- Fusion Orthopedics, LLC v. Extremity Medical, LLCSome claims unpatentablePTAB · Nov 4, 2024 · IPR2023-00894 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–10 and 12–15 are unpatentable; claim 11 was not shown unpatentable. Substitute claims 16–25 and 27–30 are unpatentable over Mazur; claim 26 was not reached.
RulingsFinal written decision- BurdenMixed
“It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the grounds for the challenge to each claim.’” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (quoting 35 U.S.C. § 312(a)(3)). Here, however, not until its Reply does Petitioner belatedly suggest that Ferrante’s disclosure of bone screws with self-tapping ends equally meets the limitation of claim 10 (with respect to the first member) as with claim 11 (with respect to the second member), and that both claims are obvious in light of “evidence” from Ferrante “that it was well known to equip bone screws with self-tapping ends.” Reply 26–27. We do not discern these arguments in the Petition, and consider them waived. See Netflix, Inc. v. DivX, LLC, 84 F.4th 1371,1377 (Fed. Cir. 2023) (“While the Board should not take an overly mechanistic view of a petition and decline to address an argument because the petitioner did not present it with ideal vigor and clarity, the Board should also not have to decode a petition to locate additional arguments beyond the ones clearly made.”). In sum, Petitioner’s error in failing to first address limitations of claim 10 in the Petition specific to the Cognet/Ferrante combination indicates a failure to meet the particularity requirements for what must be in the petition and cannot be left to be filled in on reply. See 35 U.S.C. § 312(a)(3); 37 C.F.R. §§ 42.22(a)(2) (requiring, among other things, “a detailed explanation of the significance of the evidence”), 42.104(b)(4)–(5) (requiring that petition “specify where each element of the claim is found in the prior art patents or printed publication relied upon” and, regarding submitted evidence, state “the relevance of the evidence to the challenge raised, including identifying specific portions of the evidence that support the challenge”). Microsoft, 2022 WL 989403, at *6. Accordingly, Petitioner has not shown persuasively that claim 11 would have been obvious in light of Cognet and Ferrante for the reasons set forth in the Petition. slip op. at 41
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We also find persuasive Mr. Dominguez’s explanation that one of ordinary skill in the art would have understood “bore” as including stepped diameter holes, sometimes described as a bore having a counterbore. See generally Ex. 1018 ¶¶ 4–29; Reply 3–10. Three of Mr. Dominguez’s illustrative examples are reproduced in the annotated figures below. The above figures show Mr. Dominguez’s annotated illustrations from the Jackson (Ex. 1019, Fig. 3), Brånemark (Ex. 1021, Fig. 4), and Ray (Ex. 1025, Fig. 1) references as discussed at paragraphs 10, 12, and 13, respectively, of Mr. Dominguez’s Second Declaration. With reference to the above figures, Mr. Dominguez testifies that “Jackson describes a bone repair set screw in which ‘[t]he bore 27 comprises a first bore section 31, a second bore section 32,’ etc. delineated by shoulders 41, 42, etc. (Ex. 1019, 5:24– 43)” (Ex. 1018 ¶ 10); “Brånemark describes an osseous implantation device having body 1ʺ with first and second holding portions 21ʺ, 31ʺ and ‘an inner through bore with a first portion 4ʺ in the first holding portion and a second portion 5ʺ in the second holding portion.’” Ex. 1021, 4:44–46” (id. ¶ 12); and Ray discloses surgical calipers including “handle 12 having ‘stepped cylindrical bore 14,’” wherein “[c]ollar 20 of a shaft inserted in the bore ‘rests against a step of the bore 14’ (2:14–15)” (id. ¶ 13). Patent Owner responds that Mr. Dominguez’s examples “that allegedly show a single bore encompassing two or more stepped-diameter holes or a counterbore . . . . are specific to these references and divorced from the disclosures of the ’166 patent.” Sur-Reply 7. Insofar as the ’166 patent makes no mention of the term “bore” outside the claims, and Mr. Dominguez’s examples are all taken from the field of orthopedic surgery, we do not find this argument persuasive. Patent Owner further appears to contend that exemplary references to a “cylindrical stepped down bore” or a “stepped cylindrical bore” are too specific to be within the scope of the term “bore.” Sur-Reply 7–8. As these terms merely describe species within a larger genus, and Patent Owner presents no cogent reason to exclude them, we do not find this argument availing. Relatedly, we are also not persuaded by Patent Owner’s argument that “the prior art treats a ‘bore’ as an element that is distinct from a ‘counterbore.’” Id. at 8. Rather, we credit Mr. Dominguez’s testimony that “[a] counterbore is not a structure unto itself, a counterbore is part of a larger structure” as exemplified by numerous examples including Laps (Ex. 1028 ¶ 33 (sensor assembly wherein “bore 16 includes a counterbore 18”)); Martinez (Ex. 1029, 3:61 (surgical cutting instrument wherein “bore 56 has a counterbore 64”)); Zang (Ex. 1030, 2:49 (bone anchor having a “bore [that] includes a counterbore”)); Ledet (Ex. 1022, 29:3–5 (vertebral fixation plate having “through holes . . . . countersunk, or counterbored to accommodate the head of a bone screw”)); Seo (Ex. 1031, 3:45 (chair leg employing “counterbored bore 23”)); and Exner (Ex. 1032, 2:16 (extrusion press including “counterbored axial bore 6”)). Ex. 1018 ¶¶ 17–23. That a reference may refer to a figure as showing “bore 103” with “counterbore 105 . . . formed on one end” does not indicate that they are distinct structures as Patent Owner contends, but merely that the focus of each term is directed to the entire bore or to a particular aspect of the bore, i.e., its counterbore. See” slip op. at 22
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner subsequently proposed an alternative definition, as a person having “[a] Bachelor’s Degree in biomedical and/or mechanical engineering or similar training and . . . at least three years of experience with implant devices used for internal fixation of bones.” POR 5 (citing Ex. 2012 ¶¶ 32–33). According to Patent Owner, “[t]his hypothetical person would be capable of performing various design tasks and would understand the basic mechanical features and operation of orthopaedic implant devices [and] have an appreciation for orthopaedic fusion techniques and the medical issues and concerns faced by a doctor/surgeon charged when performing operations to implant orthopaedic devices.” Id. Despite some differences in wording, Patent Owner asserts (and Petitioner does not contest) that any “distinction between the parties’ proposed definitions of a POSITA does not affect the arguments set forth herein.” Id. (citing Ex. 2012 ¶ 34). Consistent with this view, we find the parties’ constructions equally applicable in light of the prior art of record and the disclosure of the ’166 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). We adopt, for convenience, Petitioner’s definition, but our analysis does not change depending on which of the two articulations are applied here. H.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“one of ordinary skill in the art would understand that “bore,” as used in the context of claims 1 and 12, encompasses a multi-diameter passage, and in particular, one having stepped longitudinal cross sections such as that shown in Cognet’s Figure 1. See generally DI 11–13. For the reasons that follow, we conclude that one of ordinary skill in the art would have understood “bore” as such. Relying on the testimony of Mr. Dominguez, Petitioner initially proposed a construction of “bore” as “a usually cylindrical hole made by or as if by the turning or twisting movement of a tool.” Pet. 16 (citing Ex. 1002 ¶ 58). Petitioner’s proposal relied on Mr. Dominguez’s testimony that “[a] bore is a cylindrical hole made by the spinning rotation of a twist drill cutting tool. It is typically made by removing material from a solid or hollow object, similar to a tunnel or orifice.” Ex. 1002 ¶ 58. Pointing to its annotation of Cognet’s Figure 1, above, Patent Owner argued that that the term “bore” excludes a tunnel made by “two adjacent bores.” See Prelim. Resp. 21–25. In view of the then-available evidence, we provisionally construed “bore” as a hole or passage made by or as if by the turning or twisting movement of a tool such that its interior walls have cylindrical lateral cross-sections, and which do not exclude holes or passages having tapered or stepped longitudinal cross-sections. DI 13.” slip op. at 19
Patent outcomesUS 11,298,166 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,298,166 - Unified Patents, LLC v. VL Collective IP LLCSome claims unpatentablePTAB · Dec 18, 2023 · IPR2022-01086 · APJ Patrick M Boucher · IPR · Final written decision
Claims 1, 3, 5, 9, 12, 13, and 15 are unpatentable over Sonohara; claims 20 and 21 were not shown unpatentable because Sonohara’s assignment rule is based on timestamps.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner’s expert, Dr. Goodrich, proposes what Patent Owner characterizes as “a somewhat different level,” namely “an individual with at least a bachelor’s degree in Computer Science or related area and two years of experience developing software tools and/or computer systems for use in the area of audio or video creation, encoding, and/or distribution.” PO Resp. 13; Ex. 2007 ¶ 50. Although we agree that the respective articulations are “somewhat different,” they are generally similar, and our Decision does not depend on nuanced distinctions regarding the level of ordinary skill. Indeed, Dr. Goodrich describes his proposed articulation as “approximate,” such that “more work experience could compensate for less education or more education could compensate for less work experience.” Ex. 2007 ¶ 50. Because we find Petitioner’s proposal reasonable, consistent with the level of skill reflected by the prior art, and supported by Dr. Freedman’s testimony, we adopt it for this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art). We nevertheless note that we would reach the same ultimate conclusion that claims 1, 3, 5, 9, 12, 13, and 15 (but not claims 20 and 21) have been shown to be unpatentable by a preponderance of the evidence were we to adopt Patent Owner’s proposal. See PO Resp. 13 (“this Response establishes that Petitioner’s arguments fail even under its preferred definition of the level of ordinary skill”).” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notNot reached
“We need not resolve this dispute because we reach the same ultimate conclusion that Petitioner shows, by a preponderance of the evidence, that claims 1, 3, 5, 9, 12, 13, and 15 are unpatentable, but not that claims 20 and 21 are unpatentable, even if we apply Patent Owner’s proposed construction that the preambles are limiting and the first and second data files must be different. See Reply 15 (Petitioner asserting that “there is no need to construe the preambles as the prior art meets them even if construed”); Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). For purposes of this Decision, we accordingly treat the preambles of independent claims 1 and 9 as limiting, and with the recited “first data file” and “second data file” as distinct data files.4” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner
“We agree with Patent Owner’s contention that the emphasized sentence defines the term “content-related.” See PO Resp. 15–16 (Patent Owner arguing that “[t]here are thus three strong indications of lexicography: (1) ‘content-related’ is set off by quotation marks; (2) the patentee used the word ‘is’ to describe the term ‘content-related’; and (3) the patentee states what ‘content-related’ is ‘understood to mean.’” Nor does Petitioner disagree that the sentence is definitional. See Tr. 8:15–16 (referring to the “term content-related as it’s defined in the specification”). Indeed, in the Starz litigation, the district court also treated the sentence as definitional, a fact that we find significant as a matter of comity. See Ex. 1018, 111:24–112:1 (district court judge stating at Markman hearing, “I’m going to adopt . . . the express definition provided in the specification”). But like the district court, we discern insufficient reason to adopt the additional gloss that Patent Owner seeks to apply to the definition of “content-related.” That is, Patent Owner proposes that we additionally construe the phrase “syntactical meaning” within the definitional statement to arrive at Patent Owner’s proposed construction. PO Resp. 16–20. According to Patent Owner, “[t]he specification makes clear, through its use of consistent and repeated examples, that ‘syntactical meaning’ requires a specific relationship between the data segments within a data file: succeeding data segments within a data file must be ordered so as to present the content in its intended sequence when rendered.” Id. at 17 (citing VirnetX Inc. v. Cisco Sys., Inc., 767 F.3d 1308, 1317–19 (Fed. Cir. 2014); Alloc, Inc. v. ITC, 342 F.3d 1361, 1368–71 (Fed. Cir. 2003)). Patent Owner adds that the claims, the context provided by the problems solved by the ’794 patent, and the cross-examination testimony of Petitioner’s expert, Dr. Freedman, all support this additional aspect of Patent Owner’s proposed construction. Id. at 18–20. Relying on additional direct testimony by Dr. Freedman, Petitioner counters this position as “improperly import[ing] limitations from the specification that are not required by the claims” and “render[ing] other portions of claim 1 superfluous.” Reply 3 (citing Ex. 1016 ¶ 22); see Tr. 10:18–20 (Petitioner explaining at oral hearing that “the syntax information is simply just identification information which is used to find out what the order of the files is. But the identification information does not by itself indicate the order. It’s just an identifier.”). We agree with Petitioner that it would be imprudent to adopt Patent Owner’s additional gloss because, “[w]hile claims must be construed in light of the specification, . . . limitations from the specification are not to be read into the claims, . . . for ‘[i]t is the claims that measure the invention.’” Golight, Inc. v. Wal-Mart Stores, Inc., 355 F.3d 1327 (Fed. Cir. 2004) (quoting SRI Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121 (Fed. Cir. 1985) (other citations omitted). It is apparent that the Applicant for the ’794 patent understood how to define terminology recited in the claims, but chose to limit its definition of “content-related” in terms of the broader phrase “syntactical meaning” rather than through narrower specific reference to presentation order. In addition, claims 1 and 9 already specify “sequentially outputting the first and second data segments according to their chronological sequence,” which supports Petitioner’s observation that requiring an additional sequential order to “content-related . . . data segments” renders other portions of claim 1 superfluous. See Reply 3. We accordingly adopt the definitional construction provided by the” slip op. at 16
- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer not foundDecided for petitioner
“As a basic principle of claim interpretation, prosecution disclaimer promotes the public notice function of the intrinsic evidence and protects the public’s reliance on definitive statements made during prosecution.” Omega Engineering, Inc. v. Raytek Corp., 334 F.3d 1314, 1323 (Fed Cir. 2003) (citing Digital Biometrics, Inc. v. Identix, Inc., 149 F.3d 1335, 1347 (Fed. Cir. 1998)) (emphasis added). As such, a statement during prosecution qualifies as a disavowal of claim scope only if it is “so clear as to show reasonable clarity and deliberateness” and “so unmistakable as to be unambiguous evidence of disclaimer.” Id. at 1325 (citations omitted). “Consequently, for prosecution disclaimer to attach, [Federal Circuit] precedent requires that the alleged disavowing actions or statements made during prosecution be both clear and unmistakable.” Id. at 1325–26. “The party seeking to invoke prosecution history disclaimer bears the burden of proving the existence of a clear and unmistakable disclaimer that would have been evident to one skilled in the art.” Mass. Inst. of Tech. v. Shire Pharms., Inc., 839 F.3d 1111, 1119 (Fed. Cir. 2016). And “[s]tatements by the patent owner are not considered in a vacuum; rather, the skilled artisan would look at the record as a whole in assessing claim scope.” Galderma Lab’s v. Amneal Pharma, 806 F. App’x 1007, 1010 (Fed. Cir. 2022) (citing Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 867 (Fed. Cir. 1993) (“The prosecution history must be examined as a whole in determining whether estoppel applies.”)). We have reviewed the prosecution history, which we summarize supra § I.A.3., and we have particularly reviewed those portions highlighted by Patent Owner. See PO Resp. 32–40. We reach the same conclusion as the district court in the Starz litigation that the standard for attachment of prosecution disclaimer is not met. See Ex. 1018, 109:15–22 (district court stating at Markman hearing, “I’ve also carefully reviewed the portions of the prosecution history relied on by VideoLabs, including the patentee’s arguments regarding the Shin and Rosenau references, and I’m up [sic: not6] persuaded there was a clear and unmistakable disclaimer of all assignment rules that perform assignments by using exact timing information”). slip op. at 20
Patent outcomesUS 8,605,794 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,605,794 - Universal Electronics, Inc. / Gemstar Technology (Qinzhou) Co. Ltd. et al. v. ROKU, Inc.Some claims unpatentablePTAB · Oct 23, 2023 · IPR2022-00818 · APJ Patrick M Boucher · IPR · Final written decision
Claims 1–5, 8–10, and 14 are unpatentable over RadioShack; claim 11 was not shown unpatentable over Wouters and Verzulli because the combination did not disclose the claimed combining and installing steps.
RulingsFinal written decision- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“disseminated to the interested public, ‘public accessibility’ has been called the touch-stone in determining whether a reference constitutes a ‘printed publication’ . . . .” Jazz Pharm., Inc. v. Amneal Pharm., LLC, 895 F.3d 1347, 1356 (Fed. Cir. 2018) (quoting In re Hall, 781 F.2d 897, 898–99 (Fed. Cir. 1986)). A reference is considered “publicly accessible” if it was “disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it.” Id. at 1355–56 (citing In re Wyer, 655 F.2d 221, 226 (CCPA 1981)). Petitioner treats this requirement as having two aspects, namely (1) whether a person of ordinary skill could reasonably have found RemoteCentral.com and (2) whether such a skilled artisan could reasonably have found RadioShack on RemoteCentral.com. Reply 8–13; see also Tr. 33:25–34:8 (Patent Owner asserting that there are two aspects to the analysis on public accessibility: “The first is whether a [person of ordinary skill in the art] would have known to arrive at the website containing the prior art reference. The second one is . . . , [a]ssuming the [person of ordinary skill in the art] would have done so, would the [person of ordinary skill in the art], exercising reasonable diligence, have located the prior art reference on the site? And these are separate and distinct requirements, and if you fail one of them, the document is not publicly accessible.”).” slip op. at 27
- Strike new argumentNew argument consideredDecided for petitioner
“addressed squarely by the principles set forth in Hulu, which addresses the standards at the institution stage and during the trial for evaluating evidence proffered to show asserted art qualifies as a printed publication. Specifically, after a petitioner has presented “evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent,” such that trial is instituted, “some limited opportunities exist for the petitioner to present new evidence later.” Hulu at 13–14. These “limited opportunities” include “in a reply to the patent owner response,” provided that the additional evidence is “responsive to the prior briefing” and provided that the additional evidence does not require “completely reopen[ing] the record, by, for example, changing theories after filing a petition.” Id. at 14–15. Although Patent Owner contends that “[t]his is not an example of permissible rebuttal evidence, but rather a belated attempt to fill a gap in the evidence in the Petition,” we disagree. See Sur-reply 6. Rather, the 7 Patent Owner appears to refer incorrectly to Exhibit 1040 instead of Exhibit 1041 when identifying “articles allegedly referring to RemoteCentral.com.” See Sur-reply 5–6. progression within the instant proceeding comports well with the Hulu framework. During the preliminary proceeding, Petitioner came forth with “evidence sufficient to establish a reasonable likelihood that [RadioShack] was publicly accessible before the critical date of the challenged patent,” just as Hulu demands. Hulu at 13; Inst. Dec. 23 (“[W]e determine that Petitioner’s showing regarding public accessibility of RadioShack is sufficient under the standard we apply at this stage of the proceeding.”). Patent Owner challenges RadioShack’s status as a printed publication in its Response, just as Hulu contemplates. Hulu at 15; PO Resp. 28–41. And Petitioner submits additional evidence that replies to that challenge without changing its theory that RadioShack qualifies as a printed publication by virtue of its accessibility on the RemoteCentral.com web site and in light of date indicia on RadioShack itself.8 See Hulu at 15–16; Reply 7–13. Moreover, in determining that Petitioner’s additional evidence directed at RemoteCentral.com is properly considered, we are further mindful of the Federal Circuit’s endorsement that “the petitioner in an inter partes review proceeding may introduce new evidence after the petition stage if the evidence is a legitimate reply to evidence introduced by the patent owner.” Anacor Pharm., Inc. v. Iancu, 889 F.3d 1372, 1830–81 (Fed. 8 In its Reply, Petitioner also relies on evidence of publication of RadioShack on Radio Shack’s own public website and on “a third location,” hifi-remote.com. Reply 14. As we discuss below, we determine that the presence of RadioShack on RemoteCentral.com is sufficient to qualify RadioShack as a printed publication. We therefore do not reach the issue of whether presence on either the Radio Shack web site or on hifi-remote.com is an improper new theory raised by Petitioner in its Reply. See Tr. 8:13– 9:23 (Petitioner discussing whether reliance on hifi-remote.com presents a different theory than set forth in the Petition). Cir. 2018); see also Vidstream LLC v. Twitter, Inc., 981 F.3d 1060, 1065 (Fed. Cir. 2020) (“The Board denied VidStream’s Motion to Exclude, holding that it was appropriate to permit Twitter to respond to VidStream’s challenge [to the status of Bradford as a printed publication] by providing additional evidence to establish the Bradford publication date. We conclude that the Board acted appropriately, for the Board permitted both sides to provide evidence concerning the reference date of the Bradford book, in pursuit of the correct answer.”). We accordingly give due weight to Petitioner’s additional evidence of RadioShack’s accessibility on the RemoteCentral.com web site.” slip op. at 25
- ExcludeMotion to exclude, deniedDenied
“1 Patent Owner objected to Petitioner’s demonstrative slides 45 and 68 as presenting a new argument that was not previously made with respect to challenged claims 2 and 10. Paper 27; see Paper 26 (Petitioner’s demonstratives), 45, 68. At the oral hearing, we reserved ruling on the objections. Tr. 5:23–6:3. Both slides reproduce the same portions of Exhibits 1002 and 1025, with the statement that “A press and hold for an auto-scan or brand-scan is admitted prior art.” Paper 26, 45, 68. As explained below, we do not reach the predicate position upon which the objections are based. See Tr. 5:8–11 (Petitioner stating that “this Board only needs to resolve this objection if it accepts Roku’s claim construction argument that the claims cover a press and hold of a single button, but that they do not cover pressing multiple buttons to present that argument in the alternative. So, if you reject that argument, you don’t even have to resolve the objection.”). We accordingly dismiss the objections as moot.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“We agree with this assessment, and the parties do not specifically advocate for one articulation over the other in this proceeding. See Pet. 8 (Petitioner asserting that “[t]he Challenged Claims are unpatentable under both proposed levels”); PO Resp. 5 (Patent Owner stating its “position that the challenged claims are unpatentable under either proposed level of ordinary skill”). We adopt Patent Owner’s proposed statement of the level of ordinary skill as advanced in the related ITC Investigation. But we note that we would reach the same ultimate conclusion that Petitioner shows, by a preponderance of the evidence, that all challenged claims are unpatentable were we to adopt Petitioner’s proposal instead.” slip op. at 12
Patent outcomesUS 8,378,875 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,378,875 - Pelican Biothermal, LLC v. Va-Q-Tec AGSome claims unpatentablePTAB · Jun 16, 2023 · PGR2021-00085 · APJ Barry L Grossman · PGR · Final written decision
The Board granted the motion to amend but held amended claim 64 unpatentable as anticipated by NanoCool 98596-type products and obvious over the cited combinations; all other amended claims were not shown unpatentable.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that Petitioner has demonstrated by a preponderance of the evidence that amended claim 64 is unpatentable; FURTHER ORDERED that Patent Owner’s Non-Contingent Motion to Amend is granted for claims 64 and denied for all other amended claims; and” slip op. at 77
- ExcludeMotion to exclude, deniedDenied
“A. Status as Prior Art Is a Substantive Issue, Not an Evidentiary Issue. A motion to exclude is not an appropriate mechanism for challenging the sufficiency of evidence, such as whether a reference qualifies as prior art, or the proper weight that should be afforded an argument. See Flir Systems, Inc. v. Leak Surveys, Inc., IPR2014-00411, Paper 113, 4, 8–9 (PTAB September 3, 2015); PTAB Consol. Trial Practice Guide 79 (Nov. 30 Mr. Zumwalt testifies that other NanoCool products, designated by product number 85430 and 98630, also have the same configuration as the 98830 product and are made by the same process. Thus, “the 98830, 85430, and 98630 products can be collectively referred to as ‘98830-type’ products all having the same relevant design.” Ex. 1030 ¶ 17. 2019) (“A motion to exclude . . . may not be used to challenge the sufficiency of the evidence to prove a particular fact. A motion to exclude is not a vehicle for addressing the weight to be given evidence—arguments regarding weight should appear only in the merits documents.”); Caterpillar Inc. v. Wirtgen Am., Inc., IPR2017-02187, Paper 42,17 (PTAB May 21, 2019) (status as prior art “is a substantive issue, not an evidentiary issue.”) Thus, whether the NanoCool 98830 product is prior art is not the proper basis for Patent Owner’s Motion to Exclude evidence concerning the NanoCool 98830 product.” slip op. at 29
- Skill levelSkill level board ownOther
“Neither Petitioner nor Mr. Harber provide any analysis of the factors pertinent to a determination of the level of ordinary skill, identified above, to support their conclusory statements. We give Mr. Harber’s conclusory testimony minimal probative weight. 37 C.F.R. § 42.64(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Moreover, there is no persuasive evidence to which we have been directed of the need for specific education or experience in biological or chemical technologies related to the claimed containers and inserts.” slip op. at 26
- Expert testimonyPetitioner expert discountedDecided for patent owner
“With regard to the level of ordinary skill in the art, Petitioner asserts that a person of ordinary skill would have had “a bachelor’s degree or higher degree in biological, chemical or mechanical engineering, or related sciences, and at least two to five years of experience in designing and testing ISCs [insulated shipping containers] depending on education level.” Pet. 9 (emphasis added) (citing Ex. 1002 ¶¶ 23–24). Exhibit 1002 is the Declaration testimony of Mr. Paul Haber. Mr. Harber actually states a slightly different level of ordinary skill. Mr. Harber testifies: The hypothetical POSITA would have: (i) at least a bachelor’s degree in biological, chemical or mechanical engineering, or related sciences, and have at least three to five years of experience in designing and testing ISCs [Insulated Shipping Containers][29]. Such a person may also have (ii) a higher level degree, such as a PhD and/or Master’s degree in engineering, or related sciences, and have at least two to three years of experience in designing and testing ISCs. 29 See Ex. 1002 ¶ 23. Ex. 1002 ¶ 24 (emphasis added). Mr. Harber also testifies that “[t]hese descriptions are approximate, and a higher level of education or specific skill might make up for less experience, and vice-versa.” Id.” slip op. at 25
Patent outcomesUS 10,766,685 mixedClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 10,766,685 - Amphastar Pharmaceuticals, Inc. v. Aegis Therapeutics, LLCSome claims unpatentablePTAB · Feb 9, 2023 · IPR2021-01324 · APJ Cynthia M Hardman · IPR · Final written decision
Claims 1, 2, and 7–17 are unpatentable under §102 or §103; claims 3–6 and 18–20 were not shown unpatentable.
RulingsFinal written decision- Expert testimonyPetitioner expert discountedDecided for patent owner
“in Table 1 and the formulations of Potta claim 21 (i.e., ‘from about 0.1% w/w to about 15% w/w epinephrine or a salt thereof’), because such formulations would elicit the desired biological or medicinal response.” Ex. 1002 ¶ 272. Dr. Weinstein provides an essentially identical opinion. Ex. 1003 ¶ 286. Neither declarant supports their opinion with any explanation as to why the Potta formulations would provide the claimed plasma epinephrine concentration or elicit a biological or medicinal response. Accordingly, we do not credit these opinions, and determine that Petitioner has not met its burden to establish that Potta inherently anticipates claim 3. See n re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”).” slip op. at 29
- ExcludeMotion to exclude, deniedDenied
“As the moving party, Petitioner bears the burden of establishing that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). Having considered the arguments and evidence of record, we determine that Petitioner has not met its burden of proof. We agree with Patent Owner that “[n]o bright line rule prohibits the consideration of post-priority date evidence,” and that such evidence is permissible in certain contexts. Opp. 2–3. On this record we do not find that there is sufficient cause to exclude the challenged exhibits, because any consideration by the Board of these exhibits has taken into account their alleged post-priority date status. Thus, we do not find that maintaining the exhibits in this proceeding results in any unfair prejudice to Petitioner, or that the exhibits have confused the issues before us. Accordingly, we deny Petitioner’s motion to exclude.” slip op. at 73
- Skill levelOther
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“For the above reasons, on the full trial record we determine that” slip op. at 26
Patent outcomesUS 10,682,414 mixed§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,682,414 - Cooler Masters Co., Ltd. v. Aavid Thermalloy LLCSome claims unpatentablePTAB · Jun 4, 2020 · IPR2019-00337 · APJ Linda E Horner · IPR · Final written decision
Claims 9, 10, and 13 were held unpatentable as obvious; claims 11 and 12 were not shown unpatentable.
RulingsFinal written decision- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedReference is prior artDecided for petitioner
“The existence of a published abstract that would have allowed one skilled in the art exercising reasonable diligence to locate the foreign patent application and the fact that the application was classified and indexed in the patent office, were central to the Wyer court’s conclusion that the application was “publicly accessible.”” slip op. at 35
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“inherency, then the assertions of obviousness are mere conclusory statements. We are unable to recognize any proffered reasoning underlying the assertions of obviousness. “[Challenges] on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). As yet another possible alternative, Petitioner may be basing its case on improper hindsight by relying on and quoting the Specification of the ’240 patent in its obviousness analysis. See Pet. 27. That, too, is unpersuasive. Regardless as to its theory of the case, we determine that Petitioner has failed to explain sufficiently why the claimed heat pipe having a configuration of two plates having bonded together circumferential edge lips would have been obvious. Accordingly, Petitioner has not shown by a preponderance of the evidence that claim 12 is unpatentable over Morikawa alone.” slip op. at 55
- ExcludeMotion to exclude, deniedMixed
“as not relevant under FRE 104 on the grounds that Petitioner failed “to introduce sufficient proof that Exhibit 1004 was publicly accessible such that it qualifies as a prior art printed publication under United States law.” Paper 46, 3; see also id. at 4 (citing Fed. R. Evid. 104, 401). As set forth in section II.D, above, the evidence of record leads us to an entirely different conclusion regarding Nakamura’s prior art status. Because Petitioner persuades us that Nakamura qualifies as a prior art printed publication as of the earliest possible effective filing date of the challenged claims of the ’240 patent, we deny Patent Owner’s request on its merits.” slip op. at 82
Patent outcomesUS 7,066,240 mixed§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,066,240 - Cooler Masters Co., Ltd. v. Aavid Thermalloy LLCSome claims unpatentablePTAB · Jun 4, 2020 · IPR2019-00144 · APJ Linda E Horner · IPR · Final written decision
Claims 9–12 were not shown unpatentable; claim 13 was shown unpatentable as obvious over Nakamura and Takahashi.
RulingsFinal written decision- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“The existence of a published abstract that would have allowed one skilled in the art exercising reasonable diligence to locate the foreign patent application and the fact that the application was classified and indexed in the patent office, were central to the Wyer court’s conclusion that the application was “publicly accessible.”” slip op. at 36
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“made using related processes, however, says nothing about why one of ordinary skill in the art would combine them in a manner that renders the claimed subject matter obvious. See Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1368 (Fed. Cir. 2012) (quoting Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374 n.3 (Fed. Cir. 2008) (“We must still be careful not to allow hindsight reconstruction of references to reach the claimed invention without any explanation as to how or why the references would be combined to produce the claimed invention.”)). Petitioner’s argument that the references are “similar and analogous” is not adequate reasoning, by itself, to support a conclusion of obviousness.” slip op. at 54
- ExcludeMotion to exclude, deniedMixed
“as not relevant under FRE 104 on the grounds that Petitioner failed “to introduce sufficient proof that Exhibit 1004 was publicly accessible such that it qualifies as a prior art printed publication under United States law.” Paper 46, 3; see also id. at 4 (citing Fed. R. Evid. 104, 401). As set forth in section II.D, above, the evidence of record leads us to an entirely different conclusion regarding Nakamura’s prior art status. Because Petitioner persuades us that Nakamura qualifies as a prior art printed publication as of the earliest possible effective filing date of the challenged claims of the ’240 patent, we deny Patent Owner’s request on its merits.” slip op. at 73
Patent outcomesUS 7,066,240 mixed§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,066,240 - Samsung Electronics America, Inc. / Asus Computer International, Inc. v. James B. GoodmanSome claims unpatentablePTAB · Oct 29, 2019 · IPR2017-02021 · APJ Kimberly Mcgraw · IPR · Final written decision
Claims 1, 5, 10, and 16 are unpatentable over Ooishi and Palaniswami, with Abe added for claims 10 and 16; claims 2–4, 6–9, and 11–15, 17–20 were not shown unpatentable.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“reasonable construction consistent with the Specification of a control device “for selectively electrically isolating said memory devices from respective address lines and respective control lines so that when said memory devices are electrically isolated, any signals received on said respective address lines and respective control lines do not reach said memory devices” as recited in independent claims 1 and 10 requires that the control device electrically isolate the memory devices from all address and control lines that communicate with the memory devices.10” slip op. at 13
- Skill levelSkill level petitioner adoptedDecided for petitioner
“time it was made, we consider the level of ordinary skill in the pertinent art at the time of the invention. Graham v. John Deere Co, 383 U.S. 1, 17 (1966). Petitioner contends a person of ordinary skill in the art at the time of the alleged invention of the ’315 patent (a “POSITA”) would have had, inter alia, a bachelor’s degree in electrical, electronics, computer engineering; or the equivalent training, and would have had approximately 2 to 3 years of experience in computer systems, circuits, electronics, or a related discipline. Pet. 9; Ex. 1002 ¶¶ 27–30. Patent Owner does not contest Petitioner’s description of the level of ordinary skill. See PO Resp. 8. Based on our review of the ’315 patent, the cited prior art, and Dr. Wolfe’s testimony, we determine a specific finding regarding ordinary skill level is not required as the prior art reflects an appropriate level. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”). However, to the extent a specific finding regarding the level of skill is required, we find Petitioner’s articulation of a person of ordinary skill in the art is consistent with the teachings of the prior art and adopt Petitioner’s description of a POSITA as someone who “would have had a bachelor’s degree in electrical, electronics, or computer engineering; or the equivalent training, and would have had approximately two to three years of experience in computer systems, circuits, electronics, or a related discipline.” See Pet. 9.” slip op. at 10
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989). A reference is deemed publically accessible upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence can locate it. Kyocera Wireless Corp. v. ITC, 545 F.3d 1340, 1350–51 (Fed. Cir. 2008). Petitioner asserts JESD21-C was published January 1997 and is prior art under pre-AIA 35 U.S.C. § 102(b). Pet. 37–38. As support, Petitioner relies upon the Declaration of John J. Kelley (“the Kelley Declaration”), the current President of the Solid State Technology Association of the Joint Electron Device Engineering Council (“JEDEC”). See Ex. 1007 ¶ 2. Mr. Kelly states that JEDEC specification JESD21-C, Configurations for Solid State Memories, Release 7 (January 1997), a copy of which is attached to his declaration as Exhibit 17, “was made publicly available in January 1997.” Id. ¶¶ 4, 7. Mr. Kelley testifies that in January 1997 copies of the entire JESD21-C volume “would . . . have been available for purchase by anyone in the public” and that “pages comprising the specifically updated modules would have been sent to those who subscribed to the annual updating service for JESD21-C.” Id. ¶ 6. Patent Owner does not dispute that JESD21-C qualifies as prior art under 35 U.S.C. § 102(b). See PO Resp. 7. Based on the current record, we determine JESD21-C qualifies as a prior art printed publication under § 102(b).” slip op. at 19
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We agree with Patent Owner that Petitioner has not persuasively shown that Dell discloses a control device that electrically isolates the memory devices as required under the claim construction set forth above in devices even when the devices are in a low-power or self-refresh mode, Petitioner has not shown that Dell’s memory devices are electrically isolated from “respective control lines” such that “any signals received on said . . . respective control lines do not reach said memory devices” as required by claims 1 and 10. Accordingly, we determine Petitioner has not shown by a preponderance of the evidence that claim 1 of the ’315 patent is unpatentable over Dell or that claim 10 is unpatentable over the combined teachings of Dell and Abe.” slip op. at 21
Patent outcomesUS 6,243,315 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,243,315 - Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentablePTAB · Nov 29, 2018 · IPR2017-02139 · APJ Robert A Pollock · IPR · Final written decision
Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable.
RulingsFinal written decision- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Petitioner Samsung Bioepis Co., Ltd. (“Bioepis”) timely submitted a Petition presenting substantially the same challenges as set forth in Pfizer’s Petition along with a request for joinder to IPR2017-01488. IPR2017- 02139. Paper 1. We granted Bioepis’s Petition and associated request for joinder to this case. IPR2017-02139, Paper 11, 6–7.” slip op. at 3
- Skill levelSkill level patent owner adoptedDecided for patent owner
“B. Person of Ordinary Skill in the Art The parties propose similar definitions of a person of ordinary skill for the ’213 patent. See Pet. 15–16; Prelim. Resp. 18; PO Resp. 18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 8. Petitioners do not contest this definition in its Reply and we find no reason to revise our earlier determination.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Prelim. Resp. 18–19; PO Resp. 19. Patent Owner correctly points out that this “construction comes directly from the definition provided in the ’213 patent.” Prelim. Resp. 19 (citing Ex. 1001, 11:32–38). Petitioners expressly adopt this construction in their Reply. Pet. Reply 5–6. We do not agree, however, that the claims demand a consensus of “all” human immunoglobulins in the literal sense. Indeed, Petitioners point out that “the ‘consensus’ sequence used for the patent variants was generated using the most common residue at each position identified in [Kabat 198711].” Pet. Reply 15 (citations omitted). And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner. 11 Kabat et al., Sequences of Proteins of Immunological Interest: Tabulation and Analysis of Amino Acid and Nucleic Acid Sequences of Precursors, V- Regions, C-Regions, J-Chain, T-Cell Receptor for Antigen, T-Cell Surface Antigens β2-Microglobulin, Major Histocompatibility Antigens, Thy-1 Complement, C-Reactive Protein, Thymopoietin, Post-Gamma Globulin, and α2-Macroblobulin, 41–175 (4th Ed. 1987). Ex. 1052. See PO Resp. 47. Moreover, in a parallel proceeding involving the same patent, Patent Owner did not dispute that the reference to “all sequences” in the patent, “refer[s] to all known sequences and there’s no dispute . . . that was really synonymous with Kabat 1987.” See IPR2017-01374 Paper 82, Tr. 15:4–16:4; see Ex. 1202 ¶ 157; Ex. 2105 ¶¶ 24–25; Ex. 2107 ¶¶ 18–19; Ex. 1198, 56:20–61:24; Ex. 1199, 27:14–28:13, 29:25–36:2, 57:1–58:6, 115:7–17, 165:17–169:9. Indeed, in a similar parallel proceeding, counsel for Patent Owner acknowledged that the term “all human immunoglobulins” refers to “all reasonably available[,] all known at the time of the invention.” IPR2017-01373, Paper 83, 47:21–48:5. Accordingly, we adopt the parties’ proposed construction, with a clarifying modification, specifically, “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure, as set forth in Kabat 1987.”” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient.” In our institution decision, we determined that this claim language “refer[s] to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” Dec. 10–12. Neither party disputes this interpretation. See PO Resp. 19; Pet. Reply 5–6. Consistent with claim 63’s express comparison between the immunogenicity of the claimed humanized antibody and that of its non-human parent, the Specification states that one object of the invention is to “to provide methods for the preparation of antibodies which are less antigenic in humans than non-human antibodies but have desired antigen binding and other characteristics and activities.” Ex. 1001, 4:24–28. The Specification similarly states that embodiments within the scope of the claims have “low immunogenicity,” or are designed to “minimize the potential immunogenicity of the resulting humanized antibody in the clinic.” Id. at 52:54–58, 61:56–61. Moreover, with reference to claim 63 in particular, Patent Owner points to the ’272 application as “explain[ing] that the purpose of humanizing antibodies using its consensus sequence approach is to reduce immunogenicity versus the non-human parent antibody. (Id., 6:24–30, 84:24–30.).” Prelim. Resp. 42 (citing Ex. 2032 (File History for U.S. Patent Application No. 07/715,272 (“the ’272 application”)); see also id. at 38 (indicating that the limitation is satisfied where “[o]nly 1 out of 885 patients experienced an immunogenic response . . . which was a substantial improvement over the murine 4D5 antibody”). In light of the above, we do not alter our prior determination that “[a] humanized antibody which lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient,” refers to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” slip op. at 14
Patent outcomesUS 6,407,213 mixedClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 6,407,213 - Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentablePTAB · Nov 29, 2018 · IPR2017-01488 · APJ Robert A Pollock · IPR · Final written decision
Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“B. Person of Ordinary Skill in the Art The parties propose similar definitions of a person of ordinary skill for the ’213 patent. See Pet. 15–16; Prelim. Resp. 18; PO Resp. 18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 8. Petitioners do not contest this definition in its Reply and we find no reason to revise our earlier determination.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner
“variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Prelim. Resp. 18–19; PO Resp. 19. Patent Owner correctly points out that this “construction comes directly from the definition provided in the ’213 patent.” Prelim. Resp. 19 (citing Ex. 1001, 11:32–38). Petitioners expressly adopt this construction in their Reply. Pet. Reply 5–6. We do not agree, however, that the claims demand a consensus of “all” human immunoglobulins in the literal sense. Indeed, Petitioners point out that “the ‘consensus’ sequence used for the patent variants was generated using the most common residue at each position identified in [Kabat 198711].” Pet. Reply 15 (citations omitted). And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“humanized” (claims 1, 30, 62–64, 66, 79, 80); “and further comprising a Framework Region (FR) amino acid substitution at a site selected from the group consisting of” (claims 1, 30, 62, 63, 66, 79, and 80); “numbering system set forth in Kabat” (claims 1, 30, 62, 63, 66, 79, and 80); and “up to 3-fold more” (claim 65). Patent Owner does not dispute Petitioners’ proposed constructions, but asserts that “[n]o construction of those terms is necessary.” Prelim. Resp. 19; PO Resp. 19. On the present record, we agree with Patent Owner that the terms identified by Petitioners need not be construed to resolve the issues presently before us. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (instructing that claim terms need only be construed to the extent necessary to resolve the controversy). slip op. at 15
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner
“substitutions, most being unrepresented in any ’272 embodiment.” Pet. Reply 8. We do not find Petitioners’ argument persuasive in light of Patent Owner’s evidence showing that the ’272 application discloses, inter alia, each of the framework substitutions recited in claims 12, 42, 60, 65, 71, 73– 74, and 79 (collectively, 66L, 71H, 73H, 78H, 93H), along with “a generalized scheme for humanizing any non-human antibody.” See PO Resp. 43–44 (citing Ex. 2032, 87–90, 93; Ex. 2041 ¶¶ 91–95).” slip op. at 19
Patent outcomesUS 6,407,213 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,407,213
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.