Trials@uspto.gov
`571-272-7822
`
`
`
`
`
` Paper 14
`
`
`
`
` Entered: September 27, 2019
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`AQUESTIVE THERAPEUTICS, INC.,
`Petitioner,
`
`
`
`v.
`
`NEURELIS, INC.,
`Patent Owner.
`
`Case IPR2019-00451
`Patent 9,763,876 B2
`
`
`
`
`
`
`
`
`
`
`Before ZHENYU YANG, JON B. TORNQUIST, and JAMIE T. WISZ,
`Administrative Patent Judges.
`
`
`WISZ, Administrative Patent Judge.
`
`
`DECISION
`Denying Patent Owner’s Request on Rehearing of Decision on Institution
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
` Paper 14
`
`
`
`
` Entered: September 27, 2019
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`AQUESTIVE THERAPEUTICS, INC.,
`Petitioner,
`
`
`
`v.
`
`NEURELIS, INC.,
`Patent Owner.
`
`Case IPR2019-00451
`Patent 9,763,876 B2
`
`
`
`
`
`
`
`
`
`
`Before ZHENYU YANG, JON B. TORNQUIST, and JAMIE T. WISZ,
`Administrative Patent Judges.
`
`
`WISZ, Administrative Patent Judge.
`
`
`DECISION
`Denying Patent Owner’s Request on Rehearing of Decision on Institution
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`
`
`
`
`IPR2019-00451
`Patent 9,763,876 B2
`
`
`
`I.
`
`INTRODUCTION
`
`Neurelis, Inc. (“Patent Owner”) requests rehearing of the Board’s
`
`Decision (Paper 8) (“Decision”) instituting inter partes review of claims 1–
`
`36 of U.S. Patent No. 9,763,876 B2 (Ex. 1001, “the ’876 patent”). Paper 10
`
`(“Request for Rehearing” or “Req. Reh’g”). For the reasons that follow,
`
`Patent Owner’s Request for Rehearing is denied.
`
`II. ANALYSIS
`
`Pursuant to 37 C.F.R. § 42.71(d):
`
`A party dissatisfied with a decision may file a single request for
`rehearing without prior authorization from the Board. The
`burden of showing a decision should be modified lies with the
`party challenging the decision. The request must specifically
`identify all matters the party believes the Board misapprehended
`or overlooked, and the place where each matter was previously
`addressed in a motion, an opposition, or a reply.
`
`When reconsidering a decision on institution, we review the decision for an
`
`abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion exists
`
`where a “decision [i]s based on an erroneous conclusion of law or clearly
`
`erroneous factual findings, or . . . a clear error of judgment.” PPG Indus.
`
`Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed.
`
`Cir. 1988).
`
`Patent Owner contends that we (1) misapprehended the statutory
`
`requirements for claiming priority, (2) misapprehended the scope and
`
`applicability of 37 C.F.R. § 1.57, and (3) overlooked the due-process
`
`requirements of 37 C.F.R. § 1.57. Req. Reh’g 1. We need only address the
`
`first argument below for purposes of this Decision.
`2
`
`
`
`IPR2019-00451
`Patent 9,763,876 B2
`
`
`
`Patent Owner asserts that we misapprehended the statutory
`
`requirements for claiming priority because, rather than addressing the
`
`statutory written description requirement, we sua sponte applied 37 C.F.R.
`
`§ 1.57. Id. at 3. In making this argument, Patent Owner contends that “the
`
`merits of the priority claim are unchallenged” and the Petition does not even
`
`suggest that “a person of ordinary skill in the art would have failed to
`
`understand the provisional specification . . . or appreciate from the
`
`specification what the inventors had invented.” Id. at 1, 3. As discussed
`
`below, we are not persuaded by this argument.
`
`First, Petitioner did challenge the ’876 patent priority claim in
`
`contending that “the presence of any alkyl glycosides (either generally or
`
`particularly) – regardless of amount – was not disclosed, described, or
`
`enabled by [the] ’558 Provisional.” Petition 20. Furthermore, with
`
`supporting testimony from Dr. Nicholas A. Peppas, Petitioner further
`
`asserted that the ’558 provisional’s “generic disclosure of ‘surface active
`
`agents (especially non-ionic materials)’ . . . does not disclose, describe,
`
`and/or enable alkyl glycosides in general (or dodecyl maltoside in
`
`particular).” Id. (citing Ex. 1008 ¶ 152; Ex. 1041 ¶ 68).
`
`Second, Patent Owner’s argument appears to misapprehend the
`
`burden of showing entitlement to priority. Although the petitioner has the
`
`ultimate burden of persuasion to prove unpatentability, a patent owner must
`
`demonstrate entitlement to a priority date when the patent owner relies on
`
`that priority date to overcome an anticipation or obviousness argument. See
`
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1379–80
`
`3
`
`
`
`IPR2019-00451
`Patent 9,763,876 B2
`
`
`(Fed. Cir. 2015) (discussing burdens in inter partes review to show
`
`entitlement to provisional filing dates and relying on infringement cases
`
`involving continuation-in-part applications); In re NTP, Inc., 654 F.3d 1268,
`
`1276 (Fed. Cir. 2011) (“[A] patent’s claims are not entitled to an earlier
`
`priority date because the patentee claims priority. Rather, for a patent’s
`
`claims to be entitled to an earlier priority date, the patentee must
`
`demonstrate that the claims meet the requirements of 35 U.S.C. § 120.”
`
`(citations omitted)); Research Corp. Techs., Inc. v. Microsoft Corp., 627
`
`F.3d 859, 870–71 (Fed. Cir. 2010); Tech. Licensing Corp. v. Videotek, Inc.,
`
`545 F.3d 1316, 1327–29 (Fed. Cir. 2008); PowerOasis, Inc. v. T–Mobile
`
`USA, Inc., 522 F.3d 1299, 1305–06 (Fed. Cir. 2008).
`
`As explained in Dynamic Drinkware, a petitioner has the initial
`
`burden of going forward to show that there is invalidating prior art.
`
`Dynamic Drinkware, 800 F.3d at 1379. As discussed in our Decision,
`
`Petitioner satisfied its initial burden of production on the issue of whether
`
`Gwozdz is prior art by establishing that Gwozdz is entitled to the effective
`
`filing date of the Gwozdz provisional. Decision 7. Therefore, Gwozdz is
`
`prior art to the ’876 patent under 35 U.S.C. § 102(e)(1) unless Patent Owner
`
`can show that the ’876 patent is entitled to the effective filing date of its
`
`provisional application (“the ’558 provisional”). Id. Thus, the burden of
`
`production shifts to Patent Owner, who must show not only the existence of
`
`earlier applications, but also how the written description in the earlier
`
`applications supports the challenged claims. Dynamic Drinkware, 800 F.3d
`
`at 1379–80. “[T]o gain the benefit of the filing date of an earlier application
`
`4
`
`
`
`IPR2019-00451
`Patent 9,763,876 B2
`
`
`under 35 U.S.C. § 120, each application in the chain leading back to the
`
`earlier application must comply with the written description requirement of
`
`35 U.S.C. § 112.” Zenon Envtl., Inc. v. U.S. Filter Corp., 506 F.3d 1370,
`
`1378 (Fed. Cir. 2007) (quoting Lockwood v. Am. Airlines, Inc., 107 F.3d
`
`1565, 1571 (Fed. Cir. 1997)); see also In re Hogan, 559 F.2d 595, 609
`
`(CCPA 1977) (“[T]here has to be a continuous chain of copending
`
`applications each of which satisfies the requirements of § 112 with respect to
`
`the subject matter presently claimed.” (alteration in original) (quoting In re
`
`Schneider, 481 F.2d 1350, 1356 (CCPA 1973))). Thus, as discussed in our
`
`Decision, Patent Owner must show that each application in the priority
`
`chain1 makes the requisite disclosure of subject matter; otherwise, the ’876
`
`patent is not entitled to the benefit of the filing date of the ’558 provisional.
`
`Decision 7 n.6.
`
`On this record, Patent Owner fails to satisfy its burden of production
`
`to show entitlement to an earlier filing date. All of Patent Owner’s
`
`arguments are focused on the alleged deficiencies with Petitioner’s
`
`contentions regarding the disclosure of alkyl glycosides in the ’558
`
`provisional. Prelim. Resp. 24–27. Patent Owner offers no analysis
`
`demonstrating that every patent application along the priority chain conveys
`
`with reasonable clarity to those skilled in the art that the inventors were in
`
`possession of each limitation of each of the challenged claims, as well as the
`
`
`
`1 In this case, the priority chain for the ’876 patent includes a provisional
`application and a continuation-in-part application. Decision 6.
`5
`
`
`
`IPR2019-00451
`Patent 9,763,876 B2
`
`
`claimed invention as a whole. See Lockwood, 107 F.3d at 1572. Therefore,
`
`on this record, Patent Owner has not demonstrated that the claims of the
`
`’876 patent are entitled to the priority date of the ’558 provisional.
`
`Given Patent Owner’s failure to satisfy its burden of production to
`
`show that all of the ’876 patent claims are supported throughout the priority
`
`chain, we need not address Patent Owner’s additional arguments regarding
`
`the application of 37 C.F.R. § 1.57 at this time. The parties are invited to
`
`address these issues further during trial, to the extent necessary.
`
`III. CONCLUSION
`
`For the reasons given, Patent Owner has not demonstrated that we
`
`abused our discretion in instituting inter partes review of claims 1–36 of the
`
`’876 patent.
`
`Accordingly, it is
`
`IV. ORDER
`
`ORDERED that Patent Owner’s Request for Rehearing is denied.
`
`6
`
`
`
`IPR2019-00451
`Patent 9,763,876 B2
`
`
`PETITIONER:
`
`Daniel Scola
`dscola@hbiplaw.com
`
`Michael Chakansky
`mchakansky@hbiplaw.com
`
`James Harrington
`jfhdocket@hbiplaw.com
`
`Matthew Solow
`msolow@hbiplaw.com
`
`
`PATENT OWNER:
`
`Jeffrey Guise
`jguise@wsgr.com
`
`Richard Torczon
`rtorczon@wsgr.com
`
`Lorelei Westin
`lwestin@wsgr.com
`
`Lee Johnson
`ljohnson@wsgr.com
`
`Nathaniel Leachman
`nleachman@wsgr.com
`
`
`
`7
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
