• CQV Co., Ltd. v. Merck Patent GmbHNo claims unpatentable
  PTAB · Oct 14, 2025 · PGR2021-00054 · APJ Kristina M Kalan · PGR · Remand

  Claims 1–22 were not shown unpatentable because Sample C was not proven publicly available as prior art, and the original decision found the remaining grounds insufficient.

  RulingsRemand decision

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable

    “We agree with Patent Owner that Petitioner’s evidence in Kuntz (Ex. 1026), the Annual Report (Ex. 1028), Masuko (Ex. 1029), and Pfaff (Ex. 1034) is insufficient to show that Xirallic® Sample C was available to the public before the effective filing date of the ’861 patent. Petitioner has not asserted, nor do we find, that any of these documents refer to or describe the lot of Xirallic® from which Sample C was taken. See Final Dec. 26. Kuntz, the Annual Report, Masuko, and Pfaff may support a finding that the Xirallic® line of products was available to the public, but these documents do not support a finding that the lot of Xirallic® from which Sample C was taken was available to the public. We also agree with Patent Owner that the Technical Data Sheets (Exs. 1005–1010), Certificates of Analysis (Exs. 1011–1017), and Material Safety Data Sheet (Ex. 1025) are insufficient to show that Xirallic® Sample C was available to the public. Petitioner has not asserted, nor do we find, that any of these documents refer to or describe the lot of Xirallic® from which Sample C was taken. See Final Dec. 26–27. Regardless of how the Technical Data Sheets were used in the Opposition against the European counterpart of the ’861 patent (Exs. 1040, 1041) and during the prosecution of the application from which the ’861 patent issued (Ex. 1003, 102–104), the Technical Data Sheets do not refer to or describe the lot of Xirallic® from which Sample C was taken. Moreover, as noted by Patent Owner, the Technical Data Sheets (Exs. 1005–1010) indicate that they are “preliminary” and Petitioner has not provided any evidence that the Technical Data Sheets were ever issued to the public, as opposed to just issued internally. See PO Resp. 18–19. We also find persuasive Patent Owner’s argument that the Technical Data Sheets are preliminary because other, later-dated technical data sheets (Exs. 2012, 2013) lack the “preliminary” label and list characteristics that are different from those in Exhibits 1005–1010. See PO Resp. 19 (comparing, e.g., Ex. 1009 and Ex. 2013; Ex. 1005 and Ex. 2012). The Technical Data Sheets may support a finding that the Xirallic® products they describe existed as of the dates on the documents, but they do not support a finding that the lot of Xirallic® from which Sample C was taken was available to the public.” slip op. at 20

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedOther

    “witnesses. See Elbit Systems of Am., LLC v. Thales Visionix, Inc., 881 F.3d 1354, 1358 (Fed. Cir. 2018) (citing Trs. of Columbia Univ. v. Illumina, Inc., 620 F. App’x 916, 922 (Fed. Cir. 2015); Inwood Labs., Inc. v. Ives Labs., Inc., 456 U.S. 844, 856 (1982)). We have reviewed the witness testimony in the record and, more particularly, Mr. Choi’s deposition answers regarding Petitioner’s purchase of the lot of Xirallic® from which Sample C came. We find that Mr. Choi’s responses cast doubt on the credibility of his declaration testimony, namely with regard to the public availability of Sample C. Mr. Choi represented that he was involved in the purchase of the lot of Xirallic® from which Sample C was taken. Ex. 2011, 48:1–23. Mr. Choi stated that he instructed Petitioner’s marketing team manager to buy the sample from a distributor of Patent Owner’s products located in Europe. Id. at 48:24–49:4. Mr. Choi stated that he has evidence of the transaction, but refused to reveal the name of the company from which Petitioner purportedly purchased the lot of Xirallic® (id. at 49:5–50:3) and refused to produce an email in his possession that would corroborate his testimony regarding Petitioner’s acquisition of the product (id. at 50:8–16, 51:10–23). Mr. Choi represented that he does not remember how much Petitioner paid for Sample B. Id. at 56:4–5. Mr. Choi admitted that the entity from which Petitioner acquired the lot of Xirallic® from which Sample C was taken is “not currently a Merck distributor” (Ex. 2011, 50:4–7) and was not “a Merck distributor at the time” that “samples B and C were purchased” (id. at 51:25–52:2). According to Mr. Choi, the company is a “former distributor” of Patent Owner’s products. Id. at 52:3–6. Mr. Choi did not know, according to his testimony, when that unnamed entity first obtained the lot of Xirallic® (id. at 52:7–10) and he stated that he did not have personal knowledge of how the entity obtained the lot of Xirallic® (id. at 52:12–19). Instead, Mr. Choi assumed the entity was “able to obtain the sample through the routine course or process” the entity uses “to take samples or get samples.” Id. at 52:12–19. Mr. Choi believed the sample of Xirallic® from which Sample C was taken was sealed when Petitioner received it because samples from dealers are sealed, and he remembered observing that the package was from a dealer. Id. at 52:24– 54:25. However, Mr. Choi admitted that he did not obtain a technical data sheet or certificate of analysis for the lot of Xirallic® from which Samples B and C were taken. Id. at 59:6–11. Mr. Choi also answered questions regarding Petitioner’s purchase of Samples D and H. Ex. 2011, 62:20–66:8, 67:7–9, 73:12–13, 73:17–22. Similar to his testimony regarding Samples B and C, Mr. Choi admitted withholding an email regarding the purchase of the lot of Xirallic® from which Sample D was taken. Id. at 62:20–63:9. Mr. Choi also admitted that he did not know how Akzo USA or Axalta obtained the Xirallic® the companies sold to him, and admitted that Akzo USA was not a distributor of Patent Owner’s products at the time Petitioner purchased the product. Id. at 63:10–66:8, 73:17–22. Mr. Choi also admitted that Petitioner did not pay Akzo USA for the lot of Xirallic® from which Sample D was taken, and did not pay Axalta for the lot of Xirallic® from which Sample H was taken. Id. at 67:7–9, 73:12–13. Although Petitioner presents declaration testimony from Mr. Choi representing that he purchased the lot of Xirallic® from which Samples B and C were taken in October 2011 (Ex. 1004 ¶ 16), Mr. Choi’s declaration testimony lacks corroborating evidence, and his deposition testimony does not support that the product was available to the public, as we found in our Final Written Decision. See Final Dec. 27–28. Notably, Petitioner produced corroborating evidence for Mr. Choi’s acquisition of Samples A, H, and I. See Ex. 1004 ¶¶ 13 (citing Ex. 1047), 18 (citing Exs. 1024, 1025). However, Mr. Choi withheld similar evidence for the Xirallic® lots from which Samples B, C, and D were taken. See Ex. 2011, 50:8–16, 51:10–23, 62:20– 63:9; Final Dec. 28. As Patent Owner argues, there is “no information to determine when a contract was established, that there was consideration for the exchange, that the product was available to be delivered when the alleged transaction took place, or even when the product was delivered. Choi has no memory of what was paid for the product.” Sur-Reply 24–25; see also PO Resp. 13–14; PO Br. Rem. 2–4.” slip op. at 34

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

    “Based on the evidence discussed above, we are not persuaded that Petitioner has shown by a preponderance of the evidence that Sample C was available to the public. Regardless of whether a company avoids wasting shelf life of its products (Ex. 1004 ¶¶ 15–16), there is no persuasive evidence in the record showing that the lot of Xirallic® from which Sample C was taken was released from quality control and then made available to the public by Patent Owner. Mr. Choi’s testimony shows that Petitioner obtained the lot of Xirallic® from which Sample C was taken in an atypical manner (i.e., not from Patent Owner or one of Patent Owner’s current distributors) (Ex. 2011, 49:5–50:7, 50:8–16, 51:10–23, 51:25–52:6, 52:12– 19), and there is no evidence in the record to show that the lot of Xirallic® was intended for sale, rather than for experimental use only or for some other restricted use. Accordingly, we determine Petitioner has not demonstrated by a preponderance of the evidence that Sample C qualifies as prior art against the ’861 patent, and we determine that Petitioner has not shown by a preponderance of the evidence that the ’861 patent is unpatentable over the grounds relying on Sample C.” slip op. at 38

  Patent outcomesUS 10,647,861 not shown unpatentable
  § 102 anticipation§ 103 obviousness
  Patents in suitUS 10,647,861
• Fujifilm Corporation v. Sony CorporationNo claims unpatentable
  PTAB · Dec 3, 2018 · IPR2017-01390 · APJ Jeffrey W Abraham · IPR · Final written decision

  The Board held that claims 1–18 were not shown unpatentable because the prior art did not establish the claimed volume concentration in the formed magnetic layer.

  RulingsFinal written decision

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

    “define the term “volume concentration.” In the context of the ’331 patent, “volume concentration” refers to the volume concentration of the magnetic particles in the formed magnetic layer.” slip op. at 13

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “(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 materials science, physics, electrical engineering, mechanical engineering, chemistry, 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. 12; Ex. 1017 ¶ 60. Although Patent Owner does not expressly define the appropriate level of skill in the art in the Patent Owner Response or its Supplemental Response, Patent Owner’s declarant, Dr. Bain, presents a definition of a person of ordinary skill in the art in his declaration that is nearly identical to Petitioner’s definition. Ex. 2001 ¶ 44. In view of this, for purposes of this Decision, we adopt Petitioner’s definition of a person of ordinary skill in the art.” slip op. at 16

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

    “information, is not sufficient evidence to establish that Mori discloses the “volume concentration” recited in claim 1. Patent Owner does not dispute that there is some magnetic alloy present “in the magnetic layer” of Mori. The relevant question, however, is how much and how Mori’s disclosed values were determined. Unlike the term “volume concentration,” for which the parties offered undisputed evidence regarding accepted meanings of the term in the art (i.e., packing fraction and pigment volume concentration), we have not been directed to similar evidence regarding the phrase “fill rate”/“filling rate” in Mori. Thus, although Mori states “[t]he filling rate by volume of the strongly magnetic alloy powder in the magnetic layer can be equal to or higher than 30%” (Ex. 1003 ¶ 11 (emphasis added)), Petitioner has not offered sufficient evidence demonstrating that the term “filling rate” in Mori refers to a final product-based value. As a result, we find that this language in Mori does not establish, by a preponderance of evidence, that Mori discloses the “volume concentration” recited in claim 1.” slip op. at 21

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

    “For all of the foregoing reasons, we find that Petitioner has failed to demonstrate, by a preponderance of evidence, that the combined teachings of Aonuma and Mori disclose or suggest “[a] dual layer magnetic recording medium comprising . . . a magnetic upper recording layer formed over [a] lower support layer, the magnetic upper recording layer comprising a volume concentration of at least about 35% of a primary magnetic particulate pigment,” as recited in independent claims 1 and 16. Ex. 1001, 11:14–20, 12:25–31. Claims 2–15, 17, and 18 depend from claim 1 or claim 16, and, therefore, include the “volume concentration” limitation of claims 1 and 16. As a result, we find that Petitioner has failed to demonstrate that Aonuma and Mori disclose or suggest each limitation of claims 1–18, and, therefore, has not demonstrated by a preponderance of evidence that claims 1–18 are unpatentable as obvious over Aonuma and Mori.” slip op. at 26

  Patent outcomesUS 7,115,331 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 7,115,331
• Green Cross Corporation v. Shire Human Genetic Therapies, Inc.No claims unpatentable
  PTAB · Mar 22, 2017 · IPR2016-00258 · APJ Robert A Pollock · IPR · Final written decision

  The Board held claims 1–3, 16, and 17 not shown unpatentable under § 103 because Jin was not prior art.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference not prior artDecided for patent owner

    “are unpatentable, which includes the burden of establishing that any reference upon which it relies constitutes prior art under 35 U.S.C. § 102. 35 U.S.C. § 316(e); see Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1576 (Fed. Cir. 1996) (holding that the challenger “bore the burden of persuasion . . . on all issues relating to the status of [the asserted reference] as prior art”). However, because Petitioner offered Jin into evidence, which qualifies on its face as prior art under §102(e), Patent Owner bears the burden of producing evidence supporting a date of invention prior to the critical date of Jin. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378–80 (Fed. Cir. 2015). As discussed below, Patent Owner elected to antedate, and thereby remove, Jin as prior art by showing that the inventor actually reduced the claimed invention to practice prior to Jin’s 102(e) priority date(s). As a result, the burden of production returned to Petitioner to demonstrate that the invention set forth in the challenged claims was not actually reduced to practice as of the date alleged. Id. at 1380. In order to establish an inventor’s actual reduction to practice, Patent Owner must show: (1) construction of an embodiment meeting all limitations of the challenged claims; (2) that the invention would work for its intended purpose, and (3) sufficient evidence to corroborate the inventor’s testimony. Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1169 (Fed. Cir. 2006). “Sufficiency of corroboration is determined by using a ‘rule of reason’ analysis, under which all pertinent evidence is examined when determining the credibility of an inventor's testimony.” Id. at 1170 (citation omitted). “[I]t is not[, however,] necessary to produce an actual over-the-shoulder observer. Rather, sufficient circumstantial evidence of an independent nature can satisfy the corroboration requirement. Furthermore, an actual reduction to practice does not require corroboration for every factual issue contested by the parties.” Cooper v. Goldfarb, 154 F.3d 1321, 1330 (Fed. Cir. 1998) (internal citations omitted). “[E]ach corroboration case must be decided on its own facts with a view to deciding whether the evidence as a whole is persuasive.” Id. at 1331 (citation omitted),” slip op. at 11

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

    “provided sufficient evidence to show that it reduced to practice an embodiment encompassing all elements of the challenged claims prior to the critical date of Jin, and Petitioner does not convince us otherwise. Accordingly, we find that Jin is not § 102(e) prior art, as Petitioner contends. Because Petitioner’s ground for challenging the ’556 Patent as obvious depends on Jin, we conclude that Petitioner has not proven by a preponderance of the evidence that the challenged claims are unpatentable. F.” slip op. at 24

  • ExcludeMotion to exclude, deniedDenied

    “Motions i. Patent Owners Motion to Exclude Evidence (Paper 74) Patent Owner moves to exclude Exhibits 1035, 1036, 1037, 1038, 1039, 1400, 1049, and 1051, each of which relates to Petitioner’s obviousness case. As discussed above, Petitioner has failed to satisfy the threshold issue of demonstrating that Jin, the primary reference relied upon in its obviousness ground, is prior art to the ’556 Patent. Accordingly, we do not address the substance of Petitioner’s obviousness arguments and, thus, do not rely on the challenged exhibits in our analysis. Accordingly, we deny Patent Owner’s Motion as moot. ii. Petitioner’s Motion to Exclude Evidence (Paper 75) Petitioner moves to exclude Exhibit 2207 (“Webb Exhibit 4”) which is purportedly an unredacted version of the TKT report (Exhibit 2115). See Paper 81, 1. As we have no need to rely on the challenged exhibit or associated testimony in our analysis, Petitioner’s motion is denied as moot.” slip op. at 24

  • PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Denied

    “iii. Petitioner’s Request for Expungement of Papers 71 and 72 In its Response to Patent Owner’s Motions for Observations Regarding Cross-Examination of Drs. Carbonell and Webb, Petitioner requests that we expunge, or accord no weight to, Patent Owner’s Motions for Observations because Patent Owner “made no effort to faithfully quote any testimony, and its ‘observations,’ which are often crammed with multiple citations, improperly narrate and mischaracterize the testimony cited, are rife with legal argument, and include references to unauthorized exhibits.” Paper 80, 1–3 (footnotes omitted); Paper 82, 1–3 (same). Although we are not convinced that Patent Owner “color[s] so far outside the lines” as Petitioner contends, we do not rely in our analysis on Patent Owner’s Motions for Observations. Accordingly, Petitioner’s request is denied as moot.” slip op. at 25

  Patent outcomesUS 9,051,556 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 9,051,556
• Coalition For Affordable Drugs (Adroca) LLC v. Acorda Therapeutics, Inc.No claims unpatentable
  PTAB · Mar 9, 2017 · IPR2015-01853 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–52 of the ’703, claims 1–3, 5–8, and 10–41 of the ’826, claims 1–8 of the ’685, and claims 1–40 of the ’437 were not shown unpatentable under § 103.

  RulingsFinal written decision

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

    “Petitioner asserts constructions for the following claim terms, “less than 15 milligrams,” “release profile,” “matrix,” “improving walking,” and “initiating treatment.” Pet. 18–19. Patent Owner contends that Petitioner has failed to provide an explanation as to why the identified claim terms require construction and why the Board should depart from the plain and ordinary meaning of the terms. Prelim. Resp. 17, n.4. In the Institution Decision, we agreed with Patent Owner and determined that it was unnecessary to construe explicitly the claim terms for purposes of the Institution Decision. See Dec. Instit. 6 (citing Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). We also determine here that we need not construe expressly any claim term in order to issue a Final Written Decision regarding the patentability of the challenged claims.” slip op. at 7

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “1. Level of Skill Petitioner’s declarants, Drs. Pleasure and Polli, testify that a person of ordinary skill in connection with the ’703 patent would have had an M.D. or Ph.D. in neuroscience or a related field with an understanding of pharmacokinetics and at least some experience in providing drug therapy to MS patients. Ex. 1023 ¶ 16, Ex. 1044 ¶ 13. Additionally, Drs. Pleasure and Polli testify that a person of ordinary skill in the art would have had access to a person having an advanced degree in pharmaceutics or pharmaceutical formulation, specifically oral sustained release formulations, or at least five years of experience in formulating sustained oral release drug products and may work as part of a multi-disciplinary team. Ex. 1023 ¶¶ 16–17; Ex. 1044 ¶¶ 13–14. Patent Owner does not dispute this recitation of the level of ordinary skill in the art. See Ex. 2042 ¶ 68 n.5. We adopt the level of ordinary skill in the art identified by Drs. Pleasure and Polli as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating level of ordinary skill in the art may be reflected by the prior art of record); In re GPAC Inc., 14 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 14

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

    “In order for claims of the ’703 patent to be entitled to benefit of the filing date of the Provisional, the Provisional must provide written description support for those claims. See 35 U.S.C. § 120. To satisfy the written description requirement of 35 U.S.C. § 112, first paragraph, and provide support for the challenged claims of the ’703 patent under 35 U.S.C. § 120, the Provisional must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See In re Wertheim, 541 F.2d 257, 261, 262 (CCPA 1976); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563– 64 (Fed. Cir. 1991). The primary consideration in determining whether appropriate written description support exists “is factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure.” Union Oil Co. of Cal. v. Atlantic Richfield Co., 208 F.3d 989, 996 (Fed. Cir. 2000).” slip op. at 27

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

    “We are persuaded by Dr. Hayes’ testimony as confirmed by testimony from Drs. Pleasure and Polli, and conclude that the Provisional supports the CavSS ranges in claims 14–15 and 35–36. Dr. Hayes offers credible 34 testimony concerning how one of skill in the art would interpret Table 7 of the Provisional, which depicts essentially the same data as Table 3 of Hayes. See Ex. 2041 ¶ 17. Dr. Hayes interpretation of the data in Table 7 is supported by testimony from Drs. Pleasure and Polli that about two thirds of the measured data fall within one standard deviation and approximately 95 percent of measured values are within two standard deviations from the mean. Id. at 20–22 (citing deposition testimony from Drs. Pleasure and Polli confirming such an understanding). We agree with Dr. Hayes that “[i]n light of the fact that a POSA would immediately recognize that Table 7 of the ’894 Provisional (Ex. 1007-00045) shows possession of measured data beyond even two standard deviations from its reported mean values, a more complete view of the information reported in Table 7 would consider data dispersed beyond two standard deviations from the mean” to encompass a CavSS range from 3.7–37.8 ng/ml. Ex. 2041 ¶ 23. We are not persuaded by Dr. Fairweather’s testimony that Table 7 supports a CavSS of only 15.1 ng/ml to 26.5 ng.ml. See Ex. 1066 ¶ 21. Dr. Fairweather was asked if he could identify where “range” is defined as plus or minus one standard deviation, and he replied that he could not identify where he found such a definition, Ex. 2176, 44:13–22, but Dr. Fairweather confirmed such a definition is not how he would define “range” in his usual practice, Id. at 92:20–93:21. See also id. at 108:5–11 (conceding there may not be any document that defines “range” as one 35 standard deviation from the mean). When asked whether he could justify the range that he provided for CavSS in his declaration, Dr. Fairweather stated that he could not. Id. at 104:25–105:2. He testified that he conceded the smallest range so as to avoid a discussion of what’s the proper definition for range. Id. at 104:16–20. Dr. Fairweather stated twice that he was not a person of skill in the art and would not be able to answer what assumptions such a person would make when reviewing Table 7 of the Provisional. Id. 136:16–23, 138:14–139:7. Finally, Dr. Fairweather also testified that he could not rule out whether the CavSS data for the 10 mg b.i.d. dose described in Table 7 of the Provisional had a range of at least 15 to 35 ng/ml. Id. at 90:9–92:19. In light of these statements, we do not credit Dr. Fairweather’s testimony.” slip op. at 34

  Patent outcomesUS 8,007,826 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,007,826
• Coalition For Affordable Drugs (Adroca) LLC v. Acorda Therapeutics, Inc.No claims unpatentable
  PTAB · Mar 9, 2017 · IPR2015-01850 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–52 of the ’703 patent were not shown unpatentable because S-1 was not prior art under § 102(a) or (b), defeating each instituted § 103 ground.

  RulingsFinal written decision

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

    “Petitioner asserts constructions for the following claim terms, “less than 15 milligrams,” “release profile,” “matrix,” “improving walking,” and “initiating treatment.” Pet. 18–19. Patent Owner contends that Petitioner has failed to provide an explanation as to why the identified claim terms require construction and why the Board should depart from the plain and ordinary meaning of the terms. Prelim. Resp. 17, n.4. In the Institution Decision, we agreed with Patent Owner and determined that it was unnecessary to construe explicitly the claim terms for purposes of the Institution Decision. See Dec. Instit. 6 (citing Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). We also determine here that we need not construe expressly any claim term in order to issue a Final Written Decision regarding the patentability of the challenged claims.” slip op. at 7

  • Skill levelSkill level petitioner adoptedDecided for patent owner

    “1. Level of Skill Petitioner’s declarants, Drs. Pleasure and Polli, testify that a person of ordinary skill in connection with the ’703 patent would have had an M.D. or Ph.D. in neuroscience or a related field with an understanding of pharmacokinetics and at least some experience in providing drug therapy to MS patients. Ex. 1023 ¶ 16, Ex. 1044 ¶ 13. Additionally, Drs. Pleasure and Polli testify that a person of ordinary skill in the art would have had access to a person having an advanced degree in pharmaceutics or pharmaceutical formulation, specifically oral sustained release formulations, or at least five years of experience in formulating sustained oral release drug products and may work as part of a multi-disciplinary team. Ex. 1023 ¶¶ 16–17; Ex. 1044 ¶¶ 13–14. Patent Owner does not dispute this recitation of the level of ordinary skill in the art. See Ex. 2042 ¶ 68 n.5. We adopt the level of ordinary skill in the art identified by Drs. Pleasure and Polli as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating level of ordinary skill in the art may be reflected by the prior art of record); In re GPAC Inc., 14” slip op. at 14

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

    “In order for claims of the ’703 patent to be entitled to benefit of the filing date of the Provisional, the Provisional must provide written description support for those claims. See 35 U.S.C. § 120. To satisfy the written description requirement of 35 U.S.C. § 112, first paragraph, and provide support for the challenged claims of the ’703 patent under 35 U.S.C. § 120, the Provisional must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See In re Wertheim, 541 F.2d 257, 261, 262 (CCPA 1976); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563– 64 (Fed. Cir. 1991). The primary consideration in determining whether appropriate written description support exists “is factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure.” Union Oil Co. of Cal. v. Atlantic Richfield Co., 208 F.3d 989, 996 (Fed. Cir. 2000).” slip op. at 27

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

    “Because the Provisional provides written description support for the challenged claims, S-1 potentially qualifies as prior art only under 35 U.S.C. § 102(a), but not § 102(b), because the S-1 publication date of September 26, 2003 is less than one year before the filing date of the Provisional of April 9, 2004. As discussed in more detail below, however, Patent Owner has provided evidence that S-1 is not prior art to the claims of the ’703 patent under § 102(a) either because the pertinent portions of the S-1 are the original work of inventors Drs. Blight and Cohen. See 35 U.S.C. § 102(a); Katz, 687 F.2d at 454 (stating “one’s own work is not prior art under sec. 102(a) even though it has been disclosed to the public in a manner or form which otherwise would fall under [sec.] 102(a)”).” slip op. at 37

  Patent outcomesUS 8,440,703 not shown unpatentable
  Claim construction§ 102 anticipation§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,440,703
• Coalition For Affordable Drugs (Adroca) LLC v. Acorda Therapeutics, Inc.No claims unpatentable
  PTAB · Mar 9, 2017 · IPR2015-01858 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–40 of the ’437 patent were not shown unpatentable under § 103 because S-1 was not prior art under § 102(a) or (b).

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedOther

    “1. Level of Skill Petitioner’s declarants, Drs. Pleasure and Polli, testify that a person of ordinary skill in connection with the ’703 patent would have had an M.D. or Ph.D. in neuroscience or a related field with an understanding of pharmacokinetics and at least some experience in providing drug therapy to MS patients. Ex. 1023 ¶ 16, Ex. 1044 ¶ 13. Additionally, Drs. Pleasure and Polli testify that a person of ordinary skill in the art would have had access to a person having an advanced degree in pharmaceutics or pharmaceutical formulation, specifically oral sustained release formulations, or at least five years of experience in formulating sustained oral release drug products and may work as part of a multi-disciplinary team. Ex. 1023 ¶¶ 16–17; Ex. 1044 ¶¶ 13–14. Patent Owner does not dispute this recitation of the level of ordinary skill in the art. See Ex. 2042 ¶ 68 n.5. We adopt the level of ordinary skill in the art identified by Drs. Pleasure and Polli as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating level of ordinary skill in the art may be reflected by the prior art of record); In re GPAC Inc.,” slip op. at 14

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

    “Petitioner asserts constructions for the following claim terms, “less than 15 milligrams,” “release profile,” “matrix,” “improving walking,” and “initiating treatment.” Pet. 18–19. Patent Owner contends that Petitioner has failed to provide an explanation as to why the identified claim terms require construction and why the Board should depart from the plain and ordinary meaning of the terms. Prelim. Resp. 17, n.4. In the Institution Decision, we agreed with Patent Owner and determined that it was unnecessary to construe explicitly the claim terms for purposes of the Institution Decision. See Dec. Instit. 6 (citing Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). We also determine here that we need not construe expressly any claim term in order to issue a Final Written Decision regarding the patentability of the challenged claims.” slip op. at 7

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

    “We agree with Patent Owner that the Provisional provides adequate written description support for the challenged claims of the ’703 patent. We agree with Drs. Lublin and Peck and credit their testimony that one of skill in art reading the Study Design schematic for Example 11 would have understood that a patient in the 10 mg b.i.d. arm of the study would have received 10 mg b.i.d. throughout the two-week upward titration period. As 10 mg b.i.d. is the lowest dose except for placebo, we find that it necessarily 30 follows that those patients in the 10 mg b.i.d. arm of the study do not need upward titration to the treatment dose because they start and finish at the lower 10 mg dose.” slip op. at 30

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artNot shown unpatentable

    “Although the burden of persuasion for unpatentability never shifts from Petitioner during the trial, the burden of production may shift. See Dynamic Drinkware, 800 F.2d at 1379. Petitioner adequately met its burden of production by presenting S-1 as prior art that on its face lists authors that differ from the inventors of the patents at issue. See Ex. 1003, 92. Patent Owner has responded with ample and persuasive evidence, however, that Drs. Blight and Cohen are the sole source of the disclosure of S-1. Thus, Patent Owner satisfies any burden of production to refute Petitioner’s case that S-1 is prior art under 35 U.S.C. § 102(a). See supra. Petitioner’s response to Patent Owner’s evidence does not persuade us that the portions of S-1 upon which they rely are not solely attributable to Drs. Blight and Cohen. Specifically, Petitioner offers evidence from the S-1 of a statement that the MS-F202 clinical trial was designed “after extensive consultation with a panel of expert MS neurologists and with the FDA,” arguing that statement indicates that Drs. Blight and Cohen may not be the sole authors 41 of the protocol for this clinical trial. Reply 2. Petitioner further argues that Drs. Blight and Cohen’s deposition testimony supports its contention that Drs. Blight and Cohen may not be the sole authors of the protocol for this clinical trial because they could not recall the details of that consultation. Id. at 3 (citing Ex. 1064, 64:18–65:14; Ex. 1063, 76:20–77:20, 80:9–81:14, 110:13–111:2). Petitioner also takes issue with another statement in S-1 indicating that in early 2002, Drs. Blight and Cohen drafted descriptions of the MS-F201 and MS-F202, although version 1.0 of the MS-F202 protocol is dated October 2002. Id. at 2 (citing Paper 28, 16; Ex. 2050, 6). Finally, Petitioner points to publications discussing MS-F201 and MS-F202 where Drs. Blight and Cohen are not consistently named as authors and other authors, such as Drs. Goodman and Katz, are listed. Id. at 3–4. We find that Petitioner’s evidence that allegedly casts doubt on the authorship of the relevant portions of S-1 is not sufficient to overcome the ample, unequivocal evidence presented by Patent Owner that supports our finding that the relevant portions of S-1 are the original work of Drs. Blight and Cohen alone. See In re Katz, 687 F.2d at 455. Both Drs. Cohen and Blight state that they alone are the inventors and sole originators of the work in S-1 upon which Petitioner relies. See Exs. 2044, 2045. Five other declarants, intimately involved in the development of S-1, two of which now work for entities other than Acorda, substantiate this testimony. See Exs. 2046–2048, 2052, 2056. Relying on statements that may, on their face,” slip op. at 41

  Patent outcomesUS 8,354,437 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,354,437
• Coalition For Affordable Drugs (Adroca) LLC v. Acorda Therapeutics, Inc.No claims unpatentable
  PTAB · Mar 9, 2017 · IPR2015-01857 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–8 of the ’685 patent were not shown unpatentable because S-1 was not prior art, alone or with Hayes or Juarez.

  RulingsFinal written decision

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

    “filing date of the Provisional, the Provisional must provide written description support for those claims. See 35 U.S.C. § 120. To satisfy the written description requirement of 35 U.S.C. § 112, first paragraph, and provide support for the challenged claims of the ’703 patent under 35 U.S.C. § 120, the Provisional must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See In re Wertheim, 541 F.2d 257, 261, 262 (CCPA 1976); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563– 64 (Fed. Cir. 1991). The primary consideration in determining whether appropriate written description support exists “is factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure.” Union Oil Co. of Cal. v. Atlantic Richfield Co., 208 F.3d 989, 996 (Fed. Cir. 2000).” slip op. at 27

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner

    “Because the Provisional provides written description support for the challenged claims, S-1 potentially qualifies as prior art only under 35 U.S.C. § 102(a), but not § 102(b), because the S-1 publication date of September 26, 2003 is less than one year before the filing date of the Provisional of April 9, 2004. As discussed in more detail below, however, Patent Owner has provided evidence that S-1 is not prior art to the claims of the ’703 patent under § 102(a) either because the pertinent portions of the S-1 are the original work of inventors Drs. Blight and Cohen. See 35 U.S.C. § 102(a); Katz, 687 F.2d at 454 (stating “one’s own work is not prior art under sec. 102(a) even though it has been disclosed to the public in a manner or form which otherwise would fall under [sec.] 102(a)”).” slip op. at 37

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artReference not prior artDecided for patent owner

    “We find that Petitioner’s evidence that allegedly casts doubt on the authorship of the relevant portions of S-1 is not sufficient to overcome the ample, unequivocal evidence presented by Patent Owner that supports our finding that the relevant portions of S-1 are the original work of Drs. Blight and Cohen alone. See In re Katz, 687 F.2d at 455. Both Drs. Cohen and Blight state that they alone are the inventors and sole originators of the work in S-1 upon which Petitioner relies. See Exs. 2044, 2045. Five other declarants, intimately involved in the development of S-1, two of which now work for entities other than Acorda, substantiate this testimony. See Exs. 2046–2048, 2052, 2056. Relying on statements that may, on their face, 42 indicate that others may have been involved without any evidence that others were, in fact, originators of the work in question or inventors is simply not enough to carry Petitioner’s burden to show that the S-1 is prior art under 35 U.S.C. § 102(a). For the reasons discussed above, we determine that S-1 does not qualify as prior art to the claims of the ’703 patent under 35 U.S.C. § 102(a) or (b). Thus, all of Petitioner’s challenges to the patentability of the claims of the ’703 patent, which depend on S-1 alone or in combination with Hayes or Juarez, fail. Petitioner, therefore, has not carried its burden to prove unpatentability of claims 1–52 of the ’703 patent by a preponderance of the evidence.9” slip op. at 42

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityNot reached

    “For the reasons discussed above, we determine that S-1 does not qualify as prior art to the claims of the ’703 patent under 35 U.S.C. § 102(a) or (b). Thus, all of Petitioner’s challenges to the patentability of the claims of the ’703 patent, which depend on S-1 alone or in combination with Hayes or Juarez, fail. Petitioner, therefore, has not carried its burden to prove unpatentability of claims 1–52 of the ’703 patent by a preponderance of the evidence.9 D. IPR2015-01853; IPR2015-01857; and IPR2015-01858 Petitioner’s patentability challenges to the claims of U.S. Patent No. 8,354,437 B2 (“the ’437 patent”), U.S. Patent No. 8,007,826 B2 (“the ’826 patent”), and U.S. Patent No. 8,354,437 B2 (“the ’437 patent”), at issue in IPR2015-01853, IPR2015-01857, and IPR2015-01858, respectively, essentially raise the same issues presented in the patentability challenge to the claims of the ’703 patent in IPR2015-01850. Therefore, we chose to 9 Because we find that S-1 is not prior art under 35 U.S.C. § 102(a), we need not reach whether S-1 is a printed publication.” slip op. at 43

  Patent outcomesUS 8,663,685 not shown unpatentable
  § 102 anticipation§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,663,685
• Coalition For Affordable Drugs Viii, LLC v. The Trustees Of The University Of PennsylvaniaNo claims unpatentable
  PTAB · Mar 6, 2017 · IPR2015-01836 · APJ Lora M Green · IPR · Final written decision

  Claims 1–8 were not shown unpatentable under § 103 because the prior art did not establish a reasonable expectation of success using lomitapide in the claimed dosing regimen.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “The reasonable expectation of success requirement refers to the likelihood of success in combining references to meet the limitations of the claimed invention.” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016). As to reasonable expectation of success, we agree with Patent Owner that the ordinary artisan would not have had a reasonable expectation of success of combining Pink Sheet with Chang to arrive at the claimed invention. To the extent that Petitioner relies on our Institution Decision, we note that decision was based on the evidence of record at that time. The evidence advanced by Patent Owner during trial, discussed herein, however, tips the scale in favor of a finding different from that set forth in our Institution Decision. slip op. at 36

  • ExcludeMotion to exclude, deniedMixed

    “As to Exhibit 1052, which is the Deposition Transcript of S. David Kimball, and which Patent Owner acknowledges that Petitioner cites in its Reply, Patent Owner argues that it timely objected to the exhibit as an improper duplicate of Exhibit 2304. Mot. Exclude 7. Petitioner responds that Exhibits 2304 and 1052 are the transcripts of Petitioner’s expert. Opp. Mot. Exclude 4. Although acknowledging that the party taking the deposition normally files the transcript, Petitioner asserts that its Reply cites to Ex. 1056, and Patent Owner does not cite to either exhibit. Id. Patent Owner replies that Exhibit 2304 also contains Dr. Kimball’s signed errata sheet and is, thus, the more complete of the two documents. Reply Mot. Exclude. 3. Patent Owner asserts that the citations in Petitioner’s Reply can be updated to reflect the correct exhibit number, if necessary. Id. Given the posture of this proceeding, that is, it is at final written decision, and as Patent Owner notes, the two documents are not exact duplicates, we decline to exclude Ex. 1056, but will allow both Exhibit 1056 and 2034 to remain in the record.” slip op. at 44

  • PTAB / AIA Trials › Motions to amend / substitute claimsNot reached

    “the unrebutted evidence of commercial success further supports the patentability of the challenged claims. Looking at the entire record before us, we conclude that Petitioner has not meet its burden to establish unpatentability of challenged claims 1‒8 by a preponderance of the evidence over the combination of Pink Sheet and Chang. E. Motion to Amend As discussed above, because we conclude that Petitioner has not demonstrated the obviousness of the claims by a preponderance of the evidence, we need not reach the merits of Patent Owner’s contingent Motion to Amend (Paper 24). We, thus, dismiss the motion a moot.” slip op. at 44

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “biotechnology and medical device companies.” Id. The press release does not even mention Dr. Stein. Thus, there is nothing in the press release suggesting that the ordinary artisan in the cardiovascular/cardiac field, or interested in MTP inhibitors, should attend the presentation. We, therefore, decline to credit Dr. Mayersohn’s testimony that “[a]person of ordinary skill in the art interested in the development of MTP inhibitors could apparently have attended the meeting or accessed the presentation itself via webcast or on the PPD website shortly thereafter” (Ex. 1003 ¶ 25 (citing the PPD Press Release)), as there was nothing in the press release discussing MTP inhibitors. That finding informs our analysis of the factors set forth in Klopfenstein. Thus, although the ordinary artisan may have been able to copy the presentation, and although there may have been an expectation that the materials could be copied, Petitioner does not provide any evidence establishing that the target audience would have been an ordinary artisan in the relevant field.” slip op. at 19

  Patent outcomesUS 7,932,268 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,932,268
• Coalition For Affordable Drugs Viii, LLC v. The Trustees Of The University Of PennsylvaniaNo claims unpatentable
  PTAB · Mar 6, 2017 · IPR2015-01835 · APJ Lora M Green · IPR · Final written decision

  Claims 1–10 were not shown unpatentable under § 103 because the prior art did not establish a reasonable expectation of success substituting lomitapide into Pink Sheet’s dosing protocol.

  RulingsFinal written decision

  • BurdenFwd all claims patentableNot shown unpatentable

    “We have jurisdiction under 35 U.S.C. § 6. Petitioner bears the burden of proving unpatentability of the challenged claims, and that burden 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 facts supporting its challenge by a preponderance of the evidence. See 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. Based on the record before us, we conclude that Petitioner has failed” slip op. at 3

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedDecided for patent owner

    “under 35 U.S.C. § 102 “involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.” In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). “Because there are many ways in which a reference may be disseminated to the interested public, ‘public accessibility’ has been called the touchstone in determining whether a reference constitutes a ‘printed publication’ bar under 35 U.S.C. § 102(b).” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (citing In re Hall, 781 F.2d 897, 898–99 (Fed. Cir. 1986)). “A given reference is ‘publicly accessible’ upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” SRI Int’l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1194 (Fed. Cir. 2008) (quoting Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006)).” slip op. at 14

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

    “Although we find this issue to be very close, we find that the Petitioner has established by a preponderance of the evidence that the ordinary artisan would have looked at other MTP inhibitors, such as lomitapide as taught by Chang, that could be used in the dosing protocol taught by Pink Sheet. Specifically, Pink Sheet teaches a dosing method with the MTP inhibitor, implitamide, wherein, as discussed above, the dosing schedule meets the dosing schedule required by claim 1. Ex. 1013. In addition, Pink Sheet discusses MTP inhibitors generally, and notes that they may have efficacy in situations where high-dose statins are ineffective or inadequate, such as homozygous and severe heterozygous familial hypercholesterolemia. Id. Pink Sheet also acknowledges that the toxicity seen with MTP inhibitors may have been due to the high doses used during the clinical trials. Id. Chang discusses the clinical efficacy of MTP inhibitors, including implitapide (BAY-13-9952) and lomitapide (BMS-201038). Ex. 1015, 566. Specifically, Chang discusses the clinical efficacy of CP-346086, and then notes that similar efficacy was reported for implitapide and lomitapide. Id. Given that implitapide and lomitapide are from the same class of therapeutics, that is, MTP inhibitors, and that they are known to have similar clinical efficacy, based on the record before us, we determine that Petitioner has demonstrated a reasonable basis as to why the ordinary artisan would have substituted lomitapide as taught by Chang for implitapide in the method of Pink Sheet.” slip op. at 32

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

    “Initially, we note that Petitioner does not contest that Juxtapid is a commercial success, and, thus, in view of the unrebutted evidence provided by Patent Owner, we find that Patent Owner has established that Juxtapid is a commercial success. As to Petitioner’s argument that the Juxtapid website does not suggest a forced titration, as set forth in our section on claim construction above, we decline to construe independent challenged claim 1 as requiring a forced titration. Moreover, as shown in the table below, the dosing schedule of independent claim 1 encompasses the dosing method that is given to doctors on the Juxtapid website (Ex. 2301, 1):” slip op. at 43

  Patent outcomesUS 8,618,135 not shown unpatentable
  § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,618,135
• Shell Oil Company v. Exxonmobil Research And Engineering CompanyNo claims unpatentable
  PTAB · Feb 21, 2017 · IPR2016-00009 · APJ Elizabeth M Roesel · IPR · Final written decision

  Claims 1–4 were held not unpatentable because Petitioner did not prove Valyocsik disclosed ZSM-48 crystals free from ZSM-50 impurity.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “parties, we find that Petitioner has not shown by a preponderance of the evidence that Valyocsik Example 13 is necessarily free from ZSM-50. Our finding is supported by at least three categories of evidence: (1) Dr. Lobo’s concession that Experiment 5 is an “exception” to his opinion that the XRD data for Mr. Cooper’s reproductions of Example 13 show a ZSM-48 product that is free from ZSM-50 impurity (Ex. 1004 ¶ 96); (2) Dr. Higgins’ analysis of the XRD data for Mr. Cooper’s experiments (Ex. 1009) and conclusion that the data for Experiments 1–5 are consistent with the presence of ZSM- 50 in the samples (Ex. 2013, ¶¶ 33–41); and (3) Dr. Lobo’s concession on cross-examination that the XRD data for Mr. Cooper’s Experiments 1, 3, and 5 include peaks consistent with the presence of ZSM-50 (Ex. 2017, 61:1–62:20, 67:22–75:2). We discuss each category of evidence below:” slip op. at 16

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

    “First, it is inconsistent with the legal standard for inherency, which requires Petitioner to show that the product of Valyocsik Example 13 is necessarily free from ZSM-50 impurity. Robertson, 169 F.3d at 745. Evidence that the product “may in fact be” impurity-free (Pet. Reply 16) is not sufficient. Oelrich, 666 F.2d at 581 (Inherency “may not be established by probabilities or possibilities.”).” slip op. at 21

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

    “48 crystals that are “free from ZSM-50 and Kenyaite impurities.” After considering the arguments and evidence presented by both parties, we find that Petitioner has not met its burden to prove that Valyocsik discloses, either expressly or inherently, ZSM-48 crystals that are free from ZSM-50 impurity. In view of this finding, we need not address whether Valyocsik discloses ZSM-48 crystals that are free from Kenyaite impurity.” slip op. at 10

  Patent outcomesUS 6,923,949 not shown unpatentable
  § 102 anticipation
  Patents in suitUS 6,923,949

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.