Ex Parte Sanz Molinero

Patent Trial and Appeal Board

Sep 26, 2016

10553656 (P.T.A.B. Sep. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
10/553,656 10/14/2005
123223 7590 09/28/2016
Drinker Biddle & Reath LLP (WM)
222 Delaware A venue, Ste. 1410
Wilmington, DE 19801-1621
FIRST NAMED INVENTOR
Ana Isabel Sanz Molinero
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.
074053-0038-US 5797
EXAMINER
BOGGS, RUSSELL T
ART UNIT PAPER NUMBER
1663
NOTIFICATION DATE DELIVERY MODE
09/28/2016 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):
IPDocketWM@dbr.com
penelope.mongelluzzo@dbr.com
DBRIPDocket@dbr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANA ISABEL SANZ MOLINERO
Appeal2015-003948
Application 10/553656 1
Technology Center 1600
Before ERIC B. GRIMES, RY ANH. FLAX and DAVID COTTA,
Administrative Patent Judges.
COTT A, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for improving seed yield in a plant. The Examiner rejected the claims on
appeal as obvious under 35 U.S.C. § 103(a).
We affirm.
1 According to Appellants, the real party in interest is CropDesign N.V.
App. Br. 1.
Appeal2015-003948
Application 10/553656
STATEMENT OF THE CASE
Claims 3 5-51 are on appeal. Claim 3 5 is illustrative and reads as
follows:
35. A method for increasing seed yield in a plant,
compnsmg
(a) transforming a plant cell with an expression
construct comprising a nucleic acid encoding a protein
comprising the amino acid sequence of SEQ ID NO: 2 or
an amino acid sequence having at least 95% sequence
identity to SEQ ID NO: 2;
(b) regenerating from the transformed plant cell a
transgenic plant; and
( c) selecting a plant having increased seed yield
relative to a plant of the same species lacking said
construct.
The following grounds of rejection by the Examiner are before us on
review:
Claims 35--49 under 35 U.S.C. § 103(a) as unpatentable over the
combination of Basel 2 and Zhou. 3
Claims 50 and 51under35 U.S.C. § 103(a) as unpatentable over the
combination of Basel, Zhou, and Broekaert. 4
FINDINGS OF FACT
1. Basel discloses:
This invention relates to novel methods of enhancing plant
growth. The enhanced plant growth is accomplished by
2 Basel et al., WO 98/36084 A2, published Aug. 20, 1998 ("Basel").
3 Zhou et al., Structure, Organization and Expression of the Metallothionein
Gene Family in Arabidopsis, 248 MOL. GEN. GENET. 318-328 (1995)
("Zhou").
4 Broekaert et al., WO 02/00894 A2, published Jan. 3, 2002 ("Broekaert").
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selecting a plant having a heterologous DNA construct
comprising at least one heterologous gene encoding for at
least one of carbonic anhydrase, calcium binding protein,
metal binding protein or biomineralization protein, and
any suitable promoter operatively located upstream of said
heterologous gene; and growing said plant in a growth
medium. The heterologous genes include animal,
mammalian, bacteria, yeast, plant and synthetic genes.
Basel p. 1, 11. 12-22.
2. Basel discloses: "plants and crops containing the growth
enhancing gene sequences of the present invention will show significant
increases in growth rates or in crop yields when compared under identical
growing conditions to the same plants or crops not containing these gene
sequences." Id. at p. 2, 11. 14--19.
3. Basel discloses that its inventors:
determined experimentally that the proteins that
increased the photosynthetic rate of plants the most were
calcium binding proteins, especially those from animal
sources, and metal binding proteins, especially the heavy
metal binding proteins such as metallothionein. Inserted
in various combinations, the calcium and metal binding
genes substantially improve growth rates or shorten the
time period required for crop maturity, thus increasing
yields.
Id. at p. 8, 1. 33 -p. 9, 1. 5.
4. Basel discloses:
The calcium binding proteins, the hydroxyapatite
nucleating protein and the metal binding proteins, along
with the carbonic anhydrase enzymes, are all believed to
increase the transport and incorporation rate of nutrients
and micronutrients, such as calcium, phosphorous and
other metals, to the sites of photosynthetic activity of
growing tissue. Although each of these genes can function
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individually, the increased growth rates are best expressed
when two or more of these gene sequences are inserted at
the same time.
Id. at p. 9, 1. 29-p. 10, 1. 2.
5. Basel discloses:
The present inventors have discovered that the metal
binding protein, metallothionein, enhances the growth
rates of a number of plants. This therefore indicates that
the class of metal binding proteins naturally occurring in
various animals offers an advantage in growth rates by
reducing the level of toxic cations in growing plant cells.
The metallothionein proteins, i.e., the alpha and beta
subunits, and synthetic genes can be identified by
homology to some of the metal binding protein examples
disclosed in Table 5. These are intended to be illustrative
of the types of metal binding proteins that can be used
with the subject invention. They are not, however,
intended to limit the invention in any manner.
Id. at p. 36, 1. 36-p. 37, 1. 12.
6. The Examiner finds, and Appellants do not dispute, that Zhou
discloses "a nucleic acid sequence encoding a Arabidopsis type 2
metallothionein protein (MT2a) that has 100% sequence identity to instant
SEQ ID N0:2." Ans. 5.
7. Broekaert discloses using a GOS2 constitutive promoter in
expressing a coding sequence of interest in a transgenic plant. Broekaert p.
21 (Table 1 ).
8. Egli5 discloses: "Crop growth rate (CGR) was measured
5 Egli et al., Crop Growth Rate and Seed per Unit Area in Soybean, 31 Crop
Sci. 439--442 (1991). The Examiner cited Egli as evidence that "increased
growth rate[] translates into improvement in seed yield" (Office Action
mailed July 16, 2013("Final Act."), pages 10-11).
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Application 10/553656
between growth stage RI and R5 as an estimate of net canopy
photosynthesis. Yield, seeds per m2, and SGR were also measured. Within
each genotype, there was a linear relationship between CGR and seeds per
m2 across treatments and years." Egli Abstract.
REJECTION OF CLAIMS 35--49 OVER THE COMBINATION OF
BASEL AND ZHOU
Appellants argue claims 35--49 together as a group. We designate
claim 3 5 as representative for claims 3 5--49.
The Examiner found that Basel taught that "the transgenic expression
of a metallothionein protein will result in a plant with increased growth
rate," Ans. 3, but did not teach the specific nucleic acid sequence recited in
claim 35. Id. at 4. The Examiner found that Zhou taught "a nucleic acid
sequence encoding a Arabidopsis type 2 metallothionein protein (MT2a) that
has 100% sequence identity to instant SEQ ID N0:2." Id. at 5. The
Examiner concluded, based on the combined teachings of Rasel and Zhou,
that it would have been obvious to transform a plant cell using the nucleic
acid sequence disclosed in Zhou. The Examiner explained:
Given the teachings of Basel et al. that the
transgenic expression of a metallothionein will []
improve the growth rate of a plant and concomitantly
increase the yield, it would have been prima facie
obvious to one of ordinary skill in the art at the time of
filing the instant application to obtain a plant gene known
in the art encoding a metallothionein and transform the
gene into a plant cell, then regenerate a plant from that
transformed cell. Basel et al. provides emphatic
teaching, suggestion and motivation to do so.
Given that Zhou et al. teach a limited number of
metallothionein genes in Arabidopsis, at the time the
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Id. at 5---6.
invention was made it would have been prima facie
obvious to use any individual one of them as a
metallothionein gene according to the teachings of Basel
et al.
Given that Basel et al. teach that overexpressing a
metallothionein protein in a plant improves growth rate
(see, e.g., p. 9) and Zhou et al. teach that the type 2
metallothionein protein MT2a is highly expressed in
tissues like leaf and inflorescence and also expressed in
siliques and in young plant roots (see, e.g., abstract), one
of ordinary skill in the art would have been motivated to
express the MT2a sequence of Zhou et al. in a transgenic
plant, including an economically important monocot, e.g.
rice, or dicot, e.g. soybean, to obtain a transgenic plant
with an improved growth rate with a reasonable
expectation of success.
We agree with the Examiner that it would have been obvious to
express the type 2 metallothionein ("MT") protein taught by Zhou in a
transgenic plant in order to provide a plant with an improved growth rate.
Appellants argue that "not only there are numerous species [of MT
genes] in plants, animals and microorganisms, each species might possess
more than one MT gene." App. Br. 8. Appellants contend that once one
takes into account the entire universe of possible MT genes, it would have
been non-obvious to select the particular MT gene disclosed in Zhou. We
are not persuaded. Basel broadly discloses that MT genes provide improved
growth in plants, including MT genes sourced from "animal, mammalian,
bacteria, yeast, plant and synthetic genes." FFI; see also, FF5. Basel thus
suggests that all types of MT genes would be expected have this effect. Id.
Given Basel's broad teaching that MT genes improve plant growth, we agree
with the Examiner:
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[I]t would have been prima facie obvious to one of
ordinary skill in the art to modify the method of making a
transgenic plant with increased growth rate as taught by
Basel et [al.] by substituting the coding sequence
encoding Basel et al. metallothionein protein with a
nucleic acid sequence encoding any functional
metallothionein protein, including a nucleotide sequence
encoding Zhou et al.' s type 2 metallothionein protein ...
Final Act. 5---6.
In their Reply Brief, Appellants argue for the first time that plants
transformed by certain MT genes do not exhibit improved plant growth, and
thus a person of ordinary skill in the art would not have expected
transformation with any MT gene to have resulted in the effect asserted in
Basel. 6 Reply Br. at 6; see also, id. at 4. To support this argument,
Appellants cite to data provided in connection with their December 22, 2008
response to the Examiner's June 20, 2008 Office action ("The December
22nd Response"), Yeargan,7 and Thomas. 8 Id. at 4 and 6. We will address
each of these new submissions in tum.
The December 22nd Response provides a table which Appellants
contend "show[s] comparative data using a type 1 (MTl) and type 3 (MT3)
metallothionein and show[ s] that an increase in seed yield (total weight of
seeds) would not be obtained with all metallothioneins." December 22nd
6 Although Appellants could have raised this argument in their opening
brief, we will consider it here as reasonably responsive to arguments raised
in the Examiner's Answer.
7 Yeargan et al., 1 TRANSGENIC RESEARCH 261-267 (1992) ("Yeargan").
8 Thomas et al., Yeast Metallothionein in Transgenic Tobacco Promotes
Copper Uptake from Contaminated Soils, 19 BIOTECHNOL. PROG. 273-280
(2003) ("Thomas"). Thomas was cited in Appellant's Information
Disclosure Statement submitted on April 8, 2008.
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Response at 7. The data provided, however, is devoid of any explanation as
to how that data was collected. We are not told, inter alia: what was used as
the source ofMTl and MT3 genes, what type of plants were grown, how
many plants were grown, the conditions under which the plants were grown,
or what was used as a control. Moreover, the data in the December 22nd
Response is presented in the form of attorney argument and is not
accompanied by any declaration or other supporting evidence. See,
Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989) ("Attorneys'
argument is no substitute for evidence."); In re Pearson, 494 F.2d 1399,
1405 (CCPA 1974). Accordingly, the data provided in the December 22nd
Response is not persuasive.
Appellants contend that Yeargan discloses that "tobacco plants
expressing a mouse metallothionein did not exhibit any significant different
[sic] in leaf dry weights as compared to control plants." Reply Br. 6.
Appellants, however, have not pointed to any submission of Yeargan during
prosecution. We are not persuaded by Yeargan, at least because it is not a
part of the record in this case.
Thomas discloses that "seed weights of selfed T3 generation CUP 1
plants were not significantly different than GUS controls (data not shown)."
Thomas 276. Appellants suggest that the teachings of Thomas would have
countered the expectation created by Basel that "any metallothionein,
regardless of its structural similarity to that used in Basel, would have
resulted in the same effect asserted in Basel." Reply Br. 6. We are not
persuaded. Thomas provides evidence that the third generation of tobacco
plants transformed by a yeast metallothionein gene does not demonstrate
improved seed weights. We find that this teaching is not sufficient to
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discredit the broad teachings of Basel, see FF 1-3 and 5, and that the person
of skill in the art would have reasonably expected that transformation with
Zhou's MT gene would result in improved plant growth, even after having
reviewed Thomas. See, In re Langi, 759 F.2d 887, 897 (Fed. Cir. 1985)
("Only a reasonable expectation of success, not absolute predictability, is
necessary for a conclusion of obviousness.")
Appellants argue that the low degree of sequence identity between the
MT2a gene disclosed in Zhou and those exemplified in Basel would have
discouraged the use of Zhou's MT2a gene, App. Br. 9, and prevented the
person of skill in the art from forming a "reasonable expectation that the
MT2a of Zhou would have had the same function and/or activity as the MT
used in Basel." Id. at 10. We disagree. We find that the disclosures of
Basel would have created in the person of ordinary skill in the art a
reasonable expectation that transformation with any MT gene would result
in improved plant growth, regardless of the degree of homology. See FF 1
and 5.
Appellants contend that Basel does not disclose "seed-related
phenotypes or seed yield-related traits" of its transformed plants and thus
that the "skilled artisan would not have had a reasonable expectation that
plants expressing the MT gene of Basel or the MT2a of Zhou might have
increased seed yield." App. Br. 10-11. Egli, however, provides evidence of
a known correlation between plant growth and seed yield. Egli discloses
that there is a "linear relationship between CGR [crop growth rate] and seeds
per m2" for soybeans. FF8. Basel expressly suggests using its method of
enhancing plant growth with soybeans (Basel 14:36 to 15:1).
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Appellants argue that the teachings of Egli are limited to the single
cultivar used in the analysis, a soybean. App. Br. at 11. In addition,
Appellants cite to He9 and Jeon 10 as evidencing instances where an increased
growth rate did not result in increased seed yield. Id. But, even accepting
Appellants' characterization of He and Jeon, 11 Egli shows that for at least
one species within the scope of the claim, the person of ordinary skill would
have expected increased growth to also result in increased seed yield. This
is sufficient to render the claims obvious. See, Ex parte Kubin, No. 2007-
0819, 83 USPQ2d 1410, 1414 (BPAI 2007) ("A single, obvious species
within a claimed genus renders the claimed genus unpatentable under
§ 103."); aff'd 561F.3d1351 (Fed. Cir. 2009).
In their Reply Brief, Appellants argue that "Basel does not teach or
suggest that transgenic expression of a Metallothionein gene alone in a plant
would lead to increased development rate and therefore increased yield."
Reply Br. 2. We disagree. Basel discloses that metallothionein genes can
function alone. See FF4 ("Although each of these genes can function
individually, the increased growth rates are best expressed when two or
more of these gene sequences are inserted at the same time.").
9 He et al., Transformation of Rice with Arabidopsis Floral Regulator
LEAFY Causes Early Heading, 9 TRANSGENIC RESEARCH 223-227 (2000)
("He").
10 Jeon et al., Production of Transgenic Rice Plants Showing Reduced
Heading Date and Plant Height by Ectopic Expression of Rice MADS-box
Genes, 6 MOLECULAR BREEDING 581-592 (2000) ("Jeon").
11 Contrary to Appellants' assertions, the Examiner found that He and Jeon
both taught that the tallest, fastest growing plants also exhibited the highest
seed yield. Ans. 14--15.
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In sum, for the reasons discussed herein, and those provided by the
Examiner, we affirm the Examiner's rejection of claim 35 as unpatentable
over Basel and Zhou. Because they were not argued separately, claims 3 6-
49 fall with claim 35.
REJECTION OF CLAIMS 50 AND 51 OVER THE COMBINATION OF
BASEL, ZHOU AND BROEKAERT
Appellants argue claims 50 and 51 together as a group. We designate
claim 50 as representative for claims 50 and 51.
Claim 50 requires the use of a "GOS2 promoter" in connection with
the MT gene. The Examiner found that the combination of Basel and Zhou
did not disclose the GOS2 promoter recited in claim 50, but determined that
it would have been obvious to use the GOS2 promoter disclosed in
Broekaert. The Examiner explained:
Ans. at 9.
One of skill in the art would have been motivated to
express a transgene using any strong constitutive
promoter known in the prior art, including Broekaert et
al. 's GOS2 constitutive promoter, and thus obtain a
transgenic plant overexpressing Zhou et al. 's MT2a
protein with a reasonable expectation of success and
without any unexpected results.
Appellants argue that claim 50 is non-obvious for the same reasons
that claims 35--49 are non-obvious. App. Br. 12-13. For the reasons
discussed with respect to claims 35--49, Appellants' arguments do not
persuade us that a preponderance of the evidence fails to support the
obviousness of claim 50 over Basel, Zhou and Broekaert. Because it was
not argued separately, claim 51 falls with claim 50.
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survnvIARY
For these reasons and those set forth in the Examiner's Answer, the
Examiner's final decision to reject claims 35-51 is affirmed.
No time period for taking any subsequent action in connection with
this appeal maybe extended under 37 C.F.R. § 1.136(a)(l).
AFFIRMED
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