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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or
under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) filed on March 01, 2023; September 12, 2024; and May 22, 2025 were considered by the examiner.
Drawings
The drawings are objected to because Figs. 1-2 contain photographs; however, photographs are not the only practicable medium to show the depicted elements, see 37 C.F.R. 1.84(b)(1). Furthermore, the text in Fig. 2 is too small, see 37 C.F.R. 1.84(p)(3). In addition, Figs. 5(A) and 6(A) each contain arrows without label.
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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: an auditory analysis system, an oscillation selection module, and an output device in claim 1; a filtering module, an onset detection module, and a gain control module in claim 2; a light generation module, a light adjustment module, and a filtering component in claim 7; stimulation unit in claim 11; a built-in audio playback system in claim 15; visual output device in claim 21.
Prong 1: “system”, “device”, “module”, “unit”, and “component” are generic placeholders. See MPEP 2181 §I, subsection A, ¶1.
Prong 2: the transition word “to” is used, followed by functional language:
“auditory analysis system” (note, no transition word);
“oscillation selection module” (note, no transition word);
“output device” (note, no transition word);
“a filtering module having means to filter an incoming audio signal”;
“an onset detection module having means to detect an onset of acoustic events in said signal”;
“a gain control module having means to adjust a gain of said signal”;
“light generation module” (note, no transition word);
“light adjustment module” (note, no transition word);
“filtering component” (note, no transition word);
“one or more stimulation units for generating…”;
“built-in audio playback system” (note, no transition word); and
“displaying said light pattern on a visual output device” (note, no transition word).
Prong 3: there is not sufficient structure to modify the generic placeholders.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The examiner interprets the generic computer with input, auxiliary audio input, and microphone (see specification ¶[0036]) to cover the corresponding structure, materials, or acts described in the specification and equivalents thereof for the auditory analysis system.
There is no structure in the specification for the oscillation selection module. Figure 3 indicates that the oscillation selection module is a “decision algorithm”, but the specification does not specify any structure for implementing such an algorithm.
The examiner interprets the array of electromagnets or electrodes, LED lights, computer monitor, TV monitor, goggles, virtual reality headsets, augmented reality glasses, smart glasses, gloves, wearable device, smart watch, or mobile device (see specification ¶[0035] and ¶[0050]) to cover the corresponding structure, materials, or acts described in the specification and equivalents thereof for the output device.
There is no structure in the specification for the filtering module.
There is no structure in the specification for the onset detection module.
There is no structure in the specification for the gain control module.
There is no structure in the specification for the light generation module.
There is no structure in the specification for the light adjustment module.
There is no structure in the specification for the filtering component.
The examiner interprets the array of electromagnets or electrodes, gloves, wearable device, smart watch, or mobile device (see specification ¶[0035] and ¶[0050]) to cover the corresponding structure, materials, or acts described in the specification and equivalents thereof for the stimulation unit.
The examiner interprets the graphical display and input means (see specification ¶[0036]) to cover the corresponding structure, materials, or acts described in the specification and equivalents thereof for the built-in audio playback system.
The examiner interprets the LED lights, computer monitor, TV monitor, goggles, virtual reality headsets, augmented reality glasses, smart glasses, or mobile device (see specification ¶[0035] and ¶[0050]) to cover the corresponding structure, materials, or acts described in the specification and equivalents thereof for the visual output device.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 2-4, 6-7, 9-12, 15-18, and 21 are objected to because of the following informalities:
the hyphen used on words about the end of each corresponding line should be deleted in claims 2-4, 7, 9-12, 15-18, and 21;
in claim 2, line 3: “said signal” should be “said incoming audio signal”;
in claim 2, line 4: “said signal” should be “said incoming audio signal”;
in claim 6, line 4: “PAC” should be phase-amplitude coupling (PAC)”;
in claim 12, lines 2-3: “or an array of electromagnets or electrodes” should be “an array of electromagnets, or an array of electrodes”;
Appropriate correction is required.
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 2-6, 10, and 19-25 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.
Claim 2 recites “detect an onset of acoustic events in said signal” in line 3. This is clearly a computer-implemented recitation (see Figure 3).
Under the current guidelines of 35 USC 112, the specification fails to support a claim that defines the invention in functional language specifying a desired result when the specification does not sufficiently identify how the invention achieves the claimed function. For there to be sufficient disclosure for a computer-implemented claim limitation, it is not enough that one skilled in the art could write a program to achieve the claimed function. Rather, the specification must disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function in sufficient detail such that one of ordinary skill can reasonably
conclude that the inventor invented the claimed subject matter. See Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, Fed. Reg. Vol. 76, No. 27, February 9, 2011, p. 7162-7175 (“the Supplementary Examination Guidelines”). With respect to claim 2, this claim is rejected under §112, first paragraph, based on lack of written description because the specification fails to provide the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function. In particular, no specificity is provided with respect to the onset detection process. The disclosure provides no algorithm, flow chart, or other detailed description of the onset detection process itself, but only refers to the onset detection process in a “black box” description, meaning that the onset detection process is referred to in a general sense but the specifics of the onset detection process itself is not elaborated upon such that one of ordinary skill in the art would not have understood that the Applicant was in possession of the claimed invention.
Claim 3 is rejected by virtue of its dependence from claim 2.
Claim 4 recites “predict the frequencies, phases and amplitudes of a human neural response to music; and wherein said entrainment simulator provides output to said oscillation selection module in the form of one or more network states” in lines 2-5. This is clearly a computer-implemented recitation (see specification ¶[0042]-[0043] and Figure 3).
Under the current guidelines of 35 USC 112, the specification fails to support a claim that defines the invention in functional language specifying a desired result when the specification does not sufficiently identify how the invention achieves the claimed function. For there to be sufficient disclosure for a computer-implemented claim limitation, it is not enough that one skilled in the art could write a program to achieve the claimed function. Rather, the specification must disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function in sufficient detail such that one of ordinary skill can reasonably
conclude that the inventor invented the claimed subject matter. See Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, Fed. Reg. Vol. 76, No. 27, February 9, 2011, p. 7162-7175 (“the Supplementary Examination Guidelines”). With respect to claim 4, this claim is rejected under §112, first paragraph, based on lack of written description because the specification fails to provide the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function. This is a machine learning/neural network type implementation (see specification ¶[0042]-[0043] and Figure 3), but no specificity is provided with the network, such as training, layers, data propagation, logics, etc. In particular, no specificity is provided with respect to the prediction/neural state process. The disclosure provides no algorithm, flow chart, or other detailed description of the prediction/neural state process itself, but only refers to the prediction/neural state process in a “black box” description, meaning that the prediction/neural state process is referred to in a general sense but the specifics of the prediction/neural state process itself is not elaborated upon such that one of ordinary skill in the art would not have understood that the Applicant was in possession of the claimed invention.
Claim 5 is rejected by virtue of its dependence from claim 2.
Claim 6 recites “select a most prominent oscillation in the one or more frequency ranges” in lines 2-3. This is clearly a computer-implemented recitation (see ¶[0044] and Figure 3).
Under the current guidelines of 35 USC 112, the specification fails to support a claim that defines the invention in functional language specifying a desired result when the specification does not sufficiently identify how the invention achieves the claimed function. For there to be sufficient disclosure for a computer-implemented claim limitation, it is not enough that one skilled in the art could write a program to achieve the claimed function. Rather, the specification must disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function in sufficient detail such that one of ordinary skill can reasonably
conclude that the inventor invented the claimed subject matter. See Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, Fed. Reg. Vol. 76, No. 27, February 9, 2011, p. 7162-7175 (“the Supplementary Examination Guidelines”). With respect to claim 6, this claim is rejected under §112, first paragraph, based on lack of written description because the specification fails to provide the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function. In particular, no specificity is provided with respect to the selection process. The disclosure provides no algorithm, flow chart, or other detailed description of the selection process itself, but only refers to the selection process in a “black box” description, meaning that the selection process is referred to in a general sense but the specifics of the selection process itself is not elaborated upon such that one of ordinary skill in the art would not have understood that the Applicant was in possession of the claimed invention.
Claim 6 recites “to couple a gamma frequency to a beat and rhythmic structure of music through theta-gamma and delta-theta PAC” in lines 3-4. This is clearly a computer-implemented recitation (see ¶[0044] and Figure 3).
Under the current guidelines of 35 USC 112, the specification fails to support a claim that defines the invention in functional language specifying a desired result when the specification does not sufficiently identify how the invention achieves the claimed function. For there to be sufficient disclosure for a computer-implemented claim limitation, it is not enough that one skilled in the art could write a program to achieve the claimed function. Rather, the specification must disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function in sufficient detail such that one of ordinary skill can reasonably
conclude that the inventor invented the claimed subject matter. See Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, Fed. Reg. Vol. 76, No. 27, February 9, 2011, p. 7162-7175 (“the Supplementary Examination Guidelines”). With respect to claim 6, this claim is rejected under §112, first paragraph, based on lack of written description because the specification fails to provide the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function. In particular, no specificity is provided with respect to the coupling process. The disclosure provides no algorithm, flow chart, or other detailed description of the coupling process itself, but only refers to the coupling process in a “black box” description, meaning that the coupling process is referred to in a general sense but the specifics of the coupling process itself is not elaborated upon such that one of ordinary skill in the art would not have understood that the Applicant was in possession of the claimed invention. It is noted that the reference to the article by Lakatos et al. is not connected to the specific algorithm of coupling process in the present application, and thus cannot be the basis for such written description for the coupling process. There is no indication of how the specific algorithm of Lakatos et al. is applied in the different elements of the presently claimed subject matter.
Claim 10 recites “one or more selected oscillation states selected by said oscillation selection module” in lines 3-4. This is clearly a computer-implemented recitation (see ¶[0044] and Figure 3).
Under the current guidelines of 35 USC 112, the specification fails to support a claim that defines the invention in functional language specifying a desired result when the specification does not sufficiently identify how the invention achieves the claimed function. For there to be sufficient disclosure for a computer-implemented claim limitation, it is not enough that one skilled in the art could write a program to achieve the claimed function. Rather, the specification must disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function in sufficient detail such that one of ordinary skill can reasonably
conclude that the inventor invented the claimed subject matter. See Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, Fed. Reg. Vol. 76, No. 27, February 9, 2011, p. 7162-7175 (“the Supplementary Examination Guidelines”). With respect to claim 10, this claim is rejected under §112, first paragraph, based on lack of written description because the specification fails to provide the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function. In particular, no specificity is provided with respect to the selection process. The disclosure provides no algorithm, flow chart, or other detailed description of the selection process itself, but only refers to the selection process in a “black box” description, meaning that the selection process is referred to in a general sense but the specifics of the selection process itself is not elaborated upon such that one of ordinary skill in the art would not have understood that the Applicant was in possession of the claimed invention.
Claim 19 recites “selecting one or more oscillations in one or more predetermined frequency ranges” in line 2. This is clearly a computer-implemented recitation (see ¶[0044] and Figure 3).
Under the current guidelines of 35 USC 112, the specification fails to support a claim that defines the invention in functional language specifying a desired result when the specification does not sufficiently identify how the invention achieves the claimed function. For there to be sufficient disclosure for a computer-implemented claim limitation, it is not enough that one skilled in the art could write a program to achieve the claimed function. Rather, the specification must disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function in sufficient detail such that one of ordinary skill can reasonably
conclude that the inventor invented the claimed subject matter. See Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, Fed. Reg. Vol. 76, No. 27, February 9, 2011, p. 7162-7175 (“the Supplementary Examination Guidelines”). With respect to claim 19, this claim is rejected under §112, first paragraph, based on lack of written description because the specification fails to provide the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function. In particular, no specificity is provided with respect to the selection process. The disclosure provides no algorithm, flow chart, or other detailed description of the selection process itself, but only refers to the selection process in a “black box” description, meaning that the selection process is referred to in a general sense but the specifics of the selection process itself is not elaborated upon such that one of ordinary skill in the art would not have understood that the Applicant was in possession of the claimed invention.
Claim 19 recites “generating a stimulation pattern using said one or more oscillations” in line 3. This is clearly a computer-implemented recitation (see ¶[0050]-[0051], ¶[0070]-[0072], and ¶[0082]; Figure 3).
Under the current guidelines of 35 USC 112, the specification fails to support a claim that defines the invention in functional language specifying a desired result when the specification does not sufficiently identify how the invention achieves the claimed function. For there to be sufficient disclosure for a computer-implemented claim limitation, it is not enough that one skilled in the art could write a program to achieve the claimed function. Rather, the specification must disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function in sufficient detail such that one of ordinary skill can reasonably
conclude that the inventor invented the claimed subject matter. See Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, Fed. Reg. Vol. 76, No. 27, February 9, 2011, p. 7162-7175 (“the Supplementary Examination Guidelines”). With respect to claim 19, this claim is rejected under §112, first paragraph, based on lack of written description because the specification fails to provide the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function. In particular, no specificity is provided with respect to the generation process. The disclosure provides no algorithm, flow chart, or other detailed description of the generation process itself, but only refers to the generation process in a “black box” description, meaning that the generation process is referred to in a general sense but the specifics of the generation process itself is not elaborated upon such that one of ordinary skill in the art would not have understood that the Applicant was in possession of the claimed invention.
Claim 20 is rejected by virtue of its dependence from claim 19.
Claim 21 recites “filtering said acoustic signal” in line 3. This is clearly a computer-implemented recitation (see ¶[0038] and ¶[0083]; Figure 3).
Under the current guidelines of 35 USC 112, the specification fails to support a claim that defines the invention in functional language specifying a desired result when the specification does not sufficiently identify how the invention achieves the claimed function. For there to be sufficient disclosure for a computer-implemented claim limitation, it is not enough that one skilled in the art could write a program to achieve the claimed function. Rather, the specification must disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function in sufficient detail such that one of ordinary skill can reasonably
conclude that the inventor invented the claimed subject matter. See Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, Fed. Reg. Vol. 76, No. 27, February 9, 2011, p. 7162-7175 (“the Supplementary Examination Guidelines”). With respect to claim 21, this claim is rejected under §112, first paragraph, based on lack of written description because the specification fails to provide the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function. In particular, no specificity is provided with respect to the filtering process. The disclosure provides no algorithm, flow chart, or other detailed description of the filtering process itself, but only refers to the filtering process in a “black box” description, meaning that the filtering process is referred to in a general sense but the specifics of the filtering process itself is not elaborated upon such that one of ordinary skill in the art would not have understood that the Applicant was in possession of the claimed invention.
Claim 21 recites “detecting the onset of one or more acoustic events contained within said acoustic signal” in line 4. This is clearly a computer-implemented recitation (see Figure 3).
Under the current guidelines of 35 USC 112, the specification fails to support a claim that defines the invention in functional language specifying a desired result when the specification does not sufficiently identify how the invention achieves the claimed function. For there to be sufficient disclosure for a computer-implemented claim limitation, it is not enough that one skilled in the art could write a program to achieve the claimed function. Rather, the specification must disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function in sufficient detail such that one of ordinary skill can reasonably
conclude that the inventor invented the claimed subject matter. See Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, Fed. Reg. Vol. 76, No. 27, February 9, 2011, p. 7162-7175 (“the Supplementary Examination Guidelines”). With respect to claim 21, this claim is rejected under §112, first paragraph, based on lack of written description because the specification fails to provide the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function. In particular, no specificity is provided with respect to the onset detection process. The disclosure provides no algorithm, flow chart, or other detailed description of the onset detection process itself, but only refers to the onset detection process in a “black box” description, meaning that the onset detection process is referred to in a general sense but the specifics of the onset detection process itself is not elaborated upon such that one of ordinary skill in the art would not have understood that the Applicant was in possession of the claimed invention.
Claim 21 recites “simulating neural entrainment to said acoustic signal using an entrainment simulator; generating one or more coupling parameters to couple said one or more oscillations; using adaptive learning algorithms to adjust said one or more coupling parameters or intrinsic parameters” in lines 5-8. This is clearly a computer-implemented recitation (see specification ¶[0042]-[0043] and ¶[0081]; Figure 3).
Under the current guidelines of 35 USC 112, the specification fails to support a claim that defines the invention in functional language specifying a desired result when the specification does not sufficiently identify how the invention achieves the claimed function. For there to be sufficient disclosure for a computer-implemented claim limitation, it is not enough that one skilled in the art could write a program to achieve the claimed function. Rather, the specification must disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function in sufficient detail such that one of ordinary skill can reasonably
conclude that the inventor invented the claimed subject matter. See Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, Fed. Reg. Vol. 76, No. 27, February 9, 2011, p. 7162-7175 (“the Supplementary Examination Guidelines”). With respect to claim 21, this claim is rejected under §112, first paragraph, based on lack of written description because the specification fails to provide the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function. This is a machine learning/neural network type implementation (see specification ¶[0042]-[0043] and Figure 3), but no specificity is provided with the network, such as training, layers, data propagation, logics, etc. In particular, no specificity is provided with respect to the prediction/neural state process. The disclosure provides no algorithm, flow chart, or other detailed description of the prediction/neural state process itself, but only refers to the prediction/neural state process in a “black box” description, meaning that the prediction/neural state process is referred to in a general sense but the specifics of the prediction/neural state process itself is not elaborated upon such that one of ordinary skill in the art would not have understood that the Applicant was in possession of the claimed invention.
Claim 21 recites “selecting one or more oscillations in one or more predetermined frequency ranges for display” in lines 9-10. This is clearly a computer-implemented recitation (see ¶[0044] and Figure 3).
Under the current guidelines of 35 USC 112, the specification fails to support a claim that defines the invention in functional language specifying a desired result when the specification does not sufficiently identify how the invention achieves the claimed function. For there to be sufficient disclosure for a computer-implemented claim limitation, it is not enough that one skilled in the art could write a program to achieve the claimed function. Rather, the specification must disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function in sufficient detail such that one of ordinary skill can reasonably
conclude that the inventor invented the claimed subject matter. See Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, Fed. Reg. Vol. 76, No. 27, February 9, 2011, p. 7162-7175 (“the Supplementary Examination Guidelines”). With respect to claim 21, this claim is rejected under §112, first paragraph, based on lack of written description because the specification fails to provide the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function. In particular, no specificity is provided with respect to the selection process. The disclosure provides no algorithm, flow chart, or other detailed description of the selection process itself, but only refers to the selection process in a “black box” description, meaning that the selection process is referred to in a general sense but the specifics of the selection process itself is not elaborated upon such that one of ordinary skill in the art would not have understood that the Applicant was in possession of the claimed invention.
Claim 21 recites “generating a light pattern using said one or more oscillations” in line 11. This is clearly a computer-implemented recitation (see ¶[0050]-[0051], ¶[0070]-[0072], and ¶[0082]; Figure 3).
Under the current guidelines of 35 USC 112, the specification fails to support a claim that defines the invention in functional language specifying a desired result when the specification does not sufficiently identify how the invention achieves the claimed function. For there to be sufficient disclosure for a computer-implemented claim limitation, it is not enough that one skilled in the art could write a program to achieve the claimed function. Rather, the specification must disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function in sufficient detail such that one of ordinary skill can reasonably
conclude that the inventor invented the claimed subject matter. See Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, Fed. Reg. Vol. 76, No. 27, February 9, 2011, p. 7162-7175 (“the Supplementary Examination Guidelines”). With respect to claim 21, this claim is rejected under §112, first paragraph, based on lack of written description because the specification fails to provide the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function. In particular, no specificity is provided with respect to the generation process. The disclosure provides no algorithm, flow chart, or other detailed description of the generation process itself, but only refers to the generation process in a “black box” description, meaning that the generation process is referred to in a general sense but the specifics of the generation process itself is not elaborated upon such that one of ordinary skill in the art would not have understood that the Applicant was in possession of the claimed invention.
Claims 22-25 are rejected by virtue of their dependence from claim 21.
Claim 22 recites “said step of generating a light pattern comprises selecting a light pattern based on said patient profile, and adjusting said light pattern based on said patient profile” in line 11. This is clearly a computer-implemented recitation (see ¶[0050]-[0051], ¶[0070]-[0072], and ¶[0082]; Figure 3).
Under the current guidelines of 35 USC 112, the specification fails to support a claim that defines the invention in functional language specifying a desired result when the specification does not sufficiently identify how the invention achieves the claimed function. For there to be sufficient disclosure for a computer-implemented claim limitation, it is not enough that one skilled in the art could write a program to achieve the claimed function. Rather, the specification must disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function in sufficient detail such that one of ordinary skill can reasonably
conclude that the inventor invented the claimed subject matter. See Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, Fed. Reg. Vol. 76, No. 27, February 9, 2011, p. 7162-7175 (“the Supplementary Examination Guidelines”). With respect to claim 22, this claim is rejected under §112, first paragraph, based on lack of written description because the specification fails to provide the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function. In particular, no specificity is provided with respect to the selection/adjustment process. The disclosure provides no algorithm, flow chart, or other detailed description of the selection/adjustment process itself, but only refers to the selection/adjustment process in a “black box” description, meaning that the selection/adjustment process is referred to in a general sense but the specifics of the selection/adjustment process itself is not elaborated upon such that one of ordinary skill in the art would not have understood that the Applicant was in possession of the claimed invention.
Claim 23 recites “coupling said input using one or more coupling parameters; and using adaptive learning algorithms to adjust said one or more parameters to optimize the frequency, amplitude and phase of one or more outgoing oscillation signals” in lines 4-6. This is clearly a computer-implemented recitation (see specification ¶[0042]-[0043] and ¶[0081]; Figure 3).
Under the current guidelines of 35 USC 112, the specification fails to support a claim that defines the invention in functional language specifying a desired result when the specification does not sufficiently identify how the invention achieves the claimed function. For there to be sufficient disclosure for a computer-implemented claim limitation, it is not enough that one skilled in the art could write a program to achieve the claimed function. Rather, the specification must disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function in sufficient detail such that one of ordinary skill can reasonably
conclude that the inventor invented the claimed subject matter. See Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, Fed. Reg. Vol. 76, No. 27, February 9, 2011, p. 7162-7175 (“the Supplementary Examination Guidelines”). With respect to claim 23, this claim is rejected under §112, first paragraph, based on lack of written description because the specification fails to provide the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function. This is a machine learning/neural network type implementation (see specification ¶[0042]-[0043] and Figure 3), but no specificity is provided with the network, such as training, layers, data propagation, logics, etc. In particular, no specificity is provided with respect to the prediction/neural state process. The disclosure provides no algorithm, flow chart, or other detailed description of the prediction/neural state process itself, but only refers to the prediction/neural state process in a “black box” description, meaning that the prediction/neural state process is referred to in a general sense but the specifics of the prediction/neural state process itself is not elaborated upon such that one of ordinary skill in the art would not have understood that the Applicant was in possession of the claimed invention.
Claim 24 is rejected by virtue of its dependence from claim 23.
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 1-18 and 20-25 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 system with elements directed towards “an entrainment stimulator”, “an oscillation selection module”, and “a brain rhythm stimulator” in lines 3-5. From the specification, these elements are directed towards computer programs, presumed to run on a generic computer (see specification ¶[0042]-[0044] and ¶[0050]; Figure 3). As the claim is a system, and recited computer programs without any required functioning, it is not clear what specific elements are required within the bounds of the claim. This renders the scope of the claim unclear. Appropriate correction is required.
Claim 1 limitation “oscillation selection module” in line 4 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. There is no structure in the specification for the oscillation selection module. Figure 3 indicates that the oscillation selection module is a “decision algorithm”, but the specification does not specify any structure for implementing such an algorithm. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 2-18 are rejected by virtue of their dependence from claim 1.
Claim 2 limitation “filtering module having means” in line 2 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. There is no structure in the specification for the filtering module. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 2 limitation “onset detection module having means” in lines 2-3 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. There is no structure in the specification for the onset detection module. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 2 limitation “gain control module having means” in lines 3-4 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. There is no structure in the specification for the gain control module. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 3 is rejected by virtue of its dependence on claim 2.
Claim 3 recites “an onset signal” in line 2, but it is not clear what this signal is. It is not clear how this signal relates to the input signal, or how this signal relates any detected acoustic events. This confusion renders claim 3 indefinite. For the purposes of examination, this term is not being given patentable weight. Appropriate correction is required.
Claim 4 limitation “means to predict” in line 2 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. There is no structure in the specification for the means to predict. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 4 recites “one or more network states” in line 5, but it is not clear what the network states are. The specification indicates that the entrainment stimulator is a type of neural network (see specification ¶[0042]-[0043] and Figure 3). However, it is not clear how this network is implemented, or what this network actually does (see above 35 U.S.C. § 112(a) rejection), such that the output (presumably the network state) is not known. While the output is presumed to have relation to predicted frequency bands of neural data, the specific output is not clear (i.e., graphical representation of neural data over time, simple numerical representations, etc.), and the output’s relation to the network state is not stated in the specification. This confusion renders claim 4 indefinite. Appropriate correction is required.
Claim 5 is rejected by virtue of its dependence from claim 4.
Claim 5 recites the limitation “said one or more frequency ranges” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 6 limitation “means to select” in line 2 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. There is no structure in the specification for the means to select. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 6 recites the limitation “the one or more frequency ranges” in line 3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 6 recites “couple a gamma frequency to a beat and rhythmic structure of music through theta-gamma and delta-theta PAC” in lines 3-4. The recitation appears to be taking place with the element of the oscillation selection module and stimulus to be applied to the patient. However, this recitation of coupling brain frequencies appears to be referencing the response to stimulus applied to the subject. It is not clear what is actually required in this recitation. This inconsistency renders claim 6 indefinite. Appropriate correction is required.
Claim 7 recites “a light pattern buffer” in line 2; however, it is not clear what exactly the light pattern buffer is. The specification mentions the light pattern buffer in ¶[0050], but does not elaborate on what the light pattern buffer actually is. This confusion renders claim 7 indefinite, as the scope of the claim is not clear. This term is not being given patentable weight for the purposes of examination. Appropriate correction is required.
Claim 7 limitation “light generation module” in line 2 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. There is no structure in the specification for the light generation module. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 7 limitation “light adjustment module” in line 2 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. There is no structure in the specification for the light adjustment module. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 7 limitation “filtering component” in lines 2-3 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. There is no structure in the specification for the filtering component. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 8-10 are rejected by virtue of their dependence from claim 7.
Claim 8 recites the limitation “said output device includes a device selected from the group comprising…” in lines 1-2. This limitation appears to invoke a Markush grouping, see MPEP § 2117. However, the use of the term “comprises” makes the Markush grouping open, which is indefinite because it is unclear what other alternatives are intended to be encompassed by the claim, see MPEP § 2173.05(h). Amending this recitation to “said output device includes a device selected from the group consisting of” would overcome this rejection. The claim is being read as such for the purposes of examination. Appropriate correction is required.
Claim 11 recites “said output device comprises one or more stimulation units for generating tactile, vibratory stimuli, thermal stimuli, electrical transcutaneous stimuli, or electromagnetic fields and/or electrical currents to deliver transcranial stimulation” in lines 1-3; however, it is not clear how the stimuli here (i.e., the non-audio/visual stimuli) relate to the claimed system. From claim 1 and the specification, the output device receives the stimulation information/parameters from the brain rhythm stimulator, after being modified by the other components (see specification generally ¶[0041]-[0048]; Figure 3). However, the specification does not detail on where/how the other stimuli (i.e., the non-audio/visual stimuli) are related from the system. Therefore, it is not clear where the input to the other stimuli comes from, or if the claimed system is even capable of deriving such other stimulation parameters needed to implement such stimulation. This confusion renders claim 11 indefinite. Appropriate correction is required.
Claim 11 recites “generating tactile, vibratory stimuli, thermal stimuli, electrical transcutaneous stimuli, or electromagnetic fields and/or electrical currents to deliver transcranial stimulation” in lines 2-3, which is grammatically awkward and unclear. The usage of “or” followed by “and/or” is unclear. This confusion renders claim 11 indefinite. Appropriate correction is required.
Claim 12 is rejected by virtue of its dependence from claim 11.
Claim 12 recites the limitation “said output device is selected from the group comprising:” in lines 1-2. This limitation appears to invoke a Markush grouping, see MPEP § 2117. However, the use of the term “comprising” makes the Markush grouping open, which is indefinite because it is unclear what other alternatives are intended to be encompassed by the claim, see MPEP § 2173.05(h). Amending this recitation to “said output device is selected from the group consisting of” would overcome this rejection. The claim is being read as such for the purposes of examination. Appropriate correction is required.
Claim 13 recites the limitation “the brain” in line 3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 14 is rejected by virtue of its dependence from claim 13.
Claim 14 recites the limitation “said one or more means to sense electrical or magnetic fields in the brain includes one or more devices selected from the group comprising” in lines 1-3. This limitation appears to invoke a Markush grouping, see MPEP § 2117. However, the use of the term “comprising” makes the Markush grouping open, which is indefinite because it is unclear what other alternatives are intended to be encompassed by the claim, see MPEP § 2173.05(h). Amending this recitation to “said one or more means to sense electrical or magnetic fields in the brain includes one or more devices selected from the group consisting of” would overcome this rejection. The claim is being read as such for the purposes of examination. Appropriate correction is required.
Claim 15 recites the limitation “said auditory analysis system includes one or more means to receive an auditory input selected from the group comprising” in lines 1-2. This limitation appears to invoke a Markush grouping, see MPEP § 2117. However, the use of the term “comprising” makes the Markush grouping open, which is indefinite because it is unclear what other alternatives are intended to be encompassed by the claim, see MPEP § 2173.05(h). Amending this recitation to “said auditory analysis system includes one or more means to receive an auditory input selected from the group consisting of” would overcome this rejection. The claim is being read as such for the purposes of examination. Appropriate correction is required.
Claim 15 recites “an auditory input” in line 4, but it is not clear if this recitation is the same as, related to, or different from the recitation “an auditory input” in line 2. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the auditory input”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purpose of examination, these recitations are being interpreted as the same. Appropriate correction is required.
Claim 15 recites “said one or more means to receive an auditory input operatively coupled to said auditory analysis system” in lines 3-4, but also states that “said auditory analysis system includes one or more means to receive an auditory input” in lines 1-2. It is not clear how the one or more means to receive the auditory input can be operatively coupled to said auditory analysis system, if the one or more means to receive the auditory input are part of the auditory analysis system itself. This inconsistency renders claim 15 indefinite. For the purposes of examination, this recitation is not being given patentable weight. Appropriate correction is required.
Claim 16 is rejected by virtue of its dependence from claim 15.
Claim 16 limitation “auditory output means” in lines 1-2 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. There is no structure in the specification for the auditory output means. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 17 recites the limitation “said data being selected from a list comprising:” in lines 3-4. This limitation appears to invoke a Markush grouping, see MPEP § 2117. However, the use of the term “comprising” makes the Markush grouping open, which is indefinite because it is unclear what other alternatives are intended to be encompassed by the claim, see MPEP § 2173.05(h). Amending this recitation to “said data being selected from a list consisting of” would overcome this rejection. The claim is being read as such for the purposes of examination. Appropriate correction is required.
Claim 20 recites the limitation “said stimulation pattern includes a type of stimulation selected from the group comprising:” in lines 1-2. This limitation appears to invoke a Markush grouping, see MPEP § 2117. However, the use of the term “comprising” makes the Markush grouping open, which is indefinite because it is unclear what other alternatives are intended to be encompassed by the claim, see MPEP § 2173.05(h). Amending this recitation to “said stimulation pattern includes a type of stimulation selected from the group consisting of” would overcome this rejection. The claim is being read as such for the purposes of examination. Appropriate correction is required.
Claim 20 recites “wherein said stimulation pattern includes a type of stimulation selected from the group comprising: light patterns, vibro-tactile patterns, or patterns of electrical or magnetic pulses” in lines 1-3; however, it is not clear how the stimuli here (i.e., the non-audio/visual stimuli) relate to the claimed method. From claim 19 and the specification, the method steps performed as indicated in the specification as the output device receives the stimulation information/parameters from the brain rhythm stimulator, after being modified by the other components (see specification generally ¶[0041]-[0048]; Figure 3). However, the specification does not detail on where/how the other stimuli (i.e., the non-audio/visual stimuli) are related to those components/method steps. Therefore, it is not clear where the input to the other stimuli comes from, or if the claimed method is even capable of deriving such other stimulation parameters needed to implement such stimulation. This confusion renders claim 20 indefinite. Appropriate correction is required.
Claim 21 recites the limitation “the onset” in line 4. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 21 recites “simulating neural entrainment to said acoustic signal using an entrainment simulator” in line 5. A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. See MPEP § 2173.03. The recitation appears to be requiring stimulation applied to the patient and recording responses; however, no stimulation has been applied to the patient at this point. The inconsistency between what is claimed (i.e., stimulating neural entrainment) and what appears to be required for the neural entrainment (i.e., stimulation applied to the patient) renders claim 21 indefinite. Appropriate correction is required.
Claim 21 recites the limitation “said one or more oscillations” in line 6. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 21 recites the limitation “intrinsic parameters” in lines 7-8. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claims 22-25 are rejected by virtue of their dependence from claim 21.
Claim 23 recites “providing said input to one or more multi-frequency neural networks; coupling said input using one or more coupling parameters; and using adaptive learning algorithms to adjust said one or more parameters to optimize the frequency, amplitude and phase of one or more outgoing oscillation signals, wherein said one or more outgoing oscillation signals are used to generate and display said light pattern on said visual output device” in lines 3-8. However, claim 21 recites steps related towards the coupling parameters, adjusting those parameters, generating and displaying patterns in lines 5-12. It is not clear how the steps of claim 23 relate to those of claim 21. Are these step part of the process of claim 21, in addition to, or something else? Are the displayed light patterns resulting from the selected one or more oscillations, one or more outgoing oscillation signals, or a combination of both? Further confusion arises from the relationship of the multi-frequency neural networks and the adaptive learning algorithms. Given the claim language, all three are written as different networks/algorithms; however, given the context of the claim and the specification (see ¶[0041]-[0042] and Figure 3), they all appear to be the same. These inconsistencies render claim 23 indefinite. Appropriate correction is required.
The term “optimize” in claim 23, line 5 is a relative term which renders the claim indefinite. The term “optimize” 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. It is not clear to what degree or standard the frequency, amplitude, and phase should be optimized to. This renders claim 23 indefinite. Appropriate correction is required.
Claim 24 is rejected by virtue of its dependence from claim 23.
Claim 24 recites the limitation “said brain oscillation monitor comprises one or more means to sense electrical or magnetic fields in the brain selected from the group comprising” in lines 1-3. This limitation appears to invoke a Markush grouping, see MPEP § 2117. However, the use of the term “comprising” makes the Markush grouping open, which is indefinite because it is unclear what other alternatives are intended to be encompassed by the claim, see MPEP § 2173.05(h). Amending this recitation to “said brain oscillation monitor comprises one or more means to sense electrical or magnetic fields in the brain selected from the group consisting of” would overcome this rejection. The claim is being read as such for the purposes of examination. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 6 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 6 recites “couple a gamma frequency to a beat and rhythmic structure of music through theta-gamma and delta-theta PAC” in lines 3-4. If this recitation is directed towards coupling frequencies in brainwaves of the subject (see above 35 U.S.C. § 112(b) rejection), then this recitation would be directed to or encompassing a human organism. Appropriate correction is required.
Claims 17-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. A claim that covers both statutory and non-statutory embodiments (under the broadest reasonable interpretation of the claim when read in light of the specification and in view of one skilled in the art) embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter. "non-transitory and/or random-access memory" can encompass non-statutory forms of signal transmission, such as, a propagating electrical or electromagnetic signal per se (i.e., because of the “or” scenario). See In re Nuijten, 500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007). When the broadest reasonable interpretation of machine readable media encompasses transitory forms of signal transmission, the claim is directed to non-statutory subject matter. It is suggested that Applicant amend the claim to recite " non-transitory and random-access memory” in order to recite statutory subject matter. Appropriate correction is required.
Claim 18 is rejected by virtue of its dependence from claim 17.
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)(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.
The succeeding art rejections to the claims under 35 U.S.C. § 102 and 103 below are made with the claims as best understood and interpreted in light of the preceding rejections under 35 U.S.C. § 112 above.
Claims 1-8 and 11-25 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Malchano et al. (2019/0314641 – cited by Applicant), hereinafter Malchano.
Regarding Claim 1, Malchano teaches systems and methods for treating cognitive dysfunction in a subject utilizing a light source and speaker for stimulation (see abstract and Fig. 1). Malchano teaches a neural stimulation system (see abstract and Fig. 1; ¶[0244]-[0248] the visual neural stimulation system (NSS) 105, ¶[0311]-[0312] the computing device(s) 700 of the system, ¶[0385] the neural stimulation system (NSS) 905, ¶[0841] the system 3800 for sensing oscillations based on external stimulus, ¶[0912] the combination of the different disclosed features in a single embodiment; Figs. 1, 7A-7B, 9, and 37-38), the system comprising:
an auditory analysis system (¶[0388]-[0389] the audio generation module for providing audio for audio stimulation through sound waves, ¶[0400]-[0401] the audio stimulation may include bursts/beats of acoustic waves, ¶[0416]-[0425] the NSS 905 may generate the audio stimulation (i.e., the bursts/beats of acoustic waves) from a musical instrument track, including both voice and musical instruments, with the beats/pulses set according to the beats in the music, the modulation/embedding of the audio signal for entrainment, ¶[0456]-[0458] the feedback component 960 that can receive audio from the microphone 1210, including from the subject, such as audio commands; Figs. 9-11C);
an entrainment simulator operatively connected to said auditory analysis system; an oscillation selection module operatively connected to said entrainment simulator; a brain rhythm stimulator operatively connected to said oscillation selection module (¶[0311]-[0312] the computing device(s) 700 of the system including the CPU 721 and the memory 722, ¶[0597] the different components of the simulation systems include the processing and memory functionality of the computing devices, Fig. 7A-7B; ¶[0244]-[0247], ¶[0385]-[0388], and ¶[0834] the different components interface with one another; Figs. 1, 9, and 37-39); and
an output device operatively connected to said brain rhythm stimulator (¶[0247] the visual signaling component 150, such as an LED, for implementing the visual stimulation; Fig. 1).
Here, claim 1 requires an auditory analysis system, an output device, and three computer implemented programs/algorithms (i.e., the entrainment simulator, oscillation selection module, and the brain rhythm simulator) (see present application Figure 3). As explained above with the 35 U.S.C. § 112(b) rejection, it not clear what specific elements are required for the three computer implemented programs/algorithms as no function has been claimed. Since no function has been claimed, and the claim is directed towards a system, the computing device(s) of Malchano read upon the three computer implemented programs/algorithms of the present claim 1. This is further supported as Malchano teaches more than three, interfaced components, which reads upon operatively connected. Therefore, as Malchano teaches all of the structural requirements of claim 1, Malchano teaches the system of claim 1.
Regarding Claim 2, Malchano teaches the system of claim 1 as stated above. Malchano further teaches said auditory analysis system comprises a filtering module having means to filter an incoming audio signal (¶[0428]-[0429] the unwanted frequency filtering module 920 capable of filtering the audio signals; Fig. 9),
an onset detection module having means to detect an onset of acoustic events in said signal (¶[0416]-[0425] the NSS 905 may generate the audio stimulation (i.e., the bursts/beats of acoustic waves) from a musical instrument track, including both voice and musical instruments, with the beats/pulses set according to the beats in the music, the identified beats in the music for the setting of the beats/pulses is the onset, the modulation/embedding of the audio signal for entrainment, see present application specification ¶[0036]; Figs. 9-11C), and
a gain control module having means to adjust a gain of said signal (¶[0426] the audio adjustment module 915 that can adjust various aspects of the audio signal, including amplitude; Fig. 9).
Regarding Claim 3, Malchano teaches the system of claim 2 as stated above. Malchano further teaches said auditory analysis system provides output to said entrainment simulator in the form of an onset signal (¶[0416]-[0425] the output modulated/embedded audio signal, ¶[0385]-[0388] the different components interface with one another; Figs. 9-11C).
Regarding Claim 4, Malchano teaches the system of claim 1 as stated above. Malchano further teaches said entrainment simulator includes means to predict the frequencies, phases and amplitudes of a human neural response to music (¶[0848]-[0849] and ¶[0901]-[0902] the simulated response module 3735 is the entrainment simulator, the simulated response module 3735 includes a model trained off of historical responses of subjects and the subject to indicate the subject’s predicted response given a particular stimulus, ¶[0903]-[0909] the identified stimulus to give the subject based on the predicted subject response; Figs. 38, 45, and 46B); and
wherein said entrainment simulator provides output to said oscillation selection module in the form of one or more network states (¶[0848]-[0851] and ¶[0898]-[0909] the output predicted subject stimulus response and/or therapy neural stimulus for the subject, ¶[0834] the different components interface with one another; Figs. 9-11C, 38, 45, and 46B).
Regarding Claim 5, Malchano teaches the system of claim 4 as stated above. Malchano further teaches said one or more frequency ranges include delta, theta, and gamma frequency bands (¶[0238]-[0240] the system may measure neural data from the user, such as via EEG, in bands of delta, theta, alpha, beta, and gamma frequency bands).
Regarding Claim 6, Malchano teaches the system of claim 1 as stated above. Malchano further teaches said oscillation selection module includes means to select a most prominent oscillation in the one or more frequency ranges, and to couple a gamma frequency to a beat and rhythmic structure of music through theta-gamma and delta-theta PAC (¶[0245]-[0250] the light generation module 110 for generating specific visual signals with desired wavelengths and pulses for visual stimulation, ¶[0253]-[0257] the light generation module 110 may generate the pulses so as to target specific brain activity, such as gamma activity, ¶[0848]-[0851] and ¶[0898]-[0909] the output predicted subject stimulus response and/or therapy neural stimulus for the subject, the selected therapy neural stimulus, implemented as the visual light stimulus, is the selected oscillation; Figs. 1, 38, 45, and 46B); and
wherein said oscillation selection module provides output to said brain rhythm stimulator in the form of one or more selected oscillation states (¶[0244]-[0247], ¶[0385]-[0388], and ¶[0834] the different components interface with one another; Figs. 1, 9, and 37-39). Here, the oscillation selection so as to apply a specific stimulation to the subject meets the claimed recitation of “means to select”. The additional functional language following the means to select is being interpreted as intended use, as the language is not positively recited.
Regarding Claim 7, Malchano teaches the system of claim 1 as stated above. Malchano further teaches said brain rhythm stimulator comprises a light pattern buffer, a light generation module, a light adjustment module, and a filtering component (¶[0289]-[0290] the light adjustment module 115 for adjusting a parameter associated with the visual signal, the unwanted frequency filtering module 120 capable of filtering the signal, as best understood in view of the 35 U.S.C. § 112(b) rejections and 112(f) interpretations above; Fig. 1).
Regarding Claim 8, Malchano teaches the system of claim 7 as stated above. Malchano further teaches said output device includes a device selected from the group comprising LED lights, a computer monitor, a TV monitor, goggles, a virtual reality headset, augmented reality glasses, and smart glasses (¶[0247] the visual signaling component 150, such as an LED; Fig. 1).
Regarding Claim 11, Malchano teaches the system of claim 1 as stated above. Malchano further teaches said output device comprises one or more stimulation units for generating tactile, vibratory stimuli, thermal stimuli, electrical transcutaneous stimuli, or electromagnetic fields and/or electrical currents to deliver transcranial stimulation (¶[0586]-[0589] a glove 2114 may be utilized to deliver peripheral nerve stimulation to cause or induce neural oscillations via electrodes 2102a/2102b; Fig. 21A).
Regarding Claim 12, Malchano teaches the system of claim 11 as stated above. Malchano further teaches said output device is selected from the group comprising: a wearable device, gloves, a smart watch, a mobile device, or an array of electromagnets or electrodes (¶[0586]-[0589] a glove 2114 may be utilized to deliver peripheral nerve stimulation to cause or induce neural oscillations via electrodes 2102a/2102b; Fig. 21A).
Regarding Claim 13, Malchano teaches the system of claim 1 as stated above. Malchano further teaches a brain oscillation monitor operatively connected to said entrainment simulator, and with one or more means to sense electrical or magnetic fields in the brain (¶[0109] and ¶[0238]-[0240] the system may measure neural data from the user, such as via EEG, in bands of delta, theta, alpha, beta, and gamma frequency bands, ¶[0438] the feedback monitor 935 in the system may utilize the EEG measurements, ¶[0385]-[0388] the different components interface with one another; Fig. 9).
Regarding Claim 14, Malchano teaches the system of claim 13 as stated above. Malchano further teaches said one or more means to sense electrical or magnetic fields in the brain includes one or more devices selected from the group comprising electroencephalogram (EEG), intracranial EEG (iEEG), electrocorticography (ECoG), or magnetoencephalography (MEG) (¶[0109] and ¶[0238]-[0240] the system may measure neural data from the user, such as via EEG, in bands of delta, theta, alpha, beta, and gamma frequency bands, ¶[0438] the feedback monitor 935 in the system may utilize the EEG measurements, ¶[0385]-[0388] the different components interface with one another; Fig. 9).
Regarding Claim 15, Malchano teaches the system of claim 1 as stated above. Malchano further teaches said auditory analysis system includes one or more means to receive an auditory input selected from the group comprising a built-in audio playback system, an auxiliary audio input or a microphone, said one or more means to receive an auditory input operatively coupled to said auditory analysis system (¶[0388]-[0389] the audio generation module for providing audio for audio stimulation through sound waves, ¶[0400]-[0401] the audio stimulation may include bursts/beats of acoustic waves, ¶[0416]-[0425] the NSS 905 may generate the audio stimulation (i.e., the bursts/beats of acoustic waves) from a musical instrument track, including both voice and musical instruments, with the beats/pulses set according to the beats in the music, the modulation/embedding of the audio signal for entrainment, ¶[0456]-[0458] the feedback component 960 that can receive audio from the microphone 1210, including from the subject, such as audio commands; Figs. 9-11C).
Regarding Claim 16, Malchano teaches the system of claim 15 as stated above. Malchano further teaches an auditory output means (¶[0388]-[0392] the audio signaling component 950, for generating sounds waves, such as via a speaker; Fig. 9).
Regarding Claim 17, Malchano teaches the system of claim 1 as stated above. Malchano further teaches a profile manager comprising a processor or internet-enabled software application accessing non-transitory and/or random-access memory which stores data pertaining to one or more users (¶[0064] and ¶[0291] the profile manager 125, including a processor and memory for storing and managing subject information; Fig. 1),
said data being selected from a list comprising: identifying information, stored information from previous therapies, a library of audio files, and/or one or more user preferences (¶[0291] the profile information may include historical treatment information, historical brain entrainment information, dosing information, parameters of light waves, feedback, physiological information, environmental information, or other data associated with the systems and methods of brain entrainment).
Regarding Claim 18, Malchano teaches the system of claim 17 as stated above. Malchano further teaches said profile manager is operatively connected to said entrainment simulator, said auditory analysis system, and said brain rhythm stimulator (¶[0291] the NSS is interfaced with the profile manager 125, ¶[0244]-[0247] the different components interface with one another; Fig. 1).
Regarding Claim 19, Malchano teaches systems and methods for treating cognitive dysfunction in a subject utilizing a light source and speaker for stimulation (see abstract and Fig. 1). Malchano teaches a method for neural stimulation (see abstract and Fig. 1; ¶[0244]-[0248] the visual neural stimulation system (NSS) 105, ¶[0311]-[0312] the computing device(s) 700 of the system, ¶[0385] the neural stimulation system (NSS) 905, ¶[0841] the system 3800 for sensing oscillations based on external stimulus, ¶[0912] the combination of the different disclosed features in a single embodiment; Figs. 1, 7A-7B, 9, and 37-38), the method comprising:
selecting one or more oscillations in one or more predetermined frequency ranges (¶[0245]-[0250] the light generation module 110 for generating specific visual signals with desired wavelengths and pulses for visual stimulation, ¶[0253]-[0257] the light generation module 110 may generate the pulses so as to target specific brain activity, such as gamma activity, ¶[0848]-[0851] and ¶[0898]-[0909] the output predicted subject stimulus response and/or therapy neural stimulus for the subject, the selected therapy neural stimulus, implemented as the visual light stimulus, is the selected oscillation; Figs. 1, 38, 45, and 46B);
generating a stimulation pattern using said one or more oscillations (¶[0245]-[0250] the light generation module 110 for generating specific visual signals with desired wavelengths and pulses, ¶[0253]-[0257] the light generation module 110 may generate the pulses so as to target specific brain activity, such as gamma activity, ¶[0848]-[0851] and ¶[0898]-[0909] the output predicted subject stimulus response and/or therapy neural stimulus for the subject, the selected therapy neural stimulus, ¶[0288] the generation of the specified light stimulus by the light generation module 110 in response to the model; Figs. 1, 38, 45, and 46B); and
outputting said stimulation pattern on an output device (¶[0247] the visual signaling component 150, such as an LED, for implementing the visual stimulation; Fig. 1).
Regarding Claim 20, Malchano teaches the method of claim 19 as stated above. Malchano further teaches said stimulation pattern includes a type of stimulation selected from the group comprising: light patterns, vibro-tactile patterns, or patterns of electrical or magnetic pulses (¶[0245]-[0250] the light generation module 110 for generating specific visual signals with desired wavelengths and pulses for visual stimulation, ¶[0247] the visual signaling component 150, such as an LED, for implementing the visual stimulation; Fig. 1).
Regarding Claim 21, Malchano teaches systems and methods for treating cognitive dysfunction in a subject utilizing a light source and speaker for stimulation (see abstract and Fig. 1). Malchano teaches a method for neural stimulation (see abstract and Fig. 1; ¶[0244]-[0248] the visual neural stimulation system (NSS) 105, ¶[0311]-[0312] the computing device(s) 700 of the system, ¶[0385] the neural stimulation system (NSS) 905, ¶[0841] the system 3800 for sensing oscillations based on external stimulus, ¶[0912] the combination of the different disclosed features in a single embodiment; Figs. 1, 7A-7B, 9, and 37-38), the method comprising:
receiving an auditory input comprising an acoustic signal (¶[0388]-[0389] the audio generation module for providing audio for audio stimulation through sound waves, ¶[0400]-[0401] the audio stimulation may include bursts/beats of acoustic waves, ¶[0416]-[0425] the NSS 905 may generate the audio stimulation (i.e., the bursts/beats of acoustic waves) from a musical instrument track, including both voice and musical instruments, with the beats/pulses set according to the beats in the music, the modulation/embedding of the audio signal for entrainment, ¶[0456]-[0458] the feedback component 960 that can receive audio from the microphone 1210, including from the subject, such as audio commands; Figs. 9-11C);
filtering said acoustic signal (¶[0428]-[0429] the unwanted frequency filtering module 920 capable of filtering the audio signals; Fig. 9);
detecting the onset of one or more acoustic events contained within said acoustic signal (¶[0416]-[0425] the NSS 905 may generate the audio stimulation (i.e., the bursts/beats of acoustic waves) from a musical instrument track, including both voice and musical instruments, with the beats/pulses set according to the beats in the music, the identified beats in the music for the setting of the beats/pulses is the onset, the modulation/embedding of the audio signal for entrainment, see present application specification ¶[0036]; Figs. 9-11C);
simulating neural entrainment to said acoustic signal using an entrainment simulator (¶[0388]-[0389] the audio generation module for providing audio for audio stimulation through sound waves, ¶[0400]-[0401] the audio stimulation may include bursts/beats of acoustic waves, ¶[0416]-[0425] the NSS 905 may generate the audio stimulation (i.e., the bursts/beats of acoustic waves) from a musical instrument track, including both voice and musical instruments, with the beats/pulses set according to the beats in the music, the modulation/embedding of the audio signal for entrainment);
generating one or more coupling parameters to couple said one or more oscillations (¶[0245]-[0250] the light generation module 110 for generating specific visual signals with desired wavelengths and pulses, ¶[0253]-[0257] the light generation module 110 may generate the pulses so as to target specific brain activity, such as gamma activity, ¶[0848]-[0851] and ¶[0898]-[0909] the output predicted subject stimulus response and/or therapy neural stimulus for the subject, the selected therapy neural stimulus, ¶[0288] the generation of the specified light stimulus by the light generation module 110 in response to the model; Figs. 1, 38, 45, and 46B);
using adaptive learning algorithms to adjust said one or more coupling parameters or intrinsic parameters (¶[0848]-[0851] and ¶[0898]-[0909] the output predicted subject stimulus response and/or therapy neural stimulus for the subject, the selected therapy neural stimulus);
selecting one or more oscillations in one or more predetermined frequency ranges for dis- play (¶[0598]-[0616], ¶[0633]-[0636] the stimuli orchestration component 2310 to perform neural stimulation using multiple modalities of stimulation, including both audio and visual stimulation, utilizing the policy 2325 based on the subject profile and feedback from feedback components 2340 to determine and apply the stimuli, ¶[0638]-[0643] the application of visual and audio stimulation, ¶[0655] the visual and audio stimulus may be synchronized, ¶[0666]-[0668] the system 2600 for selecting dosing parameters of an appropriate stimulation modality (i.e., visual and/or audio stimulation) and delivering the determined neural stimulation, in part based on user profile and feedback, Figs. 23A-26; ¶[0245]-[0250] the light generation module 110 for generating specific visual signals with desired wavelengths and pulses for visual stimulation, ¶[0253]-[0257] the light generation module 110 may generate the pulses so as to target specific brain activity, such as gamma activity, ¶[0848]-[0851] and ¶[0898]-[0909] the output predicted subject stimulus response and/or therapy neural stimulus for the subject, the selected therapy neural stimulus, implemented as the visual light stimulus, is the selected oscillation; Figs. 1, 38, 45, and 46B);
generating a light pattern using said one or more oscillations (¶[0245]-[0250] the light generation module 110 for generating specific visual signals with desired wavelengths and pulses, ¶[0253]-[0257] the light generation module 110 may generate the pulses so as to target specific brain activity, such as gamma activity, ¶[0848]-[0851] and ¶[0898]-[0909] the output predicted subject stimulus response and/or therapy neural stimulus for the subject, the selected therapy neural stimulus, ¶[0288] the generation of the specified light stimulus by the light generation module 110 in response to the model; Figs. 1, 38, 45, and 46B); and
displaying said light pattern on a visual output device (¶[0247] the visual signaling component 150, such as an LED, for implementing the visual stimulation; Fig. 1).
Here, the systems 2300/2400/2600 apply the specific stimulus, which includes a visual stimulus, based on the user input/feedback from the user, which includes the modalities of audio input as in system 900 and light stimulus generation as in system 100.
Regarding Claim 22, Malchano teaches the method of claim 21 as stated above. Malchano further teaches prior to said step of generating a light pattern, the step of reading a patient profile from a profile manager; and wherein said step of generating a light pattern comprises selecting a light pattern based on said patient profile, and adjusting said light pattern based on said patient profile (¶[0598]-[0616], ¶[0633]-[0636] the stimuli orchestration component 2310 to perform neural stimulation using multiple modalities of stimulation, including both audio and visual stimulation, utilizing the policy 2325 based on the subject profile and feedback from feedback components 2340 to determine and apply the stimuli, ¶[0638]-[0643] the application of visual and audio stimulation, ¶[0655] the visual and audio stimulus may be synchronized, ¶[0666]-[0668] the system 2600 for selecting dosing parameters of an appropriate stimulation modality (i.e., visual and/or audio stimulation) and delivering the determined neural stimulation, in part based on user profile and feedback, Figs. 23A-26; ¶[0064], ¶[0291], ¶[0336], and ¶[0339] the profile manager 125, including a processor and memory for storing and managing subject information, can modify/determine type of stimulus based on the profile information/policy; Fig. 1).
Regarding Claim 23, Malchano teaches the method of claim 21 as stated above. Malchano further teaches receiving an input from a brain oscillation monitor (¶[0109] and ¶[0238]-[0240] the system may measure neural data from the user, such as via EEG, in bands of delta, theta, alpha, beta, and gamma frequency bands, ¶[0296] the feedback component 160 may be EEG, ¶[0438] the feedback monitor 935 in the system may utilize the EEG measurements, ¶[0385]-[0388] the different components interface with one another; Figs. 1 and 9);
providing said input to one or more multi-frequency neural networks; coupling said input using one or more coupling parameters; and using adaptive learning algorithms to adjust said one or more parameters to optimize the frequency, amplitude and phase of one or more outgoing oscillation signals, wherein said one or more outgoing oscillation signals are used to generate and display said light pattern on said visual output device (¶[0245]-[0250] the light generation module 110 for generating specific visual signals with desired wavelengths and pulses, ¶[0253]-[0257] the light generation module 110 may generate the pulses so as to target specific brain activity, such as gamma activity, ¶[0848]-[0851] and ¶[0898]-[0909] the output predicted subject stimulus response and/or therapy neural stimulus for the subject based on input EEG data, the selected therapy neural stimulus, ¶[0288] the generation of the specified light stimulus by the light generation module 110 in response to the model; Figs. 1, 38, 45, and 46B).
Regarding Claim 24, Malchano teaches the method of claim 21 as stated above. Malchano further teaches said brain oscillation monitor comprises one or more means to sense electrical or magnetic fields in the brain selected from the group comprising electroencephalogram (EEG), intracranial EEG (iEEG), electrocorticography (ECoG), or magnetoencephalography (MEG) (¶[0109] and ¶[0238]-[0240] the system may measure neural data from the user, such as via EEG, in bands of delta, theta, alpha, beta, and gamma frequency bands, ¶[0296] the feedback component 160 may be EEG, ¶[0438] the feedback monitor 935 in the system may utilize the EEG measurements, ¶[0385]-[0388] the different components interface with one another; Figs. 1 and 9).
Regarding Claim 25, Malchano teaches the method of claim 21 as stated above. Malchano further teaches said auditory input is a musical composition (¶[0416]-[0425] the NSS 905 may generate the audio stimulation (i.e., the bursts/beats of acoustic waves) from a musical instrument track, including both voice and musical instruments, with the beats/pulses set according to the beats in the music, the identified beats in the music for the setting of the beats/pulses is the onset, the modulation/embedding of the audio signal for entrainment, see present application specification ¶[0036]; Figs. 9-11C), and
wherein said musical composition is played in a synchronized fashion with said light pattern (¶[0598]-[0616], ¶[0633]-[0636] the stimuli orchestration component 2310 to perform neural stimulation using multiple modalities of stimulation, including both audio and visual stimulation, utilizing the policy 2325 based on the subject profile and feedback from feedback components 2340 to determine and apply the stimuli, ¶[0638]-[0643] the application of visual and audio stimulation, ¶[0655] the visual and audio stimulus may be synchronized, ¶[0666]-[0668] the system 2600 for selecting dosing parameters of an appropriate stimulation modality (i.e., visual and/or audio stimulation) and delivering the determined neural stimulation, in part based on user profile and feedback; Figs. 23A-26).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The succeeding art rejections to the claims under 35 U.S.C. § 103 below are made with the claims as best understood and interpreted in light of the preceding rejections under 35 U.S.C. § 112 above.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Malchano as applied to claim 7 above, and in view of Lim (US Patent Application Publication 2022/0387819), hereinafter Lim.
Regarding Claim 9, Malchano teaches the system of claim 7 as stated above. Malchano further teaches the use of LED lights (¶[0247] the visual signaling component 150, such as an LED, for implementing the visual stimulation; Fig. 1), said one or more LED lights being operatively connected to said brain rhythm stimulator (¶[0245]-[0250] the light generation module 110 for generating specific visual signals with desired wavelengths and pulses, ¶[0253]-[0257] the light generation module 110 may generate the pulses so as to target specific brain activity, such as gamma activity, ¶[0848]-[0851] and ¶[0898]-[0909] the output predicted subject stimulus response and/or therapy neural stimulus for the subject, the selected therapy neural stimulus, ¶[0288] the generation of the specified light stimulus by the light generation module 110 in response to the model, Figs. 1, 38, 45, and 46B; ¶[0244]-[0247] the different components interface with one another; Fig. 1).
Malchano does not specifically teach that said output device is a visual stimulation ring, and wherein said visual stimulation ring comprises a cylindrical body having one or more LED lights disposed around a circumferentially interior surface thereof.
Lim teaches a self-administrable apparatus for performing non-invasive neurostimulation therapy (see abstract and Figs. 1-6), in which the device utilizes a frame 124 (ring) to support irradiation units 110/112 on the inner circumference of the frame 124 (see ¶[0076]; Figs. 1-6) implemented via LEDs (see ¶[0062]-[0065]), to treat conditions such as dementia and Alzheimer’s Disease as photobiomodulation (PBM) (see ¶[0002]-[0005]), controlled via a controller (see ¶[0065]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the PBM LED device of Lim to implement the stimulation of Malchano because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) Malchano contemplates various light-based LED stimulation modality, and Lim teaches one such light-based LED stimulation modality; and/or (3) the dual LEDs provide more coverage over traditional VNS devices, with no side effects (see Lim ¶[0064]).
Regarding Claim 10, Malchano in view of Lim teaches the system of claim 9 as stated above. The modified Malchano further teaches said brain rhythm stimulator provides output to said output device in the form of a control signal, said control signal containing instructions to cause said output device to display a rhythmic light pattern corresponding to one or more selected oscillation states selected by said oscillation selection module (see Malchano ¶[0245]-[0250] the light generation module 110 for generating specific visual signals with desired wavelengths and pulses, ¶[0253]-[0257] the light generation module 110 may generate the pulses so as to target specific brain activity, such as gamma activity, ¶[0288] the generation of the specified light stimulus by the light generation module 110 in response to the model, ¶[0247] the visual signaling component 150, such as an LED, for implementing the visual stimulation, ¶[0244]-[0247] the different components interface with one another, Fig. 1; see Lim ¶[0065] the controller for controlling the LEDs).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Leuthardt et al. (US Patent Application Publication 2022/0117540) teaches of an intra-calvarial implant (ICI) with electrodes (see abstract and Fig. 1), including that the electronics may be utilized for measuring/stimulating the brain, and that phase amplitude couplings between the frequency bands (i.e., delta, theta, mu, alpha, beta, and gamma) are identified in specific stimulations for different patients (i.e., improve memory, treat Parkinson’s, etc.) (see ¶[0167]).
De Ridder (US Patent Application Publication 2016/0136427) teaches methods for treating a neurological disorder in a patient by adjusting connectivity between network nodes in a brain of a patient (see abstract and Figs. 1A-1B), in which coupling of various combinations of brainwave frequency bands may be utilized (see ¶[0070]-[0076]; Figs. 3-4G).
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/J.D.M./ Examiner, Art Unit 3791
/JENNIFER ROBERTSON/ Supervisory Patent Examiner, Art Unit 3791
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