BOSTON SCIENTIFIC SCIMED, INC.

Patent Trials and Appeals Board

Mar 29, 2022

2021003078 (P.T.A.B. Mar. 29, 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. 16/217,009 12/11/2018 CORYDON CARLSON 2001.1893101 9877 11050 7590 03/29/2022 SEAGER, TUFTE & WICKHEM, LLP 100 South 5th Street Suite 600 Minneapolis, MN 55402 EXAMINER DUDA, RINA I ART UNIT PAPER NUMBER 2846 NOTIFICATION DATE DELIVERY MODE 03/29/2022 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): BSC.USPTO@stwiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte CORYDON CARLSON, DAVID GORDON SPANGLER, DANIEL FRANK MASSIMI, LASZLO TRENT FARAGO, and MARK A. HILSE ____________ Appeal 2021-003078 Application 16/217,009 Technology Center 2800 ____________ Before DONNA M. PRAISS, JEFFREY R. SNAY, and SHELDON M. MCGEE, Administrative Patent Judges. SNAY, 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 REVERSE. 1 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies Boston Scientific Scimed, Inc., as the real party in interest. Appeal Br. 3. Appeal 2021-003078 Application 16/217,009 2 CLAIMED SUBJECT MATTER The invention relates to medical devices and methods for use in an atherectomy procedure. Spec. 1, claims 1, 11, 17. Claim 1 illustrates the subject matter at issue and is reproduced below: 1. A medical device configured for use in an atherectomy procedure in a vessel of a patient, the medical device comprising: an elongated drive shaft; a rotational tip member coupled to a distal end of the elongated drive shaft, the rotational tip member configured to rotate and engage material in a patient vessel while rotating; a motor coupled to a proximal end of the elongated drive shaft to rotate the rotational tip member; and a control unit configured to control a motor state of the motor, the control unit is further configured to adjust the motor state to decelerate the motor in response to a detected stall condition. Appeal Br. 11 (Claims Appendix). Claim 11 recites a control unit for controlling a medical device during an atherectomy which includes, inter alia, “a motor state estimator” and “a reference schedule component in communication with the controller and the motor state estimator.” Claim 17 recites a method of controlling a medical device “during an atherectomy procedure,” which device includes, inter alia, “a distal rotational tip member configured to engage material in a patient’s vessel during an atherectomy procedure.” Each remaining claim on appeal depends from claim 1, 11, or 17. Appeal 2021-003078 Application 16/217,009 3 REJECTION Claims 1-20 stand rejected under 35 U.S.C. § 102(a)(1) as anticipated by Wingardner.2 OPINION “[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). “[A]nticipation of a claim under § 102 can be found only if the prior art reference discloses every element of the claim . . . .” In re King, 801 F.2d 1324, 1326 (Fed. Cir. 1986) (citing Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick Co., 730 F.2d 1452, 1457 (Fed. Cir. 1984)). “[A]bsence from the reference of any claimed element negates anticipation.” Kloster Speedsteel AB v. Crucible Inc., 793 F.2d 1565, 1571 (Fed. Cir. 1986). The Examiner finds Wingardner describes a medical device that includes all the recitations of independent claims 1, 11, and 17. Final Act. 3. Referring generally to Wingardner’s figures, the Examiner states Wingardner’s device includes “rotational tip member 300 . . . wherein the tip member is configure[d] to rotate and engage a tissue material in a patient.” Id. (citing Wingardner 5:10-15, 6:14-18). Wingardner describes surgical device for use with removable end effectors for “clamping, cutting and/or stapling tissue.” Wingardner 1:7-14. In operation, Wingardner’s instrument selectively operates distinct components of a drive assembly to cause an end effector tool to rotate, articulate, and fire staples. Id. 5:9-19, 6:4-19. 2 US 9,265,585 B2, issued February 23, 2016. Appeal 2021-003078 Application 16/217,009 4 Claim 1 Claim 1 recites, inter alia, a rotational tip member “configured to rotate and engage material in a patient vessel while rotating.” (Emphasis added). Appellant argues Wingardner fails to describe a tip member that is configured as claimed. Appeal Br. 8. In response to Appellant’s argument, the Examiner finds Wingardner meets the disputed recitation because Wingardner’s device includes a rotatable end effector, and that a type of end effector may be selected based on the intended function of the instrument. Ans. 6 (citing Wingardner 3:53-59). We are persuaded the Examiner does not identify evidence to show Wingardner’s described instrument includes a rotational tip member configured to rotate and engage material in a patient vessel. As the Examiner correctly observes, Wingardner suggests possible attachment of different end effectors. Wingardner 3:53-59. However, the Examiner does not identify evidence in Wingardner that describes an end effector configured to engage material in a patient vessel. Nor does the Examiner provide evidence that Wingardner’s described tissue stapling end effector inherently would have been capable of operating in a patient vessel. Claim 11 Claim 11 recites a control unit comprising, inter alia, a controller, a motor state estimator, and “a reference schedule component in communication with the controller,” which reference schedule “is configured to provide an output to the controller based on an input from the motor state estimator.” We find no mention by the Examiner of any disclosure in Wingardner that would have described the recited motor state Appeal 2021-003078 Application 16/217,009 5 estimator or reference schedule. Indeed, the Examiner does not address these recitations in either the Final Office Action or Answer. Claim 17 Claim 17 recites a method of controlling a medical device “during an atherectomy procedure.” The Examiner presents no finding that Wingardner teaches use of the described instrument during an atherectomy procedure. For the foregoing reasons, we are persuaded the Examiner’s anticipation finding with regard to each independent claim is not supported by a preponderance of evidence. Accordingly, the rejection is not sustained. CONCLUSION The Examiner’s decision rejecting claims 1-20 is reversed. DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1-20 102(a)(1) Wingardner 1-20 REVERSED