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 .
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, 2, 4, 6, 7, 51-57, 59, and 60 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. The originally filed disclosure fails to provide support for a method comprising producing second electrical activity from recorded first electrical activity, wherein the second electrical activity is expressed as a function of frequency and each frequency of the second electrical activity is within the range of 60 Hz to 90 Hz. The originally filed disclosure does not support producing second electrical activity only within the range of 60 Hz to 90 Hz. When first electrical activity outside of the 60 Hz to 90 Hz range is recorded, how would second electrical activity within the range of 60 Hz to 90 Hz be produced?
The originally filed disclosure fails to provide any written description that indicates that, at the time the invention was effectively filed, the inventors were in possession of a method that produces second electrical activity within the range of 60 Hz to 90 Hz from first electrical activity that is outside of that 60 Hz to 90 Hz range.
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 1, 2, 4, 6, 7, 51-57, 59, and 60 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. Claim 1 recites a method comprising recording first electrical activity, and producing second electrical activity from the recorded first electrical activity, wherein the second electrical activity is expressed as a function of frequency and each frequency of the second electrical activity is within the range of 60 Hz to 90 Hz. It is unclear how second electrical activity within a range of 60 Hz to 90 Hz would be produced from first electrical activity recorded outside of that 60 Hz to 90 Hz range.
Furthermore, the claim later calls for modifying the treatment of the patient based only on when the second electrical activity has oscillatory activity in the range of 60 Hz to 90 Hz. According to the producing step in the claimed method, only second electrical activity within a 60 Hz to 90 Hz range is produced. If only 60 Hz to 90 Hz oscillatory brain activity is being produced, then the treatment will always be modified.
Response to Arguments
Applicant's arguments filed 22 October 2025 have been fully considered and they are not persuasive.
The Examiner maintains that the originally filed specification fails to provide support for producing second electrical activity from recorded first electrical activity, wherein each frequency of the second electrical activity is within the range of 60 Hz to 90 Hz. The Examiner also maintains that it is unclear how second electrical activity having frequencies within the range of 60 Hz to 90 Hz would be produced from recorded first electrical activity that does not include frequency components within the range of 60 Hz to 90 Hz.
Applicant appears to rely on Fourier Transforms to provide both support and clarity for the claimed subject matter. Applicant’s arguments are not persuasive as Fourier Transforms transform time domain signals into a signal in the frequency domain that represents the existing frequency components of the time domain signal. Fourier Transforms are used to analyze the already existing frequency components of a time domain signal; they do not create frequency components that are not present in the original time domain signal, nor do they remove frequency components that are present in the original time domain signal.
If an original time domain signal does not contain any frequency components within the range of 60 Hz to 90 Hz, its equivalent frequency domain signal will not comprise 60 Hz to 90 Hz values (a typical frequency domain conversion results in an x-axis Frequency vs. y-axis Amplitude graph, the “values” being the y-axis amplitude values). If an original time domain signal contains frequency components outside of a 60 Hz to 90 Hz range, its equivalent frequency domain signal will comprise values corresponding to frequency components outside of that 60 Hz to 90 Hz range. In other words, if the recorded first electrical activity signal comprises a 100 Hz frequency component, performing a Fourier Transform on the first electrical activity signal would produce a second electrical activity signal with an amplitude value at a frequency outside of the range of 60 Hz to 90 Hz (it would produce a second electrical activity signal having an amplitude value greater than 0 at 100 Hz).
For a time domain signal with no frequency components in the 60 Hz to 90 Hz range, calculating a Fourier Transform of the time domain signal at “frequencies of 60.0, 60.1, 60.2 … 89.8, 89.9, and 90.0 Hz” would result in a value of “0” for each frequency; no second electrical activity would be produced.
While the prior art does not teach a method comprising producing only second electrical activity within a 60 Hz to 90 Hz range, the claims are not allowable due to the rejections under 35 U.S.C. 112(a) and 35 U.S.C. 112(b).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Afshar et al.’447 (US Pub No. 2015/0202447 – previously cited) discloses a method of treating a movement disorder in a human patient, the method comprising: recording first electrical activity as a function of time with leads, wherein each of the leads used to record the first electrical activity is placed at the motor cortex or the subthalamic nucleus (STN), wherein the patient is receiving a treatment for the movement disorder; producing second electrical activity from the recorded first electrical activity, wherein the second electrical activity is expressed as a function of frequency; modifying the treatment of the patient based only on when the second electrical activity has oscillatory activity in the range of 60Hz to 90Hz in both the motor cortex and the STN; wherein the treatment comprises deep brain stimulation; and wherein modifying the treatment comprises adjusting a parameter of the deep brain stimulation. Halje et al. (Levodopa-Induced Dyskinesia… – previously cited) discloses a method similar to the one taught by Afshar et al.’447. Simonin et al. (Reduced levodopa-induced complications… – previously cited) teaches that levodopa-induced dyskinesia decreases with the use of subthalamic nucleus deep brain stimulation. Molnar et al.’674 (US Pub No. 2007/0225674 – previously cited) specifically teaches measuring LFPs from an STN and using the LFP recordings to define a biomarker that can be monitored to assess a patient’s neurological movement disorder (sections [0026] and [0028]). Giannicola et al. (The effects of levodopa and ongoing deep brain stimulation… – previously cited) teaches recording LFPs in the STN for individuals with Parkinson’s disease. The paper examines the combined effect of levodopa and deep brain stimulation on STN beta LFP oscillations (which requires measuring LFP oscillations in the STN). Rizzone et al. (Deep brain stimulation of the subthalamic nucleus in Parkinson’s disease… – previously cited) teaches treating Parkinson’s disease with deep brain stimulation of the subthalamic nucleus, and further discloses adjusting the parameters of the stimulation in order to provide the most effective therapy to a patient. A number of references cited by the Applicant also teach measuring oscillatory activity with a lead placed at the STN in patients suffering from neurological movement disorders.
THIS ACTION IS MADE FINAL. 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.
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791