Ex Parte 7943818 et al

Patent Trial and Appeal Board

Mar 9, 2018

95000690 (P.T.A.B. Mar. 9, 2018)

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
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
95/000,690 09/13/2012 7943818 MONS:316 6604
73905 7590 03/12/2018
DENTONS US LLP
P.O. BOX 061080
CHICAGO, IL 60606-1080
EXAMINER
CAMPELL, BRUCE R
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
03/12/2018 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 PATENT TRIAL AND APPEAL BOARD
____________

E.I. DU PONT DE NEMOURS AND COMPANY
Requester

v.

MONSANTO TECHNOLOGY LLC1
Patent Owner and Appellant
____________

Appeal 2017-011222
Reexamination Control 95/000,690
Patent 7,943,818 B2
Technology Center 3900
____________

Before MARK NAGUMO, RICHARD M. LEBOVITZ, and
RAE LYNN P. GUEST, Administrative Patent Judges.

GUEST, Administrative Patent Judge.

DECISION ON APPEAL

1 Patent Owner, Monsanto Technology LLC (hereinafter “Patent Owner”),
identifies the real party in interest as the Monsanto Company, as the parent
company of assignee Monsanto Technology LLC. See Patent Owner’s
Appeal Brief 1, filed May 31, 2016 (hereinafter “PO App. Br.”).
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Patent Owner appeals the Patent Examiner’s decision to reject
pending claims in an inter partes reexamination of U.S. Patent 7,943,818 B2
(hereinafter, “the ’818 Patent”), which issued May 17, 2011. The Board’s
jurisdiction for this appeal is under 35 U.S.C. §§ 6(b), 134, and 315. We
REVERSE AND ENTER A NEW GROUND OF REJECTION.

I. BACKGROUND
A request for inter partes reexamination under 35 U.S.C. §§ 311-318
and 37 C.F.R. §§ 1.902-1.997 for the ’818 Patent was filed September 13,
2012 by a Third-Party Requester, E.I. du Pont de Nemours and Company
(hereinafter “Requester”). See Request for Inter Partes Reexamination.
The ’818 patent is a division of US 7,790,953 B2 (“the ’953 patent”),
which is the subject of Reexamination 95/002,028, in which the Board
issued a decision on appeal on August 10, 2016. The Federal Circuit
affirmed the Board’s Decision on January 5, 2018. Monsanto Tech. LLC v.
E.I. Dupont de Nemours & Co., 878 F.3d 1336 (Fed. Cir. 2018).
This ’818 patent includes claims with subject matter similar to
Reexamination 95/002,309 of US 8,057,835 B2 (“the ’835 Patent”), for
which a Reexamination Certificate issued on August 17, 2015, cancelling all
the claims of the ’835 Patent.
The ’818 Patent describes “methods of making soybean plants that
produce soybean seed with altered oil compositions and, more particularly,
to methods where soybean seed with a mid oleic, low linolenic phenotype or
soybean seed with a mid oleic, low saturate, low linolenic phenotype.” ’818
Patent, col. 1, ll. 33-38. Claims 1-3, 5-11, 16-19, 21-31, 33-35, 37-39, 44-
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47, and 49-59 of the ’818 Patent and new claims 61, 62, 65-69, and 73-77
are pending and stand rejected.2 Independent claim 1 is representative and
reads as follows (with brackets showing deleted material and underlining
showing added material over the claims in the originally issued ’818 Patent):
1. A method of producing a soybean plant
comprising a linolenic acid content of less than [about 6%] 3%
of total seed fatty acids by weight and an oleic acid content of
[about] 55% to [about] 80% of total seed fatty acids by weight,
comprising the steps of:
a) making one or more soybean plants that comprise a
transgene that decreases the expression of an endogenous
soybean FAD2-1 gene and at least one loss-of-function
mutation in an endogenous soybean FAD3 gene;
b) obtaining at least one seed from said soybean plant
obtained in step (a);
c) determining a percentage of the total seed fatty acid
content by weight of linolenic acid and oleic acid for said seed
of step (b); [and]
d) [identifying] selecting a soybean plant homozygous
for the transgene that decreases the expression of the
endogenous soybean FAD2-1 gene and the at least one loss-of-
function mutation in the endogenous soybean FAD3 gene and
that yields seed having a seed fatty acid composition
comprising a linolenic acid content of less than [about 6%] 3%
of total seed fatty acids by weight and an oleic acid content of
[about] 55% to [about] 80% of total seed fatty acids by weight;
and

2 Original claims 12-15, 20, 40-43, and 48 of the ’818 patent were not
subject to reexamination and original or newly added claims 4, 32, 36, 60,
63, 64, and 70-72 of the ’818 patent have been cancelled. See Examiner’s
Right of Appeal Notice 2, mailed February 29, 2016 (hereinafter “RAN”).
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e) selfing the selected soybean plant in step (d) to
produce a further soybean plant homozygous for the transgene
that decreases the expression of the endogenous soybean
FAD2-1 gene and the at least one loss-of-function mutation in
the endogenous soybean FAD3 gene and that produces seed
comprising a linolenic acid content of less than 3% of total seed
fatty acids by weight and an oleic acid content of 55% to 80%
of total seed fatty acids by weight.
PO App. Br. 30, Claim App’x. Separately rejected remaining independent
claim 33 differs from claim 1 in that the soybean plant made in step a)
comprises “at least one transgene that decreases the expression of both an
endogenous soybean FAD2- l and an endogenous FATB gene, and at least
one loss-of-function mutation in an endogenous soybean FAD3 gene.” Id. at
34. In other words, claim 33 requires selecting and selfing3 triple
homozygous soybean plants. Claim 33 also requires that the selected and
selfed plant further have seeds with a saturated fatty acid content of less than
8% by weight. Id.
Claim 2 depends from claim 1 and is representative of a different
group of claims which specifically requires “at least two loss of function
mutations in at least two endogenous soybean FAD3 genes.” Id. at 31. The
Specification indicates that there are at least three endogenous FAD3 genes,
FAD3-1A, FAD3-1B and FAD-3-1C at different loci. ’818 patent, col. 4, ll.
13–17; col. 9, ll. 40-54; col. 31, ll. 37-50, Col. 35-36, Table 2, col. 45, ll. 9-
12, Example 8.

3 The verb “self” in this case refers to self-pollinating of a plant. In other
words, a plant is reproduced using only its own genetic material. See e.g.,
’818 patent, col. 23, ll. 11-36.
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The Examiner maintains the following rejection on appeal:
1. Claims 1, 25, 27, 30, 31, 65-69 and 73-77 are rejected under 35
U.S.C. 102(b) as being anticipated by Booth,4 as evidenced by the First
Kinney Declaration,5 the Second Kinney Declaration,6 the Third Kinney
Declaration,7 and the Fourth Kinney Declaration,8 submitted by Requester
(collectively referred to herein as the “Kinney Declarations”). RAN 6.
2. Claims 1, 2, 5, 6, 24, 25, 27, 30, 31, 65-69, and 73-77 stand rejected under
35 U.S.C. § 103(a) as unpatentable over Booth. RAN 8.
3. Claims 2, 6, and 8-11 are rejected under 35 U.S.C. 103(a) as being
unpatentable over Booth in view of Bilyeu 2003.9 RAN 10.
4. Claims 16-19, 24 and 28 are rejected under 35 U.S.C. 103(a) as being
unpatentable over Booth in view of Steiger.10 RAN 10.

4 US 6,426,448 B1, issued July 30, 2002 to John Russel Booth, Jr. et al.
5 Declaration of Dr. Anthony John Kinney, dated June 15, 2012 (“First
Kinney Decl.”).
6 Second Declaration of Dr. Anthony John Kinney, dated September 11,
2012 (“Second Kinney Decl.”).
7 Third Declaration of Dr. Anthony John Kinney, dated October 11, 2013
(“Third Kinney Decl.”).
8 Fourth Declaration of Dr. Anthony John Kinney, dated March 6, 2013
(“Fourth Kinney Decl.”).
9 K.D. Bilyeu et al., “Three Microsomal Omega-3 Fatty-acid Desaturase
Genes Contribute to Soybean Linolenic Acid Levels,” Crop Sci., 43:1833-
1838 (2003) (“Bilyeu 2003”).
10 US 6,791,016 B1, issued September 14, 2004, to Debra Kay Steiger et al.
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5. Claim 26 is rejected under 35 U.S.C. 103(a) as being unpatentable over
Booth in view of Christie,11 Ackman,12 Hermansson,13 Lee14 and Cahoon.15
RAN 11.
6. Claim 29 is rejected under 35 U.S.C. 103(a) as being unpatentable over
Booth in view of Steiger and Sebastian.16 RAN 12.
7. Claims 33, 37, 52, 53, 55, 58 and 59 are rejected under 35 U.S.C. 103(a) as
being unpatentable over Booth in view of Clemente17 and Buhr.18 RAN 13.
8. Claims 34, 38 and 39 are rejected under 35 U.S.C. 103(a) as being
unpatentable over Booth in view of Bilyeu 2003, Clemente, and Buhr. RAN
15.
9. Claims 44-47, 52, 56, and 57 are rejected under 35 U.S.C. 103(a) as being
unpatentable over Booth in view of Steiger, Clemente, and Buhr. RAN 16.

11 Christie, W. W., Gas Chromatography and Lipids: A Practical Guide, The
Oily Press Ltd (1989).
12 Ackman, R. G., “Flame Ionization Detection Applied to Thin-Layer
Chromatography on Coated Quartz Rods,” Methods in Enzymology, Vol.
72, pp. 205-252 (1981).
13 M. Hermansson et al., “Automated Quantitative Analysis of Complex
Lipidomes by Liquid Chromatography/Mass Spectrometry,” Anal. Chem.,
Vol. 77, pp. 2166-2175 (2005).
14 S.H. Lee et al., “Targeted lipidomics using electron capture atmospheric
pressure chemical ionization. mass spectrometry,” Rapid Commun. In Mass
Spectrom., 17: 2168-2176 (2003).
15 US 6,593,514 B1, issued July 15, 2003 to Edgar Benjamin Cahoon et al.
16 US 7,973,212 B2, issued July 5, 2011 to Scott Sebastian, and claiming an
earliest filing date of August 1, 2003.
17 US 2002/0058340 A1, published May 16, 2002 and naming Thomas E.
Clemente et al. as inventors.
18 T. Buhr et al., “Ribozyme termination of RNA transcripts down-regulate
seed fatty acid genes in transgenic soybean,” The Plant Journal, 30(2):155-
163 (2002).
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10. Claim 54 is rejected under 35 U.S.C. 103(a) as being unpatentable over
Booth in view of Christie, Ackman, Hermansson, Lee, Cahoon, Clemente
and Buhr. RAN 17.
11. Claims 1-3, 5-7, 21, 24, 25, 27, 30, 31, 33-35, 37, 49, 52, 53, 55, 58, 59, 61,
62, 65-69 and 73-77 are rejected under 35 U.S.C. 103(a) as being
unpatentable over Booth in combination with Buhr and Fehr,19 as evidenced
by Bilyeu 2006.20 RAN 19.
12. Claims 8-11, 38 and 39 are rejected under 35 U.S.C. 103(a) as being
unpatentable over Booth in combination with Buhr and Fehr (as evidenced
by Bilyeu 2006) and further in view of Bilyeu 2003. RAN 23.
13. Claims 16-19, 22, 23, 28, 44-47, 50, 51 and 56 are rejected under 35 U.S.C.
103(a) as being unpatentable over Booth in combination with Buhr and Fehr
(as evidenced by Bilyeu 2006) and further in view of Steiger. RAN 24.
14. Claims 26 and 54 are rejected under 35 U.S.C. 103(a) as being unpatentable
over Booth in combination with Buhr and Fehr (as evidenced by Bilyeu
2006) and further in view of Christie, Ackman, Hermansson, Lee and
Cahoon. RAN 24-25.
15. Claims 29 and 57 are rejected under 35 U.S.C. 103(a) as being unpatentable
over Booth in combination with Buhr and Fehr (as evidenced by Bilyeu
2006) and further in view of Steiger and Sebastian. RAN 25-26.

19 US 6,133,509, issued October 17, 2000 to Walter R. Fehr et al.
20 K. D. Bilyeu et al., “Molecular Genetic Resources for Development of 1
% Linolenic Acid Soybeans,” Crop Sci. 46:1913-1918 (2006) (“Bilyeu
2006”).
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II. ANALYSIS
Claim Interpretation and Scope
Independent Claim 1
Claim 1 is drawn to a method of obtaining a soybean plant having a
particular soybean oil fatty acid composition that includes the steps of:
(a) making a soybean plant having (i) a transgene21 that decreases the
expression of an endogenous soybean FAD2-1 gene, and (ii) at least one
loss-of-function mutation22 in an endogenous soybean FAD3 gene,
(b) obtaining a seed from the plant,
(c) determining the total seed fatty acid content by weight of linolenic
acid and oleic acid for the seed,

21 The ’818 patent defines a “transgene” as “a nucleic acid sequence
associated with the expression of a gene introduced into an organism. A
transgene includes, but is not limited to, a gene endogenous or
a gene not naturally occurring in the organism.” ’818 patent, col. 14, ll. 4-7.
Accordingly, we understand the “transgene” in this case is a gene sequence
that has been introduced into the genome of a plant having the endogenous
soybean FAD2-1, in this case, to decrease its expression. The ’818 patent
provides an example in which an FAD2-1 intron is cloned into expression
cassettes and introduced into the soybean genome in such a way that the
transgene disrupts expression of the endogenous gene. Id. at col. 31, ll. 14–
35; col. 30, ll. 4-13.
22 The ’818 patent defines a “loss-of-function mutation” as “a mutation in
the coding sequence of a gene, which causes the function of the gene
product, usually a protein, to be either reduced or completely absent. A loss-
of-function mutation can, for instance, be caused by the truncation of the
gene product because of a frameshift or nonsense mutation. A phenotype
associated with an allele with a loss of function mutation can be either
recessive or dominant.” ’818 patent, col. 14, ll. 13-20.
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(d)-(e1) selecting and then selfing a soybean plant that both (1) has a
seed having a total fatty acid content with (i) a linolenic acid content of less
than 3% and (ii) an oleic acid content of 55% to 80% of total seed fatty acids
by weight and (2) is homozygous23 both (i.e., is double homozygous) for (i)
the transgene that decreases the expression of the endogenous soybean
FAD2-1 gene and (ii) the at least one loss-of-function mutation in the
endogenous soybean FAD3 gene, and
(e2) thereby producing a “selfed” soybean plant that is (1)
homozygous for (i) the transgene that decreases the expression of the
endogenous soybean FAD2-1 gene and (ii) the at least one loss-of-function
mutation in the endogenous soybean FAD3 gene, and (2) produces seeds
having the same linolenic acid and oleic acid content as the parent plant.
Unlike claim 2, discussed infra, claim 1 encompasses plants having
only one loss-of-function FAD3 gene mutation, yet also has the recited seed
fatty acid content.24 Unlike claim 33, discussed infra, claim 1 encompasses
plants which lack a transgene that also decrease expression of the
endogenous soybean FATB gene, yet also has the recited seed fatty acid
content.

23 We understand the term “homozygous” to mean that both genes at the
same gene locus are the same allele (form of the gene) for the given
hereditary characteristic (e.g., the decrease in the expression of the FAD2-1
gene).
24 We discuss in detail below why the full scope of claim 1 and claim 33,
including plants having only one loss-of-function mutation in the FAD3
gene, yet still having the recited seed fatty acid compositions, is not
adequately supported in the ’818 patent. Accordingly, when interpreting
claim 1, the fully scope must be understood.
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Selecting step (d) requires an affirmative step of selecting for selfing a
plant having both (i) the double homozygous genotype required by the
claims and (ii) seeds with the linolenic acid and oleic acid content phenotype
required by the claims.
In performing the transformations and crosses taught by the ’818
patent and encompassed by the claims, plants with a large natural variety of
genotypes and phenotypes will be produced. For example, claim 1 is not
restricted to a specific strain of soybean; it would be understand by one of
ordinary skill in the art that different soybean strains would differ
genomically, e.g., by having different polymorphisms and gene alleles. The
Examiner finds that
there is variation in the seed oil content of progeny plants. This
is to be expected as the relative content of fatty acids in the oil
depends on the relative expression levels of many different
genes, and sexual reproduction causes random variation. This
variability is inherent to plant breeding and would have been
expected by one skilled in the art.
RAN 9 (citing Fourth Kinney declaration, ¶¶ 12, 16). Consistent with the
Examiner’s findings that the fatty acid content of soy bean seeds depends on
many different genes and random variation occurs, it is not predictable that
all plants having the double-homozygous genotype recited in the claims
necessarily have the linolenic acid or oleic acid content phenotype recited in
the claims. Similarly, it is not predictable that plants having the linolenic
and oleic acid content phenotype recited in the claims necessarily have the
double-homozygous genotype recited in the claims. Accordingly, consistent
with these findings, meeting the “selecting” step (d) in this case would
require identifying that a selfed plant that has both the double-homozygous
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genotype and the seed oil fatty acid phenotype recited in the claim.
Identifying only that a plant is double homozygous or identifying only the
seed oil fatty acid content of a plant is insufficient evidence to confirm that
the “selected” step of the claim has been met, i.e., that a plant having both
criteria has been selected for selfing.
Patent Owner’s arguments supports this interpretation of the claims in
arguing that “Booth did not examine the genotype of the progeny plants at
all, and expressly selected plants phenotypically outside those recited in the
claims.” PO App. Br. 8.
Independent claim 33
Independent claim 33 is similar to independent claim 1, but is
narrower. It requires making, selecting and selfing a plant that (1) is
homozygous for each of (i.e. is triple-homozygous for) (i) a transgene that
decreases expression of both (a) an endogenous FAD2-1 and (b) an
endogenous FATB gene and (ii) at least one loss of function mutation in the
(c) FAD3 gene, and (2) the seed oil fatty acid phenotype of (i) a linolenic
acid content of less than 3% by weight, (ii) an oleic acid content of 55-80%
by weight, and (iii) a saturated fatty acid content of less than 8% by weight.
As with claim 1 above, claim 33 encompasses plants which are homozygous
for only one loss-of-function FAD3 gene mutation.
Claim 2
Claim 2, which depends from claim 1, is representative of several
claims on appeal that are narrower in that they require a plant having the
same seed fatty acid content but further having “at least two loss of function
mutations in at least two endogenous soybean FAD3 genes.” However, as
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with claim 1, claim 2 does not require a transgene that decreases expression
of the endogenous FATB gene.

Seed Fatty Acid Background
Soybean oil from the seeds of wild-type soybeans generally have an
oleic acid content of about 20%, a linolenic acid content of about 8%, and a
saturated fatty acid content of about 16-20%. ’818 patent, col. 1, ll. 50-51,
col. 2, ll. 47-51. See also, Booth, col. 6, l. 56, Table 2 (identifying a wild-
type soybean plant having seeds with 25% oleic acid (18:1), 7% linolenic
acid (18:3), and 16% saturated fatty acid content (16:0 +18:0)).25
FAD2-1 encodes the delta-12 desaturase enzyme. It was understood
at the time of the ’818 patent that the content of oleic acid can be increased
in a soybean line by decreasing expression of the FAD2-1 gene function,
which thereby decreases activity of delta-12 desaturase and the accumulation
of poly-unsaturated fatty acids (namely linoleic acid (18:2) and linolenic
acid (18:3)), in favor of steric acid (18:0) and oleic acid (18:1). Booth, col.
23, ll. 2-6; ’818 patent, col. 2, ll. 40-49. See also Clemente, ¶ 109; First
Kinney Decl. ¶¶ 42 and 44. Thus, suppressing the FAD2-1 gene was
known to increase the oleic acid content.

25 Booth refers to the fatty acids by the number of carbon atom and the
number of double bonds. Specifically, palmitic acid (16:0) has 16 carbon
bonds and no double bonds, i.e., it is a saturated fatty acid. Similarly, stearic
acid (18:0) has 18 carbon atoms and is a saturated fatty acid. Oleic acid
(18:1) has 18 carbon bonds and one double bond (i.e., it is as mono-
unsaturated fatty acid). Linoleic acid (18:2) and linolenic acid (18:3) have
18 carbon atoms and 2 and 3 double bonds, respectively, (i.e., they are poly-
unsaturated fatty acids).
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FAD3 encodes the delta-15 desaturase enzyme. Delta-15 desaturase
converts linoleic acid (18:2) to linolenic acid (18:3). ’818 patent, col. 38-39.
See also Bilyeu (2003) at 1833; First Kinney Decl. ¶ 47. Thus, suppressing
the FAD3 gene was known to decrease linolenic acid (18:3) content in
soybean plants.
FATB encodes a thioesterase enzyme. ’818 patent, col. 2, 12-33. The
thioesterases determine chain length of the fatty acids and were known to
affect the formation of saturated fatty acids and oleic acid. Id., See also
Clemente, ¶ 109; Second Kinney Decl. ¶¶ 43-44. Thus, suppressing of the
FATB gene was known to reduce the saturated fatty acid content of soybean
seeds.
While the functions of these genes were known at the time of the
invention, as explained below, the additive effects of suppressing more than
one of these genes and the resulting range of seed fatty acid content in doing
so were not known and have not be demonstrated to have been predictable at
the time of the invention.

New Grounds of Rejection under 35 U.S.C. § 112, first paragraph
The Examiner did not adopt the Requester rejection of the 1-3, 5-11,
16-19, 21-31, 33-35, 37-39, 44-59, 61, 62, 65-69 and 73-77 under 35 U.S.C.
§ 112, first paragraph, for lack of written descriptive support for the claims,
for failure to describe a method of making a soybean plant with only a single
loss of function mutation in a FAD3 gene. RAN 18. The arguments raised
by Patent Owner in this appeal required interpreting the claims and revisiting
the non-adopted rejection. In doing so, we disagree with the Examiner’s
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findings regarding the adequacy of the written descriptive support for the
claims. In particular, the Examiner’s analysis in not adopting the rejection is
based on (1) a description of prior art transgenic lines having the recited
FAD2-1 and FAD3 suppression, but having too high an oleic acid content
(col. 3, ll. 43-51), (2) a description of plants lines having the requisite seed
fatty acid content, irrespective of their genotypes (col. 6, ll. 16-38), (3) prior
art parent plant lines with a single loss of function mutation in the FAD3
gene and having less than 3% linolenic acid, none of which are described as
having a FAD2-1 transgene or the recited oleic acid contnet (col. 2, l. 58 to
col. 3, l. 4; col. 19, l. 5-19; col. 6, ll. 10-15) as required by the claims, or (4)
plants that have both the FAD2-1 transgene and a single loss of function
mutation in the FAD3 gene that are demonstrated as having only a linolenic
acid content of less than 6%, but not less than 3% (col. 3, l. 61 to col. 4, l.
12; see col. 6, ll. 39-59) as recited in claim 1. None of these bases is
sufficient to show that the Patent Owner had possession of a plant having
both genetic modifications of FAD2-1 and FAD3 and the recited seed fatty
acid content.
The preponderance of the evidence supports Requester’s position (see
Requester’s Comments 3-4, filed September 4, 2015; Requester’s Comments
1-3, filed December 18, 2015; Req. Res. Br. 5) that the ’818 patent fails to
describe a method of making a plant having (1) a FAD2-1 transgene, (2) a
single loss-of-function mutation in the FAD3 gene, and (3) having a seed
linolenic fatty acid content of less than 3%, and, thus, fails to describe or
enable the entire scope of claims 1 and 33. To support a rejection under the
written description requirement, the initial burden is met by pointing to the
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fact that the claim reads on embodiments outside the scope of the
description. In re Werthiem, 541 F.2d 257, 263-64 (CCPA 1976). “It is a
truism that a claim need not be limited to a preferred embodiment.
However, in a given case, the scope of the right to exclude may be limited
by a narrow disclosure.” Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d
1473, 1479 (Fed. Cir. 1998). This case is such where “unpredictability in
the particular field may warrant closer scrutiny of whether disclosure of a
species is sufficient to describe a genus.” Bilstad v. Wakalopulos, 386 F.3d
1116, 1125 (Fed. Cir. 2004) (citing In re Smythe, 480 F.2d 1376, 1383
(CCPA 1973) (“In other cases, particularly but not necessarily, chemical
cases, where there is unpredictability in performance of certain species or
subcombinations other than those specifically enumerated, one skilled in the
art may be found not to have been placed in possession of a genus or
combination claimed at a later date in the prosecution of a patent
application.”)(footnote omitted)). To the extent the inventor achieved fatty
acid content having less than 3% linolenic acid and 55-80% oleic acid only
with specific genetic modifications, the claims should be narrowed to reflect
the specific genetic modification. The claims in this case appear broader
than the particular genetic modifications described.
For written descriptive support for the claims, Patent Owner directs us
to the following portions of the Specification: '818 patent at 4:42-5:58; 7:20-
50; 8:18-39; 20:18-37; 38:66-67; 39:5-8; 27-36; 46:18-25; 46:34-40; 47:35-
56. See PO App. Br. 2. As explained in detail below, these sections of the
Specification do not provide support for a method step of selecting a plant
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that is confirmed to have both the genotype and phenotype recited in the
claims.
Summary and Detailed Description of the Invention
As mentioned, the issue is whether the ’818 patent describes a method
of making a plant homozygous for FAD2-1 suppression and a single loss of
function mutation in FAD3 and having a seed oil containing less than 3%
linolenic acid and 55-80% oleic acid. The sections of column 4-5 and 7
describes subjecting F2 plants26 to at least one DNA analysis technique
permitting identification of an F2 plant that is doubly homozygous, but there
is no discussion of additional analyzing and selecting for fatty acid content
in this section. See ’818 patent, col. 4, l. 64 to col. 5, l. 58 and col. 7, ll. 43-
50. Similarly, column 8, ll. 18-39 describes transforming a soybean plant
“to obtain an R1 soybean plant”27 having the claimed genotype. This section
does not describe a step of selecting plants having both the genotype and
phenotype recited in the claims. Id., col. 8, ll. 18-39. Col. 20 describes
using known methods for “[d]etecting the single nucleotide
polymorphisms,” but does not describe selecting progeny plants having both
a particular genotype and phenotype. See id., col. 20, ll. 18-37. Thus, the

26 The ’818 patent states that the F1 generation plant is the “first generation
progeny of the cross of two plants,” the F2 generation is the “second
generation progeny of the cross of two plants,” and the F3 generation is the
“third generation progeny of the cross of two plants.” ’818 patent, col. 11,
ll. 8-15.
27 The ’818 patent states that an R0 generation plant is “a transformed plant
obtained by regeneration of a transformed plant cell.” The R1 generation is
“seeds obtained from a selfed transgenic R0 plant. R1 plants are grown from
the R1 seeds.” ’818 patent, col. 13, ll. 46-51.
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general description of the invention identified by Patent Owner does not
provide written descriptive support for the step of the claimed invention
involving selecting a plant having both the recited genotype and phenotype.
Nor do the examples describe a method step wherein both genotype
and phenotype recited in the claims were used as parameters for selecting a
plants to further self-pollinate.
Examples 1-3 are directed to isolating gene sequences for FATB and
constructing plasmid constructs containing gene suppression sequences for
FAD2-1, FAD3, and FATB for the purpose of affecting the expression of
these genes for use in constructing soybean plants with the desired
genotypes. Example 4 describes transforming soybean plants with the
constructs.
Example 5
Example 5 (see Patent Owner’s citation to “38:66-67; 39:5-8; 27-36”
of the ’818 patent) describes a vector construct (pMON68537) to produce a
transgenic soybean plant with suppressed expression of the FAD2-1, FAD3,
and FATB genes for “increased amount of oleic acid ester,” “decreased
linolenic acid,” and “reduced saturated fatty acid,” respectively. Col. 39, ll.
5-8, 27-32. The vector also enables overexpression another gene, FAB2,
which is a genetic mutation not recited at all in the claims. See col. 39, l. 5.
Example 5 describes a loss of function mutation for only one FAD3 gene
locus. See col. 39, ll. 5-20 (describing a single FAD3-1A 3' untranslated
region (3'UTR)). Table 3 shows the fatty acid seed compositions from all of
the R1 generation plants using the particular construct of Example 5. None
of the R1 seeds analyzed in Table 3 have the phenotype recited in the claims.
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The data shows only one plant having less than 3% linolenic (18:3) seed
fatty acid content (see col. 41, l. 43), but that one plant has a oleic acid
(18:1) content of 82.13%, which is outside of the claimed oleic acid content
range or 55-80%.28
Further, Example 5 does not describe genotyping as a basis to select
for plants homozygous for the transgene, but only describes performing
analysis of “fatty acid compositions” from which “selections can be made
from such lines depending upon the desired relative fatty acid composition.”
Id., col. 39, ll. 33-36. While the ’818 patent mentions the correlation of fatty
acid amounts with FAD2, FAD3, and FATB suppressants, it does not appear
to describe a step of analyzing the plants for homozygosity of the FAD2-1
transgene and loss-of-function mutation in the FAD3 gene. Id., col. 39, ll.
27-31. Specifically, while the marker CP4 was used to determine
incorporation of the transgene into the transformed plant at the initial
selection step, the Specification does not appear to disclose that the resulting
plant was homozygous29 for the transgene.
Thus, Example 5 does not provide written descriptive support for
selecting plants having both the genotype and phenotype recited in the
claims. In particular, Example 5 does not provide support for the entire
scope of claim 1, namely, because the seed fatty acid profile was not

28 These results are consistent with the prior art discussed in the ’818 patent
that says you cannot get very low linolenic acid content without getting too
high oleic acid content with just suppression of the FAD2-1 gene and one
FAD3 gene. ’818 patent, col. 3, ll. 43-46; see also Booth, discussed below.
29 We assume by “homozygous” in this context it is meant that each
chromosome has at least one copy of the transgene.
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obtained from a plant having only one loss of function mutation in the FAD3
gene.
Example 830
Example 8, which is not identified by Patent Owner as a basis of
written descriptive support, describes a construct (pMON97563) to produce
a transgenic soybean plant with suppressed expression of FAD2-1 and
FATB and loss of function mutations at FAD3-1A, FAD3-1B, and FAD3-
1C loci of the FAD3 gene. See col. 45, ll. 6-35. Accordingly, Example 8
describes altered expression of five genes, while claim 1 only requires two,
and claims 2 and claim 33 only require three.
Example 8 appears to show the presence of R1 soybean seeds of
selfed R0 plants having the recited fatty acid content phenotype, but does not
describe selecting or further selfing any of these R0 plants having the both
the genotype and phenotype recited in the claims. See id., col. 45, ll. 30-54.
Thus, Example 8, which is only directed toward the first step of making a
plant, does not provide written descriptive support for the claims having a
step of selecting and selfing R0 plants having both the genotype and the
phenotype recited in the claims.
Example 8 does not provide support for the entire scope of claim 1
and claim 33, namely, because the seed fatty acid profile was not obtained
by a plant having only one loss of function mutation in the FAD3 gene.
Example 8 also does not provide support for the entire scope of claim 2,

30 Examples 6 and 7 do not describe any loss of function mutation in the
FAD3 gene, and, thus, do not provide written descriptive support for any of
the claims. See col. 42, l. 47 to col. 43, l. 21; col. 43, ll. 44-67.
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namely because the seed fatty acid profile was not obtained by a plant
having only two loss of function mutations in the FAD3 gene.
Example 9
Example 9 (see Patent Owner’s reference to 46:18-25; 46:34-40 of the
’818 patent) describes a cross between one parent, which is a transgenic
soybean plant line designed to partially suppress the endogenous FAD2
gene, and a second non-transgenic parent, that is a fad3-1b and fad3-1c
double mutant. See col. 45, l. 67 to col. 46, l. 19. Because Example 9
describes plants which contain 2 loss of function mutations in the FAD3
gene, some of the plants resulting from this cross would be expected to meet
the genetic requirements of claim 2. However, Example 9 cannot be relied
upon as describing a plant having only one loss of function mutation in the
FAD3 gene, as is encompassed by claims 1 and 33.
Table 7 “summarizes the F3 seed composition data from 120 F2
plants,” but Table 7 does not provide any individual plant seed fatty acid
analysis data. Col. 46, ll. 39-40. Nonetheless, Example 9 reports that 27 F2
seeds out of 200 F2 seeds produced were identified having “about with
about 60% 18:1 [oleic acid], about 20% 18:2, and about 2-3% 18:3
[linolenic acid],” and that these 27 seeds were planted to produce selfed F3
seeds. Col. 46, ll. 20-25. Of these 27 F2 seeds, only 5 of the F2 plants were
identified as having double FAD3 mutants.31 Col. 46, ll. 35-39.

31 The ’818 patent describes the 27 seeds as having a linolenic acid content
of “about 2-3%.” The claim requires a plant seed having less than 3%
linoleic acid. The description is not clear that any of the five F2 plants
identified as having double FAD3 mutants have linolenic acid content as
recited in the claims since the data in Table 7 is from 120 plants and does
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Again Example 9 provides no clear written description for selecting
F2 progeny plants specifically having both the genotype and phenotype
recited in the claims. Rather the 27 seeds were selected for planting and
selfing based only phenotype, and only 5 of the 27 seeds that were planted
for selfing had the double FAD3 mutations. Example 9 states that “Putative
triple homozygous seeds were identified from 200 F2 seeds through single
seed fatty acid methyl-ester (FAME) analysis of seed chips.” Id., col. 46, ll.
21-23 (emphasis added). Accordingly, the genotype was not reported to
have been confirmed, but rather the 27 F2 plants appear to have been
selected for selfing based solely on fatty acid content. Example 9 further
states that “F2 leaf tissue samples were collected and established molecular
markers for the FAD3 mutant alleles were used to identify double positive
plants (plants having both FAD3-1B and FAD3-1C mutations).” Id., col. 46,
ll. 26-29. However, this analysis only confirmed 5 of the F2 plants
homozygous for two FAD3 mutations. There is no description of
confirming that the transgenes recited in the claims were present in the 5 of
the F2 plants found to have the FAD 3 mutations. Accordingly, there is no
written descriptive support for a step of selecting plants that are also
homozygous for the transgene that decreases the expression of the
endogenous soybean FAD2-1 gene, as recited in the claims.
Further, Example 9 does not provide support for the entire scope of
claim 1, namely, wherein the seed fatty acid profile can be obtained by a
plant having only one loss of function mutation in the FAD3 gene. Further,

not report data from individual plants. It is possible that the five F2 plants
all had a linolenic acid content of 3% or more.
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with respect to claim 33, there is no written description in Example 9 for
obtaining a plant having decreased expression of the endogenous FATB
gene or a seed saturated fatty acid (16:0+18:0) content of less than 8% by
weight.
With respect to claim 2, as discussed above, only 5 plants were found
to have both the seed fatty acid content and the double FAD3 mutations, but
it is not clearly described that any of these 5 plants were confirmed to also
have the decreased FAD2-1 expression. Because only one parent plant had
the FAD2-1 genetic mutation, we cannot presume that any of the 5 progeny
plants necessarily had the FAD2-1 mutation without confirmation thereof.
Example 10
Example 10 (see Patent Owner’s reference to 47:35-56 of the ’818
patent) describes a cross between one parent, which is a transgenic soybean
plant line designed to partially suppress the endogenous FAD2-1 gene and
the endogenous FATB gene, and a second non-transgenic parent, that is a
fad3-1b and fad3-1c double mutant. See col. 47, ll. 18-34. Accordingly,
Example 10 describes altered expression of four genes, while claim 1 only
requires two, and claims 2 and claim 33 only require three.
Example 10 teaches only “putative” identification of homozygous
plants via seed fatty acid analysis, and only confirmation for double positive
plants (plants having both FAD3 deletions). Id., col. 47, ll. 37-44 (“Seeds
with combined oil traits are identified and planted to produce selfed F3
seeds.”). Example 10 further states that “F3 seed lots which indicate
homozygosity for the transgene locus as well as the two FAD3 mutations are
selected and used for line establishment.” Id., col. 47, ll. 45-47. The F4
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field grown seeds were analyzed and found to have 55-85% oleic acid
(18:1), less than 8% saturated fatty acids, and 2-3% linolenic acid (18:3).
Id., col. 47, ll. 52-56.
Example 10 does not provide support for the entire scope of claim 1
and claim 33, namely, wherein the seed fatty acid profile can be obtained by
a plant having only one loss of function mutation in the FAD3 gene.
Example 10 also does not provide written descriptive support for the entire
scope of claim 2, wherein the seed fatty acid profile can be obtained by a
plant without decreased expression in the FATB gene.
As discussed above, we do not find sufficient evidence that the
inventor described a method of making a plant having both the genotype and
the phenotype recited in the claims. Specifically, there is no data in the
examples relied upon by Patent Owner to show that the presence of a
transgene was confirmed in a plant; the only evidence we see is that of
confirming that the transformed starting plant material contained the
construct, but not that the construct was expressed nor that the parental
plants used in the crosses were homozygous for the specified genes, i.e., that
they had copies on each chromosome. Moreover, there is no data of record
to convey that such a plant was obtained for such selection or that any such
selection was or should be performed.
As discussed above, a description in ’818 of a particular seed oil fatty
acid composition within the recited range does not necessarily convey that
the plant also has the recited genotype. To the extent that the ’818 patent
only confirms fatty acid content for its plants, we cannot presume that the
selected plants having the desired fatty acid concentration, in fact, also have
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the genotype.32 Likewise, we note with particularity, that no examples
describe a step of confirming that a plants exists having both the genotype
and the particular phenotype recited in the claims. Thus, there is no express
written descriptive support for, and we cannot confirm that the inventor had
possession of, the subject matter which is now claimed. See Chiron Corp. v.
Genentech, Inc. 363 F.3d 1247, 1255 (Fed. Cir. 2004) (“The written
description requirement prevents applicants from using the amendment
process to update their disclosures (claims or specifications) during their
pendency before the patent office.”); In re Kaslow, 707 F.2d 1366, 1375
(Fed.Cir.1983) (“The test for determining compliance with the written
description requirement is whether the disclosure of the application as
originally filed reasonably conveys to the artisan that the inventor had
possession at that time of the later claimed subject matter, rather than the
presence or absence of literal support in the specification for the claim
language.”) (emphasis added).
Accordingly, we enter a new ground of rejection of claims 1-3, 5-11,
16-19, 21-31, 33-35, 37-39, 44-59, 61, 62, 65-69 and 73-77 under 35 U.S.C.
§ 112, first paragraph, for lack of written descriptive support.
Further, we enter a new ground of rejection of claims 1-3, 5-11, 16-
19, 21-31, 33-35, 37-39, 44-59, 61, 62, 65-69 and 73-77 under 35 U.S.C. §
112, first paragraph, for lack of enablement. This lack of enablement is
based on the failure of the ’818 patent to describe a plant homozygous for

32 Patent Owner makes this same persuasive argument in rebutting the
anticipation rejection of the prior art (see PO App. Br. 6-8), as discussed in
detail below.
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the FAD2-1 and FAD3 gene modifications and having the recited fatty acid
content. Because such a plant is not described and because of the
unpredictability that one could be obtained, we set forth a rejection of lack
of enablement.
Although not explicitly stated in section 112, it is well-settled that to
be enabling, the specification of a patent must teach those skilled in the art
how to make and use the full scope of the claimed invention without “undue
experimentation.” In re Vaeck, 947 F.2d 488, 495; In re Wands, 858 F.2d
731, 736-7 (Fed. Cir. 1988); In re Fisher, 427 F.2d 833, 839, (CCPA 1970)
(the first paragraph of section 112 requires that the scope of protection
sought in a claim bear a reasonable correlation to the scope of enablement
provided by the specification). Factual considerations to consider include
“(1) the quantity of experimentation necessary, (2) the amount of direction
or guidance presented, (3) the presence or absence of working examples, (4)
the nature of the invention, (5) the state of the prior art, (6) the relative skill
of those in the art, (7) the predictability or unpredictability of the art, and (8)
the breadth of the claims.” Wands, 858 F.2d at 737.
The Examiner determined that the data in the Kinney Declarations
show a “natural variation in the seed oil content of progeny plants” that “is
to be expected as the relative content of fatty acids in the oil depends on the
relative expression levels of many different genes. Sexual reproduction
causes random variation.” RAN 9, 14, 32. The skilled artisan would have
understood that the added variability of the suppressive regime as well as the
effects of genes other than FAD2-1, FAD3, and FATB would also effect the
plants’ resulting seed fatty acid phenotype. Such unknown biology of
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soybean plant sexual reproduction creates unpredictability as to the precise
genotype and phenotype results of any particular soybean plant breeding.
This reasoning appears to be consistent with Patent Owner’s arguments that
The assertion that one of ordinary skill could “obtain plants
having oil with whatever specific fatty acid content is desired” is
a gross oversimplification and a purely speculative hindsight
assertion in contradiction to the facts. This reasoning ignores the
complexity of fatty acid biosynthesis and the different tools and
genetic backgrounds used by the various references, as well as
employs improper hindsight to allege predictability where there
was clearly none prior to the invention.
PO App. Br. 20; see also id. at 24 (“Modifying one fatty acid component
upon the content of another is unpredictable prior to making the particular
modification. First Voelker Declaration, ¶ 20.”). Similarly, Requester
acknowledges that even particular environments can affect fatty acid
content, notwithstanding the genetic makeup of a particular plant. See Req.
Res. Br. 12-13 (“[E]nvironmental conditions that may impact oleic acid
content of high-oleic soybean seeds. Variation in oleic acid content of over
20% has been noted among plants of the same genotype grown in, for
example, Puerto Rico versus Iowa.”) (citing Fehr, col. 11, ll. 4-27).
Accordingly, accommodating the unpredictability in making
minimally genetically modified soybean plants for achieving specific fatty
acid content requires more explanation in order to have an enabled
disclosure. Cf. In re Bowen, 492 F.2d 859, 862 (Cust. & Pat. App. 1974) (“In
cases involving unpredictable factors, such as most chemical reactions and
physiological activity, the scope of enablement obviously varies inversely
with the degree of unpredictability of the factors involved.”). In this case,
the prior art suggests that the minimal genetic modifications recited in the
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claims produce too high an oleic acid content or, alternatively, too high a
linolenic acid content.33 Where there is such uncertainty, a disclosure may
require specific working examples to be enabling. Genentech Inc. v. Novo
Nordisk A/S, 108 F.3d 1361, 1367 (Fed. Cir. 1997) (“Where, as here, the
claimed invention is the application of an unpredictable technology in the
early stages of development, an enabling description in the specification
must provide those skilled in the art with a specific and useful teaching.”).
Moreover, the skilled artisan would have understood that the degree of
variation and unpredictability in the art may make either the separate
identification of desirable phenotypes or the separate identification of
achievable genotypes insufficient to demonstrate that a plant has both
characteristics without actual evidence that both properties are present.
While the claims of the ’818 patent are directed to a narrow range of
seed fatty acid content, the claims recite only a few genetic modifications by
which to obtain that specific seed fatty acid content. The ’818 patent does
not direct the skilled artisan how to achieve that specific content with only
the minimal genetic modifications provided for in the claims. Specifically,
claims 1 and 33 recite making a plant having the recited phenotype, with
decreased expression of the FAD2-1 gene and only one loss of function
mutation in the FAD3 gene. Example 5 is the only example with decreased
expression of the FAD2-1 gene and only one loss of function mutation, and

33 See ’818 patent, col. 3, ll. 43-46. Booth also does not sufficiently show
that plants capable of producing seeds with the desired fatty acid content
necessarily have suppressed expression of the FAD2-1 gene and a single loss
of function mutation in FAD3, which is recited by the claims. See PO App.
Br. 7-8, 9; Booth, Example 8.
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Example 5 does not produce any plants having the recited phenotype. The
resulting plants either have too high a linolenic acid content, i.e., greater
than 3%, or too high an oleic acid content, i.e., greater than 80%. These
plants also have genetic modifications in the FATB and FAB2 genes.
The results reported in Example 5 are consistent with the data from
the Kinney Declaration that reflect the results of the DNA construct
described in Booth (i.e., a cross of a D2T plant line, with FAD2-1
suppression, with a fan allele or D3A plant line, which has a loss of function
of FAD3). See Booth, col. 25-26, Example 8; Second Kinney Decl. ¶¶ 16,
17. The Kinney Declaration data, as discussed in detail below, shows plants
with a similar DNA modification having too high an oleic acid content, i.e.,
greater than 80%, for the plants most likely to have the genotype recited in
the claims. Thus, no credible evidence has been identified to show that the
specific seed fatty acid ranges recited in the claims existed in a plant with a
decreased expression in the FAD2-1 gene and only one loss of function
mutation in the FAD3 gene.34 This situation is similar to that in In re
Goodman, 11 F.3d. 1046 (Fed. Cir. 1993), where the claims covered DNA
transformation of wide genus of plants, including plants where the
transformation technology had been applied, but no transformed plants were
obtained.35 Thus, actual failure to obtain the desired result was a basis of
finding a lack of enablement.

34 The ’818 patent further describes similar results. ’818 patent, col. 3, ll.
43-46.
35 “Goodman's own 1987 article, Gene Transfer in Crop Improvement, 236
Science 48 (1987), underscores the ‘major block’ to using the claimed
method with monocot plant cells. Goodman reports: ‘Although data have
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Given the uncertainties in the art discussed supra and the apparent
failures, the data reported in the ’818 patent are not sufficient to confirm that
the plant vectors, plant lines, and/or genetic sequences described in the ’818
patent can be used to make a plant with both the specific phenotypes and
genotypes recited in the claims. Because it is never confirmed that any
plants presented in the Examples as having recited phenotype also have the
recited genotype or vice versa, we cannot assume, on the basis of the
evidence of record, that the genotype was necessarily present for those
example having the correct phenotype.
It is unclear from the evidence of record that the skilled artisan using
the particular plant vectors, plant lines, and/or genetic sequences described
in the ’818 patent would have been enabled to make a soybean plant having
both the recited phenotypes and the minimal genetic modifications within
the full scope recited in the claims, without undue experimentation (i.e.,
without narrowing the subject matter of the claims to include further genetic
modifications). Thus, the inventions recited in the claims are not sufficiently
enabled by the disclosure of the ’818 patent.

been cited that Agrobacterium can transfer T-DNA to monocotyledonous
hosts, clear evidence of T-DNA integration exists only for asparagus, and,
even in that case, no transformed plants have been described.’ Id. at 52
(citation omitted).” 11 F.3d at 1051.
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Anticipation
The Examiner finds that Booth describes a method of crossing a
D2T36 soybean line with a D3A soybean line37 or, alternatively, a fan allele
soybean line.38 RAN 6 (citing Booth, col. 25-26, Example 8). The D2T
soybean line comprises “a transgene copy of the soybean fatty acid
desaturase gene, gmFAD2-1 . . . that results in co-suppression and therefore
down regulation of the gmFAD2-1 message level . . . [which] leads to a
decrease in activity of delta-12 desaturase, and a decrease in the
accumulation of poly-unsaturated fatty acids.” Id., col. 22, l. 64 to col. 23, l.
6. Thus, the D2T soybean line has a transgene that decreases expression of
the endogenous FAD2-1 gene, as recited in the claims. The “fan allele”
soybean line has an allele (a loss-of-function mutation) on the fan (FAD3)
gene that confers a low linolenic phenotype. Booth, col. 11, ll. 10-12, col.
12, ll. 24-27, and col. 20, ll. 22-23, col. 25, ll. 50-51. Similarly, the D3A
soybean line comprises a transgene that is an antisense construct that reduces
expression of the FAD3 gene. Booth col. 7, lines 30-32.
Seeds from the crosses were grown forming an F1 plant progeny
which were self-pollinated to produce F2 seeds, which were grown to form
F2 plants, which were also self-pollinated to produce F3 seeds. Id., col. 25,
ll. 51-56. F3 seeds were analyzed for fatty acid content. Id. F3 seeds

36 The D2T soybean line has an oleic acid (18:1) content of 85% by weight
of total fatty acid. Id.
37 The D3A soybean line has a linolenic acid (18:3)37 content of 3% by
weight of total fatty acid. See Booth, col. 6, l. 59, Table 2.
38 The fan allele soybean line has a linolenic acid (18:3) content of 4% by
weight of total fatty acid. Id.
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“containing both minimum linolenic acid content and maximum oleic acid
content were then selected and planted and allowed to self pollinate in order
to obtain F3:4 progenies [i.e., F4 seeds from the resulting F3 plants].” Id.
The F4 seeds were further analyzed for fatty acid content. Id., col. 25, ll. 56-
61.
Table 12 of Booth reports “[c]rosses were made between soybean
lines containing the D2T gene for high oleic acid content and soybean lines
containing either a fan allele or the D3A gene.” Id., col. 25, ll. 48-50. The
table shows fatty acid content of F3 seeds from “[s]ingle plants and family
means [averages of self-pollinated progeny families of the first generation
single plants] that were both lowest in linolenic acid content and highest in
oleic acid content are shown in Table 12, and are presented in order of
increasing linolenic acid.” Id., col. 25, ll. 61-65.
All the reported F3 seeds and the average of several F4 seeds (from a
“family” of F3 plants derived from a single F2 plant) identified in Table 12
have a linolenic acid (18:3) content of less than 3% of total seed fatty acid.
Id., col. 26, ll. 10-36, Table 12. However, all reported progeny in Table 12
also have an oleic acid (18:1) content greater than the recited “range of 55%
to 80% of total seed fatty acids by weight.” Id. The progeny family with the
lowest mean oleic acid content is labelled 7OL-2712-0 having a mean oleic
acid (18:1) content of 82% by weight. Id. The second lowest mean oleic
acid content is from a progeny family labelled 7OL-2709-0 having a mean
oleic acid content of 83% by weight. Id. Thus, Table 12 alone does not
provide evidence that a plant within the scope of claim 1 was made.
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In the Request for Inter Partes Reexamination, Requester provided
the First Kinney Declaration. See Request. Dr. Kinney is a named inventor
of the Booth patent. See First Kinney Decl. ¶ 7. Dr. Kinney testified that
that Line ID Number 7OL-2709-0 in Table 12 “shows the ‘mean’ fatty acid
content of 11 plants resulting from a cross between a D2T parent line and a
fan allele parent line.” Id., ¶ 60. Thus, the high value reported in Table 12
represented a mean obtained from different plants. Dr. Kinney testified that
the actual oleic acid content for each of the 11 plants in the 7OL-2709-0
family are reported in Exhibit 5 to the First Kinney Declaration. Id. Exhibit
5 of Kinney’s First Declaration reports that one F2:4 generation plant’s
soybeans 39 have an oleic acid (“OLA”) content of 72.8% by weight and
reports that all the other plants are F3:4 generation plants and have oleic acid
contents between 83.5 and 85.2% by weight. Id., ¶¶ 60-61 and Exhibit 5.
The Examiner finds that Exhibit A attached to the Third Kinney
Declaration shows “the fatty acid profiles of seeds from all the plants
produced Booth example 8.” RAN 7; see Third Kinney Decl. ¶¶ 7, 13. Dr.
Kinney identifies that these are the results of all the F2:3 generation seeds,40

39 We understand the F2:4 soybean to be the seed from the F3 progeny plant
of a self-pollinated second generation F2 soybean plant (i.e., from the F2:3
seeds).
40 Example 8 of Booth explains that each resulting F1 progeny of the initial
cross was self-pollinated to obtain F2 plants used to produce F2:3 generation
seeds. Booth, col. 25, ll. 48-53. Only the next self-pollinated F3:4
generation of seeds resulted from a preferred group of the F2:3 generation
seeds “containing both minimum linolenic acid content and maximum oleic
acid content.” Id., ll. 53-59. Accordingly, we find that the F2:3 generation
results provided in Exhibit A of the Second Kinney Declaration represents
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only the best of which (highest oleic acid content and lowest linolenic acid
content) were provided in Table 12 and were self-pollinated to produce the
F3:4 seeds, the best averages of which (highest oleic acid content and lowest
linolenic acid content) were shown in Table 12. Third Kinney Decl. ¶¶ 10-
11. The Examiner finds that
Many plants had fatty acid profiles which meet the limitations of
claim 1, as summarized in the table below. Specifically, 14 plants
had oleic acid content of 55% to 80% and linolenic acid content
below 3%. These 14 plants meet the limitations of section (d) of
claim 1, as well as claims 27, 30, 31, 65-69 and 73-77, with
regard to seed fatty acid content.
RAN 7-8 (specifically identifying the 14 plants). Accordingly, the
Examiner finds that Booth teaches all the steps recited in claim 1.
Patent Owner contends that there is no disclosure, express or inherent,
of a step of selecting a plant that is “homozygous for a transgene that
decreases expression of a FAD2-1 gene and homozygous for a loss-of-
function mutation in a FAD3 gene” and has a seed fatty acid composition
comprising a linolenic acid content of less than 3 % and an oleic acid
content of 55 % to 80% of total seed fatty acids by weight. PO App. Br. 6.
Patent Owner argues that “testing” or “phenotyping” for minimum linolenic
acid and maximum oleic acid content phenotype is not performing a step of
“selecting” doubly homozygous plants with less than 3% linolenic acid
content and 55% to 80% oleic acid content. Id. at 7. Patent Owner points
out that selecting for maximum oleic acid content, in fact, resulted in

the lines of all resulting progeny and not a preferred selection thereof, as
does the F3:4 generation of plants reported in Booth’s Table 12.
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selecting seeds outside of the 80% maximum oleic acid content recited in the
claims. Id. at 7-8.
Patent Owner further points out that genotyping for double
homozygous plants was not performed at all. PO App. Br. 7-8. Patent
Owner argues that the Examiner’s finding that the plants are also double
homozygotes is “mere assertion and assumption” based on the finding of 14
plants that meet the oleic and linolenic acid limitations. Id. at 8-9. Patent
Owner points out that the 14 plants identified by the Examiner as falling
with the ranges cited in the claims are not, in fact, the plants with the highest
oleic acid content, which draws into question whether plants with less oleic
acid content, in fact, are double homozygotes or were selected for further
selfing. Id. Thus, Patent Owner contends that the Examiner has failed to
meet the required burden to demonstrate that Booth, as evidenced by the
Kinney Declarations, inherently anticipates the claims. Id. 9-10.
The Examiner finds that “Requester has amply demonstrated that
some of the plants so selected meet the claim limitations with regard to seed
oil content.” RAN 27. The Examiner further finds that selecting the plants
that were both lowest in linolenic acid and highest in oleic acid would have
necessarily selected plants that were doubly homozygous because these
attributes would only be present in the plants that have the mutations, the
mutations being specifically loss-of-function (the low linolenic phenotype)
and gain-of-function (accumulation of oleic acid at the expense of linoleic
acid) mutations, respectively. RAN 27; see Second Kinney Decl. ¶¶ 24-31
(explaining Mendelian genetics “would result in 25% of the progeny being
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homozygous for the D2T IF AD2-1 gene and homozygous for the loss of
function mutation in the FAD3 gene.”).
We agree with Patent Owner that the Examiner and Requester have
not shown that the claimed steps are anticipated by the teachings of Booth.
The claims requires a selection step in which plants are selected based on
both (1) the plant being doubly homozygous and (2) the plant seed having
oleic and linolenic acid contents within the narrowly recited ranges. Booth
expressly teaches selecting F2 plants with F3 seeds having the highest oleic
acid content and the lowest linolenic acid content. Booth, col. 25, ll. 53-56.
While such a selection would likely have resulted in the selection of doubly
homozygous plants, there is not sufficient evidence in the phenotype alone
to support a finding that the genotype was necessary present because of the
natural variation that occurs in the reproduction of soybean plants, as
discussed above. Other genetic or environmental factors could have created
the desirable phenotype. Further, we have not been directed to evidence to
show that the “highest” oleic acid selected plants have oleic acid content
within the range of 50-80%. The data shows that 37 out of 242 plants (i.e.,
the top 15%) of the “highest” oleic acid content plants have oleic acid
contents greater than 80%, and, thus, fall outside of the range recited in the
claims.
Dr. Kinney, who had first-hand knowledge of the selected plants
recited in Booth, nonetheless did not indicate the range of oleic acid content
that was considered the “highest” and does not testify that any genotyping of
the plants was performed. Accordingly, the record does not support a
finding that the “highest” oleic content plants that were selfed in Booth
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included plants having an oleic acid content of 80% or less or the genotype
recited in the claims.
Dr. Kinney provides data for all of the F3 generation seeds of the F2
plants, and provides data for all of the F4 seeds from the F3 plants resulting
from the selfing of “selected” F2 plants. Each generation has at least one
plant that falls within the scope of the oleic and linoleic acid contents recited
in the claims. Yet, it unclear which of the F2 plants for which data was
provided were, in fact, the selected ones for selfing into F3 progeny.
Moreover, we agree with the Patent Owner that fatty acid content alone is
not sufficient to show the specific genotype recited in the claims. Without
this information, we cannot find on the record that Booth teaches, either
expressly or inherently, a step of selecting plants that are both double
homozygous and having oleic and linolenic acid contents within the claim
ranges.41
Accordingly, we reverse the Examiner’s rejection of claims 1, 25, 27,
30, 31, 65-69 and 73-77 are rejected under 35 U.S.C. § 102(b) as being
anticipated by Booth.

41 Indeed, as pointed out by Requester (Req. Res. Br. 5-6), Booth suffers
from the same problem vis-à-vis the claims as does the ’818 patent.
Namely, Booth teaches plants having the genotype recited in the claims and
plants having the particular seed fatty acid content recited in the claims, but
there is no evidence supporting a finding that a single plant having both
existed in the record.
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Obviousness
The Examiner rejected claims 1, 2, 7, 8, and 23-30 under 35 U.S.C. §
103(a) as unpatentable over Booth, as evidenced by the Kinney
Declarations. The Examiner determined that the plants recited in the claims
would have been obvious in view of the teachings of Booth because it would
have been obvious for the skilled artisan having the F2 generation, and
having analyzed the seeds therefrom for fatty acid content, to “screen the
resulting progeny to obtain plants having oil with whatever specific fatty
acid content is desired.” RAN 9. The Examiner relies on the evidence of
the Kinney Declarations to show that “Example 8 did in fact yield many
plants with this fatty acid profile.” Id.
We agree that the step of selecting a plant having a seed with a
specific oleic acid and linolenic acid content would have been obvious to do
because the Examiner found fourteen F2 plants having F3 seeds with this
specific phenotype RAN 7-8. We further agree that it would have been
obvious for the skilled artisan to confirm whether the selected plants are also
double homozygous. See RAN 10. However, we do not have sufficient
evidence of record to show that any of the fourteen F2 plants identified by
the Examiner with the recited phenotype also have the recited genotype. See
PO App. Br. 13. Thus, while such a plant may have been obvious to select,
there is no evidence that the F2 plant recited in the claims, having both the
recited genotype and phenotype, existed at the time of the invention to have
been so selected.
Moreover, the claims at issue are not limited to the selecting step.
After being selected, the desirable fatty acid plants are selfed and must result
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in an F3 generation plant that is also both doubly homozygous and have the
same oleic acid and linolenic acid content as the parent F2 plant. We do not
have sufficient evidence of record to support a finding that selfing the
particular F2 plants that have the fatty acid content recited in the claim
would have been expected to arrive at a progeny plant again having both the
recited phenotype and genotype.
As persuasively argued by Patent Owner (PO App. Br. 15-16), Booth
does not suggest that the skilled artisan would have had any expectation of
success in achieving any particular results with respect to selfing of F2
plants that were not done but might be otherwise obvious to perform.42 To
the extent the skilled artisan would have selected and selfed one of Booth’s
F2 plants having the recited phenotype, but that was not expressly selfed and
analyzed by Booth, we cannot presume to know whether or not selfing
different F2 plants, that were not selected by Booth and for which there is no
F3:4 seed fatty acid content data, would have resulted in plants having both
the desired phenotype and genotype as recited in the claims. We can only

42 Patent Owner might argue that one of ordinary skill in the art would have
understood that the ’818 patent discloses and enables a plant having both the
genotype and phenotype based on the mere descriptions of the various
mutations and what they might be expected to produce, without a specific
working example finding both properties in a single soybean plant. Booth
would have similarly suggested that the skilled artisan would have expected
the FAD2-1 and FAD3 mutations to have similar outcomes. Considering the
lack of predictability in the art and the variability of gene expression of a
particular phenotype, however, we would find these “expectations” of results
to be speculative and therefore unpersuasive without sufficient evidence to
demonstrate otherwise.
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speculate as to the seed fatty acid content and genotype of a hypothetical
plant—and such speculation is not adequate to establish obviousness.
With respect to claim 33, which requires a specific saturated fatty acid
content, Patent Owner further argues that there is no reasonable expectation
that the skilled artisan would have had success in obtaining the specific fatty
acid concentrations recited in the claim, because
Saturated and oleic acid content in soybean seed oil are part of
the same linear biosynthetic pathway, and thus a basic
stoichiometric relationship exists between all the fatty acids in
this pathway. It is obvious on its face, regardless of how
suppression is accomplished, that a decrease is saturated fatty
acids as a result of FATB suppression will necessarily result in a
stoichiometric balance towards downstream products such as
oleic acid.
PO App. Br. 20; PO Reb. Br. 9-10; see Second Voelker Declaration, ¶¶ 20,
25-31. In a related reexamination decision, we analyzed the Booth data and
found insufficient evidence to show that Booth’s method of crossing the
D2T line and either the D3A line or the fan allele line would have been
expected to result in a plant having all of the characteristics recited in claims
1 and 33 merely through natural variation. Decision mailed August 10, 2016
in Reexamination Control No. 95/002,028, p. 19-24. We further find no
evidence to conclude that, even if such a plant were produced, it would
necessarily have had the genotype recited in the claims.
The Examiner further rejects claims 1 and 33 based on alternative
proposed crosses that are not expressly taught in the prior art. See numbered
Rejections 2, 7, and 11, above. The Examiner determined that “[i]t would be
obvious to one of ordinary skill in the art to repeat the crosses taught by
Booth with . . . different parent lines, and then screen the resulting progeny
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to obtain plants having oil with whatever specific fatty acid content is
desired.” RAN 9, 14-15, 22. For example, the Examiner determined that
“[i]n order to reduce linolenic acid content in the oil of these plants, it would
have been obvious to also introduce an FAD3 loss of function mutation as in
Booth Example 8. (Essentially, then, the claimed invention combines
examples 8 and 13 of Booth.)” RAN 14. The Examiner finds that
There would have been a reasonable expectation of success
because the effects of these modifications in seed fatty acid
synthesis gene expression were all characterized. Booth had
combined FAD2-1 and FAD3 gene suppression, and suggested
combining FAD2-1 and FATB gene suppression. Buhr/Clemente
had produced FAD2-1 and FATB suppressed plants and obtained
the phenotype predicted by Booth (high oleic/low saturated fatty
acids). The results provided in Booth Tables 9-13, as well as the
first and third Kinney declarations, show that when soybean
varieties having different fatty acid profiles are hybridized, there
is variation in the seed oil content of progeny plants. This is to
be expected as the relative content of fatty acids in the oil
depends on the relative expression levels of many different
genes, and sexual reproduction causes random variation. This
variability is inherent to plant breeding and would have been
expected by one skilled in the art (fourth Kinney declaration, ¶¶
12, 16).
RAN 14. The Examiner further makes findings based on the specific
teachings of Buhr/Clemente of a FAD2-1 plant line with an oleic acid
content of 57.7-91.1% by weight. RAN 14. On this basis the Examiner
concludes
If oleic acid content of < 80% were desired, it would be obvious
to select an FAD2-1 suppressed line with a lower oleic acid
content than the D2T line (85% oleic acid) used by Booth.
Buhr[/Clemente] shows that lines completely covering the
claimed range of 55% - 80% oleic acid were readily obtainable.
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Id. The Examiner suggests a similar unperformed cross with soybean line
A29 of Fehr, which is a low linolenic acid line which is homozygous for the
recessive mutations fan1 (A5), fan2 and fan3, resulting in loss of function
mutations in FAD3-1A, FAD3-1B and FAD3-1C genes. RAN 20 (citing
Fehr, col. 5, lines 37-47, as evidence by Bilyeu 2006, p. 1915, col. 2). The
Examiner determines that “by following the guidance of Booth, one would
have had a reasonable expectation of producing soybean plants having oil
with less than 3% linolenic acid and 55% - 80% oleic acid.” RAN 21.
Generally, the Examiner determines that it would have been obvious
to select homozygous F2 plants and self-pollinate because it is well known
in the art that “homozygous lines are desirable for breeding purposes (so that
all progeny from a cross will have the desired genes).” RAN 9, 15, 22, 28.
Patent Owner disagrees and persuasively argues that “[g]enetically
modifying one fatty acid component upon others is not a certainty.” PO
App. Br. 19; see generally id. at 19-24 (discussing the speculative nature of
the Examiner’s assertions).
In each case, the Examiner relies on the wide variety of resulting fatty
acid content that would be expected for all of the F3 progeny of such
crosses. While we agree with Examiner that some plants having seeds with
the recited fatty acid content (phenotype) are expected to be obtained from
these crosses, and we agree with the Examiner that some plants having the
recited genotype are expected to be obtained from these crosses, there is
insufficient evidence to support a finding that there is a reasonable
expectation of success in producing a plant having both the recited
phenotype and genotype. The Examiner bases all the rejections on the
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supposition that any fatty acid content can be achieved in a soybean line, but
the claims are narrower than the Examiner’s obviousness rationale suggests
and further requires the recited genotype as well.
Particularly because of the expected variation and unpredictable
expression levels of many different genes, described the Examiner, there is
no guarantee that plants having the recited phenotype necessarily have the
correct genotype, and vice-versa. Using plant lines producing seeds having
oleic acid within the recited range, when crossed for the correct genotype,
may see a marked increase in oleic acid content, such that the resulting
homozygous plants ultimately do not have seeds with the recited oleic acid
content. Moreover, merely selecting the plants producing seeds with the
desired fatty acid content, does not guarantee that the seeds have the recited
genotype.
Because all of the rejections under 35 U.S.C. § 103(a) rely on the
same rationale regarding obviousness based on the teachings of Booth, Buhr,
Clemente, and Fehr, we reverse all of the rejections maintained by the
Examiner under 35 U.S.C. § 103(a).

III. SUMMARY
In sum, we reverse all of the rejections maintained by the Examiner.
We further introduce the following new grounds of rejection:
1. Claims 1-3, 5-11, 16-19, 21-31, 33-35, 37-39, 44-59, 61, 62, 65-69
and 73-77 under 35 U.S.C. § 112, first paragraph for lack of
written description and
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2. Claims 1-3, 5-11, 16-19, 21-31, 33-35, 37-39, 44-59, 61, 62, 65-69
and 73-77 under 35 U.S.C. § 112, first paragraph for lack of
enablement.

NEW GROUND OF REJECTION
This decision contains new grounds of rejection pursuant to 37 C.F.R.
§ 41.77(b) which provides that “[a]ny decision which includes a new ground
of rejection pursuant to this paragraph shall not be considered final for
judicial review.” Correspondingly, no portion of the decision is final for
purposes of judicial review. A requester may also request rehearing under
37 C.F.R. § 41.79, if appropriate, however, the Board may elect to defer
issuing any decision on such request for rehearing until such time that a final
decision on appeal has been issued by the Board.
For further guidance on new grounds of rejection, see 37 C.F.R.
§ 41.77(b)-(g). The decision may become final after it has returned to the
Board. 37 C.F.R. § 41.77(f).
37 C.F.R. § 41.77(b) also provides that the Patent Owner, WITHIN
ONE MONTH FROM THE DATE OF THE DECISION, must exercise one
of the following two options with respect to the new grounds of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. The owner may file a response requesting
reopening of prosecution before the examiner. Such a response must be
either an amendment of the claims so rejected or new evidence relating to
the claims so rejected, or both.
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(2) Request rehearing. The owner may request that the proceeding be
reheard under § 41.79 by the Board upon the same record. …
Any request to reopen prosecution before the examiner under 37
C.F.R. § 41.77(b)(1) shall be limited in scope to the “claims so rejected.”
Accordingly, a request to reopen prosecution is limited to issues raised by
the new ground(s) of rejection entered by the Board. A request to reopen
prosecution that includes issues other than those raised by the new ground(s)
is unlikely to be granted. Furthermore, should the patent owner seek to
substitute claims, there is a presumption that only one substitute claim would
be needed to replace a cancelled claim.
A requester may file comments in reply to a patent owner response.
37 C.F.R. § 41.77(c). Requester comments under 37 C.F.R. § 41.77(c) shall
be limited in scope to the issues raised by the Board’s opinion reflecting its
decision to reject the claims and the patent owner's response under
paragraph 37 C.F.R. § 41.77(b)(1). A newly proposed rejection is not
permitted as a matter of right. A newly proposed rejection may be
appropriate if it is presented to address an amendment and/or new evidence
properly submitted by the patent owner, and is presented with a brief
explanation as to why the newly proposed rejection is now necessary and
why it could not have been presented earlier.
Compliance with the page limits pursuant to 37 C.F.R. § 1.943(b), for
all patent owner responses and requester comments, is required.
The examiner, after the Board’s entry of a patent owner response and
requester comments, will issue a determination under 37 C.F.R. § 41.77(d)
as to whether the Board’s rejection is maintained or has been overcome.
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The proceeding will then be returned to the Board together with any
comments and reply submitted by the owner and/or requester under
37 C.F.R. § 41.77(e) for reconsideration and issuance of a new decision by
the Board as provided by 37 C.F.R. § 41.77(f).

REVERSED; NEW GROUNDS ENTERED UNDER 35 U.S.C. § 41.77

PATENT OWNER:
DENTONS US LLP
2000 McKINNEY AVENUE, SUITE 1900
DALLAS, TX 75201-1858

DENTONS US LLP
P.O. BOX 061080
CHICAGO, IL 60606-1080

THIRD-PARTY REQUESTER:
DICKSTEIN SHAPIRO LLP
1825 EYE STREET, NW
WASHINGTON, DC 20006-5403