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 05/06/2026 has been entered. Applicant’s amendments to claims 1 and 8, new claims 21 and 22, and cancellation of claim 7 are acknowledged. Claims 1-6, 8-12, and 21-22 remain pending in the application.
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.
Claim 21 is 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 21 recites the limitation "the active performance data" and “passive performance data” in lines 6 and 8 respectively. There is insufficient antecedent basis for this limitation in the claim.
Claims 3, 21, and 23 recite the limitation “wherein the movement data comprises... step power”. It is unclear what “step power” refers to and how it is calculated given only sensors located within wearable device/mobile device per Applicant’s specification ([0062]). For the purposes of examination step power will be considered a gait feature.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 is broader than the limitation imposed in claim 1, which require all of the disclosed active performance data while claim 5 requires a minimum of 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 6 is rejected due to dependency.
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, 8-12, and 21-22 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 International Parkinson and Movement Disorder Society (MDS-UPRS), hereinafter MDS-UPDS.
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 reduced ([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 discloses averaging data over a one week-interval. ([0049]: “duration of passive monitoring by day of week respectively, showing weekly data volume collection is effectively uniform.”) but fails to disclose specifically averaging passive movement data over a two-week interval. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the range of data averaging of Saria from one week to two weeks as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
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.
While Saria further discloses wherein the active performance data comprises dexterity (Table 1: dexterity), speech (Table 1: voice), postural tremor (Table 1: postural tremor), rest tremor (Table 1: rest tremor), balance (Table 1: balance) and U-turn (Table 1: gait “turn around and walk back"); and wherein the passive movement data comprises gait and mobility/sociability ([0038]: “to measure movement… as well as location and social behavior”), they fail to specifically disclose that the active performance data includes drawing a shape, hand turning, phonation, and cognitive test (Symbol Digit Modalities Test) and that the passive data includes arm swing/tremor.
The MDS-UPDRS discloses collecting performance data including hand turning (Page 20), speech (Page 18), phonation (Page 18), postural tremor (Page 24), rest tremor (page 26), balance (Page 23), U-turn (Page 23 see specifically “turning”), and cognitive test (Symbol Digit Modalities Test) (page 31: “cognitive impairment”) and arm swing/tremor (Page 22).
As Saria discloses using the MDS-UPDRS ([0030]: “mPDS and the MDS-UPDRS”), it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the active and passive performance data disclosed by Saria to include the additional test disclosed by the MDS-UPDRS in order to obtain a more robust data set.
Saria as modified by the MDS-UPDRS fails to disclose the active performance data includes drawing a shape and a cognitive test (Symbol Digit Modalities Test).
Baker discloses performance data includes drawing a shape and a cognitive test (Symbol Digit Modalities Test) ([0095]: “measurements of datasets during performances of a Symbol Digit Modalities Test (eSDMT), a Draw a Shape test”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to expand the performance data disclosed by Saria as modified by the MDS-UPDRS to further include the tests disclosed by Baker in order to obtain a more robust data set.
Regarding claim 2, Saria as modified by Baker, Jankovic, and MDS-UPDRS 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 MDS-UPDRS 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 MDS-UPDRS 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 8, Saria as modified by Baker, Jankovic, and MDS-UPDRS 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, also as modified above in claim 1, see MDS-UPDRS page 31); wherein postural tremor is indicative of MDS-UPDRS Rest Tremor Amplitude data (Table 1, also as modified above in claim 1, see MDS-UPDRS page 31); wherein balance is indicative of MDS-UPDRS Consistency of Rest Tremor data (as modified by MDS-UPDRS, see page 31); wherein hand turning is indicative of MDS-UPDRS Hand Movements data (as modified by MDS-UPDRS, see page 31): wherein dexterity is indicative of MDS-UPDRS Finger Tapping data (as modified by MDS-UPDRS, see page 31); wherein drawing a shape is indicative of MDS-UPDRS Handwriting data (as modified by Baker); wherein U-turn is indicative of MDS-UPDRS Body Bradykinesia data (as modified by MDS-UPDRS, see page 31); wherein cognitive test (Symbol Digit Modalities Test) is indicative of MDS-UPDRS Cognitive Impairment data (as modified by Baker above, see also MDS-UPDRS page 31: “cognitive test”); wherein phonation is indicative of MDS-UPDRS Speech Problems data (as modified by MDS-UPDRS, see page 31); wherein speech is indicative of MDS-UPDRS Saliva and Drooling data (as modified by MDS-UPDRS, see page 31); and wherein gait is indicative of MDS-UPDRS Body Bradykinesia data (as modified by MDS-UPDRS, see page 31).
Regarding claim 9, Saria as modified by Baker, Jankovic, and MDS-UPDRS and Zham 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 MDS-UPDRS and Zham 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 MDS-UPDRS and Zham 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 MDS-UPDRS and Zham 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]).
Regarding claim 21, 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”), wherein the patient movement data comprises gesture power (Table VII: Mean squared energy of the vertical tapping), step power ([0052]: “and gait features”, Table V, see 122(b) interpretation above), gait span ([0052]: “and gait features”, Table V), pathological hand tremor frequency (Table 1), gesture time ([0083]: “finger tapping speed”), turn speed ([0042]: “All the acceleration features are used by both the balance and gait tests.” Table I and Table VIII, wherein acceleration is calculated and wherein the patient turns), and gesture span duration ([0083]: “and inter-tap interval”).
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.
While Saria further discloses wherein the active performance data comprises at dexterity (Table 1: dexterity), speech (Table 1: voice), postural tremor (Table 1: postural tremor), rest tremor (Table 1: rest tremor), balance (Table 1: balance) and U-turn (Table 1: gait “turn around and walk back"); and wherein the passive movement data comprises gait and mobility/sociability ([0038]: “to measure movement… as well as location and social behavior”), They fail to specifically disclose that the active performance data includes drawing a shape, hand turning, phonation, and cognitive test (Symbol Digit Modalities Test) and that the passive data includes arm swing/tremor.
The MDS-UPDRS discloses collecting performance data including hand turning (Page 20), speech (Page 18), phonation (Page 18), postural tremor (Page 24), rest tremor (page 26), balance (Page 23), U-turn (Page 23 see specifically “turning”), and cognitive test (Symbol Digit Modalities Test) (page 31: “cognitive impairment”) and arm swing/tremor (Page 22).
As Saria discloses using the MDS-UPDRS ([0030]: “mPDS and the MDS-UPDRS”), it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the active and passive performance data disclosed by Saria to include the additional test disclosed by the MDS-UPDRS in order to obtain a more robust data set.
Saria as modified by the MDS-UPDRS fails to disclose the active performance data includes drawing a shape and a cognitive test (Symbol Digit Modalities Test).
Baker discloses performance data includes drawing a shape and a cognitive test (Symbol Digit Modalities Test) ([0095]: “measurements of datasets during performances of a Symbol Digit Modalities Test (eSDMT), a Draw a Shape test”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to expand the performance data disclosed by Saria as modified by the MDS-UPDRS to further include the tests disclosed by Baker in order to obtain a more robust data set.
Regarding claim 22, 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 reduced ([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”), wherein the patient movement data comprises gesture power (Table VII: Mean squared energy of the vertical tapping), step power ([0052]: “and gait features”, Table V, see 122(b) interpretation above), gait span ([0052]: “and gait features”, Table V), pathological hand tremor frequency (Table 1), gesture time ([0083]: “finger tapping speed”), turn speed ([0042]: “All the acceleration features are used by both the balance and gait tests.” Table I and Table VIII, wherein acceleration is calculated and wherein the patient turns), and gesture span duration ([0083]: “and inter-tap interval”).
Saria discloses averaging data over a one week-interval. ([0049]: “duration of passive monitoring by day of week respectively, showing weekly data volume collection is effectively uniform.”) but fails to disclose specifically averaging passive movement data over a two-week interval. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the range of data averaging of Saria from one week to two weeks as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
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.
While Saria further discloses wherein the active performance data comprises dexterity, speech, postural tremor, rest tremor, and U-turn (Table 1, includes speech, gait, and tremor data); and wherein the passive movement data comprises gait and mobility/sociability ([0038]: “to measure movement… as well as location and social behavior”), They fail to specifically disclose that the active performance data includes drawing a shape, hand turning, speech, phonation, balance, U-turn, and cognitive test (Symbol Digit Modalities Test) and that the passive data includes arm swing/tremor.
The MDS-UPDRS discloses collecting performance data including hand turning (Page 20), speech (Page 18), phonation (Page 18), postural tremor (Page 24), rest tremor (page 26), balance (Page 23), U-turn (Page 23 see specifically “turning”), and cognitive test (Symbol Digit Modalities Test) (page 31: “cognitive impairment”) and arm swing/tremor (Page 22),
As Saria discloses using the MDS-UPDRS ([0030]: “mPDS and the MDS-UPDRS”), it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the active and passive performance data disclosed by Saria to include the additional test disclosed by the MDS-UPDRS in order to obtain a more robust data set.
Saria as modified by the MDS-UPDRS fails to disclose the active performance data includes drawing a shape and a cognitive test (Symbol Digit Modalities Test).
Baker discloses performance data includes drawing a shape and a cognitive test (Symbol Digit Modalities Test) ([0095]: “measurements of datasets during performances of a Symbol Digit Modalities Test (eSDMT), a Draw a Shape test”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to expand the performance data disclosed by Saria as modified by the MDS-UPDRS to further include the tests disclosed by Baker in order to obtain a more robust data set.
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 I, also as modified above, see MDS-UPDRS page 31); wherein postural tremor is indicative of MDS-UPDRS Rest Tremor Amplitude data (Table I, also as modified above, see MDS-UPDRS page 31); wherein balance is indicative of MDS-UPDRS Consistency of Rest Tremor data (Table I); wherein hand turning is indicative of MDS-UPDRS Hand Movements data (as modified by MDS-UPDRS above, see page 31): wherein dexterity is indicative of MDS-UPDRS Finger Tapping data (Table I, also as modified by MDS-UPDRS, see page 31); wherein drawing a shape is indicative of MDS-UPDRS Handwriting data (as modified by Baker); wherein U-turn is indicative of MDS-UPDRS Body Bradykinesia data (Table I and also as modified by MDS-UPDRS, see page 31); wherein cognitive test (Symbol Digit Modalities Test) is indicative of MDS-UPDRS Cognitive Impairment data (as modified by Baker above, see also MDS-UPDRS page 31: “cognitive test”); wherein phonation is indicative of MDS-UPDRS Speech Problems data (as modified by MDS-UPDRS, see page 31); wherein speech is indicative of MDS-UPDRS Saliva and Drooling data (as modified by MDS-UPDRS, see page 31); and wherein gait is indicative of MDS-UPDRS Body Bradykinesia data (as modified by MDS-UPDRS, see page 31).
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 MDS-UPDRS in further view of Bassan et. all (US 20140378508 A1), hereinafter Bassan.
Regarding claim 4, Saria as modified by Baker, Jankovic, and MDS-UPDRS and Zham 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 MDS-UPDRS 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 MDS-UPDRS 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 05/06/2026, with respect to the rejection(s) of claim(s) 1-12 under 35 U.S.C. 103 have been fully considered.
Applicant argues on page 8 that Saria fails to teach all of the disclosed active and passive tests now required by amended claim 1. This argument is persuasive as Saria teaches some but not all of the test (see Table 1 of Saria and rejection above). Therefore the rejection is withdrawn. However, a new grounds of rejection is made in view of 35 U.S.C. § 103 (see above). In regards to the argument that the draw a shape test is not indicative of the MDS-UPDRS Handwriting test on page 9, Baker states ([0184]: “Draw a Shape” test is to assess fine finger control and stroke sequencing. The test is considered to cover the following aspects of impaired hand motor function”). Fine finger control and stroke sequences is directly indicative of the handwriting test disclosed by the MDS-UPDRS, which states (“writing is slow, clumsy, or uneven”.). Additionally, if the draw a shape test is not indicative of handwriting scores, it is unclear how the performance data collected by claim 1 would be indicative as it does not differ meaningfully from the test disclosed by Baker.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zham et al. (“Distinguishing Different Stages of Parkinson’s Disease Using Composite Index of Speed and Pen-Pressure of Sketching a Spiral”) – discloses drawing a shape test (see Materials and Methods) to evaluate Parkinsons, and further correlation between the drawing a shape test and the handwriting test (introduction paras 1-2)
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/KAVYA SHOBANA BALAJI/ Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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