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 .
Election/Restrictions
Applicant’s election of Species B, claims 1-5 and 14-22, in the reply filed on 01 December 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 17-20 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.
Regarding claim 17, it is unclear how “ketogenic diet” would be “provided” to the subject. For examination purposes, claim 17 is being interpreted such that a recommendation of a ketogenic diet is provided to the subject. It is noted, however, that the recommendation of a treatment is not the equivalent of providing the treatment.
Regarding claim 18, it is unclear what the difference is between a “seizure onset zone” and “a specific region involved in generating seizures”; a seizure onset zone is a specific region involved in generating seizures.
While not indefiniteness issues, it is noted that claim 16 should be amended to remove the term “and” in line 2, claim 18 should be amended to read “further comprising determining a seizure onset zone” in line 1, claim 19 should be amended to remove the term “and” in line 1, claim 20 should be amended to remove the term “and” in line 1, and claim 22 should be amended to read “further comprising conducting” in line 1.
Claims not explicitly rejected above are rejected due to their dependence on a rejected base claim.
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 1-5, 14-18, and 20-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 14 follows.
Regarding claim 14, the claim recites a series of steps or acts, including detrending neural signals, identifying HFOs through one or more objective and training-free strike tests, and analyzing presentation of the HFOs. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of identifying HFOs through one or more objective and training-free strike tests and analyzing presentation of the HFOs set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 14 fails to recite any application of the analyzed presentation of HFOs. The mere analysis of the HFOs does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the analyzed presentation of HFOs, nor does the method use a particular machine to perform the Abstract Idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites the additional step of detrending neural signals. The detrending of acquired neural signals is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the detrending step is recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining step do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The same rationale applies to claim 1.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering (what type of neural signals are acquired), or to steps capable of being performed in the human mind (the type of strike tests performed are capable of being performed by visual inspection of the detrended neural signals; analyzing presence of HFOs in numbers above a threshold/presence of HFOs in a determined location is capable of being performed mentally; determining a seizure onset zone/specific region involved in generating seizures can be performed mentally; determining whether a seizure onset zone/specific region involved in generating seizures is a candidate for surgical intervention can be performed mentally; comparing HFO analyses over time can be performed mentally). The detrending, identifying, and/or analyzing steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
It is noted that claim 19 is not being rejected under 35 U.S.C. 101 because it recites effecting a particular treatment based on the analyzed presentation of HFOs. It is further noted that while claim 16 recites providing treatment, the treatment is not in response to the analysis of presentation of HFOs.
Claim Rejections - 35 USC § 102
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.
Claims 1, 2, 14, 15, 18, 20, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by He et al.’247 (US Pub No. 2021/0106247).
Regarding claim 1, He et al.’247 discloses a method for identifying high frequency oscillations (HFOs) in neural signals from the brain (see ABSTRACT), the method comprising: detrending the neural signals (sections [0021-0023]); and identifying HFOs through one or more objective and training-free tests selected from the group consisting of (i) amplitude and (ii) rhythmicity (sections [0022-0023], and see claim 7).
Regarding claim 2, the neural signals are obtained using MEG or EEG (sections [0010-0011], [0018-0019]).
Regarding claim 14, He et al.’247 discloses a method for predicting a location in the brain of a subject that is associated with epilepsy (see TITLE, ABSTRACT, and sections [0010], [0018-0019], [0054]), the method comprising: identifying HFOs according to the method of claim 1, wherein the neural signals are obtained from the brain of the subject (see above); and analyzing presentation of the HFOs (sections [0010], [0018-0019], [0032-0033], [0043-0045]).
Regarding claim 15, presentation of the HFOs includes a presence of HFOs in a determined location (see Figure 1, 103 and 104, Figure 3, Figures 6A, 6B, 6F, 6G, and sections [0010], [0019]).
Regarding claim 18, the method further comprises determining a seizure onset zone and/or a specific region involved in generating seizures based upon the analyzed presentation of HFOs (see TITLE, ABSTRACT, and sections [0010], [0018-0019], [0032-0033], [0043-0045], [0054]).
Regarding claim 20, the method further comprises determining whether the onset zone and/or specific region is a candidate for surgical intervention (see ABSTRACT, and section [0019]).
Regarding claim 21, the subject has been diagnosed as having epilepsy (see ABSTRACT – treatment of epilepsy is provided for subjects having epilepsy; section [0010]: “… with a process for identifying HFOs in scalp EEG recordings for patients with medical refractory epilepsy…”).
Claims 1-3, 14-19, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Modur’370 (US Pub No. 2018/0000370).
Regarding claim 1, Modur’370 discloses a method for identifying HFOs in neural signals from the brain (see TITLE, ABSTRACT, and section [0005]), the method comprising: detrending the neural signals (sections [0048], [0069]); and identifying the HFOs through one or more objective and training-free strike tests selected from the group consisting of (i) amplitude, (ii) rhythmicity, and (iii) ringing (sections [0048], [0069] – amplitude, as discussed in the last line of section [0069]).
Regarding claim 2, the neural signals are obtained using EEG (see ABSTRACT and sections [0005], [0044]).
Regarding claim 3, the neural signals are obtained using ECoG or iEEG (section [0044]).
Regarding claim 14, Modur’370 discloses a method for predicting a location in the brain of a subject that is associated with epilepsy (see TITLE, ABSTRACT, and section [0014]), the method comprising: identifying HFOs according to the method of claim 1, wherein the neural signals are obtained from the brain of the subject (see above); and analyzing presentation of the HFOs (sections [0014], [0055-0057], [0066-0067], [0093]).
Regarding claim 15, the presentation of the HFOs includes a presence of HFOs in numbers above a predetermined threshold and/or a presence of HFOs in a determined location (sections [0014], [0055-0057], [0066-0067], [0093]).
Regarding claim 16, Modur’370 discloses that the method further comprises providing treatment to the subject (see ABSTRACT, and sections [0021], [0040], [0043], [0056]).
Regarding claim 17, the treatment includes responsive neurostimulation and/or anti-seizure medication (sections [0021], [0040], [0043], [0056]).
Regarding claim 18, the method determines a seizure onset zone and/or a specific region involved in generating seizures based upon the analyzed presentation of HFOs ([0014], [0055-0057], [0066-0067], [0093]).
Regarding claim 19, the method targets the onset zone and/or specific region with responsive neurostimulation (sections [0021], [0040], [0043], [0056]).
Regarding claim 21, the subject has been diagnosed as having epilepsy (treatment of epilepsy is provided for subjects having epilepsy; furthermore, sections [0075] and [0098] disclose performing the method on subjects having epilepsy).
Claim Rejections - 35 USC § 103
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.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over He et al.’247, as applied to claim 1, in view of Weiss et al.’347 (US Pub No. 2021/0145347).
Regarding claims 4 and 5, He et al.’247 discloses all of the elements of the current invention, as discussed in paragraph 8 above, except for the identifying step including ringing strike tests. Weiss et al.’347 teaches performing a ringing strike test on candidate ripple events (the same type of candidate ripple events taught by He et al.’247) in order to determine whether the candidate ripple event is a true ripple event or not (section [0097]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of He et al.’247 to be configured to implement a ringing strike test to identify HFOs, as this would help identify true HFOs as opposed to ones that result from filter ringing.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over He et al.’247, as applied to claim 15.
Regarding claims 16 and 17, He et al.’247 discloses all of the elements of the current invention, as discussed in paragraph 8 above, except for explicitly teaching that the method comprises providing treatment to the subject, wherein the treatment includes one or more of the following: vagus nerve stimulation, responsive neurostimulation, deep brain stimulation, trigeminal nerve stimulation, anti-seizure medication, sleep medication, medical cannabis, and ketogenic diet. He et al.’247 discloses that subjects having epilepsy are usually treated with anti-seizure medication to suppress or prevent seizures (section [0003]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of He et al.’247 to include treating the subject with anti-seizure medication, as He et al.’247 teaches that subjects having epilepsy are usually treated with anti-seizure medication to suppress or prevent seizures.
Furthermore, He et al.’247 discloses in its ABSTRACT that the method can be used as an aid in surgical resection for the treatment of epilepsy, and further discloses in sections [0003-0005] that HFO identification can be used to guide effective resective surgery. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of He et al.’247 to further include providing treatment to the subject (resective surgery), as He et al.’247 teaches that its method can be used to aid in surgical resection for the treatment of epilepsy. The modification to He et al.’247 would provide a method that not only identifies epileptogenic zones based on identified HFOs, but also provides treatment to the subject.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over He et al.’247, as applied to claim 18, in view of Modur’370.
He et al.’247 discloses all of the elements of the current invention, as discussed in paragraph 8 above, except for the method comprising targeting the onset zone and/or specific region with vagus nerve stimulation, responsive neurostimulation, deep brain stimulation, or trigeminal nerve stimulation. It is noted that He et al.’247 does disclose using neurostimulation that targets an epileptogenic zone to treat a subject (sections [0003], [0009]). Modur’370 teaches a method of providing neurostimulation to an epileptogenic zone responsive to identifying HFOs (see ABSTRACT). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of He et al.’247 such that its neurostimulation is provided to identified epileptogenic zones in response to the identification of HFOs, as it would merely be combining prior art methods according to known methods to yield predictable results. The modification to He et al.’247 would ensure that neurostimulation is provided to a target location upon the identification of the target location.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over He et al.’247, as applied to claim 14, in view of Weiss et al.’345 (US Pub No. 2019/0307345).
He et al.’247 discloses all of the elements of the current invention, as discussed in paragraph 8 above, except for the method comprising conducting multiple identifications of HFOs and comparing presentation of the HFOs from the multiple identifications. Weiss et al.’345 teaches generating a brain stimulation regimen based on a history of HFO detections (section [0041]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of He et al.’247 to include conducting multiple identifications of HFOs and comparing presentation of the HFOs from the multiple identifications, as this would allow a brain stimulation regimen to be generated based on historical HFO data. The modification to He et al.’247 would allow treatment to the subject to be adjusted based on trend data, which is a well known method step in the medical diagnostic and treatment art.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Modur’370 in view of He et al.’247, as applied to claim 14, in view of Weiss et al.’345.
Modur’370 discloses all of the elements of the current invention, as discussed in paragraph 9 above, except for the method comprising conducting multiple identifications of HFOs and comparing presentation of the HFOs from the multiple identifications. Weiss et al.’345 teaches generating a brain stimulation regimen based on a history of HFO detections (section [0041]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Modur’370 to include conducting multiple identifications of HFOs and comparing presentation of the HFOs from the multiple identifications, as this would allow a brain stimulation regimen to be generated based on historical HFO data. The modification to Modur’370 would allow treatment to the subject to be adjusted based on trend data, which is a well known method step in the medical diagnostic and treatment art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Blanco et al.’481 (US Pub No. 2012/0245481) teaches a method for identifying high frequency oscillations in neural signals of the brain, wherein the method is used to identify a location in the brain associated with epilepsy. It specifically teaches detrending a neural signal. Al-Bakri (High Frequency Oscillations…) discloses the claimed subject matter, but does not qualify as prior art due to an embargo placed on the reference.
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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