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 .
Priority
The instant application is a 35 U.S.C. 371 national phase application and claims priority to International Application No. PCT/EP2021/071778 (filing date 08/04/2021), which claims the benefit of the prior-filed European Provisional Patent Application No. EP20189425.0, filing date 08/04/2020.
Status of Application/Claims
The amendment, filed 02/06/2026, is acknowledged. Claims 1-27, 29-30, and 33 are canceled. Claims 28, 31-32, 34, 38-43, and 45-46 are currently amended. Claims 48-53 are new. Claims 28, 31-32, and 34-53 are currently pending and are examined on the merits herein.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/14/2026 has been fully considered by the examiner.
Withdrawn Objections & Rejections
Regarding the Specification objection for abstract length, applicant amendment has addressed the issue. Thus, the objection is withdrawn.
Regarding the Specification objection for hyperlinks, applicant amendment has addressed the issue. Thus, the objection is withdrawn.
Regarding the Specification objection for trade names and/or trademark compliance issues, applicant amendment has addressed the issue. Thus, the objection is withdrawn.
Regarding the Claim objection for claim 40, applicant amendment has addressed the issue. Thus, the objection is withdrawn.
Regarding the rejections for claims 28-34, 38-42 and 45-46 under 35 U.S.C. 112(b) for indefiniteness: Claims 29-30, 33 are canceled. Applicant amendment has addressed the rejections for claims 28, 31-34, 38-42, and 45-46. Thus, the rejections are withdrawn.
Regarding the rejections for claim 33 under 35 U.S.C. 112(d) for improper dependent form for failing to further limit the subject matter of the claim upon which it depends: Claim 33 is canceled. Thus, the rejection is withdrawn.
Regarding the rejections for claims 28-33 and 35-37 under 35 U.S.C. 112(a) for failing to comply with the written description requirement: Claims 29-30, 33 are canceled; thus, the rejection for claims 29-30 and 33 is withdrawn. However, the amendment to independent claim 28 does not fully address the issue; thus, the rejection for instant claim 28, as well as dependent claims 32, 35-47 is maintained in modified form. As, claims 49-53 are newly added and dependent on claim 28, claims 49-53 are also newly rejected. (See below rejection and Response to Arguments below.)
Regarding the rejections for claims 43-47 under 35 U.S.C. 112(a) for failing to comply with the enablement requirement: Applicant amendment has addressed the issue. Thus, the rejection is withdrawn.
Regarding the rejection for claims 28-29 and 31 under 35 U.S.C. 102 for novelty: Applicant amendment has addressed the issue. Thus, the rejection is withdrawn.
Regarding the rejections under 35 U.S.C. 103 for obviousness for claim 30; claims 32 and 36-38; and claims 36-47: Claim 30 has been canceled. Applicant amendment has addressed the issue for rejected claims 32, and 36-47. Thus, the rejections are withdrawn.
Claim Objections
Claim 34 is objected to because of the following informalities: Claim 34 recites the limitation “LESMPVDPDNES (SEQ ID NO: 66)” twice, once in lines 14 and 17. As these terms are duplicates of each other, one of the terms should be removed. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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 28, 32, 35-53 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. THIS IS AN ENABLEMENT REJECTION.
Enablement is considered in view of the Wands factors (MPEP 2164.01(a)). The court in Wands states: “Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue,’ not ‘experimentation.’” (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: The nature of the invention; the breadth of the claims; the amount of direction provided by the inventor; the existence of working examples; the state of the prior art; the level of predictability in the art; the quantity of experimentation needed to make or use the invention based on the content of the disclosure; and, the level of one of ordinary skill. While all of these factors are considered, a sufficient amount for amount for a prima facie case are discussed below.
The nature of the invention
Claim 28 is drawn to an antigenic peptide “comprising, consisting essentially of or consisting of” peptide sequences selected from those recited in instant claim 28. The term “comprising” is problematic because this includes species of larger peptide structures indefinite lengths. Claims 32 and 35-53 are dependent on claim 28 and recite additional structural limitations for the antigenic peptides and the pharmaceutical preparations thereof, and a method of use thereof for treatment of synucleinopathy, which do not address the issue.
The breadth of the claims
As claim 28 recites the term “comprising,” the claims are drawn to a genus of antigenic peptides of indefinite length and varying amino acid identities, with the claimed functions of being antigenic.
The level of one of ordinary skill
The level of skill of one skilled in this art is high.
The amount or direction provided by the inventor/ the existence of working examples
Applicant disclosure Figure 2 provides immunogenicity data for select variant antigenic peptide species p4456 (residues 115-121; M116Q and D119L substitutions) and p4572 (residues 114-122; E114Y, M116R, D119Q, and N122R substitutions) compared to the corresponding native α-syn peptides (p.36, Fig. 2A-B). Figure 3 shows immunogenicity data for peptides limited to the 113-124 amino acid residue region of the protein and species where only an alanine/A or serine/S is substituted at each position. Figure 4 shows immunogenicity data for carrier-peptide constructs where the antigenic peptide sequence consists of residues 113-124. Additionally, Figure 4 references species listed in Tables 7 and 8. Table 7 is limited to peptide species having W, I, N, K, or D substitutions at the X1/aa113 position and is limited to W, E, K, L, or N substitutions at X3/aa115 positions (p.45-46). Table 8 is limited to peptide species having W, L, N, D, or K substitutions at X4/aa116 and is limited to W, V, G, D, or K substitutions at X12/aa124 (p.46). Figure 5 is limited to species of residues 113-124 where double serine substitutions are at positions 1 or 3 and 4 or 12 (p.37). Figure 6, Table 13, and Figure 8B show immunogenicity data for 7 12-mer species of amino acid residues 113-124 where an N-terminal cysteine was added, and 3 species for which two glycines/G following the N-terminal cysteine were additionally added (p.37-38). Figure 8 and Table 16 show immunogenicity for four 11- and 12-mer species (p.38, 51). Figures 9 and 10 show IHC staining for 10 species (p.38) and sensogram binding data for 11 species (p.38), respectively. Figure 11 provides ELISA binding inhibition data for two species (p.38-39). The examples demonstrate that peptides consisting of SEQ ID NOs: 64-79 and 167-168 have antigenic properties and can be used to treat synucleinopathy. Peptides consisting of these amino acid sequences represent the antigenic peptides that applicant was in possession of at the effective filing date of the claimed invention.
Overall, the disclosure and drawings provide support for only a select number of species within the claimed genus of antigenic peptides. Thus, claims 28, 32, and 35-53 describe a broad genus of antigenic peptides of indefinite length, but the specification only describes a narrow group of species with no evidence that the genus that includes all possible antigenic peptides encompassed as recited in claim 28 that comprise an indefinite number of additional residues flanking the defined peptide α-syn structures as recited in claim 28 would predictably maintain the claimed functions. See MPEP 2163.03 (V).
The state of the prior art/ the level of predictability in the art
The state of the art around the effective filing date of the claimed invention demonstrates that antigenic peptide structures used for treatment of synucleinopathy are limited to short peptide constructs within the C-terminal domain of the human α-syn protein.
Trier, et al. Peptides, antibodies, peptide antibodies and more. Int. J. Mol. Sci. 2019, 20:6289, p.1-22 (herein referred to as Trier) teaches that traditional peptide antibody production is based on immunization, where a crucial element is the peptide selection. Peptides used for immunization are usually 10–20 amino acids long, and peptides below 10 amino acids and above 20 amino acids are usually not preferred, since these peptides may elicit Abs that do not recognize the protein with sufficient affinity or specificity.
Malonis, et al. Peptide-based vaccines: Current progress and future challenges. Chem. Rev. (2020), 120, p.3210-3229, herein referred to as Malonis, teaches that epitope specificity for T-cells is mediated by the T-cell receptor, which binds peptides presented in the “peptide binding groove of class I or class II major histocompatibility complexes (MHCs, also known as human leukocyte antigen, HLA, for humans); and that whole antigens are internalized and proteolyzed by antigen presenting cells, and then short peptides of 8-11 residues for class I and 11-30 residues for class II are loaded into MHCs/HLAs (p.3212, col.1, para.4). Additionally, Malonis teaches that peptides that are loaded into MHCs or HLAs must conform to sequence patterns harboring anchor peptides in order to bind T cell receptors, but this does not guarantee that a particular epitope will be immunogenic (p.3212, col.2, para.2). Further, Malonis teaches that the antigen specificity of the T-cell is dependent on the TCR – pMHC (peptide/MHC complex) interaction, and thus the structural features of the epitope – MHC – TCR ternary complex can be an important consideration for T-cell targeted vaccines (p.3213, col.1, para.1).
Overall, it is not evident from the disclosure or the prior art that applicant was in possession of the claimed genus of species that exhibit the antigenic function as is broadly claimed. There is no support providing that applicant had possession of nor did applicant provide a sufficient description for the claimed genus of antigenic peptides of a length longer than peptides comprising core 11-mer and 12-mer amino acid sequences that serve the claimed function. It is also, thus, unclear how one of ordinary skill in the art would use such a peptide in a method for the treatment of synucleinopathy. The claimed subject matter was not described in the specification in such a way as to reasonably convey to one of ordinary skill in the art that applicant was in possession of the claimed invention at the time of filing as is broadly claimed; and, therefore, the claims do not meet the written description requirement.
Allowable Subject Matter
Claim 28 contains allowable subject matter.
Claims 31 and 34 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:
The antigenic peptides consisting of the defined peptides recited in claim 28 are free of the prior art. The closest prior art is provided by Devidze, et al. WO2018151821A1 – Antibodies to alpha-synuclein and uses thereof, herein referred to as Devidze, as previously described in the non-final office action filed 11/06/2025. Briefly herein, Devidze teaches α-syn antigenic peptides, including SEQ ID NO: 138, which is the 11-amino acid antigenic peptide “LEDMPVDPDNE.” Thus, Devidze teaches an antigenic peptide that is 1 amino acid shorter than those instantly claimed (p.116, Table 1; Figure 1).
Response to Arguments
Regarding the rejections for claims 28-33 and 35-37 under 35 U.S.C. 112(a) for failing to comply with the written description requirement, which was described in the non-final office action filed 11/06/2025: While applicant has amended the claims by moving the antigenic peptide sequences previously recited in claim 34 to instant claim 28, the scope of instant claim 28 still recites “An antigenic peptide comprising, consisting essentially of or consisting of”, which is not entirely supported by the disclosure and fails to meet the written description requirement. See 112(a) written description rejection above, as well as the associated claim interpretation. Thus, the rejection for instant claim 28 is maintained due to the inclusion of the term “comprising.” Dependent claims 32 and 35-53 are also rejected because the limitations recited in these claims do not overcome the issue.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jami M Gurley whose telephone number is (571)272-0117. The examiner can normally be reached Monday - Friday, 8am - 4pm.
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/JAMI MICHELLE GURLEY/Examiner, Art Unit 1647
/JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647
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