DETAILED ACTION
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 action is in response to amendments filed on 11/20/2025. Claims 1, 4, 5, and 14 have been amended. Claims 13 has been cancelled. Claims 1-12, 14-17, and 19-22 are pending and examined below.
Claim Rejections - 35 USC § 112
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 12 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.
Regarding claim 12, the claim recites comprising administering a regimen Prasinezumab to the patient. However, claim 1, which claim 12 depends, already teaches administering Prasinezumab. As such the claim does not further limit the claim upon which it depends.
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 Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4, 6-12, 14, 16-17, 19-22 is/are rejected under 35 U.S.C. 103 as being unpatentable by US 20140257141 A1 (hereinafter referred to as “Guiffrida”) in view of “Safety and Tolerability of Multiple Ascending Doses of PRX002/RG7935, an Anti-α-Synuclein Monoclonal Antibody, in Patients With Parkinson Disease: A Randomized Clinical Trial” (cited in the IDS; hereinafter referred to as “Jankovic”).
Regarding claim 1, Guiffrida teaches A method for monitoring the motor function of a patient that has Parkinson's Disease (PD) or is at risk for PD who has been administered Prasinezumab (abstract; paragraph [0005]), the method comprising.
(a) providing the patient with a mobile device programmed to receive and transmit data acquired from sensors internal and/or external to the mobile device that measure passive and/or active movement of the patient or a mobile device application programmed to receive and transmit data acquired from sensors internal and/or external to the mobile device that measure passive and/or active movement of the patient (paragraph [0150]);
(b) collecting data transmitted from the mobile device (paragraph [0150]); and
(c) comparing the data acquired from the patient with control data to assess presence or extent of movement deficits in the subject and/or monitoring the data acquired from the patient for a period of time sufficient to identify changes in the patient's active or passive motor function (paragraph [0129]); but does not explicitly teach implementing administrating a regimen of Prasinezumab comprises 1000-5000 mg of Prasinezumab at intervals of 3 to 5 weeks.
However, Jankovic, a clinical trial of PRX002/RG7935 (Prasinezumab), teaches wherein the regimen of Prasinezumab comprises 1000-5000 mg of Prasinezumab at intervals of 3 to 5 weeks (“Participants were enrolled sequentially into 1 of 6 escalating-dose cohorts and were to receive a total of 3 intravenous infusions of PRX002 (0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, 10 mg/kg, 30 mg/kg, or 60 mg/kg) or placebo, administered approximately once every 28 days”; methods; experimental design; Table 1; as taught by Jankovic). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Guiffrada, to use Prasinezumab as a medication for Parkinson’s, as taught by Jankovic, because doing so provides safe and tolerable medication for Parkinson patients (conclusion; as taught by Jankovic).
Regarding claim 2, Guiffrida, in view of Jankovic, teaches wherein the sensors transmit data acquired from active movement of the patient (paragraph [0022]).
Regarding claim 3, Guiffrida, in view of Jankovic, teaches wherein the mobile device is programmed to receive and transmit data from external sensors attached to upper and lower limbs of the patient (paragraph [0079]).
Regarding claim 4, Guiffrida, in view of Jankovic, teaches wherein the mobile device acquires data from sensors on the upper and lower limbs of the subject (paragraph [0079], [0150]).
Regarding claim 6, Guiffrida, in view of Jankovic, teaches wherein the movement comprises tapping the device, sitting and standing (paragraphs [0016], [0100], [0108]).
Regarding claim 7, Guiffrida, in view of Jankovic, teaches wherein the sensors measure one or more of the following features of the patient's movement:
(a) median gesture power of passively monitored gestures:
(b) median turn speed in U-turn test and passively monitored gait,
(c) jerk in balance test,
(d) mel frequency cepstrum 2 in speech test,
(e) voice jitter in sustained phonation,
(f) number correct in Symbol Digit Modalities Test.
(g) speeded tapping variability,
(h) maximum speed of hand-turning,
(i) spiral celerity in draw-a-shape task, and
(j) median squared energy in rest and postural tremor tasks (paragraph [0100], [0112], [0138]).
Regarding claim 8, Guiffrida, in view of Jankovic, teaches wherein the independently measure movement from the least affected side and the most affected side of the patient (performs test from the UPDRS part III which includes tapping test using both hands; paragraph [0100], [0112], [0138]).
Regarding claim 9, Guiffrida, in view of Jankovic, teaches wherein the data collected from the device is compared the patient's MDS-UPDRS score (paragraph [0100], [0112], [0138], claim 20).
Regarding claim 10, Guiffrida, in view of Jankovic, teaches wherein the MDS-UPDRS score comprises of one of MDS-UPDRS Part I, MDS-UPDRS Part II, or UPDRS Part III (paragraph [0100], [0112], [0138], claim 20).
Regarding claim 11, Guiffrida, in view of Jankovic, teaches wherein the MDS-UPDRS score comprises UPDRS Part Ill (paragraph [0100], [0112], [0138], claim 20).
Regarding claim 12, Guiffrida, in view of Jankovic, teaches administering a regimen Prasinezumab to the patient (abstract; as taught by Jankovic).
Regarding claim 14, Guiffrada, in view of Jankovic, teaches wherein Prasinezumab is administered intravenously ((“Participants were enrolled sequentially into 1 of 6 escalating-dose cohorts and were to receive a total of 3 intravenous infusions of PRX002 (0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, 10 mg/kg, 30 mg/kg, or 60 mg/kg) or placebo, administered approximately once every 28 days”; methods; experimental design; Table 1; as taught by Jankovic).
Regarding claim 16, Guiffrada, in view of Jankovic, teaches wherein the patient is treatment naïve, was diagnosed as having PD in the last two years, or was previously treated with a MAO-B inhibitor (Table 1; as taught by Jankovic).
Regarding claim 17, Guiffrada, in view of Jankovic, teaches wherein the patient has a weight greater than 65 kg and is administered a dose of 4500 mg Prasinezumab once every 4 weeks (0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, 10 mg/kg, 30 mg/kg, or 60 mg/kg) or placebo, administered approximately once every 28 days”; methods; experimental design; Table 1; as taught by Jankovic).
Regarding claim 19, Guiffrada, in view of Jankovic, teaches wherein the patient is administered a dose of 1500 mg antibody every 4 weeks (0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, 10 mg/kg, 30 mg/kg, or 60 mg/kg) or placebo, administered approximately once every 28 days”; methods; experimental design; Table 1; as taught by Jankovic).
Regarding claim 20, Guiffrada, in view of Jankovic, teaches wherein the patient is administered Prasinezumab once every 4 weeks for at least 52 weeks ( for 52 weeks; Key Points, meaning; as taught by Jankovic; administered approximately once every 28 days”; methods; experimental design; Table 1; as taught by Jankovic).
Regarding claim 21, Guiffrada, in view of Jankovic, teaches wherein the period of time sufficient to identify changes in the patient's active or passive motor function comprises 4-52 weeks (0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, 10 mg/kg, 30 mg/kg, or 60 mg/kg) or placebo, administered approximately once every 28 days”; methods; experimental design; Table 1; as taught by Jankovic).
Regarding claim 22, Guiffrada, in view of Jankovic, teaches wherein the period of time is 4 weeks, 8 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 42 weeks, 46 weeks or 52 weeks (0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, 10 mg/kg, 30 mg/kg, or 60 mg/kg) or placebo, administered approximately once every 28 days”; methods; experimental design; Table 1; as taught by Jankovic).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guiffrada, in view of Jankovic, as applied to claim 1 above, and further in view of US 20070093495 A1 (hereinafter referred to as “Ruggero”).
Regarding claim 15, Guiffrada, in view of Jankovic teaches administrating a medication to a user (paragraph [0024]), but does not explicitly teach further comprising administering to the patient a MAO-B inhibitor.
However, Ruggero teaches further comprising administering to the patient a MAO-B inhibitor (abstract). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Guiffrada, in view of Jankovic, to use MAO-B as a medication for Parkinson’s, as taught by Ruggero, because doing so provides an effective medication for Parkinson’s treatment.
Response to Arguments
Applicant’s arguments, filed 11/20/2025, with respect to the 35 USC 112(b) rejections and 35 USC 101 rejections have been fully considered and are persuasive. The 35 USC 112(b) rejections and 35 USC 101 rejections have been withdrawn.
Applicant's arguments filed 11/20/2025, with respect to the prior art rejections, have been fully considered but they are not persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/ABID A MUSTANSIR/Examiner, Art Unit 3791