Ex Parte Brown et al

Patent Trial and Appeal Board

Jun 25, 2013

11837487 (P.T.A.B. Jun. 25, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte DAVID BROWN, LANCE FORD, ANGIE CHENG,
RICH JARVIS, MIKE BYROM, DMITRIY OVCHARENKO,
ERIC DVROE, and KEVIN KELNAR
__________

Appeal 2012-003581
Application 11/837,487
Technology Center 1600
__________

Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.

SNEDDEN, Administrative Patent Judge.

DECISION ON APPEAL
This appeal1 under 35 U.S.C. § 134 involves claim 102 directed to a
synthetic RNA molecule. The Examiner rejected the claim under 35 U.S.C.
§ 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

1 Appellants identify the Real Party in Interest as MiRNA Therapeutics, Inc.
(App. Br. 2).
Appeal 2012-003581
Application 11/837,487

2

STATEMENT OF THE CASE
Appellants’ invention relates to “compositions involving nucleic acid
molecules that simulate microRNA (miRNAs) and that inhibit miRNAs”
(Specification 2). Specifically, the Specification discloses as follows:
Synthetic miRNAs of the invention comprise, in some
embodiments, two RNA molecules wherein one RNA is
identical to a naturally occurring, mature miRNA. The RNA
molecule that is identical to a mature miRNA is referred to as
the active strand. The second RNA molecule, referred to as the
complementary strand, is at least partially complementary to the
active strand. The active and complementary strands are
hybridized to create a double-stranded RNA, called the
synthetic miRNA, that is similar to the naturally occurring
miRNA precursor that is bound by the protein complex
immediately prior to miRNA activation in the cell. Maximizing
activity of the synthetic miRNA requires maximizing uptake of
the active strand and minimizing uptake of the complementary
strand by the miRNA protein complex that regulates gene
expression at the level of translation. The molecular designs
that provide optimal miRNA activity involve modifications to
the complementary strand.
Two designs incorporate chemical modifications in the
complementary strand. The first modification involves creating
a complementary RNA with a chemical group other than a
phosphate or hydroxyl at its 5' terminus. The presence of the 5'
modification apparently eliminates uptake of the
complementary strand and subsequently favors uptake of the
active strand by the miRNA protein complex.
(Id. at 48.)
Claim 102, the only claim on appeal, reads as follows:
102. A synthetic RNA molecule comprising two
polynucleotides each between 17 and 25 residues in length
comprising
Appeal 2012-003581
Application 11/837,487

3
a) a first polynucleotide comprising an miRNA region
whose sequence from 5' to 3' is identical to a mature miRNA
sequence, and
b) a second polynucleotide comprising a complementary
region whose sequence from 5' to 3' is 100% complementary to
the miRNA sequence, wherein the 5' terminus of the second
polynucleotide is replaced with a lower alkylamine group.

The sole rejection before us for review is the Examiner’s rejection of
claim 102 has been rejected under 35 U.S.C. § 103(a) as obvious over Chen
(US 2005/0075492, published Apr. 7, 2005), Tuschl (US 2005/0182005,
published Aug. 18, 2005) and Manoharan (US 2005/0153337, published Jul.
14, 2005).

Issue
The issue presented is: Does the evidence of record support the
Examiner’s finding that the combined prior art teaches all elements of claim
102?
Findings of Fact
The following findings of fact (“FF”) are supported by a
preponderance of the evidence of record.
FF1. The Specification discloses as follows:
The miRNA region and the complementary region may
be on the same or separate polynucleotides. In cases in which
they are contained on or in the same polynucleotide, the
miRNA molecule will be considered a single polynucleotide. In
embodiments in which the different regions are on separate
polynucleotides, the synthetic miRNA will be considered to be
comprised of two polynucleotides.
(Specification 10, first full paragraph.)
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Appeal 2012-003581
Application 11/837,487

5
(Claim language cannot be mere surplusage. An express limitation cannot
be read out of the claim).
Analysis
The Examiner finds as follows:
A reasonable interpretation of the claim in view of the
specification is that the recited synthetic RNA molecule
comprising two polynucleotides comprising a miRNA region
and a complementary region can be a precursor molecule as
taught by Chen et al. The claimed RNA molecule does not
preclude a precursor as taught by Chen et al. because of the use
of "comprising" allows the RNA molecule to have two
polynucleotides within a single RNA molecule.
...
There is no language recited in the claim that would
allow the synthetic RNA molecule to contain only two separate
polynucleotides nor is there any language in the claims in light
of the specification that require the miRNA and complementary
region to be on two separate polynucleotides”
(Ans. 7-8.)
The Examiner then concludes that “the claims are drawn to a synthetic
RNA molecule comprising two polynucleotides comprising a miRNA region
and a complementary region can be a precursor molecule as taught by Chen
et al.” (id. at 8-9).
We are not persuaded. Rather, we agree with Appellants that “[i]t is
clear from the wording of this claim in the context of the specification that
the RNA molecule comprises two separate strands because the RNA
molecule comprises ‘two polynucleotides each between 17 and 25 residues
in length’” (App. Br. 7, emphasis in original; see e.g., FF1). The claims
recite a first and second polynucleotide, not, for example, a first and second
Appeal 2012-003581
Application 11/837,487

6
sequence. The Examiner’s interpretation attempts to read this element out of
the claims.
Having determined the scope of Appellants’ claims, we agree with
Appellants that the cited references do not support a prima facie case of
obviousness. For the reasons set forth above, the Examiner has not
adequately explained how the references would have suggested the recited
RNA molecule having two polynucleotides each between 17 and 25 residues
in length. Furthermore, as Appellants argue, the Examiner has not
adequately explained where in the references it is either taught or suggested
a double-stranded RNA molecule as recited in claim 102 (see e.g., App. Br.
8).
Since all claim limitations are not taught or suggested by the applied
prior art, the Examiner has failed to establish a prima facie case for the
obviousness of claim 102. See e.g., CFMT, Inc. v. Yieldup Intern. Corp.,
349 F.3d 1333, 1342 (Fed. Cir. 2003) (“[O]bviousness requires a suggestion
of all limitations in a claim.”).
SUMMARY
We reverse the rejection of claim 102 under 35 U.S.C. § 103(a) as
obvious over Chen, Tuschl and Manoharan.

REVERSED

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