Ex parte Waldron

Board of Patent Appeals and Interferences

Apr 15, 1999

07586317 (B.P.A.I. Apr. 15, 1999)

Application for patent filed September 19, 1990. According to appellant, this application is 1
a continuation of Application 07/169,560, filed March 17, 1988, which is a continuation of Application
06/685,824, filed December 24, 1984 (abandoned).
1
Paper No. 55
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today (1) was not written
for publication in a law journal and (2) is not binding precedent of the Board.
UNITED STATES PATENT AND TRADEMARK OFFICE
_______________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
_______________
Ex parte CLIVE WALDRON
______________
Appeal No. 94-2006
Application 07/586,3171
_______________
HEARD: MARCH 11, 1999
_______________
Before WINTERS, WILLIAM F. SMITH, and ROBINSON, Administrative Patent Judges..
WILLIAM F. SMITH, Administrative Patent Judge.

Appeal No. 94-2006
Application 07/586,317
2
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of claims 49,
51 through 59, 69 through 77, and 79 through 83. Subsequent thereto, claims 74, 76, 78
and 81 through 83 were canceled. The examiner allowed claim 79 at page
1 of the examiner's answer. The examiner also indicated at page 2 of the examiner
answer that claim 72 is free of rejection and would be allowed if rewritten in independent
form. As a result, claims 49, 51 through 59, 69 through 71, 73, 75, 77, and 80 remain for
our consideration on appeal. Claim 49 is illustrative of the subject matter on appeal and
reads as follows:
49. A chimeric gene functional in a plant cell, which chimeric gene comprises:
(a) at a position 5' to coding region (c), a plant-expressible promoter sequence;
(b) at a position 3' to coding region (c), a terminator signal sequence; and
(c) a coding region of an aphIV gene, which coding region: (1) encodes a functional
hygromycin phosphotransferase enzyme or functional portion thereof; and (ii) is positioned
between such plant-expressible promoter sequence (a) and such terminator signal
sequence (b) so as to be expressible,
which expression of such coding region in a plant cell confers resistance to hygromycin B
on such plant cell and wherein such resistance to hygromycin B is capable of providing a
basis for selection of such plant cell.
Appeal No. 94-2006
Application 07/586,317
3
Claims 49, 51 through 59, 69 through 71, 73, 75, 77 and 80 stand rejected under
35 U.S.C. § 112, first paragraph, as being non-enabled. The examiner does not rely upon
any evidence in support of this rejection. We reverse.
DISCUSSION
The claimed invention involves a chimeric gene functional in a plant cell which
comprises three coding regions. Of particular interest in this appeal is the coding region
of a aphIV gene set forth in claim 49(c) which encodes either a functional hygromycin
phosphotransferase enzyme or a functional portion thereof. It is the examiner's position
that one skilled in the art could only make and use that aspect of the claimed subject matter
which requires a coding region which encodes a functional portion of hygromycin
phosphotransferase enzyme through use of undue experimentation. We disagree.
In setting forth the statement of the rejection in the paragraph bridging pages 3-4 of
the examiner's answer, the examiner points to the fact that the specification of this
application describes only a single modification of the aphIV gene. The examiner also
relies upon the purported lack of guidance in the specification in regard to identifying or
evaluating essential or non-essential terminal or internal regions of the aphIV gene. Finally,
the examiner relies upon a declaration filed by Dr. Raymond Shillito, filed on December 2,
1992, as evidence of the “unpredictability inherent in the expression of bacterially derived
Appeal No. 94-2006
Application 07/586,317
4
antibiotic resistance genes in plant cells.” The examiner's position is summarized in the
last sentence of the paragraph bridging pages 3-4 of the examiner's answer as “undue
experimentation would have been required by one of ordinary skill in the art to evaluate a
multitude of non-exemplified terminal or internal deletions to identify and characterize
functional portions of the gene product and the corresponding coding regions of the gene.”
As explained in PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564, 37
USPQ2d 1618, 1623 (Fed. Cir. 1996):
In unpredictable art areas, this court has refused to find broad generic claims
enabled by specifications that demonstrate the enablement of only one or a
few embodiments and do not demonstrate with reasonable specificity how to
make and use other potential embodiments across the full scope of the
claim. See, e.g., In re Goodman, 11 F.3d 1046, 1050-52, 29 USPQ2d
2010, 2013-15 (Fed. Cir. 1993); Amgen, Inc. v. Chugai Pharmaceutical Co.,
927 F.2d 1200, 1212-14, 18 USPQ2d 1016, 1026-28 (Fed. Cir.), cert.
denied, 502 U.S. 856 (1991); In re Vaeck, 947 F.2d at 496, 20 USPQ2d at
1445. Enablement is lacking in those cases, the court has explained,
because the undescribed embodiments cannot be made based on the
disclosure in the specification, without undue experimentation. But the
question of undue experimentation is a matter of degree. The fact that some
experimentation is necessary does not preclude enablement; what is
required is that the amount of experimentation “must not be unduly
extensive.” Atlas Powder Co., v. E.I. DuPont de Nemours & Co., 750 F.2d
1569, 1576, 224 USPQ 409, 413 (Fed. Cir. 1984). The Patent and
Trademark Office Board of Appeals summarized the point well when it
stated:
The test is not merely quantitative, since a considerable
amount of experimentation is permissible, if it is merely
routine, or if the specification in question provides a
reasonable amount of guidance with respect to the direction in
which the experimentation should proceed to enable the
Appeal No. 94-2006
Application 07/586,317
5
determination of how to practice a desired embodiment of the
invention claimed.
Ex parte Jackson, 217 USPQ 804, 807 (1982).
Appeal No. 94-2006
Application 07/586,317
6
In considering the rejection, it is important to note that the examiner has not raised any
question in regard to the ability of a person skilled in the art to physically make truncated
aphIV genes in order to evaluate such products to determine whether they would be
functional as required by the claims on appeal. Rather, the examiner has only questioned
the ability of a person skilled in the art to “evaluate a multitude on non-exemplified terminal
or internal deletions” of the aphIV gene. However, in raising this issue the examiner has
not relied upon any evidence which allows one to reasonably conclude that such an
evaluation would be considered “undue experimentation.”
As set forth above, the test for “undue experimentation” is not merely quantitative. What
the examiner needed to have done in this case is to evaluate the prior art as of the
effective filing date of this application in light of the disclosure of this application and
determine the ability of workers in this field to identify functional portions of enzymes. It is
evidence such as this which the examiner needs to rely upon, not the unsupported
generalizations set forth in the statement of the rejection.
We have considered the Shillito declaration, but do not find that it supports the
examiner's position. The purpose of the Shillito declaration was to establish that there was
a degree of unpredictability in extrapolating successful results in developing
Appeal No. 94-2006
Application 07/586,317
7
selectable marker systems in animal cells to plant cells. As set forth in paragraph 12 of the
Shillito declaration “the results of other antibiotic studies in animal cells would not have led
to the expectation of parallel findings in plant cells.” This is not the issue raised by the
rejection under review herein.
In considering an issue of enablement, the examiner must consider not only the
relevant teachings of the prior art but also the disclosure of the supporting specification of
the application under review. While the Shillito declaration provides evidence that prior to
appellant's invention there was a degree of unpredictability in extrapolating successful
selection agents for animal cells to plant cells, that degree of unpredictability was in the
context of the prior art. In considering a prior art rejection, the examiner, of course, may not
use appellant’s description of the present invention in the supporting specification.
However, that disclosure must be considered in considering issues of enablement. Here,
appellant demonstrated that a coding region which encodes a hygromycin
phosphotransferase enzyme will confer resistance to hygromycin B on appropriately
transformed plant cells. Thus, it stands to reason that a coding region which encodes a
functional portion of hygromycin phosphotransferase enzyme would also work as claimed.
The examiner has simply not provided evidence that at the time of the present invention, it
would entail undue experimentation for those skilled in the art to determine coding regions
which encode a functional portion of hygromycin phosphotransferase enzyme.
Appeal No. 94-2006
Application 07/586,317
8
The decision of the examiner is reversed.
REVERSED
SHERMAN D. WINTERS )
Administrative Patent Judge )
)
)
)
WILLIAM F. SMITH ) BOARD OF PATENT
Administrative Patent Judge ) APPEALS AND
) INTERFERENCES
)
)
DOUGLAS W. ROBINSON )
Administrative Patent Judge )

Appeal No. 94-2006
Application 07/586,317
9
Jennifer Gordon
PENNIE & EDMONDS
1155 Avenue of the Americas
New York, NY 10036