Ex Parte Smith

Patent Trial and Appeal Board

Sep 8, 2014

12124943 (P.T.A.B. Sep. 8, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/124,943 05/21/2008 Larry J. Smith 2273-P00586US07/KDR 3598
110 7590 09/08/2014
DANN, DORFMAN, HERRELL & SKILLMAN
1601 MARKET STREET
SUITE 2400
PHILADELPHIA, PA 19103-2307
EXAMINER
MCGARRY, SEAN
ART UNIT PAPER NUMBER
1674
MAIL DATE DELIVERY MODE
09/08/2014 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte LARRY J. SMITH
____________

Appeal 2012-004391
Application 12/124,943
Technology Center 1600
____________

Before DONALD E. ADAMS, LORA M. GREEN, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL1
This appeal under 35 U.S.C. § 134 involves claims 29–36 (App. Br.
2).2 Examiner entered a rejection under the written description provision of
35 U.S.C. § 112, first paragraph. We have jurisdiction under 35 U.S.C.
§ 6(b).
We affirm.

1 The Real Party in Interest is Smith Holdings, LLC (App. Br. 1).
2 Claims 20–22 stand allowable and claims 1–19, 24–28, and 37–39 stand
“withdrawn from consideration” (App. Br. 2).
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STATEMENT OF THE CASE
The claims are directed to a pharmaceutical composition. Claim 29 is
representative and is reproduced in the Claims Appendix of Appellant’s
Brief.
Claims 29–36 stand rejected under the written description provision of
35 U.S.C. § 112, first paragraph.
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Appellant’s Specification fails to provide written
descriptive support for the claimed invention?
FACTUAL FINDINGS (FF)
FF 1. Examiner finds that Appellant’s Specification fails to provide written
descriptive support for “a pharmaceutical composition comprising a double
stranded RNA which comprises SEQ ID NO:2 or 3” (Ans. 4; id. at 5; see
also id. at 9 (Examiner finds that Appellant failed to identify “with any
particularity” a description in the Specification of “a double stranded RNA
that may be utilized as a pharmaceutical composition and comprises SEQ ID
NO:2 or 3”); id. at 9–10 (Appellant’s Specification “as filed is silent as to
double stranded RNA compounds for inhibiting a target nucleic acid”)).
FF 2. Examiner finds “that the limitation ‘ethyl- or methylphosphonate
modified oligoribonucleotides’ recited in claim 30 fails to find support in
the specification as filed. . . . [P]age[s ]64-65 [of Appellant’s Specification]
disclose[s] . . . ‘ethyl-or methylphosphonate modified
oligodeoxynucleotides’ [emphasis added to show the difference]” (Ans. 6–7
(emphasis and alteration original)).
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FF 3. Examiner finds that page 45 of Appellant’s Specification “provides a
disclosure of SEQ ID NO:2 and SEQ ID NO:3 where these oligonucleotides
are deoxyribonucleotides” (id. at 5).
FF 4. Appellant discloses that
[A]ntisense oligonucleotide selected for practice of the
invention may be any of the types described by Stein and
Cohen, Cancer Research 48:2569-2668 (1988), and including
without limitation, unmodified oligodeoxynucleotides, ethyl- or
methylphosphonate modified oligodeoxynucleotides,
phosphorothioate modified oligonucleotides, dithioates, as well
as other oligonucleotide analogs, including those incorporating
ribozyme structures, and oligoribonucleotides such as those
described by Ino[u]e et al., Nucleic Acids Res. 15 :6131 (1987);
and Chimeric oligonucleotides that are composite RNA, DNA
analogues (Ino[u]e, et al, FEBS Lett. 2115 :327 (1987).
Oligonucleotides having a lipophilic backbone, for example,
methylphosphonate analogs with ribozyme structures, may
prove advantageous in certain circumstances; these molecules
may have a longer half-life in vivo since the lipophilic structure
may reduce the rate of renal clearance while the ribozyme
structure promotes cleavage of the target RNA. Gerlach,
Nature 334:585 (1988). Oligonucleotides with 2’-O-methyl
modified ribose sugars are also suitable for the practice of this
invention. This ribose sugar modification can be used with a
variety of backbone types such as phosphorothioates and may
be limited to only some of the sugar residues such as those at
the ends of the oligonucleotide.
(Spec.3 64: 26 – 65: 11 (emphasis added).)
FF 5. Examiner finds that pages 64-65 of Appellant’s Specification
discloses “that the oligonucleotides can be of various types . . .[, but]
[n]owhere at these pages is support for an inhibitory oligonucleotide that is a
double stranded RNA present” (Ans. 5).

3 All reference to Appellant’s Specification refers to the Specification
entered into the record April 6, 2009.
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FF 6. Examiner finds that “[i]t was not known at the time of invention to
use double stranded RNA as an inhibitory molecule. Indeed a Nobel Prize
(Fire and Mello) was awarded for this discovery well after appellant[’]s date
of invention” (id. at 9).
FF 7. Stein4 expressly states that “[a] discussion of antisense RNA is
beyond the scope of this review” (Stein 2659: col. 2, ll. 36–38; see Ans. 6
and 8 (“There is no teaching in Stein . . . for double stranded
oligonucleotides”)).
FF 8. Examiner finds that Inoue5
[I]s drawn to the study of single stranded ribonucleotides to be
used as probes. The reference does not teach inhibitory
oligonucleotides. While there is a disclosure of a double
stranded RNA complex of 9mers, these complexes were made
only in the study of hybridization stability in the use of the
single stranded RNA as a probe. One in the art at the time of
invention would not have seen this disclosure for the use of a
double stranded RNA for inhibition of gene expression and
further for the use of a double stranded RNA as a
pharmaceutical.
(Ans. 6; see id. at 8.)
FF 9. Examiner finds that
Nowhere in . . . [Appellant’s] specification does appellant point
to any particular teaching in Inoue but refers to the reference in
general. At best one in the art would consider the modifications
taught in Inuoue [sic] for stabilizing a nucleic acid. It is
untenable that one in the art would look at this incorporation by
reference and assume that appellant meant that the double

4 C.A. Stein & Jack S. Cohen, Oligodeoxynucleotides as Inhibitors of Gene
Expression: A Review, 48 CANCER RESEARCH 2659–2668 (1988).
5 Hideo Inoue, et al., Synthesis and hybridication studies on two
complementary nona(2’-O-methyl)ribonucleotides, 15(15) NUCLEIC ACIDS
RESEARCH 6131–6148 (1987).
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stranded 9mer utilized for a stability assay for a probe was the
specific structure being relied upon for a double stranded RNA
ph[a]rmaceutical. This is particularly true since the Inoue . . .
reference is silent in regard to inhibitory molecules.
(Id. at 10.)
FF 10. Appellant discloses “a method for treating an individual having an
AP [Aberrant Programming6] disease comprising administering to said
individual an effective amount of a composition selected from the group
consisting of an expression vector, a double stranded ODN, and an antisense
ODN” (Spec. 12: 23–25).
FF 11. Examiner finds that the term “ODN was well known at the time of
[Appellant’s] invention to refer to oligodeoxyribonucleic acid” (Ans. 8
(emphasis added)).
ANALYSIS
Claim 29 depends from and further limits the pharmaceutical
composition of claim 20 to comprise at least one agent which inhibits p53
expression, wherein the agent comprises a double stranded
oligoribonucleotide complementary to a portion of a p53 RNA transcript in a
pharmaceutically acceptable carrier wherein said oligoribonucleotide has a
sequence corresponding to SEQ ID NO: 2 or SEQ ID NO: 3 (see Appellant’s
claims 20 and 29).
Claim 30 depends from and further limits the pharmaceutical
composition of claim 29 to comprise a modification selected from the group
consisting of ethyl- or methylphosphonate modification, phosphorothioate
modification, dithioate modification, oligonucleotides having a lipophilic

6 See Spec. 1: 17.
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backbone, and oligonucleotides with 2’-O-methyl modified ribose sugars
(see Appellant’s claim 30).
Examiner finds that Appellant’s Specification fails to provide written
descriptive support for: (1) “a pharmaceutical composition comprising a
double stranded RNA which comprises SEQ ID NO:2 or 3” and (2) methyl
modified double stranded oligoribonucleotides (FF 1 and 2; Cf. Appellant’s
claims 29 and 30).
Appellant agrees with Examiner’s finding that page 45 of Appellant’s
Specification “provides a disclosure of SEQ ID NO:2 and SEQ ID NO:3
where these oligonucleotides are deoxyribonucleotides” (FF 3 (emphasis
added); see App. Br. 5). Appellant contends, however, that the Specification
discloses “several different types of antisense oligonucleotides to inhibit
expression of target genes are contemplated for use in the invention. These
include RNA based oligonucleotides, DNA based oligonucleotides, and any
of these cloned into an expression vector” (App. Br. 5; see FF 4). While
Examiner agrees that Appellant’s Specification discloses “that the
oligonucleotides can be of various types,” Examiner finds that Appellant’s
Specification fails to describe “an inhibitory oligonucleotide that is a double
stranded RNA” (FF 5 (emphasis added)). “[T]he hallmark of written
description is disclosure . . . the test requires an objective inquiry into the
four corners of the specification from the perspective of a person of ordinary
skill in the art.” Ariad Pharms, Inc. v. Eli Lilly and Co., 598 F.3d 1336,
1351 (Fed. Cir. 2010). On this record, Examiner finds that it was not
known, at the time of Appellant’s claimed invention, that “double stranded
RNA” could have been used “as an inhibitory molecule. Indeed a Nobel
Prize (Fire and Mello) was awarded for this discovery well after appellants
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[sic] date of invention” (FF 6 (emphasis added)). Therefore,
notwithstanding Appellant’s contentions to the contrary, absent a specific
disclosure in Appellant’s Specification of an inhibitory double stranded
oligoribonucleotide, one of ordinary skill in this art would not have
contemplated such an inhibitory molecule upon reading Appellant’s
Specification (see generally App. Br. 8). See Capon v. Eshhar, 418 F.3d
1349, 1357 (Fed. Cir. 2005) (“Since the law is applied to each invention in
view of the state of relevant knowledge, its application will vary with
differences in the state of knowledge in the field and differences in the
predictability of the science”).
Notwithstanding Appellant’s contention to the contrary, the question
is not whether the term oligonucleotide coupled with sequence information
and a disclosure of double stranded oligodeoxyribonucleotides makes
obvious “double stranded RNA molecules against p53 having RNA
sequences which correspond to SEQ ID NOS: 2 or 3” (App. Br. 8). Instead,
the question is whether Appellant’s Specification provides written
descriptive support for inhibitory double stranded oligoribonucleotides.
Regents of the University of California v. Eli Lilly, 119 F.3d 1559, 1567
(Fed. Cir. 1997) (“[A] description which renders obvious a claimed
invention is not sufficient to satisfy the written description requirement of
that invention”).
We are not persuaded by Appellant’s contention that the
Specification’s reference to Stein supports a finding that, “as of Applicants
[sic] filing date, the use of antisense RNA was contemplated for down
modulation of target gene expression” (App. Br. 5–6 and 8). Stein expressly
states that “[a] discussion of antisense RNA is beyond the scope of this
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review” (FF 7; Cf. App. Br. 9 (“Stein . . . do[es] discuss antisense RNA”)).
In addition, we are not persuaded by Appellant’s attempt to incorporate-by-
reference essential subject matter that was not specifically identified in
Appellant’s Specification, but rather was somehow suggested by Stein’s
“direct[ing a] reader to reference 9 for a discussion of antisense RNA
molecules” (see App. Br. 5; Cf. Ans. 10 (“It appears that appellant is relying
upon an incorporation by reference for an essential feature of their
invention”)). See, e.g., 37 C.F.R. § 1.57(b) and (c). Further,
notwithstanding Appellant’s contention to the contrary, the issue before this
panel concerns an inhibitory double stranded oligoribonucleotide, not “the
use of antisense RNA” per se (e.g., a single stranded oligoribonucleotide)
(see App. Br. 9 (“[A]s of Applicants [sic] filing date, the use of antisense
RNA was contemplated for down modulation of target gene expression”);
Cf. Appellant’s claim 20).
We recognize, but are not persuaded by, Appellant’s contention that
“[i]t cannot be disputed that Inoue discloses double stranded
oligoribonucleotides and the necessary reagents and methods for their
synthesis” (App. Br. 8; Cf. FF 8 (Inoue is “drawn to the study of single
stranded ribonucleotides to be used as probes. The reference does not teach
inhibitory oligonucleotides”); FF 9 (Appellant’s “specification does [not]
point to any particular teaching in Inoue but refers to the reference in
general. At best one in the art would consider the modifications taught in
Inoue for stabilizing a nucleic acid”)).
We recognize, but are not persuaded by, Appellant’s contention that
“page 12, line 25 [of the Specification describes] treatment of a subject
having an aberrant programming disease with a composition selected from
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the group consisting of an expression vector, a double stranded ODN and an
antisense ODN” (App. Br. 9 (emphasis added); FF 10). As Examiner points
out, the term “ODN,” which is not defined in Appellant’s Specification, is
recognized, by those of ordinary skill in this art, “to refer to
oligodeoyribonucleic acid” (FF 11). Therefore, we are not persuaded by
Appellant’s contention that “the specification when taken as a whole fully
described the subject matter encompassed by the present claims” (App. Br.
9).
We recognize, but are not persuaded by, Appellant’s contention that
the Specification provides written descriptive support for methyl modified
double stranded oligoribonucleotides, because “page 65, line 8 . . . [of
Appellant’s Specification] teaches ‘Oligonucleotides with 2 ’-O-methyl [sic]
modified ribose sugars are also suitable for the practice of this invention’”
(App. Br. 9; Cf. FF 2). As Examiner explains, notwithstanding Appellant’s
contention to the contrary, Appellant’s Specification discloses “‘ethyl-or
methylphosphonate modified oligodeoxynucleotides’ [emphasis added to
show the difference]” not oligoribonucleotides (FF 2 (emphasis and
alteration original)).
CONCLUSION OF LAW
The preponderance of evidence on this record supports Examiner’s
finding that Appellant’s Specification fails to provide written descriptive
support for the claimed invention. The rejection of claim 29 under the
written description provision of 35 U.S.C. § 112, first paragraph is affirmed.
Claims 30–36 are not separately argued and fall with claim 29.

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TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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