• Fusion Orthopedics, LLC v. Extremity Medical, LLCSome claims unpatentable
  PTAB · Nov 4, 2024 · IPR2023-00894 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1–10 and 12–15 are unpatentable; claim 11 was not shown unpatentable. Substitute claims 16–25 and 27–30 are unpatentable over Mazur; claim 26 was not reached.

  RulingsFinal written decision

  • BurdenMixed

    “It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the grounds for the challenge to each claim.’” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (quoting 35 U.S.C. § 312(a)(3)). Here, however, not until its Reply does Petitioner belatedly suggest that Ferrante’s disclosure of bone screws with self-tapping ends equally meets the limitation of claim 10 (with respect to the first member) as with claim 11 (with respect to the second member), and that both claims are obvious in light of “evidence” from Ferrante “that it was well known to equip bone screws with self-tapping ends.” Reply 26–27. We do not discern these arguments in the Petition, and consider them waived. See Netflix, Inc. v. DivX, LLC, 84 F.4th 1371,1377 (Fed. Cir. 2023) (“While the Board should not take an overly mechanistic view of a petition and decline to address an argument because the petitioner did not present it with ideal vigor and clarity, the Board should also not have to decode a petition to locate additional arguments beyond the ones clearly made.”). In sum, Petitioner’s error in failing to first address limitations of claim 10 in the Petition specific to the Cognet/Ferrante combination indicates a failure to meet the particularity requirements for what must be in the petition and cannot be left to be filled in on reply. See 35 U.S.C. § 312(a)(3); 37 C.F.R. §§ 42.22(a)(2) (requiring, among other things, “a detailed explanation of the significance of the evidence”), 42.104(b)(4)–(5) (requiring that petition “specify where each element of the claim is found in the prior art patents or printed publication relied upon” and, regarding submitted evidence, state “the relevance of the evidence to the challenge raised, including identifying specific portions of the evidence that support the challenge”). Microsoft, 2022 WL 989403, at *6. Accordingly, Petitioner has not shown persuasively that claim 11 would have been obvious in light of Cognet and Ferrante for the reasons set forth in the Petition. slip op. at 41

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “We also find persuasive Mr. Dominguez’s explanation that one of ordinary skill in the art would have understood “bore” as including stepped diameter holes, sometimes described as a bore having a counterbore. See generally Ex. 1018 ¶¶ 4–29; Reply 3–10. Three of Mr. Dominguez’s illustrative examples are reproduced in the annotated figures below. The above figures show Mr. Dominguez’s annotated illustrations from the Jackson (Ex. 1019, Fig. 3), Brånemark (Ex. 1021, Fig. 4), and Ray (Ex. 1025, Fig. 1) references as discussed at paragraphs 10, 12, and 13, respectively, of Mr. Dominguez’s Second Declaration. With reference to the above figures, Mr. Dominguez testifies that “Jackson describes a bone repair set screw in which ‘[t]he bore 27 comprises a first bore section 31, a second bore section 32,’ etc. delineated by shoulders 41, 42, etc. (Ex. 1019, 5:24– 43)” (Ex. 1018 ¶ 10); “Brånemark describes an osseous implantation device having body 1ʺ with first and second holding portions 21ʺ, 31ʺ and ‘an inner through bore with a first portion 4ʺ in the first holding portion and a second portion 5ʺ in the second holding portion.’” Ex. 1021, 4:44–46” (id. ¶ 12); and Ray discloses surgical calipers including “handle 12 having ‘stepped cylindrical bore 14,’” wherein “[c]ollar 20 of a shaft inserted in the bore ‘rests against a step of the bore 14’ (2:14–15)” (id. ¶ 13). Patent Owner responds that Mr. Dominguez’s examples “that allegedly show a single bore encompassing two or more stepped-diameter holes or a counterbore . . . . are specific to these references and divorced from the disclosures of the ’166 patent.” Sur-Reply 7. Insofar as the ’166 patent makes no mention of the term “bore” outside the claims, and Mr. Dominguez’s examples are all taken from the field of orthopedic surgery, we do not find this argument persuasive. Patent Owner further appears to contend that exemplary references to a “cylindrical stepped down bore” or a “stepped cylindrical bore” are too specific to be within the scope of the term “bore.” Sur-Reply 7–8. As these terms merely describe species within a larger genus, and Patent Owner presents no cogent reason to exclude them, we do not find this argument availing. Relatedly, we are also not persuaded by Patent Owner’s argument that “the prior art treats a ‘bore’ as an element that is distinct from a ‘counterbore.’” Id. at 8. Rather, we credit Mr. Dominguez’s testimony that “[a] counterbore is not a structure unto itself, a counterbore is part of a larger structure” as exemplified by numerous examples including Laps (Ex. 1028 ¶ 33 (sensor assembly wherein “bore 16 includes a counterbore 18”)); Martinez (Ex. 1029, 3:61 (surgical cutting instrument wherein “bore 56 has a counterbore 64”)); Zang (Ex. 1030, 2:49 (bone anchor having a “bore [that] includes a counterbore”)); Ledet (Ex. 1022, 29:3–5 (vertebral fixation plate having “through holes . . . . countersunk, or counterbored to accommodate the head of a bone screw”)); Seo (Ex. 1031, 3:45 (chair leg employing “counterbored bore 23”)); and Exner (Ex. 1032, 2:16 (extrusion press including “counterbored axial bore 6”)). Ex. 1018 ¶¶ 17–23. That a reference may refer to a figure as showing “bore 103” with “counterbore 105 . . . formed on one end” does not indicate that they are distinct structures as Patent Owner contends, but merely that the focus of each term is directed to the entire bore or to a particular aspect of the bore, i.e., its counterbore. See” slip op. at 22

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner subsequently proposed an alternative definition, as a person having “[a] Bachelor’s Degree in biomedical and/or mechanical engineering or similar training and . . . at least three years of experience with implant devices used for internal fixation of bones.” POR 5 (citing Ex. 2012 ¶¶ 32–33). According to Patent Owner, “[t]his hypothetical person would be capable of performing various design tasks and would understand the basic mechanical features and operation of orthopaedic implant devices [and] have an appreciation for orthopaedic fusion techniques and the medical issues and concerns faced by a doctor/surgeon charged when performing operations to implant orthopaedic devices.” Id. Despite some differences in wording, Patent Owner asserts (and Petitioner does not contest) that any “distinction between the parties’ proposed definitions of a POSITA does not affect the arguments set forth herein.” Id. (citing Ex. 2012 ¶ 34). Consistent with this view, we find the parties’ constructions equally applicable in light of the prior art of record and the disclosure of the ’166 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). We adopt, for convenience, Petitioner’s definition, but our analysis does not change depending on which of the two articulations are applied here. H.” slip op. at 12

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

    “one of ordinary skill in the art would understand that “bore,” as used in the context of claims 1 and 12, encompasses a multi-diameter passage, and in particular, one having stepped longitudinal cross sections such as that shown in Cognet’s Figure 1. See generally DI 11–13. For the reasons that follow, we conclude that one of ordinary skill in the art would have understood “bore” as such. Relying on the testimony of Mr. Dominguez, Petitioner initially proposed a construction of “bore” as “a usually cylindrical hole made by or as if by the turning or twisting movement of a tool.” Pet. 16 (citing Ex. 1002 ¶ 58). Petitioner’s proposal relied on Mr. Dominguez’s testimony that “[a] bore is a cylindrical hole made by the spinning rotation of a twist drill cutting tool. It is typically made by removing material from a solid or hollow object, similar to a tunnel or orifice.” Ex. 1002 ¶ 58. Pointing to its annotation of Cognet’s Figure 1, above, Patent Owner argued that that the term “bore” excludes a tunnel made by “two adjacent bores.” See Prelim. Resp. 21–25. In view of the then-available evidence, we provisionally construed “bore” as a hole or passage made by or as if by the turning or twisting movement of a tool such that its interior walls have cylindrical lateral cross-sections, and which do not exclude holes or passages having tapered or stepped longitudinal cross-sections. DI 13.” slip op. at 19

  Patent outcomesUS 11,298,166 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 11,298,166
• Pelican Biothermal, LLC v. Va-Q-Tec AGSome claims unpatentable
  PTAB · Jun 16, 2023 · PGR2021-00085 · APJ Barry L Grossman · PGR · Final written decision

  The Board granted the motion to amend but held amended claim 64 unpatentable as anticipated by NanoCool 98596-type products and obvious over the cited combinations; all other amended claims were not shown unpatentable.

  RulingsFinal written decision

  • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part

    “VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that Petitioner has demonstrated by a preponderance of the evidence that amended claim 64 is unpatentable; FURTHER ORDERED that Patent Owner’s Non-Contingent Motion to Amend is granted for claims 64 and denied for all other amended claims; and” slip op. at 77

  • ExcludeMotion to exclude, deniedDenied

    “A. Status as Prior Art Is a Substantive Issue, Not an Evidentiary Issue. A motion to exclude is not an appropriate mechanism for challenging the sufficiency of evidence, such as whether a reference qualifies as prior art, or the proper weight that should be afforded an argument. See Flir Systems, Inc. v. Leak Surveys, Inc., IPR2014-00411, Paper 113, 4, 8–9 (PTAB September 3, 2015); PTAB Consol. Trial Practice Guide 79 (Nov. 30 Mr. Zumwalt testifies that other NanoCool products, designated by product number 85430 and 98630, also have the same configuration as the 98830 product and are made by the same process. Thus, “the 98830, 85430, and 98630 products can be collectively referred to as ‘98830-type’ products all having the same relevant design.” Ex. 1030 ¶ 17. 2019) (“A motion to exclude . . . may not be used to challenge the sufficiency of the evidence to prove a particular fact. A motion to exclude is not a vehicle for addressing the weight to be given evidence—arguments regarding weight should appear only in the merits documents.”); Caterpillar Inc. v. Wirtgen Am., Inc., IPR2017-02187, Paper 42,17 (PTAB May 21, 2019) (status as prior art “is a substantive issue, not an evidentiary issue.”) Thus, whether the NanoCool 98830 product is prior art is not the proper basis for Patent Owner’s Motion to Exclude evidence concerning the NanoCool 98830 product.” slip op. at 29

  • Skill levelSkill level board ownOther

    “Neither Petitioner nor Mr. Harber provide any analysis of the factors pertinent to a determination of the level of ordinary skill, identified above, to support their conclusory statements. We give Mr. Harber’s conclusory testimony minimal probative weight. 37 C.F.R. § 42.64(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Moreover, there is no persuasive evidence to which we have been directed of the need for specific education or experience in biological or chemical technologies related to the claimed containers and inserts.” slip op. at 26

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “With regard to the level of ordinary skill in the art, Petitioner asserts that a person of ordinary skill would have had “a bachelor’s degree or higher degree in biological, chemical or mechanical engineering, or related sciences, and at least two to five years of experience in designing and testing ISCs [insulated shipping containers] depending on education level.” Pet. 9 (emphasis added) (citing Ex. 1002 ¶¶ 23–24). Exhibit 1002 is the Declaration testimony of Mr. Paul Haber. Mr. Harber actually states a slightly different level of ordinary skill. Mr. Harber testifies: The hypothetical POSITA would have: (i) at least a bachelor’s degree in biological, chemical or mechanical engineering, or related sciences, and have at least three to five years of experience in designing and testing ISCs [Insulated Shipping Containers][29]. Such a person may also have (ii) a higher level degree, such as a PhD and/or Master’s degree in engineering, or related sciences, and have at least two to three years of experience in designing and testing ISCs. 29 See Ex. 1002 ¶ 23. Ex. 1002 ¶ 24 (emphasis added). Mr. Harber also testifies that “[t]hese descriptions are approximate, and a higher level of education or specific skill might make up for less experience, and vice-versa.” Id.” slip op. at 25

  Patent outcomesUS 10,766,685 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 10,766,685
• Amphastar Pharmaceuticals, Inc. v. Aegis Therapeutics, LLCSome claims unpatentable
  PTAB · Feb 9, 2023 · IPR2021-01324 · APJ Cynthia M Hardman · IPR · Final written decision

  Claims 1, 2, and 7–17 are unpatentable under §102 or §103; claims 3–6 and 18–20 were not shown unpatentable.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “in Table 1 and the formulations of Potta claim 21 (i.e., ‘from about 0.1% w/w to about 15% w/w epinephrine or a salt thereof’), because such formulations would elicit the desired biological or medicinal response.” Ex. 1002 ¶ 272. Dr. Weinstein provides an essentially identical opinion. Ex. 1003 ¶ 286. Neither declarant supports their opinion with any explanation as to why the Potta formulations would provide the claimed plasma epinephrine concentration or elicit a biological or medicinal response. Accordingly, we do not credit these opinions, and determine that Petitioner has not met its burden to establish that Potta inherently anticipates claim 3. See n re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”).” slip op. at 29

  • ExcludeMotion to exclude, deniedDenied

    “As the moving party, Petitioner bears the burden of establishing that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). Having considered the arguments and evidence of record, we determine that Petitioner has not met its burden of proof. We agree with Patent Owner that “[n]o bright line rule prohibits the consideration of post-priority date evidence,” and that such evidence is permissible in certain contexts. Opp. 2–3. On this record we do not find that there is sufficient cause to exclude the challenged exhibits, because any consideration by the Board of these exhibits has taken into account their alleged post-priority date status. Thus, we do not find that maintaining the exhibits in this proceeding results in any unfair prejudice to Petitioner, or that the exhibits have confused the issues before us. Accordingly, we deny Petitioner’s motion to exclude.” slip op. at 73

  • Skill levelOther

    “II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8

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

    “For the above reasons, on the full trial record we determine that” slip op. at 26

  Patent outcomesUS 10,682,414 mixed
  § 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,682,414
• Med-El Elektromedizinische Geräte Ges.M.B.H. v. Advanced Bionics AGSome claims unpatentable
  PTAB · Jun 2, 2021 · IPR2020-00190 · APJ Patrick R Scanlon · IPR · Final written decision

  Claims 1, 2, and 4–7 are unpatentable as obvious over Dooley and von Ilberg 1999; claims 3 and 8 were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In the Decision on Institution, we adopted Petitioner’s proposed level of ordinary skill in the art, stating it was “consistent with the evidence at this stage of the proceeding, including the asserted prior art.” Dec. Inst. 21. In its Response, Patent Owner notes that “Dr. Zeng explains that he would particularly emphasize experience relating to designing or developing cochlear implants and hearing aids, or systems for fitting such prostheses to patients,” but indicates that it does not dispute Petitioner’s proposed level of ordinary skill in the art for the purposes of this proceeding. PO Resp. 13 (citing Ex. 2014 ¶ 66). Based on our review of the complete record, we continue to apply the level of ordinary skill in the art adopted in the Decision on Institution. We” slip op. at 9

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

    “Petitioner asserts that the Specification of the ’747 patent defines the term “electric-acoustic processor.” Pet. 20 (citing Ex. 1001, 10:65–67, 11:1–7). In the Decision on Institution, we determined that it was not necessary to construe “electric-acoustic processor” at that stage of the proceeding. Dec. Inst. 22 (citing Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017)). Patent Owner agrees the term “electric-acoustic processor” does not require construction for purposes of this proceeding. PO Resp. 14. Accordingly, we do not expressly construe “electric-acoustic processor” for this Decision.” slip op. at 10

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

    “that “configured to generate or apply . . . acoustic stimulation signals to the acoustic sensing organs of the ear” means more than simply being capable of applying acoustic stimulation signals. Dec. Inst. 28. In its Response, Patent Owner argues that the term should be given its plain meaning and does not require explicit construction. PO Resp. 15–16. Patent Owner adds that: To the extent there is a dispute, Patent Owner agrees with the Board’s reasoning that the “configured to” language does not merely reflect an intended use and requires more than a device that is simply “capable of” generating or applying the recited acoustic or electric stimulation in different or separate configurations. Id. at 16 (citing Dec. Inst. 28). Petitioner does not respond to Patent Owner’s assertion that “configured to generate or apply” should be given its plain meaning but does indicate that it disagrees with our “construction” of the term “configured to.” Pet. Reply 14–15 (citing Dec. Inst. 27–28). Petitioner, however, does not present any reasoning supporting its assertion the Board was wrong or offer any argument regarding how “configured to” should be construed. See generally Pet. Reply. We did not expressly construe “configured to” or “configured to generate or apply” in the Decision on Institution, but, as noted above, we did determine that that “configured to generate or apply . . . acoustic stimulation signals to the acoustic sensing organs of the ear” means more than simply being capable of applying acoustic stimulation signals. Dec. Inst. 28. Based on the complete record, we still are not persuaded by Petitioner’s argument that “configured to” should be construed as merely “capable of,” and for the reasons in the Decision on Institution, which we adopt here, we determine acoustic sensing organs of the ear” means more than simply being capable of applying acoustic stimulation signals.” slip op. at 11

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

    “Anderson discloses an embodiment (“the acoustic embodiment”) in which earpiece 10 includes speaker 15 that generates acoustic waves (i.e., acoustic signals) to stimulate the user’s ear. Ex. 1003, 3:58–60, 4:33–35, 5:18–21, 6:63–67, Figs. 1, 2. Anderson also discloses in Figure 10 a different embodiment (“the cochlear implant embodiment”) that combines earpieces 10’ and 10” with a cochlear implant system. Id. at 27:25–45, Fig. 10. In this embodiment, “[s]peakers 15 in the left and right earpieces serve no purpose in the cochlear implant application, as the user is profoundly deaf, and may be disconnected to conserve power.” Id. at 27:52– 55. Because Anderson discloses that the speakers serve no purpose in the cochlear implant embodiment and could be disconnected from power, we determine that the speakers are not used in this embodiment. In addition, Petitioner does not direct us to—nor are we aware of—any disclosure in Anderson indicating that speaker 15 of the cochlear implant embodiment receives a signal that causes the speaker to generate acoustic output. In contrast, Anderson discloses that earpiece headset 21 of Figure 2, which is functionally equivalent to speaker 15 of the acoustic embodiment, receives a modified speech signal and converts this signal to acoustic waves. Ex. 1003, 4:33–35, 5:18–21; see also id. at 6:63–67 (disclosing that speaker 15 produces a processed acoustic signal that corresponds to the ambient acoustic signal detected by microphone 12). embodiment cannot generate or apply acoustic stimulation signals. For these reasons, we determine that speakers 15 in the cochlear implant embodiment are not configured to generate or apply acoustic stimulation signals.” slip op. at 16

  Patent outcomesUS 8,155,747 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,155,747
• Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-02139 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable.

  RulingsFinal written decision

  • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted

    “Petitioner Samsung Bioepis Co., Ltd. (“Bioepis”) timely submitted a Petition presenting substantially the same challenges as set forth in Pfizer’s Petition along with a request for joinder to IPR2017-01488. IPR2017- 02139. Paper 1. We granted Bioepis’s Petition and associated request for joinder to this case. IPR2017-02139, Paper 11, 6–7.” slip op. at 3

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “B. Person of Ordinary Skill in the Art The parties propose similar definitions of a person of ordinary skill for the ’213 patent. See Pet. 15–16; Prelim. Resp. 18; PO Resp. 18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 8. Petitioners do not contest this definition in its Reply and we find no reason to revise our earlier determination.” slip op. at 11

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

    “variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Prelim. Resp. 18–19; PO Resp. 19. Patent Owner correctly points out that this “construction comes directly from the definition provided in the ’213 patent.” Prelim. Resp. 19 (citing Ex. 1001, 11:32–38). Petitioners expressly adopt this construction in their Reply. Pet. Reply 5–6. We do not agree, however, that the claims demand a consensus of “all” human immunoglobulins in the literal sense. Indeed, Petitioners point out that “the ‘consensus’ sequence used for the patent variants was generated using the most common residue at each position identified in [Kabat 198711].” Pet. Reply 15 (citations omitted). And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner. 11 Kabat et al., Sequences of Proteins of Immunological Interest: Tabulation and Analysis of Amino Acid and Nucleic Acid Sequences of Precursors, V- Regions, C-Regions, J-Chain, T-Cell Receptor for Antigen, T-Cell Surface Antigens β2-Microglobulin, Major Histocompatibility Antigens, Thy-1 Complement, C-Reactive Protein, Thymopoietin, Post-Gamma Globulin, and α2-Macroblobulin, 41–175 (4th Ed. 1987). Ex. 1052. See PO Resp. 47. Moreover, in a parallel proceeding involving the same patent, Patent Owner did not dispute that the reference to “all sequences” in the patent, “refer[s] to all known sequences and there’s no dispute . . . that was really synonymous with Kabat 1987.” See IPR2017-01374 Paper 82, Tr. 15:4–16:4; see Ex. 1202 ¶ 157; Ex. 2105 ¶¶ 24–25; Ex. 2107 ¶¶ 18–19; Ex. 1198, 56:20–61:24; Ex. 1199, 27:14–28:13, 29:25–36:2, 57:1–58:6, 115:7–17, 165:17–169:9. Indeed, in a similar parallel proceeding, counsel for Patent Owner acknowledged that the term “all human immunoglobulins” refers to “all reasonably available[,] all known at the time of the invention.” IPR2017-01373, Paper 83, 47:21–48:5. Accordingly, we adopt the parties’ proposed construction, with a clarifying modification, specifically, “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure, as set forth in Kabat 1987.”” slip op. at 13

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

    “lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient.” In our institution decision, we determined that this claim language “refer[s] to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” Dec. 10–12. Neither party disputes this interpretation. See PO Resp. 19; Pet. Reply 5–6. Consistent with claim 63’s express comparison between the immunogenicity of the claimed humanized antibody and that of its non-human parent, the Specification states that one object of the invention is to “to provide methods for the preparation of antibodies which are less antigenic in humans than non-human antibodies but have desired antigen binding and other characteristics and activities.” Ex. 1001, 4:24–28. The Specification similarly states that embodiments within the scope of the claims have “low immunogenicity,” or are designed to “minimize the potential immunogenicity of the resulting humanized antibody in the clinic.” Id. at 52:54–58, 61:56–61. Moreover, with reference to claim 63 in particular, Patent Owner points to the ’272 application as “explain[ing] that the purpose of humanizing antibodies using its consensus sequence approach is to reduce immunogenicity versus the non-human parent antibody. (Id., 6:24–30, 84:24–30.).” Prelim. Resp. 42 (citing Ex. 2032 (File History for U.S. Patent Application No. 07/715,272 (“the ’272 application”)); see also id. at 38 (indicating that the limitation is satisfied where “[o]nly 1 out of 885 patients experienced an immunogenic response . . . which was a substantial improvement over the murine 4D5 antibody”). In light of the above, we do not alter our prior determination that “[a] humanized antibody which lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient,” refers to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” slip op. at 14

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 6,407,213
• Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-01488 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “B. Person of Ordinary Skill in the Art The parties propose similar definitions of a person of ordinary skill for the ’213 patent. See Pet. 15–16; Prelim. Resp. 18; PO Resp. 18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 8. Petitioners do not contest this definition in its Reply and we find no reason to revise our earlier determination.” slip op. at 11

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

    “variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Prelim. Resp. 18–19; PO Resp. 19. Patent Owner correctly points out that this “construction comes directly from the definition provided in the ’213 patent.” Prelim. Resp. 19 (citing Ex. 1001, 11:32–38). Petitioners expressly adopt this construction in their Reply. Pet. Reply 5–6. We do not agree, however, that the claims demand a consensus of “all” human immunoglobulins in the literal sense. Indeed, Petitioners point out that “the ‘consensus’ sequence used for the patent variants was generated using the most common residue at each position identified in [Kabat 198711].” Pet. Reply 15 (citations omitted). And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner.” slip op. at 13

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

    “humanized” (claims 1, 30, 62–64, 66, 79, 80); “and further comprising a Framework Region (FR) amino acid substitution at a site selected from the group consisting of” (claims 1, 30, 62, 63, 66, 79, and 80); “numbering system set forth in Kabat” (claims 1, 30, 62, 63, 66, 79, and 80); and “up to 3-fold more” (claim 65). Patent Owner does not dispute Petitioners’ proposed constructions, but asserts that “[n]o construction of those terms is necessary.” Prelim. Resp. 19; PO Resp. 19. On the present record, we agree with Patent Owner that the terms identified by Petitioners need not be construed to resolve the issues presently before us. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (instructing that claim terms need only be construed to the extent necessary to resolve the controversy). slip op. at 15

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner

    “substitutions, most being unrepresented in any ’272 embodiment.” Pet. Reply 8. We do not find Petitioners’ argument persuasive in light of Patent Owner’s evidence showing that the ’272 application discloses, inter alia, each of the framework substitutions recited in claims 12, 42, 60, 65, 71, 73– 74, and 79 (collectively, 66L, 71H, 73H, 78H, 93H), along with “a generalized scheme for humanizing any non-human antibody.” See PO Resp. 43–44 (citing Ex. 2032, 87–90, 93; Ex. 2041 ¶¶ 91–95).” slip op. at 19

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,407,213
• Celltrion, Inc. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-01374 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable because Kurrle and Queen 1990 were not prior art …

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “with respect to the ’213 patent. See Pet. 12–13; Prelim. Resp. 17–18; PO Resp. 17–18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 10–11. Petitioner does not contest this definition in its Reply and we find no reason to revise our earlier determination. We further note that the prior art itself demonstrates this level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings on 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)). C.” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner

    “Patent Owner’s proposed construction derives from the ’213 patent’s definition of consensus sequence as “refer[ing] to an amino acid sequence which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Ex. 1001, 11:32–38. In the context of the patent as a whole, however, we do not understand the term to require a consensus of “all” human immunoglobulins in the literal sense because the embodiments in the patent were generated using the most common residue at each position identified in Kabat 1987.11 See id. at 10:34–63, 11:55–60; Ex. 2016 ¶¶ 25– 26. And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner. See PO Resp. 47. Moreover, at oral argument, Patent Owner did not contest Petitioner’s assertion that the reference to “all sequences” in the patent, “refer[s] to all known sequences and there’s no dispute . . . that was really synonymous with Kabat 1987.” Tr. 15:4–16:4.12 Accordingly, we adopt the parties proposed construction, with a clarifying modification, specifically, “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure, as set forth in Kabat 1987.”” slip op. at 13

  • Prior constructionDecided for patent owner

    “We previously stated that the language of claim 63, “refer[s] to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” IPR2017-01488, Paper 27 at 10–12. Patent Owner does not dispute this interpretation. See PO Resp. 19. Petitioner argues that the recited reduction in immunogenicity is both an inherent aspect of the claimed humanized antibodies, and “the stated goal of all humanization projects, including that of Queen 1990 and Kurrle.” Pet. Reply, 28, 43. Petitioner also contends that the term is not a claim limitation and “simply a statement of the intended result of the claimed compositions,” but, nevertheless, states: “For the purpose of the present petition only, Petitioner will assume that the preambles are limiting.” Pet. 13 n.3. On balance, we see no need to alter our prior determination that “[a] humanized antibody which lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient,” refers to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody. Nevertheless, to the extent Petitioner is correct that the preambles should be accorded no weight, such a determination would not alter the outcome of this proceeding.” slip op. at 15

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner

    “The ’213 patent issued from application number 08/146,206 (“the ’206 application”), which is an application that entered the national stage on November 17, 1993, from a PCT application filed on June 15, 1992. Ex. 1001, (21), (22), (86). The ’206 application is also a continuation-in-part of the ’272 application, filed on June 14, 1991. Id. at (63). Kurrle was published on December 19, 1990 (Ex. 1071, (43)), and Queen 1990 was published on July 26, 1990 (Ex. 1050, (43)), both of which predate the earliest possible priority date, June 14, 1991, shown on the face of the ’213 patent. Accordingly, Petitioner has satisfied its initial burden of showing that Kurrle and Queen 1990, on their face, qualify as prior art to the challenged claims. We next consider whether Patent Owner has antedated these references.” slip op. at 18

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,407,213
• Fanduel, Inc. / Draftkings, Inc. v. Interactive Games LLCSome claims unpatentable
  PTAB · Nov 8, 2018 · IPR2017-01333 · APJ George R Hoskins · IPR · Final written decision

  Claims 1–3 are unpatentable as obvious over Carter and Barton; claim 6 is unpatentable as obvious over Carter, Barton, and Walker. Claims 1–3 and 6 were not shown unpatentable over Carter and Martin.

  RulingsFinal written decision

  • Prior constructionPrior construction adoptedDecided for petitioner

    “It “remains true in construing patent claims before the PTO” that “the prosecution history . . . serves as intrinsic evidence for purposes of claim construction.” Tempo Lighting, Inc. v. Tivoli, LLC, 742 F.3d 973, 977 (Fed. Cir. 2014). “The PTO should also consult the patent’s prosecution history in proceedings in which the patent has been brought back to the agency for a second review,” such as the present inter partes review. Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292, 1298 (Fed. Cir. 2015), overruled on other grounds by Aqua Prods., Inc. v. Matal, 872 F.3d 1290 (Fed. Cir. 2017). Upon our review of the entire record, we agree with the construction of “selectable betting parameter” previously provided by the Board, during ex parte prosecution of the ’952 patent, as set forth above. Therefore, for the reasons provided in that previous Board decision, none of which are disputed here, we apply that construction here. 2.” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageDisclaimer not foundDecided for patent owner

    “However, the Federal Circuit has “cautioned against reading limitations into a claim from the preferred embodiment described in the specification, even if it is the only embodiment described, absent clear disclaimer in the specification.” In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1369 (Fed. Cir. 2004); Teleflex, Inc. v. Ficosa North America Corp., 299 F.3d 1313, 1327–28 (Fed. Cir. 2002); In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). We find no such clear disclaimer in the ’952 patent specification that would require Patent Owner’s narrow interpretation of the “corresponding” claim term. In particular, while any given location in the cited example from the ’952 patent corresponds to one value of the parameter so the location “determines the bet input” (Ex. 1001, 2:20–22), there is no clear disclosure that other locations may not correspond to that same parameter. It is only in one “example” that each different location “corresponds to a different roulette number.” Id. at 2:22–24 (emphasis added). Thus, the ’952 patent disclosure does not clearly disclaim multiple different locations each corresponding to the same bet input (number or color). See id. at 2:12–31.” slip op. at 12

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

    “After full consideration of the foregoing arguments, we conclude Patent Owner’s analysis of the scope of the claim limitation at issue is vague and confusing. That claim limitation is: the first and second selectable betting parameters are different such that selecting one would cause a different result for the bet than selecting the other. Ex. 1001, 35:23–28. Such language, on its own, presents a straight-forward claim requirement. Patent Owner’s overlying varnish suggesting that the claim requires a relationship between the first and second parameters, making them “comparable variables,” is not supported by the claim language at issue, and confuses Patent Owner’s analysis of the prior art at issue. We reject Patent Owner’s implicit claim construction of this claim limitation and determine no explicit claim construction of this limitation is needed to resolve the issues presented by the arguments and evidence of record. 4. Remaining Claim Terms The parties do not offer any further explicit claim constructions. We determine no further explicit claim constructions are needed to resolve the issues presented by the arguments and evidence of record. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (per curiam) (claim terms need to be construed “only to the extent necessary to resolve the controversy”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 16

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We agree with Patent Owner that Petitioner’s reference to video game experience, as opposed to some other computer gaming experience, is not required to achieve ordinary skill in the art pertinent to the ’952 patent. The ’952 patent is concerned principally with implementing different gaming rules via computer hardware and software as a mobile gaming device moves between jurisdictions; the specific technical implementation of presenting the game on a computer screen is only a secondary consideration. See, e.g., Ex. 1001, Abstract. However, even if we were to accept Petitioner’s position on this point, it would not affect the bases for our decision set forth below. We agree with Petitioner that ordinary skill here requires gaming experience, and does not encompass telecommunications experience without gaming experience. While wireless communication and location tracking are components of the ’952 patent’s claimed invention, the specifics of how such communication and tracking occur is only a secondary consideration. See, e.g., Ex. 1001, Abstract, 1:51–2:11, 7:48–8:12. However, even if we were to accept Patent Owner’s position on this point, it would not affect the bases for our decision set forth below. We determine a person of ordinary skill in the art pertaining to the ’952 patent would have a Bachelor of Science Degree in Electrical Engineering, Computer Engineering, or a similar field. Such a person, further, would have at least about two years of experience designing and developing computer hardware and software to be used for playing games.” slip op. at 18

  Patent outcomesUS 9,306,952 mixed
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,306,952
• Motorola Mobility LLC v. Intellectual Ventures II LLCSome claims unpatentable
  PTAB · Sep 9, 2015 · IPR2014-00504 · APJ Patrick R Scanlon · IPR · Final written decision

  Claims 1–4 and 18 are unpatentable: claims 1 and 2 are anticipated by Boehm, and the challenged claims are obvious over the instituted combinations.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artDecided for petitioner

    “To remove Boehm as a prior art reference, the record must establish either: (1) a conception and reduction to practice before the filing date of Boehm; or (2) a conception before the filing date of the Boehm patent combined with diligence and reduction to practice after that date. See Taurus IP, LLC v. DaimlerChrysler Corp., 726 F.3d 1306, 1323 (Fed. Cir. 2013). Under either approach, however, it must be proven that conception occurred prior to November 4, 2002. See id. “Conception exists when a definite and permanent idea of an operative invention, including every feature of the subject matter sought to be patented, is known.” Sewall v. Walters, 21 F.3d 411, 415 (Fed. Cir. 1994). Furthermore, “[t]he conception analysis necessarily turns on the inventor’s ability to describe his invention with particularity. Until he can do so, he cannot prove possession of the complete mental picture of the invention.” Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994). Objective evidence that corroborates an inventor’s testimony regarding the conception of the invention is required “because of the danger in post-hoc rationales by an inventor claiming priority.” Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052, 1065 (Fed. Cir. 2005). The sufficiency of corroboration is determined according to a “rule of reason.” Price v. Symsek, 988 F.2d 1187, 1195 (Fed. Cir. 1993). This approach, however, “does not dispense with the requirement for some evidence of independent corroboration.” Coleman v. Dines, 754 F.2d 353, 360 (Fed. Cir. 1985).” slip op. at 12

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther

    “We agree with Patent Owner that Petitioner’s proposed construction does not take into account properly the “managing the data path” claim language, even given that Petitioner construes only the limitation “a Local Area Network (LAN) routing system” rather than the entire phrase. In any event, we decline to adopt Petitioner’s proposed construction because it erroneously equates a LAN routing system to “a local area network or equivalent circuitry.” We do not view a LAN routing system as being equivalent to a LAN itself or circuitry “equivalent” to a LAN, which Petitioner has not described. We also decline to adopt Patent Owner’s proposed construction, which is not supported adequately. Specifically, Patent Owner does not explain sufficiently why managing the data path necessarily is accomplished “by controlling client devices’ access to the Internet and by controlling access to the client devices from the Internet.” Patent Owner asserts that the Specification of the ’771 patent describes managing the data path “by controlling the client devices’ access to the Internet, such as by requiring authentication before permitting access” and preventing “unauthorized access in the opposite direction by ‘allow[ing] all client devices 30 to share a single external Internet address.’” PO Resp. 5–6 (citing Ex. 1001, 4:1–14); see also Tr. 43:10–14 (stating the Specification “talks about managing as controlling the client devices’ access to the Internet, things like authentication, and controlling access to client devices from the Internet, like sharing a single Internet address”). The Specification, however, does not describe “managing the data path” explicitly, and we are not persuaded that the “managing the data path” claim language necessarily includes the authentication and sharing functions described in the cited passages. As such, Patent Owner’s reliance on the cited passages in its construction seeks to improperly read limitations from the Specification into the claim. See In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1369 (Fed. Cir. 2004) (“We have cautioned against reading limitations into a claim from the preferred embodiment described in the specification, even if it is the only embodiment described, absent clear disclaimer in the specification.”). Dr. Tewfik testifies that “[i]n computer networking, routing systems allow data to be exchanged between networks by forwarding data to a recipient device in one network from a sending device in another network.” Ex. 2004 ¶ 10. Dr. Tewfik further testifies that, “[i]n the ’771 patent, the LAN routing system is the LAN [R]outer 16,” and the LAN routing system allows data to be exchanged between the short-range local network and the Internet. Id. ¶ 11. This testimony is not dissimilar to Dr. Roy’s testimony that a LAN routing system “routes (i.e. communicates) data between a client device that is accessible via a short-range wireless interface and the Internet that is accessible [via] a long range Internet access interface.” Ex. 1012 ¶ 18. Thus, Dr. Tewfik and Dr. Roy essentially are in agreement that a routing system directs (i.e., exchanges, routes, or communicates) data between networks. This meaning is consistent with the Specification of the ’771 patent, which describes LAN Router 16 as “direct[ing] traffic from the access point 12 to the Internet 20 via the fixed WAN interface 18.” Ex. 1001, 3:33–34. Therefore, applying the broadest reasonable interpretation of the claims in light of the Specification, we interpret the phrase “a Local Area Network (LAN) routing system managing the data path between said wireless access point and said Internet access interface” to mean “a system that directs data between a local area network and the Internet by managing the data path between a wireless access point and an Internet access interface.”” slip op. at 8

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

    “3. “stand-alone system” In the Decision on Institution, we interpreted “stand-alone system” to mean “a system capable of operating independently of any other system.” Dec. on Inst. 8–9. The parties do not dispute this interpretation (PO Resp. 10; Pet. Reply 13), and we see no reason to modify this interpretation in light of the record developed at trial. Accordingly, we adopt this interpretation for this Final Written Decision. B.” slip op. at 11

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

    “Regarding claim 1, Petitioner argues that Boehm discloses (1) the recited short-range, high-speed wireless access point in the form of wireless access point 325; (2) the recited long-range, wireless Internet access interface in the form of interchangeable network interface 350; and (3) the recited LAN routing system in the form of router 330. Pet. 13. Petitioner also argues that Boehm discloses the recited stand-alone system without the need to access an external service controller server, because Boehm discloses “performing DHCP and network address translation locally rather than by requiring an external server accessible via a long-range network connection to do so.” Id. at 13, 16. With respect to claim 2, Petitioner argues that Boehm discloses using 802.11b wireless communication technology. Id. at 16 (quoting Ex. 1005 ¶ 21).” slip op. at 21

  Patent outcomesUS 7,382,771 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
  Patents in suitUS 7,382,771

Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.