MONSANTO TECHNOLOGY LLC(OWNER) et al.

Patent Trials and Appeals Board

Oct 29, 2020

2020003200 (P.T.A.B. Oct. 29, 2020)

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 10/29/2020
DENTONS US LLP
P.O. BOX 061080
CHICAGO, IL 60606-1080
EXAMINER
CAMPELL, BRUCE R
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
10/29/2020 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 THE PATENT TRIAL AND APPEAL BOARD

E.I. DU PONT DE NEMOURS AND COMPANY
Requester and Respondent

v.

MONSANTO TECHNOLOGY LLC1
Patent Owner and Appellant

Appeal 2020-003200
Reexamination Control 95/000,690
Patent 7,943,818 B2
Technology Center 3900

Before RICHARD M. LEBOVITZ, JEFFREY B. ROBERTSON, and
RAE LYNN P. GUEST, Administrative Patent Judges.

GUEST, Administrative Patent Judge.
DECISION ON APPEAL
Final under 37 C.F.R. § 41.77(f)

1 Patent Owner, Monsanto Technology LLC (hereinafter “Patent Owner”),
identifies the real party in interest as the Monsanto Company, the parent
company of assignee Monsanto Technology LLC. See Patent Owner’s
Appeal Brief 1, filed May 31, 2016 (hereinafter “PO Appeal Br.”).
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Introduction
A. Background and Summary
In a Decision on Appeal mailed March 12, 2018 (hereinafter
“Decision”), the Board entered the following new grounds of rejection,
affecting all of the claims on appeal:
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
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.
Decision 42–43.
Patent Owner, Monsanto Technology LLC (hereinafter “Patent
Owner”), elected to request reopening of prosecution under 37 C.F.R.
§ 41.77(b)(l). See “Response to Decision on Appeal” (filed April 12, 2018)
(hereinafter “Request”). In the Request, Patent Owner submitted
amendments to claims 1–3, 5–9, 21, 24, 31, 33–35, 37–39, 49, 52, 56, and
59. Patent Owner further provides new evidence in the form of the
Declaration of Nicholas Wagner under 37 C.F.R. § 1.132, executed on April
12, 2018 (“Wagner Declaration” or “Wagner Decl.”).
On July 24, 2018, the Board ordered that the Patent Owner’s Request
be remanded to the Examiner under 37 C.F.R. § 41.77(d) for consideration
of Patent Owner’s proposed amendments and new evidence.
The Examiner entered a Determination under 37 C.F.R. § 41.77(d) on
January 16, 2020 (hereinafter “Determination”).
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The Examiner determined that “The PTAB’s new grounds of rejection
under both written description and enablement have been overcome by
Patent Owner’s amendment in view of the disclosure of the specification and
the Wagner Declaration.” Determination 3.
According to the Examiner, Examples 9 and 10 of the ’818 patent, in
light of the Wagner Declaration, demonstrate that the skilled artisan would
have understood possession of and, thus, demonstrate written descriptive
support for, and enablement of, the subject matter set forth in independent
claims 1 and 33 as amended. Determination 2–3.
Third Party Requester, E.I. du Pont de Nemours and Company2
(“Requester”) did not file any Comments under 37 C.F.R. §§ 41.77(c) or
41.77(e). Patent Owner filed no response under 37 C.F.R. § 41.77(e).
The proceeding has been returned to the Board under 37 C.F.R.
§ 41.77(f) for a final decision. Our new Decision incorporates the earlier
Decision, except for those portions specifically withdrawn herein, if any.
37 C.F.R. § 41.77(f).
For the reasons discussed in detail below, we do not agree with the
Examiner’s Determination that Patent Owner’s amendments in light of the
Wagner Declaration overcome the written description and enablement
rejections.
II. ANALYSIS
A. New Grounds of Rejection
In the Decision, we explain, in detail, our determination that
[c]onsistent with the Examiner’s findings that the fatty acid
content of soybean seeds depends on many different genes and

2 See Requester’s Respondent Brief 1 (filed June 29, 2016).
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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 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.
Decision 10–11. Further after discussing that it was known that 1)
suppressing the FAD2-1 gene increases the oleic acid content, 2)
suppressing the FAD3 gene was known to decrease linolenic acid (18:3)
content in soybean plants, and 3) suppressing of the FATB gene was known
to reduce the saturated fatty acid content of soybean seeds, we determined
that
[w]hile 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.
Decision 13. Citing Bilstad v. Wakalopulos, 386 F.3d 1116, 1125 (Fed. Cir.
2004 and In re Smythe, 480 F.2d 1376, 1383 (CCPA 1973), we determined
that the unpredictability in the case warranted the claims be limited to the
specific genetic modifications that the inventor used to achieve the fatty acid
content recited in the claims, and we explained why the claims, in this case,
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were broader than the particular genetic modifications described by the ’818
patent. Decision 15.
In light of this claim interpretation and background, we determined
that
[t]o 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.
Id. (emphasis added). Specifically with regard to the broadest claim on
appeal at the time, we stated:
[T]he ’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.
Decision 14 (emphasis added).
We further determined in the Decision that, in light of the Wands
factors (In re Wands, 858 F.2d 731, 736–737 (Fed. Cir. 1988)),
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
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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.
Decision 29 (emphasis added).
B. Claim Amendments
Claim 1, as amended, 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 transgene3 that decreases the
expression of an endogenous soybean FAD2-1 gene, and (ii) loss-of-
function mutations in at least two endogenous soybean FAD3 genes,
(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,
(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 homozygous both for (i) the transgene that decreases the
expression of the endogenous soybean FAD2-1 gene and (ii) loss-of-
function mutations in at least two endogenous soybean FAD3 genes, and

3 We refer back to our discussion of our understanding of the meaning of the
claim terms “transgene,” “loss-of-function mutation,” and “homozygous” in
footnotes 21-23 of the Decision. See Decision 8–9.
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(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) loss-of-function mutations in at
least two endogenous soybean FAD3 genes, and (2) produces seeds having
the same linolenic acid and oleic acid content as the parent plant.
In other words, independent claim 1 has been amended to have
substantially identical scope to prior claim 2, as decided in the prior
Decision on appeal.
Independent claim 33, as amended, is similar to independent claim 1,
as amended, but also requires a change in a FATB gene and a saturated fatty
acid content of less than 8% of total fatty acid content. It requires making,
selecting and selfing a plant that (1) is homozygous for each of (i) a
transgene that decreases expression of both (a) an endogenous FAD2-1 and
(b) an endogenous FATB gene and (ii) loss of function mutations in at least
two FAD3 genes, 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 loss-of-function mutations in at least two FAD3 genes.
Claim 2, as amended, which depends from claim 1, requires a plant
having the same seed fatty acid content but further having loss of function
mutations in at least three endogenous soybean FAD3 genes. However, as
with amended claim 1, amended claim 2 does not require a transgene that
decreases expression of the endogenous FATB gene.
Finally, amended claim 34, which depends from claim 33, further
requires a plant having the same seed fatty acid content but further having
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loss of function mutations in at least three endogenous soybean FAD3
genes.
C. Written Description of the ’818 Patent
Claim 1
As noted above, amended claim 1 has the scope of prior claim 2 at the
time of the last Decision. With respect to prior claim 2, which recited “at
least two loss of function mutations in at least two endogenous soybean
FAD3 genes” and the FAD2-1 transgene, we found that, in Example 9 of the
’818 patent,
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 [also a requirement of claim
1]. 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.
Decision 22.
Patent Owner contends that amended claim 1 has written description
support in Example 9 of the ’818 patent. Response 18. Example 9 describes
that fatty acid analysis was performed on F3 seeds from selfed F2 plants and
analysis of the F2 plant leaf tissue samples for FAD3-1B and FAD3-1C
mutation molecular markers. ’818 patent, col. 46, ll. 20–40. According to
Patent Owner, the 27 plants described as having seeds with about 60% oleic
acid are the plants having decreased FAD2-1 expression, which was
determined by segregation analysis of the F3 seeds from the self-pollinated
F2 plants. Response 18 (citing Wagner Decl. ¶¶ 15–16).
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Relying on the Declaration of Nicholas Wagner, dated April 12, 2018,
Patent Owner explains that, in the parent plant lacking the transgene that
reduces FAD2-1 gene expression, the oleic acid content was 30.1%, and, in
the parent plant that had the transgene to decrease the expression of the
FAD2-1 gene, the oleic acid content was 64.6%. Id. (citing Wagner Decl. ¶
14); see ’818 patent, col. 46, Table 7. Indeed, the Wagner Declaration
describes that “as soybean transgenes follow classical Mendelian patterns,
analysis of the segregation pattern in F3 seed is absolutely determinative of
the zygosity of the F2 mother plant and therefore also the F2 seed
generated.” Wagner Decl. ¶ 13. The Wagner Declaration explains that
[a]s is well understood by those familiar with soybean plant
breeding, a common and efficient manner of identifying
homozygosity in a given plant is to examine for segregation in
the subsequent self-pollinated seed from the plant, often
described as a progeny test or screen . . . . The homozygous F2
plants in which oleic acid content was not segregating (i.e.,
oleic acid content of greater than 55% in all F3 seeds) were
selected for advancement. Although F2 plants that are
heterozygous for the transgene will produce some F3 seeds that
have an oleic acid content of greater than 55%, the transgene
will segregate in progeny such that ¼ of the seeds can be
expected to lack the transgene and have an oleic acid content
lower than 55%. And none of the F3 seeds from F2 plants that
do not have the transgene will have oleic acid content of greater
than 55%. This strategy therefore identifies plants that are
homozygous for a single locus trait with high accuracy.
Id. ¶ 15.
The Examiner determined that
[a]s explained in the Wagner declaration, the skilled artisan
would understand that analysis of the F3 generation can
confirm that the putative F2 plants are triply homozygous
because heterozygosity at any locus would result in
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approximately 25% of F3 plants having the wild type
phenotype, which is readily detectable. In this way, the
specification demonstrates possession of the claimed multiply
homozygous plants and methods for making them.
Determination 3.
Relying on the Wagner Declaration, we agree with Patent Owner and
the Examiner that the skilled artisan would have understood segregation
analysis and would have understood the inventor to have confirmed
homozygosity of the FAD2-1 mutation using the F3 seed fatty acid analysis
as described. Thus, we agree that Example 9 has written description support
for a method of 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 homozygous both for (i) the transgene that decreases the
expression of the endogenous soybean FAD2-1 gene and (ii) loss-of-
function mutations in two endogenous soybean FAD3 genes.
Similarly, and for the same reason, Example 10 has written
description support for a method of 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 homozygous for (i) the
transgene that decreases the expression of (a) the endogenous soybean
FAD2-1 gene and (b) the endogenous soybean FATB gene, and (ii) loss-of-
function mutations in two endogenous soybean FAD3 genes.
Our review of the claim language does not stop there, however. In
this case, the scope of claim 1 is not limited to a method step in which a
plant is selfed having only two loss-of-function mutations in the endogenous
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soybean FAD3 gene, as was the case in Example 9. Rather, the claim reads
“loss of function mutations in at least two endogenous soybean FAD3
genes.” Thus, the scope of claim 1 includes not only loss-of-function
mutations in two or three FAD3 genes, but also loss-of-function mutations
in four or more FAD3 genes.
We discuss in detail in the Decision that
[w]hile 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.
Decision 13. This finding was based on Patent Owner’s own arguments and
evidence presented in arguing that the prior art would not have been obvious
over the prior art without a showing that the correct phenotype was achieved
with the correct genotype. See Appeal Br. 24 (“Modifying one fatty acid
component upon the content of another is unpredictable prior to making the
particular modification.”) (citing First Voelker Declaration ¶ 20); Decision
11 (citing Patent Owner’s argument on page 8 of the Appeal Brief);
Decision 24 (quoting Patent Owner’s argument on pages 20 and 24 of the
Appeal Brief). This finding also appears to be the understanding of the
Examiner. See Decision 9 (quoting page 9 of the Right of Appeal Notice
(RAN) discussing random variation inherent in plant breeding that would
have been expected by the skilled artisan) (citing Kinney Declaration ¶¶ 12,
16). Accordingly, we noted in our Decision on appeal that “[t]o 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
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should be narrowed to reflect the specific genetic modification. The claims
in this case appear broader than the particular genetic modifications
described.” Decision 15 (emphasis added). The Patent Owner does not
dispute our findings regarding unpredictability in the art.
The Specification of the ’057 patent only describes loss-of-function
mutations in three FAD3 genes, namely FAD3-1A, FAD3-1B and FAD3-
1C. See ’818 patent, see col. 11, l. 66 to col. 12, l. 8, and SEQ ID Nos. 7-27,
identifying nucleic acid sequences for intron and partial genetic clones for
only FAD3-1A, FAD3-1B, and FAD3-1C genes in the FAD3 gene family.4
As discussed above, mutations in only two loss-of-function FAD3 genes was
shown. More importantly, the Specification does not show that the inventors
were in possession of a hypothetical selfed plant having a genotype
including loss of function mutations in more FAD3 genes than those FAD3
genes that are specifically exemplified. Nor is there evidence that, in this
unpredictable art, the skilled artisan predictably would have known the fatty
acid content of such a hypothetical plant. To satisfy the written description
requirement, the specification must do more than merely invite other

4 While there may be some natural and inherent upper limit to the scope of
the term “at least two FAD3 genes” that would have been recognized by the
skilled artisan, e.g., because of the number of endogenous FAD3 genes, such
a natural limit is not reflected in the specification, and more critically, there
is no indication of achieving the recited narrow fatty acid composition with
some inherent, albeit not precisely known, upper limit. “[O]pen-ended
claims are not inherently improper; as for all claims their appropriateness
depends on the particular facts of the invention, the disclosure, and the prior
art. They may be supported if there is an inherent, albeit not precisely
known, upper limit and the specification enables one of skill in the art to
approach that limit.” Andersen Corp. v. Fiber Composites, LLC, 474 F.3d
1361, 1376–77 (Fed. Cir. 2007).
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researchers to discover additional loss of function mutations in other FAD3
genes that could conceivably produce plants with the narrow seed fatty acid
content ranges recited in the claims. See Boston Sci. Corp. v. Johnson &
Johnson, 647 F.3d 1353, 1367 (Fed. Cir. 2011) (“The patent laws do not
reward an inventor's invitation to other researchers to discover which of the
thousands of macrocyclic lactone analogs of rapamycin could conceivably
work in a drug-eluting stent.”). Our decision emphasized limiting the claim
scope to only those mutations for which the claimed fatty acid content was
demonstrably achievable.
Accordingly, the Specification does not provide written descriptive
support for a method of obtaining the recited seed fatty acid content with the
entire scope of endogenous genetic mutations encompassed by claim 1.
Claim 2
Claim 2 suffers from the same problem as claim 1. Claim 2 has been
amended to recite a plant having the same seed fatty acid content but further
having loss of function mutations in at least three endogenous soybean
FAD3 genes. As with claim 1, claim 2 recites no upper limit to the number
of endogenous soybean FAD3 genes that contain loss of function mutations.
The Specification does not provide written descriptive support that providing
loss of function mutations in four or more FAD3 genes would have provided
the precise fatty acid content recited in the claims.
Further, the Examples of the ’818 patent lack written descriptive
support for achieving the recited fatty acid content in a plant that is
homozygous both for (i) the transgene that decreases the expression of the
endogenous soybean FAD2-1 gene and (ii) loss-of-function mutations in
three endogenous soybean FAD3 genes, which is the minimum number of
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mutations in FAD3 genes recited in claim 2. Accordingly, the Specification
does not provide written descriptive support for a method of obtaining the
recited seed fatty acid content within the entire scope of endogenous genetic
mutations encompassed by the scope of claim 2.
Claim 33
Claim 33 suffers from the same problem as claim 1. Claim 33 has
been amended to recite a plant having the same seed fatty acid content but
further having loss of function mutations in at least two endogenous soybean
FAD3 genes. As with claim 1, claim 33 recites no upper limit to the number
of endogenous soybean FAD3 genes that contain loss of function mutations.
The Specification does not provide written descriptive support that providing
loss of function mutations in four or more FAD3 genes would have provided
the precise fatty acid content recited in the claims. Accordingly, the
Specification does not provide written descriptive support for a method of
obtaining the recited seed fatty acid content within the entire scope of
endogenous genetic mutations encompassed by the scope of claim 33.
Claim 34
Claim 34 suffers from the same problem as claim 1. Claim 34 has
been amended to recite a plant having the same seed fatty acid content and
further having loss of function mutations in at least three endogenous
soybean FAD3 genes. As with claim 1, claim 34 recites no upper limit to
the number of endogenous soybean FAD3 genes that contain loss of function
mutations. The Specification does not provide written descriptive support
that providing loss of function mutations in four or more FAD3 genes would
have provided the precise fatty acid content recited in the claims.
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Dependent claims having written descriptive support
Claims 3 and 7 depend directly or indirectly from claim 1 and further
recite that the endogenous soybean FAD3 genes with loss of function
mutations are the FAD3-1B and FAD3-1C genes. As noted above, Example
9 describes a method of 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 homozygous both for (i) the transgene
that decreases the expression of the endogenous soybean FAD2-1 gene and
(ii) loss-of-function mutations in two endogenous soybean FAD3 genes,
specifically the FAD3-1B and FAD3-1C genes. Because claims 3 and 7
narrow the scope of claim 1 to particular FAD3-1B and FAD3-1C genes that
is consistent with Example 9 of the ’818 patent, we determine that claims 3
and 7 have written descriptive support.
Similarly, claims 35 depends directly from claim 33 and further
recites that the endogenous soybean FAD3 genes with loss of function
mutations are the FAD3-1B and FAD3-1C genes. As noted above, Example
10 has written description support for a method of 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 homozygous for (i)
the transgene that decreases the expression of (a) the endogenous soybean
FAD2-1 gene and (b) the endogenous soybean FATB gene, and (ii) loss-of-
function mutations in two endogenous soybean FAD3 genes, specifically the
FAD3-1B and FAD3-1C genes. Because claim 35 narrows the scope of
claim 33 to particular FAD3-1B and FAD31-C genes that is consistent with
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Example 10 of the ’818 patent, we determine that claim 35 has written
descriptive support.
Thus, claims 3, 7, and 35 overcome the rejection based on 35 U.S.C.
§ 112, first paragraph, for lack of written descriptive support.
D. Enablement
The scope of claims 1, 2, 33, and 34 discussed above encompass loss
of function mutations in more FAD3 gene that are expressly enabled by the
’818 patent. We discuss in our Decision that due to the unpredictability in
the art, supported by the arguments and evidence of record in this case as
well as similar holdings in Genentech Inc. v. Novo Nordisk A/S, 108 F.3d
1361, 1367 (Fed. Cir. 1997), that “[w]here there is such uncertainty, a
disclosure may require specific working examples to be enabling.” Because
there are no specific examples for the entire scope of the claimed invention,
specifically examples where loss of function mutations in four or more
FAD3 genes will produce plants with the specific fatty acid content recited
in the claims, the claims are not enabled for the entire scope of the claimed
invention. See In re Fisher, 427 F.2d 833, 839 (CCPA 1970) (“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 the present
case we must conclude, on the record before us, that appellant has not
enabled the preparation of ACTHs having potencies much greater than 2.3,
and the claim recitations of potency of ‘at least 1’ render the claims
insufficiently supported under the first paragraph of 35 U.S.C. § 112.”).
Thus, these claims, and the claims that depend therefrom having similar
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scope, do no overcome the rejection under 35 U.S.C. § 112, 1st paragraph,
based on enablement.
However, as noted above, claims 3, 7, and 35 are narrowed to the loss
of function mutations of the specific FAD3 genes described in Examples 9
and 10 respective and have been shown to produce a plant have the fatty
acid content recited in the claims. Accordingly, one of ordinary skill in the
art would be enabled to make the plant recited in claims 3, 7, and 35 from
the ’818 patent.

III. CONCLUSION
For the reasons discussed above, we maintain the following rejections:
1. Claims 1–2, 5–6, 8–11, 16–19, 21–31, 33–34, 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
2. Claims 1–2, 5–6, 8–11, 16–19, 21–31, 33–34, 37–39, 44–59, 61,
62, 65–69, and 73–77 under 35 U.S.C. § 112, first paragraph, for
lack of enablement.
We do not maintain the following rejection:
1. Claims 3, 7, and 35 under 35 U.S.C. § 112, first paragraph, for lack
of written description and
2. Claims 3, 7, and 35 under 35 U.S.C. § 112, first paragraph, for lack
of enablement.
Appeal 2020-003200
Reexamination Control 95/000,690
Patent 7,943,818 B2

18
In summary:

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED-IN-PART

mp
Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Ba
sis
Affirmed Reversed
1–3, 5–11,
16–19, 21–
31, 33–35,
37–39, 44–
59, 61, 62,
65–69, 73–
77
112, first
paragraph
Written
description
1, 2, 5–6,
8–11, 16–
19, 21–31,
33–34, 37–
39, 44–59,
61, 62, 65–
69, 73–77
3, 7, 35
1–3, 5–11,
16–19, 21–
31, 33-35,
37–39, 44–
59, 61, 62,
65–69, 73–
77
112, first
paragraph
Enablement 1, 2, 5–6,
8–11, 16–
19, 21–31,
33–34, 37-
39, 44–59,
61, 62, 65–
69, 73–77
3, 7, 35
Overall
Outcome
1, 2, 5–6,
8–11, 16–
19, 21–31,
33–34, 37–
39, 44–59,
61, 62, 65–
69, 73–77
3, 7, 35
Appeal 2020-003200
Reexamination Control 95/000,690
Patent 7,943,818 B2

19
FOR PATENT OWNER:

DENTONS US LLP
P.O. Box 061080
Chicago, IL 60606-1080

FOR THIRD PARTY REQUESTER:

DICKSTEIN SHAPIRO LLP
1825 Eye Street N.W.
Washington, DC 20006-5403