• 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
• Google LLC / Ecobee Technologies Ulc v. Ecofactor, Inc.Some claims unpatentable
  PTAB · Feb 6, 2023 · IPR2022-00686 · APJ Scott B Howard · IPR · Final written decision

  Claims 1–3, 7, and 15–20 are unpatentable: claims 15, 19, and 20 as obvious over Hildebrand and Van Ostrand; claims 1–3, 7, 16, and 17 over those references and Rosen; and claim 18 over those …

  RulingsFinal written decision

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

    “the art would have combined the relevant teachings of Hildebrand and Van Ostrand with a reasonable expectation of success. As discussed above, Hildebrand is directed to a system for monitoring the efficiency of an HVAC system to determine when there is a fault. See Section II.E.1, supra; Ex. 1002 ¶ 60. Using much of the same data as Hildebrand, Van Ostrand teaches a method to determine which stage in a multiple stage HVAC system failed. See Section II.E.2; Ex. 1002 ¶¶ 60–61. Van Ostrand further teaches that the “[typical] HVAC system include[s] multiple stages of heating and/or cooling capacity.” Ex. 1007 ¶ 4. Because Hildebrand is silent as to which stage of the typical system—which has multiple stages— has failed, a person having ordinary skill in the art would have turned to Van Ostrand for that determination. Ex. 1002 ¶¶ 61–62. This modification would allow the Hildebrand system to detect which specific stage has failed. See Ex. 1007 ¶¶ 29–33. And because Van Ostrand represents a known method of detecting fault, it would have been obvious to use it to improve Hildebrand in a predictable way with a reasonable expectation of success. Ex. 1002 ¶ 63; see also KSR, 550 U.S. 398, 416–21. Petitioner has also sufficiently shown that a person having ordinary skill in the art would have added Rosen’s use of internet weather to the Hildebrand-Van Ostrand combination. See Ex. 1002 ¶ 115 (“Hildebrand and Van Ostrand are applied as I describe above with respect to Ground 1, with outside temperature over the Internet from a weather data provider. In my opinion, it would have been obvious to obtain outside temperature measurements from the Internet, thus replacing Hildebrand’s use of outside temperature sensors.”). Specifically, a person having ordinary skill in the art would have seen an advantage in avoiding the expense of obtaining, wiring and servicing an extra outside temperature sensor by obtaining weather information from the Internet as taught by Rosen. Ex. 1002 ¶ 120; see also Section II.F.1 (describing Rosen). Because it is undisputed that Rosen teaches using computer programming and network communications that were well-known and established at the relevant time period, there was a reasonable expectation of success. See Ex. 1002 ¶¶ 120–121.” slip op. at 35

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “There is also no dispute that ym is the output from a computer model. See Pet. 69; PO Resp. 32. Again, that is consistent with Spalink, which defines item 310—which generates ym—as a reference model. Ex. 1008 Fig. 3; ¶ 75 (describing ym as the output of the refence model). Thus, there is no meaningful dispute that the comparison shown in Figure 3—which the Petition relies on—is a comparison between a first HVAC system and a model, not a second HVAC system as recited in claim 8. Accordingly, that comparison does not teach or suggest “compar[ing] the relative efficiency of the first HVAC system and the second HVAC system” as recited in claim 8. Petitioner’s arguments that the data in the reference model comes from other buildings is inapposite. Although Petitioner accurately describes how reference model 310 is based on “data 367 collected from different buildings” (Ex. 1008 ¶ 77), Petitioner has not shown that a computer model is a second HVAC system. Therefore, comparing the output of a building to a model based on buildings does not teach or suggest the necessary comparison between the first HVAC system and the second HVAC system recited in claim 8.” slip op. at 57

  • BurdenNot shown unpatentable

    “claims 5 and 6. See Pet. 7 (listing of grounds), 45 (Ground 2 heading). However, the “Claim Mapping” section only discusses claims 1–3, 7, 15–17, and 20. Pet. 49–50. We noted this lack of mapping in the Institution Decision. Inst. Dec. 20. In its Reply, Petitioner argues as follows: The Institution Decision states “that the Petition omits any particular mapping for claim 5, 6, and 19” in the context of this Ground. (See Institution Decision, 20). Petitioner respectfully submits that the Petition makes clear that the claim mapping for these dependent claims is the same as in Ground 1, “with the exception that the outside temperature measurements, first recited in claim elements [1c] and [15c], come from an Internet weather data source.” (See Pet., 49). Pet. Reply 21–22 n.3. However, the Petition does not support that argument. Instead, page 49 of the Petition—which is all Petitioner cites to—does not mention claims 5 and 6. Instead, the page Petitioner cites shows that Petitioner misleadingly cropped the quotation. The full quotation below shows that page 49 of the Petition does not list claims 5 and 6: CLAIMS 1, 7, 15 AND 20 Independent claims 1 and 15, and their respective dependent claims 7 and 20, are obvious in the same manner discussed in Ground 1, with the exception that the outside temperature measurements, first recited in claim elements [1c] and [15c], come from an Internet weather data source. Pet. 49 (bold in original) (italics added to emphasize cropped language). Our rules require that “[t]he petition must specify where each element of the claim is found in the prior art patents or printed publications relied upon.” 37 C.F.R. § 42.104(b)(4). Petitioner did not do that with respect to” slip op. at 39

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “b) Our Analysis We agree with Patent Owner that Petitioner has not sufficiently shown that Hildebrand teaches or suggests limitation [1c]. The gravamen of Petitioner’s argument is that Hildebrand’s HVAC system is limited to HVAC system 12—the heating system, cooling system, and fan. See Pet. 12 (“The HVAC system is ‘HVAC system 12’ . . . .”); Ex. 1004, 4:1–10 (describing HVAC system 12). Although nominally supported by Mr. Shah’s testimony, that testimony is conclusory, parrots the Petition, and provides no corroborating evidence to show that a person having ordinary skill in the art would have understood that an HVAC system was limited to the heating and cooling systems. We give Mr. Shah’s testimony on that point no weight. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”); Verlander v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003) (Board has discretion to accord little weight to broad conclusory statements from expert witness); 37 C.F.R. § 42.65(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, Petitioner’s argument is inconsistent with Mr. Shahs’ direct testimony that clearly states that the HVAC system is broader then just the heating and cooling system and fan and includes other elements, such as thermostats and HVAC control systems. See Ex. 1002 ¶ 65 (“HVAC communications, and software, were widely known and understood.”). Applying Mr. Shah’s definition, the HVAC system as recited in claim 1 includes more than Hildebrand’s heating and cooling systems. Indeed, when discussing dependent claim 5, Petitioner argues that Hildebrand’s HVAC system also includes a thermostat. See Pet. 39. We do not find the Administrative Law Judge’s (“ALJ”) finding in an ITC proceeding involving a different record (and different patent) to be persuasive. Although the ALJ considered Hildebrand, there is nothing in the excerpt of the opinion to conclude that he considered Mr. Shah’s definition of an HVAC system. See Ex. 1010, 475–76. Nor is it clear from the record that the ALJ considered contrary testimony from Patent Owner’s expert. Id. Hildebrand Figure 1 shows an HVAC system including heating and” slip op. at 18

  Patent outcomesUS 8,019,567 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,019,567
• Google LLC / Ecobee Technologies Ulc v. Ecofactor, Inc.Some claims unpatentable
  PTAB · Feb 6, 2023 · IPR2021-01218 · APJ Scott B Howard · IPR · Final written decision

  Claims 1–3, 7, and 15–20 are unpatentable on specified §103 grounds; claims 4–6 and 8–14 were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “The ’567 patent is directed to a using a thermostat to detect faults in the HVAC system. See Ex. 1001, code (57). That aligns more closely with and HVAC control systems—than the one proposed by Petitioner—which focuses on energy controls. Compare Ex. 2002 ¶ 27, with Ex. 1002 ¶¶ 31– 33. Accordingly, we adopt Patent Owner’s propose definition. However, we consider the parties’ positions to be substantially similar, and note that neither party argues that the level of skill is determinative to the outcome of the case. Accordingly, we would have reached the same factual findings and conclusions of law had we adopted Petitioner’s proposed definition.” slip op. at 9

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “We decline to find Dr. Palmer less credible based solely on his experience. In judging the credibility of experts, we focus on whether the witness offers corroboration for his opinions, provides opinions that are consistent with the prior art, and the witness’ cross-examination testimony. Moreover, we note that Mr. Shah and Dr. Palmer substantially parrot the Petition and Patent Owner Response, respectively. Such testimony is generally unhelpful. Testimony which goes into more detail and expands on the points made in the papers (but not going beyond the points made in the papers) is more helpful and, as a general matter, given more weight so long as it is consistent with, and supported by, the other evidence in the record.” slip op. at 11

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

    “Because no express construction is needed for our decision, we do not construe any of the claim limitations. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we 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))).” slip op. at 11

  • BurdenNot shown unpatentable

    “that Hildebrand teaches or suggests limitation [1c]. The gravamen of Petitioner’s argument is that Hildebrand’s HVAC system is limited to HVAC system 12—the heating system, cooling system, and fan. See Pet. 12 (“The HVAC system is ‘HVAC system 12’ . . . .”); Ex. 1004, 4:1–10 (describing HVAC system 12). Although nominally supported by Mr. Shah’s testimony, that testimony is conclusory, parrots the Petition, and provides no corroborating evidence to show that a person having ordinary skill in the art would have understood that an HVAC system was limited to the heating and cooling systems. We give Mr. Shah’s testimony on that point no weight. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”); Verlander v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003) (Board has discretion to accord little weight to broad conclusory statements from expert witness); 37 C.F.R. § 42.65(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.”).” slip op. at 18

  Patent outcomesUS 8,019,567 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,019,567
• 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
• Google LLC v. Ecofactor Inc.Some claims unpatentable
  PTAB · Nov 17, 2022 · IPR2021-00982 · APJ Jeffrey W Abraham · IPR · Final written decision

  Claims 1–7 and 10–19 are unpatentable: claims 1–7 and 11–19 as obvious over Wedekind and Ehlers, and claim 10 as obvious over Wedekind, Ehlers, and Jenkins; claims 20–30 were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We note that the parties agree on the educational background of a person of ordinary skill in the art. And although the parties offer different levels of experience for a person of ordinary skill in the art, there is some overlap, as both parties require experience with HVAC systems. Pet. 15 (requiring experience with “building energy management”); PO Resp. 5–6 (requiring experience with HVAC controls, and acknowledging that “building energy management” includes controlling HVAC systems). Accordingly, we do not consider the difference between the parties’ proposals to be material. Moreover, neither party asserts that its positions or the outcome depends on which definition we apply in this proceeding.” slip op. at 10

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

    “B. Claim Construction In an inter partes review, we construe claim terms according to the standard set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–17 (Fed. Cir. 2005) (en banc). 37 C.F.R. § 42.100(b) (2020). Under Phillips, claim terms are afforded “their ordinary and customary meaning.” Phillips, 415 F.3d at 1312. “[T]he ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.” Id. at 1313. “Importantly, the person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification.” Id.” slip op. at 11

  • Strike new argumentNew argument consideredDecided for petitioner

    “Reply ignore the express statement in the Petition characterizing sensors 36 in Wedekind as “a source external to the building.” Sur-reply 2 (quoting Pet. 28), 3. Patent Owner also argues this is a new argument that we should disregard. Sur-Reply 2. We disagree. Although Patent Owner is correct that Petitioner contends Wedekind’s outside air temperature sensors 36 are a source external to the building, that is not the only argument Petitioner presents. In the Petition, Petitioner contends more generally that Wedekind’s outside air temperature sensors 36 “measure the outside air temperature.” Pet. 28. Petitioner also argues that Ehlers provides weather data including outside temperatures, and that the source of the data is a weather service provider that is external to the building. Pet. 32 (citing Ex. 1008, 9:53–54, 35:13–17). Petitioner further argues that it would have been obvious “to replace Wedekind’s outside temperature sensors 36 with receiving outside temperature data from a network connection,” as Ehlers teaches. Pet. 32. In view of this, we agree with, and are persuaded by, Petitioner’s argument that it does not rely only on Wedekind to meet the limitation that “the second data from the network connection is collected from a source external to the building.” Reply 10. Additionally, the presence of these arguments in the Petition undermines Patent Owner’s assertion that Petitioner is attempting to present new arguments in the Reply. Similarly, Petitioner acknowledges in the Petition that Wedekind does not expressly teach the second data is received from a network connection, and, therefore, relies on Ehlers’ disclosure of receiving data from a network connection. Pet. 30; Reply 11. Patent Owner does not dispute that Ehlers discloses receiving weather data from a network connection. See PO Resp. 15–28; Sur-reply 3–8. In view of the foregoing, Petitioner has demonstrated persuasively that the combined disclosures of Wedekind and Ehlers teach or suggest “the one or more processors further configured to receive a second data from a network connection, wherein the second data from the network connection is collected from a source external to the building” claim 1 requires.” slip op. at 20

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

    “We find Petitioner’s arguments to be persuasive. Petitioner presents undisputed evidence, based on the disclosure of Wedekind and Ehlers, that obtaining outside temperatures either from local sensors or over a network was known in the art. Pet. 28–32; Ex. 1006, 4:45–47; Ex. 1008, 9:50–63. Petitioner also directs us to evidence, including in Ehlers itself, supporting Petitioner’s reasoning that replacing Wedekind’s outside air temperature sensors with a network-based weather data service would have saved the cost and effort of installing multiple sensors. Pet. 32; Ex. 1002 ¶ 103; Ex. 1008, 39:54–57; Reply 13. As Petitioner points out, Patent Owner does not directly challenge Petitioner’s argument and evidence that a person of ordinary skill in the art would have had reason to modify Wedekind in view of Ehlers to avoid the cost and effort of installing multiple sensors. Reply 13.5 Indeed, Patent Owner acknowledges that Wedekind “expressly indicates that there must be multiple sensors of outdoor temperature for sufficient accuracy in Wedekind’s complex computational model.” PO Resp. 26; Ex. 1006, 3:62–67. The need for multiple sensors in Wedekind 5 We recognize Patent Owner argues that a person of ordinary skill in the art would not have been motivated to connect Wedekind’s outside air temperature sensors 36 to a network because it would “increase costs.” PO Resp. 23–24. Patent Owner, however, presents this argument before it addresses Petitioner’s proposed combination of Wedekind and Ehlers. See PO Resp. 23–24 (referring to cost increases first, and addressing the proposed combination of Wedekind and Ehlers in the next paragraph). Thus, Patent Owner’s cost argument does not appear to address Petitioner’s assertion regarding cost savings in view of the proposed combination. Nor does Patent Owner present evidence regarding, or explain adequately, what costs it is referring to, or how those costs would increase. PO Resp. 23–24; Ex. 2005 ¶ 61. By way of contrast, Petitioner’s arguments regarding cost savings are supported by the disclosure of Ehlers itself. Ex. 1008, 39:54–57. strengthens Petitioner’s argument that a person of ordinary skill in the art, in view of Ehlers’ teaching regarding avoiding the cost and effort of installing multiple sensors, would have had reason to modify Wedekind in view of Ehlers. Additionally, Patent Owner’s own declarant characterized Ehlers’ discussion of “lowering the cost of installation and ongoing maintenance” as “teach[ing] away from external sensors.” Ex. 1023, 58:7–18. These arguments and evidence undermine Patent Owner’s assertion that Petitioner failed to provide any analysis as to why a person of ordinary skill in the art would have modified Wedekind in view of Ehlers. Sur-reply 3–4; PO Resp. 25–28. Petitioner also argues, and provides evidence in the form of testimony from Dr. Shah demonstrating, that a person of ordinary skill in the art would have been able to modify Wedekind’s system by connecting Wedekind’s processing means to a network connection such as Ehlers’ phone input or communications link, and would have obtained predictable results. Pet. 33; Ex. 1002 ¶ 104. Patent Owner does not dispute this evidence. To the contrary, Patent Owner appears to concede that the proposed combination would work, although not as reliably as Wedekind’s hardwired system. PO Resp. 25–26. As a result, and in the absence of any evidence or argument suggesting otherwise, we credit Dr. Shah’s testimony. Furthermore, Ehlers teaches, in connection with providing data obtained from a weather service provider over a network, that “[t]he data may be provided at regular intervals and be sufficiently localized for acceptable accuracy.” Ex. 1008, 9:58–60. This statement from Ehlers itself undermines Patent Owner’s arguments regarding alleged problems with transmitting data over networks and insufficient accuracy, including Patent Owner’s argument that Wedekind teaches away from the approach used by Ehlers. PO Resp. 25–28. Nevertheless, even if we were to give Patent Owner the full credit of its arguments regarding unreliable transmission of data over networks and data obtained from weather service providers being less useful than data obtained from sensors at a specific structure, obviousness “does not require that the motivation be the best option, only that it be a suitable option from which the prior art did not teach away.” PAR Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d 1186, 1197-98 (Fed. Cir. 2014). As discussed above, Petitioner’s evidence and arguments demonstrate that using Ehlers’ network to transmit temperature data was at least a suitable option. For all of the foregoing reasons, we determine Petitioner has demonstrated persuasively that a person of ordinary skill in the art would have had reason to modify Wedekind in view of Ehlers, and would have had a reasonable expectation of success in doing so. iii.” slip op. at 25

  Patent outcomesUS 10,612,983 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,612,983
• Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-02139 · APJ Robert A Pollock · IPR · Final written decision

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

  RulingsFinal written decision

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

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

  • Skill levelSkill level patent owner adoptedDecided for patent owner

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

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

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

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

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

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

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

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

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

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

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

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

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

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

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

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

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

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “with respect to the ’213 patent. See Pet. 12–13; Prelim. Resp. 17–18; PO Resp. 17–18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 10–11. Petitioner does not contest this definition in its Reply and we find no reason to revise our earlier determination. We further note that the prior art itself demonstrates this level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings on ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C.” slip op. at 11

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

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

  • Prior constructionDecided for patent owner

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

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

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

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

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.