CTNF 18/821,908 CTNF 97106 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Information Disclosure Statement The information disclosure statement (IDS) submitted on 12/06/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Specification 07-44 AIA The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Regarding claim 1, the phrase “potential brain anomaly” fails to have disclosure in the instant specification. Regarding claim 6, the phrase “PTSD” fails to have disclosure in the instant specification . Claim Rejections - 35 USC § 112 07-30-01 AIA 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. 07-31-01 Claims 1-7 and 9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant has demonstrated that the inventor was in possession of the claimed invention. Such a review is conducted from the standpoint of one of ordinary skill in the art at the time the application was filed (see, e.g., Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 865, 26 USPQ2d 1767, 1774 (Fed. Cir. 1993)) and should include a determination of the field of the invention and the level of skill and knowledge in the art. For some arts, there is an inverse correlation between the level of skill and knowledge in the art and the specificity of disclosure necessary to satisfy the written description requirement. Information which is well known in the art need not be described in detail in the specification. See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986). However, sufficient information must be provided to show that the inventor had possession of the invention as claimed. See MPEP 2163 (II)(2). A "representative number of species" means that the species which are adequately described are representative of the entire genus. See MPEP 2163(III)(a)(ii). The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 "merely by clearly describing one embodiment of the thing claimed." LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). The issue is whether a person skilled in the art would understand inventor to have invented, and been in possession of, the invention as broadly claimed. In LizardTech, claims to a generic method of making a seamless discrete wavelet transformation (DWT) were held invalid under 35 U.S.C. 112, first paragraph, because the specification taught only one particular method for making a seamless DWT and there was no evidence that the specification contemplated a more generic method. Id.; see also Tronzo v. Biomet, 156 F.3d at 1159, 47 USPQ2d at 1833 (Fed. Cir. 1998)(holding that the disclosure of a species in a parent application did not provide adequate written description support for claims to a genus in a child application where the specification taught against other species). See MPEP 2163(III)(a)(ii). Claims 1, 5-7, and 9 fail to sufficiently describe the detecting of an actual or potential brain anomaly of a subject and the comparing of data with a specific condition in enough detail for one skilled in the art to have possession of the broadly claimed genus. Even though the term dementia and concussion are found in the instant specification and could be used for comparison, the instant specification only provides support for applying the method steps for comparing and detecting mild cognitive impairment (MCI) via the observing of sleep burst on the onset of sleep , see [0038]-[0039] and Figs. 7-8. The instant specification fails to detail any and all “brain anomaly” that are detected or the comparing of “neurogenerative disorders” with the subject’s particular data. Furthermore, the instant specification only nominally recites dementia and concussion but fails to detail the comparison of dementia and concussion data with the user’s particular data. The instant specification fails to disclose the detection and comparison of PTSD. Similar to Lizardtech, there is no evidence that the specification contemplated a more generic method of detecting (any) brain anomaly of a user by analyzing the recorded acceleration data to detect a particular signal distinct from surrounding signals and comparing the particular signal data with library data of the particular signal from other human subjects to determine any deviation from a normal pattern. Applicant does not disclose the comparing of sleep bursts for any other disease other than MCI. The instant specification fails to disclose any other embodiment/species, and therefore does not have a representative number of species to claim the genus, as instantly claimed. Therefore, claims 1-7 and 9 do not provide sufficient detail for a person skilled in the art to have been in possession of the invention as broadly claimed. 07-30-02 AIA 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. 07-34-01 Claims 1-10 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. 07-34-03 AIA The term “ essentially ” in claim s 1 and 10 is a relative term which renders the claim indefinite. The term “ essentially ” 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. The phrase “essentially regular intervals” is unclear if the intervals periods of time or are something different . Claims 2-9 are rejection for being dependent on rejected claim 1 . Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Each of independent claims 1 and 10 recites a step analyzing the recorded acceleration data to detect a particular signal distinct from surrounding signals and occurring at essentially regular intervals less than about one minute…comparing the particular signal data with library data of the particular signal from other human subjects to determine any deviation from a normal pattern, to detect an actual or potential brain anomaly, which is a mental process . This judicial exception is not integrated into a practical application because the generically recited computer elements, determining deviation, and detecting brain anomaly do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations are to receiving data, processing data, and detecting anomaly , which are all well-understood, routine, and conventional computer functions. See MPEP § 2106.05(d). MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject matter. The stepwise analysis for the instant claim is provided here. Step 1 – Statutory categories Claims 1 and 10 is directed to a method and thus meets the step 1 requirements. Step 2A – Prong 1 – Judicial exception (j.e.) Regarding claims 1 and 10, the following step is an abstract idea: “ analyzing the recorded acceleration data to detect a particular signal distinct from surrounding signals and occurring at essentially regular intervals less than about one minute…comparing the particular signal data with library data of the particular signal from other human subjects to determine any deviation from a normal pattern, to detect an actual or potential brain anomaly ”, which is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions. In this case, a human could analyze peaks of acceleration of a portion of the signal and comparing the particular signal to stored data to determine a deviation to detect a brain anomaly. Step 2A – Prong 2 – additional elements to integrate j.e. into a practical application Regarding claims 1 and 10, the abstract idea is not integrated into a practical application. The following claim elements do not add any meaningful limitation to the abstract idea: - “computer” is recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)]; - “accelerometer” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)]; - “sleep brain signal”, “cycle of sleep”, “(recorded) acceleration data”, “heartbeats”, “particular signal”, “surrounding signals”, “regular intervals”, “library data”, “deviation”, “normal pattern”, and “brain anomaly” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)]. Step 2B – significantly more/inventive concept The following claim elements do not add any meaningful limitation to the abstract idea: - “computer” is recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)]; - “accelerometer” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)]; - “sleep brain signal”, “cycle of sleep”, “(recorded) acceleration data”, “heartbeats”, “particular signal”, “surrounding signals”, “regular intervals”, “library data”, “deviation”, “normal pattern”, and “brain anomaly” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)]. The additional elements of claims 1 and 10, when considered separately and in combination, do not add significantly more (ie. an inventive concept) to the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the implantable medical device, processing circuitry, and storage devices, along with their associated functions, are recited at a high level of generality and simply amount to implementing the abstract idea on a computer. The accelerometer is claimed very generically and are used only to gather the data they are designed for. These are well-understood, routine and conventional structure since the diagnostic art in Najafi et al (US 20210290148) teaches an accelerometer in the head region for detecting motion signals ([0007]). The additional components (computer) are well-understood, routine, and conventional in the industry, as evidenced by, and not limited to, US 20220125323to Smith et al (Abstract, which teaches that a processor has long been known as well-understood, routine, conventional components in the art). Sensors/accelerometers are regarded as mere data gathering that is well known in the art to establish the inputs of analysis and does not add a meaningful limitation (TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48). Dependent claims 2-9 do not integrate the abstract idea into a practical application and do not add significantly more to the abstract idea of claim 1 and 10. The dependent claim limitations are directed to extra-solution activity (claims 2-9), which are insignificant extra-solution activity and do not amount to more than what is well-understood, routine, and conventional. In summary, claims 1-10 are directed to an abstract idea without significantly more and, therefore, are patent ineligible. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15-aia AIA Claim(s) 1-10 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Smith et al. (US 20220125323)(IDS)(Hereinafter Smith) . Regarding claims 1 and 10, Smith teaches A method for determining or detecting a sleep brain signal in a human subject ([0038] “The techniques may also be applied to evaluating clinical conditions during anesthesia and sleep.”), comprising: affixing an accelerometer against the cranium of a subject, such that the accelerometer remains on the subject through a cycle of sleep (Abstract “A headset, configured to be attached to a human head, includes an accelerometer providing a signal indicative of head acceleration due to blood flow through the brain.” [0038] “The techniques may also be applied to evaluating clinical conditions during anesthesia and sleep.” Examiner notes that the evaluation of acceleration occurs during sleep, which is through a sleep cycle.), connecting the accelerometer to a computer to receive acceleration data from cranial accelerations correlated with heartbeats of the subject, and recording the acceleration data with the computer (Fig. 2B(220) Abstract “An analyzer evaluates a plurality of samples indicative of acceleration over time where each sample corresponds to the head movement resulting from a cardiac contraction.”), analyzing the recorded acceleration data to detect a particular signal distinct from surrounding signals and occurring at essentially regular intervals less than about one minute (Abstract “An analyzer evaluates a plurality of samples indicative of acceleration over time where each sample corresponds to the head movement resulting from a cardiac contraction.” Examiner notes that the particular signal is not detected, due to the conditional recitation in the independent claim, and therefore, this step does not occur. See note on conditional language below.), and if the particular signal is detected, comparing the particular signal data with library data of the particular signal from other human subjects to determine any deviation from a normal pattern, to detect an actual or potential brain anomaly (Examiner notes that the particular signal is not detected, due to the conditional recitation in the independent claim, and therefore, this step does not occur. See note on conditional language below.). “The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met .” “The broadest reasonable interpretation of a system (or apparatus or product) claim having structure that performs a function, which only needs to occur if a condition precedent is met, requires structure for performing the function should the condition occur.” Note the phrase, “ if the particular signal is detected ” in claims 1 and 10 are conditional language, that is, if a condition precedent in a method claim is not met , the conditional steps recited in the claim are not required to be performed . The conditions of the particular signal being detected is not required. As such, the broadest reasonable interpretation of such a method claim does not include the conditional step along with the steps proceeding the conditional step. See MPEP 2111.04(II) and Ex Parte Schulhauser. Regarding claim 2, Smith teaches wherein the particular signal comprises a burst of spikes higher in amplitude than surrounding time-domain acceleration data (Examiner notes that the particular signal is not detected, due to the conditional recitation in the independent claim, and therefore, this step does not occur. See note on conditional language above.). Regarding claim 3, Smith teaches wherein the comparing step includes comparing frequency, number and power of the detected particular signal with the library data (Examiner notes that the particular signal is not detected, due to the conditional recitation in the independent claim, and therefore, this step does not occur. See note on conditional language above.). Regarding claim 4, Smith teaches wherein the comparing step further includes measuring variances in width or amplitude during a subject's particular signals (Examiner notes that the particular signal is not detected, due to the conditional recitation in the independent claim, and therefore, this step does not occur. See note on conditional language above.). Regarding claim 5, Smith teaches wherein the comparing step includes comparison of the human subject's particular data with signal data from one or more persons known to have at least early-stage dementia (Examiner notes that the particular signal is not detected, due to the conditional recitation in the independent claim, and therefore, this step does not occur. See note on conditional language above.). Regarding claim 6, Smith teaches wherein the comparing step includes comparison of the human subject's particular data with signal data from one or more persons with PTSD (Examiner notes that the particular signal is not detected, due to the conditional recitation in the independent claim, and therefore, this step does not occur. See note on conditional language above.). Regarding claim 7, Smith teaches wherein the comparing step includes comparison of the human subject's particular data with signal data from one or more persons known to have long-term concussion (Examiner notes that the particular signal is not detected, due to the conditional recitation in the independent claim, and therefore, this step does not occur. See note on conditional language above.). Regarding claim 8, Smith teaches wherein the comparing step includes comparison of the human subject's particular data with signal data from one or more persons known to have mild cognitive impairment (Examiner notes that the particular signal is not detected, due to the conditional recitation in the independent claim, and therefore, this step does not occur. See note on conditional language above.). Regarding claim 9, Smith teaches wherein the comparing step includes comparison of the human subject's particular data with signal data from one or more persons known to have particular neurodegenerative disorders (Examiner notes that the particular signal is not detected, due to the conditional recitation in the independent claim, and therefore, this step does not occur. See note on conditional language above.) . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Najafi et al. (US 20210290148) See [0007], [0036], and claims 9-11 that teaches a head worn sensor where peak frequency of acceleration signal is used for determining cognitive impairment. Hannemann et al. (US 20220189278) See [0135] teaches health data used to determine movement pattern analysis by comparing movement data for dementia and fall risk ([0141]) . Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MOUSSA HADDAD/Examiner, Art Unit 3796 /Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796 Application/Control Number: 18/821,908 Page 2 Art Unit: 3796 Application/Control Number: 18/821,908 Page 4 Art Unit: 3796 Application/Control Number: 18/821,908 Page 5 Art Unit: 3796 Application/Control Number: 18/821,908 Page 6 Art Unit: 3796 Application/Control Number: 18/821,908 Page 7 Art Unit: 3796 Application/Control Number: 18/821,908 Page 8 Art Unit: 3796 Application/Control Number: 18/821,908 Page 9 Art Unit: 3796 Application/Control Number: 18/821,908 Page 10 Art Unit: 3796 Application/Control Number: 18/821,908 Page 11 Art Unit: 3796 Application/Control Number: 18/821,908 Page 12 Art Unit: 3796
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