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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`Case IPR 2017-01053
`Patent 8,268,299
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner
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`v.
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`ALCON RESEARCH, LTD,
`Patent Owner
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`Case IPR2017-01053
`Patent 8,268,299
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`ALCON RESEARCH, LTD.’S OBJECTIONS TO EVIDENCE
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`Case IPR 2017-01053
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`Patent 8,268,299
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`Patent Owner Alcon Research, Ltd. (“Alcon”) objects pursuant to 37 C.F.R.
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`§ 42.64(b)(1) and the Federal Rules of Evidence (“FRE”) to the admissibility of
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`exhibits served by Petitioner Argentum Pharmaceuticals LLC on March 10, 2017.
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`The exhibits objected to, and grounds for Alcon’s objections, are listed below.
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`I.
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`IDENTIFICATION OF CHALLENGED EVIDENCE AND GROUNDS
`FOR OBJECTIONS
`A. Exhibit 1005
`Alcon objects to Exhibit 1005 under FRE 401 because it is irrelevant.
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`Exhibit 1005 purports to be an article from the American Journal of Microbial
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`Ecology titled Microorganisms and Heavy Metal Toxicity. Petitioner contends that
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`Exhibit 1005 “qualifies as prior art to the ’299 patent under 35 U.S.C. § 102(b)”
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`because it was “published in 1978, long before the [earliest possible priority date]
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`of the ’299 patent.” Pet. at 33. Exhibit 1005 is not analogous art, and thus may not
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`be considered as § 102(b) art in evaluating obviousness, because it is not from the
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`field of the invention, nor is it pertinent to the problems addressed by the claimed
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`invention. It is therefore inadmissible under FRE 401.
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`Exhibit 1008
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`B.
`Alcon objects to Exhibit 1008 under FRE 901, 1002, and 1003. Exhibit
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`1008 purports to be a copy of the file for U.S. Patent Application No. 11/858,781,
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`but it is incomplete. It has not been authenticated under FRE 901, is not self-
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`Case IPR 2017-01053
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`Patent 8,268,299
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`authenticating under FRE 902, and is not a “duplicate” as defined by FRE 1001(e).
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`Exhibit 1008 is therefore inadmissible under FRE 901, 1002, and 1003.
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`C. Exhibit 1009
`Alcon objects to Exhibit 1009 under FRE 401 and 403. Exhibit 1009 is the
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`Joint Claim Construction Statement containing the construction of certain claim
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`terms in the ’299 patent that Alcon agreed to in Alcon v. Mylan Pharmaceuticals
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`Inc. et al., No. 1:13-cv-1332-SLR (D. Del.). The construction of terms in a
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`different proceeding, particularly one that applies a different standard for claim
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`construction, is irrelevant. Even if relevant, because of the different standard for
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`claim construction applied in inter partes reviews, the minimal probative weight of
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`Exhibit 1009 is substantially outweighed by the danger of confusion or unfair
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`prejudice. Exhibit 1009 is therefore inadmissible under FRE 401 and 403.
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`D. Exhibit 1010
`Alcon objects to Exhibit 1010 under FRE 901, 1002, and 1003. Exhibit
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`1010 purports to be a copy of the file for U.S. Patent Application No. 13/086,950,
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`but it is incomplete. It has not been authenticated under FRE 901, is not self-
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`authenticating under FRE 902, and is not a “duplicate” as defined by FRE 1001(e).
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`Exhibit 1010 is therefore inadmissible under FRE 901, 1002, and 1003.
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`Case IPR 2017-01053
`Patent 8,268,299
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`Exhibit 1011
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`E.
`Alcon objects to Exhibit 1011 under FRE 901, 1002, and 1003. Exhibit
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`1011 purports to be a copy of the file for U.S. Patent Application No. 12/441,995,
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`but it is incomplete. It has not been authenticated under FRE 901, is not self-
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`authenticating under FRE 902, and is not a “duplicate” as defined by FRE 1001(e).
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`Exhibit 1011 is therefore inadmissible under FRE 901, 1002, and 1003.
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`Exhibit 1012
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`F.
`Alcon objects to Exhibit 1012 under FRE 106 and 401 because it is
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`irrelevant and incomplete. Dr. Xia cites Exhibit 1012 for information that would
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`allegedly be known to a person of ordinary skill in the art. See Argentum Ex. 1002
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`¶¶ 22, 50. However, Exhibit 1012 is not analogous art, and thus may not be
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`considered in evaluating obviousness, because it is not from the field of the
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`invention, nor is it pertinent to the problems addressed by the claimed invention.
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`In addition, Exhibit 1012 is incomplete in that it is only an excerpt from INDIRECT
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`FOOD ADDITIVES AND POLYMERS, but under FRE 106 the entirety of INDIRECT
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`FOOD ADDITIVES AND POLYMERS should in fairness be included in the exhibit.
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`Exhibit 1012 is therefore inadmissible under FRE 106 and 401.
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`G. Exhibit 1013
`Alcon objects to Exhibit 1013 under FRE 401 because it is irrelevant. Dr.
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`Xia cites Exhibit 1013 for information that would allegedly be known to a person
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`Patent 8,268,299
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`of ordinary skill in the art, including what is “common” in the relevant field. See
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`Argentum Ex. 1002 ¶ 74. However, Exhibit 1013 is not analogous art, and thus
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`may not be considered in evaluating obviousness, because it is not from the field of
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`the invention, nor is it pertinent to the problems addressed by the claimed
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`invention. It is therefore inadmissible under FRE 401.
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`Alcon further objects to Exhibit 1013 under FRE 403. Dr. Xia cites Exhibit
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`1013 for the proposition that “Polyoxyl 40 hydrogenated castor oil is a common
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`surfactant.” Argentum Ex. 1002 ¶ 74. Even if Exhibit 1013 were analogous art
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`that could be considered in evaluating obviousness, its statement that polyoxyl 40
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`hydrogenated castor oil is “common” in the field of veterinary medicine is not
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`probative of how common it is in ophthalmic compositions for use in humans, is
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`unfairly prejudicial, and may be confusing to the factfinder. Exhibit 1013 is
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`therefore inadmissible under FRE 403.
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`H. Exhibit 1014
`Alcon objects to Exhibit 1014 under FRE 106, 901, 1002, and 1003. Exhibit
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`1014 is cited as an excerpt from The United States Pharmacopeia 27. See, e.g.,
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`Argentum Ex. 1002 ¶ 104. It appears, however, to be an excerpt from The United
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`States Pharmacopeia 26. In addition, it is not an accurate reproduction of the
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`original publication because it is of such poor quality that words and details cannot
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`be discerned; it is therefore not a “duplicate,” as defined by FRE 1001(e), even of
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`The United States Pharmacopeia 26. Finally, Exhibit 1014 is incomplete in that it
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`is only an excerpt from The United States Pharmacopeia 26, but under FRE 106
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`the entirety of The United States Pharmacopeia 26 (or 27) should in fairness be
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`included in the exhibit. Exhibit 1014 is therefore inadmissible under FRE 106,
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`901, 1002, and 1003.
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`Exhibit 1017
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`I.
`Alcon objects to Exhibit 1017 under FRE 106, 401, and 901. Exhibit 1017
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`is cited as an excerpt from the Thirteenth Edition of THE MERCK INDEX. See, e.g.,
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`Pet. at vi; Argentum Ex. 1002 at 8. It appears, however, to be an excerpt from the
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`Eleventh Edition of THE MERCK INDEX. It addition, Exhibit 1017 is cited as
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`support for the statement that “mannitol and sorbitol are sugars having identical
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`chemical formulas and differing only in their stereochemistry at a single carbon
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`and therefore share many similar physical properties.” Pet. at 17. But Exhibit
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`1017 has nothing to do with mannitol or sorbitol and is therefore irrelevant to the
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`statement it purportedly supports. Finally, Exhibit 1017 is incomplete in that it is
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`only an excerpt from the Eleventh Edition of THE MERCK INDEX, but under FRE
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`106 the entirety of the Eleventh (or Thirteenth) Edition of THE MERCK INDEX
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`should in fairness be included in the exhibit. Exhibit 1017 is therefore
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`inadmissible under FRE 106, 401, and 901.
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`Exhibit 1019
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`J.
`Alcon objects to Exhibit 1019 under FRE 106. Exhibit 1019 is incomplete
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`in that it is only an excerpt from PRESERVATIVE-FREE AND SELF-PRESERVING
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`COSMETICS AND DRUGS, but under FRE 106 the entirety of PRESERVATIVE-FREE
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`AND SELF-PRESERVING COSMETICS AND DRUGS should in fairness be included in
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`the exhibit. Exhibit 1019 is therefore inadmissible under FRE 106.
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`K. Exhibit 1022
`Alcon objects to Exhibit 1022 under FRE 801. Exhibit 1022 is a Declaration
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`of Richard K. Parrish, II, M.D. from IPR 2013-00428, which also involved the
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`’299 patent. This statement was made in a different proceeding and does not fall
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`within an exclusion or exception to the hearsay rule. Exhibit 1022 is therefore
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`inadmissible hearsay under FRE 801.
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`Exhibit 1027
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`L.
`Alcon objects to Exhibit 1027 under FRE 901. Exhibit 1027 purports to be
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`an advertisement for TRAVATAN Z® from 2008. It has not been authenticated
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`under FRE 901 and it is not self-authenticating under FRE 902. Exhibit 1027 is
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`therefore inadmissible under FRE 901.
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`Case IPR 2017-01053
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`M. Exhibit 1028
`Alcon objects to Exhibit 1028 under FRE 901. Exhibit 1028 purports to be
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`an advertisement for TRAVATAN Z® from 2009. It has not been authenticated
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`under FRE 901 and it is not self-authenticating under FRE 902. Exhibit 1028 is
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`therefore inadmissible under FRE 901.
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`N. Exhibit 1029
`Alcon objects to Exhibit 1029 under FRE 901. Exhibit 1029 purports to be
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`an advertisement for TRAVATAN Z® from 2010. It has not been authenticated
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`under FRE 901 and it is not self-authenticating under FRE 902. Exhibit 1029 is
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`therefore inadmissible under FRE 901.
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`O. Exhibit 1030
`Alcon objects to Exhibit 1030 under FRE 901, 1002, and 1003. Exhibit
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`1030 purports to be an advertisement for TRAVATAN Z® from 2011. It has not
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`been authenticated under FRE 901 and it is not self-authenticating under FRE 902.
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`In addition, it is not an accurate reproduction of the purported advertisement
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`because large portions of it are incomplete and illegible; it is therefore not a
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`“duplicate,” as defined by FRE 1001(e). Exhibit 1030 is therefore inadmissible
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`under FRE 901, 1002, and 1003.
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`Case IPR 2017-01053
`Patent 8,268,299
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`Exhibit 1031
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`P.
`Alcon objects to Exhibit 1031 under FRE 901, 1002, and 1003. Exhibit
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`1031 purports to be an advertisement for TRAVATAN Z® from 2012. It has not
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`been authenticated under FRE 901 and it is not self-authenticating under FRE 902.
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`In addition, it is not an accurate reproduction of the purported advertisement
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`because large portions of it are incomplete and illegible; it is therefore not a
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`“duplicate,” as defined by FRE 1001(e). Exhibit 1031 is therefore inadmissible
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`under FRE 901, 1002, and 1003.
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`Q. Exhibit 1032
`Alcon objects to Exhibit 1032 under FRE 901, 1002, and 1003. Exhibit
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`1032 purports to be an advertisement for TRAVATAN Z® from 2013. It has not
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`been authenticated under FRE 901 and it is not self-authenticating under FRE 902.
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`In addition, it is not an accurate reproduction of the purported advertisement
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`because large portions of it are incomplete and illegible; it is therefore not a
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`“duplicate,” as defined by FRE 1001(e). Exhibit 1032 is therefore inadmissible
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`under FRE 901, 1002, and 1003.
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`R. Exhibit 1033
`Alcon objects to Exhibit 1033 under FRE 901. Exhibit 1033 purports to be
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`an advertisement for TRAVATAN Z® from 2014. It has not been authenticated
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`Patent 8,268,299
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`under FRE 901 and it is not self-authenticating under FRE 902. Exhibit 1033 is
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`therefore inadmissible under FRE 901.
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`Exhibit 1034
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`S.
`Alcon objects to Exhibit 1034 under FRE 901. Exhibit 1034 purports to be
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`an advertisement for TRAVATAN Z® from 2015. It has not been authenticated
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`under FRE 901 and it is not self-authenticating under FRE 902. Exhibit 1034 is
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`therefore inadmissible under FRE 901.
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`Exhibit 1035
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`T.
`Alcon objects to Exhibit 1035 under FRE 901. Exhibit 1035 purports to be
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`an advertisement for TRAVATAN Z® from 2016. It has not been authenticated
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`under FRE 901 and it is not self-authenticating under FRE 902. Exhibit 1035 is
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`therefore inadmissible under FRE 901.
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`U. Exhibit 1036
`Alcon objects to Exhibit 1036 under FRE 901. Exhibit 1036 purports to be
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`an advertisement for TRAVATAN Z® from 2017. It has not been authenticated
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`under FRE 901 and it is not self-authenticating under FRE 902. Exhibit 1036 is
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`therefore inadmissible under FRE 901.
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`V. Exhibit 1037
`Alcon objects to Exhibit 1037 under FRE 801. Exhibit 1037 is a Declaration
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`of Henry Grabowski, Ph.D. from IPR 2013-00428, which also involved the ’299
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`patent. This statement was made in a different proceeding and does not fall within
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`an exclusion or exception to the hearsay rule. Exhibit 1037 is therefore
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`inadmissible under FRE 801.
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`II. CONCLUSION
`To the extent Petitioner fails to correct the defects identified above, Alcon
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`may file a motion to exclude under 37 C.F.R. § 42.64(c).
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`Dated: October 6, 2017
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`Respectfully submitted,
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`/David M. Krinsky/
`David M. Krinsky
`Reg. No. 72,339
`Phone: 202-434-5338
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`Correspondence Address:
`Williams & Connolly LLP
`725 Twelfth Street NW
`Washington, D.C. 20005
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`Case IPR 2017-01053
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`Patent 8,268,299
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`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
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`The undersigned hereby certifies that the foregoing “ALCON RESEARCH,
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`LTD.’S OBJECTIONS TO EVIDENCE” was served on October 6, 2017, via
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`Federal Express and electronic mail upon the following attorneys of record for the
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`Petitioner:
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`Michael R. Houston
`Joseph P. Meara
`James P. McParland
`FOLEY & LARDNER LLP
`mhouston@foley.com
`jmeara-pgp@foley.com
`jmcparland@foley.com
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`Tyler C. Liu
`ARGENTUM PHARMACEUTICALS LLC
`tliu@agpharm.com
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`Respectfully submitted,
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`/David M. Krinsky/
`David M. Krinsky
`Reg. No. 72,339
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`Dated: October 6, 2017
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