgmentPTAB · Mar 7, 2025 · IPR2024-00834 · APJ Tawen Chang · IPR · Adverse judgment
The Board entered adverse judgment against Patent Owner on all challenged claims, 1–4, 6–10, 16, 18, 21, and 22, following their disclaimer.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“Terminate Proceeding and Parties’ Joint Motion for Entry of Adverse Judgment (collectively “Motion”). The parties jointly request that the Board enter adverse judgment in light of the disclaimer filed by Patent Owner disclaiming all challenged claims. Mot. 1 (citing 37 C.F.R. § 42.73(b)(2)). The Motion attaches as an exhibit a disclaimer under 37 C.F.R. § 1.321(a), filed January 28, 2025, of claims 1–4, 6–10, 16, 18, 21, and 22 of the ’088 patent, which constitute all of the claims challenged in the inter partes review. Ex. 2001; Paper 1, 3.” slip op. at 2
- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Denied
“Accordingly, we grant the Parties’ Joint Motion for Entry of Adverse Judgment. This Adverse Judgment is sufficient to dispose of this proceeding and Patent Owner’s Motion to Terminate is denied as moot.1” slip op. at 3
NonePatents in suitUS 11,590,088 - Biofrontera Inc. / Biofrontera Bioscience GmbH et al. v. Sun Pharmaceutical Industries, Inc.InstitutedPTAB · Feb 24, 2025 · IPR2024-01312 · APJ Erica A Franklin · IPR · Institution
The Board instituted review of claims 1, 2, 4-6, 16, 17, and 19-21 on all asserted grounds, finding a reasonable likelihood of unpatentability over Lundahl and Larsen.
RulingsInstitution decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“justification for requiring a POSITA to have both an engineering degree and a medical degree. We agree, insofar as Petitioner has not clearly set out any particular explanation or evidence in support of its dual-degree requirement. In all other respects, we note that the parties’ proposed definitions are largely similar. Because we determine that Patent Owner’s proposed definition is reasonable and consistent with the ’028 patent and the cited art, we adopt Patent Owner’s definition for purposes of this Decision. In any event, our decision whether to institute does not turn on this level of skill determination.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“used to construe the claim in a civil action under 35 U.S.C. § 282(b); 37 C.F.R. § 100(b). Under that standard, claim terms “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc) (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Petitioner and Patent Owner assert that the Board need not construe any claims for the purpose of deciding whether to institute an inter partes review. Pet. 12; Prelim. Resp. 24. We agree.” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Based on our review of the Petition, Petitioner explains that a driving motivation for a POSITA to modify Lundahl to include Larsen’s five panels is “to increase the flexibility of the device to ensure the light panels could be maintained at a distance of 2-4′′ from surface of the treatment area, whether the face, arm, or back, etc.” Pet. 29 (emphasis added). As Lundahl’s device is not flexible, and such flexibility would improve its ability to treat areas other than an average sized face, we determine, at this stage in the proceeding, that this motivation for the combination is sufficient.” slip op. at 20
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightInstituted
“would have been motivated to modify Lundahl’s device by incorporating Larsen’s use of LEDs on the surface of the light applicators in place of Lundahl’s fluorescent tubes with a reasonable expectation of success. Prelim. Resp. 55. Patent Owner argues that Petitioner’s modification is based on improper hindsight bias because “Petitioner cherry-picks Larsen’s LEDs (together with the five panels) and purports to arrange them according to the [sic] ‘the uneven spacing’ of Lundahl’s fluorescent tubes.” Id. at 56 (citing Pet. 46–49; Ex. 1015 ¶¶ 175–80). According to Patent Owner, “Petitioner cannot on the one hand argue that a ‘POSITA would have understood that Larsen’s applicator is configured to uniformly illuminate a treatment surface of the patient,’ while on the other ignore Larsen’s teaching that the ‘light sources 17 are placed in regular row arrangements.’” Id. Patent Owner asserts that Petitioner’s proposed modification “mish-mashes aspects of Lundahl and Larsen ([while] avoiding the overall teachings of [challenged] claims.” Id. at 56–57. As discussed above, based on our consideration of the current record, Petitioner has provided sufficient motivation for employing Larsen’s flexible five panel configuration. These panels in Larsen already use LEDs as their light source. So, in our view, Petitioner’s incorporation of the five panels includes the lighting source, i.e., LEDs, for those panels taught by Larsen. Further, we note that Petitioner has persuasively asserted that a skilled artisan would have been motivated to use Larsen’s LEDs as they are more cost-efficient and last longer. See Pet. 31.” slip op. at 20
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,697,028 - PTAB · Feb 6, 2025 · IPR2024-01212 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR of claims 1–27 on all petitioned grounds after finding a reasonable likelihood that claim 1 would be obvious over Racz, Fitz, and Lee.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“§ 314. An inter partes review may not be instituted unless “the information presented in the petition . . . and any response . . . 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). Further, a decision to institute may not do so on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); 37 C.F.R. § 42.108(a). After considering the evidence and arguments presented in the Petition, we determine that Petitioner demonstrates a reasonable likelihood of prevailing in showing that at least one of the challenged claims of the ’664 patent is unpatentable. Accordingly, we institute an inter partes review as to all the challenged claims of the ’664 patent on all the grounds of unpatentability set forth in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“According to Petitioner, the relevant technical field is “‘thermal ablation systems and methods,’ which includes ‘methods for performing Radio Frequency (RF) neurotomy.”’ Pet. 11 (citing Ex. 1003, 1:24–27). Relying on the testimony of Dr. Tucker, Petitioner contends that the ordinarily skilled artisan in this field would have had at least (i) a bachelor’s degree in biomedical engineering, or a related field, such as mechanical engineering, biomechanical engineering, or bioengineering, who also has at least 3 years of experience with thermal ablation system and methods; or (ii) an advanced degree in the same areas of academic study with at least 1 years of experience with thermal ablation systems and methods. Id. (citing Ex. 1034 ¶ 105) (paragraphing added). Absent evidence or argument to the contrary, we apply Petitioner’s proposed definition, as it appears consistent with the prior art and is supported by the presently unopposed testimony of Dr. Tucker. See Okajima v. Bourdeau, 261 F.3d 1350, 1355, (Fed. Cir. 2001) (the level of ordinary skill in the art may be reflected in the prior art itself). We note, however, that Petitioner’s open-ended language “at least” expands the ranges of education and experience indefinitely with no upper bound, thereby encompassing those of extraordinary skill. Therefore, we do not adopt this aspect of Petitioner’s formulation. B.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“Claim Construction The Board interprets claim terms in an inter partes review using the same claim construction standard that is used to construe claims in a civil action in federal district court. See 37 C.F.R. § 42.100(b)). In construing claims, district courts give claims 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.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). With respect to the challenged claims, Petitioner contends that no claim term requires express construction. Pet. 11 (citing Ex. 1034 ¶ 106 (Dr. Tucker’s testimony that “the terms in the Challenged Claims would be understood by a POSA to have their plain and ordinary meaning and do not require a special construction or definition”)). On the presents record, we agree with Petitioner that no term requires express construction. C.” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“through [1e]. Pet. 28–30. Petitioner further relies on “Racz as modified in view of Fitz and Lee,” with respect to elements [1e] through [1h]. See generally, id. at 30–47. Supported by the testimony of Dr. Tucker, Petitioner contends that one of ordinary skill in the art would have been motivated to combine the teachings of Racz, Fitz, and Lee with a reasonable expectation of success of arriving at the claimed invention. Id. at 1–6, 21–27; Ex. 1034 ¶¶ 132–149. In short, Petitioner contends that “[m]ost of the recited RF needle features—including an elongate cannula, a removable RF probe, a conductive tip, and a monopolar configuration—are conventional features disclosed in . . . Racz,” whereas Fitz discloses that a single-tip device, such as disclosed in Racz, “would produce limited ablation volumes and would have motivated a POSA to solve this problem by adding deployable filaments,” as recited in claim elements [1e] and [1f]. Id. at 4–5, 21–22. In addition to its reliance on the multiple electrode tips disclosed in Fitz, Petitioner contends that Lee would have “motivate[ed] a POSA to implement deployable filaments on the tip of Racz’s device using channels within the cannula,” and “also shows how the filaments can extend outwardly around the needle’s tip to advantageously expand and control the ablation volume.” Id. at 5–6. Accordingly, Petitioner contends, one of ordinary skill in the art “would have found it obvious to modify Racz’s device to include the well-known deployable filaments described in Fitz and Lee,” and would have implemented this combination as “a matter of routine engineering.” Id. at 6, 27.” slip op. at 20
Claim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,925,664 - PTAB · Feb 6, 2025 · IPR2024-01211 · APJ John G New · IPR · Institution
The Board instituted IPR on claims 18–47 and 53–74 and all petition grounds, finding a reasonable likelihood that claims 18–25, 27, and 29–33 are obvious over Racz, Fitz, and Lee.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“§ 314. An inter partes review may not be instituted unless “the information presented in the petition … and any response … 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). Further, a decision to institute may not do so on fewer than all of the claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); 37 C.F.R. § 42.108(a); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yesor-no institution choice respecting a petition, embracing all challenges included in the petition”).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Absent evidence or argument to the contrary, we apply Petitioner’s proposed definition, as it appears to be consistent with the level of skill of the prior art and is supported by the presently unopposed testimony of Dr. Tucker. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the level of ordinary skill in the art may be reflected in the prior art itself). We note, however, that the open-ended language ‘at least’ expands the ranges of education and experience indefinitely with no upper bound, thereby also encompassing those of extraordinary skill as well. Therefore, we do not adopt this aspect of Petitioner’s formulation.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“With respect to the challenged claims, Petitioner contends that no claim term requires express construction. Pet. 11 (citing Ex. 1033 ¶ 120 (Dr. Tucker’s testimony that “the terms in the Challenged Claims would be understood by a POSA to have their plain and ordinary meaning and do not require a special construction or definition”)). We agree with Petitioner that, on the record presently before us, no claim term requires express construction.” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“Petitioner argues that, in view of these teachings in Racz and Lee, a skilled artisan would have found implementing Lee’s perimeter filaments (22/1622) on Racz’s distal tip (14/38) to be a routine engineering task. Pet. 39 (citing Ex. 1033 ¶ 179). According to Petitioner, a person of ordinary skill in the arts would have recognized that it would be appropriate to implement Lee’s perimeter filaments (22/1622) without including Lee’s central filament. Id. Petitioner asserts that Lee discloses that any number and arrangement of filaments may be implemented to provide a desired ablation volume. Id. at 38 (citing Ex. 1010 ¶¶ 103, 105, 106). Additionally, Petitioner argues, because Racz’s tip (14/38) is already active, a skilled artisan would have recognized that Lee’s central filament would not be necessary. Id. (citing Ex. 1009, col. 3, ll. 60–63, col. 4, ll. 18–23; Ex. 1033 ¶ 179). Petitioner therefore argues that a person of ordinary skill in the art a person of ordinary skill in the art would have been motivated to implement Lee’s perimeter deployable filaments (22/1622) on the distal tip (14/38) of Racz’s cannula (10/33) for the purpose of expanding and controlling the energy coverage area of Racz’s device. Pet. 40. Specifically, Petitioner asserts that a skilled artisan would have been motivated to implement Lee’s perimeter filaments (22/1622) around Racz’s tip (14/38) to provide a desired ablation volume (e.g., in a full or partial “cone” shape) and omit Lee’s central filament. Pet. 38 (citing Ex. 1033 ¶¶ 179, 73–75, 79–83). Petitioner contends that, as both Lee and Fitz confirm, this would improve Racz’s device by providing an expanded and controlled energy coverage area. Id. (citing Ex. 1011 ¶¶ 9–10, Abstr.; Ex. 1010 ¶¶ 12, 84, 123–131; Ex. 1033 ¶ 179). Petitioner argues further that, in implementing Lee’s perimeter filaments (22/1622) on Racz’s distal tip (14/38), a person of ordinary skill in the art would have found it obvious to modify Racz’s tip (14/38) to include internal deflection surfaces (12/1612) (e.g., channels and ramps as disclosed in Lee) to guide the perimeter filaments (22/1622) outwardly around Racz’s tip (14/38). Pet. 41 (citing Ex. 1010 ¶¶ 16, 18, 92, 102, claims 8, 10; Ex. 1033 ¶ 180). Petitioner asserts that it would have been obvious to provide openings in Racz’s distal tip (14/38) (e.g., in communication the internal deflection surfaces as disclosed in Lee) such that Lee’s perimeter filaments (22/1622) can, when deployed, exit Racz’s distal tip (14/38). Id. (citing Ex. 1010 ¶ 92, 102; Ex. 1033 ¶ 180). Furthermore, argues Petitioner, and to preserve the functionality of Racz’s removable electrical probe (22/52) and active tip (14/38) (and consistent with Lee’s teachings) a skilled artisan would have arranged the perimeter filaments, channels, and ramps around the internal perimeter of Racz’s cannula (10/33). Pet. 41 (citing Ex. 1010 ¶¶ 91, 92, 98, 102; Ex. 1033 ¶ 181). Petitioner recapitulates that Racz’s probe (22/52) is configured to extend the full length of the cannula’s shaft (12/34) to supply RF energy to the tip (14/38) and measure tissue temperature. Pet. 42. According to Petitioner, by omitting Lee’s central filament and arranging the perimeter filaments, channels, and ramps around the inner perimeter of Racz’s cannula (10/33), a skilled artisan could have implemented Lee’s perimeter filaments (22/1622) without obstructing Racz’s cannula (10/33). Id. at 40. Petitioner contends that this modification would preserve the functionality of Racz’s electrical probe (22/52), which is needed to transmit RF energy. Id. (citing Ex. 1033 ¶ 181–182).” slip op. at 29
Claim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,736,688 - PTAB · Feb 6, 2025 · IPR2024-01210 · APJ John G New · IPR · Institution
The Board instituted IPR on claims 1–17 and 48–52 on all asserted grounds, finding a reasonable likelihood that at least one claim was obvious over Racz, Fitz, and Lee.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“§ 314. An inter partes review may not be instituted unless “the information presented in the petition … and any response … 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). Further, a decision to institute may not do so on fewer than all of the claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); 37 C.F.R. § 42.108(a); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yesor-no institution choice respecting a petition, embracing all challenges included in the petition”).” slip op. at 2
- Skill levelSkill level petitioner adoptedOther
“Absent evidence or argument to the contrary, we apply Petitioner’s proposed definition, as it appears to be consistent with the level of skill of the prior art and is supported by the presently unopposed testimony of Dr. Tucker. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the level of ordinary skill in the art may be reflected in the prior art itself). We note, however, that the open-ended language ‘at least’ expands the ranges of education and experience indefinitely with no upper bound, thereby also encompassing those of extraordinary skill as well. Therefore, we do not adopt this aspect of Petitioner’s formulation.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“With respect to the challenged claims, Petitioner contends that no claim term requires express construction. Pet. 11 (citing Ex. 1032 ¶ 120 (Dr. Tucker’s testimony that “the terms in the Challenged Claims would be understood by a POSA to have their plain and ordinary meaning and do not require a special construction or definition”)). We agree with Petitioner that, on the record presently before us, no claim term requires express construction.” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“person of ordinary skill in the art would have been motivated to implement Lee’s perimeter deployable filaments (22/1622) on the distal tip (14/38) of Racz’s cannula (10/33) for the purpose of expanding and controlling the energy coverage area of Racz’s device. Pet. 35. Specifically, Petitioner asserts that a skilled artisan would have been motivated to implement Lee’s perimeter filaments (22/1622) around Racz’s tip (14/38) to provide a desired ablation volume (e.g., in a full or partial “cone” shape) and omit Lee’s central filament. Pet. 38 (citing Ex. 1032 ¶¶ 179, 73–75, 79–83). Petitioner contends that, as both Lee and Fitz confirm, this would improve Racz’s device by providing an expanded and controlled energy coverage area. Id. (citing Ex. 1011 ¶¶ 9–10, Abstr.; Ex. 1010 ¶¶ 12, 84, 123–131; Ex. 1032 ¶ 179). Petitioner argues further that, in implementing Lee’s perimeter filaments (22/1622) on Racz’s distal tip (14/38), a person of ordinary skill in the art would have found it obvious to modify Racz’s tip (14/38) to include internal deflection surfaces (12/1612) (e.g., channels and ramps as disclosed in Lee) to guide the perimeter filaments (22/1622) outwardly around Racz’s tip (14/38). Pet. 39 (citing Ex. 1010 ¶¶ 16, 18, 92, 102, claims 8, 10; Ex. 1032 ¶ 180). Petitioner asserts that it would have been obvious to provide openings in Racz’s distal tip (14/38) (e.g., in communication the internal deflection surfaces as disclosed in Lee) such that Lee’s perimeter filaments (22/1622) can, when deployed, exit Racz’s distal tip (14/38). Id. (citing Ex. 1010 ¶ 92, 102; Ex. 1032 ¶ 180).” slip op. at 29
Claim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,736,688 - PTAB · Feb 6, 2025 · IPR2024-01209 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–27 and all petition grounds, finding a reasonable likelihood that at least one claim is obvious over Racz, Fitz, and Lee.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“314. An inter partes review may not be instituted unless “the information presented in the petition . . . and any response . . . 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). Further, a decision to institute may not do so on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); 37 C.F.R. § 42.108(a).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Absent evidence or argument to the contrary, we apply Petitioner’s proposed definition, as it appears consistent with the prior art and is supported by the presently unopposed testimony of Dr. Tucker. See Okajima v. Bourdeau, 261 F.3d 1350, 1355, (Fed. Cir. 2001) (the level of ordinary skill in the art may be reflected in the prior art itself). We note, however, that Petitioner’s open-ended language “at least” expands the ranges of education and experience indefinitely with no upper bound, thereby encompassing those of extraordinary skill. Therefore, we do not adopt this aspect of Petitioner’s formulation. B.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“With respect to the challenged claims, Petitioner contends that no claim term requires express construction. Pet. 11 (citing Ex. 1031 ¶ 106 (Dr. Tucker’s testimony that “the terms in the Challenged Claims would be understood by a POSA to have their plain and ordinary meaning and do not require a special construction or definition”)). On the presents record, we agree with Petitioner that no term requires express construction.” slip op. at 12
Claim constructioncites Phillips · KSRPatents in suitUS 10,966,782 - Parse Biosciences, Inc. v. 10x Genomics, Inc.All claims unpatentablePTAB · Feb 3, 2025 · IPR2023-00958 · APJ Michael J Fitzpatrick · IPR · Final written decision
Claims 1–28 are unpatentable as obvious: claims 1–12 and 19–28 over Linnarsson, McCloskey, and ordinary skill; claims 13–18 over those references plus McCloskey II.
RulingsFinal written decision- ExcludeMotion to exclude, grantedMotion to exclude, deniedGranted in part
“Clearly, the second Hall-Ellis declaration is offered to prove that McCloskey is a prior art printed publication. See, e.g., Ex. 1085 ¶50 (“In view of the foregoing, it is my opinion that [McCloskey] was publicly available no later than [January 3, 2008].”). Thus, the second Hall-Ellis declaration should have been served within ten business days of Patent Owner’s February 15, 2024, objection to the admissibility of McCloskey. See 37 C.F.R. § 42.64(b)(2) (“The party relying on evidence to which an objection is timely served may respond to the objection by serving supplemental evidence within ten business days of service of the objection.”). In its Opposition to the Motion to Exclude, Petitioner argues that, under Hulu LLC v. Sound View Innovations, LLC, No. IPR2018-01039, Paper 29 (Dec. 20, 2019) (precedential), it was allowed to wait until its Reply to file the second Hall-Ellis declaration. Paper 37, 2. The Board in Hulu does state that, “if the patent owner challenges a reference’s status as a printed publication, a petitioner may submit a supporting declaration with its reply to further support its argument that a reference qualifies as a printed publication.” Hulu, at 15 (37 C.F.R. § 42.23). However, the Board’s statement was referring to the scope of permissible reply arguments under 37 C.F.R. § 42.23(b). See Hulu at 14 (quoting 37 C.F.R. § 42.23(b)’s requirement that “[a] reply may only respond to arguments raised in the corresponding opposition, patent owner preliminary response, or patent owner response”). The Board in Hulu does not purport to interpret 37 C.F.R. § 42.64 or even discuss supplemental evidence. Petitioner clearly missed the deadline imposed by 37 C.F.R. § 42.64(b)(2), which was triggered by Patent Owner’s February 15, 2024, objection to McCloskey (i.e., Ex. 1004). Patent Owner’s Motion to Exclude is granted with respect to the second Hall-Ellis declaration (i.e., Ex. 1085).” slip op. at 18
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“Patent Owner is correct that, under Sanofi-Aventis, 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, as we noted when instituting this proceeding, “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.”’” Dec. on Reh’g 16 (quoting Sanofi- Aventis, 66 F.4th at 1379 (quoting 37 C.F.R. § 42.23)).” slip op. at 15
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Clearly, the second Hall-Ellis declaration is offered to prove that McCloskey is a prior art printed publication. See, e.g., Ex. 1085 ¶50 (“In view of the foregoing, it is my opinion that [McCloskey] was publicly available no later than [January 3, 2008].”). Thus, the second Hall-Ellis declaration should have been served within ten business days of Patent Owner’s February 15, 2024, objection to the admissibility of McCloskey. See 37 C.F.R. § 42.64(b)(2) (“The party relying on evidence to which an objection is timely served may respond to the objection by serving supplemental evidence within ten business days of service of the objection.”). In its Opposition to the Motion to Exclude, Petitioner argues that, under Hulu LLC v. Sound View Innovations, LLC, No. IPR2018-01039, Paper 29 (Dec. 20, 2019) (precedential), it was allowed to wait until its Reply to file the second Hall-Ellis declaration. Paper 37, 2. The Board in Hulu does state that, “if the patent owner challenges a reference’s status as a printed publication, a petitioner may submit a supporting declaration with its reply to further support its argument that a reference qualifies as a printed publication.” Hulu, at 15 (37 C.F.R. § 42.23). However, the Board’s statement was referring to the scope of permissible reply arguments under 37 C.F.R. § 42.23(b). See Hulu at 14 (quoting 37 C.F.R. § 42.23(b)’s requirement that “[a] reply may only respond to arguments raised in the corresponding opposition, patent owner preliminary response, or patent owner response”). The Board in Hulu does not purport to interpret 37 C.F.R. § 42.64 or even discuss supplemental evidence. Petitioner clearly missed the deadline imposed by 37 C.F.R. § 42.64(b)(2), which was triggered by Patent Owner’s February 15, 2024, objection to McCloskey (i.e., Ex. 1004). Patent Owner’s Motion to Exclude is granted with respect to the second Hall-Ellis declaration (i.e., Ex. 1085). Despite the exclusion of the second Hall-Ellis declaration, there is ample evidence in the record demonstrating that McCloskey is a prior art printed publication. McCloskey itself states: “Received: 31 January 2007 / Accepted: 29 May 2007 / Published online: 23 October 2007.” Ex. 1004, 1. McCloskey additionally states that it was published in a 2007 print issue of “Biochem Genet,” with Petitioner adding that the full name of the journal is BIOCHEMICAL GENETICS and that McCloskey was published in a December 2007 volume of the journal. Id.; Pet. 22. McCloskey also includes a copyright notice by “Springer Science+Business Media, LLC” with a date of 2007. Ex. 1004, 1. Patent Owner argues that this is unreliable hearsay that should be excluded. PO Mot. To Exclude 4 (citing Neste Oil Oyj v. REG Synthetic Fuels, LLC, No. IPR2013-00578, Paper 53 at 5–7 (Mar. 12, 2015); Standard Innovation Corp. v. Lelo, Inc., No. IPR2014-00148, Paper 429 at 13–18, 21–22 (Apr. 23, 2015)). We are not persuaded by Patent Owner’s argument or its reliance on these cases. The facts before us are different.” slip op. at 18
- Skill levelSkill level patent owner adoptedDecided for patent owner
“Patent Owner does not directly dispute Petitioner’s proposal but does offer its own proposal. PO Resp. 21. Patent Owner proposes that the skilled artisan “would have had a Ph.D. in molecular biology, molecular genetics, biochemistry, physics, mechanical engineering, or a related discipline, with 7 Exhibit 1002 is a declaration by Petitioner’s witness, Gregory Cooper, Ph.D. two years of academic, research, or industry experience in the field of genomic or transcriptome sequencing.” Id. (citing Ex. 2013 ¶¶25–268). Both of the parties’ proposals as to the level of ordinary skill in the art are consistent with the disclosure of the ’013 patent and the asserted prior art. The distinction between the parties’ proposals would not change the outcome of this Decision. Thus, we adopt and apply Patent Owner’s proposal.” slip op. at 9
Patent outcomesUS 10,697,013 unpatentable§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,697,013 - Parse Biosciences, Inc. v. 10x Genomics, Inc.All claims unpatentablePTAB · Jan 31, 2025 · IPR2023-00955 · APJ Michael J Fitzpatrick · IPR · Final written decision
Claims 1–26 are unpatentable as obvious: claims 1–4, 6–11, 20, and 23–25 over Linnarsson and McCloskey; claims 5, 12, 21, 22, and 26 with ordinary-skill knowledge; claims 13–19 with McCloskey II.
RulingsFinal written decision- ExcludeMotion to exclude, grantedGranted in part
“Clearly, the second Hall-Ellis declaration is offered to prove that McCloskey is a prior art printed publication. See, e.g., Ex. 1085 ¶50 (“In view of the foregoing, it is my opinion that [McCloskey] was publicly available no later than [January 3, 2008].”). Thus, the second Hall-Ellis declaration should have been served within ten business days of Patent Owner’s February 15, 2024, objection to the admissibility of McCloskey. See 37 C.F.R. § 42.64(b)(2) (“The party relying on evidence to which an objection is timely served may respond to the objection by serving supplemental evidence within ten business days of service of the objection.”). In its Opposition to the Motion to Exclude, Petitioner argues that, under Hulu LLC v. Sound View Innovations, LLC, No. IPR2018-01039, Paper 29 (Dec. 20, 2019) (precedential), it was allowed to wait until its Reply to file the second Hall-Ellis declaration. Paper 37, 2. The Board in Hulu does state that, “if the patent owner challenges a reference’s status as a printed publication, a petitioner may submit a supporting declaration with its reply to further support its argument that a reference qualifies as a printed publication.” Hulu at 15 (37 C.F.R. § 42.23). However, the Board’s statement was referring to the scope of permissible reply arguments under 37 C.F.R. § 42.23(b). See Hulu at 14 (quoting 37 C.F.R. § 42.23(b)’s in the prior sentence and in the subtitle to the relevant portion of its Objection. Id. requirement that “[a] reply may only respond to arguments raised in the corresponding opposition, patent owner preliminary response, or patent owner response”). The Board in Hulu does not purport to interpret 37 C.F.R. § 42.64 or even discuss supplemental evidence. Petitioner clearly missed the deadline imposed by 37 C.F.R. § 42.64(b)(2), which was triggered by Patent Owner’s February 15, 2024, objection to McCloskey. Patent Owner’s Motion to Exclude is granted with respect to the second Hall-Ellis declaration (i.e., Ex. 1085). Despite the exclusion of the second Hall-Ellis declaration, there is ample evidence in the record demonstrating that McCloskey is a prior art printed publication. McCloskey itself states: “Received: 31 January 2007 / Accepted: 29 May 2007 / Published online: 23 October 2007.” Ex. 1004, 1. McCloskey additionally states that it was published in a 2007 print issue of “Biochem Genet,” with Petitioner adding that the full name of the journal is BIOCHEMICAL GENETICS and that McCloskey was published in a December 2007 volume of the journal. Id.; Pet. 29. McCloskey also includes a copyright notice by “Springer Science+Business Media, LLC” with a date of date of 2007. Ex. 1004, 1. Patent Owner argues that this is unreliable hearsay that should be excluded. PO Mot. To Exclude 4 (citing Neste Oil Oyj v. REG Synthetic Fuels, LLC, No. IPR2013-00578, Paper 53 at 5–7 (Mar. 12, 2015); Standard Innovation Corp. v. Lelo, Inc., No. IPR2014- 00148, Paper 4210 at 13–18, 21–22 (Apr. 23, 2015)). We are not persuaded 10 Patent Owner actually cited to “Pap.41” of Standard Innovation. PO Mot. To Exclude 4. There is no Paper 41 in the record of that case. We presume Patent Owner intended to cite Paper 42, which is the final written decision in that case. by Patent Owner’s argument or its reliance on these cases. The facts before us are different. In Neste Oil, the Board “note[d] that the alleged ‘stamps’ of Exhibits 1125 and 1132 are actually handwritten dates, added to the documents by an unknown person at an unknown time.” Neste Oil, Paper 53 at 6. In contrast, the dates relied upon by Petitioner are printed, appear to have been included at the time of printing, and appear to have been printed by, or at the direction of, the journal and/or copyright holder, both of which are identified by McCloskey. Ex. 1004, 1. In Standard Innovation, the alleged prior art exhibits were “printouts of … webpages” bearing a copyright indication of “© 2003-2013,” which the petitioner argued was proof of subset of the webpages being disseminated publicly in 2003. Standard Innovation, Paper 42 at 13. This is a far cry from McCloskey, which is a journal article and which includes specific date information, not only of publishing, but also of when the journal received and accepted the article for publication as well as when it was copyrighted. Ex. 1004, 1.” slip op. at 18
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“Patent Owner is correct that, under Sanofi-Aventis, 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, as we noted when instituting this proceeding, “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.”’” Dec. on Reh’g 15 (quoting Sanofi- Aventis, 66 F.4th at 1379 (quoting 37 C.F.R. § 42.23)).” slip op. at 14
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“by Patent Owner’s argument or its reliance on these cases. The facts before us are different. In Neste Oil, the Board “note[d] that the alleged ‘stamps’ of Exhibits 1125 and 1132 are actually handwritten dates, added to the documents by an unknown person at an unknown time.” Neste Oil, Paper 53 at 6. In contrast, the dates relied upon by Petitioner are printed, appear to have been included at the time of printing, and appear to have been printed by, or at the direction of, the journal and/or copyright holder, both of which are identified by McCloskey. Ex. 1004, 1. In Standard Innovation, the alleged prior art exhibits were “printouts of … webpages” bearing a copyright indication of “© 2003-2013,” which the petitioner argued was proof of subset of the webpages being disseminated publicly in 2003. Standard Innovation, Paper 42 at 13. This is a far cry from McCloskey, which is a journal article and which includes specific date information, not only of publishing, but also of when the journal received and accepted the article for publication as well as when it was copyrighted. Ex. 1004, 1. That McCloskey is what it purports to be (a journal article) and that it was published in 2007 are corroborated by multiple pieces of evidence.” slip op. at 20
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“In sum, we find Petitioner’s rationale that a skilled artisan would have made the proposed combination to solve the problem of amplification bias persuasive.” slip op. at 44
Patent outcomesUS 10,240,197 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,240,197 - Bio-Rad Laboratories, Inc. v. California Institute Of TechnologyInstitution deniedPTAB · Jan 29, 2025 · IPR2024-01178 · APJ Erica A Franklin · IPR · Institution
The Board denied institution because Bio-Rad did not show a reasonable likelihood of proving any challenged claim unpatentable, as relied-upon Saxonov disclosures were not shown to qualify as prior art.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review. 35 U.S.C. § 314. Upon considering the parties’ arguments and evidence, we determine that Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we decline to institute an inter partes review of the challenged claims.” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner
“benefit of its provisional application’s filing date for pre-AIA 35 U.S.C. § 102(e) prior art purposes when two conditions are met: (1) the provisional provides sufficient support for at least one claim in the reference patent or published patent application; and (2) the provisional application provide sufficient support for the subject matter relied upon for prior art purposes in the reference patent or application. See Dynamic Drinkware, LLC v. Nat'l Graphics, Inc., 800 F.3d 1375, 1377, 1381–82 (Fed. Cir. 2015); MPEP §§ 2136 (I), 2136.03 (III), 2136 (Examples 2, 4, 7); see, e.g., Google LLC v. Ikorongo Tech, LLC, IPR 2021-00058, Paper 14 at 10–12 (PTAB May 10, 2021). The burden of production is on the Petitioner to show in its Petition that the asserted references qualify as prior art. See Dynamic Drinkware, 800 F.3d at 1380 (explaining that a petitioner bears the initial burden of production to establish that the asserted references qualify as prior art).” slip op. at 18
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not reached
“Each of the remaining grounds asserted in the Petition relies on Saxonov to reach a number of limitations of independent claim 1 and the challenged dependent claims. Because Petitioner has not shown that all of the relied-upon portions of Saxonov are prior art to the ’170 patent, we determine that Petitioner has failed to demonstrate a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim of the ’170 patent in any of the remaining grounds.” slip op. at 24
- PTAB / AIA Trials › Discretionary denialNot reached
“Because we deny institution upon consideration of the merits of Petitioner’s challenges, Patent Owner’s argument that we should exercise our discretion under 35 U.S.C. § 314(a) to deny institution is moot.” slip op. at 25
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 10,770,170
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.