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 62-65, drawn to a composition comprising SEQ ID NO:1 in certain dosing regimens for the treatment in a human subject in the reply filed on 03/19/2026 is acknowledged.
Claims 66-81 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/19/2026.
Status of Claims
Claims 62-81 are pending. Claims 66-81 are withdrawn. Claims 1-61 were previously canceled. No claims are herein amended or canceled.
Priority
This application claims priority to PRO 63/490,491 filed on 03/15/2023, PRO 63/490,465 filed on 03/15/2023, and PRO 63/422,983 filed on 11/05/2022.
Objections/Rejections Withdrawn
Objections and/or rejections not reiterated from previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
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 62-65 are rejected under 35 U.S.C. 103 as being unpatentable over US20210290732 (published 09/23/2021; cited on IDS filed 03/06/2024) in view of Kerwin (“Polysorbates 20 and 80 Used in the Formulation of Protein Biotherapeutics: Structure and Degradation Pathways”; Bruce A. Kerwin; JOURNAL OF PHARMACEUTICAL SCIENCES, VOL. 97, Issue 8, pages 2924-2935; published August, 2008).
US’732 discloses SEQ ID NO: 1 (EU-A1873 of Table 1; wherein ALT-801 is the active pharmaceutical ingredient (API) present in the disclosed pharmaceutical formulation, wherein the API is represented by SEQ ID NO: 1) has the following amino acid sequence conjugated at amino acid position 17 (aa17) to the non-ionic glycolipid surfactant: 1His-2Aib-3Gln-4Gly-5Thr-6Phe-7Thr-8Ser-9Asp-10Tyr-11Ser-12Lys-13Tyr-14Leu-15Asp-16Glu*- 17Lys#-18Ala-19Ala-20Lys*-21Glu-22Phe-23Ile-24Gln-25Trp-26Leu-27Leu-28Gln-29Thr-NH2, where * indicates a lactam bridge is formed between Glu16 and Lys 20, and 17Lys# indicates the attachment site for glucuronic acid C-18* (see [0046], TABLE 1).
SEQ ID NO: 1 disclosed by US’732 is the same as instant peptide SEQ ID NO: 1. One preferred embodiment of US’732 is the dual agonist peptide is SEQ ID NO: 1. In some embodiments, the dual agonist peptide is formulated as a solution for injection comprising pharmaceutically acceptable excipients such as a osmolarity adjusting agent or salt, a buffering agent, an stabilizing agent and/or a surfactant, a pH adjuster and a solvent (see [0056]). US’732 discloses in some embodiments, the dual agonist peptides can be associated with a saccharide, such as within a pharmaceutically acceptable composition; functionalized saccharide of a surfactant moiety has a functional group suitable for forming a stable covalent bond with an amino acid of a dual agonist peptide (see [0033]).
Regarding claim 62; US’732 discloses the dual agonist peptide can be formulated as a pharmaceutical dosage formulation comprising about 0.025-0.15% (w/w) polysorbate 20, about 0.2-0.5% (w/w) arginine, and about 3-6% (w/w) mannitol in deionized water (pH 7.7±1.0) (see [0056]); in some embodiments, the pharmaceutical dosage formulation comprises “ALT-801” represented by SEQ ID NO: 1 in a formulation comprising, consisting essentially of, or consisting of, about 0.050% (w/w) polysorbate 20, about 0.35% (w/w) arginine, and about 4.3% (w/w) mannitol in deionized water (pH 7.7±1) (see [0056]). US’732 further teaches in some embodiments, the pharmaceutical dosage formulation for “ALT-801” comprises SEQ ID NO: 1 in a formulation comprising, consisting essentially of, or consisting of, about 0.35% (w/w) arginine, and about 4.3% (w/w) mannitol 0.6 to 1.0 mg of polysorbate 20 per mg of “ALT-801” (SEQ ID NO:1) or 1.0 to 1.5 mg of polysorbate 80 per mg of “ALT-801” (SEQ ID NO:1) (See Example 8); in some embodiment, the pharmaceutical dosage formulation comprises “ALT-801” at a concentration ranging from 0.05 mg/ml to 20 mg/ml, preferably from 0.1 mg/ml to 10 mg/ml or more preferably 0.5 mg/mg to 10 mg/ml (see [0056]).
US’732 does not teach specifically about the formulation containing at 0.20% (w/w) polysorbate 20.
Kerwin teaches polysorbates 20 … used in the formulation of biotherapeutic products (see Abstract) and provides review of the structure and stability of polysorbates 20 … the most commonly used nonionic surfactants in the biotechnology industry (see page 2925, right col, paragraph 1). Kerwin teaches that polysorbates are present in a large number of biopharmaceutical drugs (listed in the 2006 Physicians Desk Reference), and the concentrations used in the formulations range from 0.0003% (w/v) to 0.3% (w/v) (see page 2932, left col, paragraph 3).
Therefore, it would have been prima facie obvious to optimize the concentrations of all the components including polysorbate 20 before the effective filing date of the claimed invention to arrive at the pharmaceutical composition of the instantly claimed invention.
MPEP 2144.05 states: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or
workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ
233, 235 (CCPA 1955)."
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 amount of each component. 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.
Regarding claims 63-65; US’732 discloses In some embodiments, the methods can include administering the pharmaceutical dosage to an adult human at from about 0.5 mg/dose, about 1.0 mg/dose, about 1.5 mg/dose, about 2.0 mg/dose, about 2.5 mg/dose (see [0098]); administering the pharmaceutical dosage formulation is configured to administer to a human between about 0.1 to about 15 mg per week; optionally about 1 to about 7 mg per week; or optionally about 1 to 5 mg per week (see [0178]); with planned dose levels of 0.40, 1.2, 2.4, 4.8, 7.2, and 9.4 mg (equivalent to a weekly dose administered once every 7 days) (see [0372]).
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 amount of each component. Thus, one skilled in the art can adjust the dosage to arrive at the pharmaceutical composition having same properties.
Therefore, the presently claimed invention was prima facie obvious to one of ordinary skill in the art at the time of the effective filing date.
Response to Arguments
Applicants’ arguments filed 06/08/2026 have been fully considered but they are not persuasive in view of the modified grounds of rejection. In response to applicant's argument, the rejection has been modified.
Applicant disagrees that the art range of about "0.025-0.15% (w/w) polysorbate 20" overlaps with the claimed "about 0.20% (w/w) polysorbate 20”. Applicant argues that those ranges, even accounting for a 10% variance, do not overlap. The cited references provide no teaching or motivation for one of skill in the art to arrive at the claimed formulation comprising "about 0.20% (w/w) polysorbate 20." Examiner has updated the 35 U.S.C. §103 rejection with supporting prior art. In the instantly claimed invention, the recitation of “about 0.20% w/w” and as claimed by US’732 as “about 0.15 (w/w)”, implies that the ranges overlap and that they are so close that a person of ordinary skill in the art would reasonably expect about 0.15% to have the same properties as 0.20%. Additionally, as taught by Kerwin, it is known in the art to the use of polysorbates (polysorbate 20) in the formulation of biotherapeutic that ranges from 0.0003%(w/v) to 0.3% (w/v) (see page 2932, left col, paragraph 3). Also, the instant specification does not specify the administration of the composition with respect to body weight, i.e., as “mg/kg/dose” (“mg/kg of body weight/dose”), therefore, it is not clear what the effective pharmaceutical dosage or percentage variance of the formulation configured for administering to the subject. Examiner would like to remind the Applicant that the rejection of record was that it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of US’732 and Kerwin to modify the therapeutic peptide composition with optimal formulation constituents.
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 62-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, and 9 of U.S. Patent No. 12171806 in view of US20210290732 (published 09/23/2021; cited on IDS filed 03/06/2024) and Kerwin (“Polysorbates 20 and 80 Used in the Formulation of Protein Biotherapeutics: Structure and Degradation Pathways”; Bruce A. Kerwin; JOURNAL OF PHARMACEUTICAL SCIENCES, VOL. 97, Issue 8, pages 2924-2935; published August, 2008).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 8, and 9 of the US‘806 recite the same SEQ ID NO:1 and the overlapping range of components of the composition of the instantly claimed invention.
US‘806 claims therapeutic effective amount of a pharmaceutical dosage formulation comprising SEQ ID NO: 1 (claim 1), wherein the pharmaceutical dosage is an aqueous formulation comprising one or more of polysorbate 20, arginine, or mannitol (claim 8). US’806 specifically claims 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) (claim 9).
SEQ ID NO: 1 (EU-A1873 of Table 1; also known as ALT-801 or pemvidutide) claimed by US‘806 is the same amino acid sequence of the instantly claimed SEQ ID NO:1 present in the pharmaceutical composition. US‘806 specifies the therapeutic effective amount of a pharmaceutical dosage formulation comprising SEQ ID NO: 1 of claim 1 of US’806 is the same as instant peptide SEQ ID NO: 1, wherein as read in light of the specification where the administration of ALT-801 (also referred to herein as pemvidutide) at a dose of 1.2 mg, 1.8 mg and 2.4 mg (see col 3, line 67 – col 4 line 2; Figure 2; Table 10).
US‘806 differs from the instant claims in that they do not claim that the amount of polysorbate 20 in the pharmaceutical composition is 0.20% (w/w) from those recited in instant claim 1.
The teachings of US’732 and Kerwin are discussed above.
It would have been prima facie obvious to one of ordinary skill in the art to have modified the therapeutic effective amount of a pharmaceutical dosage formulation comprising SEQ ID NO: 1 claimed by US’806 with the formulation composition ranges as taught by US’732 and Kerwin. An ordinarily skilled artisan would have had a reasonable expectation of success by modifying pharmaceutical dosage formulations comprising an agonist peptide product (e.g., SEQ ID NO: 1) as taught by US’806, and about 0.025-0.15% (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) (see [0138]) as taught by US’732 to an alternative dual agonist peptide formulation comprising polysorbate 20 as taught by Kerwin, before the effective filing date of the claimed invention to arrive at the pharmaceutical composition of the instantly claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to combine the teachings of US’732 and Kerwin to effectively change the amount of polysorbate 20 ( 0.20% w/w) to achieve a pharmaceutical composition comprising SEQ ID NO:1.
Claims 62-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 17, 19, 41 and 67 of Application No. 18/467608.
Claims 62-65 of this application are patentably indistinct from claims 1, 6, 17, 19, 41 and 67 of co-pending Application No. 18/467608.
Claims 1, 6, 17, 19, 41and 67 of the co-pending application recite a method comprising administering pemvidutide once weekly in an amount from at least about 1.2 mg to about 2.4 mg (see claim 1); wherein the pemvidutide is administered once weekly in an amount of 2.4 mg (see claim 6); weekly dosing of about 1.8 mg pemvidutide (see claim 17).
The claims 1, 6, 17, 19, 41and 67 of the ‘608 application differ from the instantly claimed invention in that the ‘608 application includes method of reducing body weight in a human being with fatty liver disease.
As both sets of claims recite regarding composition of ALT-801 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 62-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 40, 42, 43, and 46 of Application No. 19/076984.
Claims 62-65 of this application are patentably indistinct from claims 3, 40, 42, 43, and 46 of co-pending Application No. 19/076984.
Claims 3, 40, 42, 43, and 46 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).
The claims 3, 40, 42, 43, and 46 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 62-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 40, 45, 46, 47, 53, and 54 of Application No. 18/943449.
Claims 62-65 of this application are patentably indistinct from claims 40, 45, 46, 47, 53, and 54 of co-pending Application No. 18/943449.
Claims 40, 45, 46, 47, 53, and 54 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); and 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).
The claims 40, 45, 46, 47, 53, and 54 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.
Response to Arguments
Applicant’s arguments filed 06/08/2026 with respect to claim 62-65 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding Applicants’ argument that claims 62-65 were rejected on the ground of on non-statutory obviousness-type double patenting over (i) over claims 1, 6, 17, 19, 41, and 67 of co-pending U.S. Ser. No. 18/467,608; ( ii)claims 3, 40, 42, 43, and 46 of co-pending U.S. Ser. No. 19/076,984; and (iii) claims 40, 45, 46, 47, 53, and 54 of co-pending U.S. Ser. No. 18/943,449 - Applicant has requested that the rejections be held in abeyance until patentable subject matter is identified. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KOYELI BANERJEE whose telephone number is (571)272-5751. The examiner can normally be reached Monday-Friday 8-4PM.
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/KOYELI BANERJEE/ Examiner, Art Unit 1658
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
