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`UNITED STATES PATENT AND TRADEMARK OFFICE
`___________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
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`INITIATIVE FOR MEDICINES, ACCESS & KNOWLEDGE (I-MAK), INC.
`Petitioner
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`v.
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`GILEAD PHARMASSET LLC
`Patent Owner
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`___________
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`Case No. IPR2018-00119
`U.S. Patent No. 7,964,580
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`___________
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`PETITIONER’S REQUEST FOR REHEARING
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`I.
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`INTRODUCTION
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`Petitioner Initiative for Medicines, Access & Knowledge (I-MAK), Inc.
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`(“Petitioner”) respectfully requests rehearing of the Board’s Decision Denying
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`Institution of Inter Partes Review (“IPR”) of Gilead Pharmasset LLC’s (“Gilead”)
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`U.S. Patent 7,964,580 (“the ’580 patent”) (“Decision”; Paper 7) because the Board
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`misapprehended or overlooked that a provisional application to which the ‘580
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`patent claims priority failed to satisfy the written description requirement. The
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`Board’s resulting conclusion that the ‘580 patent was entitled to the benefit of the
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`filing date of that provisional application was, thus, incorrect, as was the Board’s
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`further conclusion that two of the references cited by Petitioner in the Petition did
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`not qualify as prior art.
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`II. LEGAL STANDARD
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`A party may request rehearing of a denial of institution by, “identify[ing] all
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`matters the party believes the Board misapprehended or overlooked, and the place
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`where each matter was previously addressed in a motion, an opposition, or a
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`reply.” 37 C.F.R. § 42.71(d). The Board reviews its decision for “abuse of
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`discretion,” Id. at § 42.71(c), which includes basing the decision on, “an erroneous
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`conclusion of law or clearly erroneous factual finding.” PPG Indus., Inc. v.
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`Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988).
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`1
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`
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`III. THE ‘580 PATENT IS NOT ENTITLED TO THE BENEFIT OF THE
`‘315 PROVISIONAL’S FILING DATE BECAUSE IT DOES NOT
`SATISFY THE WRITTEN DESCRIPTION REQUIREMENT
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`
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`“[A] patent application is entitled to the benefit of the filing date of an
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`earlier filed application only if the disclosure of the earlier application provides
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`support for the claims of the later application, as required by 35 U.S.C. § 112.” In
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`re Chu, 66 F.3d 292, 297 (Fed. Cir. 1995). “To be entitled to a parent’s effective
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`filing date, a continuation must comply with the written description requirement of
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`35 U.S.C. § 112, ¶1.” In re Owens, 710 F.3d 1362, 1366 (Fed. Cir. 2013).
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`
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`To satisfy the written description requirement, “the applicant must convey
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`with reasonable clarity to those skilled in the art that, as of the filing date sought,
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`he or she was in possession of the invention, and demonstrate that by disclosure in
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`the specification of the patent.” ULF Bamberg v. Dalvey, 815 F.3d 793, 797 (Fed.
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`Cir. 2016) (citations and internal quotation marks omitted); accord Ariad Pharms.
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`v. Eli Lilly, 598 F.3d 1336, 1351-52 (Fed. Cir. 2010) (en banc). “A disclosure in a
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`parent application that merely renders the later-claimed invention obvious is not
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`sufficient to meet the written description requirement; the disclosure must describe
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`the claimed invention with all its limitations.” Tronzo v. Biomet, 156 F.3d 1154,
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`1158 (Fed. Cir. 1998); accord Ariad, 593 F.3d at 1352.
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`“[T]he ‘580 patent claims the benefit of priority of two earlier-filed
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`provisional applications, 60/909,315 filed March 30, 2007 (Ex. 2013), and
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`2
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`60/982,309 filed on October 24, 2007 (Ex. 2014), (respectively, “the ‘315
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`provisional” and “the ‘309 provisional”).” Paper 7, 3. In the Petition, I-MAK
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`“contest[ed] that the ’580 patent is entitled to the claimed benefit of priority to the
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`’315 provisional (id. at 23, 25).” Id. at n.1. Specifically, although the ‘315
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`provisional discusses broad genera of compounds, “it does not discuss the specific
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`compounds and stereochemistry around the phosphorous atom claimed in the ‘580
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`patent.” Pet. 23, 25; Ex. 1002 ¶ 73. As a result, the two references cited in the
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`Petition that were published after the ‘315 provisional but prior to the ‘309
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`provisional constitute prior art.
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`Neither Patent Owner in its Preliminary Response, nor the Board in its
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`Decision, dispute I-MAK’s assertion that the ‘315 provisional fails to identify the
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`specific compound and stereochemistry around the phosphorous atom as claimed
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`in the ‘580 patent. Rather, Patent Owner argued, and the Board concluded, that the
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`’580 patent is entitled to claim priority to the ‘315 provisional because it contains
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`one line identifying the substituents of the claimed compound (Ex. 2013, 195) and
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`one line generically stating phosphorous can be a chiral center of the disclosed
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`compounds (Ex. 2013, 63).
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`But the ‘315 provisional identifies 12,400 different compounds (31
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`structures each having 50 tables of 8 compounds), of which the ‘315 provisional
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`states that they can have various chiral centers. Thus, there are tens of thousands of
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`3
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`possible compounds each with various particular stereochemistry identified by the
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`‘315 provisional application, and yet claims 1-7 of the ‘580 patent claim just eight
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`of those compounds (those listed in table IX-25) and claims 8-14 claim not just a
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`single compound, but a specific stereoisomer thereof, which is nowhere
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`specifically described by the ‘315 provisional. Given the vast disclosure of the
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`‘315 provisional and its failure to specifically disclose the compounds and
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`stereochemistry claimed in the ‘580 patent, the mere two lines cited by the Board
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`from the 645-page long document do not, “reasonably convey[] to those skilled in
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`the art
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`that
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`the
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`inventor had possession” of
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`the compounds with
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`the
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`stereochemistry claimed in the ‘580 patent. Ariad, 598 F.3d at 1351.
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`The Board determined that Dr. Fortunak is qualified to opine from the
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`perspective of a person of ordinary skill in the art, Paper 7 at 5, and his testimony
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`was quite clear, “[t]he ‘315 provisional application does not include a description
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`of the specific compounds claimed by the ‘580 patent.” This testimony supports
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`I-MAK’s position that the ‘580 patent is not entitled to claim the benefit of the
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`‘315 provisional. Patent Owner could have entered evidence to contradict
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`Dr. Fortunak’s testimony with its Preliminary Response, but chose not to do so.
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`Thus, the only evidence of record is that of Dr. Fortunak’s opinion.
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`The Board cites in its Decision Fujikawa v. Warranasin, 93 F.3d 1559, 1570
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`(Fed. Cir. 1996), for the proposition that, “It is well settled that ‘ipsis verbis
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`4
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`disclosure is not necessary to satisfy the written description requirement of section
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`112.’” Paper 7, 10. While of course correct, that does not mean any disclosure, no
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`matter how minor, is sufficient. Here, the mere two lines of text in the ‘315
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`provisional cited by the Board fails to, “reasonably convey[] to those skilled in the
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`art that the inventor had possession” of the compounds with the stereochemistry
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`claimed in the ‘580 patent. Ariad, 598 F.3d at 1351.
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`The Board also cites In re Ruschig, 379 F.2d 990, 994-95 (CCPA 1967) for,
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`“[a]nalogizing the direction sufficient to identify species in a genus as ‘blaze marks
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`which single out particular trees.’” As described by the en banc Federal Circuit in
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`Ariad, a reasonable interpretation of Ruschig is that, “the court properly rejected
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`the claim under a written description requirement separate from enablement
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`because the specification did not disclose the later-claimed compound to one of
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`skill in the art as something the inventors actually invented out of the myriad of
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`other compounds encompassed by the broad disclosure.” 598 F.3d at 1348.
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`Further, “the court properly affirmed the rejection because the original application
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`did not disclose the specific claimed invention, chlorpropamide, even if one of skill
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`in the art could, based on the disclosure with respect to related compounds, make
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`and use it.” Id.
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`Here, we have the same situation, a broad disclosure with no “blaze marks”
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`to identify the species claimed. Nothing in the ‘315 provisional tells one of
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`5
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`ordinary skill in the art that it the compound identified in the second row (out of 8)
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`of the 25th table (out of 50) of the 8th structure (out of 31) is the one to pursue. And
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`nothing in the ‘315 provisional tells one of ordinary skill in the art that
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`phosphorous should be employed as a single chiral center (either in the Rp or Sp
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`configuration), or as a mixture of both. Such chirality at phosphorous is referred to
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`merely as, “the inventors recognize that stereochemical configurations are possible
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`such that in a staggered (or zig-zag) line structure the oxo substituent projects
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`towards the viewer while the OR1 substituent projects away from the viewer, and
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`vice versa. Therefore, the structures below include all possible stereochemical
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`configurations possible for phosphorous.” Ex. 2013, 63-64.
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`Such possible mixtures are not described as having a configuration at
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`phosphorous of either Rp or Sp; a 50:50 mixture (racemic at phosphorous); or as
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`any other ratio of chirality at phosphorous, e.g., 60:40, 80:20, 20:80, 97:3, or 3:97
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`or any other ratio. Thus, phosphorous as a chiral center is not identified as being a
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`“preferred compound.” In short, there’s nothing at all in the ‘315 provisional
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`providing anything close to “blaze marks” that single out the particular compounds
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`and stereochemistry claimed in the ‘580 patent. As the Federal Circuit said en banc
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`in Ariad, “the original application did not disclose the specific claimed invention.”
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`598 F.3d at 1348. Whether the ‘315 provisional enabled one of skill in the art to
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`make and use the specific compounds claimed in the ‘580 patent, that is irrelevant
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`6
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`and insufficient. Id.
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`The issue here boils down to a simple question, would a POSA reading the
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`‘315 provisional have had a reasonably clear understanding that the applicant
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`possessed the precise compounds with stereochemistry claimed when the
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`compound was just one many thousands of compounds disclosed and when
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`phosphorous as a chiral center was mentioned amongst others and specifically
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`described as not being preferred.
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`The only evidence of record here on that simple question is Dr. Fortunak’s
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`testimony that it was not. Ex. 1002 ¶73. The Board accorded little weight to
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`Dr. Fortunak’s discussion of the issue because it was direct and to the point, Paper
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`7, but Gilead has introduced no testimony on the issue whatsoever even though it
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`could have done so with its Preliminary Response and still can do so post
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`institution. For now, the only conclusion to draw from the evidence of record is
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`that of Dr. Fortunak, that, “[t]he ‘315 provisional application does not include a
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`description of the specific compounds claimed by the ‘580 patent.” As such, it does
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`not satisfy the written description for the ‘580 patent’s claims.
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`Supporting the conclusion that the disclosure in the ‘315 provisional does
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`not satisfy the written description requirement is the fact that, “a description that
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`merely renders the invention obvious does not satisfy the requirement.” Ariad, 598
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`F.3d at 1352. Whether the claims of the ‘580 patent would be obvious in light of
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`7
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`the ‘315 provisional is unaddressed by both Patent Owner in its Preliminary
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`Response and the Board in the Decision. The answer to that question is unclear.
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`While the ‘315 provisional arguably teaches in separate locations all of the
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`elements of the ‘580 patent’s claims, it does so as part of an extremely broad
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`disclosure of thousands of compounds and as incalculable mixtures of such
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`compounds. It does not identify the compound in Table IX-25 row 2 as being a
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`lead compound and it does not identify phosphorous as being preferred as: 1)
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`racemic; 2) in any specific chiral configuration (Rp or Sp); or in any preferred non-
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`racemic mixture of chirality. If it is uncertain whether the ‘315 provisional would
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`render the ‘580 patent’s claims obvious, there can be no doubt that the ‘315
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`provisional fails to provide written description support for the ‘580 patents claims,
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`because even if it did render those claims obvious, that would be insufficient.
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`Ariad, 598 F.3d at 1352.
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`Indeed, in the related IPR filed by Petitioner concurrently with this IPR,
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`IPR2018-00120, the Board denied institution there because it concluded that
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`although Petitioner cited prior art disclosing a genus of compounds including that
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`claimed by the ‘580 patent, Petitioner failed to “adequately explain why this
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`particular compound was chosen over other compounds.” IPR2018-00120, Paper
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`7, 18-19. The same is true for the ‘315 provisional. It did not explain at all why the
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`compound claimed in the ‘580 patent was chosen from among the tens of
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`8
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`thousands disclosed. Thus, using the Board’s own reasoning in the related IPR, the
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`‘315 provisional fails to render the ‘580 patent’s claims obvious, which means it is
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`far from satisfying written description for those same claims.
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`This case is much different than Concert Pharm. v. Incyte Corp, PGR2017-
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`00034, where the Board found a specification satisfied written description when it
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`(1) disclosed the precise enantiomers claimed; (2) provided a working example
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`describing an exemplary chemical synthesis; (3) demonstrated separation of the
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`isomers, and (4) described the resulting claimed compound’s biological activity.
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`PGR2017-00034, Paper 13 (P.T.A.B. May 21, 2018). Here, the ‘315 provisional
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`does none of those things. It does not disclose the enantiomers claimed in the ‘580
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`patent, it does not provide a working example describing their chemical synthesis,
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`it does not demonstrate separation of the isomers, nor does it describe the resulting
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`compound’s biological activity. Thus, the ‘315 provisional’s specification is
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`materially different from the specification in Concert Pharm. is several respects.
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`While not binding on the Board, it is nonetheless instructive that the
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`European Patent Office has addressed the same issues raised here and concluded,
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`like Petitioner, that the ‘315 provisional does not provide support for the claims of
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`the ‘580 patent. Specifically, in resolving oppositions to related patent application
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`EP2203462, the EPO found that a claim to the (S) diastereomer at phosphorous
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`was not sufficiently supported by the ‘315 provisional because:
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`9
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`
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`The compound of claim 1 is a racemate with two chiral centres
`whereby the chirality is defined at the carbon atom and not at the
`phosphorus atom. The specific indication is IX-25-2 where neither
`chiral centre is defined. In order to arrive at the racemate form IX-25-
`2 it is necessary to make at least two choices: firstly to define chirality
`at one, but not both, of the two possible sites and secondly to specify
`the chirality at that particular site. This represents a selection from
`within two lists. On account of this and the general teaching of
`T1046/97 which
`is
`taken
`to represent
`the standard way of
`understanding the scope of an application which discloses compounds
`and has a reference to the (non-exemplified) enantiomers, the OD
`considers that the auxiliary request 1 is not entitled to the priority of
`D1.
`Ex. 1015, 24 (¶¶ 25.1-25.2) (D1 identified as ‘315 application on p. 3) Thus, when
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`considering the same exact disclosure, the EPO came to the exact opposite
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`conclusion as the Board here regarding the right to claim priority to the ‘315
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`application with respect to the specific (S) diastereomer at phosphorous. This, at
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`minimum, supports a finding that claims 8-14 of the ‘580 patent are not entitled to
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`claim priority to the ‘315 provisional, since claim 8 is strictly limited to that exact
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`stereoisomer and claims 9-14 all depend from claim 8.
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`IV. CONCLUSION
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`For the foregoing reasons, Petitioner respectfully requests that the Board
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`rehear its decision denying institution and institute a trial on all challenged claims.
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`Dated: June 4, 2018
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`Respectfully submitted,
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`/Daniel B. Ravicher/
`Daniel B. Ravicher (Reg. No. 47,015)
`RAVICHER LAW FIRM PLLC
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`Counsel for Petitioner
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`11
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`V. CERTIFICATE OF SERVICE
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`
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`I certify that on the date indicated below I caused a true and correct copy of
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`the foregoing PETITIONERS’ REQUEST FOR REHEARING to be served on
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`counsel for Patent Owner by filing through the PTAB – E2E system as well as by
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`electronic mail to the following email addresses:
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`Dated: June 4, 2018
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`whelan@fr.com
`kane@fr.com
`shear@fr.com
`IPR36583-0020IP2@fr.com
`PTABInbound@fr.com
`david.cavanaugh@wilmerhale.com
`emily.whelan@wilmerhale.com
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`
`
`/Daniel B. Ravicher/
`Daniel B. Ravicher (Reg. No. 47,015)
`RAVICHER LAW FIRM PLLC
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`Counsel for Petitioner
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`12
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