• Argentum Pharmaceuticals LLC v. Alcon Research, Ltd.No claims unpatentable
  PTAB · Sep 20, 2018 · IPR2017-01053 · APJ Grace Karaffa Obermann · IPR · Final written decision

  Claims 1–28 were not shown unpatentable under § 103 because the proposed combinations lacked a persuasive reason to make the required modifications and meet the claimed limitations.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “understanding of a person of ordinary skill in the art at the time of the invention. Petitioner submits that such a person would have had a Doctorate in microbiology or chemistry (or a related field) with at least a few years of experience in the development of ophthalmic formulations. Pet. 7. Alternatively, in Petitioner’s view, that person would have had a Bachelor’s or Master’s Degree combined with significant (5 years or more) practical experience developing ophthalmic formulations. Id. Patent Owner, for its part, advances a definition that “does not differ materially” from that proposed by Petitioner. Resp. 5. Petitioner’s definition is comparable to the level of skill reflected in the asserted prior art. The prior art itself is sufficient to demonstrate the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (prior art itself can reflect appropriate level of ordinary skill in the art). To the extent more specified findings are required, we adopt the definition proposed by Petitioner. Pet. 7. We observe, however, that there is no appreciable difference between the parties’ respective definitions that would “materially” alter the outcome of this decision based on our acceptance of one definition over the other. Resp. 5.” slip op. at 5

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

    “Pet. 5–7; Dec. 7–8. Patent Owner tacitly agrees. See Resp. 1 (stating that a “self-preserved” composition is “one that has sufficient antimicrobial activity to pass standard tests for ‘preservative efficacy’ without needing a conventional preservative”). Accordingly, for reasons set forth in our decision instituting review in the Apotex IPR, we determine that: (a) The preamble term “self-preserved” breathes life and meaning into the claims, and is construed as a limitation of claims 1–28; and (b) The broadest reasonable interpretation of “self-preserved” compositions is “compositions that do not contain a conventional antimicrobial preservative.” Apotex IPR, Paper 9, 5–6; Dec. 7–8. Schneider, which is asserted in each ground of unpatentability stated in the Petition, informs that edetate disodium (“EDTA”) and benzalkonium chloride (“BAC”) were conventional antimicrobial preservatives known and available at the time of the invention—an issue not meaningfully disputed by Petitioner. Ex. 1007, 7:14–21; Pet. 15. Our claim construction findings are supported by the specification of the ’299 patent, which states that “[t]he multi-dose compositions of the present invention, which do not contain a conventional antimicrobial preservative, are referred to herein as being ‘self-preserved’.” Ex 1001, 3:27–29. The specification identifies BAC as an example of a conventional antimicrobial preservative excluded from the self-preserved composition of the challenged claims. Id. at 4:23–25. No other claim term requires express construction for the purposes of this decision. See, e.g., Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (only claim terms in controversy need be construed, and then only to the extent necessary to resolve the controversy).” slip op. at 7

  • Prior constructionPrior construction adoptedDecided for patent owner

    “Petitioner argues that we should adopt the claim construction resolved in the Apotex IPR, as we did in the decision on institution in this case. Pet. 5–7; Dec. 7–8. Patent Owner tacitly agrees. See Resp. 1 (stating that a “self-preserved” composition is “one that has sufficient antimicrobial activity to pass standard tests for ‘preservative efficacy’ without needing a conventional preservative”). Accordingly, for reasons set forth in our decision instituting review in the Apotex IPR, we determine that: (a) The preamble term “self-preserved” breathes life and meaning into the claims, and is construed as a limitation of claims 1–28; and (b) The broadest reasonable interpretation of “self-preserved” compositions is “compositions that do not contain a conventional antimicrobial preservative.” Apotex IPR, Paper 9, 5–6; Dec. 7–8. Schneider, which is asserted in each ground of unpatentability stated in the Petition, informs that edetate disodium (“EDTA”) and benzalkonium chloride (“BAC”) were conventional antimicrobial preservatives known and available at the time of the invention—an issue not meaningfully disputed by Petitioner. Ex. 1007, 7:14–21; Pet. 15. Our claim construction findings are supported by the specification of” slip op. at 6

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

    “Petitioner asserts that an ordinarily skilled artisan “would have retained as much of” Formulation A “as feasible, as this was already an FDA-approved formulation, marketed as Travatan®.” Pet. 15; Ex. 1002 ¶¶ 46–47. But Petitioner’s challenge incongruously depends on at least six modifications to Formulation A; seven, if attaining UPS preservative efficacy requirements is not an inherent property of the modified composition. Petitioner does not address, much less explain, how or why an ordinarily skilled artisan, undertaking those six or seven modifications, would have done so with a reasonable expectation of success in arriving at a “self-preserved” composition using zinc as the sole preservative—in a field where zinc “had never before been the sole preservative in a marketed ophthalmic drug.” Resp. 9; Ex. 2023 ¶ 46; Ex. 2025 ¶ 30. The Petition does not articulate a rational reason why a person of ordinary skill in the art, setting out to improve Formulation A, would have selected the particular combination of ingredients required by claim 1. Formulation A bears almost no resemblance to the composition of claim 1, lacking three of the four required ingredients (zinc ions, sorbitol, and propylene glycol) and containing two others (BAC and EDTA) that are excluded by the “self-preserving” terms of the claim. Compare Ex. 1001, claim 1, with Ex. 1007, 9:25–42 (Table, Formulation A). And even if we set aside those hurdles, the challenge fails for lack of persuasive evidence showing how or why an ordinarily skilled artisan would have resolved to include the claimed ingredients in the specified concentrations, while at the same time limiting anionic species (to the extent included) to a concentration of “less than 15 mM.” Ex. 1001, claim 1. Petitioner fails to establish that the subject matter of claim 1 would have been obvious over the combined disclosures of Schneider, Xia, and Chowhan—with or without the additional disclosure of Gadd. Pet. 2–3.” slip op. at 26

  Patent outcomesUS 8,268,299 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 8,268,299
• Fujifilm Corporation v. Sony CorporationNo claims unpatentable
  PTAB · May 16, 2018 · IPR2017-00360 · APJ Kristina M Kalan · IPR · Final written decision

  Claims 1–10 were not shown unpatentable: Takahashi and Meguro did not anticipate, and the asserted combinations did not render the claims obvious.

  RulingsFinal written decision

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

    “We note, first, that the specification of the ’501 patent expressly defines the term “biaxially tensilized” as “having been subjected to tensilization in both the machine direction and the crossweb direction.” Ex. 1001, 3:33–35. Petitioner asks us to construe the term “biaxially tensilized” as it is defined in the specification. Pet. 14. Because Patent Owner has acted as its own lexicographer for the term “biaxially tensilized,” we accept the express definition set forth in the specification. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1980).” slip op. at 6

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

    “Applying the broadest reasonable interpretation, we construe the term “tensilized” to mean “stretched.” The specification defines “biaxially tensilized” as “having been subjected to tensilization in both the machine direction and the crossweb direction,” indicating that tensilization has a directional component, i.e., that tensilization can occur in a machine direction, or in a crossweb direction, or both. Ex. 1001, 3:33–35. No other properties such as heating or heat setting are mentioned in the specification’s definition of “biaxially tensilized.” Attempting to substitute the term “heating” or “heat setting” for the term “tensilized” in the definition of “biaxially tensilized” is nonsensical—it does not appear that a substrate could be, for example, “heated” in a machine direction or “heat set” in a crossweb direction. The specification’s paragraph describing “film production,” upon which both parties rely, does not mention tensilization ipsissimis verbis. Ex. 1001, 5:18–31. This paragraph’s description states that film production “typically involves” the steps identified in the paragraph, indicating that not all steps are required at all times. Id. Dictionary evidence indicates that “tensile,” the root word at issue, means “capable of being stretched.” See Ex. 1026, 6. Extrinsic evidence indicates that substrates can be cold-stretched, i.e., stretched without heat. See generally Ex. 1022. Construing “tensilized” to mean “stretched,” in view of broadest reasonable interpretation standards, does not mean that a heating or a heat-setting component must be absent, but allows for the presence of other steps without requiring them to be part of the construction. Thus, we construe the term “tensilized” to mean “stretched.” B. Level of Ordinary Skill in the Art” slip op. at 6

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

    “tensilized,” “longitudinal direction” and “crossweb direction,” “degrees,” and “ferromagnetic pigment.” Pet. 14–16. For purposes of our Institution Decision, we determined that no claim term required express construction. Dec. 5. Patent Owner, in its Response, proposes that we construe the preamble and the term “tensilized.” PO Resp. 7–10. For purposes of this Decision, we determine that the terms “longitudinal direction” and “crossweb direction,” “degrees,” and “ferromagnetic pigment” are not in controversy, and require no express construction. We discuss, here, the terms “biaxially tensilized” and “tensilized.” slip op. at 5

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “undisputed contention that a person of ordinary skill in the art would have been a person with (1) a bachelor’s degree in materials science, physics, electrical engineering, mechanical engineering, chemistry, or a closely related field, and at least five years of experience in the field of magnetic recording or (2) a master’s degree or higher in those fields, or a closely related field, with an emphasis in magnetic recording, and at least three years of experience in the field of magnetic recording. Pet. 13. Patent Owner does not, in its Response, appear to dispute this definition. In light of the evidence before us, we adopt Petitioner’s definition of one of ordinary skill in the art. We also find that Petitioner’s proposed level of skill in the art is reflected by the references themselves. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the absence of specific findings on the level of skill in the art does not give rise to reversible error ‘where the prior art itself reflects an appropriate level and a need for testimony is not shown.’”); In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (finding that the Board of Patent Appeals and Interferences did not err in concluding that the level of ordinary skill in the art was best determined by the references of record). C. Overview of the Asserted References” slip op. at 7

  Patent outcomesUS 6,979,501 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,979,501
• Changer & Dresser, Inc. v. 002152706 Ontario LimitedNo claims unpatentable
  PTAB · May 9, 2018 · IPR2017-00341 · APJ Christopher M Kaiser · IPR · Final written decision

  Petitioner did not prove claims 1, 17, or 35 unpatentable on any asserted ground, primarily because the grounds failed to establish the required access position or motivation to combine.

  RulingsFinal written decision

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

    “We agree that the Second and Fourth Examples of Takaba differ structurally. In the Second Example, “[t]he spiral spring 62 biases and rotates the cylinder 61 clockwise.” Ex. 1011 ¶ 29; see also id. ¶ 38 (“in Example 2, the cylinder 61 is rotated in a state storing the tip 18”). In the Fourth Example, spring 62 is present, but “the cylinder itself does not rotate.” Id. ¶ 38. But we disagree with Petitioner that Dr. Wagoner’s testimony relates solely to the Fourth Example. Although the first sentence of paragraph 66 of Dr. Wagoner’s testimony refers to the Fourth Example, the remainder of the paragraph relates to the function of spring 62 in both the Second and Fourth Examples of Takaba. Paragraph 66 cites paragraph 31 of Takaba, which relates to Takaba’s Second Example. In addition, paragraph 67 of Dr. Wagoner’s declaration begins “Returning to other aspects of the Second Example . . . .” Ex. 2002 ¶ 67 (emphasis added). This strongly suggests that paragraph 66 was discussing the Second Example, at least in part. Regarding the Second Example, Wagoner also testifies that “spiral spring 62 also securely holds electrode tips 18 within supply cylinder 61 in alignment” and that spiral spring 62 holds tips 18 in alignment with each ‘tip 18 . . . pressed against an inner circumferential surface of the cylinder 61 due [to] a pressing force in the outer circumferential direction of the spiral spring 62.’” Id. ¶ 58; see also id. ¶ 64 (discussing spring 62 in both Examples and identifying differences between the two Examples, none of which pertains to how spring 62 holds tips in alignment). Because Dr. Wagoner’s testimony relates to both the Second and Fourth Examples of Takaba, Ex. 2002 ¶ 66, we agree with Patent Owner that Dr. Wagoner’s testimony addresses Petitioner’s proposed combination of Takaba and Lilley and supports Patent Owner’s position that Petitioner fails to show sufficiently a reason to combine these references. As described above, even without Dr. Wagoner’s testimony, the evidence is only equivocal on the question of whether the spring-driven magazine described in the Second Example of Takaba would experience the same problems as a gravity-fed magazine. The evidence to support Petitioner’s view—Mr. Mangold’s Declaration—is contradicted by the evidence against such a view—Dr. Derby’s deposition testimony. Compare Ex. 1002 ¶ 88 (testifying that a person of ordinary skill in the art would understand that Takaba’s “welding tips 18 still have some space to move within the cylinder 61”), with Ex. 2004, 27:22–28:12 (testifying that paragraph 29 of Takaba, which refers to Takaba’s Second Example, teaches keeping tips 18 “all in contact one next to the other with no gaps or space”). In view of Dr. Wagoner’s testimony, Ex. 2002 ¶¶ 54–66, the evidence is not merely equivocal; the preponderance of the evidence contradicts Petitioner’s position that Takaba’s welding tips are subject to the same problems as tips in a gravity-fed magazine. Because Petitioner’s argument for a reason to combine Takaba with Lilley relies on such a finding, Pet. 55–56, we are not persuaded that Petitioner has demonstrated an adequate reason to combine those references. Accordingly, we conclude that Petitioner has not shown that the combination of Takaba and Lilley would have rendered claims 1 and 35 of the ’639 patent obvious.” slip op. at 16

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “Pet. 22–36. Anticipation of a claim under 35 U.S.C. § 102 requires proof that each claimed limitation and the claimed arrangement or combination of those limitations is disclosed, inherently or expressly, by a single prior art reference. Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1325, 1332 (Fed. Cir. 2010). Patent Owner argues that several limitations of claims 1 and 35 are not disclosed by Lilley. Prelim. Resp. 35–43. Claim 1 recites a limitation requiring an “access position allowing one of the spot welding caps . . . to be extracted from the cap carrier.” Ex. 1001, 4:65–5:1. Claim 35 similarly recites an “access position for allowing one of the spot welding caps to be extracted from the cap carrier.” Id. at 6:51–52. As noted above, we have construed these limitations as “a position in which one of the spot welding caps can be pulled out from the cap carrier.” Lilley, however, does not disclose a mechanism in which its pellets are pulled from its magazine. Ex. 1009, 6:63–68, Fig. 8 (“a hollow combination probe and transfer port . . . has passed through magazine 57 and pushed the pellet 61 into the barrel”). Petitioner also does not show that a person of ordinary skill in the art would understand Lilley’s disclosure to include an access position in which a pellet could be pulled from the magazine. Pet. 31–34. In fact, Petitioner acknowledges that Lilley discloses only removing a pellet by pushing it out of the pellet carrier. Pet. 33 (“just like the shaft of the pincer spot welding head of the ‘639 Patent that extracts the welding cap in the axial direction, the probe 64 [of Lilley] engages the pellet 61 in an axial direction to push the pellet 61 out of the magazine 57” (emphasis added)). Accordingly, Petitioner has not shown that Lilley discloses the recited “access position allowing one of the spot welding caps . . . to be extracted from the cap carrier” (claim 1) or “access position for allowing one of the spot welding caps to be extracted from the cap carrier” (claim 35). We determine that Petitioner has not established by a preponderance of the evidence the anticipation of claims 1 and 35 by Lilley.” slip op. at 24

  • ExcludeOther

    “I. Patent Owner’s Motion to Exclude Patent Owner filed a Motion to Exclude Evidence. Paper 25. The motion seeks to exclude paragraphs 34, 47–49, 51, 53–60, 68–69, 71, 74, 83, and 87–89 of Exhibit 1002, Mr. Mangold’s opening declaration. Id. at 9. As discussed above, even without excluding this evidence from the record, we conclude that Petitioner has not demonstrated the unpatentability of any of the challenged claims. Accordingly, even were we to grant Patent Owner’s motion, it would not change the outcome of this proceeding. Therefore, we dismiss Patent Owner’s Motion to Exclude Evidence as moot.” slip op. at 28

  Patent outcomesUS 9,393,639 not shown unpatentable
  § 102 anticipation§ 103 obviousness
  Patents in suitUS 9,393,639
• Par Pharmaceutical, Inc. / Breckenridge Pharmaceutical, Inc. et al. v. Novartis AGNo claims unpatentable
  PTAB · Jan 11, 2018 · IPR2016-00084 · APJ Christopher L Crumbley · IPR · Final written decision

  Claims 1–3 and 8–10 were not proven unpatentable because the proposed obviousness analysis did not show that the choices leading to everolimus were finite, small, or easily traversed.

  RulingsFinal written decision

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

    “The facts of the case at hand provide a stark contrast. As we have found above, while the prior art recognized rapamycin as a promising immunosuppressant, it was only one among many possible lead compounds. Furthermore, the prior art shows that chemists were pursuing a number of avenues to increase solubility, including making derivatives but also other approaches such as formulation techniques or prodrugs. And most tellingly, in contrast to Bristol-Myers Squibb where the experts agreed on the type and location of the potential substituents, here the experts diverge significantly. As discussed above, we credit the testimony of Novartis’ experts over Par’s, and find that the options of substituent and substituent position would not have been as narrow as those proposed by Par. In sum, we find that the person of ordinary skill in the art at the time the invention was made would have been faced with a large number of decision points along the lead compound analysis proposed by Par. The number of potential compounds encompassed by this decision tree is unclear, but would be far larger than the three compounds Dr. Jorgensen discusses. Only by making the “right” choice at each step would the skilled artisan arrive at everolimus, the compound of claim 10 and the basis of Par’s obviousness challenge. In light of these facts, we cannot conclude that the options faced would have been—in the words of the Federal Circuit—finite, small, or easily traversed. We, therefore, cannot conclude that the compound of claim 10, and by extension, the compounds of claims 1–3, would have been obvious to one of skill in the art as of October 1992.” slip op. at 35

  • Skill levelSkill level petitioner adoptedOther

    “Par contends, supported by the testimony of Dr. Jorgensen, that a person of ordinary skill in the art at the time of the invention would generally have a Ph.D. in organic chemistry or medicinal chemistry or physical chemistry or a related field, or a Masters or Bachelor degree in chemistry or a related field and at least three years’ experience in drug discovery and design. Pet. 16 (citing Ex. 1003 ¶ 45). Novartis’ experts, with insubstantial exceptions, agree with Dr. Jorgensen’s recitation. Ex. 2092 ¶ 22 (Klibanov); Ex. 2093 ¶¶ 47–48 (Roush). We adopt the level of skill recited by the parties for purposes of our analysis herein.” slip op. at 13

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “Based on our review of the entirety of the record, we cannot conclude, as Par contends, that the C40 hydroxyl group would be the obvious, optimal, or preferred location for substitutions to rapamycin. Dr. Jorgensen’s testimony to that effect is premised on his assertion that a person of ordinary skill in the art would have first narrowed the group of possible substitution positions to the C10, C28, or C40, because those are the hydroxyl groups of rapamycin. Ex. 1003 ¶ 142 (“person of ordinary skill in the art would have focused on hydroxyl groups on rapamycin as initial targets for modification.”). This statement, however, is based only on Dr. Jorgensen’s statement that the reactions of hydroxyl groups are “among the most fundamental and elementary reactions taught in beginning organic chemistry courses.” Id. Dr. Jorgensen provides no objective, documentary evidence that would indicate that starting with hydroxyl groups was an accepted rule followed by medicinal chemists in the field. To the contrary, Dr. Roush testifies that Dr. Jorgensen’s focus on rapamycin’s hydroxyl groups is inconsistent with the prior art as a whole, and provides multiple citations to the documentary evidence in the record supporting his testimony. Ex. 2093 ¶¶ 197, 206–216 (citing prior art modifications at the C9, C26, C27, C28, and C32 positions). For example, Ondeyka14 discloses demethylation of the methoxy group at rapamycin’s C29 position, while Caulfield15 discloses oxime substitutions at C32.16 We have weighed the testimony of Drs. Jorgensen and Roush on this point, and find Dr. Roush’s to be the more credible. While we agree with Par that a person of ordinary skill in the art would have considered rapamycin’s C40 position as a candidate for substitution, that site must be evaluated as one potential substitution site among many that were being modified in the field at the time of the invention.” slip op. at 24

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

    “obviousness challenge. In light of these facts, we cannot conclude that the options faced would have been—in the words of the Federal Circuit—finite, small, or easily traversed. We, therefore, cannot conclude that the compound of claim 10, and by extension, the compounds of claims 1–3, would have been obvious to one of skill in the art as of October 1992. With respect to the second ground of unpatentability, pertaining to the method of treatment claims 8 and 9, Par’s obviousness arguments are premised on the conclusion that everolimus would have been obvious. See Pet. 48–51 (“claims 8 and 9 would have been obvious to a person of ordinary skill in the art in view of the art that makes the 40-O-2- hydroxyethyl-rapamycin derivative obvious”). As we conclude that everolimus has not been shown to be obvious, we reach the same conclusion as to the methods of claims 8 and 9. The addition of Hughes to the ground of unpatentability does not provide any of the teachings we found lacking from the art asserted in the first ground of unpatentability. As we have concluded that Par’s articulated lead compound analysis is insufficient to establish the obviousness of any of the challenged claims, we need not reach, and do not evaluate, the objective indicia of obviousness submitted by Novartis. PO Resp. 60–68.” slip op. at 36

  Patent outcomesUS 5,665,772 not shown unpatentable
  § 103 obviousness
  Patents in suitUS 5,665,772
• Luye Pharma Group Ltd. / Luye Pharma(Usa) Ltd. et al. v. Alkermes Pharma Ireland Ltd.No claims unpatentable
  PTAB · Nov 28, 2017 · IPR2016-01096 · APJ Lora M Green · IPR · Final written decision

  Claims 1–13 and 17–23 were not shown unpatentable because Petitioner did not prove the claimed viscosity was necessarily present in either obviousness combination.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “In that regard, we note that Petitioner must “meet a high standard in order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis—the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.” PAR Pharm., Inc., 773 F.3d at 1195‒ 96.” slip op. at 17

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

    “In the Institution Decision, we determined that none of the terms in the challenged claims require express construction at that time. Dec. Inst. 6 (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (noting that only claim terms which are in controversy need to be construed, and then only to the extent necessary to resolve the controversy)); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017). Petitioner offers explicit constructions of several claim terms (Pet. 19‒22), as did Patent Owner in its Preliminary Response (Prelim. Resp. 9‒12). In its full Response, Patent Owner states that there is no need to expressly construe any of the claim terms. PO Resp. 13‒14. On the present record, we agree with Patent Owner and determine that none of the claim terms require explicit construction for purposes of this Decision.” slip op. at 7

  • Skill levelOther

    “We conclude that, for practical purposes, there is little difference between Petitioner’s and Patent Owner’s definitions of the ordinary artisan. Thus, our analysis would be the same under either Petitioner’s or Patent Owner’s definition. In addition, the level of ordinary skill in the art in this case is reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

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

    “Patent Owner argues also that objective indicia of non-obviousness, such as unexpected results and commercial success support the patentability of the challenged claims. PO Resp. 59‒61. As we conclude that the preponderance of evidence of record does not support Petitioner’s obviousness challenge, we need not address Patent Owner’s evidence of secondary indicia.” slip op. at 29

  Patent outcomesUS 6,667,061 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,667,061
• Pungkuk Edm Wire Manufacturing Company v. Seong, Ki ChulNo claims unpatentable
  PTAB · Aug 16, 2017 · IPR2016-00764 · APJ Jo-Anne M Kokoski · IPR · Final written decision

  The Board entered adverse judgment against claims 1, 3, 4, 6, and 9; Petitioner did not prove claims 2, 5, 7, 8, and 10 anticipated by Mukherjee because cracks were not shown to be necessarily …

  RulingsFinal written decision

  • Adverse judgmentAdverse judgmentGranted

    “and instead only addresses the patentability of claims 2, 5, 7, 8, and 10 of the ’036 patent over Mukherjee. See PO Resp. 2–3, 9–28. We asked Patent Owner during the hearing whether it was conceding the unpatentability of the claims that it did not address in the Patent Owner Response (i.e., claims 1, 3, 4, 6, and 9). Tr. 55:20–56:4 (“[W]e instituted on a number of grounds that you did not -- and on a number of claims that you did not address in your patent owner response. Are you conceding unpatentability of those claims on those grounds?”). Patent Owner’s counsel responded that Patent Owner was conceding the unpatentability of those claims. Id. at 55:20– 56:10 (“JUDGE KOKOSKI: You're conceding that they're [claims 1, 3, 4, 6, and 9] not patentable? MR. SUTTON: That they're not patentable, that's correct.”). The Board’s rules permit a party to “request judgment against itself at any time during a proceeding.” 37 C.F.R. § 42.73(b). The Board construes a party’s “[a]bandonment of the contest” as a request for adverse judgment. Id. § 42.73(b)(4). Accordingly, we construe Patent Owner’s concession that claims 1, 3, 4, 6, and 9 are unpatentable to be an “abandonment of the contest” and a request for adverse judgment as to those claims. Therefore, we enter adverse judgment against claims 1, 3, 4, 6, and 9 of the ’036 patent. C.” slip op. at 8

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

    “Patent Owner contends that the term “cracks,” which, for purposes of the Decision on Institution, we determined did not require an explicit construction (Dec. on Inst. 11), should be construed to be mean “narrow breaks.” PO Resp. 8–9. Petitioner did not address Patent Owner’s proposed construction in its Reply, but when asked during the hearing if it disagreed with it, Petitioner indicated that Patent Owner’s construction was “fine.” Tr. 18:3–21. Based on the record developed at trial, and in the absence of controversy about the construction of the term, we construe “cracks” to mean “narrow breaks.” B.” slip op. at 7

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable

    “Inherency requires that the claim limitation in question is necessarily present in the reference. See, e.g., Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“[A] prior art reference may anticipate without disclosing a feature of the claimed invention if that missing characteristic is necessarily present, or inherent, in the single anticipating reference.”); see also SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343–44 (Fed. Cir. 2005) (patent challenger must demonstrate “that ‘the disclosure [of the prior art] is sufficient to show that the natural result flowing from the operation as taught [in the prior art] would result in’ the claimed product.”) (citations omitted). “Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (quotation omitted). “If, however, the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient.” Cont’l Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1269 (Fed. Cir. 1991). Petitioner, therefore, must show that cracks in the alloy layer and the coating layer are necessarily present in Mukherjee.” slip op. at 10

  • ExcludeOther

    “III. PATENT OWNER’S MOTION TO EXCLUDE Patent Owner moves to exclude Exhibits 1014–1017, 1019, and 1020. Paper 59. We do not consider the merits of Patent Owner’s Motion to Exclude because, as explained above, even if the disputed evidence is considered, Petitioner has not shown by a preponderance of the evidence that claims 2, 5, 7, 8, and 10 of the ’036 patent are unpatentable as anticipated by Mukherjee. Accordingly, we dismiss Patent Owner’s Motion to Exclude as moot.” slip op. at 16

  Patent outcomesUS 6,492,036 not shown unpatentable
  Claim construction§ 102 anticipation
  Patents in suitUS 6,492,036
• Pungkuk Wire Manufacturing Company v. Seong, Ki ChulNo claims unpatentable
  PTAB · Aug 16, 2017 · IPR2016-00763 · APJ Kristina M Kalan · IPR · Final written decision

  Petitioner did not prove claims 1–4, 6, 9–11, and 14–18 unpatentable as anticipated by Mukherjee because cracks in both required layers were not shown to be inevitable.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “A reference inherently discloses an element of a claim “if that missing characteristic is necessarily present, or inherent, in the single anticipating reference.” Schering Corp. v. Geneva Pharms., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (citation omitted) (emphasis added). “Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1325, 1332 (Fed. Cir. 2010) (citing Cont’l Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1269 (Fed. Cir. 1991)). “If, however, the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient.” Cont’l Can, 948 F.2d at 1269 (emphasis added). Thus, the question we must answer to determine the inherency of a claim limitation in the prior art is whether the disclosure of the prior art shows that the limitation necessarily would result from following the express disclosure of the prior art, as opposed to showing that the limitation only might result from following the express disclosure of the prior art. Here, Petitioner has not directed us to sufficient evidence of record for us to find that this question should be answered affirmatively.” slip op. at 7

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable

    “A reference inherently discloses an element of a claim “if that missing characteristic is necessarily present, or inherent, in the single anticipating reference.” Schering Corp. v. Geneva Pharms., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (citation omitted) (emphasis added). “Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1325, 1332 (Fed. Cir. 2010) (citing Cont’l Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1269 (Fed. Cir. 1991)). “If, however, the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient.” Cont’l Can, 948 F.2d at 1269 (emphasis added). Thus, the question we must answer to determine the inherency of a claim limitation in the prior art is whether the disclosure of the prior art shows that the limitation necessarily would result from following the express disclosure of the prior art, as opposed to showing that the limitation only might result from following the express disclosure of the prior art. Here, Petitioner has not directed us to sufficient evidence of record for us to find that this question should be answered affirmatively.” slip op. at 7

  • Expert testimonyPetitioner expert discountedOther

    “Neither is Dr. Misiolek’s testimony sufficient to support a finding that the Mukherjee process necessarily creates cracks in the alloy layer or in the coating layer. In his initial declaration, Dr. Misiolek states that “[t]he wire drawing process disclosed by Mukherjee would crack the outside beta and gamma brass alloy layer and the outer zinc layer of the coated wire.” Ex. 1008 ¶ 8 (emphasis added). As support for this statement, Dr. Misiolek testifies that “beta brass, gamma brass, and zinc each have a lower ductility compared to alpha brass and these layers are exposed to the highest strain.” Id. Dr. Misiolek does not sufficiently explain, however, why the lower ductility of beta brass, gamma brass, and zinc means that the alloy layer and the coating layer necessarily would crack as a result of the Mukherjee drawing process. The presence of a relatively brittle alloy layer and zinc layer, and the application of a relatively large amount of strain to those layers, seem to make the formation of cracks more likely, but it is not clear from Dr. Misiolek’s testimony why the presence of such circumstances makes the formation of cracks completely certain. The testimony in Dr. Misiolek’s third declaration does not make the reasoning any more clear. Ex. 1019 ¶ 9 (testifying that “the drawing process in column 6 of Mukherjee would cause cracks to form on the surface of the wire” without explaining why). Thus, Dr. Misiolek’s testimony is conclusory and entitled to little weight. 37 C.F.R. § 42.65(a). Moreover, there is evidence of record that, in any given wire drawing process, “whether cracks actually occur depends on multiple factors, including . . . the temperature used during the [drawing] process, and . . . the speed of the drawing.” Ex. 2002 ¶ 14. Dr. Misiolek does not dispute this testimony, and Petitioner does not direct us to any evidence to the contrary. Ex. 1019 ¶¶ 14–18; Reply 16–28. Mukherjee does not disclose either the speed of its wire drawing process or the temperature at which that process takes place. Ex. 1002, 6:58–65. Accordingly, there is insufficient evidence of record to find that wires produced using the Mukherjee process always and inevitably must have cracks in the alloy layer and in the coating layer.” slip op. at 10

  • ExcludeMotion to exclude, deniedDenied

    “Patent Owner’s Motion to Exclude Patent Owner moves to exclude Exhibits 1020, 1021, 1022, 1023, 1025, and 1026. Paper 63. We do not consider the merits of Patent Owner’s Motion to Exclude because, as explained above, even if the disputed evidence is considered, Petitioner has not shown by a preponderance of the evidence that claims 1–4, 6, 9–11, and 14–18 of the ’523 patent are unpatentable as anticipated by Mukherjee. Accordingly, Patent Owner’s Motion to Exclude is dismissed as moot. CONCLUSION For the reasons given, we are not persuaded that Petitioner has shown by a preponderance of the evidence that claims 1–4, 6, 9–11, and 14–18 of the ’523 patent are anticipated by Mukherjee. In addition, Patent Owner’s Motion to Exclude is dismissed as moot.” slip op. at 13

  Patent outcomesUS 6,306,523 not shown unpatentable
  § 102 anticipation
  Patents in suitUS 6,306,523
• Pungkuk Wire Manufacturing Company v. Seong, Ki ChulNo claims unpatentable
  PTAB · Aug 16, 2017 · IPR2016-00762 · APJ Christopher M Kaiser · IPR · Final written decision

  Claims 1–5 were not shown unpatentable because Mukherjee did not necessarily disclose a crack structure on the alloy layer.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable

    “Cir. 2003) (citation omitted) (emphasis added). “Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1325, 1332 (Fed. Cir. 2010) (citing Cont’l Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1269 (Fed. Cir. 1991)). “If, however, the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient.” Cont’l Can, 948 F.2d at 1269 (emphasis added). Thus, the question we must answer to determine the inherency of a claim limitation in the prior art is whether the disclosure of the prior art shows that the limitation necessarily would result from following the express disclosure of the prior art, as opposed to showing that the limitation only might result from following the express disclosure of the prior art. Here, Petitioner has not directed us to sufficient evidence of record for us to find that this question should be answered affirmatively.” slip op. at 7

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Dr. Misiolek’s testimony also is not sufficient to support a finding that the Mukherjee process necessarily creates a crack structure in the surface of the alloy layer. In his initial declaration, Dr. Misiolek states that “[t]he wire drawing process disclosed by Mukherjee would crack the outside beta and gamma brass alloy layer.” Ex. 1008 ¶ 8 (emphasis added). As support for this statement, Dr. Misiolek testifies that “beta brass, gamma brass, and zinc each have a lower ductility compared to alpha brass and these layers are exposed to the highest strain.” Id. Dr. Misiolek does not explain why the first statement necessarily follows from the second. The presence of a relatively brittle alloy layer and the application of a relatively large amount of strain to that layer seem to make the formation of cracks more likely, but it is not clear from Dr. Misiolek’s testimony why the presence of such circumstances makes the formation of cracks completely certain. The testimony in Dr. Misiolek’s second declaration does not make the reasoning any more clear. Ex. 1013 ¶ 9 (testifying that “the drawing process in column 6 of Mukherjee would cause cracks to form” without explaining why). Thus, Dr. Misiolek’s testimony is conclusory and entitled to little weight. 37 C.F.R. § 42.65(a). Moreover, there is evidence of record that “whether cracks actually occur [in any given wire drawing process] depends on multiple factors, including . . . the temperature used during the [drawing] process, and . . . the speed of the drawing.” Ex. 2003 ¶ 14. Dr. Misiolek does not dispute this testimony, and Petitioner does not direct us to any evidence to the contrary. Ex. 1013 ¶¶ 14–18; Reply 12–22. Mukherjee does not disclose either the speed of its wire drawing process or the temperature at which that process takes place. Ex. 1002, 6:58–65. Accordingly, there is insufficient evidence of record to find that wires produced using the Mukherjee process always and inevitably must have a crack structure on the surface of their alloy layers. Therefore, we cannot find that Mukherjee anticipates claim 1 of the ’535 patent.” slip op. at 10

  • ExcludeMotion to exclude, deniedDenied

    “1019, and 1020. Paper 48. We do not consider the merits of Patent Owner’s Motion to Exclude because, as explained above, even if the disputed evidence is considered, Petitioner has not shown by a preponderance of the evidence that claims 1–5 of the ’535 patent are unpatentable as anticipated by Mukherjee. Accordingly, Patent Owner’s Motion to Exclude is dismissed as moot.” slip op. at 11

  Patent outcomesUS 6,482,535 not shown unpatentable
  § 102 anticipation
  Patents in suitUS 6,482,535
• Lupin Limited v. Vertex Pharmaceuticals IncorporatedNo claims unpatentable
  PTAB · Jul 28, 2017 · IPR2016-00558 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 2, 3, and 10–12 were not shown unpatentable because the evidence did not establish a reasonable expectation of success, and unexpected results supported patentability.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “Petitioner bears the burden of proving unpatentability of the challenged claims, and the burden of persuasion never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner must establish the facts supporting its challenge by a preponderance of the evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). Below, we explain why Petitioner has failed to meet its burden with respect to the challenged claims.” slip op. at 6

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

    “As discussed above, Grobelny teaches that the inclusion of a solubilizing group to a protease inhibitor compound having low water solubility for the purposes of improving water solubility and bioavailability of those compounds. Ex. 1022, 74:1116. In this regard, Grobelny provides general guidance for using a solubilizing agent phosphate ester salt to solve the solubility problem of amprenavir. However, the success of discovering fosamprenavir was not discovering a compound with improved solubility. Rather, the success was finding a compound that had the requisite bioavailability to treat HIV and minimize the development of drug-resistance mutations in patients.6 The evidence of record does not support a finding that a person of ordinary skill in the art would have had a reasonable expectation of success in developing fosamprenavir, a protease inhibitor prodrug having the same or improved bioavailability as its parent drug.” slip op. at 16

  • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia with nexusDecided for patent owner

    “b. Unexpected Results We further conclude that Patent Owner has demonstrated evidence of unexpected results regarding fosamprenavir’s improved resistance profile, pharmacokinetics, and side effect profile, which weighs in favor of patentability.” slip op. at 22

  • ExcludeMotion to exclude, deniedNot reached

    “PATENT OWNER’S MOTION TO EXCLUDE Patent Owner seeks to exclude Ex. 1093. Paper 27, 1–6. Because we do not rely on Ex. 1093 to reach the final decision, we dismiss the Patent Owner’s motion to exclude as moot. IV.” slip op. at 26

  Patent outcomesUS 6,436,989 not shown unpatentable
  § 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,436,989
• Mylan Pharmaceuticals Inc. / Mylan Laboratories Limited v. Ucb Pharma GmbHNo claims unpatentable
  PTAB · Jul 19, 2017 · IPR2016-00517 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 3, 4, and 6–8 were held not unpatentable because Petitioner did not prove either obviousness ground by a preponderance of the evidence.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “For the purpose of this decision, we accept Petitioner’s undisputed contention that: [a] person of ordinary skill in the art would have a Ph.D. in chemistry, medicinal chemistry, pharmacology, or a related field, and at least one year of industrial exposure to drug discovery, drug design, and synthesis. In lieu of an advanced degree, the individual may have additional years of industry experience, including, for example, in drug discovery, drug synthesis, and structure-activity work. Pet. 6 (citing Ex. 1003 ¶ 20); see Prelim. Resp. 9; PO Resp. 6. Based on our review of the ’772 patent, the types of problems and solutions described in the ’772 patent and cited prior art, we adopt Petitioner’s definition of a person of ordinary skill in the art at the time of the claimed invention. We note that the applied prior art also reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

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

    “the broadest reasonable construction in light of the specification of the patent in which they appear. See Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard); 37 C.F.R. § 42.100(b). Under that standard, and absent any special definitions, we give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only those terms which are in controversy need to be construed, and only to the extent necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Petitioner submits that the “claims in the ʼ772 patent are presumed to take on their ordinary and customary meaning based on the broadest reasonable interpretation of the claim language.” Pet. 6. Patent Owner “does not dispute Petitioner’s position that no claim terms require construction, which the Board also accepted for purposes of institution.” PO Resp. 7 (citing Pet. 6; Inst. Dec. 7). In our Decision on Institution, we determined that “for purposes of this Decision, none of the terms in the challenged claims require express construction at this time.” Inst. Dec. 7. As in the Decision on Institution, we apply the broadest reasonable interpretation standard here, and see no reason to construe explicitly any claim term. B. Principles of Law” slip op. at 8

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

    “Petitioner, however, fails to point to any evidence that 5-HMT is metabolized through the CYP2D6 pathway, or that administering 5-HMT would have resulted in the same risks of drug interaction and adverse effects that Petitioner contends are the result of administering tolterodine. See Pet. 22–24 (describing alleged problems associated with tolterodine, not 5 HMT); Ex. 1003 ¶¶ 95–100 (Dr. Patterson’s testimony regarding the drawbacks of tolterodine). Indeed, such an argument appears to undermine Petitioner’s position, discussed in Section III.D.1 supra, that one of ordinary skill in the art would have selected 5-HMT as a lead compound over tolterodine to avoid the CYP2D6 metabolic pathway, and Dr. Patterson’s testimony that the prior art collectively “indicated to a skilled drug designer interested in overactive bladder treatment that 5-HMT would avoid the issues associated with dosing [] tolterodine.” Ex. 1003 ¶ 101. Petitioner’s argument also is contradicted by Dr. Patterson’s testimony that “5-HMT is not metabolized by both CYP2D6 and CYP3A4, but only by CYP3A4.” Id. ¶ 111; see also Ex. 1010, 289 (Postlind indicating that 5-HMT is not a CYP2D6 substrate).” slip op. at 25

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “Following our weighing of the experts’ testimony, we find that Dr. Roush’s testimony better addresses the issue at hand and we credit that testimony over Dr. Patterson’s testimony. Dr. Patterson opines generally that the “presence of two hydroxyl groups around the left most aromatic ring (shown above in blue) would have created a product likely to have decreased oral bioavailability compared to tolterodine because of its hydrophilicity and thus lower than acceptable lipophilicity” (Ex. 1003 ¶ 112), and that it “would [have been] a matter of routine experimentation” to confirm that 5-HMT could have significantly less bioavailability than its parent, tolterodine” (Ex. 1003 ¶ 115). Dr. Patterson, however, did not perform any experiments to confirm 5-HMT’s oral bioavailability, and cites to no further evidence to support his opinions. See Ex. 2022 ¶ 92; compare Brynne (Ex.1011) discussed supra § III.C.2. Dr. Roush, on the other hand, conducts an analysis of the compound under the “Rule of 5” to determine that “5-HMT does not meet a single factor, much less two, of the rule” thus teaching the skilled artisan “away from concluding that 5-HMT had an oral absorption problem.” PO Resp. 26– 27 (citing Ex. 2022 ¶¶ 56–58, 87, 92). At oral hearing, Patent Owner restated that the analysis under the Rule of 5 indicates that 5-HMT was “not even close to being a problem . . . for all four of these properties, 5-HMT says there’s no red flags; there’s no problem,” and that “Dr. Patterson admitted in his deposition, 5-HMT does not violate the Rule of Five.” Tr. 67:35–68:3; 68:17–21; see Ex. 2020 180:14–181:14.” slip op. at 31

  Patent outcomesUS 7,985,772 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,985,772

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.