Ex Parte Rasochova et al

Patent Trial and Appeal Board

Oct 24, 2018

11621850 (P.T.A.B. Oct. 24, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/621,850 01/10/2007
23557 7590 10/26/2018
SALIW ANCHIK, LLOYD & EISENSCHENK
A PROFESSIONAL ASSOCIATION
PO Box 142950
GAINESVILLE, FL 32614
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Lada Rasochova
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
WARF.100XCD2 1901
EXAMINER
ZHENG,LI
ART UNIT PAPER NUMBER
1662
NOTIFICATION DATE DELIVERY MODE
10/26/2018 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
following e-mail address(es):
euspto@slepatents.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LADA RASOCHOV A, THOMAS GERMAN,
and PAUL AHLQUIST 1
Appeal2017-001787
Application 11/621,850
Technology Center 1600
Before RICHARD J. SMITH, TA WEN CHANG, and
RYAN H. FLAX, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of genotypically or phenotypically modifying one or more plant cells. We
have jurisdiction under 35 U.S.C. § 6(b ).
We reverse.
STATEMENT OF THE CASE
Background
"RNA viruses ... [are] valuable tools in the phenotypic and genotypic
transformation of targeted cells and tissues." (Spec. 1, 11. 17-18.)
1 According to Appellants, the real party in interest is Wisconsin Alumni
Research Foundation (WARF). (Appeal Br. 1.)
Appeal2017-001787
Application 11/621,850
[W]ith the advent of transformation and the genetic engineering
of plants, much concern has arisen concerning the potential
hazard of the dispersal of dangerous traits into the environment.
For example, genes increasing the stress tolerance and/or
herbicide resistance of an agriculturally important crop could
theoretically "leak" to surrounding less desirable and damaging
plants, e.g., through pollen, mechanical or insect dispersal. This
phenomenon could create a novel species of"super-weed" which
could wreak havoc on the agricultural industry. Existing RNA
virus-based vectors can spread to non-target plants by
mechanical means and/or by insects. Such spread can be
prevented by using vectors that can replicate and/or move only
in target plants expressing the appropriate trans-acting factors.
(Spec. 1, 1. 28-2, 1. 7.) "Accordingly, there remains a need for less
expensive and more efficient methods of transformation of target cells and
tissues. Moreover, there is a need for a novel method of transformation
which alleviates the potential dangers associated with the unwanted spread
of engineered traits into the environment." (Spec. 2, 11. 8-11.)
Claims on Appeal
Claims 8, 13, 15, 17, 18, 20, 22, 24--26, 29, and 31--40 are on appeal.
(APPENDIX, Appeal Br. 11-16.) Claim 8 is illustrative and reads as
follows ( emphases added):
8. A method of genotypically or phenotypically modifying one
or more plant cells, said plant cell or cells having been rendered
transgenic by stably comprising heterologous DNA encoding a
trans-acting viral replication element that is incapable of self
replication, said method comprising the following steps:
a) obtaining a DNA transfection vector comprising:
1) a polynucleotide molecule encoding a viral RNA
molecule that has been modified to be incapable of self
replication, but which replicates when expressed in a plant cell
in the presence of a viral trans-acting element necessary for
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Application 11/621,850
replication of the RNA, said viral RNA molecule also having
been modified to include an exogenous RNA segment,
2) a DNA-dependent RNA polymerase promoter located
at the 5' end region of the polynucleotide molecule encoding the
viral RNA molecule, and
3) a nucleotide sequence located at the 3' end region of the
polynucleotide molecule encoding the viral RNA molecule,
wherein the nucleotide sequence is selected from one of the
following:
i) a nucleotide sequence encoding a ribozyme, wherein the
ribozyme cleaves at the 3' end of the polynucleotide molecule
encoding the viral RNA molecule,
ii) a transcription termination sequence, and
iii) a restriction site that directs cleavage at the 3' end of
the polynucleotide molecule encoding the viral RNA molecule;
and
b) transfecting said one or more cells with said DNA
transfection vector, wherein said polynucleotide molecule is
transcribed thereby forming a replicatable RNA transcript that
does not self replicate but is replicatable in the presence of said
trans-acting viral replication element, wherein expression of said
RNA transcript confers a genotype or phenotype modification in
said one or more plant cells, wherein said trans-acting viral
replication element and said viral RNA molecule are derived
from the same virus, and wherein said DNA transfection vector
remains separate from the genome of the plant cell or cells.
Examiner's Rejection
Claims 8, 13, 15, 17, 18, 20, 22, 24--26, 29, and 31--40 stand rejected
under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Van Haute2 and
2 Van Haute et al., US 6,093,554, issued July 25, 2000 ("Van Haute").
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Application 11/621,850
Turpen. 3 (Final Act. 3-7.)4
DISCUSSION
Issue
Whether a preponderance of evidence of record supports the
Examiner's rejection under 35 U.S.C. § I03(a).
Analysis
Claims 8 and 20 are the only independent claims on appeal. Claim 20
also recites limitations substantially the same as those italicized above in
claim 8; namely, that both the viral replication element and viral RNA
molecule are incapable of self-replication, and that the DNA transfection
vector remains separate from the genome of the plant cells. (Appeal Br. 11-
13.)
The Examiner relies on claim 1 of Van Haute as teaching a method of
inducible production in plants or plant cells of a non-viral sequence of
interest, in which recombinant DNA corresponding to a nucleotide sequence
encoding the non-viral sequence of interest is incorporated into the genome
of the plants or plant cells, and causing the presence of a viral RNA/RNA
polymerase to induce or amplify the expression of the non-viral sequence of
interest. (Final Act. 4--5, citing Van Haute claim 1 (col. 33, 11. 42---67).) The
Examiner relies on claim 4 of Van Haute as teaching that the viral RNA
polymerase can be incorporated into the genome. (Final Act. 5, citing
Van Haute claim 4 (col. 34, 11. 61-67).)
3 Turpen, US 2002/0104123 Al, published Aug. 1, 2002 ("Turpen").
4 Final Office Action dated June 3, 2015 ("Final Act."). A correct listing of
the claims on appeal is found at Final Act. 1 and Appeal Br. 1.
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Application 11/621,850
The Examiner also relies on Example II of Van Haute as teaching
cowpea leaves infected by the STNV-GUS plasmid together with helper
virus, in which the STNV-GUS plasmid is not incorporated into the genome.
(Final Act. 5, citing Van Haute col. 20, 11. 31--42.) Based on those teachings
of Van Haute, 5 the Examiner concludes that it would have been obvious
to produce a transgenic cowpea plant expressing the trans acting
viral replication factor such as RNA polymerase and to transfect
the STNV-GUS plasmid into the resulting transgenic plant. One
would have been motivated to do so given the teaching of
Van Haute [] that the viral RNA polymerase can also be
incorporate [ d] into the genome (claim 4).
(Final Act. 7.)
Appellants argue that Van Haute teaches away from the claimed
invention because it teaches incorporating the DNA or protein of interest
into the genome of the host. (Appeal Br. 4--7.) Appellants contend that
Example II of Van Haute is "[ t ]he only instance where Van Haute describes
expression of DNA encoding a protein of interest that has not been stably
transformed into the genome of the host cell," and that Example II
"describes a proof-of-concept experiment demonstrating that a plasmid-
based GUS gene could be expressed in Cowpea leaves infected with both
plasmid and a helper virus." (Id. at 5.) Appellants argue further that in
Example II
the helper virus is the source of the trans-acting viral replication
element and the helper virus is self-replicatable. This is contrary
to the claimed invention, in which the trans-acting viral
replication element must not be capable of self-replication.
5 Turpen is cited by the Examiner for teaching that the trans-acting viral
replication element and viral RNA molecule are derived from the same
virus, and also teaching a transcriptional termination region. (Final Act. 6.)
Neither teaching of Turpen is challenged by Appellants on appeal.
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Application 11/621,850
Further, the purpose of this experiment was merely to prove that
the plasmid constructs were functional so that they could then be
transformed into the genome of target tobacco plants, which was
done.
(Id.) As further support for this argument, Appellants point to Van Haute' s
teaching that "Example II illustrates how the invention can be used to
accomplish an inducible production of a type-foreign protein .... In
[Example II] the expression was induced by infecting the transformed
tobacco plants with TNV. (emphasis added)." (Id. at 5---6, quoting
Van Haute col. 9, 11. 36-42.) Thus, according to Appellants, "Van Haute,
taken as a whole, teaches that genes of interest should be incorporated into
the host's genome." (Id. at 6.)
The Examiner's responds by stating that one would have been
motivated to
produce a transgenic cowpea plant expressing the trans acting
viral replication factor such as RNA polymerase and to transfect
the STNV-GUS plasmid into the resulting transgenic plant[,] ...
given the teaching of Van Haute that the viral RNA polymerase
can also be incorporate into the genome to provide trans-acting
element required for replication. In another word, using a helper
virus or transgene to provide trans-acting viral replication
element is merely a design choice, both of which were taught by
Van Haute.
(Ans. 5.)
It is well settled that "there must be some articulated reasoning with
some rational underpinning to support the legal conclusion of obviousness."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,418 (2007). We find this
lacking on the record before us. Although we do not agree with Appellants
that Van Haute teaches away from the claimed invention, we find that the
Examiner fails to persuasively set forth "a reason that would have prompted
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Application 11/621,850
a person of ordinary skill in the relevant field to combine the elements in the
way the claimed new invention does." Id.
Here, the Examiner's rejection is based on the proposed modification
of Van Haute' s description of the testing of expression in plants by plasmid
infections of cowpea with various STNV-GUS constructions. In particular,
the Examiner proposes use of RNA polymerase incorporated in the genome
rather than the self-replicatable helper virus because "the viral RNA
polymerase can ... be incorporate[d] into the genome;" in other words,
"using a helper virus or transgene to provide trans-acting viral replication
element is merely a design choice, both of which were taught by
Van Haute." (Ans. 5.)
It is well settled that "obviousness concerns whether a skilled artisan
not only could have made but would have been motivated to make the
combinations or modifications of prior art to arrive at the claimed
invention." Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir.
2015); see also In re Gordon, 733 F.2d 900, 902 (Fed. Cir. 1984) ("The
mere fact that the prior art could be so modified would not have made the
modification obvious unless the prior art suggested the desirability of the
modification." ( citing cases)).
In this case, saying that viral RNA polymerase can be incorporated
into the genome, or that it is "merely a design choice" to use a helper virus
or transgene to provide trans-acting viral replication element, does not
establish a persuasive reason or desirability to use a transgene rather than a
helper virus in the cowpea testing described by Van Haute. The absence of a
sufficient reason to modify the cowpea testing protocol of Van Haute is
particularly acute here where the Examiner relies on claim 4 of Van Haute in
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Application 11/621,850
which the recombinant DNA, corresponding to a nucleotide sequence
encoding the non-viral sequence of interest, is incorporated into the genome
based on the dependence of claim 4 on claim 1. Simply put, we find no
suggestion in the art of record to combine the use of an expressible sequence
encoding an RNA polymerase (incorporated into the genome) with the
cowpea plasmids described by Van Haute.
Accordingly, because the Examiner has failed to present a prima facie
case of obviousness, the rejection of independent claims 8 and 20 is
reversed. Dependent claims 13, 15, 17, 18, 22, 24--26, 29, and 31--40 stand
with claims 8 and 20. See In re Fine, 837 F.2d 1071, 1076 (Fed. Cir. 1988).
Conclusion of Law
A preponderance of evidence of record fails to support the Examiner's
rejection of claims 8, 13, 15, 17, 18, 20, 22, 24--26, 29, and 31--40 for
obviousness.
SUMMARY
We reverse the rejection of all claims on appeal.
REVERSED
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