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 with traverse of Group 1 (claims 1-21, 51 and 59-61) and without traverse election of species (a) first peptide of SEQ ID NO: 06 and second species of SEQ ID NO: 55, and (b) linker comprising Arg-Arg in the reply filed on 1/12/2026 is acknowledged. The traversal is on the ground(s) that searching for Groups1, 2 and 3 would not present serious burden. This is not found persuasive because the restriction is made under PCT Rule 13.1 which is the lack of unity and it does not require search burden (see pg. 2-5 of the office action of 11/12/2025).
The requirement is still deemed proper and is therefore made FINAL.
Status of Application, Amendments, And/Or Claims
Claims 1-67 are pending.
Claims 22-50, 52-58 and 62-67 are withdrawn for being drawn to non-elected inventions (i.e., Groups 2-7).
Claims 1-21, 51 and 59-61 are under examination to the extent they read on elected invention.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) filed on 11/19/2024, 4/11/2025 and 12/16/2025 have been considered. The crossed-out reference US Pub. No. 20150232524 has already been considered in the IDS of 12/16/20225.
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.
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.
Claim(s) 1-18, 51 and 59-61 are rejected under 35 U.S.C. 103 as being unpatentable over Agadjanyan et al. (IDS, US Pub. 20150232524) in view of US Pat. No. 7063847 and as evidenced by US Pat. 6,632,934.
The instantly claimed invention is broadly drawn to a polypeptide comprising a first peptide comprising 3-10 amino acids from residues 1-10 or 12-25 of SEQ ID NO:01 linked to a second peptide comprising 3-10 amino acids from residues 81-140 of SEQ ID NO:02, wherein the second peptide is from the C-terminal region of alpha-synuclein (residues 111-131 of SEQ ID NO:02), wherein the first peptide is N-terminal to the second peptide, wherein the first peptide is C-terminal to the second peptide. A nucleic acid comprising a nucleic acid sequence encoding a polypeptide of claim 1 (claim 51). A method of inducing an immune response in an animal, comprising administering to the animal any one of the polypeptides of claim 1 in a regimen effective to generate an immune response comprising antibodies that specifically bind to Aβ, alpha- synuclein, or both Aβ and alpha-synuclein (claim 59), wherein the immune response comprises antibodies that specifically bind to Aβand antibodies that specifically bind to alpha-synuclein (claim 60), wherein the inducing the immune response comprises antibodies that specifically bind to the N-terminal region of Aβ and/or the C-terminal region of alpha-synuclein (claim 61).
Like the instant application, Agadjanyan et al. discloses and claims a composition comprising a combination of an amyloid- β (Aβ ) and an alpha-synuclein peptides that comprises epitopes from amino acid sequence of SEQ ID NO: 1, wherein the epitopes are 4, 5, 6, 7, 8, 9, 10 amino acids or more for Aβ (see paragraph [0043]) and comprises epitopes for alpha-synuclein from SEQ ID NO: 3 having 5 to 50 amino acids. They teach that the Aβ peptide epitope can be EFRH (claim 7) as being instantly claimed. They teach a peptide epitope for alpha-synuclein having amino acid sequence of SEQ ID NO: 17 that comprises amino acids VDPDNEAYEM (instantly claimed sequence of SEQ ID NO:39 or 40-46). They teach to combine Aβ with alpha-synuclein or Aβ, tau and/or alpha-synuclein to immunize a subject or for treating conditions associated with amyloid, tau, and/or alpha-synuclein (claim 24). They teach to prepare an immunogen comprising Aβ and alpha-synuclein or Aβ, tau and alpha-synuclein (claims 1 and 19-24). They also teach a nucleic acid that encodes for Aβ and alpha-synuclein or Aβ, tau and alpha-synuclein and treating a subject at risk of developing Alzheimer’s diseases or one or more conditions associated with amyloid deposits and/or alpha-synuclein deposits (claims 20). Regarding claim 7-10, they teach using linkers to link Aβ and alpha-synuclein, wherein the linkers may be GS, GSSGSG, YNGK, A(EAAAK)nA, wherein n is 2-5 (claim 4) which are functionally equivalent to the instantly claimed linker as evidenced by US Pat. No. 7,063847 that teaches use of dibasic amino acid Arg-Arg for trypsin cleavage (col. 5, line13+). Agadjanyan et al. do not teach to insert GGC at the C-terminus of a polypeptide.
US pat. 6,632,934 teaches to insert the amino acid sequence of GGC at the C-terminus of a peptide. This is done as a routine in the art for the purpose of a protein purification (see US pat. 6,632,934, Col. 98, lines42+).
Therefore, it would have been prima facie to one ordinary skill in the art at the time the invention was made use a sequence of Gly-Gly-Cys at the end of a peptide as taught by US pat. 6,632,934 and to select any 3, 4, 5, 6 or longer peptide from Aβ to attach with a 3, 4, 5, 6, 7, 8, 9 or longer peptide from alpha-synuclein via a linker to make a composition for immunizing a subject for treating Alzheimer’s disease or alpha-synuclein deposits as taught by Agadjanyan et al. Additionally, one would have been motivated to do so because Agadjanyan et al teach to make composition comprising a peptide from Aβ to conjugate with a peptide 5-50 amino acids of alpha-synuclein via a linker to treat Alzheimer’s disease or alpha-synuclein deposit related diseases and to attach a Gly-Gly-Cys for the purpose of purification and/or to attach to surface of a matrix. Further, one would have a reasonable expectation of success in using various conjugates between Aβ peptides and alpha-synuclein peptides with linker as taught by Agadjanyan et al for treating diseases related with Aβ, and/or alpha-synuclein deposits, including Alzheimer’s disease and to attach GGC sequence at the C-terminus of the peptide. Therefore, the instantly claimed invention would have been obvious over the combined teachings of the prior art.
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 59-61 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the polypeptide of amino acid sequence of SEQ ID NO: 110 and SEQ ID NO:111 for inducing an immune response in an animal, does not reasonably provide enablement for peptides of 3 or 4 amino acids from a first polypeptide linked to 3 or 4 amino acids from a second peptide for inducing an immune response in an animal. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
In In re Wands, 8USPQ2d, 1400 (CAFC 1988) page 1404, the factors to be considered in determining whether a disclosure would require undue experimentation include: (1) Nature of the invention, (2) the state of the prior art, (3) the predictability or lack thereof in the art, (4) the amount of direction or guidance present, (5) the presence or absence of working examples, (6) the breath of the claims, (7) the quantity of experimentation needed, (8) relative skill of those in the art.
The instant disclosure fails to meet the enablement requirement for the following reasons:
The instant claims are broadly drawn to a method inducing immune response in any animal comprising administering a polypeptide of claim 1 in a regimen effective to generate antibodies that specifically bind to Aβ, α-synuclein or both.
The state of the prior art and the predictability or lack thereof in the art:
With regards to a method of inducing immune response in animal comprising peptides of 3 or 4 amino acids from a first polypeptide linked to 3 or 4 amino acids from a second peptide, the specification only provides two polypeptides of SEQ ID NO: 110 and SEQ ID NO:111 out of numerous peptides listed in Table 3. Most of the epitopes listed in Table 3 having as small as 3 amino acids for Aβ and alpha-synuclein for raising immune response. But none of these peptides are included in inducing immune response. As stated earlier, only two polypeptide have been used to induce the immune response in view of evidence provided in the specification (Figures 2-3). Therefore, only two polypeptides are enabled to induce immune response in an animal but not numerous peptides of Table 3 and it would require a large amount of experimentation to induce immune response in an animal with peptide having numerous combinations as being instantly claimed.
The amount of direction and guidance present and the presence or absence of working examples: Given the teachings found in the art, detailed teachings are required to be present in the disclosure in order to enable the skilled artisan to practice the invention as claimed. These teachings are absent. The specification at page 45, Table 1 disclose two polypeptides of SEQ ID NO: 110 and 111 that induces immune response in Guinea pigs. The specification does not teach administering any peptide that includes only 3 amino acids from Aβ and 3 amino acids from alpha-synuclein for inducing immune response in an animal. Therefore, it is unpredictable how one of the skill in the art can practice the instantly claimed invention.
The breadth of the claims and the quantity of experimentation needed: Due to the large quantity of experimentation necessary to induce immunity using a peptide of as little as 3 amino acids from Aβ and 3 amino acids from alpha-synuclein for inducing immune response in an animal, the lack of direction/guidance presented in the specification regarding the same, the state of the prior art which establishes the unpredictability about inducing immunity in an animal, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention in its full scope.
Conclusion
No claim is allowed.
Claims 19-21 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.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674