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 .
DETAILED ACTION
Claim Status
Claims 1-10, 12-14 and 16-19 are pending. Claims 11 and 15 have been canceled. Claim 1 has been amended. In the response to the restriction requirement, Applicants elected CPP12 (SEQ ID NO: 58). The claims as amened do NOT encompass the elected species. Another species has been searched (see rejection under 35 USC 102(a)(1) below). As a result, claims 1-4, 6, 16-17 and 19 have been examined and claims 5, 7-10, 12-14 and 18 are withdrawn from consideration.
Claim Objections
Claim 19 is objected to because of the following informalities: Claim 19 should be amended as follows: “The cyclic peptide of claim 17, wherein the at least one of the hydrophobic amino acids is phenylalanine”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The rejection of claims 1-4, 11 and 15 under 35 U.S.C. 102(a)(1) as being anticipated by Quian et al. is withdrawn in view of the amendments to the claims.
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.
Claims 1-4, 6, 16-17 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pei et al. (WO 2015/179691).
With respect to claim 1, Pei et al. teach a cell penetrating peptide of Formula I-3: AA1-AA2-AA3-AA4-AA5-AA6-AA7-AA8, wherein AA1, AA2, AA3, AA4, AA5, AA6, AA7, and AA8 are each independently an amino acid (claim 4); and wherein the cell penetrating peptide compound is cyclic (claim 6).
Pei et al. also teach various cyclic peptides having all amino acids in the natural stereoconfiguration (i.e. SEQ ID NOs: 17-22 and 24) which corresponds to the instantly claimed cyclic peptide of Formula I-D (see Table 2).
Pei et al. further teach that glutamine is being used to attach the cargo (page 16, lines 18-19).
Pei et al. additionally teach that the cargo comprises a linker moiety, a detectable moiety, a therapeutic moiety, a targeting moiety, and the like, or any combination thereof (page 21, lines 4-6).
With respect to claim 2, SEQ ID NOs: 17-18, 21-22 and 24 comprise naphthylalanine.
With respect to claim 3, SEQ ID NOs: 17-22 and 24 comprise phenylalanine.
With respect to claim 4, SEQ ID NOs: 17-22 and 24 comprise at least 2 aromatic hydrophobic amino acids.
With respect to claim 6, SEQ ID NO: 17 comprises 2 phenylalanine.
With respect to claim 16, Pei et al. teach that the cargo comprises 8-amino-3,6-dioxaoctanoic acid (page 21, lines 6-12).
With respect to claim 17, SEQ ID NO: 17 comprises 3 adjacent hydrophobic amino acids.
With respect to claim 19, SEQ ID NO: 17 comprises 2 phenylalanine.
Double Patenting
The rejection of claims 1-4 and 11 on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10626147 is withdrawn in view of the amendments to the claims.
The rejection of claims 1-4, 11 and 15 on the ground of nonstatutory double patenting as being unpatentable over claims 1-40 of U.S. Patent No. 10815276 is withdrawn in view of the amendments to the claims.
The rejection of claims 1-4, 11 and 15 on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of U.S. Patent No. 11168310 is withdrawn in view of the amendments to the claims.
The rejection of claims 1-4, 11 and 15 on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11987821 is withdrawn in view of the amendments to the claims.
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, 6, 17 and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 19/329358 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same cyclic peptide.
With respect to claim 1, ‘358 teaches a compound comprising; i. a cyclic cell penetrating 8 amino acid peptide that contains; a. one arginine within two amino acids of another arginine; b. an amino acid with a hydrophobic side chain within two amino acids of another amino acid with a hydrophobic side chain; and ii. an exocyclic cargo moiety conjugated to a side chain of the cell penetrating peptide wherein the conjugation is through glutamine and wherein the cargo comprises an amino acid sequence that targets an enzyme (claim 1), and wherein the cargo moiety also comprises a therapeutic moiety and a linker moiety (claim 6).
With respect to claim 2, ‘358 teaches that two amino acids with hydrophobic side chains in the cyclic cell penetrating peptide engage in pi-stacking (claim 2), wherein the two amino acids with hydrophobic side chains which engage in pi stacking are napthylalanine (claim 4).
With respect to claims 3-4 and 6, ‘358 teaches that two amino acids with hydrophobic side chains in the cyclic cell penetrating peptide engage in pi-stacking (claim 2), wherein the two amino acids with hydrophobic side chains which engage in pi stacking are phenylalanine (claim 3).
With respect to claim 17, ‘358 teaches that the cyclic cell penetrating peptide comprises at least three amino acids which have a hydrophobic side chain, wherein at least two amino acids having a hydrophobic side chain are consecutive (claim 11). One of ordinary skill in the art would have at once envisaged 3 or more adjacent hydrophobic amino acids.
With respect to claim 19, ‘358 teaches that at least one of the amino acids with a hydrophobic side chain is a phenylalanine (claim 13).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 19/329417 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same cyclic peptide.
With respect to claim 1, ‘417 teaches a cyclic peptide of structure III-B (which corresponds to the instantly claimed cyclic peptide of structure I-D), wherein a cargo is conjugated to the side chain of a glutamine, and wherein the cargo comprises a linker moiety, a therapeutic moiety, and a targeting moiety (claim 1).
With respect to claims 2-4 and 6, ‘417 teaches that at least two amino acids are a hydrophobic amino acid selected from the group consisting of glycine, alanine, valine, leucine, isoleucine, methionine, phenylalanine, tryptophan, proline, naphthylalanine, phenylglycine, homophenylalanine, tyrosine, cyclohexylalanine, piperidine-2-carboxylate, and norleucine (claim 1). One of ordinary skill in the art would have at once envisaged 2 naphthylalanine.
With respect to claim 16, ‘417 teaches that the cargo moiety comprises an 8-amino-3,6-dioxaoctanoic acid (claims 10 and 15).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6, 16-17 and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 12-15 of copending Application No. 19/329423 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same cyclic peptide.
With respect to claim 1, ‘423 teaches a cyclic peptide of structure I-D (which corresponds to the instantly claimed cyclic peptide of structure I-D), wherein a cargo is conjugated to the side chain of a glutamine, and wherein the cargo comprises a linker moiety, a therapeutic moiety, and a targeting moiety (claim 1).
With respect to claim 2, ‘423 teaches that two amino acids are aromatic hydrophobic amino acids (claim 8), and wherein the aromatic hydrophobic amino acids are napthylalanine (claim 9).
With respect to claims 3-4 and 6, ‘423 teaches that two amino acids are aromatic hydrophobic amino acids (claim 8), and wherein the aromatic hydrophobic amino acids are phenylalanine (claim 10).
With respect to claim 16, ‘423 teaches that the cargo moiety comprises an 8-amino-3,6-dioxaoctanoic acid (claim 12).
With respect to claim 17, ‘423 teaches that the cyclic cell penetrating peptide comprises at least three hydrophobic amino acids adjacent to each other (claim 13).
With respect to claim 19, ‘423 teaches that at least one of the hydrophobic amino acid is phenylalanine (claim 15).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
Prosecution Insights