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. Election/Restrictions Applicants’ election without traverse of Group I, claims 1-25, in the reply filed on 09 March 2026 is acknowledged. Applicants’ election without traversal of a species wherein the patient has a HbA1c of less than 10%, is taking metformin and an effective does of 15 mg, in the reply filed 09 March 2026 is acknowledged. In the restriction/species election response filed 09 March 2026, Applicants elected a patient population wherein their HbA1c is less than 10%. Parker McCrary (representative for Applicants) was contacted on 30 March 2026 and representative clarified the election of a patient population wherein their HbA1c is greater than 10%. Claims 26-66 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09 March 2026. Claims 1-25 are under consideration. Status of Claims The claim listing filed 15 August 2023 is pending. In response to the restriction requirement mailed on 27 February 2026, Applicant elected, without traverse, Group I, claims 1-25. Claims 26-66 are withdrawn from further consideration for the reasons set forth in the restriction requirement, 37 CFR 1.142(b). Claims 1-25 are being examined on the merits in this office action. Priority The present application claims status as a 371 (National Stage) of PCT/US22/14957 filed 02 February 2022, and claims priority under 119(a)-(d) to US Patent Application No. 63/150,187 (filed 17 February 2021 ). Information Disclosure Statement The Information Disclosure Statement (IDS) submitted on 15 August 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statement is being considered by the examiner. Drawings The drawings are objected to because Figures 1 and 2 are illegible . One of ordinary skill in the art would be unable to tell what the figures are showing due to the poor quality of the figures. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Rejections - 35 USC § 102 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. Claim s 1- 1 1, 16-19 , 22 and 23 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Frias et al . , hereafter “Frias” (“ Efficacy and safety of LY3298176, a novel dual GIP and GLP-1 receptor agonist, in patients with type 2 diabetes: a randomised , placebo-controlled and active comparator-controlled phase 2 trial. ” Lancet. 2018 Nov 17;392(10160):2180-2193. doi : 10.1016/S0140-6736(18)32260-8. Epub 2018 Oct 4. PMID: 30293770 ), as filed in the IDS filed 15 August 2023 , as evidenced Merriam-Webster, “Comorbid”, accessible online from 13 April 2019 . Regarding claim 1, Frias teaches LY3298176, another name for Tirzepatide , treating inadequately controlled (refractory) type 2 diabetes in a patient comprising administering tirzepatide to the patient once weekly (pg. 2180 , “ In this double-blind, randomised , phase 2 study, patients with type 2 diabetes were randomly assigned (1:1:1:1:1:1) to receive either once-weekly subcutaneous LY3298176 (1 mg, 5 mg, 10 mg, or 15 mg) … ” ; pg. 2182, “ Eligible participants (aged 18–75) had type 2 diabetes for at least 6 months (glycated haemoglobin A 1c [HbA 1c ] 7·0–10·5%, inclusive) that was inadequately controlled with diet and exercise alone or with stable metformin therapy …” ) . Regarding claim 2, Frias teaches wherein the patient has had type 2 diabetes for at least 8 years (pg. 2180 , “ At baseline, mean age was 57 years (SD 9), BMI was 32·6 kg/m 2 (5·9), duration from diagnosis of diabetes was 9 years… ”) . Regarding claim 3, Frias teache s the secondary endpoint of the study being patients reaching a HbA1c of <7·0% (pg. 2180 , “ Secondary endpoints … proportion of patients reaching the HbA 1c target (≤6·5% and <7·0%) from baseline to weeks 12 and 26 ”) . Regarding claim 4 , Frias teaches the secondary endpoint of the study being patients reaching a HbA1c of ≤6·5% , which comprises the goal less than or equal to 5.7% (pg. 2180 , “ Secondary endpoints … proportion of patients reaching the HbA 1c target (≤6·5% and <7·0%) from baseline to weeks 12 and 26 ”) . In the restriction/species election response filed 09 March 2026, Applicants elected a patient population wherein their HbA1c is less than 10%. Parker McCrary ( representative for Applicants ) was contacted on 30 March 2026 and representative clarified the election of a patient population wherein their HbA1c is greater than 10%. Regarding claims 5 and 6, Frias teaches the eligible participants of this study having a HbA1c between 7%-10.5%, which reads on the elected species of a HbA1c greater than 10% (pg. 2182, “ Eligible participants (aged 18–75) had type 2 diabetes for at least 6 months ( HbA 1c 7·0–10·5%, inclusive ) …”). Regarding claim 7 and 8, Frias teaches that the participants of this study were between the ages of 18 and 75 (pg. 2182 , “ This 26-week, phase 2b, randomised , double-blind study was done at 47 sites (medical and clinical research centres ) in Poland, Puerto Rico, Slovakia, and USA. Eligible participants (aged 18–75)… ”). In the restriction/species election response filed 09 March 2026, Applicants elected a patient population wherein the patient is taking metformin. Regarding claims 9-10, Frias teaches that the patient population taking metformin (pg. 2182 , “ Eligible participants (aged 18–75) had type 2 diabetes for at least 6 months (glycated haemoglobin A 1c [HbA 1c ] 7·0–10·5%, inclusive) that was inadequately controlled with diet and exercise alone or with stable metformin therapy for at least 3 months before screening …”). Regarding claim 11, Frias teaches that the exclusion criteria included having used insulin for diabetic control within the prior year (pg. 25 and 28 of the supplementary appendix, “ 6.2. Exclusion Criteria : Patients will be excluded from study enrollment if they meet any of the following criteria at screening … Prior/Concomitant Therapy … [36] Have used insulin for diabetic control within the prior year. However, short term use of insulin for acute conditions is allowed ( 14 days) in certain situations, such as during a hospitalization or perioperatively (see Section 7.7) ”). Regarding claim 16, Frias teaches that eligible participants were required to have a BMI of 23–50 kg/m 2 , with the BMI for obesity being 30.0 or higher (pg. 2182 , “ Eligible participants (aged 18–75) had … and a BMI of 23–50 kg/m 2 . ”) . In the restriction/species election response filed 09 March 2026, Applicants elected an effective amount of 15mg. Regarding claims 17-19, Frias teaches random patients in the patient population being assigned a once-weekly subcutaneous Tirezeptide of 15 mg (pg. 2180 , “ In this double-blind, randomised , phase 2 study, patients with type 2 diabetes were randomly assigned (1:1:1:1:1:1) to receive either once-weekly subcutaneous LY3298176 (1 mg, 5 mg, 10 mg, or 15 mg ) …”). Regarding claim 22 , Frias teaches the patient population representing patients with a mean BMI of 32 . 6 kg/m 2 (Class I Obesity) and type 2 diabetes (pg . 2180, “ At baseline … HbA 1c was 8.1% ...”). The combination of these two conditions would cause a patient to be categorized as having comorbid obesity , or obesity with comorbities ( “A condition existing simultaneously with and usually independently of another medical condition ” , as evidenced by Merriam-Webster). Regarding claim 2 3 , Frias teaches the patient population representing patients with at least two cardiovascular risk factors , those being an older mean age , higher BMI, longer history of diabetes and a high Hb A 1c (pg. 2180 , “ At baseline, mean age was 57 years (SD 9), BMI was 32·6 kg/m 2 (5·9), duration from diagnosis of diabetes was 9 years (6), HbA 1c was 8 . 1% ... ”). 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. Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Frias et al . , hereafter “Frias” (“ Efficacy and safety of LY3298176, a novel dual GIP and GLP-1 receptor agonist, in patients with type 2 diabetes: a randomised , placebo-controlled and active comparator-controlled phase 2 trial. ” Lancet. 2018 Nov 17;392(10160):2180-2193. doi : 10.1016/S0140-6736(18)32260-8. Epub 2018 Oct 4. PMID: 30293770 ), as filed in the IDS filed 15 August 2023 , as evidenced Merriam-Webster, “Comorbid”, accessible online from 13 April 2019, as applied to claim 1 above, and further in view of Pappachan et al . , hereafter “ Pappachan ” (“ Management of hypertension and diabetes in obesity: non- pharmacological measures. ” Int J Hypertens . 2011;2011:398065. doi : 10.4061/2011/398065. Epub 2011 Mar 22. PMID: 21629871; PMCID: PMC3095960. ) . Regarding claim 2 0 , Frias teaches a method for treating refractory type 2 diabetes comprising administering tirzepatide to the patient once weekly (pg. 2180, “ In this double-blind, randomised , phase 2 study, patients with type 2 diabetes were randomly assigned (1:1:1:1:1:1) to receive either once-weekly subcutaneous LY3298176 (1 mg, 5 mg, 10 mg, or 15 mg) … ” ; pg. 2182, “ Eligible participants (aged 18–75) had type 2 diabetes for at least 6 months (glycated haemoglobin A 1c [HbA 1c ] 7·0–10·5%, inclusive) that was inadequately controlled with diet and exercise alone or with stable metformin therapy …” ) . Further, Frias teaches that patients treated with the tirzepatide had a change in weight (pg. 2180, “ Changes in mean bodyweight ranged from −0.9 kg to −11.3 kg for LY3298176 ( vs −0.4 kg for placebo, −2.7 kg for dulaglutide) . At 26 weeks, 14–71% of those treated with LY3298176 achieved the weight loss target of at least 5% ( vs 22% with dulaglutide, 0% with placebo) and 6–39% achieved the weight loss target of at least 10% ( vs 9% with dulaglutide, 0% with placebo) . ”). Frias does not teach the method of treating as described in claim 1, wherein the patient has comorbid high bloo d pressure. Pappachan teaches that high blood pressure and type 2 diabetes are common among obese individuals due to a linear relationship (pg. 1, “ Obesity has become a global epidemic over the past few decades because of unhealthy dietary habits and reduced physical activity. Hypertension and diabetes are quite common among obese individuals and there is a linear relationship between the degree of obesity and these diseases . ”) . Pappachan also teaches that weight loss can help individuals with hypertension gain better control over their blood pressure (pg. 3, “ Overall, weight reduction achieved through lifestyle interventions like dietary modification and regular exercise programs (at least 30 minutes/day on most days) help obese individuals with hypertension to obtain better BP control and reduce complications related to uncontrolled hypertension. ”). The combination of these two conditions would cause a patient to be categorized as having comorbid obesity , or obesity with comorbities (“A condition existing simultaneously with and usually independently of another medical condition ”, as evidenced by Merriam-Webster). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Frias ’s teachings with Pappachan ’s teachings because Frias teaches that the administration of tirzepatide can result in weight loss . It would be obvious to one of ordinary skill in the art to administer tirzepatide to a patient with both type 2 diabetes and high blood pressure in the form of a treatment due to Frias teaching that tirzepatide helps with weight loss and Pappachan teaches that a reduction in weight can help with controlling their hypertension. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to arrive at the claimed invention because the references teach a relationship between type 2 diabetes and hypertension and Frias teaches a method of treating that is relevant to both conditions . Claim 2 1 is rejected under 35 U.S.C. 103 as being unpatentable over Frias et al . , hereafter “Frias” (“ Efficacy and safety of LY3298176, a novel dual GIP and GLP-1 receptor agonist, in patients with type 2 diabetes: a randomised , placebo-controlled and active comparator-controlled phase 2 trial. ” Lancet. 2018 Nov 17;392(10160):2180-2193. doi : 10.1016/S0140-6736(18)32260-8. Epub 2018 Oct 4. PMID: 30293770 ), as filed in the IDS filed 15 August 2023, as evidenced Merriam-Webster, “Comorbid”, accessible online from 13 April 2019, as applied to claim 1 above, and further in view of Barter (“ The causes and consequences of low levels of high density lipoproteins in patients with diabetes. ” Diabetes Metab J. 2011 Apr;35(2):101-6. doi : 10.4093/dmj.2011.35.2.101. Epub 2011 Apr 30. PMID: 21738891; PMCID: PMC3122896. ) . Regarding claim 2 1 , Frias teaches a method for treating refractory type 2 diabetes comprising administering tirzepatide to the patient once weekly (pg. 2180, “ In this double-blind, randomised , phase 2 study, patients with type 2 diabetes were randomly assigned (1:1:1:1:1:1) to receive either once-weekly subcutaneous LY3298176 (1 mg, 5 mg, 10 mg, or 15 mg) … ” ; pg. 2182, “ Eligible participants (aged 18–75) had type 2 diabetes for at least 6 months (glycated haemoglobin A 1c [HbA 1c ] 7·0–10·5%, inclusive) that was inadequately controlled with diet and exercise alone or with stable metformin therapy …” ) . Further, Frias teaches that patients treated with the tirzepatide had a change in weight (pg. 2180, “ Changes in mean bodyweight ranged from −0.9 kg to −11.3 kg for LY3298176 ( vs −0.4 kg for placebo, −2.7 kg for dulaglutide) . At 26 weeks, 14–71% of those treated with LY3298176 achieved the weight loss target of at least 5% ( vs 22% with dulaglutide, 0% with placebo) and 6–39% achieved the weight loss target of at least 10% ( vs 9% with dulaglutide, 0% with placebo) . ”). Frias does not teach the method of treating as described in claim 1, wherein the patient has comorbid low HDL-C. Barter teaches that type 2 diabetes is associated with having a low HDL-C (pg. 101, “ Type 2 diabetes is commonly accompanied by a low level of high-density lipoprotein cholesterol (HDL-C) that contributes to the increased cardiovascular risk associated with this condition. ”). Barter also teaches that while the underlying mechanism is uncertain, the relationship between patients being overweight, having type 2 diabetes and low HDL-C provides a basis for the recommendation of losing weight to raise HDL-C levels (pg. 103, “ The mechanism underlying a relationship between body weight and HDL-C concentration is uncertain. However, the fact that most patients with type 2 diabetes are overweight provides a strong basis for recommending weight reduction as a strategy to raise the level of HDL-C in such patients . ”) . The combination of these three conditions would cause a patient to be categorized as having comorbid obesity , or obesity with comorbities (“A condition existing simultaneously with and usually independently of another medical condition ”, as evidenced by Merriam-Webster). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Frias’s teachings with Ba rter ’s teachings because Frias teaches that the administration of tirzepatide can result in weight loss . It would be obvious to one of ordinary skill in the art to administer tirzepatide to a patient with both type 2 diabetes and low HDL-C in the form of a treatment due to Frias teaching that tirzepatide helps with weight loss and Ba rter teaching that there is a possible correlation between obesity , type 2 diabetes and low HDL-C. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to arrive at the claimed invention because the references teach a relationship between type 2 diabetes and low HDL-C and Frias teaches a method of treating that is relevant to both conditions. Allowable Subject Matter The following is a statement of reasons for the indication of allowable subject matter: The duration of treatment as described in claims 13-15 were found to be free of the prior art. The closest prior art is described in Frias (“ Efficacy and safety of LY3298176, a novel dual GIP and GLP-1 receptor agonist, in patients with type 2 diabetes: a randomised , placebo-controlled and active comparator-controlled phase 2 trial. ” Lancet. 2018 Nov 17;392(10160):2180-2193. ). The study as described in Frias was conducted across 26 weeks (pg. 2180, “ In this double-blind, randomised , phase 2 study, patients with type 2 diabetes were randomly assigned (1:1:1:1:1:1) to receive either once-weekly subcutaneous LY3298176 (1 mg, 5 mg, 10 mg, or 15 mg), dulaglutide (1 . 5 mg), or placebo for 26 weeks . ”) . The patients lack of risk factors, as described in claim 24, was found to be free of the prior art. The closest prior art is described in Frias (“ Efficacy and safety of LY3298176, a novel dual GIP and GLP-1 receptor agonist, in patients with type 2 diabetes: a randomised , placebo-controlled and active comparator-controlled phase 2 trial. ” Lancet. 2018 Nov 17;392(10160):2180-2193. ). The mean patient population as described in Frias had multiple cardiovascular risk factors, those being an older mean age, higher BMI, longer history of diabetes and a high Hb A 1c (pg. 2180, “ At baseline, mean age was 57 years (SD 9), BMI was 32·6 kg/m 2 (5·9), duration from diagnosis of diabetes was 9 years (6), HbA 1c was 8.1% ...”). The duration of the patients having type 2 diabetes, as described in claim 25, was found to be free of the prior art. The closest prior art is described in Frias (“ Efficacy and safety of LY3298176, a novel dual GIP and GLP-1 receptor agonist, in patients with type 2 diabetes: a randomised , placebo-controlled and active comparator-controlled phase 2 trial. ” Lancet. 2018 Nov 17;392(10160):2180-2193. ). The mean patient diabetes diagnosis was 9 years (pg. 2180, “ At baseline … duration from diagnosis of diabetes was 9 years ...”). Claim s 13-15, 24 and 25 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Status of Claims Claim s 1-11, 16-19, 22 and 23 are rejected under 35 U.S.C. 102 (a)(1). Claims 20 and 21 are rejected under 35 U.S.C. 103 . Claims 12-15, 24 and 25 are objected to. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Daliyah M. Brown whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0136 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Thursday 9:00 am - 4:30 pm . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Lianko Garyu can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 270-7367 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Daliyah M. Brown/ Examiner, Art Unit 1654 /LIANKO G GARYU/ Supervisory Patent Examiner, Art Unit 1654