Ex Parte Graham et al

Patent Trial and Appeal Board

Oct 23, 2017

14137737 (P.T.A.B. Oct. 23, 2017)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
14/137,737 12/20/2013 Michael Wayne Graham 0687/74768-CA-PCT-US/JPW/ 1959
23432 7590 10/23/2017
COOPER & DUNHAM, LLP
30 Rockefeller Plaza
20th Floor
NEW YORK, NY 10112
EXAMINER
WHITEMAN, BRIAN A
ART UNIT PAPER NUMBER
1674
MAIL DATE DELIVERY MODE
10/23/2017 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 MICHAEL WAYNE GRAHAM,
ROBERT NORMAN RICE, and PETER MICHAEL WATERHOUSE
__________

Appeal 2016-002740
Application 14/137,737
Technology Center 1600
__________

Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and
TAWEN CHANG, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
We vacate the Decision mailed Oct. 10, 2017 in favor of this
substitute Decision because the original Decision inadvertently failed to
address the obviousness-type double patenting rejection.
This is an appeal1 under 35 U.S.C. § 134 involving claims to a double-
stranded DNA construct that is capable of delaying, repressing, or otherwise
reducing the expression of a target gene. The Examiner rejected the claims
as obvious and obviousness-type double patenting. We have jurisdiction
under 35 U.S.C. § 6(b). We reverse.

1 Appellants identify the Real Party in Interest as the Commonwealth
Scientific and Industrial Research Organisation (see Appeal Br. 5).
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Statement of the Case
Background
“Controlling metabolic pathways in eukaryotic organisms is desirable
for the purposes of producing novel traits” (Spec. 4:2–3). “[T]here currently
exists no consensus as to the nature of genetic sequences which provide the
most efficient means for repressing, delaying or otherwise reducing gene
expression using existing technologies” (Spec. 5:4–6).
The invention is based in part on the surprising discovery
by the inventors that cells which exhibit one or more desired
traits can be produced and selected from transformed cells
comprising a nucleic acid molecule operably linked to a
promoter, wherein the transcription product of the nucleic acid
molecule comprises a nucleotide sequence which is
substantially identical to the nucleotide sequence of a transcript
of an endogenous or non-endogenous target gene, the
expression of which is intended to be modulated.

(Spec. 6:12–18).
The Claims
Claims 44–61 are on appeal. Independent claim 44 is representative
and reads as follows:
44. A double-stranded DNA construct which is capable of
delaying, repressing, or otherwise reducing the expression of a
target gene, wherein the double-stranded DNA construct
comprises a foreign nucleic acid molecule comprising multiple
copies of a nucleotide sequence that is more than 20 nucleotides
long and which is substantially identical to a region of the target
gene, and wherein the foreign nucleic acid molecule is placed
operably under the control of both a first promoter sequence
and a second promoter sequence which are each operable in a
cell, wherein said promoters are located at the distal and
proximal ends of the foreign nucleic acid molecule.
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The Issues
A. The Examiner rejected claims 44–61 under 35 U.S.C. § 103(a) as
obvious over Fire2 and Livache3 (Final Act. 7–9).
B. The Examiner rejected claims 44 and 47–61 under 35 U.S.C. § 103(a)
as obvious over Jendrisak4 and Burnham5 (Final Act. 9–12).
C. The Examiner rejected claims 44–61 on the grounds of obviousness-
type double patenting over the claims of reexamined US 6,573,099 (Final
Act. 13; cf. Ans. 20–22).

A. & B. 35 U.S.C. § 103(a)
Because the same issue is dispositive for both obviousness rejections,
we will consider the rejections together.
The Examiner relies on either Livache or Jendrisak to suggest vectors
with promoters proximal and distal to insert sequences (see Final Act. 8–9)
and relies upon Fire or Burnham for the inserted target gene (see Final Act.
7, 11).
The Examiner finds it obvious “to arrange the structural genes to form
an inverted repeat sequence or an interrupted palindrome sequence between
the first and second promoter since they are two common ways used by one
of ordinary skill in the art to produce a self-complementary RNA sequence”
(Final Act. 8–9).

2 Fire et al., US 6,506,559 B1, issued Jan. 14, 2003.
3 Livache et al., US 5,795,715, issued Aug. 18, 1998.
4 Jendrisak et al., US 4,766,072, issued Aug. 23, 1988.
5 Burnham et al., US 5,989,865, issued Nov. 23, 1999.
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The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner’s conclusion that the prior art
renders claim 44 obvious?
Findings of Fact
1. Fire teaches “introduction of RNA with partial or fully double-
stranded character into the cell or into the extracellular environment.
Inhibition is specific in that a nucleotide sequence from a portion of the
target gene is chosen to produce inhibitory RNA” (Fire 4:21–25).
2. Fire teaches the “double-stranded structure may be formed by a
single self-complementary RNA strand or two complementary RNA strands.
RNA duplex formation may be initiated either inside or outside the cell”
(Fire 7:41–45).
3. The terms “palindrome” and “inverted repeat sequence” do not
appear in Fire.
4. Livache teaches a “DNA sequence to be transcribed into
double-stranded RNA is flanked by two promoters, one controlling the
transcription of one of the strands, and the other that of the complementary
strand. These two promoters may be identical or different” (Livache 3:1–5).
5. Jendrisak teaches a vector with “two different promoter
sequences separated by a series of unique restriction sites into which foreign
DNA can be inserted. The promoters face each other such that transcription
from either promoter proceeds toward the other. Each promoter sequence is
associated with a unique RNA polymerase” (Jendrisak 2:25–32).
6. Burnham teaches by using “a polynucleotide sequence set out
in FIG. 1 [SEQ ID NO:1], a polynucleotide of the present invention
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encoding spo-rel polypeptide may be obtained using standard cloning and
screening procedures” (Burnham 10:51–55).
Principles of Law
A prima facie case for obviousness “requires a suggestion of all
limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003), and “a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
Analysis
Appellants contend “neither Fire nor Livache mention, much less
disclose, a double-stranded DNA construct comprising (1) ‘a foreign nucleic
acid molecule comprising multiple copies of a nucleotide sequence that is
more than 20 nucleotides long and which is substantially identical to a
region of the target gene’” (Reply Br. 3). Appellants contend “Jendrisak
does not teach a DNA construct comprising multiple copies of a DNA
sequence of at least 20 basepairs in length under the control of both a distal
and proximal promoter” (Id. at 7) and “Burnham does nothing to cure the
deficiencies of Jendrisak” (Id. at 8).
We find this argument persuasive because the Examiner does not
identify any teaching in Fire, Livache, Jendrisak, or Burnham that suggests
“multiple copies of a nucleotide sequence that is more than 20 nucleotides
long and which is substantially identical to a region of the target gene” as
required by claim 44.
In particular, we are not persuaded by the Examiner’s statement,
lacking supporting factual evidence, that:
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One of ordinary skill in the art would have been
motivated to arrange the structural genes to form an
inverted repeat sequence or an interrupted palindrome
sequence between the first and second promoter since
they are two common ways used by one of ordinary
skill in the art to produce a self-complementary RNA
sequence.

(Final Act. 8–9). The Examiner does not identify any teaching in the prior
art for inverted repeat sequences located in vectors such as those of Livache
or Jendrisak, and points to no specific teachings or suggestions for such
RNA or DNA sequences in Fire or Burnham (see FF 3). In the absence of
any teaching or reason to place multiple copies of a DNA sequence of 20 or
more nucleotides between distal and proximal promoters, we necessarily
reverse the Examiner’s rejections.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that the prior art renders claim 44 obvious.

C. Obviousness-type double patenting over US 6,573,099
The Examiner finds:
Claims 44-61 are rejected on the ground of
nonstatutory obviousness-type double patenting as
being unpatentable over claims 1-22 of U.S. Patent
No. 6,573,099, of record. Although the conflicting
claims are not identical, they are not patentably
distinct from each other because both set of claims
read on a similar product and using the product.

(Final Act. 13).
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The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner’s conclusion that the claims of
U.S. 6,573,099 render the instant claims obvious?
Findings of Fact
7. Claim 4 of the reexamined US 6,573,099 is representative and
reads as follows:
4. An isolated [genetic] double-stranded DNA
construct which is capable of delaying, repressing or
otherwise reducing the expression of a target gene in
an animal cell which is transfected with said [genetic]
double-stranded DNA construct, wherein said
[genetic] double-stranded DNA construct comprises at
least two identical copies of a structural gene
sequence and each identical copy of said structural
gene sequence is separately placed under the control
of a promoter which is operable in said cell, and
wherein said structural gene sequence comprises a
nucleotide sequence which is substantially identical to
[at least] a region of said target gene, wherein at least
one identical copy of said structural gene sequence is
placed operably in the sense orientation under the
control of an individual promoter sequence, and
wherein at least one other identical copy of said
structural gene sequence is placed operably in the
antisense orientation under the control of another
individual promoter sequence.

(US 6,573,099 C1 1:23–39).
Principles of Law
Obviousness-type double patenting prohibits the issuance of claims in
a second patent that are “not patentably distinct from the claims of the first
patent.” In re Longi, 759 F.2d 887, 892 (Fed. Cir. 1985) (citations omitted).
“A later patent claim is not patentably distinct from an earlier patent claim if
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the later claim is obvious over, or anticipated by, the earlier claim.” Eli Lilly
& Co. v. Barr Labs., Inc., 251 F.3d 955, 968 (Fed. Cir. 2001).
A prima facie case for obviousness “requires a suggestion of all
limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) and “a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
Analysis
Appellants contend the “Examiner has not even alleged what problem
would have motivated a POSA to modify a cited claim to arrive at the
claimed invention” (App. Br. 51). Appellants further contend
no cited claim discloses a “foreign nucleic acid
molecule comprising multiple copies of a nucleotide
sequence” which is “placed operably under the control
of both a first promoter sequence and a second
promoter sequence which are each operable in a cell
wherein said promoters are located at the distal and
proximal ends of the foreign nucleic acid molecule”
as recited in independent claim 44 (emphases added).

(App. Br. 52).
The Examiner responds
the argument is not found persuasive because claim 4
of ’099 makes obvious the claimed product because
claim 4 embraces a double stranded construct
comprising multiple copies of a structural gene
sequence and each sequence is placed under control of
a promoter which is operable in a cell, wherein the
structural gene sequence is substantially identical to at
least a region of a target gene and wherein at least one
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of the gene is placed in sense orientation and another
is placed in antisense orientation.

(Ans. 22).
We find that Appellants have the better position. Claim 4 of US
6,573,099 teaches a DNA construct with two identical sequences of a gene,
one placed in the sense orientation under a promoter and one placed in the
antisense orientation under another promoter (FF 7). The instant claim 44,
however, requires a single sequence that comprises two or more 20
nucleotide sequences from a gene, not two separate gene sequences, and
further requires this single sequence to be placed between two promoters
that are at the proximal and distal ends. Claim 4 of US 6,573,099 lacks any
requirement that the two identical gene sequences are placed between the
two promoters or that the promoters are located at the proximal and distal
ends of the sequences.
The Examiner provides no reason in the rejection or suggestion from
claim 4 of US 6,573,099 as to why this orientation would have been
selected, and other orientations are possible. We therefore agree with
Appellants that the rejection “fails to explain any rationale for making the
necessary changes to the ’099 construct to arrive at the construct of pending
claim 44” (Reply Br. 11).
Conclusion of Law
The preponderance of the evidence of record does not support the
Examiner’s conclusion that the claims of U.S. 6,573,099 render the instant
claims obvious.
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SUMMARY
In summary, we reverse the rejection of claims 44–61 under 35 U.S.C.
§ 103(a) as obvious over Fire and Livache.
We reverse the rejection of claims 44 and 47–61 under 35 U.S.C.
§ 103(a) as obvious over Jendrisak and Burnham.
We reverse the rejection of claims 44–61 on the grounds of
obviousness-type double patenting over the claims of reexamined US
6,573,099.

REVERSED