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 .
Response to Amendment
The amendment filed 01/21/2026 has been entered. Claims 1-12 remain pending in the application. Applicant’s amendments to claims 1, 4-7, and 9-12 are acknowledged.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 5, and 7-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Saria (US 20180206775 A1), hereinafter Saria in view of Baker (US 20190200915 A1, as cited by Applicant’s IDS filed 03/16/2022), in view of Jankovic (“Pathogenesis-targeted therapeutic strategies in Parkinson's disease”) in view of Sprint et al. (“Analyzing Sensor-Based Time Series Data to Track Changes in Physical Activity during Inpatient Rehabilitation”), hereinafter Sprint.
Regarding claim 1, Saria discloses a method of treating a patient having Parkinson's and an impaired motor system ([0013]: “a system for Parkinson's disease (PD) monitoring and intervention for a patient”, Figs 15A – 15C displaying motor scores of patients) comprising: administering a therapeutically effective amount of a drug to the patient ([0012]: “The method includes adjusting patient medication dosage based on the passive and active data”), and wherein the patient is confirmed as motor system impaired based on accumulated data of patient movement and motor system assessment (Table 1, [0112]: “patient's scoring can be provided… areas of concern can be highlighted”, [0038]: “(e.g. whether the individual is experiencing frozen gait or dyskinesia)”) obtained via a sensor ([0012]: “includes data from accelerometers, inertial sensors, GPS, WiFi, and phone usage”), and whether patient impairment is reduce ([0055]; “exhibits a distinct improvement on the ten features”), wherein patient movement data comprises active performance data and passive movement data ([0038]: “Passive tests”) and active performance data ([0037]: “Active tests”).
Saria further discloses calculating the treatment based on the motor system assessment ([0012]) wherein the treatment is delivering a therapeutically effective amount of a drug to the patient ([0012]: “The method includes adjusting patient medication dosage based on the passive and active data”), but fails to disclose wherein the patient is receiving physical therapy, the treatment is physical therapy and the drug is prasinezumab.
Baker discloses a method for assessing motor symptoms (abstract) in a subject with Parkinson’s ([0005]) including calculating a treatment ([0372]: “a method for recommending a therapy for a cognition and movement disease or disorder comprising the steps of the aforementioned method of the disclosure”) based on an impaired motor system assessment ([0314]: “Moreover, by determining the degree of difference between a determined parameter and a reference, a quantitative assessment of a cognition and movement disease or disorder in a subject shall be possible”), disclose wherein the patient is receiving physical therapy ([0373]: “physical-therapy”), wherein the treatment is physical therapy and delivering a therapeutically effective amount of a drug to the patient ([0373]: “including drug-based therapies, surgeries, psychotherapy, physical-therapy”).
As Saria discloses providing therapy to a patient based on the results of the calculating treatment, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the treatment disclosed by Saria to include physical therapy and drugs administered in Baker in order to expand the number of therapies deliverable to a patient.
Saria as modified by Baker fails to disclose the administered drug is prasinezumab.
Jankovic discloses a method of treating Parkinson’s disease (title) wherein a patient is administered prasinezumab (page 1 col 2 para 1: “ phase 1b multiple ascending-dose study of prasinezumab (PRX002/RG7935), an intravenously administered IgG1 monoclonal antibody targeting the C-terminus of α-synuclein, enrolled 80 patients with early PD.1”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to substitute the known drugs administered by Saria as modified by Baker to prasinezumab as disclosed by Jankovic for the predictable result of treating Parkinson’s disease.
Saria as modified by Baker and Jankovic fails to disclose wherein the passive movement data is averaged over a two-week interval.
Sprint discloses wherein the passive movement data (Conclusions para 2: “passively-collected data from commercially-available, wearable devices”) is averaged over a two-week interval (section 3.2 para 3: “two weeks of data collection.”, section 3.4 para 2: “average of all days within the window 𝑊”, equation 1).
As Saria discloses averaging data over a week ([0049]: “duration of passive monitoring by day of week respectively, showing weekly data volume collection is effectively uniform.”), it would have been obvious to modify the method disclosed by Saria as modified by Baker and Jankovic to include averaging passive movement data over a two-week interval as disclosed by Sprint to increase the volume of data collected.
Regarding claim 2, Saria as modified by Baker, Jankovic, and Sprint discloses the method of claim 1, and Saria further discloses wherein the sensor comprises a mobile telephone or a smart watch ([0014]).
Regarding claim 3, Saria as modified by Baker, Jankovic, and Sprint discloses the method of claim 1, and Saria further discloses wherein the patient movement data comprises at least one of gesture power, step power, gait span, pathological hand tremor frequency, gesture time, turn speed, and gesture span duration (Table 1, includes gait and tremor data).
Regarding claim 5, Saria as modified by Baker, Jankovic, and Sprint discloses the method of claim 1, and Saria further discloses wherein the active performance data of the patient comprises at least one of drawing a shape, dexterity, hand turning, speech, phonation, postural tremor, rest tremor, balance, U-turn, and cognitive test (Symbol Digit Modalities Test) (Table 1, includes speech and tremor data).
Regarding claim 7, Saria as modified by Baker, Jankovic, and Sprint discloses the method of claim 1, and Saria further discloses wherein the active performance data comprises at least one of drawing a shape, dexterity, hand turning, speech, phonation, postural tremor, rest tremor, balance, U-turn, and cognitive test (Symbol Digit Modalities Test) (Table 1, includes speech, gait, and tremor data); and wherein the passive movement data comprises at least one of gait, arm swing/tremor, and mobility/sociability ([0038]: “to measure movement… as well as location and social behavior”).
Regarding claim 8, Saria as modified by Baker, Jankovic, and Sprint discloses the method of claim 7, and Saria further discloses wherein the motor system assessment is correlative to disease severity ratings (MDS-UPDRS) ([0091]: “smartphone-derived score of the present invention using correlation plots of mPDS against the MDS-UPDRS part III score”), MDS-UPDRS total score and wherein rest tremor is indicative of MDS-UPDRS Rest Tremor Amplitude data (Table 1); wherein postural tremor is indicative of MDS-UPDRS Rest Tremor Amplitude data (Table 1); wherein balance is indicative of MDS-UPDRS Consistency of Rest Tremor data (Table 1); wherein hand turning is indicative of MDS-UPDRS Hand Movements data (Table 1): wherein dexterity is indicative of MDS-UPDRS Finger Tapping data (Table 1); wherein drawing a shape is indicative of MDS-UPDRS Handwriting data (Table 1, [0081]: “and Part II (motor experiences of daily living)”, wherein dexterity tests may be indicative of handwriting data, and further the method includes conducting the Part II of the MDS-UPDRS, which per the official MDS-UPRS test (page 7 table 2) includes the handwriting test); wherein U-turn is indicative of MDS-UPDRS Body Bradykinesia data (Table 1); wherein cognitive test (Symbol Digit Modalities Test) is indicative of MDS-UPDRS Cognitive Impairment data ([0081]: “The MDS-UPDRS Part I”, as part I has been conducted, this would be indicative of cognitive impairment data as part I includes the cognitive impairment data test as per the official MDS-UPDRS test (MDS-UPDRS Page 3 table 1)); wherein phonation is indicative of MDS-UPDRS Speech Problems data (Table 1); wherein speech is indicative of MDS-UPDRS Saliva and Drooling data (Table 1, though not explicitly stated to be correlated, as speech data is collected and all three sections of the MDS-UPDRS are conducted [0081], the speech data may correlate to saliva and drooling data); and wherein gait is indicative of MDS-UPDRS Body Bradykinesia data (Table 1).
Regarding claim 9, Saria as modified by Baker, Jankovic, and Sprint discloses the method of claim 1, and Saria further discloses, further comprising: calculating a threshold value defining the motor system assessment of the patient as impaired or not impaired ([0063]: “The algorithm learns scores that are consistent with clinical expectations”), based on a patient-population movement data wherein the movement data comprises passive movement data ([0041]: “passive monitoring”) and/or active performance data ([0041]: “conduct active tests”),.
Regarding claim 10, Saria as modified by Baker, Jankovic, and Sprint discloses the method of claim 9, and Saria further discloses, further comprising: calculating a patient movement and/or performance score of the patient ([0063]: “severity score”), comparing the patient movement and/or performance score to the threshold value ([0063]: “ordered pairs comparing disease severity state at different times”), and determining if the motor system assessment is impaired or not impaired ([0063]: “an adverse event”).
Regarding claim 11, Saria as modified by Baker, Jankovic, and Sprint discloses the method of claim 10, and Saria further discloses displaying a command ([0014]: “visual representation”), wherein the command is no treatment for a patient for a not impaired motor system assessment ([0012]: “adjusting patient medication dosage”); and displaying a command ([0014]: “transmitting the visual representation of the data to the healthcare provider.”), wherein the command is to initiate a treatment for the patient for an impaired motor system assessment ([0012]: “The method includes adjusting patient medication dosage based on the passive and active data”, wherein adjust implies that the dosage may be changed or not based on the data).
Regarding claim 12, Saria as modified by Baker, Jankovic, and Sprint discloses the method of claim 11, and Baker further discloses delivering, to the patient, a therapeutically effective amount of levodopa, sinemet, safinamide, carbidopa, dopamine agonists, COMT inhibitors, MAO-B inhibitors, amantadine, or anticholinergics ([0373]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Saria in view of Baker in view of Jankovic in view of Sprint in further view of Bassan et. all (US 20140378508 A1), hereinafter Bassan.
Regarding claim 4, Saria as modified by Baker, Jankovic, and Sprint discloses the method of claim 3, but fails to disclose the motor system assessment of the patient is correlative to EQ- 5D-5L health status measurement data, and wherein gesture power is indicative of EQ-5D-5L Mobility data; wherein gesture power, step power, gait span, and pathological hand tremor frequency are indicative of EQ-5D-5L Self-Care data; wherein gesture power, step power, and gesture time data are indicative of EQ-5D-5L Usual Activities data; wherein gesture power and/or tum speed are indicative of EQ-5D-5LPain/Discomfort data; and wherein gesture time, gesture span duration, and gait span data are indicative of EQ- 5D-5L Anxiety/Depression data.
Bassan discloses a method for treating motor impairment ([0019]), wherein the motor system assessment is correlative to EQ- 5D-5L health status measurement data ([0020]: “the one or more symptoms are measured by EQ5D-5L”), and wherein gesture power is indicative of EQ-5D-5L Mobility data ([0738], Table 5, while not explicitly disclosed, the EQ-5D-5L is performed and thus it can be concluded that the correlating tests were performed); wherein gesture power, step power, gait span, and pathological hand tremor frequency are indicative of EQ-5D-5L Self-Care data ([0738], Table 5); wherein gesture power, step power, and gesture time data are indicative of EQ-5D-5L Usual Activities data ([0738], Table 5); wherein gesture power and/or tum speed are indicative of EQ-5D-5LPain/Discomfort data ([0738], Table 5); and wherein gesture time, gesture span duration, and gait span data are indicative of EQ- 5D-5L Anxiety/Depression data ([0738], Table 5).
Saria discloses a method of correlating movement data to the MDS-UPDRS assessment (Saria [0091]). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to substitute the known method of using the MDS-UPDRS assessment as disclosed by Saria with the known method of performing the EQ-5D-5L assessment as disclosed by Bassan to obtain the predictable result of evaluating motor impairment.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Saria in view of Baker in view of Jankovic in view of Sprint in further view of Demonceau et all. (“Contribution of a Trunk Accelerometer System to the Characterization of Gait in Patients With Mild-to-Moderate Parkinson’s Disease”), hereinafter Demonceau.
Regarding claim 6, Saria as modified by Baker, Jankovic, and Sprint discloses the method of claim 5 but fails to disclose the motor system assessment of the patient is correlative to quality of life (PDQ-39) measurements, and wherein drawing a shape, dexterity, or hand turning is indicative of PDQ-39 Activities of Daily Living, Communication, or Mobility data; wherein speech is indicative of PDQ-39 Communication data; and wherein U-tum is indicative of PDQ-39 Mobility data.
Demonceau discloses a method for the analysis of movement in patients with Parkinson’s (abstract) wherein the motor system assessment is correlative to quality of life (PDQ-39) measurements (page 3 section E. paragraph 1 “and the PDQ-39 questionnaire”), and wherein drawing a shape, dexterity, or hand turning is indicative of PDQ-39 Activities of Daily Living, Communication, or Mobility data (table II); wherein speech is indicative of PDQ-39 Communication data (table II); and wherein U-tum is indicative of PDQ-39 Mobility data (table II).
Saria discloses a method of correlating movement data to the MDS-UPDRS assessment (Saria [0091]). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to substitute the known method of using the MDS-UPDRS assessment as disclosed by Saria as modified by Baker with the known method of performing the PDQ-39 assessment as disclosed by Demonceau to obtain the predictable result of evaluating motor impairment.
Response to Arguments
Applicant’s arguments, see Remarks, filed 12/04/2025, with respect to the rejection(s) of claim(s) 1-12 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 U.S.C. 103 (see above).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAVYA SHOBANA BALAJI whose telephone number is (703)756-5368. The examiner can normally be reached Monday - Friday 8:30 - 5:30 ET.
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/KAVYA SHOBANA BALAJI/ Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791