Ex Parte Leuer et al

Patent Trial and Appeal BoardSep 20, 2012

11273095 (P.T.A.B. Sep. 20, 2012)

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. 11/273,095 11/14/2005 Dennis Leuer 3273 3173 7590 09/20/2012 WALTER A. HACKLER, Ph.D. PATENT LAW OFFICE SUITE B 2372 S.E. BRISTOL STREET NEWPORT BEACH, CA 92660-0755 EXAMINER VU, QUYNH-NHU HOANG ART UNIT PAPER NUMBER 3763 MAIL DATE DELIVERY MODE 09/20/2012 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 PATENT TRIAL AND APPEAL BOARD __________ Ex parte DENNIS LEUER and ROBERT SIEGEL __________ Appeal 2011-011506 Application 11/273,095 Technology Center 3700 __________ Before DONALD E. ADAMS, ERIC GRIMES, and ERICA A. FRANKLIN, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method for treating an intravascular blockage. The Examiner has rejected the claims as anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE “It is known that ultrasound imaging can be used to locate intravascular thrombi … and it has been further demonstrated that the utilization of ultrasonic waves can improve the diffusion and penetration of Appeal 2011-011506 Application 11/273,095 2 medicinal fluids or the like into the vascular system” (Spec. 1:12-16). The Specification discloses “introducing an agent to a thrombus, applying the ultrasound to the site or area of the clot to enhance effectiveness, while monitoring, and stopping agent introduction once monitoring shows that the agent has been effective or undesired bleeding occurs” (id. at 1:27 to 2:3). Claims 1-11 are on appeal. Claim 1, the only independent claim, reads as follows:1 1. A method for treating an intravascular blockage, said method comprising: applying ultrasound to the blockage; introducing an agent to the blockage; monitoring the blockage to determine a status thereof; and controlling the agent introduced while blockage monitoring. The claims stand rejected as follows: • Claims 1-3, 6, and 7 under 35 U.S.C. § 102(b) in view of Siegel;2 • Claims 8-11 under 35 U.S.C. § 103(a) in view of Siegel; • Claims 4 and 5 under 35 U.S.C. § 103(a) in view of Siegel, Nyhart,3 and Theeuwes;4 • Claims 1-9 under 35 U.S.C. § 102(b) in view of Carter;5 and • Claims 10 and 11 under 35 U.S.C. § 103(a) in view of Carter. 1 The Claims Appendix of the Appeal Brief incorrectly reproduces claim 1. Claim 1 was amended to recite “controlling the agent introduced while blockage monitoring” (see the amendment filed June 17, 2010). 2 Siegel et al., US 5,695,460, Dec. 9, 1997. 3 Nyhart, Jr., US 7,616,989 B2, Nov. 10, 2009. 4 Theeuwes et al., Patent Application Publication, US 2003/0032942 A1, Feb. 13, 2003. 5 Carter, US 5,474,531, Dec. 12, 1995. Appeal 2011-011506 Application 11/273,095 3 I. The Examiner has rejected claims 1-3, 6, and 7 as anticipated by Siegel. The Examiner has also rejected claims 8-11 as obvious based on Siegel and claims 4 and 5 as obvious based on Siegel, Nyhart, and Theeuwes. The same issue is dispositive for all three rejections. The Examiner finds that Siegel discloses “a method for treating thrombosis or intravascular blockage comprising: applying ultrasound to the blockage; and introducing an agent to the blockage including ultrasound imaging agents to dissolve arterial thrombi” (Answer 3). The Examiner cites several portions of Siegel as disclosing “monitoring the blockage to determine a status of the blockage” (id.). Appellants contend that “none of the citations by the Examiner to Siegel are relevant in teaching the step of monitoring a blockage while controlling the introduced agent as presently claimed” (Appeal Br. 9). Appellants argue that “[t]here is absolutely no reference in Siegel to concurrent monitoring of blockage and controlling of the agent introduced” (id. at 9-10). We agree with Appellants that the Examiner has not adequately shown that Siegel discloses applying ultrasound, introducing an agent to a blockage, and “controlling the agent introduced while blockage monitoring.” Siegel discloses that “ultrasound diagnostic media, particularly echo contrast agents containing microbubbles, utilized in conjunction with ultrasound, provides a safe and effective method for dissolving arterial thrombi without the use of thrombolytic drugs” (Siegel, col. 1, ll. 53-58). Appeal 2011-011506 Application 11/273,095 4 In a working example, Siegel describes an experiment in which thrombi were induced in rabbits, which were then administered streptokinase and treated with ultrasound (id. at col. 9, ll. 1-23). Siegel states that “[s]erial angiograms were performed after thrombus induction, after thrombosis occlusion and during and after ultrasound exposure” (id. at col. 9, ll. 23-25). The Examiner argues that, by this disclosure, “Siegel is inherently covering the method of controlling the agent introduced while blockage monitoring” (Answer 4). The Examiner similarly argues that Siegel’s description of administering different amounts of a contrast agent, before ultrasound treatment, meets the limitation of controlling the agent while blockage monitoring (id.). We disagree with the Examiner’s claim interpretation. “[T]he PTO applies to the verbiage of the proposed claims the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by … the applicant’s specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). The ordinary meaning of “controlling the agent introduced while blockage monitoring” is that the agent is controlled at the same time as the blockage is monitored. The Specification states that controlling includes stopping the introduction of the agent, changing of the agent, or modifying the concentration of the agent (Spec. 2:19-24). Regardless of how the agent is controlled, however, the claim requires that the blockage is monitored at the same time. Appeal 2011-011506 Application 11/273,095 5 The Examiner has not pointed to any disclosure in Siegel of controlling an introduced agent while at the same time monitoring a blockage. Siegel’s disclosure of administering set dosages of streptokinase and administering ultrasound, and performing angiograms at different times during the process, does not meet the claim limitation because it does not describe simultaneously monitoring the blockage and controlling the introduction of the streptokinase. Thus, we reverse the rejection of independent claim 1 and dependent claims 2, 3, 6, and 7 as anticipated by Siegel. We also reverse the rejection of claims 4, 5, and 8-11 as obvious in view of Siegel (claims 8-11) or in view of Siegel, Nyhart, and Theeuwes (claims 4 and 5) because the Examiner relies on the same findings and reasoning with respect to Siegel as discussed above for claim 1. II. The Examiner has rejected claims 1-9 as anticipated by Carter, and has rejected claims 10 and 11 as obvious in view of Carter. The same issue is dispositive for both rejections. The Examiner finds that “Carter discloses a method for treating an intravascular blockage comprising the step[s] of: applying ultrasound to the blockage …; [and] introducing an agent to the blockage” (Answer 5). The Examiner finds that Carter discloses “monitoring the blockage to determine a status of initial weight … and final weight …, and the appearance of the clot” (id.). Regarding controlling the agent, the Examiner finds that Carter discloses that “by adjusting the feed rate of the seed fluid, the resulting cutting/dissolution activity can be controlled for maximum effect” (id., Appeal 2011-011506 Application 11/273,095 6 citing Carter at col. 6, l. 67 – col. 7, l. 3). The Examiner also reasons that “Carter discloses the step of monitoring of blockage while controlling the agent introduced” at column 7, line 56 through column 8, line 50 (Answer 10). Appellants contend that “Carter does not disclose the step of monitoring a blockage concurrently (while) controlling the introduced agent as presently claimed” (Appeal Br. 14). We agree with Appellants that the Examiner has not adequately shown that Carter discloses the disputed limitation. As discussed above in reference to Siegel, the ordinary meaning of this limitation, and the meaning consistent with the Specification, requires simultaneously monitoring the blockage and controlling the agent. Carter discloses a method for dissolving intravascular clots which “includes the steps of introducing ultrasonic waves proximate intravascular blockages and promoting cavitation of intravascular fluid proximate the intravascular blockages” (Carter, col. 3, ll. 25-29). Carter does disclose that by “adjusting the feed rate of the seed fluid, the resulting cutting/dissolution activity can be controlled for maximum effect” (id. at col. 6, l. 67 to col. 7, l. 2), but does not disclose simultaneously monitoring the clot or blockage while adjusting the feed rate of the seed fluid. The Examiner also pointed to Carter’s working example at columns 7- 8 as describing simultaneously monitoring a blockage and controlling an agent (Answer 10). That example describes an experiment in which a clot was placed in a vial, covered with a streptokinase solution of defined strength, and treated with ultrasound (Carter, col. 7, l. 56 to col. 8, l. 2). Appeal 2011-011506 Application 11/273,095 7 Thus, while this example describes introducing an agent (streptokinase) to a clot and applying ultrasound, it does not describe any control of the agent while the clot was being monitored, nor does it describe a “method of treating an intravascular blockage” (claim 1, emphasis added). We conclude that the Examiner has not adequately shown that Carter discloses all of the limitations of claim 1. We reverse the rejection of independent claim 1 and dependent claims 2-9 as anticipated by Carter. We also reverse the rejection of claims 10 and 11 as obvious in view of Carter, because the Examiner relies on the same findings and reasoning with respect to Carter as discussed above for claim 1. SUMMARY We reverse all of the rejections on appeal. REVERSED lp