Dmitri Menn et al.Download PDFPatent Trials and Appeals BoardJul 30, 201914159993 - (D) (P.T.A.B. Jul. 30, 2019) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE 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 APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 14/159,993 01/21/2014 Dmitri MENN 10121/08312(05-00225US3) 3894 104919 7590 07/30/2019 Fay Kaplun & Marcin, LLP -- BSC 150 Broadway, suite 702 New York, NY 10038 EXAMINER HIGHLAND, RACHEL S ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 07/30/2019 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): fkmiplaw@yahoo.com okaplun@fkmiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte DMITRI MENN, RUSSELL F. DURGIN, BRIAN KEITH WELLS, LANCE ALAN WOLF, GREGORY R. FURNISH, VASILIY P. ABRAMOV, and WILLIAM C. MERS KELLY1 ____________ Appeal 2017-011463 Application 14/159,993 Technology Center 3700 ____________ Before RICHARD M. LEBOVITZ, TAWEN CHANG, and RACHEL H. TOWNSEND, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL The claims in this appeal are directed to a tissue clipping device. The Examiner rejected the claims under 35 U.S.C. § 103 as obvious. Pursuant to 35 U.S.C. § 134, Appellants appeal the Examiner’s determination that the claims are unpatentable. We have jurisdiction for the appeal under 35 U.S.C. § 6(b). The Examiner’s decision is reversed. 1 The Appeal Brief (“Appeal Br.” entered May 23, 2017) lists Boston Scientific Scimed, Inc., as the Real Party in Interest. Appeal Br. 1. Appeal 2017-011463 Application 14/159,993 2 STATEMENT OF THE CASE Claims 20–39 stand finally rejected by the Examiner as follows: 1. Claims 20–28, 30–37, and 39 under pre-AIA 35 U.S.C. § 102(b) as anticipated by Kogiso et al. (EP 1 829 489 A1, published Sept. 5, 2007) (“Kogiso”). Ans. 2. 2. Claims 29 and 38 under pre-AIA 35 U.S.C. § 103(a) as obvious in view of Kogiso and Komiya (U.S. Pat. No. 3,958,576, issued May 25, 1976). Ans. 9. Independent claim 20, which is representative of the claimed subject matter, is reproduced below: 20. A tissue clipping device, comprising: a flexible insertion member extending from a proximal end which, during use remains outside a body accessible to a user to a distal end which is inserted into the body through a naturally occurring body lumen; a clip including first and second clip arms; a capsule housing a portion of the clip therein; a control wire extending through the flexible insertion member from a proximal end to a distal end removably coupled to the clip by a joint at a proximal end of the clip, the control wire being reversibly operable to move the first and second clip arms between an open configuration in which distal ends of the first and second clip arms are separated from one another and a closed configuration in which the distal ends of the first and second clip arms are drawn together to grip tissue located therebetween; and an actuator coupled to the control wire and configured to move the first and second clip arms between the open and closed configurations, application of a predetermined force to the actuator applying a force to the control wire freeing the proximal end of the clip to move radially outward to engage an increased diameter portion of the capsule and disengage the control wire from the clip. Appeal 2017-011463 Application 14/159,993 3 ANTICIPATION REJECTION BASED ON KOGISO The Examiner found Kogiso describes a tissue clipping device that meets all the limitations of the claimed device. Final Act. 2. In response to arguments made by Appellants in the Appeal Brief that Kogiso does not describe “application of a predetermined force to the actuator applying a force to the control wire freeing the proximal end of the clip to move radially outward to engage an increased diameter portion of the capsule and disengage the control wire from the clip” (Appeal Br. 8), the Examiner further cited the embodiment in Kogiso illustrated in Figures 9–13 (Ans. 2). The Examiner found that these figures and accompanying disclosure described all the structural features of the claimed control wire and proximal end of the clip, and are capable of performing the recited functions. Ans. 4, 6. In reaching this determination, the Examiner interpreted the claims to require that the “application of a predetermined force to the actuator” achieves two separate results which are products of separate forces. Ans. 13. According to the Examiner, the first result is the radial expansion of the proximal end of the clip into engagement with “an increased diameter portion of the capsule” and the second result is to “disengage the control wire from the clip.” Id. (Quoted portions correspond to the limitation in the last clause of claim 20.) The Examiner stated that these two results are “separate,” can occur in any order, and need not have a “causal relationship.” Id. Appellants challenge the Examiner’s interpretation of the claims. Appellants contends that the two results are a product of one force. Appellants argue that the claims require the application of the recited predetermined force to the control wire to free the proximal end of the clip Appeal 2017-011463 Application 14/159,993 4 “to (1) move radially outwardly to engage the increased diameter portion of the capsule and (2) disengage the control wire from the clip.” Reply Br. 4. Thus, Appellants disagree with the Examiner’s determination that the two results are separate and not causally related. Because the dispute between the Examiner and Appellants turns on the issue of claim interpretation, we begin our analysis by construing the claims. During patent examination proceedings, claim terms are given “the broadest reasonable meaning . . . in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in the applicant’s specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). The disputed claim limitation reads as follows: application of a predetermined force to the actuator applying a force to the control wire freeing the proximal end of the clip to move radially outward to engage an increased diameter portion of the capsule and disengage the control wire from the clip. The plain language of the claim requires a single force (“applying a force”) to the control wire. This force frees the proximal end of the clip allowing it “to move radially outward to engage an increased diameter portion of the capsule and disengage the control wire from the clip.” The (1) radial outward movement and (2) disengagement of the control wire from the clip are therefore a result of the action of the force “freeing the proximal end of the clip.” This interpretation of the claim is consistent with the Specification. In explaining how the predetermined force works, the Specification refers to Appeal 2017-011463 Application 14/159,993 5 Figure 10. Figure 10 is reproduced below (labels and colored shading have been added for clarity): Figure 10 shows the structural features of the claimed device, including: (1) “flexible insertion member” 330; (2) “clip” having “first and second clip arms” 304; (3) “capsule” 360 (the figure points to the entire structure, but from the description, it appears to be the structure formed from 362 and 364 (numerals shaded red); and (4) “control wire” 332 (cream-colored shading). As shown in Figure 10 reproduced above, 362 and 364 form a shell or capsule having cavities 307, 309 (green-colored shading) in which the ends of the clip arms 304 (“tabs 305”) are constrained. Spec. ¶ 17 (“The cavities 307, 309 receive proximal ends of the arms 304 and constrain them to remain therein against a bias which urges the proximal ends of the arms 304 and tabs 305 formed thereby radially outward.”). The Specification Appeal 2017-011463 Application 14/159,993 6 discloses that “the post 318 can bind the proximal and distal halves 362, 364 to one another.” Spec. ¶ 18. The Specification discloses that the movement of the clip is controlled by the control wire 332. Spec. ¶ 18. The Specification further discloses that a “proximally directed force applied to the control wire 332 increases tension on the control wire 332 and, consequently, on the post 318 until a failure level of the post 318 is exceeded.” Spec. ¶ 19. The Specification, with reference to Figure 10 reproduced above, explains what happens when the post 318 fails: When the post 318 fails, the proximal and distal halves 362, 364 can be separated from one another, and the tabs 305 which are no longer constrained by the walls of the cavity 309 of the proximal half 362 can spring outward and engage corresponding features of the capsule 360 (e.g., windows 363) to lock the clip closed and keep it in position within the capsule 360. Spec. ¶ 19. In other words, “applying a force to the control wire” breaks the post 318 which results in both claimed results of (1) “freeing the proximal end of the clip to move radially outward to engage an increased diameter portion of the capsule” and (2) “disengage the control wire from the clip.” The Examiner’s interpretation of the claim to not require the results to be causally related ignores the language in the claim that requires “applying a force” which results in “freeing the proximal end of the clip to move radially outward to engage an increased diameter portion of the capsule and disengage the control wire from the clip.” While the claim does not exclude the application of other forces, the same force must accomplish both results. Appeal 2017-011463 Application 14/159,993 7 Kogiso In the Answer, the Examiner reproduced Figures 9–13 of Kogiso, finding that these figures met the disputed “applying a force” of claim 20. Specifically, the Examiner found the Kogiso describes: application of a predetermined force to the actuator applying a force to the control wire (when wire is pulled proximally as seen starting in Fig. 11) freeing the proximal end of the clip to move radially outward (note that as wire is moved proximally, the portions 90 which are restrained in the smaller diameter portion of the capsule in Fig. 10 are freed to expand in the larger diameter section of the capsule (See Fig. 11) and continued proximal force also causes the joint 44 to separate the control wire from the clip (See Fig. 12). Ans. 4. The Examiner’s own explanation based on the disclosure of Kogiso is that a force frees the end of the clip allowing it to move radially outward and then a “continued proximal force” is applied to separate or disengage the control wire from the clip. Figure 11 of Kogiso, reproduced below, shows the clips after they have moved radially outward (label and red-colored shading added for clarity). Appeal 2017-011463 Application 14/159,993 8 Figure 11 shows a tissue clip which is grabbing tissue A by clip arms 42, 62. The clip element 90 was moved from the cavity in position 92 in Fig. 10 (not shown) to where it is shown in Fig. 11 as located in the cavity of pressing member 40. The Examiner found that operation wire 30 depicted in the figure is a “control wire.” Ans. 3. In the figure, the proximal end of the clip has been radially expanded “to engage an increased diameter portion of the capsule,” accomplishing the first result of claim 20. For clarity, the portion of the clip which engages the diameter of the cap has been marked with red-colored shading. As shown in this figure, the clip is still engaged with the control or operation wire 30. Figure 12, reproduced below, shows the clip disengaged from the control wire (30) (labels added for clarity), which is the second result of claim: Appeal 2017-011463 Application 14/159,993 9 Figure 12 shows the operation wire 30, which serves as the claimed control wire, separated from the clip by separating at breaking portion 74. Kogiso 68. The force is not “a continued proximal force” as asserted by the Examiner (Ans. 4), but is a second force accomplished after the clip has been expanded radially outward. Kogiso discloses: Referring to FIG. 12, in a state that the portion to be ligatured A has been properly ligatured and the clip claw member 42 has been sufficiently withdrawn into the pressing member 40, the slider 36 is retreated relative to the control portion main body 34, the first breaking portion 74 of the connection member 44 is broken, and the clip claw member 42 is separated from the operation wire 30. After the first breaking portion 74 is broken, the slider 36 is further retreated relative to the control portion main body 34. Kogiso ¶ 68. Thus, after the clip has been radially expanded into the portion of the device known as pressing member 40 (see Fig. 11 and corresponding structure labeled 40) (which meets the claim limitation of “freeing the proximal end of the clip to move radially outward to engage an increased diameter portion of the capsule”), the connection member is broken by a Appeal 2017-011463 Application 14/159,993 10 separate second force and the wire and clip are disengaged as required by the claim (“disengage the control wire from the clip”). The Examiner did not establish that the same applied force could both expand the proximal end of the clip and break the connection. The Examiner further stated that “[a]s long as the prior art meets the structural requirements and is capable of performing the functions, the prior art meets the limitations.” Ans. 4. The Examiner concluded that “the device of Kogiso meets all the structural requirements and is capable of performing the intended function” (id.), but did not explain how the same force could be used in Kogiso to accomplish both results. The Examiner has the burden of providing a “sound basis” on which to believe that Kogiso device is the same device as claimed. In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990). Once this burden it met, the burden shifts to Appellants to prove otherwise. Id. However, in this case, the Examiner simply made a conclusory statement based on an unreasonably broad interpretation of the claim and an incorrect finding that a “continued proximal force” separated the clip and control/operation wire 30. Ans. 4. Because the Examiner did not meet the burden of establishing a prima facie case, the anticipation rejection of claim 20 and dependent claims 21–28 are reversed. Independent claim 30, and dependent claims 31–37 have substantially the same “force” limitation as claim 20 and the rejection of these claims are reversed for the same reasons. Independent claim 39 uses different language from claim 20, but still requires the same force to move the clip proximal end into an enlarged diameter and disengage the control wire and clip (“separate a joint coupling Appeal 2017-011463 Application 14/159,993 11 the control wire to the clip”). Consequently, the anticipation rejection of these claims are reversed, as well. OBVIOUSNESS REJECTION Claims 29 and 38 are further rejected as obvious based on Kogiso and Komiya. The Examiner cited Komiya to reach additional limitations in these claims. Ans. 8–9. Komiya is not cited by the Examiner to reach the “force” limitation of the claims. The rejection based on these publications is also reversed because the Examiner did not establish that Kogiso, alone or in combination with Komiya, discloses or suggests “applying a force to the control wire freeing the proximal end of the clip to move radially outward to engage an increased diameter portion of the capsule and disengage the control wire from the clip.” REVERSED Copy with citationCopy as parenthetical citation