Ex Parte Novak et alDownload PDFBoard of Patent Appeals and InterferencesJul 18, 201211196607 (B.P.A.I. Jul. 18, 2012) Copy Citation UNITED STATES PATENT AND TRADEMARKOFFICE 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. 11/196,607 08/02/2005 Theodore A. D. Novak M24-129 5637 28156 7590 07/19/2012 COLEMAN SUDOL SAPONE, P.C. 714 COLORADO AVENUE BRIDGE PORT, CT 06605-1601 EXAMINER SEVERSON, RYAN J ART UNIT PAPER NUMBER 3731 MAIL DATE DELIVERY MODE 07/19/2012 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte THEODORE A.D. NOVAK, WERNER SLADEK-MAHARG, DAN VOIC, SCOTT ISOLA, and RONALD R. MANNA __________ Appeal 2011-005063 Application 11/196,607 Technology Center 3700 __________ Before TONI R. SCHEINER, ERIC GRIMES, and ERICA A. FRANKLIN, Administrative Patent Judges. SCHEINER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 from the final rejection of claims 8, 11, 12, and 14-20, directed to a surgical method. The claims have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. Appeal 2011-005063 Application 11/196,607 2 STATEMENT OF THE CASE The present invention is directed to an ultrasonically assisted surgical method whereby hard tissue, e.g., hard cartilage or bone, is cut and separated from adjacent soft tissue, while minimizing trauma to the soft tissue (Spec. 4: 8-12; 3: 10; 6: 5-15). Claims 8, 11, 12, and 14-20 are pending and on appeal; claims 1-7, 9, 10, and 13 have been canceled (App. Br. 2). Claim 8 is representative of the subject matter on appeal: 8. A surgical method comprising: providing a cutting blade having a thickness along a cutting edge of between about 0.0005 inch and about 0.020 inch; moving said blade in contact with relatively hard tissue located adjacent to relatively soft tissue at a surgical site in a patient, so that said cutting edge cuts through said hard tissue and leaves said soft tissue substantially intact and undamaged; and ultrasonically vibrating said blade during the moving of said blade, wherein the vibrating of said blade is initiated prior to a contacting of said surgical site with said blade and is maintained during an initial contact of said blade with the tissues at said surgical site and during the moving of said blade through said hard tissue, wherein said blade is moved in a continuous and uninterrupted stroke along an interface between said hard tissue and said soft tissue at said surgical site with said blade extending generally parallel to said interface, the ultrasonic vibrating of said blade being performed continuously and uninterruptedly during said stroke. Claims 8, 11, 12, and 14-20 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Idemoto (US 5,188,102, February 23, 1993) and Vercellotti (US 2001/0004695 A1, June 21, 2001). Appeal 2011-005063 Application 11/196,607 3 FINDINGS OF FACT 1. Idemoto discloses “a surgical ultrasonic horn . . . used in cutting and separating of the living tissue, e.g. cartilaginous tissue or bone” (Idemoto, col. 1, ll. 6-10). According to Idemoto: [O]n the cutting and separating of the bone, due to the shape of the cutting portions [of the ultrasonic horn], the cutting portions smoothly enter[] from the surface of the bone to an interior thereof by means of the mechanical ultrasonic oscillation when it contacts slightly against the bone. Therefore, any scattering of bone against the surgeon is suppressed, enabling the operation to proceed with greater precision. The elastic tissue of the bone, e.g periosteum is never damaged by the horn . . . due to the characteristics of the ultrasonic. (Id. at 3, col. 3, ll. 29-39.) 2. Vercellotti discloses “a surgical device and method for bone surgery” which is particularly suitable for “osteotomy, ostectomy, osteoplasty etc. and for oral surgical procedures such as excision of cysts, third molar extraction, preparation of implant sites, creation of an opening into the maxillary sinus and elevation of the endosteum” (Vercellotti ¶ 1). “[T]he cutting action on the bone tissue is produced by variable modulation ultrasonic vibrations that are activated only on the cutting end of the tip that comes into contact with the mineralized tissue to be cut” (id. at ¶ 20). Furthermore, when the vibrating tip encounters soft tissue, such as a neurovascular structure, it loses its cutting capacity. In fact the soft tissue absorbs the vibrations of the tip without being resected and the energy caused by the vibrations of the tip is dissipated in the form of a slight heat. This can be further reduced by the surgeon’s promptness in withdrawing the instrument as soon as he feels that it does not vibrate anymore. (Id. at ¶ 22.) Appeal 2011-005063 Application 11/196,607 4 3. Vercellotti further teaches that a spoon-shaped periosteal or endosteal elevator tip, rather than a cutting blade, is used to separate bone from surrounding membrane (periosteum) or from connective tissue (endosteum) (Vercellotti ¶¶ 71-76). DISCUSSION The Examiner finds that Idemoto discloses an ultrasonic cutting blade that “cuts tissue and provides irrigation to the tissue” (Ans. 4), and further finds that Vercellotti “teach[es] using an ultrasonic cutter to separate hard from soft tissue” (id.). The Examiner concludes that it would have been obvious for one of ordinary skill in the art to use Idemoto’s ultrasonic cutting blade “to cut bone in the manner taught by Vercellotti et al. to allow the cutter of Idemoto et al. to be used in a variety of surgical procedures” (id.). Appellants contend that neither reference discloses “moving the ultrasonically vibrating blade in a continuous and uninterrupted stroke along the interface between [] hard tissue and [] soft tissue, with the blade extending generally parallel to the interface, the ultrasonic vibrating of the blade being performed continuously and uninterruptedly during the stroke” (App. Br. 6). The Examiner concedes that neither reference discloses “moving the cutter generally parallel to the cutting surface” (Ans. 4). However, the Examiner finds that “the orientation of the blade relative to the surface to be cut is merely a matter of the way in which the surgeon[] holds and operates the instrument,” and concludes that “it would have been obvious . . . to have moved the blade ‘substantially parallel’ to the cutting surface to assist in separation of hard and soft tissue” (id.). Appeal 2011-005063 Application 11/196,607 5 Appellants further contend that the claims require cutting and separating hard tissue from adjacent soft tissue in a manner which cuts through the hard tissue and leaves the soft tissue substantially intact and undamaged, but neither Idemoto nor Vercellotti discloses a method of cutting and separating hard tissue from soft tissue using a continuously vibrating ultrasonic blade (App. Br. 5, 6, 8). In particular, Appellants contend that Idemoto “teaches the cutting and separating of bone, from itself and not from soft tissue, with an ultrasonically vibrating blade passed transversely to hard tissue, the cutting edge extending orthogonally to the tissue surface” (id. at 6-7). Similarly, Appellants contend that Vercellotti teaches “cutting into the hard tissue to perform an osteotomy, ostectomy or osteoplasty . . . or to perform a bone sampling, an excision of cysts, and extraction of molars, etc.” (id. at 8). Appellants contend that Vercellotti uses “a specialized instrument tip (a spoon shaped periosteal) to separate soft tissue from hard” (Reply Br. 4). Moreover, Appellants contend that Vercellotti teaches “interrupting a cutting operation” by “withdrawing of the surgical blade whenever the surgeon senses a contact between the tip and soft tissue” (App. Br. 8). We agree with Appellants that Idemoto discloses cutting into bone, rather than cutting and separating hard tissue (i.e., bone) from soft tissue (FF1), and that Vercellotti does not disclose using a continuously vibrating ultrasonic blade to separate hard tissue from soft (FFs 2, 3). In short, neither reference discloses a method wherein a continuously vibrating ultrasonic cutting blade is moved in a continuous and uninterrupted stroke along the interface between hard tissue and soft with the blade extending generally parallel to the interface, in such a way that the blade cuts through the hard Appeal 2011-005063 Application 11/196,607 6 tissue (rather than the soft tissue) and separates it from the soft tissue, leaving the soft tissue substantially intact and undamaged. The Examiner concedes that no combination of the method steps disclosed in the references would result in these steps (Ans. 4). Nor does the Examiner’s conclusory statement of obviousness explain how or why these steps would have been suggested by the cited art. Accordingly, we are constrained to reverse the rejection of the claims as unpatentable over Idemoto and Vercellotti. REVERSED clj Copy with citationCopy as parenthetical citation