Amr Salahieh et al.Download PDFPatent Trials and Appeals BoardSep 5, 201913612119 - (D) (P.T.A.B. Sep. 5, 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. 13/612,119 09/12/2012 Amr Salahieh 1001.2626102 5602 11050 7590 09/05/2019 SEAGER, TUFTE & WICKHEM, LLP 100 South 5th Street Suite 600 Minneapolis, MN 55402 EXAMINER COLELLO, ERIN L ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 09/05/2019 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): BSC.USPTO@stwiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte AMR SALAHIEH, ULRICH R. HAUG, CLAUDIO ARGENTO, DWIGHT MOREJOHN, DANIEL HILDEBRAND, and TOM SAUL ____________ Appeal 2019-000026 Application 13/612,119 Technology Center 3700 _______________ Before WILLIAM A. CAPP, JEREMY M. PLENZLER, and LISA M. GUIJT, Administrative Patent Judges. GUIJT, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellants1 appeal under 35 U.S.C. § 134(a) from the Examiner’s rejection of claims 23–25, 27–29, and 31–35.2 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 Boston Scientific Scimend, Inc. is identified as the real party in interest. Appeal Br. 4. 2 Appeal is taken from the Final Office Action dated November 24, 2017, as supplemented by the Advisory Action dated March 8, 2018. Appeal 2019-000026 Application 13/612,119 2 CLAIMED SUBJECT MATTER Claims 23 and 32 are the independent claims on appeal. Claim 23, reproduced below, is exemplary of the subject matter on appeal, with disputed limitations italicized for emphasis. 23. An implant system, comprising: a releasable implant adapted for endovascular delivery and deployment, the implant having a plurality of actuation element interface sites disposed circumferentially about the implant at a common axial position along a longitudinal axis of the implant; wherein the implant includes, for each actuation element interface site, a distal male locking element and proximal female locking element; an elongated deployment tool body having a lumen extending therethrough; an outer sheath, the deployment tool body disposed within the outer sheath and the implant disposed within the outer sheath distal of the deployment tool body in a pre-deployment state; an actuation controller disposed at a proximal end of the deployment tool body and proximal of the outer sheath; and a plurality of actuation elements extending from the implant toward a distal end of the deployment tool body each actuation element detachably coupled directly to one distal male locking element; wherein the plurality of actuation elements merge into a single unit near the distal end of the deployment tool body, the single unit being slidably disposed within the lumen of the deployment tool body, a proximal end of the single unit being coupled to the actuation controller; wherein the implant is actuated from the pre-deployment state to a transitional deployed state by advancing the implant distally relative to the outer sheath until the implant is disposed outside of the outer sheath; wherein operating the actuation controller to effect proximal translation of the single unit actuates the implant from the transitional deployed state to a final deployment state. Appeal 2019-000026 Application 13/612,119 3 THE REJECTIONS3 I. Claims 23, 27–29, and 31–35 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Salahieh (US 2005/0143809 A1; published June 30, 2005) and Partosh4 (RU 2 149 037 C1; published May 20, 2000). II. Claim 24 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Salahieh, Partosh, and Vanney (US 5,807,405; issued Sept. 15, 1998). III. Claim 25 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Salahieh, Partosh, and Derus (US 2003/0225445 A1; published Dec. 4, 2003). ANALYSIS Rejection I Appellants present the same arguments for independent claims 23 and 32, and do not present separate arguments for the patentability of dependent claims 27–29, 31, and 32–35. Appeal Br. 18–20. Thus, we select claim 23 as representative. See 37 C.F.R. § 41.37(c)(1)(iv) (2015). Regarding independent claim 23, the Examiner finds, inter alia, that Salahieh discloses a releasable implant (i.e., anchor 30) having actuation element interface sites (i.e., anchor attachment elements 32, 34) each with a distal male locking element (i.e., post 32) and a proximal female locking element (i.e., buckle 34), as claimed. Final Act. 8 (citing, e.g., Salahieh ¶¶ 3 The Examiner’s rejection of claims 23, 27–29, and 31–35 under 35 U.S.C. § 102(b) as anticipated by Salahieh (US 2005/0143809 A1; published June 30, 2005) has been withdrawn. Final Act. 2–3; Ans. 2–3. 4 We rely on the English language translation as provided in the record. Appeal 2019-000026 Application 13/612,119 4 72–74, 76, 86, 92–97, Figs. 1A, 1B, 3A–E). The Examiner also finds that Salahieh discloses an elongated deployment tool body having a lumen (i.e., delivery system 100, multi-lumen shaft or catheter 108, central lumen 109) and an outer sheath (i.e., external sheath 110), and an actuation controller (i.e., control handle 120), as claimed. Id. (citing Salahieh, Figs. 1A, 3A); see also Salahieh ¶ 71. The Examiner further finds that Salahieh discloses actuation elements (i.e., actuators 106[a], 106b, 112), as claimed. Id. at 8–9 (citing, e.g., Salahieh ¶¶ 72–74, 76–78, 83 86, 89, 92–97, 99–101, Figs. 1A– F, 2A–F, 3C, 3D). The Examiner relies on Partosh for teaching that “it is well known in the art” for an implant deployment device to include actuation elements detachably coupled to actuation element interface cites, wherein the actuation elements merge into a single unit near the end of a deployment tool body to allow the single unit to be slidably disposed within a lumen of the deployment tool body to allow the elements to be actuated simultaneously. Final Act. 9–10 (citing, e.g., Partosh, Figs. 1–4) (emphasis added); see also Partosh ¶ 16. The Examiner specifically finds that Partosh’s “hooks [4] merge into string [3]” to form a single unit, as claimed (Adv. Act. 2), and that Partosh’s single unit (i.e., string 3, hooks 4) “can move relative to catheter Ref 1” (Ans. 4), as claimed.5 See also Adv. Act. 2 (finding that Partosh discloses “relative motion between the string/hooks and the catheter” (emphasis added)); Partosh ¶¶ 11, 16, Figs. 2–4. The Examiner reasons that it would have been obvious to modify Salahieh’s actuation elements to merge into a single unit, as suggested by 5 Cf., e.g., Final Act. 10 (apparently relying on relative movement between hooks 4 and string 3, and capillary 5, which is not supported by a preponderance of the evidence); see also Appeal Br. 19; Reply Br. 5–7. Appeal 2019-000026 Application 13/612,119 5 Partosh, because the modification “allows the plurality of actuation elements of Salahieh to be combined such that a single element passes through a lumen of [the] device, while enabling the plurality of actuation elements to be actuated simultaneously.” Final Act. 10. Appellants argue that Partosh teaches that “a single string 3, having two or more hooks 4, is disposed within and stationary relative to a capillary 5” and that Partosh does not appear to disclose that “the use of string 3, a single unit, is slideably disposed within the lumen of capillary 5.” Appeal Br. 19; Reply Br. 5–6, 8. However, Appellants’ arguments fail to address the Examiner’s finding supra that Partosh’s single unit (i.e., string 3, hooks 4) moves relative to either main or additional catheters 1, 2. Notably, the Specification discloses that [t]o at least partially compensate for differences in path length from the interface sites to the actuator, the actuation elements are disposed along a single actuation element path, such as by placing all actuation elements within a single lumen 506. The actuation elements may also be bundled together, either into a single line 310 such as a cable, or bundled to move together as a single unit in a harness so that the actuation elements reduce to a single primary actuation element extending to the proximal end to be linked to a single actuator 204. . . . Instead of being intertwined, the individual elements are laid side by side with a minimal amount of twining or braiding. Then at the actuation controller, each actuation element 308a–n is separated out and linked to an individual actuator 204a-n. In this manner it is possible to construct the same relationship of actuators 204 and actuation elements 308 and actuation element interface sites 408 without having to construct numerous additional paths. Spec. 19:12–21; see also Appeal Br. 7 (Summary of Claimed Subject matter) (referencing Spec. 19:15–21, 26:2–5, Fig. 6B (reference numeral 310) for disclosing that the actuation elements “merge into a single unit”). Appeal 2019-000026 Application 13/612,119 6 A preponderance of the evidence supports the Examiner’s finding that Partosh discloses that it is known to arrange actuation elements, and in particular, hooks 4 of string 3, such that hooks 4 merge into a single unit: (i) hooks 4 are depicted in Figures 2 to 4 of Partosh as bundled together into string 3; and alternatively, (ii) hooks 4 and string 3 are depicted in Figures 2 to 4 of Partosh as disposed within a harness (i.e., capillary catheter 5); such that, in either case, hooks 4 move together as a single unit within catheter 2. Partosh ¶ 11 (identifying “main catheter 1” and “additional catheter 2”); ¶ 14 (“string 3 is placed into the capillary catheter 5 [and] is provided with four hooks placed at its corresponding end, and placed in front of a supplementary catheter 2”), ¶ 17 (with reference to Figure 4, “[r]emoving the hook from 4 mesh prosthesis 6 is carried out breeding strings 3 of [additional] catheter 2 further forward”), Figs. 2–4. Figure 4 of Partosh is reproduced below. Figure 4 of Partosh depicts “a device for delivery of a mesh prosthesis (in cross section) at the time when the mesh prosthesis is disconnected from the hooks of the string”), wherein an arrow identifies relative movement between additional catheter 2 (i.e., an alongated deployment tool body having a lumen) and actuation elements (i.e., hooks 4), which are bundled and/or harnessed as string 3 within capillary catheter 5 into a single unit. Partosh ¶ 10. In other words, the single unit (i.e., comprised of hooks, string Appeal 2019-000026 Application 13/612,119 7 3, and capillary catheter 5) moves relative to both main and additional catheters 1, 2. Appellants also argue that Partosh discloses “releas[ing] hooks 4 by advancing capillary 5, string 3, and hooks 4 distally beyond the distal end of catheter 2, as indicated by an arrow in Fig. 4, rather than retracting activation elements as taught by Salahieh,” and therefore, “[i]n the absence of a common mode of action, there is no reasonable expectation of success in the combination.” Appeal Br. 19; see Reply Br. 7–10. Appellants submit that “Partosh does not appear to make any presentation that hooks 4 release simultaneously.” Appeal Br. 19. Appellants further submit that “[t]he Examiner clearly errs in asserting that the withdrawal of an actuation element (3, 4, 5) of Partosh, when substituted into the delivery system of Salahieh, would function to release the prosthesis, a function contrary to the teaching of Partosh.” Reply Br. 9. The Examiner relies on Salahieh for disclosing a plurality of actuation elements, namely, actuators 106b, and indeed, Salahieh discloses at least “distal anchor actuation elements” (i.e., actuators 106b releasably coupled to a distal region of anchor 30), as relied on by the Examiner—in addition to proximal anchor actuation elements (i.e., actuators 106a) and release actuators 112. Salahieh ¶¶ 72, 73, Fig. 1A. Salahieh discloses that “actuators 106b may include control wires (e.g., st[r]ands of suture, or metal or polymer wires) which pass through one or more lumen Lu of shaft 108.” Id. ¶ 73 (emphasis added). Salahieh further discloses that “[c]ontrol handle 120 is coupled to a multi-lumen shaft 108” and “comprises knob 126, e.g., manipulating the actuators 106b to control movement of the distal region of apparatus 10 relative to its proximal region,” wherein “[k]nob 126 optionally may move actuators 106b in unison with their concomitant release actuators Appeal 2019-000026 Application 13/612,119 8 112.” Id. ¶ 74 (emphasis added). Thus, in view of Partosh’s teaching of bundling individual actuators in a single unit for common actuation, we are not persuaded by Appellants’ argument that due to a different “mode of action,” bundling Salahieh’s actuators 106b with one lumen for actuation in unison lacks a reasonable expectation of success. To the extent Appellants are interpreting the Examiner’s proposed modification as requiring a substitution of Partosh’s string 3, hooks 4, and capillary 5 into the device of Salahieh, Appellants are not addressing the Examiner’s rejection as articulated supra. The Examiner is proposing to modify Salahieh’s device to merge actuation elements that are actuated in unison into a single element to allow actuation simultaneously. In other words, the Examiner is not bodily incorporating Partosh’s actuation elements into the device of Salahieh. Appellants further argue that “Salahieh does not disclose a deficiency with regard to simultaneous actuation of the actuators 106b” and thus, “the Examiner’s proposed combination . . . appears to be directed toward solving a problem which has not been shown to exist in Salahieh alone.” Appeal Br. 20. Appellants conclude that “there is no established motivation for the proposed combination other than to replicate Appellants’ invention in hindsight.” Id. We are not persuaded by Appellants’ argument, in that, as set forth supra, Salahieh discloses the desirability to operate at least actuators 106b in unison. Further, the Examiner relies on Partosh for disclosing merging actuators into a single unit for common actuation. In other words, Appellants’ hindsight argument is of no moment where, as here, the Examiner provided a sufficient, non-hindsight reason to combine the references. See In re Cree, 818 F.3d 694, 702, n.3 (Fed. Cir. 2016). Appeal 2019-000026 Application 13/612,119 9 Accordingly, we sustain the Examiner’s rejection of independent claim 23, and claims 27–29 and 31–35 fall therewith. Rejection II Regarding dependent claim 24, Appellants argue that the Examiner’s reliance on Vanney for teaching a single unit activation element comprising a plurality of actuation elements harnessed together side-by-side does not overcome the deficiencies in the Examiner’s reliance on Salahieh and Partosh, as argued with respect to independent claim 23 in Rejection I supra. Appeal Br. 20–21. Because we do not agree that the Examiner erred in the rejection of claim 23 supra, for essentially the same reasons as stated supra, we sustain the Examiner’s rejection of claim 24. Rejection III Regarding dependent claim 25, which depends from independent claim 23 and recites, in relevant part, “wherein the single unit comprises the plurality of actuation elements intertwined together,” the Examiner finds that although Salahieh, as modified by Partosh, discloses actuation elements merging into a single unit, neither reference discloses actuation elements intertwined together, as claimed. Final Act. 14; Appeal Br. 25 (Claims App.). The Examiner relies on Derus for disclosing that “the plurality of actuation elements connect closely and can cross over one another as they pass proximally and therefore, given the broadest reasonable interpretation of ‘intertwine’ to mean close together, link closely or connect,” the Examiner interprets such a configuration as meeting the limitation of claim 24. Ans. 6; see also Final Act. 14 (citing Derus, Figs. 2, 3, 5 (reference numerals 52, 412). The Examiner reasons that it would have been obvious to modify a Salahieh’s single unit, as suggested by Partosh, such that the Appeal 2019-000026 Application 13/612,119 10 actuation elements are intertwined together, as taught by Derus, “since such a modification provides an art recognized alternate construction that would have yielded predictable results, namely, allowing the actuation elements to be actuated simultaneously.” Final Act. 14. Appellants argue that the Examiner’s finding is speculative. Appeal Br. 21. In support, Appellants submit that Figures 2 and 3 of Derus depict “a single thread 52 . . . looped through a proximal end of a stent 46 and pass[ing] proximally through a straight transfer region 38.” Id. Appellants conclude that “[t]here is no disclosure that the thread 52 is ‘intertwined’ with itself and no suggestion that the thread of Derus would benefit from being twisted about itself,” nor does Derus, which exhibits a straight lumen, “suggest to one of ordinary skilled in the art that the asserted combination with Salahieh would be beneficial in addressing the technical problem addressed by the instant invention.” Id. at 22. Appellants submit that the Examiner’s interpretation of the claim term “intertwined” is “overly broad” and effectively reads the claim term out of the claim. Reply Br. 10. An ordinary meaning of the claim term “intertwined,” consistent with the Specification, is “to unite by twining one with another” (https://merriam- webster.com/dictionary/intertwined (last visited Aug. 19, 2019)), wherein “twining” means “a strong string of two or more strands twisted together” (https://merriam-webster.com/dictionary/twining (last visited Aug. 19, 2019)). Derus discloses that “[s]tent 40 is preferably provided with at least one transfer mechanism, such as one or more threads or sutures 52 . . . for facilitating the transfer of the stent 46 from the storage area 34 to the transfer area 38.” Derus ¶ 33. Derus further discloses that “additional threads 52 can be similarly attached [(i.e., inserted through a hole or opening in one side of the stent 46)] at various points around the stent, if desired, to better Appeal 2019-000026 Application 13/612,119 11 distribute the forces that will be imparted to the stent when it is pulled,” and that “[i]n a configuration of this type, the threads 52 may cross over each other in the center area of the stent.” Id. at ¶ 34. Thus, a preponderance of the evidence supports the Examiner’s finding that Derus discloses a plurality of actuation elements (i.e., threads 52) that cross-over or are twisted together to be intertwined, as claimed. Appellants’ argument also does not apprise us of error in the Examiner’s reasoning that when operating Salahieh’s actuators 106b in unison, which are merged into a single unit, as taught in Partosh, intertwining actuators 106b (which may be sutures) would further ensure that the actuators 106b are actuated simultaneously. Accordingly, we sustain the Examiner’s rejection of claim 25. DECISION The Examiner’s decision rejecting claims 23–25, 27–29, and 31–35 is AFFIRMED. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation