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
In response to the amendment filed 1/12/2025; claims 1 – 3, 6 – 11 and 14 are pending; claims 4 - 5 and 12 - 13 have been cancelled.
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 7 - 10 and 14 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.
Claims 7 and 9 states “at least one of the following methods”; it’s unclear which one of the method should be considered by the office.
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)(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.
Claims 1, 3 and 6 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zakharenko et al. (US 2025/0161414 A1).
Re claims 1, 3:
Zakharenko teaches 1. A method for preparing a product for diagnosing mental illness and/or neurodegenerative disease, evaluating a risk of mental illness and/or neurodegenerative disease, and/or evaluating therapeutic effect of mental illness and/or neurodegenerative disease (Zakharenko, Abstract; [0006]), comprising
using a product for detecting activation condition of PV-positive neuronal cells in a primary auditory cortex (Zakharenko, [0005]; [0008], “increasing the excitability of interneurons (preferably GABAergic interneurons, most preferably parvalbumin-positive PV+ interneurons) improves auditory perception, in particular in the form of pitch-discrimination acuity”; [0095]; [0006]).
3. A method for preparing a product for resisting mental illness and/or neurodegenerative disease (Zakharenko, Abstract; [0006]), comprising
using a product for activating or enhancing activation of PV-positive neuronal cells in a primary auditory cortex or medial geniculate nucleus neurons projecting to the primary auditory cortex (Zakharenko, [0005]; [0008], “increasing the excitability of interneurons (preferably GABAergic interneurons, most preferably parvalbumin-positive PV+ interneurons) improves auditory perception, in particular in the form of pitch-discrimination acuity”; [0095]; [0006]) or projections from the medial geniculate nucleus to the primary auditory cortex (Zakharenko, [0043]; [0076] – [0077]).
Re claim 6:
6. The method according to claim 3, wherein the resisting mental illness and/or neurodegenerative disease is a treatment and/or prevention of mental illness and/or neurodegenerative disease (Zakharenko, Abstract; [0006]).
Claims 7 – 10 and 14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zakharenko et al. (US 2025/0161414 A1).
Re claims 7, 9:
Zakharenko 7. A tangible computer-readable medium encoded with a program, wherein the program, when executed, causes a device to perform a treatment method (Zakharenko, [0042], “Mouse Behavioral Tests: Auditory Brainstem Response Test. Auditory brainstem response (ABR) experiments were performed … was measured using a Tucker Davis Technology (TDT) System III with RZ6 Multiprocessor and BioSigRZ software”), and the treatment method comprises at least one of the following methods:
activating or enhancing an activation of PV-positive neuronal cells in a primary auditory cortex (Zakharenko, [0005]; [0008], “increasing the excitability of interneurons (preferably GABAergic interneurons, most preferably parvalbumin-positive PV+ interneurons) improves auditory perception, in particular in the form of pitch-discrimination acuity”; [0095]; [0006]);
activating or enhancing an activation of medial geniculate nucleus neurons projecting to the primary auditory cortex (Zakharenko, [0043]; [0076] – [0077]);
activating or enhancing an activation of MG projections to the primary auditory cortex (Zakharenko, [0043]; [0076] – [0077]); and
taking less than 14 days of a medial geniculate nucleus neuron activity inhibition treatment as a course of treatment (Zakharenko, [0036], “Subjects may receive treatment with a VIPR1 inhibitor for several days, weeks or months depending on the level of pitch-discrimination acuity improvement desired and/or rate of improvement”);
treating a subject's mental illness and/or neurodegenerative disease or reducing the subject's possibility of developing a mental illness and/or neurodegenerative disease (Zakharenko, Abstract; [0006]).
Re claim 8:
8. The computer-readable medium according to claim 7, wherein the device is an instrument that stimulates neurons through nuclear magnetic resonance, sound waves, vibration or electric current (Zakharenko, [0005]; [0008]).
Re claim 9:
9. A method for resisting mental illness and/or neurodegenerative disease, or treating and/or preventing depression (Zakharenko, Abstract; [0006]), wherein the method achieves a purpose of resisting depression through at least one of the following methods:
activating or enhancing an activation of PV-positive neuronal cells in a primary auditory cortex (Zakharenko, [0005]; [0008], “increasing the excitability of interneurons (preferably GABAergic interneurons, most preferably parvalbumin-positive PV+ interneurons) improves auditory perception, in particular in the form of pitch-discrimination acuity”; [0095]; [0006]);
activating or enhancing an activation of medial geniculate nucleus neurons projecting to the primary auditory cortex (Zakharenko, [0043]; [0076] – [0077]);
activating or enhancing an activation of projections of a medial geniculate nucleus to the primary auditory cortex (Zakharenko, [0043]; [0076] – [0077]); and
inhibiting an activity of the medial geniculate nucleus, taking less than 14 days of an activity inhibition treatment as a course of treatment (Zakharenko, [0036], “Subjects may receive treatment with a VIPR1 inhibitor for several days, weeks or months depending on the level of pitch-discrimination acuity improvement desired and/or rate of improvement”), but not limited to one treatment course (Zakharenko, [0070]).
Re claim 10:
10. The method according to claim 9, wherein the resisting mental illness and/or neurodegenerative disease is a treatment and/or prevention of mental illness and/or neurodegenerative disease (Zakharenko, [0005]; [0008]).
Re claim 14:
14. The method according to claim 9, wherein the activating or enhancing the activation is performed by using one or more of a transcranial magnetic stimulator, an electroencephalogram recorder, a vibrator, a sound frequency generator, and an electric current stimulator (Zakharenko, [0005]; [0008]).
Claim 2 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deisseroth et al. (US 2013/0347137 A1).
Re claim 2:
Deisseroth teaches 2. A system for evaluating therapeutic effect of mental illness and/or neurodegenerative disease (Deisseroth, Abstract), comprising an information acquisition module, a data processing module and a result output module (Zakharenko, [0164]; [0183]), wherein:
the information acquisition module is configured to obtain an activation condition of PV-positive neuronal cells in a primary auditory cortex of a patient before and after treatment (Deisseroth, [0016] –[0017]; [0020], “(f-h) Monochromatic absorption changes recorded at the indicated wavelength before, during and after illumination with 450 nm light for all three variants, highlighting the distinct stability of the double mutant”; [0023], “baseline and during 5510 activation in PV cells in the slice (between blue and yellow light pulses). Inset compares three 5 s periods before activation (1), after activation (2), and after deactivation (3). (d) Activity of PV cells after activation with SSFO”), or to obtain the activation condition of the PV-positive neuronal cells in the primary auditory cortex of a treatment group and a control group (Deisseroth, [0022], “control mice, before (Test 1) and after (Test light activation …”; [0028], “control mice”);
the data processing module is configured to compare an activation degree of the PV-positive neuronal cells in the primary auditory cortex before and after treatment (Deisseroth, [0016] –[0017]; [0020], “(f-h) Monochromatic absorption changes recorded at the indicated wavelength before, during and after illumination with 450 nm light for all three variants, highlighting the distinct stability of the double mutant”; [0023], “baseline and during 5510 activation in PV cells in the slice (between blue and yellow light pulses). Inset compares three 5 s periods before activation (1), after activation (2), and after deactivation (3). (d) Activity of PV cells after activation with SSFO”), or to compare the activation degree of the PV-positive neuronal cells in the primary auditory cortex of the treatment group and the control group (Deisseroth, [0022], “control mice, before (Test 1) and after (Test light activation …”; [0028], “control mice”);
the result output module is configured to output the therapeutic effect (Deisseroth, [0016], “certain embodiments allow for reversible disease states, which can be particularly useful for establishing baseline/control points for testing and/or for testing the effects of a treatment on the same animal when exhibiting the disease state and when not exhibiting the disease state”):
if the activation degree of the PV-positive neuronal cells in the primary auditory cortex after treatment is higher than that of the PV-positive neuronal cells in the primary auditory cortex before treatment, the treatment is effective; otherwise, the treatment is ineffective (Deisseroth, [0032], “FIG. 13 depicts a model for assessing treatments of various nervous system disorders, consistent with an embodiment of the present disclosure”; [0021], “Average spike rates of traces showing significant differences in activity pre- and post-stimulation before activation”; [0129], “After the observations 220 have been collected, the observations 220 from various treatments can be compared 218 to each other as well as the baseline observation and the observations of behavior after E/I elevation”; [00129], “The stimuli/treatments can then be assessed 214 by observing the subject's behavior in response to the treatment and/or the target cell population's”);
or, if the activation degree of the PV-positive neuronal cells in the primary auditory cortex of the treatment group is higher than that of the PV-positive neuronal cells in the primary auditory cortex of the control group, the treatment is effective; otherwise, the treatment is ineffective (Deisseroth, [0032], “FIG. 13 depicts a model for assessing treatments of various nervous system disorders, consistent with an embodiment of the present disclosure”; [0021], “Average spike rates of traces showing significant differences in activity pre- and post-stimulation before activation”; [0129], “After the observations 220 have been collected, the observations 220 from various treatments can be compared 218 to each other as well as the baseline observation and the observations of behavior after E/I elevation”; [00129], “The stimuli/treatments can then be assessed 214 by observing the subject's behavior in response to the treatment and/or the target cell population's”).
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 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 11 is rejected under 35 U.S.C. 103 as being unpatentable over Venturino et al. (US 20230095907 A1) in view of Deisseroth et al. (US 2013/0347137 A1).
Re claim 11:
Venturino teaches 11. A method for evaluating therapeutic effect of antidepressant treatment (Venturino, [0034]; [0061]), comprising
establishing a social defeat model on experimental animals, randomly dividing the experimental animals into a control group and a treatment group after successful establishment of the model (Venturino, [0238]; [0093]), and carrying out an antidepressant treatment on the experimental animals in the treatment group, and after treatment, comparing an activation degree of PV-positive neuronal cells in a primary auditory cortex of the experimental animals in the control group and the treatment group (Venturino, [0116]; [0238]).
Venturino et al. (US 2023/0095907 A1) does not explicitly dislcose if the activation degree of the PV-positive neuron cells in the primary auditory cortex of the treatment group is higher than that of the PV-positive neuron cells in the primary auditory cortex of the control group, the treatment is effective; otherwise, the treatment is ineffective. Deisseroth teaches the missing features (Deisseroth, [0032], “FIG. 13 depicts a model for assessing treatments of various nervous system disorders, consistent with an embodiment of the present disclosure”; [0021], “Average spike rates of traces showing significant differences in activity pre- and post-stimulation before activation”; [0129], “After the observations 220 have been collected, the observations 220 from various treatments can be compared 218 to each other as well as the baseline observation and the observations of behavior after E/I elevation”; [00129], “The stimuli/treatments can then be assessed 214 by observing the subject's behavior in response to the treatment and/or the target cell population's”). Therefore, in view of Deisseroth, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method described in Venturino, by evaluating the effectiveness of the treatment as taught by Deisseroth, in order to choose the most effective treatment for the group.
Conclusion
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/JACK YIP/Primary Examiner, Art Unit 3715
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