`
`Paper No. 27
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`FLATWING PHARMACEUTICALS, LLC and
`MYLAN PHARMACEUTICALS, INC.,
`Petitioners,
`
`v.
`
`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`________________
`
`Case No. IPR2018-00168
`(Joined with IPR2018-01358)
`
`U.S. Patent No. 9,549,938
`________________
`PETITIONER’S 37 C.F.R. § 42.64(c) MOTION TO EXCLUDE1
`January 25, 2019
`
`
`1 Corresponding motions to exclude filed in related proceedings IPR2018-00169
`(U.S. Patent No. 9,566,289, joined with IPR2018-01359), IPR2018-00170 (U.S.
`Patent No. 9,566,290, joined with IPR2018-01360), and IPR2018-00171 (U.S.
`Patent No. 9,572,823, joined with IPR2018-001361) are substantially the same as
`this motion, with citations adjusted to cite correctly the record in each proceeding.
`
`
`
`

`

`
`
`TABLE OF CONTENTS
`
`Table of Contents ..................................................................................................... i 
`
`Table of Authorities ............................................................................................. viii 
`
`Table of Exhibits Cited .......................................................................................... ix 
`
`Introduction .............................................................................................................. 1 
`
`Statement of the Precise Relief Requested ............................................................ 1 
`
`Statement of the Reasons for the Relief Requested .............................................. 2 
`
`I. 
`
`II. 
`
`Applicable Evidentiary Law In General ........................................................ 2 
`
`Specific Identification and Explanation of Objections In The Record
`In Order, per 37 C.F.R. § 42.64(c). ................................................................ 5 
`
`Exhibit 2004 ....................................................................................................... 5 
`
`Exhibit 2005 ....................................................................................................... 5 
`
`Exhibit 2006 ....................................................................................................... 6 
`
`Exhibit 2007 ....................................................................................................... 6 
`
`Exhibit 2008 ....................................................................................................... 6 
`
`Exhibit 2009 ....................................................................................................... 7 
`
`Exhibit 2015 ....................................................................................................... 7 
`
`Exhibit 2016 ....................................................................................................... 7 
`
`Exhibit 2019 ....................................................................................................... 7 
`
`Exhibit 2020 ....................................................................................................... 8 
`
`Exhibit 2021 ....................................................................................................... 8 
`
`Exhibit 2022 ....................................................................................................... 8 
`
`– i –
`
`

`

`
`
`Exhibit 2023 ....................................................................................................... 8 
`
`Exhibit 2023 ....................................................................................................... 8
`
`Exhibit 2024 ....................................................................................................... 9 
`
`Exhibit 2024 ....................................................................................................... 9
`
`Exhibit 2025 ....................................................................................................... 9 
`
`Exhibit 2025 ....................................................................................................... 9
`
`Exhibit 2026 ....................................................................................................... 9 
`
`Exhibit 2026 ....................................................................................................... 9
`
`Exhibit 2027 ..................................................................................................... 10 
`
`Exhibit 2027 ..................................................................................................... 10
`
`Exhibit 2028 ..................................................................................................... 10 
`
`Exhibit 2028 ..................................................................................................... 10
`
`Exhibit 2029 ..................................................................................................... 10 
`
`Exhibit 2029 ..................................................................................................... 10
`
`Exhibit 2030 ..................................................................................................... 11 
`
`Exhibit 2030 ..................................................................................................... 11
`
`Exhibit 2031 ..................................................................................................... 11 
`
`Exhibit 2031 ..................................................................................................... 11
`
`Exhibit 2032 ..................................................................................................... 11 
`
`Exhibit 2032 ..................................................................................................... 11
`
`Exhibit 2033 ..................................................................................................... 12 
`
`Exhibit 2033 ..................................................................................................... 12
`
`Exhibit 2034 ..................................................................................................... 12 
`
`Exhibit 2034 ..................................................................................................... 12
`
`Exhibit 2035 ..................................................................................................... 12 
`
`Exhibit 2035 ..................................................................................................... 12
`
`Exhibit 2036 ..................................................................................................... 13 
`
`Exhibit 2036 ..................................................................................................... 13
`
`Exhibit 2037 ..................................................................................................... 13 
`
`Exhibit 203 7 ..................................................................................................... 13
`
`Exhibit 2038 ..................................................................................................... 13 
`
`Exhibit 2038 ..................................................................................................... 13
`
`Exhibit 2039 ..................................................................................................... 14 
`
`Exhibit 2039 ..................................................................................................... 14
`
`Exhibit 2040 ..................................................................................................... 14 
`
`Exhibit 2040 ..................................................................................................... 14
`
`Exhibit 2041 ..................................................................................................... 14 
`
`Exhibit 2041 ..................................................................................................... 14
`
`Exhibit 2042 ..................................................................................................... 15 
`
`Exhibit 2042 ..................................................................................................... 15
`
`Exhibit 2043 ..................................................................................................... 15 
`
`Exhibit 2043 ..................................................................................................... 15
`
`– ii –
`
`_ii_
`
`

`

`
`
`Conclusion ............................................................................................................... 15 
`
`Certificate of Service .............................................................................................. 17 
`
`
`
`
`
`
`
`– iii –
`
`

`

`
`
`TABLE OF AUTHORITIES
`
`RULES 
`
`Page(s)
`
`FRE 702 ............................................................................................................ 2, 4, 5
`
`FRE 703 .................................................................................................................2, 5
`
`FRE 801 ............................................................................................................ 2, 4, 5
`
`FRE 802 ............................................................................................................ 2, 4, 5
`
`FRE 901 ............................................................................................................ 2, 4, 5
`
`REGULATIONS 
`
`37 C.F.R. § 42.53 .............................................................................................. 2, 3, 5
`
`37 C.F.R. § 42.65 .............................................................................................. 2, 4, 5
`
`
`
`– iv –
`
`

`

`
`
`TABLE OF EXHIBITS CITED
`
`Exhibit Reference
`2004
`Nair 2009a
`
`Nair 2009b
`
`Description
`Nair et al., Alteration of the diffusional barrier
`property of the nail leads to greater terbinafine drug
`loading and permeation, Int’l J. Pharm., vol. 375, pp.
`22–27 (2009)
`Nair et al., A study on the effect of inorganic salts in
`transungual drug delivery of terbinafine, J. Pharm.
`Pharmacol., vol. 61, pp. 431–37 (2009)
`Shivakumar 2010 Shivakumar et al., Bilayered Nail Lacquer of
`Terbinafine Hydrochloride for Treatment of
`Onychomycosis, J. Pharm. Sci., vol. 99, pp. 4267–76
`(2010)
`Shivakumar 2014 Shivakumar et al., Transungual drug delivery: an
`update, J. Drug Del. Sci. Tech., vol. 24, pp. 301–10
`(2014)
`Murthy et al., Iontophoretic Drug Delivery across
`Human Nail, J. Pharm. Sci., vol. 96, pp. 305–11
`(2007)
`Gupta et al., The use of topical therapies to treat
`onychomycosis, Dermatol. Clin., vol. 21, pp. 481–89
`(2003)
`Declaration of Paul J. Reider, Ph.D.
`Declaration of Majella E. Lane, Ph.D.
`Baker et al., Therapeutic potential of boron-
`containing compounds, Future Med. Chem., vol. 1,
`pp. 1275–88 (2009)
`Dennis G. Hall, Structure, Properties, and
`Preparation of Boronic Acid Derivatives: Overview
`of Their Reactions and Applications, in Boronic
`Acids: Preparation and Applications in Organic
`Synthesis, Medicine and Materials, Second Edition
`(Dennis G. Hall ed. 2011)
`Transcript of August 23, 2018 Deposition of Stephen
`B. Kahl, Ph.D.
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2013
`2014
`2015
`
`2016
`
`2017
`
`Murthy 2007
`
`Gupta 2003
`
`Reider Decl.
`Lane Decl.
`Baker 2009
`
`Hall 2011
`
`Kahl Dep.
`
`– v –
`
`

`

`
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`
`2029
`
`Murthy Dep.
`
`Ryan 1987
`
`Brown 2002
`
`Lloyd 1998
`
`Woods 1996
`
`Steiner 1994
`
`Transcript of August 20, 2018 Deposition of S.
`Narasimha Murthy, Ph.D.
`McNamara 1989 McNamara et al., Synthesis of Unsymmetrical
`Dithioacetals: An Efficient Synthesis of a Novel LTD4
`Antagonist, L-660,711, J. Org. Chem., vol. 54, pp.
`3718–21 (1989)
`Ryan et al., Enhanced Reactivity of Iminium Ions as
`Hetero-dienophiles in Lewis Acid Mediated 4+2
`Cycloaddition Reactions, Tetrahedron Letters, vol.
`28, pp. 2103–06 (1987)
`Brown et al., Boron in Plant Biology, Plant Biol. vol.
`4, pp. 205–23 (2002)
`J.D. Lloyd, Borates and their biological
`applications, 29th Annual meeting of the
`International Research Group on Wood Preservation
`(June 1998)
`William G. Woods, Review of Possible Boron
`Speciation Relating to its Essentiality, J. Trace
`Elements in Exp. Med., vol. 9, pp. 153–63 (1996)
`Steiner et al., Diphenylborinic Acid Is a Strong
`Inhibitor of Serine Proteases, Bioorg. & Med. Chem.
`Lett., vol. 4, pp. 2417–20 (1994)
`Zhdankin et al, Synthesis and structure of
`benzoboroxoles: novel organoboron heterocycles,
`Tetrahedron Letters, vol. 40, pp. 6705-08 (1999)
`Dowlut & Hall, An Improved Class of Sugar-Binding
`Boronic Acids, Soluble and Capable of Complexing
`Glycosides in Neutral Water, J. Am. Chem. Soc.,
`vol. 128, pp. 4226–27 (2006)
`Boni E. Elewski, Onychomycosis: Pathogenesis,
`Diagnosis, and Management, Clin. Microbiology
`Revs., vol. 11, pp. 415–29 (1998)
`Wang et al., Keratin: Structure, mechanical
`properties, occurrence in biological organisms, and
`efforts at bioinspiration, Prog. Mater. Sci., vol. 76,
`pp. 229–318 (2016)
`Runne & Orfanos, The Human Nail: Structure,
`Growth and Pathological Changes, Curr. Prob.
`Derm. vol. 9, pp. 102–49 (1981)
`
`Zhdankin 1999
`
`Dowlut 2006
`
`Elewski 1998
`
`Wang 2016
`
`Runne 1981
`
`– vi –
`
`

`

`
`
`2030
`
`2031
`
`2032
`
`2033
`
`2034
`
`2035
`
`2036
`
`2037
`
`2038
`
`Murthy 2013
`
`Walters 1983
`
`Mertin 1997a
`
`Mertin 1997b
`
`Topical Nail Products and Ungual Drug Delivery
`(Murthy & Maibach eds. 2013)
`Walters et al., Physicochemical characterization of
`the human nail: permeation pattern for water and
`the homologous alcohols and differences with
`respect to the stratum corneum, J. Pharm.
`Pharmacol. vol. 35, pp. 28–33 (1983)
`Kobayashi 2004 Kobayashi et al., In vitro permeation of several
`drugs through the human nail plate: relationship
`between physicochemical properties and nail
`permeability of drugs, Eur. J. Pharm. Sci., vol. 21 pp.
`471–77 (2004)
`Mertin & Lippold, In-vitro Permeability of the
`Human Nail of a Keratin Membrane from Bovine
`Hooves: Influence of the Partition Coefficient
`Octanol/Water and the Water Solubility of Drugs on
`their Permeability and Maximum Flux, J. Pharm.
`Pharmacol., vol. 49, pp. 30–34 (1997)
`Mertin & Lippold, In-vitro Permeability of the
`Human Nail and of a Keratin Membrane from
`Bovine Hooves: Penetration of Chloramphenicol
`from Lipophilic Vehicles and a Nail Lacquer, J.
`Pharm. Pharmacol., vol. 49, pp. 241–45 (1997)
`Pollak et al., Efinaconazole Topical Solution, 10%:
`Factors Contributing to Onychomycosis Success, J.
`Fungi, vol. 1, pp. 107–14 (2015)
`Sugiura et al., The Low Keratin Affinity of
`Efinaconazole Contributes to Its Nail Penetration
`and Fungicidal Activity in Topical Onychomycosis
`Treatment, Antimicrobial Agents & Chemotherapy,
`vol. 58, pp. 3837–42 (2014)
`Tatsumi et al., Therapeutic Efficacy of Topically
`Applied KP-103 against Experimental Tinea
`Unguium in Guinea Pigs in Comparison with
`Amorolfine and Terbinafine, Antimicrobial Agents &
`Chemotherapy, vol. 46, pp. 3797–801 (2002)
`Biobor JF Service Bulletin No. 982
`
`Pollak 2015
`
`Sugiura 2014
`
`Tatsumi 2037
`
`
`
`– vii –
`
`

`

`
`
`2039
`
`Yao 2002
`
`2040
`
`Lee 1979
`
`2041
`
`Marova 1995
`
`2042
`
`Bakan 1985
`
`Forslind 1970
`
`
`
`
`2043
`
`2046
`2047
`
`
`
`
`Yao et al., Borate Esters Used as Lubricant
`Additives, Lubrication Science, vol. 14, pp. 415–23
`(2002)
`Lee & Wong, Toxic Effects of Some Alcohol and
`Ethylene Glycol Derivatives on Cladosporium
`resinae, Applied & Envtl. Microbiol., vol. 38, pp.
`24–28 (1979)
`Marova et al., Non-enzymatic glycation of epidermal
`proteins of the stratum corneum in diabetic patients,
`Acta Diabetolog-ica, vol. 32, pp. 38–43 (1995)
`Bakan & Bakan, Glycosylation of nail in diabetics:
`possible marker of long-term hyperglycaemia, Clin.
`Chim. Acta, vol. 147, pp 1–5 (1985)
`Bo Forslind, Biophysical Studies of the Normal Nail,
`Acta Derm Venerol, vol. 5, pp. 161–68, (1970)
`Murthy Rebuttal Dep, Jan. 8, 2019
`Kahl Rebuttal Dep, Jan. 8, 2019.
`
`– viii –
`
`

`

`
`
`INTRODUCTION
`
`Petitioner FlatWing Pharmaceuticals, LLC (“Petitioner”) moves to exclude
`
`the exhibits and testimony cited below because Patent Owner has tried to use them
`
`in way contrary to the Federal Rules of Evidence (“FRE”) concerning
`
`authentication, foundation, expert testimony, hearsay, and improper impeachment.
`
`Technical articles are typically used in patent proceedings as prior art, offered not
`
`for the truth of the matters asserted or the expert opinions expressed by their
`
`authors, but for the legally operative fact of a prior disclosure of subject matter
`
`relevant to anticipation or obviousness. Here, however, Patent Owner has sought to
`
`use quotes from such articles for the truth of the matter asserted, which would be
`
`hearsay, amounting to expert opinion testimony from the authors of those out of
`
`court statements, contrary to the rules on expert testimony, seeking improperly to
`
`bolster their own experts or improper impeachment of petitioner’s experts, and
`
`without even laying a proper foundation authenticating the exhibits. Accordingly,
`
`petitioner seeks exclusion of those exhibits and the testimony relating to them from
`
`Patent Owner’s experts and from the cross-examination of Petitioner’s experts.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED
`
`Exhibits 2004, 2005, 2006, 2007, 2008, 2009, 2015, 2016, 2019, 2020, 2021,
`
`2022, 2023, 2024, 2025, 2026, 2027, 2028, 2029, 2030, 2031, 2032, 2033, 2034,
`
`2035, 2036, 2037, 2038, 2039, 2040, 2041, 2042, and 2043 should be excluded for
`
`– 1 –
`
`

`

`
`
`the reasons set forth in Petitioner’s Objections to Patent Owner’s Evidence, Paper
`
`15, Sept. 14, 2018 (“Pet. Obj.”). The quotations of, excerpts from, and citations to
`
`those articles in Patent Owner’s Response, Paper #13, Sept. 7, 2018 (“PO Resp.”),
`
`and in testimony including (i) paragraphs 25, 30, 33, 37, 38, 41, 42, 44, 45, 48, 51,
`
`52, 59, 60, 61 & n.1, 62, 63, 65, 66, 67, 68, and 69 of the Declaration of Paul J.
`
`Reider, Ph.D. (Ex. 2013) (“Reider Decl.”); (ii) paragraphs 22, 23, 24, 25, 26, 27,
`
`30, 32, 33, 34, 35, 36, 37, 38, 40, 41, 42 & n.1, 43, 44, 45, 46, 47, 48, 49, 51, 54,
`
`55 & n.3, 57, 74, 76, 79, and 83 of the Declaration of Majella E. Lane, Ph.D. (Ex.
`
`2014) (“Lane Decl.”); (iii) parts of the Kahl Dep. (Ex. 2017); (iv) parts of the
`
`Murthy Dep. (Ex. 2018); parts of the Murthy Rebuttal Dep. (Ex. 2046); and parts
`
`of the Kahl Rebuttal Dep. (Ex. 2047), as objected to in Pet. Obj and on the record
`
`in those depositions. The articles themselves and the quotations of, excerpts from,
`
`and citations to those articles should be excluded as improper expert testimony
`
`under FRE 702–703 and 37 C.F.R. § 42.65, direct testimony without an affidavit
`
`under 37 C.F.R. § 42.53, hearsay under FRE 801–802, and lacking adequate
`
`foundation and authentication under FRE 901.
`
`STATEMENT OF THE REASONS FOR THE RELIEF REQUESTED
`
`I.
`
`Applicable Evidentiary Law In General
`
`Books, treatises, journal articles, and other non-patent literature are typically
`
`used in patent cases as prior art, on issues such as anticipation, obviousness, the
`
`– 2 –
`
`

`

`
`
`scope and content of the prior art, or secondary considerations like teaching away.
`
`When used in that manner, the articles are neither offered for the truth of the matter
`
`asserted nor in the nature of expert testimony by their authors. The mere fact of the
`
`disclosure in such publications is itself legally relevant. Here, however, in this
`
`case, Patent Owner seeks to use the objected to articles in a fundamentally
`
`different way. Throughout PO Resp., the direct testimony of its witnesses in the
`
`Reider Decl. and Lane Decl., and in questioning during cross-examination
`
`depositions of Petitioner’s witnesses, Patent Owner sought to use quotations of,
`
`excerpts from, and citations to these articles as substantive evidence for the truth of
`
`the matters asserted therein. In effect, this amounted to trying to use the articles
`
`themselves as additional expert testimony from the authors thereof, which would
`
`be contrary to the rules of evidence and regulations governing these proceedings.
`
`Patent Owners are using the articles themselves as uncompelled direct
`
`testimony. All uncompelled direct testimony “must be submitted in the form of an
`
`affidavit.” 37 C.F.R. § 42.53. Using the articles themselves as though they were
`
`testimony by the authors violates that regulation, and is grounds for exclusion.
`
`That evidence from those articles would be in the nature of expert opinion
`
`testimony. Expert testimony requires a showing that the witness is “qualified as an
`
`expert by knowledge, skill, experience, training, or education”; that “the expert’s
`
`scientific, technical, or other specialized knowledge will help the trier of fact to
`
`– 3 –
`
`

`

`
`
`understand the evidence or to determine a fact in issue”; that “the testimony is
`
`based on sufficient facts or data”; that “the testimony is the product of reliable
`
`principles and methods”; and that “the expert has reliably applied the principles
`
`and methods to the facts of the case.” FRE 702. In addition, in Patent Office trials
`
`in particular, expert testimony must also meet the requirements of 37 CFR § 42.65,
`
`disclosing for any test or data why it is used, how it is performed, and how it is
`
`regarded in the art. Patent Owner has shown none of those things for these articles,
`
`and they are due to be excluded.
`
`The articles and statements therein are also out of court statements offered
`
`for the truth of the matters asserted, and inadmissible hearsay under FRE 801–802.
`
`For each of the articles, the hearsay declarant is the author and the out of court
`
`statement is the material patent owner quotes from the article. Such evidence is
`
`inadmissible hearsay, and due to be excluded.
`
`Moreover, nothing in the evidence submitted (including the Reider Decl.
`
`and Lane Decl.) establishes a proper foundation authenticating that these exhibits
`
`even are what they purport to be under FRE 901. Patent Owner served
`
`supplemental evidence asserting those exhibits to be “true and correct copies,” but
`
`if Patent Owner files that supplemental evidence it will be reveal that nothing in it
`
`shows that the declarant has any personal knowledge of the authenticity of those
`
`exhibits, how they were obtained, or from whence they came. In a civil action in
`
`– 4 –
`
`

`

`
`
`federal court these questions might have been addressed through discovery,
`
`requests to admit, stipulations, or a pretrial order, but in a proceeding such as this it
`
`was incumbent on Patent Owner to lay a proper evidentiary foundation for these
`
`exhibits in its submissions, and it has simply failed to do so.
`
`II.
`
`Specific Identification and Explanation of Objections In The Record In
`Order, per 37 C.F.R. § 42.64(c).
`For the reasons discussed supra, pp. 2–5, the way in which Patent Owner
`
`here seeks to use each of the following articles and the information therein violates
`
`37 C.F.R. § 42.53, FRE 702–703 and 37 C.F.R. § 42.65, FRE 801–802, and FRE
`
`901. The exhibits and the below identified quotations of, excerpts from, and
`
`citations to these articles should be excluded.
`
`Exhibit 2004 purports to be an article cited as Nair 2009a, which Patent
`
`Owner used in the Murthy Dep., Ex. 2018 at 36:13–43:23; PO Resp., Paper 13 at 2
`
`& n.2, 4, 18, 34, and 41; and the Lane Decl., Ex. 2014 ¶ 55 n.3. Patent Owner
`
`and/or the witness quotes the article as evidentiary support for propositions such
`
`as, for example, that the nail is a “formidable barrier.” Petitioner objected. (Murthy
`
`Dep. 38:21–22, Pet. Obj., Paper 15 at 4–5.)
`
`Exhibit 2005 purports to be an article cited as Nair 2009b, which Patent
`
`Owner used in Murthy Dep., Ex. 2018 at 43:24–49:15; PO Resp., Paper 13 at 2 &
`
`n.3, 4, and 19; and Lane Decl., Ex. 2014 ¶ 55 n.3. Patent Owner there quotes the
`
`article as evidentiary support for propositions such as, for example, the “inability
`
`– 5 –
`
`

`

`
`
`to deliver a therapeutically effective amount.” Petitioner objected. (Murthy Dep.,
`
`Ex. 2018 45:17–18, 46:10–11; Pet. Obj., Paper 15 at 6–7.)
`
`Exhibit 2006 purports to be an article cited as Shivakumar 2010, which
`
`Patent Owner used in Murthy Dep., Ex. 2018 at 49:16–53:24; PO Resp., Paper 13
`
`at 3 & n.4 and 4; and Lane Decl., Ex. 2014 ¶ 40, 43, 48, and 55. Patent Owner
`
`there quotes the article as evidentiary support for propositions such as, for
`
`example, that “topical therapy continues to pose a challenge.” Petitioner objected.
`
`(Murthy Dep., Ex. 2018 45:17–18, 46:10–11; Pet. Obj., Paper 15 at 7–8.)
`
`Exhibit 2007 purports to be an article cited as Shivakumar 2014, which
`
`Patent Owner used in Murthy Dep., Ex. 2018 at 63:6–75:9; PO Resp., Paper 13 at
`
`18–19, 20 (twice), 21, 22, 24, and 41; and Lane Decl., Ex. 2014 ¶¶ 40, 43, 48, 55,
`
`and 79. Patent Owner there quotes the article as evidentiary support for
`
`propositions such as, for example, that “topical therapy continues to pose a
`
`challenge.” Petitioner objected. (Murthy Dep., Ex. 2018 at 66:3–5, 67:3–6 & 20–
`
`21; Pet. Obj., Paper 15 at 8–9.)
`
`Exhibit 2008 purports to be an article cited as Murthy 2007, which Patent
`
`Owner used in Murthy Dep., Ex. 2018 at 79:14–80:22; PO Resp., Paper 13 at 1–2
`
`& n.1, 3 & n.4, 4, 16, 17, 21 (twice), 22, 43, and 45; and Reider Decl., Ex. 2013
`
`¶ 63. Patent Owner there quotes the article as evidentiary support for propositions
`
`such as, for example, “factors that could limit the accumulation and activity of
`
`– 6 –
`
`

`

`
`
`drugs in the nail on topical application.” Petitioner objected. (Pet. Obj., Paper 15 at
`
`9–10.)
`
`Exhibit 2009 purports to be an article cited as Gupta 2003, which Patent
`
`Owner used in Murthy Dep., Ex. 2018 at 69:10–74:2; and PO Resp., Paper 13 at
`
`24. Patent owner there cites the article as having been cited in Shivakumar et al.
`
`2014, making it not just hearsay but double hearsay. Petitioner objected. (Murthy
`
`Dep., Ex. 2018 at 70:24–71:2; Pet. Obj., Paper 15 at 10–11.)
`
`Exhibit 2015 purports to be an article cited as Baker 2009, which Patent
`
`Owner used in PO Resp., Paper 13 at 4 n.6, 9, and 37 and Reider Decl., Ex. 2013
`
`¶ 38. Patent Owner there quotes the article as evidentiary support for propositions
`
`such as, for example, that VELCADE® was “the only boron-based therapeutic
`
`currently on the market.” Petitioner objected. (Pet. Obj., Paper 15 at 30–31.)
`
`Exhibit 2016 purports to be an article cited as Hall 2011, which Patent
`
`Owner used in PO Resp., Paper 13 at 4–5 n.6, 8–9, 10 & n.9, 11 & n.10, 13, 14
`
`n.12, and 38 and Reider Decl., Ex. 2013 ¶¶ 25, 37, 38, 52, 59, 60, 61 & n.1, 66,
`
`and 68. Patent Owner there quotes the article as evidentiary support for
`
`propositions such as, for example, that the “ultimate fate of all boronic acids in air
`
`and aqueous media is their slow oxidation into boric acid.” Petitioner objected.
`
`(Pet. Obj., Paper 15 at 31–32.)
`
`Exhibit 2019 purports to be an article cited as McNamara 1989, which
`
`– 7 –
`
`

`

`
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`Patent Owner used in PO Resp., Paper 13 at 10 n.8; and Reider Decl., Ex. 2013
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`¶¶ 30 (twice) and 59. Patent Owner there cites the article as evidentiary support for
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`propositions such as, for example, consequences of boron’s ability to form
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`complexes. Petitioner objected. (Pet. Obj., Paper 15 at 33–34.)
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`Exhibit 2020 purports to be an article cited as Ryan 1987, which Patent
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`Owner used in PO Resp., Paper 13 at 10 n.8 and 38; and Reider Decl., Ex. 2013
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`¶¶ 30 and 59. Patent Owner there cites the article as evidentiary support for
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`propositions such as, for example, consequences of boron’s ability to form
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`complexes. Petitioner objected. (Pet. Obj., Paper 15 at 34–35.)
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`Exhibit 2021 purports to be an article cited as Brown 2002, which Patent
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`Owner used in PO Resp., Paper 13 at 10 n.9 and 38; and Reider Decl., Ex. 2013
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`¶¶ 25, 61 n.1, and 68. Patent Owner there cites the article as evidentiary support for
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`propositions such as, for example, consequences of boron’s “unique” and
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`“promiscuous” properties. Petitioner objected. (Pet. Obj., Paper 15 at 35–36.)
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`Exhibit 2022 purports to be an article cited as Lloyd 1998, which Patent
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`Owner used in PO Resp., Paper 13 at 10 n.9 and 38, and in Reider Decl., Ex. 2013
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`¶¶ 52, 61 n.1, 67, and 69. Patent Owner there cites the article as evidentiary
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`support for propositions such as, for example, consequences of boron’s “unique”
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`and “promiscuous” properties. Petitioner objected. (Pet. Obj., Paper 15 at 36–37.)
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`Exhibit 2023 purports to be an article cited as Woods 1996, which Patent
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`– 8 –
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`Owner used in PO Resp., Paper 13 at 10 n.9 and 38, and in Reider Decl., Ex. 2013
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`¶ 61 n.1. Patent Owner there cites the article as evidentiary support for propositions
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`such as, for example, consequences of boron’s “unique” and “promiscuous”
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`properties. Petitioner objected. (Pet. Obj., Paper 15 at 37–38.)
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`Exhibit 2024 purports to be an article cited as Steiner 1994, which Patent
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`Owner used in PO Resp., Paper 13 at 11 n.10, and in Reider Decl., Ex. 2013 ¶ 33.
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`Patent Owner there cites the article as evidentiary support for propositions such as,
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`for example, that boron compounds were generally known to hydrolyze in the
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`presence of water to form boric acid. Petitioner objected. (Pet. Obj., Paper 15 at
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`38–39.)
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`Exhibit 2025 purports to be an article cited as Zhdankin 1999, which Patent
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`Owner used in PO Resp., Paper 13 at 14 n.12 and 44, and in Reider Decl., Ex.
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`2013 ¶ 60 (twice). Patent Owner there cites the article as evidentiary support for
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`propositions such as, for example, that a POSA would have also known that
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`tavaborole was capable of hydrogen bonding to other molecular species based on
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`the crystallization structure of benzoxaborole as a hydrogen-bonded dimer.
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`Petitioner objected. (Pet. Obj., Paper 15 at 39–40.)
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`Exhibit 2026 purports to be an article cited as Dowlut 2006, which Patent
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`Owner used in PO Resp., Paper 13 at 14 n.12, and in Reider Decl., Ex. 2013 ¶ 61.
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`Patent Owner there cites the article as evidentiary support for propositions such as,
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`– 9 –
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`for example, that a POSA in 2005 would have had no reason to think that
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`tavaborole’s boron substituent would behave any differently with respect to its
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`reactivity, stability, and propensity to form complexes and dative bonds. Petitioner
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`objected (Pet. Obj., Paper 15 at 40–41.)
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`Exhibit 2027 purports to be an article cited as Elewski 1998, which Patent
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`Owner used in PO Resp., Paper 13 at 14 n.13, and in Lane Decl., Ex. 2014 ¶¶ 25,
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`57. Patent Owner there cites the article as evidentiary support for propositions such
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`as, for example, that the “most common form of onychomycosis . . . is
`
`characterized by invasion of the nail bed and underside of the nail plate.” Petitioner
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`objected. (Pet. Obj., Paper 15 at 41–42.)
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`Exhibit 2028 purports to be an article cited as Wang 2016, which Patent
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`Owner used in PO Resp., Paper 13 at 15 & n.14, 44, and in Lane Decl., Ex. 2014
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`¶¶ 26 (twice). Patent Owner there cites the article as evidentiary support for
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`propositions such as, for example, that a POSA in 2005 would have predicted
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`tavaborole to have high keratin-binding affinity because keratin contains a high
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`proportion of amino acids with electron-rich functional groups. Petitioner objected.
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`(Pet. Obj., Paper 15 at 42–43.)
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`Exhibit 2029 purports to be an article cited as Runne 1981, which Patent
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`Owner used in PO Resp., Paper 13 at 16 n.15, and in Lane Decl., Ex. 2014 ¶¶ 23
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`(four times), 24, 25. Patent Owner there cites the article as evidentiary support for
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`– 10 –
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`
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`propositions such as, for example, that water, which comprises from about 10% to
`
`30% of the nail depending on the relative humidity. Petitioner objected. (Pet. Obj.,
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`Paper 15 at 44.)
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`Exhibit 2030 purports to be an article cited as Murthy 2013, which Patent
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`Owner used in PO Resp., Paper 13 at 19, and in Lane Decl., Ex. 2014 ¶¶ 27, 43
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`(twice), 54-55. Patent Owner there cites the article as evidentiary support for
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`propositions such as, for example, that “[d]evelopment of topical formulations to
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`deliver effective amounts of drugs into the nail apparatus is highly challenging.”
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`Petitioner objected. (Pet. Obj., Paper 15 at 45.) In addition, Petitioner objects to
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`Patent Owner’s use of Murthy Rebuttal Dep., Ex. 2046 at 64:17-69:18, 71:6–13,
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`and moves to exclude for the reasons set forth above, and further notes that the use
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`is not proper impeachment because it is not contrary to any of Dr. Murthy’s
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`testimony on direct.
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`Exhibit 2031 purports to be an article cited as Walters 1983, which Patent
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`Owner used in PO Res