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 and Claim Status
Applicant’s election without traverse of Group 1 and the species of compound 2 in the reply filed on 9/19/25 is acknowledged.
Claims 44-47 and 49-50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 9/19/25.
Claims to the elected species are rejected as set forth below. Any relevant art that was uncovered during the search for the elected species is cited herein in order to advance prosecution. As noted by applicants, claims 1-4, 7, 12-17, 21, 23, 35-36, 38-39 and 48 encompass the elected species.
Claims 5-6, 8-11, 18-20, 22, 24-34 and 37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/19/25.
Claims 40-43 have been canceled.
Claims 1-4, 7, 12-14, 15-17, 21, 23, 35-36, 38-39 and 48 are being examined.
Priority
The priority information is found in the filing receipt dated 4/5/24.
Information Disclosure Statement
The information disclosure statement filed 12/19/22 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. In the instant case a copy has not been provided for any of the foreign references and the 3rd listed NPL.
The information disclosure statement (IDS) submitted on 7/24/25 has been considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
37 CFR 1.821(d) recognizes that references to sequences should include the corresponding sequence identifier. In the instant case, at least pages 2 and 13-15 of the 12/19/22 specification do not include the corresponding sequence identifier.
Appropriate correction is required.
The disclosure is objected to because of the following informalities:
On page 3 of the specification, the left margin includes numbers indicating the line numbers. The number for line 20 is improperly indented. The line number ‘20’ should appear in the same column as line number ‘15’ for example.
Appropriate correction is required.
Claim Objections
Claim 35 is objected to because of the following informalities: Each claim should end in a period. Instant claim 35 does not end in a period.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 7, 12-14, 15-17, 21, 23, 35-36 and 39 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites a sequence that include W and Y (lines 3-4). The claim then goes on to refer to a moiety and then recites ‘W is..’ and ‘Y is..’ and ‘W is not..’. W and Y are known to be used as abbreviations for amino acids. However, the claim adds confusion by referring to W and Y as something other than amino acids. It appears that certain occurrences of ‘W’ are intended to be interpreted as a specific amino acid while other occurrences of ‘W’ are intended to be interpreted as something else. As such, the scope of the claims is unclear. None of the dependent claims clarify the claim scope. Although unclear, the claims have been given the broadest reasonable interpretation consistent with the specification.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 7, 12-14, 15-17, 21, 23, 35-36, 38-39 and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/111971 (07-2016; ‘Alsina-Fernandez’) in view of Thennati et al. (US 2019/0309040; ‘Thennati’).
Alsina-Fernandez teach peptides useful for treating type 2 diabetes that are GLP-1 agonists (abstract). Alsina-Fernandez teach that fatty acids can improve the pharmacokinetics of a peptide by extending half-life (page 2 lines 19-20) and suggest particular fatty acid conjugates for attachment at the lysine at position 20 (page 9 line 17- page 10 line 3). Alsina-Fernandez teach compositions comprising the compounds with a carrier (page 7 lines 1-3). In claim 12, Alsina-Fernandez recites a specific compound.
Alsina-Fernandez does not recite a compound that reads on claim 1 since the compound of Alsina-Fernandez (in claim 12) is such that instant X3 is Lys and X2 is Aib and W is -C(O)-CH2-O-(CH2)2-O-(CH2)2-NH- which corresponds to the proviso in claim 1.
Thennati teach GLP-1 agonists for treatment of diabetes and specifically refers to acylated derivatives which have improved potency and duration of action (abstract). Thennati teach moieties which have more stable bonds and are less susceptible to cleavage from biological enzymes (section 0038). Thennati specifically teach acylation of lysine with a moiety of formula -U-W-Y-Z where W can be -C(O)-CH2-O-(CH2)2-O-(CH2)2-NH- or -C(O)-C(CH3)2-NH- and Z is -C(O)-(CH2)n-COOH where n is an integer from 14 to 20 (sections 0042 and 0051). Thennati specifically recites moiety D with a W group that is -C(O)-C(CH3)2-NH- (moiety D of Table 1 and compound 16 of Table 2). Thennati teach advantageous properties of the compounds (Tables 7-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Alsina-Fernandez because Alsina-Fernandez teach peptides useful for treating type 2 diabetes that are GLP-1 agonists (abstract) and teach that fatty acids can improve the pharmacokinetics of a peptide by extending half-life (page 2 lines 19-20). In claim 12, Alsina-Fernandez recites a specific compound. Thennati teach GLP-1 agonists for treatment of diabetes and specifically refers to acylated derivatives which have improved potency and duration of action (abstract). Thennati teach moieties which have more stable bonds and are less susceptible to cleavage from biological enzymes (section 0038). Thennati specifically teach acylation of lysine with a moiety of formula -U-W-Y-Z where W can be -C(O)-CH2-O-(CH2)2-O-(CH2)2-NH- or -C(O)-C(CH3)2-NH- and Z is -C(O)-(CH2)-COOH where n is an integer from 14 to 20 (sections 0042 and 0051). In claim 12, Alsina-Fernandez teach a compound with an acylated lysine of formula -U-W-Y-Z where W is -C(O)-CH2-O-(CH2)2-O-(CH2)2-NH- and Z is -C(O)-(CH2)18-COOH. Since Thennati teach advantageous properties of the compounds (Tables 7-14) and specifically teach acylation of lysine with a moiety of formula -U-W-Y-Z where W can be -C(O)-CH2-O-(CH2)2-O-(CH2)2-NH- or -C(O)-C(CH3)2-NH- one would have been motivated to substitute the W group -C(O)-C(CH3)2-NH- for -C(O)-CH2-O-(CH2)2-O-(CH2)2-NH- in the compound of claim 12 of Alsina-Fernandez. Since Alsina-Fernandez teach compositions comprising the compounds with a carrier (page 7 lines 1-3) one would have been motivated to do such. One would have had a reasonable expectation of success since Thennati teach GLP-1 agonists for treatment of diabetes and specifically refers to acylated derivatives which have improved potency and duration of action (abstract) and teach moieties which have more stable bonds and are less susceptible to cleavage from biological enzymes (section 0038) and methods of synthesis were known (example 1 of Thennati).
In relation to the polypeptide of claims 1-4, 7, 12-14, 15-17, 21, 23, 35-36, 38-39 and 48 when the W group -C(O)-C(CH3)2-NH- is substituted for -C(O)-CH2-O-(CH2)2-O-(CH2)2-NH- in the compound of claim 12 of Alsina-Fernandez the resulting compound is the elected species (compound 2).
In relation to claims 39 and 48, Alsina-Fernandez teach compositions comprising the compounds with a carrier (page 7 lines 1-3).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 7, 12-14, 15-17, 21, 23, 35-36, 38-39 and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/812,726 (reference application; ‘726’). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
726 recites a specific peptide with a specific moiety (claim 12). 726 recites a composition of the polypeptide with a carrier (claim 14).
In relation to the polypeptide of claims 1-4, 7, 12-14, 15-17, 21, 23, 35-36, 38-39 and 48 726 recites a specific peptide with a specific moiety (claim 12) which is the elected species (compound 2).
In relation to claims 39 and 48, 726 recites a composition of the polypeptide with a carrier (claim 14).
Claims 1-4, 7, 12-14, 15-17, 21, 23, 35-36, 38-39 and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,866,477 (477 as cited with IDS 7/24/25) in view of WO 2016/111971 (07-2016; ‘Alsina-Fernandez’).
477 recites a GLP-1 agonist with a specific modification (claim 1-6) specifically via lysine (claim 2). 477 recites a composition with an excipient (claim 7).
477 does not recite a specific polypeptide as claimed.
Alsina-Fernandez teach peptides useful for treating type 2 diabetes that are GLP-1 agonists (abstract). Alsina-Fernandez teach that fatty acids can improve the pharmacokinetics of a peptide by extending half-life (page 2 lines 19-20) and suggest particular fatty acid conjugates for attachment at the lysine at position 20 (page 9 line 17- page 10 line 3). Alsina-Fernandez teach compositions comprising the compounds with a carrier (page 7 lines 1-3). In claim 12, Alsina-Fernandez recites a specific compound.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 477 because 477 expressly teach modification of a GLP-1 agonist peptide so one would have been motivated to use the known peptide sequence taught by Alsina-Fernandez (see claim 12). Since 477 teach a specific W group containing moiety (claim 4) and attachment at lysine (claim 2) one would have been motivated to use such moiety. Since 447 recognizes that the length of the alkyl chain can be from 14-20 (claims 4-5) one would have been motivated to vary the length and include n is 18. Since 447 teach the compounds as part of a pharmaceutical composition with an excipient (claim 7) one would have been motivated to include an excipient. One would have had a reasonable expectation of success since Alsina-Fernandez teach methods of making (example 1). Further, 447 expressly suggest GLP-1 agonist peptides (claim 1).
In relation to the polypeptide of claims 1-4, 7, 12-14, 15-17, 21, 23, 35-36, 38-39 and 48 when the group of claim 4 of 447 (specifically the W group -C(O)-C(CH3)2-NH-) is substituted for the acylated group (specifically the W group -C(O)-CH2-O-(CH2)2-O-(CH2)2-NH-) in the compound of claim 12 of Alsina-Fernandez the resulting compound is the elected species (compound 2).
In relation to claims 39 and 48, 477 recites a composition with an excipient (claim 7).
Claims 1-4, 7, 12-14, 15-17, 21, 23, 35-36, 38-39 and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,421,289 (289) in view of WO 2016/111971 (07-2016; ‘Alsina-Fernandez’).
289 recites a compound to be conjugated to a GLP-1 agonist via a lysine and recites that R2 is hydrogen and n is 14-20 and R1 is CO2H (claim 1-6). 289 recites a composition with an excipient (claim 14).
289 does not recite a specific polypeptide as claimed.
Alsina-Fernandez teach peptides useful for treating type 2 diabetes that are GLP-1 agonists (abstract). Alsina-Fernandez teach that fatty acids can improve the pharmacokinetics of a peptide by extending half-life (page 2 lines 19-20) and suggest particular fatty acid conjugates for attachment at the lysine at position 20 (page 9 line 17- page 10 line 3). Alsina-Fernandez teach compositions comprising the compounds with a carrier (page 7 lines 1-3). In claim 12, Alsina-Fernandez recites a specific compound.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 289 because 289 expressly teach modification of a GLP-1 agonist peptide so one would have been motivated to use the known peptide sequence taught by Alsina-Fernandez (see claim 12). Since 289 teach a specific W group containing moiety (claim 1) and attachment at lysine (claim 1) one would have been motivated to use such moiety. Since 289 recognizes that the length of the alkyl chain can be from 14-20 (claims 4-5) and recites that R2 is hydrogen and n is 14-20 and R1 is CO2H (claim 1-6) one would have been motivated to vary the length and include n is 18 and use such groups. Since 289 teach the compounds as part of a pharmaceutical composition with an excipient (claim 14) one would have been motivated to include an excipient. One would have had a reasonable expectation of success since Alsina-Fernandez teach methods of making (example 1). Further, 289 expressly suggest GLP-1 agonist peptides (claim 1).
In relation to the polypeptide of claims 1-4, 7, 12-14, 15-17, 21, 23, 35-36, 38-39 and 48 when the group of claim 1 of 289 (specifically the W group -C(O)-C(CH3)2-NH-) is substituted for the acylated group (specifically the W group -C(O)-CH2-O-(CH2)2-O-(CH2)2-NH-) in the compound of claim 12 of Alsina-Fernandez the resulting compound is the elected species (compound 2).
In relation to claims 39 and 48, 289 recites a composition with an excipient (claim 14).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658