`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Paper No. ___
`Filed: December 22, 2017
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`ACRUX DDS PTY LTD., ACRUX LIMITED, and
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioners,
`
`v.
`
`KAKEN PHARMACEUTICAL CO., LTD. and
`VALEANT PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner.
`
`
`
`Case: IPR2017-001901
`U.S. Patent No. 7,214,506
`
`
`
`PATENT OWNER’S MOTION TO EXCLUDE UNDER
`37 C.F.R. § 42.64(C)
`
`
`
`
`
`
`
`
`
`
`1 Case IPR2017-01429 has been joined with the instant proceeding.
`
`
`
`

`

`
`
`Table of Contents
`
`INTRODUCTION ........................................................................................... 1
`
`
`I.
`
`II. ARGUMENT ................................................................................................... 1
`
`A.
`
`The Board Should Exclude Petitioner’s Documentary Evidence
`That Is Unauthenticated and/or Hearsay ............................................... 1
`
`1.
`
`2.
`
`3.
`
`The Ogura Reference (Exhibit 1012) Should Be
`Excluded as It Is Inadmissible Hearsay ...................................... 1
`
`The Arika Reference (Exhibit 1513) Should Be Excluded
`as It Is Improper, Unauthenticated, and Irrelevant
`Hearsay ........................................................................................ 4
`
`Exhibits 1512, 1522, 1524, 1525, 1527-1549, 1551,
`1553, 1554, 1555, 1557-1560, 1566, 1569, 1576, 1577,
`1580-1585, 1588, 1594, 1599, 1603-1605, 1607, 1609,
`1613, 1617, 1619, 1621, 1623, 1626-1629, 1632-1636,
`1638-1645, 1658, and 1660 Should Be Excluded as They
`Are Improper Unauthenticated Webpages .................................. 7
`
`B.
`
`Portions of Dr. Walters’ Declarations (Exhibits 1005 and 1509)
`Should Be Excluded Because He Is Not Qualified in the
`Pertinent Art .......................................................................................... 9
`
`III. CONCLUSION ..............................................................................................14
`
`
`
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`
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`
`
`

`

`
`
`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
`
`TABLE OF AUTHORITIES
`
`Cases
`ABS Global, Inc. v. Inguran, LLC,
`IPR2016-00927 (PTAB Oct. 2, 2017) (Paper 33) ................................................ 3
`
`Page(s)
`
`Apple Inc. v. DSS Tech. Management, Inc.,
`IPR2015-00373 (P.T.A.B. June 25, 2015) (Paper 8) ............................................ 2
`
`Daubert v. Merrell Dow Pharm., Inc.,
`509 U.S. 579 (1993) ............................................................................................ 10
`
`EMC Corp. v. Personalweb Techs., LLC,
`IPR2013-00084 (PTAB May 15, 2014) (Paper 64) .............................................. 8
`
`Hilgraeve, Inc. v. Symantex Corp.,
`271 F.Supp.2d 964 (E.D. Mich. 2003) ................................................................. 3
`
`In re Cronyn,
`890 F.2d 1158 (Fed. Cir. 1989) ............................................................................ 3
`
`In re Paoli R.R. Yard PCB Litig.,
`35 F.3d 717 (3d Cir. 1994) ................................................................................. 10
`
`Kalamazoo River Study Group v. Menasha Corp.,
`228 F.3d 648 (6th Cir. 2000) ................................................................................ 6
`
`Servicenow Inc. v. Hewlett Packard Co.,
`IPR2015-00716 (PTAB August 26, 2015) (Paper 13) ......................................... 2
`
`Smart Microwave Sensors GmbH v. Wavetronix LLC,
`IPR2016-00488 (PTAB July 17, 2017) (Paper 57) .......................................... 2, 3
`
`Standard Innovation Corp. v. Lelo, Inc.,
`IPR2014-00148 (PTAB April 23, 2015) (Paper 41)............................................. 3
`
`Sundance, Inc. v. Demonte Fabricating Ltd.,
`550 F.3d 1356 (Fed. Cir. 2008) .......................................................................... 11
`
`Threadgill v. Armstrong World Industries, Inc.,
`928 F.2d 1366 (3d Cir. 1991) ............................................................................... 6
`
`
`
`iii
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`

`

`
`U.S. v. Demjanjuk,
`367 F.3d 623 (6th Cir. 2004) ................................................................................ 6
`
`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
`
`U.S. v. Firishchak,
`468 F.3d 1015 (7th Cir. 2006) .............................................................................. 5
`
`U.S. v. Jackson,
`208 F.3d 633 (7th Cir. 2000) ................................................................................ 8
`
`Victaulic Co. v. Tieman,
`499 F.3d 227 (3d Cir. 2007), as amended (Nov. 20, 2007) .................................. 8
`
`
`Regulations and Statutes
`
`Page(s)
`
`35 U.S.C. 102 ........................................................................................................... 11
`
`35 U.S.C. 103 ........................................................................................................... 11
`
`37 C.F.R. § 42.64 ............................................................................................... 1, 4, 7
`
`
`Rules
`
`Page(s)
`
`Fed. R. Evid. 402 ....................................................................................................... 5
`
`Fed. R. Evid. 702 ........................................................................................... 9, 10, 11
`
`Fed. R. Evid. 801 ................................................................................................... 1, 5
`
`Fed. R. Evid. 802 ............................................................................................... 1, 2, 5
`
`Fed. R. Evid. 803 ....................................................................................................... 1
`
`Fed. R. Evid. 803(16) ................................................................................................. 5
`
`Fed. R. Evid. 901 ....................................................................................................... 8
`
`Fed. R. Evid. 901(b)(8) .......................................................................................... 5, 6
`
`Fed. R. Evid. 902 ....................................................................................................... 8
`
`
`
`
`
`iv
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`

`

`
`I.
`
`INTRODUCTION
`
`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
`
`Pursuant to 37 C.F.R. § 42.64(c) and the Scheduling Order (Paper No. 13),
`
`Kaken Pharmaceutical Co., Ltd. and Valeant Pharmaceuticals International, Inc.
`
`(collectively “Patent Owner”) hereby move to exclude from the record certain
`
`exhibits under the Federal Rules of Evidence for lack of relevance, lack of
`
`authenticity, and/or hearsay, and to exclude portions of Dr. Walters’ declarations
`
`as he is not qualified to testify as an expert.
`
`II. ARGUMENT
`A. The Board Should Exclude Petitioner’s Documentary Evidence
`That Is Unauthenticated and/or Hearsay
`The Ogura Reference (Exhibit 1012) Should Be Excluded as
`1.
`It Is Inadmissible Hearsay
`
`On November 2, 2016, Petitioner filed Exhibit 1012, Ogura et al., CHEM
`
`PHARM. BULL. 47(10) 1417-1425 (1999) [hereinafter “Ogura”]. Petitioner relied on
`
`Ogura in Grounds 1-3 of its petition for institution. Paper No. 1 at 4. Patent
`
`Owner timely filed objections to Ogura on May 15, 2017. See Paper No. 15 at 2
`
`(objecting that, inter alia, “Ex. 1012 appears to be inadmissible hearsay under FRE
`
`801, 802, 803.”)
`
`Fed R. Evid. 801 defines hearsay as “a statement that: (1) the declarant does
`
`not make while testifying at the current trial or hearing; and (2) a party offers in
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`1
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`evidence to prove the truth of the matter asserted in the statement.” Fed. R. Evid.
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
`
`802 renders hearsay inadmissible.
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`In an attempt to establish invalidity, Petitioner relies on Ogura’s printed
`
`publication date to prove that the article was available before the critical date of the
`
`’506 patent:
`
`Ogura was published in October of 1999. (Ex. 1012.) Because
`the ‘506 patent is not entitled to a priority date earlier than the
`PCT filing date of July 11, 2000, Ogura is prior art to the ’506
`patent pursuant to 35 U.S.C. § 102(a).
`
`Paper No. 1 at 21-22. This 1999 date, printed on the face of Ogura, is relied on by
`
`Petitioner as evidence of its publication date but constitutes inadmissible hearsay.
`
`See e.g., Smart Microwave Sensors GmbH v. Wavetronix LLC, IPR2016-00488 at
`
`25 (PTAB July 17, 2017) (Paper 57) (“we determine infra, that a copyright notice
`
`date or other alleged publication data on the [journal article and textbook] is
`
`hearsay, to which no exception applies.”); Servicenow Inc. v. Hewlett Packard Co.,
`
`IPR2015-00716 at 16-17 (PTAB August 26, 2015) (Paper 13) (denying institution
`
`as dates on documents were inadmissible hearsay, and thus there was a lack of
`
`evidence that the documents were publicly accessible); Apple Inc. v. DSS Tech.
`
`Management, Inc., IPR2015-00373 at 10-11 (P.T.A.B. June 25, 2015) (Paper 8)
`
`(denying institution as date on library stamp was inadmissible hearsay, and thus
`
`
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`2
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`

`

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`there was a lack of evidence that the document was publicly accessible); see also,
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
`
`Hilgraeve, Inc. v. Symantex Corp., 271 F.Supp.2d 964, 974 (E.D. Mich. 2003)
`
`(finding dates, such as copyright dates, on alleged prior art publications were
`
`hearsay).
`
`Petitioner has not filed or proffered any further testimony or evidence
`
`adequately establishing the publication date of Ogura, aside from the hearsay date
`
`listed on the article itself. The Board therefore lacks any information from which it
`
`could conclude that Ogura was “sufficiently accessible to the public interested in
`
`the art” before the critical date. See In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir.
`
`1989). Consequently, the grounds relying on Ogura should be withdrawn. See
`
`ABS Global, Inc. v. Inguran, LLC, IPR2016-00927 at 14, 16, 28 (PTAB Oct. 2,
`
`2017) (Paper 33) (as “there is a significant difference between a petitioner’s burden
`
`to establish a ‘reasonable likelihood of success’ at institution, and actually proving
`
`invalidity by a preponderance of the evidence at trial,” Board concluded Petitioner
`
`had not established unpatentability because cited art’s publication date was
`
`hearsay); Smart Microwave Sensors GmbH, IPR2016-00488 at 31 (concluding
`
`Petitioner has not established unpatentability prior to patent’s critical date because
`
`cited art’s publication date was hearsay); Standard Innovation Corp. v. Lelo, Inc.,
`
`IPR2014-00148 at 24 (PTAB April 23, 2015) (Paper 41) (concluding that as
`
`Exhibit was inadmissible hearsay, Petitioner had not demonstrated that the claims
`
`
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`3
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`

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`were unpatentable). It is now too late to correct that deficiency in the record. 37
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
`
`C.F.R. § 42.64(b)(2).
`
`As Ogura’s alleged date of publication is inadmissible hearsay, the Board
`
`should exclude Ogura from the record because Petitioner has not demonstrated that
`
`it serves as prior art to the ’506 patent.
`
`2.
`
`The Arika Reference (Exhibit 1513) Should Be Excluded as
`It Is Improper, Unauthenticated, and Irrelevant Hearsay
`
`On November 1, 2017, Petitioner filed Exhibit 1513, Arika et al., Nishi
`
`Nihon Journal of Dermatology 52(3) 545-549 (1990) [hereinafter “Arika”]. While
`
`Petitioner submitted Arika with its Reply (without ever explaining why it could not
`
`have been submitted earlier), Petitioner only refers to it indirectly. Petitioner
`
`quotes other articles that cite to Arika, including Ogura (Ex. 1012) and a post-
`
`filing article published many years after the critical date of the ’506 patent (Exhibit
`
`2055), to show what may have been known in the art by Arika’s alleged 1990
`
`publication date. See Paper No. 37 at 14. Petitioner also has Dr. Walters discuss the
`
`reference in his declaration. Exhibit 1509 at ¶¶ 24, 26, 56, 57, 59, 65, 66, 69, 71,
`
`91, 102, 115. Patent Owner timely filed objections to Arika on November 8, 2017.
`
`See Paper No. 39 at 16-17 (objecting to Exhibit 1513 as inadmissible hearsay and
`
`for lacking authentication and relevance).
`
`
`
`4
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`

`

`As discussed above with respect to Ogura, publication dates are
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`
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`inadmissible hearsay under Rule 801 and 802, and thus Petitioner may not rely on
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`Arika to show what may have been known in the art by Arika’s alleged 1990
`
`publication date. Petitioner has not filed or proffered any further testimony or
`
`evidence adequately establishing the publication date of Arika, aside from the
`
`hearsay date listed on the article itself. The Board therefore lacks any information
`
`from which it could conclude that Arika was “sufficiently accessible to the public
`
`interested in the art” before the critical date or has any relevance under Rule 402 to
`
`issues in this proceeding.
`
`Patent Owner recognizes that Petitioner may allege that Arika and its 1990
`
`publication date are admissible under the Ancient Documents exception to the
`
`hearsay rule, Fed. R. Evid. 803(16). Patent Owner submits, however, that there is
`
`insufficient evidence to authenticate its asserted publication date to establish this
`
`exception to hearsay.
`
`The Ancient Documents exception to hearsay requires a party asserting the
`
`exception to establish the authenticity of the document. Fed. R. Evid. 803(16)
`
`(providing an exception for a “statement in a document that was prepared before
`
`January 1, 1998, and whose authenticity is established.”) Fed. R. Evid. 901(b)(8)
`
`expressly sets out how to authenticate an ancient document. U.S. v. Firishchak, 468
`
`F.3d 1015, 1021 (7th Cir. 2006) (“Federal Rule of Evidence 901(b)(8) identifies
`
`
`
`5
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`

`

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`the means by which ‘ancient documents’ are authenticated.”); U.S. v. Demjanjuk,
`
`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`367 F.3d 623, 630 (6th Cir. 2004) (“Federal Rule of Evidence 901(b)(8) governs
`
`the admissibility of ancient documents.”); Kalamazoo River Study Group v.
`
`Menasha Corp., 228 F.3d 648, 661-62 (6th Cir. 2000) (affirming district court
`
`exclusion of ancient document for failure to meet Fed. R. Evid. 901(b)(8));
`
`Threadgill v. Armstrong World Industries, Inc., 928 F.2d 1366, 1376 (3rd Cir.
`
`1991) (criticizing district courts for not applying FRE 901(b)(8) to ancient
`
`documents). Specifically, the Rules require “evidence that [the document]:
`
`(A) is in a condition that creates no suspicion about its authenticity;
`
`(B) was in a place where, if authentic, it would likely be; and
`
`(C) is at least 20 years old when offered.”
`
`
`
`There is, however, no evidence that Arika was in a place where, if authentic,
`
`it would likely be found. On its face, Arika says that “[t]his material was copied at
`
`the NLM and may be Subject US Copyright Laws.” Ex. 1513 at 8-13. However,
`
`Petitioner has not filed or proffered any testimony or evidence to substantiate a
`
`claim that Arika was in fact present at the NLM at any time, let alone as of the
`
`asserted 1990 date.
`
`
`
`Indeed, Arika lacks any legible markings showing it was ever at the NLM,
`
`just an illegible copy of what may or may not be a stamp. Nor has Petitioner filed
`
`or proffered any other testimony or evidence to adequately certify that Arika was
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`6
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`accurately copied by anyone with personal knowledge about the document’s
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`authenticity. And even if one assumes arguendo that Arika had been found in the
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`NLM, Petitioner also has not filed or proffered any testimony or evidence
`
`indicating that Arika was there for 20 years. After all, the mere fact that an article
`
`is in the NLM today does not mean it qualifies as an ancient document and
`
`certainly not “in a place where, if authentic, it would likely be.”
`
`As Arika is not authenticated as an ancient document, it is inadmissible
`
`hearsay, including its alleged date of publication. And as a consequence, Petitioner
`
`has also failed to establish that Arika provides any relevant guidance as to what
`
`was understood in the art as of the asserted 1990 publication date. It is now too late
`
`to correct these deficiencies in the record. 37 C.F.R. § 42.64(b)(2). Thus, the
`
`Board should exclude Arika from the record.
`
`3.
`
`Exhibits 1512, 1522, 1524, 1525, 1527-1549, 1551, 1553,
`1554, 1555, 1557-1560, 1566, 1569, 1576, 1577, 1580-1585,
`1588, 1594, 1599, 1603-1605, 1607, 1609, 1613, 1617, 1619,
`1621, 1623, 1626-1629, 1632-1636, 1638-1645, 1658, and
`1660 Should Be Excluded as They Are Improper
`Unauthenticated Webpages
`
`On November 1, 2017, Petitioner filed Exhibits 1512, 1522, 1524, 1525,
`
`1527-1549, 1551, 1553, 1554, 1555, 1557-1560, 1566, 1569, 1576, 1577, 1580-
`
`1585, 1588, 1594, 1599, 1603-1605, 1607, 1609, 1613, 1617, 1619, 1621, 1623,
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`1626-1629, 1632-1636, 1638-1645, 1658, and 1660. Petitioner only cited some of
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`
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`7
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`them in parts of Exhibits 1509-1511 that were, in turn, cited in Petitioner’s Reply
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`only in bulk form. Patent Owner timely filed objections to each of these Exhibits
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`on November 8, 2017. See Paper No. 39 at 8-10, 12, 14, 17-19 (objecting to lack
`
`of authentication).
`
`Each of these exhibits is a copy of a webpage, which has not been properly
`
`authenticated under Federal Rule of Evidence 901 and is not self-authenticating
`
`under Federal Rule of Evidence 902. Petitioner has not filed or proffered any other
`
`testimony or evidence establishing the authenticity of these exhibits. While
`
`Petitioner has proffered declaration testimony that these exhibits are correct copies
`
`downloaded from the respective websites, this is legally deficient.
`
`When offering a printout of a webpage into evidence to prove the website’s
`
`contents, the proponent of the evidence must authenticate the information from the
`
`website itself, not merely the printout. See Victaulic Co. v. Tieman, 499 F.3d 227,
`
`236 (3d Cir. 2007), as amended (Nov. 20, 2007) (citing U.S. v. Jackson, 208 F.3d
`
`633, 638 (7th Cir. 2000)). For this reason, “[t]o authenticate printouts from a
`
`website, the party proffering the evidence must produce some statement or
`
`affidavit from someone with knowledge of the website . . . for example a web
`
`master or someone else with personal knowledge would be sufficient.” EMC Corp.
`
`v. Personalweb Techs., LLC, IPR2013-00084 at 45 (PTAB May 15, 2014) (Paper
`
`64).
`
`
`
`8
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`

`

`Without testimony of a witness with personal knowledge of the information
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
`
`
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`on the website or the associated printouts for any of the exhibits at issue, the Board
`
`should exclude Exhibits 1512, 1522, 1524, 1525, 1527-1549, 1551, 1553, 1554,
`
`1555, 1557 -1560, 1566, 1569, 1576, 1577, 1580-1585, 1588, 1594, 1599, 1603-
`
`1605, 1607, 1609, 1613, 1617, 1619, 1621, 1623, 1626-1629, 1632-1636, 1638-
`
`1645, 1658, and 1660 from the record for lack of authenticity.
`
`B.
`
`Portions of Dr. Walters’ Declarations (Exhibits 1005 and 1509)
`Should Be Excluded Because He Is Not Qualified in the Pertinent
`Art
`
`Petitioner filed a Declaration of Kenneth A Walters, Ph.D. (Exhibit 1005) on
`
`November 2, 2016 and a Reply Declaration of Kenneth A Walters, Ph.D. in
`
`Support of Petition for Inter Partes Review of Patent No, 7,216,506 (Exhibit 1509)
`
`on November 1, 2017. Petitioner relied on the Declarations of Dr. Walters, albeit
`
`frequently via improper citations to large sections, to support its arguments
`
`regarding the prior art. See e.g., Paper No. 1 at 22; Paper No. 37 at 5. Patent
`
`Owner timely filed objections to the two declarations on May 15, 2017 and
`
`November 8, 2017, respectively. See Paper No. 15 at 1-2 (objecting to “¶¶ 17, 38-
`
`39, 41-43, 47, 69, 71-87, 93-95, 99-105, 108, 110-115, 117, 119-124, 129-134,
`
`137-141, 144-154, 156-166, and 168 and all paragraphs that rely on those
`
`paragraphs” under, inter alia, Fed. R. Evid. 702) and Paper No. 39 at 4-5 (objecting
`
`to “¶¶ 80, 81, 86-90, 92-93, and 120-122” under, inter alia, Fed. R. Evid. 702).
`
`
`
`9
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`

`

`As evidenced by his own testimony, Dr. Walters is not qualified in the
`
`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
`
`
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`relevant art of the patent, and thus the Board should exclude portions of his
`
`declarations (Exhibits 1005 and 1509) reaching conclusions about the art and the
`
`patent under Rule 702. Petitioner tacitly admits as much by belatedly introducing
`
`Dr. Weinberg’s declaration (Ex. 1510) with its Reply to repeat many of the same
`
`arguments originally provided by Dr. Walters, at several points even using almost
`
`identical language. Compare, e.g., Ex. 1509 at ¶¶ 46-48 with Ex. 1510 at ¶¶ 39-42;
`
`see also 1509 at ¶ 53 and Ex. 1510 at ¶ 45 (including identical emphasis as well as
`
`text); Ex. 1509 at ¶¶ 36-39 and Ex. 1510 at ¶¶ 34-36.
`
`Expert testimony is admissible only if such testimony will assist the trier of
`
`fact and if “(1) the testimony is based upon sufficient facts or data, (2) the
`
`testimony is the product of reliable principles and methods, and (3) the witness has
`
`applied the principles and methods reliably to the facts of the case.” Fed. R. Evid.
`
`702; Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 588 (1993). This serves
`
`“a ‘gatekeeping role,’ the objective of which is to ensure that expert testimony
`
`admitted into evidence is both reliable and relevant.” Daubert, 509 U.S. at 597.
`
`“[A]ny step that renders the analysis unreliable . . . renders the expert’s testimony
`
`inadmissible.” In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 745 (3d Cir. 1994).
`
`The perspective of a person of ordinary skill in the art must be considered in
`
`determining whether a patent claim is anticipated or rendered obvious by prior art.
`
`
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`10
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`

`
`See 35 U.S.C. §§ 102-103. But Dr. Walters is not able to provide the Board with
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`the perspective of one of ordinary skill in the art because he lacks expertise in the
`
`field, and “it is contradictory to Rule 702 to allow a witness to testify on the issue
`
`who is not qualified as a technical expert in that art.” Sundance, Inc. v. Demonte
`
`Fabricating Ltd., 550 F.3d 1356, 1363 (Fed. Cir. 2008). Accordingly, a witness
`
`not qualified in the pertinent art may not “testify as an expert on obviousness, or
`
`any of the underlying technical questions, such as the nature of the claimed
`
`invention, the scope and content of prior art, the differences between the claimed
`
`invention and the prior art, or the motivation of one of ordinary skill in the art to
`
`combine these references to achieve the claimed invention.” Id. at 1364.
`
`At institution, the Board determined the relevant field as the “treatment of
`
`fungal infections of nails and skin” and a person of ordinary skill as one having
`
`“experience working with topical antifungal agents” and their “clinical use” to treat
`
`these infections. Paper 12, 10-11. In other words, the relevant field requires
`
`experience in specifically treating nail infections and not just designing
`
`formulations for use with skin drugs. The skilled artisan needed expertise in the
`
`specialized treatment of nail infections due to the well-documented
`
`unpredictability even in extrapolating from experience treating skin with the same
`
`drugs. A person of ordinary skill in the art, as defined by the Board, would
`
`therefore recognize the specialized nature of treating onychomycosis and need to
`
`
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`11
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`have a specific background in treating nail and its pathologies beyond just having
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`knowledge of dermatophytosis and formulations for skin more generally. See, e.g.,
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`Ex. 2011, 137-139; Ex. 2010, 422; Ex. 2009, 286; Ex. 2027, ¶¶ 77-80.
`
`However, Dr. Walters admits that he is not such an expert, and instead holds
`
`himself out as having expertise only in unrelated “dermatological or transdermal
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`formulation[s],” i.e., in formulations for drugs that treat skin conditions such as
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`tinea pedis rather than for treating onychomycosis, as required by the claims of the
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`’506 patent. Ex. 2050, 14:5-15:15 and 47:1-19.
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`In contrast to Dr. Elewski, who is Patent Owner’s expert with experience not
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`only in clinically treating onychomycosis but also in testing and evaluating new
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`treatments, Dr. Walters is not even a medical doctor. So, he has never diagnosed or
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`treated onychomycosis. Ex. 2050, 48:14-49:4; Ex. 2027, ¶¶ 2-11, 13, App’x A.
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`Moreover, Dr. Walters’ declarations, deposition testimony, and CV indicate that he
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`has never developed an effective treatment for onychomycosis, never written on or
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`researched treatments for onychomycosis, and never worked on clinical trials
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`evaluating the effectiveness of a drug against onychomycosis. Ex. 1005, App’x A;
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`Ex. 1509; Ex. 2050, 29:2-20. He thus lacks the expertise, knowledge, and/or
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`background to opine on the state of the art in treating onychomycosis as of the late
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`1990s.
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`Dr. Walters lacks any experience identifying therapeutically effective agents
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`U.S. Patent No. 7,214,506
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`for treating onychomycosis. Ex. 1005, ¶39. Dr. Walters has only ever published a
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`handful of articles directed to the permeability of the nail plate, and even there his
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`contemporaneous conclusions support the unpredictability of formulating an agent
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`to penetrate the nail, all before considering factors beyond his expertise that further
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`contribute to therapeutic efficacy as required by the claims of the ’506 patent. Ex.
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`2021, 352; Ex. 1509, ¶ 131. Dr. Walters cites to no publications or work he
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`conducted ever evaluating the efficacy of even one topical onychomycosis
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`treatment. Instead, after being challenged by Patent Owner, Dr. Walters provides a
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`meaningless assertion that he “assisted” pharmaceutical companies in developing
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`products to treat onychomycosis. Id. at 130. Notably, he does not identify what
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`these might be or whether his “assistance” went beyond formulation development.
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`Thus, Dr. Walters is not qualified to explain what one of ordinary skill in the
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`art would think or know at the time of the claimed invention.
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`While Dr. Walters urges in his reply declaration that he is an expert, he has
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`not substantiated that claim. See Ex. 1509 at ¶¶ 127-132. Indeed, Dr. Walters
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`devotes only two pages of his 93 page declaration to any attempts to rebut the
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`challenge, yet those two pages merely direct the reader back to his CV, reiterating
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`that he worked on a “study of permeation characteristics” and allegedly identified
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`“physicochemical properties of chemical compounds” and “formulations” that
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`promote permeation. Id. None of this, by his own admission, pertains to any
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`U.S. Patent No. 7,214,506
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`specific treatment for onychomcycosis. Notably, Petitioner tacitly admits the
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`weakness of Dr. Walters’ qualifications by belatedly introducing Dr. Weinberg’s
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`declaration (Ex. 1510) with its Reply to repeat many of the same arguments
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`originally provided by Dr. Walters. See Paper No. 37.
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`Given his complete lack of work treating or developing treatments for
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`onychomycosis, Dr. Walters clearly is not qualified to testify on what one of skill
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`in the art would know and think at the critical date of the ’506 patent. The Board
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`should therefore exclude Dr. Walter’s assessment of the art and ungrounded
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`conclusions.
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`III. CONCLUSION
`For the foregoing reasons, the Board should exclude Exhibits 1012, 1512,
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`1513, 1522, 1524, 1525, 1527-1549, 1551, 1553, 1554, 1555, 1557-1560, 1566,
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`1569, 1576, 1577, 1580-1585, 1588, 1594, 1599, 1603-1605, 1607, 1609, 1613,
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`1617, 1619, 1621, 1623, 1626-1629, 1632-1636, 1638-1645, 1658, and 1660 as
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`well as portions of Exhibits 1005 and 1509 from the record.
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`Respectfully submitted,
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`Dated: December 22, 2017
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`By: /John D. Livingstone/
`John D. Livingstone, Reg. No. 59, 613
`FINNEGAN, HENDERSON, FARABOW,
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`GARRETT & DUNNER, LLP
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`901 New York Avenue, NW
`Washington, DC 20001-4413
`(202) 408-4000
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`Counsel for Patent Owner in
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`IPR2017-00190
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that a copy of the foregoing Patent Owner’s
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`Motion to Exclude Under 37 C.F.R. § 42.64(C) was served electronically via
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`email on December 22, 2017, in its entirety on the following:
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`E. Anthony Figg
`Aydin H. Harston
`Lisa N. Phillips
`Rothwell, Figg, Ernst & Manbeck, P.C.
`607 14th Street, N.W., Suite 800
`Washington, DC 20005
`efigg@rothwellfigg.com
`aharston@rothwellfigg.com
`lphillips@rothwellfigg.com
`litigationparalegals@rothwellfigg.com
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`Teresa Stanek Rea
`Shannon M. Lentz
`Crowell & Moring LLP
`Intellectual Property Group
`1001 Pennsylvania Ave., NW
`Washington, DC 20004-2595
`trea@crowell.com
`slentz@crowell.com
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`Tyler C. Liu
`Argentum Pharmaceuticals, LLC
`tliu@agpharm.com
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`By: /John D. Livingstone/
`John D. Livingstone
`Reg. No. 59,613
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