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 .
Drawings
2. The drawings are objected to because Fig. 9B contains misspellings of “Target Freuency” and “HOMEOSTIC” (two instances). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
3. Figures 2 and 7 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
4. The disclosure is objected to because of the following informalities: at [00158] of the instant disclosure, “a which” should apparently read --at which--.
Appropriate correction is required.
Claim Objections
5. Claims 1 and 13 are objected to because of the following informalities: at line 11 of claim 1 and line 13 of claim 13, “application a plurality” should apparently read –application of a plurality--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
6. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
7. Claims 3-6, 8, 10, 11, 15-17, 19 and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
8. Claim 3 recites “determining a frequency between 8-12 Hz that lies within a threshold distance of a first set of peak frequencies of a majority of the plurality of EEG channels”. While the claim appears to initially require the determination of a frequency that is within a range of 8-12 Hz, it is unclear what the remainder of the claim “that lies within a threshold distance of a first set of peak frequencies of a majority of the plurality of EEG channels” imparts to that determined frequency.
9. Further in claim 3, it is unclear how to interpret “a threshold distance” with respect to frequencies as the disclosure appears to be silent on such.
10. Further in claim 3, it is unclear if “a frequency between 8-12 Hz” is the same as or different than “the target frequency” or “a frequency” at line 12 of claim 1.
11. Claims 3 and 5 at line 3 recite “a majority of the plurality of EEG channels”. It is unclear what constitutes a “majority” as it is a relative term. The term “majority” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
12. At line 2 of claim 4, it is unclear if “the frequency” is the same as or different than “the target frequency” or “a frequency” at line 12 of claim 1.
13. At line 2 of claim 4, it is unclear what defines “a nearest heart rate frequency”.
14. In claim 5, it is unclear if “a frequency” is the same as or different than “the target frequency” or “a frequency” at line 12 of claim 1.
15. Claim 6 recites “two consecutive TMS treatments”. It is unclear if this recitation is referencing “one or more individualized transcranial magnetic stimulation (TMS) treatments” recited at line 10 of claim 1 or not. If so, a suggested amendment is –two consecutive individualized TMS treatments--.
16. Claim 8 at line 2 recites the limitation "the second treatment protocol". There is insufficient antecedent basis for this limitation in the claim.
17. At line 4 of claim 10, it is unclear what comprises "a greatest frequency" as there is no recitation of what the frequency is "greatest" or "greater than" with respect to.
18. At line 5 of claim 10, it is unclear if "a plurality of EEG channel" is the same as or different than "a plurality of EEG channels" recited at line 8 of claim 1.
19. At line 5 of claim 10, it is unclear how an EEG channel is determined to be close, or "closer" to a (target) frequency as the term "closer" implies a physical location.
20. At line 3 of claim 15, it is unclear if “a frequency between 8-12 Hz” is the same as or different than “the target frequency” or “a frequency” at line 14 of claim 13.
21. Claim 15 recites “a plurality of peaks across the plurality of EEG channels are approximately aligned”. The term “approximately” in claim 15 is a relative term which renders the claim indefinite. The phrase “approximately aligned” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
22. In claim 16, it is unclear if “a frequency” recited at line 3 is the same as or different than “the target frequency” or “a frequency” at line 14 of claim 13.
23. Claim 16 at line 4 recites “a majority of the plurality of EEG channels”. It is unclear what constitutes a “majority” as it is a relative term. The term “majority” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
24. Claim 17 recites “two consecutive TMS treatments”. It is unclear if this recitation is referencing “one or more individualized transcranial magnetic stimulation (TMS) treatments” recited at line 12 of claim 13 or not. If so, a suggested amendment is –two consecutive individualized TMS treatments--.
25. Claim 19 at line 2 recites the limitation "the second treatment protocol". There is insufficient antecedent basis for this limitation in the claim.
26. At line 5 of claim 21, it is unclear what comprises "a greatest frequency" as there is no recitation of what the frequency is "greatest" or "greater than" with respect to.
27. At line 6 of claim 21, it is unclear if "a plurality of EEG channel" is the same as or different than "a plurality of EEG channels" recited at line 10 of claim 13.
28. At line 6 of claim 21, it is unclear how an EEG channel is determined to be close, or "closer" to a (target) frequency as the term "closer" implies a physical location.
Claim Rejections - 35 USC § 102
29. 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.
30. 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.
31. Claims 1, 3, 5-10, 12, 13 and 15-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stubbeman (U.S. Pub. No. 2014/0058189). Regarding claim 1, Stubbeman discloses a method for treatment of a mental disorder of a subject ([0018] and [0031]), the method comprising, by a processor:
receiving a first set of electroencephalography ("EEG") measurements, the first set of EEG measurements corresponding to brain activity at one or more of a plurality of zones of a brain of the subject [0058], [0065], [0069]);
determining, based on the first set of EEG measurement, a target frequency for the subject, the target frequency being an EEG frequency where the brain of the subject operates optimally across a plurality of EEG channels in an alpha brainwave (determining individual's alpha frequency or "IAF" - [0031] and [0073]);
generating, based on the target frequency, a treatment protocol for the subject, the treatment protocol comprising one or more individualized transcranial magnetic stimulation (TMS) treatments ([0031], [0074]-[0077]), that each include application a plurality of magnetic stimulation pulses [0078] for a defined time period and at a frequency [0078] of about the target frequency (approximately 10 Hz or "individual alpha frequency +1 Hz" [0031], [0114]; [0129], [0136], [0148]); and
causing a TMS system to provide the one or more treatments to the subject in accordance with the treatment protocol ([0031], [0055], [0059], [0066], [0067]).
Regarding claim 3 and in light of its indefinite nature, determining the target frequency comprises determining a frequency between 8 – 12Hz (approximately 10 Hz or "individual alpha frequency +1 Hz" [0031], [0114]; [0129], [0136], [0148]).
Regarding claim 5 and in view of its indefinite nature, determining the target frequency comprises determining a frequency that corresponds to an average of power spectral density (PSD) values of a majority of the plurality of EEG channels ([0069], [0073], [0114]).
Regarding claim 6, a treatment interval is interspersed between two consecutive TMS treatments ([0072], [0078] and [0144]).
Regarding claim 7, the method further comprises: receiving, after the causing the TMS system to provide the one or more treatments to the subject in accordance with the treatment protocol, a second set of EEG measurements; updating, based on the second set of EEG measurements, the target frequency to generate an updated target frequency; and generating based on the updated target frequency, a second treatment protocol ([0060], [0113] and [0117]).
Regarding claim 8, an intertrain interval of the treatment protocol is different than an intertrain interval of the second treatment protocol [0110].
Regarding claim 9, the target frequency is updated [0117] to align with a heart rate frequency of the subject (intended use/result).
Regarding claim 10 and in view of its indefinite nature, the method further comprises: receiving, after the causing the TMS system to provide the one or more treatments to the subject in accordance with the treatment protocol, a second set of EEG measurements; and displaying an improvement in the mental disorder as a movement of a greatest frequency associated with one or more of a plurality of EEG channel closer to the target frequency ([0059], [0077], [0082], [0117]).
Regarding claim 12, the mental disorder comprises at least one of the following: traumatic brain injury; tinnitus; short term memory issues; substance abuse disorder; sleep disorder; anxiety; depression; post-traumatic stress disorder; attention deficit hyperactivity disorder; bi-polar disorder; dementia; sleep disorders; balance and fine motor skills disorder; reading comprehension; verbal communication, and working memory disorders; night vision disorders; or colors and shape vision disorders ([0018], [0025]).
Regarding claim 13, Stubbeman discloses a system for treatment of a mental disorder of a subject, the system comprising: a processor; and a non-transitory computer-readable medium comprising programming instructions that when executed by the processor will cause the processor to ([0059], [0060] and [0106]):
receive a first set of electroencephalography ("EEG") measurements, the first set of EEG measurements corresponding to brain activity at one or more of a plurality of zones of a brain of the subject [0058], [0065], [0069]);
determine, based on the first set of EEG measurements, a target frequency for the subject, the target frequency being an EEG frequency where the brain of the subject operates optimally across a plurality of EEG channels in an alpha brainwave (determining individual's alpha frequency or "IAF" - [0031] and [0073]);
generate, based on the target frequency, a treatment protocol for the subject, the treatment protocol comprising one or more individualized transcranial magnetic stimulation (TMS) treatments ([0031], [0074]-[0077]), that each include application of a plurality of magnetic stimulation pulses [0078] for a defined time period and at a frequency [0078] of about the target frequency (approximately 10 Hz or "individual alpha frequency +1 Hz" [0031], [0114]; [0129], [0136], [0148]); and
cause a TMS system to provide the one or more treatments to the subject in accordance with the treatment protocol ([0031], [0055], [0059], [0066], [0067]).
Regarding claim 15 and in light of its indefinite nature, determining the target frequency comprises determining a frequency between 8 – 12Hz (approximately 10 Hz or "individual alpha frequency +1 Hz" [0031], [0114]; [0129], [0136], [0148]).
Regarding claim 16 and in view of its indefinite nature, the programming instructions cause the processor to: determine a frequency that corresponds to an average of power spectral density (PSD) values of a majority of the plurality of EEG channels ([0069], [0073], [0114]).
Regarding claim 17, a treatment interval is interspersed between two consecutive TMS treatments ([0072], [0078] and [0144]).
Regarding claim 18, the system causes the processor to: receive, after the causing the TMS system to provide the one or more treatments to the subject in accordance with the treatment protocol, a second set of EEG measurements; update, based on the second set of EEG measurements, the target frequency to generate an updated target frequency; and generate based on the updated target frequency, a second treatment protocol ([0060], [0113] and [0117]).
Regarding claim 19, an intertrain interval of the treatment protocol is different than an intertrain interval of the second treatment protocol [0110].
Regarding claim 20, the target frequency is updated [0117] to align with a heart rate frequency of the subject (intended use/result).
Regarding claim 21 and in view of its indefinite nature, the system causes the processor to: receive, after the causing the TMS system to provide the one or more treatments to the subject in accordance with the treatment protocol, a second set of EEG measurements; and display an improvement in the mental disorder as a movement of a greatest frequency associated with one or more of a plurality of EEG channel closer to the target frequency ([0059], [0077], [0082], [0117]).
Claim Rejections - 35 USC § 103
32. 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.
33. 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.
34. Claims 2, 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Stubbeman (U.S. Pub. No. 2014/0058189). Regarding claims 2 and 14, the TMS treatments each comprise applying magnetic stimulation pulses to zones which correspond to zones as designated within a 10-20 system of electrode placement to perform a baseline QEEG ([0106] and [0107]). However, Stubbeman fails to disclose explicitly the application of pulses is done simultaneously to at least two of the following: a Cz zone and a Fz zone. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for Stubbeman to apply pulses simultaneously during application to the Cz zone and Fz zones as Stubbeman discloses referencing and calibration of the EEG cap and tracking system ([0106] and [0107]), and it is well- known that Cz and Fz zones in a 10-20 electrode system are widely regarded as ground/reference electrodes, which would be necessitated during each baseline assessment/application.
Regarding claim 11, the method of Stubbeman further comprises: determining, based on a comparison of the first set of EEG measurements and the second set of EEG measurements, a change in the mental disorder that is less than a threshold ([0059], [0077], [0082], [0117]); and updating the treatment protocol to include a first TMS treatment that comprises application of about 200-400 magnetic stimulation pulses [0152] to the F3 zone of the brain of the subject ([0031] and [0117]), however Stubbeman does not disclose explicitly that the pulses are applied at about 30% amplitude. Stubbeman makes obvious to try a stimulation of 30% amplitude as Stubbeman discloses establishing a motor threshold by increasing a motor threshold at 5% intervals until spike activity begins to diminish [0113], while preventing an amplitude percentage which yields a twitching [0108]. While Stubbeman does not explicitly disclose the number of 30%, the instant application provides no criticality for the particular number of 30, and Stubbeman teaches methods for establishing a stimulation amplitude which would be beneficial to a patient, yet low enough to prevent a physical manifestation in the patient or seizure-like activity (due to spike activity - [0113] and [0108]).
Double Patenting
35. 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.
36. Claims 1, 3, 6, 7, 9-13, 15 and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 7-12 and 15-20 of U.S. Patent No. 11,786,747. Although the claims at issue are not identical, they are not patentably distinct from each other because both the enumerated instant claims and those of the patent disclose: a method for treatment of a mental disorder of a subject, the method comprising, by a processor: receiving a first set of electroencephalography (“EEG”) measurements, the first set of EEG measurements corresponding to brain activity at one or more of a plurality of zones of a brain of the subject; determining, based on the first set of EEG measurements, a target frequency for the subject, the target frequency being an EEG frequency where the brain of the subject operates optimally across a plurality of EEG channels in an alpha brainwave, wherein determining the target frequency comprises: identifying, across the plurality of EEG channels, a first homeostatic frequency as a frequency that lies within a threshold distance of a first set of maximum power spectral density (PSD) values of a majority of the plurality of EEG channels, identifying a heart rate peak frequency that is closest to the first homeostatic frequency, and assigning the heart rate peak frequency as the target frequency; generating, based on the target frequency, a treatment protocol for the subject, the treatment protocol comprising one or more individualized transcranial magnetic stimulation (TMS) treatments that each include application of a plurality of magnetic stimulation pulses for a defined time period and at a frequency of about the target frequency; and causing a TMS system to provide the one or more individualized TMS treatments to the subject in accordance with the treatment protocol; and
a system for treatment of a mental disorder of a subject, the system comprising: a processor; and a non-transitory computer-readable medium comprising programming instructions that when executed by the processor will cause the processor to: receive a first set of electroencephalography (“EEG”) measurements, the first set of EEG measurements corresponding to brain activity at one or more of a plurality of zones of a brain of the subject; determine, based on the first set of EEG measurements, a target frequency for the subject, the target frequency being an EEG frequency where the brain of the subject operates optimally across a plurality of EEG channels in an alpha brainwave, wherein determining the target frequency comprises: identifying, across the plurality of EEG channels, a first homeostatic frequency as a frequency that lies within a threshold distance of a first set of maximum power spectral density (PSD) values of a majority of the plurality of EEG channels, identifying a heart rate peak frequency that is closest to the first homeostatic frequency, and assigning the heart rate peak frequency as the target frequency; generate, based on the target frequency, a treatment protocol for the subject, the treatment protocol comprising one or more individualized transcranial magnetic stimulation (TMS) treatments that each include application of a plurality of magnetic stimulation pulses for a defined time period and at a frequency of about the target frequency; and cause a TMS system to provide the one or more individualized TMS treatments to the subject in accordance with the treatment protocol.
37. Claims 2 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 and 13 of U.S. Patent No. 11,786,747. Regarding claims 2 and 14, while Stubbeman fails to disclose explicitly the application of pulses is done simultaneously to at least two of the following: a Cz zone and a Fz zone, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for Stubbeman to apply pulses simultaneously during application to the Cz zone and Fz zones as Stubbeman discloses referencing and calibration of the EEG cap and tracking system ([0106] and [0107]), and it is well-known that Cz and Fz zones in a 10-20 electrode system are widely regarded as ground/reference electrodes, which would be necessitated during each baseline assessment/application.
Allowable Subject Matter
38. Claim 4 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Pub. No. 2018/0256912; and U.S. Patent No. 11,793,456.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE HOPKINS MATTHEWS whose telephone number is (571)272-9058. The examiner can normally be reached Monday - Friday, 7:30 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A Marmor, II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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