- 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 · IPR2024-01211 · 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 · Jan 13, 2025 · IPR2024-01156 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted inter partes review of claims 1–30 on all grounds, finding it more likely than not that the claims are unpatentable.
RulingsInstitution decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“On the current record, there is no controversy over the meaning of any of the claim terms and neither party identifies a claim construction that would impact our analysis. We therefore find that, at this stage of the proceeding, there are no terms that need claim construction. See, e.g., 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)).” slip op. at 7
- Skill levelSkill level petitioner adoptedDecided for petitioner
“VIII. LEVEL OF ORDINARY SKILL IN THE ART Petitioner asserts (without opposition): A person of ordinary skill in the art (“POSA”) at the time of invention would have a working knowledge of microbiology and would have been involved in developing testing methodologies for analysis of samples such as food products (“validation methodologies”). The POSA would most likely have an advanced degree in microbiology, food science, or animal science and at least two years of work experience but may alternatively have a bachelor’s degree in those areas and at least four years of experience with validation methodologies. The POSA would have been familiar with relevant scientific literature and industry regulations, directives, and guidelines relating to validation methodologies.” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Determining whether claims are anticipated involves a two-step analysis. The first step involves construction of the claims of the patent at issue. Claim construction is a question of law reviewed de novo.” In re Aoyama, 656 F.3d 1293, 1296 (Fed.Cir.2011). “The second step [of an anticipation analysis] involves comparing the claims to the prior art. Anticipation is a question of fact reviewed for substantial evidence.” In re Aoyama, 656 F.3d at 1296. “A prior art reference anticipates a patent claim under 35 U.S.C. § 102(b) if it discloses every claim limitation.” In re Montgomery, 677 F.3d 1375, 1379 (Fed. Cir. 2012). A reference may anticipate inherently if a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010). slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“The motivation-to-combine analysis is a flexible one. “[A]ny need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed,” [but the] “analysis ‘need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.’” Intel Corp. v. PACT XXP Schweiz AG, 61 F.4th 1373, 1379–80 (Fed. Cir. 2023) (quoting KSR, 550 U.S. at 418, 420 (emphasis added)). “[I]f there’s a known technique to address a known problem using ‘prior art elements according to their established functions,’ then there is a motivation to combine,” because KSR explains that “if a technique has been used to improve one device [or method], and a person of ordinary skill in the art would recognize that it would improve similar devices [or methods] in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” Id. at 1380 (quoting KSR, 550 U.S. at 417; and Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 797 (Fed. Cir. 2021)). If addressing a known problem, the prior art combination need not be “the best option, only . . . a suitable option.” Id. (quoting Intel, 21 F.4th at 800 (emphasis original)).” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,845,486 - PTAB · Jan 13, 2025 · IPR2024-00185 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–7, 11, 12, 14–20, 22–24, 26, and 29–36 on all asserted grounds, finding a reasonable likelihood of success on obviousness.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“III. CONCLUSION After considering the evidence and arguments presented in the Petition, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one challenged claim of the ’143 Patent is unpatentable. In particular, because Petitioner has demonstrated a reasonable likelihood that at least one claim is rendered obvious by the asserted combinations of ICMSF, Hughes, and Price, we institute inter partes review on all grounds set forth in the Petition. At this stage of the proceeding, the Board has not made a final determination as to the patentability of any challenged claim or the construction of any claim term. Thus, our view with regard to any conclusion reached in the foregoing could change upon consideration of Patent Owner’s merits response and completion of the record.” slip op. at 54
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We agree with Patent Owner that the term “lots” does not require construction because on the current record, there is no controversy over the meaning of the term, and neither Petitioner nor Patent Owner identify any way that claim construction may impact our decision. See, e.g., 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)). We also agree with Patent Owner that the ’143 patent provides definitions that guide the understanding of the term “lots” including teaching: The term “test lot” or “reportable lot” as used herein to refer to an assemblage of one or more specimens of a medium or process (e.g. assemblage of specimens of air, water, solids or of product of a production process, etc.) where such assemblage can be sampled by taking portions of the one or more specimens thereof, and where the one or more specimens of the assemblage are operationally linked in a manner (e.g. proximity, time, process step, etc.) whereby information derived about sampled portions is operationally applicable to all specimens of the assemblage, and thus to the test lot. In particular instances, portions are synonymous with specimens. Ex. 1002, 5:34–45. The Specification similarly provides definitions for “product portion,” “test lot sample,” and “single-unit production lot” that provide significant guidance and clarity as to the meaning of these terms. Id. at 5:52–63, 6:2–20.” slip op. at 16
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“validation” as used herein with respect to production lots refers to determining that a particular sample tests negative using the detection assay. Where a modular composite sample tests negative, all single-unit production lot samples comprising the composite sample are validated along with the respective single-unit production lots, which are thus cleared for release. Where a modular composite sample tests positive, individual single unit production lots may nonetheless yet be validated if particular respective single-unit production lot samples test negative. Ex.1002, 7:15–24 (emphasis added). The above text expressly equates “validation” to a determination that “a particular sample tests negative.” The initial definitional sentence makes no mention of “cleared for release” as necessary for “validation.” The subsequent sentence refers to “cleared for release” in the more limited situation where a particular composite sample “tests negative all single-unit production lot samples,” and, even then, the “cleared for release” language indicates a separate step that may happen after the samples are “validated.” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“On the current record, we are not persuaded that Petitioner has insufficiently articulated a motivation to combine or modify the asserted references. With respect to Ground 1, for example, Petitioner contends that one of ordinary skill in the art would have been motivated to modify ICMSF based on Gombas under the teaching-suggestion-motivation test so portions of the enriched, retained samples are further tested after a positive test of a composite sample by the same protocol, with a reasonable expectation of success for efficient validation. See § XII-A-1-h supra; Dickson ¶¶ 417-19. Pet. 53–54. Petitioner further argues that ordinarily skilled artisan would have sought to improve[] ICMSF with the similar methods of Gombas to yield efficient validation, which is a predictable result. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). In this combination, a POSA would have simply substituted steps of ICMSF, as described above, with those of Gombas so portions of the enrichment cultures are retained and are further tested after a positive test of a composite sample by the same protocol for predictably efficient validation. MPEP § 2143(I)(B); Dickson ¶ 420. Id. at 53. As such, the Petition provides specific reasons to combine ICMSF and Gombas that are consistent with the flexible test recited in KSR, including the benefit of efficient validation of the test and that the combination is a simple substitution of steps. As KSR notes, “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” KSR, 550 US at 417. Here, Petitioner has made its reasons to combine explicit. See Pet. 53–” slip op. at 47
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 8,822,143 - PTAB · Jan 13, 2025 · IPR2024-00183 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–6, 10, 11, 13–20, 22, 23, and 26–33 because the asserted combinations of ICMSF, Hughes, and Price showed a reasonable likelihood that at least one claim was obvious.
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 ’584 patent is unpatentable. Accordingly, we institute an inter partes review as to the challenged claims of the ’584 patent on the grounds of unpatentability set forth in the Petition. A.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art at the time of the invention (POSA/POSITA), “would most likely have an advanced degree in microbiology, food science, or animal science and at least two years of work experience but may alternatively have a bachelor’s degree in those areas and at least four years of experience with validation methodologies.” Pet. 11. (citing Ex. 1041 ¶¶ 22–24). Petitioner further contends that a person of ordinary skill in the art would have had “a working knowledge of microbiology,” “would have been involved in developing sampling and testing methodologies for analysis of food products (“validation methodologies”),” and “would have been familiar with relevant scientific literature and industry regulations, directives, and guidelines relating to validation methodologies.” Id.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We agree with Patent Owner that the term “lots” does not require construction because on the current record, there is no controversy over the meaning of the term, and neither Petitioner nor Patent Owner identify any way that claim construction impacts the decision. See, e.g., 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)).” slip op. at 16
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“This definition requires that a “validation” determines that “a particular sample tests negative.” The initial definition sentence makes no mention of “cleared for release” as necessary for “validation.” Rather, the definition only refers to “cleared for release” in the more limited situation where a particular composite sample “tests negative all single-unit production lot samples,” and even then, the “cleared for release” is a separate step that occurs after the samples are “validated.”” slip op. at 21
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 7,534,584 - Biofrontera Inc. / Biofrontera Bioscience GmbH et al. v. Sun Pharmaceutical Industries, Inc.Institution deniedPTAB · Nov 12, 2024 · IPR2024-00874 · APJ Erica A Franklin · IPR · Institution
The Board denied institution because the petition did not show a reasonable likelihood that any challenged claim was unpatentable, failing to show Bansal's claimed light intensity arrangement.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“An obviousness determination requires finding both ‘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.’” CRFD Research, Inc. v. Matal, 876 F.3d 1330, 1340 (Fed. Cir. 2017) (quoting Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367– 68 (Fed. Cir. 2016)). Obviousness grounds must be supported with “articulated reasoning with some rational underpinning” and not by “mere conclusory statements.” See KSR Int’l Co., 550 U.S at 418. slip op. at 11
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“agree with Patent Owner that Petitioner has not sufficiently shown for institution that Bansal teaches or suggests arranging light sources “such that a higher intensity of light is emitted proximate the second edges compared to the intensity of light emitted not proximate the second edges,” as required by the challenged claims. Instead, Petitioner demonstrates how Bansal describes varying the density of light source distribution throughout the array to provide a higher density of light in the entire peripheral area of the array, which includes the areas proximal to both the first and second edges, as compared to the central area of the array. See Pet. 36–37; Ex. 1005 ¶ 25. In this regard, Petitioner relies on Bansal’s Figure 9b, asserting that it “shows one embodiment where more light sources are placed near the edges of the panel compared to the light sources in the center.” Pet. 36–37. The comparison of Bansal’s light density between the entire periphery and the central area of the array is insufficient. What is missing from Petitioner’s argument and discussion of Bansal is how Bansal teaches or suggests a configuration that provides a higher density of light proximate to the second shorter edges of the periphery in comparison to the remaining areas of the array, which includes the first longer edges of the periphery. Without that discussion, we find that Petitioner has not shown sufficient for institution that Bansal is persuasively relied upon for the light source arrangement limitation of the challenged claims. likelihood of prevailing in its obviousness challenge of independent claims 1, 5, 16, 20, or 21, or dependent claims 2, 4, 6–8, and 17–19 over Larsen, Bansal, and Jones.” slip op. at 17
- Skill levelOther
“would have had at least a Bachelor of Science in electrical engineering, physics, biomedical engineering, computer engineering, chemical engineering, material science, or a related scientific or engineering field, and at least one year of work or research experience in optics, optoelectronics, radiometry, photometry, photodynamic diagnosis (PD), photodynamic therapy (PDT), phototherapy (PT), or a related field. Pet. 8. Petitioner asserts that, alternatively, a “POSITA in the relevant time frame would have had at least four years of industry or academic experience in optics, optoelectronics, radiometry, photometry, PD, PDT, PT, or a related field.” Id. (citing Ex. 1003 ¶ 37). According to Patent Owner, a person of ordinary skill in the art at the time the application for the ’028 patent was filed, “would have had a M.D. and/or a Ph.D. in an electrical engineering, physics, optical sciences, optical engineering, or a related scientific or engineering field, and at least one to two years of work or research experience in optical engineering, optics, optoelectronics, phototherapy (‘PT’), PDT, or a related field.” Prelim. Resp. 16. Patent Owner asserts that, “[a]lternatively, a POSITA could have a Bachelor’s degree in one of the above areas and at least three to four years of work or research experience in that area.” Id. (citing Ex. 2001 ¶¶ 30–31). We note that the parties’ proposed definitions are largely similar. To the extent that the proposed definitions differ, we do not need to resolve those differences as our findings and conclusion in this Decision would be the same under any of the proposed definitions.” slip op. at 9
§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,697,028 - PTAB · Nov 8, 2024 · IPR2024-00834 · APJ Tawen Chang · IPR · Institution
The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood of unpatentability and declining discretionary denial under §§ 325(d) and 314.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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) (2012) (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). The Board may authorize an inter partes review if we determine that the information presented in the Petition and Patent Owner’s Preliminary Response shows a reasonable likelihood that Petitioner will prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314(a).” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“anticipated by Sonti. Pet. 3. To show anticipation under 35 U.S.C. § 102, each and every claim element, arranged as in the claim, must be found in a single prior art reference. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359 (Fed. Cir. 2008). The prior art need not, however, use the same words as the claims to find anticipation. In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2009). In evaluating anticipation, it is permissible to take into account not only the literal teachings of the prior art reference, but also the inferences the skilled artisan would draw from it. Eli Lilly and Co. v. Los Angeles Biomedical Res. Inst. At Harbor-UCLA Med. Ctr., 849 F.3d 1073, 1074–75 (Fed. Cir. 2017) (holding that the “dispositive question regarding anticipation is whether one skilled in the art would reasonably understand or infer from a prior art reference that every claim element is disclosed in that reference”). As such, “a reference can anticipate a claim even if it does not expressly spell out all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would at once envisage the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (internal quotation and alteration marks omitted).” slip op. at 17
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“b. Reasonable Expectation of Success Petitioner asserts that an ordinarily skilled artisan would have been motivated, with a reasonable expectation of success, to topically administer 1% tapinarof composition once a day to treat mild to severe plaque psoriasis in view of Sonti’s teaching to apply its compositions (including 1% tapinarof compositions) in various application frequencies (including once daily) to treat moderate to severe plaque psoriasis. Pet. 29–30 (citing, e.g., Ex. 1003 ¶¶ 182–184, 187–188; Ex. 1005 Abstract, ¶¶ 55, 196, 288, 387).” slip op. at 32
- Obviousness (§103) › Objective indicia / secondary considerationsInstituted
“d. Objective Indicia of Non-obviousness Patent Owner asserts that, although the “Petition notes the patent’s ‘surprising[] and unexpected[]’ finding that once daily application of 1% tapinarof cream was just effective as twice daily application, . . . the Petition does not analyze, as the law requires, this surprising, unexpected finding in its obviousness arguments.” Prelim. Resp. 52. We are not persuaded by this argument. Immediately after the Petition’s acknowledgement that “[t]he specification [of the ’088 patent] contends that it was ‘surprisingly’ found that once daily application was just as effective as twice daily,” the Petition notes that, “[h]owever, during prosecution the examiner cited a set of prior art by Chen et al. disclosing treating plaque psoriasis by topically applying a composition containing 1% tapinarof once a day.” Pet. 1 (footnote omitted). Indeed, Patent Owner acknowledges that Petitioner counters “Applicant’s surprising and unexpected findings” by referring to the Chen references cited during prosecution, but asserts that “Chen . . . does not undermine Applicant’s surprising and unexpected findings” because “Chen discloses applying a composition containing 1% mixture of cis and trans 3,5-dihydroxy-4-isopropylstilbene, and not one containing 1% tapinarof (3,5-dihydroxy-4-isopropyl-trans-stilbene).” Prelim. Resp. 52–53.16 As 16 Patent Owner refers to its earlier discussion on this issue. Prelim. Resp. 53 (“As already discussed . . .”). That earlier discussion is with respect to the Chen references cited in Sonti (i.e., Exs. 1012 & 1013), not the Chen 40” slip op. at 40
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,590,088 - Fusion Orthopedics, LLC v. Extremity Medical, LLCSome claims unpatentablePTAB · Nov 4, 2024 · IPR2023-00894 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–10 and 12–15 are unpatentable; claim 11 was not shown unpatentable. Substitute claims 16–25 and 27–30 are unpatentable over Mazur; claim 26 was not reached.
RulingsFinal written decision- BurdenMixed
“It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the grounds for the challenge to each claim.’” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (quoting 35 U.S.C. § 312(a)(3)). Here, however, not until its Reply does Petitioner belatedly suggest that Ferrante’s disclosure of bone screws with self-tapping ends equally meets the limitation of claim 10 (with respect to the first member) as with claim 11 (with respect to the second member), and that both claims are obvious in light of “evidence” from Ferrante “that it was well known to equip bone screws with self-tapping ends.” Reply 26–27. We do not discern these arguments in the Petition, and consider them waived. See Netflix, Inc. v. DivX, LLC, 84 F.4th 1371,1377 (Fed. Cir. 2023) (“While the Board should not take an overly mechanistic view of a petition and decline to address an argument because the petitioner did not present it with ideal vigor and clarity, the Board should also not have to decode a petition to locate additional arguments beyond the ones clearly made.”). In sum, Petitioner’s error in failing to first address limitations of claim 10 in the Petition specific to the Cognet/Ferrante combination indicates a failure to meet the particularity requirements for what must be in the petition and cannot be left to be filled in on reply. See 35 U.S.C. § 312(a)(3); 37 C.F.R. §§ 42.22(a)(2) (requiring, among other things, “a detailed explanation of the significance of the evidence”), 42.104(b)(4)–(5) (requiring that petition “specify where each element of the claim is found in the prior art patents or printed publication relied upon” and, regarding submitted evidence, state “the relevance of the evidence to the challenge raised, including identifying specific portions of the evidence that support the challenge”). Microsoft, 2022 WL 989403, at *6. Accordingly, Petitioner has not shown persuasively that claim 11 would have been obvious in light of Cognet and Ferrante for the reasons set forth in the Petition. slip op. at 41
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We also find persuasive Mr. Dominguez’s explanation that one of ordinary skill in the art would have understood “bore” as including stepped diameter holes, sometimes described as a bore having a counterbore. See generally Ex. 1018 ¶¶ 4–29; Reply 3–10. Three of Mr. Dominguez’s illustrative examples are reproduced in the annotated figures below. The above figures show Mr. Dominguez’s annotated illustrations from the Jackson (Ex. 1019, Fig. 3), Brånemark (Ex. 1021, Fig. 4), and Ray (Ex. 1025, Fig. 1) references as discussed at paragraphs 10, 12, and 13, respectively, of Mr. Dominguez’s Second Declaration. With reference to the above figures, Mr. Dominguez testifies that “Jackson describes a bone repair set screw in which ‘[t]he bore 27 comprises a first bore section 31, a second bore section 32,’ etc. delineated by shoulders 41, 42, etc. (Ex. 1019, 5:24– 43)” (Ex. 1018 ¶ 10); “Brånemark describes an osseous implantation device having body 1ʺ with first and second holding portions 21ʺ, 31ʺ and ‘an inner through bore with a first portion 4ʺ in the first holding portion and a second portion 5ʺ in the second holding portion.’” Ex. 1021, 4:44–46” (id. ¶ 12); and Ray discloses surgical calipers including “handle 12 having ‘stepped cylindrical bore 14,’” wherein “[c]ollar 20 of a shaft inserted in the bore ‘rests against a step of the bore 14’ (2:14–15)” (id. ¶ 13). Patent Owner responds that Mr. Dominguez’s examples “that allegedly show a single bore encompassing two or more stepped-diameter holes or a counterbore . . . . are specific to these references and divorced from the disclosures of the ’166 patent.” Sur-Reply 7. Insofar as the ’166 patent makes no mention of the term “bore” outside the claims, and Mr. Dominguez’s examples are all taken from the field of orthopedic surgery, we do not find this argument persuasive. Patent Owner further appears to contend that exemplary references to a “cylindrical stepped down bore” or a “stepped cylindrical bore” are too specific to be within the scope of the term “bore.” Sur-Reply 7–8. As these terms merely describe species within a larger genus, and Patent Owner presents no cogent reason to exclude them, we do not find this argument availing. Relatedly, we are also not persuaded by Patent Owner’s argument that “the prior art treats a ‘bore’ as an element that is distinct from a ‘counterbore.’” Id. at 8. Rather, we credit Mr. Dominguez’s testimony that “[a] counterbore is not a structure unto itself, a counterbore is part of a larger structure” as exemplified by numerous examples including Laps (Ex. 1028 ¶ 33 (sensor assembly wherein “bore 16 includes a counterbore 18”)); Martinez (Ex. 1029, 3:61 (surgical cutting instrument wherein “bore 56 has a counterbore 64”)); Zang (Ex. 1030, 2:49 (bone anchor having a “bore [that] includes a counterbore”)); Ledet (Ex. 1022, 29:3–5 (vertebral fixation plate having “through holes . . . . countersunk, or counterbored to accommodate the head of a bone screw”)); Seo (Ex. 1031, 3:45 (chair leg employing “counterbored bore 23”)); and Exner (Ex. 1032, 2:16 (extrusion press including “counterbored axial bore 6”)). Ex. 1018 ¶¶ 17–23. That a reference may refer to a figure as showing “bore 103” with “counterbore 105 . . . formed on one end” does not indicate that they are distinct structures as Patent Owner contends, but merely that the focus of each term is directed to the entire bore or to a particular aspect of the bore, i.e., its counterbore. See” slip op. at 22
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner subsequently proposed an alternative definition, as a person having “[a] Bachelor’s Degree in biomedical and/or mechanical engineering or similar training and . . . at least three years of experience with implant devices used for internal fixation of bones.” POR 5 (citing Ex. 2012 ¶¶ 32–33). According to Patent Owner, “[t]his hypothetical person would be capable of performing various design tasks and would understand the basic mechanical features and operation of orthopaedic implant devices [and] have an appreciation for orthopaedic fusion techniques and the medical issues and concerns faced by a doctor/surgeon charged when performing operations to implant orthopaedic devices.” Id. Despite some differences in wording, Patent Owner asserts (and Petitioner does not contest) that any “distinction between the parties’ proposed definitions of a POSITA does not affect the arguments set forth herein.” Id. (citing Ex. 2012 ¶ 34). Consistent with this view, we find the parties’ constructions equally applicable in light of the prior art of record and the disclosure of the ’166 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). We adopt, for convenience, Petitioner’s definition, but our analysis does not change depending on which of the two articulations are applied here. H.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“one of ordinary skill in the art would understand that “bore,” as used in the context of claims 1 and 12, encompasses a multi-diameter passage, and in particular, one having stepped longitudinal cross sections such as that shown in Cognet’s Figure 1. See generally DI 11–13. For the reasons that follow, we conclude that one of ordinary skill in the art would have understood “bore” as such. Relying on the testimony of Mr. Dominguez, Petitioner initially proposed a construction of “bore” as “a usually cylindrical hole made by or as if by the turning or twisting movement of a tool.” Pet. 16 (citing Ex. 1002 ¶ 58). Petitioner’s proposal relied on Mr. Dominguez’s testimony that “[a] bore is a cylindrical hole made by the spinning rotation of a twist drill cutting tool. It is typically made by removing material from a solid or hollow object, similar to a tunnel or orifice.” Ex. 1002 ¶ 58. Pointing to its annotation of Cognet’s Figure 1, above, Patent Owner argued that that the term “bore” excludes a tunnel made by “two adjacent bores.” See Prelim. Resp. 21–25. In view of the then-available evidence, we provisionally construed “bore” as a hole or passage made by or as if by the turning or twisting movement of a tool such that its interior walls have cylindrical lateral cross-sections, and which do not exclude holes or passages having tapered or stepped longitudinal cross-sections. DI 13.” slip op. at 19
Patent outcomesUS 11,298,166 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,298,166
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.