DETAILED ACTION
Notice to Applicant
This communication is in response to the Application submitted January 24, 2025. This application is a National Stage Entry of PCT/JP2021/025428 filed on July 6, 2021. Claims 1, 3 – 4, 6 – 8, and 10 are amended. Claims 1 – 10 are pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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.
Step One
Claims 1 – 10 are drawn to a system, method, and non-transitory computer-readable recording medium, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One
Independent claims 1, 9, and 10 recite extract an eye movement feature which is a feature of an eye movement of the target patient, based on the images; store, as past cases, a plurality of cases in which each of patients and information concerning the eye movement feature and the recovery level of the patient are associated with each other; search for each similar case including a similar eye movement feature to the eye movement feature of the target patient among the past cases; and estimate the recovery level of the target patient based on information concerning the recovery level of each similar case
The respective dependent claims 2 – 7, but for the inclusion of the additional elements specifically addressed below, provide recitations further limiting the invention of the independent claim(s).
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity, by estimating the recovery level of a patient using captured images of the patients and comparing to previous (or similar) cases to ease the burden of medical professionals. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).”
Step 2A Prong Two
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including:
Claim 1: “recovery level estimation device”, “at least one memory configured to store instructions”, “at least one processor configured to execute the instructions”, “acquire images capturing eyes”
Claims 2 – 3, 5: “recovery level estimation device”
Claims 4, 6 – 8: “recovery level estimation device”, “processor”
Claim 9: “acquire images capturing eyes”
Claim 10: “A non-transitory computer-readable recording medium storing a program, the program causing a computer to perform a process”, “acquire images capturing eyes”
These features are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
Step 2B
The claims do 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, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The published specification supports this conclusion as follows:
[0044] The processor 12 corresponds to one or more processors each being a computer such as a CPU (Central Processing Unit) and controls the whole of the recovery level estimation device 1 by executing programs prepared in advance. The memory 13 is formed by a ROM (Read Only Memory) and a RAM (Random Access Memory). The memory 13 stores the programs executed by the processor 12. Moreover, the memory 13 is used as a working memory during executions of various processes performed by the processor 12.
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 2 – 8 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. These claims are directed towards a method of recovery level estimation but the claims do not recite a device (e.g. a computer) which is used for carrying out the method. Therefore, these claims are not tied to a statutory class of invention. In order to overcome this rejection, the Office recommends amending the claims so that they recite a device (e.g. a computer) which is used in carrying out the claimed method. The applicants are reminded, however, that any amendment(s) to the claim(s) must have support in the specification as it was originally filed.
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.
Claim(s) 1 – 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Macknik et al., herein after Macknik (U.S. Publication Number 2016/0106358 A1) in view of Zidan et al., herein after Zidan (U.S. Publication Number 2020/0397288 A1).
Claim 1 (Currently Amended). Macknik discloses a recovery level estimation device comprising:
at least one memory configured to store instructions (Figure 4; paragraph 30 discloses the host can include one or more processors operating under control of one or more computer programs loaded from a non-transitory computer readable medium (memory)); and
at least one processor configured to execute the instructions (Figure 4; paragraph 30 discloses the host can include one or more processors operating under control of one or more computer programs loaded from a non-transitory computer readable medium (memory)) to:
acquire images capturing eyes of a target patient for whom a recovery level is estimated (paragraph 18 discloses non-invasively monitoring eye movements for the differential diagnosis of AD and/or MCI; paragraph 30 discloses detecting and analyzing eye movements of a subject to diagnose neurological disease; paragraph 31 discloses tracking a subject's eye position);
store, as past cases, a plurality of cases in which each of patients and information concerning the eye movement feature and the recovery level of the patient are associated with each other (paragraph 8 discloses the processor may be further configured to assess the statistical differences by comparing the statistical differences to corresponding previous statistical differences to characterize one or both of progression of the neurological disease and response to treatment for the neurological disease, indicating past history of a patient; paragraph 32 discloses the report may be stored in a file in memory);
estimate the recovery level of the target patient based on information concerning the recovery level of each similar case (paragraph 20 discloses microsaccade dynamics (and/or SWJ dynamics) can be compared with dynamics of healthy subjects (similar case), considered "normal levels," and such comparisons are then assessed. Assessment of the comparisons can include, but is not limited to, assessing a statistical difference (for example, within or not within normal limits, as determined by a significant or non-significant difference), quantifying the magnitude of a difference (that is, a numerical difference), etc.).
Macknik fails to explicitly teach the following limitations met by Zidan as cited:
extract an eye movement feature which is a feature of an eye movement of the target patient, based on the images (paragraph 203 discloses The Vive™ eye-tracker captures an image of the eye, extract the region-of-interest (ROI), and detect the pupil position within the eye and relative the sensor area. The Vive™ eye-tracker takes snapshots of the eyes with high frequency to capture the eye movements);
search for each similar case including a similar eye movement feature to the eye movement feature of the target patient among the past cases (paragraph 159 discloses patient-specific historical data files and other health data that specifies, corresponds to or is associated with different possible diagnoses of disorders; paragraph 251 discloses the subject health history data includes historical clinical and health data related to the history of the particular subject who has undergone the eye examination, including patient-specific historical data files).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Macknik to further include a medical system and method operable to control sensor-based wearable devices for examining eyes as disclosed by Zidan.
One of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to expand the method of Macknik in this way to provide enhanced effectiveness, reliability, accuracy and efficiency in detecting eye abnormalities and identifying possible diagnoses of disorders related to such abnormalities (Zidan: paragraph 81).
Claim 2 (Original). Macknik and Zidan teach the recovery level estimation device according to claim 1. Macknik teaches wherein the eye movement feature includes eye vibration information concerning a vibration of the eyes (paragraph 16 discloses square wave jerk (SWJ) which are characterized by one small horizontal saccadic movement that moves the eye away from the fixation target, and is interpreted as a vibration of the eyes).
Claim 3 (Currently Amended). Macknik and Zidan teach the recovery level estimation device according to claim 1. Macknik teaches wherein the eye movement feature includes information concerning any one or more of a bias of a movement direction between the eyes and a misalignment of right and left movements of the eyes (paragraph 5 discloses the presence of Alzheimer’s may include an average microsaccade direction that is significantly less horizontal than a corresponding average healthy microsaccade direction; paragraph 17 discloses measuring microsaccades of a subject and analyzing microsaccade parameters and dynamics, such as microsaccade direction, microsaccade velocity, microsaccade magnitude, microsaccadic peak velocity magnitude relationship, microsaccade duration, and/or intersaccatic intervals, for the differential diagnosis of AD and/or MCI as well as disease progression and/or response to treatment).
Claim 4 (Currently Amended). Macknik and Zidan teach the recovery level estimation device according to claim 1. Macknik teaches wherein the processor is further configured to present a task concerning the eye movement to the target patient (paragraph 18 discloses presenting visual stimuli to a patient), wherein
the processor acquires the images capturing the eyes of the target patient (paragraph 18 discloses non-invasively monitoring eye movements for the differential diagnosis of AD and/or MCI; paragraph 30 discloses detecting and analyzing eye movements of a subject to diagnose neurological disease; paragraph 31 discloses tracking a subject's eye position).
Macknik fails to explicitly teach the following limitations met by Zidan as cited:
the processor extracts the eye movement feature during the task based on the images (paragraph 203 discloses The Vive™ eye-tracker captures an image of the eye, extract the region-of-interest (ROI), and detect the pupil position within the eye and relative the sensor area. The Vive™ eye-tracker takes snapshots of the eyes with high frequency to capture the eye movements).
The motivation to combine the teachings of Macknik and Zidan is discussed in the rejection of claim 1, and incorporated herein.
Claim 5 (Original). Macknik and Zidan teach the recovery level estimation device according to claim 4. Macknik teaches wherein the eye movement feature includes visual field defect information concerning a visual field defect (paragraph 17 discloses monitoring eye movements and, in particular, microsaccades of a subject to detect AD and/or MCI which further includes determining abnormal fixational eye movements, such as microsaccades, as an indication of neurological disease (for example, AD or MCI) and/or quantifying the abnormality to determine disease progression and/or response to treatment).
Claim 6 (Currently Amended). Macknik and Zidan teach the recovery level estimation device according to claim 1. Macknik teaches wherein the processor is further configured to store patient information concerning any one or more of an attribute of the patient and a recovery record of the patient for each patient (paragraph 8 discloses the processor may be further configured to assess the statistical differences by comparing the statistical differences to corresponding previous statistical differences to characterize one or both of progression of the neurological disease and response to treatment for the neurological disease, indicating past history of a patient; paragraph 32 discloses the report may be stored in a file in memory).
Macknik fails to explicitly teach the following limitations met by Zidan as cited:
the processor searches the similar case among the past cases by referring to the patient information (paragraph 159 discloses patient-specific historical data files and other health data that specifies, corresponds to or is associated with different possible diagnoses of disorders; paragraph 251 discloses the subject health history data includes historical clinical and health data related to the history of the particular subject who has undergone the eye examination, including patient-specific historical data files).
The motivation to combine the teachings of Macknik and Zidan is discussed in the rejection of claim 1, and incorporated herein.
Claim 7 (Currently Amended). Macknik and Zidan teach the recovery level estimation device according to claim 1.
Macknik fails to explicitly teach the following limitations met by Zidan as cited:
wherein the processor is further configured to output an alert upon the recovery level of the target patient that is lower than a threshold value (paragraph 9 discloses a medical analysis that includes a plurality of parameter deviation thresholds associated with a plurality of the eye characteristic categories and generates an examination output that indicates a plurality of the sensed eye parameters including an abnormality resource if at least one of deviations associated with one of the eye characteristic categories is greater than the parameter deviation threshold associated with the eye characteristic category).
The motivation to combine the teachings of Macknik and Zidan is discussed in the rejection of claim 1, and incorporated herein.
Claim 8 (Currently Amended). Macknik and Zidan teach the recovery level estimation device according to claim 1.
Macknik fails to explicitly teach the following limitations met by Zidan as cited:
wherein the processor searches for a predetermined number of the similar cases among the past cases, and the processor estimates the recovery level of the target patient based on a most frequent recovery level in the similar cases (paragraph 159 discloses patient-specific historical data files and other health data that specifies, corresponds to or is associated with different possible diagnoses of disorders; paragraph 251 discloses the subject health history data includes historical clinical and health data related to the history of the particular subject who has undergone the eye examination, including patient-specific historical data files).
The motivation to combine the teachings of Macknik and Zidan is discussed in the rejection of claim 1, and incorporated herein.
Claim 9 (Original). Macknik teaches a recovery level estimation method comprising:
acquiring images capturing eyes of a target patient for whom a recovery level is estimated (paragraph 18 discloses non-invasively monitoring eye movements for the differential diagnosis of AD and/or MCI; paragraph 30 discloses detecting and analyzing eye movements of a subject to diagnose neurological disease; paragraph 31 discloses tracking a subject's eye position);
estimating the recovery level of the target patient based on information concerning the recovery level of each similar case (paragraph 20 discloses microsaccade dynamics (and/or SWJ dynamics) can be compared with dynamics of healthy subjects (similar case), considered "normal levels," and such comparisons are then assessed. Assessment of the comparisons can include, but is not limited to, assessing a statistical difference (for example, within or not within normal limits, as determined by a significant or non-significant difference), quantifying the magnitude of a difference (that is, a numerical difference), etc.).
Macknik fails to explicitly teach the following limitations met by Zidan as cited:.
extracting an eye movement feature which is a feature of an eye movement of the target patient, based on the images (paragraph 203 discloses The Vive™ eye-tracker captures an image of the eye, extract the region-of-interest (ROI), and detect the pupil position within the eye and relative the sensor area. The Vive™ eye-tracker takes snapshots of the eyes with high frequency to capture the eye movements);
searching for each similar case including a similar eye movement feature to the eye movement feature of the target patient among a plurality of past cases in which each of patients and information concerning the eye movement feature and the recovery level of the patient are associated with each other (paragraph 159 discloses patient-specific historical data files and other health data that specifies, corresponds to or is associated with different possible diagnoses of disorders; paragraph 251 discloses the subject health history data includes historical clinical and health data related to the history of the particular subject who has undergone the eye examination, including patient-specific historical data files).
The motivation to combine the teachings of Macknik and Zidan is discussed in the rejection of claim 1, and incorporated herein.
Claim 10 (Currently Amended). Macknik teaches A non-transitory computer-readable recording medium storing a program (paragraph 30 discloses non-transitory computer readable medium), the program causing a computer to perform a process comprising:
acquiring images capturing eyes of a target patient for whom a recovery level is estimated (paragraph 18 discloses non-invasively monitoring eye movements for the differential diagnosis of AD and/or MCI; paragraph 30 discloses detecting and analyzing eye movements of a subject to diagnose neurological disease; paragraph 31 discloses tracking a subject's eye position);
(paragraph 20 discloses microsaccade dynamics (and/or SWJ dynamics) can be compared with dynamics of healthy subjects (similar case), considered "normal levels," and such comparisons are then assessed. Assessment of the comparisons can include, but is not limited to, assessing a statistical difference (for example, within or not within normal limits, as determined by a significant or non-significant difference), quantifying the magnitude of a difference (that is, a numerical difference), etc.).
Macknik fails to explicitly teach the following limitations met by Zidan as cited:.
extracting an eye movement feature which is a feature of an eye movement of the target patient, based on the images (paragraph 203 discloses The Vive™ eye-tracker captures an image of the eye, extract the region-of-interest (ROI), and detect the pupil position within the eye and relative the sensor area. The Vive™ eye-tracker takes snapshots of the eyes with high frequency to capture the eye movements);
searching for each similar case including a similar eye movement feature to the eye movement feature of the target patient among a plurality of past cases in which each of patients and information concerning the eye movement feature and the recovery level of the patient are associated with each other (paragraph 159 discloses patient-specific historical data files and other health data that specifies, corresponds to or is associated with different possible diagnoses of disorders; paragraph 251 discloses the subject health history data includes historical clinical and health data related to the history of the particular subject who has undergone the eye examination, including patient-specific historical data files).
The motivation to combine the teachings of Macknik and Zidan is discussed in the rejection of claim 1, and incorporated herein.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. De Villers-Sidani et al. (U.S. Patent Number 11,503,998 B1) discloses method and a system for detecting a neurological disease and an eye gaze-pattern abnormality related to the neurological disease of a user.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINE K RAPILLO whose telephone number is (571)270-3325. The examiner can normally be reached Monday - Friday 7:30 - 4 pm.
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, Fonya Long can be reached at 571-270-5096. 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.
KRISTINE K. RAPILLO
Examiner
Art Unit 3626
/KRISTINE K RAPILLO/Examiner, Art Unit 3682