• CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentable
  PTAB · Aug 13, 2026 · IPR2025-01531 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1, 3–6, and 8–14 are unpatentable as obvious; claims 2, 7, and 15 were not shown unpatentable because the prior art did not establish the claimed drug sequence.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner states that, for purposes of this proceeding, it does not dispute Petitioner’s proposed definition of a POSA. PO Resp. 8. Based on the entirety of the trial record, we adopt Petitioner’s proposed definition of a POSA’s skill level because it is consistent with the skill level reflected in the disclosures of the ’552 patent and prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 9

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “We decline to discount Dr. Oberstein’s opinion based on the alleged conflict of interest and bias. Dr. Oberstein testified that the consulting fees he receives from Patent Owner reflect a small fraction of his income. Ex. 1210, 402:21–403:9. We also agree with Patent Owner that an oncologist prescribing an FDA-approved regimen does not evince bias. See Sur-reply 23; see also Ex. 1206, 49 (showing NALIRIFOX is a category 1, NCCN-preferred first-line therapy for metastatic pancreatic cancer), 69 (explaining category 1 is based upon high-level evidence). Petitioner also contends that Dr. Oberstein “offers conclusory opinions,” “fails to properly apply the law, continues to look at each reference in isolation, refuses to acknowledge logical suggestions in the art, and imports new limitations into the claims.” Reply 3–4. We evaluate each piece of evidence, including Dr. Oberstein’s opinion, as it relates to our substantive patentability analysis, and accord it proper weight.” slip op. at 9

  • ExcludeMotion to exclude, deniedDenied

    “Petitioner, as the moving party, bears the burden of proving that the material sought to be excluded is inadmissible under the Federal Rules of Evidence. See 37 C.F.R. §§ 42.20(c), 42.62(a); see also Trial Practice Guide (“TPG”)15 § II.K (“A motion to exclude must explain why the evidence is not admissible.”). For the reasons explained below, we deny Petitioner’s Motion.” slip op. at 17

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.” 35 U.S.C. § 311(b). Whether a reference qualifies as a “printed publication” involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to the public. In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). A reference is publicly accessible upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence can locate it. Kyocera Wireless Corp. v. ITC, 545 F.3d 1340, 1350–51 (Fed. Cir. 2008). Conroy was published on May 12, 2011. Ex. 1003, 1. Conroy refers to Conroy Protocol (Ex. 1004), stating that “[t]he protocol, including the statistical analysis plan, is available with the full text of this article at NEMJ.org.” Ex. 1003, 3. When questioned whether he has “any reason to believe that the protocol would not have been provided on NEJM.org with this text when it was published,” Dr. Oberstein testified that “if they say they provided it, then I think they probably provided it.” Ex. 1210, 165:20–166:2. 17 Alternatively, to the extent necessary, under the circumstances of this case, we waive the requirement of § 42.63(b). See 37.C.F.R. § 42.5(b). In addition, Dr. Ratain testified that “most top journals require that the protocol be submitted at the time of initial submission, and it’s always published alongside any major paper.” Ex. 2073, 42:2–5. According to Dr. Ratain, “[c]ertainly, New England Journal of Medicine does that.” Id. at 42:6–7. We credit the testimony from both Dr. Oberstein and Dr. Ratain on this issue. Accordingly, we find Exhibit 1004 was publicly accessible at the same time Conroy was published. slip op. at 28

  Patent outcomesUS 11,344,552 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,344,552
• CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentable
  PTAB · Aug 13, 2026 · IPR2025-00505 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1, 3–6, and 8–14 are unpatentable as obvious over the first § 103 combination; claims 2, 7, and 15 were not shown unpatentable because the art did not support the claimed drug sequence.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that [t]he person of ordinary skill in the art (POSA) would have been an M.D. and/or Pharm. D who would have completed training in medical oncology, particularly in the field of gastrointestinal (GI) cancers, or a Ph.D. in clinical pharmacology, pharmaceutical sciences, pharmaceutics, and/or drug delivery, also particularly in the field of GI cancers, or their equivalents, along with at least 1-2 years of post-doctoral experience. Pet. 26 (citing Ex. 1002 ¶¶ 44–46). Patent Owner states that, for purposes of this proceeding, it does not dispute Petitioner’s proposed definition of a POSA. PO Resp. 8. Based on the entirety of the trial record, we adopt Petitioner’s proposed definition of a POSA’s skill level because it is consistent with the skill level reflected in the disclosures of the ’552 patent and prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 9

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “We decline to discount Dr. Oberstein’s opinion based on the alleged conflict of interest and bias. Dr. Oberstein testified that the consulting fees he receives from Patent Owner reflect a small fraction of his income. Ex. 1210, 402:21–403:9. We also agree with Patent Owner that an oncologist prescribing an FDA-approved regimen does not evince bias. See Sur-reply 23; see also Ex. 1206, 49 (showing NALIRIFOX is a category 1, NCCN-preferred first-line therapy for metastatic pancreatic cancer), 69 (explaining category 1 is based upon high-level evidence). Petitioner also contends that Dr. Oberstein “offers conclusory opinions,” “fails to properly apply the law, continues to look at each reference in isolation, refuses to acknowledge logical suggestions in the art, and imports new limitations into the claims.” Reply 3–4. We evaluate each piece of evidence, including Dr. Oberstein’s opinion, as it relates to our substantive patentability analysis, and accord it proper weight.” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner

    “In the DI, the Board stated that the ordinary understanding of a claim reciting a “method of treating metastatic adenocarcinoma of the pancreas” that comprises “administering an antineoplastic therapy to the patient” in order “to treat the metastatic adenocarcinoma of the pancreas” is that the “treatment” would have more than a de minimis therapeutic benefit or efficacy for the patient being treated. DI 14. We, however, rejected the notion that the claims “would require some particular degree of clinical efficacy” because “the level of clinical efficacy is not a claim limitation.” Id.” slip op. at 12

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Not reached

    “The parties, however, disagree over whether each recited dose must be the starting dose. Petitioner argues that “claim 1 requires that the method of treatment is a first-line therapy, but does not require that the claimed doses be used as a starting dose.” Paper 51, 1. In contrast, Patent Owner argues that “[t]he specification describes that the recited dose of each drug is a ‘starting’ or ‘initial’ dose.” Paper 50, 2 (citing Ex. 1001, 13:38–45, 30:5–7). For purposes of this Decision, we do not need to resolve this dispute. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating that claim terms need only be construed to the extent necessary to resolve the controversy). As explained below, we agree with Petitioner that, even if claim 1 recites the starting dose for each drug, Petitioner has shown, by a preponderance of the evidence, that the prior art teaches each dose and a POSA would have had a reason to start with the recited doses. See infra Section II.G.3; Paper 51, 3 n.2. Because we find that the prior art teaches or suggests the claimed subject matter even under Patent Owner’s proposed narrower claim interpretation, we need not further construe the disputed claim language.” slip op. at 16

  Patent outcomesUS 11,344,552 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,344,552
• Preomics GmbH / Biognosys AG. v. The Brigham And Women’S Hospital, Inc.Some claims unpatentable
  PTAB · Mar 23, 2026 · IPR2024-01473 · APJ Michael A Valek · IPR · Final written decision

  Claims 1, 4, 6, 17, 22, and 25 are unpatentable as anticipated by and obvious over Cai; claims 2, 3, 7, 23, and 24 were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We disagree with Patent Owner and again find Petitioner’s description of the level of ordinary skill in the art sufficient for the reasons explained in the Decision on institution. See Dec. 8–10. As explained before, the formal training required by Petitioner’s description of a POSA includes understanding of both proteins and analytical techniques for studying them. See Dec. 9. Neither Patent Owner, nor its declarant, Dr. Cimas, clearly articulates a competing POSA description at trial, but both suggest more formal training, e.g., a graduate degree, is required. See Resp. 65–66; Ex. 2023 ¶ 8 (agreeing with our observation that the educational backgrounds of the inventors and authors of Cai, Zaccaria, and Hu “suggests that a graduate degree is more typical for a POSA”) (quoting Dec. 9, n. 5). Even if we were to accept that modification, it would not change our findings herein. Nor does it suggest that Dr. Vargas, who holds a Ph.D. in chemistry from Stanford University and has substantial experience with mass spectrometry and other analytical techniques, is unqualified to testify from the perspective of one of ordinary skill in the art. See Ex. 1004 (Vargas CV). Accordingly, our findings and conclusions would be the same, even assuming the perspective of a POSA possessing the higher level of formal training and specific proteomics experience that Patent Owner suggests is appropriate here.5” slip op. at 9

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

    “Ex. 1001, 20:33–39. As Petitioner points out, the first sentence in this passage does not define the term “biological sample,” but rather the term “sample.” Id. According to that sentence, the term “sample” refers to either “a biological sample or a complex biological sample obtained from a subject.” Id. (emphasis added). Patent Owner’s argument assumes, without explanation, that the phrase “obtained from a subject” modifies both instances of “biological sample” in the first sentence. Id. But it need not be read that way. Indeed, that sentence is more naturally read to define “sample” as one of two things––either a “biological sample” or a “complex biological sample” with only the latter being “obtained from a subject.” Id. In addition, the second sentence in the passage above supports Petitioner’s view that the term “biological sample” is not limited to a sample obtained directly from a subject. It provides a broad, non-exhaustive list of “[s]uitable biological samples” that specifically includes the types of biological samples, i.e., “cell lysates,” “systemic blood,” “plasma,” assayed in Petitioner’s cited references. Ex. 1001, 20:36–39. It also lists as an example “processed tissue samples,” which would include samples that have been modified (i.e., “processed”) from the form in which they were originally obtained. Id.; see also Ex. 1001, 20:52–57 (describing tissue processing). Given this broad description, we agree with Petitioner that there is no basis in the cited intrinsic evidence for reading in the “negative limitations” Patent Owner seeks to try to distinguish the particular biological samples assayed in Cai, Hu, and Zaccaria. See Reply 3–4.” slip op. at 12

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner

    “We agree with Petitioner. Step 1(a) recites forming coronas around a plurality of particles of “different particle types.” Ex. 1001, 86:53–60. Step 1(b) recites separating a “subset of the plurality of the particles comprising the coronas.” Id. at 86:61–65. As Petitioner correctly observes, as a matter of ordinary English parlance, “there is no requirement whatsoever that the ‘subset’ have all of the same characteristics as the set from which it is separated.” Reply 10. By way of analogy, consider a jar containing a plurality of coins of different coin types, e.g., nickels and dimes. One can separate out a “subset” of that plurality of coins (plural) by removing any two coins from the jar—this is true even if the two coins are both nickels or both dimes. In the same way, nothing in the ordinary meaning of the claim language requires the subset in step 1(b) to include particles with coronas representative of each of the different particle types in step 1(a). Nor has Patent Owner identified any other evidence that supports its attempt to read such a requirement into the claims. See Resp. 16, 18 (citing expert testimony that is not inconsistent with the broader, ordinary meaning of the claim language and, even if it was, would not be a proper basis for limiting the same). For these reasons, we reject Patent Owner’s interpretation of “a subset of the plurality of particles comprising the coronas” in step 1(b) as limited to a subset of each type of particle comprising the coronas formed in step 1(a).” slip op. at 15

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

    “We credit Petitioner’s showing above and agree that Cai discloses a method comprising all of the steps in claim 1. Beginning with step 1(a), Cai discloses contacting two different particle types, i.e., MWCNT and CB, with HeLa cell lysate (i.e., a biological sample) to form protein coronas around those particles. Ex. 1003 ¶¶ 199–206; Ex. 1005, Abstr. (describing MWCNT and CB as distinct “forms of carbon nanoparticles” that bind “vastly different sets of proteins”). Cai’s results show the coronas formed around the MWCNT and CB particles comprise overlapping and distinct proteins as recited in step 1(a). Ex. 1003 ¶¶ 216–222; Ex. 1005, 587 (“a small number of CB-binding proteins also bind to MWCNTs”). A subset of the proteins from the coronas on these particles is then prepared by eluting the bound proteins and analyzing them with SDS-PAGE in a MWCNT and CB “pull-down,” which reads on step 1(b). Ex. 1005, 586 (Fig. 1A–B depicting scheme for “pull-down experiment” and describing other “pull-down experiments” used with SILAC media in Fig. 3), 588 (Fig. 3). Regarding step 1(c), Cai discloses assaying the proteins in those subsets using LC-MS/MS with SILAC encoding to characterize and quantify the relative abundance of the proteins that bind to each type of particle.11 Ex. 1003 ¶¶ 225–229; Ex. 1005, 586–587 (describing “systemic characterization of carbon nanoparticle-protein corona”), 588 (Fig. 3). Cai’s results show “the relative abundance of the MWCNT-binding proteins spread over 8 orders of magnitude” and that “some of the proteins with the highest binding efficiencies” are actually “low abundance proteins” in the lysate, meaning that that Cai’s method selectively enriches such proteins for detection. Ex. 1005, 587. We credit Dr. Vargas’s testimony that these results demonstrate that Cai’s method achieves the “dynamic range” recited in step 1(c). Ex. 1003 ¶¶ 225–229.” slip op. at 23

  Patent outcomesUS 11,435,360 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,435,360
• Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Ouraring, Inc.Some claims unpatentable
  PTAB · Nov 25, 2025 · PGR2024-00030 · APJ Linda E Horner · PGR · Final written decision

  Claims 17 and 18 are unpatentable under §112(d) for improper dependent form; claims 1–10 and 12–16 were not shown unpatentable on the asserted obviousness grounds.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “We do not credit Dr. Anthony’s testimony, which is based on the arbitrary shading in Figure 7 (see Ex. 1002 ¶ 174), that Schröder teaches or suggests limitation 1[d] because it (1) is inconsistent with Petitioner’s reasoning for limitation 1[c], and (2) it is based on an admitted misreading of the embodiment of Schröder’s Figure 5 (see Ex. 1002 ¶ 175). As to the first item, Dr. Anthony states that “a POSITA would have been motivated to place a battery in a part of the cavity that is far from a PCB holding other electrical components because that configuration allows for better thermal management.” Ex. 1002, para. 175. The problem with this statement is that Petitioner relies on Schröder’s teaching that inlay 12, i.e., the alleged PCB, could include “other electrical components,” such as a battery to support its position that Schröder suggests placing a battery between the ring halves. See, e.g., Pet. Reply 2 (pointing to Dr. Mercier’s depo testimony that inlay 12 with “other components” is inserted between ring halves); id. at 3 (relying on Schröder’s teaching about placing components in depressions on inlay 12). So, Petitioner earlier asserts for the battery limitation 1[c] that Schröder teaches or suggests putting a battery on inlay 12 inside the ring halves, but then for limitation 1[d], Dr. Anthony testifies that a POSITA would place the battery “far” away from the inlay 12 (i.e., the alleged PCB). These positions are inconsistent.” slip op. at 25

  • Skill levelSkill level board ownOther

    “at least a four-year degree in electrical engineering, mechanical engineering, biomedical engineering, optical engineering, or related field of study, or equivalent experience, and at least two years’ experience in academia or industry studying or developing physiological monitoring devices such as non-invasive biosensors. Pet. 8 (citing Ex. 1002 ¶¶ 18–22). Petitioner also contends that a person of ordinary skill would have been “familiar with, for example, sensor system design and signal processing” and that “[a] higher level of education or skill might make up for less experience, and vice versa.” Id. Patent Owner agrees with Petitioner’s proposed definition of a person of ordinary skill in the art. Resp. 26. We adopt this uncontested definition of the level of ordinary skill in the art. This definition is supported by the record and consistent with the disclosure in the ’178 patent and the references cited in the Petition.” slip op. at 10

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

    “Patent Owner indicates that in the related ITC proceeding involving the ’178 patent, the Administrative Law Judge (ALJ) adopted three constructions agreed-upon by the parties in that proceeding8 and also construed two disputed terms.9 Resp. 26–27 (citing Ex. 2016, 5, 6, 14). Patent Owner agrees with Petitioner, however, that no terms need to be construed to decide the issues raised in the Petition. Id. at 27. We reviewed the constructions adopted by the ITC. Ex. 2016, 5, 6, 14. 8 In the ITC proceeding, the ALJ adopted the parties’ agreed-upon constructions that: (1) the preamble of claim 1 [a finger-worn wearable ring device] is limiting; (2) [positioned/configured to fit] within a “cavity” is [positioned/configured to fit] within a “hollow space”; and (3) [the internal housing component] “coupled with” [the external housing component] is [the internal housing component] “connected with” [the external housing component]. Ex. 2016, 5. 9 In the ITC proceeding, the ALJ construed the claims such that: (1) the internal and external housing components of claims 1, 12, and 17 enclose space and do not necessarily exclude potting material; and (2) “circumferential,” as recited in claims 1, 17, and 18, does not require a closed shape. Ex. 2016, 14, 17. These constructions are not germane to the issues we need to decide to resolve this proceeding. Thus, we agree that no explicit claim construction is necessary for this decision. To the extent the parties’ arguments raise any implicit issues of claim construction, we address those issues within the context in which they are raised in our analysis below.” slip op. at 11

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable

    “The record supports Patent Owner’s argument that Mestas’s batteries are much too large to fit within a ring form factor, and “Mestas’s batteries, layout, and other components . . . would have to be scaled down 5 to 10 times to be appropriately sized for a finger worn ring.” Resp. 64 (internal quotation marks omitted) (citing Dr. Anthony’s cross-examination testimony at Ex. 2021, 313:12). Moreover, we do not credit Dr. Anthony’s testimony that miniaturization of the battery would have been “trivial to implement.” Ex. 1002 ¶ 242. Dr. Anthony admitted on cross-examination that it would not have been within the level of skill of a person having ordinary skill in the art to design a smaller version of Mestas’s battery, and that such a person would need to procure a battery of the appropriate size and specifications for implementation in a finger-ring from a battery manufacturer. Ex. 2021, 315:9–318:9. Yet Dr. Anthony had not ascertained, for purposes of his testimony, whether there was a battery available in 2013 that was appropriate to fit within the inlay space of the modified version of Schröder’s finger-ring that he and Petitioner allege would have been obvious to one of skill in the art at that time. Id. at 321:5–10. Further, we credit Dr. Mercier’s testimony that Dr. Anthony’s testimony fails to consider the differences in power requirements between Mestas and Schröder or to account for the constraints of such a substantially smaller form factor in Schröder’s finger-ring as compared to Mestas’s wrist device. Ex. 2018 ¶¶ 159–160. Although large curved batteries suitable for use in a wrist band or other larger wearable device, such as shown in Mestas, were known at the time of the ’178 patent, we also have evidence that prior art “finger ring wearables up to the ’178 patent had used ‘coin’ type batteries.” Id. at 66 (citing Ex. 2018 ¶ 161). We credit Dr. Mercier’s testimony that a person having ordinary skill in the art would look to a coin type battery for the necessary power requirements of Schröder’s device. Ex. 2018 ¶ 161. Indeed, this testimony is consistent with the other art of record that consistently shows the use of flat batteries in finger-ring devices, often stacked above and protruding from the general ring shape of the device. See, e.g., Ex. 1005 (Niwa), Figs. 22, 28; Ex. 2025 (Asada ’701 patent), Fig. 4; Ex. 1035 (Rhee), Figs. 7-1, 8-1, 8-2; Ex. 1037 (Asada article), Fig. 9; Ex. 1034 (Asada ’199 patent), Fig. 2; Ex. 1028 (Kimura), Fig. 24; Ex. 2018 ¶¶ 61–70. In fact, Oura’s first-generation ring design, released in 2015, used a Superbowl ring-type design, with the battery and other components mounted on top of the ring. Ex. 2034; Ex. 2018 ¶ 71. Based on these findings, Petitioner has not met its burden to show by a preponderance of the evidence that a person having ordinary skill in the art would have been led to modify Schröder’s finger-ring to place a curved battery between the internal and external housing components in light of the teachings in Mestas. Thus, Petitioner has not met its burden to show by a preponderance of the evidence that dependent claim 3 of the ’178 patent is unpatentable over Schröder and Mestas.” slip op. at 38

  Patent outcomesUS 11,868,178 mixed
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 11,868,178
• Synaffix B.V. v. Hangzhou Dac Biotech Co., Ltd.Some claims unpatentable
  PTAB · Aug 26, 2025 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–17, 20, 21, 24, 26, and 29–31 are unpatentable; claims 25 and 32–34 were not shown unpatentable, and the motion to exclude was dismissed as moot.

  RulingsFinal written decision

  • RemandOther

    “review of claims 1–17, 20, 21, 24–26, and 29–34 of the ’682 patent. Paper 2 (“Pet.”), 1, 3. Patent Owner, Hangzhou DAC Biotech Co., Ltd., filed a Preliminary Response (Paper 9, “Prelim. Resp.”). We initially determined that the information presented in the Petition did not establish a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims, and did not institute inter partes review. Paper 17. Petitioner requested Director review of our decision denying institution (Paper 18 (“Request”)). The Director delegated review of the decision to a Delegated Rehearing Panel (“DRP”). Paper 19. Patent Owner was granted the option to file a response to Petitioner’s Request (Paper 22 (“Request Resp.”)). The Delegated Review Panel vacated our decision and remanded the case to this panel with a revised claim construction for claim 1. Paper 23 (“DRP Dec.”). On August 30, 2024, we instituted an inter partes review after remand from the Director. Paper 25 (“Inst. Dec.”). Patent Owner subsequently filed a Patent Owner Response (Paper 31, “Resp.”), Petitioner filed a Reply (Paper 36, “Reply”), Patent Owner filed a Sur-reply (Paper 44, “Sur-reply”), and Petitioner filed a Sur-sur-reply (Paper 48, “Sur-sur-reply”).” slip op. at 2

  • PTAB / AIA Trials › Motions to amend / substitute claimsOther

    “I. Patent Owner’s Motion to Exclude Evidence Patent Owner moves to exclude Exhibits 1089 and 1090. Paper 50. As we did not rely on either of Exhibits 1089 or 1090 in deciding this matter, Patent Owner’s motion is dismissed as moot.” slip op. at 96

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableMixed

    “For these reasons, Patent Owner’s arguments and cited evidence also” slip op. at 31

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed

    “function as R2, and the ethyl group may function as R4, which can be a linear alkyl having 1–6 carbon atoms. We note that claim 3 permits R5 and R6 to be absent. For these reasons, the arguments presented in the Petition demonstrate that claim 3 would have been obvious over Singh’s Compound 3 when modified in view of Harris.” slip op. at 73

  Patent outcomesUS 10,131,682 mixed
  § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,131,682
• Life Spine, Inc. v. Globus Medical, Inc.Some claims unpatentable
  PTAB · Mar 20, 2024 · IPR2022-01434 · APJ Cynthia M Hardman · IPR · Final written decision

  Claims 1–9 and 15 are unpatentable over Chung and Olmos-based obviousness grounds; claims 10–14 were not shown unpatentable because the asserted references did not teach the claimed complementary relationship.

  RulingsFinal written decision

  • Expert testimonyOther

    “improperly incorporates-by-reference 12 pages of expert testimony via a single sentence.” PO Sur-reply 16 n.2 (citing Pet. Reply 17, which in turn cites Ex. 1026 (Hatch Decl.) ¶¶ 49–66). We find that many of the paragraphs within the cited range (i.e., Hatch Declaration paragraphs 49–66) appear to have a tenuous connection to the proposition for which Petitioner cites these paragraphs. See Pet. Reply 17. That said, we find that paragraphs 53–55 directly relate to Petitioner’s proposition in the Reply, i.e., that “Petitioner’s experts explain why a [person of ordinary skill in the art] would rely on a cross-sectional view over a perspective view for making the determination in question, because only the cross-sections provide the needed side view directly orthogonal to the positions of the yellow expansion portion and the end of the dovetail.” Id. Accordingly, we find that paragraphs 53–55—the only paragraphs we cite from Petitioner’s range in reaching our conclusion—are not improperly incorporated by reference into Petitioner’s Reply.” slip op. at 66

  • Strike new argumentNew argument consideredDenied

    “provide Petitioner an opportunity to respond under the new construction, and decline to strike Petitioner’s relevant argument and evidence. Cf. Axonics, 75 F.4th at 1383 (“[W]hen the Board adopts a new claim construction following institution, an IPR petitioner must have adequate notice and an opportunity to respond under the new construction.”). Like in Axonics, in its new arguments on Reply, Petitioner here relies on the same embodiment from the same prior art reference that it relies on in the Petition to support the same legal argument, i.e., that Olmos’s Figure 16 embodiment discloses the “complementary with one another” limitation of challenged claims 10– 14. See Axonics, 75 F.4th at 1384; see also Apple Inc. v. Andrea Elecs. Corp., 949 F.3d 697, 706 (Fed. Cir. 2020) (permitting petitioner to elaborate in reply on an unpatentability theory presented in the petition). Moreover, we permitted Patent Owner to file (and it indeed did file) a sur-reply brief and expert declaration that addressed Petitioner’s new obviousness theories. Accordingly, both parties had adequate notice of our preliminary construction and an opportunity to respond under that new construction. For these reasons, we deny Patent Owner’s motion to strike.” slip op. at 124

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “from the expansion portion. We agree with Patent Owner that the wording of this limitation as a whole requires that the “extension necessarily must protrude beyond a longitudinal end of the expansion portion.” Id. at 11. We also agree with Patent Owner that “[u]nder Petitioner’s tenuous theory, an extension in any direction except 90 or 180 degrees would satisfy the claim language since any such direction has a so-called ‘longitudinal component.’” Id. at 13. For these reasons, we disagree with Petitioner’s argument that the purported “longitudinal component” of Chung’s extension satisfies limitation 1[h].” slip op. at 55

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed

    “would have been motivated to add an extension to the Figure 16 embodiment because “an integrally-formed extension advantageously requires fewer parts, which facilitates both manufacturing and use.” Pet. 118. We agree with Patent Owner that this argument is unavailing. PO Resp. 50. Petitioner’s combination entails adding an extension (from Figure 8) to an embodiment lacking one (Figure 16). We agree with Patent Owner that adding a new component (whether separately or integrally) can in some instances complicate manufacturing/assembly and increase costs. See id. (citing Ex. 2013 (Culbert Decl.) ¶ 115). Petitioner has not sufficiently demonstrated that the proposed combination in this instance would reduce complexity or facilitate the manufacturing process. Accordingly, we do not rely on this argument offered by Petitioner.” slip op. at 106

  Patent outcomesUS 8,845,731 mixed
  § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,845,731
• Unified Patents, LLC v. VL Collective IP LLCSome claims unpatentable
  PTAB · Dec 18, 2023 · IPR2022-01086 · APJ Patrick M Boucher · IPR · Final written decision

  Claims 1, 3, 5, 9, 12, 13, and 15 are unpatentable over Sonohara; claims 20 and 21 were not shown unpatentable because Sonohara’s assignment rule is based on timestamps.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner’s expert, Dr. Goodrich, proposes what Patent Owner characterizes as “a somewhat different level,” namely “an individual with at least a bachelor’s degree in Computer Science or related area and two years of experience developing software tools and/or computer systems for use in the area of audio or video creation, encoding, and/or distribution.” PO Resp. 13; Ex. 2007 ¶ 50. Although we agree that the respective articulations are “somewhat different,” they are generally similar, and our Decision does not depend on nuanced distinctions regarding the level of ordinary skill. Indeed, Dr. Goodrich describes his proposed articulation as “approximate,” such that “more work experience could compensate for less education or more education could compensate for less work experience.” Ex. 2007 ¶ 50. Because we find Petitioner’s proposal reasonable, consistent with the level of skill reflected by the prior art, and supported by Dr. Freedman’s testimony, we adopt it for this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art). We nevertheless note that we would reach the same ultimate conclusion that claims 1, 3, 5, 9, 12, 13, and 15 (but not claims 20 and 21) have been shown to be unpatentable by a preponderance of the evidence were we to adopt Patent Owner’s proposal. See PO Resp. 13 (“this Response establishes that Petitioner’s arguments fail even under its preferred definition of the level of ordinary skill”).” slip op. at 12

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notNot reached

    “We need not resolve this dispute because we reach the same ultimate conclusion that Petitioner shows, by a preponderance of the evidence, that claims 1, 3, 5, 9, 12, 13, and 15 are unpatentable, but not that claims 20 and 21 are unpatentable, even if we apply Patent Owner’s proposed construction that the preambles are limiting and the first and second data files must be different. See Reply 15 (Petitioner asserting that “there is no need to construe the preambles as the prior art meets them even if construed”); 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))). For purposes of this Decision, we accordingly treat the preambles of independent claims 1 and 9 as limiting, and with the recited “first data file” and “second data file” as distinct data files.4” slip op. at 14

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

    “We agree with Patent Owner’s contention that the emphasized sentence defines the term “content-related.” See PO Resp. 15–16 (Patent Owner arguing that “[t]here are thus three strong indications of lexicography: (1) ‘content-related’ is set off by quotation marks; (2) the patentee used the word ‘is’ to describe the term ‘content-related’; and (3) the patentee states what ‘content-related’ is ‘understood to mean.’” Nor does Petitioner disagree that the sentence is definitional. See Tr. 8:15–16 (referring to the “term content-related as it’s defined in the specification”). Indeed, in the Starz litigation, the district court also treated the sentence as definitional, a fact that we find significant as a matter of comity. See Ex. 1018, 111:24–112:1 (district court judge stating at Markman hearing, “I’m going to adopt . . . the express definition provided in the specification”). But like the district court, we discern insufficient reason to adopt the additional gloss that Patent Owner seeks to apply to the definition of “content-related.” That is, Patent Owner proposes that we additionally construe the phrase “syntactical meaning” within the definitional statement to arrive at Patent Owner’s proposed construction. PO Resp. 16–20. According to Patent Owner, “[t]he specification makes clear, through its use of consistent and repeated examples, that ‘syntactical meaning’ requires a specific relationship between the data segments within a data file: succeeding data segments within a data file must be ordered so as to present the content in its intended sequence when rendered.” Id. at 17 (citing VirnetX Inc. v. Cisco Sys., Inc., 767 F.3d 1308, 1317–19 (Fed. Cir. 2014); Alloc, Inc. v. ITC, 342 F.3d 1361, 1368–71 (Fed. Cir. 2003)). Patent Owner adds that the claims, the context provided by the problems solved by the ’794 patent, and the cross-examination testimony of Petitioner’s expert, Dr. Freedman, all support this additional aspect of Patent Owner’s proposed construction. Id. at 18–20. Relying on additional direct testimony by Dr. Freedman, Petitioner counters this position as “improperly import[ing] limitations from the specification that are not required by the claims” and “render[ing] other portions of claim 1 superfluous.” Reply 3 (citing Ex. 1016 ¶ 22); see Tr. 10:18–20 (Petitioner explaining at oral hearing that “the syntax information is simply just identification information which is used to find out what the order of the files is. But the identification information does not by itself indicate the order. It’s just an identifier.”). We agree with Petitioner that it would be imprudent to adopt Patent Owner’s additional gloss because, “[w]hile claims must be construed in light of the specification, . . . limitations from the specification are not to be read into the claims, . . . for ‘[i]t is the claims that measure the invention.’” Golight, Inc. v. Wal-Mart Stores, Inc., 355 F.3d 1327 (Fed. Cir. 2004) (quoting SRI Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121 (Fed. Cir. 1985) (other citations omitted). It is apparent that the Applicant for the ’794 patent understood how to define terminology recited in the claims, but chose to limit its definition of “content-related” in terms of the broader phrase “syntactical meaning” rather than through narrower specific reference to presentation order. In addition, claims 1 and 9 already specify “sequentially outputting the first and second data segments according to their chronological sequence,” which supports Petitioner’s observation that requiring an additional sequential order to “content-related . . . data segments” renders other portions of claim 1 superfluous. See Reply 3. We accordingly adopt the definitional construction provided by the” slip op. at 16

  • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer not foundDecided for petitioner

    “As a basic principle of claim interpretation, prosecution disclaimer promotes the public notice function of the intrinsic evidence and protects the public’s reliance on definitive statements made during prosecution.” Omega Engineering, Inc. v. Raytek Corp., 334 F.3d 1314, 1323 (Fed Cir. 2003) (citing Digital Biometrics, Inc. v. Identix, Inc., 149 F.3d 1335, 1347 (Fed. Cir. 1998)) (emphasis added). As such, a statement during prosecution qualifies as a disavowal of claim scope only if it is “so clear as to show reasonable clarity and deliberateness” and “so unmistakable as to be unambiguous evidence of disclaimer.” Id. at 1325 (citations omitted). “Consequently, for prosecution disclaimer to attach, [Federal Circuit] precedent requires that the alleged disavowing actions or statements made during prosecution be both clear and unmistakable.” Id. at 1325–26. “The party seeking to invoke prosecution history disclaimer bears the burden of proving the existence of a clear and unmistakable disclaimer that would have been evident to one skilled in the art.” Mass. Inst. of Tech. v. Shire Pharms., Inc., 839 F.3d 1111, 1119 (Fed. Cir. 2016). And “[s]tatements by the patent owner are not considered in a vacuum; rather, the skilled artisan would look at the record as a whole in assessing claim scope.” Galderma Lab’s v. Amneal Pharma, 806 F. App’x 1007, 1010 (Fed. Cir. 2022) (citing Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 867 (Fed. Cir. 1993) (“The prosecution history must be examined as a whole in determining whether estoppel applies.”)). We have reviewed the prosecution history, which we summarize supra § I.A.3., and we have particularly reviewed those portions highlighted by Patent Owner. See PO Resp. 32–40. We reach the same conclusion as the district court in the Starz litigation that the standard for attachment of prosecution disclaimer is not met. See Ex. 1018, 109:15–22 (district court stating at Markman hearing, “I’ve also carefully reviewed the portions of the prosecution history relied on by VideoLabs, including the patentee’s arguments regarding the Shin and Rosenau references, and I’m up [sic: not6] persuaded there was a clear and unmistakable disclaimer of all assignment rules that perform assignments by using exact timing information”). slip op. at 20

  Patent outcomesUS 8,605,794 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,605,794
• ROKU, Inc. v. Universal Electronics, Inc.Some claims unpatentable
  PTAB · Nov 28, 2023 · IPR2022-00943 · APJ Sharon Fenick · IPR · Final written decision

  Claims 1–7, 9–13, 15, and 16 are unpatentable as obvious; claims 8 and 14 were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner argues that: On or before 7/12/2017, [one of ordinary skill in the art] would have had a bachelor’s degree in computer science, in electrical engineering, or a related field, and approximately three years of experience or equivalent study in voice-controlled devices in smart home systems. Additional graduate education could 2 Neither party presents arguments or evidence relating to such objective evidence of nonobviousness. in the field could substitute for formal education. Pet. 18. We adopted this definition for the purposes of the Decision on Institution. Dec. on Inst. 8–9. Patent Owner adopts Petitioner’s definition. PO Resp. 4. We again adopt Petitioner’s definition, which is consistent with the level of skill as reflected in the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner

    “Absent a recitation of order, or an order mandated by grammar or logic, the steps of a method claim are not construed to require a particular order. See, e.g., Altiris, Inc. v. Symantec Corp., 318 F.3d 1363, 1369 (Fed. Cir. 2003). Patent Owner argues that the steps of claim 1, a method claim, must be performed in sequential order. PO Resp. 13–16. Without commenting on or conceding Patent Owner’s proposal, Petitioner contends that “the trial grounds meet this proposed construction.” Pet. Reply 24–25; Tr. 8:25–11:16. Our record does not reflect any indication that Patent Owner’s proposed construction requiring the sequential ordering of the method steps is not at least encompassed by the correct construction of claim 1. Because of this, and because Petitioner agrees that the arguments in the Petition meet this construction, we accept Patent Owner’s construction as correct for the purposes of this Decision.” slip op. at 10

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableNot shown unpatentableMixed

    “We do not agree with Patent Owner that Petitioner’s showing uses the same sound data to teach the “first sound data” of limitation 1.a and the “second sound data” of limitation 1.c. Patent Owner is correct that Rosenberg’s claim 5 describes the determination of a volume threshold based on the volume of the ambient audio signal in which characteristic form(s) (e.g., the name of the user of the media player) are present. Ex. 1006, 13:66–21, 14:28–30. However, the Petition describes using Fu’s “predetermined threshold” in combination with Hart-787’s device, which attenuates audio output of a device upon detecting a user’s utterance intended to gain the attention of the device, in order to “include adjusting the audio output volume of a wirelessly-linked audio-producing device when the voice-controlled device determines that the ambient noise level at the time a Ex. 1004, 2:22–37, 5:61–6:10, 9:18–25; Ex. 1005 ¶¶ 24, 32, 54; Ex. 1003 ¶¶ 88–89). Petitioner further proposes including a threshold that is advantageously based on the environment in which the device is operating as described in Fu, for example to respond to differing levels of noise at different times of day. Id. at 26, 29–30, 40 (citing Ex. 1006, 10:42–67, 14:28–30; Ex. 1003 ¶¶ 48–53, 55, 58, 87, 91, 107–109). We agree with Petitioner that Patent Owner’s arguments address the references individually instead of addressing the combination of the teachings proposed in the Petition. See Pet. Reply 8, 13–14; see also Dec. on Inst. 21–22, 23–24, 25–26. The Petition relies upon a combination of elements of Hart-787 with the predetermined threshold as taught in Fu and with establishing such a threshold based on the operating environment of a device as in Rosenberg. Pet. 26–31, 34–41. Patent Owner is correct that Rosenberg’s threshold is set at the time of the utterance in Rosenberg’s claim 5 and cites Petitioner’s declarant as “conceding” issues regarding how “Rosenberg’s volume threshold is determined.” PO Resp. 20–21. But this argument and the ostensible concession do not squarely address the proposed combination, which combines Fu’s teaching of an adjustment unit that “compares the volume of the ambient noise received . . . to a predetermined threshold” with Rosenberg’s teaching that such “a threshold may be ‘determined based on the volume of [an] ambient audio signal.’” Pet. 39, 40 (emphasis omitted) (quoting Ex. 1006, 14:28–30). While Patent Owner argues that “Petitioner has not proposed using a predetermined/pre-set threshold or a previously established threshold based on environmental noise in the combination of Hart-787 with F[u] and Rosenberg” (PO Resp. 46), we find, on the contrary, that the Petition describes a combination based predetermined threshold” and on a threshold “determined according to an environmental noise level.” Pet. 29–30. Thus, we find Petitioner’s unpatentability grounds do not suffer from the issues Patent Owner argues are a consequence of the purported use of the same sound data for the “first sound data” of claim limitation 1.a and for the “second sound data” of claim limitation 1.c. We do not agree with Patent Owner’s arguments regarding Fu’s teachings with respect to limitation 1.e’s “transition from a first state having a first volume level to a second state having a second volume level that is less than the first volume level” because these arguments similarly do not address the proposed combination. See PO Resp. 26–30. The Petition cites Hart-787 for attenuating the volume of an audio-producing device when a wake word is issued. Pet. 32–34, 43–44. The Petition cites Fu for adjusting volume of an audio-producing device if the level of ambient noise exceeds a predetermined threshold. Id. at 36–39, 44–45. Thus, even if Fu teaches only increasing the volume of an audio-producing device if the predetermined threshold is exceeded, the Petition relies on the combination of teachings of Hart-787 and Fu, and Patent Owner’s argument that neither reference teaches “decreasing a controllable appliance’s volume output when a previously established volume threshold is exceeded” (PO Resp. 30) does not address the combination proposed. Patent Owner’s argument that “Petitioner has not proposed modifying Fu to decrease a controllable appliance’s volume output when a volume threshold is exceeded” (PO Resp. 30) similarly does not address the combination proposed in the Petition. We also find that the preponderance of the evidence supports Petitioner’s showing regarding the motivation to combine the references.” slip op. at 23

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

    “We also find that the preponderance of the evidence supports Petitioner’s showing regarding the motivation to combine the references. transmitted volume down control signals as the means for attenuating audio output, Petitioner contends that Hart-787 “broadly teaches” that a device transmits control command signals to the audio-producing device, relying on the testimony of its declarant. See Pet. 23 (citing Ex. 1004, 5:47–51; Ex. 1003 ¶ 82), 43–44 (citing Ex. 1004, 1:67–2:7, 2:26–27, 5:47–51; Ex. 1003 ¶ 118). In addition, Petitioner shows that these control signals were well-known in the art and would have been known to one of ordinary skill in the art at the time of the invention, supporting its showing with additional testimony from its declarant. Id. at 44 (citing Ex. 10183, 2:39–47, 5:35–38; Ex. 10194 ¶¶ 3, 13; Ex. 1003 ¶¶ 44–45, 118). We conclude Petitioner’s evidence regarding the showing in Hart-787 is sufficient with respect to this point. Hart-787 describes altering a signal sent to the speaker to attenuate the audio from that speaker. Ex. 1004, 1:67– 2:1. Petitioner’s declarant testifies that using transmitted control signals to do this would have been known to one of ordinary skill. Ex. 1003 ¶¶ 44–45, 82, 118. We consider Petitioner’s evidence regarding what one of ordinary skill in the art would have understood from Hart-787’s disclosure to be sufficient for the showing regarding the “causing one or more commands to be automatically issued to the controllable appliance to thereby cause” that appliance to transition to a lower volume level, as required in limitation 1.e. While Patent Owner argues that Petitioner’s declarant “concede[s] that Hart- 787 does not disclose or teach how its voice-controlled device decreases the audio output of the controllable appliance,” the cited portion of the” slip op. at 25

  Patent outcomesUS 10,930,276 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,930,276
• Universal Electronics, Inc. / Gemstar Technology (Qinzhou) Co. Ltd. et al. v. ROKU, Inc.Some claims unpatentable
  PTAB · Oct 23, 2023 · IPR2022-00818 · APJ Patrick M Boucher · IPR · Final written decision

  Claims 1–5, 8–10, and 14 are unpatentable over RadioShack; claim 11 was not shown unpatentable over Wouters and Verzulli because the combination did not disclose the claimed combining and installing steps.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “disseminated to the interested public, ‘public accessibility’ has been called the touch-stone in determining whether a reference constitutes a ‘printed publication’ . . . .” Jazz Pharm., Inc. v. Amneal Pharm., LLC, 895 F.3d 1347, 1356 (Fed. Cir. 2018) (quoting In re Hall, 781 F.2d 897, 898–99 (Fed. Cir. 1986)). A reference is considered “publicly accessible” if it was “disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it.” Id. at 1355–56 (citing In re Wyer, 655 F.2d 221, 226 (CCPA 1981)). Petitioner treats this requirement as having two aspects, namely (1) whether a person of ordinary skill could reasonably have found RemoteCentral.com and (2) whether such a skilled artisan could reasonably have found RadioShack on RemoteCentral.com. Reply 8–13; see also Tr. 33:25–34:8 (Patent Owner asserting that there are two aspects to the analysis on public accessibility: “The first is whether a [person of ordinary skill in the art] would have known to arrive at the website containing the prior art reference. The second one is . . . , [a]ssuming the [person of ordinary skill in the art] would have done so, would the [person of ordinary skill in the art], exercising reasonable diligence, have located the prior art reference on the site? And these are separate and distinct requirements, and if you fail one of them, the document is not publicly accessible.”).” slip op. at 27

  • Strike new argumentNew argument consideredDecided for petitioner

    “addressed squarely by the principles set forth in Hulu, which addresses the standards at the institution stage and during the trial for evaluating evidence proffered to show asserted art qualifies as a printed publication. Specifically, after a petitioner has presented “evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent,” such that trial is instituted, “some limited opportunities exist for the petitioner to present new evidence later.” Hulu at 13–14. These “limited opportunities” include “in a reply to the patent owner response,” provided that the additional evidence is “responsive to the prior briefing” and provided that the additional evidence does not require “completely reopen[ing] the record, by, for example, changing theories after filing a petition.” Id. at 14–15. Although Patent Owner contends that “[t]his is not an example of permissible rebuttal evidence, but rather a belated attempt to fill a gap in the evidence in the Petition,” we disagree. See Sur-reply 6. Rather, the 7 Patent Owner appears to refer incorrectly to Exhibit 1040 instead of Exhibit 1041 when identifying “articles allegedly referring to RemoteCentral.com.” See Sur-reply 5–6. progression within the instant proceeding comports well with the Hulu framework. During the preliminary proceeding, Petitioner came forth with “evidence sufficient to establish a reasonable likelihood that [RadioShack] was publicly accessible before the critical date of the challenged patent,” just as Hulu demands. Hulu at 13; Inst. Dec. 23 (“[W]e determine that Petitioner’s showing regarding public accessibility of RadioShack is sufficient under the standard we apply at this stage of the proceeding.”). Patent Owner challenges RadioShack’s status as a printed publication in its Response, just as Hulu contemplates. Hulu at 15; PO Resp. 28–41. And Petitioner submits additional evidence that replies to that challenge without changing its theory that RadioShack qualifies as a printed publication by virtue of its accessibility on the RemoteCentral.com web site and in light of date indicia on RadioShack itself.8 See Hulu at 15–16; Reply 7–13. Moreover, in determining that Petitioner’s additional evidence directed at RemoteCentral.com is properly considered, we are further mindful of the Federal Circuit’s endorsement that “the petitioner in an inter partes review proceeding may introduce new evidence after the petition stage if the evidence is a legitimate reply to evidence introduced by the patent owner.” Anacor Pharm., Inc. v. Iancu, 889 F.3d 1372, 1830–81 (Fed. 8 In its Reply, Petitioner also relies on evidence of publication of RadioShack on Radio Shack’s own public website and on “a third location,” hifi-remote.com. Reply 14. As we discuss below, we determine that the presence of RadioShack on RemoteCentral.com is sufficient to qualify RadioShack as a printed publication. We therefore do not reach the issue of whether presence on either the Radio Shack web site or on hifi-remote.com is an improper new theory raised by Petitioner in its Reply. See Tr. 8:13– 9:23 (Petitioner discussing whether reliance on hifi-remote.com presents a different theory than set forth in the Petition). Cir. 2018); see also Vidstream LLC v. Twitter, Inc., 981 F.3d 1060, 1065 (Fed. Cir. 2020) (“The Board denied VidStream’s Motion to Exclude, holding that it was appropriate to permit Twitter to respond to VidStream’s challenge [to the status of Bradford as a printed publication] by providing additional evidence to establish the Bradford publication date. We conclude that the Board acted appropriately, for the Board permitted both sides to provide evidence concerning the reference date of the Bradford book, in pursuit of the correct answer.”). We accordingly give due weight to Petitioner’s additional evidence of RadioShack’s accessibility on the RemoteCentral.com web site.” slip op. at 25

  • ExcludeMotion to exclude, deniedDenied

    “1 Patent Owner objected to Petitioner’s demonstrative slides 45 and 68 as presenting a new argument that was not previously made with respect to challenged claims 2 and 10. Paper 27; see Paper 26 (Petitioner’s demonstratives), 45, 68. At the oral hearing, we reserved ruling on the objections. Tr. 5:23–6:3. Both slides reproduce the same portions of Exhibits 1002 and 1025, with the statement that “A press and hold for an auto-scan or brand-scan is admitted prior art.” Paper 26, 45, 68. As explained below, we do not reach the predicate position upon which the objections are based. See Tr. 5:8–11 (Petitioner stating that “this Board only needs to resolve this objection if it accepts Roku’s claim construction argument that the claims cover a press and hold of a single button, but that they do not cover pressing multiple buttons to present that argument in the alternative. So, if you reject that argument, you don’t even have to resolve the objection.”). We accordingly dismiss the objections as moot.” slip op. at 2

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “We agree with this assessment, and the parties do not specifically advocate for one articulation over the other in this proceeding. See Pet. 8 (Petitioner asserting that “[t]he Challenged Claims are unpatentable under both proposed levels”); PO Resp. 5 (Patent Owner stating its “position that the challenged claims are unpatentable under either proposed level of ordinary skill”). We adopt Patent Owner’s proposed statement of the level of ordinary skill as advanced in the related ITC Investigation. But we note that we would reach the same ultimate conclusion that Petitioner shows, by a preponderance of the evidence, that all challenged claims are unpatentable were we to adopt Petitioner’s proposal instead.” slip op. at 12

  Patent outcomesUS 8,378,875 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,378,875
• Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.Some claims unpatentable
  PTAB · Jul 5, 2023 · PGR2022-00023 · APJ Robert A Pollock · PGR · Final written decision

  The Board held claims 2, 3, 5, 14, 26, 27, and 30 unpatentable for lack of written description, but did not find claims 1, 6, and 25 unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology and cancer biology, which would encompass the blood cancers recited by Patent Owner. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). We find that Dr. Gordon and Dr. Sharman are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art, based on either party’s definition. Ex. 1020, ¶¶ 8– 19; Ex. 2008, ¶¶ 11–24.” slip op. at 7

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “We find Dr. Sharman’s statements and deposition testimony have substantially greater credibility than Dr. Gordon’s statements and deposition testimony based on Dr. Sharman’s significantly greater relevant experience in treatment and study of hematological cancers using chemotherapeutic agents and based on Dr. Sharman’s superior recollection and more complete analysis of the record found in the ’942 patent. In particular, we found Dr. Gordon’s statement that no example “includes” every element of claim 1 factually incorrect as contradicted by at least Figure 2 of the ’942 patent where the ordinary understanding of includes to mean encompasses is used. See Ex. 1020 ¶ 131. Ebit Sys. Am., LLC v. Thales Visonix, Inc., 881 F.3d 1354, 1358 (Fed. Cir. 2018) (“The PTAB [i]s entitled to weigh the credibility of the witnesses ....”).” slip op. at 16

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

    “The parties do not identify any issue relating to the preamble that needs to be addressed to resolve the sole written description challenge and the parties do not dispute that the transitional term “comprising” is “inclusive or open-ended and does not exclude additional, unrecited elements or method steps.” Georgia-Pacific Corp. v. US. Gypsum Co., 195 F.3d 1322, 1327 (Fed. Cir. 1999). We therefore find that 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 8

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateWritten description inadequateMixed

    “We find that Figure 2 of the ’942 patent and the associated example provide literal and express descriptive support for claim 1 of the ’942 patent. As descriptive support for claim 1, the ’942 patent teaches treatment of leukemia or lymphoma, including chronic lymphocytic leukemia and small lymphocytic lymphoma (Ex. 1001, 16:21–22), by orally administering the Bcl-2 inhibitor GDC-0199 (Ex. 1001, 17:16) in escalating doses of 50 mg per day during a first week and 100 mg per day during a second week (Ex. 1001, Figure 2). Claim 1 of the ’942 patent, as written, does not exclude performance of the complete combination therapy shown in Figure 2. Rather, the reasonable understanding of the term “comprising” in claim 1 encompasses monotherapy with GDC-0199 alone and combination therapy with obinutuzumab. Both embodiments are described in the Specification. As Patent Owner points out, the ’942 Specification is replete with disclosures to administer GDC-0199 by itself to a patient, stating” slip op. at 16

  Patent outcomesUS 10,993,942 mixed
  Claim construction§ 112 disclosure
  Patents in suitUS 10,993,942

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.