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 .
Formal Matters
Applicant's response, filed 11 July 2025, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Status of Claims
Claims 2-3 are currently pending and have been examined.
Claim 2 has been amended.
Claim 1 has been canceled.
Claims 2-3 have been rejected.
Priority
The instant application claims the benefit of priority under 35 U.S.C 119(e) or under 35 U.S.C. § 120, 121, or 365(c). Accordingly, the effective filing date for the instant application is 10 September 2020 claiming benefit to IT10/2020,000021385 and PCT/IT2021/050161.
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.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma et al., SPARK: Personalized Parkinson Disease Interventions through Synergy between a Smartphone and a Smartwatch, Design, User Experience, and Usability. User Experience Design for Everyday Life Applications and Services 103-114 (2014)[hereinafter Sharma] in view of Pravika M et al, Pump on Levodopa Pharmacokinetics and Pharmacodynamics, 2019 IEEE Region 10 Conference 696-701 (2019)[hereinafter Pravika].
As per claim 2, Sharma teaches on the following limitations of the claim:
said management occurring through the analysis of the motion status of patients affected by said Parkinson's disease is taught in the § 3.1 Smartwatch/Smartphone System on p. 108 (teaching on an integrated smartphone and smartwatch mobile health system for monitoring Parkinson disease to place a patient on a rating scale (treated as synonymous to a phase));
wherein said motion status can be in one of the following phases: OFF phase, in which Parkinson's symptoms, such as rigidity, tremor and bradykinesia, emerge; ON phase, in which said symptoms markedly improve; DYS phase, in which involuntary movements emerge, called dyskinesias is taught in the § 4.3 Personalized Interventions on p. 110 (teaching on predicting an "OFF phase" when medication is not effective/movement symptoms, including bradykinesia or tremors, are not controlled and an "ON phase" when medication is effective/movement symptoms are controlled);
wherein it uses as detectors of said symptoms the following parameters: voice analysis is taught in the § 5.2 Speech Analysis on p. 111 and 4.2 Multidimensional Diagnostic Monitoring (Layer 2) on p. 109-110 (teaching on monitoring patient speech signals for voice impairments utilizing the patient's smartphone);
face analysis; tremor analysis is taught in the 5.1 Facial Tremors on p. 111 and 4.2 Multidimensional Diagnostic Monitoring (Layer 2) on p. 109-110 (teaching on a front facing camera to record facial videos for patient tremor analysis utilizing the patient's smartphone);
movement analysis is taught in the § 5.3 Active Monitoring of Movements on p. 1111 and 4.2 Multidimensional Diagnostic Monitoring (Layer 2) on p. 109-110 (teaching on monitoring motor movements of the patient for movement analysis utilizing the patients smartwatch);
an electronic bracelet, equipped with an accelerometer, a magnetometer and a gyroscope, three-axial, for collecting data continuously about tremor and movement is taught in the § 5.3 Active Monitoring of Movements on p. 1111, 4.2 Multidimensional Diagnostic Monitoring (Layer 2) on p. 109-110, and § 2.2 Survey on the Use of Wearable Technology in PD Interventions (teaching on a patient smartwatch for passively monitoring motor movements equipped with an accelerometer, gyroscopes, magnetic motion trackers (treated as synonymous to a magnetometer));
a photo-camera to shoot face expressions, to be actuated upon request of a patient is taught in the 5.1 Facial Tremors on p. 111 and 4.2 Multidimensional Diagnostic Monitoring (Layer 2) on p. 109-110 (teaching on a front facing camera to record facial videos for patient tremor analysis utilizing the patient's smartphone via active monitoring (treated as synonymous to actuated upon request of a patient));
a recorder to record the patient voice, to be actuated upon request of the patient is taught in the § 5.2 Speech Analysis on p. 111 and 4.2 Multidimensional Diagnostic Monitoring (Layer 2) on p. 109-110 (teaching on a smartphone microphone monitoring patient speech signals for voice impairments via active monitoring (treated as synonymous to actuated upon request of a patient));
a processing device, equipped with a suitable software which, using a movement stabilizing algorithm, adapted to integrate data about movement, tremor, face, voice and levodopa and metabolite levels of monoamines in said sub-cutaneous interstitial liquid, to provide the patient with information to modulate the oral therapy, using as feedback data about a starting therapeutic scheme is taught in the § 4.3 Personalized Interventions on p. 110 (teaching on the patient smartphone with corresponding hardware providing a recommendation of a medication change utilizing a software algorithm implementing a hidden Markov model to analyses the input to minimize the OFF phase for a patient);
a display on which the updated oral therapy is displayed is taught in the Figure 2 on p. 109 (teaching on a patient smartphone with a display).
Sharma fails to teach the following limitation of claim 2. Pravika, however, does teach the following:
a system for managing an oral therapy for the treatment of Parkinson's disease is taught in the § A. Oral Route on p. 679 and § B. Daily routines with PDP on p. 699 col 2 - p. 700 col 2 (teaching on managing oral or injected Levodopa delivery for a patient based on continuous patient monitoring);
levodopa and metabolite levels of monoamines in the sub-cutaneous interstitial liquid of said patients; said system comprising is taught in the § A. Oral Route on p. 679 and § B. Daily routines with PDP on p. 699 col 2 - p. 700 col 2 (teaching on subcutaneous monitoring a patient's Levodopa and monoamine metabolite levels);
a micro-dialysis pump connected to an analysing unit and to a sub-cutaneous needle, adapted to collect and analyse samples of interstitial liquid to determine levodopa and metabolite levels of monoamines in said sub-cutaneous interstitial liquid is taught in the § Introduction on p. 696 col 2, § A. Oral Route on p. 679, and § B. Daily routines with PDP on p. 699 col 2 - p. 700 col 2 (teaching on a portable duodopa pump (PDP) subcutaneously monitoring a patient's Levodopa/Duodopa and monoamine metabolite levels).
One of ordinary skill in the art before the effective filing date would combine the smartphone/smartwatch Parkinson’s symptom monitoring system of Sharma to include monitoring blood monoamine and levodopa levels of Pravika with the motivation of providing “optimal transfer of Levodopa even under inter-patient variability, intra-patient variability and disturbances” (Pravika in the § on p. 701 col 1).
As per claim 3, the combination of Sharma and Pravika discloses all of the limitations of claim 2. Sharma also discloses the following:
the system for managing an oral therapy for the treatment of Parkinson's disease according to claim 2, wherein said photo-camera, said recorder, said processing device, said display and the related software are integrated in a handheld computer/smartphone, so that the electronic bracelet and the analysing unit send analysis data about movement, tremor and levodopa and metabolite levels of monoamines directly to said handheld computer/smartphone, said handheld computer/smartphone being equipped with a display adapted to display updated oral therapy is taught in the § 3.1 Smartwatch/Smartphone System and § 4.3 Personalized Interventions on p. 110 (teaching on the patient smartphone with corresponding hardware receiving patient input data from the patient smartwatch over a network and providing a recommendation of a medication change utilizing a software algorithm implementing a hidden Markov model to analyses the input to minimize the OFF phase for a patient via the smartphone display).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent Application No. 18/025,049 in view of Pravika M et al, Pump on Levodopa Pharmacokinetics and Pharmacodynamics, 2019 IEEE Region 10 Conference 696-701 (2019)[hereinafter Pravika]. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Claim
Instant Limitation
Reference Limitation
Reference Claim
2
a system for managing an oral therapy for the treatment of Parkinson's disease said management occurring through the analysis of the motion status of patients affected by said Parkinson's disease wherein said motion status can be in one of the following phases:
A method for managing an infusion therapy for the treatment of Parkinson's disease, said method comprising determining a motor status of a patient affected by said Parkinson's disease, wherein said motor status can be in one of the following phases
1
2
OFF phase, wherein Parkinson's symptoms, comprising one or more of rigidity, tremor and bradykinesia, emerge
OFF phase, wherein Parkinson's symptoms, comprising one or more of rigidity, tremor and bradykinesia, emerge
1
2
ON phase, wherein said symptoms markedly improve
ON phase wherein said symptoms markedly improve
1
2
DYS phase, wherein involuntary movements emerge, called dyskinesias
DYS phase wherein involuntary movements emerge, called dyskinesias
1
2
wherein it uses as detectors of said symptoms the following parameters: voice analysis; face analysis; tremor analysis; movement analysis; levodopa and metabolite levels of monoamines in the sub-cutaneous interstitial liquid of said patients
wherein said method uses as detectors of said symptoms the following parameters: voice analysis; face analysis; tremor analysis; movement analysis; levodopa and metabolite levels of monoamines in the sub-cutaneous interstitial liquid of said patients
1
2
said system comprising:
A system for managing an infusion therapy for the treatment of Parkinson's disease, comprising:
2
2
an electronic bracelet, equipped with an accelerometer, a magnetometer and a gyroscope, three-axial, for collecting data continuously about tremor and movement;
an electronic bracelet, equipped with an accelerometer, a magnetometer and a gyroscope, three-axial, for collecting data continuously about tremor and movement;
2
2
a photo-camera to shoot face expressions, to be actuated upon request of a patient;
a photo-camera to shoot face expressions, to be actuated upon request of a patient;
2
2
a recorder to record the patient voice, to be actuated upon request of the patient;
a recorder to record the patient voice, to be actuated upon request of the patient;
2
2
a micro-dialysis pump connected to an analysing unit and to a sub-cutaneous needle, adapted to collect and analyse samples of interstitial liquid to determine levodopa and metabolite levels of monoamines in said sub-cutaneous interstitial liquid;
a micro-dialysis pump connected to an analysing unit and to a sub-cutaneous needle, adapted to collect and analyse samples of interstitial liquid to determine the levodopa and metabolite levels of the monoamines in said sub-cutaneous interstitial liquid;
2
2
a processing device, equipped with a suitable software which, using a movement stabilizing algorithm, adapted to integrate data about movement, tremor, face, voice and levodopa and metabolite levels of monoamines in said sub-cutaneous interstitial liquid, to provide the patient with information to modulate the oral therapy, using as feedback data about a starting therapeutic scheme;
a processing device, equipped with a suitable software which, using a movement stabilizing algorithm, adapted to integrate data about movement, tremor, face, voice and levodopa and metabolite levels of monoamines in said sub-cutaneous interstitial liquid, computes an infusion rate of a drug necessary to keep an ON motor status, using as feedback data about a starting therapeutic scheme;
2
2
a display on which the updated oral therapy is displayed.
an electronic interface, connected to said processing device, adapted to modify the infusion rate of the drug with a new rate computed by said movement stabilizing algorithm.
2
3
The system for managing an oral therapy for the treatment of Parkinson's disease according to claim 2, wherein said photo-camera, said recorder, said processing device, said display and the related software are integrated in a handheld computer/smartphone, so that the electronic bracelet and the analysing unit send analysis data about movement, tremor and levodopa and metabolite levels of monoamines directly to said handheld computer/smartphone, said handheld computer/smartphone being equipped with a display adapted to display updated oral therapy.
The system for managing an infusion therapy for the treatment of Parkinson's disease according to claim 2, wherein said photo-camera, said recorder, said processing device and related software are integrated in a handheld computer/smartphone, so that the electronic bracelet and the analysing unit send analysis data about movement, tremor and levodopa and metabolite levels of monoamines directly to said handheld computer/smartphone.
3
While co-pending application 18/025,049 teaches on an infusion therapy but fails to teach on an oral therapy instead, Pravika teaches on an oral route medication in § A. Oral Route on p. 679. One of ordinary skill in the art would combine the Parkinson’s disease monitoring for therapy delivery of the co-pending claims with the oral route of Pravika with the motivation of “safe and convenient administration” of oral drug delivery (Pravika in the § A. Oral Route on p. 679). Therefore claims 1-3 are rejected on the ground of nonstatutory double patenting.
Response to Arguments
Applicant’s arguments filed 22 August 2025 with respect to 35 USC § 101 have been considered and are persuasive regarding the newly added limitations. Therefore, the rejection has been withdrawn.
Applicant’s arguments filed 22 August 2025 with respect to 35 USC § 103 have been considered and are not persuasive. In response to applicant's argument that Sharma fails to anticipate the scientific qualities of dyskinesis as it only considered the amount of drug that is consumed by the patient without the high variance related to the dyskinesia, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Moreover, Sharma does consider the ON and OFF phases in § 4.3 Personalized Interventions on p. 110.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e.,the hiddle Markov model for determining the phase) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Finally, Applicant asserts that Pravika does not teach on measuring levodopa and metabolite levels of monoamines in the sub-cutaneous interstitial liquid of said patients. Examiner directs Applicant to § A. Oral Route on p. 679 and § B. Daily routines with PDP on p. 699 col 2 - p. 700 col 2 demonstrating a graphic of “blood plasma level of levodopa” measured from a patient throughout a day.
Applicant has not addressed the double patenting rejection on the record. As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. Therefore, an application must not be allowed unless the required compliant terminal disclaimer is filed and/or the withdrawal of the nonstatutory double patenting rejection is made of record by the examiner (see MPEP § 804.02 (IV) for filing terminal disclaimers required to overcome nonstatutory double patenting rejections in applications filed on or after June 8, 1995). Therefore, the Examiner has updated the provisional nonstatutory double patenting rejection to reflect the amendments made to the claims.
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 extension fee 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 JORDAN JACKSON whose telephone number is (571) 272-5389 and fax number is (571) 273-1626. The examiner can normally be reached on Monday – Thursday, 6:30 AM - 4:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long, can be reached on (571) 270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JORDAN L JACKSON/Primary Examiner, Art Unit 3682