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 .
Response to Amendment
The amendment filed November 3, 2025 has been entered. Claims 1, 4-6, 10-20 have been amended. Currently, claims 1-20 are pending for examination.
Response to Arguments
Applicant’s arguments, see pages 5-7, filed November 3, 2025, with respect to the rejection(s) of claim(s) 1-20 under 35 U.S.C. 102 and/or 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Laing et al. (US 2012/0323294) or Simon et al. (US 2012/0101326).
Applicant's arguments filed November 3, 2025 with respect to the rejection of claims 6-7 as being unpatentable in view of Dunseath, Jr. (US 5,003,978) have been fully considered but they are not persuasive. Applicant argues (p. 9) that the prior art does not disclose or teach, “a stimulation template which is an adhesive element having an electrically conductive region and an electrically non-conductive region… which permits passage of said at least one stimulation signal in a predetermined pattern”. Dunseath, Jr. teaches it has been known in the art to provide an adhesive electrode pad 1 (fig. 1b) having an electrically conductive region (“central aperture in adhesive 4”) and an electrically non-conductive region 4 to permit passage of a stimulation signal in a predetermined pattern (“electrode pad 1 is coated with a non-conducting pressure sensitive adhesive 4 on all of the surface of conductive substrate 2 except for an area large enough to allow an electrical contact access to conductive substrate 2” col. 5, line 60 to col. 6, line 6). Applicant has not yet defined any details toward the predetermined pattern of the stimulation signal.
Applicant's arguments filed November 3, 2025 with respect to the rejection of claims 8-9 as being unpatentable in view of Lichtenstein et al. (US 2019/0090928) have been fully considered but they are not persuasive. Applicant argues (p. 10) that the prior art does not disclose or teach matters related to providing targeted stimulation of a nerve. Lichtenstein et al. was relied upon to teach that it is known in the art to take into consideration knowledge of a patient’s anatomy through image processing to customize an arrangement or template of stimulation electrodes ([0108]). This directly addresses claims 8-9’s requirement of, “wherein establishing at least one field shaping element includes a stimulation template having a portion that is adapted to be shaped according to the patient’s anatomical data” (claim 8) and “wherein establishing at least one field shaping element is a stimulation template adapted to be shaped according to imaging data of the patient (claim 9). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant's arguments filed November 3, 2025 with respect to the rejection of claim 10 as being unpatentable in view of Feinstein (US 2019/0366087) have been fully considered but they are not persuasive. Applicant argues (p. 10-11) that the prior art does not disclose “a patient response feedback” as now amended because the sensor signal or image data taught by Feinstein is not a patient’s verbal or behavioral response provided in response to stimulation. Applicant’s amendment of claim 10 of “a patient response feedback” does not necessarily require a patient’s verbal or behavioral response as argued by the applicant. A sensor signal or image data of the patient is considered a patient response feedback.
Applicant's arguments filed November 3, 2025 with respect to the rejection of claim 18 as being unpatentable in view of Glukhovsky et al. (US 2010/0198298) have been fully considered but they are not persuasive. Applicant argues (p. 11) that the primary reference Simon et al. (US 2011/0125203) is deficient in disclosing the claimed invention. This primary reference is no longer being relied upon in the rejection.
Priority
This application discloses and claims only subject matter disclosed in prior Application No. 16/734,646, filed January 6, 2020, and names the inventor or at least one joint inventor named in the prior application. Application No. 16/734,646 repeated a substantial portion of prior Application No. 14/553,427, filed November 25, 2014, and added disclosure not presented in the prior application, such as Figures 34A,B and portions in paragraphs [0214-0217], [0274] and [0276-0283]. Claims 6-20 in the current application directed to this added disclosure not present in the prior 14/553,427 application are therefore given the priority date of January 6, 2020.
Claim Objections
Claim 1 is objected to because of the following informalities: lines 10-11 recite, “said at least one electrical stimulator” and should instead recite, “said at least one external electrical stimulator” to maintain consistency with the amended language. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: lines 15-16 recite, “the least one electrical stimulation signal” and should instead recite, “the at least one electrical stimulation signal” to maintain consistency with the amended language. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: lines 16-17 recite, “a pelvic floor disorder” and should instead recite, “the pelvic floor disorder” to maintain consistency with line 2. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: line 4 recites, “the first stimulator” and should instead recite, “the at least one external electrical stimulator” to maintain consistency with claim 1. Appropriate correction is required.
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 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,633,593 in view of Simon et al. (US 2012/0101326). Claims 1-2 as compared to claim 1 of the patent recite all of the same limitations except for requiring at least one electrical stimulator. However Simon et al. teaches it is known in the art for stimulators treating a pelvic floor disorder to be electrical stimulators (see prior art rejection below). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to regard stimulators as electrical as evidenced by Simon et al. as they are well known types of stimulators for treating pelvic floor disorders, and therefore do not add novelty to the invention.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation, “said neurostimulator being devoid of a magnetic coil” (line 6). The insertion of the above phraseology as described above positively excludes a magnetic coil, however, there is no support in the originally filed specification for such exclusions. While the originally filed specification is silent with respect to the use of an external electrical stimulator with a magnetic coil, it is noted that as stated in MPEP 2173.05(i), the “mere absence of a positive recitation is not the basis for an exclusion.”
Claim 20 states non-magnetic electrical stimulators”. Similarly, the phrase “non-magnetic” positively excludes a magnetic electrical stimulator, but there is no support in the originally filed specification for such exclusions. While the originally filed specification is silent with respect to the use of an magnetic external electrical stimulator, it is noted that as stated in MPEP 2173.05(i), the “mere absence of a positive recitation is not the basis for an exclusion.”
Claims 2-20 are rejected to for being dependent on claim 1.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 3 is/are rejected under 35 U.S.C. 102(a)(1) and/or (a)(2) as being anticipated by Laing et al. (US 2012/0323294).
Regarding claim 1, Laing et al. discloses a method of providing treatment of a nerve in a lower limb of a patient with a pelvic floor disorder ([0003]) comprising: providing a neurostimulator 10 configured for operating an electrical signal generator (“pulse generator” [0028]) to provide at least one electrical stimulation signal to at least one external electrical stimulator 16 having at least one external electrode 12 for providing electrical stimulation to the patient (“a pulse generator for electrically coupling to a transcutaneous electrode” [0016]; “current pulses” [0031], [0044]), said neurostimulator being devoid of a magnetic coil and located external to a patient (fig. 1), said at least one external electrical stimulator providing the at least one electrical stimulation signal that is at least one source of an electrical stimulation field transmitted through a tissue of the patient (“current pulses traverse the stimulation site by passing from the transcutaneous electrode 12 to the internal percutaneous electrode needle 14.” [0031]; it has been well established that electrical current between two electrodes such as 12 and 14 generate an electrical stimulation field); establishing at least one field shaping element 14 electrically coupled to said at least one electrical stimulator 16 (fig. 1) and located external to a patient, said field shaping element configured for adjusting a shape of the at least one electrical stimulation field to provide targeted stimulation of the nerve (“current pulses traverse the stimulation site by passing from the transcutaneous electrode 12 to the internal percutaneous electrode needle 14” [0031]; location of 14 would affect the shape of the electrical stimulation field); and, operationally activating the neurostimulator 10, configured to provide the least one electrical stimulation signal to the nerve in a lower limb (fig. 1) of the patient with a pelvic floor disorder (“overactive bladder (OAB)” [0004]), the at least one electrical stimulation signal having a stimulus characteristic configured to treat the pelvic floor disorder ([0003-0004]).
Regarding claim 3, Laing et al. discloses wherein providing targeted stimulation of the nerve in the lower limb includes stimulating at least one branch of a tibial nerve of the patient ([0003-0004]).
Claim(s) 1, 3-5, 11-14, 16-17, 19-20 is/are rejected under 35 U.S.C. 102(a)(1) and/or (a)(2) as being anticipated by Simon et al. (US 2012/0101326).
Regarding claim 1, Simon et al. discloses a method of providing treatment of a nerve in a lower limb of a patient with a pelvic floor disorder (abstract) comprising: providing a neurostimulator 302 configured for operating an electrical signal generator 310 ([0060]) to provide at least one electrical stimulation signal to at least one external electrical stimulator 302 having at least one external electrode 340 for providing electrical stimulation to the patient (“impulses of energy” [0060]), said neurostimulator being devoid of a magnetic coil and located external to a patient (fig. 6), said at least one external electrical stimulator providing the at least one electrical stimulation signal that is at least one source of an electrical stimulation field transmitted through a tissue of the patient ([0031-0032], [0068], [0082]); establishing at least one field shaping element 350 electrically coupled to said at least one electrical stimulator (fig. 1b) and located external to a patient, said field shaping element configured for adjusting a shape of the at least one electrical stimulation field to provide targeted stimulation of the nerve ([0062]); and, operationally activating the neurostimulator 302, configured to provide the least one electrical stimulation signal to the nerve 60 in a lower limb (fig. 6) of the patient with a pelvic floor disorder (abstract), the at least one electrical stimulation signal having a stimulus characteristic configured to treat the pelvic floor disorder ([0034]).
Regarding claim 3, Simon et al. discloses wherein providing targeted stimulation of the nerve in the lower limb includes stimulating at least one branch of a tibial nerve 60 of the patient ([0032], [0149]).
Regarding claim 4, Simon et al. discloses wherein establishing at least one field shaping element 350 comprises providing a stimulation template formed of an electrically non-conductive material portion 351 (“interface is made of an electrically insulating (dielectric) material, such as a thin sheet of Mylar” [0062]) and an electrically conductive material portion 340 that is in contact with said at least one external electrical stimulator wherein said electrically non-conductive portion limits a region of a stimulator surface of the at least one external electrical stimulator that stimulates a portion of a skin surface of the patient with the at least one electrical stimulation signal (“sinuousness or curvature shown at the outer surface of the interface 351 corresponds also to sinuousness or curvature on the surface of the body, against which the interface 351 is applied, so as to make the interface and body surface contiguous” [0062]).
Regarding claim 5, Simon et al. discloses wherein establishing at least one field shaping element comprises providing a stimulation template located external to a patient and configured with a ridge 51 (fig. 1B, 5A, 5C; the perforation of mesh 51 yields “ridges” as applicant has not yet defined any particular structure to define the ridge) defining a shape that retains electroconductive gel within the shape, the gel being in contact with said at least one external electrical stimulator (“a mesh 51 with openings that permit a conducting gel to pass from inside of the stimulator to the surface of the patient's skin at the position of nerve or tissue stimulation. Thus, the mesh with openings 51 is the part of the stimulator that is applied to the skin of the patient” [0111]).
Regarding claim 11, Simon et al. discloses wherein the at least one field shaping element is at least one of: a stimulation template having at least two layers 57 and 58 that are electrically non-conductive (“each head compartment 57 housing and its partition 58, are made of electrically insulating material”) for at least a portion of their geometry and flank an electrically conductive layer (“conducting gel”) positioned therebetween ([0113]).
Regarding claim 12, Simon et al. discloses wehrein said at least one field shaping element which is configured for adjusting the shape of the stimulation field of the at least one external electrical stimulator includes a shaping electrode grid containing at least three grid elements having fixed positions ([0061]) of which at least two are selectively activated to provide at least two different stimulation patterns ([0063], [0065-0066], [0068]).
Regarding claim 13, Simon et al. discloses wherein said at least one field shaping element which is configured for adjusting the shape of the stimulation field of the at least one external electrical stimulator includes a set of at least two additional electrode stimulators ([0061]), and said field shaping includes defining at least one stimulator of the set of the at least two additional electrode stimulators to be selectively activated to provide a stimulation pattern ([0063], [0065-0066], [0068]).
Regarding claim 14, Simon et al. discloses wherein said at least one field shaping element which is configured for adjusting the shape of the stimulation field of the at least one external electrical stimulator includes a set of at least two additional electrode stimulators ([0061]) that are physically coupled to the first stimulator (fig. 1B), and said field shaping includes defining at least one stimulator of the set of at least two additional electrode stimulators to be selectively activated to provide a stimulation pattern ([0063], [0065-0066], [0068]).
Regarding claim 16, Simon et al. discloses wherein said at least one field shaping element is configured for adjusting the shape of the stimulation field of the at least one external electrical stimulator and includes a shaping electrode grid that is divided into a plurality of electrically conductive elements (fig. 1B) each of which being selectively attached to at least one connector 345 of the signal generator 310 (fig. 1B).
Regarding claim 17, Simon et al. discloses wherein the plurality of electrically conductive elements are each separated from the other by a set of electrically non-conductive surfaces 57, 58 of said at least one field shaping element ([0113]).
Regarding claim 19, Simon et al. discloses wherein said at least one field shaping element comprises an electrode grid and at least one of a set of shaping parameter values (“executable computer programs” [0064], [0066]) that are defined for at least 3 grid elements ([0061]) of the electrode grid, and said set of shaping parameter values are stored in a memory and retrieved to provide a selected stimulation field shape ([0064], [0066]).
Regarding claim 20, Simon et al. discloses wherein the at least one external electrical stimualtor is one of at least 3 non-magnetic electrical stimulators ([0061]) provided on a surface substrate 58 that provides a fixed geometry of stimulation ([0113]), and a set of shaping parameter values are defined for the at least 3 non-magnetic electrical stimulators ([0063], [0065-0066], [0068]) to enable the neurostimulator to operate at least one external electrical stimulus generator 302 to adjustably provide at least two stimulation field shapes ([0031-0032], [0063], [0065-0066], [0068], [0082]).
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.
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.
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.
Claims 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simon et al. (US 2012/0101326) in view of Dunseath, Jr. (US 5,003,978).
Regarding claims 6-7, Simon et al. discloses wherein establishing at least one field shaping element comprises establishing a stimulation template having an electrically conductive region 56 and an electrically non-conductive region 58 ([0113]), said electrically conductive region is in electrical contact with said at least one external electrical stimulator and having a predetermined shape which permits passage of said at least one electrical stimulation signal in a predetermined pattern (fig. 1B, 5C). However, Simon et al. does not expressly disclose the stimulation template is an adhesive element having an electrically conductive region and an electrically non-conductive region, said electrically conductive region is in electrical contact with said at last one external electrical stimulator and having a predetermined shape which permits passage of said at least one electrical stimulation in a predetermined pattern, said adhesive element having a pair of opposing adhesive element surfaces selected from the group of: one of said opposing adhesive element surfaces being configured to be releasably attached to a skin surface of the patient, one of said opposing adhesive element surfaces being configured to be releasably attached to said at least one external stimulator, respective opposing adhesive element surfaces being releasably attached to said at least one external electrical stimulator and a skin surface of the patient. Dunseath, Jr. teaches it has been known in the art to provide an adhesive electrode pad 1 (fig. 1b) having an electrically conductive region (“central aperture in adhesive 4”) and an electrically non-conductive region 4 to permit passage of a stimulation signal in a predetermined pattern, the adhesive element having a pair of opposing adhesive element surfaces configured to be releasably attached to a skin surface of the patient and configured to be releasably attached to said stimulator (col. 5, line 60 to col. 6, line 6). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Simon et al. substitute the adhesive element stimulation template as taught by Dunseath, Jr. for the stimulation template 56, 58 as it provides a template that can adhere to the skin of the patient and can help better ensure the stimulator does not inadvertently migrate away from the desired skin surface.
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simon et al. (US 2012/0101326) in view of Lichtenstein et al. (US 2019/0090928).
Regarding claims 8-9, Simon et al. does not expressly disclose establishing at least one field shaping element includes a stimulation template having a portion that is adapted to be shaped according to the patient’s anatomical data or according to imaging data of the patient. Lichtenstein et al. teaches it is known in the art to take into consideration knowledge of a patient’s anatomy through image processing to customize an arrangement or template of stimulation electrodes ([0108]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Simon et al. to take into consideration the patient’s anatomical data or imaging data of the patient to determine the anatomical data for determining a stimulation template as taught by Litchtenstein et al. in order to provide a better knowledge of the patient’s geometry of target tissues to design a better treatment plan ([0108]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simon et al. (US 2012/0101326) in view of Feinstein (US 2019/0366087).
Regarding claim 10, Simon et al. does not expressly disclose establishing at least one field shaping element includes providing a stimulation template adapted to be configured according to assessment of the patient’s response feedback provided during a procedure that determines an area on the surface of the patient’s skin where stimulation is determined to be successful in stimulating a target nerve. Feinstein teaches it is known in the art to receive patient feedback (“imaging/sensor data”) during the intra-procedure stage of placing electrodes in order to determine if electrodes should be repositioned ([0053]) from a previously determined location or initial placement during a pre-procedure stage ([0052]), the sensor feedback indicative of patient parameters derived from the patient in real time during the therapeutic procedure ([0009-0010]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Simon et al. to establish at least one field shaping element by providing a stimulation template adapted to be configured according to assessment of the patient’s feedback provided during a procedure that determines an area on the surface of the patient’s skin where stimulation is determined to be successful as taught by Feinstein in order to provide a useful “patient specific model indicative of at least one of: electrode placement appropriate for the transcutaneous electrical impulses to reach the therapeutic target area” ([0009]).
Claim 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simon et al. (US 2012/0101326) in view of Moffitt et al. (US PG Pub 2012/0302912).
Regarding claim 15, Simon et al. discloses wherein said at least one field shaping element which is configured for adjusting the shape of the stimulation field of the at least one external electrical stimulator includes a shaping electrode grid containing at least three grid elements ([0061]), wherein at least two sets of grid elements are selectively activated to provide at least two patterns of stimulation ([0063], [0065-0066], [0068]). Simon et al. does not expressly disclose wherein each of said grid elements has an associated optical indicator to provide a visual indication of which of said grid elements are activated. Moffitt et al. teaches indicators 112 for providing an indication of the amount of electrical current flowing through each of the electrodes 26 in terms of a fractionalized current value ([0128]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Simon et al. to include indicators as taught by Moffitt et al. in order to provide a visual indication of the amount of electrical current flowing through each electrode during field shaping.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simon et al. (US 2012/0101326) in view of Glukhovsky et al. (US 2010/0198298).
Regarding claim 18, Simon et al. discloses wherein said at least one field shaping element includes a stimulation template that includes an electrode grid having a set of selectively activated electrically conductive contacts ([0063], [0065-0066], [0068]) that are selectively activated but does not expressly disclose to cause alignment between an edge formed by the selectively activated electrically conductive contacts and a portion of an implantable electrically conductive element. Glukhovsky et al. teaches it is known in the art for a field shaping element with selectively activated electrically conductive contacts 20a-b external to a patient to be activated to cause alignment between an edge of the electrically conductive contacts and a portion of an implantable electrically conductive element 24a-b (fig. 2) in order to deliver electrical signal to a nerve 12 ([0121-0122]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Simon et al. to incorporate an implantable electrically conductive element, and to cause alignment between an edge formed by the selectively activated electrically conductive elements and a portion of the implantable electrically conductive element as taught by Glukhovsky et al. in order to better route electrical current to selective target body tissues ([0007]) by providing an implant to act as a conductive pathway ([0041]).
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 ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David 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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/ERICA S LEE/Primary Examiner, Art Unit 3796