2020003926 (P.T.A.B. Feb. 5, 2021)

CAMERON HEALTH INC

Patent Trials and Appeals BoardFeb 5, 2021

2020003926 (P.T.A.B. Feb. 5, 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. 15/208,682 07/13/2016 G. Shantanu Reddy 1001.3887101 3657 11050 7590 02/05/2021 SEAGER, TUFTE & WICKHEM, LLP 100 South 5th Street Suite 600 Minneapolis, MN 55402 EXAMINER MANNAN, MIKAIL A ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 02/05/2021 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): BSC.USPTO@stwiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte G. SHANTANU REDDY and BRUCE A. TOCKMAN Appeal 2020-003926 Application 15/208,682 Technology Center 3700 Before MICHAEL L. HOELTER, JEREMY M. PLENZLER, and LISA M. GUIJT, Administrative Patent Judges. PLENZLER, 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 18, 31, 32, and 37–42. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 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 Cameron Health, Inc. Appeal Br. 3. Appeal 2020-003926 Application 15/208,682 2 CLAIMED SUBJECT MATTER The claims are directed to a method of placing a lead for cardiac therapy. Claim 18, reproduced below, is illustrative of the claimed subject matter: 18. A method of placing a lead at a desired location for an implantable cardiac therapy system, the lead comprising an element for receiving an advancing tool and one or more electrodes, the method comprising: without first tunneling any instrument to the desired location, advancing an insertion tool percutaneously to a position near the xiphoid of the patient along the back side of the sternum, wherein the insertion tool is shaped to direct a member passed therethrough against the back of the sternum; and pushing the lead through the insertion tool into the desired position using the advancing tool, wherein the desired position is along the posterior of the sternum, superior to the ventricles of the patient’s heart. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Cole US 2015/0105793 A1 Apr. 16, 2015 Marshall US 2015/0209077 A1 July 30, 2015 Strommer US 2015/0343228 A1 Dec. 3, 2015 REJECTIONS Claims 18, 32, 37, 40, and 42 are rejected under 35 U.S.C. § 103 as being unpatentable over Cole and Strommer. Claims 31 and 41 are rejected under 35 U.S.C. § 103 as being unpatentable over Cole, Strommer, and Marshall. Claims 18 and 37–40 are rejected under 35 U.S.C. § 103 as being unpatentable over Strommer and Cole. Appeal 2020-003926 Application 15/208,682 3 Claims 31 and 41 are rejected under 35 U.S.C. § 103 as being unpatentable over Strommer, Cole, and Marshall. OPINION Claim 18 recites a method that includes “advancing an insertion tool percutaneously to a position near the xiphoid of the patient along the back side of the sternum.” Claim 40 includes a similar recitation. In each of the rejections, the Examiner relies on a finding that Cole teaches this step. Final Act. 2, 4, 6, 7 (citing, e.g., Cole ¶ 28); Ans. 3–4 (citing Cole ¶ 34). Appellant responds that “[t]he present claims are directed at methods of implantation of a lead in a substernal position,” and although “Cole makes several mentions of a lead having this position and shows such a lead position in Figure 1, [it] never discloses how the lead is implanted in the substernal position.” Appeal Br. 5. Appellant has the better position. As noted above, there is no dispute that Cole teaches its lead ultimately being in the same location as Appellant’s lead. The claims, however, recite a method of how that leads ends up at the location. Paragraph 28 of Cole, for example, is silent as to any operation of its tool 50. Paragraph 34 of Cole discusses tool 50, but says nothing about advancing tool 50 percutaneously to a position near the xiphoid of the patient along the back side of the sternum. Rather, paragraph 34 of Cole simply states that [t]he tunneling tool 50 facilitates advancement of medical devices such as lead 18, medical tubes, catheters, or other medical devices. For example, the tunneling tool 50 is suited for advancing lead 18 through a subcutaneous location and/or an extra-pericardia space during an implant procedure. This is not a sufficient disclosure to support the Examiner’s finding. Appeal 2020-003926 Application 15/208,682 4 After review of the remainder of Cole’s disclosure, we fail to see anything expressly teaching the advancement of tool 50 to a location behind the sternum. For example, paragraph 49 of Cole discusses tunneling tool 50, but explains that “[a]fter the lead 18 is navigated to incision 4, the first portion 31 is separated from tunneling tool 50” and “the tunneling tool 50 may be pulled in a direction away from the second portion 32 such that the tunneling tool 50 slides back through the tunnel towards incision 2 until the tool is withdrawn from the patients tissue.” Cole describes incision 4 as being “adjacent to or below the xiphoid process” (Cole ¶ 31), which does not indicate that tunneling tool 50 is advanced “to a position near the xiphoid of the patient along the back side of the sternum” as recited in the claims. Because the Examiner’s finding is not sufficiently supported, we do not sustain the Examiner’s decisions to reject claims 18, 31, 32, and 37–42, which all suffer from the same deficiency noted above. CONCLUSION The Examiner’s rejections are affirmed. Appeal 2020-003926 Application 15/208,682 5 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 18, 32, 37, 40, 42 103 Cole, Strommer 18, 32, 37, 40, 42 31, 41 103 Cole, Strommer, Marshall 31, 41 18, 37–40 103 Strommer, Cole 18, 37–40 31, 41 103 Strommer, Cole, Marshall 31, 41 Overall Outcome 18, 31, 32, 37–42 REVERSED