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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
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`LIQUIDIA TECHNOLOGIES, INC.,
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`Petitioner,
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`v.
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`UNITED THERAPEUTICS CORPORATION,
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`Patent Owner.
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`_______________
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`Case IPR2020-00770
`Patent 9,604,901
`_______________
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`PATENT OWNER’S OBJECTIONS TO PETITIONER’S EVIDENCE
`SUBMITTED WITH PETITION
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`4820-4920-9551.6
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`IPR2020-00770
`Patent 9,604,901
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`Patent Owner’s Objections to Evidence
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`Patent Owner United Therapeutics Corporation (“Patent Owner”) hereby
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`objects to the admissibility of certain evidence cited in support of the Petition for
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`Inter Partes Review filed on March 30, 2020 (“Petition”). Patent Owner’s
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`objections are based on the Federal Rules of Evidence (“FRE”), relevant case law,
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`federal statute, and the Patent Trial and Appeal Board (“PTAB”) Rules. Patent
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`Owner’s objections are set forth with particularity below.
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`EXHIBIT 1002
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`Exhibit 1002 is described as “Declaration of Jeffrey D. Winkler, Ph.D.” Patent
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`Owner objects to Exhibit 1002, under FRE 701, because the opinion testimony
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`contained in this exhibit reaches legal conclusions for which the declarant has not
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`established that he is capable of providing. For example, paragraphs 4, 5, 12, 16,
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`18-21, 23, 34, 36, 37, 46, 50, 52, 57, 62, 65, 66, 71, 72, 73, 82, 92, 96, 97, 99, 103,
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`115, 117, 131, 136, 138, 148, 151, 152, 153, 178, 184, 185, 187, 207, 208, 226,
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`235, and 240 each recite an unsupported legal conclusion and, thus, should not be
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`considered by the PTAB in this proceeding. Patent Owner objects to Exhibit 1002
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`under FRE 702, on the basis that the testimony (over half of which is substantively
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`identical to the Petition) is not based on sufficient facts or data, with respect to
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`reliance on experimental data disclosed in references, and on other informal and
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`unpublished documents that are hearsay under FRE 802, have not been
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`Patent 9,604,901
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`Patent Owner’s Objections to Evidence
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`authenticated under FRE 901, are not self-authenticating under FRE 902, and are
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`not duplicates as defined by FRE 1001(e). For example, paragraphs 16, 27, 38, 47,
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`71, 72,74, 93, 95, 96, 102, 115, 117, 118, 122, 132, 134, 148, 151, 168, 170, 179,
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`180, 182, 183, 188, 191, 204, 207, 208, 221, 227, and 235 lack any cited basis.
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`Patent Owner objects to Exhibit 1002 to the extent it includes subject matter that is
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`not permitted pursuant to FRE 602 or 701, including without limitation, to the
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`extent that the declaration presents as “facts” information that is outside the
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`personal knowledge of the declarant, and/or to the extent that the document offers
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`improper lay opinion testimony. Exhibit 1002 is also objected to as irrelevant
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`under FRE 401 and 402 because it does not make any facts at issue in the inter
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`partes review more or less probable than it would have been without the evidence.
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`Patent Owner objects to Exhibit 1002 as unfairly prejudicial, confusing the issues,
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`and a waste of time under FRE 403. Patent Owner objects to the portions of
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`Exhibit 1002 that cite an exhibit objected to herein for the reasons stated herein.
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`Patent Owner objects to Exhibit 1002 under FRE 802 as hearsay without
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`exception. Patent Owner objects to Exhibit 1002 under FRE 901-902 as lacking
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`authentication and not self-authenticating because it lacks sufficient indicia that the
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`exhibit is what it purports to be.
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`4820-4920-9551.6
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`Patent 9,604,901
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`Patent Owner’s Objections to Evidence
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`Patent Owner objects under FRE 105 that use of Exhibit 1002 should be
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`restricted to the purpose for which it was admitted.
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`EXHIBIT 1005
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`Exhibit 1005 is described as “SteadyMed Ltd. v. United Therapeutics Corp.,
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`IPR2016-00006, Paper 82 (PTAB March 31, 2017).” Patent Owner objects to
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`Exhibit 1005 under FRE 402 and 403. Exhibit 1005 concerns a proceeding with a
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`different petitioner and a different patent, and it is therefore irrelevant. Even if
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`Exhibit 1005 has some marginal relevance, the relevance is substantially
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`outweighed by the unfair prejudice and likelihood of confusing the issues based on
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`use of a document from another proceeding involving different claims and
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`different prior art. The Petitioner relies on this exhibit to prove the truth of the
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`matter asserted therein (e.g., Petition at 5-6, 19, 30, and 53), but it fails to meet the
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`requirements of any hearsay exception or exemption under FRE 803-807.
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`EXHIBIT 1007
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`Exhibit 1007 is described as “U.S. Patent No. 6,765,117 to Moriarty, et al.”
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`Patent Owner objects to Exhibit 1007, which is purported to be a United States
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`patent, under FRE 802, including to the extent Petitioner has asserted that its
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`products are inherently the same as a product claimed in the ’901 patent and to the
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`extent Petitioner has asserted that Exhibit 1007’s statements regarding or relating
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`4820-4920-9551.6
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`to the level of skill in the art are true and accurate. The Petitioner relies on this
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`exhibit to prove the truth of the matter asserted therein, but it fails to meet the
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`requirements of any hearsay exception or exemption under FRE 803-807.
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`Patent Owner objects under FRE 105 that use of Exhibit 1007 should be
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`restricted to the purpose for which it was admitted.
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`EXHIBIT 1008
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`Exhibit 1008 is described as “PCT Application No. WO 2005/007081.” Patent
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`Owner objects to Exhibit 1008, which is purported to be an International
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`application published under the Patent Cooperation Treaty, under FRE 802,
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`including to the extent Petitioner has asserted that its products are inherently the
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`same as a product claimed in the ’901 patent and to the extent Petitioner has
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`asserted that Exhibit 1008’s statements regarding or relating to whether certain
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`practices or procedures were well-known, routine, or conventional, the level of
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`skill in the art, and/or the underlying chemical and physical principles discussed
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`therein are true and accurate. The Petitioner relies on this exhibit to prove the truth
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`of the matter asserted therein, but it fails to meet the requirements of any hearsay
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`exception or exemption under FRE 803-807. Exhibit 1008 is also objected to as
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`irrelevant under FRE 401 and 402 because it does not make any facts at issue in
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`the inter partes review more or less probable than they would have been without
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`the evidence.
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`Patent Owner objects under FRE 105 that use of Exhibit 1008 should be
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`restricted to the purpose for which it was admitted.
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`EXHIBIT 1009
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`Exhibit 1009 is described as “Moriarty, R.M., et al., ‘The Intramolecular
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`Asymmetric Pauson-Khand Cyclization as a Novel and General Stereoselective
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`Route to Benzindene Prostacyclins: Synthesis of UT-15 (Treprostinil),’ J. Org.
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`Chem. Vol. 69, No. 6, 1890-1902 (2004).” Patent Owner objects to Exhibit 1009,
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`which is purported to be an article from the Journal of Organic Chemistry, under
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`FRE 802, including to the extent Petitioner has asserted that its products are
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`inherently the same as a product claimed in the ’901 patent and to the extent
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`Petitioner has asserted (implicitly or explicitly) that Exhibit 1009’s statements
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`regarding whether certain practices or procedures were well-known, routine, or
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`conventional, the level of skill in the art, and/or the underlying chemical and
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`physical principles discussed therein are true and accurate. The Petitioner relies on
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`this exhibit to prove the truth of the matter asserted therein, but it fails to meet the
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`requirements of any hearsay exception or exemption under FRE 803-807. Exhibit
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`1009 is also objected to as irrelevant under FRE 401 and 402 because it does not
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`Patent 9,604,901
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`Patent Owner’s Objections to Evidence
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`make any facts at issue in the inter partes review more or less probable than they
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`would have been without the evidence.
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`Patent Owner objects under FRE 105 that use of Exhibit 1009 should be
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`restricted to the purpose for which it was admitted.
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`EXHIBIT 1010
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`Exhibit 1010 is described as “Wiberg, K., Laboratory Technique in Organic
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`Chemistry (1960), p.112.” Patent Owner objects to Exhibit 1010, which is
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`purported to be an organic chemistry lab textbook, under FRE 802, including to the
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`extent Petitioner has asserted that Exhibit 1010’s statements regarding or relating
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`to whether certain practices or procedures were well-known, routine, or
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`conventional, the level of skill in the art, and/or the underlying chemical and
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`physical principles discussed therein are true and accurate. The Petitioner relies on
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`this exhibit to prove the truth of the matter asserted therein, but it fails to meet the
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`requirements of any hearsay exception or exemption under FRE 803-807. Patent
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`Owner objects to Exhibit 1010 under FRE 901-902 as lacking authentication and
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`not self-authenticating because it lacks sufficient indicia that the exhibit is what it
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`purports to be.
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`Patent Owner objects under FRE 105 that use of Exhibit 1010 should be
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`restricted to the purpose for which it was admitted.
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`4820-4920-9551.6
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`Patent 9,604,901
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`Patent Owner’s Objections to Evidence
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`EXHIBIT 1011
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`Exhibit 1011 is described as “Schoffstall, A.M. et al., Microscale and Miniscale
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`Organic Chemistry Laboratory Experiments, 2d ed. (2004) pp. 200-202.” Patent
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`Owner objects to Exhibit 1011, which is purported to be an organic chemistry lab
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`textbook, under FRE 802, including to the extent Petitioner has asserted that
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`Exhibit 1011’s statements regarding or relating to whether certain practices or
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`procedures were well-known, routine, or conventional, the level of skill in the art,
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`and/or the underlying chemical and physical principles discussed therein are true
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`and accurate. The Petitioner relies on this exhibit to prove the truth of the matter
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`asserted therein, but it fails to meet the requirements of any hearsay exception or
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`exemption under FRE 803-807. Patent Owner objects to Exhibit 1011 under FRE
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`901-902 as lacking authentication and not self-authenticating because it lacks
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`sufficient indicia that the exhibit is what it purports to be. Patent Owner further
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`objects to Exhibit 1011 under FRE 106 and 401-403 as incomplete, irrelevant,
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`waste of time, and likely to cause confusion because a short excerpt from an
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`undergraduate organic textbook regarding micro-scale laboratory synthesis is
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`irrelevant to the invention.
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`Patent Owner objects under FRE 105 that use of Exhibit 1011 should be
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`restricted to the purpose for which it was admitted.
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`4820-4920-9551.6
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`EXHIBIT 1012
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`Exhibit 1012 is described as “Certified English translation of Japanese Patent
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`App. No. 56-122328A to Kawakami, et al.” Patent Owner objects to Exhibit 1012
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`under FRE 802, including to the extent Petitioner has asserted that the translation is
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`a true and accurate representation of the original Japanese-language patent and to
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`the extent Petitioner has asserted that Exhibit 1012’s statements regarding or
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`relating to whether certain practices or procedures were well-known, routine, or
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`conventional, the level of skill in the art, and/or the underlying chemical and
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`physical principles discussed therein are true and accurate. The Petitioner relies on
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`this exhibit to prove the truth of the matter asserted therein, but it fails to meet the
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`requirements of any hearsay exception or exemption under FRE 803-807. Patent
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`Owner further objects to this exhibit under FRE 402 and 403 because an
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`inadequate translation renders the exhibit irrelevant. Patent Owner further objects
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`to this exhibit under FRE 901 and 902 because Exhibit 1012 lacks sufficient
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`indicia to support a finding that it is what it purports to be and is not self-
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`authenticating. Patent Owner further objects to this exhibit under FRE 1001-1003
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`because Exhibit 1012 is not an original writing and genuine questions regarding its
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`authenticity and the circumstances of its production make it unfair to admit.
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`4820-4920-9551.6
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`IPR2020-00770
`Patent 9,604,901
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`Patent Owner’s Objections to Evidence
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`Patent Owner objects under FRE 105 that use of Exhibit 1012 should be
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`restricted to the purpose for which it was admitted.
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`EXHIBIT 1013
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`Exhibit 1013 is described as “Ege, S., Organic Chemistry Second Edition, Ch.
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`14 Carboxylic Acids and Their Derivates I. Nucleophilic Substitution Reactions at
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`the Carbonyl Group (1989) pp. 543-547.” Patent Owner objects to Exhibit 1013,
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`which is purported to be an organic chemistry textbook, under FRE 802, including
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`to the extent Petitioner has asserted that Exhibit 1013’s statements regarding or
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`relating to whether certain practices or procedures were well-known, routine, or
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`conventional, the level of skill in the art, and/or the underlying chemical and
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`physical principles discussed therein are true and accurate. The Petitioner relies on
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`this exhibit to prove the truth of the matter asserted therein, but it fails to meet the
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`requirements of any hearsay exception or exemption under FRE 803-807. Patent
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`Owner objects to Exhibit 1013 under FRE 901-902 as lacking authentication and
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`not self-authenticating because it lacks sufficient indicia that the exhibit is what it
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`purports to be.
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`Patent Owner objects under FRE 105 that use of Exhibit 1013 should be
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`restricted to the purpose for which it was admitted. Patent Owner further objects to
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`Exhibit 1013 under FRE 106 and 401-403 as incomplete, irrelevant, a waste of
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`time, and likely to cause confusion because a short excerpt from an undergraduate
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`organic textbook is irrelevant to the invention.
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`EXHIBIT 1014
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`Exhibit 1014 is described as “U.S. Patent No. 4,306,075 to Aristoff.” Patent
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`Owner objects to Exhibit 1014, which is purported to be a United States patent,
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`under FRE 802, including to the extent Petitioner has asserted that Exhibit 1014’s
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`statements regarding or relating to whether certain practices or procedures were
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`well-known, routine, or conventional and/or the underlying chemical and physical
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`principles discussed therein are true and accurate. The Petitioner relies on this
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`exhibit to prove the truth of the matter asserted therein, but it fails to meet the
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`requirements of any hearsay exception or exemption under FRE 803-807. Exhibit
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`1014 is also objected to as irrelevant under FRE 401 and 402 because it does not
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`make any facts at issue in the inter partes review more or less probable than they
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`would have been without the evidence.
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`Patent Owner objects under FRE 105 that use of Exhibit 1014 should be
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`restricted to the purpose for which it was admitted.
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`EXHIBIT 1015
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`Exhibit 1015 is described as “Declaration of Sylvia Hall-Ellis, Ph.D.” Patent
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`Owner objects to Exhibit 1015, under FRE 701, because the opinion testimony
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`IPR2020-00770
`Patent 9,604,901
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`Patent Owner’s Objections to Evidence
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`contained in this exhibit reaches legal conclusions for which the declarant has not
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`established that she is capable of providing. For example, paragraphs 21, 36, 42,
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`43, 45, 46, 49, 50, 51, 52, 54, 56, 57, 58, 59, 60, 63, 64, 65, 66, 67, 70, and 71 each
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`recite an unsupported legal conclusion and, thus, should not be considered by the
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`PTAB in this proceeding. Patent Owner objects to Exhibit 1015 under FRE 702(b),
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`on the basis that the testimony is not based on sufficient facts and is based on other
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`informal and unpublished documents that are hearsay under FRE 802, have not
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`been authenticated under FRE 901, are not self-authenticating under FRE 902, and
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`are not duplicates as defined by FRE 1001(e). Patent Owner objects to Exhibit
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`1015 to the extent it includes subject matter that is not permitted pursuant to FRE
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`602 or 701, including without limitation, to the extent that the declaration presents
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`as “facts” information that is outside the personal knowledge of the declarant,
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`and/or to the extent that the document offers improper lay opinion testimony.
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`Exhibit 1015 is also objected to as irrelevant under FRE 401 and 402 because it
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`does not make any facts at issue in the inter partes review more or less probable
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`than it would have been without the evidence. Patent Owner objects to Exhibit
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`1015, and the exhibits thereto, as unfairly prejudicial, confusing the issues, and a
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`waste of time under FRE 403. Patent Owner objects to the portions of Exhibit 1015
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`that cite or reproduce an exhibit objected to herein for the reasons stated herein.
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`IPR2020-00770
`Patent 9,604,901
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`Patent Owner’s Objections to Evidence
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`Patent Owner objects under FRE 105 that use of Exhibit 1015 should be
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`restricted to the purpose for which it was admitted.
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`EXHIBIT 1016
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`Exhibit 1016 is described as “Prosecution History of the ’393 patent.” Patent
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`Owner objects to Exhibit 1016 under FRE 402 and 403. Exhibit 1016 concerns a
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`different patent challenged by a different petitioner in a different proceeding, and it
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`is therefore irrelevant. Even if Exhibit 1016 has some marginal relevance, the
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`relevance is substantially outweighed by the unfair prejudice and likelihood of
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`confusing the issues based on use of a document from another proceeding
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`involving different claims and different prior art.
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`Patent Owner objects under FRE 105 that use of Exhibit 1016 should be
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`restricted to the purpose for which it was admitted.
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`Date: October 27, 2020
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`Respectfully submitted,
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
`Counsel for Patent Owner
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`IPR2020-00770
`Patent 9,604,901
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`Patent Owner’s Objections to Evidence
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Patent
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`Owner’s Objections to Petitioner’s Evidence Submitted With Petition was served
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`on counsel of record on October 27, 2020, by filing this document through the
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`PTAB E2E System as well as delivering a copy via email to the counsel of record
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`for the Petitioner at the following address:
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`zLiquidiaIPR@cooley.com
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`ielrifi@cooley.com
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`emilch@cooley.com
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`dkannappan@cooley.com
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`Date: October 27, 2020
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` /Stephen B. Maebius/
`Stephen B. Maebius
`Foley & Lardner LLP
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`4820-4920-9551.6
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