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
Applicant’s election without traverse of Group I, claims 1-3, 6-15, 17, 19, 41 and 67, drawn to method of treatment comprising administering pemvidutide; and Applicants’ species election of NASH in the reply filed on March 24, 2026 is acknowledged.
The species elected on March 24, 2026 has been examined, according to the elected species of disease to be treated - NASH, and the remaining species that are claimed or specifically disclosed are withdrawn from consideration.
Status of Claims
Claims 1-3, 6-15, 17, 19, 41, 67 and 73-75 were originally filed on December 19, 2023.
The amendment filed on March 24, 2026, cancelled claims 73-75. Claims 1, 14, 15, 17 and 41 are amended.
Claims 1-3, 6-15, 17, 19, 41 and 67 are pending.
Claims 1-3, 6-15, 17, 19, 41 and 67 are currently examined on the merits herein.
Priority
This application claims priority to U.S. Provisional Appin. Ser. No. 63/406,681 filed September 14, 2022; U.S. Provisional Appln. Ser. No. 63/422,98 1 filed November 5, 2022; U.S. Provisional Appln. Ser. No. 63/476,370 filed December 20, 2022 and U.S. Provisional Appln. Ser. No. 63/490,465 filed March 15, 2023.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on March 5, 2024 and February 17, 2025 comply with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: unit is missing after the number 12 in the recitation “human being in need thereof for at least about 12”. Based on the claims filed on December 19, 2023, it is deduced the word “weeks” is missing after 12.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 3, 14, 15, and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 2, 3, 14, 15, and 17, the instant specification does not define “baseline”, thereby rendering the scope of these claims indefinite. The language is indefinite because it is not clear whether the baseline is the starting weight of the human being or some other measure of baseline or any other experimental parameter. There is no early recitation of “baseline”; thus, it is unclear what the claim limitation is referencing.
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.
Claims 1-3, 6-15, 17, 19, 41 and 67 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2022125598 (published 06/16/2022, IDS filed on 03/05/2024).
For claim 1, WO’598 teaches a method for lowering blood glucose, lowering the body weight, and/or reducing liver fat of a human being the method comprising administering to the human being a once weekly therapeutic effective amount of a pharmaceutical dosage formulation comprising SEQ ID NO: 1 (see claim 1). WO’598 discloses SEQ ID NO: 1 (EU-A1873 of Table 1; also known as ALT-801 or pemvidutide) has the following amino acid sequence:
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35
406
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(see Table 1, [0031]). WO’598 further specifies SEQ ID NO: 1 is a peptide amide consisting of 29 amino acid residues and a glucuronic acid/C18 diacid moiety attached to 17Lys, in which the side-chains of 16Glu and 20Lys forming an intramolecular cycle as shown below:
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137
421
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(see [0031]).
WO’598 teaches the SEQ ID NO: 1, which encompasses the instantly claimed Pemvidutide, thereby anticipating claim 1.
WO’598 describes the method is a first line treatment for blood glucose control, obesity, NAFLD, NASH, and/or steatosis (see claim 6). WO’598 illustrates the weight loss results following weekly administration of ALT-801 (Pemvidutide) after 6 and 12 week treatment across the different dose groups (1.2 mg, 1.8 mg and 2.4 mg) (see Figure 2, [0016]) and the absolute change in liver fat levels at six weeks post-treatment with ALT-801 (1.8 or 2.4 mg treatments) in all steatosis subjects as compared to placebo (see Figure 9, [0023]) with the results show that ALT-801 reduced liver fat in the subjects, including those having steatosis (fatty liver disease) (see [00165]).
Regarding the preamble’s disclosure of a “method of reducing body weight in a human being”, the recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
For claims 2 and 3, WO’598 claims a pharmaceutical dosage formulation comprising about 1.8 mg SEQ ID NO: 1 is administered to the human being once per week for at least six weeks and results in at least about 3-5% whole-body weight loss (see claim 25), the net change in whole-body weight loss as compared to placebo is at least about 3% (see claim 28), wherein the weight of the human being is reduced by at least 6% from baseline at week 12; by at least 7% from baseline at week 12; by at least 8% from baseline at week 12; by at least 9% from baseline at week 12 or by at by at least 10% from baseline at week 12 (see claim 31).
Regarding claims 2 and 3, the intended use limitation “the body weight of the human being is reduced” does not confer any structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Since, the composition disclosed by WO’598 is capable of performing the intended use, WO’598 anticipates a composition comprising a pharmaceutical dosage formulation comprising pemvidutide. In re Spada [MPEP 2112.01].
Also, WO’598 specifies that the pharmaceutical dosage formulation of such dual agonist peptide(s) configured for treatment of chronic weight management. In embodiments is provided a treatment for chronic weight management of a human being with a body mass index (BMI kg/m2) of at least 25 by inducing weight loss in the human being, the method comprising administering to the human being a once weekly therapeutic effective amount of a pharmaceutical dosage formulation comprising SEQ ID NO: 1, wherein the weight of the human being is reduced by at least 5% (preferably from at least about 5% to about 10%) from baseline at week 12 (see [0013]). WO’598 further illustrates the absence of correlation between weight loss and BMI (Body Mass Index) (see [0019], Figure 5B). Since, the composition disclosed by WO’598 is capable of performing the intended use, WO’598 anticipates a composition comprising a pharmaceutical dosage formulation comprising pemvidutide.For claim 6, WO’598 illustrates the weight loss results following weekly administration of ALT-801 (Pemvidutide) after 6 and 12 week treatment across the different dose groups (1.2 mg, 1.8 mg and 2.4 mg) versus placebo group (see Figure 2, [0016]). WO’598 discloses the study were assigned to receive one of three subcutaneous doses of Pemvidutide (1.2 mg, 1.8 mg and 2.4 mg) or placebo once weekly for 12 weeks (see [00139]).
Regarding claim 6, the intended use limitation “the pemvidutide is administered” does not confer any structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Since, the composition disclosed by WO’598 is capable of performing the intended use, WO’598 anticipates a composition comprising a pharmaceutical dosage formulation comprising pemvidutide. In re Spada [MPEP 2112.01].For claim 7, WO’598 discloses steady state is assessed by comparison of trough concentrations from the first to the last dose (see [00127]). WO’598 teaches reduction of Liver fat by treatment with ALT-801 describing a study assessing the effects of ALT-801 on hepatic fat fraction in human subjects once weekly for 2 weeks (weeks 3 and 4) (see Example 8, [00163], [00164]). WO’598 further teaches in some embodiments, this disclosure provides pharmaceutical dosage formulations configured for administering to the mammal the agonist peptide product (e.g., SEQ ID NO: 1), in some embodiments, this disclosure provides pharmaceutical dosage formulations configured such that the time to reach a therapeutic dose is about four weeks or less (see [0069]).
For claims 8 and 9, WO’598 discloses in some embodiments, the human being to whom the pharmaceutical dosage is administered has type 2 diabetes mellitus. WO’598 adds that in some embodiments, the human being can exhibit established cardiovascular disease, with or without type 2 diabetes mellitus (see [0072]). WO’598 describes ALT-801 or placebo is administered by subcutaneous (SC) injection (preferably in the abdomen) once weekly for up to 12 doses to patients with type 2 diabetes mellitus (see Example 6, [00145]). WO’598 further specifies subjects will be stratified by presence or absence of diabetes at baseline (see [00156]).
For claims 10 and 11, WO’598 teaches the study is designed to assess the safety and tolerability of single and repeated subcutaneous doses of ALT-801 in healthy overweight and obese subjects (BMI 25.0 – 40.0 kg/m2) (see Table 5 & 6, [00104]). WO’598 describes a Phase 1, randomized, double-blind, placebo-controlled, parallel group study to assess the safety of ALT-801 and its effects on hepatic fat fraction, anthropometric parameters, lipid metabolism, inflammatory markers and fibrosis markers in diabetic and non-diabetic overweight and obese (body mass index [BMI] 28.0-40.0 kg/m2) subjects with Non-alcoholic Fatty Liver Disease (NAFLD) (see [00155]). WO’598 further teaches in certain embodiments, ALT-801 (also known as Pemvidutide) may be used as a treatment for chronic weight management in obese (i.e., BMI of 30 or greater) (see [00138]).
For claim 12, WO’598 discloses wherein the suitable subjects are those with NAFLD measured by magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) ≥ 10% (see [00156]).
For claim 13 , WO’598 claims the weight of the human being is reduced by at least 6% from baseline at week 12; by at least 7% from baseline at week 12; by at least 8% from baseline at week 12; by at least 9% from baseline at week 12 or by at by at least 10% from baseline at week 12 (see claim 31).
Regarding claim 13, the intended use limitation “an absolute reduction in liver fat” does not confer any structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Since, the composition disclosed by WO’598 is capable of performing the intended use, WO’598 anticipates a composition comprising a pharmaceutical dosage formulation comprising pemvidutide. In re Spada [MPEP 2112.01].
For claim 14, WO’598 teaches the pharmacodynamic (PD) endpoints include changes in hepatic fat fraction by MRI-PDFF compared to baseline (relative and absolute % change, proportion of subjects achieving 30%, 40% and 50% relative reductions in hepatic fat fraction, proportions of subjects with normalization of liver fat) (see [00157]). WO’598 further discloses the relative reduction in liver fat as measured by MRI-PDFF compared to baseline is about 40% to about 70% after 12 weeks of the once weekly dosing (see Table 1920, [00164]).
Regarding claim 15, the intended use limitation is “a relative reduction in liver fat” or “defatting of the human liver” does not confer any structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Since, the composition disclosed by WO’598 is capable of performing the intended use, WO’598 anticipates a composition comprising a pharmaceutical dosage formulation comprising pemvidutide. In re Spada [MPEP 2112.01].
Regarding claim 17, the intended use limitation is “defatting of the human liver” does not confer any structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Since, the composition disclosed by WO’598 is capable of performing the intended use, WO’598 anticipates a composition comprising a pharmaceutical dosage formulation comprising pemvidutide. In re Spada [MPEP 2112.01].
Regarding claim 19, the intended use limitation is “alanine aminotransferase (ALT) is reduced” does not confer any structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Alanine aminotransferase (ALT) reduction implies reduction in hepatic fat fraction…. and greater improvement in NASH-related alanine aminotransferase (ALT) reduction as explained by WO’598 (see [00154]). Since, the composition disclosed by WO’598 is capable of performing the intended use, WO’598 anticipates a composition comprising a pharmaceutical dosage formulation comprising pemvidutide. In re Spada [MPEP 2112.01].For claim 41, WO’598 discloses methods for lowering the blood glucose and/or lowering the body weight of a human being, the method comprising administering to the human being a pharmaceutical dosage formulation comprising SEQ ID NO: 1. In certain embodiments, this disclosure provides pharmaceutical dosage formulation of such dual agonist peptide(s) configured for treatment of chronic weight management. In embodiments is provided a treatment for chronic weight management of a human being with a body mass index (BMI kg/m.sup.2) of at least 25 by inducing weight loss in the human being, the method comprising administering to the human being a once weekly therapeutic effective amount of a pharmaceutical dosage formulation comprising SEQ ID NO: 1, wherein the weight of the human being is reduced by at least 5% (preferably from at least about 5% to about 10%) from baseline at week 12. (see [0012]-[0013]). WO’598 illustrates the absolute change in liver fat levels at six weeks post-treatment with ALT-801 (1.8 or 2.4 mg treatments) in all steatosis subjects as compared to placebo (see [0023], Figure 9). WO’598 further shows robust changes (mean relative change of greater than 90%) in liver fat content as determined by MRI-PDFF in subjects with MRI-PDFF > 5% at baseline following six weeks of treatment with ALT-801 at 1.8 and 2.4 mg (see [00165]). W)’598 exemplifies a Phase 1, randomized, double-blind, placebo-controlled, parallel group study to assess the safety of ALT-801 and its effects on hepatic fat fraction, anthropometric parameters, lipid metabolism, inflammatory markers and fibrosis markers in diabetic and non-diabetic overweight and obese (body mass index [BMI] 28.0-40.0 kg/m2) subjects with Non-alcoholic Fatty Liver Disease (NAFLD). This study is designed to assess changes in hepatic fat fraction by MRI-PDFF in diabetic and non-diabetic overweight and obese subjects with NAFLD after 12 weeks of ALT-801 treatment (see [00155]). WO’598 specifies suitable subjects are those with NAFLD without significant fibrosis, magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) ≥ 10% (see [00156]).
For claim 67, WO’598 teaches SEQ ID NO: 1 is formulated as ALT-801, in glass vials in a sterile, buffered aqueous solution (e.g., about 0.050% (w/w) polysorbate 20, about 0.348% (w/w) arginine, about 4.260% (w/w) mannitol in deionized water (pH 7.7 ± 0.1)) and comprising SEQ ID NO: 1 at a final concentration of 2.5 mg/mL. The volume of administration is based on the selected dose and a concentration of 2.5 mg/mL for the final drug product [00115].
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 1-3, 6-15, 17, 19, 41 and 67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 7, 10-12, and 15-19 of U.S. Patent No. 12171806.
Claims 1-3, 6-15, 17, 19, 41 and 67 of this application are patentably indistinct from claims 1-4, 6, 7, 10-12, and 15-19 of U.S. Patent No. 12171806.
Claims 1-4, 6, 7, 10-12, and 15-19 of the ‘806 patent recite a method comprising administering SEQ ID NO: 1 (or pemvidutide in the instant application) A method for reducing body weight of a human being in need thereof comprising administering to the human being a once weekly therapeutic effective amount of a pharmaceutical dosage formulation comprising SEQ ID NO: 1 for at least 12 weeks (see claim 1), wherein the method induces liver fat loss (see claim 2), wherein the method is a treatment for blood glucose control (see claim 2), wherein the method does not comprise a treatment initiation phase to titrate a therapeutic dose of the pharmaceutical dosage formulation (see claim 4), wherein the BMI of the human being is at least 30 kg/m2 (see claim 15), wherein liver fat is reduced (see claim 19).
The claims 1-4, 6, 7, 10-12, and 15-19 of the ‘806 patent differ from the instantly claimed invention in that the ‘806 patent includes pharmaceutical dosage and composition and method of reducing liver fat but does not specifically include the disease condition NASH.
As both sets of claims recite regarding administration of composition of SEQ ID NO: 1 or pemvidutide, even though they are not exactly matching, they are overlapping in scope. Thus rendering one set of claims to be unpatentable.
This is a nonstatutory double patenting rejection.
Claims 1-3, 6-15, 17, 19, 41 and 67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 62-65 of Application No. 18/503065.
Claims 1-3, 6-15, 17, 19, 41 and 67 of this application are patentably indistinct from claims 62-65 of co-pending Application No. 18/503065.
Claims 62-65 of the co-pending application recite a pharmaceutical composition comprising: SEQ ID NO: 1 and, about 0.20% (w/w) polysorbate 20, about 0.348% (w/w) arginine,and about 4.260% (w/w) mannitol in sterile water (pH 7.7 ± 0.1) (see claim 62); wherein the composition comprises about 1.2 mg, about 1.8 mg, or about 2.4 mg of SEQ ID NO: 1 (see claim 63).
The claims 62-65 of the ‘065 application differ from the instantly claimed invention in that the ‘065 application includes only the pharmaceutical composition for reducing body weight in a human being.
As both sets of claims recite regarding composition of SEQ ID NO: 1 or pemvidutide, even though they are not exactly matching, they are overlapping in scope. Thus rendering one set of claims to be unpatentable.
This is a nonstatutory double patenting rejection.
Claims 1-3, 6-15, 17, 19, 41 and 67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 40, 42, 43, 46, 48, 49, and 54 of Application No. 19/076984.
Claims 1-3, 6-15, 17, 19, 41 and 67 of this application are patentably indistinct from claims 3, 40, 42, 43, 46, 48, 49, and 54 of co-pending Application No. 19/076984.
Claims 3, 40, 42, 43, 46, 48, 49, and 54 of the co-pending application recite a method for treatment comprising, administering to the human being a once weekly therapeutically effective amount of a pharmaceutical dosage formulation comprising at least 1.2 mg and up to 2.4 mg of a peptide product according to SEQ ID NO: 1 or peptide product that is at least 80% identical to a peptide of SEQ ID NO: 1 (see claims 3 and 40); wherein the peptide product is at least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98% or at least 99% identical to a peptide of SEQ ID NO: 1 (see claim 42); wherein the peptide product is 100% identical to a peptide of SEQ ID NO: 1 (see claim 43); and wherein the pharmaceutical dosage formulation comprises about 0.025-0.5% (w/w) polysorbate 20, about 0.2-0.5% (w/w) arginine, and about 3-6% (w/w) mannitol in water (pH 7.7 ± 0.1) (see claim 46), wherein the human being is obese or overweight (see claim 48), wherein the human being in need thereof has a body mass index (BMI kg/m2) of at least 25 (claim 49), wherein the treatment reduces relative body weight by about at least 10%, by at least 15% or by at least 20% (see claim 54).
The claims 3, 40, 42, 43, 46, 48, 49, and 54 of the ‘984 application differ from the instantly claimed invention in that the ‘984 application includes method for treatment of chronic weight management and reducing serum lipids.
As both sets of claims recite regarding composition of GLP-1R and GCGR agonist pemvidutide (a composition comprising SEQ ID NO.: 1), even though they are not exactly matching, they are overlapping in scope. Thus rendering one set of claims to be unpatentable.
This is a nonstatutory double patenting rejection.
Claims 1-3, 6-15, 17, 19, 41 and 67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 40, 45, 46, 47, 48-51, and 53-55 of Application No. 18/943449.
Claims 1-3, 6-15, 17, 19, 41 and 67 of this application are patentably indistinct from claims 40, 45, 46, 47, 48-51, and 53-55 of co-pending Application No. 18/943449.
Claims 40, 45, 46, 47, 48-51, and 53-55 of the co-pending application recite a method for treatment comprising administering to the human being once weekly therapeutic effective amount of a pharmaceutical dosage formulation comprising SEQ ID NO: 1 (see claims 40); wherein the pharmaceutical dosage is an aqueous formulation comprising one or more of polysorbate 20, arginine, or mannitol (see claim 45); wherein the pharmaceutical dosage formulation comprises polysorbate 20, about 0.2-0.5% (w/w) arginine, and about 3-6% (w/w) mannitol in water (pH 7.7 ± 0.1) (see claim 46); wherein the pharmaceutical dosage formulation comprises about polysorbate 20, about 0.348% (w/w) arginine, about 4.260% (w/w) mannitol in water (pH 7.7 ± 0.1) (see claim 47); wherein the human being in need thereof has a body mass index (BMI kg/m2) of at least 25 (see claim 48); wherein the human being in need thereof has a body mass index (BMI kg/m2) of at least 30 (see claim 49); wherein the pharmaceutical dosage formulation is administered weekly for at least 12 weeks (see claim 53); comprising administering to the human being a once weekly therapeutic effective amount of a pharmaceutical dosage formulation comprising SEQ ID NO: 1, polysorbate 20, about 0.348% (w/w) arginine, about 4.260% (w/w) mannitol in water (pH 7.7 ± 0.1) (see claim 54); wherein the treatment reduces liver fat (see claim 55).
The claims 40, 45, 46, 47, 48-51, and 53-55 of the ‘449 application differ from the instantly claimed invention in that the ‘449 application includes method to reduce excess body weight and maintain weight reduction in treatment of chronic weight management, reduce liver fat, and lower blood glucose.
As both sets of claims recite regarding composition of GLP-1R and GCGR agonist ALT-801 (Pemvidutide), even though they are not exactly matching, they are overlapping in scope. Thus rendering one set of claims to be unpatentable.
This is a nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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/KOYELI BANERJEE/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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