• 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
• 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
• LG Display Co, Ltd. v. Innovative Display Technologies LLCNo claims unpatentable
  PTAB · Jul 15, 2016 · IPR2015-01717 · APJ Beverly M Bunting · IPR · Final written decision

  Claims 1, 3, 5, 10, 13, 16, 17, 25–29, and 33–35 were not shown unpatentable under §103 over Oe and Etsuo because the proposed combinations lacked sufficient reasoned support.

  RulingsFinal written decision

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

    “persuaded Petitioner has provided sufficient articulated reasoning with rational underpinning explaining why one with ordinary skill in the art would have modified the teachings of the applied references to address the noted differences. See KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”)). We consider Petitioner’s first reason to combine Oe and Etsuo “because they are in the same field of backlighting for liquid crystal display devices.” Pet. 36. The mere fact that both Oe and Etsuo are in the same field of endeavor falls short of an adequate rationale. The same field of endeavor analysis is merely the jumping-off point in reaching the determination of whether a claimed invention is obvious. See K-TEC, Inc. v. Vita-Mix Corp., 696 F.3d 1364, 1375 (Fed. Cir. 2012) (to qualify as prior art in an obviousness analysis, references must be analogous art—either from the same field of endeavor, or reasonably pertinent to the problem with which the inventor is involved). Next, we consider Petitioner’s second reason to combine because “both Oe and Etsuo relate to backlight devices that use light sources located at edges of a light guide.” Pet. 36 (citing Ex. 1004 ¶ 165). Although Petitioner relies on the testimony of Dr. Escuti, he does not proffer any persuasive facts, data, or analysis to support his opinion. See Ex. 1004 ¶ 165 (“Also, both Oe and Etsuo relate to backlight devices that use light sources located at edges of a light guide.”). Merely repeating an argument from the Petition in the declaration of a proposed expert does not give that argument probative value. Dr. Escuti’s opinion lacks sufficient support. For this reason, we do not credit the testimony of Dr. Escuti on this issue. See 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Petitioner’s second reason is also unavailing because it does not address the entirety of Petitioner’s proposed modification. As discussed above, Petitioner relies on the disclosure in Etsuo for both the position of the plurality of light sources adjacent a single input edge claim element, as well as the output distribution having a greater width component than height component claim element. Petitioner’s reasoning, directed only to the use of light sources at the edge of the light guide, does not explain sufficiently why one of skill in the art would have replaced a single light source positioned adjacent one input edge of Oe, with the plurality of light sources disclosed by Etsuo that have an output distribution defined by a greater width component than height component.” slip op. at 20

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed

    “We have reviewed the testimony from both Dr. Escuti, and Patent Owner’s expert, Mr. Werner (Ex. 2021). We find that both experts have, at times, taken liberties in proffering conclusory statements without real analysis.5 However, it is within our discretion to assign the appropriate weight to the testimony of both Dr. Escuti, and Mr. Werner. See, e.g., 5 Under our rules, expert testimony that does not have a proper basis is entitled to little or no weight. 37 C.F.R. § 42.65(a). Yorkey v. Diab, 601 F.3d 1279, 1284 (Fed. Cir. 2010) (holding the Board has discretion to give more weight to one item of evidence over another “unless no reasonable trier of fact could have done so”); In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004). We, therefore, are not persuaded by Patent Owner’s contention that Dr. Escuti’s testimony be disregarded in its entirety. Instead, we have accorded the testimony of both Dr. Escuti and Mr. Werner the weight that is appropriate in view of the arguments and evidence of record in this trial. 4. Overview of Oe (Ex. 1024)” slip op. at 13

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “taken into account. In making this determination, we were aided by expert testimony. According to Dr. Escuti, “a person of ordinary skill in the art relevant to the ’660 Patent would have at least an undergraduate degree in physics, optics, engineering, or applied mathematics AND 3 years of work experience (or a graduate degree) in a field related to optical technology.” Ex. 1004 ¶ 23. Mr. Werner does not take issue with this testimony, and in fact proposes a similar standard: a person of ordinary skill in the art of the ’660 patent would hold an undergraduate degree in physics, material science, electrical engineering, or mathematics and have one or both of the following: (1) three or more years of work experience in a field related to optical technology; or (2) a graduate degree in a field related to optical technology. Ex. 2021 ¶ 76. We find that Mr. Werner’s definition is too limited in that it does not include a person with an undergraduate degree in optics. We, therefore, do not accept his standard and adopt instead Dr. Escuti’s more complete definition.” slip op. at 12

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

    “disclosure in the specification of the ’600 patent to support Patent Owner’s proposed claim construction of “height” and “width.” Indeed, our review of the specification of the ’660 patent reveals that these terms are not defined explicitly or implicitly. For example, the specification states that “the deformities may vary in shape and/or size along the length and/or width of the panel members.” Ex. 1001, 5:43–44 (emphasis added). With respect to the planar optical conductor, claims 1 and 33 each recite, in relevant part, that the input edge has “at least one input edge with a greater cross-sectional width than thickness.” Ex. 1001, 9:11–12, 10:65–67 (emphasis added). Both claims 1 and 33 recite that the output distribution generated by the plurality of light sources is “defined by a greater width component than height component.”4 Id. at 9:15–16, 11:5–6 (emphasis added). Claim 33 recites that the plurality of LED light sources each have “a greater width than height.” Id. at 11:1–2 (emphasis added). Because the terms “width” and “height” are commonly understood, we also consult a general purpose dictionary. “Width” is defined as “the horizontal measurement taken at right angles to the length.” See Merriam- Webster.com, http://www.merriam-webster.com/dictionary/width, (last viewed July 10, 2015). The dictionary definition of height is “the distance from the bottom to the top of something standing upright.” See Merriam-” slip op. at 10

  Patent outcomesUS 7,404,660 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,404,660
• LG Display Co, Ltd. v. Innovative Display Technologies LLCNo claims unpatentable
  PTAB · Jul 15, 2016 · IPR2015-01717 · APJ Beverly M Bunting · IPR · Final written decision

  Claims 1, 3, 5, 10, 13, 16, 17, 25–29, and 33–35 were held not unpatentable under § 103 over Oe and Etsuo because the combination lacked an adequately supported reason to combine.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “taken into account. In making this determination, we were aided by expert testimony. According to Dr. Escuti, “a person of ordinary skill in the art relevant to the ’660 Patent would have at least an undergraduate degree in physics, optics, engineering, or applied mathematics AND 3 years of work experience (or a graduate degree) in a field related to optical technology.” Ex. 1004 ¶ 23. Mr. Werner does not take issue with this testimony, and in fact proposes a similar standard: a person of ordinary skill in the art of the ’660 patent would hold an undergraduate degree in physics, material science, electrical engineering, or mathematics and have one or both of the following: (1) three or more years of work experience in a field related to optical technology; or (2) a graduate degree in a field related to optical technology. Ex. 2021 ¶ 76. We find that Mr. Werner’s definition is too limited in that it does not include a person with an undergraduate degree in optics. We, therefore, do not accept his standard and adopt instead Dr. Escuti’s more complete definition.” slip op. at 12

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed

    “Owner’s expert, Mr. Werner (Ex. 2021). We find that both experts have, at times, taken liberties in proffering conclusory statements without real analysis.4 However, it is within our discretion to assign the appropriate weight to the testimony of both Dr. Escuti, and Mr. Werner. See, e.g., 4 Under our rules, expert testimony that does not have a proper basis is entitled to little or no weight. 37 C.F.R. § 42.65(a). Yorkey v. Diab, 601 F.3d 1279, 1284 (Fed. Cir. 2010) (holding the Board has discretion to give more weight to one item of evidence over another “unless no reasonable trier of fact could have done so”); In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004). We, therefore, are not persuaded by Patent Owner’s contention that Dr. Escuti’s testimony be disregarded in its entirety. Instead, we have accorded the testimony of both Dr. Escuti and Mr. Werner the weight that is appropriate in view of the arguments and evidence of record in this trial. 4. Overview of Oe (Ex. 1024)” slip op. at 13

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

    “Because the terms “width” and “height” are commonly understood, we also consult a general purpose dictionary. “Width” is defined as “the horizontal measurement taken at right angles to the length.” See Merriam- Webster.com, http://www.merriam-webster.com/dictionary/width, (last viewed July 10, 2015). The dictionary definition of height is “the distance from the bottom to the top of something standing upright.” See Merriam- 3 In a related district court proceeding, the claim term “output distribution defined by a greater width component than height component” was determined to have its plain meaning. Ex. 2008, 47. See TR. 21:24–22:8. Webster.com, http://www.merriam-webster.com/dictionary/height, (last viewed July 10, 2015). Within the context of the claims, we are not persuaded by Patent Owner’s contentions that the term “width” is used other than according to its ordinary and customary meaning with respect to the shape of the input edge of the optical conductor, the output distribution of the light source, and the shape of the LED light source. Along this vein, we are not persuaded by Patent Owner’s contentions that the term “height” is used other than according to its ordinary and customary meaning with respect to the light output distribution. Based on this usage in the claims, no express construction is necessary.” slip op. at 10

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

    “persuaded Petitioner has provided sufficient articulated reasoning with rational underpinning explaining why one with ordinary skill in the art would have modified the teachings of the applied references to address the noted differences. See KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”)). We consider Petitioner’s first reason to combine Oe and Etsuo “because they are in the same field of backlighting for liquid crystal display devices.” Pet. 36. The mere fact that both Oe and Etsuo are in the same field of endeavor falls short of an adequate rationale. The same field of endeavor analysis is merely the jumping-off point in reaching the determination of whether a claimed invention is obvious. See K-TEC, Inc. v. Vita-Mix Corp., 696 F.3d 1364, 1375 (Fed. Cir. 2012) (to qualify as prior art in an obviousness analysis, references must be analogous art—either from the same field of endeavor, or reasonably pertinent to the problem with which the inventor is involved). Next, we consider Petitioner’s second reason to combine because “both Oe and Etsuo relate to backlight devices that use light sources located at edges of a light guide.” Pet. 36 (citing Ex. 1004 ¶ 165). Although Petitioner relies on the testimony of Dr. Escuti, he does not proffer any persuasive facts, data, or analysis to support his opinion. See Ex. 1004 ¶ 165 (“Also, both Oe and Etsuo relate to backlight devices that use light sources located at edges of a light guide.”). Merely repeating an argument from the Petition in the declaration of a proposed expert does not give that argument probative value. Dr. Escuti’s opinion lacks sufficient support. For this reason, we do not credit the testimony of Dr. Escuti on this issue. See 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Petitioner’s second reason is also unavailing because it does not address the entirety of Petitioner’s proposed modification. As discussed above, Petitioner relies on the disclosure in Etsuo for both the position of the plurality of light sources adjacent a single input edge claim element, as well as the output distribution having a greater width component than height component claim element. Petitioner’s reasoning, directed only to the use of light sources at the edge of the light guide, does not explain sufficiently why one of skill in the art would have replaced a single light source positioned adjacent one input edge of Oe, with the plurality of light sources disclosed by Etsuo that have an output distribution defined by a greater width component than height component. We also consider Petitioner’s argument in the Reply that, in addition to Etsuo, Petitioner also relies on Oe’s explicit disclosure of “a plurality of point-like sources of light.” Reply 16–17. Petitioner directs us to the passage of Oe cited in its claim chart (Pet. 40), describing how the light source could be “a plurality of point-like sources of light arranged along the incident surface” (Ex. 1024, 7:30–31). Id. at 16. But Petitioner’s arguments in this regard do not address specifically its proffered reason to combine Oe and Etsuo. Indeed, Petitioner does not explain the relevance of the point-like sources of light to the claim element in question. See 37 C.F.R. § 42.22(a)(2) (requiring a full statement of the reasons for the relief requested, including a detailed explanation of the significance of the evidence including material facts, and the governing law, rules, and precedent). Patent Owner contends that “Petitioner never argues that ‘point-like sources’ are equivalent to LEDs.” PO Resp. 10. We agree. Petitioner’s argument that “Oe discloses a plurality of light sources 4 adjacent to the input edges” (Pet. 35 (citing Ex. 1024, 6:5–13; Ex. 1004 ¶ 161)) makes no mention of the specific passage in Oe concerning the point-like sources of light. Indeed, the cited passage states that:” slip op. at 20

  Patent outcomesUS 7,404,660 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,404,660
• Organik Kimya As v. Rohm And Haas CompanyNo claims unpatentable
  PTAB · Jun 26, 2015 · IPR2014-00350 · APJ Erica A Franklin · IPR · Final written decision

  Claims 1–7 were not shown unpatentable because the cited combinations did not establish a qualifying swelling agent under the Board’s construction.

  RulingsFinal written decision

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

    “We disagree with Petitioner that the Specification’s use of the term “include,” when describing suitable swelling agents, “mak[es] clear” that bases that are not capable of permeating the shell and swelling the core also fall within the scope of the invention. Id. Rather, the Specification’s use of the word “include,” in this instance, is modified by the phrase immediately following it, i.e., “are those which,” suggesting that suitable swelling agents include only those which exhibit the functional characteristic thereafter described. See Ex. 1001, 8:44. In contrast, the subsequent paragraph of the Specification describes the structural requirement for suitable swelling agents using the word “include,” without modifying it with a restrictive phrase. Instead, when disclosing the volatile, fixed and permanent bases, the word “include” is coupled with the phrases “such as” and “and the like,” signaling open-ended or inclusive categories of these bases. See id. at 8:49– 56. Further, we agree with Patent Owner that the Specification describes a swelling agent not merely as being capable of permeating a shell and swelling the core of a multistage emulsion polymer in the abstract, but specifically under the conditions of the specific process for which the agent is to be used. Indeed, the Specification explains that in its process for preparing emulsion polymers, the core polymer of the multistage emulsion polymer swells when it “is subjected to a basic swelling agent that permeates the shell to at least partially neutralize the hydrophilic-functionality of the core.” Ex. 1001, 9:14–17. Based on the foregoing discussion, in light of the ’004 patent Specification, we construe the claim term “swelling agent” as expressing a structural element, i.e., “an aqueous or gaseous, volatile or fixed base, or combinations thereof,” in functional terms, i.e., “capable of permeating the shell and swelling the core, in the presence of the multistage polymer and monomer, under the conditions of the specific process for which the agent is to be used.” See Greenberg v. Ethicon Endo-Surgery, Inc., 91 F.3d 1580, 1583 (Fed. Cir. 1996) (structural elements, e.g., “filter” and “brake,” may be expressed in functional terms).” slip op. at 8

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

    “After considering the arguments and evidence, we find that Patent Owner has established that a person of ordinary skill in the art would not have been motivated to substitute cresol for toluene in step 2A of Touda’s Example 2. Although cresol and toluene are both solvents, Patent Owner has established with persuasive evidence that cresol’s additional function as a polymerization inhibitor would have defeated the purpose of the solvent in Touda’s step 2A. That step is directed to the production of a filled polymer latex (multi-stage polymer). Ex. 1003, 7:35–56. During step 2A, toluene was added to a monomeric mixture over the course of 6 hours. Id. at 7:49– 50. Then the mixture was maintained at 80 °C for 2 hours to complete the polymerization reaction. Id. at 7:51–52. Dr. Schork attempted to replicate Example 2 with cresol substituting for toluene during step 2A, as proposed by Petitioner. Ex. 2005 ¶¶ 92–95 (citing Declaration Ex. I, “Synthesis Procedure for Touda ’320 Example 2 Modified”). Dr. Schork explained that the result observed from using cresol during step 2A was not surprising: “monomer was only 2.5% converted to polymer after the required eight hours.” Id. ¶ 95. Dr. Schork stated, “[i]n my opinion, these results show that the modified process of Example 2A does not make a core-shell emulsion polymer having a core stage and a shell stage because the cresol inhibits polymerization during the phase intended to make the shell.” Id. Petitioner’s assertion to the contrary—that Dr. Schork’s experiment produced “a meaningful amount of shell stage polymer,”—is merely attorney argument unsupported by any persuasive evidence. Pet. Reply 13. Indeed, Petitioner’s Declarant, Marek W. Urban, Ph.D., did not attempt to replicate Example 2 with the modifications proposed by Petitioner, i.e., substituting cresol for toluene in Step 2A. Accordingly, we conclude that Petitioner has not established that it would have been obvious to modify Touda’s Example 2 to include a polymerization inhibitor.” slip op. at 15

  • Expert testimonyPatent owner expert creditedDecided for patent owner
  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “Moreover, we agree with Patent Owner that Touda’s Example 2 also does not include a swelling agent, as required by claim 1 of the ’004 patent. PO Resp. 28. In particular, as Patent Owner asserts, Touda does not disclose expressly sodium hydroxide, or any other base, as a “swelling agent,” i.e., being capable of permeating the shell and swelling the core of the emulsion polymer under the conditions of Example 2. Id. Petitioner asserts that even if our construction of “swelling agent” requires a base that permeates the shell and swells the core, Petitioner “has established a prima facie case of inherency under Office practice.” Pet. Reply 10 (citing In re Best, 562 F.2d 1252, 1254 (C.C.P.A. 1977); In re Spada, 911 F.2d 705, 707–08 n.3 (Fed. Cir. 1990); In re Mousa, 479 F. App’x. 348, 353 (Fed. Cir. 2012)), 14. According to Petitioner, sodium hydroxide inherently permeates the shell and swells the core of the polymer particles in Touda because the same polymer particles are described in the ’004 patent as suitable for swelling. Pet. Reply 14. However, Dr. Schork explains that in Touda’s Example 1S, the core is only 5 parts (5%) methacrylic acid and the shell in Example 2A is only 6 parts (6%) acrylic acid, such that the core and the shell are only slightly acidic. Ex. 2005 ¶ 77. Dr. Schork states that a person of skill in the art “would understand that under these conditions, NaOH would at best neutralize the shell, not the core.” Id. According to Dr. Schork, “[g]iven the low levels of acid, the NaOH would be unlikely to permeate and neutralize any part of the particle. Certainly, NaOH would not permeate the shell and swell the core. Instead, to the extent that any swelling occurred, it would take place in the shell.” Id. Again, we are persuaded by Dr. Schork’s testimony and do not find that Petitioner has provided persuasive evidence contradicting Dr. Schork’s opinion. Accordingly, after considering the arguments and evidence, and based upon our construction of the term “swelling agent,” we find that Petitioner has not established that Touda discloses sodium hydroxide as a “swelling agent” in the process of Example 2.” slip op. at 16

  Patent outcomesUS 6,252,004 not shown unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 6,252,004

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.