Boston Scientific Scimed, Inc.

Patent Trials and Appeals BoardDec 7, 2021

2021002902 (P.T.A.B. Dec. 7, 2021)

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. 15/001,011 01/19/2016 Kerryn Randall 8150BSC0323C1 2829 121974 7590 12/07/2021 Kacvinsky Daisak Bluni PLLC (8150) 2601 Weston Parkway, Suite 103 Cary, NC 27513 EXAMINER DELLA, JAYMI E ART UNIT PAPER NUMBER 3794 NOTIFICATION DATE DELIVERY MODE 12/07/2021 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 KERRYN RANDALL Appeal 2021-002902 Application 15/001,011 Technology Center 3700 Before JOHN C. KERINS, MICHAEL L. HOELTER, and BENJAMIN D. M. WOOD, Administrative Patent Judges. WOOD, 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 57, 58, 60, 62–64, and 72–85. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the term “Appellant” to refer to the applicant as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as Boston Scientific Scimed, Inc. Appeal Br. 3. Appeal 2021-002902 Application 15/001,011 2 CLAIMED SUBJECT MATTER The claims are directed to tissue ablation probes and methods for treating osteoid osteomas. Claim 57, reproduced below, is illustrative of the claimed subject matter: 57. A tissue ablation probe, comprising: a cannula comprising a proximal portion and a distal portion slidable relative to each other, wherein distally advancing the distal portion relative to the proximal portion exposes an opening between the distal portion and the proximal portion through which a plurality of ablative elements are deployed, wherein a substantial length of each of the plurality of ablative elements extends transversely outward from the cannula collinearly in opposite directions after full deployment. REFERENCES Name Reference Date Day US 5,174,475 Dec. 29, 1992 Gough US 5,728,143 Mar. 17, 1998 Randall US 7,799,024 B2 Sep. 21, 2010 Coldwell US 2005/0065509 A1 Mar. 24, 2005 Pearson US 2005/0240174 A1 Oct. 27, 2005 Young US 2006/0095029 A1 May 4, 2006 Appeal 2021-002902 Application 15/001,011 3 REJECTIONS2 Name 35 U.S.C. § References 57, 58, 60, 64, 72, 74– 76, 81, 83 103 Pearson, Coldwell 62, 63, 77, 78 103 Pearson, Coldwell, Young 73, 82 103 Pearson, Coldwell, Day 75, 79, 80, 83–85 103 Pearson, Coldwell, Gough 57, 60, 62, 64, 75, 78, 80, 81, 83–85 Double Patenting US 7,799,024, Coldwell OPINION Claims 57, 58, 60, 64, 72, 74–76, 81, and 83 —§ 103—Pearson and Coldwell Appellant argues the claims subject to this rejection as a group. Appeal Br. 8–13. We select claim 57 as representative of the group, and decide the appeal of this rejection on the basis of claim 57 alone. 37 C.F.R. § 41.37(c)(1)(iv). The Examiner finds that Pearson teaches the tissue ablation probe recited in claim 57, except that Pearson “fail[s] to specifically disclose a substantial length of each of the plurality of ablative elements extends transversely outward from the cannula in opposite directions after full deployment.” Final Act. 8–9 (citing Pearson ¶¶ 30–31, 34, 36, Figs. 4–12). The Examiner therefore finds that Coldwell teaches the missing limitation. Id. at 9; see Coldwell Figs. 2–4C. The Examiner determines that it would have been obvious to one of ordinary skill in the art to modify Pearson “such that a substantial length of each of the plurality of ablative elements extends 2 Rejections under 35 U.S.C. §§ 101, 112(a), and 112(b) have been withdrawn. Ans. 4. Appeal 2021-002902 Application 15/001,011 4 transversely outward from the cannula collinearly in opposite directions after full deployment in order to provide the benefit of the ablation elements lying substantially within a plane when deployed such that they can treat a surface of a tissue structure as taught by Coldwell.” Id. at 9–10 (citing Coldwell ¶¶ 8–9, 22, 28–29, Figs. 2–4C). We have considered Appellant’s arguments in support of the patentability of claim 57, but find them unpersuasive of Examiner error. Therefore, we sustain the rejection for essentially those reasons expressed in the Final Action and Answer, and add the following primarily for emphasis. Appellant disputes that one of ordinary skill in the art would have been motivated to “exchange the curved electrodes of Pearson, which are configured for piercing and tracking through tissue, for the linear/flat electrodes of Coldwell, which are configured to be deployed and then pressed onto a tissue surface.” Appeal Br. 11–12. Appellant contends: [I]f one of ordinary skill in the art were to substitute the linear/flat electrodes of Coldwell for the curved electrodes of Pearson, the sealing member 122 and deployment member 32 of the device (see Fig. 5 of Pearson) would extend beyond the now-substituted linear/flat electrodes from Coldwell, thereby interfering the ability of the distal portions of the linear/flat electrodes to be placed in contact with a surface of a tissue structure in order to deliver electrical energy from the electrodes into the surface to treat the tissue structure, as argued by the Examiner. Id. at 12. This contention also underlies Appellant’s arguments that the rejection is based on improper hindsight and that there would be no expectation of success. Id. Appeal 2021-002902 Application 15/001,011 5 The Examiner responds that “the linear/flat deployed electrodes of Coldwell in the modified device of Pearson et al. would still be capable of being deployed ‘in or on’ the tissue structure surface with the sealing member 122 and deployment member 32 anchoring the device in the tissue.” Ans. 6. (citing Coldwell Abstract, ¶¶ 6, 8). The Examiner further asserts that “the use of linear/flat electrode arrays in Pearson would also be capable of treating the tissue within a tumor when deployed.” Id. Appellant counters that “the Examiner has not cited any portion of Pearson where the sealing member 122 and deployment member 32 are used to anchor the device while electrodes elsewhere in the device are used to treat surface tissue,” and “anchoring the device in tissue would interfere with movement of the electrodes relative to the tissue surface, including interfering with the ability to place the electrodes at adjacent surface areas.” Reply Br. 13 (citing Pearson ¶ 10; Coldwell ¶40). As stated above, the contention underlying Appellant’s arguments is that if Coldwell’s flat electrodes were used in Pearson’s ablation device, sealing member 122/deployment member 32 would extend beyond the electrodes, thereby preventing the distal portions of the electrodes from being placed in contact with the surface of the tissue in order to deliver electrical energy from the electrodes into the tissue. Appeal Br. 12. We are not persuaded, however, that this is correct. As the Examiner suggests (Ans. 6), the electrodes can lie flat against the surface of tissue if the sealing member 122/distal end of deployment member 32 is inserted below the surface of the tissue. Ans. 6. Using the combined device in this manner is consistent with Coldwell’s teaching that its device can be used to treat tissue below the surface of the tissue (Coldwell ¶¶ 8, 40), as well as Pearson’s Appeal 2021-002902 Application 15/001,011 6 teaching that the sealing member is designed to penetrate tissue (Pearson ¶ 32). Appellant notes that Pearson does not expressly teach using the sealing member/deployment member to “anchor” the device (Appeal Br. 13), but Pearson does teach that the sealing member is designed to penetrate tissue distally from where the electrodes are deployed. For example, Pearson teaches that “sealing member 122 distally extends beyond the distal cannula opening 40 when the deployment member 32 is in the deployed position, thereby allowing the electrode tines 30 to be extended therefrom without obstruction from the sealing member 122.” Pearson ¶ 34, Fig. 5. In other words, the device resulting from the combination of Pearson and Coldwell would operate in essentially the same manner as Pearson’s device does. Indeed, the combined device would be identical to Pearson’s device except the electrodes would extend perpendicularly from the deployment cannula rather than taking on an “umbrella or mushroom shaped” formation after deployment.3 Further, Appellant has not provided evidence or persuasive argument establishing that penetrating tissue with the sealing member would interfere with movement of the electrodes relative to the tissue surface to place the electrodes at adjacent surface areas. Because we are not persuaded that the Examiner erred in rejecting claim 57, we sustain the Examiner’s rejection of claims 57, 58, 60, 64, 72, 74–76, 81, and 83 as unpatentable over Pearson and Coldwell. 3 Notably, both Pearson’s ablation device and Coldwell’s ablation device may use deployment cannulas and electrode tines similar to those used in the “LeVeen NeedleTM” electrode. Pearson ¶¶ 2, 30, Figs. 1, 2, 5, 6; Coldwell ¶ 24. Appeal 2021-002902 Application 15/001,011 7 Remaining § 103 Rejections Appellant relies on the arguments above regarding claim 57, which we found to be unpersuasive, to support the patentability of claims 62, 63, 73, 75, 77–80, and 82–85. Appeal Br. 13. Therefore, we sustain the Examiner’s rejection of claims 62, 63, 77, and 78 as unpatentable over Pearson, Coldwell, and Young; claims 73 and 82 as unpatentable over Pearson, Coldwell, and Day; and claims 75, 79, 80, and 83–85 as unpatentable over Pearson, Coldwell, and Gough. Claims 57, 60, 62, 64, 75, 78, 80, 81, 83–85 —Double Patenting—US 7,799,024, Coldwell In response to the Examiner’s rejection of claims 57, 60, 62, 64, 75, 78, 80, 81, and 83–85 on the ground of non-statutory double patenting over claims 1–17 of US. Patent 7,799,024 (“the ’024 patent”), Appellant asserts that the ‘024 patent has expired due to nonpayment of maintenance fees under 37 C.F.R. § 1.362(a). Appeal Br. 13. The Examiner does not dispute this assertion. “The doctrine of double patenting seeks to prevent the unjustified extension of patent exclusivity beyond the term of a patent.” MPEP § 804. Here, the patent the unjustified extension of which this double-patenting rejection would have prevented has already expired. Accordingly, we reverse the double-patenting rejection as moot. DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 57, 58, 60, 64, 72, 74– 76, 81, 83 103 Pearson, Coldwell 57, 58, 60, 64, 72, 74– 76, 81, 83 Appeal 2021-002902 Application 15/001,011 8 Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 62, 63, 77, 78 103 Pearson, Coldwell, Young 62, 63, 77, 78 73, 82 103 Pearson, Coldwell, Day 73, 82 75, 79, 80, 83–85 103 Pearson, Coldwell, Gough 75, 79, 80, 83–85 57, 60, 62, 64, 75, 78, 80, 81, 83– 85 Double Patenting 57, 60, 62, 64, 75, 78, 80, 81, 83– 85 Overall Outcome 57, 58, 60, 62–64, 72– 85 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). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED