Ex Parte Field

Patent Trial and Appeal BoardDec 13, 2012

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

UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte STEVEN E. FIELD __________ Appeal 2012-000166 Application 11/535,092 Technology Center 3700 __________ 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: Appeal 2012-000166 Application 11/535,092 2 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. Appeal 2012-000166 Application 11/535,092 3 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: Appeal 2012-000166 Application 11/535,092 4 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 Appeal 2012-000166 Application 11/535,092 5 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. Appeal 2012-000166 Application 11/535,092 6 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 lp