• The Noco Company, Inc. v. Pilot, Inc.All claims unpatentable
  PTAB · Jan 9, 2023 · IPR2021-01235 · APJ Julia Heaney · IPR · Final written decision

  Claims 1–19 are unpatentable: claims 1–7, 9–15, and 17–19 as obvious over Richardson and Krieger; claim 8 as obvious over Richardson, Krieger, and George; claim 16 anticipated by Richardson.

  RulingsFinal written decision

  • Adverse judgmentAdverse judgmentDecided for patent owner

    “Having considered the parties’ arguments as to whether adverse judgment should be entered against Patent Owner, we determine not to enter adverse judgment based on an abandonment of the contest by Patent Owner under 37 C.F.R. § 42.73(b)(4). In light of Patent Owner’s statement regarding the merits of the Petition and its unequivocal statement that it is not seeking adverse judgment (see Response 3), we do not construe Patent Owner’s actions as an abandonment of the contest. See Apple Inc. v. Zipit Wireless, Inc., IPR2021-01124, Paper 14 (Dec. 21, 2022) (vacating entry of adverse judgment upon determination it was not sufficiently clear that Patent Owner intended to abandon the contest) (precedential). Although we have considered Patent Owner’s Response to the Order to Show Cause for the purpose of our determination whether to enter adverse judgment, Patent Owner’s statement in the Response regarding the merits of the Petition is conclusory and untimely with regard to our evaluation of the merits of the Petition. See Paper 7 (Scheduling Order) 8, 11 (setting April 8, 2022 as the deadline for Patent Owner’s response to the Petition). Accordingly, for the purpose of evaluating the merits of Petitioner’s challenges in the Petition, we decline to consider Patent Owner’s statement.” slip op. at 3

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner argues a person of ordinary skill in the art at the time of the invention “would have had an undergraduate degree in electrical engineering (or equivalent subject) together with two or three years of experience in automotive electrical systems industry.” Pet. 12 (citing Ex. 1008 ¶ 13). In light of the record before us, we adopt Petitioner’s proposal regarding the level of ordinary skill in the art. Based on our review of the ’806 patent and the prior art of record, we determine that the definition offered by Petitioner comports with the qualifications a person would have needed to understand and implement the teachings of the ’806 patent and the prior art.” slip op. at 11

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

    “Having considered Petitioner’s undisputed argument, we note that claims 7 and 8 recite a “recharging voltage level” rather than a “recharging level,” as Petitioner argues. Ex. 1001, 5:53, 58. We determine that Petitioner’s omission of “voltage” is immaterial, and further that Petitioner’s construction is consistent with the plain language of the claim and supported by the Specification. Ex. 1001, 4:43–50. In view of this, we construe the term “recharging level” to mean “the level of the first battery after it is connected to the load.” We determine that we do not need to expressly construe any other terms for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 12

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

    “Having reviewed Petitioner’s undisputed evidence and argument regarding claim 1, we find that Petitioner has demonstrated that Richardson and Krieger teach or suggest all of the limitations of claim 1, and that a person of ordinary skill in the art would have had reason to combine the teachings in the way Petitioner proposes and would have had a reasonable expectation of success in doing so. Accordingly, Petitioner has established by a preponderance of the evidence that claim 1 is obvious over the combination of Richardson and Krieger.” slip op. at 22

  Patent outcomesUS 10,328,806 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,328,806
• Shenzen Chic Electrics Co., Ltd. v. Pilot, Inc.Some claims unpatentable
  PTAB · Jan 9, 2023 · IPR2021-01232 · APJ Jeffrey W Abraham · IPR · Final written decision

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

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

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

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

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

  • Strike new argumentNew argument consideredDecided for petitioner

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

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

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

  Patent outcomesUS 10,046,653 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,046,653
• Philip Morris Products S.A. v. Healthier Choices Management Corp.All claims unpatentable
  PTAB · Dec 15, 2022 · IPR2022-00454 · APJ Julia Heaney · IPR · Final written decision

  Claims 1–8 are unpatentable as anticipated by Hammel; the revised contingent motion to amend with substitute claims 9–16 is denied for lack of written-description support.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Petitioner argues a person of ordinary skill in the art at the time of the invention “would have had a Bachelor’s degree in mechanical engineering, electrical engineering, or a related field and two to three years of industry experience, or a Master’s degree in mechanical engineering, electrical engineering, or a related field, and one to two years of industry experience” and “would have been familiar with electrically powered smoking devices and the components and underlying technology used therein.” Pet. 6–7 (citing Ex. 1003 ¶¶ 24–26). Patent Owner argues that a person of ordinary skill in the art at the time of the invention “would have had a Bachelor’s degree in mechanical engineering, electrical engineering, or a related field, an understanding of combustion reactions in electric smoking articles, and one to three years of practical experience” and would have been “familiar with electrical smoking devices and the components and design considerations thereof.” PO Resp. 8 (citing Ex. 2001 ¶¶ 28–31). Neither party has responded to the other’s position as to the level of ordinary skill, or identified any material difference between their proposals. Having considered the parties’ arguments and evidence, we adopt the level of ordinary skill in the art proposed by Patent Owner, because it is consistent with the disclosures of the ’170 patent and the prior art of record. We note, however, that neither party contends that any issue in this case turns on the differences between the parties’ definitions of one of ordinary skill in the art.” slip op. at 7

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner

    “We decline to adopt Patent Owner’s construction because it improperly reads extraneous limitations into the claim from the specification, “wholly apart from any need to interpret what the patentee meant by particular words or phrases in the claim.” E.I. du Pont de Nemours v. Phillips Petroleum Co., 849 F.2d 1430, 1433 (Fed. Cir. 1988). The ’170 patent discloses multiple embodiments of a combustible material reservoir; Patent Owner does not dispute this. See PO Sur-reply 7–8. Further, Patent Owner does not present a sufficient underlying factual basis to support Dr. Garris’s testimony that a person of ordinary skill in the art would understand “combustible material reservoir” as Patent Owner proposes. See Ex. 2001 ¶¶ 63–64. Therefore, we are not persuaded that the airflow limitations that Patent Owner reads into “combustible material reservoir” are necessary. In view of the foregoing, we construe the term “combustible material reservoir” to have its ordinary meaning, i.e., a reservoir for combustible material.” slip op. at 11

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “insufficient because its text descriptions do not state that the heating element protrudes from the top of the case body, or that the porcelain tube has holes in it, do not adequately credit the ability of a person of ordinary skill in the art to interpret Hammel’s figures as a whole. The dispositive question regarding anticipation is whether a person of ordinary skill in the art would reasonably understand or infer from the reference that every claim element is disclosed in that single reference. Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1284 (Fed. Cir. 2017). As Petitioner asserts, and Dr. Deevi credibly testifies, a person of ordinary skill would have inferred the shape and location of the heating element in Figure 2 based on the labeled heating element in the exploded view of Figure 3. See Ex. 1007 ¶ 10. We find this assertion to be reasonable. In view of the level of ordinary skill and relative structural simplicity of the claimed subject matter, we also find that a person of ordinary skill would have reasonably understood from Hammel’s figures that its heating element has legs that fix it in place in holes within the porcelain tube. Dr. Deevi’s testimony supports these findings, because he explains that a person of ordinary skill would infer that the heating element within the porcelain tube would not be connected to the battery without holes in the porcelain tube. Ex. 1003 ¶ 244; Ex. 2003, 192–196. We find no contradiction in Dr. Deevi’s testimony, as Patent Owner asserts. Although Patent Owner asserts “Dr. Deevi conceded that Hammel does not describe any holes in the bottom half of the porcelain tube” (PO Resp. 60 (citing Ex. 2003, 193:7–11)), Dr. Deevi explained in his subsequent response that his opinion is based on the inference a person of ordinary skill would draw from Hammel’s disclosure. Ex. 2003, 193:13–16. We disagree with Patent Owner that Hammel’s disclosure provides insufficient evidence to support Dr. Deevi’s opinion, and we find Dr, Deevi’s explanation of Hammel supports a reasonable inference that it discloses a heating element fixed in the combustible material reservoir.” slip op. at 24

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

    “insufficient because its text descriptions do not state that the heating element protrudes from the top of the case body, or that the porcelain tube has holes in it, do not adequately credit the ability of a person of ordinary skill in the art to interpret Hammel’s figures as a whole. The dispositive question regarding anticipation is whether a person of ordinary skill in the art would reasonably understand or infer from the reference that every claim element is disclosed in that single reference. Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1284 (Fed. Cir. 2017). As Petitioner asserts, and Dr. Deevi credibly testifies, a person of ordinary skill would have inferred the shape and location of the heating element in Figure 2 based on the labeled heating element in the exploded view of Figure 3. See Ex. 1007 ¶ 10. We find this assertion to be reasonable. In view of the level of ordinary skill and relative structural simplicity of the claimed subject matter, we also find that a person of ordinary skill would have reasonably understood from Hammel’s figures that its heating element has legs that fix it in place in holes within the porcelain tube. Dr. Deevi’s testimony supports these findings, because he explains that a person of ordinary skill would infer that the heating element within the porcelain tube would not be connected to the battery without holes in the porcelain tube. Ex. 1003 ¶ 244; Ex. 2003, 192–196. We find no contradiction in Dr. Deevi’s testimony, as Patent Owner asserts. Although Patent Owner asserts “Dr. Deevi conceded that Hammel does not describe any holes in the bottom half of the porcelain tube” (PO Resp. 60 (citing Ex. 2003, 193:7–11)), Dr. Deevi explained in his subsequent response that his opinion is based on the inference a person of ordinary skill would draw from Hammel’s disclosure. Ex. 2003, 193:13–16. We disagree with Patent Owner that Hammel’s disclosure provides insufficient evidence to support Dr. Deevi’s opinion, and we find Dr, Deevi’s explanation of Hammel supports a reasonable inference that it discloses a heating element fixed in the combustible material reservoir. For the foregoing reasons, we are persuaded that a preponderance of the evidence shows that Hammel discloses each of the limitations of claims 1 and 5.” slip op. at 24

  Patent outcomesUS 10,561,170 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 10,561,170
• Philip Morris Products S.A. v. Healthier Choices Management Corp.All claims unpatentable
  PTAB · Dec 15, 2022 · IPR2021-01079 · APJ Julia Heaney · IPR · Final written decision

  Claims 1–8 are unpatentable as anticipated by Hammel; the revised contingent motion to amend is denied for lack of written-description support for substitute claims 9–16.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “art include: “(1) educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of workers active in the field.” Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696–697 (Fed. Cir. 1983) (citing Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.2d 1376, 1381–82 (Fed. Cir. 1983)). Not all such factors may be present in every case, and one or more of these or other factors may predominate in a particular case. Id.” slip op. at 7

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

    “Petitioner argues that Patent Owner’s proposed construction imports limitations from a single embodiment of the specification into the claims. Pet. Reply 5–6. Petitioner further argues that the ’170 patent expressly describes reservoirs with attributes different than the embodiment relied on by Patent Owner, such as “the combustible material reservoir 165 may be located on the surface of and extends into the second pipe section 140.” Id. (quoting Ex. 1001, 4:57–63; also citing Ex. 1001, Fig. 3, 6:23–45, 9:15–35; Ex. 1028 ¶¶ 48–52). We decline to adopt Patent Owner’s construction because it improperly reads extraneous limitations into the claim from the specification, “wholly apart from any need to interpret what the patentee meant by particular words or phrases in the claim.” E.I. du Pont de Nemours v. Phillips Petroleum Co., 849 F.2d 1430, 1433 (Fed. Cir. 1988). The ’170 patent discloses multiple embodiments of a combustible material reservoir; Patent Owner does not dispute this. See PO Sur-reply 7–8. Further, Patent Owner does not present a sufficient underlying factual basis to support Dr. Garris’s testimony that a person of ordinary skill in the art would understand “combustible material reservoir” as Patent Owner proposes. See Ex. 2001 ¶¶ 63–64. Therefore, we are not persuaded that the airflow limitations that Patent Owner reads into “combustible material reservoir” are necessary. In view of the foregoing, we construe the term “combustible material reservoir” to have its ordinary meaning, i.e., a reservoir for combustible material.” slip op. at 11

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “insufficient because its text descriptions do not state that the heating element protrudes from the top of the case body, or that the porcelain tube has holes in it, do not adequately credit the ability of a person of ordinary skill in the art to interpret Hammel’s figures as a whole. The dispositive question regarding anticipation is whether a person of ordinary skill in the art would reasonably understand or infer from the reference that every claim element is disclosed in that single reference. Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1284 (Fed. Cir. 2017). As Petitioner asserts, and Dr. Deevi credibly testifies, a person of ordinary skill would have inferred the shape and location of the heating element in Figure 2 based on the labeled heating element in the exploded view of Figure 3. See Ex. 1007 ¶ 10. We find this assertion to be reasonable. In view of the level of ordinary skill and relative structural simplicity of the claimed subject matter, we also find that a person of ordinary skill would have reasonably understood from Hammel’s figures that its heating element has legs that fix it in place in holes within the porcelain tube. Dr. Deevi’s testimony supports these findings, because he explains that a person of ordinary skill would infer that the heating element within the porcelain tube would not be connected to the battery without holes in the porcelain tube. Ex. 1003 ¶ 244; Ex. 2003, 192–196. We find no contradiction in Dr. Deevi’s testimony, as Patent Owner asserts. Although Patent Owner asserts “Dr. Deevi conceded that Hammel does not describe any holes in the bottom half of the porcelain tube” (PO Resp. 60 (citing Ex. 2003, 193:7–11)), Dr. Deevi explained in his subsequent response that his opinion is based on the inference a person of ordinary skill would draw from Hammel’s disclosure. Ex. 2003, 193:13–16. We disagree with Patent Owner that Hammel’s disclosure provides insufficient evidence to support Dr. Deevi’s opinion, and we find Dr, Deevi’s explanation of Hammel supports a reasonable inference that it discloses a heating element fixed in the combustible material reservoir.” slip op. at 24

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

    “insufficient because its text descriptions do not state that the heating element protrudes from the top of the case body, or that the porcelain tube has holes in it, do not adequately credit the ability of a person of ordinary skill in the art to interpret Hammel’s figures as a whole. The dispositive question regarding anticipation is whether a person of ordinary skill in the art would reasonably understand or infer from the reference that every claim element is disclosed in that single reference. Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1284 (Fed. Cir. 2017). As Petitioner asserts, and Dr. Deevi credibly testifies, a person of ordinary skill would have inferred the shape and location of the heating element in Figure 2 based on the labeled heating element in the exploded view of Figure 3. See Ex. 1007 ¶ 10. We find this assertion to be reasonable. In view of the level of ordinary skill and relative structural simplicity of the claimed subject matter, we also find that a person of ordinary skill would have reasonably understood from Hammel’s figures that its heating element has legs that fix it in place in holes within the porcelain tube. Dr. Deevi’s testimony supports these findings, because he explains that a person of ordinary skill would infer that the heating element within the porcelain tube would not be connected to the battery without holes in the porcelain tube. Ex. 1003 ¶ 244; Ex. 2003, 192–196. We find no contradiction in Dr. Deevi’s testimony, as Patent Owner asserts. Although Patent Owner asserts “Dr. Deevi conceded that Hammel does not describe any holes in the bottom half of the porcelain tube” (PO Resp. 60 (citing Ex. 2003, 193:7–11)), Dr. Deevi explained in his subsequent response that his opinion is based on the inference a person of ordinary skill would draw from Hammel’s disclosure. Ex. 2003, 193:13–16. We disagree with Patent Owner that Hammel’s disclosure provides insufficient evidence to support Dr. Deevi’s opinion, and we find Dr, Deevi’s explanation of Hammel supports a reasonable inference that it discloses a heating element fixed in the combustible material reservoir. For the foregoing reasons, we are persuaded that a preponderance of the evidence shows that Hammel discloses each of the limitations of claims 1 and 5.” slip op. at 24

  Patent outcomesUS 10,561,170 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 10,561,170
• Nanofiber Solutions, LLC v. Acera Surgical, Inc.Some claims unpatentable
  PTAB · Dec 13, 2022 · IPR2021-01016 · APJ Christopher L Crumbley · IPR · Final written decision

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

  RulingsFinal written decision

  • Skill levelOther

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

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

    “construe claims “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b), including construing the claim in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” 37 C.F.R. § 42.100(b); see Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). Furthermore, we expressly construe the claims only to the extent necessary to resolve the parties’ dispute. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). The parties agree that the terms of the challenged claims should be given their “plain and ordinary meaning” and that no express claim construction is necessary to address Petitioner’s challenges. Pet. 12; PO Resp. 6. We agree that no claim terms require express construction for purposes of resolving the dispute between the parties.” slip op. at 10

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

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

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

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

  Patent outcomesUS 10,632,228 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 10,632,228
• Globalfoundries Inc. / Globalfoundries U.S. Inc. et al. v. Katana Silicon Technologies LLCInstitution denied
  PTAB · Dec 6, 2022 · IPR2022-01083 · APJ Christopher M Kaiser · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that any challenged claim was unpatentable under the asserted obviousness grounds.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a) (2020). The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted unless “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” After considering the Petition, the Preliminary Response, and the evidence of record, we determine that Petitioner has not demonstrated a reasonable likelihood that it would prevail with respect to at least one challenged claim. Accordingly, we do not institute an inter partes review of any challenged claims on any ground asserted in the Petition.” slip op. at 2

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

    “it is used consistently throughout. First, in describing related prior art, the ’903 patent states that “[t]he through plug is constituted of an insulating material covering a sidewall of a through hole and a low electrical resistance metal material . . . in a columnar shape that is positioned so as to be surrounded by the insulating material and that serves as a conductive member.” Ex. 1001, 1:35–40. In describing its own drawings, reference numeral 15 consistently is used to refer to the “through plug.” Id. at 2:37– 52. Figures 1A and 1B “are views schematically showing the structure of a semiconductor device (semiconductor chip) according to an embodiment of the present invention.” Id. at 5:46–48, Figs. 1A, 1B. In these figures, reference numeral 15 refers to “[a] through plug.” Id. at 6:16. This through plug “is constituted of a columnar electric conductor 15a . . . and an insulation layer 15b . . . surrounding the electric conductor 15a.” Id. at 6:21–25. Similarly, reference numeral 15 refers to the “through plug” in Figures 1C, 2A, 2B, 3, 4, 5, 6, 7A, and 7B. Id. at 6:35–40, 7:10–38, 8:10– 17, 8:32–38, 8:65–9:43. Where it is referred to in these same parts of the ’903 patent, the conductive core is discussed as merely a portion of the through plug and is referred to by the reference numeral 15a. Id. Thus, the ’903 patent consistently defines the through plug as having two portions: both a conductive core and a surrounding insulation layer. This is true whether the patent is referring to either of its disclosed embodiments or the prior art. Based on this unambiguous usage, we determine that the ’903 patent defines the term “through plug” as including both a conductive core and a surrounding insulating layer. See Phillips, 415 F.3d at 1320–21 (“the specification ‘acts as a dictionary when it expressly defines terms used in the claims or when it defines terms by implication’” (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996))).” slip op. at 5

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

    “We are not persuaded that the Petition adequately identifies how Christensen teaches or suggests a through plug as that term is used in the ’903 patent. As noted above, the ’903 patent requires a through plug to have both a conductive core and a surrounding insulating layer. It is clear on the current record that Christensen’s “conductive stud” could correspond to the conductive portion of such a through plug. Ex. 1033, 4:66–5:1 (“the stud 34 may comprise any number of conductive materials”). But Petitioner does not show sufficiently that Christensen teaches or suggests the surrounding insulating layer necessary to turn the conductive core into a through plug. First, Petitioner does not allege that Christensen teaches or suggests such a layer. Pet. 33–34. Second, Christensen discloses the use of “conductive materials” and “material[s] which promote[] adhesion to the surrounding oxide such as titanium or titanium nitride.” Ex. 1033, 4:66–5:1, 5:15–20. None of these materials are identified by Christensen as insulators. Id. Accordingly, we are not persuaded on the current record that Petitioner has shown sufficiently that Christensen alone teaches or suggests the through plug of the challenged claims. b. Christensen and Lin Petitioner also argues that the combination of Christensen and Lin teaches or suggests the through plug of the challenged claims. Pet. 34–36. Specifically, Petitioner argues that “[t]o the extent [it is determined] that Christensen alone is not sufficient because the conductive stud 34 does not extend all the way through wafer 12, Christensen in view of Lin renders obvious a ‘through plug.’” Id. at 34. According to this argument, “Lin teaches a backside process for forming ‘a conductive plug through a silicon’ wafer and an insulation layer,” and it would have been obvious to form such a plug “from the backside of the wafer 12 below [Christensen’s] conductive stud 34,” such that the combination of the two structures would form a conductive path all the way through the structure of Christensen’s Figures 8B and 9. Id. at 34–35 (emphasis omitted). As with the argument based on Christensen alone, however, this argument does not show sufficiently that the combination of Christensen and Lin teaches or suggests a through plug that has both a conductive core and a surrounding insulating layer. Lin describes its structure as a “conductive plug” and does not describe any insulation surrounding that structure. Ex. 1054, 1:60–64, 3:2– 34, 4:23–32, Fig. 7. “The conductive plugs” of Lin “typically compris[e] metal,” which Lin does not describe as an insulator. Id. at 3:21–25. Nor does Petitioner allege the presence of a conductive core surrounded by insulation either in Lin itself or in the combination of Lin and Christensen. Pet. 34–36. Accordingly, we are not persuaded on the current record that Petitioner has shown sufficiently that the combination of Christensen and Lin teaches or suggests the through plug of the challenged claims.” slip op. at 9

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

    “An invention is not obvious just ‘because all of the elements that comprise the invention were known in the prior art.’” Broadcom Corp. v. Emulex Corp., 732 F.3d 1325, 1335 (Fed. Cir. 2013) (quoting Power-One, Inc. v. Artesyn Techs., Inc., 599 F.3d 1343, 1351 (Fed. Cir. 2010)). Instead, “a finding of obviousness at the time of invention requires a ‘plausible rational[e] as to why the prior art references would have worked together.’” Id. (quoting Power-One, 599 F.3d at 1352). This rationale requires “some articulated reasoning with some rational underpinning” to combine the known elements in the manner required in the claim at issue. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). “[I]t can be important to” include within this reasoning “a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” Id. Here, Petitioner offers two reasons to combine the teachings of Shim and Shirakawa. First, Petitioner argues that “Shim’s diffusion teachings would facilitate the formation of” Shirakawa’s collector layer. Pet. 65–66. On the present record, we do not find this reason sufficiently persuasive. Even though Shim does teach a way to make the n-GaAs that Shirakawa uses, Shirakawa teaches a different way to make the same material, and other prior-art references agree with Shirakawa. Ex. 1022, 1:34–40 (“silicon ions of a silicon layer formed on a GaAs substrate are diffused by means of ion-implantation method using little energy and annealing treatment”); Ex. 1005, 9:36–42 (first embodiment “collector layer” is “laminated on top of a semi-insulating GaAs substrate . . . by epitaxial growth process”), 12:47–48 (fourth embodiment made in same way as first embodiment); Ex. 1016, 8:7–19 (“a highly doped n type GaAs subcollector layer . . . [and other layers] are made to grow above a semiinsulating GaAs substrate . . . by a metal organic vapor phase epitaxial growth method”); Ex. 1025, 4:40–45 (teaching “[f]orming two flat epitaxial layers of gallium arsenide to obtain [a] collector,” including “a layer . . . of the n+ conductivity type and a layer . . . of the n -conductivity type” by “epitaxial growth . . . from the vapour phase or from the liquid phase”). The mere fact that Shim offers an alternative process does not, in the absence of a reason to adopt that alternative process, provide a reason for a person of ordinary skill in the art to make Shirakawa’s n-GaAs via Shim’s method rather than via Shirakawa’s own method. In addition, Patent Owner’s declarant, Dr. Peter Elenius, testifies that the ion implantation involved in Shim’s diffusion process would damage Shirakawa’s gallium arsenide in a way that would dissuade a person of ordinary skill in the art from using that process to produce the HBT of Shirakawa. Ex. 2001 ¶¶ 52–57. The other reason that Petitioner provides to combine the teachings of Shim and Shirakawa is that Shim’s diffusion “method us[es] little energy and annealing treatment.” Pet. 66 (quoting Ex. 1022, 1:34–40). Shim’s method is described as “diffus[ion] by means of ion-implantation method using little energy and annealing treatment,” which Shim distinguishes from earlier methods “widely used in the art,” which involved “ion-implantation . . . using high energy.” Ex. 1022, 1:12–40. Shim teaches that its lower-energy ion implantation does not suffer from the “problem” of the earlier method, “damaging of ohmic contacts of metal electrodes” due to the injection of “lots of impurity ions.” Id. at 1:17–22; see id. at 3:37–40 (“the manufacturing method of the present invention can prevent damage to be generated in ohmic contacts of source/drain electrodes due to ion-injecting of high density”). Thus, the lower energy of Shim’s process is a benefit of that process over earlier ion implantation processes, which use higher energy. Shim does not teach that its use of lower-energy ion implantation is an improvement over other processes, such as the epitaxial growth taught by Shirakawa and the other references cited by Petitioner. Thus, Petitioner does not explain sufficiently why lower energy would be a benefit of the Shim- Shirakawa combination over Shirakawa alone. Accordingly, we are not persuaded on the current record that Petitioner has shown sufficiently that a person of ordinary skill in the art would have had a reason to combine the teachings of Shirakawa and Shim to arrive at a combination that teaches or suggests the “diffusion layer patterns” of the challenged claims. slip op. at 15

  Claim construction§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 7,402,903
• Pfizer, Inc. v. Uniqure Biopharma B.V.All claims unpatentable
  PTAB · Nov 15, 2022 · IPR2021-00928 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1–6 are unpatentable as anticipated by Stafford and obvious over Stafford, alone or with Manno and Schuettrumpf.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In our Decision on Institution, although we agreed with Patent Owner that the ordinarily skilled artisan would have experience in the treatment of coagulopathy, we applied a broader definition of a person of ordinary skill in the art, as articulated by Drs. Wang and Pedersen. See DI 11 (citing Ex. 1003 ¶ 48; Ex. 1094 ¶ 19). We determined a person of ordinary skill in the art would have the skill of a research team working to develop factor IX variants and gene therapies, where that team would include “(1) one or more researchers with experience in the fields of molecular biology and virology and the use of gene therapy for treatment of coagulopathies, working together with (2) one or more individuals with experience in protein structure or engineering; and where the individuals working on the team have an advanced degree and several years of experience in a relevant discipline. See id. Patent Owner states its positions on patentability of the challenged claims “would not change under that construction or Petitioner’s proposed definition ....” PO Resp. 13. Accordingly, we apply the definition of a person of ordinary skill in the art set forth supra and in our Decision on Institution.” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningOther

    “In the Petition, Petitioner proposed constructions for five terms: “vector,” “percentage identity,” “promoter,” and “percentage homology,” and “polypeptide precursor.” Pet. 12–14. In our Decision on Institution, we determined that we did not need to explicitly construe any claim terms at that stage of the proceeding. DI 12. Patent Owner “does not believe any term requires construction for this proceeding.” PO Resp. 13. Considering the arguments and evidence of record, we agree with Patent Owner and apply the plain and ordinary meaning to all claim terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 12

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

    “In sum, Stafford discloses (and claims) preferred Factor IX variants for the treatment of hemophilia B, wherein arginine 338 is replaced with, at most, one of three amino acids having similar properties: alanine, leucine, or valine. Ex. 1004, 5, claims 3–5, 10, 14; Ex. 1094 ¶ 104. Stafford further discloses vectors and associated control elements that “may be used in gene therapy to administer the expression cassette to targeted [sic] cells within the patient and produce the Factor IX in the patient.” Ex. 1004, 6–7. In addition to listing various general classes of potential expression vectors, Stafford specifically names four DNA-based viruses including AAV for the construction of vectors: “papillomavirus, adenovirus, adeno-associated virus, [and] cytomegalovirus.” Id.; Ex. 1003 ¶¶ 41, 77–78, 315. Because Stafford’s claims 15 and 17–19 describe a DNA viral vector encoding a FIX variant (of which Stafford names four), and because Stafford specifies three (if not two) preferred amino acid variants, “a POSA would have faced twelve possible combinations of DNA vector and preferred FIX variant for gene therapy.” See Ex. 1003 ¶¶ 321–323.8 Moreover, crediting 8 As previously noted, Dr. Wang misstates, in part, the dependency of Stafford’s claims. See DI 27 (citing Ex. 1003 ¶ 323). Although Stafford’s Dr. Wang’s testimony that, as of the time of the invention, “AAV vectors were considered the leading candidate for useful human gene therapy vectors, and were being used routinely in the hemophilia B field” (Ex. 1003 ¶ 39; see also id. at ¶¶ 32–36, 88, 323), we find that one of ordinary skill in the art would read Stafford as disclosing all elements of claim 1, “arranged as in the claim.” See Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). As noted above, Patent Owner does not separately argue dependent claims 3–6. We have reviewed Petitioner’s evidence and argument, and agree with Petitioner that Stafford discloses all limitations of claims 3–6.” slip op. at 26

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “recited in the challenged claims. In sum, considering the record as a whole, we agree with Dr. Wang’s testimony that one of ordinary skill in the art would have found the challenged claims obvious in view of Stafford. Ex. 1003 ¶¶ 348–370. We also do not find persuasive Patent Owner’s argument that a person of ordinary skill in the art reading Stafford would have had serious concerns regarding whether R338L would be expressed. As discussed above, Stafford discloses successful expression of R338A in vitro. As Dr. Wang explains, given that Stafford demonstrated in vitro expression for numerous other variants in the 330–338 helix region of FIX, only R338P showed reduced expression, and unlike leucine, “proline [P] is a known ‘helix breaker.’” Ex. 1004, 14–15; Ex. 1100 ¶¶ 113–116, 225; see also Ex. 1100 ¶¶ 117–121. As such, we agree with Dr. Wang that one of ordinary skill in the art would not have expected difficulties in the expression of R338L. We also find unavailing Patent Owner’s argument that a person of ordinary skill would not have expected in vivo expression of FIX-R338L at levels similar to that of wild-type FIX. To the contrary, Schuettrumpf supports a conclusion that a person of ordinary skill would have expected that gene therapy with FIX-R338A expressed in vivo from liver cells at levels similar to wild-type FIX. See Reply 13 (citing Ex. 1005, 2, 4; Ex. 2114, 53:13–55:14; Ex. 1100 ¶¶ 113–116, 225). As Dr. Wang testified, this would have suggested to a person of ordinary skill that FIX-R338L would express at a similar level. Ex. 2114, 53:13–55:14; Ex. 1100 ¶¶ 113– 16; see also Ex. 1001, 4:45–58 (’180 patent’s teaching that it was expected that conservative amino acid substitutions (e.g. alanine and leucine) “would not change phenotype of the proteins”). We do not find persuasive Patent Owner’s argument that a person of ordinary skill in the art reading Stafford would have had serious concerns regarding whether R338L would be active. To the contrary, we credit Dr. Wang’s testimony that one of ordinary skill in the art would have expected the R338L variant to exhibit higher activity than wild-type Fix based, for example, on Stafford and Schuettrumpf showing that R338A exhibited higher activity in vitro and in vivo, respectively, and the similarities between alanine and leucine. See, e.g., Ex. 1003 ¶¶ 40, 42, 158, 219, 383, Ex. 1100 ¶¶ 101–112; see also Ex. 1094 ¶¶ 41–45, Ex. 1100 ¶¶ 23–36 (Dr. Pederson’s explanation of why one of ordinary skill would have expected replacing arginine 338 with leucine would have a similar effect as replacing it with alanine). Stafford’s disclosure that numerous mutations in the FIX 330–337” slip op. at 44

  Patent outcomesUS 10,465,180 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,465,180
• Pfizer, Inc. v. Uniqure Biopharma B.V.All claims unpatentable
  PTAB · Nov 15, 2022 · IPR2021-00926 · APJ Julia Heaney · IPR · Final written decision

  Claims 2, 4–6, 11–13, 17, and 18 are unpatentable as obvious over Stafford and Manno; claims 2, 5, 6, 11–13, 17, and 18 are also anticipated or obvious over Monahan.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In our Decision on Institution, although we agreed with Patent Owner that the ordinarily skilled artisan would have experience in the treatment of coagulopathy, we applied a broader definition of a person of ordinary skill in the art, as articulated by Drs. Wang and Pedersen. See Ex. 1003 ¶ 48; Ex. 1094 ¶ 19. We determined a person of ordinary skill in the art would have the skill of a research team working to develop factor IX variants and gene therapies, where that team would include “(1) one or more researchers with experience in the fields of molecular biology and virology and the use of gene therapy for treatment of coagulopathies, working together with (2) one or more individuals with experience in protein structure or engineering;” and where the individuals working on the team have an advanced degree and several years of experience in a relevant discipline. See id. Patent Owner states its positions on patentability of the challenged claims “would not change under that construction or Petitioner’s proposed definition ....” PO Resp. 13. Accordingly, we apply the definition of a person of ordinary skill in the art set forth supra and in our Decision on Institution.” slip op. at 9

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

    “We agree with Petitioner that the ’248 patent provides an express definition of “treat” and “treatment.” The Specification states, “[i]n the present text the term ‘treat’ or ‘treatment’ of a pathology means the prophylaxis and/or therapy and/or cure of this pathology.” Ex. 1001, 5:19– 21. This definition includes “cure” as a separate concept from therapy, and further provides that therapy includes “partial or total” alleviation of symptoms. Id. at 5:21–24. The ’248 patent does not define or otherwise describe “treating a coagulopathy” as requiring any specific duration of therapeutic efficacy; therefore, a person of ordinary skill in the art would understand that partial alleviation of symptoms and a shorter duration of therapeutic efficacy is encompassed in “treating a coagulopathy” as recited in claim 1. Claim 16, which depends from claim 1, supports a construction of “treating a coagulopathy” that does not require complete alleviation of symptoms or permanent therapeutic efficacy. Claim 16 recites the “modified FIX polypeptide is expressed at a level that reduces and/or prevents hemorrhages.” Ex. 1001, 46:34–36. Because claim 16 depends from claim 1, this means that “treating a coagulopathy” as recited in claim 1 encompasses merely reducing hemorrhages, i.e., partial alleviation of symptoms. Accordingly, based on the intrinsic evidence, including the express definition of the terms “treat” and “treatment,” we construe “treating a coagulopathy” as prophylaxis and/or therapy and/or cure of the coagulopathy which includes partial alleviation of symptoms, for any duration of therapeutic efficacy. We determine that we need not explicitly construe any other claim terms.” slip op. at 11

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedReference is prior artDecided for petitioner

    “the earlier application must disclose the claimed invention “in the manner provided by § 112(a) (other than the requirement to disclose the best mode).” 35 U.S.C. §§ 119(e), 120. Section 112(a) requires that the specification contain a written description of the claimed invention. 35 U.S.C. § 112(a). “[T]he hallmark of written description is disclosure.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The written description requirement is met when the specification “conveys to those skilled in the art that the inventor had possession of” and “actually invented” the claimed subject matter. Id. The purpose of the written description requirement is to ensure that a patent’s claims “do[] not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.” Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345 (Fed. Cir. 2000). The Federal Circuit has stated: The question is not whether a claimed invention is an obvious variant of that which is disclosed in the specification. Rather, a prior application itself must describe an invention, and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought. Lockwood v. Am. Airlines, 107 F.3d 1565, 1572 (Fed. Cir. 1997).” slip op. at 21

  Patent outcomesUS 9,982,248 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 9,982,248
• Pfizer, Inc. v. Uniqure Biopharma B.V.All claims unpatentable
  PTAB · Nov 15, 2022 · IPR2021-00925 · APJ Julia Heaney · IPR · Final written decision

  Claims 1, 3, 7–10, 14–16, 19, and 20 are unpatentable as obvious over Stafford and Manno, and Stafford, Manno, and Schuettrumpf.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In our Decision on Institution, although we agreed with Patent Owner that the ordinarily skilled artisan would have experience in the treatment of coagulopathy, we applied a broader definition of a person of ordinary skill in the art, as articulated by Drs. Wang and Pedersen. Dec. Inst. 22; see Ex. 1003 ¶ 48; Ex. 1094 ¶ 19. We determined a person of ordinary skill in the art would have the skill of a research team working to develop factor IX variants and gene therapies, where that team would include (1) one or more researchers with experience in the fields of molecular biology and virology and the use of gene therapy for treatment of coagulopathies, working together with (2) one or more individuals with experience in protein structure or engineering; and where the individuals working on the team have an advanced degree and several years of experience in a relevant discipline. See id. Patent Owner states its positions on patentability of the challenged claims “would not change under that construction or Petitioner’s proposed definition ....” PO Resp. 13. Accordingly, we apply the definition of a person of ordinary skill in the art set forth supra and in our Decision on Institution.” slip op. at 8

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

    “We agree with Petitioner that the ’248 patent provides an express definition of “treat” and “treatment.” The Specification states, “[i]n the present text the term ‘treat’ or ‘treatment’ of a pathology means the prophylaxis and/or therapy and/or cure of this pathology.” Ex. 1001, 5:19– 21. This definition includes “cure” as a separate concept from therapy, and further provides that therapy includes “partial or total” alleviation of symptoms. Id. at 5:21–24. The ’248 patent does not define or otherwise describe “treating a coagulopathy” as requiring any specific duration of therapeutic efficacy; therefore, a person of ordinary skill in the art would understand that partial alleviation of symptoms and a shorter duration of therapeutic efficacy is encompassed in “treating a coagulopathy” as recited in claim 1. Claim 16, which depends from claim 1, supports a construction of “treating a coagulopathy” that does not require complete alleviation of symptoms or permanent therapeutic efficacy. Claim 16 recites the “modified FIX polypeptide is expressed at a level that reduces and/or prevents hemorrhages.” Ex. 1001, 46:34–36. Because claim 16 depends from claim 1, this means that “treating a coagulopathy” as recited in claim 1 encompasses merely reducing hemorrhages, i.e., partial alleviation of symptoms. Accordingly, based on the intrinsic evidence, including the express definition of the terms “treat” and “treatment,” we construe “treating a coagulopathy” as prophylaxis and/or therapy and/or cure of this coagulopathy which includes partial alleviation of symptoms, for any duration of therapeutic efficacy. We determine that we need not explicitly construe any other claim terms.” slip op. at 10

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “Accordingly, Patent Owner has failed to show that it is entitled to a presumption of a nexus between the objective evidence and the claimed invention. Patent Owner argues that it “need not rely on such presumption [of nexus]” under the Polaris and Fox Factory analysis. PO Resp. 67. Although Patent Owner does not fully explain its position, we note that Fox Factory provides, “[a] finding that a presumption of nexus is inappropriate does not end the inquiry into secondary considerations”; rather, “the patent owner is still afforded an opportunity to prove nexus by showing that the evidence of secondary considerations is the ‘direct result of the unique characteristics of the claimed invention.’” Fox Factory, 994 F.3d at 1374 (quoting In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996)). Here, we find that Patent Owner presents insufficient evidence to establish a nexus by this alternative route. Patent Owner does not present argument as to the “unique characteristics” of the claimed invention, or provide evidence to support such an analysis. See PO Resp. 66–67; PO Sur-reply 26–28. In addition, as discussed above, Patent Owner’s evidence is broadly directed to FIX- R338L, which was in the prior art and does not suggest non-obviousness of the claimed invention as a whole. In summary, Patent Owner does not meet its burden to show a presumption of nexus or show a nexus to the alleged long-felt need for an effective gene therapy for hemophilia B, industry praise, and unexpectedly superior efficacy of AAV-FIX-R338L. Weighing the evidence and arguments presented, we determine that even if there is some nexus, it is weak. See Merck & Cie, 808 F.3d at 837 (Where objective indicia “result[ ] from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention.”). The failure to show a nexus is fatal to Patent Owner’s contentions regarding objective indicia.” slip op. at 26

  • Expert testimonyPatent owner expert discountedDecided for petitioner

    “We also find Dr. Pedersen’s opinion with regard to a leucine substitution in FIX-R338 more credible than Dr. Spiegel’s, who states “there is no such thing as ‘conservative amino acid substitutions’ in the sense Dr. Pedersen asserts.” Ex. 2101 ¶ 72. The ’248 patent itself refers to “conservative amino acid substitutions” and states “[i]t is expected that substitutions between these homologous amino acids [including alanine and leucine] would not change the phenotype of the proteins.” Ex. 1001, 4:48– 61. Although Dr. Spiegel notes that substitution is context dependent and “the specification recognizes ... various properties of each unique amino acid all contribute to the amino acid’s interactions” (Ex. 2101 ¶ 75, citing Ex. 1001, 4:48–61; Ex. 1002, 4:45–58; Ex. 1039, 51), his opinions do not account for the knowledge of a person of ordinary skill in the art as to the properties of alanine and leucine and the structure of FIX. See Ex. 1101 ¶¶ 36–39. Further, Dr. Spiegel’s surface-exposure opinion (see, e.g., Ex. 2101 ¶ 99) is undercut by Stafford’s teaching that the 330–338 region of wild-type FIX contains two solvent-exposed leucines. Ex. 1101 ¶ 41 (citing Ex. 1004, 34). Dr. Spiegel’s opinion that a leucine substitution would reduce solubility or increase susceptibility to aggregation also lacks credibility because it is based on the protein hemoglobin S, and not on a modification to FIX positions 330–338. Ex. 2101 ¶ 62; Ex. 1103, 78:15–18; see Ex. 1101 ¶ 60. We also do not find persuasive Patent Owner’s argument that a person of ordinary skill in the art would have had serious concerns whether R338L would be expressed, based on Stafford. As discussed above, Stafford discloses successful expression of R338A in vitro, and as Dr. Wang explains, the understanding of a person of ordinary skill of similarities between R338A and R338L would have supported the understanding that R338L would express at a similar level to R338A, given Stafford’s disclosure that only R338P showed reduced expression, and unlike leucine, “proline is a known ‘helix breaker.’” Ex. 1004, 14–15; Ex. 1100 ¶¶ 113– 116. Stafford’s disclosure that mutations at 330–337 cause severe hemophilia due to loss of FIX activity (Ex. 1004, 19:16–20) does not support Patent Owner’s argument, because Patent Owner’s experts do not persuasively explain why the risk of severe hemophilia from single amino acid substitutions at positions 330–337 would be predictive of a similar risk at position 338. See Ex. 1100 ¶¶ 115–119; Ex. 1101 ¶¶ 48–51. As such, we agree with Dr. Wang that a person of ordinary skill in the art would not have expected difficulties in expression of R338L.” slip op. at 38

  Patent outcomesUS 9,982,248 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,982,248
• Eden Park Illumination, Inc. / Larson Electronics LLC et al. v. S. Edward NeisterInstituted
  PTAB · Oct 27, 2022 · IPR2022-00682 · APJ Avelyn M Ross · IPR · Institution

  Instituted IPR of claims 1, 2, 5, and 6 on all petition grounds; Petitioner showed a reasonable likelihood of prevailing on at least one challenged claim.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “review. 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a). The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless the Director determines . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least [one] of the claims challenged in the petition.” For the reasons set forth below, upon considering the Petition, Preliminary Response, and evidence of record, we determine that Petitioner has established a reasonable likelihood of prevailing with respect to at least one challenged claim. Accordingly, we grant the Petition, and institute an inter partes review.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person of ordinary skill in the art “would have had at least a bachelor’s degree in an engineering discipline, such as biological, chemical, environmental, electrical, mechanical, and/or systems engineering, or an equivalent degree such as one in physics or similar subject matter.” Pet. 9 (citing Ex. 1003 ¶ 20). “Such a person would also have had two to three years of work or research experience with UV disinfection technology and/or systems and would be familiar with the fundamentals of UV excimer lamps,” but “less education could be compensated by more experience and vice versa.” Id. Patent Owner does not, at this time, dispute Petitioner’s proposed definition. See Prelim. Resp. 7. On this record, we determine that Petitioner’s proposed definition is consistent with the prior art of record, and apply it for this Decision. 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))). We will make any final determination pertaining to the level of ordinary skill in the art, however, on the full trial record.” slip op. at 9

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

    “We agree with Patent Owner that Petitioner has shown two single line wavelengths from two separate sources. Prelim. Resp. 8–9. But, we do not view Petitioner’s showing as fatal to Petitioner’s contentions nor do we understand claim 1 to require a single “‘non-coherent light source’ that ‘generat[es] photons of at least two single line wavelengths.’” Id. at 9. Rather, on this record, the plain language of the claim simply requires “generating photons of at least two single wavelengths from a non-coherent light source,” which suggests only that the photons generated are from a non-coherent light source, not whether one or more radiation sources may be utilized. In this case, neither party proposes an express construction of this term for our consideration. See generally Prelim. Resp.; Pet. 10. And, Patent Owner does not direct us to any teaching in the ’605 patent that requires the two or more single line wavelengths to be generated by a single light source. Prelim. Resp. 8–9. Thus, we determine that it is not necessary, at this stage of the proceeding, to provide an express construction for this term. Vivid Techs., 200 F.3d at 803. We encourage the parties to address this issue in subsequent briefing and we will revisit the issue based on the full record developed over the course of trial, if needed.” slip op. at 19

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

    “We determine that Petitioner’s evidence is sufficient, at this stage of the proceeding, to show that the combined references would have suggested, to the ordinarily skilled artisan, a reason to include the low-pressure mercury lamp of Clauβ in combination with Brown-Skrobot’s 222 nm KrCl excimer lamp. We disagree with Patent Owner that Petitioner’s motivation to combine is limited to the fact that Brown-Skrobot’s preferred wavelength of 254 nm is taught by Clauβ. See Prelim. Resp. 9–10. Rather, Petitioner persuasively explains that Brown-Skrobot describes using two or more monochromatic UV radiation sources with different wavelengths in order to increase the levels of sterility and to use less energy to sterilize. Pet. 15 (citing Ex. 1003 ¶ 73; Ex. 1004 ¶ 42). Brown-Skrobot describes multiple different monochromatic UV light sources having the preferred wavelength range of 220 to 320 nm and also suggests “other monochromatic UV radiation sources can be used.” Ex. 1004 ¶¶ 33, 34, 38. Petitioner explains that the skilled artisan “would have been motivated to supplement Brown- Skrobot’s high-level disclosure . . . with the implementation details provided by Clauss.” Pet. 14. On this record, we determine that Petitioner has sufficiently shown that the ordinarily skilled artisan would have had reason to include the 254 nm low-pressure mercury lamp of Clauβ in combination with the 222 nm KrCl excimer lamp of Brown-Skrobot, as Brown-Skrobot describes the advantages of using two or more sources having different wavelengths. Further, we determine that the person of ordinary skill in the art would have had a reasonable expectation of success in the combination, as a mere substitution of one known element for another, according to its known function. KSR, 550 U.S. at 416 (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”).” slip op. at 20

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,975,605

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