W.L. Gore & Associates, Inc.

Patent Trials and Appeals Board

Mar 11, 2022

2021004191 (P.T.A.B. Mar. 11, 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. 13/961,416 08/07/2013 Christopher S. Michalak 450385.000722 MP/419US 6701 133414 7590 03/11/2022 Faegre Drinker Biddle & Reath LLP - W.L. Gore 2200 Wells Fargo Center 90 South Seventh Street Minneapolis, MN 55402-3901 EXAMINER SCHWIKER, KATHERINE H ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 03/11/2022 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 CHRISTOPHER S. MICHALAK Appeal 2021-004191 Application 13/961,416 Technology Center 3700 ____________ Before JENNIFER D. BAHR, DANIEL S. SONG, and MICHAEL L. HOELTER, Administrative Patent Judges. HOELTER, 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, 4, 5, 7, 15, 24, 27, 28, and 30-42. See Final Act. 1 (Office Action Summary). We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE the Examiner’s rejections of these claims. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as “W. L. GORE & ASSOCIATES, INC.” Appeal Br. 2. Appeal 2021-004191 Application 13/961,416 2 CLAIMED SUBJECT MATTER The disclosed subject matter “relates to the field of medicine, and more particularly, to securing devices such as anchors and barbs for securing medical devices within an anatomy or body (e.g., a human body).” Spec. ¶ 1. Apparatus claims 1 and 15, and method claim 31, are independent. Claim 1 is illustrative of the claims on appeal and is reproduced below. 1. A medical securing device coupled to a medical device that is one of a stent or a stent-graft, the medical device having a longitudinal axis, the medical securing device comprising: a barb comprising: a pointed tip including an elongate body having a length between a first end and a pointed end, the pointed tip terminating at the pointed end, the elongate body extending between the first end and the pointed end along a middle axis that extends perpendicular to the longitudinal axis of the medical device, the pointed tip adapted to penetrate tissue; and a depth stop extending radially outward from the medical device and defining an S-shape in a radial direction relative to the longitudinal axis of the medical device, the S- shape extending along the middle axis that extends perpendicular to the longitudinal axis of the medical device, the depth stop comprising an apex portion that is laterally offset from the middle axis in a first direction and coupled to a trough portion that is laterally offset from the middle axis in a second direction, the pointed tip extending at an angle from the depth stop and parallel to the middle axis, wherein each of the apex portion and the trough portion is capable of individually limiting a depth of penetration of the medical securing device into a body lumen wall. Appeal 2021-004191 Application 13/961,416 3 EVIDENCE Name Reference Date Lefebvre US 5,108,418 Apr. 28, 1992 Dwyer et al. (“Dwyer”) US 5,843,167 Dec. 1, 1998 Shaw US 2010/0324584 A1 Dec. 23, 2010 Ryan US 2011/0319980 A1 Dec. 29, 2011 Paul, Jr. et al. (“Paul, Jr.”) US 2012/0035708 A1 Feb. 9, 2012 REJECTIONS2 Claims 1, 4, 5, 15, 24, 27, 28, 30, 40, and 41 are rejected under pre- AIA 35 U.S.C. § 103(a) as unpatentable over Shaw and Dwyer. Claim 7 is rejected under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Shaw, Dwyer, and Paul, Jr. Claims 31-38 and 42 are rejected under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Shaw, Lefebvre, and Dwyer. Claim 39 is rejected under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Shaw, Lefebvre, Dwyer, and Ryan. ANALYSIS The rejection of claims 1, 4, 5, 15, 24, 27, 28, 30, 40, and 41 as unpatentable over Shaw and Dwyer The Examiner primarily relies upon the teachings of Shaw for disclosing the various limitations of independent claims 1 and 15. See Final Act. 5-6. However, the Examiner relies upon the teachings of Dwyer for teaching the limitation of “a trough portion that is laterally offset from the 2 The rejection of claims 40-42 as failing to comply with the written description requirement has been withdrawn. See Ans. 3. Appeal 2021-004191 Application 13/961,416 4 middle axis in a second direction.”3 See Final Act. 7; Ans. 6. The Examiner thereafter provides a reason to modify Shaw to have Dwyer’s laterally offset trough portion, such reason being “for the purpose of being able to have a lower profile radially inward delivery configuration and being able to easily engage and disengage the barb with the body lumen wall without tangling of the barbs to be able to reposition the device during delivery.” Final Act. 8-9 (referencing Dwyer 2:51-61, 10:65-11:4). The Examiner’s reasoning is problematic. First, regarding the “purpose of being able to have a lower profile radially inward delivery configuration,” the Examiner states that “modifying the trough portion to be further offset would not interact with the medical device or the attachment portion of Shaw.” Ans. 6. However, the Examiner does not make clear how extending the trough inwardly some distance more than Shaw presently discloses would not “interact with the medical device or the attachment portion” as asserted. Id. In other words, the Examiner does not explain how increasing the inward extent of Shaw’s anchor in such confined quarters would fail to interfere with other components. Furthermore, modifying Shaw’s anchors to enlarge or enhance the lateral offset of the trough would, instead, result in a higher profile delivery configuration (because of the added expanse), not a lower one as the Examiner asserts. We thus agree with Appellant that “the low profile configuration [asserted by the Examiner] would not be achieved.” Appeal Br. 8; see also Reply Br. 4, 5.4 3 Claims 1 and 15 each also recite the device having a depth stop with “an apex portion . . . laterally offset from the middle axis in a first direction.” The Examiner relies on Shaw for such teachings. See Final Act. 5-6. 4 Appellant’s Reply Brief lacks page numbering. We assign such numbering starting with the Title Page being number 1. Appeal 2021-004191 Application 13/961,416 5 Second, regarding the reasoning of “being able to easily engage and disengage the barb with the body lumen wall without tangling of the barbs to be able to reposition the device during delivery,” such reasoning arises from the benefit of Dwyer’s hook 24 being combined with Dwyer’s trough which extends circumferentially or transversely. Final Act. 15; see Dwyer 10:40- 11:4, Fig. 11. It is this orientation of Dwyer’s trough that assures “the retraction of the hook 24 to its intended low profile, radially inwardly disposed configuration.” Dwyer 11:1-4, see also id. at 2:51-61; Appeal Br. 7. Thus, Dwyer’s hooks 24 can be bent “radially inwardly” (i.e., become unattached) as a consequence of the “transverse extensions” of Dwyer’s trough. See above. The Examiner, however, is rotating Dwyer’s trough so that the trough is, instead, radially oriented to satisfy the limitation of “an S-shape in a radial direction.” Dwyer is silent as to any flexing of the trough in that direction (i.e., forcing the trough open against its bend) to achieve the above noted benefits and the Examiner is silent in that regard as well. We have been instructed that the Patent Office should not, “because it may doubt that the invention is patentable, resort to speculation, unfounded assumptions or hindsight reconstruction to supply deficiencies in its factual basis.” In re Warner, 379 F.2d 1011, 1017 (CCPA 1967). We have also been instructed by the Supreme Court that “rejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). In the matter before us, it appears the Examiner is relying on Appeal 2021-004191 Application 13/961,416 6 speculation or unfounded assumptions, and as such, fails to provide the requisite “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” Id. Independent claims 1 and 15 also each recite that the pointed tip extends “along a middle axis that extends perpendicular to the longitudinal axis of the” medical device/stent-graft. “Appellant notes that this feature is not present in Shaw and, further, that Shaw is incapable of fulfilling such limitation.” Reply Br. 2. The Examiner acknowledges that this teaching is lacking in Shaw but concludes that it would have been obvious to modify the combination so that “the middle axis/pointed tip extend at an angle of 90 degrees” as recited. Final Act. 9. The Examiner’s basis for this is that “a recitation of relative dimensions” is insufficient for patentability. Final Act. 9 (referencing Gardner v. TEC Syst., Inc., 725 F.2d 1338, (Fed. Cir. 1984)). The Examiner further states that “[i]n the instant case, the device of Shaw as modified would not operate differently.” Final Act. 9. First, as noted above, the Examiner’s basis is premised on “relative dimensions” whereas both independent claims recite an orientation, not a dimension. Final Act. 9. Also, regarding the Examiner’s assertion that it would have been obvious to modify the combination as recited, we reproduce the Examiner’s annotation of Figure 3B of Shaw below. Appeal 2021-004191 Application 13/961,416 7 The above is a reproduction of Figure 3 of Shaw annotated by the Examiner to identify various teachings. See Final Act. 6. As noted above, the Examiner contends that it would have been an obvious modification for “the middle axis/pointed tip [to] extend at an angle of 90 degrees” to the horizontal axis in the above figure. Final Act. 9. To achieve this, Shaw’s pointed tip would need to be rotated counter-clockwise beyond the approximately 45 degrees shown and pass through (sever) additional tissue before reaching the recited perpendicular position. This would, obviously, increase damage to adjacent body tissue even though Shaw’s illustration teaches that perpendicular rotation is not needed for suitable embedment. The Examiner does not explain why such additional tissue damage might be warranted. In summation, and as above, the Examiner has failed to provide articulated reasoning with rational underpinning to support the legal conclusion of obviousness. See KSR, 550 U.S. at 418. We reverse the Examiner’s rejection of claims 1, 4, 5, 15, 24, 27, 28, 30, 40, and 41. Appeal 2021-004191 Application 13/961,416 8 The rejection of claim 7 as unpatentable over Shaw, Dwyer, and Paul, Jr. Claim 7 depends directly from claim 1. The Examiner relies upon the additional teachings of Paul, Jr. for teaching the additional limitations recited in claim 7. See Final Act. 11. The Examiner’s application of Paul, Jr. does not cure the deficiencies noted above regarding the rejection of claim 1. Accordingly, we likewise reverse the Examiner’s rejection of claim 7. The rejection of claims 31-38 and 42 as unpatentable over Shaw, Lefebvre, and Dwyer Independent claim 31 (and hence dependent claims 32-38 and 42) includes the above limitation directed to pointed tip perpendicularity. Claim 31 was also rejected by the Examiner for the same reasons as expressed with respect to claims 1 and 15 above. See Final Act. 15. The Examiner’s additional reliance on Lefebvre does not cure the above noted defects discussed above. Accordingly, we likewise reverse the Examiner’s rejection of claims 31-38 and 42. The rejection of claim 39 as unpatentable over Shaw, Lefebvre, Dwyer, and Ryan Claim 39 depends directly from claim 31. The Examiner relies upon the additional teachings of Ryan for teaching the additional limitations recited in claim 39. See Final Act. 17. The Examiner’s application of Ryan does not cure the deficiencies noted above regarding the rejection of claim 31. Accordingly, we likewise reverse the Examiner’s rejection of claim 39. Appeal 2021-004191 Application 13/961,416 9 CONCLUSION The Examiner’s decision to reject claims 1, 4, 5, 7, 15, 24, 27, 28, and 30-42 is reversed. DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 4, 5, 15, 24, 27, 28, 30, 40, 41 103(a) Shaw, Dwyer 1, 4, 5, 15, 24, 27, 28, 30, 40, 41 7 103(a) Shaw, Dwyer, Paul, Jr. 7 31-38, 42 103(a) Shaw, Lefebvre, Dwyer 31-38, 42 39 103(a) Shaw, Lefebvre, Dwyer, Ryan 39 Overall Outcome 1, 4, 5, 7, 15, 24, 27, 28, 30-42 REVERSED