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
This application filed 09/11/2023 is a National Stage entry of PCT/JP2022/011100, with an International Filing Date of 03/11/2022, and claims foreign priority to 2021-040515, filed 03/12/2021. The claims are therefore examined as filed on 03/12/2021, the effective filing date. In future actions, the effective filing date of one or more claims may change, due to amendments to the claims, or further review of the priority application(s).
Claim Status
Claims 12-19, 21-22, 24-25, 27, 29-31, 33-35, 37, 40-41, 43-44, and 51-52 are pending.
Claim 44 is objected to.
Claims 20, 23, 26, 28, 32, 36, 38-39, 42, 45-50, and 53-54 are cancelled.
Claims 12-19, 21-22, 24-25, 27, 29-31, 33-35, 37, 40-41, 43-44, and 51-52 are examined.
Claims 12-19, 21-22, 24-25, 27, 29-31, 33-35, 37, 40-41, 43-44, and 51-52 are rejected.
Information Disclosure Statement
The Information Disclosure Statements are in compliance with the provisions of 37 CFR 1.97. Accordingly, all references have been considered.
Claim Objections
Claim 44 is objected to because of the following informalities:
Claim 44 should read “The method according to claim 43, wherein said applying comprises applying L-Dopa…or a surgical therapy selectable from deep brain stimulation or stereotactic ablation.
Appropriate correction is required.
Claim Interpretation- Contingent Limitations
A claim contains a contingent clause:
• Claim 43 includes the contingent limitation “applying a treatment to the Parkinson's disease patient and/or issuing an alert regarding a treatment if the method determines that the Parkinson's disease patient should be given an additional treatment.” The steps of applying a treatment or issuing an alert are contingent limitations because they depend on the specific condition wherein method determines that the Parkinson's disease patient should be given an additional treatment, which is not required to occur within the metes and bounds of the claimed invention.
According to MPEP 2111.04, section II, the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. Therefore, only the non-contingent claims of claim 43 and claims dependent only on the non-contingent elements are considered under broadest reasonable interpretation. Contingent limitations and dependent claims that depend on contingent limitations will not be considered as required. This includes claim 44.
It should also be noted that the broadest reasonable interpretation of a system (or apparatus or product) claim having structure that performs a function, which only needs to occur if a condition precedent is met, requires structure for performing the function should the condition occur. The system/product claim interpretation differs from a method claim interpretation because the claimed structure must be present in the system regardless of whether the condition is met and the function is actually performed. Therefore, claims 51-52, while also containing a contingent limitation, are examined such that all structural limitations are considered under broadest reasonable interpretation.
Claim Interpretation- 112(f)
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. These include claims 33 and 37, which recite “means” for performing the claimed steps. 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.
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. The specification indicates that the information obtaining means, transmission means, receiving means, estimation means, and calculation means of claims 33 and 37 are programs/software implemented by processors in a system/user device [0109, 0164-165, 192, 0195].
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 24-25, 27, and 29-31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 24 recites the limitation of “deriving a second parameter relating to the eye of the patient by treating the first parameter.” It is unclear what “treating the first parameter” means in this context, and how a second parameter could be derived from this step. As such, this claim is indefinite due to lack of clarity.
Claims 25, 27, and 29-31 are also indefinite as they depend from claim 24, and do not resolve the issue above.
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 12-19, 21-22, 24-25, 27, 29-31, 33-35, 37, 40-41, 43-44, and 51-52 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of mental processes and mathematical concepts, without significantly more.
The MPEP at MPEP 2106 sets forth steps for identifying eligible subject matter:
(1) Are the claims directed to a process, machine, manufacture or composition of matter?
(2A)(1) Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea?
(2A)(2) Do the claims recite additional elements that integrate the judicial exception into a practical application?
(2B) If the claims recite a judicial exception and do not integrate the judicial exception, do the claims recite additional elements that provide an inventive concept and amount to significantly more than the judicial exception?
With regard to step (1) (Are the claims directed to a process, machine, manufacture or composition of matter?): Claims 12-19, 21-22, 24-25, 27, 29-31, 33-35, 37, 43-44 are directed to one of the statutory classes. Claims 12-19, 21-22, 24-25, 27, 29-31, and 43-44 are directed to processes (methods), and claims 33-35 and 37 are directed to a product (a system).
Claims 40-41 and 51-52 are NOT directed to one of the statutory classes, as they are directed to “a storage medium having a program stored thereon”. The broadest reasonable interpretation of machine-readable media/storage media can encompass non-statutory transitory forms of signal transmission, such as a propagating electrical or electromagnetic signal per se. See In re Nuijten, 500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007). When the broadest reasonable interpretation encompasses transitory forms of signal transmission, a rejection under 35 U.S.C. 101 as failing to claim statutory subject matter would be appropriate (see MPEP 2106.03 section II). To remedy this, the claim language should be amended to include “a non-transitory computer-readable storage medium” or analogous phrasing. In the interest of compact prosecution, these claims will continue to be analyzed with the other statutory claims below.
With regard to step (2A)(1) (Do the claims recite a judicially recognized exception?): Yes. The claims recite the abstract ideas of processing data using mental steps and mathematical concepts. Claims that recite nothing more than abstract ideas, natural phenomena, or laws of nature are not eligible for patent protection (see MPEP 2106.04).
Abstract ideas include mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations), certain methods of organizing human activity, and mental processes (including procedures for collecting, observing, evaluating, and organizing information (See MPEP 2106.04(a)(2)). In particular, these abstract ideas include but are not limited to:
Estimating or predicting the patient's condition based on ocular information (mental process; the human mind is capable of estimating or making a prediction based on data; claims 12, 32, 37, 40)
Calculating the estimated presence or absence, amount or level of in vivo dopamine or a substance biologically equivalent to dopamine of the patient based on the ocular information, and estimating or predicting the patient's condition from the presence or absence, amount or level, or a variation thereof (mental process/mathematical concept; the human mind is capable of calculating the presence/absence or a numerical value based on data and making a prediction based on the calculation, and performing a calculation of a value is a mathematical concept; claim 14)
Estimating or predicting the presence or absence or degree or score of symptoms of Parkinson's disease or the presence or absence or degree or score of dyskinesia in the patient based on the ocular information (mental process/mathematical concept; the human mind is capable of estimating the presence/absence or a numerical value such as a degree or score based on data, and doing so is equivalent to performing a calculation; claim 17)
Estimating or predicting the patient's condition by comparing an output from the model to one or more thresholds set for the patient (mental process/mathematical concept; the human mind can compare a numerical value to a threshold to make a prediction, and doing so is a mathematical concept; claim 18)
Calculating one or more thresholds set for the patient (mental process/mathematical concept; the human mind is capable of calculating or determining a threshold, and doing so is a mathematical concept; claim 19)
Deriving from the ocular information source a first parameter relating to the eye of the patient and deriving a second parameter relating to the eye of the patient (mental process/mathematical concept; the human mind is capable of deriving parameters from data, and doing so is equivalent to performing a calculation; claim 24)
Deriving time-series data of blink frequency and blink duration of each blink from an ocular information source obtained from the patient or another patient, deriving the time-series data of blink frequency into a plurality of data according to the length of the blink duration, calculating a degree of similarity between each of the plurality of classified data and other data among the plurality of classified data adjacent to each other in the blink duration, and setting a threshold for dividing the blink duration based on the similarity (mental process/mathematical concept; the human mind is capable of deriving parameters from data, calculating a degree of similarity from a comparison of data, and setting a threshold, and doing so is equivalent to performing a calculation; claim 31)
Issuing an alert regarding a treatment (mental process; the human mind is capable of issuing an alert; claim 43, 51)
Issuing an instruction to perform a treatment (mental process; the human mind is capable of issuing an instruction to perform an action; claim 51-52)
Dependent claims 16, 25, 27, and 29 further limit the abstract ideas recited in the independent claims, and do not change their characterization as abstract ideas.
Therefore, the claims recite elements that constitute one or more judicial exceptions.
With regard to step (2A)(2) (Do the claims recite additional elements that integrate the judicial exception into a practical application?): No. Claims 12, 32, 37, and 40 recite the additional element of obtaining ocular information of the patient, with claim 21 further reciting obtaining at least one ocular information source and extracting the ocular information from the ocular information source, and claim 22 describing the source. Claim 30 also recites the additional limitation of obtaining criteria for dividing the blink duration from the ocular information source. Claim 13 and 15 also recite the additional elements of inputting information into a trained model and receiving an output.
Claim 32 also recites the additional element of a system comprising means (indicated in the specification to be software implemented by processors/a user device) for performing claimed steps, with claims 34-35 reciting the additional element of a user device and describing the device, and claim 37 further reciting a user device and server device with means for performing claimed steps. Claims 40-41 and 51-52 also recite the additional element of a computer system having a processor for running the stored programs and performing claim steps. Claims 43-44 also further recite the additional element of applying a treatment to Parkinson’s disease, but this is written in the alternative to an abstract idea, and also contingent on if the method determines that the patient should be given an additional treatment - therefore this element is not considered under the broadest reasonable interpretation.
While the claims recite the additional element of receiving/obtaining and outputting data, such steps that only amount to necessary data gathering and outputting, without any technical details of how the data is obtained/output that integrate the judicial exception, are insignificant extrasolution activities that do not add a meaningful limitation to the claims (see MPEP 2106.05(g)). As a result, the judicial exception is not integrated into a practical application. In addition, while the claims recite additional elements related to the use of computers, they do not provide any specific details by which the user device, system, storage medium or processors perform or carry out the judicial exception listed in step (2A)(1), nor do they provide any details of how specific structures of the computer are used to implement these functions. The judicial exception is therefore not integrated into a practical application because the generically recited computer elements do not add a meaningful limitation to the abstract idea, as they amount to simply implementing the abstract idea on a computer (see MPEP 2106.05(f)). This also applies to the use of trained models to process and output data, as such a model, without recited physical structure outside of general computer components, is also analogous to implementing an abstract idea of data analysis on a computer. Because the claims do not recite any additional elements that integrate the judicial exception into a practical application, the claims as a whole are directed to an abstract idea.
With regard to step (2B) (Do the claims recite additional elements that provide an inventive concept and amount to significantly more than the judicial exception?): No. The claims recite an abstract idea with additional elements; however, these additional elements are general computer elements added to abstract ideas, and non-particular instructions to apply the abstract idea by linking it to a field of use or extrasolution activity (see MPEP 2106.05(f-h)). General computer elements used to perform an abstract idea do not provide an inventive concept, and similarly, non-particular instructions to gather or produce data do not provide an inventive concept. Non-particular instructions to gather or output data are also considered well-understood, routine and conventional activities (see MPEP 2106.05(d), which indicates that limitations such as “Receiving or transmitting data over a network” from Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362, and “Storing and retrieving information in memory” from Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93 are recognized as conventional activities). The claims therefore do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As a result, the claims as a whole do not provide an inventive concept.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim Rejection
Claims 12-13, 16-17, 21-22, 24-25, 27, 33, 40, 43-44, and 51-52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CHUDZIK 2020 “Eye-Tracking and Machine Learning Significance in Parkinson’s Disease Symptoms Prediction.”
Claim Interpretation and Scope and Contents of Prior Art
Claims 12, 33, and 40 recite a method, system, and storage medium with instructions implemented on a computer system, respectively, for estimating or predicting the condition of a Parkinson's disease patient being treated with L-DOPA or an L-DOPA-related compound or a dopamine agonist, comprising A) a step of obtaining ocular information of the patient; and B) a step of estimating or predicting the patient's condition based on the ocular information.
With respect to these limitations, CHUDZIK teaches a method implemented on a computer system of predicting the progression of Parkinson’s disease in patients with different stages of the disease and with different levels of treatment, including treatment with L-Dopa, where the method comprises obtaining ocular information in the form of eye movements, and predicting the patient’s condition based on the ocular information (Abstract, pg 538-539).
Claim 13 recites the limitation wherein the step B) comprises: inputting the ocular information into a trained model, wherein the trained model has trained a correlation between the ocular information and the patient condition; and obtaining an output from the trained model. With respect to this limitation, CHUDZIK teaches inputting the ocular information into a trained model trained on a correlation between the information and patient condition and obtaining an output (pg 540).
Claim 16 recites the limitation wherein the condition includes the presence or absence or degree or score of at least one selected from the group consisting of dyskinesia, wearing off, ON-OFF, no-on phenomenon, delayed-on phenomenon, akinesia, resting tremor, muscle rigidity, postural instability, forward leaning posture, freezing phenomenon, sleep disorders, mental/cognitive/behavioral disorders, autonomic disorders and sensory disorders.
With respect to this limitation, CHUDZIK teaches that the condition includes the Hoehn and Yahr scale (which indicates progression of Parkinson’s related to balance), the Unified Parkinson’s Disease Rating (which indicates a level of dyskinesia/motor control, sleep disturbances, rigidity, tremors, etc.), and the Epworth Sleepiness Scale (pg 538).
Claim 17 recites the limitation wherein the step B) comprises: estimating or predicting the presence or absence or degree or score of symptoms of Parkinson's disease or the presence or absence or degree or score of dyskinesia in the patient based on the ocular information. With respect to this limitation, CHUDZIK teaches predicting a level of Parkinson’s disease measured as a Unified Parkinson’s Disease Rating (UPDRS) value binned into intervals, for different groups of patients, based on the ocular information (Abstract, pg 540).
Claim 21 recites the limitation wherein the step A) comprises: obtaining at least one ocular information source; and extracting the ocular information from the ocular information source. With respect to this limitation, CHUDZIK teaches obtaining ocular information in the form of eye movements from a head-mounted saccadometer, and receiving/extracting the data from it (pg 538-539).
Claim 22 recites the limitation wherein the at least one ocular information source includes optical, physical or electrical information on the muscle or surrounding skin involved in eye or eye movement of the patient, or a combination thereof, and/or wherein obtaining the at least one ocular information source includes using at least one selected from the group consisting of an image analysis method, a method using reflected light, a distance measurement method, an electrooculography method, a search coil method, and a probe method, to obtain the at least one ocular information source. With respect to these limitations, CHUDZIK teaches obtaining ocular information from a saccadometer, which provides information on eye movement speed, which is an indication of physical muscle movement (pg 539).
Claim 24 recites the limitation wherein extracting the ocular information from the ocular information source includes deriving from the ocular information source a first parameter relating to the eye of the patient and deriving a second parameter relating to the eye of the patient by treating the first parameter, and wherein the ocular information includes the first parameter and/or the second parameter. With respect to these limitations, CHUDZIK teaches deriving parameters related to the eye of the patient such as saccades and latency, amplitude, maximum velocity and duration of saccades, and deriving additional parameters by averaging the parameters in each session visit for both eyes to get mean latency, mean amplitude, mean maximum velocity and mean duration (pg 539).
Claim 25 recites the limitation wherein the first parameter includes at least one selected from the group consisting of blink frequency or number of blinks, blink duration, time between blinks, eye closing time, eye opening speed, eye closing speed, eyelid movement width, eyelid opening, and movement distance, movement direction, speed, acceleration, angular velocity, saccade, gliding eye movement, vestibulo-ocular reflex, convergence/divergence, and fixational tremor (ocular tremor, drift, micro saccade) for spontaneous blink, voluntary blink, or reflex blink, and/or wherein the second parameter includes at least one selected from the group consisting of a function output with the first parameter as an input variable, an intra-division calculated value that is a calculated value in each division when the data of the first parameter is divided into a plurality of divisions by a predetermined threshold, and an inter-division calculated value that is a calculated value of the intra-division calculated value of the plurality of divisions. With respect to these limitations, CHUDZIK teaches the parameter includes saccade duration and velocity which are divided by session/visit and averaged (pg 538-539).
Claim 27 recites the limitation wherein the intra-division calculated value includes various statistics such as maximum value, minimum value, mean value, median value, dispersion, 25% percentile value, 75% percentile value, frequency analysis spectrum, and the like, and/or wherein the inter-division calculated value includes weighted sums, differences, time differentiations, time integrals, ratios, correlation coefficients, and covariances.
With respect to these limitations, CHUDZIK teaches that the intradivision calculated values are mean values (pg 539).
Claims 43 recites the limitation of performing the method according to claim 12; and applying a treatment to the Parkinson's disease patient and/or issuing an alert regarding a treatment if the method determines that the Parkinson's disease patient should be given an additional treatment. Claim 51 similarly recites a storage medium with a program run on a processor to perform the method of claim 12, and issue an instruction to perform a treatment on the Parkinson's disease patient and/or issue an alert regarding a treatment if the method determines that the Parkinson's disease patient should be given an additional treatment.
With respect to these limitations, CHUDZIK teaches that their automated mechanism could provide a doctor with an objective opinion about applied therapy symptoms and determine that a treatment should be changed when the current treatment is determined as not optimal (pg 546).
Claim 44 recites the limitation wherein said applying comprises applying L-DOPA or an L-DOPA-related compound or a dopamine agonist, an L-DOPA adjunct, a dopamine neuronal function restoring agent, a dopamine producing cell medicine, or a dopamine producing gene therapy, or a surgical therapy to the Parkinson's disease patient when it is determined that the L-DOPA or an L- DOPA-related compound or a dopamine agonist, an L-DOPA adjunct, a dopamine neuronal function restoring agent, a dopamine producing cell medicine, or a dopamine producing gene therapy, or a surgical therapy selectable from deep brain stimulation or stereotactic ablation, should be applied to the Parkinson's disease patient, by the method. Claim 52 similarly recites that the instruction comprises an instruction to apply one of the above treatments.
With respect to this limitation, CHUDZIK teaches that L-dopa is the gold standard treatment for PD (Abstract) and that the treatment can be changed (pg 546).
Claim Rejections - 35 USC § 103
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 Rejection
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over CHUDZIK as applied to claims 12-13, 16-17, 21-22, 24-25, 27, 33, 40, 43-44, and 51-52 above, and further in view of IWAKI 2019 “Using Spontaneous Eye-blink Rates to Predict the Motor Status of Patients with Parkinson’s Disease.”
Claim Interpretation and Scope and Contents of Prior Art
CHUDZIK teaches the limitations of claims 12-13, 16-17, 21-22, 24-25, 27, 33, 40, 43-44, and 51-52 above.
Claim 14 recites the limitation wherein the step B) comprises: a) a step of calculating the estimated presence or absence, amount or level of in vivo dopamine or a substance biologically equivalent to dopamine of the patient based on the ocular information; and b) a step of estimating or predicting the patient's condition from the presence or absence, amount or level, or a variation thereof. Claim 15 similarly recites the limitation wherein the step a) comprises: inputting the ocular information into a trained model, wherein the trained model has trained a correlation between the ocular information and the presence or absence, amount or level of the in vivo dopamine or a substance biologically equivalent to dopamine; and obtaining an output from the trained model.
CHUDZIK does not teach these limitations, however IWAKI teaches that ocular information such as eye blink rate is correlated with the level of dopamine in the brain and can be used in predicting/monitoring PD condition (Abstract, pg 1418-1419). It would therefore be obvious to one of ordinary skill in the art that a model such as that in CHUDZIK could be trained on this correlation and be used in providing an output related to patient condition.
Resolving Ordinary Skill in the Art and Obviousness Rationale
A teaching, suggestion, or motivation in the prior art would have led one of ordinary skill in the art to modify or combine the prior art to arrive at the claimed invention. Specifically, a person of ordinary skill in monitoring and analysis of Parkinson’s disease would have been motivated to combine the teachings of CHUDZIK with the teachings of IWAKI, in order to achieve the claimed invention, because eye blink rate is correlated with the level of dopamine in the brain, the level of which is associated with Parkinson’s symptoms and treatment decisions, and thus can be used in predicting/monitoring PD condition (Abstract, pg 1418-1419). A person of ordinary skill would reasonably expect success from combining these teachings, as both CHUDZIK and IWAKI teach methods of using measured ocular data to predict Parkinson’s symptoms, and the correlation between ocular data and dopamine levels can be included in the model of CHUDZIK in outputting an accurate prediction. Therefore, the claims at issue would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention as there is both a reason to modify or combine the prior art, and a reasonable expectation of success (see MPEP 2143.02 (I)).
Claim Rejection
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over CHUDZIK in view of IWAKI as applied to claims 12-13, 16-17, 21-22, 24-25, 27, 33, 40, 43-44, and 51-52, and claims 14-15 above, and further in view of SCHRAG 2006 “Minimal Clinically Important Change on the Unified Parkinson’s Disease Rating Scale.”
Claim Interpretation and Scope and Contents of Prior Art
CHUDZIK in view of IWAKI teaches the limitations of claims 12-13, 16-17, 21-22, 24-25, 27, 33, 40, 43-44, and 51-52, and claims 14-15, above.
Claim 18 recites the limitation wherein step b) comprises: estimating or predicting the patient's condition by comparing an output from the model to one or more thresholds set for the patient. Claim 19 further recites the limitation of calculating one or more thresholds set for the patient.
With respect to these limitations, CHUDZIK teaches estimating the patient condition from the model output as a UPDRS score (pg 542) but does not teach comparing an output from the model to thresholds set for the patient, or calculating these thresholds. However, SCHRAG teaches estimating cutoffs defining clinically important changes in UPDRS scores in Parkinson’s patients and comparing patient UPDRS scores to the cutoffs (Abstract), where cutoffs/thresholds are in relation to patient baseline (pg 1202).
Resolving Ordinary Skill in the Art and Obviousness Rationale
A teaching, suggestion, or motivation in the prior art would have led one of ordinary skill in the art to modify or combine the prior art to arrive at the claimed invention. Specifically, a person of ordinary skill in monitoring and analysis of Parkinson’s disease would have been motivated to combine the teachings of CHUDZIK in view of IWAKI and SCHRAG, in order to achieve the claimed invention, because comparing an output patient indication of Parkinsons (such as a UPDRS score) to a threshold/cutoff established for the patient allows for determining if a meaningful clinical change has occurred, which impacts treatment decisions (Abstract, pg 1200). A person of ordinary skill would reasonably expect success from combining these teachings, as CHUDZIK in view of IWAKI and SCHRAG teach methods of using the UPDRS score to assess patients, and the methods of SCRAG can be applied after the UPDRS score is obtained in the model of CHUDZIK. Therefore, the claims at issue would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention as there is both a reason to modify or combine the prior art, and a reasonable expectation of success (see MPEP 2143.02 (I)).
Claim Rejection
Claims 29-31, 34-35, 37, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over CHUDZIK as applied to claims 12-13, 16-17, 21-22, 24-25, 27, 33, 40, 43-44, and 51-52 above, and further in view of MURRAY 2019 (WO 2019232579 A1).
Claim Interpretation and Scope and Contents of Prior Art
CHUDZIK teaches the limitations of claims 12-13, 16-17, 21-22, 24-25, 27, 33, 40, 43-44, and 51-52 above.
Claim 29 recites the limitation wherein the first parameter includes blink duration, and the second parameter includes blink frequency classified based on blink duration, or long blink frequency and short blink frequency, or the ratio of long blink frequency to short blink frequency.
CHUDZIK does not teach this limitation. However, MURRAY teaches collection of eyelid movement parameters to support analysis of neurological function impacted by degenerative issues such as Parkinson’s (Abstract, [0167]), where parameters such as blink duration and blink frequency derived from blink duration are collected [0192, 0078, 224, 227]. Because it is known that Parkinson’s impacts eye movement, it would be obvious to one of ordinary skill in the art that these parameters can be substituted in the model of CHUDZIK to produce a similar indication of Parkison’s condition.
Claim 30 recites the limitation of obtaining criteria for dividing the blink duration from the ocular information source. With respect to this limitation, MURRAY teaches that the blink duration data is defined as the time period from blink initiation to blink completion [0192] separated from other collected blink data defined by other criteria [00193].
Claim 31 recites the limitation wherein obtaining criteria for dividing the blink duration from the ocular information source includes deriving time- series data of blink frequency and blink duration of each blink from an ocular information source obtained from the patient or another patient, deriving the time-series data of blink frequency into a plurality of data according to the length of the blink duration, calculating a degree of similarity between each of the plurality of classified data and other data among the plurality of classified data adjacent to each other in the blink duration, and setting a threshold for dividing the blink duration based on the similarity.
With respect to this limitation, MURRAY teaches categorizing blink events from time-series data according to the length of the blink duration, and setting thresholds for dividing the blink duration [0204-209]. MURRAY does not specify calculating a degree of similarity between the classified data to determine the threshold; however, using similarity of datapoints to determine classification thresholds is well known in data analysis and obvious to one of ordinary skill in the art.
Claims 34 and 41 recite the limitation of claim 33 and 40, respectively, wherein the system is a user device. CHUDZIK does not teach that the system is a user device, however MURRAY teaches that its system for collecting eyelid movement data is a user device [0006-9, 27, 158].
Claim 35 recites the limitation wherein the user device is one information processing device selected from the group consisting of smart phones, tablet computers, smart glasses, smart watches, laptop computers, and desktop computers, and/or wherein the user device comprises a portion that implements the function of measuring optical information and/or electro-oculography of the muscle or peripheral skin involved in eye or eye movement. With respect to this limitation, MURRAY teaches that the user device can be a smart phone or tablet for eyelid movement data collection [27, 158].
Claim 37 recites the limitation wherein the system includes a user device and a server device, the user device includes an information obtaining means, a transmission means for transmitting the ocular information to the server device, and a receiving means for receiving the result estimated by the estimation means from the server device, and the server device includes a receiving means for receiving the ocular information from the user device, the calculation means, the estimating means, and a transmitting means for transmitting the result estimated by the estimating means to the user device, and/or wherein the system includes a user device and a server device, the user device includes the information obtaining means, the calculation means, a transmission means for transmitting the calculated presence/absence, amount or level to the server device, and a receiving means for receiving the result estimated by the estimation means from the server device, and the server device includes a receiving means for receiving the calculated presence/absence, quantity or level from the user device, the estimating means, and a transmitting means for transmitting the result estimated by the estimating means to the user device.
With respect to this limitation, MURRAY teaches that its system includes a user device and computer/server, where the user device obtains eyelid movement data and transmits it to the computer/server where it is received and analyzed [0006-9, 18-31, 115-130].
Resolving Ordinary Skill in the Art and Obviousness Rationale
A teaching, suggestion, or motivation in the prior art would have led one of ordinary skill in the art to modify or combine the prior art to arrive at the claimed invention. Specifically, a person of ordinary skill in using ocular data for neurological analysis would have been motivated to combine the teachings of CHUDZIK with the teachings of MURRAY, in order to achieve the claimed invention, because involuntary eyelid movements are impacted by degenerative brain conditions such as Parkinson’s, and analysis of eyelid movement parameters can be used to determine a patient’s brain function/condition [0167-168]. Further, gathering the data via user device allows for improved/convenient collection of the parameters [0006, 158]. A person of ordinary skill would reasonably expect success from combining these teachings, as both CHUDZIK and MURRAY teach methods of using measured ocular data to predict neurological condition, and the parameters collected by the device of MURRAY can be included in the model of CHUDZIK in outputting an accurate prediction of Parkinson’s condition. Therefore, the claims at issue would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention as there is both a reason to modify or combine the prior art, and a reasonable expectation of success (see MPEP 2143.02 (I)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY C LEVERETT whose telephone number is (571)272-5494. The examiner can normally be reached 8:00am - 5:00pm M-Th.
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/MARY C LEVERETT/ Examiner, Art Unit 1687
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