UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD. Ex parte VINOD SHARMA and DANIEL C. SIGG

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2 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte VINOD SHARMA and DANIEL C. SIGG Appeal Technology Center 1600 Before ERIC GRIMES, FRANCISCO C. PRATS, and MELANIE L. McCOLLUM, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. 134 involving claims to a system for regulating the heart. The Examiner has rejected the claims as obvious. We have jurisdiction under 35 U.S.C. 6(b). We reverse. STATEMENT OF THE CASE The Specification discloses that, in treating atrial fibrillation (AF), [t]wo distinct treatment regimens are used - rhythm control and rate control. In rhythm control an effort is made to maintain the patient in sinus rhythm using cardioversion and antiarrhythmic drugs. In rate control the emphasis is on controlling the

3 ventricular rate by modulating the AV [atrio-ventricular] node while letting the AF persist. Drugs like beta-blockers, diltiazem and verapimil are commonly used to achieve rate control. (Spec. 3, 0008.) The Specification discloses that rate control is an effective therapy for AF [but s]ince the drugs are systemically taken, side effects are common (id. at 3-4, 0009). The Specification discloses a process for implantation of fibroblasts transfected with connexin alone or with voltage gated potassium channels to modulate conduction in the AV node and provide rate control during AF (id. at 4, 0016). The Specification discloses that backup pacing can be used along with delivery of fibroblasts to the AV node (id. at 11, 0047). Claims 35, 38 and 40 are on appeal and read as follows: 35. A system comprising a catheter sufficient to deliver a biological agent to the atrioventricular node of the heart of a subject; a device for pacing the heart rhythm of said subject; and a biological intervention agent that controls the ventricular rate during atrial fibrillation. 38. The system of claim[ ] 35 wherein said biological intervention agent comprises a voltage gated potassium channel. 40. The voltage gated potassium channel of claim 38 that is Kv2.1 or Kv1.3. The Examiner has rejected claims 35, 38, and 40 under 35 U.S.C. 103(a) as obvious in view of Rostami, 1 Narula 2 and Feld. 3 The Examiner finds that Rostami discloses atrial fibrillation treatment methods comprising 1 Rostami et al., US 5,836,985, Nov. 17, Narula, US 4,882,777, Nov. 21, Feld et al., US 7,294,333 B1, Nov. 13,

4 the introducing a catheter into a subject and, in some embodiments, stimulating independent conduction zones of the heart using, e.g., a pacemaker (Answer 6). The Examiner finds that Rostami also discloses that an atrio-venticular [sic] nodal blocking agent, e.g. drugs, like digitalis, beta blockers, and calcium channel blockers, can also be given to control the ventricular response (id., emphasis deleted). The Examiner finds that Rostami does not disclose a catheter sufficient to deliver a biological agent to the atrio-ventricular node of the heart, as required by claim 1, but that Narula discloses a specially shaped catheter tip for maintaining contact with a desired internal location, e.g., the atrio-ventricular (A-V) node, which can be used to deliver chemicals or energy (id. at 7). The Examiner finds that Feld discloses modifying the electrophysiological function of an excitable cardiac tissue region of an individual [by] implanting cells into the excitable tissue region, where a potassium channel polypeptide such as the Kv1.3 ion channel is a preferred embodiment (id. at 7-8). The Examiner concludes that it would have been obvious to combine Rostami s methods of treating atrial fibrillation with Narula s specially shaped catheter tip for contacting the A-V node and Feld s biological agent because Rostami teaches all the limitations of [the] claimed system in the context of treating atrial fibrillation except using a catheter to deliver a biological agent, which includes Kv1.3 voltage gated potassium channel, and Narula et al. and Feld et al. specifically teach using a catheter to deliver a biological agent in the context of treating atrial fibrillation (id. at 9). 3

5 Appellants argue that the Examiner has failed to articulate an adequate, logical rationale for combining the cited teachings to attain the system of claims 35, 38, and 40 (Appeal Br. 8). Appellants argue that the Examiner s stated reason for combining elements from the cited references is that, when combined, they meet the elements of instant claim 35 (id.). Appellants argue that the references do not provide a logical reason to combine their teachings (id. at 12). We agree with Appellants that the Examiner has not adequately shown that the cited references would have made obvious the system of claim 35. Rostami discloses that the medical treatment of atrial fibrillation is less than optimal in that it frequently fails to ablate the arrhythmia and is ultimately directed only toward the control of the ventricular response rate (Rostami, col. 1, ll ). Rostami discloses that antiarrhythmic drugs, like quinidine and procainamide, can reduce both the incidence and the duration of atrial fibrillation episodes. Atrio-venticular [sic] nodal blocking agent, e.g. drugs, like digitalis, Beta blockers, and calcium channel blockers, can also be given to control the ventricular response. (Id. at col. 1, ll ) Rostami discloses a method of treating atrial fibrillation in which a subject with a diseased heart is treated by sectioning the heart into independent conduction zones by catheter ablation, followed by stimulating the independent conduction zones with a heart pacing device (id. at col. 6, ll. 8-12). Narula discloses a catheter that can maintain contact with the A-V node (Narula, col. 2, ll ) and can be used to deliver chemicals (id. at col. 6, ll ). Feld discloses that cells transformed with the Kv1.3 4

6 potassium channels can be transplanted into the A-V node to treat atrial fibrillation by slowing the ventricular rate (Feld, col. 17, ll ). As we understand it, the Examiner s reasoning is that Rostami discloses the use of a pacemaker in a method to control atrial fibrillation and also discloses atrio-ventricular (A-V) blocking agents to control the ventricular response to atrial fibrillation, while Feld discloses that cells expressing Kv1.3 potassium channels also control the ventricular rate, and therefore it would have been obvious to use both a biological agent (Kv1.3 potassium channels) and a pacemaker to control atrial fibrillation. We agree with Appellants, however, that the Examiner has not adequately shown that this combination would have been prima facie obvious based on the prior art. Rostami discloses that its method is a substantial improvement over existing techniques because it presents a potential cure for atrial fibrillation (Rostami, col. 6, ll. 5-7). Thus, Rostami presents its sectioning-and-stimulating method as an alternative to prior art methods such as administration of A-V blocking agents to control the ventricular response to atrial fibrillation. The Examiner has not pointed to any disclosure in Rostami that the sectioning-and-stimulating method should be used together with administered A-V blocking agents. Nor has the Examiner provided any other reason, supported by evidence or sound technical reasoning, on which to conclude that a skilled worker would have considered it obvious to combine Feld s biological agent with Rostami s treatment method. The Examiner therefore has not adequately shown that the cited references would 5

7 have made obvious the system of independent claim 35, or dependent claims 38 and 40, based on Rostami, Narula and Feld. SUMMARY We reverse the rejection of claims 35, 38 and 40 under 35 U.S.C. 103(a). REVERSED lp 6