Ex parte Rolon et al.

Board of Patent Appeals and Interferences

Jun 30, 2000

08367508 (B.P.A.I. Jun. 30, 2000)

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publication in a law journal and (2) is not binding precedent of the Board.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. 12
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte NOEL ROLON, WILLIAM PAGELS,
and RICHARD EGAN

____________
Appeal No. 1997-0881
Application No. 08/367,508
____________
ON BRIEF
____________
Before WINTERS, WILLIAM F. SMITH, and ROBINSON, Administrative Patent Judges.
ROBINSON, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on the appeal under 35 U.S.C. § 134 from the examiner's final
rejection of claims 1-5 and 8-10, all of the claims pending in the case.
Claim 1 is illustrative of the subject matter on appeal and reads as follows:
1. A method of making more than one punchout from a single dried blood spot,
the method comprising the steps of:
making a first punchout in said dried blood spot, said first punchout having first
boundaries; and
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sequentially making at least a second punchout in said dried blood spot, said
second punchout having second boundaries, wherein said second boundaries are entirely
outside of said first boundaries so that said second punchout has an inner portion
removed therefrom, said inner portion forming said first punchout.
The references relied upon by the examiner are:
Yee 5,427,953 June 27, 1995
Sadler et al. (Sadler), "Blood-Spot Thyrotropin Radioimmunoassay in a Screening
Program for Congenital Hypothyroidism," Clinical Chemistry, Vol. 25 (6), pp. 933-938
(1979).
Ground of Rejection
Claims 1-5 and 8-10 stand rejected under 35 U.S.C. § 103. As evidence of
obviousness, the examiner relies upon Yee and Sadler.
We reverse.
Background
The invention relates to the assay of blood or other body fluids wherein a sample is
deposited on filter paper and allowed to dry prior to removal for testing. This is
accomplished by punching out a portion of the filter paper including the fluid sample and
performing the assay on this punched out portion. The applicants describe the invention
at page 3 of the specification as being directed to a method of making at least a first and
second punchout of a sample of blood or other body fluids which has been dried on a filter
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paper wherein the combination of both punchouts is the minimum surface area required for
testing.
Discussion
The rejection under 35 U.S.C. § 103
Obviousness is a legal conclusion based on the underlying facts. Graham v. John
Deere Co., 383 U.S. 1, 17-18, 148 USPQ 459, 467 (1966); Continental Can Co. USA, Inc.
v. Monsanto Co., 948 F.2d 1264, 1270, 20 USPQ2d 1746, 1750 (Fed. Cir. 1991); Panduit
Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1566-68, 1 USPQ2d 1593, 1595-97 (Fed.
Cir. 1987). Here, the dispositive question is whether one of ordinary skill in this art at the
time of the invention would have found it obvious to make a first punchout in a dried blood
spot, which had previously been deposited on filter paper, and sequentially make at least a
second punchout in the same dried blood spot, wherein the boundaries of the second
punchout are entirely outside of the boundaries of the first punchout and the second
punchout has an inner portion removed therefrom which is the first punchout.
The examiner has cited Yee as disclosing a blood testing method which utilizes
filter paper which is first spotted with blood and allowed to dry. Samples are removed
from the filter paper using one or more punchouts in a predefined manner to obtain a
uniform volume of the blood sample. (Answer, page 4). The examiner acknowledges
that Yee (id.):
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does not specifically disclose a second punchout having a
second boundary, wherein the second boundary is entirely
outside of a first boundary of the first punchout so that said
second punchout has an inner portion removed therefrom, said
inner portion forming said first punchout.
The examiner cites Sadler as similarly teaching a blood testing method utilizing filter paper
that is spotted with blood, wherein the blood is allowed to dry, and more than one punchout
is made from the sample. Referring to Figure 1, the examiner urges that the disclosure of
Sadler could be interpreted to disclose a first punchout and that the second punchout
would be the remaining blood spot wherein the second boundaries is defined by the
periphery of the spot. (Answer, page 5).
In considering Yee and Sadler, the examiner has pointed to no factual evidence
which would reasonably suggest the manipulative steps of the claims on appeal which
would result in a second or subsequent punchout of the filter paper containing the blood
sample wherein the boundaries of the second punchout are entirely outside the boundaries
of the first punchout and wherein the second punchout has an inner portion removed
therefrom which is the first punchout. Both Yee and Sadler disclose the use of multiple
punchouts; but in each case the areas punched out do not overlap in the manner required
by the claims. Yee may reasonably be said to teach methods of punching out samples
which would maximize the area on the filter paper spotted with the blood (Yee, Figure 2).
In addition, the visual impact of Figure 1 of Sadler might suggest a physical similarity to the
resulting punchouts of the claims. However, the examiner's analysis of this figure (Answer,
page 5) does not provide for a second punchout as required by the claims. In those
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instances where the prior art uses a plurality of punchouts, none are similar to or would
reasonably direct one skilled in this art to the method claimed.
The initial burden of presenting a prima facie case of obviousness rests on the
examiner. In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992).
On these circumstances, we are constrained to reach the conclusion that the examiner has
failed to provide the evidence necessary to support a prima facie case of obviousness as
to the claimed method. Where the examiner fails to establish a prima facie case, the
rejection is improper and will be overturned. In re Fine, 837 F.2d 1071, 1074, 5 USPQ2d
1596, 1598 (Fed. Cir.1988). Therefore, the rejection of claims 1-5 and 8-10 under 35
U.S.C. § 103 is reversed.
Other issues
Upon return of the application to the group, we would urge the examiner and
appellants to resolve the apparent inconsistency raised by claim 5 which requires that
"said second boundaries are tangential to said first boundaries" and claim 1, on which
claim 5 ultimately depends, which requires that "said second boundaries are entirely
outside of said first boundaries." It would not appear possible for the boundaries to be
tangential to each other and yet have one boundary entirely outside the other.
Summary
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To summarize, the decision of the examiner to reject claims 1-5 and 6-8 under 35
U.S.C. § 103 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 )
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