Ex Parte Field et al

Patent Trial and Appeal Board

Nov 5, 2012

10904666 (P.T.A.B. Nov. 5, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte STEVEN E. FIELD and BRIAN R. MULDER
__________

Appeal 2011-005216
Application 10/904,666
Technology Center 3700
__________

Before DEMETRA J. MILLS, ERIC GRIMES, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
localizing wire. The Examiner rejected the claims as anticipated and as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.

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Statement of the Case
Background
“Localizing wires are well-known devices for marking areas, such as
lesions . . . it is often desirable to position a localizing wire . . . near the
lesion to facilitate locating the lesion during later procedures, such as biopsy
or surgery” (Spec. 1 ¶ 2).
The Claims
Claims 11-23, 25, 26, 34-41, and 106-109 are on appeal. Claim 11 is
representative and reads as follows:
11. A localizing wire for marking a location of a lesion in a
tissue mass, the localizing wire adapted for placement through at
least one cannula lumen relative to the lesion, the localizing wire
comprising:
a localizing anchor adapted to hold the localizing wire at a
selected location within the tissue mass relative to the lesion; and
a localizing thread connected to the localizing anchor to
define an enclosed variable area, the localizing thread extending
along an axis, the localizing thread being (i) sized to extend outside
the tissue mass and (ii) disengaged and separated from the cannula
lumen when the localizing anchor is held at the selected location,
the localizing thread and the localizing anchor being formed from
the same piece;
wherein the localizing anchor comprises a resilient material
adapted to automatically transition from a collapsed shape that
bounds a first area when the localizing anchor is in the at least one
lumen, to an expanded shape that bounds a second area larger than
the first area when the localizing anchor is outside the at least one
lumen, wherein the localizing anchor displaces but does not
puncture the tissue mass when the localizing anchor expands from
the collapsed shape to the expanded shape, and wherein the axis of
the localizing thread intersects the expanded shape of the
localizing anchor at approximately a centerpoint of an opening in
the localizing anchor.
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The issues

A. The Examiner rejected claims 11, 12, 14, 16-21, 23, 25, 26, 34, 41,
and 106-109 under 35 U.S.C. § 102(e) as anticipated by Foushee
1
(Ans. 4-6).
B. The Examiner rejected claims 11, 12, 14, 16-20, 23, 25, 26, 34, 41,
and 106-108 under 35 U.S.C. § 103(a) as obvious over Bush
2
(Ans. 6-8).
C. The Examiner rejected claim 13 under 35 U.S.C. § 103(a) as obvious
over Bush and Chia
3
(Ans. 8).
D. The Examiner rejected claim 15 under 35 U.S.C. § 103(a) as obvious
over Bush and Desai
4
(Ans. 9).
E. The Examiner rejected claims 11, 12, 14, 17-20, 23, 25, 26, 34, and 41
under 35 U.S.C. § 103(a) as obvious over Buehlmann
5
(Ans. 9-11).
F. The Examiner rejected claims 21 and 22 under 35 U.S.C. § 103(a) as
obvious over Buehlmann and Fontenot
6
(Ans. 11).
G. The Examiner rejected claims 35 and 39 under 35 U.S.C. § 103(a) as
obvious over Buehlmann and O‟Neill
7
(Ans. 11-12).
H. The Examiner rejected claims 35-40 under 35 U.S.C. § 103(a) as
obvious over Buehlmann and Fogarty
8
(Ans. 12-14).

1
Foushee et al., US 7,520,881 B2, issued Apr. 21, 2009.
2
Bush et al., US 5,282,845, issued Feb. 1, 1994.
3
Chia et al., US 5,897,554, issued Apr. 27, 1999.
4
Desai, A., US 5,976,129, issued Nov. 2, 1999.
5
Buehlmann et al., US 2004/0049224 A1, published Mar. 11,
2004.
6
Fontenot, M., US 6,685,666 B1, issued Feb. 3, 2004.
7
O‟Neill, W., US 4,986,279, issued Jan. 22, 1991.
8
Fogarty et al., US 6,405,733 B1, issued Jun. 18, 2002.
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A. 35 U.S.C. § 102(e) over Foushee
The Examiner finds that:
Foushee discloses a wire capable of marking the location of
a lesion in a tissue mass and adapted for placement through
at least one cannula lumen relative to the lesion, the wire
comprising an anchor (22) capable of holding the wire at a
selected location within the tissue mass relative to the lesion
and a thread (12) connected to the anchor to define an
enclosed variable area

(Ans. 4). The Examiner finds that “the anchor of Foushee is resilient and the
area of the anchor can be collapsed when a force is exerted on it as shown in
fig. 5” (id.).
Appellants contend that “loop 22 of Foushee is not configured as an
anchor, nor is the structure capable of performing an anchor function” (App.
Br. 17). Appellants contend that
the loop 22 of Foushee is not adapted to hold the wire at a
selected location within the tissue mass, and the loop 22 of
Foushee is not adapted to displace the tissue mass when the
loop expands to perform anchoring. Rather, in Foushee it is
the loop 22 that is displaced by the tissue mass impediment
in the vessel to allow the guide wire to navigate around the
impediment

(Id. at 18).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner‟s finding that Foushee teaches a localizing anchor as
required by claim 11?

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Findings of Fact
1. Foushee teaches “wire guides used in the placement of medical
devices. More specifically, the present invention relates to a wire guide
having a loop tip . . . Once positioned within the vessel, a second medical
device, frequently a cannula such as a catheter is placed over the wire guide
and moved along its length toward the point of treatment” (Foushee, col. 1,
ll. 12-24).
2. Figures 2 and 5 of Foushee are reproduced below:

“FIG. 1 illustrates a wire guide 10” (Foushee, col. 2, l. 45). “FIG. 5
illustrates a wire guide 10 according to the present invention encountering an
impediment 42 within a body vessel 40” (Foushee, col. 5, ll. 16-18).
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3. Foushee teaches that “the loop 22 deforms in response to its
encounter with the impediment 42. Due to the presence of the loop 22 and
closure member 24, the distal end 26 does not move relative to the
remainder of the elongate member 12” (Foushee, col. 5, ll. 18-22).
4. Figure 7 of the Specification is reproduced below:

“Fig. 7 is an enlarged side view of a fourth embodiment of the localizing
thread and localizing anchor” (Spec. 11 ¶ 48).
5. The Specification teaches that the
anchor shapes illustrated in Figs. 3-7A are similar in that
they are of a thread type structure that encloses an area.
When the anchor 40 is in the expanded condition, the
enclosed area is much greater than when in the collapsed
condition. These shapes have no sharp edges that would
penetrate the surrounding tissue, yet they still anchor the
localizing wire.

(Spec. 13 ¶ 68.)
6. Foushee teaches that “[a]ny suitable material can be used for
the elongate member 12, and a variety of suitable materials are known to
those skilled in the art. . . . Examples of suitable materials include stainless
steel and nitinol” (Foushee, col. 3, ll. 53-58).
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7. The Specification teaches that “to achieve the lie flat
functionality, the localizing wire is made from a material that provides a
Young‟s Modulus that when combined with the cross section will permit the
thread 242 to lie flat against the tissue 18. For the described cross section, a
suitable material is annealed steel” (Spec. 18 ¶ 85).
Principles of Law
“To anticipate a claim, a prior art reference must disclose every
limitation of the claimed invention, either explicitly or inherently.
Anticipation is an issue of fact, and the question of whether a claim
limitation is inherent in a prior art reference is a factual issue.” In re
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997) (citations omitted).
Analysis
Foushee teaches a wire for insertion into patients over which a
cannula can pass (FF 1) which comprises a wire with a loop tip (FF 2) where
the wire is sized to extend outside the tissue mass to permit navigation of
other devices to the tissue (FF 1) where the localizing thread and anchor
loop are formed from the same piece (FF 2) and where the localizing anchor
comprises a resilient material (FF 3, 6).
Appellants contend that “loop 22 of Foushee is not configured as an
anchor, nor is the structure capable of performing an anchor function” (App.
Br. 17).
We are not persuaded. The loop 22 of Foushee (FF 2) is almost
identical in structure to the loop shown in Figure 7 of the Specification (FF
4). The Specification teaches regarding shapes including the loop of figure 7
that “[t]hese shapes have no sharp edges that would penetrate the
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surrounding tissue, yet they still anchor the localizing wire” (Spec. 13 ¶ 68;
FF 5). Thus, contrary to Appellants‟ attorney argument in the Brief, the
Specification teaches that a loop shape will anchor the localizing wire (FF
5). This is consistent with Foushee‟s use of the wire guide, which must
remain in place to permit guidance and navigation to the desired location
(FF 1). Appellants have not provided persuasive evidence or technical
reasoning to support their position that Foushee‟s loop 22 would not
function as an anchor.
Appellants contend that
the loop 22 of Foushee is not adapted to hold the wire at a
selected location within the tissue mass, and the loop 22 of
Foushee is not adapted to displace the tissue mass when the
loop expands to perform anchoring. Rather, in Foushee it is
the loop 22 that is displaced by the tissue mass impediment
in the vessel to allow the guide wire to navigate around the
impediment

(App. Br. 18).
We are not persuaded. As noted above, the loop of Foushee is
reasonably found to hold the wire at a selected location. With regard to
tissue displacement, Foushee teaches that the loop can be composed of
suitable materials such as stainless steel and nitinol (FF 6). The evidence of
record supports the Examiner‟s inherency argument since Foushee‟s loop
can be composed of steel, the same material disclosed in the Specification
(FF 6-7), can have the same loop shape as disclosed in the Specification (FF
2, 4), and is shown to be a resilient material which can change shape (FF 3)
thereby inherently satisfying the claim requirement to be capable of
displacing tissue mass. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977)
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(“Where, as here, the claimed and prior art products are identical or
substantially identical, or are produced by identical or substantially identical
processes, the PTO can require an applicant to prove that the prior art
products do not necessarily or inherently possess the characteristics of his
claimed product.… Whether the rejection is based on „inherency‟ under 35
U.S.C. § 102, on „prima facie obviousness‟ under 35 U.S.C. § 103, jointly or
alternatively, the burden of proof is the same, and its fairness is evidenced
by the PTO‟s inability to manufacture products or to obtain and compare
prior art products.) While we recognize that Foushee teaches that the loop
does not displace the impediment 42 (FF 3), this impediment is not a tissue
mass. Appellants provide no evidence that Foushee‟s wire loop would not
satisfy the functional requirements to displace a tissue mass without
puncturing the tissue mass.
Claims 34 and 108
Appellants provide separate headings for claims 34 and 108, but the
sections make the same arguments regarding Foushee which we already
addressed above.
Conclusion of Law
The evidence of record supports the Examiner‟s finding that Foushee
teaches a localizing anchor as required by claim 11.
B. 35 U.S.C. § 103(a) over Bush
The Examiner finds that Bush teaches
a localizing wire capable of marking a location of a lesion in
a tissue mass, the localizing wire adapted for placement
through at least one cannula lumen relative to the lesion, the
wire comprising a localizing anchor (26, 28) adapted to hold
the localizing wire at a selected location within the tissue
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mass relative to the lesion and a localizing thread (12a)
connected to the localizing anchor to define an enclosed
variable area and extending along an axis.

(Ans. 6.)
Appellants contend that “Bush is not directed to a localizing wire for
marking a location of a lesion in a tissue mass, but rather is directed to an
implantable defibrillator lead including at its distal end a plurality of
electrodes” (App. Br. 25). Appellants contend that “Examiner‟s assertion
that the loop defibrillator electrodes 26, 28 are „capable‟ of holding electrical
lead 12a is not supported by Bush and, thus, is a resort to impermissible
speculation in rejecting claim 11” (id. at 26). Appellants contend, regarding
claim 17, that “the Bush loop defibrillator electrodes 26, 28 and the Bush
conductive lead member 12a are not a continuous body formed from the
same piece, but rather are two discrete connected elements” (id. at 28).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner‟s finding that Bush renders obvious a localizing
anchor as required by claim 11?
Findings of Fact
8. Bush teaches “deployable leads having electrodes which may
be held in a position for inserting of the lead into the body of a patient”
(Bush, col. 1, ll. 5-7).
9. Bush teaches that
Sheath 14a may be of similar structure and function to
sheath 14 of the previous embodiment. In FIG. 4, the
defibrillator lead is shown in its position to be advanced into
the body to its final site of implantation. Then, when the site
is released, sheath 14a is pulled backwards to deploy
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electrodes 26, 28 by their natural springing memory as may
be desired

(Bush, col. 7, ll. 20-26).

10. Figures 3 and 4 of Bush are reproduced below:

“FIGS. 3 and 4 disclose an alternative embodiment . . . a portion of lead 10a
is shown, in which conductive lead member 12a is similar to lead member
12 and is terminated at its distal end with a pair of loop electrodes 26, 28”
(Bush, col. 7, ll. 11-16).
Principles of Law
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
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argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted).
In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007), while the
Supreme Court emphasized “an expansive and flexible approach” to the
obviousness question, it also reaffirmed that “rejections on obviousness
grounds cannot be sustained by mere conclusory statements; instead, there
must be some articulated reasoning with some rational underpinning to
support the legal conclusion of obviousness.” Id. at 418.
As our reviewing court has explained, therefore, to support a
conclusion of obviousness, “[w]hether the Board relies on an express or an
implicit showing, it must provide particular findings related thereto. Broad
conclusory statements standing alone are not „evidence.”‟ In re Kotzab, 217
F.3d 1365, 1370 (Fed. Cir. 2000) (citation omitted). Thus, “section 103
requires a fact-intensive comparison of the claimed process with the prior art
rather than the mechanical application of one or another per se rule.” In re
Ochiai, 71 F.3d 1565, 1571 (Fed. Cir. 1995); see also id. at 1572
(“[R]eliance on per se rules of obviousness is legally incorrect and must
cease.”)
Analysis
We agree with Appellants that the Examiner has failed to establish a
prima facie case of obviousness. We recognize that Bush teaches an
electrode with a loop for insertion into a patient (FF 8-10), but claim 11
requires the “localizing thread and the localizing anchor being formed from
the same piece.” The Examiner acknowledges that “Bush does not expressly
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disclose that the localizing thread and localizing anchor are formed from the
same piece” (Ans. 7).
The Examiner‟s position is that Howard v. Detroit Stove Works, 150
U.S. 164 (1893) holds that forming a one piece article from two pieces is a
matter of routine skill. The Examiner, however, appears to draw from this
case turning on specific facts, a general obviousness rule: namely, that
forming several pieces integrally as a single-piece is not considered to be
patentable subject matter. No such per se rule exists. In the instant case, the
Examiner must provide evidence or scientific reasoning as to why the
ordinary artisan would have modified the electrode device of Bush, in which
the “conductive lead member 12a is similar to lead member 12 and is
terminated at its distal end with a pair of loop electrodes 26, 28” (Bush, col.
7, ll. 13-16; FF 10) so that the lead and electrode (here the anchor surrogate)
are formed of a single piece. Because the Examiner fails to provide any
evidence or reasoning in this regard, we are compelled to reverse the
rejection.
Conclusion of Law
The evidence of record does not support the Examiner‟s finding that
Bush renders obvious a localizing anchor as required by claim 11.
C. – D. 35 U.S.C. § 103(a) over Bush and Chia or Desai
Each of these rejections relies upon the underlying obviousness
rejection over Bush. Having reversed the rejection of claim 11 over Bush,
we necessarily reverse these obviousness rejections, which do not cure the
failure to teach or suggest the “localizing thread and the localizing anchor
being formed from the same piece” as required by claim 11.
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E. 35 U.S.C. § 103(a) over Buehlmann
The Examiner finds that
Buehlmann discloses a localizing wire for marking a
location of a lesion in a tissue mass, the wire adapted for
placement through at least one cannula relative to the lesion,
the wire comprising a localizing anchor (84; figs. 4, 5)
adapted to hold the wire at a selected location within the
tissue mass relative to the lesion, and a localizing thread (82)
connected to the anchor to define an enclosed variable area,
the localizing thread extending along an axis and being sized
to extend outside the tissue mass and disengaged and
separated from the cannula lumen when the anchor is held at
the selected location.

(Ans. 9.) The Examiner finds it obvious “to construct the anchor (84) of
Buehlmann out of resilient material such that it automatically expands when
freed from a constraining cannula since Buehlmann discloses that it is
known to construct anchors out of a self-expanding material and such a
modification simplifies the procedure” (id. at 10).
Appellants contend that the Examiner “recognizes that Buehlmann
fails to expressly disclose that the anchor 84 is resilient and automatically
transitions from the collapsed shape to the expanded shape and fails to
disclose that the anchor and thread are formed from the same piece” (App.
Br. 44). Appellants contend that “Buehlmann discloses a completely
different deployment mechanism from the present invention” (id.).
Appellants contend that “Buehlmann cannot disclose the aspect of claim 11
of „the localizing thread and the localizing anchor being formed from the
same piece‟” (id.).
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The issue with respect to this rejection is: Does the evidence of record
support the Examiner‟s finding that Buehlmann renders obvious a localizing
anchor as required by claim 11?
Findings of Fact
11. Buehlmann teaches “a target tissue localization assembly
including an anchor assembly comprising an elongated placement element,
an elongated anchor actuator element, typically a wire, and a radially
expandable tissue anchor” (Buehlmann 1 ¶ 0006).
12. Figures 4 and 5 of Buehlmann are reproduced below:

“FIGS. 4 and 5 illustrate an alternative embodiment of the invention”
(Buehlmann 4 ¶ 0042).
13. Buehlmann teaches that “[t]issue anchor 84 comprises a braided
tubular mesh material 86, the ends of which are captured between
concentrically arranged outer and inner sleeves 88, 90 and 88A, 90A”
(Buehlmann 4 ¶ 0043).
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Analysis
We agree with Appellants that the Examiner has failed to establish a
prima facie case of obviousness. We recognize that Buehlmann teaches a
tissue localization device with a mesh for insertion into a patient (FF 11-13),
but claim 11 requires the “localizing thread and the localizing anchor being
formed from the same piece.” The Examiner acknowledges that Buehlmann
“fails to disclose that the anchor and thread are formed from the same piece”
(Ans. 10).
The Examiner again relies upon Howard v. Detroit Stove Works for
the position forming a one piece article from two pieces is a matter of
routine skill. As discussed above, the Examiner must provide evidence or
scientific reasoning as to why the ordinary artisan would have modified the
mesh localization device of Buehlmann so that the mesh and actuator wire
are formed of a single piece. Because the Examiner fails to provide any
evidence or reasoning in this regard, we are compelled to reverse the
rejection.
Conclusion of Law
The evidence of record does not support the Examiner‟s finding that
Buehlmann renders obvious a localizing anchor as required by claim 11.
F.-H. 35 U.S.C. § 103(a) over Buehlmann and Fontenot, O’Neill, or
Fogarty
Each of these rejections relies upon the underlying obviousness
rejection over Buehlmann. Having reversed the rejection of claim 11 over
Buehlmann, we necessarily reverse these obviousness rejections, which do
not cure the failure to teach or suggest the “localizing thread and the
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localizing anchor being formed from the same piece” as required by claim
11.

SUMMARY
In summary, we affirm the rejection of claims 11, 12, 14, 16-21, 23,
25, 26, 34, 41, and 106-109 under 35 U.S.C. § 102(e) as anticipated by
Foushee.
We reverse the rejection of claims 11, 12, 14, 16-20, 23, 25, 26, 34,
41, and 106-108 under 35 U.S.C. § 103(a) as obvious over Bush.
We reverse the rejection of claim 13 under 35 U.S.C. § 103(a) as
obvious over Bush and Chia.
We reverse the rejection of claim 15 under 35 U.S.C. § 103(a) as
obvious over Bush and Desai.
We reverse the rejection of claims 11, 12, 14, 17-20, 23, 25, 26, 34,
and 41 under 35 U.S.C. § 103(a) as obvious over Buehlmann.
We reverse the rejection of claims 21 and 22 under 35 U.S.C. § 103(a)
as obvious over Buehlmann and Fontenot.
We reverse the rejection of claims 35 and 39 under 35 U.S.C. § 103(a)
as obvious over Buehlmann and O‟Neill.
We reverse the rejection of claims 35-40 under 35 U.S.C. § 103(a) as
obvious over Buehlmann and Fogarty.

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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

cdc