• Fluidmaster, Inc. v. Danco, Inc.Some claims unpatentable
  PTAB · Mar 5, 2026 · IPR2024-00634 · APJ Meredith C Petravick · IPR · Final written decision

  Claims 1, 3, 8–13, 15, 16, and 19–24 are unpatentable over Brown and Ho, with claims 16 and 19 also relying on the Quick Connection Art; the remaining challenged claims were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Patent Owner proposes that: A [person of ordinary skill in the art (“POSITA”)] in the field to which the ’105 Patent is directed would have had at least a Bachelor of Science degree in mechanical engineering or a related field or, as a substitute, at least two years of work or” slip op. at 9

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

    “of “integrally molded with” as “molded together as a single structure.” Paper 21, 15.” slip op. at 11

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

    “Patent Owner responds that: a POSITA would not have been motivated to make the proposed modification, nor does the Petition include any analysis regarding why a POSITA would be motivated to move from a vertical extended portion to a radial extended portion. Indeed, a radial extended portion is directly counter to the stated goals of Brown (e.g., reducing noise caused by turbulence), at least insofar as it introduces another sudden directional change into the fluid flow system. PO Resp. 58–59 (citing Ex. 2013 ¶ 242).” slip op. at 32

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “Patent Owner argues that the ’105 patent claims were “fully supported as of the filing date of at least the ’606 Application . . . March 11, 2004” because the ’606 Application discloses regulating water flow and a POSITA would know that appropriate devices for regulating water flow includes nonadjustable waterflow restrictors. PO Resp. 63–65; PO Sur-reply 26–29. Patent Owner’s argument is persuasive. The ’606 Application discloses: [W]hen the toilet fill valve 100 is open and water flows from the water inlet 103 to the water outlets 106 and into a toilet tank, an amount of water is also supplied to the bowl fill valve inlet 113 that flows through the bowl fill valve 109 and out the bowl fill valve outlet 116. By virtue of the manual setting of handle 119 of the bowl fill valve 109, the flow of water through the bowl fill valve 109 is regulated. In this manner, the flow of water is regulated so that enough water flows out of the bowl fill valve 109 to fill a toilet bowl without wasting any water down a drain. seen from the passage above, the ’606 Application discloses regulating an amount of water supplied to a toilet bowl using a valve (i.e., a water flow regulator). Ex. 2013 ¶ 288. Further, the ’606 Application states: The bowl fill valve 109 may be, for example, a ball valve, a gate valve, a globe valve, a plug valve, a diaphragm valve, a butterfly valve, a needle valve, a sliding gate, a quick turn valve, a knife valve or any other appropriate type of valve as can be appreciated by those with ordinary skill in the art.” slip op. at 42

  Patent outcomesUS 9,103,105 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 9,103,105
• Mobileye Global, Inc. / ZF Active Safety And Electronics US LLC v. Facet Technology Corp.Some claims unpatentable
  PTAB · Jan 23, 2026 · IPR2025-00749 · APJ Sean P O’Hanlon · IPR · Final written decision

  Claims 1–4 and 8–13 are unpatentable as obvious over Gallagher and Schofield; claims 5–7 and 14–16 were not shown unpatentable on the asserted combinations.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “skilled artisan would have, with Petitioner contending four years and Patent Owner contending two years. Patent Owner’s witness, Dr. Papanikolopoulos, does not provide an explanation for his opinion or support his definition of the level of ordinary skill with citations to evidence. See Ex. 2023 ¶ 57 (“In my opinion, [Petitioner’s definition] is an excessive level of ordinary skill in the art, and I believe instead [an ordinarily skilled artisan] would more likely have two years of experience rather than four years.”). On the other hand, Petitioner’s witness, Dr. Thorpe, does provide an explanation for his opinion, explaining that his assertion that four years of experience is required is based on the state of the art, typical undergraduate curricula, and his supervision of doctoral students. Ex. 1030 ¶ 21. Based on the arguments presented and the cited references, we find Petitioner’s definition of the level of ordinary skill reasonable and for purposes of this Decision, adopt it as our own. We note that we would reach the same conclusions under either proposed standard.” slip op. at 11

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

    “As a general rule, unless the steps of a method claim actually recite an order, the steps are not ordinarily construed to require one.” Mformation Techs., Inc. v. Rsch. in Motion Ltd., 764 F.3d 1392, 1398 (Fed. Cir. 2014) (citation modified). “However, a claim requires an ordering of steps when the claim language, as a matter of logic or grammar, requires that the steps be performed in the order written, or the specification directly or implicitly requires an order of steps.” Id. (cleaned up). “[O]rdinarily in process claims steps taken concurrently are the equivalent of steps taken successively.” In re White, 39 F.2d 974, 975 (CCPA 1930); see also Cybersettle, 243 F. App’x. at 609 (finding “the step of calculating the differences between demands and offers can occur concurrently with the [next enumerated step of] receipt of multiple demands and offers” and “the testing step of ‘determining whether any of the differences fall within the predetermined settlement range’ may occur concurrently with the receipt and comparison of the bids” (citation modified)). This is especially true here, given that the recitations at issue are functional language in an apparatus (system) claim. We further agree with Petitioner that the ’328 patent discloses such concurrent performance of these steps: Either concurrent with or subsequent to the identification of road signs 30 and generation of asset management database 24, the computer processor 22 evaluates that portion 32 of each video frame or image that depicts a road sign 30 to determine a set of color values 40, 42 for each of a plurality of colors on the road sign 32. A retroreflectivity value is generated for each color portion 34, 36 on each frame of the tagged videostream 20 containing the road sign 30 that represents a different color value 40, 42. slip op. at 13

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

    “Petitioner is correct to the extent that it need not show that “the features of [Schofield] may be bodily incorporated into the structure of [Gallagher],” but Petitioner must prove that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention.” Allied Erecting, 825 F.3d at 1381. For claim 9, Petitioner proposes to modify Gallagher’s system to use “Schofield’s determination of a light source’s location within a field of view” in Gallagher’s system. Pet. 23. Thus, Petitioner’s combination does not require the combination of Gallagher’s and Schofield’s sensors into a single system, and Patent Owner’s “sensor fusion” argument is inapposite. See Tr. 48:8–49:6 (Patent Owner’s counsel confirming that the problem of “sensor fusion” stems from combining disparate sensors in a single system). As noted above, Schofield teaches considering the relative location of the light source in determining whether the light source is from headlights or taillights (that is, an object of interest). See Ex. 1006, 9:26–35. We are persuaded that an ordinarily skilled artisan would be motivated to use this teaching in Gallagher’s device to help distinguish between road markers that are arranged side-by-side and have a reasonable expectation of success in doing so. See Ex. 1005 ¶ 40; Ex. 1003 ¶¶ 77 (“[An ordinarily skilled artisan] would have seen Schofield’s determination of a light source’s location within the field of view as advantageous because it would have allowed Gallagher’s computer to associate the measured reflectance level with the appropriate road marker.”), 79 (“[I]mplementing this determination would have required [an ordinarily skilled artisan] to implement only conventional techniques of image processing (identifying a location of a particular pixel within an array), which was well known by [an ordinarily skilled artisan], to predictably yield the result of the location within a field of view indicating an intensity value associated with a road marker. Given that Schofield and Gallagher disclose similar types of arrays, this combination would have merely required the use of Schofield’s known technique to improve Gallagher’s similar device in the same way.”).” slip op. at 30

  • Obviousness (§103) › Analogous artNon analogous artNot shown unpatentable

    “A reference qualifies as prior art for a determination under § 103 when it is analogous to the claimed invention. In re Clay, 966 F.2d 656, 658 (Fed. Cir. 1992). Two separate tests define the scope of analogous prior art: (1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004) (citing In re Deminski, 796 F.2d 436, 442 (Fed. Cir. 1986)).” slip op. at 49

  Patent outcomesUS 9,671,328 mixed
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,671,328
• Mobileye Global, Inc. / ZF Active Safety And Electronics US LLC v. Facet Technology Corp.Some claims unpatentable
  PTAB · Jan 23, 2026 · IPR2024-01111 · APJ Sean P O’Hanlon · IPR · Final written decision

  Claims 1–4 and 8–13 are unpatentable as obvious over Gallagher and Schofield; claims 5–7 and 14–16 were not shown unpatentable on the asserted grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “The parties disagree only on the length of experience an ordinarily skilled artisan would have, with Petitioner contending four years and Patent Owner contending two years. Patent Owner’s witness, Dr. Papanikolopoulos, does not provide an explanation for his opinion or support his definition of the level of ordinary skill with citations to evidence. See Ex. 2023 ¶ 57 (“In my opinion, [Petitioner’s definition] is an excessive level of ordinary skill in the art, and I believe instead [an ordinarily skilled artisan] would more likely have two years of experience rather than four years.”). On the other hand, Petitioner’s witness, Dr. Thorpe, does provide an explanation for his opinion, explaining that his assertion that four years of experience is required is based on the state of the art, typical undergraduate curricula, and his supervision of doctoral students. Ex. 1030 ¶ 21. Based on the arguments presented and the cited references, we find Petitioner’s definition of the level of ordinary skill reasonable and for purposes of this Decision, adopt it as our own. We note that we would reach the same conclusions under either proposed standard.” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITANo construction needed

    “As a general rule, unless the steps of a method claim actually recite an order, the steps are not ordinarily construed to require one.” Mformation Techs., Inc. v. Rsch. in Motion Ltd., 764 F.3d 1392, 1398 (Fed. Cir. 2014) (citation modified). “However, a claim requires an ordering of steps when the claim language, as a matter of logic or grammar, requires that the steps be performed in the order written, or the specification directly or implicitly requires an order of steps.” Id. (cleaned up). “[O]rdinarily in process claims steps taken concurrently are the equivalent of steps taken successively.” In re White, 39 F.2d 974, 975 (CCPA 1930); see also Cybersettle, 243 F. App’x. at 609 (finding “the step of calculating the differences between demands and offers can occur concurrently with the [next enumerated step of] receipt of multiple demands and offers” and “the testing step of ‘determining whether any of the differences fall within the predetermined settlement range’ may occur concurrently with the receipt and comparison of the bids” (citation modified)). This is especially true here, given that the recitations at issue are functional language in an apparatus (system) claim. We further agree with Petitioner that the ’328 patent discloses such concurrent performance of these steps: Either concurrent with or subsequent to the identification of road signs 30 and generation of asset management database 24, the computer processor 22 evaluates that portion 32 of each video frame or image that depicts a road sign 30 to determine a set of color values 40, 42 for each of a plurality of colors on the road sign 32. A retroreflectivity value is generated for each color portion 34, 36 on each frame of the tagged videostream 20 containing the road sign 30 that represents a different color value 40, 42. Ex. 1001, 5:52–60. Thus, the ’328 patent discloses concurrently detecting objects of interest (road signs) and determining whether the object of interest has a particular color value. slip op. at 13

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

    “Petitioner is correct to the extent that it need not show that “the features of [Schofield] may be bodily incorporated into the structure of [Gallagher],” but Petitioner must prove that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention.” Allied Erecting, 825 F.3d at 1381. For claim 9, Petitioner proposes to modify Gallagher’s system to use “Schofield’s determination of a light source’s location within a field of view” in Gallagher’s system. Pet. 23. Thus, Petitioner’s combination does not require the combination of Gallagher’s and Schofield’s sensors into a single system, and Patent Owner’s “sensor fusion” argument is inapposite. See Tr. 48:8–49:6 (Patent Owner’s counsel confirming that the problem of “sensor fusion” stems from combining disparate sensors in a single system). As noted above, Schofield teaches considering the relative location of the light source in determining whether the light source is from headlights or taillights (that is, an object of interest). See Ex. 1006, 9:26–35. We are persuaded that an ordinarily skilled artisan would be motivated to use this teaching in Gallagher’s device to help distinguish between road markers that are arranged side-by-side and have a reasonable expectation of success in doing so. See Ex. 1005 ¶ 40; Ex. 1003 ¶¶ 77 (“[An ordinarily skilled artisan] would have seen Schofield’s determination of a light source’s location within the field of view as advantageous because it would have allowed Gallagher’s computer to associate the measured reflectance level with the appropriate road marker.”), 79 (“[I]mplementing this determination would have required [an ordinarily skilled artisan] to implement only conventional techniques of image processing (identifying a location of a particular pixel within an array), which was well known by [an ordinarily skilled artisan], to predictably yield the result of the location within a field of view indicating an intensity value associated with a road marker. Given that Schofield and Gallagher disclose similar types of arrays, this combination would have merely required the use of Schofield’s known technique to improve Gallagher’s similar device in the same way.”).” slip op. at 30

  • Expert testimonyPatent owner expert discountedOther

    “The parties disagree only on the length of experience an ordinarily skilled artisan would have, with Petitioner contending four years and Patent Owner contending two years. Patent Owner’s witness, Dr. Papanikolopoulos, does not provide an explanation for his opinion or support his definition of the level of ordinary skill with citations to evidence. See Ex. 2023 ¶ 57 (“In my opinion, [Petitioner’s definition] is an excessive level of ordinary skill in the art, and I believe instead [an ordinarily skilled artisan] would more likely have two years of experience rather than four years.”). On the other hand, Petitioner’s witness, Dr. Thorpe, does provide an explanation for his opinion, explaining that his assertion that four years of experience is required is based on the state of the art, typical undergraduate curricula, and his supervision of doctoral students. Ex. 1030 ¶ 21. Based on the arguments presented and the cited references, we find Petitioner’s definition of the level of ordinary skill reasonable and for purposes of this Decision, adopt it as our own. We note that we would reach the same conclusions under either proposed standard.” slip op. at 11

  Patent outcomesUS 9,671,328 mixed
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,671,328
• 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
• 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
• Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, IncSome claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-01489 · APJ Zhenyu Yang · IPR · Final written decision

  The Board held claims 1, 2, 4, 12, 25, 29–31, 33, 42, 60, 62–64, 66, 67, 69, 71, 73, 74, 78, 80, and 81 unpatentable as obvious; claims 65, 72, 75–77, and 79 were not …

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Level of Ordinary Skill in the Art In the Decision to Institute, we found the parties’ proposed definitions of a person of ordinary skill for the ’213 patent are similar. Dec. 7 (citing Pet. 16; Prelim. Resp. 17). We adopted Patent Owner’s proposed definition 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.” Id. During trial, Patent Owner points out that Petitioner’s proposed definition “encompasses persons without advanced degrees but who have ‘knowledge gained through 4–5 years of work experience.’” PO Resp. 17. A person of ordinary skill in the art is a hypothetical person who is presumed to know the relevant prior art. Custom Accessories, Inc. v. Jeffrey–Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). The artisan may gain such knowledge through either formal education or extensive work experience. Thus, we do not discern an appreciable difference in the parties’ respective definitions of the level of ordinary skill in the art, and any perceived distinction does not impact our Decision. Having considered the complete record developed at trial, we see no reason to change our assessment.” slip op. at 9

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

    “In the Decision to Institute, we agreed with Patent Owner that the ’213 patent expressly defined “consensus human 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.” Dec. 9–10; Ex. 1501, 11:32–38. During trial, the parties did not argue otherwise, and we see no reason to change our position as to claim construction. See PO 17–18; Reply 5. We, however, clarify that “all” in the consensus of “all human immunoglobulins” is not in the literal sense. In fact, Patent Owner does not appear to argue otherwise.7 Dr. Wilson, the expert witness for Patent 7 In a parallel proceeding involving the same patent, counsel for Patent Owner acknowledged that the term “all human immunoglobulins” refers to Owner, testified that the consensus sequence of the ’213 patent was “derived from ‘all’ known antibody sequences of any particular subclass or subunit structure.” Ex. 2041 ¶ 210 (emphasis added); see also PO Resp. 52 (arguing the same); Ex. 1698, 59:22–60:1 (Dr. Carter testifying that the consensus sequence, as defined in the ’213 patent, “only describes what was known at that time or it’s only available sequences at that -- at that time”); Ex. 1699, 35:9–16 (Dr. Presta explaining that the consensus sequence of the ’213 patent had the most common residue at every position “for the sequences that were available”). And evidence of record shows that at the priority date of the ’213 patent, the sequences that were listed in Kabat 1987 “were the sequences available.” Ex. 1699, 35:9–20; see also Ex. 2016 ¶ 25 (Kabat 1987 “collected known sequence data of antibodies”); Ex. 1698, 60:13–25 (Dr. Carter explaining the consensus sequence was derived from Kabat 1987, which is what was available at the time of the ’213 patent); Ex. 1699, 27:19–25 (Dr. Presta stating that “Elvin Kabat had taken all known human/mouse/rabbit antibody sequences, published them in a government publication, and that there were human subgroups of sequences within the heavy and the light chains”).” slip op. at 11

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

    “For the purpose of this Decision, we see no need to expressly construe any other claim terms. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating claim terms need only be construed to the extent necessary to resolve the controversy).” slip op. at 13

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

    “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. KSR, 550 U.S. at 421. Here, Queen 1989 recognizes the need to substitute framework residues in order to “reduce immunogenicity while retaining high binding affinity.” See Ex. 1534, 3. Thus, even if Queen 1990 is not available as prior art, we find that an ordinary artisan would have identified the candidates for substitution, as recited in claims 12, 42, 60, 71, 73, and 74. Indeed, Dr. Wilson testified that he performed a “good analysis” and identified 19 amino acid positions in the light chain and 19 in the heavy chain, including 66L (recited in claims 12 and 42), 73H (recited in claim 71), 78H (recited in claims 60 and 73), 93H (recited in claim 74). Ex. 1697, 242:4–6; Ex. 2041 ¶ 186, Appendix 1. Claims 12, 66, 67, 71, 73, 74, and 78” slip op. at 22

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 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.