`
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`
`EVERGREEN THERAGNOSTICS, INC.,
`
`Petitioner,
`
`v.
`
`ADVANCED ACCELERATOR APPLICATIONS S.A.,
`
`Patent Owner.
`
`______________________
`
`Case PGR2021-00001
`
`U.S. Patent No. 10,596,278
`______________________
`
`PATENT OWNER’S AUTHORIZED SUR-REPLY
`
`
`
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`TABLE OF AUTHORITIES
`
`Pages
`
`
`Cases
`Blue Calypso, LLC v. Groupon, Inc.,
`815 F.3d 1331 (Fed. Cir. 2016) ............................................................................ 1
`Bruckelmyer v. Ground Heaters, Inc.,
`445 F.3d 1374 (Fed. Cir. 2006) ............................................................................ 2
`Celltrion, LLC v. Biogen, Inc.,
`No. IPR2017-01230, Paper 10 (PTAB Oct. 12, 2017) ......................................... 3
`Cisco Sys., Inc. v. Centripetal Networks, Inc.,
`No. IPR2018-01506, Paper 10 (PTAB Oct. 7, 2019) ........................................... 3
`Cornell Univ. v. Hewlett-Packard Co.,
`No. 01-CV-1974, 2008 WL 11274580 (N.D.N.Y. May 14, 2008) ...................... 1
`Fanduel, Inc. v. Interactive Games LLC,
`966 F.3d 1334 (Fed. Cir. 2020) ............................................................................ 3
`Google LLC v. IPA Techs. Inc.,
`No. IPR2018-00476, Paper 12 (PTAB Dec. 20, 2018) ........................................ 2
`In re Hall,
`781 F.2d 897-99 (Fed. Cir. 1986) ......................................................................... 3
`Incyte Corp. v. Concert Pharm., Inc.,
`No. IPR2017-01256, Paper 119 (PTAB Apr. 8, 2019) ........................................ 2
`Rules
`Fed. R. Evid. 802, 805 ............................................................................................... 3
`
`
`
`
`
`
`ii
`
`
`
`
`
`Evergreen had the burden to establish the Protocol (Ex. 1012) as prior art in
`
`its petition. It has failed to carry that burden because, among other things, Evergreen
`
`cannot show the Protocol was more likely than not publicly accessible. Now
`
`admitting the Protocol is a separate document from Strosberg (Ex. 1011), Evergreen
`
`pivots to argue for the first time that Strosberg is a “research aid” for the Protocol.
`
`But Strosberg lacks any definite reference to the Protocol, nor does it have directions
`
`for one to follow to reach the Protocol. Evergreen’s lawyers testify concerning
`
`“supplemental material” generally, without personal knowledge or foundation. Plus,
`
`this lawyer testimony ignores the contrary record facts previously highlighted.
`
`Evergreen’s assertion that it is “not disputed…that following the instruction
`
`of [Strosberg] led to the Protocol” is false: Patent Owner identified substantial
`
`contrary evidence. Strosberg only generically refers to a “protocol” providing two
`
`specific locations to two other documents: one found at the “clinicaltrial.gov” URL
`
`provided under the abstract, and the other found within the cited “Supplemental
`
`Appendix.” Paper 7 at 32–34. Never does Strosberg refer explicitly to the Protocol.
`
`Strosberg neither provides a URL for it, nor describes it, nor how to get to it in any
`
`definite way. A “research aid” must “provide a skilled artisan with a sufficiently
`
`definite roadmap” which “is reasonably certain” to lead the artisan to the alleged
`
`prior art. Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1350 (Fed. Cir. 2016).
`
`Cases illuminate what comprises such a definite roadmap. See Cornell Univ.
`
`1
`
`
`
`v. Hewlett-Packard Co., No. 01-CV-1974, 2008 WL 11274580, at *5–7 (N.D.N.Y.
`
`May 14, 2008) (article was a research aid where it explicitly cited the alleged prior
`
`art); Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378–79 (Fed. Cir. 2006)
`
`(patent was a research aid for its application to which it explicitly referred); Incyte
`
`Corp. v. Concert Pharm., Inc., No. IPR2017-01256, Paper 119 at 17 (PTAB Apr. 8,
`
`2019) (article was a research aid where it had “the precise website URL…link to the
`
`reference”). Strosberg provides no roadmap to the Protocol, and instead, points
`
`elsewhere by clearly referencing two other, different “protocols.” Paper 7 at 32–34.
`
`Tellingly, Evergreen offers no testimony that anyone used Strosberg in 2017
`
`(one year prior to the Patent’s priority date) to find the Protocol. See Google LLC v.
`
`IPA Techs. Inc., No. IPR2018-00476, Paper 12 at 10 (PTAB Dec. 20, 2018)
`
`(affirming Moran was not a “research aid” because “no proof that the web address
`
`in Moran would have led to Cheyer”). Although given this chance on reply,
`
`Evergreen ignores the contrary facts Patent Owner set out: the Protocol cross-
`
`references Strosberg as if the Protocol was published after Strosberg; and the
`
`Protocol is marked confidential and may have been redacted. Paper 7 at 25–38.
`
`Instead, Evergreen offers lawyer testimony attaching portions of emails it had
`
`with the NEJM long before its petition was filed. One attachment indicates some
`
`copying and pasting from emails ostensibly received from the NEJM staff. See Ex.
`
`A to Ex. 1037. This appears to be multiple hearsay and as such is unreliable. See
`
`2
`
`
`
`Fed. R. Evid. 802, 805; see also Cisco Sys., Inc. v. Centripetal Networks, Inc., No.
`
`IPR2018-01506, Paper 10 at 7 (PTAB Oct. 7, 2019) (institution denied where cited
`
`evidence “is hearsay for the purpose of establishing…public [accessibility] and is
`
`not reliable evidence”); Celltrion, LLC v. Biogen, Inc., No. IPR2017-01230, Paper
`
`10 at 15–16 (PTAB Oct. 12, 2017). Evergreen’s strategic decision to omit these
`
`materials from their petition should invoke a negative inference. Such omission is
`
`understandable, since these materials: lack personal knowledge and corroborating
`
`evidence; do not refer to the Protocol itself (as opposed to “supplemental material”
`
`generally); fail to say when the Protocol was posted; fail to address whether the
`
`Protocol was redacted, and if so when; and fail to explain why the cover page of the
`
`Protocol refers to the page numbers of Strosberg as if it was already published.
`
`Evergreen’s burden to prove the art it relies upon is prior remains Evergreen’s
`
`alone. See Fanduel, Inc. v. Interactive Games LLC, 966 F.3d 1334, 1341–42 (Fed.
`
`Cir. 2020). Evergreen cites In re Hall but the mere undisputed lack of rebuttal there
`
`was of no moment while the court relied on evidence of “indexing, cataloging, and
`
`shelving of theses[.]” In re Hall, 781 F.2d 897, 897–99 (Fed. Cir. 1986). Evergreen
`
`admits it lacks such evidence here, pivoting now to a “research aid” theory, but lacks
`
`factual support necessary for a “definite roadmap.” Through it all, Evergreen leaves
`
`unanswered the numerous conflicting record facts Patent Owner has highlighted.
`
`Patent Owner respectfully requests denial of institution.
`
`3
`
`
`
`Respectfully submitted,
`
`
`
`Dated: February 26, 2021
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` /Jane M. Love, Ph.D./
`Jane M. Love, Ph.D.
`Reg. No. 42,812
`
`4
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 4.26, I hereby certify that on February 26, 2021, a true
`
`and accurate copy of the foregoing Sur-Reply in support of Patent Owner
`
`Preliminary Response for PGR2021-00001 was served via electronic mail, on the
`
`following counsel of record for Petitioner:
`
`C. Kyle Musgrove, kylemusgrove@parkerpoe.com
`Paul Dietze, pauldietze@parkerpoe.com
`Elizabeth Crompton, elizabethcrompton@parkerpoe.com
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/Jane M. Love, Ph.D. /
`Jane M. Love, Ph.D.
`Reg. No. 42,812
`
`Dated: February 26, 2021
`
`
`
`
`
`
`
`
`
`
`
`
`
`