- PTAB · Sep 9, 2025 · PGR2025-00023 · APJ Michael J Fitzpatrick · PGR · Institution
Instituted PGR on claims 1–9 because the Board found it more likely than not that at least one challenged claim is unpatentable over the ’629 publication.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Institution of a post-grant review requires that “the information presented in the petition filed under section 321, if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable” or that “the petition raises a novel or unsettled legal question that is important to other patents or patent applications.” 35 U.S.C. § 324(a)–(b). Determining whether to institute has been delegated to the Board. See 37 C.F.R. § 42.4(a) (“The Board institutes the trial on behalf of the Director.”). Upon consideration of the Petition and the Preliminary Response, and for the reasons explained below, we determine that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable. Accordingly, we grant the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“III. LEVEL OF ORDINARY SKILL IN THE ART Petitioner contends a person of ordinary skill in the art (“POSITA”) would have a Ph.D. degree in biological, chemical or biochemical engineering, molecular biology, or biochemistry and at least two years of experience in the field of utilizing or assessing horseshoe crab zymogen proteins (lysate, purified native and/or recombinantly produced) for endotoxin detection and quantitation. More education could substitute for experience to a certain extent, and vice versa. Pet. 22 (citing Ex. 1003 ¶¶48–49). Patent Owner does not dispute Petitioner’s description of a POSITA in its Preliminary Response. Prelim. Resp. 10. 1 In addition to other changes to Title 35, the AIA introduced amendments to 35 U.S.C. § 102. Because Patent Owner concedes that the ’725 application “contains, or contained at any time, a claim to a claimed invention that has an effective filing date on or after March 16, 2013” (Ex. 1022), the AIA version of § 102 applies to the ’109 patent. AIA § 3(n)(1)(B); Ex. 1001, 1:11–14 (claiming priority to the ’725 application). 2 US 2019/0241629 A1, published August 8, 2019 (“the ’629 publication” (Ex. 1015)). At this stage, we find Petitioner’s description of the level of ordinary skill in the art sufficiently supported by the record and apply it for purposes of this decision.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither party proposes an express construction of any claim term. See Pet. 22–23; Prelim. Resp. 10. We determine that no express claim construction is necessary based on the present record.” slip op. at 10
- Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable
“To show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23– 24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in which a POSA would have understood the prior art, or what a POSA would have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [written description] test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description.” slip op. at 12
Claim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 11,959,109 - PTAB · Jul 16, 2025 · PGR2025-00012 · APJ Debra L Dennett · PGR · Institution
Instituted PGR on claims 1–3 based on five grounds; the Board found each ground met the institution threshold on the preliminary record.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority to determine whether to institute a post-grant review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). A post-grant review may also be instituted when “the petition raises a novel or unsettled legal question that is important to other patents or patent applications.” See id. § 324(b). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition, Preliminary Response, and the evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 1–3 of the ’201 patent.” slip op. at 2
- Skill levelSkill level board ownOther
“At this stage of the proceedings, neither Petitioner’s nor Patent Owner’s proffered definitions of the level of skill appear appropriate. Petitioner’s proposal requires as little as a bachelor’s degree in organic chemistry and two years of experience as a laboratory technician working on development of molecules with targeted biological activity, and an ambiguous “understanding” of certain processes. Patent Owner’s proposal, other the other hand, requires multiple years of both formal training and actual, practical experience in highly specialized fields that involve detection of optical or radiolabeled compounds and use of molecular imaging techniques such as PET and SPECT. For the purposes of this decision, on the record at this time, we find that a POSA would have had a Ph.D. in chemistry, biochemistry, or a comparable field or an M.D., and at least four years of experience in chemical synthesis of compounds that may be used to target biologically-significant tissues. This definition appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). The parties will have the opportunity to cross-examine Dr. Martin and Dr. VanBrocklin in this proceeding to develop a full record for us to determine the weight that each expert’s testimony should be given. We invite the parties to further brief the definition of a POSA here, and whether we should discount either experts’ testimony due to lack of qualifications.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other
“c) Analysis On the present record, we find that “low molecular weight” is not limited to Patent Owner’s proposed “from about 50 Daltons to about 1,500 Daltons.” The cited evidence relied on in the Pomper Declaration all concerns metabolomics and metabolites, and we find no reason that even a vague definition of metabolites applies to the claimed compounds. See Ex. 1002, ¶ 102. Moreover, the uncontested fact that several of the B moieties alone—without the A moiety or L linker—specifically identified in the ’201 patent fall outside of Patent Owner’s proposed definition is persuasive (see id., ¶ 103), as we normally do not interpret claim terms in a way that excludes examples disclosed in the specification. See, e.g., Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1305 (Fed. Cir. 2007) (rejecting proposed claim interpretation that would exclude disclosed examples in the specification). In addition, the opinion stated in the Pomper Declaration that “the term of ‘low molecular weight’ is well accepted in the chemical arts’” and the declarant “recognize[s] that low molecular weight compounds would have a molecular weight of typically form about 50 Daltons to about 1,500 Daltons” is offered by a co-inventor. We, as factfinder, have discretion to weigh the credibility of expert witnesses and to give each item of evidence such weight as appropriate. See In 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.”). In this case, we find that the published references on metabolites do not support the opinion. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d at 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.”) The Pomper reference (Ex. 1006) also uses the term “low molecular weight”—without further characterization of the term—and is uninformative as to the meaning of the term. See Ex. 2002, ¶ 60; Ex. 1006, ¶ 12. The table giving the molecular weight of a “selection of compounds disclosed by Pomper” (see Ex. 2002, ¶ 62) is not persuasive in defining “low molecular weight,” as it does not explain how those included were “selected” and does not include molecular weights for all of the examples.7 In addition, Patent Owner’s definition does not appear to apply to all claimed compounds.8 7 At least one of the examples (SRV73) not included in the table appears to have a molecular weight well over “about 1,500 Daltons.” 8 See, e.g., claim 113 of Ex. 1006. Patent Owner’s arguments distinguishing “low molecular weight” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“The ’201 patent defines “alkyl” as “a straight (i.e., unbranched) or branched chain, acyclic or cyclic hydrocarbon group, or combination thereof” “ that has “the number of carbon atoms designated (i.e., C1–C10 means one to ten carbons, including 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 carbons)” and “[i]n particular embodiments, the term ‘alkyl’ refers to C1-20 inclusive, including 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, and 20 carbons” “unless otherwise stated.” Ex. 1001, 39:44–58. Although substituents at the R1x position in the claims are limited to “C1-6alkyl,” those at position R3x are not. Ex. 1001, Certif. Corr. Patent Owner’s representation that “Jansen I provides ‘the following definitions’ stating that ‘alkyls groups of this invention comprise from 1 to 6 carbon atoms’” is inaccurate. See Prelim. Resp. 19. In fact, Jansen I states: The term “alkyl” by itself or as part of another substituent refers to a fully saturated hydrocarbon of Formula CxH2x+1 wherein x is a number greater than or equal to 1. Generally, alkyl groups of this invention comprise from 1 to 6 carbon atoms. Alkyl groups may be linear or branched and may be substituted as indicated herein. When a subscript is used herein following a carbon atom, the subscript refers to the number of carbon atoms that the named group may contain. Ex. 1007, 22:16–23 (emphasis added). Neither the ’201 patent nor its incorporation by reference of Jansen I would have conveyed to a POSA that the “(CO)alkyl” of the substituent in the R3x position in the claims is intended to comprise from one to six carbon atoms or is limited to any particular length and size. “(C(O)alkyl,” having no number of carbon atoms designated, means” slip op. at 15
Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · NautilusPatents in suitUS 11,938,201 - Painteq, LLC v. Orthocision, Inc.All claims unpatentablePTAB · Dec 1, 2023 · IPR2023-00451 · APJ Michael A Valek · IPR · Final written decision
Claims 1–23 are unpatentable as obvious over Vestgaarden-981, Vestgaarden-818, and Lins, with Paltzer additionally applied to claims 6, 7, and 10–23.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner’s description of the level of ordinary skill in the art is sufficiently supported by the record. Therefore, we apply that understanding in our analysis herein.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner submits that the parties have submitted joint claim construction in the Florida litigation, and asserts that “[t]he grounds set forth in this [P]etition render the challenged claims obvious under either party’s construction.” Pet. 8 (citing Ex. 1002 ¶ 34; Ex. 1017). Nevertheless, Petitioner urges that “express construction is not necessary.” Id. at 7. We agree that no express construction is required for this decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017); Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).” slip op. at 9
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“We agree with Petitioner. Figures 30, 32A and 32B in the Specification depict a working channel with tangs 180a and 180b. See Ex. 1001, Figs. 30, 32A–B. These figures and all of the related description in the Specification describing a working channel with tangs appear in the Parent (Ex. 1006, Figs. 30, 32A–B, 3:17–21, 6:47–54, 15:25–51), but not in the Grandparent. See also Ex. 1002 ¶¶ 42–43 (explaining the same). Accordingly, the Grandparent application does not provide sufficient written description for the limitations requiring that the working channel have tangs in the independent claims. See Ex. 1001, 42:7 (limitation 1.b.4 “at least one tang on a distal end”), 43:9–11 (limitation 10.b.2 “two bilateral blunt tangs on a distal end”), 44:31–32 (limitation 18.b.2 “plurality of blunt tangs on a distal end”). For this reason, the challenged claims are not entitled to the benefit of the Grandparent’s filing date.” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“We find that Petitioner has articulated sufficient reasoning with rational underpinning for combining the asserted references. Vestgaarden- 818 expressly incorporates the teachings of Vestgaarden-981, providing a motivation to use the implant and related tools taught in Vestgaarden-981 in its method for fusing a SI joint. Ex. 1010, 4:10–16. Moreover, we credit Dr. Bovinet’s testimony describing additional reasons for combining Vestgaarden-981’s implant and surgical implants with Vestgaaren-818’s method. Ex. 1002 ¶¶ 67–74. Petitioner’s reasoning for combining Lins’s guidance slots and protrusions is also supported by the evidence of record. Ex. 1002 ¶¶ 77–84. In particular, Dr. Bovinet persuasively testifies that a POSA would have motivated to make this combination because it “enables a surgeon to visually align the guide protrusions on a shaft with the guidance slots of the working channel,” which is “a major improvement” over the flat portion depth stop taught in Vestgaarden-981. Id. ¶ 83; see also id. ¶ 84 (“As someone who has personally performed hundreds of SI joint fusion surgeries, I can attest that the guide protrusions and guidance slots taught in Lins would offer a surgeon a significantly better user experience” as compared to Vestgaarden- 981’s flat portions). Finally, Petitioner has demonstrated that the combination would have produced a “predictable result” and therefore that a (citing Ex. 1002 ¶¶ 76, 85).” slip op. at 21
Patent outcomesUS 11,083,511 unpatentableClaim construction§ 103 obviousness§ 112 disclosurePatents in suitUS 11,083,511 - Nextremity Solutions, Inc. / Zimmer Biomet Holdings, Inc. et al. v. Extremity Medical, LLCAll claims unpatentablePTAB · Jul 26, 2023 · IPR2022-00802 · APJ Jeffrey N Fredman · IPR · Final written decision
Claim 59 is unpatentable as anticipated by Brumfield, Marcus, and Chandran; the motion to amend proposing substitute claim 62 is denied because claim 62 is unpatentable.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“We find this argument unpersuasive. As Patent Owner notes, Petitioner’s expert provides a definition of POSITA that is very similar to that recited by Patent Owner in its Motion to Amend, substantively differing only in the number of years of experience of the engineer at issue. This congruity supports the conclusion that the level of ordinary skill in the art may be recognized in the prior art itself. Okajima, 261 F.3d at 1355 (“the absence of specific findings on the level of skill in the art does not give rise to reversible error ‘where the prior art itself reflects an appropriate level and a need for testimony is not shown’”).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“In our Institution Decision, we agreed with Petitioner that the “portion of the preamble reciting ‘for compressing bone’ is not limiting to the claim” and found that other terms did not require construction. Dec. 8–9. We agreed with Petitioner that “[t]he phrase ‘for compressing bone’ merely identifies an intended use.” Pet. 20; Dec. 9. Patent Owner does not dispute this interpretation. See generally PO Resp. We agree with Petitioner that “the patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). Therefore, having considered the entire record developed during trial, we adhere to the preliminary construction that the limitation “for compressing bone” does not impose a structural limitation on claim 59 and that the other terms do not require construction.” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Patent Owner disputes the Petition generally but Patent Owner does not identify any error in Petitioner’s foregoing arguments. Accordingly, we adopt the factual statements regarding the specific teachings of the references as findings of fact. See generally In re NuVasive, 841 F.3d 966, 974 (Fed. Cir. 2016) (explaining that the Board need not make specific findings as to claim limitations that Patent Owner does not dispute are disclosed in the prior art). We have reviewed Petitioner’s analysis and the underlying evidence cited in support and conclude that Petitioner has shown, by a preponderance of the evidence, that the limitations of claim 59 are disclosed by Brumfield.” slip op. at 26
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied
“For the reasons discussed below, Patent Owner has shown that proposed substitute claim 62 meets the statutory and regulatory requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121. For the reasons discussed below, however, Petitioner has proven by a preponderance of the evidence that proposed substitute claim 62 is unpatentable over prior art. Therefore, we deny Patent Owner’s Revised Motion to Amend.” slip op. at 38
Patent outcomesUS 8,303,589 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · NautilusPatents in suitUS 8,303,589 - Painteq, LLC v. Orthocision, Inc.InstitutedPTAB · Jul 12, 2023 · IPR2023-00451 · APJ Michael A Valek · IPR · Institution
The Board instituted IPR on claims 1–23 based on all petition grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“On the current record, we determine that the Petition demonstrates “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Accordingly, we institute an inter partes review.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have had a medical or an engineering degree and would have had experience with surgical instruments and implants used for spinal joint fusion, including [sacroiliac (“SI”)] joint fusion.” Pet. 7 (citing Ex. 1002 ¶ 15). At this stage, we find Petitioner’s description of the level of ordinary skill in the art to be sufficiently supported by the record and apply it for purposes of this Decision. slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner submits that the parties have submitted joint claim construction in the Florida litigation, and asserts that “[t]he grounds set forth in this [P]etition render the challenged claims obvious under either party’s construction.” Pet. 8 (citing Ex. 1002 ¶ 34; Ex. 1017). Nevertheless, Petitioner urges that “express construction is not necessary.” Id. at 7. At this stage of the proceeding and for purposes of instituting trial, we determine that there are no terms that require express construction. See” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“We agree with Petitioner. Figures 30, 32A and 32B in the Specification depict a working channel with tangs 180a and 180b. See Ex. 1001, Figs. 30, 32A–B. These figures and all of the related description in the Specification describing a working channel with tangs appear in the Parent (Ex. 1006, Figs. 30, 32A–B, 3:17–21, 6:47–54, 15:25–51), but not in the Grandparent. See also Ex. 1002 ¶¶ 42–43 (explaining the same). Accordingly, based on the current record, we find that the Grandparent application does not provide sufficient written description for the limitations requiring that the working channel have tangs in the independent claims. See Ex. 1001, 42:7 (limitation 1.b.4 “at least one tang on a distal end”), 43:9–11 (limitation 10.b.2 “two bilateral blunt tangs on a distal end”), 44:31–32 the challenged claims are not entitled to the benefit of the Grandparent’s filing date.” slip op. at 9
Claim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,083,511 - PTAB · Apr 24, 2023 · IPR2023-00074 · APJ Erica A Franklin · IPR · Institution
The Board instituted IPR on claims 1, 2, 5–8, 11, and 15 on all asserted grounds, finding a reasonable likelihood that claims 1, 2, 5–7, and 11 are obvious over the May Article.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Based on our review of the record, we find that Petitioner has not shown persuasively that the Examiner did not consider the same or substantially the same art that Petitioner relies upon for its obviousness challenges. Petitioner’s grounds primarily rely on three different “May” references, only one of which the Examiner considered during prosecution, i.e., the May Article. The additional primary references relied upon by Petitioner are the May Thesis, which provides a more detailed disclosure than the May Article, and the May Abstract, which provides less detail than the May Article, in terms of the HS2, HS3, and HS4 fragments used to generate the disclosed TNS9 vector. Those differences are only material with respect to whether each reference discloses the fragments as recited in independent claim 1, or renders those fragments obvious. As discussed in Section II.D.2., however, we determine that the May Thesis is not prior art. 11 The ’221 application claims priority to provisional application no. 60/301,861 (Ex. 1034) (“the ’861 provisional application”), filed June 29, 2001, and provisional application no. 60/302,852 (Ex. 1035) (“the ’852 provisional application”), filed on July 2, 2001, referred to, collectively, as “the provisional applications,” “the provisionals” and “the Provisionals.” Article, but in less detail, the May Abstract may be considered cumulative to the May Article. Because the May Thesis provides more explicit details regarding the fragments disclosed in the May Article, it may not be considered to be cumulative to the May Article. However, as discussed in Section II.D.2., we determine that the May Thesis is not prior art. When considering the extent of the overlap between the arguments made during examination and the manner in which Petitioner relies on the May Article or Patent Owner distinguishes the May Article, we note that Patent Owner alleged during prosecution and here that the May Article is not prior art for a number of reasons, including that it is the work of the inventors and that it was published one year or less before the priority date asserted by Patent Owner for the challenged claims. We note also that Petitioner contends that the challenged claims are not entitled to the priority date asserted by Patent Owner, and recognized by the Examiner. Based on the foregoing, we conclude that substantially the same prior art that Petitioner relies upon was previously presented to the Examiner during prosecution. The first part of the § 325(d) framework is, therefore, met. Accordingly, we turn to the second part of the § 325(d) and determine whether error by the Office has been shown. See Advanced Bionics at 8.” slip op. at 10
- Skill levelSkill level petitioner adoptedOther
“Petitioner asserts that a person of ordinary skill in the art (“POSA”) “at the time of the alleged invention would have had: (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, biotechnology, protein chemistry, genetics, molecular and structural biology, bioengineering, or similar disciplines.” Pet. 18–19 (citing Ex. 1002 ¶¶ 14– 15). Petitioner further asserts that a POSA would have had “(2) several years of post-graduate training or related experience in one or more of these areas” and “(3) an understanding of vector design and the effect of LCR fragments on gene expression, including experience with how the LCR regulates gene expression.” Id. At this stage in the proceeding, Patent Owner does not dispute Petitioner’s description of the level of ordinary skill in the art. See Prelim. Resp. Because Petitioner’s uncontested definition of one of ordinary skill in the art is reasonable and consistent with the ’061 patent and the prior art of record, we adopt Petitioner’s definition for purposes of this Decision.” slip op. at 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner states that “that no term of the ’061 patent requires construction to resolve the challenges in this Petition.” Pet. 25 (citing Ex. 1002 ¶¶ 50–51) (footnote omitted). Patent Owner does not argue for any express claim constructions. See Prelim. Resp. Based upon our review of the current record, we determine that no claim terms require express construction for purposes of deciding whether to institute an inter partes review of the challenged claims. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (Only those terms that are in controversy need be construed, “and only to the extent necessary to resolve the controversy.”).” slip op. at 16
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.” Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). Rather, “the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). Based on our consideration of the arguments and evidence presented at this stage of the proceeding, we determine, for purposes of this Decision, that claims 1, 2, 5–7, and 11 of the ’061 patent are not entitled to receive benefit of the filing date for either the ’861 provisional application or the ’852 provisional application. In particular, we find persuasive Petitioner’s arguments that the provisional applications do not satisfy the written description requirements of 35 U.S.C. § 112 for those claims. Independent claim 1 recites, in part, “a recombinant lentiviral vector which comprises a nucleic acid encoding a functional globin operably linked to a 3.2-kb nucleotide fragment . . . said vector providing expression of the globin in a mammal in vivo.” Ex. 1001, 11:57–67. Independent claim 11 recites, in part, “a recombinant lentiviral vector comprising a nucleic acid encoding a functional globin operably linked to a 3.2-kb nucleotide fragment . . . said vector providing expression of the globin in a mammal in vivo.” Ex. 1001, 12:64–13:7. Based upon our review, we agree with Petitioner that these limitations are not adequately described in the provisional applications. The ’061 patent Specification (and the ’221 Application) describe the term “functional globin gene” as: that does not produce a hemoglobinopathy phenotype, and which is effective to provide therapeutic benefits to an individual with a defective globin gene. The functional globin gene may encode a wild-type globin appropriate for a mammalian individual to be treated, or it may be a mutant form of globin, preferably one which provides for superior properties, for example superior oxygen transport properties. . . . Suitably, the globin may encode α-globin, β-globin, or γ-globin. Ex. 1001, 2:44–55 (emphasis added); see also Ex. 1032, 3:24–4:3 (same). Based on this description, we agree with Petitioner that the ’061 patent claims cover a recombinant vector comprising a nucleic acid encoding a “functional globin” genus that includes wild-type globin and mutant forms of globin, wherein the globin may encode different globin types, i.e., α-, β-, or γ-globin. Patent Owner does not identify, nor do we see, any portion of the provisional applications describing the genus of functional globin. Rather, as Petitioner demonstrates, the provisional applications describe one species of that genus, i.e., the wild-type human β-globin. Pet. 14–18. The provisionals do not describe the “functional globin” genus. Indeed, as Petitioner correctly asserts, during the ’061 patent prosecution, Applicants/Patent Owner, relied on a description of “functional globin,” quoted above, that does not appear and has not counterpart in the provisional applications. Compare Ex. 1001, 2:44–55 and Ex. 1032, 3:24–4:3 with Ex. 1034 and Ex. 1035.” slip op. at 21
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 8,058,061 - PTAB · Apr 24, 2023 · IPR2023-00070 · APJ Erica A Franklin · IPR · Institution
The Board instituted IPR of claims 1, 10, 19, and 22 on all asserted grounds, finding a reasonable likelihood that claim 1 is obvious over the May Article.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“In evaluating matters under § 325(d), the Board uses the following two-part framework: (1) determining whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, determining whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, Paper 6 at 8.” slip op. at 7
- Skill levelSkill level petitioner adoptedOther
“Petitioner asserts that a person of ordinary skill in the art (“POSA”) “at the time of the alleged invention would have had: (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, biotechnology, protein chemistry, genetics, molecular and structural biology, bioengineering, or similar disciplines.” Pet. 17 (citing Ex. 1002 ¶¶ 14–15). Petitioner further asserts that a POSA would have had “(2) several years of post-graduate training or related experience in one or more of these areas” and “(3) an understanding of vector design and the effect of LCR fragments on gene expression, including experience with how the LCR regulates gene expression.” Id. At this stage in the proceeding, Patent Owner does not dispute Petitioner’s description of the level of ordinary skill in the art. See Prelim. Resp. Because Petitioner’s uncontested definition of one of ordinary skill in record, we adopt Petitioner’s definition for purposes of this Decision.” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner states that “no term of the ’179 patent requires construction to resolve the challenges in this Petition.” Pet. 22 (citing Ex. 1002 ¶¶ 49– 50) (footnote omitted). Patent Owner does not argue for any express claim constructions. See Prelim. Resp. Based upon our review of the current record, we determine that no claim terms require express construction for purposes of deciding whether to institute an inter partes review of the challenged claims. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (Only those terms that are in controversy need be construed, “and only to the extent necessary to resolve the controversy.”).” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“As the Federal Circuit has noted, however, “[i]n order to satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.” Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). Rather, “the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010).” slip op. at 20
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 7,541,179 - Sandoz Inc. v. Boehringer Ingelheim International GmbHInstitution deniedPTAB · Nov 7, 2022 · PGR2022-00037 · APJ Devon Zastrow Newman · PGR · Institution
The Board denied institution because Petitioner did not show that the patent was eligible for post-grant review; the challenged claims were entitled to the pre-AIA priority date.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Accordingly, we find that Petitioner has not identified any challenged claim that has an effective filing date on or after March 16, 2013. For this reason, we find that Petitioner has not shown sufficiently that the ’265 patent is eligible for post-grant review. IV. CONCLUSION After considering the evidence and arguments presently before us, we determine Petitioner has not shown that the ’265 patent is eligible for post-grant review. Accordingly, we do not institute a post-grant review. V. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(d), the Petition is denied.” slip op. at 29
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“To interpret “stable,” we begin with how the term is used in independent claims 7 and 19. Both terms recite “stable” in relation to the pharmaceutical formulation as a whole by reciting “wherein the formulation is stable.” Ex. 1001, 189:62–190:27. From this, we conclude that the ordinary artisan, as defined above to have a relevant advanced degree and at least two years of experience in development or manufacture of therapeutic protein formulations, would have understood that the components of a “stable” formulation would maintain their integrity and desired function following preparation, including when stored as described. This meaning is supported by the following language in the specification pertaining to the disclosed pharmaceutical compositions: Pharmaceutical compositions according to the present invention are described in further details hereinbelow. In one aspect, the pharmaceutical compositions disclosed herein are physico-chemically stable and maintain the integrity of an antibody comprised in said pharmaceutical composition, for example when stored for 8 weeks at 40° C. as shown hereinbelow. Ex. 1001, 84:20–26. We also note, as Petitioner argued, that the prosecution history supports that the formulation components needed to remain functional during storage, and that Patent Owner cited to formulation integrity after a storage period of 8 weeks at 40° C as evidence of such integrity. Ex. 1004, 7380. As disclosed in the ’265 patent, Examples 9 and 12 measure function and identity of the components following storage to confirm formulation stability.” slip op. at 11
- Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable
“burden of showing that claim 7 or 14 lacks written description support in the priority application, which Petitioner has conceded provides the same support as the ’265 patent specification. In this regard, we agree that the reasoning in Fresenius likewise applies: there is no legal requirement that a patent specification must include test results or working examples demonstrating stability for every possible composition that is covered by the claims. Fresenius at 13, citing Ariad Pharms., 598 F.3d at 1352 (stating that “the written description requirement does not demand either examples or an actual reduction to practice”). Formulations 2 and 3, disclosed in the ’265 patent specification, which Petitioner acknowledges falls within the scope of claims 7 and 14 (Pet. 26–27 (citing Ex. 1002 ¶¶ 134, 135)), were shown to be stable for 8 weeks in a syringe. Moreover, the ordinary artisan was provided with guidance in making such formulations from the teachings of the specification and has additional knowledge from the art. See Ex. 1001, 85:32–94:35. Claims 7 and 14 identify specific structures (risankizumab) and required excipients within a defined pH range, which are stable as confirmed by testing results presented in the specification. Prelim. Resp. 33; Ex. 1001, 94:14–36. On this record, we conclude that the evidence presented does not establish that it is more likely than not that an ordinarily skilled artisan would not have reasonably believed that the inventors of the ’265 patent possessed the claimed subject matter, each limitation of which is demonstrated as supported in the specification. As we have interpreted the claim term “wherein the formulation is stable” to mean “wherein the formulation maintains the functional integrity of the antibody and other components, for example when stored for 8 weeks at 40° C,” the specification supports maintenance of functional integrity as shown by the stability of Formulations 2 and 3, including when stored for a period of time. For this reason, we find that Petitioner has not shown that the ordinary artisan would not have understood the inventors of the ’265 patent possessed the subject matter of claims 7 and 14 as of the filing date of the priority application.” slip op. at 23
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not shown unpatentable
“We acknowledge that in the Fresenius case, the extensive testing disclosed in that specification supported the ordinary artisan’s ability to formulate stable compounds using such guidance, and that the specification here discloses less testing. See, e.g., Sur-Reply. 8–9. Nevertheless, it is Petitioner’s burden on this issue, and we are not persuaded that the concerns raised by Dr. Klibanov provide sufficient evidence of actual instability to justify institution on this record. See, e.g., Atlas Powder Co. v. E.I. du Pont De Nemours & Co., 750 F.2d 1569, 1577 (Fed. Cir. 1984) (finding lack of evidence that district court erred in upholding claims as enabled where defendant did not identify inoperable embodiments despite extensive testing). In particular, we are persuaded that, on this record, Petitioner’s lack of evidence of instability of any formulation falling within the limitations of claim 14 indicates that Petitioner has not established sufficiently, for purposes of trial institution, that it is more likely than not that an ordinarily skilled artisan would not have been able to practice the full scope of claim 14 invention based on the teachings of the specification.” slip op. at 28
Claim construction§ 112 disclosurecites PhillipsPatents in suitUS 11,078,265 - Askeladden LLC v. Leigh M. RothschildAll claims unpatentablePTAB · Nov 19, 2020 · IPR2019-00855 · APJ Mitchell G Weatherly · IPR · Final written decision
The Board canceled original claims 1, 2, 11, 14–19, and 21 and denied the motion to amend because the proposed substitute claims were obvious over Karthik, Robinson, and Ortiz.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner
“The claim language itself implies that the financial services provider decides which biometric information is required during the enrollment stage because the Decision Limitation is added to element 17A, which is the first step in the enrollment stage recited in elements 17A–D. However, “in assessing definiteness, claims are to be read in light of the patent’s specification and prosecution history.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 908 (2014). Patent Owner identifies support for the Decision Limitation in the Specification that favors interpreting the Decision Limitation as occurring during the transaction stage (i.e., during elements 17E–G). Mot. 14–15 (citing Ex. 1001, 9:9–14). The cited portion of the Specification states: “In another embodiment, the financial service provider may have the system set up such that the server 114 queries through the point-of-sale terminal 102 and informs the merchant which biometric identification data is/are required for the desired transaction.” Ex. 1001, 9:9–14 (emphasis added). The plain language of the claim is consistent with our interpretation because it specifies that the biometric data is the data “required for the transaction,” which refers to the “transaction” recited in element 17G (describing the operation of the claimed system during a transaction stage). Based on our review of the Specification and claim language, we conclude that the Decision Limitation is sufficiently definite under 35 U.S.C. § 112, ¶ 2. Based on that review, we also interpret the Decision Limitation to require that the financial services provider informs, through the server, which type(s) of user biometric identification data must be received at the terminal (e.g., a point-of-sale terminal) to validate the transaction. E. WHETHER THE MOTION MEETS THE REQUIREMENTS OF 35 U.S.C. § 316(d) AND 37 C.F.R. § 42.121” slip op. at 14
- Disclosure Requirements (§112) › Definiteness (Nautilus)DefiniteDecided for patent owner
“The claim language itself implies that the financial services provider decides which biometric information is required during the enrollment stage because the Decision Limitation is added to element 17A, which is the first step in the enrollment stage recited in elements 17A–D. However, “in assessing definiteness, claims are to be read in light of the patent’s specification and prosecution history.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 908 (2014). Patent Owner identifies support for the Decision Limitation in the Specification that favors interpreting the Decision Limitation as occurring during the transaction stage (i.e., during elements 17E–G). Mot. 14–15 (citing Ex. 1001, 9:9–14). The cited portion of the Specification states: “In another embodiment, the financial service provider may have the system set up such that the server 114 queries through the point-of-sale terminal 102 and informs the merchant which biometric identification data is/are required for the desired transaction.” Ex. 1001, 9:9–14 (emphasis added). The plain language of the claim is consistent with our interpretation because it specifies that the biometric data is the data “required for the transaction,” which refers to the “transaction” recited in element 17G (describing the operation of the claimed system during a transaction stage). Based on our review of the Specification and claim language, we conclude that the Decision Limitation is sufficiently definite under 35 U.S.C. § 112, ¶ 2. Based on that review, we also interpret the Decision Limitation to require that the financial services provider informs, through the server, which type(s) of user biometric identification data must be received at the terminal (e.g., a point-of-sale terminal) to validate the transaction. E. WHETHER THE MOTION MEETS THE REQUIREMENTS OF 35 U.S.C. § 316(d) AND 37 C.F.R. § 42.121” slip op. at 14
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied
“Petitioner argues that if Patent Owner were to argue that the Decision Limitation can be met by the financial services provider deciding which biometric information is required for a transaction during the enrollment or transaction stages, then the claims would be unpatentable for lack of written description support in the Specification. Opp. 8. Petitioner concedes that the portion of the Specification relied upon by Patent Owner for support describes making the decision about what biometric information is needed during the transaction stage. Id. at 9. As explained in Part II.D above, we have narrowly interpreted the Decision Limitation to encompass only such decisions. Accordingly, Petitioner does not persuade us that the Specification fails to provide the required written description for the 7 Normally, a Patent Owner must identify material in the originally filed application leading to issuance of the patent at issue that supports the proposed amendment. Lectrosonics, Paper 15 at 7. Failing to cite the original disclosure is a basis for denying a motion to amend. Id. However, because Patent Owner appears pro se, we reviewed the original disclosure ourselves to verify that the portion of the Specification cited is identically found in that disclosure. Compare Ex. 1016 ¶ 42, with Ex. 1001, 9:9–14. Accordingly, in this case, we find that Patent Owner’s citation to the Specification functionally refers to material in the original disclosure. Decision Limitation as we have interpreted it. Additionally, we conclude that Patent Owner has established that the Specification meets the written description requirement for the Decision Limitation. F. PROPOSED SUBSTITUTE CLAIMS 1, 2, 11, 14–19, AND 21:” slip op. at 17
- ScopeDecided for patent owner
“3. Whether the Amendments Enlarge the Scope of the Claims An amendment may not enlarge the scope of the claims of the patent. 35 U.S.C. § 316(d)(3); 37 C.F.R. § 42.121(a)(2)(ii). We determine that Patent Owner’s addition of the Decision Limitation narrows the scope of every challenged claim and thus satisfies the prohibition against enlarging the scope of any claim.” slip op. at 16
Patent outcomesUS 8,799,088 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Graham · NautilusPatents in suitUS 8,799,088 - Edmit Industries, Inc. v. Smartdoor Holdings, Inc.All claims unpatentablePTAB · Mar 29, 2016 · IPR2015-00013 · APJ James A Worth · IPR · Final written decision
Claims 16–17 are unpatentable over Shea and Burke; claim 18 over Shea, Burke, and O’Brien; and claim 27 over Shea, Burke, and Leivenzon. The motion to amend is denied.
RulingsFinal written decision- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“Patent Owner disagrees for three reasons. First, Patent Owner implies that Burke is not analogous art because Burke does not disclose a door. See PO Resp. 6. Art is analogous when it is: (1) from the same field of endeavor as the claimed invention; or (2) reasonably pertinent to the particular problem faced by the inventor, if the art is not from the same field of endeavor. See In re Bigio, 381 F.3d 1320, 1325–26 (Fed. Cir. 2004). In this case, as observed by Petitioner’s Declarant, Burke expressly describes an application “as in cases where an electrical braking action is required.” Ex. 1004 ¶ 25 (quoting Ex. 1003, 1:18–22). Thus, even under Patent Owner’s argument that Burke is not specific to the field of doors, we agree with Petitioner’s Declarant that Burke is relevant to the problem of braking in electrified devices. Burke discloses an approach to that problem by absorbing energy from a motor, operated as a generator, for the purpose of braking. Ex. 1003, 1:16–25, 3:11–12.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“brake shoes based on the application of centrifugal force. Ex. 1009, 5:59– 63. Petitioner’s assertion is that a person of ordinary skill would have found it obvious to use a different braking mechanism as a substitute for a governor to achieve the same function. In particular, Petitioner proposes substitution of the frictional braking mechanism of Shea (i.e., a braking mechanism that is purely mechanical), with the dissipative braking mechanism of Burke (i.e., a braking mechanism that also converts mechanical energy to electrical energy). In this case, the fire door of Shea, with the motor/generator of Burke substituted for the motor/governor of Shea, would operate to blunt or slow the movement of the door on descent while allowing the door to close. See Ex. 1004 (Haas Decl.) ¶ 26. We determine that the asserted combination of Shea and Burke would operate in the same manner as the fire door of Shea—to slow the movement of the door, while allowing the door to close under the force of gravity. Id. ¶ 24. We agree with Petitioner’s Declarant that this would have been an obvious substitution as the use of a known technique to improve functionality. See id. ¶ 26. Petitioner’s proposed combination is thus the substitution of an electrical component for an analog component, which does not destroy the principle of operation because it does not destroy the overall principle of operation of the device. See Mouttet, 686 F.3d at 1332. We conclude that this type of fitting together of teachings would have been obvious to a person of ordinary skill in the art. KSR, 550 U.S. at 420 (“a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle”). Viewing the evidence as a whole, we conclude that a person of ordinary skill in the art would have applied the teachings of Burke regarding regenerative braking to the fire door of Shea in order to improve operation of the door and to make use of excess energy from rotation. We are further persuaded by Petitioner’s arguments that Burke teaches that the braking can have the additional advantage of powering another device and that a person of ordinary skill would have sought a substitution of components in order to achieve the advantages of Burke’s motor/generator. See Pet. Reply 11–12 (quoting Randall Mfg., 733 F.3d at 1363 (“doing so would allow the designer to achieve the other advantages of the Aquino assembly while using a stowage strategy that was very familiar in the industry”)).” slip op. at 15
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied
“However, the additional limitations would not avoid unpatentability because Burke and O’Brien both use a motor/generator system, O’Brien’s motor/generator uses DC power (Ex. 1008, 5:15), Burke and O’Brien both use regenerative braking, and Burke recites the charging of a storage battery by the motor/generator which is capable of braking (Ex. 1003, 3:4–16). Therefore, the asserted combination of Shea, Burke, and O’Brien already contains the features recited as additional limitations in proposed substitute claim 40 (and the similar recitations in proposed substitute claims 41 and 42). We have already concluded supra, that the combination of Shea, Burke, and O’Brien would have been obvious to a person of ordinary skill in the art. Patent Owner does not explain why the additional recitations of its proposed substitute claims would have been nonobvious over this combination. Mot. Amend 4–14. Patent Owner argues that the combination of Shea and Burke would not make use of a DC battery by itself to open or close a door. Id. at 11–12. However, nothing in the additional limitations of proposed substitute claims 40–42 requires that a DC battery provide power to open or close a door without an additional power supply (as discussed above with respect to claim 16). More importantly, the combination of Shea, Burke, and O’Brien would make use of the DC-powered components—the DC motor/generator of O’Brien. Ex. 1008, 5:4–15. Burke discloses using the motor/generator to charge a battery with the regenerated energy. Ex. 1003, 3:12–13. Therefore, the combination of Shea, Burke, and O’Brien already contains the elements of the additional limitations. We conclude that Patent Owner has not met its burden of proving that the additional recitations of proposed substitute claims 40–42 would have been nonobvious over this combination. See Paper 15, 4–16.9” slip op. at 23
- Disclosure Requirements (§112) › Definiteness (Nautilus)DefiniteDecided for patent owner
“As to Petitioner’s argument that proposed substitute claim 43 is indefinite, we determine that the term “substantially uniform speed” is reasonably clear to a person of ordinary skill when read in context of the entire claim limitation and disclosure, which requires the application of “more and more braking” to compensate for the dynamics of the door during closing, e.g., to offset the potential for acceleration due to gravity. Ex. 1001, 12, 19–29; see In re Packard, 751 F.3d 1307, 1311 (Fed. Cir. 2014).” slip op. at 25
Patent outcomesUS 6,484,784 unpatentable§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 6,484,784
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.