DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3 and 14-16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Grey et al. (US 6,272,383, hereinafter “Grey”) in view of Mann et al. (US 2002/0055761, hereinafter “Mann”).
In regards to claims 1 and 14, Mann discloses a method of treating dysmenorrhea or menstrual cramps (col. 2, line 48, “pre-menstrual cramps”), comprising:
non-invasively positioning a first portion of a patient’s body relative to an electrical stimulator in communication with a controller such that a tibial nerve within the first portion of the body is directly targeted by the electrical stimulator (Fig. 1; col. 2, lines 53- col. 3, line 14);
passing a current through the electrical stimulator (col. 1, lines 27-32, col. 2, lines 3-15); and
delivering an electrical stimulation from the electrical stimulator to the tibial nerve such that the tibial nerve directly receives the electrical stimulation to treat dysmenorrhea or menstrual cramps (Fig. 1; col. 2, lines 53-col. 3, line 14, col. 1, lines 27-32, col. 2, lines 3-15).
Grey does not expressly disclose detecting a muscular response via a sensor in communication with the controller, wherein the muscular response is caused by the electrical stimulation of the tibial nerve.
However, Mann in the same field of endeavor of electrical nerve stimulation teaches that it is known to detect a muscular response via a sensor in communication with the stimulation controller, wherein the muscular response is caused by the electrical stimulation of the nerve (pars. 0154-0155) to provide the predictable results of controlling the stimulation parameters in a closed-loop manner, thusly providing more precise control of the stimulation (par. 0155).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Grey by detecting a muscular response via a sensor in communication with the stimulation controller, wherein the muscular response is caused by the electrical stimulation of the nerve to provide the predictable results of controlling the stimulation parameters in a closed-loop manner, thusly providing more precise control of the stimulation.
In regards to claims 2 and 15, Mann teaches that the controller monitors or controls the electrical stimulation based on feedback from the muscular response (pars. 0154-0155) to provide the same predictable results as set forth above.
In regards to claims 3 and 16, Grey discloses wherein non-invasively positioning comprises positioning an electrode patch in communication with the electrical stimulator upon a foot of the patient (col. 3, lines 8-14).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 4 and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Grey and Mann, as applied to claim 1 above, and further in view of Herregraven et al. (US 2008/0033510, hereinafter “Herregraven”).
Grey discloses the essential features of the claimed invention except for activating the electrical stimulator for a duration of about 30 minutes per week to treat the patient.
However, Herregraven in the same field of endeavor of tibial nerve stimulation teaches activating the electrical stimulator for a duration of about 30 minutes per week to treat the patient (par. 0061) to provide the predictable results of a treatment regimen that is known to be effective in activating the tibial nerve pathways.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Grey by activating the electrical stimulator for a duration of about 30 minutes per week to treat the patient to provide the predictable results of a treatment regimen that is known to be effective in activating the tibial nerve pathways.
Claims 5-13 and 18-26 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Grey and Mann, as applied to claim 1 above, and further in view of Lund et al. (US 2007/0265675, hereinafter “Lund”).
Grey’s modified invention discloses the essential features of the claimed invention, including using a sensor to adjust stimulation parameters in a closed-loop manner (pars. 0154-0155), but does not expressly disclose displaying physiological parameters detected from the patient (claims 5 and 18); that the lacking presence of conduction is an indicator of electrode migration, electrode malfunction, or proper electrode placement (claims 6, 8, 10, 12, 19, 21, 23 and 25 and 12); or determining the response with an electrode patch (claims 7, 9, 11, 13, 20, 22, 24 and 26).
However, Lund in the same field of endeavor of neural stimulation teaches acquiring and displaying an evoked EMG from the neural stimulation (pars. 0071, 0074, 0075) to provide the predictable results of allowing the user to visualize when an evoked response or optimal evoked response has been generated by the stimulation (pars. 0071, 0074, 0075); and determining stimulation response or lack thereof (Fig. 3) with EMG electrodes (par. 0056) as an indicator of electrode migration (par. 0037), electrode malfunction (by virtue of its migration), and proper electrode placement (migration indicates improper position) to provide the predictable results of optimizing therapy based on feedback from the patient (par. 0035).
Furthermore, it is well-known in the art to embody surface EMG electrodes as patches to provide the predictable results of comfortable and self-carrying electrodes that do not require a user to hold them in contact with the body.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Grey by acquiring and displaying an evoked EMG from the neural stimulation to provide the predictable results of allowing the user to visualize when an evoked response or optimal evoked response has been generated by the stimulation; determining stimulation response or lack thereof with EMG electrodes as an indicator of electrode migration, electrode malfunction, and proper electrode placement to provide the predictable results of optimizing therapy based on feedback from the patient; and to embody the EMG electrodes as patches to provide the predictable results of comfortable and self-carrying electrodes that do not require a user to hold them in contact with the body.
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 1-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,083,334. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the issued patent are narrower than (i.e., “anticipate”) the claims of the instant application.
Claims of the ‘334 issued patent (narrower limitations in bold)
Claims of the instant application (broader limitations underlined)
1. A method of treating dysmenorrhea or menstrual cramps, comprising: non-invasively positioning a first portion of a patient's body relative to an electrical stimulator in communication with a controller such that a branch of a posterior tibial nerve within the first portion of the body is directly targeted by the electrical stimulator; passing a current through the electrical stimulator; delivering an electrical stimulation from the electrical stimulator to the branch of the posterior tibial nerve such that the branch directly receives the electrical stimulation to treat dysmenorrhea or menstrual cramps; and detecting a muscular response via a sensor in communication with the controller, wherein the muscular response is caused by the electrical stimulation of the branch of the posterior tibial nerve, and wherein the controller monitors or controls the electrical stimulation based on feedback from the muscular response.
1. A method of treating dysmenorrhea or menstrual cramps, comprising: non-invasively positioning a first portion of a patient’s body relative to an electrical stimulator in communication with a controller such that a tibial nerve within the first portion of the body is directly targeted by the electrical stimulator; passing a current through the electrical stimulator; delivering an electrical stimulation from the electrical stimulator to the tibial nerve such that the tibial nerve directly receives the electrical stimulation to treat dysmenorrhea or menstrual cramps; and detecting a muscular response via a sensor in communication with the controller, wherein the muscular response is caused by the electrical stimulation of the tibial nerve.
2. The method of claim 1 wherein the controller monitors or controls the electrical stimulation based on feedback from the muscular response.
14. A method of treating dysmenorrhea or menstrual cramps, comprising: non-invasively positioning a first portion of a patient’s body relative to an electrical stimulator in communication with a controller such that a nerve within the first portion of the body is directly targeted by the electrical stimulator; passing a current through the electrical stimulator; delivering an electrical stimulation from the electrical stimulator to the nerve such that the nerve directly receives the electrical stimulation to treat dysmenorrhea or menstrual cramps; and detecting a muscular response via a sensor in communication with the controller, wherein the muscular response is caused by the electrical stimulation of the nerve.
15. The method of claim 14 wherein the controller monitors or controls the electrical stimulation based on feedback from the muscular response.
2. The method of claim 1 wherein non-invasively positioning comprises positioning an electrode patch in communication with the electrical stimulator upon a foot of the patient.
3. The method of claim 1 wherein non-invasively positioning comprises positioning an electrode patch in communication with the electrical stimulator upon a foot of the patient.
16. The method of claim 14 wherein non-invasively positioning comprises positioning an electrode patch in communication with the electrical stimulator upon a foot of the patient.
3. The method of claim 1 wherein delivering the electrical stimulus comprises activating the electrical stimulator for a duration of about 30 minutes per week to treat the patient.
4. The method of claim 1 wherein delivering the electrical stimulus comprises activating the electrical stimulator for a duration of about 30 minutes per week to treat the patient.
17. The method of claim 14 wherein delivering the electrical stimulus comprises activating the electrical stimulator for a duration of about 30 minutes per week to treat the patient.
4. The method of claim 1 further comprising displaying physiological parameters detected from the patient.
5. The method of claim 1 further comprising displaying physiological parameters detected from the patient.
18. The method of claim 14 further comprising displaying physiological parameters detected from the patient.
5. The method of claim 1 further comprising detecting for a lack of presence of electrical conduction at a second portion of the patient's body distant from the first portion as an indicator of electrode migration from the first portion.
6. The method of claim 1 further comprising detecting for a lack of presence of electrical conduction at a second portion of the patient’s body distant from the first portion as an indicator of electrode migration from the first portion.
19. The method of claim 14 further comprising detecting for a lack of presence of electrical conduction at a second portion of the patient’s body distant from the first portion as an indicator of electrode migration from the first portion.
6. The method of claim 5 wherein detecting for the presence of electrical conduction comprises detecting via an electrode patch positioned upon the second portion.
7. The method of claim 6 wherein detecting for the presence of electrical conduction comprises detecting via an electrode patch positioned upon the second portion.
20. The method of claim 19 wherein detecting for the presence of electrical conduction comprises detecting via an electrode patch positioned upon the second portion.
7. The method of claim 1 further comprising detecting for a lack of presence of electrical conduction at a second portion of the patient's body distant from the first portion as an indicator of electrode malfunction from the first portion.
8. The method of claim 1 further comprising detecting for a lack of presence of electrical conduction at a second portion of the patient’s body distant from the first portion as an indicator of electrode malfunction from the first portion.
21. The method of claim 14 further comprising detecting for a lack of presence of electrical conduction at a second portion of the patient’s body distant from the first portion as an indicator of electrode malfunction from the first portion.
8. The method of claim 7 wherein detecting for the presence of electrical conduction comprises detecting via an electrode patch positioned upon the second portion.
9. The method of claim 7 wherein detecting for the presence of electrical conduction comprises detecting via an electrode patch positioned upon the second portion.
22. The method of claim 21 wherein detecting for the presence of electrical conduction comprises detecting via an electrode patch positioned upon the second portion.
9. The method of claim 1 further comprising detecting for a lack of presence of electrical conduction at a second portion of the patient's body distant from the first portion as an indicator of proper electrode placement upon the first portion.
10. The method of claim 1 further comprising detecting for a lack of presence of electrical conduction at a second portion of the patient’s body distant from the first portion as an indicator of proper electrode placement upon the first portion.
23. The method of claim 14 further comprising detecting for a lack of presence of electrical conduction at a second portion of the patient’s body distant from the first portion as an indicator of proper electrode placement upon the first portion.
10. The method of claim 9 wherein detecting for the presence of electrical conduction comprises detecting via an electrode patch positioned upon the second portion.
11. The method of claim 10 wherein detecting for the presence of electrical conduction comprises detecting via an electrode patch positioned upon the second portion.
24. The method of claim 23 wherein detecting for the presence of electrical conduction comprises detecting via an electrode patch positioned upon the second portion.
11. The method of claim 1 further comprising detecting for a lack of presence of electrical conduction through tissue at a second portion of the patient's body distant from the first portion as an indicator of electrode placement upon the first portion.
12. The method of claim 1 further comprising detecting for a lack of presence of electrical conduction through tissue at a second portion of the patient’s body distant from the first portion as an indicator of electrode placement upon the first portion.
25. The method of claim 14 further comprising detecting for a lack of presence of electrical conduction through tissue at a second portion of the patient’s body distant from the first portion as an indicator of electrode placement upon the first portion.
12. The method of claim 11 wherein detecting for the presence of electrical conduction through tissue comprises detecting via an electrode patch positioned upon the second portion.
13. The method of claim 12 wherein detecting for the presence of electrical conduction through tissue comprises detecting via an electrode patch positioned upon the second portion.
26. The method of claim 25 wherein detecting for the presence of electrical conduction through tissue comprises detecting via an electrode patch positioned upon the second portion.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Rezai et al. (US 2006/0111754) is another example of treating dysmenorrhea via neural stimulation, but utilizes an implantable system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/MICHAEL W KAHELIN/ Primary Examiner, Art Unit 3792
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