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
The drawings are objected to under 37 CFR 1.83(a) because they fail to show details of the control operations such as “different frequencies”, “electrodes in contact with human ears”, etc. as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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.
Claim Rejections - 35 USC § 112
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.
Claims 2, 9-10 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.
Claim 2 recites “or when an electrical stimulus is applied to only one of the both ears, [] is equal to a frequency difference between the sound waves applied to the both ears”. This limitations is unclear and indefinite. Are the stimulation being applied to only one ear or both ears.
Claim 9 recites “or when the control unit controls an electrical stimulus to be applied to only one of the both ears, the control unit controls the sound waves applied to the both ears so that the frequency of the electrical stimulus applied to each of the electrodes is equal to”. This limitations is unclear and indefinite. The claim requires electrical stimulus to only one ear, which renders unclear and indefinite how it recites “so that the frequency of the electrical stimulus applied to each of the electrodes is equal to a frequency…”. Clarification is required.
Claim 9 is rejected for depending on rejected claim 8.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat No. 9415220 to Spinelli et al. (hereinafter “Spinelli”) in view of US Pat Pub no. 20220233860 to Hamner et al. (hereinafter “Hamner”).
Regarding claim 1. Spinelli discloses a method for controlling a complex stimulation (Col 2, ln 49-55 and Col 3, ln 3-6), which is a method for controlling a complex stimulation device having electrical stimulation units (Col 7, ln 33, device 102) comprising electrodes in contact with human ears (Col. 7, lns 53-56 “one or more stimulation electrodes 122, 124”) and sound output units for stimulating hearing by using sound waves (Col 7, lns 46 “generation of sound by speaker(s) 126”), wherein the sound output units generate sound waves having different frequencies (Col. 3, ln 7-10 “the stimulation in each ear can be sequential, simultaneous and/or have other relationships relative to phase, frequency, and amplitude or duty cycle”), and control a frequency difference between the sound waves applied to the both ears on a basis of frequencies of electrical stimuli applied to the electrodes (Col 25, lns 44-46 “the stimulation current, frequency and pulse duration can be changed until the optimum effect is achieved.”, see col. 10 lns 54-67) but fails to disclose generate sound waves having different frequencies in both ears
Hamner from a similar field of endeavor teaches a similar vagal stimulator stimulating the right and left auricular nerves with different parameters (para 0204 and 0216). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to create a difference in power applied between the two ears as taught by Hamner, because doing so would provide the predictable result of obtaining the benefit of synchronizing stimulation to accommodate the difference in biofeedback between the two sides (para 0216).
Regarding claim 2. Spinelli as modified by Hamner renders obvious the method of claim 1, wherein when an electrical stimulus having an equal frequency is applied to each of both ears (Spinelli, Col. 3, ln 7-10 “the stimulation in each ear can be sequential, simultaneous and/or have other relationships relative to phase, frequency, and amplitude or duty cycle”, Col 25, lns 44-46 “the stimulation current, frequency and pulse duration can be changed until the optimum effect is achieved.”, see col. 10 lns 54-67), or when an electrical stimulus is applied to only one of the both ears (considered to be optional limitation), the sound waves applied to the both ears are controlled (Col 26, lns 46-54 “control switch 1808 can be configured to control delivery of audio signals to earpieces 1802, 1804. Earpieces 1802, 1804 can include audio transducers 1806 for converting the audio signals into sound waves”) so that the frequency of the electrical stimulus applied to each of the electrodes is equal to a frequency difference between the sound waves applied to the both ears (Hamner, para 0204 and 0216).
Regarding claim 3. Spinelli as modified by Hamner renders obvious the method of claim 1, wherein when electrical stimuli having different frequencies are applied to the electrodes of both ears, respectively, the sound waves applied to the both ears are controlled so that a frequency difference between the electrical stimuli applied to the electrodes in contact with the vagus nerves of the both ears is equal to a frequency difference between the sound waves applied to the both ears (Col 2, ln 49-55 and Col 3, ln 3-6; Hamner, para 0204 and 0216).
Regarding claim 4. Spinelli as modified by Hamner renders obvious the method of claim 3, wherein the frequency difference between the electrical stimuli applied to the electrodes in contact with both ears is 5Hz or more (Hamner, para 0246). "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 5. Spinelli as modified by Hamner renders obvious the method of claim 1, wherein the frequencies of the electrical stimuli applied to the electrodes are in a range of 10Hz to 120Hz (Col 22, ln 22). "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 6. Spinelli as modified by Hamner renders obvious the method of claim 1, wherein intensities of the electrical stimuli applied to the electrodes are in a range of 3V to 80V (Col 21, ln 56). "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 7. Spinelli as modified by Hamner renders obvious the method of claim 1, wherein pulse widths of the electrical stimuli applied to the electrodes are in a range of 10ijs to 250ps (Col 22, ln 22-23). "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 8. Spinelli discloses a complex stimulation device (Col 2, ln 49-55 and Col 3, ln 3-6) comprising: two electrodes (Col. 7, lns 53-56 “one or more stimulation electrodes 122, 124”) in contact with the vagus nerves (Col 2, ln 49-55 and Col 3, ln 3-6), respectively, located in both ears (Col. 7, lns 53-56 “one or more stimulation electrodes 122, 124”); two sound output units that stimulate hearing in the both ears, respectively (Col 7, lns 46 “generation of sound by speaker(s) 126”); and a control unit (Col 25, lns 44-46 “the stimulation current, frequency and pulse duration can be changed until the optimum effect is achieved.”, see col. 10 lns 54-67) that controls electrical stimuli applied to the electrodes and sound waves output from the sound output units (Col. 3, ln 7-10 “the stimulation in each ear can be sequential, simultaneous and/or have other relationships relative to phase, frequency, and amplitude or duty cycle”), and controls a frequency on a basis of frequencies of the electrical stimuli applied to the electrodes (Col 25, lns 44-46 “the stimulation current, frequency and pulse duration can be changed until the optimum effect is achieved.”, see col. 10 lns 54-67), but fails to disclose generate sound waves having different frequencies in both ears and controls a frequency difference between sound waves applied to the both ears
Hamner from a similar field of endeavor teaches a similar vagal stimulator stimulating the right and left auricular nerves with different parameters (para 0204 and 0216). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to create a difference in power applied between the two ears as taught by Hamner, because doing so would provide the predictable result of obtaining the benefit of synchronizing stimulation to accommodate the difference in biofeedback between the two sides (para 0216).
Regarding claim 9. Spinelli as modified by Hamner renders obvious the complex stimulation device of claim 8, wherein when the control unit controls an electrical stimulus having an equal frequency to be applied to each of both ears (Spinelli, Col. 3, ln 7-10 “the stimulation in each ear can be sequential, simultaneous and/or have other relationships relative to phase, frequency, and amplitude or duty cycle”, Col 25, lns 44-46 “the stimulation current, frequency and pulse duration can be changed until the optimum effect is achieved.”, see col. 10 lns 54-67), or when the control unit controls an electrical stimulus to be applied to only one of the both ears (considered to be optional limitation), the control unit controls the sound waves applied to the both ears (Hamner, para 0204 and 0216) so that the frequency of the electrical stimulus applied to each of the electrodes is equal to a frequency difference between the sound waves applied to the both ears (Hamner, para 0204, 0216 0246).
Regarding claim 10. Spinelli as modified by Hamner renders obvious the complex stimulation device of claim 8, wherein when the control unit controls electrical stimuli having different frequencies to be applied to the electrodes of both ears, respectively, the control unit controls the sound waves applied to the both ears so that a frequency difference between the electrical stimuli applied to the electrodes in contact with the vagus nerves of the both ears is equal to a frequency difference between the sound waves applied to the both ears (Hamner, para 0204, 0216, 0246).
Double Patenting
Claim 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of copending Application No. 18/568,912 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
1. A method for controlling a complex stimulation, which is a method for controlling a complex stimulation device having electrical stimulation units comprising electrodes in contact with human ears and sound output units for stimulating hearing by using sound waves, wherein the sound output units generate sound waves having different frequencies in both ears, and control a frequency difference between the sound waves applied to the both ears on a basis of frequencies of electrical stimuli applied to the electrodes.
1. (Currently Amended) A method for controlling vagus nerve stimulation to stimulate vagus nerves in both ears, wherein one or more of intensity (V), a frequency (F), and a pulse width (PW) of electrical stimulation that is applied to both vagus nerves are separately controlled, and the electrical stimulation that is applied to the vagus nerves in both ears is controlled
2. The method of claim 1, wherein when an electrical stimulus having an equal frequency is applied to each of both ears, or when an electrical stimulus is applied to only one of the both ears, the sound waves applied to the both ears are controlled so that the frequency of the electrical stimulus applied to each of the electrodes is equal to a frequency difference between the sound waves applied to the both ears.20
wherein a difference of the frequency (F) is 5Hz or more,
3. The method of claim 1, wherein when electrical stimuli having different frequencies are applied to the electrodes of both ears, respectively, the sound waves applied to the both ears are controlled so that a frequency difference between the electrical stimuli applied to the electrodes in contact with the vagus nerves of the both ears is equal to a frequency difference between the sound waves applied to the both ears.
wherein a difference of the frequency (F) is 5Hz or more,
4. The method of claim 3, wherein the frequency difference between the electrical stimuli applied to the electrodes in contact with both ears is 5Hz or more.
wherein a difference of the frequency (F) is 5Hz or more,
5. The method of claim 1, wherein the frequencies of the electrical stimuli applied to the electrodes are in a range of 10Hz to 120Hz.
3. (Original) The method of claim 1, wherein the frequency (F) is in a range of 10~120Hz.
6. The method of claim 1, wherein intensities of the electrical stimuli applied to the electrodes are in a range of 3V to 80V.
2. (Original) The method of claim 1, wherein the intensity (V) is in a range of 3~80V.
7. The method of claim 1, wherein pulse widths of the electrical stimuli applied to the electrodes are in a range of 10ijs to 250ps.
7. (Original) The method of claim 1, wherein a ramp up time and a ramp down time are applied in a range of 0.5~5 seconds when electrical stimulation is changed.
8. A complex stimulation device comprising: two electrodes in contact with the vagus nerves, respectively, located in both ears; two sound output units that stimulate hearing in the both ears, respectively; and a control unit that controls electrical stimuli applied to the electrodes and sound waves output from the sound output units, wherein the control unit controls the sound output units to generate sound waves having different frequencies, respectively, and controls a frequency difference between sound waves applied to the both ears on a basis of frequencies of the electrical stimuli applied to the electrodes.
1. (Currently Amended) A method for controlling vagus nerve stimulation to stimulate vagus nerves in both ears, wherein one or more of intensity (V), a frequency (F), and a pulse width (PW) of electrical stimulation that is applied to both vagus nerves are separately controlled, and the electrical stimulation that is applied to the vagus nerves in both ears is controlled
9. The complex stimulation device of claim 8, wherein when the control unit controls an electrical stimulus having an equal frequency to be applied to each of both ears, or when the control unit controls an electrical stimulus to be applied to only one of the both ears, the control unit controls the sound waves applied to the both ears so that the frequency of the electrical stimulus applied to each of the electrodes is equal to a frequency difference between the sound waves applied to the both ears.
wherein a difference o fthe frequency (F) is 5Hz or more,
10. The complex stimulation device of claim 8, wherein when the control unit controls electrical stimuli having different frequencies to be applied to the electrodes of both ears, respectively, the control unit controls the sound waves applied to the both ears so that a frequency difference between the electrical stimuli applied to the electrodes in contact with the vagus nerves of the both ears is equal to a frequency difference between the sound waves applied to the both ears.
wherein a difference of the freqiuency (F) is 5Hz or more,
Conclusion
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/SANA SAHAND/Examiner, Art Unit 3796