Boston Scientific Scimed, Inc.Download PDFPatent Trials and Appeals BoardSep 30, 20212021002357 (P.T.A.B. Sep. 30, 2021) 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. 15/003,308 01/21/2016 John Alan O'Brien 8150BSC0269 9324 121974 7590 09/30/2021 Kacvinsky Daisak Bluni PLLC (8150) 2601 Weston Parkway, Suite 103 Cary, NC 27513 EXAMINER TYSON, MELANIE RUANO ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 09/30/2021 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): docketing@kdbfirm.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte JOHN ALAN O’BRIEN, CONOR O’SULLIVAN, and FRANK RYAN Appeal 2021-002357 Application 15/003,308 Technology Center 3700 ____________ Before MICHAEL J. FITZPATRICK, BRANDON J. WARNER, and MICHAEL L. WOODS, Administrative Patent Judges. FITZPATRICK, Administrative Patent Judge. DECISION ON APPEAL Appellant, Boston Scientific Scimed, Inc.,1 appeals under 35 U.S.C. § 134(a) from the Examiner’s final decision rejecting claims 1–4, 6, 7, 21– 24, 26–30, 32, and 33. Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 “Appellant” refers to the applicant as defined in 37 C.F.R. § 1.42. Appellant identifies itself as the real party in interest. Appeal Br. 2. Appeal 2021-002357 Application 15/003,308 2 STATEMENT OF THE CASE The Specification The Specification’s disclosure “relates generally to occlusive devices for creating vascular occlusions.” Spec. ¶2. Such “[v]aso-occlusive devices are implants that are placed within the vasculature of the body . . . to block the flow of blood through a vessel making up that portion of the vasculature via the formation of an embolus or to form an embolus within an aneurysm or other structure stemming from the vessel.” Id. ¶3. They “are typically implanted using a delivery catheter that is advanced endoluminally to the treatment site.” Id. “An example of a well-known vaso-occlusive device has an elongated helically-wound device having ‘primary shape’ when constrained within a delivery catheter, and a three-dimensional ‘secondary’ [(or ‘memorized’ per the claims)] shape once deployed from the catheter and left, more or less, unconstrained in the implantation site.” Id. ¶4. The Claims Claims 1–4, 6, 7, 21–24, 26–30, 32, and 33 are rejected. Final Act. 1. No other claims are pending. Id. Claim 1 is representative and reproduced below. 1. An occlusion device having a memorized spherical shape and comprising a single wire having a memorized shape in which the wire comprises a spherical outer wire layer having a first axis and a spherical inner wire layer having a second axis disposed within the spherical outer wire layer, wherein the outer wire layer comprises a first spherical helix about the first axis, wherein the first axis and the second axis are substantially perpendicular to each other. Appeal Br. 17. Appeal 2021-002357 Application 15/003,308 3 The Examiner’s Rejections Pursuant to 35 U.S.C. § 103, the Examiner made the following rejections: 1. claims 1–4, 7, 21–24, 27–30, and 33 as unpatentable over Ken2 (Final Act. 4); 2. claims 1–4, 7, 21–24, 27–30, and 33 as unpatentable over Dieck3 (id. at 7); 3. claims 1–4, 7, 21–24, 27–30, and 33 as unpatentable over Dieck and Ken (id. at 11); 4. claims 6, 26, and 32 as unpatentable over Ken and O’Connor4 (id. at 14); and 5. claims 6, 26, and 32 as unpatentable over Dieck, Ken, and O’Connor (id. at 15). DISCUSSION Rejection 1 The Examiner rejected claims 1–4, 7, 21–24, 27–30, and 33 as unpatentable over Ken. Final Act. 4. Appellant argues against the rejection of these claims together. Appeal Br. 8–11. We select claim 1 as representative. See 37 C.F.R. § 41.37(c)(1)(iv) (“When multiple claims subject to the same ground of rejection are argued as a group or subgroup by appellant, the Board may select a single claim from the group or subgroup and may decide the appeal as to the ground of rejection with respect to the group or subgroup on the basis of the selected claim alone.”). 2 US 5,749,891, issued May 12, 1998 (“Ken”). 3 US 2008/0221600 A1, published Sept. 11, 2008 (“Dieck”). 4 US 2008/0221554 A1, published Sept. 11, 2008 (“O’Connor”). Appeal 2021-002357 Application 15/003,308 4 Ken discloses “a vaso-occlusive device comprising one or more vaso- occlusive helical coils which are formed by first winding a wire into a first helix; the first helix is then wound into a secondary form which is wound back onto itself to form two or more layers of the primary coil.” Ken 2:42– 45. The Examiner found that Ken expressly teaches or suggests all of the subject matter of claim 1. Final Act. 4–5, 7 (citing Ken 2:48–50, 3:6–12, 6:23–33, Figs. 2A–2C); see also Ken Fig. 3 (discussed by Ken at 6:23–33). Appellant argues that “the outer layer 138 and inner layers 132, 134 of the linear coil of FIG. 2C of Ken are formed with the linear mandrels” and, thus, “could not form perpendicular ‘spherical’ or ‘variable diameter’ constructions of the inner and outer wire layers as recited in the independent claims.” Appeal Br. 9 (citing Ken 5:65–6:7, 7:20–35). But Ken is not limited to linear coils. In that regard, and as the Examiner points out in the Final Action, “Ken teaches that[,] in addition to the memorized tubular shape illustrated, the occlusion device may also have an overall memorized spherical shape and suggests the inner layer may also have a spherical shape corresponding to the spherical shape of the outer layer.” Final Act. 7 (citing Ken, Abstract, 2:48–50, 6:23–30). Appellant further argues that Ken’s disclosure of a spherical shape is limited to “the overall form of the coil and [is] not a description of ‘a spherical inner wire layer,’” as recited in claim 1. Appeal Br. 11. However, as the Examiner points out, the rejection relies on Ken’s disclosure “that ‘The inner layers (not shown in Figure 3) may either correspond in shape to the outer layer (142) or may be columnar or tubular as shown in earlier Figures.’” Ans. 14 (citing Ken 6:29–33). In other words, the inner coil layers of Ken are not necessarily columnar or tubular shaped, as Appellant Appeal 2021-002357 Application 15/003,308 5 argues, but instead “may . . . correspond in shape to the outer layer,” (Ken 6:29–30), which itself may be “ovoid” (id. at 6:26) or “generally spherical or ovoid” (id. at 2:48–49). Appellant additionally argues that “constructi[ng] such an orthogonally layered occlusive device as purported in the Advisory Action using the disclosed methods of FIGS. 6A through 6E appears unlikely, if not impossible, and certainly a suggestion that would not be obvious to one of skill in the art.” Appeal Br. 10 (emphasis added); see also id. at 17 (claim 1 reciting that “the first axis and the second axis are substantially perpendicular to each other”). This argument is not persuasive, as neither the Final Action nor the Advisory Action relies on the method(s) disclosed in Ken Figures 6A–6E for the rejection. Figures 6A–6E illustrate a step-by-step “procedure for winding a coil such as shown in FIGS. 2A to 2C according to the invention.” Ken 3:40–41; see also id. at 7:20–35 (describing the procedure). The Examiner does cite Figures 2A–2C for teaching many of the features of claim 1, including an occlusion device having a memorized shape formed of a single wire in which an outer and inner layers have axes perpendicular or orthogonal to each other. Final Act. 4–5. However, the Examiner additionally relies on Figure 3 and on Ken’s explicit disclosure that, instead of the columnar shapes of the layers of Figures 2A–2C, Ken’s vaso-occlusive device may have an outer layer that is “general spherical or ovoid shape” and inner layers that “may correspond” thereto. Ken 2:48–50, 6:23–33. We have considered Appellant’s arguments, but they do not apprise us of error in the Examiner’s rejection of claim 1 as unpatentable over Ken. Accordingly, we affirm this rejection of claim 1 as well as that of claims 2– Appeal 2021-002357 Application 15/003,308 6 4, 7, 21–24, 27–30, and 33, which fall therewith. 37 C.F.R. § 41.37(c)(1)(iv). Rejection 2 The Examiner also rejected claims 1–4, 7, 21–24, 27–30, and 33 as unpatentable over Dieck. Final Act. 7. Appellant argues against the rejection of these claims together. Appeal Br. 11–13. We select claim 1 as representative. See 37 C.F.R. § 41.37(c)(1)(iv). Dieck discloses “devices . . . to occlude blood vessels, such as endoleaks, to improve the isolation of aneurysms.” Dieck, Abstract. The Examiner found that Dieck discloses all of the subject matter of claim 1 except for the occlusion device “comprising a single wire,” as recited in claim 1. Final Act. 7–8, 10 (citing Dieck ¶64, Figs. 18A–18C). The Examiner determined: It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form Dike’s [sic, Dieck’s] inner and outer wire layers from a single wire since it has been held that the use of a one piece of construction instead of the structure disclosed in the prior art would be merely a matter of obvious engineering choice. Final Act. 10 (citing In re Larson, 340 F.2d 965, 968 (CCPA 1965)). Appellant argues that “the coil formation methods of Dieck are unable to produce the single wire comprising inner and outer wire layers as recited.” Appeal Br. 12. Appellant neither supports this argument with factual evidence or technical reasoning, nor explains why, if accurate, it would support non-obviousness. The Examiner’s rejection is based on a modification to Dieck. Appellant also argues that the Examiner’s proposed modification of Dieck’s Figure 18 embodiment is incompatible with the teachings of Dieck Appeal 2021-002357 Application 15/003,308 7 and, thus, the modification “requires impermissible hindsight bias.” Appeal Br. 13. In that regard, Appellant points out that in the two-wire (or two-coil) embodiment of Figure 18, “the first coil 60 engages the smaller ends of the second coil 62 and vice versa.” Id. (quoting Dieck ¶64). Based on this disclosure, Appellant asserts that this engagement of Dieck’s inner and outer coils thus “necessitates four ends of wires” (or coils), whereas in the proposed modification would be only two ends. Id. We are not persuaded by this argument. Dieck does not describe the engagement of the two ends of one coil engaging the other coil and vice versa as being necessary. Moreover, if there were only one coil as per the Examiner’s modification, all portions of such coil would be integral and thus not disengaged. Appellant’s assertion of “impermissible hindsight bias” is also not persuasive. Appeal Br. 13. The Examiner articulated an adequate reason why a person of ordinary skill in the art would have made the proposed modification, namely because “use of a one piece of construction instead of the [two piece] structure disclosed in the prior art would be merely a matter of obvious engineering choice.” Final Act. 10 (citing In re Larson, 340 F.2d 965 (CCPA 1965)). Larsen indeed supports this proposition. 340 F2d. at 967–968 (finding that “the brake disc and clamp of Tuttle et al. comprise several parts” and holding “the use of a one piece construction instead of the structure disclosed in Tuttle et al. would be merely a matter of obvious engineering choice”). Appellant has not distinguished Larsen or otherwise rebutted the Examiner’s reason for the proposed modification. As such, the assertion of impermissible hindsight bias is unpersuasive. See In re Cree, Inc., 818 F.3d 694, 702 n.3 (Fed. Cir. 2016) (explaining that a hindsight Appeal 2021-002357 Application 15/003,308 8 argument is of no moment where an examiner provides a sufficient, non- hindsight reason to modify/combine prior art). We have considered Appellant’s arguments, but they do not apprise us of error in the Examiner’s rejection of claim 1 as unpatentable over Dieck. Accordingly, we affirm this rejection of claim 1 as well as that of claims 2– 4, 7, 21–24, 27–30, and 33, which fall therewith. 37 C.F.R. § 41.37(c)(1)(iv). Rejection 3 The Examiner also rejected claims 1–4, 7, 21–24, 27–30, and 33 as unpatentable over Dieck and Ken. Final Act. 11. Appellant argues against the rejection of these claims together. Appeal Br. 13–14. We select claim 1 as representative. See 37 C.F.R. § 41.37(c)(1)(iv). The instant rejection of claim 1 relies on Dieck in the same manner as in Rejection 2. Final Act. 11–12. However, instead of relying on design choice for using a single wire instead of Dieck’s two wires, the instant rejection relies on Ken’s express teaching of a single wire vaso-occlusion device and the predictable result of incorporating such a feature into Dieck. Id. at 14 (citing Ken 2:42–3:12, 3:52–67). Appellant’s arguments against this rejection are limited to those already considered above. Appeal Br. 14. Those arguments likewise are unpersuasive here. Accordingly, we affirm this rejection of claim 1 as well as that of claims 2–4, 7, 21–24, 27–30, and 33, which fall therewith. 37 C.F.R. § 41.37(c)(1)(iv). Appeal 2021-002357 Application 15/003,308 9 Rejections 4 and 5 The Examiner rejected claims 6, 26, and 32 as unpatentable over Ken and O’Connor and also over Ken, Dieck, and O’Connor. Final Act. 14–15. Claims 6, 26, 32 recite “an atraumatic distal coil tip.” Appeal Br. 17, 19, 20. In these rejections, the Examiner relies on O’Connor for teaching this feature. Final Act. 14 (citing O’Connor ¶¶66, 70), 15 (same). Appellant does not present any additional arguments separate from those discussed above with respect to Rejections 1 and 3, asserting only that O’Connor does not remedy the asserted deficiencies. Appeal Br. 14. Those arguments likewise are unpersuasive here, and we thus affirm these rejections. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–4, 7, 21–24, 27–30, 33 103 Ken 1–4, 7, 21– 24, 27–30, 33 1–4, 7, 21–24, 27–30, 33 103 Dieck 1–4, 7, 21– 24, 27–30, 33 1–4, 7, 21–24, 27–30, 33 103 Dieck, Ken 1–4, 7, 21– 24, 27–30, 33 6, 26, 32 103 Ken, O’Connor 6, 26, 32 6, 26, 32 103 Dieck, Ken, O’Connor 6, 26, 32 Overall outcome 1–4, 6, 7, 21–24, 26– 30, 32, 33 Appeal 2021-002357 Application 15/003,308 10 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