Ex Parte Tackett

Board of Patent Appeals and Interferences

Aug 19, 2002

08677838 (B.P.A.I. Aug. 19, 2002)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.

Paper No. 17

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte SCOTT E. TACKETT
__________

Appeal No. 2001-1925
Application No. 08/677,838
__________

ON BRIEF
__________

Before WINTERS, ADAMS, and GREEN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the examiner’s
final rejection of claim 1, the only claim remaining. Claim 1 reads as follows:
1. A method for reducing wrinkles and discoloration in humans which
comprises the step of applying to human tissue skin cells an effective amount of
a nuclease solution, said nuclease solution comprised of:
(a) water;

(b) an amount of nuclease equal to from about 1 Kunitz unit per millimeter
of water to about 70 Kunitz units per milliliter of water, and

(c) a co-factor capable of activating the nuclease, where after application
of said nuclease solution wrinkles are reduced in humans.
Appeal No. 2001-1925 Page 2
Application No. 08/677,838

The examiner relies upon the following references:
Canadian Patent Application
Tackett 1,312,298 Jan. 5, 1993

Pacifici et al. (Pacifici), “Protein, Lipid and DNA Repair Systems in Oxidative
Stress: The Free-Radical Theory of Aging Revisited,” Gerontology, Vol. 37, pp.
166-180 (1991)

Claim 1 stand rejected under 35 U.S.C. § 112, first paragraph, on the
grounds that specification fails to adequately teach one skilled in the art how to
make and/or use the claimed invention. After careful review of the record and
consideration of the issue presented, the rejection is reversed.
BACKGROUND
The invention is drawn to the use of known nucleases in solution for the
reduction of wrinkles and discoloration in humans. See Specification, page 1.
According to the specification:
[T]he treatment involves altering the gene expression in human
skin cells by means of contacting the skin cells with an effective
amount of a nuclease solution containing an exogenous nuclease
(an enzyme capable of degrading extra-cellular DNA and/or RNA).
The nuclease in the nuclease solution will degrade extra-cellular
nucleic acids into nucleotides or oligonucleotides which are too
short to have substantial avidity for chromosomal DNA. This in turn
will prevent oligonucleotides and polynucleotides from binding to
the chromosome in human tissue cells, which prevents the over-
production of protein and improper production of protein by
individual cells. By altering the production of protein, wrinkles are
reduced.

Id. at 5.
Appeal No. 2001-1925 Page 3
Application No. 08/677,838

Four examples are presented. Examples 1, 2 and 4 are drawn to
application of the solution to wrinkles, and Example 3 is drawn to the application
of the solution to an age spot. Examples 2 and 4 have accompanying pictures,
which, according to the specification, demonstrates the reduction in wrinkles.
See id. at 16-20. In addition, the specification states in Example 1 that use of
the nuclease solution “resulted in the reduction of the subject’s wrinkles,” id. at
18, and in Example 3, states that “the method results in the reduction of
discoloration spots on humans,” id. at 19.
DISCUSSION
Claim 1 stands rejected under 35 U.S.C. § 112, first paragraph, on the
grounds that the specification fails to adequately teach how to make and/or use
the claimed invention, i.e., fails to provide an enabling disclosure.
The rejection focuses on the portions of the specification that explain the
purported mechanism of how the nuclease solution may reduce the appearance
of wrinkles and age spots. See Examiner’s Answer, pages 3-7. However, “it is
axiomatic that an inventor need not comprehend the scientific principles on
which the practical effectiveness of his invention rests.” Fromson v. Advance
Offset Plate, Inc., 720 F.2d 1565, 1570, 219 USPQ 1137, 1140 (Fed. Cir. 1983);
see also In re Storrs, 245 F.2d 474, 478, 114 USPQ 293, 297 (CCPA 1957) (“It
is well established that an applicant for patent need not understand the theory of
operation of [his] invention.”)
Appeal No. 2001-1925 Page 4
Application No. 08/677,838

The one relevant portion of the rejection discusses the examples in the
specification, and the results as presented by the Figures of the application of
the nuclease solution to the skin for the reduction of wrinkles. That portion of the
rejection is reproduced below.
Though the specification provides examples were [sic] the
nuclease solution is applied to the skin, the results of these
examples (i.e., the photographs) are equivocal. For instance, in
Figures 1, 2, and 3, it is not possible to accurately assess the
amount of wrinkling present due to the differences in lighting and
facial expression. In this example, the specification states that
Figure 1 is a photograph of a sixty-four year old female before
treatment with the invention, and that Figure 2 is a photograph of
the same woman after treatment. However, upon observation, the
notable differences in the lighting preclude an accurate assessment
of the amount of wrinkling and discoloration. Furthermore, while
the photograph in Figure 3 is a clear, close-up profile shot of the
same woman after treatment, her facial expression is different (i.e.,
not smiling which alone reduces folds around the eyes), and
moreover, the disclosure fails to provide a corresponding before
treatment photograph with which to accurately compare the results.
Likewise, Figures 4, 5, and 6 are ambiguous as well. Figures 4 and
4 are the before treatment photographs of a forty-three year old
female, yet once again, the lighting combined with the distance are
such that no fine details of the skin can be ascertained in Figure 4.
Accordingly, that leaves Figure 5 as the only before treatment
close-up photograph with which to compare to the after treatment
photographs of Figures 6 and 7. Yet, in this photograph (Figure 5)
the woman appears to be squinting, something which she is not
doing in the other photographs (Figures 6 & 7). Consequently, the
absence of the folds present around the eye in Figures 6 and 7
could be the result of her facial expression or the absence thereof
(i.e., no squinting). In addition, the pictures do not even address
the ability of the claimed method to reduce skin discoloration.
Accordingly, the pictures are equivocal and do not support the
notion that the claimed method will in fact reduce wrinkles and
discoloration in the skin.

Answer, pages 3-4.
Appeal No. 2001-1925 Page 5
Application No. 08/677,838

The burden is on the examiner to set forth a prima facie case of
unpatentability. See In re Glaug, 283 F.3d 1335, 1338, 62 USPQ2d 1151, 1156
(Fed. Cir. 2002). Facts that should be considered in determining whether a
specification is enabling, or if it would require an undue amount of
experimentation to practice the invention include: (1) the quantity of
experimentation necessary to practice the invention, (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. See In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1403 (Fed.
Cir. 1988). In order to make a record that is amenable to meaningful review, we
recommend that when making an enablement rejection, the examiner should
explicitly state the factors as set forth in Wands and set forth facts pertaining to
the pertinent factors. See In re Lee, 277 F.3d 1338, 1342, 61 USPQ2d 1430,
1432 (Fed. Cir. 2002) (stating that for meaningful judicial review to occur, the
agency must present a full and reasoned explanation of its decision).
The examiner has not set forth a Wands analysis. At most, the
examiner’s analysis of the pictures is pertinent to the presence of absence of
working examples. But in the examiner’s own words, the results presented by
the pictures are “equivocal” or “ambiguous.” The presentation of equivocal or
ambiguous results, however, does not in and of itself, support the conclusion that
Appeal No. 2001-1925 Page 6
Application No. 08/677,838

the specification fails to provide an enabling disclosure. The rejection does not
set forth other factors, such as the unpredictability of the art or the level of skill in
the art that would support the analysis of the pictures in the rejection, and
buttress the conclusion that the specification fails to provide an enabling
disclosure.1 Thus, the examiner has failed to meet the burden of setting forth a
prima facie case of enablement, and the rejection is reversed.
OTHER MATTERS
Upon return of the application, the examiner may wish to look at the
format of claim 1. Claim 1 specifies that the nuclease solution is comprised of
components (a), (b) and (c). There is also a limitation of the claim labeled with
(d), which would also make it a component of the nuclease, but the limitation is
actually drawn to the step of applying the solution to the skin. Thus, it appears
as if the “(d)” should be deleted from the beginning of the application step in
order to avoid confusion.

1 The two references discussed in the rejection as evidence of the
unpredictability of the art, i.e., Tackett and Pacifici, are again directed to the
putative theory of operation of the invention, and not the treatment of wrinkles
and age spots generally.
Appeal No. 2001-1925 Page 7
Application No. 08/677,838

CONCLUSION
The rejection under 35 U.S.C. § 112, first paragraph, is reversed. In
addition, an additional matter has been raised for the examiner’s attention upon
receipt of the applications.
REVERSED

SHERMAN D. WINTERS )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
DONALD E. ADAMS )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
LORA M. GREEN )
Administrative Patent Judge )
Appeal No. 2001-1925 Page 8
Application No. 08/677,838

PATRICK C WOOLLEY
HAVERSTOCK GARRETT & ROBERTS
611 OLIVE STREET SUITE 1610
ST LOUIS MO 63101

LMG/jlb