Ex Parte Alphey et al

Patent Trial and Appeal Board

Apr 25, 2017

11733737 (P.T.A.B. Apr. 25, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/733,737 04/10/2007 Luke Alphey 750402000301 8713
25225 7590 04/27/2017
MORRTSON fr FOFRSTFR T T P
EXAMINER
12531 HIGH BLUFF DRIVE MONTANARI, DAVID A
SUITE 100
SAN DIEGO, CA 92130-2040 ART UNIT PAPER NUMBER
1632
NOTIFICATION DATE DELIVERY MODE
04/27/2017 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LUKE ALPHEY and DEAN THOMAS
Appeal 2015-000048
Application 11/733,737
Technology Center 1600
Before CHRISTOPHER G. PAULRAJ, TAWEN CHANG and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON REHEARING
This is a request for rehearing under 37 C.F.R. § 41.52 (“Req.
Reh’g.”) of the decision on Appeal (“Decision”), entered February 2, 2017,
in the above-identified application. In the Decision, we: (1) affirmed the
rejection of claims 50—54 on the ground of nonstatutory obviousness-type
double patenting as being unpatentable over claims 1,2, 18, and 25—31 of
U.S. Patent No. 7,998,475; (2) affirmed the Examiner’s the rejection of
claims 38-44, 48-55, 61-69, 71-73, 75-83, and 87-91 under 35 U.S.C. §
Appeal 2015-000048
Application 11/733,737
103(a) as obvious over Fryxell,1 Bello,2 and Hammock;3 (3) affirmed the
Examiner’s the rejection of claim 57 under 35 U.S.C. § 103(a) as obvious
over Fryxell, Bello, Hammock, and Namciu;4 and (4) affirmed the
Examiner’s the rejection of claim 59 under 35 U.S.C. § 103(a) as obvious
over Fryxell, Bello, Hammock, and Deng.5 Decision 17. Appellants have
requested rehearing of our Decision in its entirety.
We have granted Appellants’ request to the extent we have
reconsidered our original Decision in light of Appellants’ timely raised
points. We withdraw our summary affirmance of the rejection of claims 50—
54 on the ground of nonstatutory obviousness-type double patenting as being
unpatentable over claims 1, 2, 18, and 25—31 ofU.S. Patent No. 7,998,475,
but we decline to modify the Decision with regard to any of the obviousness
rejections. We address the Appellants’ arguments below.
1 Karl J. Fryxell and Thomas A. Miller, Autocidal Biological Control: A
General Strategy for Insect Control Based on Genetic Transformation with a
Highly Conserved Gene, 88 J. ECONOMIC ENTOMOLOGY 1221-1232
(1995) (“Fryxell”).
2 Bruno Bello et al., Spatial and temporal targeting of gene expression in
Drosophila hy means of a tetracycline-dependent trans activator system, 125
DEVELOPMENT 2193-2202 (1998) (“Bello”).
3 Hammock et al., US 5,674,747, issued October 7, 1997 (“Hammock”).
4 Stephanie J. Namciu et al., Human Matrix Attachment Regions Insulate
Transgene Expression from Chromosomal Position Effects in Drosophila
melanogaster, 18(4) MOL. and CELLULAR BIO. 2382-2391 (1998)
(“Namciu”).
5 Wu-Min Deng, et al., A targeted gene silencing technique shows that
Drosophila myosin VI is required for egg chamber and imaginal disc
morphogenesis, 112 J. CELL SCIENCE 3677—3690 (Oct. 1999) (“Deng”).
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Appeal 2015-000048
Application 11/733,737
DISCUSSION
Nonstatutory Obviousness-type Double Patenting
Appellants argue the Board “committed error when it misapprehended
the claims actually on appeal.” Req. Reh’g 3. Appellants argue the Board
erred by asserting “that the ODP rejection of claims 50—54 over claims 1, 2,
18, and 25—31 of U.S. Patent No. 7,998,475 B2 was on appeal” because “the
Advisory Action mailed June 3, 2013 clearly indicated that the ODP
rejection was withdrawn in view of Appellants’ response to the Final Office
Action” and the Examiner stated in the Advisory Action that the rejection
was “withdrawn in view of Applicant’s arsuments.” Id. (emphasis original).
Appellants are correct that the nonstatutory obviousness-type
rejection of claims 50—54 was withdrawn by the Examiner in the Advisory
Action and, therefore, claims 50-54 were not rejected on that basis at the
time of the appeal.6 Accordingly, we withdraw our affirmance of that
rejection. We do not, however, agree that we erred in finding claims 50-54
were on appeal, as the Examiner also rejected claims 50-54 (along with
other claims) under 35 U.S.C. § 103 over Fryxell, Bello, and Hammock.
Final Act. 6.
Obviousness
The claimed subject matter is directed to a recombinant insect whose
genome comprises a dominant lethal genetic system comprising, inter alia,
6 The Examiner’s provisional rejection on the ground of nonstatutory
obviousness-type double patenting over claims 83—88 of copending
Application no. 12/278,849 is also moot as that application has been
abandoned. Notice of Abandonment, mailed May 9, 2016.
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Application 11/733,737
“a lethal gene under the control of a promoter . . . wherein the lethal effect of
the system is sex-specific.” See Claim 38. Appellants argue the Board erred
by misconstruing the claim term “wherein the lethal effect of the system is
sex-specific” to encompass the expression of a non-specific lethal gene in
only one sex, and, using this construction, in finding that Fryxell disclosed a
transgenic insect containing a lethal gene “wherein the lethal effect of the
system is sex-specific.” Req. Reh’g 4. Appellants argue the Board “failed
to consider whether the lethal effect of such gene expression is specific to
any single sex” and instead effectively interpreted the term to mean that “the
expression or presence of the system is sex-specific.” Id. at 4—5.
Appellants argue that the meaning ascribed by the Board is
inconsistent with the ordinary and customary meaning of the term, because
“‘specificity’ means having the quality of being specific rather than general.
. . [and] the lethal effect of the Fryxell system is not specific to any single
sex.” Id. at 5.
We are not persuaded that we erred in our original Decision. During
examination, claims are given their “broadest reasonable construction ‘in
light of the specification as it would be interpreted by one of ordinary skill in
the art.’” Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005).
The claim language specifies that “the lethal effect of the system is sex-
specific,” but does not otherwise limit the manner by which sex-specificity
is achieved for the recombinant insect. Cl. 38 (emphasis added).
Accordingly, the broadest reasonable construction of the phrase
encompasses a system in which the lethal effect of the gene is felt in only
one sex because the gene is expressed only in that sex. As noted previously
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(Decision 9), this construction is supported by Appellants’ Specification,
which describes how the skilled artisan can achieve sex-specific lethality in
the claimed transgenic insect:
[Expression of the lethal gene or gene product may be controlled
so that it is expressed or produced only in one sex (or in only one
gamete or sexual organ of a hermaphrodite). For example, sex-
specific promoters or enhancers may be used, either in
combination with sex-specific lethal genes or non-specific lethal
genes. Sex-specific splicing provides another mode for sex-
specific gene expression. All possible combinations of non­
specific lethal genes, sex-specific lethal genes, non-specific
promoters and sex-specific promoters are envisaged by the
present invention.
Spec. 21,12 (emphasis added).
As discussed at length in our Decision, the skilled artisan reading the
language above would understand the broadest reasonable interpretation of
the claim term “wherein the lethal effect of the system is sex-specific” to
encompass the expression of a non-specific lethal gene in only one sex, as
accomplished by Fryxell with both male-only and female-only populations.
Decision at 8—11; FF2—8. In particular, we note that combinations of “non­
specific lethal genes” with “non-specific promoters” are contemplated
within the scope of the invention. With that particular combination, the
skilled artisan would recognize that one manner in which the lethal effect of
the system could be sex-specific is to ensure that the non-specific lethal gene
along with the non-specific promoter is expressed in only one sex. This is
consistent with the disclosure noted by Appellants (i.e., “the original
specification discloses that when ‘the sex specific lethal effect of the genetic
system [is] manifested’ in a population where both males and females have
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Application 11/733,737
the genetic system, only one sex is killed and ‘ [a] single sex population
remaining may then be isolated’” (Req. Reh’g. 7)), because the skilled
artisan would recognize that the Specification describes that the system can
also use a sex-specific promoter and/or sex-specific lethal gene to trigger
lethality of the system. Notably, the claims do not require either a sex-
specific gene or a sex-specific promoter.
Appellants acknowledge that the claimed system “may well comprise
non-sex specific lethal genes and/or non-sex specific promoters,” but argue:
Nevertheless, the lethal effect of the system must still be sex-
specific as recited in the claims (e.g., by sex-specific splicing of
the non-sex specific lethal genes).” Interpretation of the sex-
specific lethal effect must be consistent with the original
specification. . . . One of ordinary skill in the art would
understand the difference between sex-specific “presence” (or
“expression,” using the Board's terminology) and sex-specific
“lethal effect” of the system as recited in the claims. The recited
sex-specific “lethal effect” requires more than simple “presence”
or “expression” of the system.
Req. Reh’g. 8.
Appellants’ argument is not persuasive, as the record does not support
Appellants’ attorney argument that a skilled artisan would understand that
“sex-specific splicing of the non-sex specific lethal genes” is the only
mechanism by which the combination of non-sex specific lethal genes and
non-sex specific promoters may be used in accordance with the invention.
The word “splicing” occurs once in the Specification at page 2112 as
quoted above: “Sex-specific splicing provides another mode for sex-specific
gene expression.” Although that language suggests that the technique of
sex-specific splicing may be used, such as to splice a gene into an insect
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Application 11/733,737
genome so that the gene would be driven by an endogenous sex-specific
promoter, this disclosure does not teach use of splicing with non-sex specific
lethal genes and/or non-sex specific promoters, or mandate that when non
sex-specific genes and promoters are used, splicing must be necessarily used
in order to achieve a sex-specific “effect.” Appellants offer only attorney
argument regarding the restrictive meaning they posit that an ordinary
artisan would have ascribed to the claim term at issue. We do not find the
argument persuasive in light of the teachings of the Specification discussed
above.
Appellants further argue that the Examiner’s proposed replacement of
Fryxell’s temperature-sensitive lethal gene system with the tetracycline
lethal gene system taught by Bello “directly contradicted blackletter law that
the proposed modification cannot change the principle of operation of a
reference to make a prima facie case.” Req. Reh’g. 11. Although the
Examiner found that this feature was met by Fryxell by at least the Final
Action dated January 7, 2013, Appellants have not raised this issue before
their Request for Rehearing. The Board will not consider a new argument
that is “not raised in the appeal brief, or is not responsive to an argument
raised in the examiner’s answer . . . unless good cause is shown.” 37 CFR
41.41 (b)(2). Appellants have not explained why they waited until this
Request for Rehearing to raise this issue, nor do they present sufficient
persuasive evidence regarding why a lethal gene triggered by the presence of
tetracycline in the organism’s food cannot be successfully substituted for a
lethal gene triggered by temperature, as the Examiner has proposed.
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Consequently, we shall not consider this new attorney argument, presented
without evidence.
Appellants have not persuasively explained how their proposed claim
construction of the term “wherein the lethal effect of the system is sex-
specific” reconciles with the full scope of the disclosure regarding the
manner in which sex-specific lethality may be achieved. Accordingly, we
decline to construe the term in the limited manner Appellants request, and
we decline to modify our Decision in regards to any of the obviousness
rejections in light of the teachings of the prior art.
SUMMARY
We withdraw our summary affirmance of the rejection of claims 50—
54 on the ground of nonstatutory obviousness-type double patenting as being
unpatentable over claims 1, 2, 18, and 25—31 ofU.S. Patent No. 7,998,475.
We maintain the rejections under 35 U.S.C. § 103(a) based on our
findings that a preponderance of the evidence supports the Examiner’s
conclusion that the combination of Fryxell, Bello, and Hammock discloses
the claimed recombinant insect with a dominant lethal genetic system,
therefore rendering the appealed claims obvious.
GRANTED-IN-PART; DENIED-IN-PART
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