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
In the amendment filed 08/04/2026, the following has occurred: claims 1, 3, 6, 8, 11, and 13 have been amended and claims 2, 5, 7, 10, 12, and 15 have been canceled. Now, claims 1, 3-4, 6, 8-9, 11, and 13-14 are pending.
Claim Objections
Claim 3 is objected to because of the following informalities: in the marked-up amendment of claim 3, the language of both “Claim 1” and “Claim 2” are struck through, leaving claim 3 to recite “The physician system as set forth in, further comprising…” This appears inadvertent and the “Claim 1” language should be underlined, adding it to the recitation of claim 3. Appropriate correction is required.
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 1, 3-4, 6, 8-9, 11, and 13-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,478,558 in view of Kimmel, US Patent Application Publication No. 2022/0131699. Although the claims at issue are not identical, they are not patentably distinct from each other because each of the limitations recited in claims 1, 3-4, 6, 8-9, 11, and 13-14 of the instant application are included in claims 1-12 of the ‘558 patent. The differences are found in additional limitations recited in the ‘558 patent. Additionally, claims 1-12 of the ‘558 patent do not recite the “pushing the dose schedule” to be “upon linking with the patient system.” Kimmel teaches upon linking with the patient system, pushing the dose schedule to the patient system (see paragraph 0087; communicates schedules for dispensing of the drug with a communication link between the patient and medication dispensing device). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to add the “upon linking” recitation to the “pushing” step in claims 1-15 of the ‘558 patent with the motivation of improving authorized use of the dispensing device (see paragraph 0005 of Kimmel).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3-4, 6, 8-9, 11, and 13-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 2A Prong One
Claims 1, 6, and 11 (claim 1 representative) recite registering a patient under the care of a doctor; recording a dose schedule for the patient, the dose schedule having parameters specifying a particular medication and associated volume and timing interval for administration to the patient via a medication dispensing device; associating a medication cartridge with the dose schedule, the medication cartridge operable for dispensing the particular medication from the medication dispensing device; generating an invitation link for the patient to link the physician system with a patient system and the medication dispensing device; and upon linking with the patient system, pushing the dose schedule to the patient system; wherein in pushing the dose schedule to the patient system, the medication dispensing device is unlocked to activate within the parameters of the dose schedule; and receiving notifications regarding patient adherence and providing an alert to the doctor when the patient fails to adhere to the dose schedule.
These limitations, as drafted, given the broadest reasonable interpretation, but for the recitation of generic computer components, encompass managing interactions between people, which is a subgrouping of Certain Methods of Organizing Human Activity. For example, the claim encompasses manually registering a patient, manually recording a dose schedule for the registered patient, manually associating, carried out by the patient or doctor, a medication cartridge with the dose schedule, manually inviting the patient to link with the physician system and medication device, manually sending the schedule to the patient after linking, and notifying a doctor the patient has not adhered to the dose schedule. While it is acknowledged that the above identified steps include recitations of “a medication dispensing device” and “a medication cartridge,” these structural elements only define manual information processing steps (e.g. recording, associating, generating an invitation). These structural elements are not recited as physical components of the system, executing any of the functions. Further the claims recite the “the medication dispensing device is unlocked,” but do not recite a step or function of physically unlocking the device or that any of the recited functions or steps cause the unlocking. Therefore, but for the recitation of generic computer components, such manual steps encompass Certain Methods of Organizing Human Activity.
Claims 3-4, 7-10, and 12-15 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea, but for the recitation of generic computer components. For example, claims 2-5, 8-9, and 13-14 further expand on modifying and sending the medication dose schedule. Again, the recitation of “a medication dispensing device” is part of the abstract idea, as explained above. Therefore, these manual steps similarly encompass Certain Methods of Organizing Human Activity.
Step 2A Prong Two
This judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract ideas.
Claims 1 and 3-4, directly or indirectly, recite the following generic computer components configured to implement the abstract idea: “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.”
Claims 6 and 8-9, directly or indirectly, recite the following generic computer components configured to implement the abstract idea: “a non-transitory computer-readable medium having executable instructions encoded thereon, such that upon execution of the instructions by one or more processors, the one or more processors perform operations.”
Claims 11 and 13-14, directly or indirectly, recite the following generic computer components configured to implement the abstract idea: “causing one or more processers to execute instructions encoded on a non-transitory computer-readable medium, such that upon execution, the one or more processors perform operations.”
The written description discloses that the recited computer components encompass generic components including “The system is typically in the form of a computer system operating software or in the form of a “hard-coded” instruction set. This system may be incorporated into a wide variety of devices that provide different functionalities” (see paragraph 00072). As set forth in the MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application.
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as discussed above with respect to integration into a practical application, the additional elements are recited at a high level of generality, and the written description indicates that these elements are generic computer components. Using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.”).
Additionally, the aforementioned additional elements, considered in combination, do not provide an improvement to a technical field or provide a technical improvement to a technical problem. Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-4, 6, 8-9, 11, and 13-14 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Kimmel, US Patent Application Publication No. 2022/0131699.
As per claim 1, Kimmel teaches a physician system for interfacing with and controlling a medication dispensing device, the system comprising: one or more processors and associated memory, the memory being a non-transitory computer-readable medium having executable instructions encoded thereon (see paragraph 0009; computer program product for implementing the system and method), such that upon execution of the instructions, the one or more processors perform operations of: registering a patient under the care of a doctor (see paragraph 0087; initial authentication and enrollment of the user; paragraph 0037 describe patient being under the care of a doctor); recording a dose schedule s for the patient, the dose schedule having parameters specifying a particular medication and associated volume and timing interval for administration to the patient via a medication dispensing device (see paragraph 0046; defined schedule of times and dosages for dispensing a drug by a device on a dose-by-dose basis); associating a medication cartridge with the dose schedule, the medication cartridge operable for dispensing the particular medication from the medication dispensing device (see paragraph 0087; a replaceable cartridge for dispensing the drug is associated with the dispensing device); generating an invitation link for the patient to link the physician system with a patient system and the medication dispensing device (see paragraph 0087; the downloaded app is encompassed by the generated invitation because it links the patient and medication dispensing device, which is also linked to the prescribing physician through the network-connection); and upon linking with the patient system, pushing the dose schedule to the patient system (see paragraph 0087; communicates schedules for dispensing of the drug with a communication link between the patient and medication dispensing device); wherein in pushing the dose schedule to the patient system, the medication dispensing device is unlocked to activate within the parameters of the dose schedule (see paragraph 0221; automatically unlocking the device to authorize a dose); and receiving notifications regarding patient adherence and providing an alert to the doctor when the patient fails to adhere to the dose schedule (see paragraph 0286; user compliance is monitored for each dose delivery and communicated to a physician to follow up and ensure patient compliance receiving substance).
As per claim 3, Kimmel teaches the system of claim 1 as described above. Kimmel further teaches operations of modifying the dose schedule for the patient to generate a modified dose schedule and pushing the modified dose schedule to the patient system associated with the patient (see paragraph 0036; communicates dosage adjustment to the mediation device).
As per claim 4, Kimmel teaches the system of claim 3 as described above. Kimmel further teaches in pushing the modified dose schedule to the patient system, the medication device is activated to dispense a medication dose if the medication dose is within the modified dose schedule (see paragraph 0210; transmits control information permitting dispensing of the dosage of medication).
Claims 6, 8-9, 11, and 13-14 recite substantially similar computer program product and method limitations as system claims 1 and 3-4 and, as such, are rejected for similar reasons as given above.
Response to Arguments
In the remarks filed 08/04/2026, Applicant argues (1) the amendments to the claims patentably distinguish over the claims of US Patent No. 12,478,558; (2) the abstract idea is integrated into a practical application by unlocking a medication dispensing device per a dose schedule and alerting a doctor when a patient fails to adhere to the dose schedule; (3) Kimmel does not teach only pushing a dose schedule to a patient system upon linkage and monitoring patient adherence to the dose schedule.
Applicant’s argument (1) is moot in view of the updated double patenting rejections set forth above.
In response to argument (2), as noted in the updated 101 rejections, the claims do not require the physical unlocking of the medical device. The relevant recitation is “wherein in pushing the dose schedule to the patient system, the medication dispensing device is unlocked to activate within the parameters of the dose schedule.” The claimed recitation describes the devices being in an “unlocked” state in some undefined relation to the “pushing” of the dose schedule. For example, the device could be unlocked by a user after the schedule is pushed. Additionally, the recitation of “to activate within the parameters of the dose schedule,” defines an intended use of the device. Because these broad recitations do not require any physical operations of the device, this recitation is part of the abstract idea.
Regarding alerting a doctor when a patient fails to adhere to the dose schedule, this is a step that could be carried out manually between healthcare providers and a patient receiving care. These manual steps are part of the Certain Methods of Organizing Human Activity grouping of abstract ideas and do not integrate the abstract idea into a practical application.
In response to argument (3), as described at paragraph 0087, the system requires the user to download an app to initiate communication between the app and the device, including for defining operating parameters that further include schedules for dispensing the drug. Therefore, the pushing of the dose schedule occurs “upon linking.” Additionally, Kimmel des describes “user compliance can be monitored for a device…” and “failure to communicate such compliance information results in the device being flagged to allow…a physician to follow up…” Therefore, the examiner respectfully submits that Kimmel teaches the monitoring of patient adherence.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to C. Luke Gilligan whose telephone number is (571)272-6770. The examiner can normally be reached Monday through Friday 9:00 - 5:00.
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C. Luke Gilligan
Primary Examiner
Art Unit 3683
/CHRISTOPHER L GILLIGAN/ Primary Examiner, Art Unit 3683
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