Ex Parte Brown et al

Patent Trial and Appeal Board

Jan 29, 2013

10142666 (P.T.A.B. Jan. 29, 2013)

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.
10/142,666 05/08/2002 Bob D. Brown 042602-0502 9452
30542 7590 01/29/2013
FOLEY & LARDNER LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
EXAMINER
GIBBS, TERRA C
ART UNIT PAPER NUMBER
1635
MAIL DATE DELIVERY MODE
01/29/2013 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 BOB D. BROWN and TIMOTHY A. RILEY
__________

Appeal 2012-001310
Application 10/142,666
Technology Center 1600
__________

Before LORA M. GREEN, FRANCISCO C. PRATS, and
ERICA A. FRANKLIN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 1-4, 7-9, 22-29, 31, and 33-44. We have
jurisdiction under 35 U.S.C. § 6(b).
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STATEMENT OF THE CASE
Claim 1 is the only independent claim on appeal, and reads as follows:
1. A pharmaceutical composition comprising an improved
antisense oligonucleotide and a pharmaceutically acceptable carrier,
wherein said oligonucleotide has increased specificity and ability to
inhibit the expression of a gene, wherein the improvement comprises
the incorporation of at least two juxtaposed universal bases and one or
more flexible non-nucleotide linkers connecting bases in said
oligonucleotide, and wherein said universal bases stack in duplex
nucleic acid helices.

The following grounds of rejection are before us for review:
I. Claims 1-4, 7-9, 22-29, 31, 34, 37-40, 43, and 44 stand rejected
over the combination of Bergstrom,1 Tormo,2 and Jäschke3 (Ans.
4). As Appellants do not argue the claims separately, we focus our
analysis on claim 1, and claims 2-4, 7-9, 22-29, 31, 34, 37-40, 43,
and 44 stand or fall with that claim.
II. Claims 35 and 41 stand rejected over the combination of
Bergstrom, Tormo, and Jäschke, as further combined with
Torrence4 (Ans. 7).
III. Claims 36 and 42 stand rejected over the combination of
Bergstrom, Tormo, and Jäschke as further combined with Krupp5
(Ans. 9).

1 Bergstrom et al., US 5,681,947, Oct. 28, 1997
2 Tormo et al., US 6,977,244 B2, Dec. 20, 2005
3 Andres Jäschke, Oligonucleotide-Poly(ethylene glycol) Conjugates:
Synthesis, Properties, and Applications, in Harris et al., Polyethylene Glycol
ACS Symposium Series, American Chemical Society Washington, DC 265-
283 (1997)
4 Torrence et al., US 5,583,032, Dec. 10, 1996
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We affirm.

ISSUE
Does the preponderance of the evidence of record support the
Examiner’s conclusion that the combination of Bergstrom, Tormo, and
Jäschke renders claim 1 obvious?

FINDINGS OF FACT
FF1. As we agree with the Examiner’s findings and conclusions with
respect to the obviousness rejections (see Ans. 4-10), we adopt them as our
own.

ANALYSIS
Appellants argue that Bergstrom “is directed primarily to
oligonucleotide primers for use in Sanger Method sequencing” (App. Br. 7).
Appellants assert that as Bergstrom teaches that “the inclusion of universal
bases in order to allow the oligonucleotide primer to indiscriminately
hybridize to mismatched sequences and to still initiate DNA synthesis in
Sanger Method sequencing,” that Bergstrom is disclosing “that universal
bases would result in binding to ambiguous or mismatched sequences, thus
decreasing sensitivity” (App. Br. 7-8). Appellants assert that Bergstrom
only refers to the use of the bases in antisense oligonucleotides, and “fails to
disclose any antisense oligonucleotides having universal bases that were

5 G. Krupp, Antisense oligoribonucleotides and RNase P. A great potential,
75 BIOCHIMIE 135-139 (1993)
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actually made and found to be effective in inhibiting the expression of a
gene, much less any antisense oligonucleotide having a combination of
juxtaposed universal bases and flexible linkers, where the antisense
oligonucleotide has increased specificity and ability to inhibit the expression
of a gene” (id. at 8).
As to Tormo, Appellants argue that Tormo fails to remedy the
deficiencies of Bergstrom, and that Tormo does not teach or suggest the
claimed invention (id.). Appellants argue further that Tormo is drawn to
oligonucleotides that are specific for Bcl-2 sequences, and as Bergstrom
teaches that the universal bases decrease the specificity of an oligonucleotide
for a target, Bergstrom teaches away from the combination (id. at 9).
Appellants further assert that “there would be no reasonable expectation that
the resultant oligonucleotides would have increased specificity and ability
to inhibit the expression of a gene as is required by the claims” (id.).
As to Jäschke, Appellants argue that Jäschke fails to remedy the
deficiencies of Bergstrom and Tormo (id.). Appellants reiterate the
argument that Bergstrom teaches away from the combination as Bergstrom
that the universal bases decrease the specificity of an oligonucleotide for a
target (id.). Appellants further argue that there is no reasonable expectation
of combining the reference to achieve the claimed invention without the use
of improper hindsight (id.).
Appellants’ arguments have been carefully considered, but are not
convincing.
In determining whether obviousness is established by combining the
teachings of the prior art, “the test is what the combined teachings of the
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references would have suggested to those of ordinary skill in the art.” In re
Keller, 642 F.2d 413, 425 (CCPA 1981). In addition, a reference disclosure
is not limited only to its preferred embodiments, but is available for all that it
discloses and suggests to one of ordinary skill in the art. In re Lamberti, 545
F.2d 747, 750 (CCPA 1976). Moreover, all that is required is a reasonable
expectation of success, not absolute predictability of success. In re
O’Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988).
As found by the Examiner, Bergstrom teaches that the incorporation
of universal bases increases the effective specific activity of the
oligonucleotide to the correct target (Ans. 5; Bergstom, col. 2, ll. 45-47). In
addition, as found by the Examiner (Ans. 8), Bergstrom specifically teaches
that the oligonucleotides containing the universal bases will find
“widespread applicability in both clinical and therapeutic settings,” such as
in antisense oligonucleotides (Bergstrom, col. 8, ll. 55-65). Tormo teaches a
bcl-2 antisense peptide (Ans. 5-6), and Jäschke teaches the use of PEG for
linking oligonucleotides in nucleic acid based drugs (id. at 5). Thus, based
on the teachings of Bergstrom, as discussed in the Answer and above, it
would have been well within the level of skill of the ordinary artisan to
incorporate two juxtaposed universal bases into the bcl-2 antisense peptide
of Tormo, as well as a flexible non-nucleotide linker such as PEG as taught
by Jäschke, to obtain the composition of claim 1.
Thus, the references as combined suggest the composition of claim 1.
“[T]he patentability of apparatus or composition claims depends on the
claimed structure, not on the use or purpose of that structure.” Catalina
Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir.
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2002). That is, “[f]rom the standpoint of patent law, a compound and all of
its properties are inseparable; they are one and the same thing.” In re
Papesch, 315 F.2d 381, 391 (CCPA 1963). As found by the Examiner (Ans.
14), the claim limitation that the oligonucleotide have increased specificity
and ability to inhibit the expression of a gene does not impart additional
structural limitations, and would be an inherent property of the composition
of claim 1. Also, as noted above, Bergstrom explicitly teaches that the
incorporation of universal bases increases the effective specific activity of
the oligonucleotide to the correct target (Ans. 5; Bergstom, col. 2, ll. 45-47).
We also do not agree with Appellants that Bergstrom teaches away
from the combination of Tormo, and Jäschke with Bergstrom. “Under the
proper legal standard, a reference will teach away when it suggests that the
developments flowing from its disclosures are unlikely to produce the
objective of applicant’s invention. A statement that a particular combination
is not a preferred embodiment does not teach away absent clear
discouragement of that combination.” Syntex (USA) LLC v. Apotex, Inc.,
407 F.3d 1371, 1380 (Fed. Cir. 2005) (citations deleted). Here, Bergstrom
specifically teaches that the universal bases may be used in antisense
oligonucleotides, and thus does not teach away from the combination.
As to Rejections 2 and 3, Appellants argue that neither Torrence nor
Krupp remedy the deficiencies of the combination of Bergstrom, Tormo, and
Jäschke (App. Br. 10-11). Those arguments are not found to be convincing
for the reasons set forth above with respect to claim 1.

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SUMMARY
We affirm the rejection of claims 1 over the combination of
Bergstrom, Tormo, and Jäschke. Claims 2-4, 7-9, 22-29, 31, 34, 37-40, 43,
and 44 fall with that claim.
We also affirm the rejection of claims 35 and 41 over the combination
of Bergstrom, Tormo, and Jäschke, as further combined with Torrence; and
the rejection of claims 36 and 42 over the combination of Bergstrom,
Tormo, and Jäschke as further combined with Krupp.

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.R.R. § 1.136(a)(1)(iv).

AFFIRMED

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