PGR2021-00003
`U.S. Patent No. 10,596,276
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________________
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`EVERGREEN THERAGNOSTICS, INC.
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`Petitioner
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`– vs. –
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`ADVANCED ACCELERATOR APPLICATIONS SA
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`Patent Owner
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`____________________
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`CASE NO. PGR2021-00003
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`PETITIONER’S AUTHORIZED REPLY TO
`PATENT OWNER’S PRELIMINARY RESPONSE
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`U.S. Patent No. 10,596,276
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________________
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`EVERGREEN THERAGNOSTICS, INC.
`
`Petitioner
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`– vs. –
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`ADVANCED ACCELERATOR APPLICATIONS SA
`
`Patent Owner
`
`____________________
`
`CASE NO. PGR2021-00003
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`
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`PETITIONER’S AUTHORIZED REPLY TO
`PATENT OWNER’S PRELIMINARY RESPONSE
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`PGR2021-00003
`U.S. Patent No. 10,596,276
`TABLE OF AUTHORITIES
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`Cases
`Bruckelmyer v. Ground Heaters, Inc.,
`445 F.3d 1374 (Fed. Cir. 2006) .............................................................................. 1
`Cornell University v. Hewlett-Packard Co.,
`No. 01-CV-1974, 2008 WL 11274580 (N.D.N.Y. May 14, 2008) ........................ 2
`In re Hall,
`781 F.2d 897 (Fed. Cir. 1986) ................................................................................ 3
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`PGR2021-00003
`U.S. Patent No. 10,596,276
`Patent Owner’s Preliminary Response in PGR2021-00003 challenged
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`Petitioner’s showing that Exhibit 1012 (“Protocol”) is a “printed publication.”
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`This authorized reply addresses two points: (1) Protocol was publicly accessible;
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`and (2) Petitioner has carried its present burden to demonstrate availability.
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`Public accessibility is the touchstone for determining qualification as a
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`printed publication, and public accessibility turns on whether a “person of ordinary
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`skill in the art interested in the subject matter of the patent[] in suit and exercising
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`reasonable diligence would have been able to locate the [publication].”
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`Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006).
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`There was no objection to the printed publication status of Exhibit 1011, the
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`article that refers to Protocol. Exhibit 1011 is an article from the New England
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`Journal of Medicine (“NEJM”) and was readily accessible to the interested public.
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`As noted in the Petition (Paper 2) and the Declaration of Dr. Hsieh-Yee (Ex. 1008),
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`Exhibit 1011 states, “The protocol and statistical analysis plan are available with
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`the full text of this article at NEJM.org.” Ex. 1011 at 127 (cited in the Petition at
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`21; Ex. 1008 at ¶¶ 19-23). Thus, Exhibit 1011 itself acted as a “research aid” to
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`one of ordinary skill in the art and provided Protocol’s location.
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`The Federal Circuit has made clear that even where traditional indexing may
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`be lacking, a “research aid” such as Exhibit 1011 which provides the location of a
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`publication renders that publication sufficiently accessible. Bruckelmyer, 445 F.3d
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`- 1 -
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`PGR2021-00003
`U.S. Patent No. 10,596,276
`at 1379 (“In this case, however, it does not matter whether the ’119 application
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`was catalogued or indexed ‘in a meaningful way’ because the ’119 patent was
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`indexed and could serve as a ‘research aid.’”); Cornell University v. Hewlett-
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`Packard Co., No. 01-CV-1974, 2008 WL 11274580, at *5-7 (N.D.N.Y. May 14,
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`2008) (Rader, J.) (finding a master’s thesis was a printed publication despite a lack
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`of meaningful indexing where an article cited to the thesis and provided its
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`location). It is not disputed (and was established by Dr. Hsieh-Yee) that following
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`the instructions of Exhibit 1011 led to Protocol. Thus, because Exhibit 1011
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`pointed to Protocol, and Protocol could have been accessed, Exhibit 1012 was
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`publicly accessible and qualifies as a printed publication.
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`Turning to the second point, Petitioner provided sufficient evidence of the
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`contemporaneous availability of Protocol. Indeed, the best evidence of
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`contemporaneous availability is provided by Exhibit 1011, which states: “The
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`protocol and statistical analysis plan are available with the full text of this article
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`at NEJM.org.” Ex. 1011 at 127 (emphasis added); see Petition at 21-22. In other
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`words, Exhibit 1011 indicates that Protocol was available at the time of
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`publication. Exhibit 1011 also lists exactly what was present in Protocol: the trial
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`protocol and the statistical analysis plan. Id. The cover of Protocol specifies it
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`contains“[t]his trial protocol.” See Petition at 21-22. Moreover, Protocol contains
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`only the trial protocol and statistical analysis plan noted in Exhibit 1011. Thus,
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`PGR2021-00003
`U.S. Patent No. 10,596,276
`Exhibit 1011 confirms the contents of Protocol at the time of publication. Dr.
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`Hsieh-Yee’s Declaration provides further support of the availability of Protocol.
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`Ex. 1008, ¶¶ 19-23.
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`Thus, Petitioner believes it sufficiently demonstrated contemporaneous
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`availability. Nevertheless, Exhibit 1037 provides testimonial evidence from Dr.
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`Dietze, an attorney representing Petitioner. Dr. Dietze contacted NEJM staff pre-
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`Petition filing. Ex. 1037, ¶¶ 6-7. As relayed in Dr. Dietze’s Declaration and its
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`accompanying exhibits, NEJM indicated that the Supplementary Material
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`(including Protocol) was available at the time of publication of Exhibit 1011. Id. at
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`¶¶ 7-9. NEJM testimonial evidence is not presently available, however, because
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`NEJM requires a subpoena to provide a testimonial response. Id. at ¶¶ 10-14.
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`Upon institution of this PGR, Petitioner will request authorization to compel
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`testimony from NEJM under 35 U.S.C. § 24.
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`Finally, Patent Owner sponsored the study in Exhibit 1011 and employed
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`some of the authors; yet, as of the filing of this paper, Patent Owner has presented
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`no evidence of unavailability of Protocol. Lack of rebuttal evidence in similar
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`circumstances was relevant in determining that a document was publicly
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`accessible. See In re Hall, 781 F.2d 897, 897-99 (Fed. Cir. 1986). Thus, Patent
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`Owner’s silence supports a finding that Protocol was contemporaneously available.
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`Thus, Petitioner requests that the PGR be instituted.
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`February 22, 2021
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`PGR2021-00003
`U.S. Patent No. 10,596,276
`Respectfully submitted,
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`/C. Kyle Musgrove/
`C. Kyle Musgrove
`Registration No. 40,742
`Attorney for Evergreen Theragnostics, Inc.
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`Attorney Docket No.: 34328-00001
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`PGR2021-00003
`U.S. Patent No. 10,596,276
`CERTIFICATE OF SERVICE
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`The undersigned certifies, in accordance with 37 C.F.R. § 42.6(e), that service
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`was made on counsel of record for the Patent Owner as detailed below.
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`Date of service: February 22, 2021
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`Manner of service: electronic mail
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`Documents served: Petitioner’s Authorized Reply to Patent Owner’s
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`Preliminary Response and Exhibit 1037
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`Persons served:
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`Jane M. Love, Ph.D.
`(Reg. No. 42,812)
`Kyanna Sabanoglu
`(Reg. No. 79,206)
`Gibson, Dunn & Crutcher LLP
`200 Park Avenue
`New York, NY 10166
`Office: (212) 351-3922
`Mobile: 917-376-8790
`Fax: (212) 351-6322
`Email: jlove@gibsondunn.com
` ksabanoglu@gibsondunn.com
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`/C. Kyle Musgrove/
`C. Kyle Musgrove
`Registration No. 40,742
`Attorney for Evergreen Theragnostics, Inc.
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