Ex parte Hughes et al.

Board of Patent Appeals and Interferences

Jul 26, 1999

07920013 (B.P.A.I. Jul. 26, 1999)

Application for patent filed July 27, 1992. According to appellants, the application1
is a continuation of Application 07/484,573, filed February 26, 1990, now abandoned.
1
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publication in a law journal and (2) is not binding precedent of the Board.
Paper No. 34
UNITED STATES PATENT AND TRADEMARK OFFICE
________________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
________________
Ex parte STEPHEN H. HUGHES, RAMESH KUMAR
and JOHN BRUMBAUGH
________________
Appeal No. 95-2215
Application 07/920,0131
________________
ON BRIEF
________________
Before WILLIAM F. SMITH, ELLIS and ROBINSON, Administrative Patent Judges.
ROBINSON, 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 claims 1 - 10, which are all of the claims pending in this application.
Appeal No. 95-2215
Application 07/920,013
2
Independent claim 1 is illustrative of the subject matter on appeal and is reproduced
below:
1. A method for detecting a DNA sequence comprising the steps of:
i) asymmetrically amplifying the DNA sequence so that one strand of the DNA
sequence is amplified to a greater extent than the strands' (sic, strand's) complement
forming an amplified DNA strand;
ii) hybridizing a fluorescently labeled probe to the amplified DNA strand
wherein said fluorescently labeled probe is complementary to a segment of the amplified
DNA strand, the hybridization being effected in solution and forming a fluorescently labeled
hybridized probe;
iii) separating the fluorescently labeled hybridized probe from unhybridized
labeled probe by electrophoresis; and
iv) detecting during electrophoresis the presence or absence of the
fluorescently labeled hybridized probe by fluorescence detection, wherein the presence of
the fluorescently labeled hybridized probe indicates the presence of said DNA sequence.
The references relied upon by the examiner are:
Mullis 4,683,202 Jul. 28, 1987
Gyllensten et al. (Gyllensten), " Generation of single-stranded DNA by the polymerase
chain reaction and its application to direct sequencing of the HLA-DQA locus", Proc. Natl.
Acad. Sci., vol. 85, pages 7652-7656, (October, 1988).
Brumbaugh et al. (Brumbaugh), " Continuous, on-line DNA sequencing using
oligodeoxynucleotide primers with multiple fluorophors", Proc. Natl. Acad. Sci., vol. 85,
pages 5610-5614, (August, 1988).
Appeal No. 95-2215
Application 07/920,013
Applicants define "real time" as "no delay between the time of the electrophoretic2
run and the time the results are available." Specification, page 6,
lines 32-35.
3
Grounds of Rejection
Claims 1-10 stand rejected under 35 U.S.C. § 103. As evidence of
obviousness, the examiner relies on Gyllensten, Mullis, and Brumbaugh.
We reverse.
Background
At pages 2-3 of the specification, the applicants describe the invention as relating
to a method of detecting a DNA sequence wherein the DNA sequence is asymmetrically
amplified, hybridized, in solution, with a fluorescent labeled probe complementary to a
segment of the amplified DNA sequence, followed by separation of the hybridized and
non-hybridized product using electrophoresis. Applicants state that the labeled DNA is
detected during the electrophoresis process in "real time." Applicants also describe the2
use of the detection method for detecting the presence or absence of one or more
pathogens in a test sample.
Discussion:
Claims:
Claim 1 is directed to a method of detecting a DNA sequence by asymmetrically
amplifying the DNA sequence, hybridizing, in solution, a fluorescently labeled probe to the
Appeal No. 95-2215
Application 07/920,013
4
amplified DNA strand, wherein the labeled probe is complementary to a segment of the
amplified DNA strand, separating the fluorescently labeled hybridized probe from
unhybridized probe by electrophoresis, and detecting the presence or absence of the
fluorescently labeled hybridized probe by fluorescence detection during the
electrophoresis. Claims 5 and 8, the remaining independent claims, are directed to a
method for detecting a DNA sequence to screen a sample for the presence or absence of
a pathogen or several pathogens, respectively.
The rejection under 35 U.S.C. § 103
It is the initial burden of the patent examiner to establish that claims
presented in an application for patent are unpatentable. In re Oetiker, 977 F.2d 1443,
1446, 24 USPQ2d 1443, 1445 (Fed. Cir. 1992). We have carefully considered the
evidence and discussion in support of the rejection presented by the examiner. However,
a fair evaluation of the references, applicants' specification and consideration of the
claimed subject matter as a whole, dictates a conclusion that arriving at the claimed
method from the prior art teachings is not suggested by the record before us. When we
view the three applied references, apart from appellants' disclosed invention, we find no
reason, suggestion, or motivation to combine the references to arrive at the claimed
invention. To establish a prima facie case of obviousness, there must be more than the
demonstrated existence of all of the components. There must be some reason,
suggestion, or motivation found in the prior art whereby a person of ordinary skill in the
Appeal No. 95-2215
Application 07/920,013
5
field of the invention would make the substitutions required. That knowledge cannot come
from the applicants' invention itself. Diversitech Corp. v. Century Steps, Inc., 850 F.2d
675, 678-79, 7 USPQ2d 1315, 1318 (Fed. Cir. 1988); In re Geiger,
815 F.2d 686, 688, 2 USPQ2d 1276, 1278 (Fed. Cir. 1987); Interconnect Planning Corp.
v. Feil, 774 F.2d 1132, 1143, 227 USPQ 543, 551 (Fed. Cir. 1985). The extent to which
such suggestion must be explicit in or may be fairly inferred from, the references, is
decided on the facts of each case, in light of the prior art and its relationship to the
invention. It is impermissible, however, simply to engage in a hindsight reconstruction of
the claimed invention using applicants' specification as a template and selecting elements
from references to fill the gaps. In re Gorman, 933 F.2d 982, 986-987, 18 USPQ2d 1885,
1888 (Fed. Cir. 1991).
As pointed out by appellants (Brief, page 17):
. . . there is no teaching or suggestion in the cited references to
combine asymmetric amplification with solution phase hybridization with a
fluorescently labeled probe.
We conclude that the rejection before us is predicated on impermissible hindsight and that
it would not have been obvious to one of ordinary skill in the art at the time of the invention
to combine the teachings of the individual references to arrive at the DNA detection
method of claims 1-10.
The rejection under 35 U.S.C. § 103 is reversed.
Appeal No. 95-2215
Application 07/920,013
6
Summary
We reverse the rejection of claims 1-10 under 35 U.S.C. § 103.
REVERSED
WILLIAM F. SMITH )
Administrative Patent Judge )
)
)
)
JOAN ELLIS ) BOARD OF PATENT
Administrative Patent Judge ) APPEALS AND
) INTERFERENCES
)
)
DOUGLAS W. ROBINSON )
Administrative Patent Judge )
Appeal No. 95-2215
Application 07/920,013
7
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Morgan & Finnegan
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