Ex Parte Hung

Board of Patent Appeals and Interferences

Jul 22, 2008

09912499 (B.P.A.I. Jul. 22, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte DAVID HUNG
__________

Appeal 2008-2336
Application 09/912,499
Technology Center 3700
__________

Decided: July 22, 2008
__________

Before ERIC GRIMES, LORA M. GREEN, and FRANCISCO C. PRATS,
Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a device
for collecting breast duct fluid. The Examiner has rejected the claims as
anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm-in-part.
Appeal 2008-2336
Application 09/912,499

STATEMENT OF THE CASE
Claims 1-8, 10-13, 26, and 27 are pending and on appeal (App. Br. 2).
Claim 1 is representative of the claimed subject matter and reads as follows:
1. A device for collecting breast duct fluid from
within a breast duct in order to detect breast cancer or precancer
comprising:
a probe having a diameter sized to access a breast duct
and a distal portion being capable of contacting an interior
lumen of a breast duct and retrieving a sample of the breast duct
fluid from within the duct for analysis, and wherein said probe
is free of an opening through which a fluid from an external
source can be introduced into said probe and pass through said
probe into the duct when said probe is positioned within the
breast duct, and wherein said probe is rigid before entry into the
breast duct, and flexible upon resistance in the duct.

The Examiner relies on the following documents as evidence of
unpatentability:
Nicholson US 4,616,656 Oct. 14, 1986
Butler US 4,767,011 Aug. 30, 1988
Marchosky US 4,947,842 Aug. 14, 1990
Raynor US 5,003,905 Apr. 2, 1991
Pestes US 5,623,942 Apr. 29, 1997
Jones US 6,101,635 Aug. 15, 2000
Kurz US 6,319,267 B1 Nov. 20, 2001
Hung US 6,391,026 B1 May 21, 2002
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The following rejections are before us for review:
Claims 1-6, 12, and 13 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Pestes (Ans. 4).
Claims 26 and 27 stand rejected under 35 U.S.C. § 103(a) as being
obvious in view of Pestes (Ans. 5).1
Claims 7, 8, and 10 stand rejected under 35 U.S.C. § 103(a) as being
obvious in view of Pestes and Nicholson (Ans. 5).
Claim 11 stands rejected under 35 U.S.C. § 103(a) as being obvious in
view of Pestes and Marchosky (Ans. 6).
ANTICIPATION
ISSUE
Claims 1-6, 12, and 13 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Pestes (Ans. 4).
The Examiner cites Pestes as disclosing a flexible probe “having a
diameter that is sized to access a breast duct and a distal portion being
capable of contacting an interior lumen of a breast duct and retrieving a
sample of the breast duct fluid from within the duct for analysis” (id). The
Examiner states that Pestes’ probe “is rigid before entry into the breast duct,
and flexible upon resistance into the duct” (id. (citing Pestes, col. 2, ll. 16-25
and 32-40)). The Examiner cites Hung as evidence that the diameter of

1 Although the Examiner includes claims 26 and 27 as part of the rejection
over Pestes combined with Nicholson, the Examiner bases the obviousness
conclusion on Pestes alone (see Ans. 5), and Appellant argues the rejection
as being over Pestes alone (see App. Br. 10-13). We therefore consider the
rejection of claims 26 and 27 separately from the rejection of claims 7, 8,
and 10.
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Pestes’ probe renders it “capable of performing the function as set forth in
claim 1” (id.).
Appellant contends that Pestes’ probe fails to meet the limitation of
claim 1 requiring that the probe be “rigid before entry into the breast duct,
and flexible upon resistance in the duct” (App. Br. 3), and that Pestes
therefore “cannot anticipate independent claim 1” (id. at 5). Appellant
contends that Pestes does not anticipate claim 6, because Pestes “does not
teach or suggest a surface having molecules affixed that bind an agent in the
ductal fluid” (App. Br. 6). Appellant contends that Pestes does not
anticipate claim 13, because Pestes “does not teach or suggest a probe
[which] comprises a shape memory material” (App. Br. 7). Appellant does
not argue any claims separately other than claims 1, 6, and 13.
The issue with respect to this rejection, then, is whether the Examiner
erred in finding that Pestes meets all of the limitations recited in claims 1, 6,
and 13.
FINDINGS OF FACT (“FF”)
1. Claim 1 recites a probe for collecting breast duct fluid from a breast
duct to detect breast cancer or precancer. The probe’s diameter is sized to
access a breast duct and its distal portion is capable of contacting an interior
lumen of a breast duct and retrieving a sample of the breast duct fluid for
analysis. The probe may not have an opening through which fluid from an
external source can be passed through the probe into the breast duct.
The probe must be “rigid before entry into the breast duct, and
flexible upon resistance in the duct.”
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2. Claim 6 recites “[a] device as in claim 1, wherein the distal portion
comprises a surface having molecules affixed that bind an agent in the ductal
fluid it contacts.”
3. Claim 13 recites “[a] device as in claim 1, wherein the probe
comprises a shape memory material.”
4. The Specification states:
The probe can be made of a material that provides that it is
rigid before entry into the breast duct, and that it then becomes
flexible upon residence in the duct. Thus, the probe can be made
of a thermo-sensitive polymer that is stiff at room temperature,
and which softens and become[s] flexible at body temperature.
This feature provides a probe that can reside in a duct over a
period of time exceeding an office visit, e.g. for several hours, or
several days, or several weeks. The residence feature allows for
the collection and sampling of a sufficient quantity of ductal
fluid for making a particular analysis. An example of material
that the probe can comprise to achieve this feature is a shape
memory material, such as, for example a nickel titanium alloy
material.

(Spec. 8.)
5. Pestes discloses:
A swab for collecting cell samples from a male urethra
including a unitary elongate shaft having a constant diameter
cylindrical handle at one end and a tapered circular cross-
sectioned probe at the other end. The shaft is injection molded
from a glass filled nylon material with the fiberglass being
between 5 and 20 percent by volume and preferably being 10
percent by volume. A fiber tip is mounted at the end of the
probe to collect cell specimens.

(Pestes, abstract.)
6. Pestes discloses that “the distal extremity . . . of the probe has a
diameter of 0.035 inches” (Pestes, col. 2, ll. 15-16). Pestes states that the
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disclosed general shape of the probe “permits injection molding of a one-
pieced shaft from a particular material that provides the necessary
combination of ductility, stiffness and tip size” (id. at col. 2, ll. 22-25).
7. Pestes discloses that “the swab shaft must be ductile enough so that it
will not break and yet be stiff enough that it will not flex excessively during
use” (Pestes, col. 1, ll. 18-20). Pestes discloses that:
In order to provide sufficient ductility that the shaft will not
break in use and still be stiff enough to prevent it from being
bent during its intended use, the fiberglass must constitute 5 to
20 percent of the volume of the shaft. Ideally, the fiberglass
would constitute 10 percent of the shaft.

(Pestes, col. 2, ll. 32-37).
8. Hung discloses “methods and apparatus for ablating or inhibiting the
proliferation of epithelial and other cells lining a breast duct” (Hung, col. 1,
ll. 17-19). Hung discloses “[a]n exemplary catheter . . . suitable for
accessing ductal lumens for both diagnosis and therapy” that has an “outer
tip diameter . . . about 0.8 mm” (id. at col. 10, ll. 54-61).
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).
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However, “[a]bsent claim language carrying a narrow meaning, the
PTO should only limit the claim based on the specification or prosecution
history when those sources expressly disclaim the broader definition.” In re
Bigio, 381 F.3d 1320, 1325 (Fed Cir. 2004). Thus, “while 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.” Sjolund v. Musland, 847 F.2d
1573, 1581 (Fed. Cir. 1988).
ANALYSIS
We agree with the Examiner that Pestes discloses all of the limitations
in claims 1, 6, and 13. With respect to claim 1, we detect no error in the
Examiner’s finding that, based on the diameter of Hung’s breast duct probe
(see FF 8), the 0.035 inch diameter of Pestes’ urethral probe (see FF 6) has a
diameter suitable for probing breast ducts. Thus, given the configuration
and size of Pestes’ probe (see FF 5-7), we agree with the Examiner’s finding
that it would be capable of contacting an interior lumen of a breast duct and
retrieving a sample of the breast duct fluid for analysis.
Appellant argues that the Examiner erred in finding that Pestes meets
the limitation in claim 1 requiring the probe to be “rigid before entry into the
breast duct, and flexible upon resistance in the duct” (App. Br. 3-4).
Specifically, Appellant argues that because Pestes discloses that its probe is
stiff enough such that it will neither break nor bend during use, “[c]learly,
not all of the functional features of the present invention are disclosed in
Pestes” (id. at 5).
We are not persuaded by these arguments, nor do we agree with
Appellant’s interpretation of Pestes. Rather, we agree with the Examiner
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that the disputed limitation in claim 1 is broad enough to encompass Pestes’
probe.
We note that Appellant’s Specification discloses embodiments in
which a material such as a temperature sensitive polymer can be used to
make a probe that is “stiff at room temperature, and which softens and
become[s] flexible at body temperature” (Spec. 8 (FF 4)). However, it is
well settled that it is improper to read limitations from the Specification into
the claims. See Sjolund v. Musland, 847 F.2d at 1581.
Moreover, claim 1 does not, by its terms, limit the probe’s flexibility
based on temperature in the manner described in the Specification. Nor does
claim 1 place any empirical limitation or absolute value on the probe’s
flexibility. Rather, claim 1 uses the relative terms “stiff” and “flexible,” and
only requires the probe to be “flexible upon resistance in the duct.”
We therefore agree with the Examiner that claim 1 encompasses a
fairly stiff probe that will flex, even a small amount, when it encounters
resistance in a breast duct. Because Pestes discloses that its probe is stiff,
i.e., rigid, enough to be used as a probe, but also ductile, i.e., flexible,
enough to avoid breaking when in use (see FF 5-7), we also agree with the
Examiner that the limitation in claim 1, requiring the probe to be “rigid
before entry into the breast duct, and flexible upon resistance in the duct,” is
broad enough to encompass Pestes’ probe.
We therefore affirm the Examiner’s anticipation rejection of claim 1
over Pestes. Because claims 2-5 and 12 were not argued separately from
claim 1, they fall with claim 1. See 37 C.F.R. § 41.37(c)(1)(vii).
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Appellant argues that Pestes “does not teach or suggest a surface
having molecules affixed that bind an agent in the ductal fluid” and,
therefore, does not anticipate claim 6 (App. Br. 6). We do not agree.
Pestes discloses that its probe has a “fiber tip . . . mounted at the end
of the probe to collect cell specimens” (Pestes, abstract (FF 5)). Because the
molecules in the fiber tip must bind to cells to collect and retrieve them from
the urethra, we agree with the Examiner that Pestes meets the limitations of
claim 6. We therefore affirm the Examiner’s anticipation rejection of claim
6 over Pestes.
With respect to claim 13, Appellant argues that Pestes “does not teach
or suggest a probe compris[ing] a shape memory material. The materials
disclosed in Pestes et al. are nylon and fiberglass, neither of which are shape
memory materials” (App. Br. 7).
In response, the Examiner cites Butler and Raynor as evidence that
“fiberglass may be manufactured to be highly flexible or rigid,” and cites
Jones and Kurz as evidence that “nylon may be manufacture[d] to be highly
flexible or rigid. These ranges of flexibility or rigidity of fiberglass and
nylon show that devices may be manufactured to a sufficient rigidity such
that it would exhibit shape memory qualities” (Ans. 7).
We agree with the Examiner that the language “shape memory
material” in claim 13 encompasses Pestes’ flexible nylon/fiberglass probe.
Appellant points to no definition or evidence, either in the Specification or
the prior art, to support the assertion that nylon and fiberglass are not shape
memory materials. While the Specification provides an example of a nickel
titanium alloy as a shape memory material (Spec. 8 (FF 4)), as noted above,
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preferred embodiments are not to be read from the Specification into the
claims. See In re Bigio, 381 F.3d at 1325.
Moreover, because Pestes discloses that its probe is stiff, i.e. rigid,
enough to be used as a probe, but also ductile, i.e. flexible, enough to avoid
breaking when in use (see FF 5-7), one of ordinary skill in the art would
reason that Pestes’ probe would return to its original shape after bending or
flexing. Thus, when the term “shape memory material” is given its broadest
reasonable interpretation consistent with the Specification, we agree with the
Examiner that claim 13 encompasses Pestes’ probe. We therefore affirm the
Examiner’s anticipation rejection of claim 13 over Pestes.
OBVIOUSNESS -- PESTES ALONE
ISSUE
Claims 26 and 27 stand rejected under 35 U.S.C. § 103(a) as being
obvious in view of Pestes alone (Ans. 5).
The Examiner cites Pestes as disclosing the device recited in claims
26 and 27, “except for a probe diameter between 0.008 cm to about 0.045
cm. Pestes discloses a probe with a diameter of 0.08 cm” (Ans. 5). The
Examiner contends that “it would have been an obvious matter of design
choice to a person of ordinary skill in the art to vary the diameter of the
probe, since it would only involve a mere change in the size of a
component” (id.). The Examiner also finds that “[o]ne of ordinary skill in
the art, furthermore, would have expected Appellant’s invention to perform
equally well with a diameter of 0.08 cm. Therefore, such a change in size is
considered to be well within the level of skill of the ordinary artisan” (id.).
Appellant contends that the significantly larger diameter of Pestes’
probe compared to the claimed probe “would make it impractical to be used
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as a device to retrieve fluid from a breast duct” (App. Br. 11). Appellant
also contends that the Examiner’s conclusion of obviousness is erroneous
because the claimed probe and Pestes’ probe are directed to different fields
of medicine, and that, therefore, “it is not correct to assume that the issues
relating to collecting cells from a male urethra are reasonably pertinent to
the issues relating to collecting fluid from a female breast duct” (id. at 12-
13). Appellant does not present separate arguments with respect to claims
26 and 27.
The issue with respect to this rejection, then, is whether the Examiner
erred in concluding that one of ordinary skill would have considered a probe
having the diameter recited in claim 26 obvious in view of Pestes’ probe.
FINDINGS OF FACT
9. Claim 26 recites “[a] device as in claim 1, wherein said diameter of
said probe is between about 0.008 cm and about 0.040 cm.”
10. Regarding the dimensions of its probe, Pestes discloses:
The preferred embodiment of the shaft has an overall length of
slightly less than six inches and the probe covers about one
quarter of this length. The preferred diameter of the handle is
approximately 0.100 inches and the distal extremity 18 of the
probe has a diameter of approximately 0.035 inches. While the
foregoing configuration is preferred in order to provide an
instrument that is properly balanced for ease of use, a handle
size that is easy to hold and will not inadvertently break or
unnecessarily bend, a considerable amount of dimensional
variation is acceptable.

(Pestes, col. 2, ll. 11-21.)
Appellant states that Pestes’ probe diameter of 0.035 inches is
equivalent to 0.089 centimeters (App. Br. 11).
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11. Pestes states the following regarding the process of collecting cell
samples from a patient’s urethra:
This process has inherent difficulties with respect to males due
to the small size of the urethra and the sensitivity surrounding
its opening. First of all the probe end of the swab shaft must be
small enough that when covered with the fiber tip that is used to
capture cells it will fit comfortably in the urethra. At the same
time the handle at the other end of the swab shaft must be
sufficiently large to allow it to be firmly gripped.

(Pestes, col. 1, ll. 13-18.)
PRINCIPLES OF LAW
In proceedings before the Patent and Trademark Office,
the Examiner bears the burden of establishing a prima facie
case of obviousness based upon the prior art. “[The Examiner]
can satisfy this burden only by showing some objective
teaching in the prior art or that knowledge generally available to
one of ordinary skill in the art would lead that individual to
combine the relevant teachings of the references” (footnote
omitted).

In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992) (citations omitted,
bracketed material in original). Furthermore, “[e]ven when obviousness is
based on a single prior art reference, there must be a showing of a suggestion
or motivation to modify the teachings of that reference.” In re Kotzab,
217 F.3d 1365, 1370 (Fed. Cir. 2000).
Regarding the showing required to establish obviousness, the
Supreme Court, emphasizing a flexible approach to the question, has stated
that 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.” KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007). The
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Court has further advised that “[a] person of ordinary skill is . . . a person of
ordinary creativity, not an automaton.” Id. at 1742.
Regarding hindsight reasoning, the Court stated that “[a] factfinder
should be aware, of course, of the distortion caused by hindsight bias and
must be cautious of arguments reliant upon ex post reasoning. Rigid
preventative rules that deny factfinders recourse to common sense, however,
are neither necessary under our case law nor consistent with it.” Id. at 1742-
1743 (citations omitted).
Moreover, “[w]here ‘the difference between the claimed invention
and the prior art is some range or other variable within the claims . . ., the
[applicant] must show that the particular range is critical, generally by
showing that the claimed range achieves unexpected results.’” Iron Grip
Barbell Co., v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004)
(quoting In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990)); see also
Gardner v. TEC Systems, Inc., 725 F.2d 1338, 1349 (Fed. Cir. 1984)
(claimed device that differed from the prior art with respect to dimensional
limitations but performed and operated in the same manner as the prior art
device held obvious).
ANALYSIS
We agree with the Examiner that a person of ordinary skill in the art
would have considered a probe having the diameter recited in claim 26
obvious in view of Pestes. We note that the upper limit of the diameter
range recited in claim 26, 0.040 centimeters, is a little less than half of
Pestes’ preferred probe diameter of 0.089 centimeters.
However, Pestes explicitly discloses that “a considerable amount of
dimensional variation is acceptable” outside of the preferred dimensions for
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its probe (Pestes, col. 2, ll. 20-21 (FF 10)). Given this teaching, we agree
with the Examiner that one of ordinary skill in the art would have reasoned
that Pestes’ probe would acceptably perform its intended function with the
diameter recited in claim 26.
Moreover, one of ordinary skill in the art, being a person of ordinary
creativity and common sense, see KSR, 127 S. Ct. 1742-43, being aware that
the dimensions of Pestes’ probe could be varied considerably, and also
aware of the small size and sensitivity of the male urethra (FF 11), would
have reasonably inferred that reducing the diameter of Pestes’ probe would
be desirable in order to minimize the probe’s intrusiveness. We therefore
also agree with the Examiner that one of ordinary skill would have
considered it obvious to provide Pestes’ probe with the diameter recited in
claim 26.
Appellant argues that the tip of Pestes’ probe is “actually much larger
[than 0.089 centimeters] due to the fiber tip which surrounds the distal end
of the device,” and that “[t]herefore, the overall diameter of the probe
described in Pestes et al. would make it impractical to be used as a device to
retrieve fluid from a breast duct” (App. Br. 11). Moreover, Appellant
argues, given the taper of Pestes’ probe, inserting it into a breast duct “may
be successful for the very tip of the probe (assuming no fiber tip), however,
as the probe is inserted deeper into the ductal canal, the increased diameter
of the probe (to a maximum of 0.254cm) would cause considerable pain to
the patient as well as potentially causing damage to the ducts themselves”
(id. at 11-12).
Appellant further urges that Pestes’ examination of the male urethra is
a “completely different problem[]” than examining breast ducts (id. at 12),
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and that “because the problems concerning artisans relying on the disclosure
in Pestes et al. are not pertinent to the problems concerning the present
disclosure, artisans lack the required motivation to combine them in a
manner that renders the claimed invention obvious” (id. at 13).
We are not persuaded by these arguments. Claim 26 is directed to a
probe having specific properties, not a method of its use. The relevant issue
with respect to this rejection, therefore, is not whether one of ordinary skill
in the art would have been motivated to use Pestes’ probe, as disclosed, to
collect samples from breast ducts. Rather, the issue is whether a probe
having the diameter recited in claim 26 would have been obvious in view of
Pestes’ probe.
As discussed above, although Pestes’ probe has a diameter slightly
more than twice that recited in claim 26, one of ordinary skill in the art
would have reasoned from Pestes’ teachings (FF 10) that a probe with a
significantly smaller diameter would function acceptably as a urethral probe,
and would also have inferred that a narrower probe would be desirable,
given the size and sensitivity of the male urethra (FF 11). Moreover, while
Pestes’ probe may be intended as a urethral probe rather than a breast duct
probe, a claim must be considered prima facie obvious when the prior art
suggests its practice, even if the prior art’s reason for practicing the claimed
subject matter is different than the applicant’s. See KSR, 127 S. Ct. at 1741-
1742 (“In determining whether the subject matter of a patent claim is
obvious, neither the particular motivation nor the avowed purpose of the
patentee controls. What matters is the objective reach of the claim. If the
claim extends to what is obvious, it is invalid under § 103.”)
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Thus, we do not agree with Appellant that the probe diameter recited
in claim 26 would have been unobvious over Pestes. We therefore affirm
the Examiner’s rejection of claim 26 as obvious over Pestes. Because claim
27 was not argued separately, it falls with claim 26. See 37 C.F.R.
§ 41.37(c)(1)(vii).
OBVIOUSNESS -- PESTES AND NICHOLSON
ISSUE
Claims 7, 8, and 10 stand rejected under 35 U.S.C. § 103(a) as being
obvious in view of Pestes and Nicholson (Ans. 5).
The Examiner concedes that Pestes does not disclose a probe with “a
means (marker/indicia) to measure a quality of the ductal fluid in situ,” and
cites Nicholson to meet that limitation (id. (citing Nicholson, col. 4, ll. 12-
17)). The Examiner contends that one of ordinary skill in the art would have
considered it obvious “to modify the distal portion of Pestes with the
m[e]ans to measure a quality of the ductal fluid, as taught by Nicholson, for
providing markings to indicate the depth of the device distal end when
anchored. It is noted that Appellant indicates that such quality/means can
comprise a marker” (id. (citing Spec. 4:8)).
Appellant argues that the Examiner has not established that the
rejected claims would have been obvious over the cited references because
the term “marker” is defined in the Specification as meaning biological
rather than physical indicia (App. Br. 8-9), and because the depth
measurement provided by Nicholson’s device is not properly considered a
quality (id. at 9-10).
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The issue with respect to this rejection, then, is whether the Examiner
has shown that the cited references would have rendered claims 7, 8, and 10
obvious to one of ordinary skill in the art.
FINDINGS OF FACT
12. Claims 7, 8, and 10 read as follows:
7 A device as in claim 1, wherein the distal portion
comprises a means to measure a quality of the ductal fluid in
situ.
8 A device as in claim 7, wherein the quality
comprises an indicia selected from the group consisting of cell
size, cell density, nuclear size, nucleoli size, and chromatin
coarseness.
10 A device as in claim 7, wherein the quality
comprises a marker.

13. The Specification discloses:
The agent or marker sought in the ductal fluid can be,
e.g. a molecule such as an antibody, a peptide, a polypeptide, a
nucleic acid, a polynucleotide, a small organic molecule, a
macromolecule, a polymer, a carbohydrate, or a lipid. In
general any marker characteristic of ductal precancer or cancer
can be used, provided it is retrievable by the probe.

(Spec. 10.)
14. Nicholson discloses a device for “detection and location of
presymptomatic, non-palpable lesion[s] within the female breast”
(Nicholson, col. 1, ll. 8-10). Nicholson’s device consists of a needle cannula
with a probe wire inside it (id. at col. 2, ll. 41-56). To locate lesions in the
breast, the device is “inserted into the body tissue to a location whereat the
distal end lies hopefully at about 2 cm from the lesion as previously
determined by mammography” (id. at col. 2, ll. 56-59). The device’s
location adjacent to the lesion is confirmed by repeating the mammography,
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and the needle sheath is removed, leaving the wire probe in the tissue as a
marker to indicate the lesion’s location to the surgeon (see id. at col. 2, l. 59,
through col. 3, l. 62).
15. Nicholson discloses that its wire probe is advantageous in that it is
made of a memory shape material that can be shaped like a hook to maintain
its location in the breast tissue, but is flexible enough to be dislodged and
repositioned without breaking, unlike previous probe wires (Nicholson, col.
3, ll. 4-19; see also Figures 2 and 3). Nicholson does not specifically
mention that its probe is suitable for examining breast ducts.
16. Nicholson discloses:
Graduations 26 are provided on the proximal extent of
the probe wire. These markings indicate both the depth of the
probe wire's distal end when anchored and the depth of the
probe unit's distal end when the wire is properly sheathed in the
cannula.
Graduations 28 on the extended distal portion of the
probe wire are an indication to the surgeon as to relation of
incision to the distal end of the wire.

(Nicholson, col. 4, ll. 12-19.)
PRINCIPLES OF LAW
As the Supreme Court recently pointed out, “it 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.” KSR Int'l v.
Teleflex Inc., 127 S. Ct. 1727, 1741 (2007). Thus, “[i]n determining whether
obviousness is established by combining the teachings of the prior art, the
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test is what the combined teachings of the references would have suggested
to those of ordinary skill in the art.” In re GPAC Inc., 57 F.3d 1573, 1581
(Fed. Cir. 1995) (internal quotations omitted).
When evaluating claims for obviousness, “the prior art as a whole
must be considered. The teachings are to be viewed as they would have
been viewed by one of ordinary skill.” In re Hedges, 783 F.2d 1038, 1041
(Fed. Cir. 1986). Moreover, “‘[i]t is impermissible within the framework of
section 103 to pick and choose from any one reference only so much of it as
will support a given position, to the exclusion of other parts necessary to the
full appreciation of what such reference fairly suggests to one of ordinary
skill in the art.’” Id. (quoting In re Wesslau, 353 F.2d 238, 241 (CCPA
1965)).
ANALYSIS
We agree with Appellant that the Examiner has not made out a prima
facie case of obviousness based on Pestes and Nicholson.
Pestes discloses that its probe is to be used to collect samples from a
male urethra (FF 5, 11). Nicholson discloses that the hook-shaped wire on
its probe is configured to be deployed into breast tissue and maintained at a
specific location, to designate to a surgeon the location of a lesion to be
excised (see FF 14). We do not see, and the Examiner does not explain,
where the references would have suggested to one of ordinary skill that it
would be desirable to provide Pestes’ urethral probe with a wire that is
intended to be maintained within breast tissue to indicate the location of
lesions.
Even assuming for argument’s sake that Pestes’ probe is suitable for
examining breast ducts, we do not see, and the Examiner does not point to,
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any specific disclosure in Nicholson suggesting that its wire probe would be
desirable on a breast duct probe having a fiber tip like Pestes’ probe. We do
not agree with the Examiner that one of ordinary skill examining breast
ducts with Pestes’ probe would have considered it desirable to exchange
Pestes’ cell-collecting fiber tip for a hook-shaped wire probe configured to
maintain its position in breast tissue. We therefore do not agree with the
Examiner that one of ordinary skill would have been prompted to combine
the Pestes and Nicholson disclosures.
Regarding the gradations on Nicholson’s probe wire, the Examiner
argues that in addition to being used to measure the probe’s depth “[i]t is
also possible that these markings provide a scale to measure . . . cell size. If
cell size is an indicator of a quality of ductal fluid as suggested by
Appellant’s claim 8, then markings suggested by Nicholson is certainly a
means to measure a qualitative aspect of ductal fluid” (Ans. 8).
We are not persuaded by this argument. The Examiner points to
nothing in Nicholson disclosing or suggesting that the gradations were of a
suitable size or configuration for measuring cells.
Because we do not agree with the Examiner that one of ordinary skill
in the art would have been prompted to combine Pestes and Nicholson in the
manner advanced by the Examiner, we reverse the Examiner’s obviousness
rejection of claims 7, 8, and 10 over those references.
OBVIOUSNESS -- PESTES AND MARCHOSKY
ISSUE
Claim 11 stands rejected under 35 U.S.C. § 103(a) as being obvious in
view of Pestes and Marchosky (Ans. 6).
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The Examiner concedes that Pestes does not disclose a probe having
“a coating of an anesthetic on the exterior of the probe” as recited in claim
11, and cites Marchosky to meet that limitation (Ans. 6). The Examiner
contends that one of ordinary skill in the art would have considered it
obvious “to modify the device of Pestes with the coating taught by
Marchosky to relieve pain in the treatment of tumors particularly in the
breast area” (id. (citing Marchosky, col. 5)).
Appellant contends that “[t]here is no clear, particular motivation in
the references to reach the claimed invention” (App. Br. 17).
The issue with respect to this rejection, then, is whether the Examiner
has shown that the cited references would have rendered claim 11 prima
facie obvious to one of ordinary skill in the art.
FINDINGS OF FACT
17. Claim 11 recites “[a] device as in claim 1, further comprising a
coating of an anesthetic on the exterior of the probe.”
18. Marchosky discloses an “apparatus for treating tissue interstitially
with multiple modalities of treatment” (Marchosky, col. 3, ll. 7-9).
Marchosky’s apparatus includes a hollow probe that provides the different
treatment modalities directly to the treatment site, for example a tumor (id.
at col. 3, ll. 9-14). Thus, for example, in addition to applying a
chemotherapeutic agent to a tumor, the probe can also enhance the
medicament’s activity by applying heat to the tumor with a heating element
(id. at col. 3, ll. 14-25).
19. Marchosky discloses that the probe may also carry “an anesthetic or
analgesic for relieving pain. An anesthetic or analgesia is particularly
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helpful to relieve pain in the treatment of tumors particularly in sensitive
areas such as the breast” (Marchosky, col. 5, ll. 33-37).
ANALYSIS
We agree with the Examiner that one of ordinary skill in the art would
have considered claim 11 prima facie obvious in view of Pestes and
Marchosky. A person of ordinary skill, advised by Pestes of the sensitivity
of the urethral area examined by its probe (FF 11), and further advised by
Marchosky of the desirability of using anesthetic on probes used in sensitive
areas (FF 19), would have been prompted to include an anesthetic on Pestes’
probe to alleviate the potential discomfort occurring upon examining the
urethra.
Appellant argues that the Examiner failed to provide the specific
motivation required to establish a prima facie case of obviousness (App. Br.
14-17). We are not persuaded by this argument.
As discussed above, the Supreme Court has rejected a rigid approach
to the obviousness question, stating that the analysis under § 103 “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.” KSR Int’l Co.
v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007). The Court further advised
that “[a] person of ordinary skill is . . . a person of ordinary creativity, not an
automaton.” Id. at 1742.
As also pointed out above, the Supreme Court stated that “[a]
factfinder should be aware, of course, of the distortion caused by hindsight
bias and must be cautious of arguments reliant upon ex post reasoning.
Rigid preventative rules that deny factfinders recourse to common sense,
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however, are neither necessary under our case law nor consistent with it.”
Id. at 1742-1743 (citations omitted).
Because a person of ordinary creativity and common sense, see KSR,
127 S. Ct. at 1742-43, would have been prompted to include an anesthetic on
Pestes’ probe to alleviate the potential discomfort occurring upon examining
the urethra, we do not agree with Appellant that the prior art fails to provide
a reason for combining the references. We therefore affirm the Examiner’s
obviousness rejection of claim 11.
SUMMARY
We affirm the Examiner’s rejection of claims 1-6, 12, and 13 under
35 U.S.C. § 102(b) as anticipated by Pestes.
We affirm the Examiner’s rejection of claims 26 and 27 under
35 U.S.C. § 103(a) as being obvious in view of Pestes alone.
We reverse the Examiner’s rejection of claims 7, 8, and 10 under
35 U.S.C. § 103(a) as being obvious in view of Pestes and Nicholson.
We affirm the Examiner’s rejection of claim 11 under 35 U.S.C.
§ 103(a) as being obvious in view of Pestes and Marchosky.

AFFIRMED-IN-PART

clj
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