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  • PTAB · Jun 2, 2025 · IPR2025-00176 · APJ Michael A Valek · IPR · Institution

    The Board denied institution of IPR on all challenged claims under § 314(a), finding the Fintiv factors—particularly investment, overlap, and merits—weighed against review.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied

      “raised by this overlap, but given the circumstances, it does not effectively mitigate them. First, the disputed issues for Petitioner’s ODP defense are the same or substantially similar to those for the obviousness grounds in the Petition, but the Sotera stipulation does not prevent Petitioner from litigating those issues before both the district court (as part of its ODP defense) and here in the event an IPR is instituted.19 Second, the MDL proceeding 19 ODP or nonstatutory double patenting is, as the name implies, not premised on any statute. See, e.g., Ostuka Pharm. Co., Ltd. v. Sandoz, Inc., 678 F.3d 1280, 1297 (Fed. Cir. 2012) (“Nonstatutory double patenting is a judicially created doctrine grounded in public policy.”). Accordingly, it is not a ground Petitioner reasonably could have raised in this IPR. See 35 U.S.C. § 311(b) (inter partes review may be requested “only on a ground that could be raised under section 102 or 103”). includes other biosimilar applicant defendants who are similarly motivated to try to invalidate the ’865 patent claims, but who are not subject to any Sotera stipulation. Even if we institute review on Petitioner’s grounds here, those other defendants remain free to litigate the same grounds in the consolidated MDL proceeding. For these reasons and given the particular circumstances of this case, Petitioner’s Sotera stipulation does not sufficiently mitigate the risks of duplicated efforts or inconsistent decisions by making this IPR a “true alternative” to resolution of these issues by the district court. See Motorola Solutions, Inc. v. Stellar, LLC, IPR2024-01205, Paper 19, 3–4 (PTAB Mar. 28, 2005) (determining on Director Review that a Sotera stipulation did not ensure IPR would be a “true alternative” because Petitioner’s invalidity arguments “include combinations of the prior art asserted in these proceedings with unpublished system prior art, which Petitioner’s stipulation is not likely to moot” and thus the same or similar issues would remain in the parallel proceeding); SAP America, Inc. v. Cyandia, Inc., IPR2024-01496, Paper 13, 8–9 (PTAB Apr. 7, 2025) (similar).” slip op. at 19

    Discretionary denial
    Patents in suitUS 11,084,865
  • PTAB · Jun 2, 2025 · PGR2025-00003 · APJ Jeffrey N Fredman · PGR · Institution

    Instituted PGR on claims 1–4 and 8–21 because the Board found a more-likely-than-not showing of written description and enablement failures; the obviousness ground did not meet that threshold.

    RulingsInstitution decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner’s contentions are, at this stage, unavailing because Patent Owner’s proffered definition of a POSA is too restrictive. Petitioner’s proposal is sufficiently comprehensive to encompass the prior art relevant to the ’600 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not be an expert in hyaluronidases. See Pet. 16. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases.” slip op. at 8

    • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner

      “refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 48:38–53 (emphasis added). Based on this express definition, the current record does not support the interpretation of Dr. Triggs-Raine that the “term ‘modified PH20 polypeptide,’ therefore, has a purely structural meaning in the context of the specification.” Ex. 2001 ¶ 68.4 Indeed, when reproducing the definition from this column of the ’600 patent, Dr. Triggs-Raine does not include any text after the first period, but the ’600 patent text continues to detail specific elements required including a requirement that replacements in the PH20 polypeptide are permitted “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 48:44‒46. On this” slip op. at 13

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner

      “on the ’429 patent, and there is no evidence of record that the Examiner meaningfully considered the relevant disclosures of the ’429 patent. We find unpersuasive Patent Owner’s reliance on the Examiner’s issuance of an office action with a written description rejection over a different issue that also included some double patenting rejections. As to Becton, Dickinson Factor (e), “whether Petitioner has pointed out sufficiently how the [E]xaminer erred in its evaluation of the asserted prior art,” Petitioner provides persuasive evidence of Examiner error. See Pet. 36–39 (citing Ex. 1009, 21–27). We agree with Petitioner that the Examiner overlooked the written description requirement with regard to claim 1. As discussed below, we find that, on the current record, the evidence sufficiently shows that it is more likely than not that the claims fail to comply with the written description requirement. See Section X. We, thus, find that the Examiner erred by either overlooking, or failing to appreciate, the factual underpinning necessary to support a written description for the breadth of an enormous genus claim such as claim 1 of the ’600 patent.” slip op. at 22

    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “XIII. CONCLUSION Petitioner has, at this stage, established that it will more likely than not prevail in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. XIV. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a) post grant review of claims 1–4 and 8–21 of the ’600 patent is hereby instituted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 324(d) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; and” slip op. at 60

    Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 11,952,600
  • PTAB · May 28, 2025 · IPR2024-00235 · APJ Carl M Defranco · IPR · Final written decision

    Claims 1–6, 8, 10, and 14–16 are unpatentable as anticipated by Young and obvious over Young and Norrie; the Johnson and Belk ground was not reached.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Provisur proposes that one of ordinary skill in the art would have had: (1) a bachelor’s degree (or equivalent) in mechanical engineering (or a similar field) and at least two years of experience working as an engineer (or similar role) on food processing and/or packaging systems (or in a similar field); or (2) at least seven years of experience working as an engineer (or similar role) on food processing and/or packaging systems (or in a similar field). Pet. 12. Weber does not contest Provisur’s framing of the level of ordinary skill in the art. See generally PO Resp. There being no dispute, we adopt Provisur’s definition of the level of skill in the art.” slip op. at 5

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

      “Provisur construes the claim terms “according to their plain and ordinary meanings as understood by a [person of ordinary skill in the art] in view of the specification and prosecution history” and posits that “[n]o terms require an explicit construction to resolve the unpatentability controversy between the parties here.” Pet. 13. Weber appears to agree, stating in the related district court action that “most of [its] patent claims are plain and ordinary . . . [t]hey’re not difficult or complex claims or claim terms.” Ex. 3 US 5,514,032, issued May 7, 1996 (Ex. 1004, “Young”). 4 US 4,979,269, issued Dec. 25, 1990 (Ex. 1005, “Norrie”). 5 US 6,929,540 B2, issued Aug. 16, 2005 (Ex. 1006, “Johnson”). 6 US 6,198,834 B1, issued Mar. 6, 2001 (Ex. 1007, “Belk”). 1028, 5. This being the case, we do not find the need to expressly construe any claim terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (confirming that the Board need not construe claim terms where their construction is not material to the dispute).” slip op. at 5

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

      “without first determining how much fat existed to begin with, i.e., prior to the side of meat being trimmed. But, as Provisur correctly notes, Weber ignores what one skilled in the art reasonably would have understood from reading Young’s disclosure as a whole. See Pet. 30–36 (citing Ex. 1003 ¶¶ 104–106, 109–112); Pet. Reply 2–12. When that is done, one skilled in the art would have understood that a necessary premise of Young’s determination of the thickness of fat to remain on the loin is knowing the thickness of the fat to begin with, which Young’s imaging system 190 and imaging processing routine 240 determine by first analyzing a series of “fat/lean separation lines” and “edge lines” in the side of meat being trimmed. Pet. 30–32 (citing Ex. 1004, 17:34–62, 18:33–56, 22:53–24:38, Figs. 2, 13); Pet. Reply 3–7 (citing portions of same evidence). More specifically, as described in Young (and articulated by Provisur), the side of meat is placed fat side down on a product support, i.e., platen 20. See Ex. 1004, 7:16–21, Figs. 1, 2. Using several cameras—top plan camera 196, end view camera 197, and fat line camera 198—Young’s imaging system 190 acquires multiple images of the side of meat from various angles and under various lighting conditions to “provide image data regarding each side of [meat].” See id. at 17:34–18:56. That image data is then used by Young’s image processing routine 240 to generate a series of demarcation lines on the side of meat, including: (1) fat/lean separation lines (representing the interface between the loin meat and the fat layer along top, side, and end views of the meat product; and (2) edge lines (representing lines along the outer surface of the meat product). See id. at 22:53–23:67, Figs. 10, 13 (Blocks 242, 246, 250, 254). In addition, “a plurality of points (preferably 20) are generated for each of the fat/lean separation and edge lines using known pattern matching routines.” Id. at 23:28–30, Fig. 13 (Blocks 244, 248, 252, 256); see also id. at 23:61–63 (essentially same). The fat/lean separation and edge lines (and points therein) generated by Young’s image processing routine 240 are then used to calculate certain dimensions and characteristics of the side of meat, such as height, length, and width. Id. at 24:10–22, Fig. 13 (Block 258). As Provisur’s expert credibly testifies, one skilled in the art would have understood that the dimension from the fat/lean separation line to the edge line along the outer surface represents the thickness of fat cover on the side of meat, i.e., before the fat is trimmed. See Ex. 1003 ¶ 106. Insofar as how that dimension is used, Young states that controller 172 uses “dynamic (real time) image data” of the fat/lean separation and edge lines “to dynamically modify the cutting profile of the loin knife assembly 100 so that the assembly follows a fixed distance from the separation line to provide the optimum fat cover for the loin.” Ex. 1004, 18:32–45; see also id. at 17:48–52 (describing “real time processor” for “image processing routines”). Notably, according to Young, the “fixed distance” represents the “desired” thickness of fat that remains on the loin, after trimming, and “sufficiently keeps the loin from drying out, but doesn’t make the loin look too fat,” although “[o]ther fat thicknesses may be desired in the alternative.” Id. at 20:60–66; see also id. at 10:39–42 (“Through control of the knife blade along several axes, assembly 100 preferably produces an optimum separation between loin and belly, with a desired fat covering left on the loin.” (emphases added)). Because the desired thickness of fat cover is what remains on the loin” slip op. at 9

    • Strike new argumentNew argument consideredDecided for patent owner

      “argument that Weber considers vital to its dispute of Provisur’s showing for the claimed fat thickness determination. During oral hearing, Weber repeatedly argued that Provisur changed theories midstream, i.e., between the time of the petition and the hearing. See Hrg. Tr. 22:18–24:47; see also id. at 31:14–22, 33:8–18, 34:16–20, 49:17–50:15, 54:16–56:25 (repeating same argument). More specifically, according to Weber, Provisur originally relied only on image data from Young’s “top view” camera as processed in “block 246” of Young’s image processing routine 240 when showing how Young meets the claimed fat thickness determination, whereas now Provisur relies on image data from Young’s “end view” cameras as processed in “Block 254.” Compare PO Sur-Reply 3–6 (focusing on Young’s “top view camera” in “block 246”), with Hrg. Tr. 27:4–16 (“[Block] 246, which is what they relied on, is processing images from the top-view camera in Young’s system. It is generating lines from the top-view camera in Young’s system. What they are newly trying to rely on today, for the first time, is Block 254 that is discussed toward the bottom of column 23 in Young, and that analyzes different images from a different camera. It is the end camera. It generates different lines. It demonstrates an end fat/lean line and an end edge line. Prior to today’s hearing, neither Petitioner, nor its expert, had ever discussed Block 254. You will not find a single reference to 254 in their papers, nor have they discussed the end edge line. It is completely new today. It finds absolutely no support in the record.” (emphases added)). We disagree with Weber’s contention. As shown and described in the petition, Provisur relies on more than simply Young’s “top view” camera and “block 246.” See Pet. 29–31. Rather, in its petition, Provisur annotates Young’s Figure 2 to show that image data from all three cameras of “imaging system 190”—“top plan camera 196, end view camera 197, [and] fat line camera 198”—play a role in the determination of fat thickness.8 Id. at 30. Moreover, Provisur cites the entire process depicted in “Figure 13” and described in columns “22:53–24:38” of Young as critical to the determination. Id. at 31. Those cited portions of Young involve not only the analysis of fat/lean and edge lines from “top view” images (block 246), but also the analysis of fat/lean and edge lines from “end view” images (blocks 250 and 254). See Ex. 1004, 23:12–24:13. In other words, Provisur’s showing for the claimed fat thickness determination is based on Young’s collective analysis of all those images. Indeed, Provisur’s expert confirms as much when confronted by Weber on cross-examination— Q. How does [Young] use the other cameras to identify that fat/lean separation line? A. Again, this is a -- this is a three-dimensional product that’s not regular, and all the views basically are needed to be able to describe that complex three-dimensional shape, so that the knife will be able to cut at that -- at that line, offset by whatever desired thickness there is, on that three-dimensional shape. Ex. 2006, 25:15–27:19 (emphasis added). 8 Indeed, contrary to Weber’s assertion, Provisur highlights “fat lean separation camera 198,” not top view camera 196, as most critical to the determination of fat thickness. Pet. 31. In the end, we reject the notion that Provisur changed theories” slip op. at 12

    Patent outcomesUS 8,529,321 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousness
    Patents in suitUS 8,529,321
  • PTAB · May 23, 2025 · IPR2025-00196 · APJ Ryan H Flax · IPR · Institution

    The Board instituted IPR on claims 1–16 under both § 103 grounds, finding a reasonable likelihood that at least one claim would have been obvious over Best-2008 and Osada.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied

      “Under our current guidance, the filing of a Sotera-type stipulation is not conclusive, but remains “highly relevant” and will be considered “as part of [our] holistic analysis” here. See Guidance Memo. Whether Petitioner has other bases for invalidating the ’457 patent, such as the CarnoJet prior art product identified in the district court, is not a consideration here if such bases could not be asserted in this proceeding (and are not being used to argue over the asserted prior art here as a loop hole from the stipulation, of which there is no evidence).” slip op. at 15

    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “satisfied that Petitioner has met its burden for institution. No argument by Patent Owner persuades us otherwise. Petitioner has shown that each limitation and element of claim 1 is taught or suggested by the combination of Best-2008 and Osada. Moreover, Petitioner’s asserted reason to combine the references is supported by the references’ disclosures: Best-2008 suggests filtration of its coolant is desirable, but provides no specific means for doing so; Osada teaches a way of filtering fluid from an open-top tank, similar to Best-2008’s.” slip op. at 42

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “A POSITA[12]in the field of the ’457 patent at the time of the earliest possible effective filing date (December 14, 2012) would have had Bachelor of Science degree in mechanical or chemical engineering and at least two years of experience relating to the design and/or implementation of fluid circulation systems involving application of fluid dynamics and heat transfer principles. Additional education may serve as a substitute for a lack of experience and vice versa. (Ex-1003- Dahm at ¶¶36-41, 63-70.) Pet. 18–19. Patent Owner applies this same definition. Prelim. Resp. 6–7. At this stage of the proceeding, we accept and use Petitioner’s proposed and unopposed definition of the ordinarily skilled artisan. It appears that Petitioner’s proposed definition comports with the level of skill in the art reflected in the prior art of record and the ‘457 patent, itself. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art” slip op. at 20

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

      “Although either of the district court proceedings’ definitions of the term “weir” appears to accurately describe the feature, at this stage of the proceeding, we do not find it necessary to expressly interpret this claim language.” slip op. at 23

    Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · Graham
    Patents in suitUS 10,405,457
  • PTAB · May 16, 2025 · IPR2024-01487 · APJ Julia Heaney · IPR · Institution

    The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood that claim 1 would have been obvious over Nakazawa and Glaug.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “Institution of an inter partes review is authorized by statute when “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.” 35 U.S.C. § 314(a). Upon consideration of the Petition in view of the record at this stage, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. We also determine that the arguments and evidence of record do not support discretionary denial of the Petition under 35 U.S.C. § 314(a). Accordingly, we grant institution of an inter partes review of all claims and all grounds asserted in the Petition.1” slip op. at 2

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted

      “person of ordinary skill would modify either Nakazawa’s diffusion sheet or Glaug’s fluid acquisition system, but rather Petitioner argues “various layers in absorbent articles are invariably interchangeable.” Prelim. Resp. 41–42. Contrary to Patent Owner’s argument, as discussed above, Petitioner explains why and how a person of ordinary skill would modify Nakazawa’s diffusion sheet, and provides reasons for doing so. On this record, we find Petitioner’s reasoning sufficient.” slip op. at 24

    • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

      “Patent Owner further argues Nakazawa teaches away from Petitioner’s asserted modification in which Glaug’s lower non-perforated layer is added to Nakazawa’s diffusion sheet. Prelim. Resp. 42. Specifically, Patent Owner argues Nakazawa teaches that its embodiment in which the second absorbent material is wrapped in a hydrophilic sheet has the advantage of preventing leakage of super absorbent polymer (“SAP”) from the second absorbent material without impeding permeation of excretory fluid through the hydrophilic sheet. Id. at 43 (citing Ex. 1008 ¶ 85, Fig. 15). Patent Owner further relies on Petitioner’s argument that Nakazawa’s hydrophilic layer is analogous to the lower non-perforated layer in Glaug. Id. (citing Pet. 93–94). Therefore, Patent Owner argues, Nakazawa teaches that Glaug’s fluid acquisition system would impede permeation of fluid rather than promote it. Id. Patent Owner’s teaching away argument is unavailing based on the current record. Patent Owner improperly relies on Petitioner’s contention in its anticipation challenge based on Nakazawa, and characterizes it as an argument about Glaug. As further discussed in Section II.G below, Petitioner’s anticipation challenge is based on analogizing Nakazawa’s hydrophilic sheet to a core wrap feature identified in Patent Owner’s infringement contention in parallel district court litigation. See Pet. 92–93. Contrary to Patent Owner’s argument, Petitioner’s obviousness contention does not argue Nakazawa’s hydrophilic layer is analogous to Glaug’s nonperforated fibrous layer. Because Patent Owner is not properly characterizing Petitioner’s obviousness contention, Patent Owner’s teaching away argument is not persuasive.” slip op. at 24

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied

      “Under Fintiv, we consider the following factors: 1. whether the court granted a stay or evidence exists that one may be granted if a proceeding is instituted; 2. proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision; 3. investment in the parallel proceeding by the court and the parties; 4. overlap between issues raised in the petition and in the parallel proceeding; 5. whether the petitioner and the defendant in the parallel proceeding are the same party; and 6. other circumstances that impact the Board’s exercise of discretion, including the merits. Fintiv at 5–6.” slip op. at 35

    Claim construction§ 103 obviousnessDiscretionary denialcites KSR · Graham
    Patents in suitUS 9,308,138
  • PTAB · May 15, 2025 · IPR2025-00033 · APJ Susan L C Mitchell · IPR · Institution

    The Board denied institution of IPR on claims 1–13 under § 314(a), finding the Fintiv factors favored denial and the petition did not present compelling merits.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied

      “We determine that this factor weighs heavily in favor of exercising discretion to deny the Petition. The trial date in the district court litigation is scheduled for October 6, 2025. See Prelim. Resp. 16 (citing Ex. 2010). This date is at least six months before our projected statutory deadline should we go forward in this case. Patent Owner points out that this trial date is nine months later than the median time to trial in the District of Delaware, and in Patent Owner’s view, the parties are on track to satisfy the current schedule. Id. at 16–17 (citing Ex. 2011).” slip op. at 9

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached

      “1 Patent Owner also asserts that the Petition should be denied under 35 U.S.C. § 325(d), but we need not reach this issue because we are exercising discretion under Section 314(a) to deny the Petition. See Prelim. Resp. 2–3.” slip op. at 2

    Discretionary denial
    Patents in suitUS 11,744,802
  • PTAB · May 1, 2025 · PGR2024-00009 · APJ Sheridan K Snedden · PGR · Final written decision

    Claims 1–8, 12, and 20 are unpatentable for lack of written description under § 112(a); the Board did not reach the enablement, anticipation, or obviousness grounds.

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986).” slip op. at 10

    • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

      “used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.200(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). Moreover, “claim terms need only be construed ‘to the extent necessary to resolve the controversy.’” See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). The parties agree that the preamble of the claims should be limiting and that the terms “optionally substituted fused heterocyclic ring system” and “irreversible” BTKIs should be construed consistent with the definitions provided in the Specification. Pet. 42–45; see also id. at 42 (citing Ex. 1001, 19:57–20:7 (defining “optionally substituted” or “substituted”), 14:51–52 (defining “fused”), 15:66–16:21 (defining “heterocycle”), 14:36–44 (defining “ring” and “ring system”), 26:23–25 (defining “irreversible Btk inhibitor”); PO Resp. 26.” slip op. at 14

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner

      “used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.200(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). Moreover, “claim terms need only be construed ‘to the extent necessary to resolve the controversy.’” See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). The parties agree that the preamble of the claims should be limiting” slip op. at 14

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable

      “To satisfy written description for the claimed genus of iBTKIs, the Specification must describe either a representative number of members of the genus or structural features common to the members of the genus with enough precision that a POSA can visualize or recognize the members of the genus. See Ariad, 598 F.3d at 1350. Patent Owner concedes that the Specification does not describe a representative number of members of the genus, stating “this is a common structural features case.” Tr. 65:25–66:3. We, therefore, focus our analysis on whether the Specification adequately describes common structural features of the genus. We find that it does not.” slip op. at 30

    Patent outcomesUS 11,672,803 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
    Patents in suitUS 11,672,803
  • PTAB · May 1, 2025 · IPR2025-00136 · APJ Jeffrey N Fredman · IPR · Institution

    Institution of inter partes review was denied for claims 1–10 because Petitioner did not establish a reasonable likelihood of prevailing on any asserted ground.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

      “Accordingly, we find that on the current record Petitioner has not shown that it has a reasonable likelihood that it would prevail on these obviousness grounds. XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5. XIII. CONCLUSION After reviewing the information presented in the Petition and the Preliminary Response, we determine that, based on the evidence of record, Petitioner has not established a reasonable likelihood that claims 1–10 of the ’841 patent are unpatentable. XIV. ORDER Accordingly, it is ORDERED that, pursuant to 35 U.S.C. § 314(a), institution of an inter partes review of all challenged claims on all grounds presented in the Petition is denied.” slip op. at 35

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable

      “However, neither Petitioner nor Dr. Jansky provide specific data on the record before us showing the actual measured homozygosity of either of the inbred lines, US-W 5309 and US-W 5315. And Phumichai experimentally demonstrates that Dr. Jansky’s assumption that theoretical heterozygosity reduction of 50% per generation is not necessarily accurate, stating the “observed average percentage of reduction of heterozygosity per generation (38.4% or 38.5%) was lower than the theoretically expected value of 50%.” Ex. 1005, 982. Indeed, Phumichai disclosed that the “SOPH [Section-based observed percentage of heterozygosity] decreased steadily from the original 100% in 99H2–1 (S0) to the family means of 62.4% in 3H2 (S1), 37.9% in 3H3 (S2).” Id. at 981. That is, Phumichai experimentally shows that in an S2 generation of a potato line, the heterozygosity was 37.9%, resulting in homozygosity of about 62.1%, below the 75% theoretically expected and the 75% required by claim 1 of the ’841 patent. Therefore, the evidence of record does not show that the S2 generation of potato lines in Jong necessarily satisfies the homozygosity recitation in claim 1 of the ’841 patent, and so cannot establish on the record before us that Jong inherently teaches this limitation.” slip op. at 15

    • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedNot shown unpatentableNot shown unpatentable

      “Owner is telling. Petitioner does not refute Patent Owner’s evidence of objective indicia. On the current record, the objective indicia evidence is compelling. As to long felt need, Patent Owner cited evidence on record before the Examiner that showed a persistent need recognized by ordinarily skilled artisans. In re Gershon, 372 F.2d 535, 538 (CCPA 1967). For example, Dr. Huang states “This research is the breakthrough we have been waiting for since nearly a century . . . This is crucial for the potato breeding worldwide.” Ex. 2009, 687. There is no evidence that this long-felt need was satisfied by another before Appellant’s invention. See Newell Companies, Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988) (“[O]nce another supplied the key element, there was no long-felt need or, indeed, a problem to be solved . . . .”). Lastly, Dr. Lindhout explains that this invention satisfies the long-felt need, stating “I have discovered, and disclosed in the present application for patent, how a fertile homozygote in” slip op. at 33

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached

      “XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5.” slip op. at 35

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 11,140,841
  • PTAB · Apr 25, 2025 · IPR2024-01463 · APJ David Cotta · IPR · Institution

    The Board instituted inter partes review of claims 1–10 on all asserted grounds, finding a reasonable likelihood of success on at least one claim.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner

      “predict how the district court in the related district court litigation will proceed because the court may determine whether or not to stay any individual case . . . based on a variety of circumstances and facts beyond our control and to which the Board is not privy.” Sand Revolution II LLC v. Cont’l Intermodal Grp., IPR2019-01393, Paper 24, 7 (PTAB June 16, 2020) (informative). We decline to speculate on how the court may rule on the pending motion to stay. Accordingly, this factor is neutral.” slip op. at 13

    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “Under 35 U.S.C. § 314(a), inter partes review may not be instituted unless 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.” Petitioner has established a reasonable likelihood of prevailing on its assertion that at least one of the challenged claims is unpatentable based on the grounds advanced here. We decline to deny the Petition on a discretionary basis as requested by Patent Owner. Thus, for reasons explained below, we institute inter partes review of claims 1–10 of the ’706 patent.” slip op. at 2

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted

      “TC(220), and ΔRz/Ra are result effective variables and that copper foils having ΔPD, TC(220), and ΔRz/Ra values that meet the values recited in claim 1 have advantageous properties. See, e.g., Ex. 1005 ¶ 45 (Kim ’761, disclosing that preferably the “difference in peak count roughness Rpc between the shiny surface . . . and the matte surface . . . of the electrolytic copper foil . . . is preferably 60 or less” because “when the difference in the peak count roughness Rpc exceeds 60 capacity maintenance of the secondary battery is deteriorated.”);15 Ex. 1007, 3:16–23, 4:14–23 (Cheng, disclosing that the foils of Cheng’s invention have (220) and (311) surfaces that provide increased elongation and that solve a high roughness problem that rendered traditional products unsuitable for use in a lithium ion secondary battery), 10:27–34 (Cheng, disclosing that in the foils of Cheng’s invention “the roughness difference between both sides was extremely small” and thus “it was . . . not easy for the electrolytic copper foil to break or fracture during the charging-discharging cycles and the life of a battery is thus increased”), Tables 3 & 4 (Cheng, disclosing embodiments and comparative examples with TC(220) values meeting the requirements of claim 1); Ex. 1008, 6:36–44 (Wolski, disclosing that “the surface roughness Rz at the matte side of the untreated copper foil of the present invention is the same or smaller than the surface roughness Rz at the shiny side . . . so that the surface treated copper foil . . . becomes more low-profiled . . . whereby it becomes a foil having a large etching factor”), 9:1–29 & Table 2 (Wolski, disclosing 15 Dr. Randall testifies that “Kim ’761’s peak count roughness Rpc corresponds to the peak density PD of the ’706 patent.” Ex. 1003 ¶ 52. At this stage in the proceeding, this testimony is unrebutted. 38 embodiments meeting the ΔRz/Ra of claim 1, describing them as having “matte side roughnesses” that are “sufficiently small,” and as having “excellent” “high temperature elongation characteristics”), 11:37–41 (Wolski, describing comparative examples as having “large” matte side roughnesses “whereby etching factors are not good”), 12:12–27 (Wolski, teaching that “as compared with a conventional untreated copper foil, both surfaces of the untreated copper foil obtained by [Wolski’s] invention are flat” resulting in a low profile foil that has “excellent elongations at room temperature and high temperature and also high tensile strength”). The teachings in the prior art support the presently unrebutted testimony of Dr. Randall explaining why the POSA would have been motivated to modify Kim ’761’s copper foil to have the claimed TC(220) and ΔRz/Ra. Ex. 1003 ¶¶ 66–68, 71–74; Pfizer Inc., v. Sanofi Pasteur Inc., 94 F.4th 1341, 1348 (Fed. Cir. 2024) (“Where [a gap in prior art] includes a parameter not necessarily disclosed in the prior art, it is not improper to consider whether or not it would have been recognized as result-effective. If so, then the optimization of that parameter is ‘normally obvious.’”). Accordingly, we are not persuaded by Patent Owner’s argument that Petitioner failed to articulate a sufficient motivation to combine the references. To the contrary, the preliminary record presents a strong showing that the POSA would have been motivated to combine the references in the manner described in the Petition.” slip op. at 38

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “At this stage of the proceeding, Patent Owner does not contest Petitioner’s definition of the level of skill in the art. Prelim. Resp. 4 (“For purposes of this Preliminary Response, Patent Owner applies Petitioner’s level of skill for a person of ordinary skill in the art”). Petitioner’s definition appears to be consistent with the field of the invention reflected in the prior art of record and the disclosure of the ’706 patent. Accordingly, for purposes of this Decision, we adopt Petitioner’s proposed definition of the person of ordinary skill in the art.” slip op. at 21

    Claim construction§ 103 obviousnessDiscretionary denialcites KSR · Graham
    Patents in suitUS 11,591,706
  • PTAB · Apr 25, 2025 · IPR2024-01419 · APJ Susan L C Mitchell · IPR · Institution

    The Board instituted IPR of claims 1–9 on all asserted grounds, finding a reasonable likelihood that claim 1 is anticipated by Chee.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “We analyze the asserted grounds of unpatentability in accordance with these principles to determine whether Petitioner has met its burden to establish a reasonable likelihood of success at trial.” slip op. at 13

    • BurdenDecided for petitioner

      “Having considered the parties’ positions and evidence of record, summarized above, we determine that the information presented in the Petition establishes that Petitioner has shown sufficiently a reasonable likelihood of succeeding with respect to at least claim 1 challenged in Ground I. Petitioner provides sufficient support on the record before us to provide a reasonable likelihood of succeeding in showing that claim 1 is anticipated by Chee.” slip op. at 18

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionNo construction neededDecided for petitioner

      “tags,” and “locus of origin” need be addressed at this stage of the proceeding. We determine that no express construction of “consensus base call” is necessary to determine whether to institute inter partes review. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). 1. “Set of [Unique] Differentiator Tags” Petitioner asserts that both “set of differentiator tags” as used in claim 1 and “set of unique differentiator tags” as used in claim 9 should be given the same construction—“set of prepared tags where each tag includes a unique sequence as compared to the other tags.” See Pet. 16 (citing Ex. 1005 ¶ 89; Ex. 1001, 28:25–29, 28:53–57). Petitioner further asserts that “[t]hese unique differentiator tags are associated with target nucleic acids so that each nucleic acid is uniquely identifiable.” Pet. 16. Petitioner also points to the prosecution history of the ’730 patent in which Petitioner asserts the Patent Owner argued and the Board acknowledged that each differentiator tag is unique. Id. at 16–17. Petitioner concludes that “[a]n interpretation of ‘differentiator tags’ to include non-unique tags is not possible, and if it were, Applicant disclaimed any interpretation that would allow non-unique tags.” Id. at 17.” slip op. at 7

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted

      “Having considered the parties’ positions and evidence of record, summarized above, we determine that the information presented in the Petition establishes that Petitioner has shown sufficiently a reasonable likelihood of succeeding with respect to at least claim 1 challenged in Ground I. Petitioner provides sufficient support on the record before us to provide a reasonable likelihood of succeeding in showing that claim 1 is anticipated by Chee.” slip op. at 18

    Claim construction§ 102 anticipation§ 103 obviousnesscites Graham
    Patents in suitUS 11,840,730

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.