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 .
Applicant’s preliminary amendment filed 11/15/2023 has been entered. Claims 13-21 are hereby the claims under examination.
All references to Applicant’s specification are made using the paragraph numbers assigned in the US publication of the present application US 2024/0090817 A1.
Specification
The abstract of the disclosure is objected to because the provided abstract is not a single narrative paragraph but rather a cover sheet of the earlier filed PCT application. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/519,561 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. In particular, the provisional application 62/519,561 makes no mention of Brodmann Areas and thus does not support claims 13-21 which are directed towards the measurement and evaluation of EEG data from a specific Brodmann Area. The instant Application is supported by PCTUS2018037342 and will be granted the priority date of 06/13/2018 as the effective filing date for the claimed subject matter of claims 13-21.
Claim Objections
Applicant is advised that should claim 13 be found allowable, claim 16 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). In particular, claims 13 and claim 16 are supposed directed towards the detection and quantification of different parameters, memory encoding and memory recall, yet the two methods of detecting and quantifying these parameters are identical the parameters themselves are not defined by the claim. Thus it would seem that these parameters are substantially identical.
Claims 13 16 and 19 are objected to because of the following informalities:
Claim 13 line 2 it appears that “the left BA 40 from a patient” should read “a patient’s left Brodmann Area (BA) 40”. This objection further applies to the similar language in claims 16 and 19.
Claim 13 line 4 it appears that “the memory performance of a patient” should recite “a memory performance of the patient”. This objection further applies to the similar language in claims 16 and 19.
Claim 13 line 4 it appears that “high gamma and beta biomarkers” should read “the high gamma and the beta biomarkers”. This objection further applies to the similar language in claims 16 and 19.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 13-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Examiner’s Note: Claims 13, 16, and 19 each recite the limitation “high gamma” and “beta”. The specification defines high gamma waves as being between 65-240Hz in paragraph 0036 and beta waves as being between 14-30Hz in paragraph 0035. These limitations are being interpreted as corresponding to the described ranges set forth in the specification.
Claim 13 recites “a method for detecting and quantifying the level of memory encoding comprising: …” but the recited method does not appear to result in the detection or quantification of a level of memory encoding. It is unclear how the last step of comparing biomarkers results in the detection and/or quantification of the level of memory encoding. For the purposes of this examination, the method will be interpreted as the detection and quantification of memory encoding being implicitly performed by the comparison of the data at the first time and the second time. This rejection is further applied to the similar recitations of claims 16 and 19.
Claim 13 recites “collecting data from the left BA 40 from a patient” but is unclear what type of data is being collected. The scope of data collection encompasses any and all forms of data related to the left BA 40 but the following classifying step requires the evaluation of high gamma and beta biomarkers from said data. It would seem that not all types of data include elements that may be classified as “high gamma” or “beta” and thus it is unclear what the meets and bounds of the collected “data” include. For the purposes of this examination, the limitation will be interpreted as collecting electroencephalogram (EEG) data. This rejection is further applied to the similar recitations of claims 16 and 19.
Claim 13 recites “classifying memory status by evaluating high gamma and beta biomarkers from said data” but it is unclear what “memory status” entails or how it is classified. It is further unclear what the meets and bounds of “high gamma and beta biomarkers” entails. For the purposes of this examination, the limitation of memory status will be interpreted as any type, status, or condition related to a user’s cognitive function, and the limitation of high gamma and beta biomarkers will be interpreted as any measure derived from high gamma EEG signals and beta EEG signals. This rejection is further applied to the similar recitations of claims 16 and 19.
Claim 13 recites “measuring the memory performance of a patient based on the quantification of high gamma and beta biomarkers” but it is unclear what measure, value, parameter, or status “memory performance” is meant to encompass and refer to. For the purposes of this examination, any measure of cognitive ability will be considered “memory performance”. This rejection is further applied to the similar recitations of claims 16 and 19.
Claim 13 recites “measuring the memory performance of a patient based on the quantification of high gamma and beta biomarkers” but the limitation “the quantification of high gamma and beta biomarkers” lacks sufficient antecedent basis and it is unclear if “the quantification” is the same as, related to, or different from the previous classification step. It is unclear what “the quantification of high gamma and beta biomarkers” entails. For the purposes of this examination, the limitation of “the quantification” will be interpreted as a separate measure of the high gamma and beta biomarkers. This rejection is further applied to the similar recitations of claims 16 and 19.
Claim 13 recites “collecting data from the left BA 40 from said patient at a second time” but is unclear what type of data is being collected and if the data collected at the second time must be the same type of data collected as the first time or if different types of data may be collected. For the purposes of this examination the limitation will be interpreted as collecting the same type of data as the first time. This rejection is further applied to the similar recitations of claims 16 and 19.
Claim 13 recites “comparing the high gamma and beta biomarkers between the first time and the second time” but there is no recitation stating that the data collected at the second time has “high gamma and beta biomarkers” determined therefrom. It is unclear if the data collected at the second tome is processed in the same manner as the data collected at the first time or in a different manner. It is further unclear what the comparison of the biomarkers entails, what such a comparison produces, and how the output relates to the purpose of the claimed method of detecting and quantifying the level of memory encoding. For the purposes of this examination, this limitation will be interpreted as the second data being of the same type as the first data and having the same features extracted therefrom. The comparison will be interpreted as any type of comparison to determine any differences therebetween and those differences will be interpreted as relating to memory encoding. This rejection is further applied to the similar recitations of claims 16 and 19.
Claims 14-15 are rejected by virtue of their dependence on claim 13.
Claims 17-18 are rejected by virtue of their dependence on claim 16.
Claims 20-21 are rejected by virtue of their dependence on claim 19.
Claim 14 recites “wherein the beta oscillations are defines as those between 14-30 Hz” but the limitation “the beta oscillations” lacks sufficient antecedent basis and it is unclear if this limitation is the same as, related to, or different from “beta biomarkers” of claim 13. It is unclear if the “beta oscillations” are the biomarkers or if the biomarkers are derived from the beta oscillations. It is further unclear how the beta oscillations related to the data collected at the first and second times. For the purposes of this examination, the beta biomarkers will be interpreted as being derived from the beta oscillations and the beta oscillations will be interpreted as further defining the data collected. This rejection is further applied to the similar recitations of claims 17 and 20.
Claim 14 recites “the beta oscillations are … detected within a predefined temporal interval using the topographical analysis of the wavelet convolution at each of these locations in left BA40.” But it is unclear how this recitation relates to the claimed method as no topographical analysis, wavelet convolution, or locations have been recited. This rejection is further applied to the similar recitations of claims 17 and 20.
Claim 15 recites “the high gamma oscillations are defined as those between 65-240 Hz” but the limitation “the high gamma oscillations” lacks sufficient antecedent basis and it is unclear if this limitation is the same as, related to, or different from “high gamma biomarkers” of claim 13. It is unclear if the “high gamma oscillations” are the biomarkers or if the biomarkers are derived from the high gamma oscillations. It is further unclear how the high gamma oscillations related to the data collected at the first and second times. For the purposes of this examination, the high gamma biomarkers will be interpreted as being derived from the high gamma oscillations and the high gamma oscillations will be interpreted as further defining the data collected. This rejection is further applied to the similar recitations of claims 18 and 21.
Claim 15 recites “the high gamma oscillations are … detected within a predefined temporal interval using the topographical analysis of the wavelet convolution at each of these locations in left BA40” But it is unclear how this recitation relates to the claimed method as no topographical analysis, wavelet convolution, or locations have been recited. This rejection is further applied to the similar recitations of claims 18 and 21.
Claim 19 recites “classifying whether the subject's data is encoding, recalling, or performing another cognitive task” but it is unclear how such a classification is performed and how this classification relates to the subsequent classification step of “classifying memory status by evaluating high gamma and beta biomarkers from said data” it is unclear if “the subject's data is encoding, recalling, or performing another cognitive task” is the same as, related to, or different from “memory status”. It is further unclear what the meets and bounds of “performing another cognitive task” entails. For the purposes of this examination, the two limitations will be interpreted as separate and distinct classification steps.
Claim Rejections - 35 USC § 112(a)
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 13-21 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 13 recites “collecting data from the left BA 40 from a patient at a first time” and “collecting data from the left BA 40 from said patient at a second time” but the specification does not fully support the claimed scope of collecting any and all possible types of data from this Brodmann area to carry out the recited method. In particular, paragraphs 0059, 0081, 0083, 0085, and 0089 all indicate that the collected data is intracranial EEG data. This rejection is further applied to the similar recitations of claims 16 and 19.
Claim 13 recites “classifying memory status by evaluating high gamma and beta biomarkers from said data” but the specification does not fully support the implicitly claimed generation of any and all types of high gamma and beta biomarkers. In particular, paragraph 0083 appears to indicates that the biomarkers derived from the recorded oscillations include properties such as onset, offset, power, duration, and spectral content. Additionally, the specification does not appear to support the classification of “memory status” according to any and all high gamma and beta biomarkers. In particular, the specification does not appear to define what “memory status” is and how it is classified from the recited biomarkers. Paragraphs 0033, and 0037-0038 include mere generic statements of functionality reciting that a subject’s “memory status” may be classified from these biomarkers but do not elaborate on what such a status entails or how the classification is carried out. This rejection is further applied to the similar recitations of claims 16 and 19.
Claim 13 recites “measuring the memory performance of a patient based on the quantification of high gamma and beta biomarkers” but the specification does not fully support the claimed scope of measuring “memory performance” based on any and all “quantification(s) of high gamma and beta biomarkers”. In particular, paragraphs 0095-0143 describe a particular process of selecting ripple and spike events and performing power and spectral analysis on these events to serve as predictors. Additionally, the specification does not appear to describe how the “memory performance” is “measured” using the “quantification of high gamma and beta biomarkers. In particular, paragraphs 0033, 0037-0039, 0078-0079, and 0158 include mere generic statements of functionality reciting that the memory performance is measured from the biomarkers. Paragraphs 0083 and 0134 appear to indicate that the high gamma and beta oscillations are biomarkers and that a measurement of memory performance is derived from them, but do not appear to elaborate on how such a measurement is derived from the biomarkers. Paragraph 0151 appears to indicate that some form of classifier is used to determine a strong or weak memory performance using the biomarkers and their properties. Finally, paragraphs 0156 and 0161-0162 appear to indicate that a measurement of memory performance is relative and based upon comparisons to previous memory performance measures and the differences in the properties of the biomarkers between these times. The specification does not appear to describe how one could “measure” the “memory performance” of a patient based on the “quantification of high gamma and beta biomarkers”. This rejection is further applied to the similar recitations of claims 16 and 19.
Claims 14-15 are rejected by virtue of their dependence on claim 13.
Claims 17-18 are rejected by virtue of their dependence on claim 16.
Claims 20-21 are rejected by virtue of their dependence on claim 19.
Claim 19 recites “classifying whether the subject's data is encoding, recalling, or performing another cognitive task” but the specification does not support the claimed scope of any and all known and as of yet unknown methods of classifying data as “encoding, recalling, or performing another cognitive task” In particular, paragraph 0038 provides a mere statement of functionality and is the only mention of a “cognitive task” within the specification. The specification does not set forth the meets and bounds of other cognitive tasks. Paragraph 0137 recites that encoding can be differentiated from recall through statistically significant stimulus-induced responses but indicates that the response may be positive, negative, or both positive and negative. Paragraph 0149 recites that a classifier is trained to differentiate encoding and recall periods using training data but such a description is not sufficient support for a classifier that performs the recited function because the specification does not detail how the classifier is trained or describe the particular method performed by the classifier to carry out the recited function.
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.
Claims 13-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 13-21 are directed to a method of processing data using a computational algorithm, which is an abstract idea. Claims 13-21 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019) and the 2024 Update on Subject Matter Eligibility (Federal Register, Vol 89, No. 137, page 58128, July 17, 2024).
The analysis of claim 13 is as follows:
Step 1: Claim 13 is drawn to a process.
Step 2A – Prong One: Claim 13 recites an abstract idea. In particular, claim 13 recites the following limitations:
[A1] collecting data from the left BA 40 from a patient at a first time
[B1] classifying memory status by evaluating high gamma and beta biomarkers from said data
[C1] measuring the memory performance of a patient based on the quantification of high gamma and beta biomarkers
[D1] collecting data from the left BA 40 from said patient at a second time
[E1] comparing the high gamma and beta biomarkers between the first time and the second time
These elements [A1]-[E1] of claim 13 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 13 recites no additional limitations that are beyond the judicial exception.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 14-15 depend from claim 13, and recite the same abstract idea as claim 13. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 16 and 19 recite the same abstract idea as claim 13 and are rejected on the same basis as claim 13.
Claim 19 further recites “classifying whether the subject's data is encoding, recalling, or performing another cognitive task” but this additional limitation is also drawn to an abstract idea since it involves a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper. Therefore this additional limitation does not qualify as significantly more than the abstract idea itself. Neither of claims 16 or 19 recite additional elements beyond the judicial exception.
Claims 17-18 depend from claim 16, and claims 20-21 depend from claim 19. These claims recite the same abstract ideas as claims 16 and 19 respectively. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Prior Art
A full prior art mapping is precluded by the above presented clarity rejections as the meets and bounds of the claims are unclear. The closest prior art of record is considered to be:
US Patent Application Publication Number US 2018/0021579 A1 hereinafter Kahana teaches a method for delivering electrical stimulation to alter a cognitive state of a user, the method comprising: monitoring a brain signal from the user via one or more intracranial electrodes implanted in the brain of the user while the user is presented with a stimulus; comparing the brain signal to a testing phase biomarker, wherein the testing phase biomarker is derived from a cognitive test performed on a contributor during a testing phase; delivering electrical stimulation to a brain of the user based on the comparing step to steer the brain of the user towards a high performance cognitive state (Abstract). Kahan teaches that different brain regions are activated when performing different cognitive tasks such as encoding and recall. The activation of various brain regions may be monitored during these tasks and regions that show statistically significant increases or decreases in activation during these tasks can be noted. The brain signals associated with these regions may be associated with each stage of the cognitive task and can be used as biomarkers indicative of accurate or inaccurate memory formation (Paragraph 0064-0065 and Fig. 1). The brain signals can be used to determine if the user is in a high or low performance cognitive state and stimulation may be provided to guide the user towards a high-performance cognitive state (Paragraph 0066). Biomarkers are assessed during cognitive tasks by correlating brain signals with task performance. The biomarkers may be associated with a level of cognitive performance. A large number of biomarkers may be identified but the biomarker set may be reduced to one or more biomarkers to classify brain signals into performance states (Paragraphs 0068-0069).
US Patent Number US 8918176 B2 hereinafter Nelson teaches systems and methods for assessing a degenerative cognitive disorder of a patient based on a plurality of episodes of non-motor epileptiform bioelectrical activity. The non-motor epileptiform bioelectrical activity can be detected from one or more bioelectrical brain signals. A worsening cognitive disorder may be indicated by an increase in one or more of intensity, duration, and frequency of occurrence of the episodes of non-motor epileptiform bioelectrical activity. A therapy can be delivered to reduce one or more of intensity, duration, and frequency of occurrence of the episodes of non-motor epileptiform bioelectrical activity. The delivery of the therapy can be controlled based on the plurality of episodes of non-motor epileptiform bioelectrical activity (Abstract). Nelson teaches that gamma and/or beta oscillations may indicate an acceptable or improved cognitive state (Col 19 lines 7-10).
US Patent Number US 9116835 B1 hereinafter Smyth teaches that Brodmann Area 40 (BA 40) is associated with language processing and understanding (Col 13 lines 10-15). This is further taught by US Patent Application Publication Number US 2009/0299126 A1 hereinafter Fowler which teaches that BA 39 and 40 are typically involved with sensory integration or speech. Additionally, US Patent Application Publication Number US 2010/0057159 A1 hereinafter Lozano teaches that BA 40 may be one of a plurality of suitable target sites for stimulation to treat a variety of neurological conditions including those associated with cognitive ability.
Lundqvist et. al. “Gamma and Beta Bursts Underlie Working Memory” published by Neuron a Cell Press Journal on 04/06/2016, pages 152-164 teaches that working memory id thought to result from sustained neuron spiking. Lundqvist teaches that brief bursts of narrow-band gamma oscillations (45-100Hz) were present in monkeys performing a working memory task and that these spikes accompanied encoding and re-activation of sensory information. Beta oscillations (20-35Hz) also occurred (Summary). Lundqvist teaches that Gamma and Beta oscillations have specific roles in encoding and decoding (Discussion paragraph 6)
Double Patenting
The present application is a divisional application of 16622098 and drawn towards a restricted group. Thus, no double patenting rejection is necessitated. Amendments to the scope of the claims may necessitate new grounds of double patenting rejections.
Conclusion
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/MATTHEW ERIC OGLES/ Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791