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 .
Applicant’s renewed request on 6 June 2025 to participate in the Patent Prosecution Highway (PPH) program was granted on 16 June 2025. The examiner believes this to be in error as applicant has not presented the amended claims from PCT/EP2025/054317 that were the subject of the Form PCT/IPEA/409. See the two claim sets (8 pages each) included with the Form PCT/IPEA/409 documents submitted by applicant on 6 June 2025. The PCT/IPEA/409 document (dated 18 April 2024) was based on claims 1-15 as filed on 3/27/2024. It is noted that no sequence listing was used for preparing the search report. It is unclear which claimed sequence(s) were searched and what sequence listing was used for the final report.
In addition, the originally submitted claims (filed on 20 August 2024) in the instant application were numbered as 1-10 and 12-16. There was no claim numbered as claim 11. According to 37 CFR 1.126, these claims should have been renumbered as 1-15. The amendment submitted on 6/6/2025 should have cancelled claims 1-15 and added claims 16-27. Applicant must submit a revised claim set with the correct claim numbering in their next response.
Specification
Applicant filed substitute specifications on 1/2/2025, 4/21/2025, 6/6/2025, and 7/14/2025. The current substitute specification is the version dated 7/14/2024 which has been entered.
Applicant filed replacement sequence listings on 1/2/2025, 4/21/2025, 6/6/2025, and 7/14/2025. The current sequence listing is the version dated 7/14/2024 which has been entered.
Claim Objections
Claims 17-18 and 20 are objected to because of the following informalities: Claim 17, line 16, for X11, recites “aMeL.” This appears to be a word processing error and that “αMeL” was intended. See for example claim 17, line 22, for X15. In addition, some choices for different amino acid positions are separated by semicolons (“;”) and some are not. For example, the choices for X1 are not followed by a semicolon whereas the choices for X2 are. It appears that the choices for each position should be followed by a semicolon for consistency and clear separation. See also claims 18 and 20. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: Claim 19, line 1, recites “wherein at least at least one of.” This appears to be a word processing error. 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 17-28 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 17 is confusing in reciting “or a pharmaceutically acceptable salt thereof” in the last few lines of the claim. It is unclear if this limitation is intended with respect to only the embodiment wherein X1 is isoleucine and optionally N-terminally acetylated or N-methylated. The claim as written is confusing. Claim 18 is confusing for the same reason.
Regarding claims 18-23, the phrases “in particular” and “more in particular” (multiple places in each claim) renders the claims indefinite because it is unclear whether the limitation(s) following the phrases are part of the claimed invention. See MPEP § 2173.05(d). The metes and bounds of the claims cannot be determined.
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 17-20 and 24-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-25 and 27 of co-pending Application No. 18/021,712 (9/22/2025 claim set; applicant Sanofi; inventors Illiano, Lucats, Ledein, Beauverger, Janiak, Ozoux, Halland, Li, Elvert, Evers, Bianchi, Santoprete, Roversi, and Tripepi; inventors Janiak, Ozoux, Roversi, Bianchi, Tripepi, and Santoprete are in common with the instant application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Co-pending claim 16 is directed to a compound which is a peptide comprising the amino acid sequence of Formula (I): X1-X2-X3-X4-X5-X6-X7-X8-X9-X10-X11-X12-X13-X14-X15-X16-X17-X18-X19- X20-X21-X22-X23-X24-X25-X26-X27-X28-X29-X30-X31-X32- X33-X34-X35-X36-X37-X38 or a pharmaceutically acceptable salt thereof, wherein: X1 can be isoleucine (I); X2 can be valine (V); X3 is leucine (L); X4 is serine (S); X5 is leucine (L); X6 is aspartate (D); X7 is valine (V) or D-valine (v); X8 is proline (P); X9 can be isoleucine (I); X10 can be lysine (K) or glycine (G); X11 can be isoleucine (I) or leucine (L); X12 is lysine (K), wherein the epsilon-amino group of the lysine side chain is covalently bound to an albumin-binding moiety; X13 can be glutamine (Q) or lysine (K); X14 can be isoleucine (I) or 2-aminoisobutyric acid (Aib); X15 can be leucine (L); X16 can be leucine (L); X17 can be glutamate (E) or lysine (K); X18 is glutamine (Q); X19 can be glutamate (E); X20 can be lysine (K) or arginine (R); X21 can be glutamine (Q); X22 can be lysine (K); X23 can be lysine (K) or 2-aminoisobutyric acid (Aib); X24 can be glutamine (Q); X25 can be arginine (R) or 2-aminoisobutyric acid (Aib); X26 can be glutamate (E) or 2-aminoisobutyric acid (Aib); X27 can be glutamine (Q); X28 is alanine (A); X29 can be glutamate (E); X30 can be lysine (K) or threonine (T); X31 can be asparagine (N) or alanine (A); X32 can be lysine (K), alanine (A), valine (V), threonine (T), glutamate (E), or 2-aminoisobutyric acid (Aib); X33 can be glutamine (Q); X34 can be isoleucine (I); X35 is leucine (L); X36 is alanine (A) or glutamate (E); X37 can be glutamine (Q); and X38 can be valine (V). All combinations are suggested by the co-pending claim 16 and include embodiments of instant claims 17-20.
Co-pending claim 16 further recites “wherein the albumin-binding moiety is a group of the formula (II):-Z1-Y- Z²_C(O)R (II) wherein:Y is AEEA, {AEEA}₂, {AEEA}₃, Gly, {Gly}₂, {Gly}₃, N-MeGly, {N- MeGly}2, {N-MeGly}₃ or absent, wherein Y is absent when Z² is gGlu, or {gGlu}₂, and wherein AEEA denotes [2-(2-aminoethoxy)ethoxy]-acetyl; Zi and Z² are each independently selected from gGlu, {gGlu}2, {gGlu}3, {gGlu}4 or absent, wherein Z¹ is absent when Y is {AEEA}₂ and Z² is gGlu or {gGlu}₂; andR¹ is -(CH2)xCOOH or - (CH2)xCH₃, wherein X is an integer from 12 to 22. These are embodiments of instant claims 24-26.
Co-pending claim 21 recites where X1 is acetylated. See instant claims 17-18.
SEQ ID NO: 186 in co-pending application 18/021,712 is recited in claim 25 of the co-pending application. This sequence has wild-card choices that would include at least for example instant SEQ ID NO: 40 as recited in instant claim 27.
Pharmaceutical compositions comprising the compound of co-pending claim 16 are taught by instant claim 28.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant SEQ ID NOS: 33-34, 80, 92-93, 96, 219, 222, and 235 have valine (V) at the N-terminal and are excluded by SEQ ID NOS: 1-227 in co-pending application 18/021,712. The co-pending sequences have either isoleucine (I) or phenylalanine (F) at the N-terminal. See instant claim 27.
Instant SEQ ID NOS: 51, 54, 55, 57, 104, 131, 132, 136, and 210 have Abu, αMeL Dap, 4-Pip, Cpx or Thp at amino acid position 32 and are excluded by SEQ ID NOS: 1-227 in co-pending application 18/021,712. The co-pending sequences do not have these sequences. See instant claim 27.
SEQ ID NOS: 17-24, 35-38, 67-69, 77, 79, 81, 83-87, 94-99, 101-142, 147-152, 154-155, 157-160, 162-164, 171-181, 183-185, 187-220, 223, and 225-227 in co-pending application 18/021,712 have isoleucine (I) at the N-terminal and lysine (K) at amino acid position 32 and are excluded by the instant claim 27. Co-pending SEQ ID NOS: 3 and 7 in claims 25-26 of co-pending application 18/021,712 do not correspond to any sequences in instant claim 27. There is no double patenting between instant claim 27 and co-pending claim 26.
Claim Rejections - 35 USC § 102
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.
Claim 27 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Illiano et al. (WO 2022/038179, published 22 February 2022, filed 18 August 2021)
Claims 1-20 and 24-28 are rejected under 35 USC 102(a)(2) as being anticipated by Illiano et al. (WO 2022/038179, of record, published 22 February 2022, filed 18 August 2021) or Illiano et al. (U.S. Patent Application Publication 2025/0243255 filed 18 August 2021).
Co-pending U.S. application 18/021,712 is a 371 application of PCT/EP2021/072923 (published as WO 2022/038179) and corresponds to U.S. Patent Application Publication 2025/0243255. They are equivalent documents and WO 2022/038179 will be referenced.
The effective filing date of the instant application is 23 February 2022) for claims 17-26 and 28. Not all of the sequences disclosed in claim 27 are present in the foreign priority document. This claim has an effective filing date of 21 February 2023.
The applied references have a common inventor with the instant application (applicant Sanofi; inventors Illiano, Lucats, Ledein, Beauverger, Janiak, Ozoux, Halland, Li, Elvert, Evers, Bianchi, Santoprete, Roversi, and Tripepi; inventors Janiak, Ozoux, Roversi, Bianchi, Tripepi, and Santoprete are in common with the instant application). Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
At least claim 1 of Illiano et al. is directed to a compound which is a peptide comprising the amino acid sequence of Formula (I): X1-X2-X3-X4-X5-X6-X7-X8-X9-X10-X11-X12-X13-X14-X15-X16-X17-X18-X19- X20-X21-X22-X23-X24-X25-X26-X27-X28-X29-X30-X31-X32- X33-X34-X35-X36-X37-X38 or a pharmaceutically acceptable salt thereof, wherein: X1 can be isoleucine (I); X2 can be valine (V); X3 is leucine (L); X4 is serine (S); X5 is leucine (L); X6 is aspartate (D); X7 is valine (V) or D-valine (v); X8 is proline (P); X9 can be isoleucine (I); X10 can be lysine (K) or glycine (G); X11 can be isoleucine (I) or leucine (L); X12 is lysine (K), wherein the epsilon-amino group of the lysine side chain is covalently bound to an albumin-binding moiety; X13 can be glutamine (Q) or lysine (K); X14 can be isoleucine (I) or 2-aminoisobutyric acid (Aib); X15 can be leucine (L); X16 can be leucine (L); X17 can be glutamate (E) or lysine (K); X18 is glutamine (Q); X19 can be glutamate (E); X20 can be lysine (K) or arginine (R); X21 can be glutamine (Q); X22 can be lysine (K); X23 can be lysine (K) or 2-aminoisobutyric acid (Aib); X24 can be glutamine (Q); X25 can be arginine (R) or 2-aminoisobutyric acid (Aib); X26 can be glutamate (E) or 2-aminoisobutyric acid (Aib); X27 can be glutamine (Q); X28 is alanine (A); X29 can be glutamate (E); X30 can be lysine (K) or threonine (T); X31 can be asparagine (N) or alanine (A); X32 can be lysine (K), alanine (A), valine (V), threonine (T), glutamate (E), or 2-aminoisobutyric acid (Aib); X33 can be glutamine (Q); X34 can be isoleucine (I); X35 is leucine (L); X36 is alanine (A) or glutamate (E); X37 can be glutamine (Q); and X38 can be valine (V). All combinations are suggested by claim 1 of Illiano et al. and include embodiments of instant claims 17-20.
At least claim 7 of Illiano et al. further recites “wherein the albumin-binding moiety is a group of the formula (II):-Z1-Y- Z²_C(O)R (II) wherein:Y is AEEA, {AEEA}₂, {AEEA}₃, Gly, {Gly}₂, {Gly}₃, N-MeGly, {N- MeGly}2, {N-MeGly}₃ or absent, wherein Y is absent when Z² is gGlu, or {gGlu}₂, and wherein AEEA denotes [2-(2-aminoethoxy)ethoxy]-acetyl; Zi and Z² are each independently selected from gGlu, {gGlu}2, {gGlu}3, {gGlu}4 or absent, wherein Z¹ is absent when Y is {AEEA}₂ and Z² is gGlu or {gGlu}₂; andR¹ is -(CH2)xCOOH or - (CH2)xCH₃, wherein X is an integer from 12 to 22. These are embodiments of instant claims 24-26.
At least claim 5 of Illiano et al. recites where X1 is acetylated. See instant claims 17-18.
SEQ ID NO: 186 of Illiano has wild-card choices that would include at least for example instant SEQ ID NO: 40 as recited in instant claim 27. See at least page 3 and claim 10 of Illiano et al. SEQ ID NO: 186 also includes various embodiments of instant claims 17-20.
Pharmaceutical compositions are disclosed in at least claim 12 of Illiano et al. and meet the limitations of instant claim 28.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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