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species of disease to be treated - NASH, and the remaining species that are claimed or specifically disclosed are withdrawn from consideration.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, and 67 are pending in the present application. Claims 4-5, 16, 18, 20-40, 42-66, and 68-75 were previously canceled. Claims 1-3, 14, 15, 17, and 19 are herein amended to clarify embodiments, filed on June 15, 2026.
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.
Withdrawn Objections/Rejections
The objection to the specification is withdrawn in view of the amendment to the informalities in claim 1; the word “weeks” is added after “about 12”.
The 35 USC 112(b) rejection over claims 2, 3, 14, 15, and 17 are withdrawn in view of the amended claim now recites a generic experimental parameter.
Claim Rejections - 35 USC § 102 (modified)
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 and 67 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2021168386 (published 08/26/2021).
For claim 1; WO’386 teaches a method for inducing weight loss in a mammal, the method comprising administering pharmaceutical dosage formulation (see claim 31); when the method is for treating NASH (see claim 30); wherein the pharmaceutical dosage is administered about weekly (see claim 34); a pharmaceutical dosage formulation comprising an agonist peptide product (see claim 1); wherein administration of the dosage formulation to a mammal: induces whole-body weight loss; and/or, induces liver weight loss….induces greater whole-body weight loss, optionally about twice thereof; induces lower body fat mass, optionally about 50 to 100% lower; and/or, when administered to treat NASH induces increased whole-body weight reduction, liver weight loss (see claim 13); wherein the dosage is configured as a weekly dosage form (see claim 14); with planned dose levels of …1.2, 2.4 mg….. (equivalent to a weekly dose administered once every 7 days) (see [00345]); for a total of 12 weeks (see [00266]; in further embodiments, a dual agonist peptide product described herein is used to treat fatty liver disease (FLD); in some embodiments, the FLD is non-alcoholic fatty liver disease (NAFLD); in certain embodiments, the NAFLD is non-alcoholic steatohepatitis (NASH), FLD, also known as hepatic steatosis, is characterized by excessive fat accumulation in the liver (see [0074]).
WO’386 discloses SEQ ID NO: 1 (EU-A1873 of Table 1; also known as ALT-801) has the following amino acid sequence:
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35
406
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(see Table 1, [0046]). WO’386 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 [0046]).
WO’386 teaches the SEQ ID NO: 1 or ALT-801, which encompasses the instantly claimed Pemvidutide, thereby anticipating claim 1.
For claim 67; WO’386 teaches ALT-801 is formulated in glass vials in a sterile, buffered aqueous solution to a final concentration of 2.5 mg/mL …and administered as a subcutaneous injection (see [00345]).
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. WO’386 teaches, a dual agonist peptide product used to treat fatty liver disease (FLD); in some embodiments, the FLD is non-alcoholic fatty liver disease (NAFLD); in certain embodiments, the NAFLD is non-alcoholic steatohepatitis (NASH) (see [0074]). WO’386 discloses the dosage is configured to control blood glucose and/or induce weight loss (see [0080] and claim 2); the pharmaceutical dosage formulation wherein administration of the dosage formulation to a mammal induces whole-body weight loss, and/or induces liver weight loss (see claim 13); induces greater whole-body weight loss, and/or, when administered to treat NASH induces increased whole-body weight reduction, liver weight loss (see claim 13); the pharmaceutical dosage formulation wherein administration thereof to a mammal results weight loss in an obese mammal sufficient to return the mammal the normal weight range of a lean normal mammal (see claim 15); wherein the dosage is configured to administer to a human (see claim 54). Thus, since the composition disclosed by WO’386 is capable of performing the intended use, WO’386 anticipates a composition comprising a pharmaceutical dosage formulation comprising pemvidutide. In re Spada [MPEP 2112.01].
Claim Rejections - 35 USC § 103 (modified)
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.
Claims 1-3, 6-15, 17, 19, 41, and 67 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021168386 (published 08/26/2021).
The teachings of WO’386 are discussed above.
Regarding claim 1; WO’386 teaches a method for inducing weight loss in a mammal, the method comprising administering pharmaceutical dosage formulation (see claim 31); when the method is for treating NASH (see claim 30); wherein the pharmaceutical dosage is administered about weekly (see claim 34); a pharmaceutical dosage formulation comprising an agonist peptide product (see claim 1); wherein administration of the dosage formulation to a mammal: induces whole-body weight loss; and/or, induces liver weight loss….induces greater whole-body weight loss, optionally about twice thereof; induces lower body fat mass, optionally about 50 to 100% lower; and/or, when administered to treat NASH induces increased whole-body weight reduction, liver weight loss (see claim 13); wherein the dosage is configured as a weekly dosage form (see claim 14); with planned dose levels of …1.2, 2.4 mg….. (equivalent to a weekly dose administered once every 7 days) (see [00345]); for a total of 12 weeks (see [00266]; in further embodiments, a dual agonist peptide product described herein is used to treat fatty liver disease (FLD); in some embodiments, the FLD is non-alcoholic fatty liver disease (NAFLD); in certain embodiments, the NAFLD is non-alcoholic steatohepatitis (NASH), FLD, also known as hepatic steatosis, is characterized by excessive fat accumulation in the liver (see [0074]).
WO’386 discloses SEQ ID NO: 1 (EU-A1873 of Table 1; also known as ALT-801), which encompasses the instantly claimed Pemvidutide.
Regarding claims 2 and 3; WO’386 discloses the pharmaceutical dosage formulation, wherein weight loss is at least 5%, at least 10%; or from about 1% to about 20%; or from about 5% to about 10% (see claim 50). WO’386 studied a summary of change from baseline at each protocol specified time point by treatment group …. pharmacokinetics includes individual ALT-801 concentration …..the effects of baseline BMI on pharmacokinetics parameters are evaluated by correlation analyses (see [00356]); for a total of 12 weeks of QD dosing (see [00265]).
Regarding claims 6 and 7; WO’386 teaches the pharmaceutical dosage formulation to administer to a human between about 1 to 5 mg per week. (see claim 26); wherein administration to a mammal of a weekly dose for …. results in greater whole- body weight loss at about 1 week, about 2 weeks, about 3 weeks, about 4 weeks…. following administration (see claim 6).
Regarding claims 8 and 9; WO’386 teaches in some embodiments, the human being to whom the pharmaceutical dosage is administered has type 2 diabetes mellitus; in some embodiments, the human being can exhibit established cardiovascular disease, with or without type 2 diabetes mellitus (see [0090]).
Regarding claims 10 and 11; WO’386 discloses study is designed to assess the safety and tolerability of single and repeated SC doses of ALT-801 in healthy overweight and obese subjects (BMI 25.0 – 40.0 kg/m2) (see [00333]).
Regarding claims 12-15; WO’386 teaches the study assessments, including liver fat content by MRI-PDFF (see [00335]); MRI-PDFF is a quantitative imaging biomarker that enables accurate, repeatable and reproducible quantitative assessment of liver fat over the entire liver (see [00348]). WO’386 discloses lower body fat mass (optionally at least about any of 10, 20, …); greater loss in body weight by approximately 14 days (see [0082]); a pharmaceutical dosage formulation of any preceding aspect, wherein weight loss is at least 5%, at least 10%; or from about 1% to about 20%; or from about 5% to about 10% (see [0096]); the pharmaceutical dosage is administered to the human being about weekly from about 2 weeks to about 8 weeks, or longer (see [0091]); in some embodiments, a sustained-release composition delivers a peptide product over a period of at least about 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months or longer (see [0071]); In some embodiments, a dual agonist peptide product is administered chronically to treat a condition disclosed herein, such as at least about 2 months, 3 months, 6 months (see [0077]); induces greater whole-body weight loss, optionally about twice thereof; induces lower body fat mass, optionally about any of 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100% lower, preferably at least about 100% lower); and/or, when administered to treat NASH induces increased whole-body weight reduction, liver weight loss, improved NAS score, improved hepatosteatosis (see [0080]). WO’386 further teaches in some embodiments, administration to a human being with a body mass index (BMI) indicative of obesity (e.g., about 30 or higher) exhibit a decrease in body weight of about 5-20%, such as about 15%, for an appropriate time (e.g., after any of about two, four, eight, 10, 20, or 30- 100 weeks, such as about any of 50, 60, or 70 weeks); in preferred embodiments, the weight loss in such human beings is significant (e.g., P<0.001, 95% confidence interval (CI)); in some preferred embodiments, within about four weeks, administration to a human being results in at least about a 2-5% reduction in body weight, and in some embodiments continues and/or stabilizes until administration ceases (see [0091]), and the percent change achieved in the ALT-801 10 nmol/kg group (both p<0.0001) (see [00269]); including ALT-801 treated mice (p<0.0001 and p<0.01, respectively) (see [00270]).
Regarding claims 19 and 41; WO’386 teaches the pharmaceutical dosage formulation of any preceding claim wherein: administration of the dosage formulation to a mammal: induces whole-body weight loss; and/or, induces liver weight loss; exhibits about equal or greater glucoregulatory effects; induces greater whole-body weight loss, optionally about twice thereof; induces lower body fat mass, optionally about 50 to 100% lower; and/or, when administered to treat NASH induces increased whole-body weight reduction, liver weight loss, improved NAS score, improved hepatosteatosis, improved ballooning, improved col1A1 staining, improved ALT (see claim 13); administration to a human being with a body mass index (BMI) indicative of obesity (e.g., about 30 or higher) exhibit a decrease in body weight of about 5-20%, such as about 15%, for an appropriate time (e.g., after any of about two, four, eight, 10, 20 weeks (see [0091]); in certain embodiments, the one or more additional therapeutic agents for treatment of NAFLD (e.g., NASH) (see [0078]); repeated doses of ALT-801 in healthy overweight and obese subjects (BMI 25.0 – 40.0 kg/m2) and to characterize the effective dose range (see [00334]); dose levels are planned: …. 1.2, 2.4 mg…. as a weekly dose administered once a week (see [00336]). WO’386 teaches the study assessments, including liver fat content by MRI-PDFF, and subjects are provided a standardized diet during the inpatient periods at the research unit, with daily calories are individualized ….standardized at … 30-40% fat (see [00349]).
Regarding claim 67; WO’386 teaches ALT-801 is formulated in glass vials in a sterile, buffered aqueous solution to a final concentration of 2.5 mg/mL …and administered as a subcutaneous injection (see [00345]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the pharmaceutical dosage parameters. One would have been motivated to do so in order to arrive at the pharmaceutical composition having same properties. One of ordinary skill in the art would have a reasonable expectation of success since the prior art teaches a range that could guide the experimentation for the instantly claimed range of the various components of the formulation. It is noted that MPEP 2144.05 states: "In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium." The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties”. See MPEP § 2144.05.
Response to Arguments
Applicants’ argument (see page 6; section IV), filed 06/15/2026, with respect to the rejection of claims 1-3, 6-15, 17, 19, 41 and 67 under 35 U.S.C. 102(a)(1) and 102(a)(2) 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 a newly found prior art reference as set forth above.
Double Patenting (modified)
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 (‘806).
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. ‘806 specifies a dual agonist peptide product described herein is used to treat fatty liver disease (FLD). In some embodiments, the FLD is non-alcoholic fatty liver disease (NAFLD). In certain embodiments, the NAFLD is non-alcoholic steatohepatitis (NASH). FLD, also known as hepatic steatosis, is characterized by excessive fat accumulation in the liver (see col 24, line 63-67, col 25, line 1-3); and ALT-801 at a weekly dose of 1.2 mg, 1.8 mg and 2.4 mg (see FIG. 14); comprising 12 week treatment with ALT-801 (1.2, 1.8 and 2.4 mg doses) (see FIG. 12).
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 1-4, 6, 7, 10-12, and 15-19 of U.S. Patent No. 12171806 (‘806) and in view of claims 62-65 of Application No. 18/503065 (‘065 reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
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.
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of ‘065 into ‘806, thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as ‘065 teach using combinations of different therapeutics to treat non-alcoholic steatohepatitis (NASH). Thus, the claims are obvious in view of ‘806.
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 1-4, 6, 7, 10-12, and 15-19 of U.S. Patent No. 12171806 (‘806) and in view of claims 3, 40, 42, 43, 46, 48, 49, and 54 of Application No. 19/076984 (‘984). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
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.
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of ‘984 into ‘806, thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as ‘984 teach using combinations of different therapeutics to treat non-alcoholic steatohepatitis (NASH). Thus, the claims are obvious in view of ‘806.
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 1-4, 6, 7, 10-12, and 15-19 of U.S. Patent No. 12171806 (‘806) and in view of claims 40, 45, 46, 47, 48-51, and 53-55 of Application No. 18/943449 (‘449). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
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.
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of ‘449 into ‘806, thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as ‘449 teach using combinations of different therapeutics to treat non-alcoholic steatohepatitis (NASH). Thus, the claims are obvious in view of ‘806.
This is a nonstatutory double patenting rejection.
Response to Arguments
Applicants’ arguments filed 06/15/2026 have been fully considered but they are not persuasive in view of the modified grounds of rejected necessitated by amendment.
Applicant argues claims 1-3, 6-15, 17, 19, 41 and 67 were rejected on the ground of alleged non- statutory obviousness-type double patenting over claims 1-4, 6, 7, 10-12 and 15-19 of U.S. Pat. No. 12,171,806. The reference claims are directed to 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." Those method claims "for reducing body weight of a human being" do not teach or suggest a "method of reducing body weight in a human being with fatty liver disease, the method comprising administering pemvidutide once weekly in an amount from at least about 1.2 mg to about 2.4 mg, to the human being in need thereof for at least about 12 weeks wherein the fatty liver disease is non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH)." The reference claims provide no teaching or suggestion as to the underlying condition ("NASH") or the dose of weekly pemvidutide ("at least about 1.2 mg to about 2.4 mg"). In response to applicant's argument that the Examiner has modified and added details regarding the therapeutic dosage and other parameters that are claimed in ‘806.
Applicant asserts the present method of treatment claims are patentably distinct and non- obvious over the composition claims 62-65 of co-pending U.S. Ser. No. 18/503,065; the pending claims are patentably distinct over the reference claims of the '984 application and the '449 application. Moreover, U.S. Ser. No. 18/503,065 and U.S. Ser. No. 19/076,984 are later filed applications, and Applicant requests withdrawal of this rejection when all other remaining rejections have been withdrawn.
The request to hold the rejection in abeyance has been noted and as no arguments regarding the merits of the rejection have been submitted, the rejection is maintained for reasons of record.
Conclusion
No claim is allowed.
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/KOYELI BANERJEE/ Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
