- Novartis Pharmaceuticals Corporation v. Regents Of The University Of Michigan And University Of South FloridaAll claims unpatentablePTAB · Mar 5, 2025 · IPR2023-01346 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 10, 11, and 18 are unpatentable because Hickey anticipates each claim; the Board did not reach the alternative Almarsson grounds.
RulingsFinal written decision- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“For a functionally-defined genus, “the written description requirement [can be met] when the art has established a correlation between structure and function.” Ariad, 598 F.3d at 1350. Here, the challenge claims recite two types of functional limitations. First, independent claim 10 requires the coformer to have a second chemical functionality, which is defined as being complementary to the first chemical functionality via non-covalent hydrogen bonding. That is, the co-former’s second chemical functionality must be complementary to either a carboxamide, carbonyl, or amine functionality of an API via non-covalent hydrogen bonding. Second, the non-covalent hydrogen bonding between the first chemical functionality of the API and the second chemical functionality of the co-former must result in the formation of supramolecular synthons.” slip op. at 21
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artDecided for petitioner
“We therefore find that the parent ’956 application lacks written description support for the challenged claims, and thus, on the record before us, we determine that the effective filing date of the challenged claims is February 13, 2014, the filing date the ’344 patent. Thus, the references relied upon by Petitioner (Hickey, Almarsson, and Martindale) qualify as prior art to the ’344 patent. Pet. 33, 45.” slip op. at 26
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“III. ANALYSIS A. Principles of Law To anticipate a claim under 35 U.S.C. § 102, “a single prior art reference must expressly or inherently disclose each claim limitation.” Finisar Corp. v. DirecTV Group, Inc., 523 F.3d 1323, 1334 (Fed. Cir. 2008). Accordingly, “‘the dispositive question regarding anticipation [i]s whether one skilled in the art would reasonably understand or infer from the [prior art reference’s] teaching’ that every claim element was disclosed in that single reference.” Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 1368 (Fed. Cir. 2003) (quoting In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991)).” slip op. at 26
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 7–8. “Patent Owners do not contest the level of ordinary skill in the art set forth in the Petition.” PO Resp. 11. Because Petitioner’s unopposed definition is consistent with the ’344 patent and the prior art of record, we adopt that definition. See Okajima v. Bourdeau, 261 F.3d 1350, 1354–55 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579–80 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 8
Patent outcomesUS 10,633,344 unpatentable§ 102 anticipation§ 112 disclosurecites KSR · GrahamPatents in suitUS 10,633,344 - PTAB · Feb 25, 2025 · IPR2024-01294 · APJ Michael J Fitzpatrick · IPR · Institution
The Board instituted IPR on claims 1, 12, 25, and 26 on all asserted grounds, finding a reasonable likelihood that claim 1 is anticipated by Zwinkels.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“3. Conclusion Regarding Claim 1 Petitioner has demonstrated a reasonable likelihood of prevailing on its challenge to claim 1 as unpatentable under 35 U.S.C. § 102 as anticipated by Zwinkels. D. Remaining Claims of Ground 1 and Grounds 2 and 3 The threshold for institution is a reasonable likelihood of Petitioner prevailing as to any single claim. 35 U.S.C. § 314(a). “Once that single claim threshold is satisfied, it doesn’t matter whether the [P]etitioner is likely to prevail on any additional claims.” SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348, 1356 (2018). Thus, because we have decided to grant review of claim 1, we do the same for all claims challenged and all grounds raised. Id.; see also 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”). III. CONCLUSION For the reasons discussed above, we are persuaded that Petitioner has demonstrated a reasonable likelihood of prevailing in establishing that at least one of the challenged claims is unpatentable. IV. ORDER In consideration of the foregoing, it is hereby ORDERED that the Petition is granted and inter partes review is hereby instituted as to claims 1, 12, 25, and 26 of U.S. Patent No. 10,434,394 B2 on the grounds presented; and” slip op. at 15
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“to move forwardly and rearwardly relative to the frame. Pet. 33–38. For example, paragraph 20, as cited by Petitioner, discloses that the rollers “are movably suspended in the frame in vertical direction, wherein the suspension of said roll or rollers is arranged to convert relative horizontal movements of the roll or rollers into vertical movements thereby compensating and/or attenuating said horizontal movements by gravity.” Ex. 1004 ¶20 (cited at Pet. 34). Further, Zwinkels attributes the forward and rearward movement to the use of the bicycle by the person exercising on it. See Ex. 1004 ¶27 (describing the “horizontal movements induced by the accelerations and decelerations of the training cyclist”) (cited at Pet. 35). Petitioner also cites multiple figures that illustrate forward and rearward movement. Pet. 35–37 (reproducing Ex. 1004, Figs. 3, 5, and 6). There is a reasonable likelihood Zwinkels teaches “wherein the movable interconnection of the upper member with the lower member is configured to enable the upper member to move forwardly and rearwardly in the fore-aft direction relative to the lower member in response to fore-aft forces that are transferred to the upper member from the item of exercise equipment in response to use of the item of exercise equipment,” as recited in claim 1. e) “wherein the movable interconnection of the upper member with the lower member is further configured to provide upward and downward movement of the upper member relative to the support surface during movement of the upper member forwardly and rearwardly in the fore-aft direction relative to the lower member.” Petitioner argues that Zwinkels’s pendulum arms 6 enable the rollers to move upward and downward relative to the frame while the rollers are also moving forwardly and rearwardly relative to the frame. Pet. 39–42. For example, paragraph 24, as cited by Petitioner, discloses that the pendulum arms connecting the rollers at fixed pivoting points on the frame “provides an easy and effective solution for absorbing and attenuating horizontal movements by converting these horizontal movements to vertical movements.” Ex. 1004 ¶24 (cited at Pet. 39). Petitioner also reproduces Figures 5 and 6, which illustrate the displacement of rollers in both the vertical and horizontal directions. Pet. 40 (citing Ex. 1004, Figs. 5–6). Figure 5 is reproduced below. Figure 5, reproduced above, “shows the embodiment in which there are two rollers 4 for the bicycle back wheel.” Ex. 1004 ¶34. Figure 5 shows two configurations of the embodiment on left and right sides. Ex. 1004 ¶34, Fig. 5. The configuration “at the left of FIG. 5 shows the pendulum arms 6 in a resting position, whereas the [configuration] on the right shows the pendulum arms 6 after they have due to the connecting link 7 concertedly moved to the right due to a force FH, causing that the rollers 4 have moved vertically upwards.” Ex. 1004 ¶34. There is a reasonable likelihood Zwinkels teaches “wherein the movable interconnection of the upper member with the lower member is further configured to provide upward and downward movement of the upper member relative to the support surface during movement of the upper member forwardly and rearwardly in the fore-aft direction relative to the lower member,” as recited in claim 1. f) “wherein the upper member is oriented parallel to the support surface plane during movement of the upper member relative to the lower member in the fore-aft direction and during upward and downward movement of the upper member relative to the support surface” Petitioner argues that Zwinkels’s rollers are oriented parallel to the ground or floor at all times. Pet. 42–44. Petitioner argues that this is clearly shown in Figure 5, which we reproduced in the immediate section above. See Pet. 43 (citing and annotating Ex. 1004, Fig. 5). We agree. There is a reasonable likelihood Zwinkels teaches “wherein the upper member is oriented parallel to the support surface plane during movement of the upper member relative to the lower member in the fore-aft direction and during upward and downward movement of the upper member relative to the support surface,” as recited in claim 1. 3. Conclusion Regarding Claim 1 Petitioner has demonstrated a reasonable likelihood of prevailing on its challenge to claim 1 as unpatentable under 35 U.S.C. § 102 as anticipated by Zwinkels.” slip op. at 12
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner
“1. Zwinkels (Ex. 1004) Zwinkels was filed November 4, 2010, and published June 9, 2011. Ex. 1004, codes (22), (43). Petitioner argues that, based on its filing date, “Zwinkels is thus prior art under at least 35 U.S.C. § 102(a)(2).” Pet. 15. On the record presented, we agree. In addition, the current record supports that, based on its publication date, Zwinkels is prior art also under 35 U.S.C. § 102(a)(1).” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner does not propose an express construction of any term of claim 1. See Pet. 14 (“Petitioner submits that for the purposes of this proceeding, the terms of the challenged claims should be given their plain and ordinary meaning, and no terms require specific construction.”). At this stage of the proceeding, we discern no need to provide an express construction of any term of any claim.” slip op. at 8
Claim construction§ 102 anticipationPatents in suitUS 10,434,394 - 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 · 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 - 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 · IPR2024-00186 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted inter partes review on all challenged claims and all grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have jurisdiction under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted unless the information presented in the Petition “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.” A decision to institute under § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). In addition, if the Board institutes trial, it will “institute on all grounds in the petition.” PTAB Consolidated Trial Practice Guide, 5–6 (Nov. 2019); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). Having considered the arguments and evidence presented in the Petition and the Preliminary Response, for the reasons described below, we institute inter partes review.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“Office (“USPTO”) issued a Memorandum titled “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings With Parallel District Court Litigation” (“Memorandum”)11, which states, among other things, that “the PTAB will not discretionarily deny institution in view of parallel district court litigation where a petitioner presents a stipulation not to pursue in a parallel proceeding the same grounds or any grounds that could have 11 Available at www.uspto.gov/sites/default/files/documents/interim_proc_ discretionary_denials_aia_parallel_district_court_litigation_memo_2022 0621_.pdf. reasonably been raised before the PTAB.” Memorandum 3 (citing Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) (precedential as to § II.A)). By email dated November 25, 2024, Petitioner requested leave to file a Reply to Patent Owner’s Preliminary Response to address, inter alia, its proposed submission of a Sotera stipulation. Ex. 3001. We denied Petitioner’s request for briefing, but granted its request to submit the stipulation. Id. The Sotera stipulation avers that “if IPR Nos. IPR2024- 00183, IPR2024-00185, and IPR2024-00186 are instituted, National Beef will not pursue in the related district court proceeding, Inst. for Envtl. Health, Inc. v. Nat’ / Beef Packing Co., LLC, No. 1:23-cv-00826 (D. Del. Aug. 1, 2023), any ground National Beef raised or reasonably could have raised in the aforementioned IPRs,” and that the stipulation “binds National Beef in the related district court proceeding, Inst. for Envtl. Health, Inc. v. Nat'l Beef Packing Co., LLC, No. 1:23-cv-00826 (D. Del. Aug. 1, 2023).” Ex. 1064. Applying the guidance provided in the Memorandum, we decline to exercise our discretion to deny institution in this proceeding under Fintiv because Petitioner submitted a Sotera stipulation.” slip op. at 20
- BurdenInstituted
“Thus, Petitioner has accounted for each step/element of independent claims 1 and 37 as taught by the combination of ICMSF and Gombas, and has also provided a reason why, with rational underpinnings, the prior art would have been combined and modified, with a reasonable expectation of success. On the current record, including Patent Owner’s arguments that we considered and are addressed in detail below, Petitioner’s evidence for this ground is sufficient to provide a reasonable likelihood of success in demonstrating unpatentability of at least one claim.” slip op. at 31
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“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. We also agree with Patent Owner that the ’771 patent provides definitions that guide the understanding of the term “lots” including: 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 products 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. 1003, 5:43‒54. The ’771 patent similarly provides definitions for “product portion,” “test lot sample,” and “composite lot-unit” that provide significant guidance and clarity as to the meaning of these terms. Ex. 1003, 5:60‒6:4, 6:12‒29, 7:49‒63. 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 decline to expressly interpret this term at this time.” slip op. at 11
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,637,771
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.