DETAILED ACTION
Status of Application, Amendments, And/Or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The preliminary amendment of 29 November 2022 has been entered in full. Claims 1-20 are canceled. Claims 21-32 are under examination.
Claim Objections
Claim 21 is objected to because of the following informalities: Claim 21 recites the phrase “… and a rapid-acting insulin analog is insulin aspart A21G…” which is grammatically incorrect. The following is suggested: “…and a rapid-acting insulin analog that is insulin aspart A21G…” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 28-32 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 28-32 are directed to the pharmaceutical composition of claim 21, wherein it is administered in a specific way or it has a specific effect after administration. However, since the claims are directed to products, not methods, the intended uses or effects do not further limit the claimed subject matter, which is the product. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 21, 22, and 24-32 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by FR 3 069 436 – A1 (ADOCIA; published 27 July 2017; hereinafter ‘436).
‘436 teaches a pharmaceutical composition in the form of an injectable aqueous solution, the pH of which is from 3.0 to 4.0, comprising pramlintide and a rapid-acting insulin analog that is insulin aspart A21G, wherein the composition is free of zinc. See abstract and p. 22, formulation A21-2. This anticipates claims 21, 22, and 28-32.
Regarding claims 24-26, ‘436 teaches the compositions wherein the concentration of A21G is 3.5 mg/mL and the concentration of pramlintide is 1.0 or 0.6 mg/mL. See [00061], [00067], [00068], claim 8.
Regarding claim 27, ‘436 teaches pH between 3.2 and 3.8. See p. 22, formulation A21-3, for example.
Claim(s) 21-32 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Chan (US 2019/0054149 A1; published 21 February 2019).
The applied reference has a common inventor and Applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Chan teaches a pharmaceutical composition in the form of an injectable aqueous solution, the pH of which is from 3.0 to 4.0, comprising pramlintide and a rapid-acting insulin analog that is insulin aspart A21G, wherein the composition is free of zinc. See abstract and p. 10, formulation A21-2. See also claims 1 and 4. This anticipates claims 21, 22, and 28-32.
Regarding claim 23, Chan teaches the inclusion of nicotinamide. See [0137].
Regarding claims 24-26, Chan teaches the compositions wherein the concentration of A21G is 3.5 mg/mL and the concentration of pramlintide is 1.0 or 0.6 mg/mL. See [0077], [0083], [0084], claim 8.
Regarding claim 27, Chan teaches pH between 3.2 and 3.8. See p. 10, formulation A21-3, for example.
Additionally, regarding claims 28-32, Chan teaches methods of administering the pharmaceutical compositions in the manner and for the effects recited in these claims. See [0001] regarding treatment of diabetes; [0229] regarding administration at mealtime; [0015], [0165], and [0166] regarding use of a pump; [0022], [0028] regarding postprandial glycemia; [0034] and claim 19 regarding decreasing the adverse effects of pramlintide; [[0035] regarding decreasing food consumption induced by insulin.
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.
US 10,610,572 B2:
Claims 21, 22, and 24-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,610,572 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Both sets of claims are directed to compositions in the form of an injectable aqueous solution at acidic pH (including pH 4.0), comprising pramlintide and insulin aspart A21G. See instant claim 21 and patented claims 1, 4, and 11.
Both sets of claims recite or imply that the composition is free of zinc. See instant claim 22 and patented claims 1and 12. Note that patented claim 12’s recitation of a further inclusion of a zinc salt implies that the composition of claim 1 does not include a zinc salt.
Both sets of claims refer to insulin aspart A21G concentrations of 2-20 mg/mL or 3.5 mg/mL. See instant claims 24 and 25, and patented claims 7 and 8.
Instant claim 27 recites a pH range of 3.2 to 3.8, which overlaps the pH range recited in patented claim 10 of 3.8 to 4.2 The lower end of the range recited in the patented claim anticipates the range recited in the instant claim.
Instant claims 28-32 recite administration in a specific way or specific effects after administration. However, since the claims are directed to products, not methods, the intended uses or effects do not further limit the claimed subject matter, which is the product. Accordingly, the patented claims anticipate pending claims 28-32 for the reasons discussed above regarding claim 21.
A major difference between the two sets of claims is that the instant claims are directed to pharmaceutical compositions whereas the patented claims only recite compositions. However, patented claims 17-20 refer to administration of the compositions to treat diabetes, and thus the patented compositions must be consistent with use as a pharmaceutical composition.
Another difference between the claim sets is that instant claim 26 recites pramlintide concentrations of 0.32 to 5 mg/mL whereas the patented claims recite glucagon suppressor concentrations (such as pramlintide) of 0.01-10 mg/mL. See patented claims 1, 4, and 9.
US 10,610,572 B2 in view of Kildegaard:
Claim 23 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,610,572 B2 in view of Kildegaard et al. (February 2019, Pharm Res 36:49; pp. 1-14). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
As discussed above, Both sets of claims are directed to compositions in the form of an injectable aqueous solution at acidic pH (including pH 4.0), comprising pramlintide and insulin aspart A21G. See instant claim 21 and patented claims 1, 4, and 11.
The patented claims do not recite a composition that further comprises nicotinamide as per instant claim 23. However, Kildegaard et al. explain that the addition of niacinamide (an alternative name for nicotinamide) to a composition comprising fast acting insulin derivatives such as insulin aspart mediates the acceleration of initial insulin aspart absorption, See p. 1, abstract. Accordingly, it would have been obvious to the ordinary skilled artisan at the time the instant application was filed to modify the compositions of the patented claims by adding nicotinamide/niacinamide in order to accelerate absorption of the claimed insulin aspart A21G with a reasonable expectation of success. The motivation to do so would have been apparent from the teachings of Kildegaard regarding the desirability of accelerating the absorption of insulin derivative.
US 11,065,305 B2:
Claims 21, 22, and 24-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,065,305 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Both sets of claims are directed to compositions in the form of an injectable aqueous solution at acidic pH (including pH 4.0), comprising pramlintide and insulin aspart A21G. See instant claim 21 and patented claims 1 and 8.
Both sets of claims recite or imply that the composition is free of zinc. See instant claim 22 and patented claims 1 and 9. Note that patented claim 9’s recitation of a further inclusion of a zinc salt implies that the composition of claim 1 does not include a zinc salt.
Instant claim 26 recites pramlintide concentrations of 0.32 to 5 mg/mL which is anticipated by the narrower range of 0.4 to 3.0 mg/mL recited in patented claim 1. Accordingly, patented claim 1 anticipates claim 26 in this aspect.
Instant claim 27 recites a pH range of 3.2 to 3.8, which overlaps the pH range recited in patented claim 7 of 3.8 to 4.2 The lower end of the range recited in the patented claim anticipates the range recited in the instant claim.
Instant claims 28-32 recite administration in a specific way or specific effects after administration. However, since the claims are directed to products, not methods, the intended uses or effects do not further limit the claimed subject matter, which is the product. Accordingly, the patented claims anticipate pending claims 28-32 for the reasons discussed above regarding claim 21.
A major difference between the two sets of claims is that the instant claims are directed to pharmaceutical compositions whereas the patented claims only recite compositions. However, patented claims 14-19 refer to administration of the compositions to treat diabetes, and thus the patented compositions must be consistent with use as a pharmaceutical composition.
Also, the instant claims recite concentrations of insulin aspart A21G in terms of mg/mL whereas the patented claims recite the concentrations in terms of Units/mL. However, absent evidence to the contrary, it can be assumed that the amounts recited in the patented claims reflect the amounts recited in the instant claims. Also, the optimization of concentrations of agents in a composition is routine for the ordinary skilled artisan, who would take into account factors such as the age and weight of the patient, the amount of the composition to be administered, the severity of symptoms that need to be alleviated, etc.
US 11,065,305 B2 in view of Kildegaard:
Claim 23 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,065,305 B2 in view of Kildegaard et al. (February 2019, Pharm Res 36:49; pp. 1-14). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
As discussed above, Both sets of claims are directed to compositions in the form of an injectable aqueous solution at acidic pH (including pH 4.0), comprising pramlintide and insulin aspart A21G. See instant claim 21 and patented claim 1.
The patented claims do not recite a composition that further comprises nicotinamide as per instant claim 23. However, Kildegaard et al. explain that the addition of niacinamide (an alternative name for nicotinamide) to a composition comprising fast acting insulin derivatives such as insulin aspart mediates the acceleration of initial insulin aspart absorption, See p. 1, abstract. Accordingly, it would have been obvious to the ordinary skilled artisan at the time the instant application was filed to modify the compositions of the patented claims by adding nicotinamide/niacinamide in order to accelerate absorption of the claimed insulin aspart A21G with a reasonable expectation of success. The motivation to do so would have been apparent from the teachings of Kildegaard regarding the desirability of accelerating the absorption of insulin derivative.
USSN 17/928,434:
Claims 21-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 17/928,434 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Both sets of claims are directed to pharmaceutical compositions in the form of an injectable aqueous solution at acidic pH (including pH 4.0), comprising pramlintide and insulin aspart A21G. See instant claim 21 and copending claims 1, 3, and 8.
Both sets of claims recite that the composition is free of zinc. See instant claim 22 and copending claim 2.
Both sets of claims recite that the composition incudes nicotinamide. See instant claim 23 and copending claim 5.
Both sets of claims recite compositions comprising insulin aspart A21 G at a concentration of from 2 to 20 mg/mL, or at 3.5 mg/mL. See instant claims 24 and 25 and copending claims 11 and 12.
Instant claim 27 recites a pH range of 3.2 to 3.8, which overlaps the pH range recited in copending claim 1 (pH 3.0 to 4.4) and copending claim 14 (pH 3.7 to 4.3) The lower end of the range recited in the at least copending claim 14 anticipates the range recited in the instant claim.
Instant claims 28-32 recite administration in a specific way or specific effects after administration. However, since the claims are directed to products, not methods, the intended uses or effects do not further limit the claimed subject matter, which is the product. Accordingly, the patented claims anticipate pending claims 28-32 for the reasons discussed above regarding claim 21.
The major difference between the two sets of claims is that the copending claim set recites alternative insulin derivatives. However, since these are recited in the alternative, each recited insulin derivative is fairly suggested.
Another difference is that instant claim 26 recites pramlintide concentrations of 0.32 to 5 mg/mL whereas the copending claims do not recite any concentration range for pramlintide. However, absent evidence of unexpected results tied to these concentrations, the optimization of concentrations of agents in a composition is routine for the ordinary skilled artisan, who would take into account factors such as the age and weight of the patient, the amount of the composition to be administered, the severity of symptoms that need to be alleviated, etc.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Rivera (2019, Drugs of the Future 44(10): 819-820). This reference discusses a formulation called ADO-09 which comprises A21G insulin and pramlintide, and its effects in a human trial. Details regarding the formulation are not disclosed.
Meiffren et al. (2019, Diabetologia 62:S57) This reference is a conference abstract discussing human trails with ADO09. Details regarding the formulation are scant.
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/ELIZABETH C. KEMMERER/Primary Examiner, Art Unit 1674
/ECK/
04 September 2025