From:
`To:
`Cc:
`
`Subject:
`Date:
`
`Trials
`Mills, Jad; Trials
`Rosato, Michael; Green, Lora (External); Hostetler, Michael; Cuomo, Peter; Wintner, Thomas; Dixon, Williams;
`McGrath, Todd
`RE: IPR2022-00384, -00414, & -00415 - Request for leave to file reply to Patent Owner"s Preliminary Response
`Monday, May 23, 2022 10:21:31 AM
`
`Counsel, Patent Owner’s request for authorization to file a motion to strike Petitioner’s pre-
`institution reply submissions in IPR2022-00384, -414, and -415 is denied. Patent Owner’s challenge
`of Petitioner’s Exhibit 1057 is noted, but deemed insufficient to support authorizing a motion to
`strike. Insofar as Patent Owner alleges that the Reply exceeds the scope of our authorized additional
`briefing, we encourage Patent Owner to raise the issue in its Sur-reply due tomorrow. Any matter
`(i.e., argument, exhibit, or page count) that exceeds our instruction for additional briefing will not be
`considered at this stage of the proceedings.
`
`Thank you,
`
`Maria King
`Deputy Chief Clerk for Trials
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`703-756-1288
`
`
`
`From: Mills, Jad <jmills@wsgr.com>
`Sent: Thursday, May 19, 2022 11:55 PM
`To: Trials <Trials@USPTO.GOV>
`Cc: Rosato, Michael <mrosato@wsgr.com>; Green, Lora (External) <lgreen@wsgr.com>; Hostetler,
`Michael <mhostetler@wsgr.com>; Cuomo, Peter <PJCuomo@mintz.com>; Wintner, Thomas
`<TWintner@mintz.com>; Dixon, Williams <WSDixon@mintz.com>; McGrath, Todd
`<TMMcGrath@mintz.com>
`Subject: RE: IPR2022-00384, -00414, & -00415 - Request for leave to file reply to Patent Owner's
`Preliminary Response
`
`CAUTION: This email has originated from a source outside of USPTO. PLEASE CONSIDER THE SOURCE before
`responding, clicking on links, or opening attachments.
`
`Dear Trials,
`
`Patent Owner Sydnexis seeks to strike Petitioner’s pre-institution reply submissions in each of the
`above-referenced IPR proceedings. Petitioner filed the submissions on Tuesday, May 17, 2022.
`
`The basis is that Petitioner exceeded the number of new pieces of evidence authorized by the Board
`(relying on ten new documents instead of the maximum of three that were authorized) and
`exceeded the scope of authorized reply by attempting to pivot to new prior art bases (pages 4-7 of
`
`

`

`EX1057 and product art) instead of Exhibit 1004.
`
`Counsel for Sydnexis reached out to counsel for Petitioner (see below, and copied here) but has
`received no response. Due to the impending deadline for Sydnexis’s Sur-Reply this coming Tuesday,
`Sydnexis is raising this issue with the Board now in the hope of receiving timely guidance from the
`Board before the Sur-Replies becomes due.
`
`Respectfully submitted,
`
`Jad A. Mills
`Back-Up Counsel for Patent Owner
`
`
`From: Mills, Jad
`Sent: Thursday, May 19, 2022 10:43 AM
`To: Cuomo, Peter <PJCuomo@mintz.com>; Wintner, Thomas <TWintner@mintz.com>; Dixon,
`Williams <WSDixon@mintz.com>; McGrath, Todd <TMMcGrath@mintz.com>
`Cc: Rosato, Michael <mrosato@wsgr.com>; Green, Lora <lgreen@wsgr.com>; Hostetler, Michael
`<mhostetler@wsgr.com>
`Subject: RE: IPR2022-00384, -00414, & -00415 - Request for leave to file reply to Patent Owner's
`Preliminary Response
`
`Counsel,
`
`
`I’m writing because the Petitioner Replies and accompanying evidence that you submitted
`on Tuesday exceed the submission scope that was authorized by the Board. Accordingly, we will be
`seeking to strike your reply submissions.
`
`As you know, the Board authorized your request to file a pre-institution “Reply to Patent
`Owner’s Preliminary Response” in each case to address “only those issues” of “the public
`accessibility of Exhibit 1004 and the proposed claim construction for the ‘buffer’ and ‘buffering
`agent’” limitations. You requested authorization to submit “2-3 exhibits to corroborate the public
`accessibility of Exhibit 1004,” and the Board expressly limited the scope of additional evidence you
`were authorized to submit to “no more than 3 exhibits addressing the public accessibility of Exhibit
`1004.”
`
`
`Notwithstanding the clarity of the Board’s order, you exceeded both the quantity of new
`evidence and the scope of the submission authorized by the Board. For example, you purported to
`submit only three new exhibits (EX1056-EX1058) with each reply, but you aggregated at least five
`different documents into EX1057. That EX1057 is a conglomeration of five different documents that
`you created for your Replies is evidenced by the different URLs at the bottoms of each of the pages
`that you numbered 1, 2, 3, 4-7, and 8-9 in EX1057. In addition to submitting seven new exhibits
`when only three were authorized, your reply further evaded the limits established by the Board by
`citing and relying on three additional documents that you did not submit into evidence. See, e.g.,
`IPR2022-00384, Reply at 2 n.1 (two URLs), 3 (URL last visited 5/12/2022). Petitioner’s reply briefing
`
`

`

`thus relies on 10 separate pieces of alleged evidence where the Board authorized no more than
`three. These blatant attempts to circumvent the limits on new evidence ordered by the Board justify
`expungement of the submission.
`
`
`In addition to violating the Board’s order regarding the number of new exhibits, the Replies
`also violate the Board’s order regarding the scope of the submission. As discussed above, the
`submission was required to be limited to corroborating the “public accessibility of Exhibit 1004.”
`Instead of staying within the authorized scope, the replies pivot away from corroborating the public
`availability of EX1004 as a printed publication at the FDA web site to a new reference (pages 4-7 of
`EX1057) that Petitioner alleges was publicly available from the NIH. IPR2022-00384, Reply at 3-4.
`Petitioner also pivots away from corroborating the public availability of EX1004 by arguing product-
`based prior art. See, e.g., IPR2022-00384, Reply at 2 (“not a new product…FDA records show ‘Akorn
`[] marketed their atropine ophthalmic product since 1995’” (citing EX1022-EX1023), 4 (arguing
`“757,000 patients received a dispensed prescription for atropine sulfate ophthalmic solution 2%
`from U.S. outpatient retail pharmacies” before August 4, 2017). Product-based prior art is not
`permitted in IPRs. See 35 U.S.C. §311(b). Petitioner’s departures from the scope of briefing
`authorized by the Board also justify expungement of the submission.
`
`
`Please let us know by 5pm Eastern time today whether you will withdraw your Reply
`submissions. Otherwise, we will approach the Board for authorization to strike them.
`
`Regards,
`
`Jad A. Mills
`Wilson Sonsini Goodrich & Rosati
`701 5th Ave. Suite 5100
`Seattle, WA 98104
`Direct: 206.883.2554
`Fax: 206.883.2699
`
`From: Trials <Trials@USPTO.GOV>
`Sent: Tuesday, May 10, 2022 10:12 AM
`To: Cuomo, Peter <PJCuomo@mintz.com>; Trials <Trials@USPTO.GOV>
`Cc: Mills, Jad <jmills@wsgr.com>; Rosato, Michael <mrosato@wsgr.com>; Green, Lora
`<lgreen@wsgr.com>; Hostetler, Michael <mhostetler@wsgr.com>; Wintner, Thomas
`<TWintner@mintz.com>; Dixon, Williams <WSDixon@mintz.com>; McGrath, Todd
`<TMMcGrath@mintz.com>
`Subject: RE: IPR2022-00384, -00414, & -00415 - Request for leave to file reply to Patent Owner's
`Preliminary Response
`
`EXT - trials@uspto.gov
`
`
`Counsel, Petitioner’s request for additional briefing is granted. Under the circumstances, we find
`that additional briefing from both parties regarding the public accessibility of Exhibit 1004 and the
`
`

`

`proposed claim construction for the “buffer” and “buffering agent” would be useful. Accordingly, in
`each of IPR2022-00384, IPR2022-00414, and IPR2022-00415, Petitioner is authorized to file a Reply
`to Patent Owner’s Preliminary Response of no more than five pages that addresses only those
`issues. The Reply may be accompanied by no more than 3 exhibits addressing the public accessibility
`of Exhibit 1004. The Reply and any accompanying exhibits shall be filed by May 17, 2022. Patent
`Owner is authorized to file a Sur-reply of no more than five pages, limited to addressing the
`substance of Petitioner’s Reply. Patent Owner is not authorized to file additional evidence with the
`Sur-reply. The Sur-reply shall be filed no later than May 24, 2022. In view of this authorization for
`additional briefing from both parties, a conference call is not necessary at this time.
`
`Thank you,
`
`Maria King
`Deputy Chief Clerk for Trials
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`703-756-1288
`
`
`
`From: Cuomo, Peter <PJCuomo@mintz.com>
`Sent: Monday, May 9, 2022 9:36 AM
`To: Trials <Trials@USPTO.GOV>
`Cc: Mills, Jad <jmills@wsgr.com>; Rosato, Michael <mrosato@wsgr.com>; Green, Lora (External)
`<lgreen@wsgr.com>; Hostetler, Michael <mhostetler@wsgr.com>; Wintner, Thomas
`<TWintner@mintz.com>; Dixon, Williams <WSDixon@mintz.com>; McGrath, Todd
`<TMMcGrath@mintz.com>
`Subject: IPR2022-00384, -00414, & -00415 - Request for leave to file reply to Patent Owner's
`Preliminary Response
`
`CAUTION: This email has originated from a source outside of USPTO. PLEASE CONSIDER THE SOURCE before
`responding, clicking on links, or opening attachments.
`
`Dear Trials,
`
`Petitioner requests leave to file a short Reply to Patent Owner’s preliminary response in IPR2022-
`00384, -00414, & -00415 to address arguments regarding the public accessibility of Exhibit 1004 as
`well as Patent Owner’s claim construction arguments for the “buffer” and “buffering agent”
`limitations. Petitioner believes that good cause exists to do so and seeks authorization to file a reply
`of no more than five (5) pages along with 2-3 exhibits to corroborate the public accessibility of
`Exhibit 1004. Petitioner is also amenable to Patent Owner receiving leave to file a sur-reply of equal
`length.
`
`The parties have conferred, and Patent Owner has indicated that it would be willing to assent to a 2-
`page reply limited to addressing the public accessibility of Exhibit 1004, but otherwise opposes
`
`

`

`Petitioner’s request. The parties are additionally available for a telephone conference on any of the
`following dates and times should the Board wish to discuss Petitioner’s request:
`
`
`Monday, May 9th (1-4 pm EST)
`Tuesday, May 10th (noon-4 pm EST)
`Wednesday, May 11th (noon-4 pm EST)
`
`
`Sincerely,
`Peter J. Cuomo
`Lead Counsel for Petitioner
`Peter J. Cuomo
`Member
`
`Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
`One Financial Center, Boston, MA 02111
`+1.617.348.1854
`PJCuomo@mintz.com | Mintz.com
`
`
`
`
`
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