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  • PTAB · Sep 12, 2018 · IPR2017-01051 · APJ Elizabeth M Roesel · IPR · Final written decision

    Claims 1, 4–12, and 15–19 were held unpatentable as obvious over Hagiwara; claims 2, 3, 13, and 14 were not shown unpatentable. The motion to amend was granted in part.

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

      “j. Conclusion Regarding Obviousness Based on Hagiwara (Proposed Substitute Claims) We conclude that Petitioner has shown by a preponderance of the evidence that proposed substitute claims 20, 22, 23, and 26–29 are unpatentable as obvious in view of Hagiwara. We conclude that Petitioner has not shown by a preponderance of the evidence that proposed substitute claims 21, 24 and 25 are unpatentable as obvious in view of Hagiwara. 2. Remaining Grounds of Unpatentability Asserted by Petitioner (Proposed Substitute Claims) In view of our determination that Petitioner has shown by a preponderance of the evidence that proposed substitute claims 20, 22, 23, and 26–29 are unpatentable as obvious in view of Hagiwara, we do not reach Petitioner’s remaining grounds of unpatentability as to these claims. Regarding proposed substitute claims 24 and 25, Petitioner’s contentions regarding the Handbook, Wilson, and Say do not remedy the deficiencies in Petitioner’s contentions regarding Hagiwara, as discussed above. Accordingly, we conclude that a preponderance of the evidence does not show that proposed substitute claims 24 and 25 are unpatentable as obvious based on Hagiwara in view of the Handbook, Wilson, or Say. H.” slip op. at 71

    • ExcludeOther

      “As discussed above, we do not reach the Wilson-Based Grounds with respect to claims 1, 4–12, and 15–19 of the ’574 patent. As for claims 2, 3, 13, and 14, we determine that Petitioner has not shown unpatentability based on the Wilson-Based Grounds, even if Exhibit 1037 and the corresponding portions of Petitioner’s Reply (Paper 37) are not excluded, because Petitioner does not offer Exhibit 1037 to cure the deficiency we noted in Wilson. See Section II.F, supra. For this reason, we dismiss as moot Patent Owner’s motion.” slip op. at 72

    • Expert testimonyPetitioner expert discountedPatent owner expert discountedDecided for patent owner

      “sensor would not have been a motivation to combine Hagiwara’s embodiments” because Hagiwara’s catheter prevents damage to the sensor during insertion and because a sensor with a side sensor window creates a greater risk of damage and vascular injury and reduces exposure to blood, as compared with a sensor with an end sensor window. PO Resp. 20–25. We have considered Patent Owner’s arguments, but, for the reasons discussed above, we are persuaded that Petitioner has established a motivation to combine, notwithstanding the conflicting expert testimony regarding the disadvantages of a side sensor window versus an end sensor window. Neither of the expert opinions on this topic is supported by objective facts or data. Ex. 1006 ¶ 155;13 Ex. 2008 ¶¶ 54–57, 87–95; Ex. 2009, 92:8–97:12. For this reason, we give little or no weight to either side’s expert testimony 13 Dr. Vachon cites “WO 01/13102, Vadgama” (Ex. 1006 ¶ 155), however, this reference was not submitted as an exhibit in this proceeding. on this topic. 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”); Rohm & Haas Co. v. Brotech Corp., 127 F.3d 1089, 1092 (Fed. Cir. 1997) (nothing in the Federal Rules of Evidence or Federal Circuit jurisprudence requires the fact finder to credit unsupported assertions of an expert witness). As discussed above, however, there is no disagreement that a side sensor window was a known alternative to an end sensor window. Ex. 1006 ¶¶ 73, 155; Tr. 43:22–44:3. That undisputed fact, together with Petitioner’s other evidence, is sufficient to establish a motivation to combine.” slip op. at 42

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Level of Ordinary Skill in the Art For purposes of our Institution Decision, we accepted the definition of a person of ordinary skill in the art (“POSITA”) provided by Petitioner’s declarant, Dr. Vachon. Dec. 11 (citing Ex. 1006 ¶ 28). That definition is: a person having a bachelor’s degree or the equivalent training or experience in mechanical engineering, bioengineering, or related field and at least three years of experience relating to biosensor research and development, or a master’s degree or the equivalent training or experience in mechanical engineering, bioengineering, or related field, and at least one year of experience relating to biosensor research and development. Id. Patent (https://www.uspto.gov/sites/default/files/documents/guidance_on_motions_ to_amend_11_2017.pdf); Bosch Automotive Service Solutions, LLC v. Matal, 878 F.3d 1027 (Fed. Cir. 2017); Bosch Automotive Service Solutions, LLC v. Iancu, Order on Petition for Panel Rehearing, No. 2015-1928 (Fed. Cir. Mar. 15, 2018). Owner’s declarant accepts and applies this definition of a POSITA for purposes of his opinions. Ex. 2008 ¶ 30. Neither party’s declarant indicates that any proffered opinion would change depending on the level of ordinary skill in the art. Therefore, consistent with our Institution Decision, we adopt Dr. Vachon’s definition of a POSITA. Ex. 1006 ¶ 28. We also rely on the cited prior art references as reflecting the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 20

    Patent outcomesUS 7,529,574 mixed
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 7,529,574
  • PTAB · Feb 9, 2018 · IPR2016-01502 · APJ Jon B Tornquist · IPR · Final written decision

    Claim 2 is unpatentable as anticipated by MacKay; claims 3–5 were not shown unpatentable over MacKay and Cipkowski.

    RulingsFinal written decision
    • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner

      “structure or steps, or if it is ‘necessary to give life, meaning, and vitality’ to the claim.” Catalina Mkt’g Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quoting Pitney Bowes, Inc. v. Hewlett–Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999)). For example, a preamble may be limiting when the disputed preamble phrase provides antecedent basis for a claim term in the body of a claim, the specification underscores that the additional structure recited in the preamble is important, or when the patentee clearly relied upon the preamble during prosecution to distinguish the claimed invention from the prior art. Id. at 808–09. “Conversely, a preamble is not limiting ‘where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention,’” id. at 808, or where the patentee uses the preamble to give “a descriptive name to the set of limitations in the body of the claim,” IMS Tech., Inc. v. Haas Automation, Inc., 206 F.3d 1422, 1434 (Fed. Cir. 2000) (“The phrase ‘control apparatus’ in the preamble merely gives a descriptive name to the set of limitations in the body of the claim that completely set forth the invention.”). The term “device” is not recited in the body of any claim of the ’019 patent,4 the body of claim 1 recites a structurally complete invention, and the preamble phrase “device for collecting and assaying a sample of biological fluid” specifies the intended use of the invention. Thus, we find the claims of the ’019 patent do not support construing “device” as a limitation. See Catalina Mkt’g, 289 F.3d at 808–09.” slip op. at 8

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

      “device” set forth above requires a single, unitary structure rather than a collection of separate structures that could be used during the test. See id. at 18 (concluding without analysis that the dictionary definition requires a “single, unitary structure”). Indeed, despite the ubiquitous use of the term “device” in patents generally, we are directed to no case in which the term “device,” by itself, was found to require a single, unitary structure. See Manual of Patent Examining Procedure, Section 2106, I (identifying “devices” as one of the four categories of statutory subject matter); Saffran v. Johnson & Johnson, 712 F.3d 549, 565 (Fed. Cir. 2013) (O’Malley concurring in part) (confirming that, in general, the term “device” is generic). Thus, we are not persuaded that the ordinary meaning of the term “device” requires a “single, unitary structure.” See Ex. 1023 ¶ 66 (Dr. Bohannon testifying that the word device, like the words “apparatus” or “system,” is merely a generic term that does not have a specialized meaning in the art and does not require a single, unitary structure). slip op. at 12

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

      “We do not find this argument persuasive. As noted above, we do not construe claim 1 to contain a method step of adding fluid to the container. We construe the first wherein clause of claim 1(c), instead, to require a structure that is capable of allowing liquid to enter the container when the flow control channel is properly disposed therein and is capable of directing this liquid to the sample loading zone of the assay test strip without the liquid having to migrate through an intermediate structure, such as a wicking material. We are persuaded—and Patent Owner does not dispute—that the apparatus of MacKay, as disclosed in Figures 8A–C, has a structure that is capable of achieving both functions. See, e.g., Tr. 26:10–30:20. First, given the open nature of the container, it is evident that liquid may be added to the container when the flow control channel is disposed within the container, and Patent Owner does not assert otherwise. See, e.g., id. Second, even if the fluid present in Figures 8A–C is considered, there is no intermediate structure in the container of MacKay that would prevent additional assay sample fluid from entering the container and being immediately directed to the sample loading zone of the assay test strips.6 Based on the foregoing, we find that MacKay discloses every limitation of claims 1 and 2 of the ’019 patent. Accordingly, Petitioner has demonstrated by a preponderance of the evidence that claim 2 is anticipated by MacKay.” slip op. at 21

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

      “discloses the subject matter of claims 3–5 of the ’019 patent. Pet. 26–30. Petitioner also asserts that one of ordinary skill in the art would have sought to insert the test trip and flow control channel of MacKay in the holder of Cipkowski, in order to prevent “flooding of the test strip as taught in MacKay.” Id. at 29.” slip op. at 23

    Patent outcomesUS 6,548,019 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 6,548,019
  • PTAB · Apr 12, 2017 · IPR2015-01992 · APJ Jon B Tornquist · IPR · Final written decision

    Claims 1, 2, 4–12, 14–24, and 34–48 are unpatentable over the stated grounds; claims 3 and 13 were not shown unpatentable, and claims 25–33 and 49 were disclaimed.

    RulingsFinal written decision
    • Adverse judgmentAdverse judgmentOther

      “On February 8, 2017, Patent Owner informed the Board that it had “disclaimed claims 25–33 and 49” of the ’002 patent, thereby “rendering the institution of claims 25–33 and 49 in the subject inter partes review proceeding moot.” Paper 18, 1; Ex. 2005 (disclaimer of claims 25–33 and 49 pursuant to 37 C.F.R. § 1.321(a)).” slip op. at 2

    • BurdenMixed

      “2. Analysis To anticipate a claim a “prior art reference must disclose each and every feature of the claimed invention, either explicitly or inherently.” Eli Lilly & Co. v. Zenith Goldline Pharm., 471 F.3d 1369, 1375–76 (Fed. Cir. 2006). An inherent disclosure may be found when an asserted prior art reference “necessarily” includes the unstated limitation. Transclean Corp. v. Bridgewood Servs., Inc., 290 F.3d 1364, 1373 (Fed. Cir. 2002).” slip op. at 13

    • ExcludeMotion to exclude, deniedDenied

      “Upon review of Petitioner’s arguments and supporting evidence, we are persuaded that Petitioner has identified where each limitation of independent claim 1 is disclosed in Huang. Claims 11, 34, and 40 contain limitations similar to claim 1, Petitioner provides detailed arguments as to where each limitation of these claims is disclosed in Huang, and Patent Owner does not present any arguments for these claims separate from those 7 At oral argument, Patent Owner asserted that we should not consider Petitioner’s argument that the icons of Huang contain URL information because this argument was presented for the first time in Petitioner’s Reply. Tr. 32:19–35:5. Patent Owner did not file a motion to exclude this evidence, however, or request a sur-reply to address any allegedly new issues raised for the first time in Petitioner’s Reply. Id. at 34:18–23. Nor is it evident why Petitioner’s arguments are not appropriate rebuttal arguments addressing Patent Owner’s proposed construction of “pointer.” Accordingly, we decline to exclude Petitioner’s URL arguments and evidence.” slip op. at 15

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

      “be used in conjunction with the mobile interface agent, including “a computer, cable set top box, cellular phone, or other device.” Ex. 1001, 4:44–45. Patent Owner does not explain why the description of a “pointer” in one “context,” i.e., on a computer or PDA, represents a clear and deliberate attempt to define the term in all contexts, such that all pointers must be a “reference” to “a type of menu item” and be “accessible on a computer, PDA, or server.” See In re Paulsen, 30 F.3d at 1480 (noting that an inventor is “free to define the specific terms used to describe his or her invention,” but “this must be done with reasonable clarity, deliberateness, and precision”). The broadest definition of the term “pointer” in the ’002 patent is “a link/shortcut to an item.” Ex. 1001, 10:8–10 (“As discussed above, a pointer is a link/shortcut to an item such as . . . .”); Dec. on Inst. 10. This definition is consistent with the description of “pointers” in the ’002 patent written description and claims. Ex. 1001, 20:4–6 (“wherein the pointers provide links to access the corresponding user specific resources and information.”). Accordingly, we construe “pointer” to mean “a link or shortcut to an item.”” slip op. at 9

    Patent outcomesUS 6,546,002 mixed
    Claim construction§ 102 anticipation§ 103 obviousness
    Patents in suitUS 6,546,002
  • PTAB · Mar 1, 2017 · IPR2015-01839 · APJ Jacqueline T Harlow · IPR · Final written decision

    Claims 1, 2, 4–7, 28–31, 36, 38, 39, 43, and 44 are unpatentable under § 103(a); claims 8, 32, 33, and 48–54 were not shown unpatentable.

    RulingsFinal written decision
    • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageTerm construed board ownDecided for patent owner

      “The disclosure of the ’829 patent is expressly addressed to the problem of, and a solution for, unreliable and vulnerable electrical connections caused by splicing auxiliary lights into OEM headlight wiring. The Background of the Invention explains that “[t]raditionally, the auxiliary lights were spliced into the existing wiring for the headlights of the vehicle.” slip op. at 11

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

      “As an initial matter, we observe that whether or not the preamble term “light circuit” is limiting has little bearing on the ultimate disposition of this inter partes review, as it is undisputed that Douglas has identified, for each asserted ground of unpatentability, disclosure of a light circuit. See PO Resp. 11–12. Furthermore, we agree with Douglas that “light circuit” does not connote any structure beyond that explicitly recited in the body of the claims. Indeed, it is unclear that either Meyer or Mr. Ricca disputes such conclusion. For example, Meyer states in its Patent Owner Response that” slip op. at 18

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

      “As a general rule, the words “a” or “an” in a patent claim carry the meaning of “one or more.” Baldwin Graphic Sys., Inc. v. Siebert, Inc., 512 F.3d 1338, 1342–43 (Fed. Cir. 2008). That rule is particularly applicable 15 where, as here, those words are used in combination with the open-ended antecedent “comprising.” See, e.g., Abtox, Inc. v. Exitron Corp., 122 F.3d 1019, 1023 (Fed. Cir. 1997). “An exception to the general rule that ‘a’ or ‘an’ means more than one only arises where the language of the claims themselves, the specification, or the prosecution history necessitate a departure from the rule.” Baldwin Graphic, 512 F.3d at 1342–43. We discern no such exception here. First, Meyer has not identified, and we do not discern, any requirement in the language of the claims to support the conclusion that the recited “an auxiliary light connector to connect an auxiliary light” must be a single auxiliary light connector.” slip op. at 15

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

      “As set forth above, Möller explicitly teaches the incorporation of microprocessors and microcontrollers to improve relay-circuitry-based vehicle electronics systems. Ex. 1006, 4:41–48. Contemporaneous prior art 33 references, including Gould and COP8, disclose advantages obtained through the incorporation of microprocessors and microcontrollers into relay circuitry for controlling end devices, further underscoring that an ordinarily skilled artisan would have sought to modify the relay circuitry of Knepel with the microprocessors and microcontrollers of Möller. See Ex. 1010, 9, 11; Ex. 1011, 14. Moreover, Dr. Neuhalfen testifies, without challenge, that it was well-known at the time of invention of the ’829 patent to use microprocessors to control original vehicle lights, as well as auxiliary lights, and identifies numerous advantages that the proposed combination would afford. Ex. 1014 ¶ 59. Indeed, Meyer’s expert, Mr. Ricca, agrees that it would not have been difficult for an ordinarily skilled artisan to supplement the circuit of Knepel to provide microprocessor control of the relays in that circuit. Ex. 1033, 182:6–11. In view of the teachings of Möller itself, and the contemporaneous prior art, as well as the testimony of Dr. Neuhalfen and Mr. Ricca, we find that a person of ordinary skill in the art at the time of the invention would have recognized the value of using known elements, i.e., microprocessors and microcontrollers, as taught by Möller, to improve the relay circuitry for controlling original vehicle lights and auxiliary lights of Knepel. We likewise find that a person of ordinary skill in the art would have appreciated that the microprocessors of Möller could be incorporated into, i.e., used to supplement, the relay circuitry of Knepel. See KSR, 550 U.S. at 418 (an obviousness analysis “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account” slip op. at 33

    Patent outcomesUS 6,265,829 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 6,265,829
  • PTAB · Jan 4, 2017 · IPR2015-01490 · APJ Lora M Green · IPR · Final written decision

    Claims 1–3, 10–15, 23, 25, 27, 30, and 41–43 are unpatentable; claims 17 and 47 were not shown unpatentable; claims 28 and 29 were cancelled.

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

      “based on the complex as a whole, rather than just the carbohydrate component, as Fishbane related to iron dextran complexes. Reply 10. We agree with Petitioner that the language of the term “substantially non-immunogenic carbohydrate component” itself only requires an assessment of the immunogenicity of the carbohydrate component, and disagree with Patent Owner that the claims require an assessment of the immunogenicity of the iron carbohydrate complex as a whole. In that regard, we note that the Specification of the ’702 patent supports our construction that the “substantially non-immunogenic carbohydrate component” is limited to the carbohydrate component as opposed to the iron carbohydrate complex as a whole. Specifically, the Specification teaches in the background section that previously available iron dextran products suffered from a “high incidence of anaphylactoid reactions . . . believed to be caused by the formation of antibodies to the dextran moiety,” while “[o]ther parenteral iron products (e.g., iron sucrose and iron gluconate) do not contain the dextran moiety, and the incidence of anaphylaxis with these products is markedly lower.” Ex. 1001, 1:53–57; see also id. at 11:3‒4 (“non-immunogenic carbohydrate component; no cross reactivity with anti-dextran antibodies”). Moreover, the language of independent claim 1 itself does not require a non-immunogenic complex, but only specifies that the “iron carbohydrate complex has a substantially non-immunogenic carbohydrate component.” Moreover, we decline to limit the term “substantially non- immunogenic carbohydrate complex” to require an incidence level of lower than 0.6%. Rather, what is supported by the claim language and the Specification is a low risk such that the incidence of adverse events of the carbohydrate complex is lower than dextran. See, e.g., Tr. 53‒54 (counsel for Patent Owner acknowledging that Fishbane was not incorporated by reference, and that it was only cited as a “see generally”).” slip op. at 10

    • Skill levelOther

      “We do not find a significant different between the requirements for the ordinary artisan proposed by Petitioner and Patent Owner. We agree with Petitioner (Pet. 14) that the best evidence of the level of skill in the art are the references themselves, see Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001), and, thus, we need not explicitly adopt either Petitioner’s or Patent Owner’s characterization of the level of skill in the art. Moreover, we note that the result of the analysis regarding the patentability of the claims would be the same under the requirements for the ordinary artisan proposed by either Petitioner or Patent Owner.” slip op. at 12

    • Expert testimonyPetitioner expert creditedDecided for petitioner
    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableInherency foundUnpatentable

      “Petition (Pet. 22–27), we find that Petitioner has demonstrated by a preponderance of the evidence that Geisser teaches all the limitations of claim 1, either inherently or explicitly. That is, we agree with Petitioner that Geisser teaches a method of treating a disease characterized by an iron deficiency, specifically iron deficiency anemia (Pet. 23; Ex. 1003, Abstract, 1:4‒7, 2:4‒7, 9:30‒31). We further agree that Geisser teaches a method of administering an iron carbohydrate complex, that is, iron carboxymaltose, in a single dosage form of at least 0.6 grams of elemental iron, as Geisser teaches administering iron carbohydrate complexes as a single dose of 500‒ 1000 mg of iron. Pet. 23 (citing Ex. 1003, 1:26‒4:1, 8:7-10, 10:14‒17). In that regard, we credit the testimony of Dr. Linhardt that Geiser discloses iron carboxymaltose, and that Geisser describes a general synthetic method that is nearly identical to the method described in the ʼ702 patent. Ex. 1005 ¶¶ 8‒10, 13. In addition, as Geisser teaches one of the iron carbohydrate complexes explicitly recited by claim 1, that is, iron carboxymaltose, it would inherently meet the limitation that the carbohydrate component is substantially non-immunogenic and would have substantially no cross-reactivity with anti-dextran antibodies. In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) (“Products of identical chemical composition can not have mutually exclusive properties.”). The teachings of Geisser support that finding, as Geisser specifically teaches that the complexes have low toxicity and a reduced danger of anaphylactic shock. Pet. 23 (citing Ex. 1003, 1:26‒ 2:1, 8:7‒10); see also Ex. 1001, 12:12‒14 (noting that as “[t]he iron carboxymaltose complex (e.g., VIT-45) generally does not contain dextran and [it] does not react with dextran antibodies.”).” slip op. at 18

    Patent outcomesUS 7,754,702 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 7,754,702
  • Dermira, Inc. v. Purepharm, Inc.Some claims unpatentable
    PTAB · Dec 27, 2016 · IPR2015-01594 · APJ Zhenyu Yang · IPR · Final written decision

    Claims 1–3 and 5–8 are unpatentable as anticipated by Hays or obvious over the listed combinations; claim 4 was not shown unpatentable for lack of a reason to add another sweating therapy.

    RulingsFinal written decision
    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

      “In interpreting claim terms, the claims themselves provide substantial guidance. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Here, claim 1, from which claims 2–8 depend, recites the dosed amount of glycopyrrolate in solution as “an amount ranging from 3.0 wt. % to 4 wt. %.” Because claim 1 describes the dosed amount by the strength/concentration, it supports our conclusion that term “dosed amount” is not limited by the volume of the glycopyrrolate solution.” slip op. at 6

    • BurdenMixed

      “Petitioner may well be correct that preferring a non-anticholinergic does not necessarily exclude administering “another oral and/or topical therapy for reduction of sweating,” as required by challenged claim 4. Petitioner, however, does not point to any credible evidence or otherwise explain why an ordinary artisan would have chosen another therapy to reduce sweating to be administered in combination with glycopyrrolate. Without some articulated reasoning with rational underpinning as to why an ordinary artisan would have added a second therapeutic for reducing sweating to the transdermal patch of Bodor, which uses the anticholinergic to eliminate the formation of an aqueous layer between the delivery system and the skin to enhance the penetration of the transdermal drug being delivered, Petitioner has not met its burden of demonstrating that claim 4 20 would have been obvious over the combination of Bobrove and Bodor. See KSR, 550 U.S. at 418.” slip op. at 20

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

      “(citing Ex. 1009, 1821). Hays instructs that glycopyrrolate solutions should be carefully applied while avoiding the mouth, nose, and eyes. Id. (citing Ex. 1009, 1798, 1809). For example, it discloses applying a cotton applicator dipped in the glycopyrrolate solution to the skin while holding the hair up out the way to treat patients with gustatory sweating in the hairline. Id. at 31 (citing Ex. 1009, 1819). Dr. Guy testifies that an ordinary artisan would have understood the cotton applicator in Hays “as being any of a cotton ball, a cotton pad, a cotton swab, or having a cotton component as a part of a larger applicator.” Ex. 1003 ¶ 72. According to Hays, glycopyrrolate in concentrations of 0.5%, 1.0%, and up to 4% provided effective control of gustatory sweating with no significant side effects. Pet. 29 (citing Ex. 1009, 1819). Thus, we agree with Petitioner that Hays discloses each and every limitation of claim 1.” slip op. at 11

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

      “Bobrove specifically teaches applying a “roll on” glycopyrrolate solution. Ex. 1008, 6:26–27, 6:36–37. It, however, also generally teaches that glycopyrrolate is administered topically. Id. at 4:1. Thus, one of ordinary skill in the art would have had a reason to look for other means to apply glycopyrrolate. As Dr. Guy testifies, “[t]here are a limited number of ways to topically deliver a drug to a patient’s skin.” Ex. 1003 ¶ 16. In addition, Bobrove suggests to avoid the eyes, nose, and mouth during the topical administration. Ex. 1008, 5:37–39. Given these considerations, Bodor provides an effective alternative: a cotton cloth to absorb the drug and rub it on the skin. Ex. 1030, 15:39–54; see also Ex. 1003 ¶ 17 (explaining that, at the time of the invention, an ordinary artisan would have known that use of medicated pads “allowed for topical application of a solution, for example to a subject’s face, while excluding application to sensitive areas such as the eyes or mucous membranes”). Thus, we conclude Petitioner has shown, by a preponderance of the evidence, that an ordinary artisan would have had a reason to combine the teachings of Bobrove and Bodor. In sum, Petitioner has shown, by a preponderance of the evidence, that an ordinary artisan would have had a reason to combine the teachings of Bobrove and Bodor, and that the combination teaches each and every limitation of claims 1 and 2. Claims 4, 5, and 8” slip op. at 19

    Patent outcomesUS 8,252,316 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
    Patents in suitUS 8,252,316
  • Dermira, Inc. v. Purepharm, Inc.Some claims unpatentable
    PTAB · Dec 27, 2016 · IPR2015-01593 · APJ Zhenyu Yang · IPR · Final written decision

    Claims 1–3 and 5–10 are unpatentable as anticipated by Hays or obvious over the stated combinations; claim 4 was not shown unpatentable for lack of a reason to add another sweating therapy.

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

      “In interpreting claim terms, the claims themselves provide substantial guidance. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Here, the challenged claims recite the dosed amount of glycopyrrolate in solution as “an amount ranging from 1.0 wt. % to 6 wt. %” (claim 1); “an amount ranging from 2.0 wt. % to 6.0 wt. %” (claim 9); and “an amount ranging from 2.0 wt. % to 4.0 wt. %” (claim 10). Because the claims describe the dosed amount by the strength/concentration, they support our conclusion that term “dosed amount” is not limited by the volume of the glycopyrrolate solution.” slip op. at 6

    • Skill levelSkill level board ownOther

      “The parties disagree over the level of ordinary skill.8 See Pet. 17–18; PO Resp. 3; Reply 9. For purposes of this Decision, we do not need to resolve this dispute because the prior art itself reflects an appropriate skill level. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 16

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “not qualify as one of ordinary skill in the art because he is not a clinician, physician, or pharmacist. PO Resp. 3–4. We disagree with Patent Owner on this issue. All asserted references relate to topical administration of pharmaceutical compositions. See, e.g., Ex. 1008, 4:1; Ex. 1010, 2:35–38; Ex. 1030, 3:60–61. In addition, the challenged ’524 patent relates to the topical delivery of glycopyrrolate to reduce excessive sweating and minimize side effects. Ex. 1001, Abstract, 1:13–21. Dr. Guy has over 30 years of experience in fields including topical drug delivery, transdermal” slip op. at 16

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

      “water base and a vanishing cream base in 0.5 to 1% concentration. It completely controls gustatory sweating for several days or more.” Pet. 30 (citing Ex. 1009, 1821). Hays instructs that glycopyrrolate solutions should be carefully applied while avoiding the mouth, nose, and eyes. Id. at 31 (citing Ex. 1009, 1798, 1809). For example, it discloses applying a cotton applicator dipped in the glycopyrrolate solution to the skin while holding the hair up out the way to treat patients with gustatory sweating in the hairline. Id. (citing Ex. 1009, 1819). Dr. Guy testifies that an ordinary artisan would have understood the cotton applicator in Hays “as being any of a cotton ball, a cotton pad, a cotton swab, or having a cotton component as a part of a larger applicator.” Ex. 1003 ¶ 90. According to Hays, glycopyrrolate in concentrations of 0.5%, 1.0%, and up to 4% provided effective control of gustatory sweating with no significant side effects. Pet. 31 (citing Ex. 1009, 1819). Thus, we agree with Petitioner that Hays discloses each and every limitation of claim 1.” slip op. at 11

    Patent outcomesUS 8,679,524 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
    Patents in suitUS 8,679,524
  • PTAB · Dec 9, 2016 · IPR2015-01309 · APJ Jon B Tornquist · IPR · Final written decision

    Claims 1, 3, 5, 6, 10–13, 16, and 19 are unpatentable as obvious; claims 7–9, 14, and 15 were not shown unpatentable.

    RulingsFinal written decision
    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached

      “Petitioner and Patent Owner propose constructions for all, or a portion of, the term “Formula I, XCF3(I), where X is a C2 unsaturated, substituted, alkyl radical.” Pet. 17–19 (proposing a construction for the term “C2 unsaturated, substituted, alkyl radical”); PO Resp. 12–15. Neither party contends, however, that express construction of this claim term, or any other term in the ’808 patent, would impact any of Petitioner’s or Patent Owner’s arguments in this proceeding. Accordingly, we determine that no claim terms require construction for purposes of this Final Written Decision. See 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 7

    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “art. Patent Owner, relying upon the testimony of Dr. Bivens, asserts that one of ordinary skill in the art would have had either: “(1) a bachelor of science degree in a specialty area (such as chemical engineering or chemistry) and five years of work experience in developing/testing refrigerants, blowing agents, and propellants, or (2) a Ph.D. or masters of science degree and 2-3 years of work experience.” PO Resp. 12 (citing Ex. 2034 ¶¶ 21–24). Patent Owner’s identification of a person of ordinary skill in the art is uncontroverted and is consistent with the prior art of record. Accordingly, we adopt Patent Owner’s identification for purposes of this Final Written Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (noting that the prior art itself may reflect the level of ordinary skill in the art).” slip op. at 8

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

      “Accordingly, we are persuaded that: (1) Petitioner has identified where every limitation of claim 1 is disclosed or suggested in the combination of Kruse, Inagaki, and Butler; (2) Petitioner has set forth reasoned explanations supported by factual underpinnings to explain why one of ordinary skill in the art, prior to the earliest filing date of the ’808 patent, would have sought to combine Kruse, Inagaki, and Butler to achieve the invention set forth in claim 1 of the ’808 patent; and (3) Petitioner has set forth reasoned arguments, supported by record evidence, to show why a person of ordinary skill in the art would have had a reasonable expectation of success in combining Kruse, Inagaki, and Butler to achieve the composition of claim 1.” slip op. at 17

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

      “patent met a long-felt but unresolved need or were commercially successful, we have been directed to no persuasive evidence to demonstrate these propositions. See Graham, 383 U.S. at 17–18 (noting that “long felt but unsolved needs” and commercial success may be utilized as indicia of nonobviousness). Indeed, we have been directed to no persuasive evidence that a mixture of CO2 and a fluoroalkene of claim 1 has ever been used commercially, or that such a mixture was considered by those of ordinary skill in the art to have met a long felt but previously unresolved need.9, 10 See Tr. 51:24–52:7; Pet. Reply 9 (asserting that Patent Owner “has provided no evidence, post- or pre- issuance of the ’808 patent, of the commercial advantages or uses of the claimed compositions”). With respect to Petitioner’s prior patent applications, although Patent Owner initially characterizes these applications as relating to CO2 and partially fluorinated hydrocarbons, Patent Owner later notes that these patents are directed to blends of HFO-1234yf, CO2, and R-134a. PO Resp. 44; Ex. 2024, 12 (arguing in support of patentability that “[t]he specific 9 To be relevant, Patent Owner must show that the asserted secondary considerations are attributable to “the merits of the claimed invention beyond what was readily available in the prior art.” Asyst Techs. v. Emtrak, Inc., 544 F.3d 1310, 1316 (Fed. Cir. 2008). Here, Inagaki discloses using compounds within the scope of claim 1 of the ’808 patent as refrigerants. Patent Owner presents no persuasive evidence that the addition of CO2 to the compounds of Inagaki, or the particular ranges recited in claim 1, resulted in a product that met a long felt but unresolved need or resulted in a commercially successful product beyond what was provided in Inagaki. Thus, we are also not persuaded that there is any nexus between the asserted secondary considerations and the features of claim 1 that are not disclosed in Inagaki. 10 As Patent Owner has not demonstrated any commercial use of the claim 1 compounds for any purpose, or provided evidence that those of skill in the art considered the claimed compounds to have met an unresolved need in the art, this analysis applies equally to the dependent claims of the ’808 patent, which each depend, directly or indirectly, from claim 1. combination of trans-R1234ze and R134a and CO2 simply is not suggested in Singh, let alone in the amounts defined in claim 1”). Patent Owner does not explain sufficiently why Petitioner’s arguments directed to the patentability of a blend of three compounds, utilized in specific proportions, are necessarily applicable to the combination of Kruse, Inagaki, and Butler proposed by Petitioner, or why these arguments are otherwise strong evidence of the nonobviousness of claim 1 of the ’808 patent. Based on the foregoing, and upon review of Patent Owner’s arguments as a whole, we are not persuaded that Patent Owner’s proffered objective evidence of nonobviousness is strong or tends to refute Petitioner’s arguments and evidence with respect to the obviousness of claim 1 of the ’808 patent.” slip op. at 25

    Patent outcomesUS 8,623,808 mixed
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 8,623,808
  • PTAB · Jul 7, 2016 · IPR2015-00529 · APJ Robert A Pollock · IPR · Final written decision

    Claims 1–8 and 10–19 are unpatentable as obvious over the INOmax label, Bernasconi, Loh, and Goyal; claims 1, 7, 12, and 14 are also anticipated and obvious over the INOmax label.

    RulingsFinal written decision
    • Expert testimonyOther

      “method of providing pharmaceutically acceptable nitric oxide gas requires providing information to the medical provider to safely administer the nitric oxide gas,” thus “confirm[ing] that the ‘providing . . . information’ step is functionally related to the steps in the claimed method.” PO Resp. 31–33. As an initial matter, whether the claims should be interpreted as requiring such a functional relationship is a legal conclusion. See PO Resp. 13. Patent Owner’s conclusion regarding functional relationship between claim terms is based, at least in part, on an overly-limited reading of “pharmaceutically acceptable nitric oxide gas,” as discussed above. See PO Resp. 27. Further, we do not read the transcript testimony relied on by Patent Owner as clearly admitting a functional relationship between the steps of “providing pharmaceutically acceptable nitric oxide gas” and the information of (ii). See PO Resp. 31–32 (citing Ex. 2022, 78:15–80:4, 81:11–22, 111:2–17)). To the contrary, Dr. Beghetti appears to have testified that the claim elements are not directly related. Ex. 2022, 86:10– 25. Although Patent Owner points to In re Distefano, 808 F.3d at 848, as evidence that a “printed matter analysis includes ‘factual findings’” (PO Sur Reply 4, n.6), which inform the ultimate legal conclusion, we do not find the evidence as a whole compelling.” slip op. at 19

    • ExcludeMotion to exclude, deniedOther

      “IV. PETITIONER’S MOTION TO EXCLUDE Petitioner moves to exclude certain portions of Ex. 2024 on the grounds that they “are declarations and supporting materials submitted during patent examination . . . in violation of 37 C.F.R. § 42.53(a)” and “lack foundation (FRE 602) and authentication (FRE 901) and constitute impermissible hearsay (FRE 901).” Paper 31, 2–3. Petitioner likewise moves to exclude Exhibit 2029 as not relied on in the Patent Owner Response or by Patent Owner’s expert. Id. at 3. As we do not rely on the objected-to materials in this opinion, we dismiss the motion as moot.” slip op. at 45

    • Strike new argumentNew argument disregardedOther

      “V. OBJECTIONS TO DEMONSTRATIVES The parties also submit competing objections to demonstrative exhibits used at trial. Papers 46, 47. Specifically, both parties object to certain slides as setting forth a new argument not previously made in any paper. Papers 46, 47. The parties are reminded that demonstrative exhibits are illustrative only and are not part of the trial record. Indeed, in accordance with our Order on requests for oral argument, neither party filed its demonstratives with the Board. See Paper 45, 2 (“Notwithstanding 37 C.F.R. § 42.70(b), the parties shall not file any demonstrative exhibits in this proceeding without prior authorization from the Board. 37 C.F.R. § 42.5(b). Demonstrative exhibits are intended to be visual aids to assist a party in making its oral presentation and will not be entered into the record of these proceedings.”). Nevertheless, in this Final Written Decision, we rely on the arguments presented properly in the parties’ briefs and the evidence of record and do not consider any new arguments not previously set forth in any paper. See Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). (“No new evidence or arguments may be presented at the oral argument.”).” slip op. at 45

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

      “The Applicant amended the preamble of the rejected independent claims to recite “[a] method of providing pharmaceutically acceptable nitric oxide gas,” as presently set forth in claims 1 and 7. Id. at 746–747. Subsequent to the amendment, the Examiner withdrew the objection. Id. at 765; see id. at 733 (“If all the priority issues are resolved then it appears that the primary reference in the 103 rejection will no longer be prior art.” (italics omitted)). On pages 19 and 20 of its Response, Patent Owner argues that the preamble is, therefore, limiting in light of Catalina Mktg. International, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002), which holds that “clear reliance on the preamble during prosecution to distinguish the claimed invention from the prior art transforms the preamble into a claim limitation because such reliance indicates the use of the preamble to define, in part, the claimed invention.” Although the prosecution history shows that amendment of the preamble only indirectly distinguished the claims over the prior art by establishing an earlier priority date, we conclude that both the Applicant and the Examiner treated the preamble as a claim limitation. Accordingly, we agree with Patent Owner that the preamble language “pharmaceutically acceptable nitric oxide gas” is limiting.” slip op. at 11

    Patent outcomesUS 8,846,112 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,846,112
  • PTAB · Jun 20, 2016 · IPR2015-00345 · APJ Kevin F Turner · IPR · Final written decision

    Claims 9–16, 23, and 24 were held unpatentable as anticipated by Iwamura; the Board did not find claims 1–8, 21, 22, 25–27, 29, 30, 33–35, 37, and 38 unpatentable.

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

      “Although the sections of the Specification of the ’237 Patent cited by Petitioner relate to disk size, that size is a direct result of the number of records in the data set. Claim 1, for example, recites “using the received features extracted from the media work to perform a sub-linear time search of extracted features of identified media works.” For that claim, under our adopted claim construction, the size of the data set would be the number of extracted features of the identified media works. It would not be logical to assume that the size of the data set would be the length of an individual record or the amount of disk space the data set occupies when the number of extracted features would be readily available. Although disk space could be used as a measure, it would be variable with respect to the format of the disk space, for example. Therefore, we are not persuaded that disk space should be used as a determinant of data set size in the construction of “sub-linear search.” As such, the data set would be the number of extracted features, in claim 1, irrespective of the exact number of commercials or frames.” slip op. at 7

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

      “ii) “non-exhaustive search” With respect to the claim term “non-exhaustive search,” Patent Owner emphasizes that a non-exhaustive search makes a comparison without all possible matches but does not concern itself with whether all data within all possible matches have been compared. PO Resp. 6–7. Petitioner does not dispute the construction, and we remain persuaded that a “non-exhaustive” search need not consider all data within all possible matches, but rather should be exhaustive or non-exhaustive with respect to the number of records in a database. See Dec. 5–7.” slip op. at 8

    • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageTerm construed board ownDecided for petitioner

      “Petitioner responds that the statements in the Specification do not rise to the level of lexicography or disavowal. Reply 4–5 (citing Facebook, Inc. v. Pragmatus AV, LLC, 582 F. App'x 864, 868 (Fed. Cir. 2014); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1249 (Fed. Cir. 1998)). We agree, given that the cited portion provides that an approximate nearest neighbor search may be an example of a sublinear search, but not that all approximate nearest neighbor searches must be sub-linear. Additionally, Patent Owner has not provided persuasive evidence that all approximate nearest neighbor searches must be sub-linear, other than the citation to the Specification. As well, similar to our discussion of neighbor searches above, we are not persuaded that if an approximate nearest neighbor search happens to arrive at an exact match, that would negate the nature of the search. We are persuaded that an approximate nearest neighbor search would depend on the search methodology and not on the specific results obtained. Additionally, as Petitioner points out, the instant claims confirm that sublinearity is not necessarily required for an approximate nearest neighbor search. Reply 5–6. Claim 33 recites, in part, a “sublinear approximate nearest neighbor search,” whereas claims 9 and 12 simply recite an “approximate nearest neighbor search,” without the sublinear modifier. Interpreting all recitations of approximate nearest neighbor searches as intrinsically sublinear would render the limitation in claim 33 superfluous. Id. (citing Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005); Digital-Vending Servs. Int’l, LLC v. Univ. of Phoenix, Inc., 672 F.3d 1270, 1274–75 (Fed. Cir. 2012)). For this additional reason, we remain persuaded that an approximate nearest neighbor search corresponds to “identifying a close match that is not necessarily the closest match,” without a requirement of being sublinear.” slip op. at 9

    • Expert testimonyPetitioner expert discountedDecided for patent owner

      “in which he agrees that Iwamura’s system compares a work to be identified with each reference work in the database. PO Resp. 26–28 (citing Ex. 2006, 207:18–23, 223:2–8, 247:18–20, 269:19–270:2, 271:19–21); see also Tr. 17:17 (Petitioner conceding at oral hearing that “every song is looked at”). Dr. Moulin also acknowledges that if a non-exhaustive search is one that does not look at each of the melodies in the database, Iwamura discloses an exhaustive search rather than a non-exhaustive search. Ex. 2006, 233:24– 234:14; see PO Resp. 27. Despite Dr. Moulin’s testimony and Iwamura’s description of a search that compares an input melody to each melody in the database, Petitioner contends that Iwamura discloses a non-exhaustive search. First, Petitioner submits that Iwamura specifically identifies its peak note search as a non-exhaustive search because the “search speed using peak notes is 20% of a brute force search.” Pet. 9–10 (quoting Ex. 1012, 9:8–11); Reply 7–8 (citing Ex. 1012, 9:7–11; Ex. 2005 ¶ 82; Ex. 2001). We agree with Patent Owner, however, that Iwamura’s peak note search accelerates a search within a single comparison between a work to be identified and an individual record in the database, while still comparing the work to each record in the database. See PO Resp. 29–30. In other words, the peak search technique may improve the efficiency of an individual comparison between an entered melody and a reference melody in the database, but it is still an exhaustive search because it compares the entered melody with each musical work in the database, as confirmed by Petitioner’s declarant, Dr. Moulin. Id. (citing Ex. 2006, 269:19–270:2). Petitioner further argues that Iwamura discloses a non-exhaustive search because the search can be accelerated by stopping the search when computations “exceed[] a certain limit.” Pet. 10 (quoting Ex. 1012, 7:56– 57). We agree with Patent Owner that this disclosure also refers to improving the speed of a comparison between the work to be identified and a single record in the reference database. See PO Resp. 32 (citing Ex. 2005 ¶ 179). As Dr. Karypis explains and Dr. Moulin confirms, when the total absolute difference computed between the entered melody and a particular reference melody exceeds a certain limit, the computation stops, and the search shifts to the next peak range comparison within the same record. Id. at 32–35 (citing Ex. 2005 ¶¶ 180–81; Ex. 2006, 241:24–242:2). Thus, Iwamura’s computation “limit” does not describe a non-exhaustive search because Iwamura still compares a work to be identified with each reference melody in the database.” slip op. at 16

    Patent outcomesUS 8,205,237 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,205,237

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.