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 .
Status of the Application
The amendment and election of 22 June 2026 are entered.
Claims 1-56 are pending. Claims 1, 3-29, 32, and 34 are withdrawn with traverse. Claims 2, 30, 31, 33, and 35-56 are being examined on the merits.
Election/Restrictions
Applicant's election with traverse of Group II (claims 2 and 30-56) and the species of insulin lispro A21G, pramlintide, and formula B1’ in the reply filed on 22 June 2026 is acknowledged. The traversal is on the ground(s) that Groups I and II are interrelated to warrant examination as a single group. The Applicants argue no burden on the Office to search and examine both Groups. The Applicants argue examination of the generic claims would not pose a burden on the office. This is not found persuasive because the need for different searches and utilization of search resources is sufficient to demonstrate burden on the Office. Furthermore, different classification is sufficient to demonstrate distinctness of invention and a search burden on the Office. As to the species, the Applicants offer nothing more than attorney arguments on burden for searching of the genus without offering any evidence that such a search is not burdensome.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1, 3-29, 32, and 34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 22 June 2026.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claims 2, 30, 31, 33, 35-42, and 50-56 are rejected under 35 U.S.C. 103 as being unpatentable over Chan Y (WO 2021/240004 A1, published 2 December 2021, filed 28 May 2021, priority to 29 May 2020, hereafter referred to as ‘004) and Fellinger et al. (Wien Klin Wochenschr 131:55-60, published 7 January 2019, hereafter referred to as Fellinger).
The ‘004 art discloses a combination of an amylin agonist and a glucagon suppressor with prandial action (see e.g. Abstract). In particular, a pharmaceutical composition is disclosed containing insulin lispro A21G and pramlintide (see e.g. claims 1, 4, and 8). ‘004 also discloses that type 1 diabetes patients utilize short-acting prandial insulins for rapid glucose control at mealtime (see e.g. [0002]). The compositions can be utilized in a method of treating diabetes (see e.g. [000217]-[000218]). ‘004 indicates that insulin lispro A21G absorption is surprisingly faster when combined with pramlintide (see e.g. [0011]).
The difference between ‘004 and the claimed invention is that ‘004 does not disclose or suggest the criteria for T1D patients as claimed, including a BMI of >28 kg/m2 and/or an HbA1c of more than 7.6%, nor treatment of at least 15 weeks.
The Fellinger art discloses that T1D patients typically match general population trends in terms of BMI, and for those with BMI >27.5 kg/m2 the associated HbA1c is 7.8±1.1 %/mmol/mol (see e.g. Table 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the ‘004 composition in a method of treating T1D in a patient having T1D, including those with a BMI of >28 kg/m2 and/or a HbA1c before treatment of more than 7.6%, given that Fellinger describes such patients and ‘004 mentions that short-acting prandial insulins such as insulin lispro are utilized in T1D to manage glucose control at mealtime. Furthermore, since T1D is a chronic condition, it would have been obvious to utilize the composition of ‘004 daily, i.e. treatment would overlap with a 15 week period as claimed. There would have been a reasonable expectation of success because ‘004 describes the combination as offering advantages over insulin lispro A21G alone, and the skilled artisan would expect a combination of an insulin and a glucagon suppressor to be useful in treatment of T1D. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to claims 30, 31, 33, and 35, as noted above ‘004 discloses insulin lispro A21G.
With respect to claim 36, ‘004 describes formulations where 100 U/mL insulin lispro A21G are utilized with pramlintide at 0.6 mg/mL (see e.g. Table 3). ‘004 also generally describes insulins with an A21 substitution at 100-500 U/mL (see e.g. [00092]-[00093]).
With respect to claims 37-40, as noted above ‘004 describes both pramlintide as well as the dosage when combined with insulin lispro A21G.
With respect to claim 41, the ‘004 composition is an aqueous solution (see e.g. Abstract).
With respect to claim 42, as noted above ‘004 discloses the insulin, and also discloses a pH of 3.0-4.4 (see e.g. Abstract).
With respect to claims 50-54, as noted above Fellinger provides for the patient population criteria.
With respect to claim 55, the patients in Fellinger are humans.
With respect to claim 56, by necessity treatment of T1D involves chronic treatment.
2. Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Chan Y (WO 2021/240004 A1, published 2 December 2021, filed 28 May 2021, priority to 29 May 2020) and Fellinger et al. (Wien Klin Wochenschr 131:55-60, published 7 January 2019) as applied to claims 2 and 41 above, and further in view of Chan et al. (WO 2019/110788 A1, published 13 June 2019, see US 20190328842 A1 for translation of specification, hereafter referred to as ‘788).
The relevance of ‘004 and Fellinger is set forth above. The difference between the prior art references and the claimed invention is that neither discloses a pH of 6.0-8.0 or a co-polyamino acid.
The ‘788 application discloses an injectable aqueous solution at pH 6-8 having an amylin receptor agonist, a co-polyamino acid, and a prandial insulin (see e.g. Abstract, claim 1). ‘788 discloses the compound B1, which matches the elected compound B1’ where the number of repeats at n is 26 and R1 is H or pyroglutamate (see e.g. p.109). The ‘788 application also indicates the compound B1 is combined with pramlintide and insulin (see e.g. Table 16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the method of ‘004 and Fellinger could have been altered by inclusion of the co-polyamino acid B1 as in ‘788. The rationale comes from ‘788 showing that the co-polyamino acid B1 can be combined stably with pramlintide and insulin. There would have been a reasonable expectation of success because the combination is stable per ‘788. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
3. Claim(s) 45-49 are rejected under 35 U.S.C. 103 as being unpatentable over Chan Y (WO 2021/240004 A1, published 2 December 2021, filed 28 May 2021, priority to 29 May 2020) and Fellinger et al. (Wien Klin Wochenschr 131:55-60, published 7 January 2019) as applied to claim 2 above, and further in view of Anonymous (FirstWord PHARMA, Press Release “Adocia Initiates Phase 2 Clinical Trial for M1Pram in Patients with Type 1 Diabetes”, https://firstwordpharma.com/story/5245829, published 10 March 2021, hereafter referred to as Anonymous).
The relevance of ‘004 and Fellinger is set forth above. The difference between the prior art references and the claimed invention is that neither discloses body weight loss as claimed.
The Anonymous art discloses use of M1Pram in 80 patients with T1D and being overweight (see e.g. entire document). Anonymous also discloses that in a 16 week treatment period weight loss averaged 1.6 kg (see e.g. “About the Phase 2 Study”). M1Pram is described as being a combination of a prandial insulin and pramlintide (See e.g. “About M1Pram”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the treatment method of ‘004 and Fellinger could have been modified by utilizing the weight loss results of Anonymous for a highly similar insulin and pramlintide combination in 16 week-long treatment of T1D patients with obesity. The rationale comes from the highly similar formulation in Anonymous, such that one of ordinary skill in the art would have expected an insulin lispro A21G to similarly or more effective in weight loss as compared to normal insulin. There would have been a reasonable expectation of success also given the similar nature of the ‘004 composition and that utilized in Anonymous. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to claim 47, as noted above Anonymous discloses an average 1.6 kg weight loss over 16 weeks.
With respect to claims 48 and 49, while Anonymous only discloses an average 1.6 kg weight loss, this is sufficiently close to 2 kg to expect at least some patients would have achieved that level of weight loss. Furthermore, one of ordinary skill in the art could have adjusted dosing as needed to achieve higher levels of weight loss in patients and also expect effects from the use of insulin lispro A21G as compared to standard insulin.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY J MIKNIS whose telephone number is (571)272-7008. The examiner can normally be reached Mon-Thurs 7-5.
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/ZACHARY J MIKNIS/Patent Examiner, Art Unit 1658
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