Ex Parte Chesbrough et al

Patent Trial and Appeal Board

Nov 19, 2014

11162814 (P.T.A.B. Nov. 19, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte RICHARD M. CHESBROUGH, STEVEN E. FIELD,
RYAN L. GOOSEN, JEFF ZERFAS, and RICHARD E. DAVIS
_________

Appeal 2012-001324
Application 11/162,814
Technology Center 3700
__________

Before DONALD E. ADAMS, ERIC B. GRIMES, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

PAULRAJ, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a method
for percutaneous marking of a tissue mass and a marker for use in
percutaneous marking. The Examiner rejected the claims for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.

STATEMENT OF THE CASE
Background
The Specification describes “an apparatus for the percutaneous
positioning of a radiopaque marker for identifying the location of a lesion in

1 Appellants identify the Real Party in Interest as C.R. Bard, Inc. (see App.
Br. 3).
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Application 11/162,814

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a stereotactic biopsy procedure. More particularly, the invention relates to
an introducer having a hollow cannula in combination with a movable stylet
and a radiopaque marker disposed within the cannula and ejected from it by
movement of the stylet” (Spec. ¶ 2).
The Claims
Claims 1–30 and 34–39 are under appeal. Independent claims 1, 22,
and 23 are representative, and read as follows:
1. A method for the marking of a predetermined location
in a tissue mass by the percutaneous placement of a marker in
the tissue mass using a self-contained marking device
comprising an introducer having a handle integrally carrying a
cannula, stylet, and plunger, with the cannula defining a lumen
and having a distal end defining an insertion tip with an axial
opening, the stylet slidably received within the lumen and
having a distal end spaced inwardly from the insertion tip to
form a marker recess between the distal end of the stylet and the
insertion tip, the plunger being movably mounted to the handle
and operably engaging the stylet, such that movement of the
plunger effects movement of the stylet, and an imaging marker
disposed within the marker recess, the method comprising:
grasping the handle of the introducer with a single hand
for operating the introducer with the same single hand;
manipulating the handle grasped by the single hand to
insert the cannula having the imaging marker contained within
the marker recess into the tissue mass;
manipulating the handle grasped by the single hand to
position the marker recess relative to the predetermined location
such that upon the expulsion of the imaging marker from the
imaging recess, the imaging marker will reside at the
predetermined location; and
operating the insertion device with the single hand to
expel the imaging marker from the marker recess into the tissue
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mass by axially moving the imaging marker through the axial
opening of the insertion tip and into the tissue mass.
22. A marker for use in the percutaneous marking of a
predetermined location in a tissue mass, comprising:
a marker body and an anchor extending away from the
body for fixing the location of the marker in the tissue mass by
the tissue mass prolapsing about the anchor;
the body being formed by an elongate wire defining a
pair of legs, each leg having a first and second end, at least one
leg of the pair of legs forming the anchor; and
the elongate wire having a cross section that defines an
interior hollow portion forming an air trap to enhance the
radiopaque characteristic of the marker.
23. A marker for use in the percutaneous marking of a
biopsy site from a tissue mass, the marker comprising:
a marker body formed as a cylindrical body having at
least one circumferential groove for receiving a portion of
tissue mass and having a corresponding ridge for abutting
prolapsed tissue, thereby forming an anchor to retard migration
of the marker relative to the tissue mass.
The Rejections
The Examiner rejected the claims as follows:
I. Claims 1–21 under 35 U.S.C. § 103(a) as being unpatentable
over the combination of Dowlatshahi2 and Scribner.3
II. Claims 22 and 25–30 under 35 U.S.C. § 103(a) as being
unpatentable over the combination of Dowlatshahi and
Nudeshima.4

2 Dowlatshahi, US 5,853,366, issued Dec. 29, 1998.
3 Scribner et al., US 6,241,734 B1, issued Jun. 5, 2001.
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III. Claims 23, 24, and 34–39 under 35 U.S.C. § 103(a) as being
unpatentable over the combination of Dowlatshahi, Nudeshima,
Sirimanne,5 and Sloan.6
FINDINGS OF FACT
FF1. Dowlatshahi teaches “a marker element [that] is made of
radiopaque material and includes at least two leg portions of
approximately equal length connected at an angle relative to each
other to form a generally V-shaped resilient member that is capable
of being positioned wholly within the body of a patient”
(Dowlatshahi, Abstract).
FF2. Dowlatshahi teaches:
A localizing device and method using the marker element
for marking a tissue mass of interest are also provided.
The device and method include an elongate guide
member, such as a cannula, having a first end that is
inserted into the body so as to be directed toward a
position proximate the tissue mass of interest and an
opposite second end that extends from the body. A guide
path extends between the first end and the second end of
the guide member. The marker element is introduced
into the second end of the guide member using a marker
element dispenser and then urged along the guide path
using a stylet or similar prodding member.
(Id.).
FF3. Figures 7A-7D of Dowlatshahi are reproduced below:

4 Nudeshima, US 6,354,989 B1, issued Mar. 12, 2002.
5 Sirimanne et al., US 6,371,904 B1, issued Apr. 16, 2002.
6 Sloan, US 5,409,004, issued Apr. 25, 1995.

App
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Appeal 2012-001324
Application 11/162,814

7
mass of interest in accordance with the method of the subject
invention” (Id., col. 4 ll. 55–58).
FF4. Dowlatshahi teaches:
With the guide member 20 properly inserted into the
body and the prodding member 30 removed, the marker
element dispenser 50 is engaged with the second end 24
of the guide member 20. The plunger assembly 60 is
actuated using the actuation pad 64, such that the stem
portion 62 forces a marker element 10 through the
aperture 55 and into the guide path 26 beyond the funnel
shape 25 of the guide member 20. Upon release of the
actuation pad 64, the stem portion 62 returns to its
retracted position and the next marker element 10 that is
supported on the track 56 is sequentially advanced into
alignment with the aperture 55.
(Id., col. 11 ll. 4–13).
FF5. Scribner teaches “[s]ystems and methods for delivering material
into bone [that] deploy a cannula through soft tissue to establish a
subcutaneous path into bone” (Scribner, Abstract).
FF6. Fig. 27 of Scribner is reproduced below:
App
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Application 11/162,814

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“FIG. 1 is a longitudinal sectional view showing a radiation source
delivery wire according to a first embodiment of the present
invention; . . . FIG. 2 is a sectional view taken along the line II—II
of FIG. 1” (Nudeshima, col. 2 ll. 50–54).
FF8. Nudeshima teaches:
Each of the radiopaque markers 5a and 5b is composed
of a hollow cylinder whose outer diameter at its distal
end is substantially equal to or slightly smaller than a
maximum diameter of the operating wire member 2a. A
fitting portion 51 capable of fitting to a distal end 21 of
the operating wire member 2a is provided at a distal end
of the radiopaque marker 5a.
(Id., col. 6 ll. 10–16).
FF9. Sloan teaches a localization device with radiopaque markings.
Figures 8 and 9 of Sloan are reproduced below:
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“FIGS. 8 and 9 show the indicia elements as comprising grooves
within guidewires 34 and 42, respectively” (Sloan, col. 5 ll. 15–
17).

ANALYSIS
Rejection I
With respect to independent claim 1, the Examiner finds that
“Dowlatshahi discloses a method for the marking of a predetermined
location in a tissue mass by the percutaneous placement of a marker in the
tissue mass” using a marking device that satisfies the claim requirements,
with the exception that “Dowlatshahi does not explicitly disclose grasping
the handle of the introducer with a single hand; manipulating the handle
grasped by the single hand and operating the insertion device with the single
hand” (Ans. 4–5). The Examiner relies upon Scribner’s Figure 27 as
disclosing a single hand operation, and asserts that
It would have been obvious to one of ordinary skill in the art at
the time of the invention to modify Dowlatshahi to grasp the
handle of the introducer with a single hand; manipulate the
handle grasped by the single hand and operate the insertion
device with the single hand as taught by Scribner because this is
more convenient for the user and allow user to perform other
medical procedure with the free hand.
(Id. at 5).
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Based on the cited teachings of the prior art (FF1–6) and the rationale
supplied by the Examiner, we determine that a prima facie showing of
obviousness has been made for claim 1. We have considered Appellants’
arguments, but are not persuaded otherwise.
Appellants argue that the structure of Dowlatshahi’s device does not
allow a single hand operation because “Dowlatshahi requires the use of two
hands in removing the marker element dispenser and subsequently requires
the use of two hands in introducing the stylet into the second funnel-shaped
end of the cannula” (App. Br. 19). Appellants further argue with regard to
Scribner that “[t]he syringe piston 112 does not enter the cannula 106 to
advance the cement material, but rather, relies on the hydraulic pressure
generated by the syringe type mechanism to produce a flow of the cement
material 170,” and “[t]hus, due to the differences in operating principles, one
skilled in the art would not be motivated to combine Scribner with
Dowlatshahi in an attempt to achieve the present invention” (id.).
We do not find these arguments convincing. Contrary to Appellants’
unsupported attorney argument, we find nothing in Dowlatshahi to suggest
that the marking device must necessarily be operated using two hands. As
depicted in Fig. 27 of Scribner, one of ordinary skill in the art would
recognize that a single hand operation for a device that delivers material to
subcutaneous tissue through a cannula would be advantageous for the
operator (FF5–6). We further note that the claimed method uses open-ended
“comprising” language and therefore, does not preclude additional
operations of the device using more than one hand, e.g., using two hands to
remove the marker element dispenser or inserting the stylet into the cannula.
See Invitrogen Corp. v. Biocrest Manufacturing, L.P., 327 F.3d 1364, 1368
Appeal 2012-001324
Application 11/162,814

12
(Fed. Cir. 2003) (“The transition ‘comprising’ in a method claim indicates
that the claim is open-ended and allows for additional steps.”)
We conclude that the skilled artisan would have found it obvious to
modify the device of Dowlatshahi (e.g., to shorten the length of the stylet) in
order to allow for single hand operation of the recited method steps. See
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) (“A person of
ordinary skill is also a person of ordinary creativity, not an automaton.”).
We therefore, affirm the obviousness rejection of claim 1 based on
Dowslatshahi and Scribner. Appellants do not present separate arguments
for the patentability of claims 2–21, and we therefore, also affirm the
rejection of those claims based on the same prior art.
Rejection II
With respect to independent claim 22, the Examiner finds that
“Dowlatshahi discloses a marker body and an anchor extending away from
the body for fixing the location of the marker in the tissue mass by the tissue
mass prolapsing about the anchor,” but acknowledges that “Dowlatshahi
does not disclose [an] interior hollow portion of the marker” (Ans. 7). The
Examiner relies upon Nudeshima’s teaching of radiopaque markers
composed of a hollow cylinder (FF8) and asserts that “[i]t would have been
obvious to one of ordinary skill in the art at the time of the invention to
modify Dowlatshahi to have a marker with hollow portion as taught by
Nudeshima because it is a design choice that only requires routine skill in
the art and also hollow shape markers are better for ultrasound detection”
(Ans. 8).
Appellants argue that in Nudeshuima “any initial hollow opening is
filled with the structure of solid operating wire members 2a, 2b,
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respectively, that eliminates the hollow region, as is clearly shown for
example, in the cross-section drawings of Nudeshima Figs. 1–4, when the
radiation delivery wire 1, 1' is fully assembled” (App. Br. 24). We find that
Appellants have the better argument with regard to claim 22. The Examiner
asserts that “the operating wire does not completely fill the hollow diameter
at the tip of the device due to the tapered shape” (Ans. 10). However, there
is nothing in Nudeshima to support that position. To the contrary, as
depicted in Figure 2 of Nudeshima, there appears to be no gap or hollow
region between wire member 2a and marker 5a even at the cross-section
near the tip of the tapered portion marked by line II—II in Figure 1 (FF7).
We therefore, reverse the obviousness rejection of claims 22 and 25–
30 based on Dowlatshahi and Nudeshima. We do not reach the merits of the
additional arguments presented by Appellants for dependent claims 29 and
30.
Rejection III
With respect to independent claim 23, the Examiner acknowledges
that “Dowlatshahi and Nudeshima do not disclose marker[s] with
circumferential grooves with ridges,” but asserts that “Sirimanne and Sloan
disclose markers with circumferential grooves with ridges, with wire and
plate” and concludes that “[i]t would have been obvious to one of ordinary
skill in the art at the time of the invention to modify Dowlatshahi to design
markers with circumferential grooves and ridges because this enables the
markers to anchor into the tissue and provide position/location to the
physician as a ruler” (Ans. 8–9). We agree with the Examiner that a prima
facie showing of obviousness has been made for claim 23 based on Sloan’s
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disclosure of a guidewire comprising “marker groove portions” (FF9). We
have considered Appellants’ arguments, but are not persuaded otherwise.
In particular, Appellants argue that “due to the scale of the spacing of
the marker bodies along the length of the guide wire in Sloan, one skilled in
the art would not be motivated to provide a marker as a cylindrical marker
body that has at least one circumferential groove for receiving a portion of
tissue mass and having a corresponding ridge” (App. Br. 31–32). We do not
find this convincing because Figures 8 and 9 of Sloan plainly show indicia
elements (i.e., markers) as having a cylindrical body and circumferential
marker grooves with corresponding ridges that can form an anchor to retard
migration of the marker relative to the tissue mass (FF9). To the extent that
Sloan discloses a different use for the grooves, i.e., as a distance/unit length
marker, rather than for anchoring the marker relative to tissue mass, that
distinction is merely directed to an intended use of the product that does not
impart patentability. See Bettcher Indus., Inc. v. Bunzl USA, Inc., 661 F.3d
629, 654 (Fed. Cir. 2011) (“Where all structural elements of a claim exist in
a prior art product, and that prior art product is capable of satisfying all
functional or intended use limitations, the claimed invention is nothing more
than an unpatentable new use for an old product.”).
We therefore affirm the obviousness rejection of claim 23 based on
the combination of Dowlatshahi, Nudeshima, and Sloan.7 Appellants do not
present separate arguments for the patentability of claims 24 and 34–39, and

7 We do not rely upon Sirimanne in our affirmance of the Examiner’s
rejection. In affirming an obviousness rejection, the Board may rely upon
less than all the references cited by the Examiner. See In re Kronig, 539
F.2d 1300, 1302 (CCPA 1976).
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we therefore, also affirm the rejection of those claims based on the same
prior art.

SUMMARY
We affirm the rejection of claims 1–21 under 35 U.S.C. § 103(a) as
being unpatentable over the combination of Dowlatshahi and Scribner.
We affirm the rejection of claims 23, 24, and 34–39 under 35 U.S.C.
§ 103(a) as being unpatentable over the combination of Dowlatshahi,
Nudeshima, Sirimanne, and Sloan.
We reverse the rejection of claims 22 and 25–30 under 35 U.S.C.
§ 103(a) as being unpatentable over the combination of Dowlatshahi and
Nudeshima.

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-IN-PART

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