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 .
DETAILED ACTION
Priority
Acknowledgement is made of applicant’s claim to priority under 35 U.S.C. 120, 121, 365(c), or 386(c) and 37 CFR 1.78 for a continuing application, which claims priority to U.S. Application 18/614,062 filed 03/22/2024.
Response to Amendment
In the amendment dated 10/14/2025, the following occurred: Claims 1, 3, 8, 10-15 and 17-20 have been amended; and claims 2, 9 and 16 have been cancelled.
Claims 1, 3-8, 10-15 and 17-20 are pending and have been examined.
Information Disclosure Statement
The Information Disclosure Statements (IDS)(s) submitted on 01/22/2026 are in compliance with the provisions of 37 CFR 1.97 and have been fully considered by the Examiner.
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.
Claim 8 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claim 8 recites “the computer program product”, which now lacks antecedent basis. The Examiner suggests amending to recite “[[the computer program product]] the computer readable-medium”. Appropriate correction is required.
Double Patenting – Manual of Patent Examining Procedure § 804
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this 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 §§ 706.02(1)(1) -706.02(1)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-l.jsp.
Claims 1, 3-8, 10-15 and 17-20 are rejected on the grounds of non-statutory double patenting over claims 1, 3-8, 10-15 and 17-20 of U.S. Patent No. 12/347,541 issued for parent Application No. 18/614,062.
Claims 1, 8 and 15 recite substantially similar limitations to claims 1, 8 and 15 of U.S. Patent No. 12/347,541. The subject matter in the instant application amounts to claims which are generally broader scope. The issued patent merely adds narrowing limitations upon the limitations recited in both cases (e.g., parameters specifying a particular medication and an associated volume and timing interval for administration, a handheld medication dispensing device, housing with a rotatable cartridge carrier, rotates the cartridge carrier to move the medication cartridge with the cartridge carrier).
Dependent claims 3-7, 10-14 and 17-20 recite similar limitations to dependent claims 3-7, 10-14 and 17-20 of the issued patent and are also rejected as being obvious variations of the claims of the ‘221 application.
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.
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.
Claims 1, 7-8, 14-15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Abadi et al. (US 2023/0065458 A1; “Abadi” herein) in view of The John Hopkins University (WO 2022/165349 A1; “JHU” herein), Brown (US 2003/0046090 A1), Kimmel et al. (US 2022/0131699 A1; “Kimmel” herein), and Dejonge (US 2021/0225503 A1).
Re. Claim 1, Abadi teaches a caregiver system for interfacing with and controlling a medication dispensing device (Abstract teaches healthcare providers HCPs may render oversight and control over the patient medication self-administration device and its use to mitigate risks associated with patients self-administering medication. See Applicant’s disclosure at para. 6-7), the system comprising: one or more processors […], the one or more processors perform operations of (Figs. 5A-5B, [34]-[35], [73] teach remotely generated control signals 590 generated by HCP 592 terminal 557 (processor) manage the operation of device 500… For HCP to remotely monitor patient and control device 500, embodiments of system 501 include HCP interface program 566… executing on server 562 (processor) and accessible via a web-based portal by physician via terminal 557):
[…] (Fig. 10, [73] teach embodiments of system 501 include HCP interface program 566 executing on terminal 557 or executing on server 562 and accessible via a web-based portal used by the physician (necessarily registered).);
providing the caregiver a list of one or more patients under the caregiver's care and associated medication dose schedules for each of the one or more patients (Fig. 11A, [200] teach a tabular list of overseen patients… list 1194 indicates each patient’s next dose time as well as other prescription information (medication dose schedules). Also, Fig. 11A, [200] teach to the left of the list of patients 1194 are control buttons 1153, which can be used to quickly create a new prescription. Also, Fig. 11B, 11D, [214]-[215] teach a patient settings page 1100D including a tool / options to create the new prescription 1174 with a specified dose and schedule.);
modifying the dose schedule for at least one of the one or more patients to generate a modified dose schedule, each modified dose schedule having […] (Fig. 7, [157] teach adjusting treatment through the HCP interface 566… modifications for all patients, a subset or a single patient experience, e.g., modification of the dose schedule 547. See also [50], [67], [116].);
pushing […] to a patient system associated with a medication dispensing device (Fig. 5B, 7, [32], [152] teach all system 501 devices, e.g., patient terminal 568 (patient system) and device 500 (medication dispensing device), are paired with one another through server 562. Fig. 5B, [71] teaches instructions to display notices are transmitted (pushing information) to patient self-management interface 570 on the patient terminal 568 by patient management software 561 executing on server 562. Fig. 5A, [34]-[35], [67] teach patient management software 561 executing on server 562 transmits data to device 500, e.g., modifications to the dose schedule 547.), the medication dispensing device having a housing and a medication cartridge stored therein, the medication cartridge containing the particular medication (Fig. 3, [0117]-[0118] teach the medication delivery device 300 is configured to provide an administered dose 382 of prescribed (particular) medication; and regulated subassembly 306 has a set of independent cartridges 308 each configured to store at least a single dose of prescribed medication.); and
wherein in pushing the modified dose schedule to the patient system, the patient system […] (see previous citations.)
Abadi does not explicitly teach pushing the modified dose schedule to the patient system.
However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the noted features of Abadi with teachings thereof, since the combination is merely combining prior art elements according to known methods to yield predictable results (KSR rationale A). It can be seen that each element claimed is present in Abadi. Providing transmission technology (as taught by Abadi) does not change or affect the normal communication-related functionality of Abadi. Utilizing the system 501 to transmit control signals to the medication self-administration device 500 would be performed the same way even with the addition of sending device-related information to other system components such as the patient terminal. Since the functionalities of the elements in Abadi do not interfere with each other, the results of the combination would be predictable.
Abadi does not explicitly teach
one or more processors and associated memory, the memory being a non-transitory computer-readable medium having executable instructions encoded thereon, such that upon execution of the instructions, the one or more processors perform operations.
JHU teaches
one or more processors and associated memory, the memory being a non- transitory computer-readable medium having executable instructions encoded thereon, such that upon execution of the instructions, the one or more processors perform operations (see Abstract, [0005]. See additionally [41]-[43].)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the system and method for utilization of data from remote regulation and monitoring of drug delivery of Abadi to describe computing resource components and to use this information as part of a smart pill dispenser as taught by JHU, with the motivation of improving prescription medication management with regulated dispensing, e.g., reducing misuse, diversion, and pilfering (see JHU at Abstract).
The Examiner notes that Kimmel also teaches this feature at Fig. 12, [9], [224], [270] and the need for JHU will be reevaluated should the Applicant proceed with prosecution.
Abadi may not explicitly teach registering a caregiver.
Brown teaches registering a caregiver (Fig. 2, [0128]-[130] teach New CareGiver Registration.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the system and method for utilization of data from remote regulation and monitoring of drug delivery of Abadi/JHU to register a user as taught by Brown, with the motivation of improving patient compliance with a medical program / improving health maintenance (see Brown at para. 0001, 0003, and 0024).
Abadi/JHU/Brown may not teach
each modified dose schedule having parameters specifying a particular medication and administration;
the patient system unlocks the medication dispensing device to allow the medication dispensing device to activate within the parameters of the modified dose schedule, such that in activating within the parameters of the modified dose schedule, an activator mechanism in the medication dispensing device is activated to move the medication cartridge from a stored position to a dispensing position in which at least a portion of the medication cartridge is raised from the housing and at least partially exposed beyond the housing for actuation by the patient.
Kimmel teaches
associated memory, the memory being a non-transitory computer-readable medium having executable instructions encoded thereon, such that upon execution of the instructions, the one or more processors perform operations (Fig. 12, [9], [224], [270] teach a tangible computer program product for implementing the system and method);
each modified dose schedule having parameters specifying a particular medication and administration ([46] teaches a defined schedule of times and dosages, which can be adjusted based on feedback data, for dispensing a drug by a device.);
the patient system unlocks the medication dispensing device to allow the medication dispensing device to activate within the parameters of the modified dose schedule, such that in activating within the parameters of the modified dose schedule, […] ([87] teaches a downloadable app that a user downloads onto a smart phone or PC (Abadi’s patient terminal)… and which then communicates with a device by any communication means supported by the smart phone and the device… direct communication between the app and the device to define operating conditions (parameters), e.g., authorized doses, schedules for dispensing of the drug (Abadi’s modified dose schedule 547), and authorized locations for use of the device. Figs. 3-4, [221] teach authenticating the user of the device (medication dispensing device), thus automatically unlocking the device to authorize a dose in a single seamless action. Figs. 3-5 teach release/delivery/dispensation (necessitates activating).)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the system and method for utilization of data from remote regulation and monitoring of drug delivery of Abadi/JHU/Brown to define dose schedules, communicate between a smart phone and a device (104), control unlocking of the device, dispense a drug, and monitor patient compliance and to use this information as part of a system and method for monitoring and controlling high risk substances as taught by Kimmel, with the motivation of improving dosage safety and efficacy as well as improving user oversight for controlled self-medication (see Kimmel at para. 89 and 328-346).
Abadi/JHU/Brown/Kimmel may not teach the patient system unlocks the medication dispensing device to allow the medication dispensing device to activate within the parameters of the modified dose schedule, such that in activating within the parameters of the modified dose schedule, an activator mechanism in the medication dispensing device is activated to move the medication cartridge from a stored position to a dispensing position in which at least a portion of the medication cartridge is raised from the housing and at least partially exposed beyond the housing for actuation by the patient.
Dejonge teaches
an activator mechanism in the medication dispensing device is activated to move the medication cartridge from a stored position to a dispensing position in which at least a portion of the medication cartridge is raised from the housing and at least partially exposed beyond the housing for actuation by the patient (Abstract, [22] teach a dispenser that includes a cartridge receiver being positioned for alignment of a multi-unit medication cartridge… and a control gate mechanism lock connected… to a medication release control gate to permit or prohibit activation of the gate for medication dosage release. Fig. 14D, [63], [66] teach loading a pill into an outlet chamber of the mechanical gate 453 (the medication cartridge), mechanical gate is moved, medication detecting sensor determines the user has properly moved a med unit into the gate outlet chamber 467, the unit energizes the cartridge solenoid to unlock the gate mechanism 451 (the activator mechanism is activated), and the user moves the mechanical gate to the dispense position 455 (from the stored position). Fig. 6 and [53] teach, because the locking solenoid and piston is in the unlocked position, the user is able to slide the gate 31 further down so that pill 44 is properly aligned with the exit outlet 39. Fig. 7 and [53] teach the pill 44 moves to the outlet 39 and is dumped out for consumption. Fig. 10 and [51]-[52] teach that the gate 31 slides to its dispensing position to release the medication dosage (in which at least a portion of the medication cartridge is raised from the housing and at least partially exposed beyond the housing); and the gate 31 may optionally carry a legend, such as “SLIDE HERE” with an arrow, to show the patient which part to move for dispensing.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the system and method for utilization of data from remote regulation and monitoring of drug delivery of Abadi/JHU/Brown/Kimmel to implement a medication cartridge gate control mechanism or lock of a medication dispensing device to permit or prohibit activation of the medication cartridge gate for medication dosage release and to use this information as part of a programmable, refillable medication package with scheduled metered dispensing as taught by Dejonge, with the motivation of improving patient care related to medication distribution/release devices (see Dejonge, e.g., at para. 2).
Re. Claim 7, Abadi/JHU/Brown/Kimmel/Dejonge teaches the caregiver system as set forth in Claim 1, further comprising an operation of recording notes regarding at least one of the one or more patients for viewing by a user of an associated doctor portal system (Abadi Figs. 5B, 6G, 10, [141], [189] teaches a health checkup form 623 provides information to help the patient’s doctor optimize their treatment… a free response comment section 641 is supplied to allow patients to give any feedback (record notes). Also, Abadi Fig. 10, [73] teaches an HCP terminal 557 (doctor portal system); and Brown Fig. 16 teaches a nurse entering clinical notes on a screen (an associated doctor portal system), and the notes are viewed and saved (recorded). The Examiner notes that “for viewing…” is an intended use of “recording notes…”, which is not required for the claim to be met.)
Re. CLAIM 8, the subject matter of claim 8 is essentially defined in terms of a manufacture, which is technically corresponding to system claim 1. Since claim 8 is analogous to claim 1, it is similarly analyzed and rejected in a manner consistent with the rejection of claim 1.
Re. CLAIM 14, the subject matter of claim 14 is essentially defined in terms of a manufacture, which is technically corresponding to system claim 7. Since claim 14 is analogous to claim 7, it is similarly analyzed and rejected in a manner consistent with the rejection of claim 7.
Re. CLAIM 15, the subject matter of claim 15 is essentially defined in terms of a method, which is technically corresponding to system claim 1. Since claim 15 is analogous to claim 1, it is similarly analyzed and rejected in a manner consistent with the rejection of claim 1.
Claims 3-6, 10-13 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Abadi in view of JHU, Brown and Clarke et al. (US 2021/0257068 A1; “Clarke” herein).
Re. Claim 3, Abadi/JHU/Brown/Kimmel/Dejonge teaches the caregiver system as set forth in Claim 1, further comprising an operation of […] authentication information regarding at least one of the one or more patients (Abadi [176] teaches patient input data 994 is any data input into system 501 directly by the patient, for example via the data collection features 586 on patient interface 570 / companion app 573, and may include input biometrics 537, input feedback 523, and may collect user identification data such as authentication confirmations through a password, fingerprint sensor, or camera… including, for example, data input as a prerequisite to administer a dose.)
Abadi/JHU/Brown/Kimmel/Dejonge may not teach modifying authentication information.
Clarke teaches modifying authentication information (see Applicant’s disclosure at para. 144. [60]-[70] teach creating a patient’s profile… adding (editing) a fingerprint (new patient only)… add and store picture (new patient only)… once done, save and transfer the record. Abstract, [12] teach the fingerprint reader is used to authenticate its owner’s identity.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the system and method for utilization of data from remote regulation and monitoring of drug delivery of Abadi/JHU/Brown/Kimmel/Dejonge to add user identification data to a system user profile/record and to use this information as part of a device using a fingerprint reader to authenticate a user’s identity as taught by Clarke (see Abstract and para. 12), with the motivation of improving patient care and device pairing (see Clarke at Abstract and para. 0001, 0011-0013).
Re. Claim 4, Abadi/JHU/Brown/Kimmel/Dejonge/Clarke teaches the caregiver system as set forth in Claim 3, wherein modifying authentication information regarding at least one of the one or more patients includes editing a fingerprint record (see Applicant’s disclosure at para. 144. Clarke [60]-[70] teaches creating a patient’s profile… adding (editing) a fingerprint (new patient only)… add and store picture (new patient only)… once done, save and transfer the record. Clarke Abstract, [12] teaches the fingerprint reader is used to authenticate its owner’s identity. The Examiner interprets adding and/or saving a fingerprint to the patient record as editing a fingerprint record.)
Re. Claim 5, Abadi/JHU/Brown/Kimmel/Dejonge/Clarke teaches the caregiver system as set forth in Claim 4, further comprising an operation of recording notes regarding at least one of the one or more patients for viewing by a user of an associated doctor portal system (Abadi Figs. 5B, 6G, 10, [141], [189] teaches a health checkup form 623 provides information to help the patient’s doctor optimize their treatment… a free response comment section 641 is supplied to allow patients to give any feedback (record notes). Also, Abadi Fig. 10, [73] teaches an HCP terminal 557 (doctor portal system); and Brown Fig. 16 teaches a nurse entering clinical notes on a screen (an associated doctor portal system), and the notes are viewed and saved (recorded). The Examiner notes that “for viewing…” is an intended use of “recording notes…”, which is not required for the claim to be met.)
Re. Claim 6, Abadi/JHU/Brown/Kimmel/Dejonge teaches the caregiver system as set forth in Claim 1, further comprising an operation of […] authentication information regarding at least one of the one or more patients (Abadi [176] teaches patient input data 994 is any data input into system 501 directly by the patient, for example via the data collection features 586 on patient interface 570 / companion app 573, and may include input biometrics 537, input feedback 523, and may collect user identification data such as authentication confirmations through a password, fingerprint sensor, or camera… including, for example, data input as a prerequisite to administer a dose.)
Abadi/JHU/Brown/Kimmel/Dejonge may not teach modifying authentication information.
Clarke teaches modifying authentication information (see Applicant’s disclosure at para. 144. [60]-[70] teach creating a patient’s profile… adding (editing) a fingerprint (new patient only)… add and store picture (new patient only)… once done, save and transfer the record. Abstract, [12] teach the fingerprint reader is used to authenticate its owner’s identity.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the system and method for utilization of data from remote regulation and monitoring of drug delivery of Abadi/JHU/Brown/Kimmel/Dejonge to add user identification data to a system user profile/record and to use this information as part of a device using a fingerprint reader to authenticate a user’s identity as taught by Clarke (see Abstract and para. 12), with the motivation of improving patient care and device pairing (see Clarke at Abstract and para. 0001, 0011-0013).
Re. CLAIM 10, the subject matter of claim 10 is essentially defined in terms of a manufacture, which is technically corresponding to system claim 3. Since claim 10 is analogous to claim 3, it is similarly analyzed and rejected in a manner consistent with the rejection of claim 3.
Re. CLAIM 11, the subject matter of claim 11 is essentially defined in terms of a manufacture, which is technically corresponding to system claim 4. Since claim 11 is analogous to claim 4, it is similarly analyzed and rejected in a manner consistent with the rejection of claim 4.
Re. CLAIM 12, the subject matter of claim 12 is essentially defined in terms of a manufacture, which is technically corresponding to system claim 5. Since claim 12 is analogous to claim 5, it is similarly analyzed and rejected in a manner consistent with the rejection of claim 5.
Re. CLAIM 13, the subject matter of claim 13 is essentially defined in terms of a manufacture, which is technically corresponding to system claim 6. Since claim 13 is analogous to claim 6, it is similarly analyzed and rejected in a manner consistent with the rejection of claim 6.
Re. CLAIM 17, the subject matter of claim 17 is essentially defined in terms of a method, which is technically corresponding to system claim 3. Since claim 17 is analogous to claim 3, it is similarly analyzed and rejected in a manner consistent with the rejection of claim 3.
Re. CLAIM 18, the subject matter of claim 18 is essentially defined in terms of a method, which is technically corresponding to system claim 4. Since claim 18 is analogous to claim 4, it is similarly analyzed and rejected in a manner consistent with the rejection of claim 4.
Re. CLAIM 19, the subject matter of claim 19 is essentially defined in terms of a method, which is technically corresponding to system claim 5. Since claim 19 is analogous to claim 5, it is similarly analyzed and rejected in a manner consistent with the rejection of claim 5.
Response to Arguments
Drawing Objections
Regarding the drawing objection(s), the Applicant has submitted replacement sheets to overcome the drawing objections, hereby withdrawn.
Claim Objections
Regarding the claim objection(s), the Applicant has canceled or amended the claims to obviate or overcome the claim objections, hereby withdrawn.
Rejections under 35 U.S.C. §112(b)
Regarding the rejections, the Applicant has cancelled or amended the claims to obviate or overcome the previous issues of indefiniteness; however, the amended claim 8 causes a new issue.
Double Patenting
Regarding the rejections, the Applicant may be attempting to table the discussion of a terminal disclaimer until later on in the prosecution. The Examiner respectfully encourages the Applicant to file a terminal disclaimer as the Applicant is attempting to secure broader claims than the issued parent claims. Applicant has not provided any evidence to the contrary.
Rejections under 35 U.S.C. §101
Regarding the rejection of Claims 1-20, the Applicant has cancelled Claims 2, 9 and 16, rendering the rejection of those claims moot.
Regarding the remaining claims 1, 3-8, 10-15 and 17-20, the Applicant has amended the claims to recite “modifying the dose schedule for at least one of the one or more patients to generate a modified dose schedule, each modified dose schedule having parameters specifying a particular medication and administration; pushing the modified dose schedule to a patient system associated with a medication dispensing device, the medication dispensing device having a housing and a medication cartridge stored therein, the medication cartridge containing the particular medication; and wherein in pushing the modified dose schedule to the patient system, the patient system unlocks the medication dispensing device to allow the medication dispensing device to activate within the parameters of the modified dose schedule, such that in activating within the parameters of the modified dose schedule, an activator mechanism in the medication dispensing device is activated to move the medication cartridge from a stored position to a dispensing position in which at least a portion of the medication cartridge is raised from the housing and at least partially exposed beyond the housing for actuation by the patient” (emphasis added) (Claim 15 being representative).
The patient system unlocking the medication dispensing device to allow the medication dispensing device to activate within the parameters of the modified dose schedule, as drafted, provides a practical application under subject eligibility analysis step 2A2, since the patient system uses the modified dose schedule to control the medication dispensing device, i.e., to cause the medication dispensing device to undergo a physical configuration change. Note: Pairing the recitation of “… to allow…” with the recitation of “such that in activating…” was considered of utmost importance to the eligibility of method claim 15.
Rejection under 35 U.S.C. §103
Regarding the rejection of Claims 1-20, the Applicant has cancelled Claims 2, 9 and 16, rendering the rejection of those claims moot. Regarding the remaining claims 1, 3-8, 10-15 and 17-20, the Examiner has considered the Applicant’s arguments but does not find them persuasive for at least the following reasons. Applicant argues:
F1. “the Applicant directs the Examiner to Currently Amended Claims 1, 8 and 15, which have been amended, in part, to require… Such limitations are not found in the cited prior art and, as such, the cited prior fails to teach each element as required to sustain a Section 103 rejection” (Remarks, pgs. 13-14).
Re. argument F1: The Examiner respectfully submits the basis of rejection as necessitated by amendment. Given the broadest reasonable interpretation (BRI), Abadi in view of JHU, Brown, Kimmel, Dejonge and/or Clarke teach or render obvious the recited claim features.
Regarding the rejection of dependent claims 3-7, 10-14 and 17-20, the Applicant has not offered any arguments with respect to these claims other than to reiterate the argument(s) present for the claim(s) from which they depend. As such, the rejection of these claims is also respectfully maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Arric et al. (US 2019/0392936 A1) for teaching the recited “caregiver system for interfacing with and controlling a medication dispensing device” (see Fig. 19A); “providing the caregiver a list of one or more patients under the caregiver's care” (see Fig. 14); “and associated medication dose schedules for each of the one or more patients” (see Fig. 15A); “modifying the dose schedule for at least one of the one or more patients to generate a modified dose schedule” (see Fig. 16A); “pushing the modified dose schedule to a patient system associated with a medication dispensing device” (see Fig. 27); “an associated doctor portal system” (see Fig. 14).
Lam (US 2019/0282450 A1) for teaching the recited “and associated medication dose schedules for each of the one or more patients” and “modifying the dose schedule for at least one of the one or more patients to generate a modified dose schedule” (see para. 0076-0077). See also Abstract.
Poutiatine et al. (US 2007/0186923 A1) for teaching the recited “a patient system associated with a medication dispensing device” (see Figs. 22A, 24); “modifying authentication information regarding at least one of the one or more patients” (see Fig. 24, para. 0271); “an associated doctor portal system” (see Fig. 22A).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jessica M Webb whose telephone number is (469)295-9173. The examiner can normally be reached Mon-Fri 9:00am-1:00pm CST.
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/J.M.W./Examiner, Art Unit 3683
/CHRISTOPHER L GILLIGAN/Primary Examiner, Art Unit 3683