J. Landon. Gilkey et al.Download PDFPatent Trials and Appeals BoardApr 15, 202013650507 - (D) (P.T.A.B. Apr. 15, 2020) 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. 13/650,507 10/12/2012 J. Landon Gilkey APO-019D1 6974 119800 7590 04/15/2020 Donald K. Jones Apollo Endosurgery US, Inc. 1120 S. Capital of Texas Hwy Bldg 1, Suite 300 Austin, TX 78746 EXAMINER HIGHLAND, RACHEL S ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 04/15/2020 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): USIPDocketing@apolloendo.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte J. LANDON GILKEY, BRETT E. NAGLREITER, PETER K. KRATSCH, DONALD K. JONES, and VLADIMIR MITELBERG ____________ Appeal 2019-001519 Application 13/650,507 Technology Center 3700 ____________ Before ANTON W. FETTING, MICHAEL C. ASTORINO, and AMEE A. SHAH, Administrative Patent Judges. SHAH, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the Examiner’s final decision to reject claims 72–87 and 89–96, which are all of the pending claims. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. The Appellant identifies the real party in interest as “Apollo Endosurgery US, Inc.” Appeal Br. 3. Appeal 2019-001519 Application 13/650,507 2 CLAIMED SUBJECT MATTER The Appellant’s invention “relates to a treatment device which can be inserted into a body through a natural orifice with an endoscope or other steerable guide member.” Spec. ¶ 1. Claims 72, 75, 80, and 90 are the independent claims. Claim 72 is illustrative of the subject matter on appeal and is reproduced below: 72. A method of suturing tissue of a mammal using an endoscopic suturing system, comprising the follow steps: (a) inserting an endoscope into a body with a suturing device coupled to the endoscope, the endoscope having an instrument channel extending therethrough; (b) opening a needle arm of the suturing device having a removable needle removably coupled to the needle arm; (c) drawing tissue at a desired suture site between the needle and a distal end of the endoscope; (d) closing the needle arm of the suturing device such that the needle axially aligns with the instrument channel of the endoscope; (e) piercing the tissue with the needle; (f) recovering the needle within the distal end of the endoscope by using a needle capture device extended through the instrument channel of the endoscope; (g) opening the needle arm to disengage the needle arm relative to the needle; (h) closing the needle arm; and (i) removing the suturing device from the body. Appeal Br. 18 (Claims App.). Appeal 2019-001519 Application 13/650,507 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Yamamoto et al. (“Yamamoto”) US 2003/0181924 A1 Sept. 25, 2003 Saadat et al. (“Saadat”) US 2005/0065401 A1 Mar. 24, 2005 Baker et al. (“Baker”) US 2008/0086148 A1 Apr. 10, 2008 REJECTIONS Claims 72–75, 78, 80, 83, 85, 87, and 89–96 stand rejected under pre- AIA 35 U.S.C. § 103(a) as being unpatentable over Yamamoto and Saadat. Claims 76, 77, 79, 81, 82, 84, and 86 stand rejected under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over Yamamoto, Saadat, and Baker. OPINION Each of the independent claims 72, 75, 80, and 90 sets forth a method “of suturing tissue of a mammal using an endoscopic suturing system.” See Appeal Br. 18–23 (Claims App.). Claims 72 and 75 recite closing the needle arm of the suturing device such that the needle, or needle clip, axially aligns with the instrument channel of the endoscope. Id. at 18–19 (Claims App.). Claim 90 recites “(e) positioning the needle in alignment with the instrument channel of the endoscope.” Id. at 23 (Claims App.). We refer to these recitations as the “alignment limitations.” Claims 72 and 75 recite recovering the needle or grasping the needle clip by using a needle capture device extended through the instrument channel of the endoscope. Id. at 18–19 (Claims App.). Claim 80 recites Appeal 2019-001519 Application 13/650,507 4 “(f) engaging the needle with a needle capture device passed through the endoscope; [and] (g) recovering the needle with the needle capture device within the instrument channel.” Id. at 20–21 (Claims App.). Claim 90 recites “(f) mechanically engaging the needle with an instrument extending through the instrument channel of the endoscope.” Id. at 23 (Claims App.). We refer to these recitations as the “needle capture device limitations.” Common to each of the independent claims is a method using an endoscope with an instrument channel and a suturing device that includes a needle arm, a needle clip, a needle and/or a needle capture device. The Examiner relies on the combination of Yamamoto and Saadat to teach the alignment and needle capture device limitations. See Final Act. 3–4, 6–11; Ans. 2–4. The Appellant presents the same arguments for each of the independent claims. See Appeal Br. 15–16. After careful review of the Briefs, Final Action, and Answer, we agree with the Appellant that the Examiner does not adequately explain how the combined teachings of Yamamoto and Saadat would have resulted in the subject matter of the alignment and needle capture device limitations. See Appeal Br. 10–12; Reply Br. 3–6. The Examiner finds that Yamamoto teaches a method using an endoscope with instrument channel 6 extending therethrough and suturing device 3, and suturing device 3 that may include needle arm 16, needle clip 154/157, needle 34/157, and needle capture device 147/153/161/171/178. Final Act. 3–4, 6–11. The Examiner finds that Yamamoto “does not teach that the needle [or needle clip] axially aligns with the instrument channel of the endoscope” (id. at 3–4, 6), “the needle capture device is passed through the instrument channel of the endoscope” (id. at 8–9), or “that the needle is Appeal 2019-001519 Application 13/650,507 5 positioned in alignment with the instrument channel of the endoscope” (id. at 11). However, the Examiner finds that Yamamoto teaches “a separate external tube (35/160) for the needle to move into,” and that the suturing device and endoscope can be removably fixed or structurally integrated with each other (id. at 3–4, 6–7, 9, 11 (citing Yamamoto ¶ 150, Figs. 46–50, 57–59)2). Put simply, the Examiner finds that Yamamoto teaches aspects of the alignment and needle capture device limitations, but not the entirety thereof. The Examiner relies on Saadat to teach the remainder of the alignment and needle capture device limitations. Specifically, The Examiner finds that Saadat “teaches an endoscopic suturing device where the tissue grasper, needle arm, and needle capture device are each contained within the outer endoscopic tool (10),” and that “the needle arm can be bent such that the needle aligns axially with an instrument channel of the endoscope.” (Id. at 4, 7, 9, 11 (citing Saadat Figs. 7, 15, 20, 37, and 42). The Examiner determines [i]t would have been obvious to one of ordinary skill in the art at the time of invention as a matter of design choice to have the needle be moved into the instrument channel (as taught by Saadat) instead of an external auxiliary channel (as taught by Yamamoto) so as to make the device more compact. Id. 2 Figures 46–50 and 57–59 are figures that represent two different embodiments of Yamamoto’s invention. More specifically, Figures 46–49 represent a sixth embodiment and Figures 57–59 represent an eighth embodiment. See Yamamoto ¶¶ 234, 263. Figure 50 “show[s] a state in which a tissue is sutured while the tissue is pulled by a grasping forceps,” and is common to many embodiments of Yamamoto’s invention. Id. ¶ 66; see also id. ¶¶ 188, 245. Appeal 2019-001519 Application 13/650,507 6 For the needle capture device limitations, the Examiner relies on Yamamoto as modified by Saadat. Id. In the Answer at page 4, the Examiner clarifies that Yamamoto teaches the alignment limitations, but does not “explicitly depict” the arrangement of the tissue capture device, needle, needle arm, and needle capture device being “integrally contained within one outer tube,” i.e., the needle capture device limitations. The Examiner relies on Saadat solely “for the teaching of having all the various parts within one outer tube.” Id. at 3–4. In other words, the Examiner does not rely on Saadat to teach any instruments (structure), only the relative positioning of Yamamoto’s structure. Accordingly, it appears that the Examiner’s position is that one of ordinary skill in the art would place needle capturing device 147/178 within instrument channel 6 without any further modification to the device of Yamamoto. Yamamoto discloses an endoscopic suturing system comprising, in relevant part, endoscope 12, suturing device 3, instrument channel 6, light guides 8 and 9, camera 10, and washing nozzle 11. Yamamoto, Title, ¶¶ 149, 150, Figs. 2,3 50. “[T]he suturing device 3 is removably fixed at a distal end of the endoscope 12 by a fixing member 40, [but] the suturing device 3 and the endoscope 12 may be structured integrally with each other instead thereof.” Id. ¶ 150 (emphasis omitted), Fig. 8. Suturing device 3 comprises, in relevant part, flexible tube 73, holding member 18 formed of two support plate portions, hole 19 with push rod 20, and channel member 35 fixed to member 18 via an L-shaped supporting member. Id. ¶¶ 151, 160, Figs. 3–11. Push rod 20 has, in part, arm members 24 and 25 at 3 Figs. 1–11 refer to Yamamoto’s first embodiment. See Yamamoto ¶¶ 14–22, 148. Appeal 2019-001519 Application 13/650,507 7 a proximal end, members 24 and 25 integrally formed with actuating members 16 and 17 rotatably linked with support plate portion 18 via pins 28 and 29, and having needles 34, 41, and 42 fixed to their distal ends. Id. ¶¶ 151, 158, 159. Channel 35 can contain needle fixing means 147 in a sixth embodiment (id. ¶¶ 236, 241, Figs. 47–49), and actuating member 15 can have fixed to its distal end needle holder 178 in an eighth embodiment (id. ¶ 265, Fig. 57). Figure 50 is illustrative and is reproduced below. Figure 50 shows endoscope 12 with instrument port 6 having grasping forceps 152 inserted therethrough, light guides 8 and 9, camera 10, nozzle 11, support plate 18, pin 28, actuating arms 16 and 17, and needles 34, 41, and 42. See id. ¶¶ 149–154, 245. Saadat discloses an endoluminal tool deployment system comprising, in relevant part, main body 10 including guide lumens through which tools 40 having tool arms 30 are inserted. Saadat, Title, ¶¶ 60–62, 68, 113, Figs. 7A, 7B. Appeal 2019-001519 Application 13/650,507 8 To the extent the Examiner relies on Yamamoto as teaching the alignment limitations, i.e., needle arm 16 aligning with endoscope 12’s instrument channel 6, the Examiner does not adequately explain how Yamamoto’s “separate external tube (35/160) for the needle to move into” and the suturing device and endoscope being removably fixed or structurally integrated with each other (Final Act. 3–4, 6–7, 9, 11) teaches needle arm 16 aligning with channel 6. The Examiner further does not adequately explain how Yamamoto teaches “closing the needle arm such that it aligns with a channel of the endoscope” by depicting in Figures 30, 37, and 38 (second and fourth embodiments of Yamamoto (see Yamamoto ¶¶ 190, 208) “how the needle is captured by the needle capture device which is within the outer cover.” Ans. 3. In other words, the Examiner does not explain how the drawings depict such an alignment. The Examiner also does not explain how Saadat cures the deficiency of the finding concerning the alignment limitations. To the extent the Examiner relies on the combined teachings of Yamamoto and Saadat to result in the needle capture device limitations, the limitations do not require a tissue grasper, needle arm, and needle capture device to be contained within one channel. The Examiner determines that Saadat modifies Yamamoto’s capture device so as to be extended through Yamamoto’s channel 6 by combining various tools in one tube. However, the Examiner does not adequately explain how combining elements into one tube would modify Yamamoto’s channel 35 comprising tubular member 151 with needle fixing means 147 to fit into Yamamoto’s channel 6 comprising grasping forceps 152 that pulls the tissue thereby closing member 16 and 17 Appeal 2019-001519 Application 13/650,507 9 (located on device 3 outside of channel 6) to puncture the removable needle into the tissue. To the extent the Examiner is modifying Yamamoto’s needle holder 178 fixed to needle arm 16 connected to suturing device 3 with holding member 18 and pin 28, to fit within Yamamoto’s channel 6 with forceps 152 as one tube, as taught by Saadat’s body 10 with tools 40 (see Final Act. 4, 6–7, 9, 11; Ans. 3–4), the Examiner does not adequately explain how Yamamoto’s arm 16 would be disconnected from device 3 to be combined in one tube with forceps 16. To the extent the Examiner is modifying Yamamoto’s channel 6 to contain suturing device 3 with holding member 18 and pin 28, arm 16, and needle capture device 147 or needle holder 178 in one tube, as taught by Saadat’s body 10 with tools 40 (see Final Act. 4, 6–7, 9, 11; Ans. 3–4), the Examiner does not explain such a modification would be made to device 3. At best, the Examiner explains that Saadat teaches combining multiple tools into one tube member 10, but does not explain how such a tube would be able to encompass a support plate with a rotatable arm, needle, and connected channel with a needle capture device, how the support plate with an arm, needle, and channel/capture device would be modified to be encompassed within a tube, and how the modified tube would have a needle aligned with channel 6. Moreover, the Examiner does not explain how such a modification would make the device more compact. In sum, the Examiner does not adequately explain how, and in what way(s), Yamamoto is being modified by Saadat to teach the alignment and needle capture device limitations as recited in the independent claims. Appeal 2019-001519 Application 13/650,507 10 Thus, based on the record before us, we are persuaded of Examiner error, and we do not sustain the rejection over Yamamoto and Saadat of independent claims 72, 75, 80, and 90. We also do not sustain the rejection of dependent claims 73, 74, 78, 83, 85, 87, 89, and 91–96, under the same ground of rejection. The rejection of claims 76, 77, 79, 81, 82, 84, and 86 as obvious over Yamamoto, Saadat, and Baker is also not sustained, as it fails to include additional findings and/or reasoning that cures the deficiency in the rejection of the independent claims, from which they ultimately depend. CONCLUSION The Examiner’s decision to reject claims 72–87 and 89–96 is not sustained. In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 72–75, 78, 80, 83, 85, 87, 89–96 103(a) Yamamoto, Saadat 72–75, 78, 80, 83, 85, 87, 89–96 76, 77, 79, 81, 82, 84, 86 103(a) Yamamoto, Saadat, Baker 76, 77, 79, 81, 82, 84, 86 Overall Outcome 72–87, 89–96 REVERSED Copy with citationCopy as parenthetical citation