DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
In view of the amendment filed on March 9, 2026, claims 1-20 have been canceled and claims 21-35 have been added. Accordingly, claims 21-35 are pending and under examination.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of U.S. Patent No. 11,241,238 (hereinafter “the patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because all limitation in claim 1 of the application can be found in claim 19 of the patent.
The claims match-up with respect to one another is listed below:
Patent Application No. 18/653,421
Patent No. 11,241,238
Claim 21. (new) A system for treating heart muscle tissue, the system comprising:
an occlusion catheter comprising a fluid lumen and an inflatable balloon device configured to occlude a portion of a coronary venous system when the inflatable balloon device is inflated with fluid via the fluid lumen; and
a control system comprising a pressure signal input that receives a pressure signal indicative of a pressure in the coronary venous system and a control circuit that activates a pneumatic subsystem to inflate or deflate the inflatable balloon device of the occlusion catheter for intermittently occluding the portion of the coronary venous system,
wherein the control system is programmed to, during a first period of operation, activate the inflatable balloon device of the occlusion catheter to intermittently occlude the portion of the coronary venous system according to a first set of occlusion periods and release periods, the control system being programmed such that the occlusion periods and the release periods of the first set having lengths of time that are independent of the pressure signal,
wherein the control system is programmed to, during a second period of operation and after the first period of operation, activate the inflatable balloon device of the occlusion catheter to intermittently occlude the portion of the coronary venous system in a second set of occlusion periods and release periods, the control system being programmed such that occlusion periods and the release periods of the second set being dependent at least in part on the pressure signal, and
wherein the control system is programmed to, during a third period of operation after the second period of operation, repeat the first set of the occlusion periods and the release periods that are independent of the pressure signal.
Claim 16. A system for treating heart muscle tissue, comprising:
a coronary sinus occlusion catheter including a distal tip portion, a proximal hub portion, and a balloon fluid lumen, the distal tip portion of the coronary sinus occlusion catheter comprising an inflatable balloon device configured to occlude a coronary sinus when inflated with fluid via the balloon fluid lumen; and
a control system to control inflation and deflation of the inflatable balloon device for intermittent coronary sinus occlusion, the control system comprising a display device, a pressure signal input that receives a pressure signal indicative of coronary sinus pressure, an electrocardiogram (ECG) signal input, and a control circuit that activates a pneumatic subsystem to inflate or deflate the inflatable balloon device of the coronary sinus occlusion catheter for intermittently occluding the coronary sinus,
wherein the control system, during a first period of operation, is programmed to activate the inflatable balloon device of the coronary sinus occlusion catheter to intermittently occlude the coronary sinus according to an automated and predetermined first pattern of occlusion periods and release periods that is stored by the control system and that is independent of the pressure signal indicative of the coronary sinus pressure, the occlusion periods and the release periods of the first pattern having predetermined lengths of time that are independent of the pressure signal, and
wherein the control system, during a second period of operation and after the first period of operation, is programmed to activate the inflatable balloon device of the coronary sinus occlusion catheter to intermittently occlude the coronary sinus in a second pattern of occlusion periods and release periods, the occlusion periods and the release periods of the second pattern being dependent at least in part on the pressure signal, and
wherein during a third period of operation after the second period of operation, the control system repeats the first pattern of occlusion periods and release periods that is previously stored by the control system and that is independent of the pressure signal indicative of the coronary sinus pressure.
Allowable Subject Matter
Claims 21-35 would be allowable if a Terminal Disclaimer is filed to overcome the nonstatutory double patenting rejection set forth in this Office action.
There is no prior art of record alone or in combination that teaches a system for treating heart muscle tissue, comprising: inter alias, a control system comprising a pressure signal input that receives a pressure signal indicative of a pressure in the coronary venous system and a control circuit that activates a pneumatic subsystem to inflate or deflate the inflatable balloon device of the occlusion catheter for intermittently occluding the portion of the coronary venous system, wherein the control system is programmed to, during a first period of operation, activate the inflatable balloon device of the occlusion catheter to intermittently occlude the portion of the coronary venous system according to a first set of occlusion periods and release periods, the control system being programmed such that the occlusion periods and the release periods of the first set having lengths of time that are independent of the pressure signal, wherein the control system is programmed to, during a second period of operation and after the first period of operation, activate the inflatable balloon device of the occlusion catheter to intermittently occlude the portion of the coronary venous system in a second set of occlusion periods and release periods, the control system being programmed such that occlusion periods and the release periods of the second set being dependent at least in part on the pressure signal, and wherein the control system is programmed to, during a third period of operation after the second period of operation, repeat the first set of the occlusion periods and the release periods that are independent of the pressure signal.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TUAN V NGUYEN whose telephone number is (571)272-5962. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM.
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771
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