Ex Parte Avitall et alDownload PDFPatent Trial and Appeal BoardApr 9, 201311429051 (P.T.A.B. Apr. 9, 2013) 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. 11/429,051 05/05/2006 Boaz Avitall 05-0203 (US02) 2293 11050 7590 04/09/2013 SEAGER, TUFTE & WICKHEM, LLC 1221 Nicollet Avenue Suite 800 Minneapolis, MN 55403 EXAMINER SCOTT, AMANDA L ART UNIT PAPER NUMBER 3739 MAIL DATE DELIVERY MODE 04/09/2013 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 BOAZ AVITALL and JOSEF V. KOBLISH __________ Appeal 2011-008156 Application 11/429,051 Technology Center 3700 __________ Before DEMETRA J. MILLS, STEPHEN WALSH and ERICA A. FRANKLIN, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134. The Examiner has rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). Appeal 2011-008156 Application 11/429,051 2 STATEMENT OF CASE 1. A catheter for performing a medical procedure on tissue adjacent an ostium of an anatomical vessel, comprising: an elongated flexible catheter body including a proximal shaft portion and a distal shaft portion having a proximal section pre-shaped to form a simple curve having an apex sized to be inserted into the vessel ostium, a medial section pre-shaped to form a complex curve, and a distal section configured to contact the adjacent tissue when the curve apex is inserted within the vessel ostium; and at least one tracking element carried by the distal shaft portion. 11. A method of performing a medical procedure adjacent an anatomical vessel using a catheter having a proximal section and a distal section, comprising: forming the proximal section into a curve having an apex; inserting the curve apex into the vessel ostium to place the distal section in contact with a first tissue site adjacent an ostium of the vessel; determining a location of the distal section within a coordinate system while contacting the first tissue site; rotating the curve within the vessel about the curve apex while the curve apex is in the vessel ostium to place the distal section in contact with a second tissue site adjacent the vessel ostium; and determining another location of the distal section within the coordinate system while contacting the second tissue site. Cited References Kuck et al. US 5,823,955 Oct. 20, 1998 Bowe US 2001/0039413 A1 Nov. 8, 2001 Willis et al. US 6,490,474 B1 Dec. 3, 2002 Gilboa US 6,887,236 B2 May 3, 2005 Haissaguerre et al. US 6,064,902 May 16, 2000 Appeal 2011-008156 Application 11/429,051 3 Grounds of Rejection 1. Claims 1-5 are rejected under 35 U.S.C. §103(a) as being unpatentable over Kuck in view of Bowe. 2. Claims 6-10 are rejected under 35U.S.C. §103(a) as being unpatentable over Kuck in view of Bowe further in view of Willis. 3. Claims 11, 16, 18-19 and 21-24 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Gilboa in view of Haissaguerre. 4. Claims 17, 20 and 25 are rejected under 35 U.S.C. §103(a) as being unpatentable over Gilboa in view of Haissaguerre in view of Willis. 5. Claims 13, 14 and 15 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Gilboa in view of Haissaguerre in view of Kuck. FINDINGS OF FACT The Examiner’s findings of fact are set forth in the Answer at pages 3- 11. The following facts are highlighted. 1. Specification Figs. 4 and 5 are reproduced below. Appeal 2011-008156 Application 11/429,051 4 Specification Figure 4 shows complex curve 42. “The medial section 42 is configured to be internally actuated from a straight geometry to form a complex curve (ie., a curve that can be projected onto more than one plane) in the absence of an external force, and in particular, a compressive force.” (Spec. 17-18.) “The particular unconstrained shape of the medial section 42, is such, that it bends opposite to and out-of-plane with the simple curve C1. That is, the complex curve has a proximal curve C2 that, when projected onto the plane, P1 (see Fig. 4), bends opposite to the simple curve C1, and a distal curve C3 that, when projected on a plane P2 that is perpendicular to the longitudinal axis L of the proximal member 28” (see Fig. 6), bends out of the plane P1. (Spec. 18.) 2. Figures 1 and 1B of Kuck are reproduced below. Appeal 2011-008156 Application 11/429,051 5 Figures 1 and 1B of Kuck show proximal curve 44 and distal segment (curve) 66 (annotated). 3. Kuck discloses that, for example, “if manipulator wire 16 were passed into one of the satellite lumens 40 oriented 90 degrees from the satellite lumen through which manipulator wire 16 passed, distal segment 66 would be curved in a plane about 90 degrees to the plane of the figures. Also, distal curve 66 could deflect in the same plane and same direction as proximal curve 44. In an alternative embodiment, distal curve 66 and proximal curve 44 could be actuated by a single manipulator wire and a single handle control.” (Col. 5, ll. 20-29.) Discussion 1. Claims 1-5 are rejected under 35 U.S.C. §103(a) as being unpatentable for obviousness over Kuck in view of Bowe. Appeal 2011-008156 Application 11/429,051 6 2. Claims 6-10 are rejected under 35 U.S.C. §103(a) as being unpatentable over Kuck in view of Bowe further in view of Willis. ISSUE The Examiner concludes that Kuck teaches each element claimed except Kuck et al. fail to disclose the proximal section simple curve as being pre-shaped. However, Bowe et al. discloses a catheter (30) employs a shaped-memory wire (104) having a preshaped bend in distal end region (106). At the time of the invention, it would have been obvious to one of ordinary skill in the art to use a pre-formed bend in order to provide the benefit of the catheter conforming to the contour of the biological cavity containing the tissue to be ablated as taught by Bowe et al. ([0046]). (Ans. 4.) Appellants argue that The specification defines a complex curve in its ordinary and accustomed manner, i.e., a curve that can be projected onto more than one plane (see page 17, line 22 to page 18, line 1). This should be contrasted with a simple curve, which is defined in the specification in accordance with its ordinary and accustomed meaning, i.e., a curve that lies in a single plane (see page 17, lines 8-12). (Br. 5-6.) Appellants argue that However, there is no disclosure in Kuck of a single embodiment that bends the medical section (66) in a complex curve that both bends in a direction opposite to the simple curve and bends out-of-plane with the simple curve. Kuck characterizes the medial section (66) as nothing more than a simple curve that can be bent in one direction, or alternatively, Appeal 2011-008156 Application 11/429,051 7 bent in another direction-but not both directions at the same time to form a complex curve. (Br. 7.) Appellants further explain that Kuck discloses at col. 5, lines 18-25 that "if manipulator wire 16 were passed into one of the satellite lumens 40 oriented 90 degrees from the satellite lumen through which manipulator wire 16 passed, distal segment 66 would be curved in a plane about 90 degrees to the plane of the figures." However, this does not result in the distal segment 66 being placed in a complex curve that both bends in a direction opposite to the simple curve and bends out-of-plane with the simple curve. The most that this alternative embodiment suggests is that pulling on one manipulator wire 16 will place the distal segment 66 into a simple curve that bends opposite to the simple curve 44, and pulling on the other manipulator wire 16 (90 degrees clocked from the first manipulator wire 16) will place the distal segment 66 into a simple curve that bends out- of-plane with the simple curve 44. There is simply no disclosure in Kuck that manipulation of the two wires 16 will place the distal segment 66 into the claimed complex curve. (Reply Br. 2.) The dispositive issue with respect to both of the above rejections 1 and 2 is: Does the Examiner’s cited evidence support the Examiner’s conclusion that the references disclose a medial section pre-shaped to form a complex curve, and a distal section configured to contact the adjacent tissue when the curve apex is inserted within the vessel ostium, as claimed? PRINCIPLES OF LAW “In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden of presenting a prima facie case of obviousness. Only if that Appeal 2011-008156 Application 11/429,051 8 burden is met, does the burden of coming forward with evidence or argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993) (citations omitted). In order to determine whether a prima facie case of obviousness has been established, we consider the factors set forth in Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content of the prior art; (2) the differences between the prior art and the claims at issue; (3) the level of ordinary skill in the relevant art; and (4) objective evidence of nonobviousness, if present. Moreover, “obviousness requires a suggestion of all limitations in a claim.” CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) (citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)). ANALYSIS We do not find that the Examiner has provided sufficient evidence to support a prima facie case of obviousness for the catheter of claim 1 and its dependent claims, on the evidence before us. In particular, we agree with Appellants that the Examiner has not explained how Figures 1, 1B and 4 of Kuck disclose a complex curve consistent with the definition in Appellants’ specification, “a complex curve in its ordinary and accustomed manner, i.e., a curve that can be projected onto more than one plane (see page 17, line 22 to page 18, line 1).” Appellants have argued that Kuck discloses at col. 5, lines 18-25 that "if manipulator wire 16 were passed into one of the satellite lumens 40 oriented 90 degrees from the satellite lumen through which manipulator wire 16 passed, distal segment 66 would be curved in a plane about 90 degrees to the plane of the figures." However, this does not result in the distal segment Appeal 2011-008156 Application 11/429,051 9 66 being placed in a complex curve that both bends in a direction opposite to the simple curve and bends out-of-plane with the simple curve. The most that this alternative embodiment suggests is that pulling on one manipulator wire 16 will place the distal segment 66 into a simple curve that bends opposite to the simple curve 44, and pulling on the other manipulator wire 16 (90 degrees clocked from the first manipulator wire 16) will place the distal segment 66 into a simple curve that bends out-of-plane with the simple curve 44. There is simply no disclosure in Kuck that manipulation of the two wires 16 will place the distal segment 66 into the claimed complex curve. (Reply Br. 2.) The Examiner has failed to specifically address this argument of Appellants to indicate how Kuck discloses a complex curve. Rejections 1 and 2 are reversed. Discussion 3. Claims 11, 16, 18-19 and 21-24 are rejected under 35 U.S.C. §103(a) as being unpatentable over Gilboa in view of Haissaguerre. 4. Claims 17, 20 and 25 are rejected under 35 U.S.C. §103(a) as being unpatentable over Gilboa in view of Haissaguerre in view of Willis. 5. Claims 13, 14 and 15 are rejected under 35 U.S.C. §103(a) as being unpatentable over Gilboa in view of Haissaguerre in view of Kuck. Appeal 2011-008156 Application 11/429,051 10 ISSUE The Examiner argues that Gilboa discloses forming the proximal section into a curve having an apex (view figure 4A); inserting the curve apex into the vessel ostium to place the distal section in contact with a first tissue site adjacent an ostium of the vessel(view figure 4A, the device is implemented with a shape memory configured to facilitate positioning in around the pulmonary vein ostium); and determining a location of the distal section within a coordinate system while contacting the first tissue site(column 6, lines 30-61 ); and determining another location of the distal section within the coordinate system while contacting the second tissue site (once the second site is in contact the use of the coordinate system with the locating element can be used again; column 6, lines 30-61) but fails to disclose rotating the curve within the vessel about the curve apex while the curve apex is in the vessel ostium to place the distal section in contact with a second tissue site adjacent the vessel ostium. However, Haissaguerre et al. disclose a catheter (10) for ablating and mapping tissue that forms a curve apex (43) that is inserted into an ostium of a vessel, placing the distal section (42) in contact with a first tissue site and the proximal section in firm contact with an inner surface of the vessel while the apex is in the ostium. Haissaguerre et al. further discloses rotating the catheter within the vessel about the curve apex while the apex is in the vessel ostium to place the distal section in contact with a second tissue site. (Abstract; Column 8, Lines 60-66, Column 9, Lines 13-14, 41-42; Fig. 5-6). (Ans. 7-8.) Appellants argue that In particular, independent claim 11 requires inserting the curve apex into the vessel ostium to place the distal section in contact with a first tissue site adjacent the vessel ostium. The Examiner concluded that, by virtue of the fact that Gilboa catheter is implemented with a shape memory, the curve apex Appeal 2011-008156 Application 11/429,051 11 of the Gilboa catheter is capable of being positioning in around the pulmonary vein ostium (see page 6, lines 8-9 of Final Office Action). However, whether or not the curve apex of the Gilboa catheter is capable of being inserted into a pulmonary vein ostium is irrelevant to an inquiry into whether or not Gilboa actually discloses inserting the curve apex into a pulmonary vein. Significantly, "under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device." (Br. 9.) The dispositive issue with respect to rejections 3-5 is: Does Gilboa disclose “inserting the curve apex into the vessel ostium to place the distal section in contact with a first tissue site adjacent the vessel ostium,” as claimed. ANALYSIS We do not find that the Examiner has provided sufficient evidence to support a prima facie case of obviousness as set forth in the Answer. Gilboa generally discloses a catheter for ablating atrial tissue. (Col. 1, ll. 13-17.) Figure 2E of Gilboa is reproduced below. Appeal 2011-008156 Application 11/429,051 12 Figure 2E of Gilboa shows gradually deploying catheter assembly 10 distal portion along a line around the internal tissue surface of the atrium. (Col. 7, ll. 25-27.) The Examiner relies on Gilboa for disclosing, “inserting the curve apex into the vessel ostium to place the distal section in contact with a first tissue site adjacent an ostium of the vessel” (Ans. 7), referencing Fig. 4A of Gilboa. Figure 4A of Gilboa does not show insertion of the curve of a catheter into a vessel ostium. The Examiner further argues that Gilboa teaches in column 7, lines 41-52, that Figure 4A, which was cited in the final action as disclosing the claimed feature, shows a varint [sic] implementation of the present invention in which hollow catheter 12' is implemented with a shape memory configured to facilitate positioning for performing an ablation procedure requiring a line of a particular defined shape, for instance a circular ablation around the pulmonary vein ostium. (Ans. 12.) As set forth in In re Oelrich, 666 F.2d 578, 581, (CCPA 1981)(quoting Hansgirg v. Kemmer, 102 F.2d 212, 214 (CCPA 1939)), inherency may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient. If, however, the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient. The Examiner has not pointed to any disclosure in Gilboa of inserting the curve apex into a pulmonary vein. Nor is there sufficient disclosure to Appeal 2011-008156 Application 11/429,051 13 show that the natural result flowing from the operation of the catheter as taught would result in “inserting the curve apex into the vessel ostium to place the distal section in contact with a first tissue site adjacent the vessel ostium.” For this reason, rejections 3-5 are reversed. CONCLUSION OF LAW The cited references do not support the Examiner’s obviousness rejections. The rejections are reversed. REVERSED dm Copy with citationCopy as parenthetical citation