Ex Parte Burg

Board of Patent Appeals and Interferences

Feb 23, 2010

11291723 (B.P.A.I. Feb. 23, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte LARRY BURG
__________

Appeal 2009-0095521
Application 11/291,723
Technology Center 1600
__________

Decided: February 23, 2010
__________

Before TONI R. SCHEINER, FRANCISCO C. PRATS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to methods of
determining the effectiveness of deposition of cells onto a planar surface.
The Examiner rejected the claims as anticipated and obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 Hologic, Inc. is the real party in interest.
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STATEMENT OF THE CASE
Cytology “is a medical and laboratory science that makes diagnoses
based on visual assessment of cellular characteristics. A typical cytological
technique is a ‘pap smear’ test, which is used, in one instance, to detect
abnormal cells in a woman’s cervix before they develop into cancer cells”
(Spec. [02]).
Cells used in cytological evaluations are generally obtained, for
example, by swabbing, scraping, or aspirating a sample from the tissue of
interest, and then placing the cells “into a solution to preserve cellular
morphology and other characteristics[;] the cells are [then] collected from
the solution, transferred onto a glass slide and stained for microscopic
viewing” (id.).
“Diagnostic accuracy by cytological evaluation depends on having a
sufficient number of cells for inspection and displaying those cells in a
manner that facilitates inspection of cellular features (i.e. a thin layer of cells
distributed uniformly on the surface)” (id.). To that end, the Specification
discloses a method “for the quantitative assessment of cell deposition onto a
planar surface” (id. at [01]).
Claims 1-13 are pending and on appeal (App. Br. 2-3). Claims 1 and
7, the independent claims, are representative and read as follows:
1. A method for determining the deposition of cells onto a
planar surface, the method comprising the steps of:

a. labeling tracer cells;

b. adding a known amount of said labeled cells to a
collection of sample cells that are in liquid
suspension;

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c. dispersing said sample cells onto a planar surface;

d. determining the effectiveness of transfer of the
sample cells by determining the number of labeled
cells transferred to the planar surface.

7. A method for determining the effectiveness and
uniformity of cells deposited onto a planar surface, the method
comprising the steps of:

a. labeling tracer cells;

b. adding a known amount of said labeled cells to a
collection of sample cells that are in liquid
suspension;

c. transferring the sample cells onto a microscope
slide;

d. determining the effectiveness and uniformity of
transfer of the sample cells by determining the
number and distribution of labeled cells transferred
to the microscope slide.

The Examiner cites the following documents as evidence of
unpatentability:
Hajek US 5,340,719 Aug. 23, 1994
Monforte US 7,091,046 B2 Aug. 15, 2006
Edmondson US 5,008,202 Apr. 16, 1991
Mattes US 4,666,845 May 19, 1987

M.A. King, Simultaneous Detection of Two Cell Surface Antigens by
a Red Blood Cell Rosette-Microsphere Binding Method, and Its Application
to the Study of Multiple Myeloma, 72 JOURNAL OF IMMUNOLOGICAL
METHODS 481-488 (1984).

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The following rejections are before us for review:2
(1) Claims 1, 3, and 6, rejected under 35 U.S.C. § 102(b) as
anticipated by King (Ans. 3-4);
(2) Claims 1-3, 5-9, and 11-13, rejected under 35 U.S.C. § 103(a) as
obvious in view of Hajek, Edmondson, and Monforte (Ans. 5-6); and
(3) Claims 4 and 10, rejected under 35 U.S.C. § 103(a) as obvious in
view of Hajek, Monforte, and Mattes (Ans. 7).
ANTICIPATION
ISSUE
The Examiner finds that King discloses a method “comprising
labeling red blood cells with antibody (labeled tracer cells),” adding a set
volume of the labeled cells to a sample containing cells to be detected,
dispersing the cells “into flat bottom microwells (planar surface) . . . [and]
counting the cells” (Ans. 4).
The Examiner contends that, “[w]ith respect to the effectiveness of
transfer of the sample cells as recited in the instant claims, King discloses
counting the cells using method steps consonant to the claimed invention;
hence, meets all the limitations of the claims” (id.).
Appellant contends that “King does not teach or suggest the addition
of a known amount of red blood cells to said labeled cells to a collection of
sample cells that are in liquid suspension and dispersing the sample cells
onto a planar surface” (App. Br. 6-7). Moreover, Appellant argues,
“[n]owhere in King is there teaching or suggestion of the use of labeled cells

2 The Examiner withdrew a rejection of claims 1-13 for indefiniteness under
35 U.S.C. § 112, second paragraph (Ans. 3).
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to determine the effectiveness of the transfer of sample cells to a surface”
(id. at 7).
In response, the Examiner contends that the claims “are broadly
drawn to determining the effectiveness of transfer and the specification does
not provide a clear definition of the effectiveness of transfer” (Ans. 8).
Moreover, the Examiner argues, while King is “silent with respect to
determining the effectiveness of transfer of the sample cells, King
specifically teaches adding set volumes of sample and tracer cells and
counting the cells using methods steps consonant to the claimed invention.
Therefore the publication of King describes and enables the limitations of
the claims” (id.).
Appellant does not present separate arguments with respect to any of
the claims subject to this ground of rejection. We select claim 1 as
representative of the rejected claims. See 37 C.F.R. § 41.37(c)(1)(vii).
In view of the positions advanced by Appellant and the Examiner, the
issue with respect to this rejection is whether the Examiner erred in finding
that King describes a method of determining the deposition of cells onto a
planar surface, the method including the steps of (b) “adding a known
amount of . . . labeled cells to a collection of sample cells that are in liquid
suspension,” and (d) “determining the effectiveness of transfer of the sample
cells by determining the number of labeled cells transferred to the planar
surface,” as recited in claim 1.
FINDINGS OF FACT (“FF”)
The Claims
1. Claim 1 recites a method for determining the deposition of cells onto a
planar surface. The method includes the steps of (a) labeling tracer cells, (b)
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adding a known amount of the labeled cells to a collection of sample cells
that are in liquid suspension, (c) dispersing said sample cells onto a planar
surface and (d) “determining the effectiveness of transfer of the sample cells
by determining the number of labeled cells transferred to the planar surface.”
2. The Specification does not contain a specific definition for the claim
term “effectiveness of transfer” (see Spec. [09]-[13] (section entitled
“DEFINITIONS”)).
3. The Specification does, however, disclose:
The present invention generally relates to a method for the
quantitative assessment of cell deposition onto a planar surface.
In particular, the present invention provides a method of
measure of the quantitative transfer of labeled tracer cells to a
glass slide to evaluate the effectiveness of and uniformity of
cell transfer to the surface of the slide. The method provides a
means to quantify these parameters and provides a basis of
standardization for comparing results between experiments or
samples. In one embodiment of the present invention, a method
for determining the deposition of cells onto a planar surface is
presented, such method comprising labeling tracer cells, adding
the labeled cells to a collection of non-labeled cells or sample
cells that are in liquid suspension, dispersing the sample cells
onto a planar surface and determining the effectiveness of
transfer of the sample cells by determining the number of
labeled cells transferred to the planar surface.

(Id. at [14].)
4. The Specification further discloses, in Example 1, a method of
evaluating the effect of different lubricants on cell transfer from a liquid
solution to a slide, by comparing the percentage of pre-stained tracer cells
transferred to a slide in the presence of the lubricant, to the amount of tracer
cells transferred to a slide from a control sample lacking the lubricant (id. at
[31]-[33]).
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5. As seen in Table 1, when present in the liquid sample, lubricant “A”
allowed only 36% of the pre-stained tracer cells to be transferred to the slide,
only 26% of the tracer cells to be transferred in the presence of lubricant
“B”, and only 18% transfer in the presence of lubricant “C” (id. at [33]).
6. Appellant’s Example 2 similarly shows the effect of the presence of
blood on the transfer of samples containing two different preservative
solutions (id. at [35]-[37]). As seen in Table 2, significantly more cells were
transferred to the slide in the absence of blood, as compared to the
percentage of cells transferred in the presence of blood (id. at [37]).

The Prior Art
7. King “describes a double marker assay system for human B
lymphocytes using antibody coated BRBC [bovine red blood cells], and
antibody coated small polystyrene Covaspheres” (King 482).
8. King discloses that the BRBC were coated with antibodies using a
modified chromic chloride method (id.).
9. King’s double marker assay identified B cells from a population of
human peripheral blood mononuclear cells (“PMBC”) (id. at 483).
10. King discloses that, in the double marker assay, the PMBC were first
reacted with “a-B1” a monoclonal antibody specific for human B-cells (id. at
482), and then Covaspheres coated with “a-huIg,” a goat antibody specific
for the light chains of human immunoglobulin (id.), were added (id. at 484).
11. King then discloses:
This suspension was then split equally to form a monolayer in 2
flat-bottom microwells in a 96-well culture plate . . . . The plate
was centrifuged . . . then left undisturbed for 30 min, at 4°C.
After gentle resuspension the cells plus Covaspheres were
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layered over 1 ml FCS and centrifuged . . . . The unbound
Covaspheres remained above the FCS. The PBMC were
resuspended in 100 μl and mixed with 300 μl BRBC/a-mIg
[BRBC coated with sheep antibody specific for mouse
immunoglobulin (id. at 482)], centrifuged, and left on ice for 1
h.

(Id. at 484.)
12. King then discloses that “PBMC were stained with toluidine blue and
viewed either under UV and low intensity visible light simultaneously, or,
after allowing the rosettes to flatten, under visible light only. Those PBMC
binding ≥ 10 Covaspheres and ≥ 6 BRBC were counted as positive for both
antigens” (id.).
PRINCIPLES OF LAW
“To anticipate a claim, a prior art reference must disclose every
limitation of the claimed invention, either explicitly or inherently.” In re
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997).
During examination, the PTO must interpret terms in a claim using
“the broadest reasonable meaning of the words in their ordinary usage as
they would be understood by one of ordinary skill in the art, taking into
account whatever enlightenment by way of definitions or otherwise that may
be afforded by the written description contained in the applicant’s
specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
However, “while ‘the specification [should be used] to interpret the
meaning of a claim,’ courts must not ‘import[ ] limitations from the
specification into the claim.’ . . . [I]t is improper to ‘confin[e] the claims to
th[e] embodiments’ found in the specification . . . .” In re Trans Texas
Holdings Corp., 498 F.3d 1290, 1299 (Fed. Cir. 2007) (quoting Phillips v.
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AWH Corp., 415 F.3d 1303, 1323 (Fed.Cir.2005), citations omitted,
bracketed text in internal quotes in original); see also Sjolund v. Musland,
847 F.2d 1573, 1581 (Fed. Cir. 1988) (“[W]hile it is true that claims are to
be interpreted in light of the specification and with a view to ascertaining the
invention, it does not follow that limitations from the specification may be
read into the claims.”); In re Bigio, 381 F.3d 1320, 1325 (Fed Cir. 2004)
(“[A]bsent claim language carrying a narrow meaning, the PTO should only
limit the claim based on the specification . . . when [it] expressly disclaim[s]
the broader definition.”).
Moreover, as stated in In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989),
“during patent prosecution when claims can be amended, ambiguities should
be recognized, scope and breadth of language explored, and clarification
imposed.”
ANALYSIS
Appellant’s arguments do not persuade us that the Examiner erred in
finding that King describes a method of determining the deposition of cells
onto a planar surface, the method including the steps of (b) “adding a known
amount of . . . labeled cells to a collection of sample cells that are in liquid
suspension,” and (d) “determining the effectiveness of transfer of the sample
cells by determining the number of labeled cells transferred to the planar
surface,” as recited in claim 1.
With respect to step (b), King explicitly discloses that the PMBC
sample cells in the double marker assay were “resuspended in 100 μl and
mixed with 300 μl BRBC/a-mIg [BRBC coated with sheep antibody specific
for mouse immunoglobulin (id. at 482)], centrifuged, and left on ice for 1 h”
(FF 11). We agree with the Examiner that, by disclosing that a specific
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amount, 300 microliters, of antibody-labeled bovine red blood cells was
added to the resuspended PMBC sample cells, King discloses “adding a
known amount of . . . labeled cells to a collection of sample cells that are in
liquid suspension,” as recited in claim 1.
King discloses that, in determining which of the sample cells adhered
to the culture plate are B cells, only those cells binding six or more antibody-
coated BRBC “were counted as positive” (FF 12). Thus, in determining
which cells are B cells, King counted the number of antibody-labeled cells
that were bound to the culture plate-adhered cells.
We therefore agree with the Examiner that King meets the
requirement in step “d” of “determining the number of labeled cells
transferred to the planar surface.” As step “d” specifies that this is all that is
required to “determine[e] the effectiveness of transfer of the sample cells,”
we also agree with the Examiner that King meets this aspect of step “d.”
Appellant’s arguments do not persuade us otherwise. We
acknowledge the Specification’s disclosure that the invention relates to
“quantitative assessment of cell deposition onto a planar surface,” which
“provides a basis of standardization for comparing results between
experiments or samples” (FF 3). We also acknowledge that, when compared
to a control or standard, determining the rate of transfer of tracer cells can
demonstrate the effects of different substances or contaminants in the
original sample (FF 4-6).
Claim 1, however, does not recite any steps of providing control or
comparative samples, nor does it recite any steps related to standardizing the
results of any particular cell deposition process. Rather, claim 1 recites only
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that the effectiveness of sample cell transfer is determined “by determining
the number of labeled cells transferred to the planar surface.”
As noted above, we agree with the Examiner that King performs that
step. Moreover, the formation of rosettes containing antibody-labeled
BRBC bound to B cells determines that the transfer of the sample cells to the
culture plate was, in fact, effective, which is all that claim 1 requires.
In sum, Appellant’s arguments do not persuade us that the Examiner
erred in finding that King meets all of the limitations in claim 1. We
therefore affirm the Examiner’s rejection of claim 1 as anticipated by King,
as well as the rejection of claims 3 and 6, which were not argued separately.
See 37 C.F.R. § 41.37(c)(1)(vii).

OBVIOUSNESS -- HAJEK, EDMONDSON, AND MONFORTE
ISSUE
Claims 1-3, 5-9, and 11-13, rejected under 35 U.S.C. § 103(a) as
obvious in view of Hajek, Edmondson, and Monforte (Ans. 5-6).
The Examiner cites Hajek as disclosing a method in which
antibody-labeled microspheres are mixed with a collection of sample cells
and then placed on a microscope slide to identify “a cell population [which
is] reflected in the number of cells which are bound by the microsphere
(tracers)(e.g. col 8-col 9). Hajek et al disclose adding a known amount of
labeled tracer to the sample (e.g. col 11, lines 40-42)” (id. at 5).
The Examiner cites Edmondson to show that the EDTA used in
Hajek’s samples meets the requirement of Appellant’s claim 5 for a cell
preservative (id.). The Examiner concedes, however, that Hajek differs from
the claims by “failing to teach the tracer is a cell” (id.).
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To meet that limitation the Examiner cites Monforte as disclosing
“bacteri[a] (cells) expressing antibodies (labels) (tracer cells) for binding to
a component of interest. Monforte teaches contacting these tracer cells with
a biological sample and allowing the tracer cell to bind to the component of
interest and then determining the tracer cells bound to component” (id. at 6).
Based on the references’ teachings, the Examiner concludes that an
ordinary artisan would have considered it obvious to substitute Monforte’s
tracer cells for Hajek’s tracer microspheres because “Monforte teaches that
the use of these tracer cells provides for the use of a broad range of in vivo
and in vitro selection methodologies and also teaches that these tracer cells
enable rapid monitoring of the binding to polypeptides via detection and
quantitation of their associated DNA codes” (id.).
Appellant contends that the Examiner has failed to identify a
“motivating force” that would have prompted an ordinary artisan to practice
the claimed invention (App. Br. 9). Moreover, Appellant argues, Hajek does
not teach or suggest “a method to determine the effectiveness of the transfer
of cells from a sample to a planar surface using labeled tracer cells” but
instead “only looks at subsets of cells which have selected properties or
characteristic[s]” (id.).
Appellant argues that the Examiner “has made no reference to any
calculations or analysis in Hajek et al. concerning cell transfer because such
an analysis does not exist. The same holds true for Monforte and
Edmondson” (id. at 10). Thus, Appellant argues, “[n]one of the references
cited by the Examiner, either alone or in combination, teaches the
measurement of effectiveness of cell transfer from a sample to a slide by
using labeled cells” (id.).
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Appellant further argues that it “makes absolutely no biological sense
to substitute the labeled bacterial cells described in Monforte for the
microspheres of Hajek et al. because the labeled bacterial cells of Monforte
do not have the same binding characteristics as the microspheres” (id.).
Moreover, Appellant urges:
Even assuming arguendo that the labeled bacterial cells of
Monforte have the same binding characteristics as the
microspheres in Hajek et al. neither the labeled bacterial cells
nor the microspheres are used for determining the efficiency of
transfer of cells from the sample to a slide. Without this key
limitation, there can be no suggestion to combine the references
cited by the Examiner. The fundamental principle of the
present invention is not disclosed in any of the references cited
by the Examiner and thus the Examiner has failed to establish a
case of obviousness.

(Id. at 10-11.)
Appellant does not present separate argument with respect to any of
the claims subject to this ground of rejection. We select claim 1 as
representative of the rejected claims. See 37 C.F.R. § 41.37(c)(1)(vii).
In view of the positions advanced by Appellant and the Examiner, the
issue with respect to this rejection is whether the Examiner erred in
concluding that an ordinary artisan viewing the teachings of the cited
references would have considered the process recited in claim 1 obvious.
FINDINGS OF FACT
Hajek
13. Hajek discloses a method “for optically screening cells to identify the
morphology and selected characteristics or properties expressed by the cells”
(Hajek, col. 3, l. 66 through col. 4, l. 2).
14. Hajek describes its method:
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The cells are combined with one or a plurality of different sets
of microspheres, each set having a reactant bound thereto which
will bind to a specific molecule which can exist on one or more
types of the cells. The cells and microspheres are prepared as a
smear on a slide and stained with a Wright type stain. The cells
then are optically viewed by an operator and/or automatically,
to identify the type of cells, if any, to which the different
microspheres are bound.

(Id. at col. 4, ll. 2-10.)
15. Hajek discloses that its microspheres have attached to their surfaces
“an antibody specific to a particular antigen which can exist on at least one
type of cell bound thereto” (id. at col. 5, ll. 42-44).
16. Hajek discloses adding a discrete volume of microspheres to the cells
to be evaluated, depending on the number of cells in the sample (id. at col. 9,
ll. 15-20.
17. Hajek discloses that, when viewing the stained slide, “[q]ualitative
positive results are seen when a specific cell type is consistently tagged with
two or more microspheres. The degree of positivity of a cell population for
a particular antigen can be reflected in the number of cells of that population
which are bound by microspheres” (id. at col. 9, ll. 34-39).

Monforte
18. Monforte discloses “methods of detecting one or more polypeptide[s]
in a sample” (Monforte, col. 2, ll. 53-54).
19. Monforte discloses that its methods “include the steps of contacting a
sample, such as a blood or other body fluid or tissue sample that contains
one or more polypeptides of interest, with at least one genetic package, such
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as a bacteriophage, a baculovirus, or a bacterium” (id. at col. 2, l. 64 through
col. 3, l. 1).
20. Monforte discloses that the “genetic package is selected to display a
polypeptide-binding component, such as an antibody on its surface. . . . In
addition, the genetic package can contain a predetermined marker
component for detection” (id. at col. 3, ll. 4-21).
21. Monforte discloses that its protein-binding detectable bacterial cells
can be used to “test a large number of samples, such as samples of test
proteins or cells containing nucleic acids encoding the proteins of interest to
identify structures of interest or to identify test compounds that interact with
the variant proteins or cells containing them” (id. at col. 5, ll. 30-34).
22. Monforte discloses that its method “provides a high level of flexibility
and selectivity because antibodies can be selected for virtually any target or
mixture of target polypeptides” (id. at col. 20, ll. 56-58).
PRINCIPLES OF LAW
As the Supreme Court pointed out in KSR Int' l Co. v. Teleflex
Inc., 550 U.S. 398, 418 (2007), “a patent composed of several elements is
not proved obvious merely by demonstrating that each of its elements was,
independently, known in the prior art.” Rather, the Court stated:
[I]t can be important to identify a reason that would have
prompted a person of ordinary skill in the relevant field to
combine the elements in the way the claimed new invention
does . . . because inventions in most, if not all, instances rely
upon building blocks long since uncovered, and claimed
discoveries almost of necessity will be combinations of what, in
some sense, is already known.

Id. at 418-419 (emphasis added).
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The Court advised, however, that in determining whether the prior art
supplied a reason for practicing the claimed subject matter, the analysis
“need not seek out precise teachings directed to the specific subject matter of
the challenged claim, for a court can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.” Id. at
418; see also id. at 421 (“A person of ordinary skill is . . . a person of
ordinary creativity, not an automaton.”).
The Court thus ultimately reaffirmed that “when a patent ‘simply
arranges old elements with each performing the same function it had been
known to perform’ and yields no more than one would expect from such an
arrangement, the combination is obvious.” Id. at 417 (quoting Sakraida v.
Ag Pro, Inc., 425 U.S. 273 (1976)).
The Court reasoned that “if a technique has been used to improve one
device, and a person of ordinary skill in the art would recognize that it would
improve similar devices in the same way, using the technique is obvious
unless its actual application is beyond his or her skill. Id. at 418.
ANALYSIS
Appellant’s arguments do not persuade us that the Examiner erred in
concluding that an ordinary artisan viewing the teachings of the cited
references would have considered the process recited in claim 1 obvious.
As the Examiner points out, Monforte discloses that detectable
bacterial cells expressing antibodies on their surfaces were useful for
detecting a wide variety of target polypeptides. We agree with the Examiner
that an ordinary artisan advised of that fact would have reasoned that cells
expressing the appropriate antibodies on their surfaces would be useful in
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the same manner as the detectable antibody-displaying microspheres used in
Hajek’s process of identifying cells in a sample.
We are therefore not persuaded that a person of ordinary skill would
have lacked sufficient impetus for substituting Monforte’s detectable tracer
cells for the detectable beads used in Hajek’s methods. Moreover, because
Monforte discloses that antibodies can be targeted to virtually any protein or
polypeptide of interest (FF 22), we are not persuaded that Monforte’s
disclosure is limited to the use of detectable cells that would be incapable of
binding to the cells of interest in Hajek.
Nor are we persuaded that the cited combination of references fails to
meet the requirement of step “d” in claim 1 of “determining the
effectiveness of transfer of the sample cells by determining the number of
labeled cells transferred to the planar surface.”
As the Examiner notes, once Hajek’s mixture of labeled tracer
particles is dispersed onto a microscope slide and stained (FF 14), the degree
to which a sample cell population expresses a particular antigen is
determined by “the number of cells of that population which are bound by
microspheres” (FF 17). By substituting Monforte’s labeled cells for the
microspheres, which the references suggest would be useful, the practitioner
would determine the percentage of antigen-expressing cells transferred to the
slide by determining, that is counting, the number of labeled cells which
bind to the substrate-bound sample cells, which is all that step “d” requires.
We acknowledge, as Appellant argues, that Hajek’s methods are
directed to identifying sub-populations of cells in a larger sample of cells.
We are not persuaded, however, that claim 1 excludes such processes.
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Contrary to Appellant’s argument, claim 1 simply does not require the
practitioner to perform any calculations or comparisons to standardized or
control preparations, nor does claim 1 require the practitioner to prepare any
control or comparative samples. Rather, claim 1 recites only that the
effectiveness of sample cell transfer is determined “by determining the
number of labeled cells transferred to the planar surface.”
As noted above, we agree with the Examiner that Hajek and Monforte
suggest performing that step. Moreover, by counting the number of labeled
cells that bind to the antigen-expressing cells adhered to the slide, the
practitioner would, in fact, determine whether the transfer of the sample cells
to the slide was effective, which is all that claim 1 requires. Claim 1 simply
does not require an assessment of the degree of effectiveness, as Appellant
appears to assert.
In sum, Appellant’s arguments do not persuade us that the Examiner
erred in finding that an ordinary artisan would have considered the process
recited in claim 1 obvious in view of Hajek and Monforte. We therefore
affirm the Examiner’s obviousness rejection of claim 1 over those
references, as well as the rejection of claims 2, 3, 5-9, and 11-13, which
were not argued separately. See 37 C.F.R. § 41.37(c)(1)(vii).

OBVIOUSNESS -- HAJEK, MONFORTE, AND MATTES
Claims 4 and 10 stand rejected under 35 U.S.C. § 103(a) as obvious in
view of Hajek, Monforte, and Mattes et al (Ans. 7). Claim 4 is
representative of the rejected claims and recites “[t]he method of claim 1
wherein the sample cells are cervical cells.”
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The Examiner cites Mattes as teaching “the use of antibodies for
detecting cervical cells” (id.). Based on the cited references’ disclosures the
Examiner reasons that an ordinary artisan would have considered it obvious
“to incorporate anti-cervical cell antibodies as taught by Matte[s] et al into
the modified method of Hajek et al because Hajek et al is generic with
respect to the cells to be detected and one would use the appropriate reagent
to determine the cells of interest in this case cervical cells” (id.).
Appellant does not traverse the Examiner’s conclusion regarding the
detection of cervical cells by Hajek’s methods, as modified by Monforte, but
instead reiterates the argument that “[n]one of the references cited by the
Examiner, either alone or in combination, teaches the measurement of
effectiveness of cell transfer from a sample to a slide by using labeled cells”
as required by claim 1 (App. Br. 12).
For the reasons above, we are not persuaded by this argument.
Neither claim 1, nor its dependent claim 4, requires the practitioner to
perform any calculations or comparisons to standardized or control
preparations, nor does claim 1 require the practitioner to prepare any control
or comparative samples. Rather, claim 1 recites only that the effectiveness
of sample cell transfer is determined “by determining the number of labeled
cells transferred to the planar surface.”
As discussed above, we agree with the Examiner that the cited
references suggest that step. With respect to claim 4, which depends from
claim 1, Appellant does not point to, nor do we detect, any deficiency in the
Examiner’s conclusion of obviousness. We therefore affirm the Examiner’s
obviousness rejection of claim 4, as well as the rejection of claim 10, which
was not argued separately.
Appeal 2009-009552
Application 11/291,723

20
SUMMARY
We affirm the Examiner’s rejection of claims 1, 3, and 6 under 35
U.S.C. § 102(b) as anticipated by King.
We also affirm the Examiner’s rejection of claims 1-3, 5-9, and 11-13
under 35 U.S.C. § 103(a) as obvious in view of Hajek, Edmondson, and
Monforte (Ans. 5-6).
We also affirm the Examiner’s rejection of claims 4 and 10 under 35
U.S.C. § 103(a) as obvious in view of Hajek, Monforte, and Mattes.

Appeal 2009-009552
Application 11/291,723

21
TIME PERIOD
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

alw

THEODORE ALLEN, ESQ.
CYTYC CORPORATION
250 CAMPUS DRIVE
MARLBOROUGH, MA 01752