`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`NALOX-1 PHARMACEUTICALS, LLC,
`Petitioner,
`v.
`ADAPT PHARMA OPERATIONS LIMITED, and
`OPIANT PHARMACEUTICALS, INC.
`Patent Owners.
`_____________________
`
`Case IPR2019-00694
`U.S. Patent No. 9,629,965
`_____________________
`
`
`PETITIONER NALOX-1 PHARMACEUTICALS, LLC’S OBJECTIONS TO
`EVIDENCE SUBMITTED WITH THE PATENT OWNER RESPONSE
`PURSUANT TO 37 C.F.R. § 42.64(B)(1)
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`IPR2019-00694
`U.S. Patent No. 9,629,965
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`Pursuant to 37 C.F.R. § 42.64(b)(1), Petitioner Nalox-1 Pharmaceuticals,
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`LLC objects as follows to the admissibility of evidence submitted with the Patent
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`Owner Response:
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`1.
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`EXHIBIT 2067 is objected to under Fed. R. Evid. 401–402 as
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`irrelevant as used, as it is not prior art to the claims at issue, and under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources.
`
`2.
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`EXHIBIT 2068 is objected to under Fed. R. Evid. 401–402 as
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`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`3.
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`EXHIBIT 2073 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`4.
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`EXHIBIT 2075 is objected to under Fed. R. Evid. 401–402 as
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`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
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`IPR2019-00694
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`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
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`as it was not filed with a document citing it.
`
`5.
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`EXHIBIT 2077 is objected to under Fed. R. Evid. 901 as
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`insufficiently authenticated.
`
`6.
`
`EXHIBIT 2080 is objected to under Fed. R. Evid. 901 as
`
`insufficiently authenticated.
`
`7.
`
`EXHIBIT 2090 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`8.
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`EXHIBIT 2093 is objected to under Fed. R. Evid. 106 as incomplete,
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`as it fails to include additional portions of chapters 12 and 19 of the reference that
`
`should be considered along with the remainder of the portions provided in the
`
`interests of justice; under Fed. R. Evid. 401–402 as irrelevant, as it is not relied on
`
`or cited in any document or paper; under Fed. R. Evid. 403 because its minimal
`
`probative value is substantially outweighed by the fact that it is wasteful of time
`
`and PTAB resources; and under 37 C.F.R. § 42.6(c), as it was not filed with a
`
`document citing it.
`
`9.
`
`EXHIBIT 2095 is objected to under Fed. R. Evid. 401–402 as
`
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`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
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`10. EXHIBIT 2098 is objected to under Fed. R. Evid. 901 as
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`insufficiently authenticated, and under Fed. R. Civ. P. 801–2 as providing out-of-
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`court statements relied upon for the truth of the matter asserted.
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`11. EXHIBIT 2099 is objected to under Fed. R. Evid. 901 as
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`insufficiently authenticated, and under Fed. R. Civ. P. 801–2 as providing out-of-
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`court statements relied upon for the truth of the matter asserted.
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`12. EXHIBIT 2100 is objected to under Fed. R. Evid. 901 as
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`insufficiently authenticated, and under Fed. R. Civ. P. 801–2 as providing out-of-
`
`court statements relied upon for the truth of the matter asserted.
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`13. EXHIBIT 2101 is objected to under Fed. R. Evid. 901 as
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`insufficiently authenticated, and under Fed. R. Civ. P. 801–2 as providing out-of-
`
`court statements relied upon for the truth of the matter asserted.
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`14. EXHIBIT 2102 is objected to under Fed. R. Evid. 901 as
`
`insufficiently authenticated, and under Fed. R. Civ. P. 801–2 as providing out-of-
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`court statements relied upon for the truth of the matter asserted.
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`15. EXHIBIT 2103 is objected to under Fed. R. Evid. 901 as
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`insufficiently authenticated, and under Fed. R. Civ. P. 801–2 as providing out-of-
`
`court statements relied upon for the truth of the matter asserted.
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`16. EXHIBIT 2104 is objected to under Fed. R. Evid. 901 as
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`insufficiently authenticated, and under Fed. R. Civ. P. 801–2 as providing out-of-
`
`court statements relied upon for the truth of the matter asserted.
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`17. EXHIBIT 2105 is objected to under Fed. R. Evid. 901 as
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`insufficiently authenticated, and under Fed. R. Civ. P. 801–2 as providing out-of-
`
`court statements relied upon for the truth of the matter asserted.
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`18. EXHIBIT 2106 is objected to under Fed. R. Evid. 901 as
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`insufficiently authenticated, and under Fed. R. Civ. P. 801–2 as providing out-of-
`
`court statements relied upon for the truth of the matter asserted.
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`19. EXHIBIT 2107 is objected to under Fed. R. Evid. 901 as
`
`insufficiently authenticated, and under Fed. R. Civ. P. 801–2 as providing out-of-
`
`court statements relied upon for the truth of the matter asserted.
`
`20. EXHIBIT 2108 is objected to under Fed. R. Evid. 901 as
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`insufficiently authenticated, and under Fed. R. Civ. P. 801–2 as providing out-of-
`
`court statements relied upon for the truth of the matter asserted.
`
`21. EXHIBIT 2109 is objected to under Fed. R. Evid. 901 as
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`insufficiently authenticated, and under Fed. R. Civ. P. 801–2 as providing out-of-
`
`court statements relied upon for the truth of the matter asserted.
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`22. EXHIBIT 2113 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
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`23. EXHIBIT 2114 is objected to under Fed. R. Evid. 401–402 as
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`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`24. EXHIBIT 2115 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`25. EXHIBIT 2116 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
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`26. EXHIBIT 2117 is objected to under Fed. R. Evid. 401–402 as
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`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
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`27. EXHIBIT 2118 is objected to under Fed. R. Evid. 401–402 as
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`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`28. EXHIBIT 2119 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`29. EXHIBIT 2121 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
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`30. EXHIBIT 2122 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and as needlessly cumulative
`
`of Exhibit 2097.
`
`31. EXHIBIT 2123 is objected to under Fed. R. Evid. 401–402 as
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`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`32. EXHIBIT 2124 is objected to under Fed. R. Evid. 401–402 as
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`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`33. EXHIBIT 2125 is objected to under Fed. R. Evid. 401–402 as
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`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
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`34. EXHIBIT 2126 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`35. EXHIBIT 2129 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`36. EXHIBIT 2130 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`37. EXHIBIT 2131 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
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`38. EXHIBIT 2132 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`39. EXHIBIT 2133 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`40. EXHIBIT 2134 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`41. EXHIBIT 2135 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
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`42. EXHIBIT 2136 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`43. EXHIBIT 2140 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`44. EXHIBIT 2165 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`45. EXHIBIT 2166 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
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`46. EXHIBIT 2167 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`47. EXHIBIT 2168 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`48. EXHIBIT 2169 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`49. EXHIBIT 2170 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
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`50. EXHIBIT 2171 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`51. EXHIBIT 2172 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`52. EXHIBIT 2173 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; under Fed. R. Evid. 901 as
`
`insufficiently authenticated; and under 37 C.F.R. § 42.6(c), as it was not filed with
`
`a document citing it.
`
`53. EXHIBIT 2174 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
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`as it was not filed with a document citing it.
`
`54. EXHIBIT 2183 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`55. EXHIBIT 2188 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it was not publicly available to a POSA prior to the priority date;
`
`under Fed. R. Evid. 403 because its minimal probative value is substantially
`
`outweighed by the fact that it is wasteful of time and PTAB resources; under Fed.
`
`R. Evid. 901 as insufficiently authenticated, and under Fed. R. Civ. P. 801–2 as
`
`providing out-of-court statements relied upon for the truth of the matter asserted.
`
`56. EXHIBIT 2193 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`57. EXHIBIT 2194 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
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`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`58. EXHIBIT 2195 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`59. EXHIBIT 2196 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`60. EXHIBIT 2197 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
`
`as it was not filed with a document citing it.
`
`61. EXHIBIT 2198 is objected to under Fed. R. Evid. 401–402 as
`
`irrelevant, as it is not relied on or cited in any document or paper; under Fed. R.
`
`Evid. 403 because its minimal probative value is substantially outweighed by the
`
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`IPR2019-00694
`U.S. Patent No. 9,629,965
`fact that it is wasteful of time and PTAB resources; and under 37 C.F.R. § 42.6(c),
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`as it was not filed with a document citing it.
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`Date: January 8, 2020
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`Respectfully submitted,
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`BY: /s/ Yelee Y. Kim
`Yelee Y. Kim, Reg. No. 60,088
`ARENT FOX LLP
`1717 K Street, NW
`Washington, DC 20006
`(202) 857-6000
`Yelee.Kim@arentfox.com
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`Counsel for Petitioner Nalox-1
`Pharmaceuticals, LLC
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`- 14 -
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`IPR2019-00694
`U.S. Patent No. 9,629,965
`Certificate of Service
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`/s/ Yelee Y. Kim
`Yelee Y. Kim, Reg. No. 60,088
`ARENT FOX LLP
`1717 K Street, NW
`Washington, DC 20006
`(202) 857-6000
`Yelee.Kim@arentfox.com
`
`Counsel for Petitioner Nalox-1
`Pharmaceuticals, LLC
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`- 1 -
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`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e), 42.105(a))
`The undersigned hereby certifies that the above-captioned Petitioner Nalox-1
`Pharmaceuticals, LLC’s Objections to Evidence Submitted During the Preliminary
`Proceeding Pursuant to 37 C.F.R. § 42.64(b)(1) was served in its entirety on
`January 8, 2020, via electronic mail on the following counsel of record for Patent
`Owners:
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`Jessamyn S. Berniker (jberniker@wc.com)
`Ana C. Reyes (areyes@wc.com)
`David M. Krinsky (dkrinsky@wc.com)
`Anthony H. Sheh (asheh@wc.com)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, NW
`Washington, DC 20005
`(202) 434-5000
`Counsel for Patent Owner
`Adapt Pharma Operations Limited
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`Jessica Tyrus Mackay (jmackay@greengriffith.com)
`Ann K. Kotze (akotze@greengriffith.com)
`GREEN, GRIFFITH & BORG-BREEN, LLP
`676 North Michigan Avenue, Suite 3900
`Chicago, IL 60611
`(313) 883-8000
`Counsel for Patent Owner
`Opiant Pharmaceuticals, Inc.
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