Ex Parte Dan et al

Patent Trial and Appeal Board

Jan 30, 2014

10715910 (P.T.A.B. Jan. 30, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte YINGHUI DAN, TICHAFA R. I. MUNYIKWA,
KIMBERLY A. RAYFORD, and CAIUS M. T. ROMMENS
____________

Appeal 2012-008847
Application1 10/715,910
Technology Center 1600
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Before ERICA A. FRANKLIN, ULRIKE W. JENKS, and
ZHENYU YANG, Administrative Patent Judges.

JENKS, Administrative Patent Judge

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to
introducing nucleic acid sequences into plant cells. The Examiner has
rejected the claims as being indefinite and obvious. We have jurisdiction
under 35 U.S.C. § 6(b). We affirm.

1 Appellants identify Monsanto Company as the Real Party in Interest (App.
Br. 2).
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STATEMENT OF THE CASE
The Specification discloses “transforming dicotyledonous and
monocotyledonous plant tissue and regenerating fertile transgenic plants
therefrom comprising the inclusion of an effective amount of lipoic acid or
an analog thereof in at least one of the plant transformation media during the
transformation and/or regeneration process.” (Spec. 4, ll. 3-7.)
Claims 1-4, 15-18, and 22 are on appeal, and can be found in the
Claims Appendix Appeal Brief. Claim 1 is representative of the claims on
appeal and reads as follows:
1. A method for introducing a nucleic acid sequence into the
genome of a plant cell and regenerating a transformed plant
therefrom, said method comprising:
a) transforming a plant cell; and
b) regenerating a transformed plant therefrom, wherein
the transforming and/or regenerating comprises culturing said
plant cell on at least one plant transformation media, said at
least one plant transformation media comprising an amount of
lipoic acid or an analog thereof effective for increasing the
efficiency of the transformation and/or regeneration of a plant
therefrom, relative to a plant transformed and/or regenerated in
the absence of lipoic acid or an analog thereof.
The following grounds of rejection are before us for review:
A. Claim 15 stands rejected under 35 U.S.C. § 112, second
paragraph as being indefinite (Ans. 5).
B. Claims 1-4 and 17 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Enríquez-Obregón2 in view of Packer3 (Ans. 5).

2 Gil A Enríquez-Obregón et al., Genetic Transformation of Sugarcane by
Agrobacterium tumefaciens using antioxidant compounds, 14
BIOTECNOLOGIA APLICADA 169-174 (1997).
3 Lester Packer et al., Alpha-Lipoic Acid as a Biological Antioxidant, 19
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C. Claims 1-4 and 16 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Peri4 in view of Packer (Ans. 6).
D. Claims 1-3 and 17 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Cai5 in view of Packer (Ans. 7).
E. Claim 1-3, 15-16, 18, and 22 stand rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Olhoft6 in view of Packer (Ans. 8).
F. Claim 1-4 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Ciccarone7 (Ans. 9).

A. Indefiniteness
The Examiner takes the position that claim 15 is indefinite because
the “explant” is transformed and not the “plant cell” as recited in parent
claim 1 (Ans. 5).
Appellants contend that “[e]xplants inherently and necessarily are
comprised of cells (a feature of claim 1).” (Reply Br. 5; see also App. Br.
6). Accordingly, “[t]ransforming an explant thus necessarily and inherently
includes transformation of a cell” (App. Br. 6).
We find that Appellants have the better position. “The standard of
indefiniteness is somewhat high; a claim is not indefinite merely because its
scope is not ascertainable from the face of the claims.” Amgen, Inc. v.

FREE RADICAL BIOLOGY & MEDICINE 227-250 (1995).
4 Avihai Peri et al., Establishment of an Agrobacterium-mediated
transformation system for grape (Vitis vinifera L.): The role of antioxidants
during grape- Agrobacterium interactions, 14 NATURE BIOTECHNOLOGY
624-628 (1996).
5 Tishu Cai et al., US 6,369,298 B1, issued Apr. 9, 2002.
6 Paula Olhoft et al., US 2001/0034888 Al, published Oct. 25, 2001.
7 Valentina C. Ciccarone et al., US 2003/0096414 Al, published May 22,
2003.
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Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1342 (Fed. Cir. 2003).
Rather, “[a] claim is indefinite if, when read in light of the specification, it
does not reasonably apprise those skilled in the art of the scope of the
invention.” Id. Here, the Specification provides that the disclosed method is
suitable for “transforming a plant cell, tissue or other suitable explant
[material] and regenerating a transformed plant therefrom.” (Spec. 3, ll. 12-
13.) Thus, the Specification refers to cells or tissues in relation to explant
material, which is consistent with the use of the term explant in the art.
Accordingly, we agree with Appellants that explants are essentially a
collection of cells. As such, the transformation of an explant would involve
transforming the underlying cells.
We reverse the rejection of claim 15 as being indefinite.

B-F. Obviousness
For the obviousness rejections, the Examiner takes the position that
“the antioxidants in the prior art [e.g., each of Enríquez-Obregón, Peri, Cai,
Olhoft] increased explant viability and transformation efficiencies at the
same concentrations” as those claimed for lipoic acid (Ans. 13; see also id.
at 10, 17). The Examiner combined this teaching of each of the references
with Packer, a reference that teaches lipoic acid is not only an antioxidant
but is considered an ideal antioxidant (id. at. 6-8). The Examiner reasoned
that “[s]ubstitution of one antioxidant for another is obvious.” (id. at 14.)
With regard to the rejection based on Ciccarone, the Examiner finds that the
reference discloses the transformation of plant cells using lipoic acid in the
culture media and reasons that regeneration of the transformed cells into a
whole plant would have been obvious (id. at 9).
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The issue is: Does the preponderance of evidence support the
Examiner’s conclusion that the combination of references renders the claims
obvious, and if so, have Appellants provided sufficient rebuttal or evidence
of unexpected results to overcome the Examiner’s prima facie case?
Appellants argued all of the obviousness rejections together,
contending that the claimed invention provides unexpected results not
related to antioxidant activity (App. Br. 7-13). According to Appellants,
“[t]he claimed method has been demonstrated to yield substantially
improved plant transformation efficiencies at lipoic acid concentrations at
which no appreciable antioxidant activity is observed. Thus, the results of
the cited references and the claimed method are not similar.” (Reply Br. 7.)
Specifically, Appellants contend that:
[T]he claimed methods provide for enhanced transformation
efficiency using lipoic acid at levels below that at which
appreciable antioxidant activity is detected. Specifically, Dr.
Duncan explains that no to negligible antioxidant activity was
detected at lipoic acid concentrations up to 100μM in an assay
to detect antioxidant activity, and concluded that “...the
significant benefits provided by use of lipoic acid for plant
transformation are not based on antioxidant activity of lipoic
acid.”
(Reply Br. 8-9.)
After considering the evidence and the arguments, we conclude the
evidence favors the Examiner’s conclusion of obviousness. Accordingly, we
adopt the Examiner’s reasoning (see Grounds of Rejection, Ans. 5-10), and
agree that the Examiner properly found Appellants’ arguments unpersuasive
(see Response to Argument, Ans. 10-17). We provide the following points
for emphasis.
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“In United States v. Adams, . . . [t]he Court recognized that when a
patent claims a structure already known in the prior art that is altered by the
mere substitution of one element for another known in the field, the
combination must do more than yield a predictable result.” KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 416 (2007). Indeed, an “[e]xpress suggestion to
substitute one equivalent for another need not be present to render such
substitution obvious.” In re Fout, 675 F.2d 297, 301 (CCPA 1982); see also
In re Mayne, 104 F.3d 1339, 1340 (Fed. Cir. 1997) (“Because the applicants
merely substituted one element known in the art for a known equivalent, this
court affirms [the rejection for obviousness].”).
The Examiner finds that the art showed:
[T]hat antioxidants increased explant viability and
transformation efficiencies. The prior art also taught [that]
lipoic acid is the ideal antioxidant (Packer et al, pg 228, right
column, paragraph 2). One of skill in the art would be
motivated to substitute an ideal antioxidant for another
antioxidant in plant transformation. The actual mechanism of
action of lipoic acid is not relevant.
(Ans. 16.) We agree with the Examiner’s conclusion that it would have been
obvious to substitute one antioxidant for another (id. at 14). Because the
Examiner presents a prima facie case of obviousness, we consider whether
Appellants submit sufficient evidence or argument in rebuttal. In re
Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993).
Appellants contend that the invention provides unexpected results not
related to antioxidant activity (App. Br. 7-13). Appellants refer to the
Duncan8 declaration in support of this contention. In the declaration, Dr.
Duncan discusses the results of an antioxidant assay in the presence of

8 Declaration of Dr. David Duncan, submitted March 9, 2011.
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increasing concentrations of lipoic acid (Decl. ¶ 7). According to Dr.
Duncan, “[t]hese results demonstrate that the substantial benefits observed
from use of lipoic acid during plant transformation are not based on
antioxidant activity” (Id.).
According to the Examiner, the evidence presented by Appellants is
not persuasive (Ans. 10-17). With respect to Dr. Duncan’s declaration, the
Examiner notes that the declaration does not “show that other antioxidants
had antioxidant activity at the level normally incorporated in plant tissue
culture compared to lipoic acid at the same amounts” (Ans. 10). We agree
with the Examiner’s position that without comparing other antioxidants next
to lipoic acid in the same assay system, it is not possible to determine
whether the lack of antioxidant activity at the lower concentrations is merely
an artifact of the assay.
Even if the effect of lipoic acid on transformation efficiency acts by
some mechanism other than through antioxidant activity, as asserted by
Appellants, the Duncan declaration does not undermine the Examiner’s
reason for combining the references, namely, that it would have been
obvious to substitute one known antioxidant for another. The declaration
shows that lipoic acid above 100 μM possess antioxidant activity (Dec. ¶ 7;
see also Reply Br. 11). The Examiner reiterates that the prior art disclosed
using antioxidants at concentrations ranging from “85 and 170 μM ascorbic
acid, 330 and 740 μM cysteine, and/or 12 and 29 μM silver nitrate increased
the percent sugarcane explant viability 5-9 fold relative to the antioxidant
control” (Ans. 16-17). As such, we agree with the Examiner’s position that
it would have been obvious to substitute lipoic acid at the same
concentrations as those shown effective for other antioxidants. KSR Int’l
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Co. v. Teleflex Inc., 550 U.S. at 416. We agree with the Examiner that
Appellants have not provided sufficient evidentiary basis to overcome the
Examiner’s prima facie case.
We conclude that the evidence cited by the Examiner supports a prima
facie case of obviousness, for each of the obviousness rejections, with
respect to claim 1, and Appellants have not provided sufficient evidence of
secondary considerations that outweighs the evidence supporting the prima
facie case. As Appellants do not argue separately claims 15-18, and 22,
these claims fall with claim 1 (App. Br. 1-12). 37 C.F.R. § 41.37 (c)(1).
Regarding claims 2-4, Appellants additionally assert that the claimed
concentration of lipoic acid “is well below the level at which 100% activity
is observed” (App. Br. 16) or below the level at “which any antioxidant
activity above background is observed” (id. at 17). We find Appellants’
argument with respect to antioxidant activities unpersuasive because the
claims do not recite a particular antioxidant activity level. Accordingly, we
affirm the rejection of claims 2-4.

SUMMARY
We reverse the rejection of claim 15 under 35 U.S.C. § 112, second
paragraph as being indefinite.
We affirm the rejection of claims 1-4 and 17 under 35 U.S.C. § 103(a)
as being unpatentable over Enríquez-Obregón in view of Packer.
We affirm the rejection of claims 1-4 and 16 under 35 U.S.C. § 103(a)
as being unpatentable over Peri in view of Packer.
We affirm the rejection of claims 1-3 and 17 under 35 U.S.C. § 103(a)
as being unpatentable over Cai in view of Packer.
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We affirm the rejection of claims 1-3, 15-16, 18, and 22 under
35 U.S.C. § 103(a) as being unpatentable over Olhoft in view of Packer.
We affirm the rejection of rejected claims 1-4 under 35 U.S.C.
§ 103(a) as being unpatentable over Ciccarone.

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

AFFIRMED

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