• Fresenius Kabi USA, LLC / Fresenius Kabi Swissbiosim GmbH v. Coherus Biosciences, Inc.Rehearing denied
  PTAB · Jan 27, 2021 · PGR2019-00064 · APJ Christopher G Paulraj · PGR · Rehearing

  The Board denied Petitioner’s rehearing requests, leaving in place denial of institution based on the merits of the written-description and enablement challenges.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “II. DISCUSSION A party requesting rehearing has the burden to show a decision should be modified by specifically identifying all matters the party believes were misapprehended or overlooked, and the place where each matter was addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2

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

    “Petitioner’s arguments are unpersuasive because our construction of “stable” does not exclude the preferred embodiments. As Petitioner acknowledges, “[t]he Board did not construe ‘stable’ to be limited to formulations that are as stable as Humira or lose 20% of activity upon storage.” Id. at 3. Although our construction encompasses the “most” preferred embodiment (e.g., those that do not lose more than 5% of their activity during two years of long-term storage), it also encompasses other embodiments that are considered less preferred but nonetheless within the scope of what is defined to be “stable” in the specification, i.e., compositions that do “not lose more than 20%, or more preferably 15%, or even more preferably 10%” of activity. Ex. 1001, 9:28–33. Furthermore, consistent with the specification, our construction of “stable” encompasses embodiments in which stability is determined by comparison to the commercial formulation of adalimumab known in the prior art, i.e., Humira. Decision 8–9. We find no basis to construe “stable” to be limited to the only most preferred embodiment by requiring a loss of no more than 5% activity. See Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (stating “a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment”).” slip op. at 3

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not shown unpatentable

    “These arguments are also unpersuasive. As stated in the Decision: [W]e find that the specification provides a detailed disclosure of the testing used to assess stability (using Humira as the control), and identifies specific ingredients to be included and excluded from the claimed composition, and further identifies the pH that is necessary to achieve the claimed stability. Although there may be certain concentrations of adalimumab or certain types of buffers and sugars that may render the compositions more difficult to stabilize, Petitioner does not explain sufficiently why a POSA would not have known how to adjust or select those ingredients in order to achieve the claimed stable aqueous pharmaceutical composition. Decision 17. As further stated in the Decision: Moreover, even if a POSA would have needed to test whether a particular composition was stable, “[t]he fact that some experimentation is necessary does not preclude enablement; what is required is that the amount of experimentation ‘must not be unduly extensive.” PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564 (Fed. Cir. 1996) (citing Atlas Powder Co. v. E.I. DuPont De Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984)). Indeed, even “a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the invention claimed.” Id. (citing Ex parte Jackson, 217 USPQ 804, 807 (BPAI 1982)). Id. at 17–18. Petitioner’s arguments do not persuade us that we committed legal or factual error in making the foregoing determinations. Accordingly, we are not persuaded that we abused our discretion in determining that Petitioner did not satisfy its burden with respect to the lack of enablement ground for claims 1–12.” slip op. at 5

  • Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable

    “the specification identifies with sufficient clarity each of the ingredients that must be included as part of the claimed composition (i.e., adalimumab, a buffer, polysorbate 80, and a sugar) and further provides a reason to exclude the ingredients that must not be included in theclaimed composition (i.e., mannitol, a citrate/phosphate buffer combination, and sodium chloride). Id. at 13–14. The Decision also explained how one of ordinary skill in the art would recognize that the inventors possessed the claimed invention: Patent Owner identifies teachings in the specification indicating the structural features required for achieving a stable adalimumab composition, which include: 1) avoiding the citrate/phosphate buffer combination in favor of another more stable buffer (such as an acetate buffer); 2) including polysorbate 80 as a stabilizer; 3) removing sodium chloride (NaCl) from the formulation; 4) using a sugar or polyol as the tonicity modifier in place of mannitol/NaCl; and 5) maintaining a pH of at least 5 (with an optimal pH near 5.2). Id. at 60 (citing Ex. 1001, 5:42–44, 21:40–47, 37:25–38:4, 38:1–7, 61:24–25). Patent Owner further asserts, and we agree, that the specification “provides working examples that demonstrate comparable or superior stability to the commercial Humira® formulation” and that Petitioner fails to demonstrate why a POSA would doubt that the formulations that demonstrated improved stability relative to Humira would be stable. Id. at 60–61. Id. at 14. Petitioner’s arguments do not persuade us that we committed legal or factual error in making the foregoing determinations. Accordingly, we are not persuaded that we abused our discretion in determining that Petitioner did not satisfy its burden with respect to the lack of written description ground for claims 1–12.” slip op. at 7

  Claim construction§ 112 disclosure
  Patents in suitUS 10,155,039
• Illumina, Inc. v. Natera, Inc.No claims unpatentable
  PTAB · Dec 11, 2020 · IPR2019-01201 · APJ Cynthia M Hardman · IPR · Final written decision

  Claims 1–27 were not shown unpatentable: the single-cell Dhallan theories lacked a reasonable expectation of success, and Rabinowitz was not established as prior art.

  RulingsFinal written decision

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

    “In sum, Petitioner’s evidence in the Petition establishes that single cells were used for genetic analysis, amplification techniques were known, and SNP arrays could be used to analyze chromosome imbalances. Petitioner’s evidence, however, does not persuasively address the interplay between the amount of DNA in a single cell and the amount of DNA or amplified DNA needed to carry out the claimed method using a SNP 22 genotyping array and Dhallan’s aneuploidy analysis. This is important because Patent Owner cites evidence demonstrating that at the relevant time, “various researchers had determined that very low amounts of DNA could not be reliably used for SNP genotyping arrays (even with intervening amplification).” PO Resp. 47.” slip op. at 22

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

    “On this record, we agree with Patent Owner and Dr. Quackenbush that the ’406 application and ’741 provisional together demonstrate to persons of 23 The ’741 provisional is incorporated by reference into the ’406 application. Ex. 1026, 1:5–13. 48 ordinary skill that the inventors understood pyrosequencing could be used for high-throughput sequencing, if expensive machines were purchased. In other words, the ’741 provisional gives context to the statement in the ’406 application, and we agree with Dr. Quackenbush that “‘[s]uitability’, as the provisional makes clear to a person of ordinary skill in the art, is a cost issue, rather than a technical one.” Ex. 2012 (Quackenbush Decl.) ¶ 277; see also id. ¶¶ 276–80 (opining on disclosures in the ’741 provisional).” slip op. at 48

  • ExcludeMotion to exclude, deniedDenied

    “As to Dr. Quackenbush’s qualifications, although Petitioner characterizes his expertise as relating to statistics, the record reflects that he also has adequate experience in the fields of genetics and biotechnology. For example, he is Professor of Computational Biology and Bioinformatics, the Chair of the Department of Biostatistics, and the Director of the Health Data Science Center at the Harvard TH Chan School of Public Health. Ex. 2013, 1. He has almost three decades of experience in research and teaching in the fields of genetics and biotechnology (id. at 1–8, 12), has published hundreds of articles in these fields (id. at 13–52), was the Editor-in-Chief of the journal Genomics for over a decade (id. at 8), and has served as a peer reviewer, or on the editorial board, of a dozen other publications relating to genetics and biotechnology (id. at 7–8). Paper 49, 2. Given that experience in genetics and biotechnology, we find that Dr. Quackenbush has sufficient 54 specialized knowledge, experience, and education in the techniques of the ’592 Patent and prior art, such as DNA amplification, genotyping, and analysis of genetic data, for his testimony to be helpful to us. Moreover, even if Dr. Quackenbush did not personally work in fetal diagnostics at the relevant time, there is no requirement that a declarant must actually be a person of ordinary skill in the art to present testimony as to what such a person would have understood at the time of the invention. See, e.g., SEB S.A., 594 F.3d at 1373 (stating there is no requirement of a perfect match between an expert’s experience and the field of the art in question, provided the expert has “sufficient relevant technical experience” to testify). The remaining arguments raised in Petitioner’s motion relate to the sufficiency, rather than admissibility, of evidence. Such arguments are improperly advanced in a motion to exclude. See TPG 79 (stating that a motion to exclude may not be used to challenge the sufficiency of the evidence to prove a particular fact); see also Corning Inc. v. DSM IP Assets B.V., IPR2013-00053, Paper 66 at 19 (PTAB May 1, 2014) (“[T]he Board, sitting as a non-jury tribunal, is well-positioned to determine and assign appropriate weight to the evidence presented in this trial.”). Moreover, “there is a strong public policy for making all information filed in an administrative proceeding available to the public.” Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012-00010, Paper 59 at 40 (PTAB February 24, 2014). Rather than excluding evidence that is allegedly 55 confusing, misleading, or incorrect, we simply give it the appropriate weight in our analysis.” slip op. at 54

  • Strike new argumentNew argument disregardedDecided for patent owner

    “success arguments focus solely on Dhallan’s single cell disclosure, while “ignor[ing] Dhallan’s disclosure that its methodology can be performed using 2–32 cells, which also falls within the claims.” Reply 18 (citing, e.g., Pet. 13–14). Patent Owner responds that this is an improper attempt to change the thrust of the obviousness theory presented in the Petition. Sur-reply 16–17. We agree with Patent Owner. Although the Petition references portions of Dhallan that address using sources of DNA other than a single cell (see, e.g., Pet. 13–14, citing Ex. 1002 ¶¶ 44, 74), this is by way of background only, falling within a section titled “Introduction to Dhallan.” See Pet. 11. Petitioner’s detailed obviousness arguments for claim 1 are limited to use of DNA from a single cell, and do not extend to DNA from multiple cells.15 See, e.g., id. at 19–20 (arguing that, because Dhallan’s preferred embodiment is one embryo cell, Dhallan teaches the claimed limitation reciting “wherein the small amount of genetic material from the individual is from fifty or fewer of the individual’s 15 As noted above, claim 1 recites several possible sources for the claimed “small amount of genetic data.” See supra n.9. Here we focus on Petitioner’s unpatentability arguments based on option [i], but note that Petitioner’s unpatentability arguments under options [ii] and [iii] also did not extend to use of DNA from multiple cells. See, e.g., Pet. 20 (cross-referencing arguments for claims 4, 5, and 17); id. at 34 (for claim 4, arguing option [ii] based on “a single human cell”); id. at 35 (for claim 5, arguing option [iii] based on “extracellular fetal DNA from maternal blood”); id. at 42 (for claim 17, arguing option [iii] based on a “single fetal cell”). 30 cells”); id. at 29 (“A POSA would have been motivated to use a single cell as the source of genetic material . . . .”); id. at 31 (“A POSA would have reasonably expected success in using Dhallan’s methodology, for example as described in Example 14, on one embryonic cell.”). Accordingly, we agree with Patent Owner that Petitioner is impermissibly attempting to change the thrust of its obviousness theory on reply. Sur-reply 16–17. We will not consider Petitioner’s belated attempt to argue a reasonable expectation of success in using more than a single cell in the claimed method. 37 C.F.R. § 42.23(b) (“A reply may only respond to arguments raised in the . . . patent owner response.”).” slip op. at 30

  Patent outcomesUS 8,682,592 not shown unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,682,592
• Genome & Company v. The University Of ChicagoAll claims unpatentable
  PTAB · Apr 14, 2020 · PGR2019-00002 · APJ John E Schneider · PGR · Final written decision

  Claims 1–29 are unpatentable: claims 1–17 and 19–28 for lack of enablement and obviousness; claims 18 and 29 for obviousness.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Dr. Braun, Petitioner’s proffered expert, defines a person of ordinary skill in the art as having an advanced degree or its substantial equivalent in the biological sciences, including specifically in the fields of immunology, microbiology and the microbiome, and oncology, coupled with research experience in those fields. Ex. 1002 ¶ 40. Patent Owner does not contest Petitioner’s definition of a person of ordinary skill in the art. See generally, PO Resp. We determine that Petitioner’s description of the level of ordinary skill in the art is supported by the current record. For purposes of this Decision, therefore, we adopt Petitioner’s description. We also note that the applied prior art reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

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

    “interprets claim terms in an unexpired patent according to the broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R. § 100(b) (2018);3 Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (affirming applicability of broadest reasonable construction standard to trial proceeding before the USPTO.). Under that standard, and absent any special definitions, we generally give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definitions for claim terms must be set forth with reasonable clarity, deliberateness, and precision. See In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). We determine that it is unnecessary to expressly construe any claim terms for purposes of this Decision. See 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)).” slip op. at 9

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “We have considered the arguments presented by the parties and the evidence of record and conclude that the unpredictability of the art weighs in favor of finding non-enablement with respect to CPIs in general. While we agree with Patent Owner that CPIs can be effective in treating some cancers, the Specification and the evidence of record show that all of the effective CPIs are antibodies. For example, all of the CPIs listed in the chart of page 10 of Patent Owner’s Response are antibodies. Tr. 39. We find nothing in the record, other than attorney argument that one skilled in the art would know how to make of use other CPIs, such as an interfering nucleic acid molecule, in the claimed method. For example, as Petitioner points out, Patent Owner’s expert did not consider CPIs other than antibodies, in reaching his conclusions regarding enablement. Pet. Reply, 4; Ex. 1042, 19–29. The record also does not support the contention that one skilled in the art could predict the action of non-antibody CPIs based on the action of an antibody CPI. The art and the Specification identify one non-antibody CPI, and the Fe region of human IgG. Ex. 1001, col. 5, ll. 20–23; Ex. 2034, 206. At the time the ’302 patent was filed, studies of this potential CPI indicated that it acted differently than antibody CPIs and that efficacy was lacking compared to other CPIs. Id. This evidence supports Petitioner’s contention that the use of CPIs, especially non-antibody CPIs, was unpredictable at the time the ’302 patent was filed. We also agree with Petitioner that the selection of Bifidobacterium was unpredictable. The evidence of record supports Petitioner’s contention that the immunostimulatory activity of Bifidobacterium varies from strain to strain, even within the same species. Pet. 44–45. O’Mahony teaches that Bifidobacterium longum strain AH1714 is immunosuppressive while another stain of B. longum exhibits immunostimulatory activity. Ex. 1017 ¶¶ 103– 109. Similarly, Lopez evaluated 12 strains of four different species of Bifidobacterium and concluded that the properties exhibited by Bifidobacterium varied among the strains. Ex. 1038, Abstr. Patent Owner’s arguments regarding the credibility of O’Mahony and Lopez are unpersuasive. Patent Owner made specific representations to the Examiner on several occasions that strain AH1714 disclosed in O’Mahony was immunosuppressive to support Patent Owner’s argument that one would not combine an immunosuppressive agent with an immunostimulatory agent. See, e.g. Ex. 1014, 8–9. Patent Owner suggests that it was not asserting that the statements in O’Mahony were accurate, but merely argues that those statements would have led away from making the combination proposed by the Examiner. PO Sur-Reply 10. This argument fails in its logic. If one skilled in the art upon reading O’Mahony would have recognized the alleged errors in O’Mahony’s teachings and disregarded them as Patent Owner now combination advanced by the Examiner in prosecution as Patent Owner argued. With respect to Lopez, Lopez states unambiguously that the immune effects of Bifidobacteria are species and strain specific. Petitioner has advanced evidence that those skilled in the art accepted these conclusions, citing Lopez in subsequent articles. Pet. Reply 10–11 (citing Ex. 1044). Moreover, the present inventors found Lopez to be sufficiently credible to incorporate the teachings of Lopez in their entirety into the instant Specification of the ’302 patent. Ex. 1001, col. 37, l. 62–col. 38, l. 4.” slip op. at 23

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledEnabledMixed

    “evidence of record and conclude that applying the all the Wands factors, Petitioner has demonstrated by a preponderance of the evidence that claims 1–17 and 19–28 are not enabled. In reviewing the evidence of record, we find that the nature of the invention that involves very broad claims, the high level of skill required in such an unpredictable art, and the dearth of working examples and lack of specific guidance on the full range of CPIs and cancers challenged claims are not enabled. Because claims 18 and 29 require known CPIs, however, we find that Petitioner has failed to show that these claims are not enabled.” slip op. at 26

  Patent outcomesUS 9,855,302 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 9,855,302
• Nautilus Hyosung Inc. v. Diebold Nixdorf, Inc.All claims unpatentable
  PTAB · Aug 14, 2017 · CBM2016-00034 · APJ Barbara A Benoit · CBM · Final written decision

  Claims 1–24 are unpatentable under § 101; claims 1–3 and 5 are also anticipated by Riach, and specified claims are obvious over combinations of Riach, Graf, Gustin, and Anderson.

  RulingsFinal written decision

  • Patent Eligibility (§101) › Alice/Mayo step one — 'directed to'Step1 directed to exceptionUnpatentable

    “For these reasons, we determine that claim 20—its focus and its” slip op. at 37

  • Patent Eligibility (§101) › Alice/Mayo step two — inventive conceptStep2 no inventive conceptUnpatentable

    “For the foregoing reasons, we conclude that claim 20 is directed to an” slip op. at 52

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

    “encompasses Riach’s process that copies a portion (but not all) of the original check image data to produce the required modified check image data. Accordingly, we agree that the portion of Riach on which Petitioner relies discloses step (b) of claim 1 that requires, among other limitations, the modified check image data not include at least some visual feature data included in the check image data. Pet. 30 (relying on Ex. 1008, 5:16–30, Figs. 4, 7).” slip op. at 73

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

    “several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 550 U.S. at 418. Rather, “it can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” Apple, 839 F.3d at 1058 (quoting KSR, 550 U.S. at 418–19); see also KSR, 550 U.S. at 418 (“[T]here must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”) (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)).” slip op. at 89

  Patent outcomesUS 7,314,163 unpatentable
  § 101 eligibility§ 102 anticipation§ 103 obviousnesscites Alice · Mayo · Bilski · Enfish · Electric Power · Phillips · Graham
  Patents in suitUS 7,314,163
• 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
• Ultratec, Inc. v. Captioncall, L.L.C.Institution denied
  PTAB · Feb 22, 2017 · PGR2016-00037 · APJ Barbara A Benoit · PGR · Institution

  The Board denied institution on all challenged claims because the petition did not show that any claim was more likely than not unpatentable under § 101 or § 103.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “review of claims 1–23 of U.S. Patent No. 9,197,745 B1 (Ex. 1001, “the ’745 patent” or “the challenged patent”). Paper 1 (“Pet.”). Patent Owner, CaptionCall, L.L.C., filed a Preliminary Response. Paper 9 (“Prelim. Resp.”). We have authority to determine whether to institute a post-grant review. 35 U.S.C. § 324; 37 C.F.R. § 42.4(a). The standard for instituting a post-grant review is set forth in 35 U.S.C. § 324(a), which provides that a post-grant review may be instituted only if “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). After considering the Petition and the Preliminary Response, we determine that the information presented in the Petition does not demonstrate it is more likely than not that at least one of the challenged claims is unpatentable. Accordingly, we do not institute a post-grant review.” slip op. at 2

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

    “interpreted according to their broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R. § 42.200(b); see Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of broadest reasonable construction standard in inter partes review9). Consistent with the broadest reasonable construction standard, claim terms are presumed to have their ordinary and customary meaning as understood by one of ordinary skill in the art in the context of the entire patent disclosure at the time of the invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Petitioner proposes constructions for “message” recited in claims 2, 4–8, and 12 and for “module” recited in claims 2–6 and 8. Pet. 9–11. Patent Owner challenges Petitioner’s proposed claim constructions as overly narrow. Prelim. Resp. 8–9. We determine, however, that no claim terms need express construction for this decision.” slip op. at 9

  • Patent Eligibility (§101) › Alice/Mayo step one — 'directed to'Step1 not directed to exceptionNot shown unpatentable

    “We agree with Patent Owner (Prelim. Resp. 12) that claim 1, as a whole, is directed to an apparatus that facilitates voice communication and captioned text communication using a relay for hearing-impaired users over one or more communications networks and, under specified circumstances— when captioning has been enabled by the hearing-impaired user and the system determines that an attempted connection has failed—automatically reconnects to a captioning communication service. In other words, the claim is directed to a communication device that automatically reconnects to a captioning communication service following an unwanted interruption to the 12 captioning communication service in certain circumstances. See Ex. 1001, 1:13–16 (describing the field of the disclosure as relating to a communication device that automatically reconnects to the captioning communication service “following an unwanted interruption to the captioning communication session”). We determine that claim 1 as a whole is not directed to redialing a telephone as “callers have performed for as long as there have been telephones.” See Pet. 20. Moreover, the claim is directed to an apparatus having communication elements and a processor, and requires two connections and captioning, which, taken as a whole, distinguish claim 1 from a conventional telephone and further supports our determination that the claim merely involves, but is not directed to, the concept of reconnection or redialing. Moreover, looking at the elements individually, claim 1 requires communication elements coupled with a processor configured to able to connect a communication device and connect with a captioning session over two connections. Claim 1 recites a function—“automatically connect with the captioning communication service through a second connection to establish a captioning communication session during the voice communication session responsive to a determination that an attempted connection to the captioning communication service failed during a time in which a caption select option has been enabled by the hearing-impaired user, wherein the attempted automatic connection through the second connection is not made during a time in which the caption select option has been 13 disabled by the hearing-impaired user”—which requires more than “redialing” a telephone. See Prelim. Resp. 11–12. Specifically, the claimed apparatus only performs the “automatically connect” function if three conditions are met: (i) responsive to a determination that an attempted connection to the captioning communication service failed (ii) during a time in which a caption select option has been enabled by the hearing-impaired user, and (iii) “the attempted automatic connection through the second connection is not made during a time in which the caption select option has been disabled by the hearing-impaired user.”” slip op. at 12

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

    “excerpts from Parker as purportedly describing aspects of the automatically reconnect limitation. Id. at 40–42. Petitioner does not assert that either the Ultratec User Guide or Parker alone would have conveyed to one of ordinary skill in the art the automatically connect function with the three conditional limitations (id.), nor is such an assertion required under 35 U.S.C. § 103. Petitioner is required under 35 U.S.C. § 103, however, to explain how the combination of the references would have conveyed to one of ordinary skill 25 in the art the recited automatically connect function with its three conditional limitations. Petitioner has not provided such an explanation, much less adequate analysis by Mr. Zatkovich or factual support as to how one of ordinary skill in the art would understand the separate disclosures of the references to teach the automatically connect limitations. Specifically absent from the Petition is any discussion as to how Petitioner’s combination of references would have conveyed to one of ordinary skill in the art the limitations of automatically connecting under the required conditions—the failed attempt limitation, the when-enabled limitation, and the when-not-disabled limitation. Petitioner’s combination relies on Parker’s reconnection function to establish a lost persistent connection, but Parker’s reconnection function does not do so conditionally, much less under the specific conditions required by claim 1. Petitioner does not explain how the combination of Parker’s unconditional reconnection function would be understood by one of ordinary skill in the art to retry conditionally based on whether the Ultratec User Guide’s caption button was enabling captioning and had not been disabled by the caption telephone user. Furthermore, Petitioner contends that “adding an auto-retry and/or auto-reconnect feature as in Parker to a captioned telephone device as disclosed in [the Ultratec User Guide and Engelke] would amount to simply adding a known technique to a known system, wherein the technique operates in the same way as it was already known to operate and dos not have any unpredictable result.” Pet. 34. As such, Petitioner’s combination 26 expressly relies on Parker’s auto-retry and/or auto-reconnect feature “as in Parker,” which is an unconditional retry in the event of a lost connection. In sum, neither reference by itself describes the automatically reconnect limitation and Petitioner fails to articulate how one of ordinary skill in the art would have understood the claimed automatic reconnect in view of the cited disparate disclosures from the references. “[A] patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Petitioner asserts in a conclusory manner that the combination of a teaching of a button to enable or disable captioning with a teaching of automatic reconnection unrelated to whether captioning is enabled or disabled would have conveyed to one of ordinary skill in the art the automatic reconnection limitation. Petitioner fails to provide adequate explanation or factual support. This flaw of the Petition is particularly problematic when the threshold for institution is “more likely than not,” as here, rather than the threshold of “a reasonable likelihood” required to institute an inter partes review. Compare 35 U.S.C. § 324(a), with 35 U.S.C. § 314(a).” slip op. at 25

  Claim construction§ 101 eligibility§ 103 obviousnesscites Alice · Mayo · Enfish · KSR
  Patents in suitUS 9,197,745
• Captioncall, L.L.C. / Sorenson Communications, Inc. v. Ultratec, Inc.All claims unpatentable
  PTAB · Sep 7, 2016 · IPR2015-00637 · APJ William V Saindon · IPR · Final written decision

  Claims 1–30 are unpatentable as obvious; Patent Owner’s contingent motion to amend is denied for lack of written-description support and indefiniteness.

  RulingsFinal written decision

  • ExcludeMotion to exclude, grantedMotion to exclude, deniedGranted in part

    “admitted that the patented features of voice and revoiced text are responsible for ‘giv[ing] the phone back to folks with hearing loss.’” PO Resp. 48 (emphasis added). Thus, Patent Owner is offering the statement for the truth that voice and re-voiced text gives the phone back to folks with hearing loss. Patent Owner’s argument that Mr. Puzey was discussing the existence of features in his company’s product rather than features in Patent Owner’s product does not change that his statement is offered as proof regarding an alleged long-felt need for the features. Accordingly, his testimony is hearsay. slip op. at 15

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “art is telecommunication systems. Thus, a [POSA] is a person familiar with at least that technology by way of background and/or experience.” CaptionCall, LLC v. Ultratec, Inc., Case IPR2013-00549, Paper 71, 13 (Final Written Decision) (PTAB 2015); see also CaptionCall, LLC v. Ultratec, Inc., Case IPR2013-00780, Paper 35, 9 (Final Written Decision) (PTAB 2015) (reaffirming our finding in IPR2013- 00549). Patent Owner states that it “does not agree” with that definition of a person of ordinary skill in the art, and that, “without waiving the foregoing objection and reserving all rights,” states that it will “appl[y]” our prior definition of a person of ordinary skill in the art “for purposes of this Response.” PO Resp. 3. By not setting forth arguments advocating a particular definition of the level of ordinary skill in the art, and by applying our prior definition, Patent Owner has waived arguments for any other definition. Accordingly, we adopt Petitioner’s proposed level of ordinary skill in the art, as expressed by its declarant, Mr. Occhiogrosso. Ex. 1009 ¶¶ 26–27. This person typically has “a bachelor’s degree” slip op. at 35

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

    “understand a “communication link,” as claimed, to refer to the “communication line” described in the specification. In particular, the link is “intended not only to apply to a traditional land-line . . . but also to all equivalents that offer similar functionality.” Id. at 8:60–63. A link could be “a portion of the bandwidth” of a particular connection, such that a single mode of connection (e.g., IP) could carry out two types of communication (voice and text), with each type corresponding to a different “communication link.” See id. at 8:44–47, 8:63–65. For example, as explained in the ’838 patent, “[e]ach of the telephone lines could be . . . a portion of the bandwidth of an ISDN or DSL service.” Id. at 8:53–65. Accordingly, we adopt Petitioner’s construction of “communication link” as “any communication session, protocol, link, connection, or path distinguishable from [another] communication link[].”” slip op. at 22

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

    “3. Combination of References As we discussed above, Petitioner’s combination takes the two-line” slip op. at 43

  Patent outcomesUS 8,908,838 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR
  Patents in suitUS 8,908,838

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.