Commonwealth Scientific and Industrial Research Organisation

Patent Trials and Appeals Board

Mar 8, 2021

2020004726 (P.T.A.B. Mar. 8, 2021)

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.
14/910,577 02/05/2016 Stephen Alan Jobling 88361/JPW/GJG/DH 1623
23432 7590 03/08/2021
COOPER & DUNHAM LLP
90 PARK AVENUE, 21 ST. FLOOR
NEW YORK, NY 10016
EXAMINER
DEVEAU ROSEN, JASON
ART UNIT PAPER NUMBER
1662
NOTIFICATION DATE DELIVERY MODE
03/08/2021 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
DUSPTO@cooperdunham.com
patcomm-in-grp@cooperdunham.com
pdocketing@cooperdunham.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEPHEN ALAN JOBLING,
DAMIEN PAUL BELOBRAJDIC, and
ANTHONY RICHARD BIRD1
Appeal 2020-004726
Application 14/910,577
Technology Center 1600
Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and
FRANCISCO C. PRATS, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims
related to transgenic wheat, which have been rejected as obvious. We
have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 Appellant identifies the real party in interest as Commonwealth
Scientific and Industrial Research Organisation (“CSIRO”). Appeal Br.
4. We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42.
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Application 14/910,577

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STATEMENT OF THE CASE
“The present invention relates to transformed wheat having high
levels of beta-glucan and the use of this wheat.” Spec.2 ¶ 1. The
Specification states that “wheat grain has relatively low BG [β-glucan]
levels, much lower than barley or oats. . . . There is [a] need for wheat
with increased levels of BG, in particular with increased levels of
water-extractable (soluble) BG, for improved nutritional functionality.”
Id. ¶¶ 9–10.
BG from each cereal grain has a characteristic and
different fine structure as indicated by digestion with
lichenase and separation of the oligosaccharides by
HPLC. Lichenase specifically cleaves BG at a (β,1-4)
linkage after a (β,1-3) linkage releasing mainly
oligosaccharides of degree of polymerisation (DP3 and
DP4, having 3 and 4 glucosyl units, respectively).
Id. ¶ 5.
“Some of the genes involved in BG biosynthesis have recently
been identified as belonging to the cellulose-synthase-like CslF and
CslH gene families.” Spec. ¶ 7. “Overexpression of the endogenous
barley HvCslF6 gene in an endosperm specific manner was shown to
increase BG levels by up to 80% in transgenic barley.” Id. ¶ 8. The
Specification states that “wheat contains an endogenous CslF6 gene
that is functional. However, it is not known which genes might be
needed to be expressed in order to increase BG levels in wheat.” Id.
Claims 1, 5, 7, 11–13, 15, 17–20, 22, 27, 29, 35, 38, 47, and 59–
66 are on appeal. Claim 1, reproduced below, is illustrative:

2 Substitute Specification filed Jan. 16, 2018.
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1. Transgenic wheat grain comprising an exogenous
polynucleotide which encodes a CslF6 polypeptide, and
comprising between 3% and 8% (w/w) (1,3;1,4)-β-D-glucan
(BG) which is characterised by one or both of:
a) a DP3/DP4 ratio between 1.0 and 2.3; and
b) partial water solubility such that between 8.0% and
25% of the BG of the grain is water soluble, as
determined by a method that comprises treatment of a
sample of wholemeal flour obtained from the grain
with (i) 80% ethanol for 1 hour at 80°C, followed by
(ii) solubilisation of BG in aqueous buffer for 2 hours
at 37°C, and (iii) determination of the level of BG
solubilised from the sample.

The claims stand rejected as follows:
Claims 1, 5, 7, 12, 13, 15, 17–20, 22, 27, 29, 35, 38, 47, and 59–
66 under 35 U.S.C. § 103 as obvious based on Nemeth,3 Cseh,4 and
Burton5 (Ans. 3) and
Claims 1 and 11 under 35 U.S.C. § 103 as obvious based on
Nemeth, Cseh, Burton, and Doblin6 (Ans. 8).

3 Csilla Nemeth et al., Down-Regulation of the CSLF6 Gene Results in
Decreased (1,3;1,4)-β-D-Glucan in Endosperm of Wheat, Plant
Physiology 152:1209–18 (2010).
4 A. Cseh et al., Expression of HvCslF9 and HvCslF6 barley genes in
the genetic background of wheat and their influence on the wheat
β-glucan content, Ann. Appl. Biol. 163:142–50 (2013).
5 Rachel A. Burton et al., Over-expression of specific HvCslF cellulose
synthase-like genes in transgenic barley increases the levels of cell
wall (1,3;1,4)-β-D-glucans and alters their fine structure, Plant
Biotechnology Journal 9:117–35 (2011).
6 Doblin et al., US 2011/0107467 A1, iss. May 5, 2011.
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OPINION
Obviousness based on Nemeth, Cseh, and Burton
All of the claims except claim 11 stand rejected as obvious
based on Nemeth, Cseh, and Burton. The Examiner finds that “Nemeth
teaches the identification of the CSLF6 gene in wheat as a putative BG
synthase and confirmed its function by RNAi suppression.” Ans. 4.
“Nemeth specifically teaches that CSLF6 plays a major role in
mediating BG synthesis in developing grain and hence a key target for
manipulation to increase total BG.” Id. at 5.
The Examiner also finds that “Nemeth teaches that BG has the
benefit of reducing coronary heart disease in food products and that
transgenic manipulation can be used to modify the amounts and
properties of BG in wheat to enhance the health benefits.” Ans. 5.
However, the Examiner finds that Nemeth “fails to teach expressing an
exogenous/transgenic polynucleotide encoding a CslF6 polypeptide.”
Id.
“Cseh teaches that the BG contents of bulked wheat grain in the
‘1HS’ addition line and the ‘7H’ addition line was 7.88 mg g-1 and
10.21 mg g-1, respectively, as compared to control line ‘Mv9Kr1’
wheat line having 6.43 mg g-1.” Ans. 5. “Addition lines 1HS and 7H
are wheat plants carrying barley CslF9 and CslF6 genes, respectively.”
Id.
The Examiner finds that “Burton . . . teaches the overexpression
of CslF in transgenic barley increases BG content.” Ans. 6. “Under the
control of . . . the ‘ProASGLO’ grain specific promoter . . . , CslF6
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expression led to increases in grain BG content in the endosperm of
grain.” Id. The Examiner finds that “the grain had an average of 6.8%
(w/w) BG with a high of 7.8% (w/w) BG, equaling an average of 2.7%
(w/w) more grain BG when compared to control grain comprising
roughly 4.0% (w/w) BG.” Id. “Moreover, the DP3/DP4 ratio was
observed to decrease from about 2.6 to 2.1.” Id.
The Examiner concludes that it would have been obvious “to
modify the method as taught by Nemeth by overexpressing a
polynucleotide encoding a CslF6 polypeptide rather than inhibiting
expression of the gene encoding said polypeptide,” reasoning that
“[o]ne would be motivated to do so because the art recognizes the
importance of increasing the BG content of wheat grain and because
Nemeth explicitly suggests increasing the amounts and characteristics
of BG in wheat.” Ans. 7.
The Examiner finds that
[o]ne would have a reasonable expectation of success in
doing so because Cseh teaches that it is possible to
significantly increase BG content in the grain of wheat
plants by introducing an additional CslF6 gene, and
because Burton teaches that transformation of plants with
a CslF6 gene can, in fact, increase BG content.
Ans. 7. The Examiner also reasons that the wheat grain resulting from
the combined references
would be structurally indistinguishable from the claimed
transgenic wheat grain because the only requirement of
the instant claims is that wheat grain comprise an
exogenous polynucleotide encoding a CslF6 polypeptide,
and would therefore necessarily have between 3% and 8%
(w/w) BG characterized by a DP3/DP4 ratio between 1.0
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and 2.3 and/or that is partially water soluble such that
between 8.0% and 25% of the BG grain is water soluble.
Id. at 8.
Appellant argues that, although “the Examiner relies of the
allegation that wheat grain comprising an exogenous polynucleotide
which encodes a CslF6 polypeptide necessarily has between 3% and
8% (w/w) (1,3;1,4)-β-D-glucan (BG)[, the] data presented in the
subject specification shows that this is not the case.” Appeal Br. 13.
Appellant points out that the Specification’s Figures 6 and 7 show
results for individual wheat grains “transformed with a chimeric gene
for expression of HvCslF6 [barley CslF6],” and demonstrate that they
“do not necessarily have between 3% and 8% BG.” Id. at 13–15.
Appellant also argues that a skilled artisan “would not have had
a reasonable expectation of successfully producing wheat grain
comprising between 3% and 8% (w/w) (BG) as recited in the claims.”
Appeal Br. 18. Appellant cites the Jobling Declaration7 as evidence
that “a POSA [person of skill in the art] would not have expected to
achieve between 3% and 8% β-glucan content (w/w) in wheat grain at
the effective filing date of the subject application.” Id. at 19. “In
summary, the art cited by the Examiner suggested that transgenically
expressing a CslF6 polypeptide in wheat produces only moderate
increases in β-glucan content in wheat grain, which would result in
wheat grain with a β-glucan content far lower than the 3% to 8% (w/w)
recited in the claims.” Id.

7 Declaration under 37 C.F.R. § 1.132 of Stephen Alan Jobling, filed
Jan. 22, 2019.
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We will reverse the rejection. While we agree with the Examiner
that the cited references would have provided a reason to make
transgenic wheat expressing the barley CslF6 gene, we agree with
Appellant that a preponderance of the evidence does not show that a
skilled artisan would have reasonably expected the resulting transgenic
wheat to produce grain with a β-glucan level of 3–8%.
As the Examiner correctly found, Nemeth teaches that
“TaCSLF6 [wheat CslF6 gene] plays a major role in mediating
β-glucan synthesis in developing grain of wheat and hence [is] a key
target for manipulation to increase or decrease total β-glucan.” Nemeth
1216, left–right cols. Nemeth, however, does not demonstrate any
increased β-glucan level in wheat; rather, it shows that inhibition of
CslF6 by RNA inhibition (RNAi) (id. at 1210, left col.) resulted in a
42% decrease in β-glucan content (id. at 1212, left col.).
Cseh discloses a wheat line (“7H”) containing the barley
chromosome that includes the barley CslF6 gene. See Cseh 143, right
col. (“The aim of this study was to investigate the effect of the
HvCslF6 and HvCslF9 barley genes on the β-glucan content . . . with
the help of the winter wheat/winter barley 7H . . . and 1HS . . . lines,
respectively.”); id. at 145, left col. (“The presence of two added barley
chromosomes was confirmed . . . in 10 plants of the [wheat/barley] 7H
disomic addition line.”). “[T]he HvCslF6 gene was normally
transcribed at relatively high levels.” Id. at 142, Abstract.
Cseh reports that “[t]he β-glucan level (mg g-1 grain) was 6.43
mg g-1 in the [parental] wheat line and approximately eight times
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higher in the [parental] barley cultivar (49.82 mg g-1).” Cseh 146, right
col. By contrast, the β-glucan content of “the 7H addition line [was]
10.21 mg g-1.” Id. Cseh concludes that the barley CslF6 gene
“significantly increased both the leaf and grain β-glucan content in the
wheat background.” Id. at 147, left–right cols. “Nevertheless, despite
an increase of 60% compared to the control wheat, the β-glucan
content in the grains of the 7H addition line only reached 1/5 of that of
barley.” Id. at 147, right col. Cseh thus teaches that expression of the
barley CslF6 gene in wheat, at relatively high levels, resulted in a 60%
increase in β-glucan content.
Burton states that “we have transformed barley with selected
barley CslF cDNAs, driven . . . by an oat globulin promoter
(ProASGLO), in attempts to increase (1,3;1,4)-β-D-glucan levels in
grain.” Burton 118, right col. Burton reports that “[o]ver-expression of
the barley CslF6 gene under the control of an endosperm-specific oat
globulin promoter results in increases of more than 80% in (1,3;1,4)-β-
D-glucan content in grain of transgenic barley.” Id. at 117, Summary.
In summary, Cseh discloses that expression of the barley CslF6
gene in wheat, “normally transcribed at relatively high levels” (Cseh
142, Abstract), resulted in a 60% increase in β-glucan content in grain.
Burton discloses that overexpression of the barley CslF6 gene in barley
resulted in an 80% increase in β-glucan content in grain. A skilled
artisan might therefore have reasonably expected that overexpression
of the barley CslF6 gene in wheat would result in a 60–80% increase in
β-glucan content in the wheat grain.
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The evidence of record, however, shows that the β-glucan
content in wild-type wheat grain is 1% (w/w) or less. The Specification
states that “BG content of wild-type whole wheat grain was about
0.6% on a weight basis, compared to about 4.2% for barley, 3.9% for
oats and 2.5% for rye.” Spec. ¶ 73. See also Cseh 143, left col.
(“Gebruers et al. (2008) reported that the mean β-glucan content in the
wholemeal of the 150 HEALTHGRAIN wheat lines ranged from 0.5%
to 0.9%.”). Cseh also reports that the grain of the parental wheat line
(“Mv9kr1”) used in its experiment had a β-glucan content of 6.43 mg
per gram, or 0.643% (w/w). Cseh 146, right col.
Consistent with these statements, Dr. Jobling declared that “[t]he
level of β-glucan in wheat grain is typically well below 1% (w/w).”
Jobling Decl. ¶ 9. Dr. Jobling also declared that “[t]he highest level of
β-glucan in non-transgenic wheat varieties barely exceeds 1% (w/w)”
and, to his knowledge, “the highest level of β-glucan content achieved
by others in wheat grain at the effective filing date was around 1%
(w/w).” Id.
Dr. Jobling acknowledged that Cseh discloses that the β-glucan
content of grain from its “7H addition line was about 59% higher than
the β-glucan content of the parental wheat line” and Burton disclosed
increased β-glucan content of around 80% with overexpression of the
barley CslF6 gene. Jobling Decl. ¶¶ 6, 7. The evidence of record thus
supports Dr. Jobling’s position that “[t]he art cited by the Examiner
suggested that transgenically expressing a CslF6 polypeptide[] in
wheat produces only moderate increases in β-glucan content in wheat
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grain, resulting in wheat grain with a β-glucan content far lower than
3% to 8% (w/w) as recited in the claims.” Id. ¶ 8.
That is, because wild-type wheat grain has a β-glucan content of
1% (w/w) at most, a 60–80% increase would only result in a β-glucan
content of 1.6–1.8% (w/w), not 3–8% (w/w) as required by the claims.
Thus, the Examiner’s position that a skilled artisan would have
reasonably expected to achieve the claimed wheat grain by combining
the teachings of Nemeth, Cseh, and Burton is not supported by a
preponderance of the evidence of record.
The Examiner, however, reasons that “Cesh [sic] teaches wheat
addition lines,” with the barley CslF6 gene under the control of its
native promoter, but
if one of ordinary skill in the art were to follow the
teachings of Burton by instead over-expressing an
exogenous polynucleotide which encodes a CslF6
polypeptide, then it would be expected that the grain
would have greater levels of CslF6 polypeptide and, in
turn, a greater percentage of BG in the grain as compared
to that as taught by Cesh [sic].
Ans. 20–21. Thus, the Examiner concludes that “one would reasonably
expect the BG percentage as claimed.” Id. at 20.
We cannot agree with this reasoning. Cseh notes that, “despite
an increase of 60% compared to the control wheat, the β-glucan
content in the grains of the 7H addition line only reached 1/5 of that of
barley.” Cseh 147, right col. Cseh also notes Burton’s results obtained
by overexpressing barley CslF6 in barley under control of the ASGLO
promoter, as well as Nemeth’s results when wheat CslF6 is inhibited.
Id.
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Thus, Cseh itself considered all of the references cited by the
Examiner, and does not suggest that simply overexpressing barley
CslF6 in wheat would result in higher β-glucan content. Rather, Cseh
concludes that Burton’s and Nemeth’s findings, “together with the
present results indicate that the cellulose synthase-like F gene
subfamily is not responsible alone for the entire β-glucan synthesis in
the developing grain, but that other genes, transcription factors or
regulatory mechanisms might also participate in the process.” Cseh
147, right col. The record therefore indicates that those skilled in the
art would not have expected to achieve 3–8% β-glucan content (w/w)
in wheat grain by over-expressing barley CslF6 in transgenic wheat.
The Examiner also reasons that the β-glucan content recited in
the claims would be inherent in the transgenic wheat suggested by the
combined references:
[T]he combination of cited references clearly provides
teachings, suggestions and motivation to arrive at a wheat
grain that is structurally indistinguishable from that which
is claimed: a transgenic wheat grain comprising an
exogenous polynucleotide which encodes a CslF6
polypeptide and which is under the control of a grain
specific promoter.
Coupled with the scientific finding that transgenic barley
grain as taught by Burton and comprising an exogenous
polynucleotide encoding a CslF6 polypeptide comprises
the BG content as claimed . . . and that the fact that CslF
genes appear to have the same function in both barley and
wheat, one of ordinary skill in the art would have
recognized that said grain would necessarily have the
features as recited in the instant claims.
Ans. 13–14 (emphasis added).
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As Appellant has shown, however, this finding is not consistent
with the evidence of record. Appellant has pointed to the
Specification’s Figures 6 and 7 (Appeal Br. 13–15), which show an
“[a]nalysis of the BG levels in mature single T2 grains” and “[t]he BG
content in the T3 grain,” respectively, for different transgenic wheat
lines. Spec. ¶¶ 243–244. Figures 6 and 7 show that many, indeed most,
of the grains from the different lines had β-glucan contents below 3%
(w/w). Consistent with the Specification, Burton shows that
overexpression of barley CslF6 in barley results in a range of β-glucan
content in the barley grain. See Burton 126, Fig. 7 (showing “Min,”
“Mean,” and “Max” β-glucan levels for the CslF6 (“F6”) grain). The
evidence thus shows that grain with a β-glucan content between 3%
and 8% (w/w) does not necessarily result when a barley CslF6 gene is
expressed in wheat.
In summary, a preponderance of the evidence of record does not
support a reasonable expectation that a β-glucan content of 3–8%
(w/w) in wheat grain would result from expressing the barley CslF6
gene in transgenic wheat. The cited references therefore do not support
a prima facie case of obviousness. The rejection under 35 U.S.C. § 103
based on Nemeth, Cseh, and Burton is reversed.
Obviousness based on Nemeth, Cseh, Burton, and Doblin
Claims 1 and 11 stand rejected as obvious based on Nemeth,
Cseh, Burton, and Doblin. The Examiner relies on Nemeth, Cseh, and
Burton for the same teachings discussed above, and concludes that “the
combination of these prior art references reasonably teaches and
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provides motivation for making a transgenic wheat plant comprising an
exogenous polynucleotide encoding a CslF polypeptide.” Ans. 9. The
Examiner cites Doblin only for teaching “transgenic lines expressing
CslH and CslF” in combination. Id.
Thus, the Examiner does not point to any disclosure in Doblin
that would provide a reasonable expectation of achieving a 3–8%
(w/w) β-glucan level in transgenic wheat grain, expressing either
CslF6 alone or in combination with a CslH polypeptide. Because the
Examiner has not shown that Doblin makes up for the deficiency in
Nemeth, Cseh, and Burton, we reverse the rejection of claims 1 and 11
under 35 U.S.C. § 103 based on Nemeth, Cseh, Burton, and Doblin.
DECISION SUMMARY
In summary:
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 5, 7, 12,
13, 15, 17–
20, 22, 27,
29, 35, 38,
47, 59–66
103 Nemeth, Cseh, Burton 1, 5, 7, 12,
13, 15, 17–
20, 22, 27,
29, 35, 38,
47, 59–66
1, 11 103 Nemeth, Cseh, Burton,
Doblin
1, 11
Overall
Outcome
1, 5, 7, 11–
13, 15, 17–
20, 22, 27,
29, 35, 38,
47, 59–66
REVERSED