Ex Parte FeinbergDownload PDFPatent Trial and Appeal BoardAug 25, 201410674653 (P.T.A.B. Aug. 25, 2014) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte MARC E. FEINBERG ____________ Appeal 2012-005728 Application 10/674,6531 Technology Center 3700 ____________ Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and KENNETH G. SCHOPFER, Administrative Patent Judges. SCHOPFER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a tissue approximation device. The Examiner rejected the claims as not enabled and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 According to Appellant, the real party in interest is Ethicon, Inc. of Somerville, New Jersey. App. Br. 1. Appeal 2012-005728 Application 10/674,653 2 STATEMENT OF THE CASE Background The present Specification describes the invention as follows. Described herein is a tissue approximation device that is capable of maintaining approximation of a wound without substantial eversion of the edge surfaces of the wound during application of a topical skin adhesive, an adhesive film or skin staples to close a wound, without requiring the physician or health care attendant to manually secure the approximation device. In particular, described herein is a tissue approximation device comprising two elongate arms, an attachment means to secure the two elongate arms to each other, adhesive pads to anchor the tissue approximation device to the skin, and a locking means to lock the two elongate arms in place relative to each other[.] Spec. 2. The Claims Claims 5, 6, 8, 38–42, and 46–48 are on appeal. The only independent claims, 8 and 38, read as follows (emphasis added): 8. A tissue approximation device comprising two elongate arms having proximal and distal ends, an attachment means to secure the elongate arms to each other at one or more locations, adhesive pads movably connected on the ends of the elongate arms to anchor the tissue approximation device to the skin, and a locking means to lock the elongate arms in place relative to each other, wherein (i) the adhesive pads are spaced apart from the one or more locations of the attachment means in the direction of the elongate arms, and (ii) the tissue approximation device has an open and a closed position, and when in the closed position, the adhesive pads are parallel and non- contiguous to each other, where the adhesive pad has a first adhering surface and a second surface rotatably coupled to the distal end of each of the elongate arms by a ball and socket connector, wherein the second surface has one of a socket and a ball that communicates with the other one of a ball and a socket Appeal 2012-005728 Application 10/674,653 3 on the distal end of each of the elongate arms, and the adhesive pad is rotatable around the ball and socket connector about at least two axes. 38. A tissue approximation device for application to a skin surface adjacent to a wound, comprising: a pair of arms, each arm having a longitudinal axis and opposed ends, wherein one end includes a handle and the other end includes a tong with a connector; an attachment mechanism coupled to each arm that movably couples the arms to each other so that a distance between each tong is selectively variable; an adhesive pad removably coupled to the connector of each tong, wherein each adhesive pad has an adhesive surface that extends in a plane generally parallel to the longitudinal axis of the respective tong, the adhesive surface having a high shear resistance for holding the skin surface and a low peel resistance for removal from the skin surface, and wherein the connectors support the adhesive pads to be positionable in a common plane on opposed sides of the wound and conform to the skin surface adjacent to the wound; and a locking mechanism coupled to each arm to selectively lock the pair of arms in a fixed position relative to each other, wherein the connector is a rotatable connector that connects the adhesive pad to the tong to pivot at least about the longitudinal axis and an axis substantially perpendicular to the longitudinal axis and the rotatable connector is one of a ball and a socket and the adhesive pad includes the other of the ball and the socket, wherein the ball and socket are snap fit together in an interference fit. Reply Br. 14–15 (Revised Claims App’x). The Rejections 1. The Examiner maintains that claims 38–42 are unpatentable under 35 U.S.C. § 112, first paragraph, for failing to comply with the enablement requirement. Appeal 2012-005728 Application 10/674,653 4 2. The Examiner maintains that claims 5, 6, 8, and 46–48 are unpatentable under 35 U.S.C. § 103(a) over Hasson2 in view of Taylor.3 DISCUSSION 1. Enablement As an initial matter, we note that Appellant first raises arguments with respect to this rejection in reply to the Examiner’s Answer. Although we do not always consider arguments raised for the first time in the Reply Brief, we exercise our discretion to do so here in light of the specific circumstances4 set forth by the Appellant and the nature of the Examiner’s rejection and support provided therefor. See Ex parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (informative). In rejecting claims 38–42 as failing to comply with the enablement requirement, the Examiner asserts that the Specification does not enable the requirement in independent claim 38 that “the connector is a rotatable 2 U.S. Patent No. 4,724,838, issued Feb. 16, 1988. 3 U.S. Patent No. 6,394,951 B1, issued May 28, 2002. 4 Appellant acknowledges that these arguments were not previously presented, but requests our consideration of them “in view of the Examiner’s delay (more than three months) in responding to Appellants’ [sic] proposed amendment under 37 C.F.R. 41.33(a).” Reply Br. 3. In response to the Examiner’s rejection under 35 U.S.C. § 112, Appellant submitted a proposed amendment in an attempt to cure the rejection on September 6, 2011. Id. However, the Examiner did not respond to the proposed amendment until issuing an Advisory Action that denied entry of the amendment on December 21, 2011, two days before the Examiner’s Answer issued. Id. Appellant asserts that the Advisory Action should have been issued within thirty days, and had that occurred, Appellant would have had an opportunity to file a revised Appeal Brief to address the substance of the rejection. Id. at 3–4. Appeal 2012-005728 Application 10/674,653 5 connector.” Ans. 4–5. According to the Examiner, “the connector as shown in the drawings . . . does not rotate as it is fixed to the arm.” Id. at 5 (citing Spec. Fig. 7, element 139). In response, Appellant argues that the Examiner improperly limits the connector to element 139 in Figure 7 of the Specification. Reply Br. 5. Appellant asserts that there is nothing in claim 38 that limits the connector to this element and that the description of the connector as being rotatable in claim 38 would have been well understood by a skilled artisan. Id. To wit, Appellant explains that “[b]all and socket connectors are known to be designed and used to provide a certain degree of rotation between two elements connected thereby.” Id. We find that the Examiner erred in rejecting claims 38–42 under 35 U.S.C. § 112 based on an unduly narrow interpretation of the term “rotatable connector” in light of the remainder of claim 38 and the Specification. Specifically, the Examiner’s interpretation of the claim would require that connector 139 is rotatable about arm 122 in Figure 7 of the Specification. The Examiner points to no language in the claim or Specification to support this limited interpretation. We find that this interpretation does not acknowledge that the connector 139 in Figure 7 is rotatable in relation to the pad 132 when connected to the ball 141. The language of claim 38 supports this interpretation, stating that the “rotatable connector . . . connects the adhesive pad to the tong to pivot at least about the longitudinal axis and an axis substantially perpendicular to the longitudinal axis . . . .” Claim 38 (emphasis added). We find that this language would inform one of skill in the art that the connector becomes “a rotatable connector” only when it forms a connection between the tong/arm and the pad. Further, the claim Appeal 2012-005728 Application 10/674,653 6 requires that the connection between the tong and pad is a ball and socket connection, and we agree with Appellant that these “connectors are known to be designed and used to provide a certain degree of rotation between two elements connected thereby.” Reply Br. 5. Based on the foregoing, we find that the Examiner’s rejection of claims 38–42 under 35 U.S.C. § 112, for failing to comply with the enablement requirement, should be reversed. 2. Obviousness: Hasson in view of Taylor In rejecting independent claim 8, from which claims 5, 6, and 46–48 depend, the Examiner asserts that Hasson teaches the following. Hasson teaches a tissue approximation device comprising two elongate arms (54, Fig. 7), an attachment means (56) to secure the elongate arms to each other at one or more locations, pads (24, pad is defined in the World English Dictionary as any of various level surfaces of flat-topped structures) movably connected (move via the ball and socket (301, 302, Fig. 14)[)] on at least a portion of the elongate arms to anchor the tissue approximation device to the tissue, and a locking means (64) to lock the elongate arms in place relative to each other, wherein (i) the pads are spaced apart from the one or more locations of the attachment means (56) in the direction of the elongate arms (the pads 24 are spaced apart from 56 in the direction of the arms), and (ii) the tissue approximation device has an open (when moving 62 it opens and closes, Fig. 7) and a closed position, and when in the closed position, the pads are parallel and non-contiguous to each other ([F]ig. 7, the pads are not touching when closed). The pad has a second surface that is rotatably coupled to the distal end of each of the elongate arms by a ball and socket connector (301,302, col. 5, ll. 11, 12), wherein the second surface [has] a socket (302) and the distal end of the elongate arms has a ball (301), the pad is rotatable about the ball and socket connector about at least two axes (col. 5, ll. 15–18). Appeal 2012-005728 Application 10/674,653 7 Ans. 5–6 (emphasis added). The Examiner acknowledges that Hasson fails to disclose that the pad is an adhesive pad and relies on Taylor for this limitation. Id. at 6. Appellant contends that the Examiner has failed to establish a prima facie case of obviousness because Hasson fails to disclose that the pads are non-contiguous to each other when the device of Hasson is in the closed position. App. Br. 12–16. Appellant asserts that the forceps blades are attached at the lateral edges of the feet 24 of Hasson such that the medial edges of the feet are contiguous when the device is closed, contrary to the requirements of claim 8. Id. at 12–13 (citing Hasson, Fig. 2; col. 3, ll. 34– 40; Fig. 3; col. 3, ll. 56–59). According to Appellant, “the Examiner’s interpretation of Hasson fails to consider the clear teaching therein that the forceps blades thereof are ‘closable at their distal ends.’” Reply Br. 7 (citing Hasson, Abstract). In response, the Examiner asserts that the claims do not state what the closed position consists of and that when element 64 in Figure 7 of Hasson is locked on the first tab the pads are non-contiguous. Ans. 7. The Examiner concludes that “[t]he device of Hasson would be considered ‘closed,’ for example, when fully engaged with tissue and in this instance the pads are non-contiguous to each other because the tissue is between them.” Id. Claim interpretation is at the heart of patent examination because before a claim is properly interpreted, its scope cannot be compared to the prior art. Medichem, S.A. v. Rolabo, S.L., 353 F.3d 928, 933 (Fed. Cir. 2003). During prosecution, claim terms are given their broadest reasonable interpretation as they would be understood by persons of ordinary skill in the Appeal 2012-005728 Application 10/674,653 8 art in the light of the Specification. In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). In this case, the issue is drawn to the limitation “closed position” in claim 8. Therefore, we first turn to the Specification to interpret the term “closed position.” The Specification states: Ratchet mechanism 224 is designed such that when the ratchet catch 228 is engaged with the first ratchet tooth of ratchet arm 226, the tissue approximation is defined herein as being in a closed position, and tongs 212b and 214b remain parallel to each other and are non-contiguous such that the distance between the distal end of tongs 212b and 214b allows access to the wound for application of a permanent wound closure means. *** Ratchet mechanism 124 is designed such that when the first ratchet catch is engaged with ratchet arm 126, the tissue approximation is defined herein as being in a closed position and the distance between the distal end of tongs 112 band 114b allows access to the wound for application of a permanent wound closure means. Spec. 8, 10 (emphasis added). Based on this definition, we find that claim 8 requires that locking means must be engaged for the device to be in the closed position. The Examiner relies on Figure 7 of Hasson to show that the pads are non-contiguous when the device of Hasson is closed. This figure is reproduced below: App App Figu force first Ans. first when “clos betw cont we c requ eal 2012-0 lication 10 re 7 shows ps.” Hass asserts tha 5. The Ex tab, the pa this devi ed” and th een them. First, we iguous, the onclude th ired by cla 05728 /674,653 a tissue a on col. 4, t in this fig aminer al ds 24 are n ce is “fully e pads wo Id. . note that, locking m at this figu im 8. We pproximat ll. 53–55. ure “the p so argues on-contig engaged uld not be while the eans 64 d re does no also find t 9 ion device Referring ads are no that when uous. An with tissue contiguou pads 24 in oes not ap t depict a hat Hasso in the for to this fig t touching element 64 s. 7. The E ” it would s because Figure 7 pear to be device in n is silent m of “scis ure, the Ex when clo is locked xaminer a be consid there is ti of Hasson engaged, the closed regarding sors-type aminer sed.” on the sserts that ered ssue are non- and thus, position a the s Appeal 2012-005728 Application 10/674,653 10 position of the pads when locking means 64 is engaged. See Hasson col. 4, ll. 53–63. However, the pads 24 in Figure 7 appear to project inward relative to distal ends 58 and Hasson teaches, with respect to Figure 3, that “the inward projection of feet 24 relative to forceps blades 12 [is] for closing beneath a tubular structure 40 for gently lifting or stabilizing the structure.” Hasson col. 3, ll. 56–59; col. 4, ll. 53–63. We conclude that this suggests the pads are intended to be contiguous when the device of Hasson is in the closed position, and the Examiner has not persuasively shown otherwise. Finally, we disagree with the Examiner’s unsupported conclusion that the device of Hasson is closed when fully engaged with tissue and the pads are non-contiguous because there is tissue between them. To the extent the Examiner is arguing that the device of Hasson is closed simply because it is fully engaged with tissue, we disagree because, as shown above, claim 8 requires that the closed position occurs only when the locking means is engaged and there is no description of the device of Hasson in the closed position—i.e. when ratchet 64 is engaged—beyond what can be inferred from Figure 7. Based on the foregoing, we conclude that the Examiner has not provided sufficient persuasive evidentiary support for the conclusion that pads on the device of Hasson are non-contiguous when the device is in the closed position, as required by claim 8. Accordingly, we find that the Examiner has not established a prima facie case of obviousness because the proposed combination of Hasson and Taylor does not disclose all elements of claim 8. Appeal 2012-005728 Application 10/674,653 11 CONCLUSION For the reasons set forth above, we reverse the Examiner’s rejections of claims 5, 6, 8, 38–42, and 46–48. REVERSED Klh Copy with citationCopy as parenthetical citation