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 .
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Drawings
The Applicant is reminded to carefully review the drawing figures and the accompanying specification to ensure that all reference numerals present in the drawing figures are defined within the specification.
Specification
The disclosure is objected to because of the following informalities: prior to allowance, Applicant should update the first paragraph of the specification to indicate the present status of all applications referred to therein.
Appropriate correction is required.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Faltys et al. (U.S. 2011/0190849). Faltys discloses a system for treating chronic inflammation in a subject, the system comprising: an implantable microstimulator configured to apply a low duty-cycle stimulation to a vagus nerve (“an implantable microstimulator configured for implantation around a cervical portion of a vagus nerve to modulate inflammation by applying low duty-cycle stimulation to the vagus nerve”, paragraph [0043]); and a controller adapted to set a dose regimen, wherein the dose regimen comprises a plurality of electrical stimulations to the vagus nerve that are separated by an off period of at least 4 hours (“The Dose Interval may be set by changing the duration between Doses (e.g. 12, 24, 48 hours).”, paragraph [0119]), wherein each electrical stimulation comprises less than 100 supra-threshold pulses (where zero is included in the range of “less than 100 supra-threshold pulses”).
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Huston et al. (U.S. 2009/0143831) in view of Whitehurst et al. (U.S. Patent No. 7,167,751). Huston discloses a system for treating chronic inflammation in a subject, the system comprising: an implantable stimulator configured to apply a low duty-cycle stimulation to a vagus nerve (“These methods, systems and devices typically stimulate all or a portion of a patient's inflammatory reflex (e.g., the vagus nerve), to inhibit inflammation, pro-inflammatory cytokine production or release, or the pro-inflammatory cytokine cascade. For example, the inhibitory stimulation described herein includes extremely low duty-cycle stimulation, such as stimulation of the vagus nerve at levels that do not provoke other non-immune, biological effects mediated by the vagus nerve (e.g., blood pressure, heart rate, etc.).”, paragraph [0013]); and a controller adapted to set a dose regimen, wherein the dose regimen comprises a plurality of electrical stimulations to the vagus nerve that are separated by an off period of at least 4 hours (“The off-time before the vagus nerve is re-stimulated may be from about 2 hours to about 48 hours.”, paragraph [0017]), wherein each electrical stimulation comprises less than 100 supra-threshold pulses (where zero is included in the range of “less than 100 supra-threshold pulses” and paragraph of Huston teaches that the signal ‘on’ time can be from 1 to 120 seconds, and the signal controller can set the frequency of stimulation to be between 0.1 and 30 Hz. Thus, for a 1 second signal on time, 30 pulses would be delivered, which is less than 100 pulses.). However, Huston fails to explicitly disclose that the stimulator is a microstimulator. Whitehurst teaches a microstimulator (see column 3, lines 12-19) to stimulate the vagus nerve (see column 2, lines 49-52), which provides the advantage of being capable of implantation with a minimal surgical procedure (see column 2, lines 49-52). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Huston to utilize a microstimulator as the stimulator, as taught by Whitehurst, in order to minimize the surgical trauma caused by implantation of the stimulator.
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 1 of U.S. Patent No. 8,788,034. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the present application is anticipated by claim 1 of the patent.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,211,410. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the present application is anticipated by claim 1 of the patent.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,849,286. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the present application is anticipated by claim 1 of the patent.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,357,826. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the present application is anticipated by claim 1 of the patent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
