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 .
Priority
The present application is a CON of 17/544,908 filed 12/07/2021 US. Patent No. 12,171,806 which claims benefit of Provisional Application No. 63/249,468 filed 09/28/2021, which claims benefit of Provisional Application No. 63/211,157 filed 06/16/2021, which claims benefit of Provisional Application No. 63/122,117 filed on 12/07/2020.
Claim Status
Claims 1-12 were originally filed on 11/11/2024.
The amendment filed on 01/21/2025, added new claims 40-59 and cancelled claims 1-39; however there is no previous record of claims 13-39.
The amendment filed on 02/05/2025, amended claims 46-47, 52, 54 and 59.
Claims 40-59 are currently pending and under consideration.
Information Disclosure Statement
The IDSs filed on 02/11/2025, 02/12/2025 and 07/11/2025 have been considered by the Examiner. Please note that the forms filed on 02/11/2025 and 02/12/2025 are duplicates of each other and the form filed on 07/11/2025 is empty. Additionally, NPL No. 23 listed in duplicate filed forms has not been considered because the document was not attached nor included in the parent application (i.e., 17/544,908 filed 12/07/2021 US. Patent No. 12,171,806).
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of brow of ser-executable code at pg. 80 of 106, para[00141]. Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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.
1. Claims 40-59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 7-9, 11, 15 and 19 of U.S. Patent No. 12,171,806 B2 Date of Patent: Dec. 24, 2024 (herein after “US ‘806”), as evidenced by CDC, “Adult BMI Categories” first available online on 03/19/2024, at https://www.cdc.gov/bmi/adult-calculator/bmi-categories.html, retrieved on 06/12/2025 (herein after “CDC”), and CDC, “BMI Frequently Asked Questions” first available online on June, 28, 2024 at https://www.cdc.gov/bmi/faq/index.html, accessed on 06/12/2026 (herein after “CDC_2”); in view of Monami et al. Exp Diabetes Res. 2012;2012:672658, pp. 1-8 (herein after “Monami”).
Regarding instant claims 40, 45-47, and 53-54, US ‘806 claims:
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 column 103, claim 1).
The method of claim 1, wherein the pharmaceutical dosage is an aqueous formulation comprising one or more of polysorbate 20, arginine, or mannitol (see column 103, claim 8).
The method of claim 1, wherein the pharmaceutical dosage formulation comprises about 0.025-0.075% (w/w) polysorbate 20, about 0.2-0.5% (w/w) arginine, about 3-6% (w/w) mannitol in deionized water (pH 7.7±0.1); optionally 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) (see column 103, claim 9).
A method for reducing body weight of a human being with a body mass index (BMI kg/m2) of at least 25 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% from baseline at week 12 (see column 104, claim 11).
As evidenced by CDC, BMI is a calculated measure of body weight relative to height. For adults, BMI categories are underweight (i.e., BMI range (kg/m2) Less than 18.5), healthy weight (i.e., BMI range (kg/m2) 18.5 to less than 25), overweight (i.e., BMI range (kg/m2) 25 to less than 30), and obesity (i.e., BMI range (kg/m2) 30 or greater) (see CDC, pg. 1). As such, a human being with a body mass index of at least 25 kg/m2 would be considered to be overweight or obese based on the calculated measure of body weight (in kilograms) relative the square of their height (in meters). Thereby a human being that is overweight (BMI of 25 kg/m2) or obese (BMI > 25kg/m2) carries excess body weight, thus constitutes a human being in need of reducing excess body weight and in need of maintaining weight reduction.
Moreover, having a BMI outside the healthy weight range can increase a person's risk for certain health problems (see CDC_2, pg. 1). For example, people with BMIs in the obesity category are at increased risk for type 2 diabetes, heart disease, and other health problems (see CDC_2, pg. 1). BMI is just one potential indicator of health; and cannot distinguish between fat, muscle, and bone mass. Therefore, people with a lot of muscle might have a BMI that falls in the overweight category (BMI of 25.0 to less than 30.0) or obesity category (BMI of 30.0 or more), and for a more complete assessment other factors such as a patient's medical history, health behaviors, physical exam findings, and laboratory findings should also be considered (see CDC_2, pg. 2).
Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). This is pertinent because in US ‘806, SEQ ID NO: 1 is represented by:
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and includes the following annotations:
As such, US ‘806 SEQ ID NO: 1 and instant SEQ ID NO: 1 correspond to the same sequence.
Regarding instant claims 41 and 55, US ‘806 claims:
The method of claim 1, wherein the method induces liver fat loss (see column 103, claim 2); and the method of claim 11, wherein liver fat is reduced (see column 104, claim 19).
Regarding instant claims 42 and 56, US ‘806 claims:
The method of claim 1, wherein the method is a treatment for blood glucose control (see column 103, claim 3).
Regarding instant claims 43 and 57, US ‘806 claims:
The method of claim 1, wherein the pharmaceutical dosage formulation is administered subcutaneously (see column 103, claim 7).
Regarding instant claims 44 and 58, US ‘806 claims:
The method of claim 1, wherein the method is an adjunct treatment with diet and/or exercise (see column 103, claim 5).
Regarding instant claim 48-51, US ‘806 claims:
A method for reducing body weight of a human being with a body mass index (BMI kg/m2) of at least 25 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% from baseline at week 12 (see column 104, claim 11); and the method of claim 1, wherein the BMI of the human being is at least 30 kg/m2 (see column 104, claim 15).
However, US. ‘806 do not expressly claim wherein the human being in need thereof has a co-morbidity selected from one or more of type 2 diabetes, polycystic ovary syndrome (PCOS), hyperglycemia, and hyperinsulinemia, as recited in instant claims 52 and 59.
Accordingly, the issue is whether or not the instant claims are patently distinct from the granted claims (i.e., US ‘806 claims 1-3, 5, 7-9, 11, 15 and 19) under an obviousness rationale.
Monami performed a meta-analysis of the effects of Glucagon-like peptide-1 receptor agonists on body weight and found that GLP-1 receptor agonists, approved as glucose-lowering drugs for the treatment of type 2 diabetes, have also been shown to reduce body weight (see pg. 1, Title and abstract). Thus, an ordinary skilled artisan would have been motivated with reasonable expectation of success to arrive at the claimed invention as described in instant claims 52 and 59, because it was known that GLP-1 receptor agonists help reduce body weight and also treat type 2 diabetes. Therefore, an ordinary skilled artisan would conclude that the invention defined by instant claims 52 and 59 is an obvious variation of US ‘806’s 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.
Accordingly, the present claims are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 7-9, 11, 15 and 19 of U.S. ‘806.
2. Claims 40, 43, 46, and 48-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 41, 44, 46 and 48-49 of Copending Application No. 19/076,984 claim set filed 08/22/2025, PG Pub No. US20250288650A1(here in after “Copending App ‘984”), as evidenced by CDC, “Adult BMI Categories” first available online on 03/19/2024, at https://www.cdc.gov/bmi/adult-calculator/bmi-categories.html, retrieved on 06/12/2025 (herein after “CDC”), and CDC, “BMI Frequently Asked Questions” first available online on June, 28, 2024 at https://www.cdc.gov/bmi/faq/index.html, accessed on 06/12/2026 (herein after “CDC_2”).
Regarding instant claim 40, Copending App ‘984 claims:
A method for treatment of chronic weight management in a human being in need thereof 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, and wherein the treatment further reduces serum lipids (see Copending App ‘984, claim 3); and a method for treatment of reducing serum lipids in a human being in need thereof, 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 Copending App ‘984, claim 40).
Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)).
This is pertinent because the specification filed on 03/11/2025 of Copending App ‘984 at para[0069], pg. 23-24, recites that “methods for treating chronic weight management refer to treatment of obesity and pre-obese” and that the term “obese” is defined as a body mass index (BMI)>30 (see specification filed 03/11/2025, pg. 23, para[0069]) and that a BMI of 25-30 is pre-obese (also referred to as “overweight”) (see specification filed 03/11/2025, pg. 24, para[0069]). Therefore, the patient population (i.e., a human being in need thereof) that would benefit from the method of treatment of chronic weight management as recited in copending App ‘984 would also benefit from the instantly claimed method to reduce excess body weight and maintained weight reduction in treatment of chronic weight management as recited in instant claim 40. As such, there is an overlap in scope of the copending Application and the instantly claimed method.
The specification of Copending App ‘984 was also used as as a dictionary to learn the meaning of SEQ ID NO: 1, which has the following amino acid sequence, as depicted at pp. 11-12, para[0047]:
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As such, Copending App ‘984’s SEQ ID NO: 1 and instant SEQ ID NO: 1 correspond to the same sequence.
Regarding instant claim 43, Copending App ‘984 claims:
The method of claim 40, wherein the pharmaceutical dosage formulation is administered subcutaneously or by parenteral injection (see Copending App ‘984, claim 44).
Regarding instant claim 46, Copending App ‘984 claims:
The method of any claim 40, 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 Copending App ‘984, claim 46).
Regarding instant claims 48-51, Copending App ‘984 claims:
The method of any claim 40, wherein the human being in need thereof has a body mass index (BMI kg/m2) of at least 25 (see Copending App ‘984, claim 49). As evidenced by CDC, BMI is a calculated measure of body weight relative to height. For adults, BMI categories are underweight (i.e., BMI range (kg/m2) Less than 18.5), healthy weight (i.e., BMI range (kg/m2) 18.5 to less than 25), overweight (i.e., BMI range (kg/m2) 25 to less than 30), and obesity (i.e., BMI range (kg/m2) 30 or greater) (see CDC, pg. 1). As such, a human being with a body mass index of at least 25 kg/m2 would be considered to be overweight or obese based on the calculated measure of body weight (in kilograms) relative the square of their height (in meters). Thereby a human being that is overweight (BMI of 25 kg/m2) or obese (BMI > 25kg/m2) carries excess body weight, thus constitutes a human being in need of reducing excess body weight and in need of maintaining weight reduction.
Moreover, having a BMI outside the healthy weight range can increase a person's risk for certain health problems (see CDC_2, pg. 1). For example, people with BMIs in the obesity category are at increased risk for type 2 diabetes, heart disease, and other health problems (see CDC_2, pg. 1). BMI is just one potential indicator of health; and cannot distinguish between fat, muscle, and bone mass. Therefore, people with a lot of muscle might have a BMI that falls in the overweight category (BMI of 25.0 to less than 30.0) or obesity category (BMI of 30.0 or more), and for a more complete assessment other factors such as a patient's medical history, health behaviors, physical exam findings, and laboratory findings should also be considered (see CDC_2, pg. 2).
Regarding instant claim 52, Copending App ‘984 claims:
The method of claim 40, wherein the human being in need thereof has a co- morbidity selected from one or more of obesity, cardiovascular disease, hypertension, dyslipidemia, dysglycemia, type 2 diabetes and obstructive sleep apnea (see Copending App ‘984, claim 41).
Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the instant invention is broad and covers reducing excess body weight and maintaining weight reduction in a human being in need thereof, by administering a once weekly therapeutic effective amount of a pharmaceutical dosage formulation comprising SEQ ID NO: 1. As such, the entire scope of claims 3, 41, 44, 46 and 48-49 in Copending App ‘984 fall within the scope of the instant invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
3. Claims 40-41 and 49-53, 55 and 59 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 10-11, 13 and 41 of Copending Application No. 18/467,608 claim set filed 03/24/2026, PG Pub No. US20240269238A1 (here in after “Copending App ‘608”), as evidenced by CDC, “Adult BMI Categories” first available online on 03/19/2024, at https://www.cdc.gov/bmi/adult-calculator/bmi-categories.html, retrieved on 06/12/2025 (herein after “CDC”), and CDC, “BMI Frequently Asked Questions” first available online on June, 28, 2024 at https://www.cdc.gov/bmi/faq/index.html, accessed on 06/12/2026 (herein after “CDC_2”); in view of Brunner et al. Curr Obes Rep. 2019 September; 8(3): 220-228 (herein after “Brunner”).
Regarding instant claim 40, Copending App ‘608 claims:
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 wherein the fatty liver disease is non-alcoholic fatty liver disease (NAFLD) or non- alcoholic steatohepatitis (NASH) (see Copending App ‘608, claim 1).
Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). This is pertinent because the specification filed on 09/14/2023 of Copending App ‘608, at pp. 10, para[0052], teaches that ALT-801 (SEQ ID NO: 1 (also referred to herein as pemvidutide)) has the following amino acid sequence:
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As such, pemvidutide represented by SEQ ID NO: 1 in Copending App ‘608 and instant SEQ ID NO: 1 correspond to the same sequence.
With respect to the “human being with fatty liver disease” as recited in claim 1 of Copending App ‘608, the specification filed on 09/14/2023 of Copending App ‘608 does not expressly teach whether the human being with fatty liver disease is in need of reducing body weight and maintain weight reduction. However, Brunner’s review pertains to Nonalcoholic fatty liver disease and obesity treatment (see Brunner, pg. 1, Title). Brunner adds that significant weight loss can improve NAFLD and nonalcoholic steatohepatitis (NASH). Diet and exercise that result in a sustained body weight reduction of 7 10% can improve liver fat content (see Brunner, pg. 1, Abstract). Thereby, the patient population with fatty liver disease, as claimed in copending App ‘608, will also benefit from the instantly claimed method to reduce excess body weight and maintain weight reduction in the treatment of chronic weight management in a human being in need thereof, as recited in instant claim 40. Regarding instant claims 41 and 55, Copending App ‘608 claims:
The method of claim 1, wherein an absolute reduction in liver fat as measured by MRI-PDFF is a reduction of about 8% to about 15% after 12 weeks of the once weekly dosing (see Copending App ‘608, claim 13).
Regarding instant claims 49-51, Copending App ‘608 claims:
The method of claim 1, wherein the human being has a body mass index (BMI kg/m2) of at least 28 (see Copending App ‘608, claim 10); wherein the human being has a body mass index (BMI kg/m2) of 30 or greater (see Copending App ‘608, claim 11).
As evidenced by CDC, BMI is a calculated measure of body weight relative to height. For adults, BMI categories are underweight (i.e., BMI range (kg/m2) Less than 18.5), healthy weight (i.e., BMI range (kg/m2) 18.5 to less than 25), overweight (i.e., BMI range (kg/m2) 25 to less than 30), and obesity (i.e., BMI range (kg/m2) 30 or greater) (see CDC, pg. 1). As such, a human being with a body mass index of at least 28 kg/m2 would be considered to be overweight or obese based on the calculated measure of body weight (in kilograms) relative the square of their height (in meters). Thereby a human being that is overweight (BMI of 28 kg/m2) or obese (BMI > 25kg/m2) carries excess body weight, thus constitutes a human being in need of reducing excess body weight and in need of maintaining weight reduction.
Moreover, having a BMI outside the healthy weight range can increase a person's risk for certain health problems (see CDC_2, pg. 1). For example, people with BMIs in the obesity category are at increased risk for type 2 diabetes, heart disease, and other health problems (see CDC_2, pg. 1). BMI is just one potential indicator of health; and cannot distinguish between fat, muscle, and bone mass. Therefore, people with a lot of muscle might have a BMI that falls in the overweight category (BMI of 25.0 to less than 30.0) or obesity category (BMI of 30.0 or more), and for a more complete assessment other factors such as a patient's medical history, health behaviors, physical exam findings, and laboratory findings should also be considered (see CDC_2, pg. 2).
Regarding instant claims 52 and 59, Copending App ‘608 claims:
The method of claim 1, wherein the human being does not have a diagnosis of type 2 diabetes (see Copending App ‘608, claim 8).
Regarding instant claim 53, Copending App ‘608 claims:
A method of inducing weight loss in a human being with fatty liver disease, the method comprising administering pemvidutide once weekly for at least 12 continuous weeks in an amount from at least about 1.2 mg up to about 2.4 mg to the human being, wherein the human being: has been diagnosed with fatty liver disease that is non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH);has a body mass index (BMI kg/m2) of greater than about 28; and, has a liver fat content of at least about 10% as measured by MRI-PDFF (see Copending App ‘608, claim 41).
Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the instant invention is broad and covers reducing excess body weight and maintaining weight reduction in a human being in need thereof, by administering a once weekly therapeutic effective amount of a pharmaceutical dosage formulation comprising SEQ ID NO: 1. As such, the entire scope of claims 1, 8, 10-11, 13 and 41 in Copending App ‘608 fall within the scope of the instant invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
4. Claims 40, 45, 47-52, 54, and 59 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 62 and 66-70 of Copending Application No. 18/503,065 claim set filed 10/28/2025, PG Pub No. US20240277815A1 (here in after “Copending App ‘065”), as evidenced by CDC, “Adult BMI Categories” first available online on 03/19/2024, at https://www.cdc.gov/bmi/adult-calculator/bmi-categories.html, retrieved on 06/12/2025 (herein after “CDC”); and CDC, “BMI Frequently Asked Questions” first available online on June, 28, 2024 at https://www.cdc.gov/bmi/faq/index.html, accessed on 06/12/2026 (herein after “CDC_2”); in view of Wing et al. Diabetes Care. 2011 Jun 17; 34(7):1481-1486 (herein after “Wing”).
Regarding instant claims 40, 45, 47 and 54, Copending App ‘065 claims:
A liquid 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 Copending App ‘065, claim 62); wherein the human subject is overweight (see Copending App ‘065, claim 67); wherein the human subject is obese (see Copending App ‘065, claim 68); and wherein the pharmaceutical composition is administered about once weekly in an amount of about 1.8 mg of SEQ ID NO: 1 (see Copending App ‘065, claim 70).
As evidenced by CDC, BMI is a calculated measure of body weight relative to height. For adults, BMI categories are underweight (i.e., BMI range (kg/m2) Less than 18.5), healthy weight (i.e., BMI range (kg/m2) 18.5 to less than 25), overweight (i.e., BMI range (kg/m2) 25 to less than 30), and obesity (i.e., BMI range (kg/m2) 30 or greater) (see CDC, pg. 1). The CDC also defines three sub-categories, i.e., class 1, class 2 and class 3 for a BMI of 30 or greater. For instance class 1 obesity encompass BMI of 30 to less than 35 kg/m2; class 2 obesity encompass BMI of 35 to less than 40 kg/m2; and class 3 obesity (severe obesity) encompass BMI of 40 or greater kg/m2 (see CDC, pg. 1). As such, a human being that is overweight would have a body mass index between 25 to less than 30 kg/m2; and a human being that is obese would have a body mass index between 30 or greater kg/m2; based on the calculated measure of body weight (in kilograms) relative the square of their height (in meters). Thereby a human being that is overweight (BMI between 25 and 30 kg/m2) or obese (BMI > 25kg/m2) carries excess body weight, thus constitutes a human being in need of reducing excess body weight and in need of maintaining weight reduction.
Moreover, having a BMI outside the healthy weight range can increase a person's risk for certain health problems (see CDC_2, pg. 1). For example, people with BMIs in the obesity category are at increased risk for type 2 diabetes, heart disease, and other health problems (see CDC_2, pg. 1). BMI is just one potential indicator of health; and cannot distinguish between fat, muscle, and bone mass. Therefore, people with a lot of muscle might have a BMI that falls in the overweight category (BMI of 25.0 to less than 30.0) or obesity category (BMI of 30.0 or more), and for a more complete assessment other factors such as a patient's medical history, health behaviors, physical exam findings, and laboratory findings should also be considered (see CDC_2, pg. 2).
Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). This is pertinent because the specification filed on 11/06/2023 of Copending App ‘065, at pg. 8, para[0028], teaches that ALT-801 (SEQ ID NO: 1) has the following amino acid sequence:
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As such, Copending App ‘065’s SEQ ID NO: 1 and instant SEQ ID NO: 1 correspond to the same sequence.
Regarding instant claims 48-51, Copending App ‘065 claims:
The method of claim 66, wherein the human subject has a body mass index (BMI kg/m2) of greater than or equal to 25 (see Copending App ‘065, claim 69).
Regarding instant claims 52 and 59, Copending App ‘065 claims:
A method for the treatment of cardiovascular (CV) disease risk factors in a human subject in need thereof, comprising: administering to the human subject the pharmaceutical composition according to claim 62 comprising a therapeutically effective amount of SEQ ID NO: 1, or a pharmaceutically acceptable salt thereof, wherein the human subject is overweight, obese, has a body mass index (BMI kg/m2) of greater than or equal to 25, and/or has Type II diabetes and wherein the treatment reduces at least one CV disease risk factor as compared to baseline, the CV disease risk factor being selected from the group consisting of body weight, waist circumference, blood pressure, hyperglycemia, serum lipids, total cholesterol, triglycerides, HDL, LDL and/or VLDL particle concentration and/or diameter, phosphatidylethanolamines, phosphatidylcholines, lysophosphatidylethanolamines, sphingolipids and lysophosphatidylcholines (see Copending App ‘065, claim 66).
With respect to the “human subject in need thereof” as recited in claim 66 of Copending App ‘065, the specification filed on 11/06/2023 of Copending App ‘065 does not expressly teach whether the human subject in need thereof to whom the method for the treatment of cardiovascular (CV) disease risk factors comprising administration of a composition comprising SEQ ID NO: 1, is also in need of reducing body weight and maintain weight reduction.
Wing reports on the benefits of modest weight loss in improving cardiovascular risk factors in overweight and obese individuals with type 2 diabetes (see Wing, pg. 1481, Title). Wing adds that overweight and obese individuals are encouraged to lose 5–10% of their body weight to improve cardiovascular disease (CVD) risk (see pg. 1481, Abstract). Wing concludes that modest weight losses of 5 to <10% were associated with significant improvements in CVD risk factors at 1 year, but larger weight losses had greater benefits (see pg. 1481, Abstract). Therefore, the patient population human subject in need thereof, as claimed in copending App ‘065, will also benefit from the instantly claimed method to reduce excess body weight and maintain weight reduction in the treatment of chronic weight management in a human being in need thereof, as recited in instant claim 40.
Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the instant invention is broad and covers reducing excess body weight and maintaining weight reduction in a human being in need thereof, by administering a once weekly therapeutic effective amount of a pharmaceutical dosage formulation comprising SEQ ID NO: 1. As such, the entire scope of claims 62 and 66-70 in Copending App ‘065 fall within the scope of the instant invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
6. Claims 40, 45-47 and 57 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 63-64 and 66-69 of Copending Application No. 17/180,827claim set filed 12/10/2025, PG Pub No. US20210290732A1 (here in after “Copending App ‘827”).
Regarding instant claim 40, Copending App ‘827 claims: A liquid pharmaceutical formulation comprising: a) a therapeutically effective dose of peptide product selected from any one of any one of SEQ ID NOS: 1-10 or 12-27 wherein the peptide product is modified with a glycolipid surfactant (beta-D-glucuron-1-yl)-1-oxa)17-carboxyheptadecane via attachment to a lysine side chain; and, b) at least about 0.60 milligram (mg) of polysorbate 20 per mg of the peptide product in the formulation, wherein about means ±10% (see Copending App ‘827, claim 63); and wherein the peptide product is SEQ ID NO: 1 (see Copending App ‘827, claim 64).
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Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). This is pertinent because the specification filed on 02/21/2021 of Copending App ‘827, at pg. 7, para[0045], Table 1, teaches EU-A1873 represented by SEQ ID NO: 1, wherein ALT-801 has the following amino acid sequence and Z17C02H= (beta-D-glucoron-1-yl-1oxa)17-carboxyheptadecane.
Thereby, SEQ ID NO: 1 in Copending App ‘827 corresponds to instant SEQ ID NO: 1.
Regarding instant claims 45-47, Copending App ‘827 claims:
The pharmaceutical formulation of claim 63, further comprising 0.2-0.5% (w/w) arginine, and 3-6% (w/w) mannitol in water (pH 7.7 ± 1.0) (see Copending App ‘827, claim 66);
A liquid pharmaceutical formulation comprising: a) a therapeutically effective dose of peptide product according to SEQ ID NO: 1 wherein the peptide product is modified with a glycolipid surfactant (beta-D-glucuron-1-yl)-1- oxa)17-carboxyheptadecane via attachment to a lysine side chain; and, b) at least about 0.60 milligram (mg) of polysorbate 20 per mg of the peptide product in the formulation, wherein about means ±10% (see Copending App ‘827, claim 68); and
further comprising about 0.2-0.5% (w/w) arginine, and about 3-6% (w/w) mannitol in water (pH 7.7 ± 1.0) (see Copending App ‘827, claim 69).
Regarding instant claim 57, Copending App ‘827 claims:
The pharmaceutical formulation of claim 63, configured for once weekly subcutaneous delivery to a human being in need thereof (see Copending App ‘827, claim 67).
Copending App ‘827 does not expressly claim a method of using SEQ ID NO: 1 (e.g., method to reduce excess body weight and maintain weight reduction in treatment of chronic weight management in a human being in need thereof, as recited in instant claim 40).
However, the specification filed on 02/21/2021 of Copending App ‘827, at pg. 3, para[0010], teaches the intended use of SEQ ID NO: 1, see paragraph below:
“Described herein are dual agonist peptides and products thereof (e.g., formulations) and uses of the same for treating disorders associated with the function of glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR), including but not limited to insulin resistance or/and obesity, such as type 2 diabetes, metabolic syndrome, cardiovascular diseases (including coronary artery diseases such as atherosclerosis and myocardial infarction), hypertension, NASH, chronic kidney disease and PCOS, and in treating conditions associated with such disorders.”
As such, since SEQ ID NO: 1 as claimed in Copending App ‘827 is intended to be used in the treatment of disorders associated with the function of GLP-1R and GCGR receptors, included but not limited to insulin resistance or/and obesity, such as type 2 diabetes, metabolic syndrome, cardiovascular diseases (including coronary artery diseases such as atherosclerosis and myocardial infarction), hypertension, NASH, chronic kidney disease and PCOS. Then the intended use of a sequence that is 100 identical to instant SEQ ID NO: 1 reads on the instantly claimed method.
The claims at issue are not identical, however they are not patentably distinct from each other because the scope of the instant invention is broad and covers reducing excess body weight and maintaining weight reduction in a human being in need thereof, by administering a once weekly therapeutic effective amount of a pharmaceutical dosage formulation comprising SEQ ID NO: 1. As such, the entire scope of claims 63-64 and 66-69 in Copending App ‘827 fall within the scope of the instant invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
7. Claims 40, 45-47 and 57 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 61-63, 67-69, 70 and 72-73 of Copending Application No. 19/034,251 claim set filed 07/11/2025, PG Pub No. US20250262280A1 (here in after “Copending App ‘251”).
Regarding instant claims 40 and 45, Copending App ‘251 claims:
A liquid pharmaceutical formulation comprising: a) a therapeutically effective dose of a dual agonist peptide product with affinity for glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR) wherein the peptide product is modified with a glycolipid; and, b) at least about 0.60 milligram (mg) of polysorbate 20 per mg of the peptide product in the formulation; wherein the formulation is configured for once weekly subcutaneous delivery to a human being in need thereof (see Copending App ‘251, claim 61); wherein the agonist peptide product is any one of SEQ ID NOS: 1-10 or 12-27 (see Copending App ‘251, claim 62); wherein the agonist peptide product is SEQ ID NO: 1 (see Copending App ‘251, claim 63); and A liquid pharmaceutical formulation comprising: a) a therapeutically effective dose of SEQ ID NO: 1; and, b) at least about 0.60 milligram (mg) of polysorbate 20 per mg of SEQ ID NO: 1 in the formulation; wherein the formulation is configured for once weekly subcutaneous delivery to a human being in need thereof (see Copending App ‘251, claim 70).
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Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). This is pertinent because the specification filed on 01/22/2025 of Copending App ‘251, at pg. 7, para[0045-0046], Table 1, teaches EU-A1873 represented by SEQ ID NO: 1, wherein ALT-801 has the following amino acid sequence and Z17C02H= (beta-D-glucoron-1-yl-1oxa)17-carboxyheptadecane.
Thereby, SEQ ID NO: 1 in Copending App ‘827 corresponds to instant SEQ ID NO: 1.
Regarding instant claims 46-47, Copending App ‘251 claims:
The pharmaceutical formulation of claim 61, further comprising about 0.2-0.5% (w/w) arginine, and about 3-6% (w/w) mannitol in water (pH 7.7± 1.0) (see Copending App ‘251, claim 67); further comprising about 0.35% (w/w) arginine and about 4.3% (w/w) mannitol in water (pH 7.7 ± 1.0) (see Copending App ‘251, claim 68);
The pharmaceutical formulation of claim 70, further comprising about 0.2-0.5% (w/w) arginine, and about 3-6% (w/w) mannitol in water (pH 7.7 ± 1.0) (see Copending App ‘251, claim 72); and
The pharmaceutical formulation of claim 70, further comprising about 0.35% (w/w) arginine and about 4.3% (w/w) mannitol in water (pH 7.7 ± 1.0) (see Copending App ‘251, claim 73).
Regarding instant claim 57, Copending App ‘251 claims:
A method for the treatment of metabolic dysfunction, comprising administering to a subject in need thereof the pharmaceutical formulation according to claim 61 as a weekly subcutaneous dose (see Copending App ‘251, claim 69).
Copending App ‘251 does not expressly claim a method of using SEQ ID NO: 1 to reduce excess body weight. However, since claim 69 in copending App ‘251 is drawn to a method for the treatment of metabolic dysfunction, comprising administering to a subject in need thereof the pharmaceutical formulation according to Claim 61 as a weekly subcutaneous dose.
And since the specification filed on 05/12/2025 of Copending App ‘251, at pg. 3, para[0010], teaches the intended use of SEQ ID NO: 1, see paragraph below:
“Described herein are dual agonist peptides and products thereof (e.g., formulations) and uses of the same for treating disorders associated with the function of glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR), including but not limited to insulin resistance or/and obesity, such as type 2 diabetes, metabolic syndrome, cardiovascular diseases (including coronary artery diseases such as atherosclerosis and myocardial infarction), hypertension, NASH, chronic kidney disease and PCOS, and in treating conditions associated with such disorders.”
As such, since SEQ ID NO: 1 as claimed in Copending App ‘521 is intended to be used in the treatment of disorders associated with the function of GLP-1R and GCGR receptors, included but not limited to insulin resistance or/and obesity, such as type 2 diabetes, metabolic syndrome, cardiovascular diseases (including coronary artery diseases such as atherosclerosis and myocardial infarction), hypertension, NASH, chronic kidney disease and PCOS. Then the intended use of a sequence that is 100 identical to instant SEQ ID NO: 1 reads on the instantly claimed method, as recited in instant claim 40.
Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the instant invention is broad and covers reducing excess body weight and maintaining weight reduction in a human being in need thereof, by administering a once weekly therapeutic effective amount of a pharmaceutical dosage formulation comprising SEQ ID NO: 1. As such, the entire scope of claims 61-63, 67-69, 70 and 72-73 in Copending App ‘251 fall within the scope of the instant invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The Examined claims are free of the prior art because the instant application claims benefit of Provisional Application No. 63/122,177 filed on 12/07/2020. As such, the prior art published before 12/07/2020 (i.e., the first effective filing date) does not teach a formulation comprising instant SEQ ID NO: 1, nor a method to reduce excess body weight and maintain weight reduction in treatment of chronic weight management in a human being in need thereof.
Although the instant claims are free of the prior art, under an obviousness analysis, the claims are unpatentable over copending Applications which share the same inventive entity, at least one common (joint) inventor, a common applicant, and/or a common owner/assignee.
No claims are allowed.
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/CLAUDIA ESPINOSA/ Patent Examiner, Art Unit 1654
/LIANKO G GARYU/ Supervisory Patent Examiner, Art Unit 1654
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