- 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 · Sep 9, 2025 · IPR2025-00440 · APJ Tawen Chang · IPR · Institution
The Board instituted IPR of claim 21 on both asserted § 103 grounds, finding a reasonable likelihood that claim 21 is obvious over Mizumura with the ’498 PCT and over Mizumura with McClymont.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons discussed below, we determine Petitioner has demonstrated a reasonable likelihood that the challenged claim of the ’318 patent is unpatentable. Accordingly, we institute an inter partes review of the challenged claim on each of the Grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther
“Nevertheless, we determine that the contrary evidence Petitioner has cited suffices to establish a reasonable likelihood of success at this preliminary stage of the proceeding. In this regard, we also note Dr. Jain’s testimony — currently unrebutted — that an ordinarily skilled artisan would have known, based on Tokunaga’s sequence comparisons of Factor C proteins, that “certain sequence differences between [Limulus polyphemus] and Tachypleus tridentatus were non-conservative (i.e., potentially giving rise to changes in function in terms of enzymatic activity of Factor C).” Ex. 1002 ¶ 94 (citing Ex. 1022, 157). We likewise note Dr. Jain’s testimony that such artisan would have recognized Tokunaga’s conclusion, regarding “immunological and biochemical properties” of Factor C proteins of the two different horseshoe crab species, to be “based on only gross biophysical-biochemical properties” that are not “granular enough” to predict functional properties such as residual activity in presence of specific ions. Ex. 1002 ¶ 100.” slip op. at 22
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledOther
“submitted in a different proceeding and in a different forum, and our rules contemplate objections to admissibility only after institution. See 37 C.F.R. § 42.64(b)(1) (“Any objection to evidence submitted during a preliminary proceeding must be filed within ten business days of the institution of the trial.”); also compare Fed. R. Evid. 801(c) (defining hearsay as a statement, not made at the current trial or hearing, “offer[ed] in evidence to prove the truth of the matter asserted”), with Fed. R. Evid. 801(d)(2) (excluding from hearsay statement offered against an opposing party where statement was made by “a person whom the party authorized to make a statement on the subject” or by a “party’s agent or employee on a matter within the scope of that relationship and while it existed”). Nevertheless, as discussed above, Petitioner has provided contrary evidence, including statements from Patent Owner’s patent application, suggesting that, “due to the various differences and diversity of biomolecules depending on the genus and species of the horseshoe crab,” it had not been possible “to accurately determine the full-length sequence structure, expression, and function of [Limulus] proteins and genes using conventional methods” more than 20 years after complete gene and amino sequences from two Tachypleus horseshoe crab species had been reported. Pet. 35 (citing, e.g., Ex. 1005 ¶¶ 12–17). Thus, even if we were to take the Frohman Declaration into account, we find that Petitioner has established a reasonable likelihood 28 of success that the ’767 application disclosures did not enable an ordinarily skilled artisan to make and use the invention of the challenged claim without undue experimentation. Furthermore, assuming that the disclosures in ’767 application would have enabled an ordinarily skilled artisan to express recombinant Limulus polyphemus Factor C protein in HEK293, we find Petitioner has established, sufficient for purposes of institution, that the disclosures do not enable an ordinarily skilled artisan to make such a protein exhibiting the “full scope” of the claimed residual activity, without undue experimentation. Patent Owner cites to disclosures in the ’767 application that (1) describe how to produce recombinant Factor C in HEK293 cells and measure residual activity, (2) suggest “Factor C expressed in mammalian cells can have low susceptibility to activity inhibition by ions,” and (3) provide examples where residual activity met the required minimum. Prelim. Resp. 26–27, 32–34. Nevertheless, whether an ordinarily skilled artisan would have been able to make, based on these disclosures and without undue experimentation, a recombinant Factor C protein having residual activity encompassed by claim 21 but higher — even significantly higher — than that achieved in the example, is a fact intensive issue that would benefit from further development during trial.15 See, e.g., In re” slip op. at 28
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedOther
“the proceeding, and for the reasons set forth below, we are persuaded that Petitioner has shown sufficiently, for purposes of institution, that the ’767 application does not provide adequate written description support for claim 21 of the ’318 patent and that, accordingly, Mizumura, the ’498 PCT, and McClymont qualify as prior art to the challenged claim.” slip op. at 19
§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 11,236,318 - 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 - Catalyst Orthoscience Inc. v. Shoulder Innovations, Inc.Institution deniedPTAB · Apr 24, 2025 · PGR2025-00001 · APJ James A Tartal · PGR · Institution
The Board denied institution of post-grant review of claims 1–22, exercising its discretion under § 324(a) based on the Fintiv factors.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivInstitution denied
“1. whether the court granted a stay or evidence exists that one may be granted if a proceeding is instituted; 2. proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision; 3. investment in the parallel proceeding by the court and the parties; 4. overlap between issues raised in the petition and in the parallel proceeding; 5. whether the petitioner and the defendant in the parallel proceeding are the same party; and 6. other circumstances that impact the Board’s exercise of discretion, including the merits. Fintiv 5−6. We consider these factors to assess “whether efficiency, fairness, and the merits support the exercise of authority to deny institution in view of an earlier trial date in the parallel proceeding.” Id. at 6. In” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“parties, we do not find the merits to be particularly strong on the current record. For example, limitation [1-4] recites, in part, “a locking nut having . . . an external thread on an outside surface of the locking nut.” Ex. 1001, 9:46–47. In alleging obviousness based in part on Orphanos, Petitioner equates the claimed “locking nut” to Orphanos’s collet 230 in a first embodiment of Orphanos, or Orphanos’s collet portion 1052 in a second embodiment of Orphanos. Pet. 37–38. Petitioner acknowledges that the collet and collet portion do not have external threads, but rather are designed to have a snap-fit engagement with the inner sidewall of the baseplate’s central throughbore. Id. at 38. Petitioner argues that modifying the collet and collet portion to have external threads would have been obvious to the skilled artisan in view of Orphanos’s teachings and the knowledge of a person having ordinary skill in the art. Pet. 38–42 (arguing, inter alia, that it would have been “a substitution of a known part for a known problem” and “obvious as a matter of design choice”). Petitioner does not allege that replacing the snap-fit coupling with external threads would either: (1) result in any advantages; or (2) preserve any of Orphanos’s stated benefits of its snap-fit arrangement. See Pet. 34–37. That Petitioner describes no advantages to making its proposed modification potentially undermines Petitioner’s case that the skilled artisan would have done so. Cf. Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n.8 (Fed. Cir. 2000) (“The fact that the motivating benefit comes at the expense of another benefit . . . should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another. Instead, the benefits, both lost and gained, should be weighed against one another.”).” slip op. at 16
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITANot reached
“Petitioner’s arguments regarding the central post and locking nut include an implicit claim construction argument that these components need not be separate structures. Pet. 74, 76–81. Patent Owner, on the other hand, would have us interpret the claim to require that they be separate structures. Patent Owner raises credible evidence to support its theory. Specifically, Patent Owner directs us to the language of claim 1, which separately recites “a central screw” and “a locking nut.” Prelim. Resp. 51; see Ex. 1001, 9:44–53. Patent Owner further contends, in view of the claim language, that the claimed central post and locking nut are separate and distinct components. According to Patent Owner, however, Lefebvre’s main head and anchor rod portions are parts of a single monolithic anchoring screw. Prelim. Resp. 53–58. Where a claim lists elements separately, there is a rebuttable presumption that these elements have separate and distinct physical structures. See Google LLC v. EcoFactor, Inc., 92 F.4th 1049, 1058 (Fed. Cir. 2024) (citing Powell v. Home Depot U.S.A., Inc., 663 F.3d 1221, 1231–1232 (Fed. Cir. 2011)). The presumption may be rebutted by the intrinsic record. Id. At this stage, however, Petitioner does not address that claim 1 appears to separately recite a central post and a locking nut, and does not direct us to any portion of the intrinsic record that might rebut the presumption that these elements are, therefore, separate and distinct structures. See Pet. 73–77. Petitioner also argues that the claim terms “baseplate central channel” and “central channel . . . configured to interface with the baseplate” are indefinite. Pet. 95–102. Patent Owner argues that the plain and ordinary meaning of the terms is clear and that Petitioner “had no problem” arguing how the asserted art purportedly rendered the claims obvious. Prelim. Resp. 69–77.” slip op. at 17
- Disclosure Requirements (§112) › Definiteness (Nautilus)Not reached
“Petitioner also argues that the claim terms “baseplate central channel” and “central channel . . . configured to interface with the baseplate” are indefinite. Pet. 95–102. Patent Owner argues that the plain and ordinary meaning of the terms is clear and that Petitioner “had no problem” arguing how the asserted art purportedly rendered the claims obvious. Prelim. Resp. 69–77. In sum, even if Petitioner’s contentions show it is more likely than not that at least one of the claims challenged in the Petition is unpatentable, we find Patent Owner’s arguments identify credible weaknesses in Petitioner’s contentions. Accordingly, we find that that the sixth Fintiv factor is neutral and does not weigh against discretionary denial.” slip op. at 18
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialPatents in suitUS 12,023,254 - Apple Inc. v. Aire Technology LimitedAll claims unpatentablePTAB · Dec 15, 2023 · IPR2023-00188 · APJ Brian J Mcnamara · IPR · Final written decision
Claims 1–3, 11, 12, 16, 18, and 20 are unpatentable under the stated obviousness grounds; the motion to amend with substitute claims 23–26 is denied.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedDecided for petitioner
“We do not accord the testimony of Dr. Phinney little or no weight simply because it matches what Petitioner states in the Petition. The Xerox case cited by Patent Owner does not require or indicate otherwise. See Xerox at 1517 (noting that the deficiencies with expert testimony are that they are conclusory and lacking supporting evidence or technical reasoning.). Dr. Phinney’s testimony apprises us of why one of ordinary skill in the art would have understood the assertions made in the Petition, and his testimony is supported by evidence. We find that the declarations of Dr. Phinney are based on specific factual disclosures in the evidence of record. Therefore, we credit Dr. Phinney’s declaration testimony for the matters asserted based on the evidence and technical reasoning provided therein. Having considered the arguments and evidence of record, we” slip op. at 23
- Skill levelSkill level petitioner adoptedDecided for petitioner
“knowledgeable and familiar with the smart card and Radio Frequency Identifier (RFID) arts. Pet. 13. Petitioner states that such a “person would have a bachelor’s degree in electrical engineering, computer engineering, computer science, or equivalent training, and approximately two years of experience working in the electrical engineering field. Lack of work experience can be remedied by additional education, and vice versa.” Id. at 13. Patent Owner does not address the level of ordinary skill. See generally, PO Resp. 1 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), amended 35 U.S.C. § 103. Because the ’249 patent has an effective filing date prior to the effective date of the applicable AIA amendment, we refer to the pre-AIA version of § 103. 2 U.S. Patent No. 6,824,064 (Ex. 1005) 3 Japanese Paten Application No. 2000-163539A (Ex. 1006) 4 RFID Handbook: Radio-Frequency Identification Fundamentals and Applications, Klause Finkenzeller, 1999 (Ex. 1007) 5 Smart Card Handbook: Third Edition, Wolfgang Rankl, 2003 (Ex. 1008) references themselves. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978). As Petitioner’s description of a person of ordinary skill appears commensurate with the subject matter before us, we apply Petitioner’s definition.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“Further, although Patent Owner is correct in stating that Guthery discloses an embodiment of a request-to-send packet that includes size information, we do not agree that Guthery requires this information to be included in the request-to-send packet. Rather, we agree with Petitioner, that Guthery’s description of a request-to-send packet as shown in Figure 8, which does not include information about the size of the message, indicates that the size information is not required by the request-to-send packet in at least some embodiments of Guthery. Ex. 1005, 8:65–9:12, Fig. 8; see id. at 8:25–29 (The “present invention is not limited to the packet types discussed and in fact assumes that new types can and will be defined in the future as needed.”); 7:43–50 (“In one particular embodiment,” packets have a fixed number of bytes, but “in other embodiments, packet types may have different sizes.”). We agree with Petitioner, that Guthery discloses multiple embodiments, and the combination made by Petitioner relies on the embodiments shown in Figures 14 and 15, where the requested application only needs two buffers and therefore would know, without receiving information from the request-to-send packet, to ask for two buffers. Ex. 1005, 12:19–59. We find that a person of ordinary skill, in combining the teachings in Guthery with Nozawa to identify and initialize an application most likely to be selected by the smart card reader, would rely on (a) information about the size of a message as shown in Figure 8, (b) Guthery’s teaching of an application programmed to determine its own memory requirements (Ex. 1005, 9:25–31), and (c) Guthery’s teaching of an application that only needs two buffers as shown in Figures 15A-15D, to preemptively transmit a permission-to-send packet from the application to the reader without waiting to receive the request-to-send packet from the reader, to yield the benefit of improving efficiency and reducing latency as taught by Nozawa. See Phinney Decl. ¶¶ 55 (testifying that Guthery’s system would preemptively prepare the buffers and transmit the permissionto-send packet without waiting to receive the request-to-send packet).” slip op. at 17
- 112 supportMotion to amend, deniedDenied
“In light of the full record before us, including Patent Owner’s arguments at the Oral Hearing, we now consider whether the proposed amended claim properly encompasses a device other than the reader performing the claimed selection. We agree with Petitioner’s contention, that the “claim doesn’t tell us . . . which element performs the selection,” and that “[t]his difference . . . divorces the claim from the functionality described in the specification.” Opp. 3–4 (citing Ex. 1002, 290 (Spec. ¶ 21)). Dr. Phinney’s testimony supports this contention. Ex. 1026 ¶ 12. We do not give weight to the arguments by Patent Owner’s attorney at the Oral Hearing, because attorney argument cannot take the place of objective evidence. Gemtron Corp., 572 F.3d at 1380. This is especially true here, where the specification discloses that the reader makes the selection, but does not disclose that any other device makes or would be capable of performing the selection. Patent Owner has not shown, nor do we find, support in the disclosure of the ’706 patent for a device other than the reader performing or capable of performing a selection. Thus, based on Patent Owner’s position that the proposed claim amendment would encompass non-reader devices making the selection, the proposed amendment adds new matter and is impermissible. See Gentry Gallery Inc. v. Berkline Corp., 134 supporting disclosure, and therefore . . . a narrow disclosure will limit claim breadth.”). Accordingly, Patent Owner has not shown, nor do we find, support for “wherein after selection of one of the plurality of applications, subsequent communication between the reading device and the selected application takes place without requiring any further steps” as recited in independent proposed substitute claims 23, 25, and 26. Due to the lack of support in the original disclosure of the ’706 patent for this limitation, proposed substitute claims 23, 25, and 26, and claim 24 by virtue of its dependency from claim 23, seek to introduce new subject matter.” slip op. at 40
Patent outcomesUS 8,581,706 unpatentable§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 8,581,706 - Apple Inc. v. Aire Technology LimitedAll claims unpatentablePTAB · Dec 15, 2023 · IPR2022-01137 · APJ Jeffrey S Smith · IPR · Final written decision
Claims 1–3, 11, 12, 16, 18, and 20 are unpatentable as obvious; the motion to amend with proposed substitute claims 23–26 is denied.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“knowledgeable and familiar with the smart card and Radio Frequency Identifier (RFID) arts. Pet. 13. Petitioner states that such a “person would have a bachelor’s degree in electrical engineering, computer engineering, computer science, or equivalent training, and approximately two years of experience working in the electrical engineering field. Lack of work experience can be remedied by additional education, and vice versa.” Id. at 13. Patent Owner does not address the level of ordinary skill. See generally, PO Resp. 1 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), amended 35 U.S.C. § 103. Because the ’249 patent has an effective filing date prior to the effective date of the applicable AIA amendment, we refer to the pre-AIA version of § 103. 2 U.S. Patent No. 6,824,064 (Ex. 1005) 3 Japanese Paten Application No. 2000-163539A (Ex. 1006) 4 RFID Handbook: Radio-Frequency Identification Fundamentals and Applications, Klause Finkenzeller, 1999 (Ex. 1007) 5 Smart Card Handbook: Third Edition, Wolfgang Rankl, 2003 (Ex. 1008) references themselves. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978). As Petitioner’s description of a person of ordinary skill appears commensurate with the subject matter before us, we apply Petitioner’s definition.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“We construe only those claim terms that require analysis to determine whether to institute inter partes review. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that “only those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”). Any special definition for a claim term must be set forth in the specification with reasonable clarity, 1994). Petitioner submits that the terms of the challenged claims should be given their plain and ordinary meaning, and no terms require specific construction. Pet. 13–14. Although we may discuss the scope of the claim language during our analysis, we agree that no specific construction is necessary for us to reach our decision.” slip op. at 8
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We do not accord the testimony of Dr. Phinney little or no weight simply because it matches what Petitioner states in the Petition. The Xerox case cited by Patent Owner does not require or indicate otherwise. See Xerox at 1517 (noting that the deficiencies with expert testimony are that they are conclusory and lacking supporting evidence or technical reasoning.). Dr. Phinney’s testimony apprises us of why one of ordinary skill in the art would have understood the assertions made in the Petition, and his testimony is supported by evidence. We find that the declarations of Dr. Phinney are based on specific factual disclosures in the evidence of record. Therefore, we credit Dr. Phinney’s declaration testimony for the matters asserted based on the evidence and technical reasoning provided therein.” slip op. at 23
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“discloses an embodiment of a request-to-send packet that includes size information, we do not agree that Guthery requires this information to be included in the request-to-send packet. Rather, we agree with Petitioner, that Guthery’s description of a request-to-send packet as shown in Figure 8, which does not include information about the size of the message, indicates that the size information is not required by the request-to-send packet in at least some embodiments of Guthery. Ex. 1005, 8:65–9:12, Fig. 8; see id. at 8:25–29 (The “present invention is not limited to the packet types discussed and in fact assumes that new types can and will be defined in the future as needed.”); 7:43–50 (“In one particular embodiment,” packets have a fixed number of bytes, but “in other embodiments, packet types may have different sizes.”). We agree with Petitioner, that Guthery discloses multiple embodiments, and the combination made by Petitioner relies on the embodiments shown in Figures 14 and 15, where the requested application only needs two buffers and therefore would know, without receiving information from the request-to-send packet, to ask for two buffers. Ex. 1005, 12:19–59. We find that a person of ordinary skill, in combining the teachings in Guthery with Nozawa to identify and initialize an application most likely to be selected by the smart card reader, would rely on (a) information about the size of a message as shown in Figure 8, (b) Guthery’s teaching of an application programmed to determine its own memory requirements (Ex. 1005, 9:25–31), and (c) Guthery’s teaching of an application that only needs two buffers as shown in Figures 15A-15D, to preemptively transmit a permission-to-send packet from the application to the reader without waiting to receive the request-to-send packet from the reader, to yield the benefit of improving efficiency and reducing latency as taught by Nozawa. See Phinney Decl. ¶¶ 55 (testifying that Guthery’s system would preemptively prepare the buffers and transmit the permissionto-send packet without waiting to receive the request-to-send packet).” slip op. at 17
Patent outcomesUS 8,581,706 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 8,581,706 - 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
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.