Jacob A. Goble et al.Download PDFPatent Trials and Appeals BoardJul 31, 201913838166 - (D) (P.T.A.B. Jul. 31, 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. 13/838,166 03/15/2013 Jacob A. Goble 25931-0059001 / MP/456 7729 133414 7590 07/31/2019 Faegre Baker Daniels - W.L. Gore 2200 Wells Fargo Center 90 South Seventh Street Minneapolis, MN 55402-3901 EXAMINER WEISBERG, AMY REGINA ART UNIT PAPER NUMBER 3649 NOTIFICATION DATE DELIVERY MODE 07/31/2019 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): patentdocketing@faegrebd.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte JACOB A. GOBLE, BRANDON A. LURIE, STEVEN J. MASTERS, SCOT K. MATHENA, and RICHARD L. McCLURE1 ____________________ Appeal 2018-008065 Application 13/838,166 Technology Center 3600 ____________________ Before JENNIFER D. BAHR, FREDERICK C. LANEY, and BRENT M. DOUGAL, Administrative Patent Judges. BAHR, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant appeals under 35 U.S.C. § 134(a) from the Examiner’s decision rejecting claims 122, 124, 127–129, 131, 134–136, 138, 140–144, 148–178, 180, and 183–185.2 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 W.L. GORE & ASSOCIATES, INC. (Appellant) is the applicant as provided in 37 C.F.R. § 1.46 and is identified as the real party in interest. Appeal Br. 2. 2 The Examiner withdrew the rejection of claims 123, 125, 130, 132, 137, 145–147, 179, and 181. Ans. 2. Appeal 2018-008065 Application 13/838,166 2 THE CLAIMED SUBJECT MATTER Claims 122 and 129, reproduced below, are illustrative of the claimed subject matter. 122. A medical device for sealing a defect or structure in tissue, the medical device comprising: a wire frame that includes a plurality of wound wires that each extend from a proximal end of the wire frame to a distal end of the wire frame, the plurality of wound wires being configured to move substantially independently of adjacent wires to adapt to a shape of a defect, the plurality of wound wires forming: a first eyelet arranged near the proximal end of the wire frame; a second eyelet arranged near the distal end of the wire frame; a first occluding member having a nominal diameter from 27 mm to 48 mm; a second occluding member having a nominal diameter from 27 mm to 48 mm; a defect-occupying portion disposed between the first occluding member and the second occluding member, wherein the defect-occupying portion comprises a nominal diameter from 17 mm to 36 mm, and each of the plurality of wound wires includes a first generally linear segment and a first generally curved segment that define a petal of the first occluding member, a second generally linear segment and a second generally curved segment that define a petal of the second occluding member, a third generally linear segment, a fourth generally linear segment, a third generally curved segment disposed between the third generally linear segment and the fourth generally linear segment that define the defect-occupying portion; a sealing member in contact with the frame; and a non-metal attachment member arranged through one of the first eyelet and the second eyelet and configured to interface with a delivery apparatus. Appeal 2018-008065 Application 13/838,166 3 129. A medical device for sealing a defect or structure in a heart, the medical device comprising: a wire frame that includes a plurality of wound wires that each extend from a proximal end of the wire frame to a distal end of the wire frame, the plurality of wound wires being configured to move substantially independently of adjacent wires to adapt to a shape of a defect, the plurality of wound wires forming: a first eyelet arranged near the proximal end of the wire frame; a second eyelet arranged near the distal end of the wire frame; a first occluding member having a nominal diameter from 27 mm to 48 mm; a second occluding member having a nominal diameter from 27 mm to 48 mm; a defect-occupying portion disposed between the first occluding member and the second occluding member, wherein the defect-occupying portion comprises a nominal diameter from 17 mm to 36 mm, and each of the plurality of wound wires includes a first generally linear segment and a first generally curved segment that define a petal of the first occluding member, a second generally linear segment and a second generally curved segment that define a petal of the second occluding member, a third generally linear segment, a fourth generally linear segment, a third generally curved segment disposed between the third generally linear segment and the fourth generally linear segment that define the defect-occupying portion, and a first outer peripheral edge section extending between the first generally curved segment and the third generally linear segment and a second outer peripheral edge section extending between the second generally curved segment and the fourth generally linear segment; a sealing member in contact with the frame; and a non-metal attachment member arranged through one of the first eyelet and the second eyelet and configured to interface with a delivery apparatus. Appeal 2018-008065 Application 13/838,166 4 THE REJECTION Claims 122, 124, 127–129, 131, 134–136, 138, 140–144, 148–178, 180, and 183–185 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Aurilia (US 2010/0324652 A1, published Dec. 23, 2010) and Van Orden (US 2010/0324538 A1, published Dec. 23, 2010). See Non-Final Act. 2–53; Ans. 2.3 DISCUSSION Appellant argues the patentability of the claims involved in this appeal without regard to any particular claim. Appeal Br. 16–22. All but one of the arguments presented by Appellant are pertinent to all of the claims involved in this appeal. See id. Appellant’s argument on page 21 of the Appeal Brief regarding peripheral edge sections is pertinent only to independent claims 129, 169, 172, and 175, as well as their dependent claims, because only these claims contain limitations directed to peripheral edge sections. See Appeal Br. 25–45 (Claims App.). We select claim 122 as representative of the group of claims that do not recite peripheral edge sections and claim 129 as representative of the group of claims that do recite peripheral edge sections; claims 124, 127, 128, 136, 138, 140–144, 148–168, 178, 180, and 183–185 stand or fall with claim 122; and claims 131, 134, 135, and 169–177 stand or fall with claim 129. See 37 C.F.R. § 41.37(c)(1)(iv) (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). 3 We refer herein to the Non-Final Action (“Non-Final Act.”) dated November 24, 2017. Appeal 2018-008065 Application 13/838,166 5 Claims 122, 124, 127, 128, 136, 138, 140–144, 148–168, 178, 180, and 183–185 The Examiner’s findings explaining how the elements of claim 122 read on the structure of Aurilia are set forth on pages 2–4 of the Non-Final Action. The Examiner initially found that “Aurilia fails to teach a non-metal attachment member arranged through one of the first eyelet and the second eyelet and configured to interface with a delivery apparatus” and relied on Van Orden for this feature. Non-Final Act. 3 (citing Van Orden ¶¶ 47–50). Appellant, correctly, pointed out that paragraphs 47–50 of Van Orden, on which the Examiner relies for the non-metal attachment member, are identical to paragraphs 47–50 of Aurilia. Appeal Br. 17. Moreover, Figure 1 of Van Orden and Figure 1 of Aurilia, which paragraphs 47–50 of each of the references describe, are at least substantially, if not wholly, identical. In other words, Aurilia contains the very disclosure for which the Examiner relies on Van Orden in the rejection.4 The Examiner, agreeing with Appellant that the disclosure of paragraphs 47–50 of Van Orden are identical to paragraphs 47–50 of Aurilia, finds that “Aurilia does in fact teach a non-metal attachment mechanism.” Ans. 4. Thus, the Examiner finds that Aurilia in fact anticipates the subject matter of claim 122 and states that, although an obviousness rejection under 35 U.S.C. § 103(a) is “still proper,” a rejection under 35 U.S.C. § 102 “would also have been proper.” Id. The Examiner points out that the fact that Aurilia anticipates the subject matter of claim 122 does not change the basic thrust of the rejection and that Appellant has 4 Notably, paragraphs 86–89 of Appellant’s Specification, which describe an embodiment of the present invention, contain the same disclosure set forth in paragraphs 47–50 of Aurilia and Van Orden. Appeal 2018-008065 Application 13/838,166 6 had an opportunity to react to this rejection. Id. The Examiner is correct in this regard. It is well settled that “anticipation is the epitome of obviousness.” In re McDaniel, 293 F3d. 1379, 1385 (Fed. Cir. 2002) (quoting Connell v. Sears Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)); In re Fracalossi, 681 F.2d 792, 794 (CCPA 1982). In affirming a multiple reference rejection under 35 U.S.C. § 103, the Board may rely on fewer than all of the references relied on by the Examiner in an obviousness rationale without designating it as a new ground of rejection. In re Bush, 296 F.2d 491, 496 (CCPA 1966). Appellant also argues that the Examiner has not presented “a valid rationale” for combining Aurilia and Van Orden because the “proposed combination would attempt to fix a problem that is not an issue in [Aurilia] as [Aurilia] already teaches an attachment mechanism to a delivery system.” Appeal Br. 21–22. This argument is unavailing because, as discussed above, Aurilia discloses the features for which the Examiner relies on Van Orden, and, thus, no combination is required. Appellant argues that the structure described in paragraphs 47–50 of Aurilia or Van Orden cited by the Examiner does not include a non-metal attachment member as claimed. Appeal Br. 17–18. Appellant states that the claims require that the “non-metal attachment member is arranged through one of the first eyelet and the second eyelet and configured to interface with a delivery apparatus.” Id. at 17. Appellant argues that locking loop 111, which provides attachment to the delivery system, is a portion of the metal wires of the frame, and, thus, is not a non-metal attachment member. Id. Appellant contends that the Examiner does not identify retrieval cord 110, described in paragraph 50 of Aurilia and Van Orden, as the non-metal Appeal 2018-008065 Application 13/838,166 7 attachment member, but, according to Appellant, even if the Examiner had identified retrieval cord 110, it “is a part of the delivery system and not part of the device as is described in the claims.” Id. at 17–18. Appellant’s arguments regarding locking loop 111and retrieval cord 110 are unavailing because the Examiner relies on second tube 108 as the non-metal attachment member. See Ans. 4–5. The Examiner finds that second tube 108 may be fabricated from a biocompatible material including a polymer, such as “PEEK (polyetheretherketone)” and “is threaded through the eyelets of sealing device 100 to hold sealing device 100 on the delivery system and to provide stability while deploying the sealing device 100.” Id. at 5 (citing Aurilia ¶ 49). Thus, Aurilia’s second tube 108 satisfies the limitations set forth in claim 122, namely, being “arranged through one of the first eyelet and the second eyelet and configured to interface with a delivery apparatus” (i.e., configured to interface with a delivery system to hold sealing device 100 on the delivery system). Appellant contends that “[t]he Examiner’s new explanation regarding [Aurilia or Van Orden on pages 4–5 of the Answer] ignores the claim limitations” and maintains that “[t]he cited portions of [Van Orden] refer to a portion of a delivery system and not a portion of a device as is described in the claims” or “a portion of a sealing device that interfaces with a delivery apparatus as recited in the claims.” Reply Br. 1–2. However, Appellant does not elaborate on why Aurilia’s (or Van Orden’s) second tube 108 cannot reasonably be considered part of the “medical device for sealing” and “configured to interface with a delivery apparatus” as claimed. Claim 122 is directed broadly to “[a] medical device for sealing a defect or structure in tissue” and refers to “a delivery apparatus” only Appeal 2018-008065 Application 13/838,166 8 nominally, without specifying any structure of the “delivery apparatus.” Further, Appellant does not identify, nor do we find, any particular definition of “delivery apparatus” in Appellant’s Specification that would suggest that second tube 108 is part of “a delivery apparatus,” and not “a non-metal attachment member” that is “configured to interface with a delivery apparatus.” See Appeal Br. passim; Reply Br. passim. Appellant’s Specification refers to a “super elastic wire” device inserted into a “delivery sheath.” Spec. ¶ 4. Appellant’s Specification also refers to “trans-catheter delivery devices” using a handle and a flexible urging member for urging the sealing device through a catheter. Id. ¶ 6. The Specification also describes “a non-metal attachment member adapted to couple with one or more components of a delivery system.” Id. ¶¶ 8, 10, 15, 16, 17. The Specification discloses “advancing a delivery apparatus, to which the medical device is attached.” Id. ¶¶ 25, 26, 27. Further, Appellant’s Specification describes “[s]econd tube 108 . . . threaded through the eyelets of sealing device 100 to hold sealing device 100 on the delivery system and to provide stability while deploying the sealing device 100.” Id. ¶ 88. The Specification also discloses device 1702 delivered or deployed “using the delivery apparatuses or systems described herein,” but does not specify what structures are part of a delivery apparatus or system and what structures are not part of the delivery apparatus or system but are used with the delivery apparatus or system. Id. ¶ 111. The Specification discloses that frame 1700 of device 1702 “may be elongated, extended, or collapsed for passage through a delivery apparatus in the delivery configuration.” Id. ¶ 112 (emphasis added). Thus, to the extent that the “delivery apparatus” referred to in claim 122 is construed, in accordance with this description in Appeal 2018-008065 Application 13/838,166 9 the Specification, as a structure through which the claimed medical device for sealing passes, second tube 108 is not part of the “delivery apparatus” of Aurilia or Van Orden. Rather, the “delivery apparatus” of Aurilia or Van Orden would seemingly include first tube 102 and third tube 104, through which sealing device 100 and second tube 108 pass. See Aurilia ¶¶ 48–50; Van Orden ¶¶ 48–50. In short, Appellant does not point to evidence in the record before us defining or describing a “delivery apparatus” in such a way as to necessarily include second tube 108. Thus, Appellant does not apprise us of error in the Examiner’s interpretation of Aurilia’s or Van Orden’s second tube 108 as the “non-metal attachment member” recited in claim 122. Appellant, referring to the Examiner’s annotated reproduction of Figure 5B of Aurilia on page 4 of the Non-Final Action, also argues that “the alleged third linear segment, third curved segment and fourth linear segment identified by the Examiner appear to fall within a center eyelet of the device shown.” Appeal Br. 20. More specifically, Appellant contends that the Examiner draws the area identified as the third curved segment as being curved, but Aurilia “teaches that this portion of the device shown in FIG. 5B is a center eyelet 203 formed by wires ‘wound around keyed center pin 300.’” Id. According to Appellant, these wires “would not allow for a curvature as drawn by the Examiner.” Id. Appellant also objects that the Examiner identifies features on different wires, rather than identifying all of the claimed segments on any one of the wires.5 Id. at 21. 5 This criticism seems a bit incongruous, given that Appellant’s Figure 34 identifies first linear segment 1716 and first curved segment 1718 on a first wire; second linear segment 1720 and second curved segment 1722 on a Appeal 2018-008065 Application 13/838,166 10 In response to Appellant’s criticism that the Examiner did not identify all features of the wires on a single wire, the Examiner provides an annotated version of Figure 5B of Aurilia with the other wires having “been erased to show the segments more clearly” on one wire of the device, by way of example. Ans. 8. The Examiner states that “[t]his example should be extrapolated for the remaining wires to meet the claim limitation.” Id. The Examiner’s annotated version of Aurilia’s Figure 5B identifying all of the linear and curved segments on a single wire is reproduced below from page 8 of the Answer. The annotated version of Aurilia’s Figure 5B reproduced above identifies a “[t]hird linear” segment and a “third curved” segment just to the left of the center eyelet and a “[f]ourth linear” segment to the right of the center eyelet. Id. Appellant does not allege any deficiency in the Examiner’s identification of each of the recited segments of a wire on the example wire shown in the annotated version of Aurilia’s Figure 5B on page 8 of the Answer. See Reply Br. 3. Rather, Appellant takes issue with the second wire; and third linear segment 1726, third curved segment 1730, and fourth linear segment 1728 on a third wire. Appeal 2018-008065 Application 13/838,166 11 Examiner’s statement that the particular wire example shown should be extrapolated for all of the other wires. Id. Once again, Appellant’s criticism seems unwarranted. The Examiner focuses on a single wire in response to Appellant’s argument, discussed above, that the Examiner failed to identify all of the claimed wire segments on any one wire. It strikes us as no more unreasonable for one to extrapolate the identified segments of the one example wire shown in the Examiner’s annotated version of Figure 5B of Aurilia to the remaining wires than for one to extrapolate the linear and curved segments identified in Appellant’s Figure 34 to the remaining wires in Appellant’s device. One of ordinary skill in the art would have gleaned from Figures 5A and 5B, and the corresponding disclosure, in Aurilia that the plurality of wires of Aurilia’s wire frame are similarly shaped. For the above reasons, Appellant does not apprise us of error in the rejection of claim 122. Accordingly, we sustain the rejection of claim 122, as well as claims 124, 127, 128, 136, 138, 140–144, 148–168, 178, 180, and 183–185, which fall with claim 122, as unpatentable over Aurilia and Van Orden. Claims 129, 131, 134, 135, and 169–177 Independent claim 129 contains limitations substantially similar to independent claim 122, but claim 129 additionally recites “a first outer peripheral edge section extending between the first generally curved segment and the third generally linear segment and a second outer peripheral edge section extending between the second generally curved segment and the fourth generally linear segment.” Appeal Br. 26–27 (Claims App.). The analysis set forth above applies equally to claim 129, and we incorporate it herein. For the reasons set forth above, the aforementioned Appeal 2018-008065 Application 13/838,166 12 arguments of Appellant fail to apprise us of error in the rejection of claim 129. Appellant also takes issue with the manner in which the Examiner attempted to show the first and second outer peripheral edges in the annotated version of Aurilia’s Figure 5B on page 4 of the Non-Final Action because, according to Appellant, in the annotated figure, “each of the first peripheral edge section and the second peripheral edge section . . . identified by the Examiner span multiple wires and are not shown as matching with any one of the wires.” Appeal Br. 21. In response to Appellant’s argument, the Examiner explains that the wire shown in the annotated version of Aurilia’s Figure 5B presented on page 8 of the Answer (reproduced above) “clearly has a first and second [‘]peripheral edge section[,’] that is an outer boundary portion.” Ans. 8 (boldface omitted). According to the Examiner, “this corresponds to a portion near the first and second curved portion which are outer boundaries of the device (radially).” Id. (boldface omitted). The wire shown in the annotated version of Aurilia’s Figure 5B presented on page 8 of the Answer transitions from a generally linear segment on one end (labeled “first linear” in the annotated drawing) and from a generally linear segment on the other end (labeled “second linear” in the annotated drawing) to generally curved segments (labeled “first curved” and “second curved”) that extend to the radially outermost peripheral sections of the wire. The wire then runs radially inward again from the first generally curved segment to a third generally linear segment (labeled “[t]hird linear” in the annotated drawing) and from the second generally curved segment to a fourth generally linear segment (labeled “[f]ourth linear” in the annotated drawing). See Ans. 8. As such, the wire has first Appeal 2018-008065 Application 13/838,166 13 and second peripheral edge sections between the first generally curved segment and the third generally linear segment. Further, as shown in the annotated version of Figure 5B of Aurilia presented on page 4 of the Non- Final Action, the other wires of Aurilia’s device have similar peripheral edge sections. Appellant does not specifically dispute the Examiner’s explanation regarding the first and second peripheral edge sections set forth on page 8 of the Answer. For the above reasons, Appellant fails to apprise us of error in the rejection of claim 129. Accordingly, we sustain the rejection of claim 129, as well as claims 131, 134, 135, and 169–177, which fall with claim 129, as unpatentable over Aurilia and Van Orden. DECISION The Examiner’s decision rejecting claims 122, 124, 127–129, 131, 134–136, 138, 140–144, 148–178, 180, and 183–185 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