DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,464,976 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because US 11,464,976 B2 has been found to anticipate each and every element of the present invention, for instance both provide a system for reversibly modulating the neural activity of a sympathetic nerve, wherein the system comprises: at least two neural interfacing elements suitable for placement on or around the nerve adjacent to a ganglion, wherein the ganglion transmits sympathetic signals between the ganglion and an effector; and at least one voltage or current source configured to generate at least one electrical signal to be applied to the nerve, via the at least two neural interfacing elements, to modulate the neural activity of the nerve to reduce sympatho-excitation in the effector, wherein the at least two neural interfacing elements are configured such that the electrical signal incites action potentials in the nerve that propagate away from the effector, towards the ganglion, wherein the charge density per phase applied to the nerve by the electrical signal is below a predetermined threshold, the predetermined threshold defined as the minimum charge density per phase required to produce a response associated with sympatho-excitation in the effector by modulating the neural activity of the sympathetic nerve.
As set forth above, the present invention is not viewed to be patentably distinct from US 11,464,976 B2.
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,157,007. Although the claims at issue are not identical, they are not patentably distinct from each other because US 12,157,007 has been found to anticipate each and every element of the present invention, for instance both provide a system for reversibly modulating the neural activity of a sympathetic nerve, wherein the system comprises: at least two neural interfacing elements suitable for placement on or around the nerve adjacent to a ganglion, wherein the ganglion transmits sympathetic signals between the ganglion and an effector; and at least one voltage or current source configured to generate at least one electrical signal to be applied to the nerve, via the at least two neural interfacing elements, to modulate the neural activity of the nerve to reduce sympatho-excitation in the effector, wherein the at least two neural interfacing elements are configured such that the electrical signal incites action potentials in the nerve that propagate away from the effector, towards the ganglion, wherein the charge density per phase applied to the nerve by the electrical signal is below a predetermined threshold, the predetermined threshold defined as the minimum charge density per phase required to produce a response associated with sympatho-excitation in the effector by modulating the neural activity of the sympathetic nerve.
As set forth above, the present invention is not viewed to be patentably distinct from US 12,157,007.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rezai (US 8,155,744).
Rezai discloses a system for reversibly modulating the neural activity of a sympathetic nerve (Abstract), wherein the system comprises: at least two neural interfacing elements (electrodes, depicted as 34 in Figure 2; col. 6, lines 4-30) suitable for placement on or around the nerve adjacent to a ganglion, wherein the ganglion transmits sympathetic signals between the ganglion and an effector ( Abstract; col. 11, lines 14-40); and at least one voltage or current source (col. 6, lines 42-55; cols. 9-10, lines 60-67 and 1-3, respectively) configured to generate at least one electrical signal to be applied to the nerve, via the at least two neural interfacing elements, to modulate the neural activity of the nerve to reduce sympatho-excitation in the effector (cols. 11-12, lines 41-67 and 1-9, respectively; cols. 15-16, lines 63-67 and 1-21, respectively; claim 1 in col. 17) wherein the at least two neural interfacing elements are configured such that the electrical signal incites action potentials in the nerve that propagate away from the effector, towards the ganglion, wherein the charge density per phase applied to the nerve by the electrical signal is below a predetermined threshold, the predetermined threshold defined as the minimum charge density per phase required to produce a response associated with sympatho-excitation in the effector by modulating the neural activity of the sympathetic nerve (col. 3, lines 9-18; since Rezai discloses "inhibitory stimulation", the stimulation applied by the electrical signal is below a "minimum charge density per phase required to produce a response associated with sympatho-excitation in the effector" (i.e., inhibiting a response)).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796
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