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

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

  RulingsFinal written decision

  • BurdenMixed

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

  • Expert testimonyPetitioner expert creditedDecided for petitioner

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

  • Skill levelSkill level petitioner adoptedDecided for petitioner

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

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

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

  Patent outcomesUS 11,298,166 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 11,298,166
• Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.Some claims unpatentable
  PTAB · Jul 5, 2023 · PGR2022-00023 · APJ Robert A Pollock · PGR · Final written decision

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

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

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

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

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

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

    “The parties do not identify any issue relating to the preamble that needs to be addressed to resolve the sole written description challenge and the parties do not dispute that the transitional term “comprising” is “inclusive or open-ended and does not exclude additional, unrecited elements or method steps.” Georgia-Pacific Corp. v. US. Gypsum Co., 195 F.3d 1322, 1327 (Fed. Cir. 1999). We therefore find that there are no terms that need claim construction. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 8

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

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

  Patent outcomesUS 10,993,942 mixed
  Claim construction§ 112 disclosure
  Patents in suitUS 10,993,942
• Pelican Biothermal, LLC v. Va-Q-Tec AGSome claims unpatentable
  PTAB · Jun 16, 2023 · PGR2021-00085 · APJ Barry L Grossman · PGR · Final written decision

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

  RulingsFinal written decision

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

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

  • ExcludeMotion to exclude, deniedDenied

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

  • Skill levelSkill level board ownOther

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

  • Expert testimonyPetitioner expert discountedDecided for patent owner

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

  Patent outcomesUS 10,766,685 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 10,766,685
• Allstate Insurance Company v. Atos, LLCSome claims unpatentable
  PTAB · Mar 7, 2023 · IPR2021-01449 · APJ Julia Heaney · IPR · Final written decision

  Claim 5 is unpatentable as anticipated by Kim; claims 1–4 were not shown unpatentable under the asserted obviousness grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Having considered the parties’ arguments and evidence, we adopt the level of ordinary skill in the art proposed by Petitioner, because it is consistent with the disclosures of the ’174 patent and the prior art of record. We note, however, that neither party contends that any issue in this case turns on the differences between the parties’ definitions of one of ordinary skill in the art.” slip op. at 10

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

    “Having reviewed the parties’ arguments and evidence, we determine that Petitioner’s proposed construction of “rotation vector” is consistent with the ’174 patent’s usage of the term “rotation vector” (or “vector of rotation”). See Ex. 1001, 1:54–2:11. Dr. Kanellakopoulos’s opinion supports that “rotation vector” would be understood by a person of ordinary skill in the art to describe the motion of a body that is rotating around a point. As to the other aspects of Patent Owner’s proposed construction, describing the characteristics of magnitude and direction, we determine that those attributes are not necessary to interpreting how a skilled artisan would understand “rotation vector” in light of the claim language and specification. See Tr. 47:26–48:7 (in Patent Owner’s proposed construction of “rotation vector,” “the magnitude requirement is not particularly important”). We address the parties’ arguments as to differences between a rotation vector and angular momentum vector in Section II.D.2 below, because they underlie Petitioner’s challenges involving Kleppner.” slip op. at 14

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

    “Having considered the parties’ positions as to construction of the term “movement vector” and applicability of the definition of “movement vector” set forth in the ’174 patent specification (Ex. 1001, 2:29–31), we construe the term “movement vector” to mean “a vector derived from the cross product of the centrifugal force vector and the rotation vector.” We adopt the definition set forth in the ’174 specification because we determine patentee acted as its own lexicographer. Cont’l Cirs. LLC v. Intel Corp., 915 F.3d 788, 796 (Fed. Cir. 2019) (citing Phillips, 415 F.3d at 1316) (“When the patentee acts as its own lexicographer, that definition governs.”). We agree with Petitioner that the words “while a vehicle is turning” would be superfluous in the construction, because the step of “detecting a movement vector during the turn” already recites that the vehicle is turning. Apple, Inc. v. Ameranth, 842 F.3d 1229, 1237 (Fed. Cir. 2016) (“Construing a claim term to include features of that term already recited in the claims would make those expressly recited features redundant.”)” slip op. at 16

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

    “We decline to adopt Patent Owner’s construction because it improperly reads into claim 5 a requirement that the specification and claim language do not support. The specification passages relied on by Patent Owner do not expressly state that a vehicle independent state must be determined while the device is inside a vehicle, and contrary to Patent Owner’s argument, they also do not necessarily imply that. For example, the descriptions of “vehicle independent movement” and “vehicle independent event” in the specification (see Ex. 1001, 1:16, 42) refer to “phone falling to the ground.” “Falling to the ground” implies that the phone may be outside a vehicle, not inside. Further, the specification’s reference to detecting a vehicle dependent state “while also” recognizing a vehicle independent event does not necessarily imply that the vehicle dependent state and vehicle independent event are being detected simultaneously, as Patent Owner argues. In the language of claim 5, a “vehicle independent state” is recited in the determining step (step c), and the requirement that the portable device is located “inside a vehicle” relates to creation of an operation indicator, as part of the detecting step (step b). Patent Owner does not dispute this, and agrees that a portable device “not in the vehicle” can satisfy the determining step (step c). Tr. 73:5–8. Patent Owner, however, argues step c’s recitation that a “vehicle independent state” is based on step b’s “predetermined criteria” creates a link between “vehicle independent state” and step b, and thus an “express requirement” in step c that the device is located inside the vehicle. See Tr. 73:8–26, 76:1–3. We decline to read this requirement into the claim language. Although the claim language states that determining a “vehicle independent state” is based on “predetermined criteria,” and step b describes comparing “predetermined criteria” to an “operation indicator” that is created when the device is inside a vehicle, it does not limit the step of determining a vehicle independent state to a time when the portable device is inside a vehicle. Accordingly, we construe “vehicle independent state” to mean a state triggered when the portable device is moved independently of the movement of the vehicle.” slip op. at 23

  Patent outcomesUS 9,846,174 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,846,174
• Sunspec Alliance v. Tigo Energy, Inc.Some claims unpatentable
  PTAB · Jan 26, 2023 · IPR2021-01287 · APJ Kristina M Kalan · IPR · Final written decision

  Claims 12–13 are unpatentable; claims 14–16 are not shown unpatentable because the asserted grounds fail to establish the required predetermined number of heartbeat skips or sensor-triggered skips.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “contention that a person of ordinary skill in the art “would have had a bachelor’s degree or similar degree in electrical engineering and one year of experience in the design of solar power systems, power control systems, and/or power safety systems” or “could have also obtained similar knowledge and experience through other means.” Dec. 6. Patent Owner does not appear to dispute this definition. See generally PO Resp; see also id. at 51 (employing Petitioner’s definition of a person of ordinary skill in the art in discussing Mr. Dunton’s testimony). In its Reply, Petitioner argues that “Patent Owner does not challenge but adopts Petitioner’s proposed level of skill for a POSITA for the relevant time period.” Reply 1 (citing Ex. 2003 ¶ 28; Ex. 1030, 119:25–120:14). Neither party argues that the outcome of this case would differ based on our adoption of any particular definition of one of ordinary skill in the art. Accordingly, we adopt Petitioner’s definition, because it is consistent with the cited prior art. We further note that the prior art itself demonstrates the level of skill in the art at the time of the invention. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that “specific findings on the level of skill in the art . . . [are not required] ‘where the prior art itself reflects an appropriate level and a need for testimony is not shown’” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 9

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

    “We interpret the term “heartbeat signals” as “periodic signals.” The term “heartbeat” appears only once in the in the specification outside of the claims: “the ‘heartbeats’ of the ping are set at a high rate, such as 100 or even 1000 per second.” Ex. 1001, 18:7–13. The disclosure of “the heartbeats” having a “rate” defined in “per second” terms indicates that they are periodic, as is generally recognized for heartbeats, i.e. human heartbeats. The term “heartbeat signals” appears in the challenged claims in conjunction with the detection of an anomaly (claim 12, “wherein the controller detects an anomaly in heartbeat signals from the remote unit”) and in conjunction with “skips” (claim 13, “wherein the anomaly includes skips of heartbeat signals”; claim 14, “when the anomaly includes a predetermined number of skips of the heartbeat signals”; claim 15, “when skips of the heartbeat signals are less than the predetermined number”). Accordingly, the heartbeat signals allow for the detection of an anomaly therein, indicating that they are typically predictable, and for the detection of skips of heartbeat signals, indicating that they are periodic. In view of the specification and the claims, and the parties’ arguments, we find that the plain and ordinary meaning of “heartbeat signals” is “periodic signals.”” slip op. at 12

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

    “Because patentee has acted as its own lexicographer, and because the ’321 patent specification is incorporated by reference into the ’770 patent specification (Ex. 1001, 1:7–37; Tr. 9:10–22), we adopt the construction: “Skips refers to the event of missing a communication or pulse.” Ex. 2005, 9:36–37. Cont’l Cirs. LLC v. Intel Corp., 915 F.3d 788, 796 (Fed. Cir. 2019) (citing Phillips, 415 F.3d at 1316) (“When the patentee acts as its own lexicographer, that definition governs.”).” slip op. at 13

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “We agree with Patent Owner that the preamble of claim 12 is limiting. The body of claim 12 recites “photovoltaic panel” and thus refers back to the preamble, and other challenged claims use the term “photovoltaic panel” in the non-preamble portions of the claims. See, e.g., Ex. 1001, 20:51, 20:58, 20:67, 21:5, 21:10. Aside from the preamble issue, the parties do not dispute the meaning of “photovoltaic panel.” Accordingly, we need not expressly construe the term “photovoltaic panel” for the purposes of this Decision.” slip op. at 14

  Patent outcomesUS 10,256,770 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,256,770
• Shenzen Chic Electrics Co., Ltd. v. Pilot, Inc.Some claims unpatentable
  PTAB · Jan 9, 2023 · IPR2021-01232 · APJ Jeffrey W Abraham · IPR · Final written decision

  Claims 1 and 4–20 are unpatentable as obvious; claim 3 was not shown unpatentable because Petitioner presented no evidence under the adopted construction.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “of battery charging systems.” Pet. 8. Patent Owner states that it adopts this definition for purposes of its Response. PO Resp. 4. In light of the record before us, we adopt Petitioner’s proposal regarding the level of ordinary skill in the art. Based on our review of the ’653 patent and the prior art of record, we determine that the definition offered by Petitioner comports with the qualifications a person would have needed to understand and implement the teachings of the ’653 patent and the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). It is also consistent with the level of skill in the art adopted in the 777 IPR, which also involves the ’653 patent. IPR2021-00777, Paper 7 at 6–7.” slip op. at 9

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

    “construction “contradicts the technical disclosure of the ’653 patent” and that “[t]he proper construction of this term is ‘switching circuit under control of the microcontroller that selectively conducts power supply or power outage for the load.’” Pet. Suppl. Br. 3.10 In particular, Petitioner contends that claim 3, through claim 1, only recites one connection between the microcontroller and the first battery, such that the connections in claim 3 do not allow the power supply from the first battery to pass through the microcontroller to the load. Pet. Suppl. Br. 4–5. Claim 1, however, recites “an automobile charger, comprising . . .” which is an open-ended term, meaning that claim 1 is not limited to only the connections expressly recited therein. Petitioner’s arguments do not address this open-ended aspect of the plain language of the claims. Petitioner also argues that the language of claim 3 is consistent with its construction because claim 3 “places the switching circuit between the second pole of the first battery . . . and the second lead of the load.” Pet. Suppl. Br. 5. Although Petitioner’s interpretation may be consistent with the language in claim 3, we discern nothing in claim 3 that expressly limits the placement of the switching circuit, especially considering the open-ended “comprising” language used in claims 1 and 3.” slip op. at 11

  • Strike new argumentNew argument consideredDecided for petitioner

    “Specifically, Dr. Kirtley testifies that a person of ordinary skill in the art would have understood that connections between components depicted as single lines in Yu’s figures “may comprise multiple connections, such as multiple signal connections, and common power and ground connections for sensors and microprocessors.” Ex. 1020 ¶ 84 (citing Ex. 1021 (US 7,973,534 B2)). We credit Dr. Kirtley’s testimony, as Patent Owner does not dispute the substance of Dr. Kirtley’s testimony or the supporting exhibit. Instead, Patent Owner argues that Petitioner is attempting to “sneak in new evidence that is improper in a reply” and create a new ground. Sur-reply 13–15. We disagree, as Petitioner and Dr. Kirtley offer this evidence to demonstrate what a person of ordinary skill in the art would have understood in considering Yu—not as a new ground. Moreover, Petitioner properly offered this exhibit and Dr. Kirtley’s testimony in response to Patent Owner’s arguments that claim 1 requires negative side switching, which Yu does not disclose. In its Reply, Petitioner is entitled to “respond to arguments raised in the corresponding . . . patent owner response.” 37 C.F.R. § 42.23(b). A party also may submit rebuttal evidence in support of its reply. See Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1077–78 (Fed. Cir. 2015).” slip op. at 26

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

    “After considering the parties’ arguments and evidence, we find Petitioner has established, by a preponderance of the evidence, that claim 4 is unpatentable as obvious in view of Yu and Thomason. As discussed above, we disagree with Patent Owner’s arguments regarding negative pole switching, and find that Petitioner presents persuasive evidence that Yu teaches or suggests the limitations of claim 1. Petitioner also presents undisputed evidence that Yu and Thomason teach or suggest the additional limitations in claim 4. Pet. 52–54. Additionally, Petitioner directs us to a disclosure in Thomason itself regarding a protection mechanism to prevent the jump starter from self-destructing, and presents testimony from Dr. Kirtley that a person of ordinary skill in the art would have considered Thomason’s teaching in order to avoid damage to Yu’s internal battery, and would have been able to implement Thomason’s teachings. Pet. 52–54; Reply 20–21; Ex. 1004 ¶¶ 189–192. Patent Owner and Mr. McAlexander do not challenge or otherwise refute this testimony. PO Resp. 9–10. Thus, contrary to Patent Owner’s assertions, Petitioner does direct us to evidence in the asserted prior-art references themselves that provide a reason to combine their teachings, and does not rely solely on conclusory statements regarding the similarities of Yu and Thomason to support its obviousness challenge. In view of Petitioner’s persuasive evidence demonstrating where the prior-art references teach or suggest each limitation in the challenged claims, and explaining why a person of ordinary skill in the art would have had reason to combine the prior-art references with a reasonable expectation of success, we find Petitioner has established, by a preponderance of the evidence, that claim 4 is unpatentable as obvious in view of Yu and Thomason.” slip op. at 33

  Patent outcomesUS 10,046,653 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,046,653
• Nanofiber Solutions, LLC v. Acera Surgical, Inc.Some claims unpatentable
  PTAB · Dec 13, 2022 · IPR2021-01016 · APJ Christopher L Crumbley · IPR · Final written decision

  Claims 1, 2, 4–7, and 13 are unpatentable: claims 1, 2, 4, 5, and 13 as anticipated by Johnson, and claims 6 and 7 as obvious over Johnson and Johnson–Liu, respectively.

  RulingsFinal written decision

  • Skill levelOther

    “Petitioner contends that: A person of ordinary skill in the art (“POSITA”) at the time of filing the ‘228 Patent would have been a person having a bachelor's degree in science or engineering, for example in the fields of chemistry, chemical engineering, or biomedical engineering, with undergraduate research experience, coupled with at least three years of industry experience, that linked the fabrication of fibrous polymeric materials to performance requirements for scaffolds for the promotion of proliferation of biological cells and the growth and/or reconstruction of biological tissues. Pet. 11–12 (citing Ex. 1002 ¶¶ 112–116). In response, Patent Owner notes that all challenged claims recite electrospun fibers but that Petitioner’s proposed level of skill “requires (1) no coursework, training or experience with electrospinning and (2) improperly focuses on scaffolds for the promotion of proliferation of biological cells and the growth and/or reconstruction of biological tissues.” PO Resp. 7 (citing Ex. 2001, ¶¶ 38–39). But Patent Owner then concedes that this “difference is immaterial to deciding the issues raised by the Petition.” Id. at 8.” slip op. at 9

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

    “construe claims “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b), including construing the claim in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” 37 C.F.R. § 42.100(b); see Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). Furthermore, we expressly construe the claims only to the extent necessary to resolve the parties’ dispute. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 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))). The parties agree that the terms of the challenged claims should be given their “plain and ordinary meaning” and that no express claim construction is necessary to address Petitioner’s challenges. Pet. 12; PO Resp. 6. We agree that no claim terms require express construction for purposes of resolving the dispute between the parties.” slip op. at 10

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

    “Upon review, we are unpersuaded that Petitioner has improperly mixed and matched disclosures from Johnson to arrive at an anticipatory reference. Patent Owner is correct that Petitioner primarily relies on Example 1 as evidence for the method by which its scaffold is made. But the disclosure found in paragraph 98 is not a “distinct” teaching of the type described in Net MoneyIN; rather, it is a general description of the structures that may be created by Johnson’s method: “A scaffold may comprise any number of layers, including about 1 layer, about 2 layers, about 3 layers, about 4 layers, about 5 layers, and so on.” Ex. 1009 ¶ 98. Patent Owner has not directed us to anything in the disclosure of Johnson that indicates that this is a “distinct” teaching or embodiment, instead of a general description of the types of scaffolds that Johnson encompasses. We see no reason why the general disclosures regarding Johnson’s scaffolds should be limited to specific embodiments, or precluded from applying to the method of Example 1.” slip op. at 14

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableNot shown unpatentable

    “We are unconvinced by Petitioner’s arguments and evidence. While we recognize that the range of claim 3 is very broad, and it is possible that scaffolds having fiber diameters as set forth in Johnson could have a mean pore size falling within the range, inherency “may not be established by probabilities or possibilities.” Par Pharm., Inc. v. Twi Pharms., Inc., 773 F.3d 1186, 1196 (Fed. Cir. 2014). Nor does Petitioner sufficiently explain why a person of ordinary skill in the art would have understood the process of Example 1 to necessarily result in the claimed mean pore size. We are also persuaded by Patent Owner’s argument that Boland 2005’s disclosure of a fiber diameter similar to Johnson’s that nevertheless falls outside the claimed mean pore size range. We note that Petitioner never addresses Boland 2005 in its Reply. 4. Conclusion as to Anticipation For these reasons, we find that Petitioner has met its burden of showing that claims 1, 2, 4, 5, and 13 are anticipated by Johnson, but has failed to meet its burden as to claim 3.” slip op. at 18

  Patent outcomesUS 10,632,228 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 10,632,228
• The Noco Company, Inc. v. Pilot, Inc.Some claims unpatentable
  PTAB · Oct 3, 2022 · IPR2021-00777 · APJ Jeffrey W Abraham · IPR · Final written decision

  Claims 1, 4–9, 11–18, and 20 are unpatentable; claim 3 was not shown unpatentable, because the adopted construction foreclosed the asserted obviousness ground.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art Petitioner asserts that a person of ordinary skill in the art “would have had an undergraduate degree in electrical engineering (or equivalent subject) together with two or three years of experience in [the] automotive electrical systems industry.” Pet. 11–12 (citing Ex. 1008 ¶ 13). Patent Owner does not challenge Petitioner’s definition or offer its own. Mr. McAlexander indicated that he adopted Petitioner’s definition for purposes of his declaration. Ex. 2005 ¶ 16. In light of the record before us, we adopt Petitioner’s proposal regarding the level of ordinary skill in the art. Based on our review of the ’653 patent and the prior art of record, we determine that the definition offered by Petitioner comports with the qualifications a person would have needed to understand and implement the teachings of the ’653 patent and the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 9

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

    “After considering the parties’ arguments and evidence, we adopt Petitioner’s proposed construction of the phrase “the switching circuit conducts power supply or power outage for the load through the microcontroller.” Petitioner’s construction is consistent with the plain language of the claim, and comports with the Federal Circuit’s decision in Chef America. Ex. 1001, 6:13–14; Chef Am., 358 F.3d at 1373–74 (holding that courts may not redraft claims to make them operable or sustain their validity, and construing the claims “based on the patentee’s version of the claim as he himself drafted it”). Additionally, the Specification of the ’653 patent states that “the automobile start control module conducts the power supply or power outage for the load module through the microcontroller.” Ex. 1001, 1:61–65. Furthermore, Patent Owner does not challenge Petitioner’s arguments or evidence, or present a competing construction. In view of this, we construe the phrase “the switching circuit conducts power supply or power outage for the load through the microcontroller” to mean “[t]he power for charging the load passes through the microcontroller.” Pet. 15; Reply 3–6.” slip op. at 11

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

    “We determine that we do not need to expressly construe any other terms for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 13

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “Ex. 1008 ¶ 12 (under the heading “Basis for My Opinion”). In addition to this general statement, Dr. Kattamis also cites to exhibits in specific paragraphs of the Kattamis Declaration to support the statements made therein. See, e.g., Ex. 1008 ¶ 18 (citing Ex. 1013), ¶ 22 (citing Ex. 1014), ¶¶ 63–68 (citing Krieger and Richardson), ¶¶ 70–74 (citing Baxter and Krieger), ¶¶ 76–79 (citing Richardson and George). In view of this, we consider Dr. Kattamis to have provided a sufficient disclosure regarding the basis for his opinions to at least avoid a determination that the Kattamis Declaration, in its entirety, is entitled to little or no weight. The fact that Dr. Kattamis, in preparing the Kattamis Declaration, re- used material he had previously written for an earlier proceeding involving a different patent does not justify a different outcome. To the extent Dr. Kattamis used previously prepared material in the Kattamis Declaration, he indicates that he “reviewed all of these passages in detail and confirmed that they were all still accurate and suitable for inclusion in his declaration in the current proceeding.” Reply 8; Ex. 1016 ¶ 6. Additionally, as Patent Owner demonstrates, Dr. Kattamis supplemented the re-used material by adding, where appropriate and necessary, language directed to the facts of this proceeding and specific citations to exhibits in this proceeding. See PO Resp. 8–9 (showing in redline the additions Dr. Kattamis included in the Kattamis Declaration).” slip op. at 17

  Patent outcomesUS 10,046,653 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 10,046,653
• Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-02139 · APJ Robert A Pollock · IPR · Final written decision

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

  RulingsFinal written decision

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

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

  • Skill levelSkill level patent owner adoptedDecided for patent owner

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

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

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

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

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

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

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

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

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

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

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

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

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

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

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

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,407,213

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.