Ex Parte Tissot et al

Patent Trial and Appeal Board

Jan 24, 2017

10538130 (P.T.A.B. Jan. 24, 2017)

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
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
10/538,130 06/29/2006 Ghislaine Tissot 037759.00016 1355
4372 7590 01/26/2017
ARENT FOX LLP
1717 K Street, NW
WASHINGTON, DC 20006-5344
EXAMINER
KUBELIK, ANNE R
ART UNIT PAPER NUMBER
1662
NOTIFICATION DATE DELIVERY MODE
01/26/2017 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
following e-mail address(es):
patentdocket @ arentfox. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GHISLAINE TISSOT, NATHALIE DUFOURMANTEL,
FREDERIC GARCON, JEAN-MARC FERULLO,
and BERNARD PELISSIER1
Appeal 2015-006391
Application 10/538,130
Technology Center 1600
Before TAWEN CHANG, TIMOTHY G. MAJORS,
and RACHEL H. TOWNSEND, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to
genetically transformed plants and methods of obtaining the same, which
have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Appellants’ “invention relates to the transformation of plastids from
plants, and more precisely to the production of fertile transplastomic
1 Appellants identify the Real Party in Interest as Bayer S.A.S. (Br. 2.)
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Application 10/538,130
leguminous plants, in particular of fertile transplastomic soybean.” (Spec.
1:3—5.) According to the Specification, “[i]n plants, the genetic information
is distributed in three cell compartments: the nucleus, the mitochondria and
the plastids. . . . The plastid genome, or plastome, of higher plants consists
of a double-stranded circular DNA molecule of 120-160 kilobases, carrying
a large repeated and inverted sequence.” {Id. at 1:8—19.)
Claims 1, 5—7, and 11—15 are on appeal. Claims 1 and 7 are
illustrative:
1. A fertile transplastomic soybean plant characterized in that
it comprises at least one expression cassette inserted into the
plastome intergenic region located between the TmV gene and
the rps 12/7 operon.
7. A transformation vector suitable for soybean plant plastid
transformation, characterized in that it comprises at least two
sequences homologous with a zone of the soybean plastome, said
homologous sequences bordering at least one expression
cassette, and wherein one of the two homologous sequences
comprises the genes encoding 16S ribosomal RNA (16SrRNA)
and the Valine transfer RNA (TmV), and the other homologous
sequence comprises the intergenic region located between the
TmV gene and the rps 12/7 operon.
(Br. 15 (Claims App’x).)
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Application 10/538,130
The claims stand rejected as follows:
I. Claims 7 and 11—13 under 35 U.S.C. § 103(a) over Maliga2 and
von Allmen3 (“Rejection I”).
II. Claims 1, 5—6, and 14—15 under 35 U.S.C. § 103(a) over
Maliga, von Allmen, and Santarem4 (“Rejection II”).
REJECTION I
Issue
Has the Examiner established by a preponderance of the evidence that
claims 7 and 11—13 would have been obvious over Maliga and von Allmen?
Findings of Fact (FF)
The Examiner’s findings of fact and statement of Rejection I may be
found at pages 2—6 of the Final Action dated March 6, 2014. (See also Ans.
2—3; see also 9/15/14 Adv. Act. 2.) We adopt the Examiner’s findings
concerning the scope and content of the prior art and provide the following
for emphasis.
FF 1. Maliga teaches DNA constructs for transforming plastids of
multicellular plants. (Maliga Abstract.)
FF 2. Maliga teaches
[tjargeted insertion of foreign genes into the plastid genome is []
obtained by flanking the heterologous sequence with
homologous plastid DNA segments. This homologous plastid
2 Maliga et al., US 5,977,402, issued Mar. 2, 1999.
3 von Allmen, GenBank Accession No. X07675 (1992).
4 Santarem, Transformation Of Soybean [Glycine Max (L.) Merrill] Using
Proliferative Embryonic Tissue Maintained On Semi-Solid Medium, 35 In
Vitro Cell. Dev. Biol.-Plant 451^455 (1999).
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DNA is referred to as a targeting segment (or targeting fragment)
because it directs the insertion of the foreign DNA to a particular
location in the plastid genome.
(Mat 21:31-37.)
FF 3. Maliga teaches “[o]ne example of a suitable site for insertion of
foreign genes in the inverted repeat region is between the tmV and 16S
rDNA genes” and “[ajnother example of a suitable insertion site ... is
between the tmV gene and the adjacent operon on the other side, rps 12/7.
Insertion of an expression cassette containing the aadA coding region into
this site is described in Example 6.” {Id. at 22:20-31; see also id. at 51:58
through 57:40 (Example 6) and Fig. 17C.) Maliga teaches “[t]he
aforementioned tmV-rps7/12 insertion site is particularly useful. . . because
the transforming DNA is transcribed without detectable read-through
transcription when oriented toward the rps 12/7 operon (see Example 6).)
{Id. at 22:37-41.)
FF 4. Maliga teaches “[gjiven that the plastid genome of higher
plants is highly conserved . . . , the vectors are likely to find applications in a
large number of species.” {Id. at 57:36-40; see also id. at 16:46—50
(“Although tobacco is exemplified, it will be appreciated by those skilled in
the art that the DNA constructs and methods . . . can easily be applied or
adapted to other types of plastids, as well as other plant species.”); see also
id. at 17:35—39 (“The availability of gene mapping information for plastid
genomes of many species facilitates the choice of suitable insertion sites, as
does the strong conservation among plastid genomes across species.”); see
also id. at 28:58—62 and 29:11—15 (“DNA constructs of the invention may
be widely applied for improvement of crop plants (dicotyledonous or
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monocotyledonous) or plants having horticultural or environmental
value.”)-)
FF 5. von Allmen teaches the sequence of soybean plastid DNA for
16s rRNA, tRNA-Val (TmV), rpsl2, and rps7. (von Allmen passim; Ans. 3;
Br. 6.)
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “[W]hen the
question is whether a patent claiming the combination of elements of prior
art is obvious,” the answer depends on “whether the improvement is more
than the predictable use of prior art elements according to their established
functions.” Id. at 417.
Analysis
Appellants argue the patentability of claims 7 and 11—13 as a group.
We select claim 7 as representative. 37 C.F.R. § 41.37(c)(l)(iv).
The Examiner finds claim 7 is “drawn to a plastid transformation
vector comprising expression cassettes flanked by soybean plastid sequences
from a region encoding the [16S] rRNA, tmV and rpsl2[/7 operon].” (Ans.
2.) According to the Examiner, “Maliga [] teach[es] a method of tobacco
plastid transformation by particle bombardment using a vector comprising
expression cassettes comprising the aadA selection marker and a gene of
interest. . ., wherein the expression cassettes are flanked by tobacco plastid
sequences from a region encoding the 16S rRNA, tmV and rps 12/7.” (Id.)
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The Examiner finds “Maliga [] do[es] not disclose a soybean plastid
transformation vector” having at least one expression cassette “flanked by
soybean plastid sequences from a region encoding the 16S rRNA, tmV and
rps 12[/7].” (Id.) The Examiner thus turns to von Allmen, which the
Examiner finds teaches the sequence of the portion of the soybean plastid
genome that encodes 16S rRNA, tmV and rps 12 and rps 7. (Id. at 3.)
The Examiner concludes “it would have been obvious ... to modify
the plastid transformation vector taught by Maliga [] to replace the tobacco
flanking regions with the corresponding ones from soybean plastid as
described in von Allmen.” (Id.) The Examiner reasons the skilled artisan
would have made this modification “because plastid transformation works
by homologous recombination” as taught by Maliga and the skilled person
“would know that the higher the homology between the targeting segment
and the target, the higher the probability of transformation.” (Id.) Also,
according to the Examiner, the skilled artisan “would use targeting
sequences based on the sequence taught by von Allmen because it
corresponds to the region Maliga [] has shown works effectively in tobacco
and because the sequence for that region [was] readily available.” (Id.)
We agree with, and adopt, the Examiner’s findings of fact, reasoning,
and conclusion that claim 7 would have been obvious over Maliga and von
Allmen. Maliga teaches DNA constructs and methods of transforming
plastids of multicellular plants. (FF 1—2.) Maliga further teaches an
expression cassette flanked by homologous sequences comprising the
intergenic regions encoding 16S rRNA and TmV and the rps 12/7 operon.
(FF 2—3.) Indeed, Maliga discloses that the “tmV-rps7/12 insertion site is
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particularly useful” for constructing a transformation vector. (FF 3.) von
Allmen teaches the sequences for 16S rRNA, tmV, and the rps 12/7 operon
in soybean. (FF 5.) Although Maliga exemplifies transformation in
tobacco, Maliga expressly teaches the vectors may be applied to other plant
species. (FF 4.) Accordingly, we agree the skilled artisan would have
predictably, and with a reasonable expectation of success, modified Maliga’s
constructs, using homologous flanking sequences of soybean that correspond
to the plastid insertion site that worked well in tobacco.
We address below the Appellants’ arguments.
Appellants argue “there was no reasonable expectation that persons
skilled in the art would obtain vectors targeting the intergenic region
between the TmV gene and the rps 12/7 operon suitable for transforming
plastids by substituting soybean plastid sequences disclosed by von Allmen,
for the tobacco plastid sequences of Maliga.” (Br. 6—7.)
This argument is unpersuasive. As discussed above, the combination
of Maliga and von Allmen teach the transformation vector of claim 7,
Maliga’s teachings are not limited to tobacco, and Maliga broadly suggests
application to other species, including other crop plants. Pfizer, Inc. v.
Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007) (“[T]he expectation of
success need only be reasonable, not absolute.”).
Appellants contend “[i]t was no simple matter for the inventors to
extrapolate from tobacco to soybean. The inventors had to overcome
problems encountered with published methods ... as well as incorrect
sequences reported for the soybean plastid genome.” {Id. at 7.) Appellants
have not, however, established by persuasive argument or evidence that the
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problems overcome are more than obvious modifications that the skilled
person would have undertaken based on the express teachings and
suggestions of the art. As the Examiner noted, Appellants have “not
explained why sequencing the region [to correct for mismatches from
reported sequences] was [] more than routine experimentation.” (Ans. 8; see
also id. at 5.)
In support of their contentions, Appellants also cite Life Technologies,
Inc. v. Clontech Labs, Inc., 224 F.3d 1320, 1326 (Fed. Cir. 2000). (Br. 10.)
But, as stated in that case, “[t]he path that leads an inventor to the invention
is expressly made irrelevant to patentability by statute.” Life Tech., 224 F.
3d at 1325. As discussed above, the skilled artisan would have predictably
modified Maliga with a reasonable expectation of success based on the
teachings of the cited art. Appellants have not shown the inventors’ work in
overcoming “problems” — especially to the extent the “problems” and work
is allegedly evidenced in publications like Dufourmantel5 that post-date the
putative priority date of the appealed claims — is relevant to the perspective
and expectation of the skilled artisan at the time of the invention. (Br. 7—
10.)
Appellants also argue there was no reasonable expectation of success
in combining Maliga and von Allmen to arrive at the vector of claim 7
5 Dufourmantel, et al., Generation of fertile transplastomic soybean, 55
Plant Molecular Biology 479-89 (2004). The Amendment to the
Specification dated June 6, 2005 indicates that the “application is a national
stage application . . . of PCT/EP2003/015007 filed December 8, 2003 which
claims benefit to French application 02/15490 filed December 6, 2002.
Applicants claim the benefit of the December 8, 2003 filing date.”
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because other vectors and insertion sites were known. (Br. 7—8.) Appellants
contend “the intergenic region between the TmV gene and the rps 12/7
operon[] was not the only successful site used in other plants at the time of
the invention.” (Br. 7 (citing Dufourmantel).) According to Appellants,
“[t]he site most often reported in the literature was not the tmV-rpsl2/7 site,
but the tml-tmA and the rbc-accD sites.” (Id. (citing Daniell6).) Appellants
contend, however, that “[a]s discussed in Dufourmantel [], the rbcL-accD
site . . . could not be used due to differences in the organization of the
tobacco and soybean plastid genomes.” (Id.) Appellants contend that
Daniell ’3917 “suggested that a single ‘universal’ vector with a unique
homologous recombination sequence [at the 16S-23S spacer region] could
be used in all species.” (Id.) But, according to Appellants, based on
“reports in the scientific literature ... it was unlikely that the universal
vector [of Daniell ’391] would be capable of transforming soybean plants.”
(Id. at 8 (citing Daniell and Verma8).)
These arguments are unpersuasive. First, the existence of other
potential vectors and insertion cites does not detract from the fact that an
insertion site between TmV and the rps 12/7 operon is disclosed by Maliga
as “particularly useful,” giving rise to the obviousness of its selection to one
of ordinary skill in the art. (FF 3.) Merck & Co., Inc. v. Biocraft Labs., Inc.,
6 Daniell et al., Breakthrough in chloroplast genetic engineering of
agronomically important crops, 23 Trends in Biotechnology 5 238-45
(2005).
7 Daniell, US 7,129,391 Bl, issued Oct. 31, 2006.
8 Verma et al., Chloroplast Vector Systems for Biotechnology Applications,
45 Plant Physiology 1129-1143 (2007).
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874 F.2d 804, 807 (Fed. Cir. 1989) (“[D]isclos[ing] a multitude of effective
combinations does not render any particular formulation less obvious.”); In
re Mouttet, 686 F.3d 1322, 1334 (Fed. Cir. 2012) (“[J]ust because better
alternatives exist in the prior art does not mean that an inferior combination
is inapt for obviousness purposes.”). Second, inasmuch as Appellants
contend the other vectors or insertion sites did not work (or work well) for
soybean transformation, that does not teach away from the claimed vector
and insertion site because the results with other vectors or insertion sites do
not teach that the claimed vector and insertion site would behave similarly.
In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Third, Appellants’
evidence (i.e., Dufourmantel, Daniell, and Verma)9 was published after the
asserted priority date of the pending claims (see supra n. 5), and thus does
not persuasively demonstrate what the person of ordinary skill in the art
would have known or reasonably expected at the time of invention.
Conclusion of Law
For the above reasons, we conclude the Examiner established by a
preponderance of the evidence that claim 7 would have been obvious over
Maliga and von Allmen. Claims 11—13 have not been argued separately and
therefore fall with claim 7.
9 Daniell ’391 lists “examples of higher plants which may be transformed
with the universal vector include[] ... oil crops such as canola and soybean;
solanaceous plants such as tobacco . . . .” {Id. at 15:59—65.)
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REJECTION II
The Examiner rejected claims 1, 5, 6, 14, and 15 as obvious over
Maliga and von Allmen, as applied to claim 7, and in further view of
Santarem. (Ans. 4.)
We adopt the Examiner’s findings of fact, reasoning, and conclusion
that claims 1, 5, 6, 14, and 15 would have been obvious. (Final Act. 6—7;
Ans. 4—5.)
Appellants argue the patentability of the claims subject to Rejection II
as a group. Appellants contend “[sjtep (a) of the method of claim 14 recites
a vector suitable for soybean plastid transformation, comprising the
components of the vector recited in claim 7.” (Br. 13.) As such, Appellants
reprise their arguments concerning Rejection I. Appellants also contend
“Santarem [] does not cure the deficiencies” of Maliga and von Allmen.
These arguments are unpersuasive because, as discussed above, Maliga and
von Allmen are not deficient in the manner suggested by Appellants.
Appellants argue “Santarem [] is concerned with nuclear
transformation rather than chloroplast transformation” and that Santarem
does not, therefore, disclose or suggest “plastid transformation vectors for
insertion of an expression cassette” in the same way as claimed. (Br. 13.)
As the Examiner points out, however, the rejection is based on the art’s
combined teachings, and the Examiner is relying on Maliga and von Allmen
for teaching the claimed vector and plastid transformation. (Ans. 9.)
Appellants’ argument is an unpersuasive attack on Santarem individually
without accounting for the teachings of Maliga and von Allmen. In re
Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (“Non-obviousness
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cannot be established by attacking references individually where the
rejection is based upon the teachings of a combination of references.”)
For the above reasons, we conclude the Examiner established by a
preponderance of the evidence that claims 1, 5, 6, 14, and 15 would have
been obvious over Maliga, von Allmen, and Santarem.
SUMMARY
We affirm the rejection of claims 7 and 11-13 under 35 U.S.C.
§ 103(a) over Maliga and von Allmen.
We affirm the rejection of claims 1, 5, 6, 14, and 15 under 35 U.S.C.
§ 103(a) over Maliga, von Allmen, and Santarem.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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