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 .
DETAILED ACTION
The present office action represents the first action on the merits.
Claims 1-10 are pending.
Priority
This application claims priority to Patent Application No. JP2023-042429 dated 16 March 2023.
Claim Objections
Claim 1 is objected to because the claim recites an abbreviation without its full form. The first occurrence of all acronyms or abbreviations should be written out for clarity, whether or not they may be considered well known. Appropriate corrections/clarification 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 1-10 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.
Claims 1, 8, and 9 are rejected for lack of adequate written description.
Claims 1, 8, and 9 recite a prediction model for which the Applicant has not provided a disclosure of the model in sufficient detail to demonstrate to one of ordinary skill in the art that the Applicant had possession of the invention at the time of filing.
Specifically, the claims recite “inputting information to a prediction model trained using training data.” The Applicant has provided no disclosure of the model. The claimed prediction model thereof amounts to a black box into which information is inputted and a result is received; however, there is no disclosure as to what occurs in the box. As such, the claimed invention lacks adequate written description.
By virtue of their dependence from claims 1, 8, and 9, this basis of rejection also applies to dependent claims 2-7 and 10.
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 1-10 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 1, 8, and 9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claims recite a device, a method, a program, and a storage medium for predicting the probability of the advance of symptoms of mild cognitive impairment (MCI) or mild Alzheimer’s dementia (mild AD), and therefore meet step 1 (or are presumed to for subject matter eligibility analysis purposes).
Step 2A1
The limitations of (Claim 8 being representative) acquiring patient information; predicting a probability of advance of a symptom of mild cognitive impairment (MCI) or mild Alzheimer's dementia (mild AD) in a patient, by inputting information…, in which at least four variables that fall under at least any of first information relating to orientation, second information relating to memory, third information relating to memory of a holiday, a family gathering, a reservation, or schedule of taking medication in IADL, or memory of a meal or actual work of travel in IADL, and fourth information relating to positive/negative of a biomarker are associated with presence/absence of advance of a symptom of mild cognitive impairment (MCI) or mild Alzheimer's dementia (mild AD), with the information that is input corresponding to each of the at least four variables included in the patient information; and outputting a prediction result relating to the probability of advance of a symptom of mild cognitive impairment (MCI) or mild Alzheimer's dementia (mild AD) in the patient, wherein the at least four variables include a first variable that is information relating to orientation relating to time out of the first information, a second variable that is information relating to delayed recall out of the second information, a third variable that is information relating to memory regarding a holiday, a family gathering, a reservation, or schedule for taking medication in IADL, out of the third information, and a fourth variable that is information relating to amyloid β positive/negative out of the fourth information, as drafted, is a process that, under the broadest reasonable interpretation, falls in the grouping of certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions).
That is, other than reciting a method implemented by a computer, the claimed invention amounts to managing personal behavior or interaction between people. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people (i.e., rules or instructions for a person or persons to follow) but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. The Examiner notes that the Applicant has not described the prediction model and thus the prediction model is interpreted to be part of the abstract idea. Accordingly, the claims recite an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of a computer (claim 9) and a computer-readable non-transitory storage medium (claim 10) that implement the identified abstract idea. These additional elements are not exclusively described by the applicant and are recited at a high-level of generality such that it amounts to no more than mere instructions to apply the exception using a generic computer component. See MPEP 2106.05(f). Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a general-purpose computer to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component cannot provide an inventive concept (“significantly more”). As such, the claims are not patent eligible.
Claims 2-7 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claims 2 and 3 merely describe the at least four variables, which further defines the abstract idea.
Claims 4-7 merely describe the fifth variable, which further defines the abstract idea.
Claims 9 and 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 9 is recited to comprise a program having various features that, under the broadest reasonable interpretation, may be entirely embodied in software. According to MPEP 2106 (I), there are four categories of invention: process, machine, article of manufacture, and composition of matter. Therefore, as "software" is neither a category of invention nor a subset of one of the categories it does not represent patent eligible subject matter. See In re Nuijten, Docket No. 2006-1371 (Fed. Cir. Sept. 20, 2007). As such, the system is directed to software per se and is not directed to a statutory category of invention as described below. The Examiner suggests changing claim 9 to a non-transitory computer-readable medium, per claim 10.
By virtue of their dependence from the independent claim, this basis of rejection also applies to dependent Claim 10.
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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Sobol et al. (U.S. 2021/0319894), referred to hereinafter as Sobol, in view of Alam (U.S. 2019/0030035).
REGARDING CLAIM 1
Sobol teaches the information processing device that
inputs information of a patient to a prediction model trained using training data, in which [Para. 0298 teaches inputting data unique to an individual being monitored into a machine learning model trained using training data.]
at least four variables that fall under at least any of
[…]
third information relating to memory of a holiday, a family gathering, a reservation, or schedule of taking medication in IADL, or memory of a meal or actual work of travel in IADL, and [Para. 0288 teaches meal preparation and adherence to medication-taking protocols, which is information relating to memory of a schedule for taking medication in IADL and memory of a meal.]
[…]
presence/absence of advance of a symptom of mild cognitive impairment (MCI) or mild Alzheimer's dementia (mild AD), with the information, which is input, of the patient corresponding to each of the at least four variables, and that [Para. 0255 teaches processing multiple variables (often in the form of hundreds of input nodes) to model complex relationships such as identifying the onset and progression of cognitive impairment or other diseases or related health conditions. Para. 0227 teaches decision tree classification may be used in medical diagnosis and disease identification, where the output of a classification tree is a class (“yes” or “no”), therefore teaching determining the presence/absence of progression.]
predicts a probability of advance of a symptom of mild cognitive impairment (MCI) or mild Alzheimer's dementia (mild AD) in the patient, wherein [Para. 0275 teaches predicting the likelihood of an imminent onset of a disease such as ADRD (Alzheimer’s Disease and Related Dementias) or the like. A machine learning model is used with acquired data in order to divine changes in IADL patterns to provide early insight into whether the patient is symptomatic for Alzheimer’s disease as well as other forms of dementia.]
the at least four variables include
[…]
a third variable that is information relating to memory regarding a holiday, a family gathering, a reservation, or schedule for taking medication in IADL, out of the third information, and [Para. 0288 teaches adherence to medication-taking protocols, which is information relating to memory regarding a schedule for taking medication in IADL.]
[…]
Sobol may not explicitly teach
first information relating to orientation,
second information relating to memory,
fourth information relating to positive/negative of a biomarker are associated with
a first variable that is information relating to orientation relating to time out of the first information,
a second variable that is information relating to delayed recall out of the second information,
a fourth variable that is information relating to amyloid β positive/negative out of the fourth information.
However, Alam teaches the following:
first information relating to orientation, [Para. 0090 teaches the mini-mental state examination (MMSE) is commonly used to assess the severity and progression of dementia. The test examines functions including orientation.]
second information relating to memory, [Para. 0091 teaches the Wechsler Memory Scale (WMS) is a test designed to measure different memory functions. A person’s performance is reported as five Index Scores.]
fourth information relating to positive/negative of a biomarker are associated with [Para. 0180 teaches positive AD-related biomarkers.]
a first variable that is information relating to orientation relating to time out of the first information, [Para. 0008 teaches the MMSE is often used to document cognitive decline over time. Para. 0090 teaches the test examines functions including orientation.]
a second variable that is information relating to delayed recall out of the second information, [Para. 0091 teaches Delayed Recall Index scores.]
a fourth variable that is information relating to amyloid β positive/negative out of the fourth information. [Para. 0166 teaches evaluating samples for amyloid-beta peptides.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the information processing device of Sobol to consider variables related to orientation, memory, and biomarkers as taught by Alam, with the motivation of mitigating or preventing adverse changes in patient health (see Alam at Para. 0367).
REGARDING CLAIM 2
Sobol in view of Alam teaches the information processing device according to claim 1.
Sobol further teaches
wherein the at least four variables are four variables which are… the third variable… [Para. 0288 teaches adherence to medication-taking protocols, which is information relating to memory regarding a schedule for taking medication in IADL. (third variable)]
Alam further teaches
… the first variable, the second variable, …and the fourth variable. [Para. 0008 teaches the MMSE is often used to document cognitive decline over time. Para. 0090 teaches the test examines functions including orientation. (first variable) Para. 0091 teaches Delayed Recall Index scores. (second variable) Para. 0166 teaches evaluating samples for amyloid-beta peptides. (fourth variable)]
REGARDING CLAIM 3
Sobol in view of Alam teaches the information processing device according to claim 1.
Sobol further teaches
wherein the at least four variables are five variables which are… the third variable… [Para. 0288 teaches adherence to medication-taking protocols, which is information relating to memory regarding a schedule for taking medication in IADL. (third variable)]
Alam further teaches
… the first variable, the second variable, …the fourth variable, and a fifth variable that is information of any of the first information, the second information, and the third information. [Para. 0008 teaches the MMSE is often used to document cognitive decline over time. Para. 0090 teaches the test examines functions including orientation. (first variable) Para. 0091 teaches Delayed Recall Index scores. (second variable) Para. 0166 teaches evaluating samples for amyloid-beta peptides. (fourth variable) Para. 0288 teaches meal preparation, which is information relating to memory of a meal. (fifth variable)]
REGARDING CLAIM 4
Sobol in view of Alam teaches the information processing device according to claim 3.
Alam further teaches
wherein the fifth variable is information relating to orientation of a place out of the first information. [Para. 0008 teaches the MMSE is often used to document cognitive decline over time. Para. 0090 teaches the test examines functions including orientation.]
REGARDING CLAIM 5
Sobol in view of Alam teaches the information processing device according to claim 3.
Alam further teaches
wherein the fifth variable is information relating to memory of a name or a type of an object out of the second information. [Para. 0008 teaches the MMSE is often used to document cognitive decline over time. The MMSE includes an object-naming component.]
REGARDING CLAIM 6
Sobol in view of Alam teaches the information processing device according to claim 3.
Alam further teaches
wherein the fifth variable is information relating to memory of actual work of meals in IADL out of the third information. [Para. 0288 teaches meal preparation, which is information relating to memory of a meal.]
REGARDING CLAIM 7
Sobol in view of Alam teaches the information processing device according to claim 3.
Alam further teaches
wherein the fifth variable is information relating to memory of actual work of travel in IADL out of the third information. [Para. 0288 teaches shopping and ambulating, which is information relating to a patient’s performance of travel-related IADL activities, since shopping inherently requires traveling.]
REGARDING CLAIM 8
Sobol teaches the information processing method comprising the steps of:
acquiring patient information; [Para. 0225 teaches acquiring data.]
predicting a probability of advance of a symptom of mild cognitive impairment (MCI) or mild Alzheimer's dementia (mild AD) in a patient, [Para. 0275 teaches predicting the likelihood of an imminent onset of a disease such as ADRD (Alzheimer’s Disease and Related Dementias) or the like. A machine learning model is used with acquired data in order to divine changes in IADL patterns to provide early insight into whether the patient is symptomatic for Alzheimer’s disease as well as other forms of dementia.]
by inputting information to a prediction model trained using training data, in which [Para. 0298 teaches inputting data unique to an individual being monitored into a machine learning model trained using training data.]
at least four variables that fall under at least any of
[…]
third information relating to memory of a holiday, a family gathering, a reservation, or schedule of taking medication in IADL, or memory of a meal or actual work of travel in IADL, and [Para. 0288 teaches meal preparation and adherence to medication-taking protocols, which is information relating to memory of a schedule for taking medication in IADL and memory of a meal.]
[…]
presence/absence of advance of a symptom of mild cognitive impairment (MCI) or mild Alzheimer's dementia (mild AD), with the information that is input corresponding to each of the at least four variables included in the patient information; and [Para. 0255 teaches processing multiple variables (often in the form of hundreds of input nodes) to model complex relationships such as identifying the onset and progression of cognitive impairment or other diseases or related health conditions. Para. 0227 teaches decision tree classification may be used in medical diagnosis and disease identification, where the output of a classification tree is a class (“yes” or “no”), therefore teaching determining the presence/absence of progression.]
outputting a prediction result relating to the probability of advance of a symptom of mild cognitive impairment (MCI) or mild Alzheimer's dementia (mild AD) in the patient, [Para. 0238 teaches outputting a prediction indicating the likelihood that the individual suffers from agitation (a symptom of MCI or mild AD).]
wherein the at least four variables include
[…]
a third variable that is information relating to memory regarding a holiday, a family gathering, a reservation, or schedule for taking medication in IADL, out of the third information, and [Para. 0288 teaches adherence to medication-taking protocols, which is information relating to memory regarding a schedule for taking medication in IADL.]
[…]
Sobol may not explicitly teach
first information relating to orientation,
second information relating to memory,
fourth information relating to positive/negative of a biomarker are associated with
a first variable that is information relating to orientation relating to time out of the first information,
a second variable that is information relating to delayed recall out of the second information,
a fourth variable that is information relating to amyloid β positive/negative out of the fourth information.
However, Alam teaches the following:
first information relating to orientation, [Para. 0090 teaches the mini-mental state examination (MMSE) is commonly used to assess the severity and progression of dementia. The test examines functions including orientation.]
second information relating to memory, [Para. 0091 teaches the Wechsler Memory Scale (WMS) is a test designed to measure different memory functions. A person’s performance is reported as five Index Scores.]
fourth information relating to positive/negative of a biomarker are associated with [Para. 0180 teaches positive AD-related biomarkers.]
a first variable that is information relating to orientation relating to time out of the first information, [Para. 0008 teaches the MMSE is often used to document cognitive decline over time. Para. 0090 teaches the test examines functions including orientation.]
a second variable that is information relating to delayed recall out of the second information, [Para. 0091 teaches Delayed Recall Index scores.]
a fourth variable that is information relating to amyloid β positive/negative out of the fourth information. [Para. 0166 teaches evaluating samples for amyloid-beta peptides.]
Motivation to combine the teaching of Alam with the teaching of Sobol is the same as that used with respect to claim 1 and is therefore reiterated here.
REGARDING CLAIM 9
Claim 9 is analogous to Claim 8, thus Claim 9 is similarly analyzed and rejected in a manner consistent with the rejection of Claim 8.
REGARDING CLAIM 10
Sobol in view of Alam teaches the storing the program according to claim 9.
Sobol further teaches
A computer-readable non-transitory storage medium. [Para. 0010 teaches a non-transitory computer readable medium.]
Conclusion
Prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Sobol et al. (U.S. 2019/0209022) which discloses a wearable electronic device and system for tracking location and identifying changes in salient indicators of patient health.
Png et al. (U.S. 2026/0188525) which discloses a method of predicting or determining healthy aging in an individual.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAMRYN B LEWIS whose telephone number is (703)756-1807. The examiner can normally be reached Monday - Friday, 11:00 am - 8:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert W Morgan can be reached on 571-272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAMRYN B LEWIS/
Examiner, Art Unit 3683
/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683
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