Ex Parte WIER

Board of Patent Appeals and Interferences

Jun 26, 2002

09059573 (B.P.A.I. Jun. 26, 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for publication and is not binding precedent of the Board.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. 31
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MARJORIE L. WIER
__________

Appeal No. 2001-2027
Application No. 09/059,5731
__________

HEARD: June 11, 2002
__________

Before SCHEINER, MILLS and GRIMES, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. ' 134 from the final rejection of claims 1 and
32 through 36, the only claims remaining in the application.
Claim 1 is representative of the subject matter on appeal and reads as follows:
1. A method for detecting activation of lymphocytes comprising the steps of:

incubating a sample containing a mixed population of cell types including a
plurality of subsets of lymphocytes where each subset includes lymphocytes with
characteristic determinants that distinguish one subset from another, with an inducing
agent selected from the group consisting of mitogens and antigens; then

separating a selected subset of lymphocytes from said sample; then

lysing lymphocytes in said selected subset to release an activation-correlated
intracellular component selected from the group consisting of ATP, NADP, and PCNA;
then

1 Application for patent filed April 14, 1998. According to appellant, this application is a
continuation of serial no. 08/928,392, filed September 12, 1997, now U.S. Patent no. 5,773,232, which is a
continuation of serial no. 08/621,878, filed March 26, 1996, now abandoned.
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Application No. 09/059,573

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measuring a level of said activation-correlated intracellular component; and

determining activation of lymphocytes for said selected subset of lymphocytes
from said level of said activation-correlated intracellular component measured in said
measuring step.

The examiner relies on the following references:

Gottlieb 4,778,750 Oct. 18, 1988
Melnicoff et al. (Melnicoff) 5,385,822 Jan. 31, 1995

Ishizaka et al. (Ishizaka), AEvaluation of the Proliferative Response of Lymphocytes by
Measurement of Intracellular ATP,@ Journal of Immunological Methods, Vol. 72, pp.
127-132 (1984)

Claims 1, 32, 33, 35 and 36 stand rejected under 35 U.S.C. ' 103 as
unpatentable over Ishizaka and Melnicoff, while claim 34 stands rejected as
unpatentable over the same references in combination with Gottlieb.
We reverse both of these rejections.
DISCUSSION
The rejection of claims 1, 32, 33, 35 and 36
According to the examiner, Ishizaka describes Aa method for evaluating the
proliferative response of lymphocytes comprising incubating the lymphocytes with
lectins . . . , monokines, lymphokines . . . , and B cell growth factors . . . and measuring
ATP levels,@ while Melnicoff describes Aquantifying subsets of lymphocytes within a
subpopulation of a mixed cell population,@ Aseparating the lymphocytes after incubation
with a reporter substance,@ and Athe use of solutions which lyse the separated
lymphocytes enabling the measurement of a released product.@ Examiner=s Answer,
page 4.
Based on these teachings, the examiner concludes that A[i]t would have been
prima facie obvious . . . to modify the method of Ishizaka [ ] by employing a separation
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step after activating lymphocytes and before lysing the specific subset of lymphocytes
and measuring the ATP levels as taught by Melnicoff.@2 Examiner=s Answer, paper no.
27, page 4.
Appellant, while Anot conced[ing] that combining the cited prior art [is]
appropriate in the present case,@ asserts that the examiner=s proposed combination
would not, in any case, result in Adetection of lymphocyte activation.@ Amended Brief,
paper no. 26, page 7. Appellant argues that the examiner has ignored the Adistinct
difference between activation and the subsequent proliferation event that is seen
following activation@ (Id., page 11), and notes that Ishizaka Aspecifically discloses that
the ATP levels observed [were] due to an increase in the number of cells through the
proliferative response of the lymphocytes@ (Id., page 8), whereas the claims on appeal
are directed to measuring Athe increase in the level of ATP . . . during the activation
event and prior to proliferation@ (Id., page 9).
In our view, this argument is not entirely satisfactory. The claims on appeal do
not explicitly recite any particular time frame, and it is not clear to us that the recitation
Adetecting activation@ implicitly limits the claims to measurements taken Aprior to
proliferation.@ The record establishes that activation precedes proliferation in a
stimulated lymphocyte culture, and that the level of ATP, an Aactivation-correlated
intracellular component,@ is elevated during both activation and proliferation. It seems

2 The examiner=s statement is somewhat misleading. Ishizaka, not Melnicoff, describes
measuring endogenous ATP. Melnicoff measures a detectable reporter substance incorporated by a
mixed population of unstimulated cells prior to their separation into subsets and subsequent lysis.
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to us that Ishizaka=s measurement of ATP necessarily, if indirectly, detects the
activation event that precedes proliferation.
Nevertheless, the examiner=s statement of rejection, on its face, is inadequate to
establish a prima facie case of obviousness. ATo prevent the use of hindsight based on
the invention . . . the examiner must show reasons that the skilled artisan . . . with no
knowledge of the claimed invention, would select the elements from the cited prior art
references for combination in the manner claimed.@ In re Rouffet, 149 F.3d 1350, 47
USPQ2d 1453, 1457-58 (Fed. Cir. 1998). This the examiner has not done. That is, the
examiner=s statement of rejection is entirely conclusory, providing no reasons at all for
combining Ishizaka and Melnicoff, much less explaining why one skilled in the art would
have selected particular elements from each reference and arranged them in the order
required by claims.
Nor are we persuaded by the examiner=s belated statement, in response to
appellant=s arguments in the Brief, that A[o]ne of ordinary skill . . . would have been
motivated to separate a specific subset of lymphocytes after incubation in order to be
able to assay whole blood and to determine whether or not a particular subset of
lymphocytes was activated by the mitogen or antigen.@ Examiner=s Answer, page 8.
The examiner=s reliance on motivation is misplaced here. It is not enough to assert that
one skilled in the art would have been motivated to achieve that which the invention
achieves. Again, the examiner must explain why one would have been motivated to
select particular elements from particular references and combine them in precisely the
manner claimed.
Finally, it is irrelevant whether A[i]t would have been expected, barring evidence
to the contrary, that combining the teachings of [Ishizaka and Melnicoff] would result in
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an assay which would analyze lymphocytes for lymphocyte activation@ (Examiner=s
Answer, pages 4-5), when the examiner has not identified a reason to combine the
references in the first place.
The fact that the prior art could have been modified in a manner consistent with
appellants= claims would not have made the modification obvious unless the prior art
suggested the desirability of the modification. In re Gordon, 733 F.2d 900, 902, 221
USPQ 1125, 1127 (Fed. Cir. 1984). On this record, the only reason or suggestion to
combine the references in the manner claimed comes from appellant=s specification.
Accordingly, we are constrained to reverse the rejection of claims 1, 32, 33, 35 and 36
under 35 U.S.C. ' 103.
The rejection of claim 34
Claim 34 depends from claim 1 and requires a viral, bacterial or fungal inducing
agent. The examiner=s proposed combination of Ishizaka and Melnicoff forms the basis
of this rejection as well, with the addition of Gottlieb as evidence that it was known in
the art Athat any particular antigen or mitogen may be used to stimulate a[n] [immune]
response.@ The addition of Gottlieb does nothing to cure the underlying deficiency in
the proposed combination of Ishizaka and Melnicoff, thus, the rejection of claim 34
under 35 U.S.C. ' 103 is reversed as well.
REVERSED

)
Toni R. Scheiner )
Administrative Patent Judge )
)
) BOARD OF PATENT
)
Demetra J. Mills ) APPEALS AND
Administrative Patent Judge )
) )INTERFERENCES
)
Appeal No. 2001-2027
Application No. 09/059,573

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)
Eric Grimes )
Administrative Patent Judge )

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