Trials@uspto.gov
`571-272-7822
`
`Paper 9
`Entered: October 10, 2018
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ____________
`
`ALNYLAM PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`SILENCE THERAPEUTICS GMBH,
`Patent Owner.
`____________
`
`Case PGR2018-00059
`Patent 9,695,423
`____________
`
`
`
`
`Before JEFFREY B. ROBERTSON, RAMA G. ELLURU, and
`MONTÉ T. SQUIRE, Administrative Patent Judges.
`
`SQUIRE, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Post-Grant Review
`35 U.S.C. § 324
`
`
`571-272-7822
`
`Paper 9
`Entered: October 10, 2018
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ____________
`
`ALNYLAM PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`SILENCE THERAPEUTICS GMBH,
`Patent Owner.
`____________
`
`Case PGR2018-00059
`Patent 9,695,423
`____________
`
`
`
`
`Before JEFFREY B. ROBERTSON, RAMA G. ELLURU, and
`MONTÉ T. SQUIRE, Administrative Patent Judges.
`
`SQUIRE, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Post-Grant Review
`35 U.S.C. § 324
`
`
`
`PGR2018-00059
`Patent 9,695,423
`
`
`A. Background
`
`I. INTRODUCTION
`
`Alnylam Pharmaceuticals, Inc. (“Petitioner”) filed a Petition (“Pet.,”
`
`Paper 2) requesting post-grant review of claims 1–25 of U.S. Patent
`
`No. 9,695,423 (“the ’423 patent,” Ex. 1001). Silence Therapeutics GMBH
`
`(“Patent Owner”) filed a Preliminary Response (“Prelim. Resp.,” Paper 7).
`
`We have authority to determine whether to institute a post-grant review. 35
`
`U.S.C. § 324; 37 C.F.R. § 42.4(a).
`
`The standard for instituting a post-grant review is set forth in 35
`
`U.S.C. § 324(a), which provides that a post-grant review may not be
`
`instituted unless “the information presented in the petition filed under
`
`section 321, if such information is not rebutted, would demonstrate that it is
`
`more likely than not that at least 1 of the claims challenged in the petition is
`
`unpatentable.” After considering the Petition and Preliminary Response, we
`
`determine that Petitioner has not demonstrated that it is more likely than not
`
`that at least one of the challenged claims is unpatentable. We, therefore, do
`
`not institute post-grant review of any claim of the ’423 patent.
`
`B. Related Matters
`
`Petitioner identifies Alnylam Pharmaceuticals, Inc. v. Silence
`
`Therapeutics, Civil Action No. 1:18-cv-10613-MLW, filed in the United
`
`States District Court for the District of Massachusetts, as a pending suit in
`
`which Petitioner seeks declaratory judgment of non-infringement of the ’423
`
`patent and related patents. Pet. 3; Paper 5. Petitioner also identifies the
`
`following applications that claim priority to the ’423 patent’s filing date:
`
`U.S. Patent Application No. 15/589,968, filed on May 8, 2017 (issued as
`
`U.S. Patent No. 9,790,501); U.S. Patent Application No. 15/589,971, filed
`
`
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`2
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`PGR2018-00059
`Patent 9,695,423
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`on May 8, 2017 (issued as U.S. Patent No. 9,758,784); U.S. Patent
`
`Application No. 15/594,349, filed on May 12, 2017 (issued as U.S. Patent
`
`No. 9,783,802); U.S. Patent Application No. 15/594,438, filed on May 12,
`
`2017 (issued as U.S. Patent No. 9,790,505); and U.S. Patent Application No.
`
`15/678,024, filed on August 15, 2017. Paper 5.
`
`Patent Owner identifies the following post-grant reviews, which
`
`involve the same parties and related patents: PGR2018-00067 (filed June 11,
`
`2018); PGR2018-00075 (filed July 9, 2018); PGR2018-00088 (filed July 17,
`
`2018); and PGR2018-00089 (filed July 17, 2018). Paper 8.
`
` C. The ’423 Patent
`
`The ’423 patent is titled “Interfering RNA Molecules” and issued on
`
`July 4, 2017 from U.S. Application No. 14/977,710.1 Ex. 1001, (21), (22),
`
`(54). The ’423 patent is directed to interfering ribonucleic acid molecules
`
`having a double-stranded structure. Id. at 1:28–29. The ’423 patent
`
`describes small interfering RNA (“siRNA” or “RNAi”) molecules and
`
`methods for using such molecules, for example, for inhibiting expression of
`
`a target gene. Id. at 1:34–36, 2:22–24, 6:49–54 (disclosing “a method for
`
`inhibiting the expression of a target gene in a cell or derivative thereof
`
`comprising introducing a ribonucleic acid according to any of the aspects of
`
`
`1 U.S. Application No. 14/977,710 (“’710 application,” Ex. 1004), filed
`December 22, 2015, is a continuation of a series of patent applications and
`claims priority to European Patent Application No. 02017601, filed August
`5, 2002 (“EP1,” Ex. 1006); U.S. Provisional Application No. 60/402,541,
`filed August 12, 2002 (“’541 provisional,” Ex. 1007); and European Patent
`Application No. 03008383, filed April 10, 2003 (“EP2,” Ex. 1008).
`Ex. 1001, (30), (63), 1:6–20. In this Decision, we refer to underlying
`applications to which the ’423 patent claims priority collectively as the
`“priority applications.”
`
`
`
`
`3
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`PGR2018-00059
`Patent 9,695,423
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`the present invention into a cell in an amount sufficient to inhibit expression
`
`of the target gene”), 12:30–32 (disclosing “that all of the ribonucleic acids of
`
`the present invention are suitable to cause or being involved in methods of
`
`RNA mediated interference”). The target nucleic acid sequence or target
`
`nucleic acid is typically “a single stranded RNA” and “more preferably an
`
`mRNA” (messenger RNA). Id. at 11:61–64.
`
`The ’423 patent discloses that the siRNA molecules consist of a
`
`ribonucleic acid comprising a double-stranded structure, formed by a first
`
`strand and a second strand. Id. at 11:25–28. The ’423 patent further
`
`discloses that the first strand comprises a stretch of contiguous nucleotides
`
`that is at least partially complementary to a target nucleic acid, and the
`
`second strand comprises a second stretch of contiguous nucleotides that is at
`
`least partially identical to a target nucleic acid. Id. at 1:30–34, 11:28–31.
`
`The ’423 patent explains that the “length of the first stretch and second
`
`stretch, respectively, is typically about 15 to about 23, preferably 17 to 21,
`
`and more preferably 18 or 19 bases.” Id. at 18:33–35, 3:29–32 (“In an
`
`embodiment of the ribonucleic acid according to any aspect of the present
`
`invention the double-stranded structure has a length of 17 to 21 nucleotides,
`
`preferably 18 to 19 nucleotides.”).
`
`The ’423 patent discloses that at least one nucleotide of the siRNA
`
`molecule has a modification at the 2’-position and the modification is
`
`preferably selected from the group comprising amino, fluoro, methoxy,
`
`alkoxy and alkyl. Id. at 3:50–54, 15:48–51 (disclosing that “modification of
`
`the nucleotides may be any form of modification described herein”). The
`
`’423 patent describes that a “flanking nucleotide or group of nucleotides is
`
`arrayed on both sides of the modified nucleotide or group” and discloses that
`
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`4
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`Patent 9,695,423
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`“the flanking nucleotide or group either is unmodified or does not have the
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`same modification of the preceding nucleotide or group of nucleotides.” Id.
`
`at 16:30–34.
`
`The ’423 patent further discloses that the
`
`first strand and/or said second strand comprises a plurality of
`groups of modified nucleotides having a modification at the 2’-
`position whereby within the strand each group of modified
`nucleotides is flanked on one or both sides by a flanking group
`of nucleotides whereby the flanking nucleotides forming the
`flanking group of nucleotides is either an unmodified nucleotide
`or a nucleotide having a modification different from the
`modification of the modified nucleotides.
`
`Id. at 3:54–4:5. See also id. at 7:6–12 (stating that the “unmodified
`
`nucleotides or unmodified groups of nucleotides referred to as flanking
`
`group(s) of nucleotides herein . . . are different from the modification of the
`
`nucleotides forming the group(s) of modified nucleotides”).
`
`
`
`The ’423 patent explicitly defines the term “unmodified nucleotide” to
`
`mean “either not having any of the aforementioned modifications at the
`
`nucleotide forming the respective nucleotide or group of nucleotides, or
`
`having a modification which is different from the one of the modified
`
`nucleotide and group of nucleotides, respectively.” Id. at 16:45–50, 16:51–
`
`59 (disclosing that modification of the unmodified nucleotide “can be the
`
`same or even different for the various nucleotides forming said unmodified
`
`nucleotides or for the various flanking groups of nucleotides”).
`
`The ’423 patent describes several embodiments and examples that
`
`illustrate certain advantages and aspects of the claimed invention. Id. at
`
`2:25–6:56, 21:52–33:31. In one embodiment, the ’423 patent describes a
`
`“17 nucleotide long siRNA” molecule, including experimental data
`
`suggesting that the molecule showed decreased or reduced activity, as
`
`
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`5
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`Patent 9,695,423
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`compared to certain other siRNA molecules 18 nucleotides or longer in
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`length. Id. at 24:62–64 (disclosing that “[t]he RNAi molecule 55A/55B
`
`comprises a stretch of 17 nucleotides and has a clearly decreased activity in
`
`terms of degradation of Akt1 mRNA”), 25:1–5 (disclosing that the “17
`
`nucleotide long siRNA” showed “reduced silencing activity”).
`
`D. Illustrative Claims
`
`As noted above, Petitioner challenges claims 1–25 of the ʼ423 patent,
`
`of which claims 1 and 12 are the only independent claims. Pet. 6–7. Claims
`
`1 and 12 are illustrative of the challenged claims and are reproduced below:
`
`1.
`
`A double-stranded siRNA molecule wherein:
`
`(i) at least one strand of the double-stranded siRNA
`molecule comprises one or more groups of modified nucleotides
`and one or more groups of flanking nucleotides, the flanking
`nucleotides being on one or both sides of the modified
`nucleotides, wherein:
`
`the one or more groups of modified nucleotides
`have an amino, fluoro, alkoxy, or alkyl modification at the
`2’-position; and
`
`the one or more groups of flanking nucleotides have
`an amino, fluoro, alkoxy, or alkyl modification at the 2’-
`position, the modification at the 2’-position of the flanking
`nucleotide being different from the modification at the 2’-
`position of the modified nucleotide,
`
`(ii) the number of nucleotides in the one or more groups of
`modified nucleotides is 1-10 and the number of nucleotides in
`the one or more groups of flanking nucleotides is 1-10;
`
`(iii) the double-stranded siRNA molecule has a double-
`stranded region of 17-21 nucleotides in length; and
`
`(iv) the double-stranded siRNA molecule is capable of
`RNA interference.
`
`Ex. 1001, 147:21–43 (indentation added).
`
`
`
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`6
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`PGR2018-00059
`Patent 9,695,423
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`12. A double-stranded siRNA molecule wherein:
`
`(i) each strand of the double-stranded siRNA molecule
`comprises one or more groups of modified nucleotides and one
`or more groups of flanking nucleotides, the flanking nucleotides
`being on one or both sides of the modified nucleotides, wherein
`
`the one or more groups of modified nucleotides
`have an amino, fluoro, alkoxy, or alkyl modification at the
`2’-position; and
`
`the one or more groups of flanking nucleotides have
`an amino, fluoro, alkoxy, or alkyl modification at the 2’-
`position, the modification at the 2’-position of the flanking
`nucleotide being different from the modification at the 2’-
`position of the modified nucleotide,
`
`(ii) the number of nucleotides in the one or more groups of
`modified nucleotides is 1-10 and the number of nucleotides in
`the one or more groups of flanking nucleotides is 1-10;
`
`(iii) the double-stranded siRNA molecule has a double-
`stranded region of 17-21 nucleotides in length; and
`
`(iv) the double-stranded siRNA molecule is capable of
`RNA interference.
`
`Ex. 1001, 148:32–54 (indentation added).
`
`E. Asserted Grounds of Unpatentability
`
`Petitioner contends that claims 1–25 of the ’423 patent are
`
`unpatentable based on the following grounds (Pet. 5):
`
`Ground Claims Challenged Statutory Basis
`
`Prior Art
`Reference
`
`
`
`
`1
`
`2
`
`1–25
`
`1–25
`
`§ 112(a)
`Written Description
`§ 112(a)
`Enablement
`§ 102
`
`1–9, 11–19, 21–25
`3
`
`2 McSwiggen et al. (Int’l Pub. No. WO 03/070918 A2) was filed on
`February 20, 2003, and published on August 28, 2003 (Ex. 1015, (22), (43)).
`
`McSwiggen2
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`
`
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`7
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`PGR2018-00059
`Patent 9,695,423
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`Ground Claims Challenged Statutory Basis
`
`4
`
`1–4, 7–14, 17–25
`
`
`§ 102
`
`
`Prior Art
`Reference
`
`Allerson3
`
`Petitioner relies on the Declaration of Dr. Jonathan K. Watts (“Watts
`
`Declaration,” Ex. 1002) in support of its contentions. Pet. 5.
`
`
`
`II. ANALYSIS
`
`A. Level of Ordinary Skill in the Art
`
`We begin our analysis by addressing the level of ordinary skill in the
`
`art. In determining the level of skill in the art, various factors may be
`
`considered, including the types of problems encountered in the art, prior art
`
`solutions to those problems, the sophistication of the technology, rapidity
`
`with which innovations are made, and educational level of active workers in
`
`the field. In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). In
`
`addition, we may be guided by the level of skill in the art reflected by the
`
`prior art of record. See Okajima v. Bourdeau, 261 F.3d. 1350, 1355 (Fed.
`
`Cir. 2001).
`
`Petitioner contends that a person of ordinary skill in the art at the time
`
`of the effective filing date of the ’423 patent would have (a) a Ph.D. in
`
`chemistry, medicinal chemistry, biochemistry, molecular biology, molecular
`
`
`Pet. 52. McSwiggen claims priority to a series of provisional applications,
`including Provisional Application 60/408,378, filed September 5, 2002 (Ex.
`1019). Pet. 53.
`3 Allerson et al., Fully 2’-Modified Oligonucleotide Duplexes with Improved
`in Vitro Potency and Stability Compared to Unmodified Small Interfering
`RNA, J. Med. Chem. 2005, 48, 901–904 was published on January 20, 2005
`(Ex. 1016). Pet. 53.
`
`
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`8
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`Patent 9,695,423
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`pharmacology, or a closely related discipline, (b) an M.S. degree in
`
`chemistry, medicinal chemistry, biochemistry, molecular biology, molecular
`
`pharmacology, or a closely related discipline, with at least two years of
`
`practical experience in the field of RNAi, or (c) a bachelor’s degree in
`
`chemistry, biochemistry, or a closely related discipline, with post-graduate
`
`work relating to RNAi. Pet. 17–18.
`
`At this stage of the proceeding, Patent Owner does not dispute
`
`Petitioner’s assessment regarding the level of ordinary skill in the art or
`
`propose an alternative assessment. Based on the record before us and for
`
`purposes of this Decision, we adopt Petitioner’s assessment of the level of
`
`ordinary skill in the art.
`
`B. Claim Construction
`
`In a post-grant review, we interpret claims of an unexpired patent
`
`using the broadest reasonable construction in light of the specification of the
`
`patent in which the claims appear. 37 C.F.R. § 42.200(b). Consistent with
`
`the broadest reasonable construction, claim terms are presumed to have their
`
`ordinary and customary meaning as understood by a person of ordinary skill
`
`in the art in the context of the entire patent disclosure. In re Translogic
`
`Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only those terms in
`
`controversy need to be construed, and only to the extent necessary to resolve
`
`the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor
`
`Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“we need only construe terms
`
`‘that are in controversy, and only to the extent necessary to resolve the
`
`controversy’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200
`
`F.3d 795, 803 (Fed. Cir. 1999)).
`
`
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`9
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`Patent 9,695,423
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`Petitioner proposes specific constructions for the following two
`
`phrases of the ’423 patent claims: (1) “capable of RNA interference,” as set
`
`for in claims 1–25 and (2) “inhibits the expression of a target nucleic acid,”
`
`as set forth in claims 11 and 21–23. Pet. 18–19.
`
`1. “capable of RNA interference”
`
`Petitioner contends that the phrase “the double-stranded siRNA
`
`molecule is capable of RNA interference” should be construed to mean that
`
`the “claimed siRNA molecules exhibit RNAi activity.” Pet. 18–19. As
`
`support for the proposed construction, Petitioner argues (Pet. 18) that
`
`although the ’423 patent specification does not explicitly define the phrase
`
`“capable of RNA interference,” the specification does indicate that the
`
`claimed siRNA molecules are functionally active in mediating RNA
`
`interference or RNAi (Ex. 1001, 12:11–22, 32:4–6, 32:45–46); achieving
`
`RNAi activity (id. at 27:23–25); or having RNAi activity (id., Examples 2–4,
`
`6–8, 11). Petitioner also argues that the ’423 patent specification provides
`
`methods of measuring RNAi activity with assays measuring target mRNA or
`
`protein expression and that a person of ordinary skill in the art would have
`
`understood the phrase as having the proposed meaning. Pet. 18–19. Patent
`
`Owner does not challenge Petitioner’s proposed construction at this stage.
`
`Upon review of the’423 patent specification, we do not find an
`
`explicit or special definition for the phrase “the double-stranded siRNA
`
`molecule is capable of RNA interference.” The ’423 patent specification,
`
`however, does describe “RNAi” molecules (Ex. 1001, 1:40–44, 2:16–18; see
`
`generally id. at cols. 17–20, 25–28) and methods for using the claimed
`
`siRNA molecules “for inhibiting expression of a target gene” (id. at 34–35),
`
`and discloses that “all of the ribonucleic acids of the present invention are
`
`
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`10
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`Patent 9,695,423
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`suitable to cause or being involved in methods of RNA mediated
`
`interference” (id. at 12:30–32). The ’423 patent specification also discloses
`
`methods for introducing the siRNA molecules “into a cell in an amount
`
`sufficient to inhibit expression of the target gene.” Id. at 6:49–54.
`
`For purposes of this Decision, based on the record before us, we adopt
`
`Petitioner’s proposed construction and interpret the phrase “the double-
`
`stranded siRNA molecule is capable of RNA interference” to mean that the
`
`claimed siRNA molecule exhibits RNA interference activity.
`
`2. “inhibits the expression of a target nucleic acid”
`
`
`
`Petitioner contends that the claim phrase “inhibits the expression of a
`
`target nucleic acid” should be construed to mean “to inhibit RNA
`
`expression, and preferably mRNA expression.” Pet. 19. As support for its
`
`proposed construction, Petitioner argues (Pet. 19) that the ’423 patent
`
`specification repeatedly refers to inhibition of a target gene, including a
`
`target gene of a ribonucleic acid (Ex. 1001, 1:34–37, 6:49–56) and discloses
`
`that the target nucleic acid sequence or target nucleic acid is “a single strand
`
`RNA, more preferably an mRNA” (id. at 11:61–64). Patent Owner does not
`
`challenge Petitioner’s proposed construction at this stage.
`
`Based on the record before us, we agree with Petitioner’s proposed
`
`construction. Therefore, for purposes of this Decision, we adopt Petitioner’s
`
`proposed construction and interpret the phrase “inhibits the expression of a
`
`target nucleic acid” to mean to inhibit RNA expression, and preferably
`
`mRNA expression.
`
`C. Eligibility for Post-Grant Review
`
`As a threshold matter, we must determine whether the ’423 patent
`
`may be the subject of a post-grant review. There are two specific threshold
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`requirements that must be met in order for post-grant review to be available.
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`First, post-grant reviews are available only if the petition is filed within nine
`
`months of issuance of the challenged patent. 35 U.S.C. § 321(c). Here, the
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`Petition was filed April 2, 2018, which is within nine months of the ’423
`
`patent’s July 4, 2017 issue date. Ex. 1001, (45). Second, post-grant review
`
`is available only for patents that issue from applications that at one point
`
`contained at least one claim with an effective filing date of March 16, 2013,
`
`or later. See Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125
`
`Stat. 284 (2011) (“AIA”), §§ 3(n)(1), 6(f)(2)(A), 125 Stat. 284, 293, 311
`
`(2011), available at https://go.usa.gov/xQA4b; 35 U.S.C. § 100(i). The
`
`“effective filing date” for a claim is either the application’s actual filing date
`
`or the filing date of the earliest application that supports the claim. 35
`
`U.S.C. § 100(i).
`
`Petitioner bears the burden of proving that a patent is eligible for post-
`
`grant review. See, e.g., US Endodontics, LLC v. Gold Standard Instruments,
`
`LLC, PGR2015-00019, Paper 54, 9–10 (PTAB Dec. 28, 2016). To show
`
`that the ’423 patent is eligible for post-grant review, Petitioner bears the
`
`burden of proving that the challenged claims lack the benefit of the filing
`
`date of the earliest application that supports the claims. In particular,
`
`Petitioner must prove that at least one of the challenged claims of the ’423
`
`patent was “not disclosed in compliance with the written description and
`
`enablement requirements of § 112(a) in the earlier application for which the
`
`benefit of an earlier filing date prior to March 16, 2013 was sought.”
`
`Inguran, LLC v. Premium Genetics (UK) Ltd., PGR2015-00017, Paper 8, 11
`
`(PTAB Dec. 22, 2015); see also US Endodontics, PGR2015-00019, Paper
`
`54, 7 (“Entitlement to the benefit of an earlier date under §§ 119, 120, 121,
`
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`12
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`and 365 is premised on disclosure of the claimed invention ‘in the manner
`
`provided by § 112(a) (other than the requirement to disclose the best mode)’
`
`in the earlier application.”) (citations omitted).
`
`Petitioner argues that the ’423 patent is eligible for post-grant review
`
`because the challenged claims of the ’423 patent each has an effective filing
`
`date on or after March 16, 2013. Pet. 1–2, 20–23. According to Petitioner,
`
`none of the prior applications in the chain leading to the ’423 patent provides
`
`written description support and enabling disclosure for the claims of the ’423
`
`patent. Id. Petitioner, thus, asserts that because the priority applications on
`
`which the ’423 patent relies for an effective filing date do not provide
`
`written description support and enabling disclosure for certain recitations of
`
`the challenged claims, none of the claims of the ’423 patent is entitled to an
`
`effective filing date earlier than December 22, 2015 –– the actual filing date
`
`of the application for the ’423 patent. Id.
`
`In particular, Petitioner argues that none of the priority applications
`
`describe or enable a double-stranded siRNA molecule having the structural
`
`modifications and functional limitations recited in claims 1–25. Pet. 1–2,
`
`22–24, 33–40, 41–45. In particular, Petitioner contends that there is no
`
`disclosure or indication of a double-stranded siRNA molecule with two
`
`different 2’- modified nucleotides that is “capable of RNA interference,”
`
`“has increased stability,” and “inhibits the expression of a target nucleic
`
`acid,” as required by the claims. Id. at 2, 25–26. Petitioner further contends
`
`that none of the priority applications describe or enable a double-stranded
`
`siRNA molecule having a double-stranded region of 17 nucleotides that is
`
`“capable of RNA interference” and “inhibits the expression of a target
`
`nucleic acid,” as encompassed by the claims. Id. at 23, 41, 43. Petitioner
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`13
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`also contends that the priority applications do not provide sufficient written
`
`description support or enabling disclosure for the ’423 patent because the
`
`applications and the ’423 patent specification teach that siRNA molecules
`
`having a double-stranded region of 17 nucleotides in length are not
`
`functional. Id. at 2, 41–42, 45–47.
`
`Patent Owner maintains that the ’423 patent is not eligible for post-
`
`grant review because Petitioner has failed to meet the burden of proving that
`
`any of the challenged claims of the ’423 patent have an effective filing date
`
`on or after March 16, 2013. Prelim. Resp. 1–12. Patent Owner contends
`
`that Petitioner has failed to prove that the priority applications upon which
`
`the ’423 patent relies do not provide sufficient written description support
`
`and enabling disclosure for the challenged claims. Id. at 1–2, 4. Thus,
`
`Patent Owner submits that Petitioner has failed to demonstrate that the ’423
`
`patent is not entitled to the benefit of the filing date of the earliest
`
`application, which dates back to August 5, 2002 (Ex. 1006). Id.
`
`Because, as discussed below, we are not persuaded Petitioner has
`
`satisfied its burden to prove that the priority applications fail to provide
`
`sufficient written description support and enabling disclosure for the
`
`challenged claims, we conclude that the ’423 patent is entitled to the benefit
`
`of the filing date of the earliest application (August 5, 2002) and thus, the
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`’423 patent is not eligible for post-grant review.
`
`1. Written Description
`
`To satisfy the written-description requirement under 35 U.S.C.
`
`§ 112(a), the specification must “reasonably convey[] to those skilled in the
`
`art that the inventor had possession” of the claimed invention as of the filing
`
`date. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir.
`
`
`
`
`14
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`
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`PGR2018-00059
`Patent 9,695,423
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`2010) (en banc). An adequate description does not require any particular
`
`form of disclosure or that the specification recite the claimed invention in
`
`haec verba, but must do more than render the claimed invention obvious.
`
`Id. at 1352.
`
`Petitioner argues that the priority applications underlying the ’423
`
`patent fail to provide written description support for the following
`
`limitations of the challenged claims: (a) “the modification at the 2’-position
`
`of the flanking nucleotide being different from the modification at the 2’-
`
`position of the modified nucleotide,” (b) “has a double-stranded region of
`
`17–21 nucleotides in length” and (c) “is capable of RNA interference”
`
`(claims 1–25); (d) “has increased stability” (claims 10 and 20); and (e)
`
`“inhibits the expression of a target nucleic acid” (claims 11 and 21–23). Pet.
`
`24, 41, 44–45.
`
`Petitioner contends that because the applications leading to the ’423
`
`patent expressly teach that siRNA molecules having a double-stranded
`
`region of 17 nucleotides in length are not functional, the inventors were not
`
`in possession of an siRNA molecule having a double-stranded region of 17
`
`nucleotides in length that has the claimed RNA interference activity and/or
`
`the ability to inhibit the expression of a target nucleic acid. Id. at 41–42, 44–
`
`46. Petitioner further contends that the inventors were not in possession of
`
`the full scope of the ’423 patent claims because the claims encompass an
`
`“enormous number of siRNA molecules having an almost unlimited variety
`
`of modifications.” Id. at 45. Petitioner asserts that “the claimed genus
`
`covers potentially billons of structurally diverse siRNA molecules including
`
`those with various combinations of amino, fluoro, alkoxy and/or alkyl group
`
`modifications at the 2’-position for the modified and flanking groups of
`
`
`
`
`15
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`
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`PGR2018-00059
`Patent 9,695,423
`
`nucleotides.” Id. at 29. Petitioner also asserts that “there is no data for any
`
`species that meets the structural and functional features of the claims” (id. at
`
`27) and “there is no description of [the claimed] molecules either in the
`
`figures or examples” (id. at 9).
`
`Patent Owner responds that Petitioner has failed to meet its burden to
`
`prove that the priority applications do not provide adequate written
`
`description support for all of the limitations recited in the claims. Prelim.
`
`Resp. 1–12. Specifically, Patent Owner contends that Petitioner “fails to
`
`account for the fact that the claims are expressly limited to molecules that
`
`are ‘capable of RNA interference’ (claims 1, 12) or ‘inhibit[] the expression
`
`of a target nucleic acid’ (claims 22–25).” Id. at 10. Patent Owner further
`
`contends that Petitioner “fails to show that a siRNA molecule with a double-
`
`stranded region 17 nucleotides long is necessarily non-functional.” Id.
`
`In addition, Patent Owner argues that Petitioner improperly relies on
`
`post-filing evidence. Id. at 1, 5–8. Patent Owner contends that Petitioner
`
`relies extensively on the Watts Declaration (Ex. 1002) and the vast majority
`
`of publications referenced by Dr. Watts post-date the 2002 filing of the
`
`earliest priority application. Prelim. Resp. 5–8. Patent Owner contends that
`
`[t]his post-filing evidence does not and cannot show that one of
`skill in the art, as of the effective filing date of the priority
`applications, would have concluded that the inventors possessed
`the claimed invention. Nor can it show that as of the priority date
`the priority applications failed to teach one of skill in the art how
`to practice the claimed invention.
`
`Id. at 1. Patent Owner also contends that Petitioner fails to offer “any claim
`
`construction for the phrase ‘has a double-stranded region of 17-21
`
`nucleotides in length.’” Id. at 10 (citing 37 C.F.R. § 42.204(b)(3)).
`
`
`
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`16
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`PGR2018-00059
`Patent 9,695,423
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`
`The ’710 application underlying the ’423 patent (Ex. 1004) is a
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`continuation application and claims priority to a series of applications,
`
`including the EP1 application filed on August 5, 2002 (Ex. 1006), the ’541
`
`provisional filed on August 12, 2002 (Ex. 1007), and the EP2 application
`
`filed on April 10, 2003 (Ex. 1008), respectively. See also Ex. 1001, (30),
`
`(63), 1:6–20. We have reviewed the ’423 patent, the priority applications,
`
`and the cited prosecution history and, on this record, find that the ’423 patent
`
`specification and figures, the ’710 application, the EP1 application, the ’541
`
`provisional, and the other continuation applications to which the ’423 patent
`
`claims priority are substantially identical. Compare Ex. 1004, with Exs.
`
`1006–1008; see also Pet. 11, 22 (acknowledging that the disclosures in the
`
`priority applications are substantially identical to the ’423 patent
`
`specification).
`
`On this record, we are not persuaded that Petitioner has put forth
`
`evidence sufficient to prove that the priority applications do not provide
`
`adequate written description support for the challenged claims. Rather, as
`
`described below, we determine that the priority applications actually do
`
`provide disclosure for each of the claim limitations argued by Petitioner
`
`sufficient to satisfy the written-description requirement under § 112.
`
`a. “the modification at the 2’-position of the
`flanking nucleotide being different from
`the modification at the 2’-position of the
`modified nucleotide”
`
`Regarding the “the modification at the 2’-position of the flanking
`
`nucleotide being different from the modification at the 2’-position of the
`
`modified nucleotide” limitation of the claims, Petitioner admits that the
`
`priority applications “provide a generic embodiment of siRNA molecules
`
`
`
`
`17
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`
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`PGR2018-00059
`Patent 9,695,423
`
`with groups of modified nucleotides flanked by nucleotides that are either
`
`unmodified or differently modified and a claim that covers such molecules.”
`
`Pet. 9; see also Prelim. Resp. 2–3. For example, both the EP1 application
`
`and the ’541 provisional each describes: modified nucleotides with an
`
`amino, fluoro, alkoxy, or alkyl modification at the 2’ position; nucleotides
`
`flanking the modified nucleotides with an amino, fluoro, alkoxy, or alkyl
`
`modification at the 2’ position; and where the modification at the 2’ position
`
`of the flanking nucleotides is different from the modification at the 2’
`
`position of the modified nucleotides. Exs. 1006 and 1007, 4–5. The ’423
`
`patent includes the same disclosure. Ex. 1001, 3:55–4:5, 7:4–13, 16:23–50.
`
`b. “has a double-stranded region of 17–21
`nucleotides in length”
`
`We determine that the priority applications provide sufficient written
`
`description support for the recitation “has a double-stranded region of 17–21
`
`nucleotides in length.” For example, the EP1 application and the ’541
`
`provisional each explicitly discloses that the “length of the first stretch and
`
`second stretch, respectively, is typically about 15 to about 23, preferably 17
`
`to 21, and more preferably 18 or 19 bases” (Exs. 1006 and 1007, 4) and
`
`“according to any aspect of the present invention the double-stranded
`
`structure has a length of 17 to 21 nucleotides, preferably 18 to 19
`
`nucleotides” (Exs. 1006 and 1007, 7). The ’423 patent contains the same
`
`disclosure. Compare Ex. 1001, 3:29–32, 18:33–35 (’423 patent), with Exs.
`
`1006 and 1007, 4, 7.
`
`c. “capable of RNA interference”
`
`The priority applications also provide sufficient written description to
`
`support the recitation that the double-stranded siRNA molecule “is capable
`
`of RNA interference.” In particular, both t
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