IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`GUARDANT HEALTH, INC.
`Petitioner,
`v.
`UNIVERSITY OF WASHINGTON,
`Patent Owner.
`_____________________
`
`Case No. IPR2022-01115
`Patent No. 10,801,063
`_____________________
`
`PETITIONER’S EXPLANATION OF MULTIPLE PETITIONS
`CHALLENGING PATENT NO. 10,801,063
`AND RANKING OF PETITIONS
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`
`
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`GUARDANT HEALTH, INC.
`Petitioner,
`v.
`UNIVERSITY OF WASHINGTON,
`Patent Owner.
`_____________________
`
`Case No. IPR2022-01115
`Patent No. 10,801,063
`_____________________
`
`PETITIONER’S EXPLANATION OF MULTIPLE PETITIONS
`CHALLENGING PATENT NO. 10,801,063
`AND RANKING OF PETITIONS
`
`
`
`
`
`
`
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`
`I.
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`
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`U.S. Patent No. 10,801,063
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`Introduction
`Petitioner TwinStrand Biosciences is filing a second petition challenging the
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`patentability of the claims of U.S. Patent Number 10,801,063. Pursuant to the
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`Board’s July 2019 Trial Practice Guide Update, TwinStrand submits this paper to
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`“identify: (1) a ranking of the petitions in the order in which it wishes the Board to
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`consider the merits … , and (2) a succinct explanation of the differences between
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`the petitions, why the issues addressed by the differences are material, and why the
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`Board should exercise its discretion to institute additional petitions.”
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`II. Ranking of the Petitions
`As explained below, the Board should institute on both Petitions. But, if the
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`Board institutes on only one Petition, TwinStrand requests the Board institute
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`IPR2022-01115 (“the Narayan Petition”).
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`III. Succinct Explanation of Rationale for Multiple Petitions and the
`Differences Between the Petitions
`Mere days before Petitioner TwinStrand filed its first petition against
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`Guardant’s challenged ’063 patent, Illumina (an unrelated third party) sued Patent
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`Owner Guardant in district court, alleging that the ’063 patent’s inventorship is
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`incorrect. Illumina alleged that two inventors named on the ’063 patent, who were
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`formerly Illumina employees, misappropriated Illumina trade secrets and breached
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`their contracts with Illumina. Illumina further alleged that other Illumina
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`employees contributed to the conception of the claimed inventions of the ’063
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`1
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`U.S. Patent No. 10,801,063
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`patents and therefore should be named as inventors to the patent. EX1069, 19. The
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`Illumina lawsuit casts significant doubt about whether the proper inventors are
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`currently listed on the face of the ’063 patent. For example, inventors may be
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`added or subtracted by settlement agreement at any time, or eventually by court
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`order. Accordingly, there is a live, new dispute about the proper inventorship of the
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`’063 patent.
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`Additionally, about three weeks ago, and after Petitioner filed its first
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`petition, the PTAB issued its decision in Incyte Corp. v. Concert Pharm., Inc.
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`(PGR2021-00006), Paper 68 (May 11, 2022), which addressed the legal contours
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`of the inventor disclosure exceptions of AIA § 102(b)(1). (Id. at 40). 35 U.S.C. §§
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`102(b)(1)(B) and 102(b)(2)(B) provide for certain exceptions to AIA §102(a) prior
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`art if the relied-upon subject matter in the prior art reference was publicly disclosed
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`by the inventor, joint inventor, or someone who obtained the subject matter from
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`the inventor, before the § 102(a) date of the prior art reference. In Incyte Corp., the
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`Board, for the first time, articulated an analysis of the certain types of inventor
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`disclosure exceptions of AIA § 102(b)(1). At the time it filed its first Petition,
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`Petitioner could not have known of the PTAB’s opinion regarding inventor-
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`publication exceptions.
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`TwinStrand’s first petition for IPR of the ’063 patent in IPR2022-00746 (the
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`Murtaza Petition), demonstrates that claims 1-28 are unpatentable as obvious over
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`2
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`U.S. Patent No. 10,801,063
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`Murtaza, Schmitt, and Meyer (Ground 1) and further in view of Craig (Ground 2)
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`or Kivioja (Ground 3). See IPR2022-00746, Paper 2, at 19-20. The petition relied
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`on Murtaza, which has a publication date of May 2, 2013, approximately eight
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`months before the earliest possible priority date of the ’063 patent.
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`Petitioner is not aware of any public disclosures of the alleged invention by
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`Guardant’s named inventors prior to Murtaza’s publication date of May 2, 2013.
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`But the Illumina lawsuit has created significant uncertainty regarding whether the
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`named inventors of the ’063 patent are, in fact, properly named, and whether issues
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`of non-joinder of other proper inventors also exist. Naturally, these issues affect
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`the possible scope of the inventor exceptions to §102(a) prior art, especially in
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`light of the Incyte Corp. decision.
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`Therefore, Petitioner files a second petition challenging the ’063 patent’s
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`claims with similar grounds of unpatentability as the first petition, but relies on
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`Narayan (EX1082) —which published on July 15, 2012, more than one year before
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`the earliest possible priority date of the ’063 patent — instead of Murtaza
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`(EX1004). No reference relied on in the Grounds of the Narayan Petition can fall
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`under any exception to prior art under AIA § 102(b). Therefore, the second petition
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`forecloses any argument from Patent Owner that an inventor-originated disclosure
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`could except any reference in its Grounds. For this reason, if the Board were to
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`institute only on one petition, TwinStrand requests that it be the Narayan petition.
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`3
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`U.S. Patent No. 10,801,063
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`However, on the merits, both petitions should be instituted. As explained in
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`the first petition, Murtaza explicitly discloses enriching cfDNA using hybrid
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`capture techniques before sequencing specific cancer genes. And, as noted above,
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`Petitioner is not aware of any disclosure of the subject matter of the reference that
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`might cause it to fall under an exception to AIA § 102(b). Further, the Board has
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`recognized that the potential to antedate a reference weighs in favor of instituting
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`multiple petitions. Comcast Cable Commc’ns, LLC v. Veveo, Inc., No. IPR2019-
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`00239, Paper 15 at 18 (P.T.A.B. July 5, 2019) (The Board was “persuaded that the
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`potential to antedate a reference relied on in a Petition” weighs in favor of
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`instituting two petitions.). Here, similar facts are in play.
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`The second petition is filed more than a month before Patent Owner’s
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`Preliminary Response is due, and therefore, Petitioner has no knowledge of Patent
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`Owner’s strategy in defending its claims. Additionally, should the Board institute
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`both Petitions, Petitioner will work to streamline these cases. For example,
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`Petitioner would agree to a single deposition of witnesses for both cases. And
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`Petitioner would agree to consolidate the case schedules as much as possible.
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`Petitioner respectfully requests institution of both Petitions, or at least the Narayan
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`Petition.
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`4
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`U.S. Patent No. 10,801,063
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`IV. CONCLUSION
`Petitioner respectfully requests that the Board consider both petitions and
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`institute both.
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`
`
`Date: June 7, 2022
`1100 New York Avenue, NW
`Washington, DC 20005
`(202) 371-2600
`
`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`/R. Wilson Powers III/
`
`Ralph Wilson Powers III, Ph.D.
`Registration No. 63,504
`Lead Attorney for Petitioner
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`5
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`U.S. Patent No. 10,801,063
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`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e))
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`The undersigned hereby certifies that the above-captioned PETITIONER’S
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`EXPLANATION OF MULTIPLE PETITIONS CHALLENGING PATENT
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`NO. 10,801,063 AND RANKING OF PETITIONS was served in its entirety on
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`June 7, 2022, upon the following parties via FedEx® at the following addresses:
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`Guardant Health / WSGR
` 650 Page Mill Road
`Palo Alto CA 94304
`Patent Owner’s Correspondence
`Address of Record for U.S. Patent No.
`10,801,063
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`Dated: June 7, 2022
`1100 New York Avenue, NW
`Washington, DC 20005
`(202) 371-2600
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`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`/R. Wilson Powers III/
`
`Ralph Wilson Powers III, Ph.D.
`Registration No. 63,504
`Lead Attorney for Patent Owner
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