Ex Parte Pan et al

Board of Patent Appeals and Interferences

Jun 26, 2008

10247892 (B.P.A.I. Jun. 26, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte
JEFFREY Y. PAN, THOMAS A. NEMCEK, CARLOS GONZALEZ,
EUGENE S. MASLANA, REZA S. SABET, JENNIFER B. DONNELLY,
DAVID J. BURNS, DUNCAN R. GROEBE, and
USHA WARRIOR
__________

Appeal 2008-3447
Application 10/247,892
Technology Center 1600
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Decided: June 26, 2008
__________

Before TONI R. SCHEINER, ERIC GRIMES, and LORA M. GREEN,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
to assay chemical entities for biological activity. The Examiner has rejected
the claims as anticipated. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm.
Appeal 2008-3447
Application 10/247,892

BACKGROUND
The Specification states that Beutel1 discloses an assay format known
as Continuous Format High Throughput Screening (CF-HTS), in which “a
multiplicity of chemical entities is introduced into or onto a porous matrix
that typically contains one or more assay components.” (Spec. 1.) “A
porous matrix suitable for the assay described in that patent can be prepared
by adding, mixing, pouring, dispensing, or soaking these assay component(s)
into the porous matrix” (id.). The Specification states that CF-HTS
“provides many advantages over assays in which components are separated
by impenetrable barriers into distinct wells. CF-HTS makes extraordinarily
high-density screening of chemical entities routinely possible.” (Id.)
The Specification discloses that the “assay described in [Beutel] calls
for uniformly distributing assay components throughout the porous matrix”
(id. at 2), but “[c]urrently existing methods for adding assay components
into the gel material of the porous matrix . . . can result in significant
changes in the distribution of any substances that are capable of diffusing
freely out of the porous matrix” (id. at 3-4).
The Specification discloses a method that is said to “provide[ ]
numerous advantages relative to previously known methods of performing
continuous format high throughput screening” (id. at 6).
DISCUSSION
1. CLAIMS
Claims 1-3 and 7-27 are pending and on appeal. Claims 1 and 14 are
representative and read as follows:

1 Beutel et al., U.S. Patent 5,976,813, issued Nov. 2, 1999.
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Application 10/247,892

Claim 1: A method for testing at least one chemical entity for the
ability of said chemical entity to enhance or inhibit a biological process, said
method comprising the steps of:
(a) providing a blank matrix having at least two major surfaces, said at
least two major surfaces capable of receiving assay components and
chemical entities;
(b) applying at least one chemical entity to at least one of said at least
two major surfaces of said blank matrix, whereby an impregnated matrix is
formed;
(c) applying to at least one of said at least two major surfaces of said
impregnated matrix at least one assay component required for a biological
process, wherein said at least one assay component is applied to at least one
of said at least two major surfaces of said impregnated matrix by means of
liquid dispensing apparatus; and
(d) evaluating the ability of said at least one chemical entity to
enhance or inhibit said biological process involving said at least one assay
component.

Claim 14: A method for testing at least one chemical entity for the
ability of said chemical entity to enhance or inhibit a biological process, said
method comprising the steps of:
(a) providing a blank matrix having at least two major surfaces, said at
least two major surfaces capable of receiving assay components and
chemical entities;
(b) applying at least one assay component required for a biological
process to at least one of said at least two major surfaces of said blank
matrix, whereby an impregnated matrix is formed, said at least one assay
component being applied in the form of an array;
(c) applying to at least one of said at least two major surfaces of said
impregnated matrix at least one chemical entity; and
(d) evaluating the ability of said at least one chemical entity to
enhance or inhibit said biological process involving said at least one assay
component.

2. ANTICIPATION
Claims 1-3 and 7-27 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Beutel. The claims have been argued in two groups, claims
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Application 10/247,892

1-3, 7-13, and 27 (group 1, with claim 1 representative) and claims 14-26
(group 2, with claim 14 representative), and the claims in each group stand
or fall together. 37 C.F.R. § 41.37(c)(1)(vii).
The Examiner finds that Beutel discloses “screening assays in a
variety of embodiments” (Ans. 4). One embodiment involves three
matrixes: a porous ligand matrix, a test matrix and a receptor matrix (id.).
The Examiner further finds that Beutel discloses that the “test matrix is
brought in contact with the ligand matrix and the test compounds or samples
are allowed to diffuse into the ligand matrix,” and that “[a]fter incubation,
the ligand matrix is brought into contact with a receptor matrix, allowing the
ligand and the samples or test compounds to come in contact with the
receptor by diffusion” (id.). “During incubation, ligands will bind to the
immobilized receptor unless a sample compound inhibits the ligand/receptor
binding” (id.).
We agree with the Examiner that Beutel discloses all of the limitations
in claim 1. The assay method of claim 1 has four steps: a) providing a
blank matrix having at least two major surfaces capable of receiving assay
components and chemical entities; b) applying at least one chemical entity to
at least one of the surfaces of the blank matrix to form an impregnated
matrix; c) applying at least one assay component required for a biological
process to at least one of the surfaces of the impregnated matrix; and (d)
evaluating the ability of the chemical entity to enhance or inhibit the
biological process involving the assay component. Appellants do not
dispute that Beutel’s method involves these steps.
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Application 10/247,892

Claim 1 also requires that the application of the assay component to at
least one of the major surfaces of the impregnated matrix in step (c) is
accomplished “by means of liquid dispensing apparatus.” Appellants argue
that Beutel “specifies that the one or more assay component is introduced to
the assay by using at least one matrix” and that a “matrix is not a liquid
dispensing apparatus” (App. Br. 8). “According to the specification of the
present application, a liquid dispensing apparatus can be a sprayer, a
dropper, a pipette, a pin, a bead, or some other microfluidic device. See
page 12, line 33 through page 13, line 7 of the specification. Accordingly,
Beutel et al. does not anticipate claim 1” (id. ).
We do not find this argument to be persuasive. It is well settled that
“claims in an application are to be given their broadest reasonable
interpretation consistent with the specification and that claim language
should be read in light of the specification as it would be interpreted by one
of ordinary skill in the art.” In re Sneed, 710 F.2d 1544, 1548 (Fed. Cir.
1983) (citation omitted).
In the instant case, the Specification does not define the phrase “liquid
dispensing apparatus.” The passage of the Specification relied on by
Appellants relates to applying chemical entities to a matrix by microfluidics.
Claim 1 does not require the assay components to be applied via
microfluidics, so the relationship of the cited passage to the claimed method
is unclear.
The Specification makes very clear, however, that “assay components
can be applied to a major surface of the impregnated matrix by any of
several methods, including, but not limited to, pouring, spraying,
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Application 10/247,892

transferring by surface-to surface contact, or soaking” (Spec. 13: 16-19).
Therefore, given the lack of specific definition in the Specification of a
“liquid dispensing apparatus” and the indications in the Specification that
assay components can be applied to an impregnated matrix by means that
include face-to-face contact with another matrix, we interpret the phrase
“liquid dispensing apparatus” to mean any apparatus for dispensing liquid,
including a gel matrix that supplies liquid containing the assay component
when in contact with an impregnated matrix.
Appellants do not dispute that Beutel teaches a method that
corresponds to the method defined by claim 1 but for using a matrix as a
liquid dispensing apparatus (App. Br. 7-9). Because we interpret claim 1 to
encompass a method that uses a matrix as a liquid dispensing apparatus, we
agree with the Examiner that the assay method of claim 1 encompasses the
assay method disclosed in Beutel.
We also agree with the Examiner that Beutel discloses all of the
limitations in claim 14. The assay method of claims 14 is similar to that of
claim 1 except that it does not require the assay component to be applied by
a liquid dispensing apparatus, but requires the assay component to be
“applied in the form of an array.”
Appellants argue that the “array” limitation “calls for a specific
pattern of the at least one assay component on the matrix” and that
distribution of an assay component in the bulk of the matrix, as disclosed by
Beutel, does not meet that limitation (App. Br. 9).
We do not find this argument to be persuasive. The Specification
defines “chemical entity” to mean “any biological or chemical substance of
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known or unknown organic or inorganic composition having known or
unknown biological and chemical effect” (Spec. 7, ll. 9-16). The
Specification defines “assay component” to mean “a chemical reagent or a
biological reagent involved in an assay to test for a response involving the
enhancement or the inhibition of a given biological process” (id. at 7, ll. 16-
19). Given these broad definitions, virtually any compound included in an
assay would qualify as either a “chemical entity” or an “assay component.”
Thus, under the broadest reasonable interpretation, claim 14 requires
applying a first assay reagent to a matrix in an array format to form an
impregnated matrix, applying a second assay reagent to the impregnated
matrix, and assessing the ability of the assay reagents to interact. As the
Examiner has pointed out (Ans. 5), Beutel discloses applying reagents to a
matrix in an array format (see Beutel, col. 7, ll. 44-48). We agree with the
Examiner that the assay method defined by claim 14 encompasses the assay
method disclosed in Beutel.
SUMMARY
The Examiner’s rejection is supported by the preponderance of the
evidence of record. We therefore affirm the rejection of claims 1-3 and 7-27
under 35 U.S.C. § 102(b).

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Appeal 2008-3447
Application 10/247,892

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

Ssc:

PAUL D. YASGER
ABBOTT LABORATORIES
100 ABBOTT PARK ROAD
DEPT. 377/AP6A
ABBOTT PARK, IL 60064-6008
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