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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/5/2024 was received and placed in the record on file. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
No limitation of the instant claims are being interpreted as invoking 35 USC 112(f).
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 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding claims 1-7; using the two-part test for subject matter eligibility, independent claims 1 and 4 are the exemplary claims and are directed to a machine (claim 1) and a process (claim 4) (Step 1: Yes). The claims are also directed to a judicial exception regarding an abstract idea (Step 2A, Prong 1: Yes). The claims are recreated below and the abstract idea is bolded and italicized:
Claim 1:
A three-dimensional gait signal-based geriatric cognitive impairment diagnosis device comprising:
a data transmission/reception module;
a memory storing a geriatric cognitive impairment diagnosis program; and
a processor configured to execute the geriatric cognitive impairment diagnosis program stored in the memory,
wherein the geriatric cognitive impairment diagnosis program collects a three-dimensional gait signal including a spatiotemporal gait signal and a kinematic gait signal of an examinee, calculates a cognitive disorder disease probability value by using a cognitive disorder diagnosis model based on the three-dimensional gait signal, and determines whether the examinee has a cognitive disorder disease based on the calculated cognitive disorder disease probability value, and
the cognitive disorder diagnosis model is constructed by applying the three-dimensional gait signal of a patient with a geriatric cognitive disorder disease to a logistic function.
Claim 4:
A geriatric cognitive impairment diagnosis method which is performed by a three-dimensional gait signal-based geriatric cognitive impairment diagnosis device, the geriatric cognitive impairment diagnosis method comprising:
collecting a three-dimensional gait signal including a spatiotemporal gait signal and a kinematic gait signal of an examinee;
calculating a cognitive impairment disease probability value by using a cognitive impairment diagnosis model based on the three-dimensional gait signal; and
determining whether the examinee has a cognitive impairment disease based on the calculated cognitive impairment disease probability value,
wherein the cognitive impairment diagnosis model is constructed by applying a three-dimensional gait signal of a patient with a geriatric cognitive impairment disease to a logistic function.
The independent claims encompass an abstract idea drawn to mental processes and mathematical concepts that can be performed in the human mind and/or by hand using a pen and paper. In this case, calculating a cognitive impairment disease probability value by using a cognitive impairment diagnosis model based on the three-dimensional gait signal is a mental process (calculating the probability value using a mathematical model); determining whether the examinee has a cognitive impairment disease based on the calculated cognitive impairment disease probability value (mental process of taking the calculated value and thinking, analyzing and making an observation about it); and constructing a cognitive impairment diagnosis model by applying a three-dimensional gait signal of a patient with a geriatric cognitive impairment disease to a logistical function (mathematical concept of performing a logistical regression on data to determine/obtain a model/function) are drawn to mental processes and mathematical concepts. In other words, the mathematical concepts are using collected data of a subject known to have cognitive impairment and fitting the data to a mathematic function as defined by equations 1 and 2 of the specification to construct a model, and using the contracted model to calculate a cognitive impairment disease probability value; and the mental process includes observation, evaluation, judgment and opinion (observing the cognitive impairment disease probability value, evaluating/thinking about the value and making a judgement/opinion on if they have cognitive impairment).
Furthermore, the claims do not recite additional elements that integrate the judicial exception into a practical application (Step 2A, Prong 2: No). The claims fail to recite additional element or combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes meaningful limitations on the judicial exception. In the instant claims, the identified additional elements include:
a data transmission/reception module (claim 1);
a memory storing a geriatric cognitive impairment diagnosis program (claim 1); and
a processor configured to execute the geriatric cognitive impairment diagnosis program stored in the memory (claim 1)
collecting a three-dimensional gait signal including a spatiotemporal gait signal and a kinematic gait signal of an examinee (claims 1 and 4)
three-dimensional gait signal-based geriatric cognitive impairment diagnosis device (claim 4)
These additional elements do not integrate the judicial exception into a practical application. Instead, the additional elements amount to merely applying the judicial exception by including the instruction to implement on a computer, or merely using a computer as a tool to perform the abstract idea (i.e. implementing the steps on a general purpose computer/processor or storing the steps on a generic computer readable storage medium for execution by a general purpose computer/processor, wherein the parts of the computer are all recited at a high level of generality); generally linkin ghte use of the judicial exception to a particular technological environment (the processors, data transmission/reception module and storage medium with a computer program); and adding insignificant extra-solution activity to the judicial exception (in this case, collecting a three-dimensional gait signal including a spatiotemporal gait signal and a kinematic gait signal of an examinee is mere data gathering recited at a high level of generality and is considered extra-solution activity; see MPEP 2106.05(g)). In addition, all uses of the recited judicial exception require such data gathering and outpour, and as such, these limitations do not impose any meaningful limits on the claims. Further, the additional elements, considered individually and as a whole, along with the abstract idea: does not apply the judicial exception in conjunction with a particular machine or manufacture which is integral to the claims (wherein the processors, the memory, the data transmission/reception module and three-dimensional gait signal-based geriatric cognitive impairment diagnosis device [which is just the generic data transmission/reception module, memory and processors of claim 1] are all recited as conventional and recited at a high level of generality); does not affect the transformation or reduction of a particular article to a different state or thing (calculating a probability score from data is not a transformation to a different state or thing); utilize well-understood, routine and conventional activity or elements (collecting data is extra-solution activity and the additional elements are all conventional general purpose computer elements recited at a high level of generality); and does not apply the judicial exception in a meaningful way beyond generally linking the use of the judicial exception to a particular technological environment (wherein the recitation of the computer and the three-dimensional gait signal-based geriatric cognitive impairment diagnosis device merely are there to tie the abstract idea to computer).
Finally, the claims as a whole do not include additional elements that are sufficient to amount to significantly more than the judicial exception (Step 2B: No). The additional elements include:
a data transmission/reception module (claim 1);
a memory storing a geriatric cognitive impairment diagnosis program (claim 1); and
a processor configured to execute the geriatric cognitive impairment diagnosis program stored in the memory (claim 1)
collecting a three-dimensional gait signal including a spatiotemporal gait signal and a kinematic gait signal of an examinee (claims 1 and 4)
three-dimensional gait signal-based geriatric cognitive impairment diagnosis device (claim 4)
These additional elements do not amount to, or contribute to the inventive concept recited in the abstract idea. The additional elements, considered individually and as a whole, amount to merely implementing the abstract idea on a computer by reciting implementation by one or more computer processors or on a program for causing a general-purpose computer to carry out the abstract idea, wherein the elements of the general-purpose computer are recited at a high level of generality and do not attempt to meaningfully limit the abstract idea. Further, the program/method causing the computer to carry out the operation of collecting a three-dimensional gait signal including a spatiotemporal gait signal and a kinematic gait signal of a examinee are mere data gathering which is identified as extra solution activity (see MPEP 2106.05(g)). Thus, when considered as a whole, implementing the abstract idea on a general-purpose computer and performing extra-solution activity does not amount to significantly more than the abstract idea as identified above.
Accordingly, claims 1-7 are rejected as non-statutory as being directed to a judicial exception (abstract idea: mental process and mathematical concepts) without significantly more.
Furthermore, claims 2-3 and 5-7 do not recite any additional elements that implement the abstract idea into a practical application or amount to significantly more than the abstract idea as they:
merely further specify details of the abstract idea or recite further steps to the abstract idea wherein eligibility cannot be furnished by the unpatentable abstract idea itself (MPEP 2106.04, II, A, 2; referring to the further mental process calculation steps and the mathematical concept of the logistic function recited in claims 2, 3, 5 and 6)
recite additional elements which are conventional, well known and recited at a high level of generality (referring to the measurement unit recited in claims 2, 3, 5 and 6 and the non-transitory computer readable medium on which the computer program is recorded recited in claim 7)
The examiner notes that the measurement unit is considered conventional, well known and routine as the applicant’s specification merely outlines that the measurement unit is a generic IMU capable of recorded data that is used to calculate the desired values. The IMU is recited at a high level of generality and the examiner takes official notice that the use of IMUs to measure characteristics of gait and posture are well known, conventional and routine absent any claim limitations or further description in the specification identifying the measurement unit as a special purpose IMU different than conventional well known IMUs.
Accordingly, the dependent claims 2, 3, and 5-7 do not include any additional elements that when considered individually and as a whole integrate the abstract idea into a practical application or amount to significantly more than the abstract idea.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Konno (applicant cited IDS cited foreign patent document JP 2020146435 A, examiner relies on provided English Machine Translation) in view of Morris et al (US 2021/0059565 A1).
Regarding claims 1-3; Konno discloses a gait signal-based geriatric cognitive impairment diagnosis device (figure 17) comprising:
a data transmission/reception module (communication and interface device; elements 106 and 107);
a memory storing a geriatric cognitive impairment diagnosis program (hard disk drive; element 109); and
a processor (CPU; element 101) configured to execute the geriatric cognitive impairment diagnosis program (program; element 111) stored in the memory,
wherein the geriatric cognitive impairment diagnosis program collects a gait signal including a spatiotemporal gait signal and a kinematic gait signal of an examinee (wherein the collected user data includes temporal gait data; page 2, last paragraph through page 3, fourth paragraph; figures 1-8), calculates a cognitive disorder disease probability value by using a cognitive disorder diagnosis model based on the gait signal (determines a statistical difference value between model and user data; page 2, last paragraph through page 5, paragraph 7; figures 1-8), and determines whether the examinee has a cognitive disorder disease based on the calculated cognitive disorder disease probability value (wherein the dementia discrimination unit determines the presence of cognitive impairment dependent on the statistical difference between the input user data and the model; page 2, last paragraph through page 5, paragraph 7; figures 1-8), and
the cognitive disorder diagnosis model is constructed by applying the gait signal of a patient with a geriatric cognitive disorder disease to a logistic function (wherein model is created based training and fits data to a logistic function; page 2, last paragraph through page 7, line 1; figures 9-11).
However, Konno does not explicitly disclose that the gait data is a three-dimensional gait signal.
Morris teaches a similar system for assessing neurodegeneration using a gait signal wherein the system utilizes a measurement unit (camera elements 104) to measure a three-dimensional gait signal that includes parameters including stride length and gait speed measured during a gait cycle and calculates (using processing unit element 106) a kinematic gait measurement including angles of an ankle, a knee, and a hip joint of the examinee, tilts of a front, a back, a left side and a right side of the pelvis, and an acceleration applied to a lower body including a foot, a thigh and a shin (paragraph [0023]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Konno to utilize three-dimensional gat signal including spatiotemporal gait signal and a kinematic gait signal as taught by Morris in order to provide a more details analysis using more data points.
Further regarding claim 2; the Konno/Morris combination as described in the rejection of claim 1 above discloses the cognitive impairment diagnosis program calculates a spatiotemporal gait measurement value including a stride length and gait speed measured during a gait cycle of the examinee by using a measurement unit, and calculates a kinematic gait measurement value including angles of an ankle, a knee, and a hip joint of the examinee, tilts of a front, a back, a left side and a right side of the pelvis, and an acceleration applied to a lower body including a foot, a thigh and a shin (as taught by Morris). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing that the Konno/Morris combination would use the measurement unit the acquire the gait signals as taught by Morris for implementation into the geriatric cognitive impairment diagnosis device of Konno in order to improve the accuracy and precision by providing more data point to the learning model.
Further regarding claim 3; Konno discloses a logistic function that calculates a geriatric cognitive impairment disease probability value by using variables including the gait signal (determines function used to determine the statistical difference value between model and collected/input user gait data; page 2, last paragraph through page 5, paragraph 7; figures 1-8). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Konno/Morris combination to utilize the spatiotemporal gait measurement value and the kinematic gait measurement values calculated by Morris in the Konno/Morris combination to create the logistic function as described by Konno to improve the determination of the probability of cognitive impairment.
Further regarding claims 4-6; The Konno/Morris combination described in the rejection of claims 1-3 further disclose the method as described in the rejections above.
Further regarding claim 7; Konno discloses a computer readable medium (element 109) on which a computer program (element 111) is stored for performing the gait signal-based geriatric cognitive impairment diagnosis method (see rejection of claim 1 above). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing that the Konno/Morris combination would also utilize a computer readable medium for storing the Konno/Morris method as a program for execution by a processor as described in the rejection of claims 1-6 above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2020/0405216 A1 to Matsumura et al; discloses a cognitive function evaluation device, system and method.
US 2019/0290184 A1 to Matsumura et al; discloses a cognitive function evaluation device, system and method.
US 2017/0249434 A1 to Brunner; discloses a metalearner system for monitoring human health and deriving health status and trajectory which includes using gait for cognitive function.
WO 2020/208944 A1 to Aihara et al; discloses a behavior support system and method.
KR 2022/0073153 to Mun et al; discloses a method and system for predicting the severity of cognitive impairment in the elderly using gait parameters at fast-pace walking.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 PM).
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/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
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