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 without traverse of Group I (claims 1, 5, 8, and 11) in the reply filed on 03/12/2026 is acknowledged. Claims 2-4, 6, 7, 9, 10, 12, and 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/12/2026.
Remarks
This action is in response to the remarks filed 03/12/2026.
Claims 1, 5, 8, and 11 are examined in the office action below.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5, lines 2-3, “dementia comparing of a ratio” should read “dementia by comparing of a ratio”.
Appropriate correction is required.
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 limitation(s) is/are: the acquisition unit, first and second estimation units, and judgement unit in claims 1, 5, and 8. The acquisition unit, first and second estimation units, and judgement unit are being understood as any sensing and processing devices, as shown in Fig. 2 of the instant specification.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) 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 limitation(s) recite(s) 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 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, 8, and 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite a system and method for determining if a user has Alzheimer-type dementia. To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claim 1 is directed to a system, claim 8 is directed to a method, and claim 11 is directed to a non-transitory computer readable medium, and thus meet the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1, 8, and 11 recite a system, method, and non-transitory computer readable medium for determining if a user has Alzheimer-type dementia comprising acquiring heart rate information, estimating a circadian rhythm of the heart rate, estimating a non-circadian rhythm of the heart rate, and determining if the user has Alzheimer-type dementia based on a signal amplitude of the circadian and non-circadian rhythms of the heart rate. The limitation of determining if a user has Alzheimer-type dementia, as drafted in claims 1, 5, 8, and 11, under its broadest reasonable interpretation, covers performance of the limitation in the mind or using pen and paper. For example, determining if a user has Alzheimer-type dementia in the context of this claim encompasses a user gathering heart rate information, estimating a circadian rhythm of the heart rate, estimating a non-circadian rhythm of the heart rate, and determining if the user has Alzheimer-type dementia based on a signal amplitude of the circadian and non-circadian rhythms of the heart rate.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
The step of acquiring heart rate information is considered to be the pre-solution activity of data gathering by no more than routine means. The steps of estimating a circadian rhythm of the heart rate, estimating a non-circadian rhythm of the heart rate, and determining if the user has Alzheimer-type dementia based on a signal amplitude of the circadian and non-circadian rhythms of the heart rate are considered to be data analysis steps.
The additional elements of an acquisition unit, estimation unit, and judgement unit are recited at a high level of generality (i.e., as generic computer components for inputting, processing, and storing data). Specifically, these additional elements are generically recited computing elements that perform the steps of gathering, analyzing, and outputting data.
Accordingly, these additional elements do no integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. See MPEP 2106.04(a)(2)(III)(C).
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
The additional elements when considered individually and in combination is not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the additional elements of an acquisition unit, estimation unit, and judgement unit amounts to no more than generically claimed computer components which enable the above-identified abstract idea to be conducted by performing the basic functions of automating mental tasks. Furthermore, the additional elements do not amount to more than generically linking the use of a judicial exception to a particular technological environment or field of use (see MPEP 2106.05(h)). Therefore, the claims are not patent eligible.
Claim 5 depends on claim 1 and recites the same abstract idea as claim 1 from which it depends. Further, this claim only contains recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). For example, the additional limitations recited in claim 5 (i.e. explaining how the judgement unit determines Alzheimer-type dementia based on comparisons to thresholds) is a further data analysis step. The additional elements individually do not amount to significantly more than the judicial exception explained above (the abstract idea). Looking at the limitations 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 any technology or includes a particular solution to a computer-based problem or a particular way to achieve a computer-based outcome. Rather, the collective functions of the claimed invention merely provides a conventional computer implementation, i.e. the computer (processor) is simply a tool to perform the claimed invention.
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.
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.
Claims 1, 5, 8, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Mirow (US Patent Application Publication 2009/0292180 – APPLICANT CITED ON 03/05/2025 IDS), further in view of Zhang et al. (US Patent Application Publication 2013/0226078), hereinafter Zhang.
Regarding claims 1, 8, and 11, Mirow discloses an Alzheimer-type dementia judgement device, method, and non-transitory computer readable storage medium storing a program (e.g. Pars. [0274], [0277]: diagnosis of Alzheimer’s and other dementing diseases), comprising:
an acquisition unit configured to acquire information about a heart rate (e.g. Par. [0051]; Par. [0121]: heart rate information is gathered from a Holter monitor);
an estimation unit configured to estimate a non-circadian rhythm of the heart rate, which is a rhythm different from the circadian rhythm of the heart rate (e.g. Par. [0035]: physiological rhythms are tracked; Par. [0121]: heart rate is determined); and
a judgement unit configured to judge whether a subject has Alzheimer-type dementia according to a signal amplitude of the estimated non-circadian rhythm of the heart rate (e.g. Par. [0035]; Par. [0114]: computer used for processing; Claim 6: processor; Par. [0170]: amplitude of signal is determined; Pars. [0274], [0277]: diagnosis of Alzheimer’s and other dementing diseases).
However, Mirow fails to specifically disclose estimating a circadian rhythm of the heart rate from the information about the heart rate, and determining whether a subject has Alzheimer-type dementia according to a signal amplitude of the estimated circadian rhythm of the heart rate.
Zhang, in a similar field of endeavor, is directed towards determining a health state of a user. Zhang discloses estimating a circadian rhythm of the heart rate from the information about the heart rate, and determining whether a subject has a medical condition according to a signal amplitude of the estimated circadian rhythm of the heart rate (e.g. Par. [0093]: circadian rhythm of heart rate is determined, and if there it changes then it can indicate health conditions).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Mirow to include determining a circadian rhythm of a heart rate as taught by Zhang because doing so would allow an accurate estimation of onset of a disease state (e.g. Zhang, par. [0093]).
Regarding claim 5, Mirow fails to specifically disclose wherein the judgement unit judges whether a subject has Alzheimer-type dementia by comparing of a ratio or difference between a signal amplitude of the estimated circadian rhythm of the heart rate and a signal amplitude of the estimated non-circadian rhythm of the heart rate with a threshold value. Zhang, in a similar field of endeavor, is directed towards determining a health state of a user. Zhang discloses determining whether a subject has a medical condition by comparing of a difference between a signal amplitude of the estimated circadian rhythm of the heart rate and a signal amplitude of the estimated non-circadian rhythm of the heart rate with a threshold value (e.g. Par. [0093]: circadian rhythm of heart rate is determined and compared to a baseline that is non-circadian, and if there is a difference it can indicate health conditions).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Mirow in view of Zhang to include determining whether a subject has a medical condition as taught by Zhang because doing so would allow an accurate estimation of onset of a disease state (e.g. Zhang, par. [0093]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Stampfer (US 6,245,021) is directed towards a method for diagnosis psychiatric disorders.
Arai et al. (US 2002/0156392) is directed towards determining a neurological disease.
Lian et al. (US 2009/0312649) is directed towards monitoring and analyzing physiological signals.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHREYA P ANJARIA whose telephone number is (571)272-9083. The examiner can normally be reached M-F: 8:00-5:00 EST.
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.
/SHREYA ANJARIA/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
Prosecution Insights