W. L. Gore & Associates, Inc.

Patent Trials and Appeals Board

Mar 2, 2022

2021002133 (P.T.A.B. Mar. 2, 2022)

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. 15/459,591 03/15/2017 Coby C. Larsen 450385.001448 MP/385AUS02 1073 133414 7590 03/02/2022 Faegre Drinker Biddle & Reath LLP - W.L. Gore 2200 Wells Fargo Center 90 South Seventh Street Minneapolis, MN 55402-3901 EXAMINER LYNCH, ROBERT A ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 03/02/2022 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): patentdocketing@faegredrinker.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte COBY C. LARSEN, STEVEN J. MASTERS, and EDWARD E. SHAW Appeal 2021-002133 Application 15/459,591 Technology Center 3700 Before JILL D. HILL, CARL M. DEFRANCO, and LEE L. STEPINA, Administrative Patent Judges. DEFRANCO, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1-20. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as W. L. Gore & Associates, Inc. Appeal Br. 2. Appeal 2021-002133 Application 15/459,591 2 CLAIMED SUBJECT MATTER The claims are directed to occlusive devices. Spec. ¶ 2. Claims 1, 9, and 18 are independent. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. An occlusive device comprising: an engagement feature; a plurality of elongate members extending from different locations about a perimeter of the engagement feature; and a membrane arranged on the plurality of elongate members, the membrane and the plurality of elongate members forming: an occlusive face having an outer perimeter, the occlusive face including first portions of the plurality of elongate members that each include a common radial curved pattern relative to the outer perimeter of the occlusive face with at least one point of inflection altering curvature from one of a clockwise direction or a counterclockwise direction, and a body portion extending distally relative to the occlusive face to a distal end, the body portion defining a taper toward the distal end and including second portions of the plurality of elongate members converging toward one another to define the taper. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Larsen ’806 US 9,554,806 B2 Jan. 31, 2017 Larsen ’086 US 9,597,086 B2 Mar. 21, 2017 McGuckin US 2007/0270891 A1 Nov. 22, 2007 Brumleve US 2009/0062838 A1 Mar. 5, 2009 Appeal 2021-002133 Application 15/459,591 3 REJECTIONS 1. Claims 1-20 stand rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. 2. Claims 1-18 and 20 are rejected under 35 U.S.C. § 102(b) as being anticipated by Brumleve. 3. Claim 19 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Brumleve and McGuckin. 4. Claims 1-7, 9-13, and 15-17 are rejected on the ground of nonstatutory double patenting as unpatentable over claims 1, 2, 6, 7, and 9 of Larsen ’806. 5. Claims 1-13 and 15-20 are rejected on the ground of nonstatutory double patenting as unpatentable over claims 1-3, 7, 9, 11, 15- 17, 22, and 23 of Larsen ’086. The Examiner additionally objects to the drawings under 37 C.F.R. § 1.83(a) as failing to show every feature specified in the claims. The drawing objection appears to be coextensive with the reasons presented in the rejection of the claims under 35 U.S.C. § 112, first paragraph, as failing to meet the written description requirement. ANALYSIS A. Written Description Appellant argues claims 1-20 as a group. See Appeal Br. 4-5. We select independent claim 1 as representative. See 37 C.F.R. § 41.37(c)(1)(iv) (2019) (permitting the Board to select a single claim to decide the appeal as to a single ground of rejection of a group of claims argued together). Claims 2-20 stand or fall with claim 1. Appeal 2021-002133 Application 15/459,591 4 The Examiner finds that the claim 1 limitation “first portions of the plurality of elongate members that each include a common radial curved pattern relative to the outer perimeter of the occlusive face with at least one point of inflection altering curvature from one of a clockwise direction or a counterclockwise direction,” is not supported by the Specification as filed. Final Act. 5-6. In particular, the Examiner asserts that Appellant’s drawings fail to depict an elongate member “hav[ing] two opposite curvatures.”2 Id. at 6 (annotating Appellant’s Figures 1-3). Because both the Examiner and Appellant rely on the Examiner’s annotated figures, we reproduce below Figures 1, 2, and 3 as annotated by the Examiner. Annotated Figure 1 depicts a side view of occlusive device 100 with a solid line added by the Examiner and labeled, “first portion,” and a dashed line added by the Examiner that curves downwardly from the solid line and is labeled, “body portion.” Spec. ¶ 13; Final Act. 6. Annotated Figure 2 depicts a front view of occlusive device 100 with a substantially C-shaped 2 Although the Examiner cites to Merriam-Webster, our review of this citation reveals multiple definitions, and the Examiner does not state which definition of “point of inflection” is being relied upon. See Final Act. 3. Appeal 2021-002133 Application 15/459,591 5 solid line added by the Examiner and labeled, “first portion.” Spec. ¶ 14; Final Act. 6. Though unidentified here, the third annotated figure corresponds to Appellant’s Figure 3. Annotated Figure 3 depicts a perspective view of frame 102 of occlusive device 100 with an inverted U- shaped solid line added by the Examiner and labeled, “first portion,” and a U-shaped dashed line added by the Examiner and labeled “body portion.” Spec. ¶ 15; Final Act. 6. Referencing annotated Figures 1-3 (as depicted above), Appellant responds that “the first portion shows a curvature and the curvature changes the direction of the first portion from traveling or pointing in one direction to another direction. The change in direction occurs due to the at least one point of inflection.” Appeal Br. 4. The Examiner has the better position. We note that claim 1 requires “at least one point of inflection.” The term “inflection” includes a mathematical definition, which the Examiner appears to rely on and which requires a “change in curvature of an arc or curve from concave to convex or conversely,” and also includes a broader definition, “the act or result of curving or bending.” See Merriam- Webster.com/Dictionary/inflection, definitions 3 and 4 (accessed February 16, 2022). We understand Appellant’s argument that the curvature changes the direction of the first portion to be consistent with the second, broader definition. The claims, however, require more than just a change in direction. In particular claim 1 recites, in part, “at least one point of inflection altering curvature from one of a clockwise direction or a counterclockwise direction.” Appeal Br. 8 (Claims App.). Thus, consistent with Appellant’s broader definition, the point of inflection must alter the curve or bend from, for example, a clockwise direction. Annotated Figure 2, Appeal 2021-002133 Application 15/459,591 6 upon which Appellant relies, depicts elongate member 101 curving in the clockwise direction, i.e., the direction denoted by arrow 51. See Spec. ¶ 44. Although there is a change in direction with elongate member 101 initially pointing to the left from proximal end 110 and then changing direction to point to the right, i.e., at the point that Appellant considers the at least one point of inflection, this change in direction does not alter the curvature from a clockwise direction. Rather, the curvature of the first portion of the elongate member extends in the clockwise direction for its entire length. As depicted in annotated Figure 3 above, the only change in the curvature occurs in the body portion, not in the first portion of the occlusive face, as required by the claims. See Final Act. 6 For these reasons, we sustain the Examiner’s written description rejection of claim 1. Claims 2-20 fall with claim 1. B. Anticipation (Claims 1-18 and 20) In determining that the claims are anticipated by Brumleve, the Examiner finds, inter alia, that Brumleve’s elongate members 24 each include a common radial curved pattern relative to the outer perimeter of the occlusive face, because “each leg 24 [is] expressly shown to have the same/common bend or curve at the distal end of the first portion adjacent reference numeral 26 disposed along/relative to the outer perimeter of the occlusive face.” Final Act. 8 (citing Brumleve, Fig. 1B.). Appellant argues that Brumleve’s elongate members do not meet the claims, because they “curve downwardly relative to a longitudinal axis.” Appeal Br. 6. We agree with Appellant. Although we appreciate the Examiner’s position that the claims do not explicitly require that the elongate members are curved clockwise or Appeal 2021-002133 Application 15/459,591 7 counterclockwise relative to the longitudinal axis (see Ans. 7), that is how one of ordinary skill in the art would understand this limitation under a broadest reasonable interpretation consistent with the Specification. For edification, we reproduce below Appellant’s Figure 2 and Brumleve’s Figure 1B. Appellant’s Figure 2 is a front view of an occlusion device and Brumleve’s Figure 1B is a partial section of an occlusion device. Spec. ¶ 14; Brumleve ¶ 19. The only portion of Appellant’s Specification that describes the “clockwise” and “counterclockwise” directions of Figure 2 is paragraph 44. There, the Specification discloses that “one or more, or all, of the anchors 50 may extend from the frame 102 in a generally clockwise direction, as indicated by the arrow 51 in Figure 2.” Spec. ¶ 44. In other embodiments, “one or more, or all, of the anchors 50 may extend from the frame 102 in a generally counterclockwise direction, as indicated by the arrow 53 in Figure 2.” Id. Given that this is the only disclosure of the orientation of the anchors, one of ordinary skill would understand that “clockwise” or “counterclockwise” are used in their ordinary way to mean with respect to a front view, which is relative to the longitudinal axis. Appeal 2021-002133 Application 15/459,591 8 This interpretation is also consistent with Brumleve, which discloses that legs 24 extend radially away from central axis 22 when device 10 is in an open, deployed configuration. Brumleve ¶ 34; Fig. 1B. Thus, one of ordinary skill in the art would understand that “radial” or “radially” extend away from the central or longitudinal axis. Bearing this in mind, we now turn to the distal portion 26 of Brumleve’s legs, upon which the Examiner relies. Brumleve describes this portion as having “an angled distal end segment 27 for anchoring the device 10 to the body vessel 32. The distal end segment 27 may, for example, be angled back toward the central axis 22 to facilitate later removal of the device 10.” Id.; see also Fig. 1B. Thus, as Appellant notes, the first portion of the elongate members of Brumleve curves toward or along the longitudinal or central axis direction. In view of this, the Examiner’s rejection relies on an unreasonably broad interpretation of a radial curved pattern. Accordingly, the Examiner has not established adequately that the first portions of Brumleve’s elongate members “each include a common radial curved pattern relative to the outer perimeter of the occlusive face,” as one of ordinary skill in the art would interpret this term consistent with the Specification. For these reasons, we do not sustain the Examiner’s anticipation rejection of independent claims 1, 9, and 18, and their respective dependent claims. C. Obviousness (Claim 19) Claim 19 depends from independent claim 18 and further defines the invention. The Examiner does not rely on the disclosure of McGuckin in any manner to remedy the deficiency of Brumleve with respect to claim 18 as discussed in Rejection B. For the same reasons, as discussed above, we do not sustain the Examiner’s obviousness rejection of claim 19. Appeal 2021-002133 Application 15/459,591 9 D. Nonstatutory Double Patenting As part of a response filed after the Final Action, Appellant asserts that “a terminal disclaimer over U.S. 9,554,806 and U.S. 9,597,086 is submitted herewith.” See Response to Office Action, 8-9, filed June 22, 2020. However, there is no terminal disclaimer of record in the image file wrapper of the present application. Nor is there any indication in the Advisory Action mailed July 2, 2020 (“Advisory Action”), which acknowledges receipt of the June 6, 2020 Response that a terminal disclaimer was submitted and approved. See Advisory Action 1-2. Because there is no record that a terminal disclaimer was filed and entered, we sustain the Examiner’s double patenting rejections. E. Objection under 37 C.F.R. § 1.83(a) Because the drawing objection correlates to the written description rejection, which we have sustained, the drawing objection is also sustained. CONCLUSION The Examiner’s written description and double patenting rejections, as well as the drawing objection are affirmed, and the Examiner’s anticipation and obviousness rejections are reversed. DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1-20 112(a) Written Description 1-20 1-18, 20 102(b) Brumleve 1-18, 20 19 103(a) Brumleve, McGuckin 19 1-7, 9-13, 15-17 Nonstatutory Double Patenting U.S. 9,554,806 1-7, 9-13, 15-17 Appeal 2021-002133 Application 15/459,591 10 1-13, 15-20 Nonstatutory Double Patenting U.S. 9,597,086 1-13, 15-20 Overall Outcome3 1-20 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)(1)(iv). AFFIRMED 3 37 C.F.R. § 41.50(a)(1) states: “The affirmance of the rejection of a claim on any of the grounds specified constitutes a general affirmance of the decision of the examiner on that claim.”