• 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
• Apple Inc. v. Memoryweb, LLCSome claims unpatentable
  PTAB · Jun 7, 2023 · PGR2022-00006 · APJ Jason M Repko · PGR · Final written decision

  Claims 1–12, 17–44, and 49–59 are unpatentable over A3UM or for lack of written description; claims 13–16 and 45–48 were not shown unpatentable.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “2. Analysis A person is not entitled to a patent if their invention was “described in” slip op. at 9

  • Skill levelOther

    “B. Level of Ordinary Skill in the Art According to Petitioner, A person of ordinary skill in the art in 2011 would have had (1) at least a bachelor’s degree in computer science, computer engineering, or electrical engineering, and (2) at least applications such as photo management systems. Pet. 12 (citing Ex. 1003 ¶¶ 44–46). In the Institution Decision, we applied Petitioner’s proposed definition. Inst. Dec. 12. Patent Owner does not dispute Petitioner’s proposed level of ordinary skill in the art. PO Resp. 7. We continue to find that the skill level identified by Petitioner (Pet. 12) is consistent with the record. Thus, we use the same definition here that we used in the Institution Decision.” slip op. at 30

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableNot shown unpatentableMixed

    “e. Conclusion Petitioner provides articulated reasoning, supported by rational” slip op. at 68

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable

    “11. Written Description: Claims 6, 7, 38, and 39 Petitioner asserts that claims 6, 7, 38, and 39 are unpatentable as lacking adequate written-description support. Pet. 91–93. Claim 6 recites, in part, “The method of claim 4, wherein, in the people view, the first name is displayed adjacent to the first digital file associated with the first thumbnail image and the second name is displayed recites similar limitations. See id. at 38:47–50. Claim 7 depends from claim 6, and claim 39 depends from claim 38. Id. at 35:63–65 (claim 7), 38:51–53 (claim 39). Petitioner asserts that claims 6 and 38 require that the “people view” includes at least the following: (i) “a first thumbnail image associated with a first person,” (ii) “a first name associated with the first person,” (iii) “a second thumbnail image associated with a second person,” (iv) “a second name associated with the second person,” and (v) a “first digital file associated with the first person.” Pet. 91. Petitioner argues that the ’020 patent lacks written-description support for a people view with these features. Id. at 92 (citing Ex. 1003 ¶ 315). Under Petitioner’s interpretation, digital files are “plainly distinct”” slip op. at 96

  Patent outcomesUS 11,017,020 mixed
  § 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR
  Patents in suitUS 11,017,020
• Amphastar Pharmaceuticals, Inc. v. Aegis Therapeutics, LLCSome claims unpatentable
  PTAB · Feb 9, 2023 · IPR2021-01324 · APJ Cynthia M Hardman · IPR · Final written decision

  Claims 1, 2, and 7–17 are unpatentable under §102 or §103; claims 3–6 and 18–20 were not shown unpatentable.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “in Table 1 and the formulations of Potta claim 21 (i.e., ‘from about 0.1% w/w to about 15% w/w epinephrine or a salt thereof’), because such formulations would elicit the desired biological or medicinal response.” Ex. 1002 ¶ 272. Dr. Weinstein provides an essentially identical opinion. Ex. 1003 ¶ 286. Neither declarant supports their opinion with any explanation as to why the Potta formulations would provide the claimed plasma epinephrine concentration or elicit a biological or medicinal response. Accordingly, we do not credit these opinions, and determine that Petitioner has not met its burden to establish that Potta inherently anticipates claim 3. See n re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”).” slip op. at 29

  • ExcludeMotion to exclude, deniedDenied

    “As the moving party, Petitioner bears the burden of establishing that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). Having considered the arguments and evidence of record, we determine that Petitioner has not met its burden of proof. We agree with Patent Owner that “[n]o bright line rule prohibits the consideration of post-priority date evidence,” and that such evidence is permissible in certain contexts. Opp. 2–3. On this record we do not find that there is sufficient cause to exclude the challenged exhibits, because any consideration by the Board of these exhibits has taken into account their alleged post-priority date status. Thus, we do not find that maintaining the exhibits in this proceeding results in any unfair prejudice to Petitioner, or that the exhibits have confused the issues before us. Accordingly, we deny Petitioner’s motion to exclude.” slip op. at 73

  • Skill levelOther

    “II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8

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

    “For the above reasons, on the full trial record we determine that” slip op. at 26

  Patent outcomesUS 10,682,414 mixed
  § 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,682,414
• Shenzhen Carku Technology Co., Ltd. v. The Noco CompanySome claims unpatentable
  PTAB · Nov 3, 2021 · IPR2020-00944 · APJ Jameson Lee · IPR · Final written decision

  Claims 1–10 and 12–23 are unpatentable over the listed grounds; claim 11 was not shown unpatentable because the evidence did not establish the claimed connection sequence.

  RulingsFinal written decision

  • Expert testimonyOther

    “Q. So Richardson contemplates a flow of control where the shunt calibration flag was not set, correct? A. That is reasonable. He shows an option -- an option of a “no” result from Step 406. Ex. 1047, 110:14–18. Dr. Wood also agrees that when the shunt calibration flag is not set and the procedure advances to Step 420, the contact relay in Richardson is still open: Q. Now, if the shunt calibration flag is not set and we go to Step 420, the starter contact relay in Richardson is still open, correct? A. That is my understanding. Id. at 77:10–13. Dr. Wood further agrees that when the shunt calibration flag is not set and the procedure advances to Step 214, where reverse polarity connection is tested, the starter contact relay is still open: Q. Okay. Then if we continue to Step 214 in this example, where the shunt calibration flag was not set, when we’re testing for the condition reverse jumper cable voltage, the starter contact relay is still open, right? A. That appears to be the case.” slip op. at 65

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

    “Referring to FIG. 3, Klang states: “[t[he reverse polarity sensor 48, connected in a like manner across the battery terminals 20, 22, senses negative voltage indicating that the battery leads are connected backwards.” Ex. 1007, 6:20–23. Klang’s reverse polarity sensor provides an output signal (sensed negative voltage) indicating whether the battery has a proper polarity connection. Klang states: “[i]f the start button has not been pressed, at step 144, the OCV [battery open circuit voltage] is compared to a low negative voltage to determine whether the conducting cables 18 are properly connected to the battery 16. If the OCV is less than -0.5V, the method proceeds at step 146 to notify the operator that the leads are reversed.” Ex. 1007, 8:55– 60.” slip op. at 26

  • Obviousness (§103) › Objective indicia / secondary considerationsNot reached

    “references. Accordingly, consideration and discussion of the objective evidence of nonobviousness is unnecessary.” slip op. at 92

  • ExcludeMotion to exclude, deniedDenied

    “discussed below, the Motion is denied.” slip op. at 94

  Patent outcomesUS 9,007,015 mixed
  § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,007,015
• Cooler Masters Co., Ltd. v. Aavid Thermalloy LLCSome claims unpatentable
  PTAB · Jun 4, 2020 · IPR2019-00337 · APJ Linda E Horner · IPR · Final written decision

  Claims 9, 10, and 13 were held unpatentable as obvious; claims 11 and 12 were not shown unpatentable.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedReference is prior artDecided for petitioner

    “The existence of a published abstract that would have allowed one skilled in the art exercising reasonable diligence to locate the foreign patent application and the fact that the application was classified and indexed in the patent office, were central to the Wyer court’s conclusion that the application was “publicly accessible.”” slip op. at 35

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

    “inherency, then the assertions of obviousness are mere conclusory statements. We are unable to recognize any proffered reasoning underlying the assertions of obviousness. “[Challenges] on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). As yet another possible alternative, Petitioner may be basing its case on improper hindsight by relying on and quoting the Specification of the ’240 patent in its obviousness analysis. See Pet. 27. That, too, is unpersuasive. Regardless as to its theory of the case, we determine that Petitioner has failed to explain sufficiently why the claimed heat pipe having a configuration of two plates having bonded together circumferential edge lips would have been obvious. Accordingly, Petitioner has not shown by a preponderance of the evidence that claim 12 is unpatentable over Morikawa alone.” slip op. at 55

  • ExcludeMotion to exclude, deniedMixed

    “as not relevant under FRE 104 on the grounds that Petitioner failed “to introduce sufficient proof that Exhibit 1004 was publicly accessible such that it qualifies as a prior art printed publication under United States law.” Paper 46, 3; see also id. at 4 (citing Fed. R. Evid. 104, 401). As set forth in section II.D, above, the evidence of record leads us to an entirely different conclusion regarding Nakamura’s prior art status. Because Petitioner persuades us that Nakamura qualifies as a prior art printed publication as of the earliest possible effective filing date of the challenged claims of the ’240 patent, we deny Patent Owner’s request on its merits.” slip op. at 82

  Patent outcomesUS 7,066,240 mixed
  § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,066,240
• Cooler Masters Co., Ltd. v. Aavid Thermalloy LLCSome claims unpatentable
  PTAB · Jun 4, 2020 · IPR2019-00144 · APJ Linda E Horner · IPR · Final written decision

  Claims 9–12 were not shown unpatentable; claim 13 was shown unpatentable as obvious over Nakamura and Takahashi.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “The existence of a published abstract that would have allowed one skilled in the art exercising reasonable diligence to locate the foreign patent application and the fact that the application was classified and indexed in the patent office, were central to the Wyer court’s conclusion that the application was “publicly accessible.”” slip op. at 36

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

    “made using related processes, however, says nothing about why one of ordinary skill in the art would combine them in a manner that renders the claimed subject matter obvious. See Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1368 (Fed. Cir. 2012) (quoting Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374 n.3 (Fed. Cir. 2008) (“We must still be careful not to allow hindsight reconstruction of references to reach the claimed invention without any explanation as to how or why the references would be combined to produce the claimed invention.”)). Petitioner’s argument that the references are “similar and analogous” is not adequate reasoning, by itself, to support a conclusion of obviousness.” slip op. at 54

  • ExcludeMotion to exclude, deniedMixed

    “as not relevant under FRE 104 on the grounds that Petitioner failed “to introduce sufficient proof that Exhibit 1004 was publicly accessible such that it qualifies as a prior art printed publication under United States law.” Paper 46, 3; see also id. at 4 (citing Fed. R. Evid. 104, 401). As set forth in section II.D, above, the evidence of record leads us to an entirely different conclusion regarding Nakamura’s prior art status. Because Petitioner persuades us that Nakamura qualifies as a prior art printed publication as of the earliest possible effective filing date of the challenged claims of the ’240 patent, we deny Patent Owner’s request on its merits.” slip op. at 73

  Patent outcomesUS 7,066,240 mixed
  § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,066,240
• Feit Electric Company, Inc. v. Signify Holding B.V. F/K/A Philips Lighting Holding B.V.Some claims unpatentable
  PTAB · Oct 18, 2019 · IPR2018-00921 · APJ Jason M Repko · IPR · Final written decision

  Claims 1, 22, and 30 are unpatentable as obvious over Biebl; claims 7 and 14 were not shown unpatentable because the proposed combinations lacked sufficient support.

  RulingsFinal written decision

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

    “The Specification supports the construction that an oscillating signal is periodically varying. For instance, the Specification states that “the low frequency oscillating signal changes from low to high.” Ex. 1001, 2:35–37. In another example, “the oscillating signal can be a square wave oscillating between 0 and 16 volts with a frequency of 200 to 300 Hertz.” Id. at 4:17– 20. In these examples, the ’890 patent uses term “oscillating” to describe signals having periodic variation or change. Thus, we construe “an oscillating signal” as a signal with periodic variation. generating an oscillating signal. Petitioner’s definition from a technical dictionary merely adds that an oscillator is (1) an electronic circuit and (2) “converts energy from a direct-current source.” Pet. Reply 4 (citing Ex. 1021, 3 (McGraw-Hill Dictionary of Scientific and Technical Terms 1341–40 (4th ed. 1989))). There is no dispute about a direct-current source. The Specification discusses an “oscillator” in terms of its function. See Ex. 1001, 2:17–19, 26–27; 44–48. Thus, we determine that “oscillator” means an electronic circuit that generates an oscillating signal.” slip op. at 7

  • Claim Construction › Functional claiming / §112(f) means-plus-function › Corresponding structure / algorithm (indefinite if none)Term construed board ownDecided for patent owner

    “We agree with Patent Owner that the Patent indicates that either set of resistors can perform the claimed function. Prelim. Resp. 12. For instance, R1A1, R1A2, and R1A3 appear in the schematic diagram in Figure 2A. This diagram shows a first power supply 112 that supplies current to LED array 114. Ex. 1001, 3:11–12. LED array 114 responds to signals for the STOP input 104 or TURN input 102. Id. at 3:12–14. The resistors are between the first power supply 112 and LED array 114 to sense current. Id. at 3:31–35. By contrast, R1B1, R1B2, and R1B3 appear in the schematic diagram in Figure 2C. This diagram shows a second power supply (130) that supplies power to LED array 126. Id. at 3:55–56. LED array 126 responds to signals for the STOP input 104 or TAIL input 106, depending on the input mode. Id. at 3:56–59. Figure 2C shows the resistors connected to the second power supply 130. Id., Fig. 2C. So the two sets of resistors perform the same function but are connected to different power supplies. Thus, the structures disclosed in the Specification as corresponding to the claimed function are (1) R1A1, R1A2, or R1A3 or (2) R1B1, R1B2, or corresponding structure because it is immaterial to our analysis below.” slip op. at 10

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Any difference between Petitioner’s and Patent Owner’s proposed levels of ordinary skill in the art are immaterial because, as Dr. Zane explains, “applying Dr. Shackle’s standard for the level of ordinary skill in the art would not affect [Dr. Zane’s] analysis and conclusion regarding the patentability of any challenged claim.” Id. ¶ 27. So we apply Petitioner’s proposed definition, which appears to be consistent with the level of skill reflected in the asserted references. See Okajima v. Bordeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that the prior art itself can reflect an appropriate level of skill in the art).” slip op. at 22

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

    “Yet nothing in the claim suggests that visual characteristics are relevant. Rather, claim 1’s system uses the recited states for a purpose unrelated to viewing waveforms—i.e., to determine whether to supply power or not. See Ex. 1001, 5:24–27. So we are unpersuaded by Patent Owner’s argument that slope or other visual characteristics should be the only basis for defining the states. See PO Resp. 15. Thus, Petitioner has shown that Biebl teaches “an oscillating signal having a first state and a second state.”” slip op. at 26

  Patent outcomesUS 6,586,890 mixed
  Claim construction§ 103 obviousness
  Patents in suitUS 6,586,890
• 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.