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 .
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Response to Arguments
Applicant’s arguments, filed 5/15/2026 with respect to the claim rejections under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. The rejections have been withdrawn based upon the statement disqualifying prior art under 102(b)(1)(A) as a disclosure made by a joint inventor or by another who obtained the subject matter disclosed directly or indirectly from a joint inventor (see Remarks, Pg 5).
Applicant’s arguments, filed 5/15/2026, with respect to the claim rejections under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the new claim amendments.
Further, Applicant’s request that the double patenting rejections be held in abeyance until patentable subject matter has been identified is noted but the rejections have been modified/maintained herein.
Priority
The present application claims priority to EP25167042.8, filed 3/28/2025, and EP24213241.3, filed 11/15/2024, and the provisional application 63/716,349, filed 11/5/2024. The priority date of 11/5/2024 is acknowledged.
This statement has been updated from the prior Office Action and previously stated: The present application claims priority to EP25167042.8, filed 3/28/2025, and EP24213241.3, filed 11/15/2024, which claim priority to the provisional application 63/716,349, filed 11/5/2024. The priority date of 11/5/2024 is acknowledged.
Claim Status
Claims 1-26 are pending under examination. Claim 1 is currently amended.
Information Disclosure Statement
The IDS submitted on 5/15/2026 is under consideration.
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.
Claim 8 is 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. Claim 8 recites the method wherein the treatment increase the maximum distance that the subject is capable of walking, which is recited in claim 1; thus, claim 8 does not further limit the parent claim from which it depends. 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 § 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.
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.
Claim(s) 1, 8, 9, 12-14, 16-17, 22 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Hathaway et al. (US20030073626A1, published 4/17/2003) in view of Aroda et al. (Safety and tolerability of semaglutide across the SUSTAIN and PIONEER phase IIIa clinical trial programmes. Diabetes Obes Metab. 2023 May;25(5):1385-1397.).
Hathaway teaches a method of treating intermittent claudication in individuals with peripheral vascular disease (PVD or PAD) comprising administering a therapeutically effective amount of a GLP-1 molecule ([0016; claim 1]). Hathaway teaches PAD is a common disease caused by atherosclerotic narrowing of the arteries of the lower extremities ([0003]). Diabetes mellitus is a significant risk factor associated with PAD ([0004]).
Hathaway further teaches the specific dosage and treatment regimen for any particular patient will depend upon a variety of factors, including the particular GLP-1 molecule, the patient's age, body weight, general health, gender, and diet, and the time of administration, rate of excretion, drug combination, and the severity of the particular disease being treated. Judgment of such factors by medical caregivers is within ordinary skill in the art. The amount of GLP-1 molecule will also depend on the individual patient to be treated, the route of administration, the type of formulation, the characteristics of the compound used, the severity of the disease, and the desired effect. The amounts of GLP-1 molecules can be determined by pharmacological and pharmacokinetic principles well-known in the art ([0076]).
The efficacy of GLP-1 will be monitored by absolute claudication distance (ACD), which is measured on a treadmill at constant or graded workload. The ACD should increase for patients treated with GLP-1. The dose of GLP-1 may be adjusted (e.g. increased) to improve ACD ([0090]). Per the instant specification, ACD is another term for maximum walking distance (see instant Pg 4, lines 32-33).
Hathaway does not explicitly teach administering semaglutide as the GLP-1 species, treating T2D as the diabetes species, nor that administration leads to a 13% improvement in maximum walking distance.
Aroda teaches semaglutide is a GLP-1 molecule that can treat T2D; semaglutide can also reduce the risk of major cardiac events (Abstract; Introduction, Pg 1286, left column).
In summary, Hathaway teaches a method of treating intermittent claudication in a subject in who has PAD through administration of a GLP-1 molecule, which leads to improvements in the maximum walking distance; diabetes is a significant risk factor for PAD; and the dosage of GLP-1 administered is dependent upon a number of factors evaluated by medical caregiver and can be adjusted to improve or increase the maximum walking distance. Aroda teaches administering semaglutide to treat T2D, which can reduce the risk of cardiovascular events.
Thus, regarding claims 1 and 8, it would be prima facie obvious to administer semaglutide to a subject who has T2D and PAD in order to improve intermittent claudication as measured by the maximum walking distance. One skilled in the art would be motivated to do so and have a reasonable expectation of success as Hathaway established that intermittent claudication could be improved in patents with diabetes and PAD through administration of a GLP-1, and Aroda established that semaglutide is a GLP-1 that can effectively treat T2D and associated cardiovascular events.
Moreover, although Hathaway does not explicitly teach administering semaglutide to a subject who has T2D and PAD results in an improvement in the maximum walking distance by 13%, Hathaway does teach dosage and treatment regimens for any particular patient will depend on a variety of factors assessed by a medical caregiver, including the amount of GLP-1 administered. Hathaway also teaches that the amount of GLP-1 administered can be increased to improve the maximum walking distance. Thus, it would have been obvious to optimize the amount of semaglutide administered to a subject with T2D and PAD in order to improve maximum walking distance by 13%.
Regarding claim 9, reductions in intermittent claudication caused by treatment would also necessarily result in increased distances that the subject is capable of walking without feeling pain.
Regarding claims 12-14, 16-17, 22 and 25-26, Adora teaches that patients taking semaglutide received once-weekly subcutaneous semaglutide 0.5 or 1.0mg or once-daily oral semaglutide 3, 7, or 14mg. One skilled in the art would recognize that subcutaneous semaglutide would be administered as a liquid, injectable formulation.
Claim(s) 1-14, 16-17, 22 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Hathaway et al. (US20030073626A1, published 4/17/2003) and Aroda et al. (Safety and tolerability of semaglutide across the SUSTAIN and PIONEER phase IIIa clinical trial programmes. Diabetes Obes Metab. 2023 May;25(5):1385-1397.), as applied to claims 1, 8, 9, 12-14, 16-17, 22 and 25-26, and further in view of Jakubiak et al. (Chronic Lower Extremity Ischemia and Its Association with the Frailty Syndrome in Patients with Diabetes. Int J Environ Res Public Health. 2020 Dec 14;17(24):9339.).
The teachings of Hathaway and Adora have been set forth above. Hathaway and Adora do not teach treating subjects who have intermittent claudication corresponding to Fontaine stage IIA.
Jakubiak teaches that T2D is an important risk factor of the development of cardiovascular diseases, including atherosclerosis (Abstract; Pg 1, “1. Introduction”, first paragraph); diabetes is not only a risk factor for occurrence of atherosclerosis but also for acceleration of its development (Pg 3, “3. Pathology and epidemiology of PAD”, first paragraph). In turn, atherosclerosis can lead to the development of chronic lower extremity ischemia, which is a manifestation of peripheral arterial disease (PAD; Pg 1, “1. Introduction”, second paragraph). A typical symptom for chronic lower extremity ischemia is intermittent claudication, which is characterized by limb (especially calf) pain associated with walking and relieved by rest (Pg 3, “3. Pathology and epidemiology of PAD,” third paragraph).
Jakubiak further teaches that individuals with T2D and PAD may display intermittent claudication that qualifies under stage IIA based on the Fontaine classification scale, which corresponds to mild claudication (Table 1, Pg 4).
In summary, Hathaway and Adora teach a method of treating intermittent claudication in a subject who has T2D and PAD comprising administering semaglutide to improve maximum walking distance by 13%. Jakubiak teaches that T2D increases ones chances of developing PAD, which manifests as intermittent claudication; Fontaine Stage IIA corresponds to mild claudication.
Based on these teachings, regarding claim 2, it would be obvious to treat Fontaine Stage IIA individuals with the method of Hathaway and Adora. One skilled in the art would be motivated to do so because one would want to treat as many patients with T2D and PAD as possible. One would have a reasonable expectation of success as Hathaway and Aroda teach treating subjects with T2D and PAD, irrespective of their Fontaine Stage.
Regarding claims 3-7, Jakubiak teaches that an ABI value below 0.9 correlates with significant disorder of blood supply of the lower extremity, which makes it possible to diagnose PAD affecting lower limbs (Pg 5, “4. The significance of ankle-brachial index (ABI) and toe-brachial index (TBI), first paragraph). Jakubiak further teaches that the TBI is defined as the quotient of systolic blood pressure measured at the big toe vs systolic blood pressure measured at the arm, and values below 0.7 are criteria for the diagnosis of PAD according to the European Society of Vascular Medicine (Pg 6, “4. The significance of ankle-brachial index (AIB) and toe-brachial index (TBI), second paragraph).
Regarding claims 10 and 11, given that values indicative of PAD are equal to or less than 0.9 for ABI or equal to or less than 0.7 for TBI, treatment of T2D and PAD would necessarily lead to increases in these values.
Claim(s) 1-26 are rejected under 35 U.S.C. 103 as being unpatentable over Hathaway et al. (US20030073626A1, published 4/17/2003), Aroda et al. (Safety and tolerability of semaglutide across the SUSTAIN and PIONEER phase IIIa clinical trial programmes. Diabetes Obes Metab. 2023 May;25(5):1385-1397.), and Jakubiak et al. (Chronic Lower Extremity Ischemia and Its Association with the Frailty Syndrome in Patients with Diabetes. Int J Environ Res Public Health. 2020 Dec 14;17(24):9339.), as applied to claims 1-14, 16-17, 22 and 25-26, and further in view of Tornoee et al. (US20150344540 A1, published 12/3/2015; from IDS filed 11/4/2025).
The teachings of Hathaway, Aroda, and Jakubiak have been set forth above. Hathaway, Aroda, and Jakubiak do not teach administering semaglutide as a liquid formulation at dosages of 0.25, 1.7, 2.0, 2.4, or 7.2mg nor orally as a solid formulation at 25 or 50mg.
Tornoee teaches GLP-1 receptor agonist compounds that can be used in methods of treating cardiovascular complications found in patients with diabetes (Abstract, [0068, 0072]). The term diabetes includes type II diabetes (T2D; [0179]). The term “cardiovascular disease” or CVD refers to any disease that affects the cardiovascular system, including peripheral arterial disease (PAD; [0182]). Tornoee also teaches that GLP-1 receptor agonist peptides of the invention can be used to treat intermittent claudication ([0255, 0263]). GLP-1 receptor agonist peptides can be administered at dosages from 0.01mg-100mg of the peptide in pharmaceutical compositions that come in a variety of forms, for instance, by the mouth or orally or parenteral or dermal (injection); the dosages forms can be solutions, suspensions (liquid formulations), or solid forms such a coated tablet ([0240-0243]).
Thus, regarding claims 15, 18-21, and 23-24, Hathaway, Aroda, and Jakubiak teach a method of treating intermittent claudication comprising administering semaglutide to a subject who has T2D and PAD to improve the subject’s maximum walking distance by 13%. Tornoee teaches administering GLP-1 receptor agonist peptides to treat intermittent claudication in subjects with T2D and PAD as well as the dosages required to treat it. Therefore, it would be prima facie obvious to administer semaglutide to patients with T2D and PAD based upon the dosages taught by Tornoee. One skilled in the art would be motivated to do so because semaglutide is also a GLP-1 receptor agonist peptide, and, thus, the dosages taught by Tornoee would serve as a useful starting point. Moreover, one skilled in the art would have a reasonable expectation of success Tornoee already established that such dosages worked to improve symptoms of intermittent claudication in patients with T2D and PAD.
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, 8, 9, 12-14, 19, and 25-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,295,988 B2 (US ‘988) in view of Hathaway et al. (US20030073626A1, published 4/17/2003).
Claim 1 of US ‘988 recites a method for treating type 2 diabetes in a subject in need thereof, comprising administering semaglutide to the subject in an amount of 2.0 mg once weekly, wherein the semaglutide is administered subcutaneously.
US ‘988 does not teach treating a subject with T2D and PAD wherein the treatment increases the subject’s maximum walking distance by 13%.
As described above, Hathaway teaches a method of treating intermittent claudication in a subject in who has PAD through administration of a GLP-1 molecule, which leads to improvements in the maximum walking distance; diabetes is a significant risk factor for PAD; and the dosage of GLP-1 administered is dependent upon a number of factors evaluated by medical caregiver and can be adjusted to increase the maximum walking distance.
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Hathaway into US ‘988, thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Hathaway teaches that diabetes is a risk factor for PAD, and, thus, by treating T2D, one would necessarily treat the physiological conditions that lead to PAD. Thus, the claims are obvious in view of US ‘988.
Claims 1, 8, 9, 12-14, 20, and 25-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5-7, and 11-14 of U.S. Patent No. 12,029,779 B2 (US ‘779) in view of Hathaway et al. (US20030073626A1, published 4/17/2003).
Independent claim 1 of US ‘779 recites a method for reducing body weight of a subject in need thereof, comprising administering semaglutide subcutaneously to the subject in an amount of about 2.4 mg weekly. Independent claim 7 of US ‘779 recites a method for reducing body weight of a subject in need thereof, comprising administering semaglutide subcutaneously to the subject in an amount of 2.4 mg once weekly.
Dependent claims include the semaglutide is administered once weekly (claim 2) and the subject has type 2 diabetes mellitus (claims 5, 6, and 11-14).
US ‘779 does not teach treating a subject with T2D and PAD wherein the treatment increases the subject’s maximum walking distance by 13%.
As described above, Hathaway teaches a method of treating intermittent claudication in a subject in who has PAD through administration of a GLP-1 molecule, which leads to improvements in the maximum walking distance; diabetes is a significant risk factor for PAD; and the dosage of GLP-1 administered is dependent upon a number of factors evaluated by medical caregiver and can be adjusted so as to increase the maximum walking distance.
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Hathaway into US ‘779, thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Hathaway teaches that diabetes is a risk factor for PAD, and, thus, by treating T2D, one would necessarily treat the physiological conditions that lead to PAD. Thus, the claims are obvious in view of US ‘779.
Claims 1, 8, 9, and 25-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9,993,430 B2 (US ‘430) in view of Hathaway et al. (US20030073626A1, published 4/17/2003).
In Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 (Fed. Cir. 2010), the Court determined that Claims of a later patent were held invalid for obviousness-type double patenting when the earlier patent claimed a compound and disclosed its utility in specification, and later patent claimed a method of using compound for use described in specification of earlier patent.
Independent claim 1 of US ‘430 recites a tablet comprising a granulate wherein said granulate comprises i) no more than 15% (w/w) semaglutide, and ii) at least 50% (w/w) salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (NAC), and wherein said tablet has a) a bulk density of at least 1.0 g/cm3, b) a median pore diameter of no more than 1.5 μm, c) a maximum pore diameter of no more than 4 μm, d) a crushing strength of at least 50 N, and e) a disintegration time of 12-18 minutes for a tablet with a total weight of 300-500 mg comprising at least 60% (w/w) salt of NAC. Dependent claims include additional formulations of the tablet (claims 2-10). The specification of US ‘430 indicates that tablets of the invention can be used for treating type 2 diabetes or obesity (Col. 2, lines 5-7).
US ‘430 does not teach treating a subject with T2D and PAD wherein the treatment increases the subject’s maximum walking distance by 13%.
As described above, Hathaway teaches a method of treating intermittent claudication in a subject in who has PAD through administration of a GLP-1 molecule, which leads to improvements in the maximum walking distance; diabetes is a significant risk factor for PAD; and the dosage of GLP-1 administered is dependent upon a number of factors evaluated by medical caregiver and can be adjusted so as to increase the maximum walking distance.
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Hathaway into US ‘430, thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Hathaway teaches that diabetes is a risk factor for PAD, and, thus, by treating T2D, one would necessarily treat the physiological conditions that lead to PAD. Thus, the claims are obvious in view of US ‘430.
Claims 1, 8, 9, and 25-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-9, and 18 of copending Application No. 18/815,630 (copending Application No. ‘630, reference application; claim set filed 8/26/2024) in view of Hathaway et al. (US20030073626A1, published 4/17/2003).
Claim 1 recites a liquid pharmaceutical composition comprising semaglutide, an isotonic agent, and histidine, wherein the concentration of the histidine is 0.5-100mM and wherein the pH of the composition is in the range of 6.0-10.0.
Dependent claims include the concentration of semaglutide in the composition (claims 7-9) and a method of treating diabetes and/or obesity (claim 18).
Copending Application No. ‘630 does not teach treating a subject with T2D and PAD wherein the treatment increases the subject’s maximum walking distance by 13%.
As described above, Hathaway teaches a method of treating intermittent claudication in a subject in who has PAD through administration of a GLP-1 molecule, which leads to improvements in the maximum walking distance; diabetes is a significant risk factor for PAD; and the dosage of GLP-1 administered is dependent upon a number of factors evaluated by medical caregiver and can be adjusted so as to increase the maximum walking distance.
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Hathaway into copending Application No. ‘630, thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Hathaway teaches that diabetes is a risk factor for PAD, and, thus, by treating T2D, one would necessarily treat the physiological conditions that lead to PAD. Thus, the claims are obvious in view of copending Application No. ‘630.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 8, 9, 12-19 and 25-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-16, 18-22, 24-25, 29, 31-33 and 35 of copending Application No. 19/023,039 (copending Application No. ‘039, reference application; claim set filed 6/6/2025), as evidenced by Jakubiak et al. (Chronic Lower Extremity Ischemia and Its Association with the Frailty Syndrome in Patients with Diabetes. Int J Environ Res Public Health. 2020 Dec 14;17(24):9339.), and in view of Hathaway et al. (US20030073626A1, published 4/17/2003).
Independent claim 15 of copending Application No. ‘039 recites a method for reducing the risk of one or more major adverse cardiovascular events selected from cardiovascular (CV) death, non-fatal myocardial infarction (MI), and non-fatal stroke, in a subject who has type 2 diabetes mellitus and high cardiovascular risk, comprising: subcutaneously administering semaglutide to a subject in need thereof who has type 2 diabetes mellitus and high cardiovascular risk, wherein the semaglutide is administered once weekly by subcutaneous injection of an effective amount of about 0.2-2.0 mg semaglutide, wherein the subject has one or both clinical evidence of cardiovascular disease prior to treatment and subclinical evidence of cardiovascular disease prior to treatment. Independent claims 20, 25, and 32 recite the above method with different dosages administered (0.5, 1.0, and 2.0mg, respectively).
Dependent claims include the clinical evidence of cardiovascular disease comprises one or more selected from prior peripheral arterial revascularization (claims 16, 22, 29, and 33), the subclinical evidence comprises one or more selected from ankle-brachial index <0.9 (claims 18, 24, 31, and 35), and the method of administration and dosage (claims 19, 21, and 26-27).
Jakubiak indicates that revascularization surgery can be used to treat PAD (Pg 6, “5. Revascularization treatment” section); thus, wherein the cardiovascular disease comprises peripheral arterial revascularization reads on patients with PAD.
Copending Application No. ‘039 does not teach treating a subject with T2D and PAD wherein the treatment increases the subject’s maximum walking distance by 13%.
As described above, Hathaway teaches a method of treating intermittent claudication in a subject in who has PAD through administration of a GLP-1 molecule, which leads to improvements in the maximum walking distance; moreover, the dosage of GLP-1 administered is dependent upon a number of factors evaluated by medical caregiver and can be adjusted so as to increase the maximum walking distance.
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Hathaway into copending Application No. ‘039, thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Hathaway teaches administering a GLP-1 such as semaglutide to improve or increase the maximum walking distance in subjects with T2D and PAD. Thus, the claims are obvious in view of copending Application No. ‘039.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3, 4, 8-10, 12-19 and 25-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 8 of U.S. Patent No. 12,569,543 (US ‘543, previously copending Application No. 16/097,032), as evidenced by Jakubiak et al. (Chronic Lower Extremity Ischemia and Its Association with the Frailty Syndrome in Patients with Diabetes. Int J Environ Res Public Health. 2020 Dec 14;17(24):9339.), and in view of Hathaway et al. (US20030073626A1, published 4/17/2003).
Independent claim 1 recites a method of reducing the risk of a major adverse cardiovascular event (MACE) comprising: administering by subcutaneous injection a pharmaceutical composition comprising semaglutide in a therapeutically effective amount of 0.05-2.0 mg once weekly to a subject in need thereof, wherein the subject has type 2 diabetes and cardiovascular disease; and wherein the MACE is selected from the group consisting of CV (cardiovascular death), non-fatal MI (myocardial infarction), and non-fatal stroke.
Dependent claim 2 specifies that clinical evidence of cardiovascular disease is selected from the group consisting of prior peripheral arterial revascularization and subclinical evidence of cardiovascular disease is selected from the group consisting of ankle/brachial index <0.9. Jakubiak indicates that revascularization surgery can be used to treat PAD (Pg 6, “5. Revascularization treatment” section); thus, wherein the cardiovascular disease comprises peripheral arterial revascularization reads on patients with PAD.
Independent claim 8 recites a method of reducing the risk of a major adverse cardiovascular event (MACE) comprising: administering by subcutaneous injection a pharmaceutical composition comprising semaglutide in a therapeutically effective amount of 0.05-2.0mg once weekly to a subject in need thereof; wherein the subject has type 2 diabetes and cardiovascular disease; wherein the MACE is selected from the group consisting of CV (cardiovascular) death, non-fatal MI (myocardial infarction), and non-fatal stroke; wherein the cardiovascular disease is selected from the group consisting of prior myocardial infarction; prior stroke or transient ischemic attack; prior coronary, carotid, or peripheral arterial revascularization; >50% stenosis on angiography or imaging of coronary, carotid, or lower extremity arteries; history of symptomatic coronary heart disease; asymptomatic cardiac ischemia; heart failure; and chronic renal impairment by estimated glomerular filtration rate <60mL/min/1.73m^2 per MDRD.
US ‘543 does not teach treating a subject with T2D and PAD wherein the treatment increases the subject’s maximum walking distance by 13%.
As described above, Hathaway teaches a method of treating intermittent claudication in a subject in who has PAD through administration of a GLP-1 molecule, which leads to improvements in the maximum walking distance; moreover, the dosage of GLP-1 administered is dependent upon a number of factors evaluated by medical caregiver and can be adjusted so as to increase the maximum walking distance.
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Hathaway into US ‘543, thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Hathaway teaches administering a GLP-1 such as semaglutide to improve or increase the maximum walking distance in subjects with T2D and PAD. Thus, the claims are obvious in view of US ‘543.
Claims 1, 3, 4, 8-10, 12-19 and 25-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-17, 19-26, 28-35, 37-41, and 43-44 of copending Application No. 19/197,677 (copending Application No. ‘677, reference application; claim set filed 2/12/2026), as evidenced by Jakubiak et al. (Chronic Lower Extremity Ischemia and Its Association with the Frailty Syndrome in Patients with Diabetes. Int J Environ Res Public Health. 2020 Dec 14;17(24):9339.), and in view of Hathaway et al. (US20030073626A1, published 4/17/2003).
Independent claim 15 recites a method of reducing the risk of non-fatal stroke in a subject who has type 2 diabetes mellitus and cardiovascular disease comprising: subcutaneously administering semaglutide to a subject in need thereof who has type 2 diabetes mellitus and cardiovascular disease, wherein the semaglutide is administered once weekly by subcutaneous injection of an effective amount of about 0.2-2.0mg semaglutide, wherein the subject has one or both of clinical evidence of cardiovascular disease prior to treatment and subclinical evidence of cardiovascular disease prior to treatment. Independent claims 23, 30, and 39 recite the above method with different dosages administered (0.5, 1.0, and 2.0mg, respectively).
Dependent claims include the clinical evidence of cardiovascular disease comprises one or more selected from prior peripheral arterial revascularization (claims 16, 17, 25, 26, 34, 35, 40, and 41), the subclinical evidence of cardiovascular disease comprises one or more selected from an ankle/brachial index <0.9 (claims 19, 20, 28, 29, 37, 38, 43, and 44), the dosage of semaglutide administered (claims 21, 22, 24, and 31-33).
Jakubiak indicates that revascularization surgery can be used to treat PAD (Pg 6, “5. Revascularization treatment” section); thus, wherein the cardiovascular disease comprises peripheral arterial revascularization reads on patients with PAD.
Copending Application No. ‘677 does not teach treating a subject with T2D and PAD wherein the treatment increases the subject’s maximum walking distance by 13%.
As described above, Hathaway teaches a method of treating intermittent claudication in a subject in who has PAD through administration of a GLP-1 molecule, which leads to improvements in the maximum walking distance; moreover, the dosage of GLP-1 administered is dependent upon a number of factors evaluated by medical caregiver and can be adjusted so as to increase the maximum walking distance.
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Hathaway into copending Application No. ‘677, thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Hathaway teaches administering a GLP-1 such as semaglutide to improve or increase the maximum walking distance in subjects with T2D and PAD. Thus, the claims are obvious in view of copending Application No. ‘677.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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