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 .
Claim Objections
Claim 1 is objected to because of the following informalities: “Biguanide” in line 30 of claim 1 should read as “biguanide”. 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.
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Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,251,242 in view of Haq et al. (“Comparative Review of Drugs Used in Diabetes Mellitus – New and Old” – 2021).
Regarding claim 1, the US Patent teaches a method for management of type 2 diabetes comprising:
receiving, from a practitioner user via a first client device, a plurality of user-generated inputs comprising a plurality of clinical parameters for management of type 2 diabetes in a patient,
wherein the plurality of clinical parameters comprise at least one dosage amount and at least one dosage frequency for a glucagon-like peptide 1 (GLP-1) agonist drug in a GLP-1 agonist drug regimen,
wherein the plurality of clinical parameters comprise at least one blood sugar or hemoglobin A1C range for the patient;
configuring, with at least one server communicably engaged with the first client device, a clinical algorithm for the GLP-1 agonist drug regimen for the patient according to the plurality of user-generated inputs,
wherein the clinical algorithm comprises parameters for titrating the at least one dosage amount and modifying the at least one dosage frequency for the GLP-1 agonist drug in the GLP-1 agonist drug regimen according to the at least one blood sugar or hemoglobin A1C range for the patient;
configuring, with the at least one server, a conversational Al model according to the clinical algorithm,
wherein the conversational Al model comprises a large language model configured to drive a plurality of generative text-to-speech outputs of a conversational agent;
receiving, with the at least one server, a first set of blood sugar or hemoglobin A1C data for the patient;
outputting, with the conversational agent, a first generative voice prompt to the patient according to the conversational Al model, wherein the first generative voice prompt comprises a medication log prompt for the GLP-1 agonist drug regimen,
wherein the conversational agent comprises a smart speaker communicably engaged with the at least one server via a network interface;
receiving, with the conversational agent, a first voice input from the patient in response to the first generative voice prompt, wherein the first voice input comprises a first set of medication log data for the GLP-1 agonist drug for the patient;
processing, with the at least one server, the first set of medication log data for the GLP-1 agonist drug for the patient and the first set of blood sugar or hemoglobin A1C data for the patient according to the clinical algorithm;
titrating the dosage amount and/or modifying the dosage frequency of the GLP-1 agonist drug for the patient in response to processing the first set of medication log data for the GLP-1 agonist drug for the patient and the first set of blood sugar or hemoglobin A1C data according to the clinical algorithm;
configuring, with the at least one server, a second generative voice prompt according to the conversational Al model, wherein the second generative voice prompt comprises a dosage instruction for the GLP-1 agonist drug regimen for the patient,
wherein the dosage instruction comprises the titrated dosage amount and/or the modified dosage frequency for the GLP-1 agonist drug according to the clinical algorithm;
outputting, with the conversational agent, the second generative voice prompt to the patient; and
administering, by the patient, a dose of the GLP-1 agonist drug to the patient in accordance with the dosage instruction provided by the second generative voice prompt.
The US Patent teaches all of the elements of the current invention as mentioned above except for wherein the GLP-1 agonist drug in the GLP-1 agonist drug regimen is a biguanide drug in a biguanide drug regimen.
Haq et al. teaches that biguanides and GLP-1s are types of drugs that can be used to treat type 2 diabetes (page 117). Biguanides are widely used in diabetes mellitus type 2 (page 119). GLP-1 is also suitable for DM type 2 (page 120).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted biguanide drug in a biguanide drug regimen of Haq et al. for the GLP-1 agonist drug in the GLP-1 agonist drug regimen of the US Patent as Haq et al. teaches that both biguanide and GLP-1 can be used for diabetes mellitus type 2.
Regarding claim 2, the US Patent teaches establishing a data transfer interface between a continuous glucose monitor device or a glucometer for the patient and the at least one server (claim 2).
Regarding claim 3, the US Patent teaches receiving, with the at least one server, the first set of blood sugar or hemoglobin A1C data for the patient via the continuous glucose monitor device or the glucometer (claim 3).
Regarding claim 4, the US Patent, as modified by Haq et al., teaches outputting, with the conversational agent, a third generative voice prompt according to the conversational Al model, wherein the third generative voice prompt comprises a medication log prompt for the biguanide drug regimen for a subsequent specified time period (claim 4);
receiving, with the conversational agent, a second voice input from the patient in response to the third generative voice prompt, wherein the second voice input comprises a second set of medication log data for the patient for the subsequent specified time period (claim 4); and
recording, with the at least one server, the second set of medication log data for the patient according to the second voice input (claim 4).
Regarding claim 5, the US Patent teaches receiving, with the at least one server, a second set of blood sugar or hemoglobin A1C data for the patient (claim 5); and
analyzing, with the at least one server, the second set of blood sugar or hemoglobin A1C data and the second set of medication log data for the patient according to the clinical algorithm (claim 5).
Regarding claim 6, the US Patent, as modified by Haq et al., teaches calculating, according to the clinical algorithm, a subsequently titrated dosage amount and/or a subsequently modified dosage frequency for the biguanide drug for the patient according to the second set of medication log data for the biguanide drug for the patient for the subsequent specified time period and the second set of blood sugar or hemoglobin A1C data for the patient for the subsequent specified time period.
Regarding claim 7, the US Patent teaches outputting, with the conversational agent, a fourth generative voice prompt according to the conversational Al model, wherein the fourth generative voice prompt comprises a check-in prompt for the patient (claim 11).
Regarding claim 8, the US Patent, as modified by Haq et al., teaches configuring, with the at least one server, a fourth generative voice prompt according to the conversational Al model, wherein the fourth generative voice prompt comprises a subsequent dosage instruction for the biguanide drug regimen for the patient (claim 7).
Regarding claim 9, the US Patent, as modified by Haq et al., teaches wherein the subsequent dosage instruction comprises the subsequently titrated dosage amount and/or the subsequently modified dosage frequency for the biguanide drug according to the clinical algorithm (claim 8).
Regarding claim 10, the US Patent teaches outputting, with the conversational agent, the fourth generative voice prompt to the patient (claim 9).
Regarding claim 11, the US Patent, as modified by Haq et al., teaches administering, by the patient, a subsequent dose of the biguanide drug to the patient in accordance with the subsequent dosage instruction (claim 10).
Conclusion
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/AURELIE H TU/ Primary Examiner, Art Unit 3791
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