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
Applicants’ election without traverse of Group I, claims 1-13 and 22, in the reply filed on 21 April 2026 is acknowledged.
Applicants’ election without traversal of the species of peptide (SEQ ID NO: 33) and the single and specific identity of each amino acid groups bound/amidated/esterified moieties, sidechains and connection points in the reply filed 21 April 2026 is acknowledged.
Claims 5-12 and 15-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 02 January 2026.
Applicants added claims 23-24 and assert that said claims depend on claims 1 and 23, respectively, and read on the elected species.
Claims 1-4, 13 and 22-24 are under consideration.
Status of Claims
The claim listing filed 21 April 2026 is pending. Claims 5-12 and 15-21 are withdrawn from further consideration for the reasons set forth above, 37 CFR 1.142(b). Claims 1-4, 13 and 22-24 are being examined on the merits of this office action.
The search was expanded to the full scope of the species as described in part (a) of claim 1 and part (b) in claim 4. The closest match to the elected peptide of SEQ ID NO: 33 is a sequence described by Noviana et al. (“Hypericibacter terrae gen. nov., sp. nov. and Hypericibacter adhaerens sp. nov., two new members of the family Rhodospirillaceae isolated from the rhizosphere of Hypericum perforatum.” Int J Syst Evol Microbiol. 2020 Mar;70(3):1850-1860. doi: 10.1099/ijsem.0.003983. PMID: 31958043.) with 75.4% sequence similarity.
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The restriction between Groups I-VII is maintained.
Priority
The present application claims status as a 371 (National Stage) of PCT/EP2021/077611 filed 06 October 2021, and claims priority under 119(a)-(d) to European Patent Application No. EP20200499.0 filed 07 October 2020.
Receipt is acknowledged of certified copies of papers submitted under 35 USC 119(a)-(d) for European Application No. EP20200499.0, which papers have been placed of record in the file.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 05 April 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Figures 17A, 17B, 17C, 17D, 17E are labeled in the drawings, but are not specified in the disclosure. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See page 53, line 9. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 13 and 22 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.
Regarding claims 1 and 4, the claim language “preferably” renders the limitations of the claim unclear because one is unable to tell if the claims specifically require the limitations or not. (See pg. 3 lines 16-19, 23-24; pg. 4, lines 6, 11-12, 16-19, 24-25, 30; pg. 5, lines 1, 4-5, 8, 12-15, 19-24, and 28-29; pg. 6, lines 3-4, 6-7, 10 17-20, 22-25, pg. 7, lines 4-5, 8-9, 12, 16-17, 19-20, 22-23; pg. 8, lines 1-2, 4-5, 7-8 10-11, 26-27 and 29-30; pg. 9, lines 1-2, 6-9, 13-16 and 25-26; pg. 10, lines 3-4, 11-12 15-16, 24-25 and 27-28; pg. 11, lines 1-2, 4-5, 10-11 and 13-14).
Dependent claims 2, 3, 13, and 22-24 do not add any additional clarity and therefore are also indefinite.
Claim Rejections - 35 USC § 103
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.
Claims 1-3 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Pannell and Rocker, hereafter “Pannell” (WO 2014160499 A2), Scholtz, J. M., & Baldwin , R. L., hereafter “Scholtz” (“The mechanism of alpha-helix formation by peptides.” Annual Review of Biophysics and Biomolecular Structure, 21(1), 93–118. June 1992. https://doi.org/10.1146/annurev.biophys.21.1.93), and Henchey et al., hereafter “Henchey” (“Contemporary strategies for the stabilization of peptides in the alpha-helical conformation.” Curr Opin Chem Biol. 2008 Dec;12(6):692-7. doi: 10.1016/j.cbpa.2008.08.019. Epub 2008 Sep 13. PMID: 18793750; PMCID: PMC2650020.).
Regarding claim 1, Pannell discloses a peptide that comprises the amino acid sequence “SWIEKREIQTERAN”. See the peptide represented by SEQ ID NO: 134, amino acid residues 2300-2314 (pg. 69, “SEQ ID NO: 134 – NCBI Accession No.: 114155133 – Protein Name: dynein heavy chain 9 axonemal isoform 2 [Homo sapiens] …”; pg. 189-190, “SEQ ID 134 …SWIEKREIQTERAN…”) which reads on the limitations set by claim 1.
Pannell also teaches that the pH of a sample can be adjusted to help stabilize the sample (pg. 24, “In some embodiments, the pH of the sample may be adjusted to help stabilize the samples.”).
Pannell does not teach X2-X12 assuming an alpha-helix structure.
Scholtz teaches that there are helix-favoring amino acids (Alanine, Glutamate, Glutamine, and Lysine) and polar amino acids and a lack of helix disruptors like proline are desirable properties needed to form an alpha helix (pg. 107, “Marqusec & Baldwin (41) described the first de novo-designed a-helical peptide system. It has some of the desirable properties necessary for a simple a-helical host. The peptides in this system mostly contain Ala, with Glu and Lys inserted for solubility. … Lyu et al (37) synthesized two peptides that contain primarily Glu and Lys; they found modest a-helical structure in solution.”).
Pannell and Scholtz do not teach X4 being covalently bound to the side chain of X11.
Henchey teaches that an alpha helix makes a full turn every 3.6 amino acids and that a known strategy of stabilizing alpha-helical confirmation in peptides is to have covalent bonds between the side groups of i and i+7 (pg. 2, “The α-helix features 3.6 residues per complete turn, which places the i, i+4, i+7, and i+11 side chains on the same face of the folded structure. The classical strategy to stabilize the α-helical conformation in peptides employs covalent bonds between the i and i+4 or i and i+7 side chain groups.”).
It would be obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify Pannell’s teaching with Scholtz’s and Henchey’s teachings due to Pannell teaching the peptide of the instant invention, Scholtz teaching that the presence of certain amino acids are needed to form an alpha helix and Henchey teaching that a covalent bond between the side chains of i and i+7 stabilize α-helical conformation. One of ordinary skill in the art would, with reasonable expectation of success, believe that the sequence as taught by Pannell would form an alpha helical structure and that having the side chains of i and i+7 covalently bonded would result in stability.
One would have had a reasonable expectation of success because the well-established idea that the presence of helix-favoring amino acids would result in a helical structure forming.
Regarding claim 2, with regard to the limitation “wherein said peptide or peptidomimetic is capable of interfering with ubiquitination”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The peptide as described in Pannell contains the same structure as the peptide as described in BY sequence (a) of the instant claim, thus it is interpreted as being sufficient in being capable of interfering with ubiquitination, as described in the instant claim.
Regarding claim 3, with regard to the limitation “wherein said peptide or peptidomimetic stops cell division or induces cell death”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The peptide as described in Pannell contains the same structure as the peptide as described in sequence (a) of the claim 1, thus it is interpreted as being sufficient in being capable of stopping cell division or inducing cell death, as described in the instant claim.
Regarding claim 22, the limitation of “A kit comprising or consisting of one or more peptides or peptidomimetics of claim 1”, the inclusion of instructions in a kit not considered a novel step in the case where no functional relationship exists between the peptide and putting the peptide in a kit. See MPEP 2111.05 (b). As there is no functional relationship between the peptide and the kit claimed in the instant application, that is to say that the limitation of the peptide being in a kit does not add functionality to the peptide, therefore the inclusion of kit as described in claim 22 is not considered a novel step.
Additionally, it would also be obvious to a person of ordinary skill in the art, before the effective filing date, to put a peptide in a kit. The assembly of known peptides disclosed in the prior art into a “kit” and supplementing them with the written instructions and teaching of the prior art does not impart additional meaningful structural limitations to the claims in this scenario.
Regarding claim 23, Pannell discloses a peptide that comprises the amino acid sequence “SWIEKREIQTERAN”. See the peptide represented by SEQ ID NO: 134, amino acid residues 2300-2314 (pg. 69, “SEQ ID NO: 134 – NCBI Accession No.: 114155133 – Protein Name: dynein heavy chain 9 axonemal isoform 2 [Homo sapiens] …”; pg. 189-190, “SEQ ID 134 …SWIEKREIQTERAN…”). The third amino acid of the sequence comprised in SEQ ID NO: 134 of Pannell has a proteinogenic amino acid (Isoleucine or “I”) (pg. 189-190, “SEQ ID 134 …SWIEKREIQTERAN…”).
Regarding claim 24, Pannell discloses a peptide that comprises the amino acid sequence “SWIEKREIQTERAN”. See the peptide represented by SEQ ID NO: 134, amino acid residues 2300-2314 (pg. 69, “SEQ ID NO: 134 – NCBI Accession No.: 114155133 – Protein Name: dynein heavy chain 9 axonemal isoform 2 [Homo sapiens] …”; pg. 189-190, “SEQ ID 134 …SWIEKREIQTERAN…”). The seventh amino acid (X7) of the sequence comprised in SEQ ID NO: 134 of Pannell is Glutamic acid (E) (pg. 189-190, “SEQ ID 134 …SWIEKREIQTERAN…”).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Pannell and Rocker, hereafter “Pannell” (WO 2014160499 A2), Scholtz, J. M., & Baldwin , R. L., hereafter “Scholtz” (“The mechanism of alpha-helix formation by peptides.” Annual Review of Biophysics and Biomolecular Structure, 21(1), 93–118. June 1992. https://doi.org/10.1146/annurev.biophys.21.1.93), and Henchey et al., hereafter “Henchey” (“Contemporary strategies for the stabilization of peptides in the alpha-helical conformation.” Curr Opin Chem Biol. 2008 Dec;12(6):692-7. doi: 10.1016/j.cbpa.2008.08.019. Epub 2008 Sep 13. PMID: 18793750; PMCID: PMC2650020.), as applied to claim 1 above, and further in view of Di Gioia et al., hereafter “Di Gioia” (“N-Methylated α-Amino Acids And Peptides: Synthesis And Biological Activity.” Mini Rev Med Chem. 2016;16(9):683-90. doi: 10.2174/1389557516666160322152457. PMID: 27001259.).
Regarding claim 4, Pannell discloses a peptide that comprises the amino acid sequence “SWIEKREIQTERAN”. See the peptide represented by SEQ ID NO: 134, amino acid residues 2300-2314 (pg. 69, “SEQ ID NO: 134 – NCBI Accession No.: 114155133 – Protein Name: dynein heavy chain 9 axonemal isoform 2 [Homo sapiens] …”; pg. 189-190, “SEQ ID 134 …SWIEKREIQTERAN…”). The third amino acid of the sequence comprised in SEQ ID NO: 134 of Pannell has a proteinogenic amino acid (Isoleucine or “I”) (pg. 189-190, “SEQ ID 134 …SWIEKREIQTERAN…”).
Pannell does not teach an alpha-amino group of X1 is bound to a methyl.
Di Gioia teaches that a methylated peptide increases stability (pg. 683,“N-Methylation determines changes of the conformations, the hydrogen bond patterns, and different steric constraints of the peptide chains; metabolic stability”).
It would be obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify Pannell’s teaching with Di Gioia’s teachings due to Pannell teaching the peptide of the instant invention and Di Gioia teaching that the addition of a methyl group to a peptide increases metabolic stability. This modification of the art takes a known peptide and a known method of stabilizing peptides.
One would have had a reasonable expectation of success because the well-established function of N-Methylation being used as a way to stabilize peptides under KSR rationale D. (See MPEP 2143 (I)(D)).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Pannell and Rocker, hereafter “Pannell” (WO 2014160499 A2), Scholtz, J. M., & Baldwin , R. L., hereafter “Scholtz” (“The mechanism of alpha-helix formation by peptides.” Annual Review of Biophysics and Biomolecular Structure, 21(1), 93–118. June 1992. https://doi.org/10.1146/annurev.biophys.21.1.93), and Henchey et al., hereafter “Henchey” (“Contemporary strategies for the stabilization of peptides in the alpha-helical conformation.” Curr Opin Chem Biol. 2008 Dec;12(6):692-7. doi: 10.1016/j.cbpa.2008.08.019. Epub 2008 Sep 13. PMID: 18793750; PMCID: PMC2650020.), as applied to claim 1 above, and further in view of Kannt and Đikić, hereafter “Kannt” (“Expanding the arsenal of E3 ubiquitin ligases for proximity-induced protein degradation.” Cell Chem Biol. 2021 Jul 15;28(7):1014-1031. doi: 10.1016/j.chembiol.2021.04.007. Epub 2021 May 3. PMID: 33945791.).
Regarding claim 13, Pannell discloses a peptide that comprises the amino acid sequence “SWIEKREIQTERAN”. See the peptide represented by SEQ ID NO: 134, amino acid residues 2300-2314 (pg. 69, “SEQ ID NO: 134 – NCBI Accession No.: 114155133 – Protein Name: dynein heavy chain 9 axonemal isoform 2 [Homo sapiens] …”; pg. 189-190, “SEQ ID 134 …SWIEKREIQTERAN…”). The third amino acid of the sequence comprised in SEQ ID NO: 134 of Pannell has a proteinogenic amino acid (Isoleucine or “I”) (pg. 189-190, “SEQ ID 134 …SWIEKREIQTERAN…”).
Pannell does not teach that the peptide or peptidomimetic is conjugated via a linker to a ligand of an E3 ligase.
Kannt teaches that the addition of a E3 ligase to a peptide reprograms the cells waste delivery systems to selectively destroy disease causing proteins (pg. 1014,“Targeted protein degradation refers to the use of small molecules that hijack the cellular protein homeostasis system to degrade proteins of interest. This can be accomplished by utilizing the ubiquitin-proteasome system (UPS) as exemplified by proteolysis targeting chimeras (PROTACs, Sakamoto et al., 2001) … PROTACs are heterobifunctional molecules that consist of two moieties, one each binding to the target protein and an E3 ligase, connected by an appropriate linker …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pannell’s teachings with Kannt’s teachings because due to Pannell teaching the peptide of the instant invention and Kannt’s teaching that the addition of an E3 ligase connected to a peptide via a linker modifies the peptide to facilitates the degradation of target proteins. One of ordinary skill in the art would think to modify Pannell’s teaching due to Kannt teaching that the addition of a E3 ligase can induce cell death in disease causing proteins.
Status of Claims
Claims 1-4, 13 and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Claims 1-4, 13 and 22-24 are rejected under 35 U.S.C. 103.
No claims allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Daliyah M. Brown whose telephone number is (571)272-0136. The examiner can normally be reached Monday-Thursday 9:00 am - 4:30 pm.
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/Daliyah M. Brown/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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