`571-272-7822
`
`
`
`
`
`
`
`
` Paper 7
`
`
`
` Entered: October 14, 2020
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`
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`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`ETON PHARMACEUTICALS, INC..,
`Petitioner,
`
`v.
`
`EXELA PHARMA SCIENCES, LLC,
`Patent Owner.
`
`PGR2020-00068
`Patent 10,583,155 B1
`
`
`
`
`
`Before ULRIKE W. JENKS, SUSAN L.C. MITCHELL, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`PAULRAJ, Administrative Patent Judge.
`
`
`
`
`ORDER
`
`Conduct of Proceeding
`
`37 C.F.R. §§ 42.5; 42.208(c)
`
`
`
`
`
`
`
`PGR2020-00068
`Patent 10,583,155 B1
`
`
`On October 2, 2020, the Board received an email from counsel for
`
`Petitioner Eton Pharmaceuticals, Inc. seeking authorization to file a reply
`
`brief, no more than 6 pages, to Patent Owner Exela Pharma Science, LLC’s
`
`Preliminary Response. Ex. 3001. Petitioner asserts that good cause supports
`
`a reply to address the following arguments raised by Patent Owner:
`
`[1] Eton’s particularity challenge is unexpected and incorrect.
`Grounds 1-2 of Eton’s petition rely on the four corners of the
`Sandoz Label as invalidating prior art.
`
`[2] Exela’s assertions regarding the prior art should be
`considered in view of the Examiner’s July 23, 2020 rejections
`in related, co-pending application nos. 16/773,641 and
`16/746,028 (the rejections occurred after the filing of Eton’s
`petition) and the materials that provide the relevant context for
`those rejections.
`
`[3] Exela’s assertions that the Petition fails to explain “how a
`POSITA applying ‘routine optimization’ would have achieved”
`the claimed invention (POPR at 8) and fails to explain “why a
`POSITA would have a reasonable expectation of success”
`solving the aluminum problem (POPR at 9).
`
`Id. (bracketed numbers added).
`
`In a related case, PGR2020-00064, we recently authorized Petitioner
`
`to a file a reply to address the first two issues identified in Petitioner’s email
`
`above in addition to the issue of whether the “Allergy Process” is a public
`
`use. PGR2020-00064, Paper 7. Petitioner, however, did not previously
`
`request a reply to address Patent Owner’s arguments regarding “routine
`
`optimization” and “reasonable expectation of success.”
`
`Having considered Petitioner’s request, we determine that additional
`
`briefing would clarify the record with respect to first two topics identified in
`
`Petitioner’s email of October 2, 2020. Accordingly, we authorize a reply to
`
`allow Petitioner to present arguments in this proceeding similar to those
`
`2
`
`
`
`PGR2020-00068
`Patent 10,583,155 B1
`
`presented on the same topics in PGR2020-00064. We determine, however,
`
`that Petitioner has not identified any good cause to file a reply on the third
`
`topic identified in Petitioner’s email. We also determine to grant Patent
`
`Owner an opportunity to file a sur-reply in response to Petitioner’s reply.
`
`For the reasons given, it is:
`
`ORDERED that Petitioner is authorized to submit a 6-page reply no
`
`later than October 19, 2020 to address Patent Owner’s particularity
`
`challenge and Patent Owner’s assertions regarding the Examiner’s rejections
`
`in related applications;
`
`FURTHER ORDERED that Patent Owner is authorized to submit a 6-
`
`page sur-reply no later than October 26, 2020, responsive to Petitioner’s
`
`reply.
`
`
`
`
`
`3
`
`
`
`PGR2020-00068
`Patent 10,583,155 B1
`
`PETITIONER:
`
`Ralph Gabric
`Eugene Goryunov
`Jeff Wolfson
`Judy He
`HAYNES AND BOONE LLP
`Ralph.gabric.ipr@haynesboone.com
`Eugene.goryunov.ipr@haynesboone.com
`Jeff.wolfson.ipr@haynesbooonecom
`Judy.he@haynesboone.com
`
`
`PATENT OWNER:
`
`Dorothy P. Whelan
`Alana Mannige
`FISH & RICHARDSON P.C.
`whelan@fr.com
`alana.canfield@gmail.com
`
`
`4
`
`
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