Ex Parte Field

Patent Trial and Appeal Board

Dec 13, 2012

11535092 (P.T.A.B. Dec. 13, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte STEVEN E. FIELD
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Appeal 2012-000166
Application 11/535,092
Technology Center 3700
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Before DEMETRA J. MILLS, ERIC GRIMES, and ULRIKE W. JENKS,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
apparatus for implanting a marker in tissue. The Examiner has rejected the
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
reverse.
STATEMENT OF THE CASE
Claims 30-36, 39-47, 50, and 51 are on appeal. Claim 30, the only
independent claim, reads as follows:
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30. An apparatus for implanting a locatable marker at a target site
within a tissue mass comprising:
an insertion device including a first lumen having an exit opening, and
including a first tip to facilitate insertion of the insertion device into the
tissue mass to position the exit opening at the target site;
a sheath slidably received within the first lumen and configured for
deployment through the exit opening of the insertion device into the tissue
mass, the sheath including a second lumen having a distal opening;
a locatable marker received within the second lumen and deployable
through the distal opening; and
an anchor operably coupled to the sheath and configured to extend
through the exit opening of the insertion device with the sheath, the anchor
being configured to move relative to the sheath to fix the location of the
sheath in the tissue mass for deployment of the locatable marker at the target
site.

The claims stand rejected under 35 U.S.C. § 103(a) as follows:
• Claims 30-32, 34-36, 39-42, and 44-47 in view of Burbank1 and
Vetter;2
• Claims 33 and 43 in view of Burbank, Vetter, and Selis;3
• Claim 50 in view of Burbank, Vetter, and LaBash;4 and
• Claim 51 in view of Burbank, Vetter, and Ashby.5
The Examiner has rejected all of the claims on appeal as being
obvious in view of Burbank and Vetter, either by themselves or combined
with an additional reference. Since the same issue is dispositive for all of
the rejections, we will consider them together.

1 Burbank et al., US 6,725,083 B1, Apr. 20, 2004.
2 Vetter et al., US 6,936,014 B2, Aug. 30, 2005.
3 Selis, US 7,670,350 B2, Mar. 2, 2010.
4 LaBash, US 5,499,989, Mar. 19, 1996.
5 Ashby et al., US 6,846,320 B2, Jan. 25, 2005.
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The Examiner finds that Burbank discloses an apparatus “for
implanting a locatable marker at a target site within a tissue mass comprising
an insertion device …, a sheath …, and a locatable marker,” as required by
claim 30 (Answer 4). The Examiner finds that Vetter discloses “an anchor
(20) operably coupled to a sheath and movable relative to the sheath to fix
the location of the sheath in the tissue mass” (id. at 5). The Examiner
concludes that it “would have been obvious to one skilled in the art to have
modified the device of Burbank to include an anchor operably coupled to the
sheath as taught by Vetter in order to ensure that the sheath maintains its
desired position” (id.).
Appellant argues that the cited references would not have made
obvious the apparatus of claim 30 because Vetter “discloses fixing the
marker itself in tissue” but does not disclose an anchor operably coupled to a
sheath to fix the sheath location (Appeal Br. 15-16). Appellant argues that
combining elements of Burbank and Vetter as required by claim 30 is more
than the predictable use of elements according to their established functions
and that the Examiner’s combination of elements from the cited references is
based on hindsight (id. at 17-18).
We agree with Appellant that the Examiner has not adequately
explained how Burbank and Vetter would have made obvious the apparatus
of claim 30. Burbank discloses “devices and methods of marking a biopsy
site, so that the location of the biopsy cavity is readily visible by ultrasonic
imaging, as well as by conventional imaging methods, such as x-rays”
(Burbank, col. 2, l. 67 to col. 3, l. 2). Figure 9 of Burbank is shown below:
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Figure 9A shows a “schematic view of a biopsy sampler device at a tissue
site with … [a] marker delivery system,” Figure 9B shows the distal end of
the delivery device, and Figure 9C shows the distal end with marker 84
being discharged (id. at col. 7, ll. 14-21; col. 12, ll. 45-57).
Vetter discloses a needle “for performing a procedure on a patient’s
breast.… The proximal portion is movable between a rigid condition and a
flexible condition.… [A] rigid needle protruding from the breast can cause
obvious problems from inadvertent contact” when moving a patient between
locations (Vetter, col. 2, l. 63 to col. 3, l. 8). Vetter discloses that “the
needle may also have one or more indicators for indicating angular
orientations relative to a longitudinal axis of the needle.… The indicator
may be coupled to an anchoring element … such as a wire.” (Id. at col. 3, ll.
18-25.)
We agree with Appellant that the Examiner has not adequately
explained how the cited references would have made it obvious to combine
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Vetter’s anchor element with Burbank’s marker delivery sheath. The
Examiner reasons that “[s]ince Burbank discloses a sheath that is meant to
remain stationary while a pusher (54) is moved within the sheath to expel
markers (10), one skilled in the art would have recognized that a releasable
anchor would facilitate this relative motion between the pusher and the
sheath. In other words, anchoring the sheath protects against the sheath
sliding forward with the pusher.” (Answer 8.) The Examiner further
reasons that “anchoring the sheath facilitates correct placement of the
marker by ensuring that the opening in the sheath … remains in the correct
location” (id. at 8-9).
However, the Examiner has not pointed to anything in Burbank to
suggest that those of ordinary skill in the art would have recognized sheath
movement as a potential problem with Burbank’s device. Burbank’s marker
delivery sheath is disposed within a biopsy sampler device, and implants a
marker immediately after the biopsy has been taken (Burbank, col. 5, ll. 33-
38). Vetter, by contrast, discloses that its marker needle includes an
anchoring element to ensure that the marker needle does not shift after being
inserted, and thus provides an accurate guide for a biopsy device in marking
the position of the breast tissue to be removed (see Vetter, col. 3, ll. 1-37).
Thus, Vetter’s needle performs a different function from Burbank’s marker
delivery sheath. Although Burbank discloses that a marker itself can move
after implantation (Burbank, col. 2, ll. 29-37) and may benefit from
anchoring elements (id. at col. 5, ll. 58-61), the Examiner has not
persuasively shown that it would have been obvious to transfer Vetter’s
anchor elements to Burbank’s delivery sheath.
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Thus, we reverse the rejection of independent claim 30 and dependent
claims 31, 32, 34-36, 39-42 and 44-47 as being obvious in view of Burbank
and Vetter. We also reverse the rejections of claims 33, 43, 50 and 51 under
35 U.S.C. § 103(a) because these rejections rely on the reasoning with
respect to Burbank and Vetter as discussed above, and the Examiner relies
on Selis, LaBash, and Ashby only to show the obviousness of limitations in
dependent claims.
SUMMARY
We reverse the rejection of claims 30-36, 39-47, 50, and 51 under 35
U.S.C. § 103(a).

REVERSED

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