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15 decisions · 495msnewest first
  • PTAB · Aug 4, 2026 · IPR2025-00249 · APJ Michael J Fitzpatrick · IPR · Final written decision

    Claims 1 and 4–8 are unpatentable: claims 1 and 4–6 as obvious over Huang2 and Kuo, and claims 7–8 as anticipated by Huang2; claims 2–3 were not shown unpatentable.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for patent owner

      “(“POSITA”) “would be a Ph.D. student with a minimum of two years of experience in their faculty advisor’s laboratory” and would have an understanding of “electrospinning fibers, including for tissue engineering, tissue engineering techniques, and using/performing FFT analysis.” Pet. 20– 21 (citing Ex. 1003 § II.C7). Patent Owner does not dispute Petitioner’s proposal but specifies the set of disciplines within which the Ph.D. would have been earned, namely “bioengineering, chemical engineering, mechanical engineering, or a related engineering discipline.” PO Resp. 6. We adopt and apply Petitioner’s proposal as clarified by Patent Owner regarding the Ph.D. discipline.” slip op. at 7

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

      “At the outset, we agree with Patent Owner that the Specification purports to define “major peaks” in the following sentence: “The ‘major peaks’ herein refer to peaks higher than the average of the peaks in the result.” Ex. 1001, 13:28–29. We determine that this language satisfies at least two of the criteria set forth in Alnylam. Specifically, the sentence at “refers to” to explain what qualifies as major peaks. That is not the end of the inquiry, however, as we find there is still some ambiguity as to whether the patentee intended to define “major peaks” so as to require so-called “minor peaks” in the claimed invention. See Bell Atlantic, 262 F.3d at 1268 (“[T]he intrinsic evidence must ‘clearly set forth’ or ‘clearly redefine’ a claim term so as to put one reasonably skilled in the art on notice that the patentee intended to so redefine the claim term.”). Importantly, the Specification does not treat the existence of minor peaks as prerequisites for the existence of major peaks. Indeed, the Specification does not discuss “minor peaks” at all. See generally Ex. 1001. Likewise, none of the claims of the ’227 patent, whether challenged or unchallenged, recites “minor peaks” or any additional peaks beyond the disputed “major peaks.” Id. at 23:30–24:42. Nor does the Specification include an example of FFT analysis results in which the average of the peaks therein is calculated and those higher than the average are identified as major peaks.8” slip op. at 9

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

      “Petitioner has the better position. Huang2 teaches crosslinking and provides a reason for doing so (stability). In particular, Huang2 states: “To better mimic skin ECM, electrospun collagen fibers have been fabricated, however, the rapid degradation and poor mechanical properties determine that either crosslinking or combination with other materials is necessary to obtain a stable scaffold.” Ex. 1005, 1791 (emphasis added). It is true that, in describing work actually carried out, Huang2 states that blending with PCL was performed and does not mention crosslinking. See id. at 1792 (“Nanofibrous matrices of PCL and Collagen at a weight ratio of 3:1 were fabricated using electrospinning as previously described.”). However, the prior art – here, Huang2 – is not limited to that which it describes having created. See In re Mills, 470 F.2d 649, 651 (C.C.P.A. 1972) (“a reference is not limited to the disclosure of specific working examples”); see also In re Lemelson, 397 F.2d 1006, 1009 (CCPA 1968) (“The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.”); In re Fritch, 972 F.2d 1260, 1264 (Fed. Cir. 1992) (“It is well settled that a prior art reference is relevant for all that it teaches to those of ordinary skill in the art.”). Huang2 teaches two stabilization methods when using collagen in scaffolds. Huang2 states that one or the other “is necessary to obtain a stable scaffold” (when using collagen), but it does not preclude or teach away from using Patent Owner-cited testimony of Dr. Mikos is not as definitive as Patent Owner suggests; Dr. Mikos’s testimony is that a person of ordinary skill in the art “typically would not have done both.” Ex. 2015 ¶64 (emphasis added). The bottom line is that Huang2 teaches the person of ordinary skill in the art two ways to stabilize scaffolds/matrices comprised of collagen, provides a reason for doing so (stability), and does not teach away from using both. We are persuaded that a “scaffold comprising crosslinked fibers comprising collagen” would have been obvious in view of the cited teachings of Huang2.” slip op. at 33

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

      “We are not persuaded by Appellant’s citations to either reference. As discussed above, Petitioner’s Ground 1 is premised on a person of ordinary skill in the art altering the native flat sheet structure of Huang2 by rolling it into a jelly-roll structure as taught by Kuo. See Pet. 41 (Beginning its claim 2 arguments with the following: “Claim 1 is obvious for the reasons expressed above in § X.A., supra, which are incorporated herein.”); see also Pet. Reply 17 (“[B]ased on the explicit teaching of Kuo, a POSA would have been motivated to take the electrospun flat scaffold made by the techniques of Huang2, seed it with the desired cells, and roll it to treat a tendon and ligament.” (emphasis added)). Indeed, the paragraphs of Kuo that Petitioner cites for disclosing “scaffold sheets,” explicitly describe rolling them into jelly-roll like structures. See Ex. 1018 ¶7 (stating that “the sheet is spirally contacting a scaffold sheet of fibrous material with a cell; and rolling the scaffold sheet in a jelly-roll like manner to form a spirally wound tissue construct”), ¶22 (describing a method comprising “forming a tissue construct by contacting a scaffold sheet of fibrous material with a cell; and rolling the scaffold sheet in a jelly-roll like manner to form a spirally wound tissue construct” and implanting it in a patient). Petitioner fails to argue that that “one or more elongated sheets” recited in claim 2 would encompass the rolled structure of its proposed modification. Nor does Petitioner articulate a claim construction argument that could support such an argument. Petitioner has failed to prove, by a preponderance of the evidence, that claim 2 would have been obvious over Huang2 and Kuo.” slip op. at 42

    Patent outcomesUS 11,318,227 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Markman · KSR
    Patents in suitUS 11,318,227
  • PTAB · Mar 6, 2025 · IPR2023-01292 · APJ David C Mckone · IPR · Final written decision

    Claims 1–4, 6–10, and 17–21 are unpatentable over Ohel; claims 5 and 11–16 were not shown unpatentable over Ohel or Nigawara.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “III. ANALYSIS A. Level of Skill in the Art Petitioner, relying on the testimony of Mr. Williams, contends that a person of ordinary skill in the art “would have had at least a bachelor’s degree in computer science, electrical engineering, or a similar field, and would have had approximately two years industry experience in networking or communication systems.” Pet. 3 (citing Ex. 1002 ¶¶ 55–58). Patent Owner does not dispute Petitioner’s proposal. PO Resp. 9. Petitioner’s proposal is consistent with the technology described in the Specification and the cited prior art. On the complete record, we adopt this level of skill.” slip op. at 9

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

      “We have considered the parties’ citations to the specification and find examples that support Petitioner’s view that the term “entity” is broad enough to encompass dispatchers and individual users. See e.g., Ex. 1001, 3:52–4:5, 7:18–20, Fig. 1). However, we find no disclosure that redefines “entity” or excludes dispatchers and individual users from the category of “entity.” Patent Owner’s best examples (e.g., Ex. 1001, 1:15–21, 3:59–62) are no more than non-limiting examples. On the complete record, we conclude that “entity” is broad enough to include dispatchers and individual users.” slip op. at 20

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

      “have used a queue with Ohel’s system. This is insufficient because it does not provide evidence of a reason why a skilled artisan would have implemented Ohel’s system with a queue. See Auris Health, Inc. v. Intuitive Surgical Operations, Inc., 32 F.4th 1154, 1158 (Fed. Cir. 2022) (“The motivation-to-combine inquiry asks whether a skilled artisan ‘not only could have made but would have been motivated to make the combinations . . . of prior art to arrive at the claimed invention.’” (quoting Belden Inc. v. Berk- Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (emphasis omitted))).” slip op. at 35

    • Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightNot reached

      “have used a queue with Ohel’s system. This is insufficient because it does not provide evidence of a reason why a skilled artisan would have implemented Ohel’s system with a queue. See Auris Health, Inc. v. Intuitive Surgical Operations, Inc., 32 F.4th 1154, 1158 (Fed. Cir. 2022) (“The motivation-to-combine inquiry asks whether a skilled artisan ‘not only could have made but would have been motivated to make the combinations . . . of prior art to arrive at the claimed invention.’” (quoting Belden Inc. v. Berk- Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (emphasis omitted))).” slip op. at 35

    Patent outcomesUS 7,324,802 mixed
    Claim construction§ 103 obviousnesscites Phillips · Graham
    Patents in suitUS 7,324,802
  • PTAB · Mar 9, 2018 · IPR2016-01749 · APJ Michelle N Wormmeester · IPR · Final written decision

    Claims 1, 4, 6–13, 20, and 22 are unpatentable as obvious; claims 2 and 3 were not shown unpatentable because the cited art did not establish portability or handheld use.

    RulingsFinal written decision
    • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

      “We agree with Petitioner. Although Petitioner bears the burden of correctly identifying the real parties-in-interest, “[w]e generally accept the petitioner’s identification of real parties-in-interest at the time of filing the petition.” See Zerto, Inc. v. EMC Corp., Case IPR2014-01254, at 6 (PTAB Mar. 3, 2015) (Paper 35) (citing Office Patent Trial Practice Guide, 77 Fed. Reg. 48,680, 48,695 (Aug. 14, 2012)). Here, Petitioner identifies in its Petition the real party-in-interest: “Pursuant to 37 C.F.R. § 42.8(b)(1), Unified Patents Inc. (‘Unified’ or ‘Petitioner’) certifies that Unified is the real party-in-interest.” Pet. 1. Such identification gives rise to a rebuttable presumption that Petitioner has complied with its obligation to identify all real parties-in-interest. See Zerto at 6–7. Patent Owner recognizes that “it [is] incumbent on the patent owner to come forward with some rebuttal evidence.” PO Resp. 52. In response to Petitioner’s identification of the real party-in-interest, Patent Owner contends that “this is not an instance where a petitioner’s certification in a petition can be taken at face value” because “evidence proffered by [Petitioner] in support of its position was withdrawn deliberately.” Id. at 53. We do not, however, require evidence beyond a petitioner’s identification of real parties-in-interest in the absence of rebuttal evidence that such identification is erroneous or incomplete. Petitioner’s withdrawal of Exhibit 1012 from the record does not constitute such rebuttal evidence. In view of the foregoing, we find that the circumstances here do not raise sufficient doubt about whether Petitioner has satisfied its obligation to name all real parties-in-interest. Therefore, we determine that the Petition should not be dismissed on this basis.” slip op. at 7

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

      “by applying the broadest reasonable interpretation in light of the specification of the patent in which they appear. See 37 C.F.R. § 42.100(b); Cuozzo Speed Techs. LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard). Under that standard, claim terms generally are given their ordinary and customary meaning, as would be understood by one of ordinary skill in the art in the context of the entire disclosure. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). A “claim term will not receive its ordinary meaning if the patentee acted as his own lexicographer,” however, and clearly set forth a definition of the claim term in the specification. CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002). Petitioner proposes an express construction for the claim term “transceiver.” Pet. 10. Patent Owner does not propose an express construction for any claim term. See generally PO Resp. In light of the parties’ arguments, we determine that no term requires express interpretation to resolve any controversy in this proceeding.” slip op. at 8

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed

      “Rovira teaches each of the recited claim limitations, Petitioner must provide “some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006); see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). In that regard, Petitioner directs us to Rovira’s teaching that “it is highly desirable to communicate program content information” because “having such information as music title, composer, artist and record label is vital” to music lovers. Pet. 16 (citing Ex. 1003, 1:30–32, 2:5–10); see also Ex. 1003, 1:32–35 (“Frustration of customers, and possible loss of revenue due to subscription cancellation can occur if a subscriber has no method of knowing the title, composer or artist of the particular selection of music.”). Petitioner argues it, thus, would have been obvious to modify Schotz’s system to incorporate a signal that includes both audio data and program data, as taught by Rovira. Pet. 17; see also, e.g., id. at 21 (“[O]ne would have been motivated to (1) modify Schotz’s transmitter 4 to transmit the digital audio signal of Rovira . . . and (2) modify Schotz’s receiver 6 to receive this digital audio signal.”); id. at 23 (“[T]his modification would result in Schotz’s user interface switch 18 selecting the digital audio data . . . within the digital audio signal [of Rovira].”); id. at 25 (“It would have been obvious to utilize the tuner 110 of Rovira in Schotz for [tuning] to frequencies that Schotz is receiving based on its use of Rovira’s digital audio signal. . . . Schotz is essentially doing this already, i.e., tuning to a frequency associated with audio data.”); id. at 27 (“[I]t would have been obvious to modify Schotz to utilize Rovira’s disclosed demodulator 125 to extract the selected digital audio data and the audio program information from the carrier wave, as taught by Rovira.”); id. at 28–29 (“It would have been obvious to modify Schotz to include the digital to analog converter 160 disclosed in Rovira. . . . The receiver 6 of Schotz would necessarily need a digital to analog converter when using the digital signals disclosed in Rovira so that the user can hear the selected music.”). We are persuaded by Petitioner’s reasoning, including specifically the quoted material in the preceding string citation to the Petition, for modifying Schotz’s system to include Rovira’s signal as well as various components for processing such a signal. See Kahn, 441 F.3d at 988. We note that “[a] person of ordinary skill is also a person of ordinary creativity, not an automaton,” and, in modifying Schotz’s system to include Rovira’s signal, would have made any necessary additional modifications such that Schotz’s system could process appropriately Rovira’s signal. See KSR, 550 U.S. at 421.” slip op. at 13

    Patent outcomesUS 6,757,913 mixed
    Claim construction§ 103 obviousnesscites KSR
    Patents in suitUS 6,757,913
  • 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 · 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 · Nov 16, 2015 · IPR2014-01351 · APJ James P Calve · IPR · Final written decision

    Claims 60, 61, 70–74, and 77 are unpatentable as obvious over Blank, Kakinami, and Schofield; the other challenged claims were not shown unpatentable.

    RulingsFinal written decision
    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “Dr. Nranian testifies that the proposed modification would require substantial reconstruction or a redesign of Blank or a change in the principle of operation. Ex. 2005 ¶¶ 106–110. Dr. Nranian does not elaborate on this opinion or explain what redesigns and reconstructions would be required. We find persuasive the testimony of Dr. Kazerooni that designing a housing to hold components therein is a basic engineering concept within the level of ordinary skill in the art, particularly in view of, and as evidenced by, the disclosures of Blank and Schofield. Ex. 1016 ¶¶ 21–23. Blank discloses that circuit board 150 may be configured for a supplemental vision system. Ex. 1005, 7:51–59. TRW proposes to use this principle of operation and include Kakinami’s camera with Blank’s module 26. Pet. Reply 15–17. As discussed above, Blank and Schofield disclose reconfiguration and redesign of accessory housings, both internally and externally, to accommodate a variety of different accessories. Ex. 1005, 3:8–11, 7:6–10; Ex. 1006, 9:24– 36. Kakinami also discloses mounting of video camera 20, which includes lens 14, video device 15, and signal processing unit 16. Ex. 1010, 2:15–26, Fig. 2a. Physical incorporation is not required to demonstrate obviousness. See In re Yamamoto, 740 F.2d at 1573.” slip op. at 25

    • Skill levelSkill level petitioner adoptedOther

      “sophistication of the technology, all as addressed herein, it is submitted that the person of ordinary skill in the art of the ’590 Patent at the time of the invention would have had at least the qualifications of or equivalent to either a undergraduate degree in electrical engineering or mechanical engineering with course work or research in automobile accessory systems with at least two years of work making automobile accessory systems. Ex. 1012 ¶ 30. This discussion appears in Dr. Kazerooni’s Declaration in a section entitled “LEVEL OF ORDINARY SKILL.” Ex. 1012 ¶¶ 29–30. This definition of a skilled artisan in paragraph 30 immediately precedes Dr. Kazerooni’s discussion of the “STATE OF THE ART IN THE RELEVANT TIMEFRAME.” See id. ¶¶ 31–48. This definition of a skilled artisan in paragraph 30 of Dr. Kazerooni’s Declaration matches TRW’s definition of a skilled artisan in the Petition and is cited as the basis of TRW’s definition of a skilled artisan. See Pet. 17 (citing Ex. 1012 ¶¶ 29–30); Ex. 1012 ¶ 30. Another definition of a skilled artisan appears in Dr. Kazerooni’s Declaration in a section entitled “SUMMARY OF OPINIONS.” Ex. 1012 ¶ 10. It is unclear what use, if any, is made of this definition. Accordingly, we understand TRW and Dr. Kazerooni to assert the same definition of a skilled artisan, which definition appears at page 17 of the Petition and paragraph 30 of Dr. Kazerooni’s Declaration. Dr. Kazerooni identifies November 4, 1999 as the priority date of the ’590 patent invention. Ex. 1012 ¶ 26. Magna does not dispute this date. PO Resp. 57. Dr. Kazerooni testifies to the level of ordinary skill at the time of the invention. Id. ¶ 30. Dr. Kazerooni provides a detailed discussion of the state of the art at the time of the invention by discussing the disclosures of Blank, Kakinami, Schofield, Carter, Anderson, and Klappenbach. Id. ¶¶ 31– 48. These references were filed and issued before November 4, 1999. TRW” slip op. at 32

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

      “We interpret “bus communication” as “information transferred over a set of signal lines between devices connected to the signal lines.” We are not persuaded that a bus must include an interface. The IEEE Standard 969 Interface Devices (Ex. 1004) defines a bus in that context. The’590 patent discloses a CAN bus without disclosing an interface. Ex. 1002, 4:15–17. An ordinary meaning of “bus” includes “[a] set of signal lines to which a number of devices are connected and over which information is transferred between them.” See ANSI/IEEE Standard 1196-1987 IEEE Standard for a Simple 32-Bit Backplane Bus: NuBus (Ex. 3001).” slip op. at 7

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner

      “We construe “cluster of individual sensors” as “a group of individual sensors or components of individual sensors positioned close together.” Pet. 6–7; Prelim. Resp. 11–12. This interpretation is consistent with an ordinary meaning of “cluster” which includes “a group of things or people that are close together” (Pet. 6) and the claims, which recite “a cluster of individual sensors resides on or near said in-cabin surface of said windshield.” This interpretation is consistent with the ’590 patent specification, which discloses that housing 10 is divided by wall 16 into adjacent first and second compartments 18, 20. Ex. 1002, 3:29–31, Fig. 2. One embodiment contains rain sensor 26 in first compartment 18 and printed circuit board 30 bearing a compass sensor 30 in second compartment 20. Id. at 5:62–6:12, 7:52–55, Figs. 2, 8. The ’590 patent specification discloses that the housing may accommodate a plurality of electrical accessories. Id. at 6:42–44. The ’590 patent further discloses that component 30 “can be any of a number of sensors or circuits which can be made small enough to fit in the compartment 20.” Id. at 7:64–67 (emphasis added). Preferably, component 30 is provided as a unitary module received in compartment 20. Id. at 7:67– 8:1. An ordinary meaning of “any” is one or more. Thus, the ’590 patent specification discloses that component 30 may include more than one sensor.” slip op. at 9

    Patent outcomesUS 8,513,590 mixed
    Claim construction§ 103 obviousnesscites KSR
    Patents in suitUS 8,513,590
  • PTAB · Oct 26, 2015 · IPR2014-00727 · APJ Michael J Fitzpatrick · IPR · Final written decision

    Claims 1, 3–7, 9, 10, 12–14, 16–19, 21, 22, 24–29, 31, and 33–37 are unpatentable as obvious over Betts; claims 8, 20, 30, and 38 were not shown unpatentable over Betts and the Orange Book.

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

      “The term “enclosure unit” encompasses lavatories, aircraft closets, and aircraft galleys. Given the grounds of unpatentability that Petitioner raises, there is no need to further construe this term. 2. “lavatory stall unit” Whereas independent claim 1 recites “enclosure unit,” independent claim 9 recites “lavatory stall unit.” Patent Owner proposes the latter be construed as “a single room, enclosed on all sides, having a toilet and washbasin and large enough to fit a person inside.” PO Resp. 12. For reasons similar to those with respect to “enclosure unit,” we reject Patent Owner’s proposed construction of “lavatory stall unit.” Further, given the grounds of unpatentability that Petitioner raises, there is no need to provide an express construction for this term. More specifically, Petitioner does not rely on any particular prior art lavatory. Indeed, Petitioner does not rely on either of the asserted references to teach a “lavatory stall unit,” instead relying on the knowledge and skill of a person of ordinary skill in the art.” slip op. at 9

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

      “These proposed constructions would render the claim language “in a vertical plane” meaningless because tilting a seatback between an upright position and another position would have no effect on the shape of the aft surface of the seatback. Therefore, we do not adopt them. See Cardiac Pacemakers, Inc. v. St. Jude Med., Inc., 296 F.3d 1106, 1115 (Fed. Cir. 2002) (proposed construction that rendered a portion of the claim language meaningless held improper). Rather, we construe “in a vertical plane” according to its ordinary and customary meaning and consistent with the specification, which contrasts a forward wall in a vertical plane (see Fig. 1—the prior art) against a recessed forward wall (see Fig. 2—an embodiment of the claimed invention). In sum, the full limitation at issue encompasses an aft portion (in the case of claim 1) and an aft portion with an exterior aft surface (in the case of claims 9, 21, and 31) that has a flat shape but which is not within a vertical plane. This is within the broadest reasonable construction in light of the Specification, which discloses a substantially conforming recessed forward wall positioned behind the seat (see Ex. 1001, Fig. 2), as opposed to a wall that is flat in a vertical plane (see id. at Fig. 1). 4. “forward wall portion is shaped to substantially conform to the shape of the” slip op. at 10

    • BurdenFwd mixedMixed

      “As discussed below, Petitioner has shown by a preponderance of the evidence that claims 1, 3–7, 9, 10, 12–14, 16–19, 21, 22, 24–29, 31, and 33–37 of the ’838 patent are unpatentable as obvious over Betts. But, Petitioner has not shown by a preponderance of the evidence that claims 8, 20, 30, and 38 are unpatentable as obvious in view of Betts and the Orange Book, as Petitioner has not established that the evidence relied upon within the Orange Book is a printed publication.” slip op. at 3

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

      “motivated to efficiently use space on an aircraft, as evidenced by Betts, “to provide more room for passengers.” Id. ¶ 65 (quoting Ex. 1003, 1:6–7). Mr. Anderson further testifies that Betts teaches the person of ordinary skill in the art a recessed forward wall configuration that uses space more efficiently than a flat configuration, and that a person of ordinary skill in the art would have been motivated to apply the recessed configuration to other aircraft enclosures, including lavatories. Patent Owner argues that a person of ordinary skill in the art “would have been discouraged from attempting to tailor Betts’ divided space design to any lavatory stall unit (or any other enclosure unit) because Betts required separate enclosures divided both functionally and spatially.” PO Resp. 29. But, Petitioner’s ground of unpatentability is not premised on whether it would have been practical or possible to convert Bett’s “divided space” (i.e., its overhead coat compartment and floor luggage space) into a lavatory. Rather, Petitioner argues that it would have been obvious to apply Bett’s recessed forward wall design to other aircraft enclosures, including a lavatory. Pet. 19 (“One of ordinary skill in the art would recognize that the teachings of the McDonnell Douglas patent [i.e., Betts] are equally applicable to the forward walls of other enclosure units, such as lavatories or galleys.”) (citing Ex. 1009 ¶¶ 65–68); cf. In re Etter, 756 F.2d 852, 859 (Fed. Cir. 1985) (en banc) (“Etter’s assertions that Azure cannot be incorporated in Ambrosio are basically irrelevant, the criterion being not whether the references could be physically combined but whether the claimed inventions are rendered obvious by the teachings of the prior art as a whole.”); In re Keller, 642 F.2d 413, 425 (CCPA 1981) (“The test for obviousness is not whether the 15 features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art.”).” slip op. at 15

    Patent outcomesUS 8,590,838 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
    Patents in suitUS 8,590,838
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