Ex Parte CrowDownload PDFBoard of Patent Appeals and InterferencesMar 28, 201110998454 (B.P.A.I. Mar. 28, 2011) Copy Citation 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. 10/998,454 11/29/2004 Loren M. Crow 1001.2177101 3942 11050 7590 03/28/2011 SEAGER, TUFTE & WICKHEM, LLC 1221 Nicollet Avenue Suite 800 Minneapolis, MN 55403 EXAMINER BOUCHELLE, LAURA A ART UNIT PAPER NUMBER 3763 MAIL DATE DELIVERY MODE 03/28/2011 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 BOSTON SCIENTIFIC SCIMED, INC. ____________________ Appeal 2010-001736 Application 10/998,454 Technology Center 3700 ____________________ Before JAMESON LEE, RICHARD TORCZON, and SALLY GARDNER LANE, Administrative Patent Judges. LEE, Administrative Patent Judge. DECISION ON APPEAL A. STATEMENT OF THE CASE This is a decision on appeal by an Appellant, whose real party in interest is Boston Scientific Scimed, Inc. (“Boston Scientific”), under 35 U.S.C. § 134(a) from a final rejection of claims 1-20. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Appeal 2010-001736 Application 10/998,454 2 References Relied on by the Examiner Goldberg et al. (“Goldberg”) 5,152,777 Oct. 6, 1992 Schwartz 6,746,463 Jun. 8, 2004 The Rejections on Appeal The Examiner rejected claims 1-20 under 35 U.S.C. § 103(a) as unpatentable over Schwartz and Goldberg. The Invention The invention relates to a catheter used to incise or cut an aortic valve stenosis, i.e., a narrowing or constricting portion within the valve, where a portion of the blade of the catheter is configured with a blunt tip to prevent inadvertent incision. (Spec. 1:2-8.) Examples of a blunt tip include a “fine coil wire,” a “ball shaped element,” or a “protective sheath” which may be positioned to cover the distal end of the blade so that the tip of the blade is prevented from incising tissue. (Id. at 3:13-28.) Claim 1 is representative and reproduced below (App. Br. 14 Claims App’x.): 1. A cutting device comprising: a catheter; an elongated balloon defining an axis, the balloon being mounted on the catheter for reconfiguration between an inflated configuration and a deflated configuration; an elongated blade formed with a cutting edge and having a distal end and a proximal end, with the proximal end thereof attached to the balloon to orient the blade in a plane with the axis of the balloon and to project the cutting edge of the blade in a radial direction from the axis of the balloon; and Appeal 2010-001736 Application 10/998,454 3 a blunt tip member at the distal end of the blade to prevent tissue incision by the distal end of the blade during a movement of the blade. B. ISSUE Did the Examiner correctly determine that the combined teachings of Schwartz and Goldberg would have led a person of ordinary skill in the art to implement a blunt tip onto the end of a cutting blade in a device used for cutting an aortic valve stenosis? C. PRINCIPLES OF LAW The test for obviousness is what the combined teachings of those references would have suggested to one of ordinary skill in the art. In re Young, 927 F.2d 588, 591 (Fed. Cir. 1991). D. FINDINGS AND ANALYSIS The Examiner rejected claims 1-20 as unpatentable over Schwartz and Goldberg. Claims 1, 9, and 17 are independent claims. Claims 2-8, 10-16, and 18-20 are ultimately dependent on one of claims 1, 9, and 17. The dependent claims are argued collectively with the independent claims. Claims 1 and 9 are drawn respectively to a “cutting device” and a “device for incising tissue.” (App. Br. 14, 16 Claims App.’x.) Claim 17 is directed to a “method of incising target tissue with a blade.” (Id. at 17.) Each of claims 1, 9 and 17 includes a similar feature in connection with the configuration of a portion of a blade component and at issue with regard to the rejection on appeal. In claim 1, the pertinent feature reads (id. at 14): Appeal 2010-001736 Application 10/998,454 4 a blunt tip member at the distal end of the blade to prevent tissue incision by the distal end of the blade during a movement of the blade. In claim 9, the pertinent feature reads (id. at 16): a blunt tip member at the distal end of the blade[.] In claim 17, the pertinent feature reads (id. at 17): the blade having a blunt tip member at the distal end thereof to prevent tissue incision by the distal end during movement of the blade[.] The Examiner determined that Schwartz discloses a cutting or incising device and method having all the features of claims 1, 9, and 17, including a blade, with the exception of a blunt tip member formed at the distal end of the blade. The Examiner reasoned, however, that in view of the teachings of Goldberg taken with those of Schwartz, a person of ordinary skill in the art would have known to implement a blunt member onto the tip of a blade of a device which is operated within the aortic valve of a patient. (Ans. 3-4.) Boston Scientific first disputes the Examiner’s determination and reasoning on the premise that there is “no reasonable expectation of success” in combining the teachings of the references. (App. Br. 12:6-11.) According to Boston Scientific, that is so because of the “different natures and desired results” of the two references. (Id. at 12:12-15.) Boston Scientific’s argument is unpersuasive. It is not necessary that two references must have the same nature and desired result for one of ordinary skill in the art to reasonably expect success in combining their teachings. Schwartz discloses a system “for incising a stenosis in the aortic valve of a patient.” (Schwartz Abstract.) Appeal 2010-001736 Application 10/998,454 5 Schwartz’s Figure 1 illustrates its system and is reproduced below: Figure 1 depicts a system according to Schwartz’s invention. As shown in the figure above, system 10 includes a catheter 12, a balloon 18 (shown inflated), and a plurality of cutting blades 26 (shown as 26a and 26b). (Id. at 3:31-51.) The cutting blades include a sharp cutting edge 42 and a distal end 40. (Id. at 4:14-19.) Schwartz’ Figure 5 illustrates the system employed in a patient. Figure 5 is reproduced below: Figure 5 depicts Schwartz’s invention positioned within the ventricle of a patient. Appeal 2010-001736 Application 10/998,454 6 During the procedure, Schwartz’s device is delivered into a patient’s ventricle along a guidewire 22. (Schwartz 4:53-56.) When delivered, balloon 18 is in a deflated configuration such that the material of the balloon covers the cutting edges of blades 26a and 26b. (Id. at 4:48-51.) Schwartz recognizes that covering portions of the blades during delivery is important to “reduce the possibility of an unintended incision of tissue.” (Id. at 4:51- 52.) Once positioned as shown in the figure above, the balloon is then inflated so as to radially deploy blades 26 and orient cutting edges 42 to incise the stenosis in aortic valve 54. (Id. at 4:53-58.) The device is then retracted in the proximal direction toward aorta 56 to perform the incising action by operation of cutting edges 42. (Id. at 4:58-65.) Schwartz does not disclose that the distal ends 40 of cutting blades 26a and 26b are formed with a blunt tip, but, as noted above, does describe that “unintended incision of tissue” is undesirable. Schwartz also states the following in describing the operation of the cutting structure of its device (id. at 4:15-17): [T]his cooperation of structure allows the sharp cutting edge 42 of the blade 26a, at the distal end 40 of the blade 26a, to extend radially outward from the axis… Thus, the cutting surface as described in Schwartz is “cutting edge” 42 and not the distal tip 40 of blade 26a. Goldberg discloses a device for preventing occlusion in a blood vessel. (Goldberg Abstract.) Although Goldberg’s device is not intended to cut portions of the blood vessel, Goldberg recognizes that the presence of sharpened hooks or tips in such devices presents a hazard that may cause damage to a vessel wall when the device is positioned within a blood vessel. Appeal 2010-001736 Application 10/998,454 7 (Id. at 3:39-43.) To alleviate that hazard, Goldberg proposes capping such tips with blunt rounded balls which minimize the potential for undesired impaling or puncturing of the vessel walls. (Id. at 6:38-43; 7:4-7.) In light of the teachings of Schwartz and Goldberg, a person of ordinary skill in the art would have realized that the distal end of Schwartz’s blade presents a puncturing hazard of the type recognized by Goldberg as detrimental. That the devices of Goldberg and Schwartz may have different functions when inserted into a vessel of a patient is of no moment, as in each reference a portion of a device presents a similar danger of unintended cutting of vessel tissue. A skilled artisan would have reasonably expected that implementing blunt portions, such as the balls of Goldberg, onto the tips of Schwartz’s blades would be successful in minimizing the risk of unintended tissue incision by those tips. We reject Boston Scientific’s argument to the contrary as it does not adequately account for how a person of ordinary skill in the art would have viewed the combined teachings of those references. Boston Scientific also alternatively argues that Schwartz already incorporates a solution for reducing the risk of unintended incision of tissue from portions of its blade and that Schwartz’s device is therefore already “fully capable” of alleviating the problem. (Reply Br. 5:2-9.) According to Boston Scientific, that means a skilled artisan would not look to any other teaching for other possible solutions to the problem. Boston Scientific’s conclusion is misplaced. Schwartz’s disclosure does not foreclose further inquiry by a skilled artisan into other potential solutions. The obviousness analysis does not end simply because one reference, i.e., Schwartz, demonstrates awareness of one possible solution to Appeal 2010-001736 Application 10/998,454 8 a problem. Rather, where, as here, a rejection is based on the teachings of multiple references, the test for obviousness is what the combined teachings of those references would have suggested to one of ordinary skill in the art. In re Young, 927 F.2d at 591. As discussed above, in light of the combined teachings of Schwartz and Goldberg, a person of ordinary skill in the art would have recognized that a blunt tip implemented onto the distal end of a blade in a device for incising an aortic valve stenosis is a viable mechanism for minimizing the risk of unintended puncturing of vessel tissue. Boston Scientific’s arguments have been carefully considered but are unpersuasive. For the foregoing reasons, we sustain the rejection of claims 1-20 as unpatentable over Schwartz and Goldberg. E. CONCLUSION The Examiner correctly determined that the combined teachings of Schwartz and Goldberg would have led a person of ordinary skill in the art to implement a blunt tip onto the end of a cutting blade in a device used for cutting an aortic valve stenosis. F. ORDER The rejection of claims 1-20 under 35 U.S.C. § 103(a) as unpatentable over Schwartz and Goldberg is affirmed. 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). Appeal 2010-001736 Application 10/998,454 9 AFFIRMED SEAGER, TUFTE & WICKHEM, LLC 1221 Nicollet Avenue Suite 800 Minneapolis MN 55403 Copy with citationCopy as parenthetical citation