DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 11 is objected to because of the following informalities: the acronym “MPF” in line 4 should first be spelled out. 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 21 and 22 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. Regarding claim 21, the originally filed specification fails to provide support for a PSWE occurrence rate exceeding a reference level determined from control subjects not diagnosed with a neurological disease or disorder (in combination with claim 3). Regarding claim 22, the originally filed specification fails to provide support for classifying a subject as at increased risk of developing a neurological disease or disorder using a statistical classification model that uses PSWE occurrence frequency data.
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 2-4, 18, 21, and 22 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 2, it is unclear if the step of determining increased BBB permeability and the BBB control is part of the claimed method; neither step is positively recited as part of the claimed invention. Regarding claim 3, the phrase “and wherein the PSWE occurrence rate exceeds a predetermined threshold associated with increased disease risk” renders the claim indefinite. Not only does the phrase “the PSWE occurrence rate” lack proper antecedent basis, it is also unclear how a single identified event would have an occurrence rate. Clarification is requested. Regarding claim 4, the phrase “wherein the increased risk is determined by comparison to a control population” renders the claim indefinite; it is unclear what is compared to the control population to determine the increased risk. Regarding claim 18, the phrase “said determining” lacks proper antecedent basis as claim 3 was amended to replace “determining” with “analyzing”. Regarding claim 21, it is unclear if the “a reference level” recited in the claim is the same as or different than the “predetermined threshold” recited in claim 3. Clarification is requested. Regarding claim 22, the phrase “the PSWE occurrence frequency data” lacks proper antecedent basis. Furthermore, it is unclear if the increased risk determination is made using a statistical classification model, as recited in claim 22, or by identifying a PSWE having an MPF of 3-10Hz and a duration of at least 5 seconds, as recited in claim 3. According to claim 3, merely identifying a PSWE having an MPF of 3-10Hz and a duration of at least 5 seconds determines the increased risk, whereas claim 22 requires using a statistical classification model on PSWE occurrence frequency data to determine the increased risk.
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 1-4, 6, 7, 9-11, 13-15, and 17-23 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 1 follows.
Regarding claim 1, the claim recites a series of steps or acts, including determining blood-brain barrier dysfunction (BBBD) in a subject by identifying a paroxysmal slow waves event (PSWE) in the subject. 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 step of determining BBBD in a subject by identifying a PSWE in the subject, wherein said PSWE has a median power frequency (MPF) of 3-10 Hz and a duration of at least 5 seconds, sets forth a judicial exception. This step describes 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. The determining of BBBD 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 determined BBBD, nor does the method use a particular machine to perform the Abstract Idea. It is noted that the claimed invention makes no mention of the use of any machine to perform the claimed method.
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 additional steps of recording brain activity signals using a neural signal recording modality, and analyzing the recorded brain activity signals using, at least, spectral analysis signal processing. The recording and analyzing steps are each recited at a high level of generality such that they amount to insignificant presolution activity, e.g., mere data gathering steps 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 and analyzing activity engaged in by medical professionals prior to Applicant's invention.
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 claims 3 and 11. While claim 11 recites a step of administering a BBB permeability-rectifying agent to a subject based on a PSWE determination, the entirety of claim 11 is capable of being performed mentally and/or by hand.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering and what PSWE is indicative of. The recording and analyzing steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Response to Arguments
Applicant's arguments filed 11 August 2025 have been fully considered and they are not fully persuasive.
While Applicant’s amendments have overcome some of the previous objections, as noted in paragraph 2 above, an objection to claim 11 still remains.
While Applicant’s amendments have overcome some of the previous rejections under 35 U.S.C. 112(b), as discussed in paragraph 6 above, indefiniteness issues remain within claims 2-4, 18, 21, and 22.
Regarding Applicant’s arguments against the rejection of the claims under 35 U.S.C. 101, Applicant’s arguments are not persuasive. Applicant argues on page 9 of the Remarks that claims 1 and 3 recite specific, technical processes implemented through defined hardware and algorithmic signal processing. The Examiner respectfully disagrees. Neither claim 1 nor claim 3 (or claim 11) recites any structural element/hardware configured to perform the recited steps, nor is “specific” algorithmic signal processing used. “Spectral analysis signal processing” is a broad type of signal processing; it is not “specific” in that multiple different types of spectral analysis signal processing exist.
Applicant then argues that claim 1 is a specific implementation to a solution to a problem in the neurophysiological diagnostic arts. This argument is not persuasive as the specific implementation is not to a problem in the software arts. The current claims do not recite a method that is computer-implemented, and Applicant has not explained why the current invention provides an improvement to a computer-related technology/functioning of a computer.
Each of claims 1, 3, and 11 is capable of being performed mentally and/or by hand, with the exception of the “recording brain activity” and “analyzing… using, at least, spectral analysis signal processing” steps in claims 1 and 3. The recording and analyzing steps are broadly recited, pre-solutional data gathering activity steps that fail to add something significantly more to the claimed Abstract Idea. Once the pre-solutional data gathering activity has happened, a user is capable of looking at an output of the spectral analysis, visually recognizing a PSWE event based on MPF and duration, and determining, based on recognizing a PSWE event, a BBBD or increased risk of developing a neurological disease or disorder.
Applicant’s arguments on pages 9 and 10 of the Remarks regarding claim 1 providing an implementation of frequency-domain signal processing using specific filters and transforms, machine-based input, and digital processing is not persuasive as Applicant is arguing limitations not present in the claims. Regarding Applicant’s assertion that a processing device would be necessitated for the claimed invention to function, (1) no processing device is recited in the claims, and (2) even if a processing device were recited, a human is still capable of looking at spectral analysis data and mentally recognizing a PSWE having an MPF of 3-10Hz and a duration of at least 5 seconds. While a processing device may be needed to record brain activity signals and perform spectral analysis signal processing on the recorded brain activity signals, the step of analyzing the signals and determining the presence of BBBD or increased risk of developing a neurological disease or disorder is capable of being performed mentally by a human.
Regarding Applicant’s argument on pages 10-11 of the Remarks that the claimed invention, consistent with McRO, provide an improvement, Applicant’s arguments are not persuasive as Applicant has not provided evidence of any improvement. The mere assertion of an improvement without any evidence is not persuasive.
Regarding Applicant’s arguments on pages 11-12 of the Remarks that paragraphs [0046], [0095], and [0128] of the application as filed illustrate the technical advantages of the claimed invention, the Examiner notes that none of these paragraphs discuss or imply a technical advantage provided by the claimed invention.
Examiner’s Note
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kiviniemi et al. (Real-time monitoring…) discusses analyzing slow EEG waves to monitor for blood-barrier disruption. References cited in the previous PTO-892 generally discuss slow wave EEG events in a subject. In particular, Figure 1 of Wernicke et al.’303 (USPN 5,269,303 – previously cited) provides a visual of EEGs of a person exhibiting normal activity, excessive slow wave activity, and paroxysmal activity. Wernicke et al.’303 goes on to state that individuals with dementia, brain tumors and certain other disorders exhibit slow wave activity and higher voltage in an abnormal EEG, and that paroxysmal activity is somewhat similar to this, but with somewhat faster wave activity and higher synchronous spikes. Wernicke et al.’303 fails to mention any details of the paroxysmal slow wave activity events with regard to power frequency or duration.
None of the prior art teaches or suggests, either alone or in combination, a method comprising determining a paroxysmal slow waves event in a subject, wherein said paroxysmal slow waves event has a median power frequency of 3-10 Hz and a duration of at least 5 seconds, in combination with the other claimed steps.
Conclusion
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791