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
Response to Election/Restriction filed on April 28, 2026 is acknowledged. Claims 1-4 were canceled and claims 95-114 are pending in the instant application.
Election/Restrictions
Applicant elected without traverse invention 1 (claims 95-111) drawn to a peptide and without traverse a peptide according to Formula III-C and instant SEQ ID NO:132 as the peptide species in the reply filed April 28, 2026.
The restriction is deemed proper and is made FINAL in this office action. Claims 104-109, 112-114 are withdrawn from consideration as being drawn to non-elected invention/species.
Claims 95-103, 110-111 are examined on the merits of this office action.
Claim Rejections - 35 USC § 112, First Paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 95-103, 111 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
Scope of the claims
The claims are directed to a broad genus of cyclic peptide compounds defined primarily by numerical and functional limitations rather than by specific sequences or narrowly circumscribed structural features. In particular, the claims encompass cyclic peptides that comprise at least two-three arginine residues; comprise at least two hydrophobic amino acid residues, without restriction as to identity, position, or spacing; permit all remaining amino acid positions to be occupied by any amino acid, include a cargo moiety conjugated optionally via a linker; and allow substantial variability in peptide length (up to 16 amino acids in length), residue order, residue composition, and cargo attachment location. Claims 96-97 specify hydrophobic amino acids that can be present but are not particularly limiting; claims 99-103 generally claim location of the arginine/hydrophobic residues and claim 111 claims pharmaceutical formulations thereof.
As drafted, the claims encompass an exceptionally large and structurally diverse genus of cyclic peptides, including peptides with markedly different charge distributions, hydrophobicity profiles, conformational flexibility, and secondary structure characteristics.
Therefore, to meet the written description requirement of 35 U.S.C. § 112, first paragraph, the specification must disclose a representative number of species that meet both the structural and functional limitations of the genus or the specification and/or the prior art must identify the structural elements that correlate to the claimed function in a manner that demonstrates to one of ordinary skill in the art that Applicant was in possession of the claimed genus at the time the application was filed.
Actual Reduction to Practice
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Although the specification describes synthesis and testing of certain peptide species, the disclosure demonstrates actual reduction to practice only for a relatively limited subset of the claimed genus. The experimental examples and Table 4 disclose a finite number of peptide sequences having specific amino acid arrangements and stereochemical configurations. However, the claims encompass substantially broader subject matter including numerous undisclosed amino acid combinations, undisclosed linker embodiments, undisclosed cargo moieties, undisclosed bicyclic architectures and undisclosed stereochemical permutations. The disclosed examples do not establish possession of the full claimed genus because the tested peptides represent only a small fraction of the structurally possible embodiments encompassed by the claims. Moreover, the specification does not provide experimental data for many embodiments now encompassed by the claims, including numerous linker containing structures, cargo containing structures, formula III-B through III-D embodiments or peptides containing all combinations of the recited hydrophobic amino acids.
Accordingly, the disclosed examples do not constitute representative species of the claimed genus. Therefore, the instant specification has failed to meet the written description requirement by actual reduction to practice of a representative number of species alone.
Sufficient relevant identifying characteristic
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination thereof.
The specification fails to provide sufficient identifying characteristics common to the full claimed genus. While the disclosure identifies certain peptide sequences and reports functional activity for selected species, the specification does not adequately identify structural features that reliably distinguish peptides within the claimed genus from peptides outside the genus. In particular, the specification does not sufficiently described which structural features are necessary for the claimed activity, which amino acid substitutions are toleration or which residue arrangements are critical to function. The claims permit substantial variation in amino acid identity, residue positioning, stereochemistry, cyclization, cargo incorporation and linker inclusion. However, the specification does not disclose a unifying structural principle applicable across the full scope of the claims. Instead, the disclosure primarily provides a collection of individual peptide examples without sufficient guidance demonstrating possession of the entire genus. The specification therefore does not provide representative species or common structural features sufficient to satisfy the written description requirement for the broad genus presently claimed.
Physical/Chemical Properties
The specification provides limited physical and chemical characterization of the claimed peptides. Although the disclosure reference peptide synthesis, HPLC purification, and MALDI-TOF confirmation for selected species, the specification does not adequately characterize the physical or chemical properties of the full claimed genus. For example, the specification does not adequately describe conformational properties across the claimed genus, physiochemical limitations associated with linker incorporation, effects of cargo attachment, or properties associated with different cyclic structures. The broad claims encompass numerous structurally distinct compounds having potentially different chemical and biophysical characteristics. However, the specification does not provide sufficient characterization demonstrating possession of these diverse embodiments. Furthermore, the disclosed physical and chemical properties are insufficient to support the full scope of the claims.
Functional characteristics when coupled with a known or disclosed correlation between function and structure
The specification fails to establish a sufficient correlation between structure and function across the full scope of the claimed genus. Although Table 4 reports relative cytosolic delivery efficiencies for selected peptide sequences, the data demonstrate substantial variability among closely related peptide species. The disclosed activity values vary significantly across peptides differing only modestly in stereochemistry, residue ordering or amino acid substitutions. This variability suggests that peptide function is highly sequence dependent and unpredictable. The specification therefore does not establish that the broad genus recited in claim 95 shares a common structural feature reliably correlated with the claimed functional properties. Moreover, the claims encompass numerous undisclosed peptide for which no functional data are provided.
The specification does not sufficiently explain which structural elements are responsible for enhanced cytosolic delivery, whether all claimed peptides would exhibit the asserted functionality, or how one of ordinary skill would identify operative embodiments across the full scope of the claims without undue experimentation. Accordingly, the specification fails to provide an adequate structure function correlation sufficient to demonstrate possession of the full claimed genus.
Method of Making
While the specification provides general peptide synthesis procedures, the disclosure does not adequately describe methods for making the full breadth of the claimed embodiments. In particular, the specification provides limited guidance regarding preparation of all claimed linker embodiments, synthesis of all bicyclic architectures, incorporation of all claimed cargo moieties, or synthesis of all stereochemical variants encompassed by the claims. The disclosure primarily describes standard peptide synthesis techniques applied to selected peptide examples. However, the ability to make certain disclosed species does not establish possession of the entire claimed genus, particularly where the claims encompass numerous structurally diverse embodiments not specifically described in the specification. Accordingly, the disclosed methods of making do not sure the deficiencies in written description support for the full scope of the claims.
Conclusion
The specification, as originally filed, does not reasonably convey to one of ordinary skill in the art that the inventors possessed the full scope of the claimed cyclic peptide genus at the time of filing. The claims encompass a broad and structurally diverse genus defined largely by functional and partially result oriented limitations, while the specification discloses only a limited number of representative species and does not identify common structural features predictive of the claimed functionality across the entire genus. Accordingly, the claims are rejected under 35 U.S.C. §112(a) for lack of adequate written description.
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 95-103 and 110-111 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 95 claims “A cyclic peptide comprising Formula III-A, III-B, III-C, or III-D:….and then lists of the structures of III, III-B, III-C or III-D…” Paragraph [0151, pgpub] states that the disclosed CPPs have a structure according to “Formula III-A to III-D”. However, the corresponding structures are labeled “III”, “III-B”, “III-C”, and “III-D”. Thus, it is unclear whether Formula III and Formula III-A refer to the same structure or whether a separate Formula III-A is intended. Accordingly, one of ordinary skill in the art would not be reasonably apprised of the scope of the claim. Claims 96-103, 110-111 are also rejected due to their dependence on claim 95 and not further clarifying this point of confusion.
Claims 99-100 are rejected under 35 U.S.C. 112(b) as indefinite because the limitation “wherein at least two arginines are adjacent to each other” or “wherein three arginines are adjacent” is subject to multiple reasonable interpretations. Specifically, it is unclear whether the recited arginines must be located within the CPP portion of Formula III-B, within the cargo moiety, or within the overall cyclic structure inclusive of the cargo moiety. Accordingly, the metes and bounds of the claim cannot be reasonably ascertained. The claims do no recite “the arginines” and thus, the claim can have multiple interpretations.
Claims 101-102 is rejected under 35 U.S.C. 112(b) as indefinite because the limitation “wherein at least two/three hydrophobic amino acids are adjacent to each other” is subject to multiple reasonable interpretations. Specifically, it is unclear whether the recited hydrophobic amino acids must be located within the CPP portion of Formula III-B, within the cargo moiety, or within the overall cyclic structure inclusive of the cargo moiety. Accordingly, the metes and bounds of the claim cannot be reasonably ascertained.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 95-103, 111 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pei (WO2015179691 A9).
Pei discloses cyclic cell penetrating peptides (CPPs) comprising arginine containing peptide sequences and hydrophobic amino acids within cyclic peptide architectures corresponding to the presently claimed Formula III-B embodiments. See Formula IIa and IIb (pages 109-111) and more specifically linkers as part of the cargo moiety (see “Cargo moiety section”). Regarding claim 95, formula III-C, Pei teaches the cyclic CPP and cyclic cargo moiety which creates a bicyclic system (claim 30). Pei further discloses cyclic CPP compounds containing multiple arginine residues and hydrophobic residues positioned within the cyclic peptide sequence (see claims 13-38 and Tables 2, 6 and 18).
Regarding claim 95, Pei discloses cyclic CPP compounds comprising no more than three arginine residues and at least two hydrophobic amino acids. In particular, Table 16, page 96, discloses SEQ ID NO:196 (c(FΦRRRQ) in Table 16 falls within Formula III-C comprising exactly three arginine residues, at least two hydrophobic amino acids (phe, Nap) (see Table 16, Table 2). Pei additionally teaches attachment to a cargo moiety (see abstract and also “cargo moiety” section, Table 4).
Regarding claim 96, Pei discloses hydrophobic amino acids including phenylalanine and naphthyl alanine residues (see claim 38, page 113, table 16, SEQ ID NO:196, also Table 2).
Regarding claim 97, Pei discloses cyclic CPP compounds containing multiple hydrophobic amino acids within the cyclic peptide sequence (see Table 16, including SEQ ID NO:196).
Regarding claim 98, Pei discloses stereochemical variants of cyclic CPP compounds, including D- and L-amino acid configurations (see pages 20-21 and Table 16, including lower case amino acid notation identifying stereochemical variants).
Regarding claim 99, Pei discloses cyclic CPP compounds containing adjacent arginine resiudes (see Table 16, including SEQ ID NO:196, “RRR”).
Regarding claim 100, Pei discloses cyclic CPP compounds containing adjacent arginine resiudes (see Table 16, including SEQ ID NO:196, “RRR”).
Regarding claim 101, Pei discloses cyclic CPP compounds containing at least two hydrophobic amino acids within the cyclic peptide sequence(see Table 16, including SEQ ID NO:196, Phe and Φ).
Regarding claim 103, Pei discloses cyclic CPP compounds containing hydrophobic amino acids and arginine residues possess defined stereochemical configurations within the cyclic peptide sequence (see pages 20-21, Table 16, SEQ ID NO:196 c(FΦRRRQ)).
Regarding claim 111, Pei discloses pharmaceutical compositions comprising the disclosed cyclic CPP compounds (see claims 41-42, page 113).
Regarding claim 102, the claim recites “wherein at least three hydrophobic amino acid are adjacent to each other”. Claim 102 does not expressly limit the “three hydrophobic amino acids” to the hydrophobic amino acids previously recited in instant claim 95, nor does claim 102 require that the hydrophobic amino acids be located exclusively within the CPP portion of formula III-C. Rather, formula III-B/C encompasses embodiments in which the cargo moiety participates in the cyclic structure. Accordingly, the broadest reasonable interpretation of claim 102 includes embodiments in which the recite adjacent hydrophobic amino acids can be located within the CPP portion or within the cargo moiety. This interpretation is consistent with the specification and the prior art of record, which contemplate cargo moieties comprising amino acid sequences including hydrophobic amino acids (see Table 4 for example). Pei discloses cyclic CPP compounds comprising cargo moieties that comprise at least three hydrophobic adjacent amino acids (see Table 4).
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.
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.
Claim(s) 110 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pei (WO2015179691 A9) in view of Kawczynski (“"Synthesis of conjugates of enzyme inhibitors with amino acid structure and penetrating peptides as potential compounds antifungal”, Doctoral dissertation, pages 1-119).
Pei teaches cyclic cell penetrating peptides (CPPs) comprising combinations of hydrophobic aromatic amino acids and arginine residues for intracellular delivery of cargo molecules and therapeutic moieties. See, e.g., claims 7–35; Tables 2, 16; Example 4.
Pei discloses cyclic cell penetrating peptides (CPPs) comprising arginine containing peptide sequences and hydrophobic amino acids within cyclic peptide architectures corresponding to the presently claimed Formula III-B embodiments. See Formula IIa and IIb (pages 109-111) and more specifically linkers as part of the cargo moiety (see “Cargo moiety section”). Regarding claim 95, formula III-C, Pei teaches the cyclic CPP and cyclic cargo moiety which creates a bicyclic system (claim 30). Pei further discloses cyclic CPP compounds containing multiple arginine residues and hydrophobic residues positioned within the cyclic peptide sequence (see claims 13-38 and Tables 2, 6 and 18). Pei discloses cyclic CPP compounds comprising no more than three arginine residues and at least two hydrophobic amino acids. In particular, Table 16, page 96, discloses SEQ ID NO:196 (c(FΦRRRQ) in Table 16 falls within Formula III-C comprising exactly three arginine residues, at least two hydrophobic amino acids (phe, Nap) (see Table 16, Table 2). Pei additionally teaches attachment to a cargo moiety (see abstract and also “cargo moiety” section, Table 4).
As stated above, Pei specifically teaches cyclic CPPs containing phenylalanine-derived hydrophobic residues and arginine residues in varying stereochemical arrangements, including sequences such as c(FΦRRRQ), c(fΦRrRq), c(fΦrRrRQ), and related variants exhibiting cellular uptake and membrane binding activity. Pei further teaches that uptake efficiency can be affected with regards to addition of hydrophobic residues, arginine content, residue arrangement, and stereochemical configuration (see page 56, Introduction, last paragraph, see page 71, second paragraph, lines 6-7, See Table 16 and accompanying discussion). Pei expressly teaches that stereochemical variation of amino acid residues affects membrane binding and cellular uptake efficiency. See, e.g., Table 16, which discloses multiple cyclic CPP variants differing in D- and L-configurations of phenylalanine- and arginine-containing residues while exhibiting differing uptake efficiencies and membrane affinities. Pei therefore teaches that modification of residue stereochemistry constitutes a result-effective variable for optimizing CPP activity.
Pei is silent to wherein the cyclic peptides comprise one of the sequences in instant claim 110.
However, Kawczyński teaches simplified penetrating peptides comprising combinations of hydrophobic aromatic residues and arginine residues for delivery of biologically active agents. See Table 2. In particular, Kawczyński teaches the penetrating peptide sequences FFFRRR (“FR”) and FFFRRR-NH2 (“FRN”) (see table 2 of translation), and explains that penetrating properties depend on the presence of Arg/Lys residues together with Phe/Trp residues (see table 2). Kawczyński further teaches conjugates comprising such peptides linked to biologically active inhibitor moieties, including FMDP-FRN conjugates synthesized for intracellular delivery applications (see page 56, section 1.1).
It would have been obvious to before the effective filing date of the claimed invention to modify the cyclic CPPs of Pei to incorporate the phenylalanine/arginine sequence motifs taught by Kawczyński, including motifs containing three phenylalanine residues and three arginine residues, because both references teach that amphipathic combinations of hydrophobic aromatic residues and cationic arginine residues promote membrane penetration and intracellular delivery of therapeutic cargo. Further, Pei expressly teaches optimization of stereochemical arrangement and residue ordering to improve uptake efficiency, thereby providing motivation to employ routine variation of residue sequence and stereochemistry to obtain predictable CPP variants, including the presently claimed sequences.
Accordingly, it would have been obvious to one of ordinary skill in the art to routinely optimize the relative placement and D/L stereochemical configuration of the phenylalanine and arginine residues in the combined Pei/Kawczyński peptide motifs in order to obtain improved intracellular delivery properties, such optimization amounting to no more than routine experimentation yielding predictable results. Accordingly, the claimed subject matter would have been obvious over the combined teachings of Pei and Kawczyński.
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.
Claim(s) 95-103, 110-111 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of U.S. Patent No. 11168310 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a cyclic peptide comprising formula IIIA-IIID wherein each of each of AA1, AA₂, AA₃, and AA4, are independently selected from an amino acid; at each instance AAu and AAz are independently selected from an amino acid; each of m and n are a number from 0 to 6, provided that at least one of m or n is not O; Xₙ is a cargo moiety; L is a linker moiety; wherein: two or three of AA1, AA₂, AA₃, AA4, each AAu, and each AAz are arginine, with the remaining amino acids thereof being an amino acid other than arginine; at least two of AA₁, AA₂, AA₃, AA4, each AAu, and each AAz are independently a hydrophobic amino acid; and wherein when Xₙ is attached to AAu, m is not 0 (claim 95). The instant application further claims wherein the hydrophobic amino acid is selected from phenylglycine, leucine….tyrosine…naphthylalanine…optionally substituents thereof” (claim 96); opposite chirality (Claim 98); at least two arginines adjacent to each other (claim 99); wherein three arginines are adjacent to each other (claim 100); at least two/three hydrophobic amino acids adjacent to each other (claim 101-102); SEQ ID Nos:131-136 (claim 110); and pharmaceutical formulations thereof (claim 111).
US Patent No. ‘310 claims a compound comprising a therapeutic and a CPP conjugated thereto (claim 1); and wherein the CPP comprises SEQ ID NOS: 14-101, 108, 110, 124-127 (claim 8, see table 4), the peptides overlap with the instant claims including instant claim 110 (SEQ ID Nos:77-80) and D- and L- amino acids; pharmaceutical compositions thereof (claim 26).
Claim(s) 95-103, 111 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11987821. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a cyclic peptide comprising formula IIIA-IIID wherein each of each of AA1, AA₂, AA₃, and AA4, are independently selected from an amino acid; at each instance AAu and AAz are independently selected from an amino acid; each of m and n are a number from 0 to 6, provided that at least one of m or n is not O; Xₙ is a cargo moiety; L is a linker moiety; wherein: two or three of AA1, AA₂, AA₃, AA4, each AAu, and each AAz are arginine, with the remaining amino acids thereof being an amino acid other than arginine; at least two of AA₁, AA₂, AA₃, AA4, each AAu, and each AAz are independently a hydrophobic amino acid; and wherein when Xₙ is attached to AAu, m is not 0 (claim 95). The instant application further claims wherein the hydrophobic amino acid is selected from phenylglycine, leucine….tyrosine…naphthylalanine…optionally substituents thereof” (claim 96); opposite chirality (Claim 98); at least two arginines adjacent to each other (claim 99); wherein three arginines are adjacent to each other (claim 100); at least two/three hydrophobic amino acids adjacent to each other (claim 101-102); SEQ ID Nos:131-136 (claim 110); and pharmaceutical formulations thereof (claim 111).
US Patent No. ‘821 claims a compound comprising a therapeutic and a CPP conjugated thereto (claim 1); and wherein the CPP comprises three consecutive arginine residues; three consecutive hydrophobic amino acids; D and L amino acids (see claim 1). US Patent No. ‘821 does not claim pharmaceutical compositions thereof this is a main utility of US Patent No. ‘821 for delivery of therapeutic drugs (see abstract). It would have been obvious to include the conjugate in a pharmaceutical formulation with a pharmaceutically carrier for the intended use of delivery a therapeutic target. Furthermore, it would have been obvious to optimize the L or D amino acids in the peptide to promote optimal therapeutic stability for delivery of the therapeutic cargo.
Claim(s) 95-103, 111 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12171838. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a cyclic peptide comprising formula IIIA-IIID wherein each of each of AA1, AA₂, AA₃, and AA4, are independently selected from an amino acid; at each instance AAu and AAz are independently selected from an amino acid; each of m and n are a number from 0 to 6, provided that at least one of m or n is not O; Xₙ is a cargo moiety; L is a linker moiety; wherein: two or three of AA1, AA₂, AA₃, AA4, each AAu, and each AAz are arginine, with the remaining amino acids thereof being an amino acid other than arginine; at least two of AA₁, AA₂, AA₃, AA4, each AAu, and each AAz are independently a hydrophobic amino acid; and wherein when Xₙ is attached to AAu, m is not 0 (claim 95). The instant application further claims wherein the hydrophobic amino acid is selected from phenylglycine, leucine….tyrosine…naphthylalanine…optionally substituents thereof” (claim 96); opposite chirality (Claim 98); at least two arginines adjacent to each other (claim 99); wherein three arginines are adjacent to each other (claim 100); at least two/three hydrophobic amino acids adjacent to each other (claim 101-102); SEQ ID Nos:131-136 (claim 110); and pharmaceutical formulations thereof (claim 111).
US Patent No. ‘838 claims a compound comprising a therapeutic and a CPP conjugated thereto (claim 1); and wherein the CPP comprises three consecutive arginine residues; three consecutive hydrophobic amino acids; D and L amino acids (see claims 1, 9-11). The peptides of US Patent NO. ‘838 overlap and encompass the CPPs of the instant claims. US Patent No. ‘838 does not claim pharmaceutical compositions thereof this is a main utility of US Patent No. ‘838 for delivery of therapeutic drugs (see abstract, claim 20). It would have been obvious to include the conjugate in a pharmaceutical formulation with a pharmaceutically carrier for the intended use of delivery a therapeutic target. Furthermore, it would have been obvious to optimize the L or D amino acids in the peptide to promote optimal therapeutic stability for delivery of the therapeutic cargo.
Claim(s) 95-103, 111 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No.19/329410(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a cyclic peptide comprising formula IIIA-IIID wherein each of each of AA1, AA₂, AA₃, and AA4, are independently selected from an amino acid; at each instance AAu and AAz are independently selected from an amino acid; each of m and n are a number from 0 to 6, provided that at least one of m or n is not O; Xₙ is a cargo moiety; L is a linker moiety; wherein: two or three of AA1, AA₂, AA₃, AA4, each AAu, and each AAz are arginine, with the remaining amino acids thereof being an amino acid other than arginine; at least two of AA₁, AA₂, AA₃, AA4, each AAu, and each AAz are independently a hydrophobic amino acid; and wherein when Xₙ is attached to AAu, m is not 0 (claim 95). The instant application further claims wherein the hydrophobic amino acid is selected from phenylglycine, leucine….tyrosine…naphthylalanine…optionally substituents thereof” (claim 96); opposite chirality (Claim 98); at least two arginines adjacent to each other (claim 99); wherein three arginines are adjacent to each other (claim 100); at least two/three hydrophobic amino acids adjacent to each other (claim 101-102); SEQ ID Nos:131-136 (claim 110); and pharmaceutical formulations thereof (claim 111).
Copending Application No. 19/329410 claims “a cyclic peptide comprising A1-A8 conjugated to a cargo moiety via a side chain, wherein the peptide comprises two arginine, two hydrophobic amino acids and the cargo is couple to side chain of glutamine (claim 1). Co-pending Application No. 19329410 further claims the cargo moiety comprise mini-peg (claim 10), the peptide comprise L-configuration (Claim 12), arginines adjacent to glycines (Claim 9), phenylalanine and glycine (claim 11).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim(s) 95-103, 111 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 46-72 of copending Application No.18/858718(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a cyclic peptide comprising formula IIIA-IIID wherein each of each of AA1, AA₂, AA₃, and AA4, are independently selected from an amino acid; at each instance AAu and AAz are independently selected from an amino acid; each of m and n are a number from 0 to 6, provided that at least one of m or n is not O; Xₙ is a cargo moiety; L is a linker moiety; wherein: two or three of AA1, AA₂, AA₃, AA4, each AAu, and each AAz are arginine, with the remaining amino acids thereof being an amino acid other than arginine; at least two of AA₁, AA₂, AA₃, AA4, each AAu, and each AAz are independently a hydrophobic amino acid; and wherein when Xₙ is attached to AAu, m is not 0 (claim 95). The instant application further claims wherein the hydrophobic amino acid is selected from phenylglycine, leucine….tyrosine…naphthylalanine…optionally substituents thereof” (claim 96); opposite chirality (Claim 98); at least two arginines adjacent to each other (claim 99); wherein three arginines are adjacent to each other (claim 100); at least two/three hydrophobic amino acids adjacent to each other (claim 101-102); SEQ ID Nos:131-136 (claim 110); and pharmaceutical formulations thereof (claim 111).
Copending Application No. 18/858718 claims a cyclic peptide comprising two arginine residues; at least two hydrophobic amino acids linked to a cargo (See claim 70 and 72). The cyclic peptide of claim 72 claims two arginine residues and two phenylalanine residues, a PEG linker and a cargo. Copending Application No. 18/858718 does not claim pharmaceutical compositions thereof this is a main utility of Co-pending 18/858718 for delivery of therapeutic drugs (see paragraphs 002-005). IT would have been obvious to include the conjugate in a pharmaceutical formulation with a pharmaceutically carrier for the intended use of delivery a therapeutic target.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim(s) 95-103, 111 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:
The instant application claims a cyclic peptide comprising formula IIIA-IIID wherein each of each of AA1, AA₂, AA₃, and AA4, are independently selected from an amino acid; at each instance AAu and AAz are independently selected from an amino acid; each of m and n are a number from 0 to 6, provided that at least one of m or n is not O; Xₙ is a cargo moiety; L is a linker moiety; wherein: two or three of AA1, AA₂, AA₃, AA4, each AAu, and each AAz are arginine, with the remaining amino acids thereof being an amino acid other than arginine; at least two of AA₁, AA₂, AA₃, AA4, each AAu, and each AAz are independently a hydrophobic amino acid; and wherein when Xₙ is attached to AAu, m is not 0 (claim 95). The instant application further claims wherein the hydrophobic amino acid is selected from phenylglycine, leucine….tyrosine…naphthylalanine…optionally substituents thereof” (claim 96); opposite chirality (Claim 98); at least two arginines adjacent to each other (claim 99); wherein three arginines are adjacent to each other (claim 100); at least two/three hydrophobic amino acids adjacent to each other (claim 101-102); SEQ ID Nos:131-136 (claim 110); and pharmaceutical formulations thereof (claim 111).
Copending Application No. 19329417 claims a cyclic peptide comprising the same peptide III-B formula of the instant claims (see claim 1) with a cargo moiety and linker moiety wherein two amino acids are arginine; at least two are hydrophobic (see claim 1); arginine adjacent to hydrophobic amino acids (see claims 6-8); natural configuration (claim 9). Copending Application No. 19329417 does not claim pharmaceutical compositions thereof this is a main utility of Co-pending 19/329417 for delivery of therapeutic drugs (see paragraphs 002-005). It would have been obvious to include the conjugate in a pharmaceutical formulation with a pharmaceutically carrier for the intended use of delivery a therapeutic target. Furthermore, it would have been obvious to optimize the L or D amino acids in the peptide to promote optimal therapeutic stability for delivery of the therapeutic cargo.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim(s) 95-103, 111 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 83-84, 86-105 of copending Application No. 17/639014(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a cyclic peptide comprising formula IIIA-IIID wherein each of each of AA1, AA₂, AA₃, and AA4, are independently selected from an amino acid; at each instance AAu and AAz are independently selected from an amino acid; each of m and n are a number from 0 to 6, provided that at least one of m or n is not O; Xₙ is a cargo moiety; L is a linker moiety; wherein: two or three of AA1, AA₂, AA₃, AA4, each AAu, and each AAz are arginine, with the remaining amino acids thereof being an amino acid other than arginine; at least two of AA₁, AA₂, AA₃, AA4, each AAu, and each AAz are independently a hydrophobic amino acid; and wherein when Xₙ is attached to AAu, m is not 0 (claim 95). The instant application further claims wherein the hydrophobic amino acid is selected from phenylglycine, leucine….tyrosine…naphthylalanine…optionally substituents thereof” (claim 96); opposite chirality (Claim 98); at least two arginines adjacent to each other (claim 99); wherein three arginines are adjacent to each other (claim 100); at least two/three hydrophobic amino acids adjacent to each other (claim 101-102); SEQ ID Nos:131-136 (claim 110); and pharmaceutical formulations thereof (claim 111).
Copending Application No. 17639014 claims a cyclic peptide comprising the same peptide III-B formula of the instant claims (see claims 84 and 86) with a cargo moiety and linker moiety wherein two amino acids are arginine (see claim 91); at least two are hydrophobic (see claim 86); D or L hydrophobic amin acids (claim 87); SEQ ID Nos:7-119(see claim 97) which overlap with all the instant claims. Co-pending Application No. 17639014 claims pharmaceutical formulations (Claim 104) but does not claim pharmaceutical carrier. However, it would have been obvious to include the conjugate in a pharmaceutical formulation with a pharmaceutically carrier for the intended use of delivery a therapeutic target. Furthermore, it would have been obvious to optimize the L or D amino acids in the peptide to promote optimal therapeutic stability for delivery of the therapeutic cargo.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim(s) 95-103, 111 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 19/671828(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a cyclic peptide comprising formula IIIA-IIID wherein each of each of AA1, AA₂, AA₃, and AA4, are independently selected from an amino acid; at each instance AAu and AAz are independently selected from an amino acid; each of m and n are a number from 0 to 6, provided that at least one of m or n is not O; Xₙ is a cargo moiety; L is a linker moiety; wherein: two or three of AA1, AA₂, AA₃, AA4, each AAu, and each AAz are arginine, with the remaining amino acids thereof being an amino acid other than arginine; at least two of AA₁, AA₂, AA₃, AA4, each AAu, and each AAz are independently a hydrophobic amino acid; and wherein when Xₙ is attached to AAu, m is not 0 (claim 95). The instant application further claims wherein the hydrophobic amino acid is selected from phenylglycine, leucine….tyrosine…naphthylalanine…optionally substituents thereof” (claim 96); opposite chirality (Claim 98); at least two arginines adjacent to each other (claim 99); wherein three arginines are adjacent to each other (claim 100); at least two/three hydrophobic amino acids adjacent to each other (claim 101-102); SEQ ID Nos:131-136 (claim 110); and pharmaceutical formulations thereof (claim 111).
Copending Application No. 19/671828 claims a cyclic peptide comprising the same peptide III-B formula of the instant claims (see claim 16) with a cargo moiety and linker moiety (claim 1) wherein two amino acids are arginine (see claim 16); at least two are hydrophobic (see claim 16); D or L hydrophobic amin acids (claim 16); formula III which overlaps with all the instant claim which encompasses two arginines adjacent or hydrophobic amino acids. Co-pending Application No. 19/671828 claims pharmaceutical formulations (Claim 44) but does not claim pharmaceutical carrier. However, it would have been obvious to include the conjugate in a pharmaceutical formulation with a pharmaceutically carrier for the intended use of delivery a therapeutic target. Furthermore, it would have been obvious to optimize the L or D amino acids in the peptide to promote optimal therapeutic stability for delivery of the therapeutic cargo.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim(s) 95-103, 111 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/630088(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a cyclic peptide comprising formula IIIA-IIID wherein each of each of AA1, AA₂, AA₃, and AA4, are independently selected from an amino acid; at each instance AAu and AAz are independently selected from an amino acid; each of m and n are a number from 0 to 6, provided that at least one of m or n is not O; Xₙ is a cargo moiety; L is a linker moiety; wherein: two or three of AA1, AA₂, AA₃, AA4, each AAu, and each AAz are arginine, with the remaining amino acids thereof being an amino acid other than arginine; at least two of AA₁, AA₂, AA₃, AA4, each AAu, and each AAz are independently a hydrophobic amino acid; and wherein when Xₙ is attached to AAu, m is not 0 (claim 95). The instant application further claims wherein the hydrophobic amino acid is selected from phenylglycine, leucine….tyrosine…naphthylalanine…optionally substituents thereof” (claim 96); opposite chirality (Claim 98); at least two arginines adjacent to each other (claim 99); wherein three arginines are adjacent to each other (claim 100); at least two/three hydrophobic amino acids adjacent to each other (claim 101-102); SEQ ID Nos:131-136 (claim 110); and pharmaceutical formulations thereof (claim 111).
Copending Application No. 19/630088 claims a cyclic peptide comprising two arginine residues and at least two hydrophobic amino acids (see claim 13) with a cargo moiety and linker moiety (claims 18) wherein two amino acids are arginine (see claim 16); at least two are hydrophobic (see claim 16). The peptides found in claim 18 overlap with the requirements of the instant claims regarding arginines, hydrophobic amino acids and position (and also D or L amino acids). Co-pending Application No. 19630088 is silent to pharmaceutical formulations thereof but the main utility is for treating subjects (see claim 21) and delivering the therapeutic. However, it would have been obvious to include the conjugate in a pharmaceutical formulation with a pharmaceutically carrier for the intended use of delivery a therapeutic target. Furthermore, it would have been obvious to optimize the L or D amino acids in the peptide to promote optimal therapeutic stability for delivery of the therapeutic cargo.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim(s) 95-103, 110-111 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 289-317 of copending Application No. 19/512008(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a cyclic peptide comprising formula IIIA-IIID wherein each of each of AA1, AA₂, AA₃, and AA4, are independently selected from an amino acid; at each instance AAu and AAz are independently selected from an amino acid; each of m and n are a number from 0 to 6, provided that at least one of m or n is not O; Xₙ is a cargo moiety; L is a linker moiety; wherein: two or three of AA1, AA₂, AA₃, AA4, each AAu, and each AAz are arginine, with the remaining amino acids thereof being an amino acid other than arginine; at least two of AA₁, AA₂, AA₃, AA4, each AAu, and each AAz are independently a hydrophobic amino acid; and wherein when Xₙ is attached to AAu, m is not 0 (claim 95). The instant application further claims wherein the hydrophobic amino acid is selected from phenylglycine, leucine….tyrosine…naphthylalanine…optionally substituents thereof” (claim 96); opposite chirality (Claim 98); at least two arginines adjacent to each other (claim 99); wherein three arginines are adjacent to each other (claim 100); at least two/three hydrophobic amino acids adjacent to each other (claim 101-102); SEQ ID Nos:131-136 (claim 110); and pharmaceutical formulations thereof (claim 111).
Copending Application No. 19/512008 claims a cyclic peptide comprising two arginine residues and at least two hydrophobic amino acids (see claim 289) with a cargo moiety and linker moiety (claims 289) wherein two amino acids are arginine (see claim 302); at least two are hydrophobic (see claim 302). The peptides found in claim 302 overlap with the requirements of the instant claims regarding arginines, hydrophobic amino acids and position (and also D or L amino acids) and specific sequences found in instant claim 110 (see SEQ ID NO;80 for example). Co-pending Application No. 19/512008 claims pharmaceutical formulations and carriers thereof (claim 314).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim(s) 95-103, 111 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of copending Application No. 19/329431(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a cyclic peptide comprising formula IIIA-IIID wherein each of each of AA1, AA₂, AA₃, and AA4, are independently selected from an amino acid; at each instance AAu and AAz are independently selected from an amino acid; each of m and n are a number from 0 to 6, provided that at least one of m or n is not O; Xₙ is a cargo moiety; L is a linker moiety; wherein: two or three of AA1, AA₂, AA₃, AA4, each AAu, and each AAz are arginine, with the remaining amino acids thereof being an amino acid other than arginine; at least two of AA₁, AA₂, AA₃, AA4, each AAu, and each AAz are independently a hydrophobic amino acid; and wherein when Xₙ is attached to AAu, m is not 0 (claim 95). The instant application further claims wherein the hydrophobic amino acid is selected from phenylglycine, leucine….tyrosine…naphthylalanine…optionally substituents thereof” (claim 96); opposite chirality (Claim 98); at least two arginines adjacent to each other (claim 99); wherein three arginines are adjacent to each other (claim 100); at least two/three hydrophobic amino acids adjacent to each other (claim 101-102); SEQ ID Nos:131-136 (claim 110); and pharmaceutical formulations thereof (claim 111).
Copending Application No. 19/329431 claims a cyclic peptide comprising two arginine residues and at least two hydrophobic amino acids (see claim 14) with a cargo moiety and linker moiety (claims 1) wherein two amino acids are arginine (see claim 14); at least two are hydrophobic (see claim 14). The peptides found in claims 17-27 overlap with the requirements of the instant claims regarding arginines, hydrophobic amino acids and position (and also D or L amino acids). Co-pending Application No. 19/329431 is silent to pharmaceutical formulations thereof but the main utility is for treating subjects (see paragraph 0005) and delivering the therapeutic. However, it would have been obvious to include the conjugate in a pharmaceutical formulation with a pharmaceutically carrier for the intended use of delivery a therapeutic target. Furthermore, it would have been obvious to optimize the L or D amino acids in the peptide to promote optimal therapeutic stability for delivery of the therapeutic cargo.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim(s) 95-103, 110-111 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 111-114, 116-117, 119-125, 132-133, 135 of copending Application No. 18/553379(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a cyclic peptide comprising formula IIIA-IIID wherein each of each of AA1, AA₂, AA₃, and AA4, are independently selected from an amino acid; at each instance AAu and AAz are independently selected from an amino acid; each of m and n are a number from 0 to 6, provided that at least one of m or n is not O; Xₙ is a cargo moiety; L is a linker moiety; wherein: two or three of AA1, AA₂, AA₃, AA4, each AAu, and each AAz are arginine, with the remaining amino acids thereof being an amino acid other than arginine; at least two of AA₁, AA₂, AA₃, AA4, each AAu, and each AAz are independently a hydrophobic amino acid; and wherein when Xₙ is attached to AAu, m is not 0 (claim 95). The instant application further claims wherein the hydrophobic amino acid is selected from phenylglycine, leucine….tyrosine…naphthylalanine…optionally substituents thereof” (claim 96); opposite chirality (Claim 98); at least two arginines adjacent to each other (claim 99); wherein three arginines are adjacent to each other (claim 100); at least two/three hydrophobic amino acids adjacent to each other (claim 101-102); SEQ ID Nos:131-136 (claim 110); and pharmaceutical formulations thereof (claim 111).
Copending Application No. 18/553379 claims a cyclic peptide comprising two arginine residues and at least two hydrophobic amino acids (see claim 125) with a cargo moiety and linker moiety (claims 125) wherein two amino acids are arginine (see claim 125); at least two are hydrophobic (see claim 125). The peptides found in claim 125 overlap with the requirements of the instant claims regarding arginines, hydrophobic amino acids and position (and also D or L amino acids, claim 125). Co-pending Application No. 18/553379 claims pharmaceutical formulations and carriers thereof (claim 135).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim(s) 95-103, 111 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 18/506057(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a cyclic peptide comprising formula IIIA-IIID wherein each of each of AA1, AA₂, AA₃, and AA4, are independently selected from an amino acid; at each instance AAu and AAz are independently selected from an amino acid; each of m and n are a number from 0 to 6, provided that at least one of m or n is not O; Xₙ is a cargo moiety; L is a linker moiety; wherein: two or three of AA1, AA₂, AA₃, AA4, each AAu, and each AAz are arginine, with the remaining amino acids thereof being an amino acid other than arginine; at least two of AA₁, AA₂, AA₃, AA4, each AAu, and each AAz are independently a hydrophobic amino acid; and wherein when Xₙ is attached to AAu, m is not 0 (claim 95). The instant application further claims wherein the hydrophobic amino acid is selected from phenylglycine, leucine….tyrosine…naphthylalanine…optionally substituents thereof” (claim 96); opposite chirality (Claim 98); at least two arginines adjacent to each other (claim 99); wherein three arginines are adjacent to each other (claim 100); at least two/three hydrophobic amino acids adjacent to each other (claim 101-102); SEQ ID Nos:131-136 (claim 110); and pharmaceutical formulations thereof (claim 111).
Copending Application No. 18/506057 claims a cyclic peptide comprising two arginine residues and at least two hydrophobic amino acids (see claims 1, 18) with a cargo moiety and linker moiety (claims 18) wherein two amino acids are arginine (see claim 18); at least two are hydrophobic (see claim 18). The peptides found in claim 18 overlap with the requirements of the instant claims regarding arginines, hydrophobic amino acids and position (and also D or L amino acids, claim 18). Co-pending Application No. 18/506057 is silent to pharmaceutical formulations thereof but the main utility is for treating subjects (see paragraph 0007-9) and delivering the therapeutic. However, it would have been obvious to include the conjugate in a pharmaceutical formulation with a pharmaceutically carrier for the intended use of delivery a therapeutic target. Furthermore, it would have been obvious to optimize the L or D amino acids in the peptide to promote optimal therapeutic stability for delivery of the therapeutic cargo.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim(s) 95-103, 111 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 100-124 of copending Application No. 18/560080(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a cyclic peptide comprising formula IIIA-IIID wherein each of each of AA1, AA₂, AA₃, and AA4, are independently selected from an amino acid; at each instance AAu and AAz are independently selected from an amino acid; each of m and n are a number from 0 to 6, provided that at least one of m or n is not O; Xₙ is a cargo moiety; L is a linker moiety; wherein: two or three of AA1, AA₂, AA₃, AA4, each AAu, and each AAz are arginine, with the remaining amino acids thereof being an amino acid other than arginine; at least two of AA₁, AA₂, AA₃, AA4, each AAu, and each AAz are independently a hydrophobic amino acid; and wherein when Xₙ is attached to AAu, m is not 0 (claim 95). The instant application further claims wherein the hydrophobic amino acid is selected from phenylglycine, leucine….tyrosine…naphthylalanine…optionally substituents thereof” (claim 96); opposite chirality (Claim 98); at least two arginines adjacent to each other (claim 99); wherein three arginines are adjacent to each other (claim 100); at least two/three hydrophobic amino acids adjacent to each other (claim 101-102); SEQ ID Nos:131-136 (claim 110); and pharmaceutical formulations thereof (claim 111).
Copending Application No. 18/560080 claims a cyclic peptide comprising two arginine residues and at least two hydrophobic amino acids (see claims 100) with a cargo moiety and linker moiety (claims 100) wherein two amino acids are arginine (see claim 100, 114); at least two are hydrophobic (see claim 100, 114). The peptides found in claim 114 overlap with the requirements of the instant claims regarding arginines, hydrophobic amino acids and position (and also D or L amino acids, claim 118). Co-pending Application No. 18560080 claims pharmaceutical formulations thereof (see claim118) and administration thereof which would require a pharmaceutically acceptable carrier (claims 118-120).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim(s) 95-103, 111 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 48-67 of copending Application No. 19/115637 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a cyclic peptide comprising formula IIIA-IIID wherein each of each of AA1, AA₂, AA₃, and AA4, are independently selected from an amino acid; at each instance AAu and AAz are independently selected from an amino acid; each of m and n are a number from 0 to 6, provided that at least one of m or n is not O; Xₙ is a cargo moiety; L is a linker moiety; wherein: two or three of AA1, AA₂, AA₃, AA4, each AAu, and each AAz are arginine, with the remaining amino acids thereof being an amino acid other than arginine; at least two of AA₁, AA₂, AA₃, AA4, each AAu, and each AAz are independently a hydrophobic amino acid; and wherein when Xₙ is attached to AAu, m is not 0 (claim 95). The instant application further claims wherein the hydrophobic amino acid is selected from phenylglycine, leucine….tyrosine…naphthylalanine…optionally substituents thereof” (claim 96); opposite chirality (Claim 98); at least two arginines adjacent to each other (claim 99); wherein three arginines are adjacent to each other (claim 100); at least two/three hydrophobic amino acids adjacent to each other (claim 101-102); SEQ ID Nos:131-136 (claim 110); and pharmaceutical formulations thereof (claim 111).
Copending Application No. 19/115637 claims a cyclic peptide comprising two arginine residues and at least two hydrophobic amino acids (see claims 48, 57) with a cargo moiety and linker moiety (claims 48, 57) wherein two amino acids are arginine (see claims 48, 57); at least two are hydrophobic (see claims 48, 54, 57). The peptides found in claim 54, 57 overlap with the requirements of the instant claims regarding arginines, hydrophobic amino acids and position (and also D or L amino acids, claim 118). Co-pending Application No. 19/115637 claims pharmaceutical formulations thereof (see claims 48 and 62) and administration thereof which would require a pharmaceutically acceptable carrier (claims 48, 62).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim(s) 95-103, 111 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 19/329353 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a cyclic peptide comprising formula IIIA-IIID wherein each of each of AA1, AA₂, AA₃, and AA4, are independently selected from an amino acid; at each instance AAu and AAz are independently selected from an amino acid; each of m and n are a number from 0 to 6, provided that at least one of m or n is not O; Xₙ is a cargo moiety; L is a linker moiety; wherein: two or three of AA1, AA₂, AA₃, AA4, each AAu, and each AAz are arginine, with the remaining amino acids thereof being an amino acid other than arginine; at least two of AA₁, AA₂, AA₃, AA4, each AAu, and each AAz are independently a hydrophobic amino acid; and wherein when Xₙ is attached to AAu, m is not 0 (claim 95). The instant application further claims wherein the hydrophobic amino acid is selected from phenylglycine, leucine….tyrosine…naphthyl alanine…optionally substituents thereof” (claim 96); opposite chirality (Claim 98); at least two arginines adjacent to each other (claim 99); wherein three arginines are adjacent to each other (claim 100); at least two/three hydrophobic amino acids adjacent to each other (claim 101-102); SEQ ID Nos:131-136 (claim 110); and pharmaceutical formulations thereof (claim 111).
Copending Application No. 19/329353 claims a cyclic peptide comprising two arginine residues and at least two hydrophobic amino acids (see claim 1) with a cargo moiety and linker moiety (claim 1) wherein two amino acids are arginine (see claim 1); at least two are hydrophobic (see claim 1); at least two L amino acids (claim 8). The peptide formula of AN19/329353 encompasses hydrophobic amino acids including Phenylalanine and arginine residues and the amino acids being adjacent to each other.
Co-pending Application No. 19/329353 is silent to pharmaceutical formulations thereof but the main utility is for treating subjects (see page 4) and delivering the therapeutic. However, it would have been obvious to include the conjugate in a pharmaceutical formulation with a pharmaceutically carrier for the intended use of delivery a therapeutic target. Furthermore, it would have been obvious to optimize the L or D amino acids in the peptide to promote optimal therapeutic stability for delivery of the therapeutic cargo.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim(s) 95-103, 111 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 101-120 of copending Application No. 18/950272 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a cyclic peptide comprising formula IIIA-IIID wherein each of each of AA1, AA₂, AA₃, and AA4, are independently selected from an amino acid; at each instance AAu and AAz are independently selected from an amino acid; each of m and n are a number from 0 to 6, provided that at least one of m or n is not O; Xₙ is a cargo moiety; L is a linker moiety; wherein: two or three of AA1, AA₂, AA₃, AA4, each AAu, and each AAz are arginine, with the remaining amino acids thereof being an amino acid other than arginine; at least two of AA₁, AA₂, AA₃, AA4, each AAu, and each AAz are independently a hydrophobic amino acid; and wherein when Xₙ is attached to AAu, m is not 0 (claim 95). The instant application further claims wherein the hydrophobic amino acid is selected from phenylglycine, leucine….tyrosine…naphthyl alanine…optionally substituents thereof” (claim 96); opposite chirality (Claim 98); at least two arginines adjacent to each other (claim 99); wherein three arginines are adjacent to each other (claim 100); at least two/three hydrophobic amino acids adjacent to each other (claim 101-102); SEQ ID Nos:131-136 (claim 110); and pharmaceutical formulations thereof (claim 111).
Copending Application No. 18/950272 claims a cyclic peptide comprising two arginine residues and at least two hydrophobic amino acids (see claim 101, 107) with a cargo moiety and linker moiety (claims 101, 107) wherein two amino acids are arginine (see claim 107); at least two are hydrophobic (see claim 107-108); D and L amino acids (claim 107). The peptide formula of AN18950272 encompasses hydrophobic amino acids including Phenylalanine and arginine residues and the amino acids being adjacent to each other (see claims 107-108).
Co-pending Application No. 18/950272 is silent to pharmaceutical formulations thereof but the main utility is for treating subjects (see claim 120) and delivering the therapeutic. However, it would have been obvious to include the conjugate in a pharmaceutical formulation with a pharmaceutically carrier for the intended use of delivery a therapeutic target. Furthermore, it would have been obvious to optimize the L or D amino acids in the peptide to promote optimal therapeutic stability for delivery of the therapeutic cargo.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim(s) 95-103, 111 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/734759 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a cyclic peptide comprising formula IIIA-IIID wherein each of each of AA1, AA₂, AA₃, and AA4, are independently selected from an amino acid; at each instance AAu and AAz are independently selected from an amino acid; each of m and n are a number from 0 to 6, provided that at least one of m or n is not O; Xₙ is a cargo moiety; L is a linker moiety; wherein: two or three of AA1, AA₂, AA₃, AA4, each AAu, and each AAz are arginine, with the remaining amino acids thereof being an amino acid other than arginine; at least two of AA₁, AA₂, AA₃, AA4, each AAu, and each AAz are independently a hydrophobic amino acid; and wherein when Xₙ is attached to AAu, m is not 0 (claim 95). The instant application further claims wherein the hydrophobic amino acid is selected from phenylglycine, leucine….tyrosine…naphthyl alanine…optionally substituents thereof” (claim 96); opposite chirality (Claim 98); at least two arginines adjacent to each other (claim 99); wherein three arginines are adjacent to each other (claim 100); at least two/three hydrophobic amino acids adjacent to each other (claim 101-102); SEQ ID Nos:131-136 (claim 110); and pharmaceutical formulations thereof (claim 111).
Copending Application No. 18/734759 claims a cyclic peptide comprising two arginine residues and at least two hydrophobic amino acids (see claim 1, 5) with a cargo moiety and linker moiety (claims 1, 5) wherein two amino acids are arginine (see claim 16); at least two are hydrophobic (see claims 1, 16); D and L amino acids (claims 1, 16). The peptide formula of AN18734759 encompasses hydrophobic amino acids including Phenylalanine and arginine residues and the amino acids being adjacent to each other (see claim 16).
Co-pending Application No. 18/734759 claims pharmaceutical formulations (claim 17).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERINNE R DABKOWSKI whose telephone number is (571)272-1829. The examiner can normally be reached Monday-Friday 7:30-5:30 Est.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERINNE R DABKOWSKI/Examiner, Art Unit 1654
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