Ex Parte GerberDownload PDFPatent Trial and Appeal BoardNov 27, 201311606627 (P.T.A.B. Nov. 27, 2013) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte MARTIN T. GERBER __________ Appeal 2012-002319 Application 11/606,627 Technology Center 3700 __________ Before TONI R. SCHEINER, ERIC GRIMES, and ERICA A. FRANKLIN, Administrative Patent Judges. SCHEINER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 from the final rejection of claims 1-13, 15, and 19-23, directed to a device for aiding the implantation of an implantable medical device. The Examiner has rejected the claims as obvious, indefinite, and lacking written descriptive support. We have jurisdiction under 35 U.S.C. § 6(b). 1 Appellant identifies the Real Party-In-Interest as Medtronic, Inc. of Minneapolis, Minnesota (App. Br. 3). Appeal 2012-002319 Application 11/606,627 2 STATEMENT OF THE CASE Claims 1-13, 15, and 19-23 are pending and on appeal. Claims 24-37 are also pending, but have been withdrawn from appeal, while claims 14 and 16-18 have been canceled (App. Br. 3). The Examiner relies on the following evidence: Mamo et al. US 2002/0147485 A1 Oct. 10, 2002 Konstorum et al. US 6,749,560 B1 Jun. 15, 2004 Griffin et al. US 2004/0193140 A1 Sep. 30, 2004 Harris et al. US 2005/0049664 A1 Mar. 3, 2005 Claims 1-13, 15, and 19-23 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Mamo, Griffin, and Konstorum (Ans. 6-11). Claim 15 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Mamo, Griffin, Konstorum, and Harris (Ans. 12). Claims 12 and 22 stand rejected under 35 U.S.C. § 112, first paragraph, as lacking written descriptive support (new matter) (Ans. 3-5). Claim 11 stands rejected under 35 U.S.C. § 112, second paragraph, as indefinite (Ans. 5). We reverse the obviousness rejections of the claims; affirm the written description rejection with respect to claim 12 and reverse with respect to claim 22; and affirm the indefiniteness rejection of claim 11. Representative claim 1 is reproduced below: 1. An apparatus to facilitate implantation of a therapy element into tissue of a patient, the apparatus comprising: a dilator; and a sheath defining an inner lumen configured to interchangeably receive the dilator and the therapy element, wherein a first portion of the dilator is configured to preferentially flex in at least a first direction over at least a second direction that is different from the first direction, and wherein a second portion of the dilator is configured to preferentially flex in the second direction. Appeal 2012-002319 Application 11/606,627 3 DISCUSSION Obviousness Both obviousness rejections are premised on the Examiner’s finding that Konstorum discloses a device wherein a “first flexible portion is configured to preferentially flex in at least a first direction over a second direction and [a] second portion is configured to preferentially flex in the second direction” (Ans. 7). Accordingly, we will discuss the rejections together. The Examiner finds that Mamo discloses a dilator, but does not “disclose the flexibility characteristics of the dilator” (Ans. 6), while Griffin “teaches the importance of flexibility of an elongated device of this purpose” (id.). The Examiner further finds that Konstorum “teaches the design of an elongated medical device where . . . preferentially flexing in at least a first direction over at least a second direction can be achieved” (id.), as shown in Konstorum’s Figure 3, reproduced below: Figure 3 of Konstorum depicts tube 40, with slots 46 along at least part of its length. “[I]n this embodiment, the slots 46, are configured into three sections 52, 54, 56. Each section has a different pattern of the slots 46” (Konstorum, col. 3, ll. 32-35). Konstorum teaches that first section 52 represents an active deflection section of the tube, while second section 54 represents a passive deflection section (id. at col. 3, ll. 52-54; col. 4, ll. 11-12). In this embodiment section 52 is provided with two slot directions, “A and B . . . Appeal 2012-002319 Application 11/606,627 4 which are 180º offset from each other” (id. at col. 3, ll. 59-61), while section 54 is provided with slots “in four directions A, B, C and D which are offset 90º from each other” (id. at col. 4, ll. 15-17). Thus, section 52 is “two-way deflectable” (id. at col. 3, ll. 52-61), while the slots in section 54 “provide four way deflection capability” (id. at col. 4, l. 46). According to the Examiner, Konstorum’s “first flexible portion [52] is configured to preferentially flex in at least a first direction over a second direction and the second portion [54] is configured to preferentially flex in the second direction” (Ans. 7). Specifically, the Examiner finds that: Appellant’s “first direction” reads upon Konstorum et al.’s two- way deflection, and Appellant’s “second direction” reads upon the other of the two directions in Konstorum et al.’s four directions such that “the first portion is configured to preferentially flex in at least a first direction over at least a second direction that is different from the first direction, and wherein the second portion of the dilator is configured to preferentially flex in the second direction” as required by claim 1. (Id. at 14.) The Examiner concludes that it would have been obvious for one of ordinary skill in the art to modify Mamo’s dilator with “the slot design of Konstorum et al. as suggested by Griffin et al. to enable the elongated body to preferentially flex in at least a first direction over at least a second direction, in order to provide different flexibility and column strength patterns along the dilator length” (id. at 7). Appellant contends, in relevant part, that Konstorum’s endoscope is “configured to flex in multiple directions without . . . any particular preferential flexing” (App. Br. 9), and “preferential flexing, as required by Appeal 2012-002319 Application 11/606,627 5 Appellant’s claim 1, is not the same as multi-directional flexibility” (Reply Br. 8). Specifically, Appellant contends that: The first section 52 of the endoscope of Konstorum may be deflectable in two directions, e.g. in an up and down direction from the perspective of the view of FIG. 3 in Konstorum. The second section 54 . . . is deflectable in four directions, e.g., in the up and down directions of the first section 52 and in two directions into and out of the page on which FIG. 3 of Konstorum lies. This design of the endoscope of Konstorum yields a device that, in one example, will deflect up in the first section 52 and also in the same up direction in the second section 54. In another example, the first section 52 will deflect down and the second section 54 will also deflect in the same down direction. In the multi-directional deflection arrangement of the Konstorum endoscope, these results in which the first and second sections identified by the Examiner deflect in the exact same direction is just as likely as the first section deflecting, e.g., in the up direction and the second section 54 deflecting in a different direction, e.g., down. Thus, the endoscope of Konstorum does not exhibit preferential flexing, let alone, a first portion of a dilator that is configured to preferentially flex in at least a first direction over at least a second direction that is different from the first direction and a second portion of the dilator that is configured to preferentially flex in the second direction, as required by Appellant's claim 1. (Id.) Appellant’s argument is persuasive. Konstorum teaches that different slot patterns “can be used to form endoscopes with different shaft properties, such as different stiffness properties along their lengths and different active deflection capabilities at their active deflection sections” (Konstorum, col. 6, ll. 7-10). However, the Examiner has not identified any embodiment of Konstorum’s device wherein a first portion “is configured to preferentially Appeal 2012-002319 Application 11/606,627 6 flex in at least a first direction over at least a second direction that is different from the first direction, and wherein a second portion of the dilator is configured to preferentially flex in the second direction,” as required by claim 1. Accordingly, we will reverse both obviousness rejections of the claims. Written Description Claims 12 and 22 stand rejected as lacking written descriptive support (new matter). Appellant acknowledges the rejection of claim 12, but has not addressed it (App. Br. 3; Reply Br. 3). Accordingly, the rejection of claim 12 as lacking written descriptive support is summarily affirmed. With respect to claim 22, we agree with Appellant that the “disclosure conveys to one having ordinary skill in the art that Appellant had possession of an apparatus that comprises a sheath defining an inner lumen that has a diameter in a range of approximately one millimeter to approximately ten millimeters” (App. Br. 7), given the size range described for the dilator, which is designed to fit inside it (see e.g., Spec. ¶ 15). Accordingly, the rejection of claim 22 as lacking written descriptive support is reversed. Indefiniteness Appellant acknowledges the rejection of claim 11 as indefinite under 35 U.S.C. § 112, second paragraph (App. Br. 3; Reply Br. 3), but has not otherwise addressed the rejection. The rejection of claim 11 as indefinite is summarily affirmed. Appeal 2012-002319 Application 11/606,627 7 SUMMARY The rejection of claims 1-13, 15, and 19-23 under 35 U.S.C. § 103(a) as unpatentable over Mamo, Griffin, and Konstorum is reversed. The rejection of claim 15 under 35 U.S.C. § 103(a) as unpatentable over Mamo, Griffin, Konstorum, and Harris is reversed. The rejection of claims 12 and 22 under 35 U.S.C. § 112, first paragraph, as lacking written descriptive support is affirmed with respect to claim 12 and reversed with respect to claim 22. The rejection of claim 11 under 35 U.S.C. § 112, second paragraph, as indefinite is affirmed. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED-IN-PART lp Copy with citationCopy as parenthetical citation