Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`Paper 100
`Entered: September 3, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`ELI LILLY AND COMPANY,
`Petitioner,
`
`v.
`
`LOS ANGELES BIOMEDICAL RESEARCH INSTITUTE AT
`HARBOR-UCLA MEDICAL CENTER,
`Patent Owner.
`_______________
`
`Case IPR2014-00752
`Patent 8,133,903
`_______________
`
`
`Before FRANCISCO C. PRATS, SHERIDAN K. SNEDDEN, and
`SUSAN L. C. MITCHELL, Administrative Patent Judges.
`
`
`
`
`ORDER
`Denying Patent Owner’s Motion to Strike
`37 C.F.R. § 42.5
`
`
`
`
`Tel: 571-272-7822
`
`
`
`
`Paper 100
`Entered: September 3, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`ELI LILLY AND COMPANY,
`Petitioner,
`
`v.
`
`LOS ANGELES BIOMEDICAL RESEARCH INSTITUTE AT
`HARBOR-UCLA MEDICAL CENTER,
`Patent Owner.
`_______________
`
`Case IPR2014-00752
`Patent 8,133,903
`_______________
`
`
`Before FRANCISCO C. PRATS, SHERIDAN K. SNEDDEN, and
`SUSAN L. C. MITCHELL, Administrative Patent Judges.
`
`
`
`
`ORDER
`Denying Patent Owner’s Motion to Strike
`37 C.F.R. § 42.5
`
`
`
`
`
`IPR2014-00752
`Patent 8,133,903 B2
`
`I. INTRODUCTION
`With our prior authorization (Paper 79), Patent Owner filed a Motion
`to Strike (Paper 81; “Mot.”) seeking to strike portions of Petitioner’s Reply
`(Paper 73; “Reply”), portions of Dr. Goldstein’s Reply Declaration
`(Ex. 1153), portions of Ex. 1002, and portions of Ex. 1151. Mot. 1–2.
`Petitioner filed an Opposition to Patent Owner’s Motion to Strike.
`Paper 83 (“Opp.”).
`Based on our consideration of the parties’ positions, we deny Patent
`Owner’s Motion to Strike for the reasons that follow.
`
`II. DISCUSSION
`The Board recently issued guidance in the form of a “Trial Practice
`Guide Update,” dated August 2018 (“Practice Guide”). See 83 Fed. Reg.
`38,989 (Aug. 13, 2018) (notifying the public of the updated “Practice
`Guide” and its accessibility through the USPTO website:
`https://go.usa.gov/xU7GP). With regard to motions to strike, the Practice
`Guide provides the option to request authorization to file a motion “[i]f the
`party believes that a brief filed by the opposing party raises new issues, is
`accompanied by belatedly presented evidence, or otherwise exceeds the
`proper scope of reply or sur-reply.” Practice Guide 17. Specifically, the
`Practice Guide addresses the distinct applicability of these two alternatives:
`
`A motion to strike may be appropriate when a party believes the
`Board should disregard arguments or late-filed evidence in its
`entirety, whereas further briefing may be more appropriate when
`the party wishes to address the proper weight the Board should
`give to the arguments or evidence. In most cases, the Board is
`capable of identifying new issues or belatedly presented evidence
`when weighing the evidence at the close of trial, and disregarding
`any new issues or belatedly presented evidence that exceeds the
`
`2
`
`
`
`IPR2014-00752
`Patent 8,133,903 B2
`
`
`proper scope of reply or sur-reply. As such, striking the entirety
`or a portion of a party’s brief is an exceptional remedy that the
`Board expects will be granted rarely.
`
`Id.
`
`Patent Owner contends that Petitioner’s Reply introduces two new
`theories and evidence to support those two new theories. Mot. 1. Patent
`Owner contends that Petitioner’s Reply introduces a first new theory
`because Petitioner “tries to redefine “fibrosis” by advancing a new theory it
`calls ‘collagen remodeling.’” Mot. 1. Patent Owner contends that “[t]he
`‘collagen remodeling’ theory is not responsive to arguments in [Patent
`Owner]’s supplemental response, nor to new claim constructions.” Id. at 1–
`2 (citing Reply 6:10–8:11, 24:4–25:4, 25:10–26:3; Ex. 1153 ¶¶ 22–23, 25–
`27, 30–37, 39, 45, 49, 56; and Ex. 1002, 1169–72).
`Patent Owner additionally contends that Petitioner’s Reply “advances
`a [second] new theory that PDE-5 inhibitors ‘amplify’ NOS and the
`NO/cGMP pathway.” Mot. 3–4 (citing Reply 12 (diagram), 13:3–10, 18:7–
`9, 18:16–19:7, 19:16–20:7, 23:4–15; Ex. 1153 ¶¶ 7–13, 17, 19–20, 50–56,
`58, 60–63, 68; and Ex. 1002, 1169–72). Specifically, Patent Owner
`contends as follows:
`
`The “amplification” theory is new. For example, although Lilly’s
`reply argues 19 times that PDE-5 inhibitors “amplify” NOS and
`the NO/cGMP pathway, “amplify” does not appear in the petition
`even once. And although Dr. Goldstein attempts to anchor this
`theory in the petition by citing 17 paragraphs from his original
`declaration (Ex. 1153 ¶ 7 (citing Ex. 1089 ¶¶ 102–118)), in
`deposition he failed to identify any concrete support for the
`theory. Ex. 2117 at 61:19–64:3, 65:7–66:2, 69:15–70:18, 72:10–
`79:14 (discussing Ex. 1089 ¶¶ 106, 108, 113, 118).
`Id. at 3.
`
`3
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`IPR2014-00752
`Patent 8,133,903 B2
`
`
`Petitioner responds that it “relies on the same evidence and reasoning
`as the Petition to establish obviousness (e.g., Reply, 8-10) and is directly
`responsive to [Patent Owner]’s new arguments.” Opp. 1.
`Having considered the parties’ positions and evidence of record, we
`agree with Petitioner. For example, in its Petition (Paper 1, “Pet.”),
`Petitioner argues that Ferrini 2002 taught that once formed fibrosis is “in a
`state of flux” such that “interventions aiming to reduce collagen deposition
`may be beneficial” as they can “counteract[] collagen deposition in PD
`plaque tissues.” Pet. 44. In response, Patent Owner argues in its
`Supplemental Patent Owner Response (Paper 63, “Supp. PO Resp.”) that
`Ferrini 2002 does not teach “arrest[ing] or regress[ing] . . . an already
`developed fibrosis” and further argues that Ferrini 2002 “do[es] not suggest
`or envision any role for what [Petititioner] calls the ‘nitric oxide pathway’ or
`the ‘NO/cGMP pathway’—i.e., for downstream mediators of NO such as
`cGMP—in penile fibrosis.” Supp. PO Resp. 36. In its Reply, Petitioner
`presents argument and evidence explaining how a person of ordinary skill in
`the art would have understood that the fibrotic plaque exists in a “state of
`flux” or “dynamic balance” due to continuous “collagen remodeling” by
`opposing collagen synthesis and degradation processes. Reply 6–7. Such
`evidence, “to document the knowledge that skilled artisans would bring to
`bear in reading the prior art identified as producing obviousness,” is entirely
`proper. Genzyme Therapeutic Prod. Ltd. P’ship v. Biomarin Pharm. Inc.,
`825 F.3d 1360, 1369 (Fed. Cir. 2016).
`Similarly, in its Petition (Paper 1, “Pet.”), Petitioner argues that
`PDE5-inhibitors were a known “means for enhancing the penile NO/cGMP
`pathway,” i.e., “agents to increase nitric oxide and/or cGMP in a tissue.’”
`
`4
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`
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`IPR2014-00752
`Patent 8,133,903 B2
`
`Pet. 7–9. The argument and evidence identified by Patent Owner in its
`Motion further explain this theory expressed throughout the Petition and
`rebutted in the Supplemental Patent Owner Response. Cf. Pet. 6, 7–9, 43;
`Supp. PO Resp. 36, 38, 43; Reply 12 (diagram), 13:3–10, 18:7–9, 18:16–
`19:7, 19:16–20:7, 23:4–15. We also determine that Petitioner’s evidence
`submitted with its Reply merely supports the arguments made in the Reply,
`which is proper in an inter partes review. Genzyme, 825 F.3d at 1369.
`Accordingly, we determine that Patent Owner has not met its burden
`to establish that Petitioner’s Reply is improper and we see no good cause to
`grant the rare remedy of striking the evidence as requested by Patent Owner.
`Upon consideration thereof, it is
`ORDERED that Patent Owner’s Motion to Strike is denied.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`5
`
`
`
`IPR2014-00752
`Patent 8,133,903 B2
`
`PETITIONER:
`
`Mark J. Feldstein
`Charles E. Lipsey
`Joshua L. Goldberg
`Maureen Queler
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`mark.feldstein@finnegan.com
`charles.lipsey@finnegan.com
`joshua.goldberg@finnegan.com
`maureen.quele@finnegan.com
`
`Mark J. Stewart
`Dan L. Wood
`ELI LILLY AND COMPANY
`stewart_mark@lilly.com
`wood_dan_l@lilly.com
`
`
`PATENT OWNER:
`
`David K. Tellekson
`Ewa M. Davison
`Virginia DeMarchi
`Michael Shuster
`Jonathan T. McMichael
`FENWICK & WEST LLP
`dtellekson@fenwick.com
`edavison@fenwick.com
`vdemarchi@fenwick.com
`mshuster@fenwick.com
`jmcmichael@fenwick.com
`
`6
`
`
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