`571-272-7822
`
`Paper 14
`Date: March 1, 2021
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`LIQUIDIA TECHNOLOGIES, INC.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
`
`IPR2020-00770
`Patent 9,604,901 B2
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`
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`
`
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`
`
`Before ERICA A. FRANKLIN, ZHENYU YANG, and
`JOHN E. SCHNEIDER, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Patent Owner’s Request
`on Rehearing of Decision on Institution
`37 C.F.R. § 42.71(d)
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`IPR2020-00770
`Patent 9,604,901 B2
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`INTRODUCTION
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`Liquidia Technologies, Inc. (“Petitioner”) filed a Petition (Paper 1
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`(“Pet.”)), seeking an inter partes review of claims 1–9 of U.S. Patent No.
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`9,604,901 B2 (Ex. 1001, “the ’901 patent”). We granted the Petition and
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`instituted inter partes review on all challenges to all claims. Paper 7
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`(“Decision” or “Dec.”). United Therapeutics Corporation (“Patent Owner”)
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`filed a Request for Rehearing of the Decision. Paper 9 (“Req. Reh’g”).
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`For the reasons expressed below, the Request for Rehearing is denied.
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`As a result, inter partes review shall continue on all grounds challenging all
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`claims addressed in the Petition.
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`STANDARD OF REVIEW
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`The party challenging a decision in a request for rehearing bears the
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`burden of showing the decision should be modified. 37 C.F.R. § 42.71(d)
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`(2019). A request for rehearing “must specifically identify all matters the
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`party believes the Board misapprehended or overlooked, and the place where
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`each matter was previously addressed.” Id. When rehearing a decision on
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`institution, the Board reviews the decision for an abuse of discretion. 37
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`C.F.R. § 42.71(c). It is not an abuse of discretion to have made an analysis
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`or conclusion with which a party disagrees. Instead, an abuse of discretion
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`occurs if a decision is based on an erroneous interpretation of law, if a
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`factual finding is not supported by substantial evidence, or if the decision
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`represents an unreasonable judgment in weighing relevant factors. Arnold
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`P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004).
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`ANALYSIS
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`In our Decision, we determined that Petitioner demonstrated a
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`reasonable likelihood of success in showing that the challenged claims
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`2
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`IPR2020-00770
`Patent 9,604,901 B2
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`would have been obvious over the asserted combination of Moriarty and
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`Phares. See Dec. 22–28. In its Request for Rehearing, Patent Owner
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`contends that our determination to institute inter partes review is improper
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`for three reasons. First, Patent Owner argues that we misapprehended the
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`differences between the prior art and the claims at issue. Reh’g Req. 2–5.
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`Second, Patent Owner argues that we misapprehended the standard for
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`inherency. Id. at 5–7. Third, Patent Owner argues that we overlooked
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`objective indicia of nonobviousness. Id. at 7–10.
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`Because we did not expressly address Patent Owner’s arguments with
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`respect to objective indicia of nonobviousness (see Paper 6 (“Prelim. Resp.”)
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`69–71), we address those arguments now. For the reasons explained below,
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`however, we deny the Request for Rehearing because none of Patent
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`Owner’s arguments persuade us of an abuse of discretion in instituting
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`review in this proceeding.
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`Differences between the Prior Art and Claim 1
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`Patent Owner contends that “the Decision mistakenly finds that ‘the
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`combination of Moriarty and Phares teaches the same process steps as
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`challenged claim 1.’” Reh’g Req. 4 (citing Dec. 27). Patent Owner contends
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`that claim 1’s recited steps do not involve isolating the treprostinil
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`intermediate. Id. at 2–3. Patent Owner contends that claim 1 differs from
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`Phares and Moriarty because each reference separately describes isolating
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`the treprostinil intermediate. Id. at 3. Patent Owner contends that Petitioner
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`relies on the ordinarily skilled artisan being motivated to modify the prior art
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`by removing the isolating step from the Moriarty and Phares processes. Id. at
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`2–3. Because of this modification, Patent Owner contends that “Moriarty
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`3
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`IPR2020-00770
`Patent 9,604,901 B2
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`and Phares do not teach the same process steps” resulting in the claimed
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`product. See id. at 4. We are not persuaded by Patent Owner’s argument.
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`As an initial matter, to the extent that Patent Owner attacks the
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`references individually, we emphasize that we consider the combination of
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`the prior art as a whole. See In re Merck & Co., Inc., 800 F.2d 1091, 1097
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`(Fed. Cir. 1986) (“Non-obviousness cannot be established by attacking
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`references individually where the [challenge] is based upon the teachings of
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`a combination of references.”).
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`In the Decision, we explained that Phares explicitly describes the
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`Moriarty process in teaching the synthesis of (-)-treprostinil, the enantiomer
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`of (+)-treprostinil. Dec. 25 (citing Ex. 1008, 40). Thus, on the record before
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`us at that time, we “agree[d] with Petitioner that an ordinarily skilled artisan
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`would have combined the process of Moriarty with the step of adding
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`diethanolamine to treprostinil as taught by Phares.” Id. The resulting
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`combination of Moriarty and Phares would not involve isolating the
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`treprostinil intermediate and accordingly, teaches the same process steps as
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`challenged claim 1. Having reconsidered the pre-institution record, we
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`continue to find persuasive Petitioner’s argument that a skilled artisan would
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`have found it obvious to add diethanolamine to a treprostinil solution
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`without isolating treprostinil when combining Moriarty with Phares. See Pet.
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`61–62 (citing Ex. 1008, 40; Ex. 1002 ¶¶ 177–178).
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`Our analysis is consistent with the Board’s previous finding in a
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`related proceeding involving U.S. Patent No. 8,497,393 (“the ’393 patent”),
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`which is a parent of the ’901 patent. See Ex. 1001, code (63). The Board
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`previously held that claims of the ’393 patent are unpatentable. Dec. 3
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`(citing IPR2016-00006, Paper 82 (PTAB Mar. 31, 2017) (“the ’393
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`4
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`IPR2020-00770
`Patent 9,604,901 B2
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`Decision” or “the ’393 Dec.”)). In doing so, the Board found that “an
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`ordinarily skilled artisan would have modified the process of Moriarty to
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`incorporate the step of adding and dissolving diethanolamine to treprostinil
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`as taught by Phares to eliminate the requirement for intermediate
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`purification, thus, improving synthetic efficiency and reducing cost.” The
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`’393 Dec. 47. The Federal Circuit has affirmed that decision. United
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`Therapeutics Corp. v. SteadyMed Ltd., 702 F. App’x. 990 (Fed. Cir. 2017).
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`As we did in the Decision, we continue to “encourage the parties here to
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`discuss whether issue preclusion applies in this proceeding such that Patent
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`Owner cannot reargue this point.” Dec. 25 n.7.
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`In sum, we are not persuaded that we misapprehended the differences
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`between the prior art and claim 1.
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`Inherency of the Claimed Product
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`Patent Owner contends that “[b]ecause the recited steps are different
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`from those disclosed in Moriarty and Phares (no isolation of treprostinil after
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`alkylation and hydrolysis steps before forming a salt), then the resulting
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`products cannot be assumed to be the same.” Reh’g Req. 5. Patent Owner
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`contends that given the different process steps, Petitioner cannot argue
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`“identical impurities” and “effectively conceded that the resulting impurities
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`may not necessarily be the same as recited in the claims.” Id. at 6. On the
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`current record, we are not persuaded by Patent Owner’s argument.
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`As discussed above, at this stage of the proceeding, we remain
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`persuaded by Petitioner’s argument that the combination of Moriarty and
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`Phares teaches the same process steps, including adding a base to treprostinil
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`solution without isolating treprostinil. Accordingly, we remain persuaded
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`5
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`IPR2020-00770
`Patent 9,604,901 B2
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`that there is a reasonable likelihood that the product from these steps would
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`include the same resulting impurities. See Dec. 27.
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`Patent Owner also argues that “the Decision appears to improperly
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`rely on inherency in an obviousness context to address the ‘pharmaceutical
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`batch’ limitation by citing Moriarty while ignoring the arguments that a
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`storage stable batch would not have been expected based on Phares.” Reh’g
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`Req. 10 (citing Dec. 26–27). On the pre-institution record, we disagree with
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`Patent Owner’s inherency argument because Patent Owner is attacking the
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`references individually. See In re Merck & Co., Inc., 800 F.2d 1091, 1097
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`(Fed. Cir. 1986) (“Non-obviousness cannot be established by attacking
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`references individually where the [challenge] is based upon the teachings of
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`a combination of references.”). Moreover, claim 1 does not require “a
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`storage stable batch.” And contrary to Patent Owner’s assertion (Reh’g Req.
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`8 n.2), we did not construe the term “pharmaceutical batch” in claim 1 to
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`require storage stability (see Dec. 15–16).
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`In sum, we are not persuaded that we misapprehended the standard for
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`inherency of a product resulting from process taught by the prior art.
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`Objective Indicia of Nonobviousness
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`Patent Owner contends that “[t]he Board overlooked evidence of
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`objective indicia of nonobviousness, as set forth in the ’901 patent
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`specification and prosecution history and outlined by Patent Owner.” Reh’g
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`Req. 7. Patent Owner presents two arguments that we should have denied
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`institution based on Patent Owner’s proffered evidence of objective indicia.
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`See Req. Reh’g 7–10. First, Patent Owner argues that we should have denied
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`institution because Petitioner did not address objective indicia of
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`nonobviousness in the Petition, except to assert that it does not exist. Id.
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`6
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`IPR2020-00770
`Patent 9,604,901 B2
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`at 7–8 (citing Pet. 71). Second, Patent Owner contends that the evidence of
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`objective indicia supports the patentability of the claims over the prior art.
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`See id. at 8–10. Despite having considered Patent Owner’s evidence and
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`argument related to objective indicia pre-institution, we did not expressly
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`address them in our Decision. We do so now.
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`As for Patent Owner’s first contention that the Petition should have
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`been denied for failing to address objective indicial of nonobviousness, we
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`are not persuaded. Patent Owner cites Semiconductor Components
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`Industries, LLC v. Power Integrations, Inc., IPR2016-01588, Paper 15 at
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`28–29 (PTAB Feb. 17, 2017) as authority for denying a petition for inter
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`partes review due to Petitioner’s failure to address objective indicia of
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`nonobviousness. Id. at 7. In Semiconductor Components, the Federal Circuit
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`previously determined that the claims at issue were not obvious due to
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`evidence of commercial success presented during extensive litigation.
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`Semiconductor Components, Paper 15 at 28. Accordingly, the panel
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`concluded that “it was incumbent on Petitioner to address substantively such
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`objective considerations in the context of its obviousness challenges.” Id.
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`Unlike the patent in Semiconductor Components, the ’901 patent does
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`not have an extensive litigation record of objective indicia supporting
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`nonobviousness. Rather, similar claims in the parent ’393 patent were
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`determined unpatentable by the Board in an inter partes review proceeding.
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`See Dec. 3. In the ’393 Decision, the Board determined that evidence of
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`objective indicia, including long-felt need, unexpected results, and process
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`advantages, did not establish nonobviousness. The ’393 Dec. 56–67. In the
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`Decision in the instant proceeding, we considered the expert testimony of
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`“higher average purity” that Patent Owner submitted during the prosecution
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`7
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`of the challenged ’901 patent, and determined, based on the pre-institution
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`record, that “the examiner erred in relying on the applicant’s argument on
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`the improved purity profile to allow the challenged claims.” Dec. 13–15. As
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`we explained in the Decision, “higher average purity” is not a limitation in
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`the challenged claims of the ’901 patent. Id. at 14.
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`Because the asserted evidence of objective indicia in the of the ’901
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`patent and in a prior proceeding involving its parent ’393 patent either does
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`not apply to the claims at issue (which do not recite “higher average
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`purity”), or was previously found unpersuasive of nonobviousness, we do
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`not find the Petition “facially deficient” because it does not address that
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`evidence. Reh’g Req. 8; see Dec. 14; The ’393 Dec. 56–67. Insofar as Patent
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`Owner asserts additional evidence and arguments related to objective indicia
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`of nonobviousness in the Preliminary Response, Petitioner has not had an
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`opportunity to address that evidence and argument. As a result, arguments
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`and evidence of objective indicia are better suited for resolution on a fuller
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`record developed during trial.
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`In any event, we considered Patent Owner’s evidence of
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`nonobviousness at the institution stage, and we provide our analysis here. In
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`the Preliminary Response, Patent Owner argued that the ’901 patent includes
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`comparative data illustrating multiple advantages over a process that “is
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`essentially the same as Liquidia’s Moriarty references.” Prelim. Resp. 70–71
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`(citing Ex. 1001, 1:27–34, 15:25–16:64 (Example 6), 16:65–17:12; Ex. 2002
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`¶ 134). In the Rehearing Request, Patent Owner contends that the
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`’901 patent’s file history “contains evidence and argument” for objective
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`indicia of nonobviousness. Reh’g Req. 9 (citing Ex. 2007, 3819–3825).
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`8
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`Based on the pre-institution record, we are not persuaded by Patent Owner’s
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`arguments and evidence on this issue.
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`Patent Owner has made generalized arguments as to evidence of “less
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`waste,” “higher purity,” “storage at ambient temperatures,” “better-quality
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`final product,” and “significant savings in material and labor.” See Prelim.
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`Resp. 70–71. At this stage of the proceeding, Patent Owner has not
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`established that these are more than an expected improvement in properties
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`given the skilled artisan’s desire to make a “faster, more efficient and more
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`economical” process. See Ex. 1002 ¶ 178. Moreover, “unexpected results
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`must be established by factual evidence. Mere argument or conclusory
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`statements in the specification does not suffice.” In re Soni, 54 F.3d 746, 750
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`(Fed. Cir. 1995). We find Patent Owner has not presented sufficient factual
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`evidence to show unexpected results on the preliminary pre-institution
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`record.
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`Accordingly, based on the pre-institution record, we remain persuaded
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`that Petitioner demonstrated a reasonable likelihood of showing that at least
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`one claim is unpatentable based upon our consideration of the arguments and
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`evidence in the Petition and Preliminary Response, including Patent
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`Owner’s asserted arguments and evidence as to objective indicia.
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`CONCLUSION
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`For the foregoing reasons, the Request for Rehearing is denied.
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`Accordingly, it is
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`ORDER
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`ORDERED that Patent Owner’s Request for Rehearing is denied.
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`9
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`IPR2020-00770
`Patent 9,604,901 B2
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`FOR PETITIONER:
`
`Ivor R. Elrifi
`Erik B. Milch
`Cooley LLP
`ielrifi@cooley.com
`emilch@cooley.com
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`
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`FOR PATENT OWNER:
`
`Stephen B. Maebius
`George Quillin
`Daniel R. Shelton
`Foley & Lardner LLP
`smaebius@foley.com
`gquillin@foley.com
`dshelton@foley.com
`
`
`Shaun R. Snader
`United Therapeutics Corp.
`ssnader@unither.com
`
`Douglas Carsten
`Richard Torczon
`Wilson, Sonsini, Goodrich & Rosati
`dcarsten@wsgr.com
`rtorczon@wsgr.com
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`10
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