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 .
Status of the Claims
Claims 1-38 were originally filed November 22, 2023.
The preliminary amendment received November 22, 2023 cancelled claims 1-38 and added new claims 39-56.
The amendment received June 23, 2026 amended claims 39-42, 46-48, and 53-56.
Claims 39-56 are currently pending.
Claims 39, 40, 47, 48, and 51-53 are currently under consideration.
Please note: withdrawn claim 45 is missing a conjunction in the Markush group.
Please note: withdrawn claim 55 is missing a transitional phrase (e.g. comprising, consisting, etc.).
Election/Restrictions
Applicant’s election without traverse of Group I (claims 39-53) in the reply filed on June 23, 2026 is acknowledged.
Claims 54-56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 23, 2026.
Applicant’s election without traverse of SEQ ID NO: 88, the capability of enhancing or inducing a7nAChr mediated calcium influx, intravenous formulation, and a M35P substitution in the reply filed on June 23, 2026 is acknowledged.
Please note: SEQ ID NO: 88 is SEQ ID NO: 1 with a M35P substitution.
Claims 41-46, 49, and 50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 23, 2026.
Please note: claim 42 is withdrawn due to the definition of a conservative amino acid substitution in the specification at paragraph 48 (i.e. M35P is not a conservative amino acid substitution).
Please note: claims 43-46 are withdrawn because proline is not an amino acid analogue.
Potential Rejoinder
Applicant elected claims directed to a product. If a product claim is subsequently found allowable, withdrawn process claims that depend from or otherwise include all the limitations of the allowable product claim will be rejoined in accordance with the provisions of MPEP § 821.04. Process claims that depend from or otherwise include all the limitations of the patentable product will be entered as a matter of right if the amendment is presented prior to final rejection or allowance, whichever is earlier. Amendments submitted after final rejection are governed by 37 CFR 1.116; amendments submitted after allowance are governed by 37 CFR 1.312.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all the criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103, and 112. Until an elected product claim is found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowed product claim will not be rejoined. See “Guidance on Treatment of Product and Process Claims in light of In re Ochiai, In re Brouwer and 35 U.S.C. § 103(b),” 1184 O.G. 86 (March 26, 1996). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution either to maintain dependency on the product claims or to otherwise include the limitations of the product claims. Failure to do so may result in a loss of the right to a rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Priority
The present application is a 371 (National Stage) of PCT/EP2022/064374 filed May 26, 2022 which claims the benefit of 63/193,258 filed May 26, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on February 27, 2024 and December 11, 2025 are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: paragraph 33 should be split into two paragraphs (i.e. one for the description of Figures 12A-12D and one for the description of Figure 13).
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 39 is objected to because of the following informalities: the first “the Ab42 peptide” in line 2 should read “an Ab42 peptide”. Appropriate correction is required.
Claim 39 is objected to because of the following informalities: “beta- sheet” in line 4 should read “beta-sheet”. Appropriate correction is required.
Claim 39 is objected to because of the following informalities: “amino-acid” in lines 5 and 9 should read “amino acid”. Appropriate correction is required.
Claim 40 is objected to because of the following informalities: “comprises capability” should read “comprises the capability”. Appropriate correction is required.
Claim 47 is objected to because of the following informalities: “a substitution of M35” should read “a substitution at M35”. Appropriate correction is required.
Claim 51 is objected to because of the following informalities: spaces should be present between “SEQ ID NO:” and the number. Appropriate correction is required.
Claim 51 is objected to because of the following informalities: “beta- sheet” in line 4 should read “beta-sheet”. Appropriate correction is required.
Claim 52 is objected to because of the following informalities: spaces should be present between “SEQ ID NO:” and the number. Appropriate correction is required.
Claim 53 is objected to because of the following informalities: “or” in lines 3 and 4 should be removed (i.e. a single conjunction should be present in the Markush group). Appropriate correction is required.
Claim 53 is objected to because of the following informalities: the semicolon in line 3 should be a comma to correlate with the rest of the claim. Appropriate correction is required.
Claim 53 is objected to because of the following informalities: “intramuscular ; topical” should read “intramuscular, topical”. Appropriate correction is required.
Sequence Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising a sequence of SEQ ID NO: 1” requires only a 2mer of SEQ ID NO: 1, “comprising the sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with any N-/C-terminal additions or any 5’/3’ additions, “consisting of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 and the same length as SEQ ID NO: 1, and “selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3. Any claim requiring a specific percent identity, necessarily requires at least the recited percent identity.
Please note: independent claim 39 contains open ended ranges (i.e. no more than 3, no more than 5) which encompass zero. Therefore, the Ab42 peptide of SEQ ID NO: 1 (i.e. Ab42 peptide with residues 1-42) as presently claimed does not require any deletions, insertions, or substitutions. Furthermore, Ab 1-40 peptide (i.e. 2 deletions in residues 29-42) and Ab 1-43 peptide (i.e. 1 insertion in residues 29-42) also read on present independent claim 39. Regarding the functional limitation in the claim, the functional limitation does not negate breadth of the structure recited because the claim reads on a single peptide (i.e. nonaggregate form) and/or fibrils in the nonaggregate form.
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 39, 40, 47, 48, and 51-53 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear if “having” and “corresponding to” are open, closed, etc. See line 3.
Claims 39, 40, 47, 48, and 51-53 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear if the open-ended ranges of no more than 3 and no more than 5 require any deletions, insertions, and/or substitutions.
Claims 39, 40, 47, 48, and 51-53 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear how the functional limitation (claim 39, lines 12 and 13) alters the structure of the present claims.
Claim 40 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear what structure is required for the recited function.
Claim 47 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.
Claim 47 recites the limitation "the beta-sheet destabilizing modification" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Please also refer to withdrawn claims 43, 44, 49, and 50.
Claim 48 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.
Claim 48 recites the limitation "the beta-sheet destabilizing modification" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 51 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. One of skill in the art would not be able to determine the scope of the presently claimed pharmaceutical composition. For example, it is unclear what the scope of “having” is (e.g. open, closed, etc.).
Claim 51 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. One of skill in the art would not be able to determine the scope of the presently claimed pharmaceutical composition. For example, it is unclear if the “with at most three conservative amino acid substitutions in either or both of the N-terminal domain and the beta- sheet aggregation domain” is simply describing the substitutions already present in SEQ ID NOs: 3, 88, 100, 190, or 192 or if additional substitutions are necessary. Furthermore, it is unclear how the substitutions can all be conservative when paragraph 48 of the present specification defines conservative substitutions as not being an M35P substitution (SEQ ID NO: 88).
Claim 52 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. One of skill in the art would not be able to determine the scope of the presently claimed pharmaceutical composition. For example, it is unclear what the scope of “having” is (e.g. open, closed, etc.).
Claim 53 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. One of skill in the art would not be able to determine the scope of the presently claimed pharmaceutical composition. For example, it is unclear “(including sublingual or buccal)” is required by the claim or not.
Please note: due to the myriad of objections and 35 USC 112 issues with the claims, applicants are respectfully requested to carefully review the claims for any additional issues.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 39, 40, and 53 are rejected under 35 U.S.C. 101 because the claimed invention is directed to Ab40, Ab42, Ab43 and fragments thereof without significantly more. The claims recite SEQ ID NO: 1 (Ab42) with 0-8 deletions (i.e. encompassing fragments and Ab40) or 0-8 insertions (i.e. encompassing Ab43). This judicial exception is not integrated into a practical application because the present claims are drawn to a product. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the formulations of claim 53 do not require anything specific or anything that would structurally alter the Ab40, Ab42, Ab43 and fragments thereof. Claims 39 and 40 are drawn to the structure of Ab40, Ab42, Ab43 and fragments thereof only.
RESULT 1
Q56JJ6_GRAGR
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
ID Q56JJ6_GRAGR Unreviewed; 42 AA.
AC Q56JJ6;
DT 10-MAY-2005, integrated into UniProtKB/TrEMBL.
DT 10-MAY-2005, sequence version 1.
DT 27-NOV-2024, entry version 51.
DE RecName: Full=Amyloid-beta precursor protein {ECO:0000256|ARBA:ARBA00021782};
DE AltName: Full=ABPP {ECO:0000256|ARBA:ARBA00032275};
DE AltName: Full=Alzheimer disease amyloid A4 protein homolog {ECO:0000256|ARBA:ARBA00031698};
DE AltName: Full=Amyloid precursor protein {ECO:0000256|ARBA:ARBA00030489};
DE AltName: Full=Amyloid-beta (A4) precursor protein {ECO:0000256|ARBA:ARBA00030741};
DE AltName: Full=Amyloid-beta A4 protein {ECO:0000256|ARBA:ARBA00030344};
DE Flags: Fragment;
OS Grampus griseus (Risso's dolphin) (Delphinus griseus).
OC Eukaryota; Metazoa; Chordata; Craniata; Vertebrata; Euteleostomi; Mammalia;
OC Eutheria; Laurasiatheria; Artiodactyla; Whippomorpha; Cetacea; Odontoceti;
OC Delphinidae; Grampus.
OX NCBI_TaxID=83653 {ECO:0000313|EMBL:AAX81918.1};
RN [1] {ECO:0000313|EMBL:AAX81918.1}
RP NUCLEOTIDE SEQUENCE.
RA Gallego C., Sarasa M.;
RT "The molecular machinery of Alzheimer's disease in the dolphin.";
RL Submitted (FEB-2005) to the EMBL/GenBank/DDBJ databases.
CC -!- SUBCELLULAR LOCATION: Cell membrane {ECO:0000256|ARBA:ARBA00004251};
CC Single-pass type I membrane protein {ECO:0000256|ARBA:ARBA00004251}.
CC Cell projection, growth cone {ECO:0000256|ARBA:ARBA00004624}.
CC Cytoplasmic vesicle {ECO:0000256|ARBA:ARBA00004541}. Early endosome
CC {ECO:0000256|ARBA:ARBA00004412}. Membrane, clathrin-coated pit
CC {ECO:0000256|ARBA:ARBA00004600}. Perikaryon
CC {ECO:0000256|ARBA:ARBA00004484}.
CC -!- SIMILARITY: Belongs to the APP family. {ECO:0000256|ARBA:ARBA00009449}.
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DR EMBL; AY926589; AAX81918.1; -; mRNA.
DR AlphaFoldDB; Q56JJ6; -.
DR GO; GO:0005905; C:clathrin-coated pit; IEA:UniProtKB-SubCell.
DR GO; GO:0005769; C:early endosome; IEA:UniProtKB-SubCell.
DR GO; GO:0030426; C:growth cone; IEA:UniProtKB-SubCell.
DR GO; GO:0043204; C:perikaryon; IEA:UniProtKB-SubCell.
DR GO; GO:0005886; C:plasma membrane; IEA:UniProtKB-SubCell.
DR CDD; cd21707; JMTM_APP; 1.
DR FunFam; 4.10.230.10:FF:000001; Amyloid beta A4 protein; 1.
DR Gene3D; 4.10.230.10; Amyloidogenic glycoprotein, amyloid-beta peptide; 1.
DR InterPro; IPR013803; Amyloid_glyco_Abeta.
DR InterPro; IPR037071; Amyloid_glyco_Abeta_sf.
DR Pfam; PF03494; Beta-APP; 1.
DR PRINTS; PR00204; BETAAMYLOID.
PE 2: Evidence at transcript level;
KW Amyloid {ECO:0000256|ARBA:ARBA00023087};
KW Cell membrane {ECO:0000256|ARBA:ARBA00022475};
KW Cell projection {ECO:0000256|ARBA:ARBA00023273};
KW Coated pit {ECO:0000256|ARBA:ARBA00023176};
KW Cytoplasmic vesicle {ECO:0000256|ARBA:ARBA00023329};
KW Endosome {ECO:0000256|ARBA:ARBA00022753};
KW Membrane {ECO:0000256|ARBA:ARBA00023136}.
FT DOMAIN 5..42
FT /note="Amyloidogenic glycoprotein amyloid-beta peptide"
FT /evidence="ECO:0000259|Pfam:PF03494"
FT NON_TER 1
FT /evidence="ECO:0000313|EMBL:AAX81918.1"
FT NON_TER 42
FT /evidence="ECO:0000313|EMBL:AAX81918.1"
SQ SEQUENCE 42 AA; 4514 MW; 3AC85563D7858C37 CRC64;
Query Match 100.0%; Score 217; Length 42;
Best Local Similarity 100.0%;
Matches 42; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DAEFRHDSGYEVHHQKLVFFAEDVGSNKGAIIGLMVGGVVIA 42
||||||||||||||||||||||||||||||||||||||||||
Db 1 DAEFRHDSGYEVHHQKLVFFAEDVGSNKGAIIGLMVGGVVIA 42
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.
Claims 39, 40, and 53 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yankner U.S. Patent 5,876,948 issued March 2, 1999.
For present claims 39, 40, and 53, Yankner teaches Ab40 (b1-40; SEQ ID NO: 69; two deletions in residues 29-42 of present SEQ ID NO: 1) and Ab43 (b amyloid residues 1-43; SEQ ID NO: 70; 100% identity and the same length as present SEQ ID NO: 1) and intracerebral injection (please refer to the entire specification particularly the abstract; Figure 3; columns 1-3, 6, Table 1).
Therefore, the teachings of Yankner anticipate the presently claimed pharmaceutical composition.
Claims 39, 40, and 47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krafft et al. U.S. Patent Application Publication 2007/0213512 published September 13, 2007.
For present claims 39, 40, and 47, Krafft et al. teach amyloid b peptides including amyloid b 1-40 (SEQ ID NOs: 59-62), 1-42 (SEQ ID NOs: 26-46), and 1-43 (SEQ ID NOs: 1-11) with 0-8 deletions; a variable sequence of SEQ ID NO: 65 wherein M35 is L, I, V, norvaline, or norleucine (please refer to the entire specification particularly the abstract; paragraphs 3-25, 28-41, 43-48, 50-55, 57; Tables 1-4).
Therefore, the teachings of Krafft et al. anticipate the presently claimed pharmaceutical composition.
Claims 39, 40, and 47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Delisa et al. WO 2008/089132 published July 24, 2008.
For present claims 39, 40, and 47, Delisa et al. teaches amyloid b peptides including Ab42 of present SEQ ID NO: 1; variants including substitutions, deletions, and insertions; fragments; and variants with a M35T substitution (please refer to the entire specification particularly the abstract; pages 2-10, 13, 14, 19, 20, 24, 36; Example 5; Figure 4d).
Therefore, the teachings of Delisa et al. anticipate the presently claimed pharmaceutical composition.
Claims 39, 40, 47, 48, and 51-53 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wetzel U.S. Patent Application Publication 2006/0079447 published April 13, 2006.
For present claims 39, 40, 47, 48, and 51-53, Wetzel teaches Ab peptides with proline scanning mutagenesis (i.e. residues 4-39 are individually mutated to protein; M35P), Ab(1-40), Ab(1-42), and Ab(1-43) wherein methionine at residue 25 is replaced with proline (i.e. M35P; present SEQ ID NO: 88) and oral, intravenous, subcutaneous, nasal, intramuscular, or intraperitoneal compositions wherein replacement of methionine at residue 25 with proline results in more amyloid fibril formation and less aggregate formation (please refer to the entire specification particularly the abstract; paragraphs 6-8, 11-13, 16, 24-26, 31, 32, 38, 40, 43-49, 60-62, 94, 95, 98, 117, Examples 1-5; Figures 6-8; Table 1; claims).
Therefore, the teachings of Wetzel anticipate the presently claimed pharmaceutical composition.
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.
Claims 39, 40, 47, 48, and 51-53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-57 of copending Application No. 19/510,666 in view of Wetzel U.S. Patent Application Publication 2006/0079447 published April 13, 2006.
Copending Application No. 19/510,666 claims Ab42 peptide analogues.
Wetzel teaches Ab peptides with proline scanning mutagenesis (i.e. residues 4-39 are individually mutated to protein; M35P), Ab(1-40), Ab(1-42), and Ab(1-43) wherein methionine at residue 25 is replaced with proline (i.e. M35P; present SEQ ID NO: 88) and oral, intravenous, subcutaneous, nasal, intramuscular, or intraperitoneal compositions wherein replacement of methionine at residue 25 with proline results in more amyloid fibril formation and less aggregate formation (please refer to the entire specification particularly the abstract; paragraphs 6-8, 11-13, 16, 24-26, 31, 32, 38, 40, 43-49, 60-62, 94, 95, 98, 117, Examples 1-5; Figures 6-8; Table 1; claims).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (M35P mutation results in less aggregation) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (M35 substitution) for another (M35P substitution) would have yielded predictable results (reduced aggregation) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (M35P mutagenesis; making compositions for various administration routes) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WO 00/42166 (SEQ ID NO: 70 Ab43 and SEQ ID NO: 72 Ab42)
U.S. Patent 6,136,548 (SEQ ID NO: 1 is present SEQ ID NO: 1 wherein deletions, insertions, additions, and substitutions are taught)
U.S. Patent Application Publication 2001/0016326 (SEQ ID NO: 2 – 100% identity and the same length as present SEQ ID NO: 1)
Future Communications
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER D STEELE whose telephone number is (571)272-5538. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
Prosecution Insights