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 15 – 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 14 of U.S. Patent No. 12,285,609. Although the claims at issue are not identical, they are not patentably distinct from each other because the current application and the ‘609 patent both claim a system and method for providing sub-perception stimulation to a patient. For example, claim 29 of the present application requires the additional limitation wherein the supra-perception biphasic stimulation pulses are symmetric, and wherein the sub-perception biphasic stimulation pulses are symmetric that is not required in claim 12 of the ‘609 patent. However, that limitation is required in dependent claim 14.
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(s) 15, 17, 20, and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Doan (US PGPUB 2014/0364919 – in IDS).
Regarding claim 15, Doan discloses a spinal cord stimulator comprising a plurality of electrodes in an electrode array (e.g. Figs. 2 and 3), the method comprising in order: programming a first amplitude for the implantable spinal cord stimulator (e.g. ¶ 46); providing supra-perception biphasic stimulation pulses at a frequency via one or more first of the plurality of electrodes and one or more second of the plurality of electrodes (e.g. ABSTRACT and ¶ 49), wherein the supra-perception biphasic stimulation pulses have first and second phases, wherein during the first phases the one or more first electrodes provide the first amplitude in sum as an anodic current and the one or more second electrodes provide the first amplitude in sum as a cathodic current, wherein during the second phases the one or more second electrodes provide the first amplitude in sum as an anodic current and the one or more first electrodes provide the first amplitude in sum as a cathodic current (e.g. ¶ 49); programming a second amplitude for the implantable spinal cord stimulator, wherein the second amplitude is lower than the first amplitude; providing sub-perception biphasic stimulation pulses at the frequency via the one or more first electrodes and the one or more second electrodes (e.g. ABSTRACT and ¶ 46), wherein the sub- perception biphasic stimulation pulses have third and fourth phases, wherein during the third phases the one or more first electrodes provide the second amplitude in sum as an anodic current and the one or more second electrodes provide the second amplitude in sum as a cathodic current, and wherein during the fourth phases the one or more second electrodes provide the second amplitude in sum as an anodic current and the one or more first electrodes provide the second amplitude in sum as a cathodic current (e.g. ¶ 49).
Regarding claim 17, Doan discloses wherein a charge of the first phase equals a charge of the second phase for each supra-perception biphasic stimulation pulse, and wherein a charge of the third phase equals a charge of the fourth phase for each sub-perception biphasic stimulation pulse (e.g. Fig. 5b; the charge for the first and second phase appears to be equal).
Regarding claim 20, Doan discloses programming the first and second amplitudes for the implantable spinal cord stimulator comprises entering the first and second amplitudes into an external system in communication with the implantable stimulator device (e.g. Fig. 2).
Regarding claim 21, Doan discloses the plurality of electrodes are located on one or more leads implanted in a spinal column of the patient (e.g. Figs. 2 and 3).
Claim Rejections - 35 USC § 103
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.
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(s) 16, 23, 25, 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Doan in view of Moffitt et al. (US PGPUB 2017/0173335 – in IDS).
Regarding claims 16, 23, and 25, Doan discloses the stimulation pulses as previously discussed, but fails to teach the frequency is 130 Hz or less and, more specifically, 90 Hz.
Moffitt teaches wherein the biphasic test pulses are formed at 130 Hz or less (e.g. ¶ 70, modulation delivered at frequencies less than 130 Hz and as low as 2 Hz).
It would have been obvious to one having ordinary skill in the art to modify the frequencies as taught by Doan with the specific lower frequencies as taught by Moffitt, since different patients react differently to different therapies, and determining the optimal parameters would require only routine skill in the art.
Regarding claim 26, Doan discloses programming the first and second amplitudes for the implantable spinal cord stimulator comprises entering the first and second amplitudes into an external system in communication with the implantable stimulator device (e.g. Fig. 2).
Regarding claim 27, Doan discloses the plurality of electrodes are located on one or more leads implanted in a spinal column of the patient (e.g. Figs. 2 and 3).
Claim(s) 18, 19, 29 - 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Doan in view of Jaax et al. (US PGPUB 2013/0053923 – in IDS)
Regarding claims 18, 19, and 29, Doan discloses the stimulation as previously discussed. Doan does not disclose wherein the biphasic pulses comprises symmetric biphasic pulses, wherein a duration of the first phases is equal to a duration of the second phase.
Jaax teaches a SCS method wherein the biphasic pulses comprises symmetric biphasic pulses, wherein a duration of the first phases is equal to a duration of the second phase (¶ 95).
It would have been obvious to one of ordinary skill in the art at the time of invention to substitute the asymmetrical biphasic pulses disclosed by Doan with the symmetric biphasic pulses taught by Jaax as such a modification is a simple substitution between one known element (asymmetrical biphasic pulses) with another (symmetric biphasic pulses) in order to yield the predictable result of performing SCS.
Regarding claims 30 and 31, Doan discloses wherein a charge of the first phase equals a charge of the second phase for each supra-perception biphasic stimulation pulse, and wherein a charge of the third phase equals a charge of the fourth phase for each sub-perception biphasic stimulation pulse (e.g. Fig. 5b; the charge for the first and second phase appears to be equal).
Regarding claim 32, Doan discloses programming the first and second amplitudes for the implantable spinal cord stimulator comprises entering the first and second amplitudes into an external system in communication with the implantable stimulator device (e.g. Fig. 2).
Regarding claim 33, Doan discloses the plurality of electrodes are located on one or more leads implanted in a spinal column of the patient (e.g. Figs. 2 and 3).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Doan in view of Moffitt et al. as applied to claim 23 above, and further in view of Jaax et al.
Regarding claim 24, Doan in view of Moffitt discloses the stimulation as previously discussed. Doan in view of Moffitt does not disclose wherein the biphasic pulses comprises symmetric biphasic pulses, wherein a duration of the first phases is equal to a duration of the second phase.
Jaax teaches a SCS method wherein the biphasic pulses comprises symmetric biphasic pulses, wherein a duration of the first phases is equal to a duration of the second phase (¶ 95).
It would have been obvious to one of ordinary skill in the art at the time of invention to substitute the asymmetrical biphasic pulses disclosed by Doan in view of Moffitt with the symmetric biphasic pulses taught by Jaax as such a modification is a simple substitution between one known element (asymmetrical biphasic pulses) with another (symmetric biphasic pulses) in order to yield the predictable result of performing SCS.
Allowable Subject Matter
Claims 22, 28, and 34 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art fails to teach wherein the sub-perception biphasic stimulation pulses wash in for a period of one hour or less during the programming session to provide pain relief to the patient without paresthesia.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached on 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3796
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