DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-3, 9, 12, 25, 30, 32, 35-36, 52-54, 56, 58, 60, and 68) in the reply filed on May 22nd, 2026 is acknowledged.
Applicant’s election without traverse of SEQ ID NO: 27 and crosslink (alk) in the reply filed on May 22nd, 2026 is also acknowledged.
SEQ ID NO:27 and SEQ ID NO:1 with the substitutions listed in claim 1 with crosslink (alk) were not found in the prior art search. Thus, the election species requirement is withdrawn and examination is expanded to include all the species of Group I.
Claims 81-82, 107, and 109 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 22nd, 2026.
Priority
The instant application claims priority to 371 National Stage Application PCT/US2022/019940, filed March 11th, 2022, under 35 U.S.C. 119(a)-(d), and claims benefit to provisional application 63160245, filed March 12th, 2021, under 35 U.S.C.119 (e). The priority date of March 12th, 2021 is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on December 6th, 2023, April 2nd, 2024, and May 22nd, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claims Status
The claims listing filed on April 2nd, 2024 is pending. Claims 81-82. 107, and 109 are withdrawn from further consideration for the reasons set forth in the restriction requirement, 37 CFR 1.142(b). Claims 1-3, 9, 12, 25, 30, 32, 35, 36, 52-54, 56, 58, 60, and 68 are being examined on the merits in this office action.
Claim Interpretation
Claims 30-31 use the word “optionally” to refer to the number of substitutions the claimed sequence may have.
Another alternative format which requires some analysis before concluding whether or not the language is indefinite involves the use of the term "optionally." In Ex parte Cordova, 10 USPQ2d 1949 (Bd. Pat. App. & Inter. 1989) the language "containing A, B, and optionally C" was considered acceptable alternative language because there was no ambiguity as to which alternatives are covered by the claim…. In the instance where the list of potential alternatives can vary and ambiguity arises, then it is proper to make a rejection under 35 U.S.C. 112(b) and explain why there is confusion [MPEP 2173.05 (h)].
Presently, there is no ambiguity with the potential alternative number of substitutions possible. Thus, claims 30-31 are not rejected for being indefinite.
Claim Rejections - 35 USC § 112
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 1-3, 9, 12, 25, 30, 32, 35-36, 60, and 68 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification does not provide a representative number of species to support the genus claimed. While there is support for the StAMPs reduced to practice (SEQ ID NO: 4-39, 59-77, 81-100, 40-53, and 102-105 with an (alk) crosslink), there is not support for the complete claimed genus of variations SEQ ID NO: 1, 2, 3, and 101 with any type of crosslink. A detailed analysis is below.
Claim 1 recites a peptide comprising SEQ ID NO: 1, wherein X1 and X2 are connected via a crosslink, and X3 and X4 are connected via a crosslink; and the amino acid sequence includes 1 to 9 amino acid substitutions, inclusive, at positions other than X1, X2, X3, and X4; provided that at least one amino acid substitution is at H7, S8, G18, or E19. However, the specification does not support that the inventors, at the time of filing, possessed the complete recited genus.
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, reduction to drawings, 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 inventor was in possession of the claimed genus [MPEP 2163 ii)].
The inventors provide direction by testing StAMP species comprising of the SEQ ID NO: 4-39, 59-77, and 81-100 with X1 and X2 and X3 and X4 forming (alk) crosslinks for broad-spectrum Gram-negative antimicrobial activity and selectivity over renal and hepatic cells [332 and Table A and D]. However, sequences reduced to practice by the applicant are not representative of the entire genus of claimed.
A "representative number of species" means that the species which are adequately describe 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. [MPEP 2163 ii)].
The sequence claimed comprises of a minimum of 20 residues, 9 of which can be substituted with any amino acid. Furthermore, the claimed StAMPs can have X1 and X2 and X3 and X4 forming any type of crosslink. There is substantial variation within the genus, and SEQ ID NO: 4-39, 59-77, and 81-100 and the (alk) crosslink do not represent the entire genus. Thus, there is a lack of support in the specifications that the applicant had possession of the entire genus claimed prior to the effective filing date.
Regarding claim 3, the specification does not support that the inventors, at the time of filing, possessed the complete recited genus of a peptide comprising SEQ ID NO: 2 with 1 to 11 amino acid substitutions because sequences reduced to practice by the applicant are not representative of the entire genus of claimed.
The sequence claimed comprises of a minimum of 23 residues, 11 of which can be substituted with any amino acid. Furthermore, the X1 and X2 and X3 and X4 can form any type of crosslink. There is substantial variation within the genus, and SEQ ID NO: 4-39, 59-77, and 81-100 and the (alk) crosslink do not represent the entire genus. Thus, there is a lack of support in the specifications that the applicant had possession of the entire genus claimed prior to the effective filing date.
Regarding claim 9, the specification does not support that the inventors, at the time of filing, possessed the complete recited genus of a peptide comprising SEQ ID NO: 1, wherein X1 and X2 are connected via a crosslink, and X3 and X4 are connected via a crosslink; and the amino acid sequence includes 1 to 9 amino acid substitutions, inclusive, at positions other than X1, X2, X3, and X4; provided that at least one amino acid substitution is at H7, S8, G18, E19, or K4. The species reduced to practice is not representative of the entire genus.
The sequence claimed comprises of a minimum of 20 residues, 9 of which can be substituted with any amino acid. Furthermore, the X1 and X2 and X3 and X4 can form any type of crosslink. There is substantial variation within the genus, and SEQ ID NO: 4-39, 59-77, and 81-100 and the (alk) crosslink do not represent the entire genus. Thus, there is a lack of support in the specifications that the applicant had possession of the entire genus claimed prior to the effective filing date.
Regarding claim 12, the specification does not support that the inventors, at the time of filing, possessed the complete recited genus of a peptide comprising SEQ ID NO: 1, wherein X1 and X2 are connected via a crosslink, and X3 and X4 are connected via a crosslink; and the amino acid sequence includes 1 to 9 amino acid substitutions, inclusive, at positions other than X1, X2, X3, and X4; provided that at least one amino acid substitution is at H7, S8, G18, E19, or K4.
The sequence claimed comprises of a minimum of 20 residues, 9 of which can be substituted with any amino acid, not just H7, S8, and K4. Furthermore, the X1 and X2 and X3 and X4 can form any type of crosslink. The species reduced to practice is not representative of the entire genus. There is substantial variation within the genus, and SEQ ID NO: 4-39, 59-77, and 81-100 and the (alk) crosslink do not represent the entire genus. Thus, there is a lack of support in the specifications that the applicant had possession of the entire genus claimed prior to the effective filing date.
Regarding claim 12, the specification does not support that the inventors, at the time of filing, possessed the complete recited genus of a peptide comprising SEQ ID NO: 1, wherein X1 and X2 are connected via a crosslink, and X3 and X4 are connected via a crosslink,; and the amino acid sequence includes 1 to 9 amino acid substitutions, inclusive, at positions other than X1, X2, X3, and X4; provided that at least one amino acid substitution is at H7, S8, G18, E19, or K4, wherein the amino acid substitution at H7 is selected from H7K, H7W, H7Dab, H7Orn, H7Dap, H7R, and H7hArg; the amino acid substitution at S8 is selected from S8K, S8W, S8N, S8Q, S8T, S8Y, S8Dab, S8Orn, S8Dap, S8R, and S8hArg; and the amino acid substitution at K4 is selected from K4S, K4Dab, K4Orn, K4Dap, K4R, and K4hArg.
The sequence claimed comprises of a minimum of 20 residues, 9 of which can be substituted with any amino acid, not just H7, S8, and K4. Furthermore, the X1 and X2 and X3 and X4 can form any type of crosslink. The species reduced to practice is not representative of the entire genus. There is substantial variation within the genus, and SEQ ID NO: 4-39, 59-77, and 81-100 and the (alk) crosslink do not represent the entire genus. Thus, there is a lack of support in the specifications that the applicant had possession of the entire genus claimed prior to the effective filing date.
Regarding claim 35, the specification does not support that the inventors, at the time of filing, possessed the complete recited genus of a peptide comprising SEQ ID NO: 1, wherein X1 and X2 are connected via a crosslink, and X3 and X4 are connected via a crosslink,; and the amino acid sequence includes 1 to 9 amino acid substitutions, inclusive, at positions other than X1, X2, X3, and X4; wherein one or more instances of K are independently substituted by an amino acid selected from Orn, Dab, Dap, R, and hArg.
The sequence claimed comprises of a minimum of 20 residues, 8 of which can be substituted with any amino acid, not just the lysines. Furthermore, the X1 and X2 and X3 and X4 can form any type of crosslink. The species reduced to practice is not representative of the entire genus. There is substantial variation within the genus, and SEQ ID NO: 4-39, 59-77, and 81-100 and the (alk) crosslink do not represent the entire genus. Thus, there is a lack of support in the specifications that the applicant had possession of the entire genus claimed prior to the effective filing date.
Regarding claim 36, the specification does not support that the inventors, at the time of filing, possessed the complete recited genus of a peptide comprising SEQ ID NO: 1, wherein X1 and X2 are connected via a crosslink, and X3 and X4 are connected via a crosslink,; and the amino acid sequence includes 1 to 9 amino acid substitutions, inclusive, at positions other than X1, X2, X3, and X4; wherein each instance of K is independently substituted by an amino acid selected from Orn, Dab, Dap, R, and hArg.
The sequence claimed comprises of a minimum of 20 residues, 4 of which can be substituted with any amino acid after each lysine. Each subcombination of the lysine substitutions and other 4 possible substitutions makes up a large genus of sequences. Furthermore, the X1 and X2 and X3 and X4 can form any type of crosslink to form the StAMP. The species reduced to practice is not representative of the entire genus. There is substantial variation within the genus, and SEQ ID NO: 4-39, 59-77, and 81-100 and the (alk) crosslink do not represent the entire genus. Thus, there is a lack of support in the specifications that the applicant had possession of the entire genus claimed prior to the effective filing date.
Regarding claim 60, the specification does not support that the inventors, at the time of filing, possessed the complete recited genus of a peptide comprising SEQ ID NO: 1, wherein X1 and X2 are connected via a crosslink, and X3 and X4 are connected via a crosslink; and the amino acid sequence includes 1 to 9 amino acid substitutions, inclusive, at positions other than X1, X2, X3, and X4; wherein the crosslinks are attached to the α-positions of the amino acids X1, X2, X3, and X4.
The sequence claimed can have X1 and X2 and X3 and X4 form any type of crosslink from the α-position. Even though (alk) crosslinks that are reduced to practice are connected at α-positions, there are other crosslinks that would fit the genus claimed. Furthermore, the peptide comprises of a minimum of 20 residues, 9 of which can be substituted with any amino acid. There is substantial variation within the genus, and SEQ ID NO: 4-39, 59-77, and 81-100 and the (alk) crosslink do not represent the entire genus. Thus, there is a lack of support in the specifications that the applicant had possession of the entire genus claimed prior to the effective filing date.
Regarding claim 68, the specification does not support that the inventors, at the time of filing, possessed the complete recited genus of a peptide comprising SEQ ID NO: 1, wherein X1 and X2 are connected via a crosslink, and X3 and X4 are connected via a crosslink; and the amino acid sequence includes 1 to 9 amino acid substitutions, inclusive, at positions other than X1, X2, X3, and X4; wherein X1, X2, X3, and X4 are each connected by a (alk) crosslink at the α-position.
Even though the peptide claimed has X1 and X2 and X3 and X4 connected by (alk) crosslinks at α-positions, the sequence of the peptide is still substantially varied. The peptide comprises of a minimum of 20 residues, 9 of which can be substituted with any amino acid and SEQ ID NO: 4-39, 59-77, and 81-100 and the (alk) crosslink do not represent the entire genus. Thus, there is a lack of support in the specifications that the applicant had possession of the entire genus claimed prior to the effective filing date.
Regarding claim 2, the specification does not support that the inventors, at the time of filing, possessed the complete recited genus of a peptide comprising SEQ ID NO: 1, wherein X1 and X2 each independently comprise a reactive moiety capable of forming a crosslink with the other and X3 and X4 each independently comprise a reactive moiety capable of forming a crosslink with the other; and the amino acid sequence includes 1 to 9 amino acid substitutions, inclusive, at positions other than X1, X2, X3, and X4; provided that at least one amino acid substitution is at H7, S8, G18, or E19.
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, reduction to drawings, 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 inventor was in possession of the claimed genus [MPEP 2163 ii)].
The inventors provide direction by testing StAMP species comprising of the SEQ ID NO: 4-39, 59-77, and 81-100 with X1 and X2 and X3 and X4 forming alk crosslinks for broad-spectrum Gram-negative antimicrobial activity and selectivity over renal and hepatic cells [332 and Table A and D]. However, sequences reduced to practice by the applicant are not representative of the entire genus of claimed.
A "representative number of species" means that the species which are adequately describe 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. [MPEP 2163 ii)].
The sequence claimed comprises of a minimum of 20 residues, 9 of which can be substituted with any amino acid. Furthermore, the X1 and X2 and X3 and X4 can form any type of crosslink. There is substantial variation within the genus, and SEQ ID NO: 4-39, 59-77, and 81-100 and the (alk) crosslink do not represent the entire genus. Thus, there is a lack of support in the specifications that the applicant had possession of the entire genus claimed prior to the effective filing date.
Regarding claim 25, the specification does not support that the inventors, at the time of filing, possessed the complete recited genus of a peptide comprising SEQ ID NO: 2, wherein X1 and X2 are connected via a crosslink and X3 and X4 are connected via a crosslink; or X1 and X2 each independently comprise a reactive moiety capable of forming a crosslink with the other and X3 and X4 each independently comprise a reactive moiety capable of forming a crosslink with the other; and the amino acid sequence includes 1 to 11 amino acid substitutions, inclusive, at positions other than X1, X2, X3, and X4; provided that at least one amino acid substituted with W.
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, reduction to drawings, 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 inventor was in possession of the claimed genus [MPEP 2163 ii)].
The inventors provide direction by testing StAMP species comprising of the SEQ ID NO: 40-53 with X1 and X2 and X3 and X4 forming {alk} crosslinks for broad-spectrum Gram-negative antimicrobial activity and selectivity over renal and hepatic cells [332 and Table B]. However, sequences reduced to practice by the applicant are not representative of the entire genus of claimed.
A "representative number of species" means that the species which are adequately describe 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. [MPEP 2163 ii)].
The sequence claimed comprises of a minimum of 23 residues, 11 of which can be substituted with any amino acid. Furthermore, the X1 and X2 and X3 and X4 can form any type of crosslink. There is substantial variation within the genus, and SEQ ID NO: 40-53 and the (alk) crosslink do not represent the entire genus. Thus, there is a lack of support in the specifications that the applicant had possession of the entire genus claimed prior to the effective filing date.
Regarding claim 30, the specification does not support that the inventors, at the time of filing, possessed the complete recited genus of a peptide comprising SEQ ID NO: 3, wherein X1 and X2 are connected via a crosslink and X3 and X4 are connected via a crosslink; or X1 and X2 each independently comprise a reactive moiety capable of forming a crosslink with the other and X3 and X4 each independently comprise a reactive moiety capable of forming a crosslink with the other; and the amino acid sequence includes 1 to 5 amino acid substitutions, inclusive, at positions other than X1, X2, X3, and X4.
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, reduction to drawings, 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 inventor was in possession of the claimed genus [MPEP 2163 ii)].
The inventors provide direction by testing StAMP species comprising of the SEQ ID NO: 3 with X1 and X2 and X3 and X4 forming {alk} crosslinks for broad-spectrum Gram-negative antimicrobial activity and selectivity over renal and hepatic cells [332 and Table C]. However, sequence reduced to practice (SEQ ID NO:3) is not representative of the entire genus of claimed.
A "representative number of species" means that the species which are adequately describe 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. [MPEP 2163 ii)].
The sequence claimed comprises of a minimum of 23 residues, 5 of which can be substituted with any amino acid. Furthermore, the X1 and X2 and X3 and X4 can form any type of crosslink. There is substantial variation within the genus, and SEQ ID NO: 3 with the (alk) crosslink does not represent the entire genus. Thus, there is a lack of support in the specifications that the applicant had possession of the entire genus claimed prior to the effective filing date.
Regarding claim 32, the specification does not support that the inventors, at the time of filing, possessed the complete recited genus of a peptide comprising SEQ ID NO: 101, wherein X1 and X2 are connected via a crosslink, or X1 and X2 each independently comprise a reactive moiety capable of forming a crosslink with the other; and the amino acid sequence includes 1 to 5 amino acid substitutions, inclusive, at positions other than X1 and X2.
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, reduction to drawings, 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 inventor was in possession of the claimed genus [MPEP 2163 ii)].
The inventors provide direction by testing StAMP species comprising of the SEQ ID NO: 102-105 with X1 and X2 forming {alk} crosslinks for broad-spectrum Gram-negative antimicrobial activity and selectivity over renal and hepatic cells [332 and Table A]. However, sequences reduced to practice are not representative of the entire genus of claimed.
A "representative number of species" means that the species which are adequately describe 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. [MPEP 2163 ii)].
The sequence claimed comprises of a minimum of 17 residues, 5 of which can be substituted with any amino acid. Furthermore, the X1 and X2 and X3 and X4 can form any type of crosslink. There is substantial variation within the genus, and SEQ ID NO: 102-105 with (alk) crosslinks do not represent the entire genus. Thus, there is a lack of support in the specifications that the applicant had possession of the entire genus claimed prior to the effective filing date.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 9, 12, 25, 30, 32, 35-36, 60, and 68 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “inclusive” in claims 1-3, 25, 30, and 32 is used by the claim to mean “inside the sequence,” while the accepted meaning is “conservative.” The term is indefinite because the specification does not clearly redefine the term.
The applicant uses the term “inclusive” to refer to the substitutions claimed. However, there is no written description in the specification that would acclaim one of ordinary skill in the art the scope of an inclusive substitution. If the applicant is intending to use the word in a way synonymous to conservative, it is unclear what would encompass a conservative substitution. Therefore, the use of the word “inclusive” renders the claims indefinite.
Claim 3 is 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.
The preface of claim 3 states “the peptide of claim 1,” and the body goes on to recite “includes 1-11 amino acid substitutions” A peptide of claim 1 can only have 1-9 substitutions. The peptide can have 10 or 11 substitutions, which is outside the scope of the claim. Therefore, the scope of claim 3 unclear, rendering it indefinite.
Claims 9 and 12 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 9 recites “The peptide of claim 1 or a pharmaceutically acceptable salt thereof, wherein the amino acid sequence comprises an amino acid substitution at H7, S8, and/or K4.” This renders the scope of the claim indefinite. The peptide of claim 1 comprises of at least one substitution at H7, S8, G18, or E19. Repeating the substitutions at H7 or S8, while introducing the new claim limitation of a substitution at K4 makes the sequence of the peptide unclear because the peptide of claim 1 already comprises of the stated substitutions at H7 or S8. It is hard to perceive what the claim limitation for a substitution at H7 or S8 is there to do if only K4 is outside the scope of the claim. Thus, claim 9 is indefinite.
The substitution for K4 has support in the StAMP species tested for broad-spectrum Gram-negative antimicrobial activity and selectivity over renal and hepatic cells, such as SEQ ID NO: 7, 25-27, 39, 67, 81, 83, and 89 [332 and Table A and D and claim 52]. Therefore, to overcome the indefiniteness, the claim can be construed as:
The peptide of claim 1, or a pharmaceutically acceptable salt thereof, wherein the amino acid sequence further comprises an amino acid substitution at
Claim 12 is rejected because of its dependency to base claim 12 and inability to overcome its indefiniteness as it still refers to amino acid substitutions at H7 and S8.
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.
Claim 32 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mourtada et al. (Mourtada, R., Herce, H.D., Yin, D.J. et al. Design of stapled antimicrobial peptides that are stable, nontoxic and kill antibiotic-resistant bacteria in mice. Nat Biotechnol 37, 1186–1197 (2019)).
Mourtada et al. analyze a 58-member library of stapled AMPs (StAMPS) based on magainin II and apply the insights from structure-function-toxicity measurements to devise an algorithm for the design of stable, protease-resistant, potent, and nontoxic StAMP prototypes. Of the StAMPs explored, Mag(i+4)1, with a sequence of GXGKFXHSAKKFGKAFVGEIBNS reads on the claimed variant comprising of instant SEQ ID NO: 101 with one substitution [pg 1188 Fig 1 a]. Thus, Mourtada et al. anticipates a peptide comprising instant SEQ ID NO: 101 where X1 and X2 are independently amino acids and are connected via a crosslink, optionally including 1 to 5 amino acid substitutions.
Allowable Subject Matter
Claims 52-54, 56, and 58 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: a peptide comprising SEQ ID NO: 4-39, 59-77, 81-100, and 40-53, wherein X1 and X2 are connected via a crosslink and X3 and X4 are connected via a crosslink; or X1 and X2 each independently comprise a reactive moiety capable of forming a crosslink with the other and X3 and X4 each independently comprise a reactive moiety capable of forming a crosslink with the other; and SEQ ID NO: 102-105 wherein X1 and X2 are connected via a crosslink, or X1 and X2 each independently comprise a reactive moiety capable of forming a crosslink with the other are found to be allowable subject matter over Mourtada et al. (Mourtada, R., Herce, H.D., Yin, D.J. et al. Design of stapled antimicrobial peptides that are stable, nontoxic and kill antibiotic-resistant bacteria in mice. Nat Biotechnol 37, 1186–1197 (2019)).
Mourtada et al. analyzes a 58-member library of stapled AMPs based on magainin II [Abstract line 4]. The StAMP Mag(i+4) 1, 15(A9K) comprises of SEQ ID NO: 1 [pg 1192 Fig 5]. The author teaches additional substitutions at K4, K10, K11, B21, N22, and S23. However, the substitutions at H7, S8, G18, and E19 are not taught. Thus, the Mourtada et al.’s teachings do not fulfill the requirement for obviousness as there is no motivation to arrive at the claimed substitutions forming SEQ ID NO: 4-39, 59-77, 81-100, and 40-53.
Mourtada et al. also teaches a peptide comprising SEQ ID NO: 101 with a Z1G substitution [pg 1188 Fig 1 a]. However, the other substitutions forming instant SEQ ID NO: 102-105 are not taught. Mourtada et al. only teaches other substituting amino acids in the sequence with lysine [pg 1188 Fig 2d]. Thus, the specific StAMPs reduced to practice by the applicant are allowable subject matter over Mourtada et al.
Summary
Claims 1-3, 9, 12, 25, 30, 32, 35-36, 60, and 68 are rejected under 35 U.S.C. 112(a). Claims 1-3, 9, 12, 25, 30, 32, 35-36, 60, and 68 are rejected under 35 U.S.C. 112(b). Claim 32 is rejected under 35 U.S.C. 102. Claims 52-54, 56, and 58 are objected to as being dependent upon a rejected base claim.
Correspondence
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/SACHI JAUHARI/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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