Ex Parte Bhatt et al

Patent Trials and Appeals BoardFeb 7, 2019

14535403 - (D) (P.T.A.B. Feb. 7, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/535,403 90039 7590 Covidien LP Attn: IP Legal 5920 Longbow Drive Mail Stop A36 11/07/2014 02/11/2019 Boulder, CO 80301-3299 FIRST NAMED INVENTOR Amit Bhatt UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www .uspto.gov ATTORNEY DOCKET NO. CONFIRMATION NO. 01988-00434 3811 EXAMINER FOWLER, DANIEL WAYNE ART UNIT PAPER NUMBER 3794 NOTIFICATION DATE DELIVERY MODE 02/11/2019 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): rs. patents. two@medtronic.com docket@carterdeluca.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte AMIT BHATT and YUT AKA SAITO 1 Appeal2018-002770 Application 14/535,403 Technology Center 3700 Before KEVIN F. TURNER, DANIELS. SONG, and EDWARD A. BROWN, Administrative Patent Judges. SONG, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE The Appellant appeals under 35 U.S.C. Â§ 134(a) from the Examiner's Final Office Action ("Final Act.") rejecting claims 1, 3, 5, 7, 9-12, and 14-- 26 in the present application. (App. Br. 4). We have jurisdiction under 35 U.S.C. Â§Â§ 6(b) and 134(a). We AFFIRM-IN-PART. 1 The Appellant is the Applicant, The Cleveland Clinic Foundation, which is identified as the real party in interest. (Appeal Brief ("App. Br.") 3). Appeal2018-002770 Application 14/535,403 The claimed invention is directed to an endoscopic endocap for excising tissue. (Abstract). Representative independent claim 1 reads as follows (App. Br. 33-34, Claims App'x, emphasis added): 1. An endoscopic endocap for excising a target portion of a native tissue from a remaining portion of the native tissue during a surgical procedure, the endocap comprising: a longitudinal central axis; an annular main body extending concentrically about the longitudinal central axis the annular main body having a proximal end, an oppositely disposed distal end longitudinally spaced from the proximal end, the distal end including an extension that protrudes longitudinally beyond a remaining portion of a front face of a base portion of the distal end, an outer surface extending longitudinally between the proximal and distal ends, and an inner surface extending longitudinally between the proximal and distal ends, the inner surface defining at least one lumen, an opening of the at least one lumen terminating at a terminal portion of the distal end; at least one excisor disposed on the extension such that the at least one excisor is laterally spaced from the outer surface of the annular main body, the at least one excisor being fixedly engaged with the annular main body, the at least one excisor being configured to remain stationary with respect to the lumen during use of the at least one excisor to excise the target portion of the native tissue, the at least one excisor including a mechanical blade. Independent claim 7 is directed to a method of excising tissue using an endoscopic endocap, while independent claim 21 is directed to an endoscopic endocap. (App. Br. 34--35, 39--40, Claims App'x). 2 Appeal2018-002770 Application 14/535,403 REJECTI0NS 2 1. The Examiner rejects claims 1, 3, 5, 7, 9-12, 14, 15, 17, 20, 21, 23 and 26 under 35 U.S.C. Â§ I02(a)(l) as anticipated by Miyamoto et al. (US 2008/0132759 Al, pub. June 5, 2008 ("Miyamoto")). (Final Act. 6). 2. The Examiner rejects claims 1, 7, 14--16, 18-22, 24, and 25 under 35 U.S.C. Â§ I02(a)(2) as anticipated by Goshayeshgar et al. (US Patent 9,216,057 B2, iss. Dec. 22, 2015 ("Goshayeshgar")). (Final Act. 9). ANALYSIS Miyamoto The Examiner rejects claims 1, 3, 5, 7, 9-12, 14, 15, 17, 20, 21, 23 and 26 finding that Miyamoto discloses each and every limitations of these claims. (Final Act. 7 (citing Miyamoto, Figs. 5, 10)). The initial3 Examiner found that the elements 6c, 6d [ of Miyamoto] are described as 'projections for incision' by Miyamoto. According to the dictionary, "incise" is defined as "to cut with a knife". [J Furthermore, Miyamoto states, "excision of tissues can be performed by pressing the projections for incision 6c, 6d against tissues such as mucous membrane to incise the lesion site around its entire periphery, and then utilizing the tip electrodes 6a, 6b" (paragraph [0062]). Furthermore, the tip of the excising part 4 itself can also act as a mechanical blade. It is noted that the cap attachment of Figs. 5-7 is denoted as "the cap attachment knife" in paragraph [0069] of Miyamoto, which also suggests mechanical cutting. (Final Act. 11-12). 2 Rejections under 35 U.S.C. Â§ 112 of various claims have been withdrawn by the Examiner. (Ans. 2-3). 3 The Examiner examining the present application changed during prosecution. 3 Appeal2018-002770 Application 14/535,403 The Appellant disagrees and argues that Miyamoto "does not teach, show, disclose, or suggest that the excisor includes a mechanical blade" (App. Br. 21 ), and does not disclose "any mechanical cutting or separation function provided by those portions of the tip electrodes [6a, 6b]." (App. Br. 22). We agree with the Appellant that the electrodes of Miyamoto do not constitute a "mechanical blade" as recited in claim 1, or function to "mechanically excis[ e ]" tissue as required by claim 7 in that the electrodes cut tissue through application of electrical current. (Miyamoto ,r 62 ("a current can be applied between a pair of the projections for incision 6d, 6d by applying a current to the tip electrodes 6a, 6b.")). Focusing on the disclosed structure of Miyamoto's device, the second Examiner finds that as to the apparatus claims: The angled face rake 41 (best shown in figure 7) [ of Miyamoto] is clearly capable of mechanically separating tissue given soft enough tissue and enough force applied to the face rake. That Miyamoto discusses that electrical energy is applied to tissue does not change the fact that the angled face rake could be used, with or without electrical energy, to separate tissue which is all that is required by the term "excise." (Ans. 4). To support of this finding, the Examiner points out that The dictionary definition of excision ( according to Merriam- Webster) is "the act or procedure of removing by or as ifby cutting out." Appellant's definition of excision is "removal or separation of at least a portion of the target portion of the native tissue from the remaining portion of the native tissue." (Ans. 4, quoting Spec. ,r 12). Accordingly, the Examiner states that "neither definition strictly requires a sharp cutting edge," and that "[e]ven blunt separation of tissue 4 Appeal2018-002770 Application 14/535,403 would qualify under both definitions as excision." (Ans. 4). Thus, the Examiner finds that "[g]iven its broadest reasonable interpretation, the face rake of Miyamoto is a mechanical blade that could be used to excise (separate) tissue." (Ans. 5). The Appellant argues that the Examiner's interpretation is unreasonably broad, pointing to portions of the Specification disclosing that "the excisors 126 can be any suitable device to mechanically shave the target portion, such as blades," and that the shaving of tissue can be attained by "a mechanical means (e.g., a sharpened blade)." (Spec. ,r,r 18, 22; see also id. ,r 21 ). The Appellant argues that "a 'mechanical blade', as consistently referenced by the Appellants, performs a severing-type operation ('shaving') to excise the tissue." (Reply Br. 7). Accordingly, the Appellant argues that consideration of the entirety of the Specification would lead one of ordinary skill in the art to realize that a mechanical excisor--as referenced and used consistently throughout the present application and prosecution--must have some cutting or severing nature not present in a blunt-ended flap. (Reply Br. 6; see also id. at 8). The Appellant concludes: While the face rake 41 might inherently be able to become located between tissues which have already been separated or removed from one another, ... the actual separation or removal of those tissues--i.e., the excision, in a shaving-type motion as with a sharpened blade--cannot reasonably be said to be an "inherent" property of the device of the [Miyamoto] publication. Instead, one of ordinary skill in the art would understand that the forces required to shove the face rake 41 into some sort of ripping or tearing contact with the tissue would likely be damaging to the tissue and/or the endocap, as 5 Appeal2018-002770 Application 14/535,403 well as likely being difficult to control and would thus be unwanted and unreasonable for achieving the desired excision. (Reply Br. 8; see also Reply Br. 7 ("the face rake 41 is able to become interposed in between tissues that the electrical excisor has already excised-- i.e., removed or separated from one another--by virtue of the electrical excisor's position on the front of the face rake 41.")). We agree with the Appellant. The review of the Specification indicates that the term "excisor" is used to refer to a device that cuts tissue. (Spec. ,r,r 13, 18, 21-23). While a sharpened blade is disclosed as an example, the Specification is clear that the recited excisor cuts, and excising means to cut. The Examiner's cited dictionary definition of "excise" is supportive of this interpretation. We find it speculative that face rake 41 of Miyamoto is capable of excising, i.e., cutting, any tissue. We also find it unreasonable to interpret excising to encompass simple tearing of tissue in view of the Specification and in considering the general surgical arts to which the present invention is directed. Accordingly, we reverse the Examiner's anticipation rejection based on Miyamoto of independent claim 1, and of claims 3, 5, 14, 15, and 17 that ultimately depend from independent claim 1. As to the method claim 7, the Examiner finds that: even if the separation does not originate from the face rake or the mechanical features of the electrodes, it is certainly assisted by them as the device travels along the tissue region being excised. That is, ultimately the device excises tissue both electrically (to initially separate tissue) and mechanically (pushing the device which further separate tissue). (Ans. 5). 6 Appeal2018-002770 Application 14/535,403 However, we do not agree that mere pushing to separate the tissue by the face rake of the device in Miyamoto, or positioning thereof between the tissue, qualifies as mechanically excising the tissue for substantially the same reasons discussed above relative to claim 1. In that regard, as noted, we find it speculative that face rake 41 of Miyamoto is capable of excising, i.e., cutting, any tissue. Therefore, we reverse the Examiner's anticipation rejection of claim 7 based on Miyamoto, as well as of claims 9-12, 20, 21, and 23 that ultimately depend from independent claim 7. The Appellant relies on the same arguments for patentability of independent claim 26 directed to an endocopic endocap, stating that it "contain[s] recitations related to those addressed above." (App. Br. 27). However, that is an incorrect characterization because claim 26 does not recite a mechanical blade. As the initial Examiner found, Miyamoto includes electrodes 6, 8 that together excise tissue (Final Act. 11-12; Miyamoto Abs., Figs. 1, 2, 4). Indeed, Miyamoto discloses that "excision of tissues can be performed by pressing the projections for incision 6c, 6d against tissues such as mucous membrane to incise the lesion site around its entire periphery" and "application of a current between the projection for incision provided on one of the tip electrodes and the other tip electrode enables to perform incision operation." (Miyamoto ,r 62). Furthermore, Miyamoto' s excisor is laterally spaced from the outer surface of the annular main body (Miyamoto, Figs. 2, 7). The Appellant did submit arguments directed to the other claims, which are pertinent to the language of claim 26 reciting "the extension being configured such that force exerted on the endocap by an endoscope causes the extension to move at least a portion of the native tissue to bring the target 7 Appeal2018-002770 Application 14/535,403 portion into sufficient proximity with the excisor to facilitate excision of the target portion." (App. Br. 39--40, Claims App.). Specifically, the Appellant argues that Miyamoto "does not teach, show, disclose, or suggest that applying a force to the endocap includes causing the extension to move at least a portion of the native tissue to bring the target portion into sufficient proximity with the at least one excisor to facilitate excision of the target portion." (Reply Br. 8-9). However, it is clear that the endocap of Miyamoto is pushed, and the tissue moved in order for the tissue to contact the tip electrode 6 and the top counter electrode 8 so that the tissue can be cut. (Miyamoto, Figs. 2- 4; ,r 42). Specifically, Miyamoto discloses that "the tip electrode 6 is connected to the anode side of the high-frequency generating apparatus 14, while the counter electrode for excision 8 and the counter electrode for hemostasis 10 are connected to the cathode side of the high-frequency generating apparatus 14 via the switch box 16." (Miyamoto ,r 48, Fig. 3). Considering the position of the top counter electrode 8 relative to the tip electrode 6, the extension is configured such that force exerted on the endocap moves a portion of the native tissue to bring the target portion into position for excision as required by claim 26. Accordingly, we affirm the Examiner's rejection of claim 26 as being anticipated by Miyamoto. Goshayeshgar The Examiner also finds that Goshayeshgar discloses each and every limitations of these claims. (Final Act. 7 ( citing Goshayeshgar, Fig. 6) ). In addressing the Appellant's argument that Goshayeshgar fails to disclose an excisor "including a mechanical blade" as recited in claim 1 (App. Br. 28), 8 Appeal2018-002770 Application 14/535,403 the Examiner explains that "it does not matter whether Goshayeshgar specifically teaches mechanical cutting because the narrow edge [in Figure 6] is capable of performing the function and so reads on the claim." (Ans. 6; see also Ans. 7). The Appellant argues, inter alia, that Goshayeshgar "does not teach, show, disclose, or suggest at least one excisor disposed on the extension such that the at least one excisor is laterally spaced from the outer surface of the annular main body, as presently claimed." (App. Br. 10). According to the Appellant, edge 603 [ of Goshayeshgar] ( which the Examiner seems to be characterizing as the claimed mechanical excisor) itself forms a boundary of the outer surface of the annular main body, by virtue of comprising the thickness between the outer and inner surfaces. Thus, edge 603 is not, and cannot be, laterally spaced from a surface for which it itself forms or defines a portion of the edge or perimeter. (Reply Br. 10). We agree with the Appellant for the reason argued. The Examiner does not address this argument. Accordingly, we reverse the anticipation rejection of independent claims 1, 7, and 26 based on Goshayeshgar. Accordingly, we also reverse the rejection with respect to claims 14--16, 18- 22, 24, and 25 that ultimately depend from claim 1 or claim 7. CONCLUSIONS 1. The Examiner's anticipation rejection based on Miyamoto is REVERSED as to claims 1, 3, 5, 7, 9-12, 14, 15, 17, 20, 21, and 23, but is AFFIRMED as to claim 26. 9 Appeal2018-002770 Application 14/535,403 2. The Examiner's anticipation rejection of claims 1, 7, 14--16, 18-22, 24, and 25 based on Goshayeshgar is REVERSED. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a). See 37 C.F.R. Â§ 1.136(a)(l )(iv). AFFIRMED-IN-PART 10