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 .
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Specifically, no sequence identification has been provided for the sequences presented on p.25, line 25 of the instant specification filed 02/24/2026.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
DETAILED ACTION
Status of Application/Election/Restrictions
Applicant’s election of Group I (claims 1-7, 14 and 25-26) and SEQ ID NO:1 in the reply filed on February 24, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 3, 5, 8-13 and 15-31 are canceled. Claims 32-42 are newly added. Claims 1-2, 4, 6-7, 14 and new claims 32-42 are pending in this application. Election was treated as without traverse in the reply filed on February 24, 2026.
Claims 1-2, 4, 6-7, 14 and 32-42 are under examination with respect to SEQ ID NO:1 in this office action.
Specification
The disclosure is objected to because of the following informalities: The use of the term “Agilent” “Xbridge” (p. 55-57), “Gilson” “Gemini” (p.56-57), “Neurobasal” (p.58-62; p.75); “FluoroBrite” (p. 76), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Appropriate correction is required.
Claim Objections
Claims 41-42 are objected to because of the following informalities: Claims 41-42 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only, and/or, cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims 41-42 have not been further treated on the merits.
Claim Rejections - 35 USC § 112
8. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 41-42 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 41-42 are of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 41-42 depend from claim 14 and also depend from claims 6 and 7 respectively, which does not further limit the subject matter of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112
9. 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 1-2, 4, 14, 32-35, 38, and 41-42 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
Claims 1-14 Claims 1-2, 4, 14, 32-35, 38, and 41-42 are drawn to a cyclic peptide or a salt thereof, wherein the cyclic peptide comprises an amino acid sequence of MTEPVEHEEDV (instant SEQ ID NO: 1), which includes fragments within SEQ ID NO:1.
The claims encompass a genus of cyclic peptides or salts thereof comprising fragments within instant SEQ ID NO:1.
Applicant has not disclosed sufficient species for the broad genus of cyclic peptide or salt thereof comprising an amino acid sequence of instant SEQ ID NO:1.
The specification only describes a cyclic peptide consisting of the amino acid sequence of instant SEQ ID NO:1 (P1) capable of activating CREB in cultured primary cortical neurons compared to a scrambled peptide, increasing survival increasing levels of BDNF, PGC1a and TFEB and AMPK in cultured wild type mouse cortical neurons compared to a scramble peptide and in wild type mice or R6/2 mice (figures 2-8; figures 14-19), clearing soluble mutated HTT in Huntington’s patient (HD)-derived fibroblasts (GM04719) compared to a healthy individual (GM01650E) (Figure 9) or TDP-43 ∆NLS-HEK293 cells (figure 25), increasing active mitochondrial mas in a cell model of HD (Q111) compared to the healthy cell (Q7) (Figure 10) or increasing neuronal branching, activation of CREB , lysosomal acidification in GRN-deficient neurons (Figures 26-27, 29).
However, the claims are not limited to the cyclic peptide or salt thereof set forth above but also encompass structurally and functionally undefined cyclic peptides or salts thereof comprising structurally and functionally undefined fragments within instant SEQ ID NO:1.
In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant is in possession of and what Applicant is claiming.
M.P.E.P. § 2163 instructs:
An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. . . .
An applicant may show possession of an invention by disclosure of drawings or structural chemical formulas that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole. . . .
An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.”
This standard has not been met in this case. From the specification, Applicant is in possession of a cyclic peptide or salt thereof consisting of the amino acid sequence of instant SEQ ID NO:1 (P1) for activating CREB in cultured primary cortical neurons compared to a scrambled peptide, increasing survival increasing levels of BDNF, PGC1a and TFEB and AMPK in cultured wild type mouse cortical neurons compared to a scramble peptide and in wild type mice or R6/2 mice, clearing soluble mutated HTT in Huntington’s patient (HD)-derived fibroblasts (GM04719) compared to a healthy individual (GM01650E) or in TDP-43 ∆NLS-HEK293 cells, increasing active mitochondrial mas in a cell model of HD (Q111) compared to the healthy cell (Q7), or increasing neuronal branching, activation of CREB or lysosomal acidification in GRN-deficient neurons.
However, Applicant is not in possession of other structurally and functionally undefined cyclic peptides or salts thereof comprising structurally and functionally undefined fragments within instant SEQ ID NO:1.
The specification provides no structural and functional relationship between the claimed genus of comprising structurally and functionally undefined fragments within instant SEQ ID NO:1 and the P1 peptide of instant SEQ ID NO:1 in activating CREB in cultured primary cortical neurons compared to a scrambled peptide, increasing survival increasing levels of BDNF, PGC1a and TFEB and AMPK in cultured wild type mouse cortical neurons compared to a scramble peptide and in wild type mice or R6/2 mice, clearing soluble mutated HTT in Huntington’s patient (HD)-derived fibroblasts (GM04719) compared to a healthy individual (GM01650E) or in TDP-43 ∆NLS-HEK293 cells, increasing active mitochondrial mas in a cell model of HD (Q111) compared to the healthy cell (Q7), or increasing neuronal branching, activation of CREB or lysosomal acidification in GRN-deficient neurons.
It is known that a single amino acid change on a molecule or protein can abolish the binding ability or activity of the molecule or protein. For example, a substitution of lysine residue by glutamic acid at position 118 of acidic fibroblast growth factor results in a substantial loss of its biological activity including the binding ability to heparin and its receptor (Burgess et al. J of Cell Bio. 1990, 111:2129-2138). Even if an active or binding site were identified in the specification, they may not be sufficient, as the ordinary artisan would not immediately recognize that an active or binding site must assume the proper three-dimensional configuration to be active because conformation is dependent upon surrounding residues; i.e. substitution of non-essential residues can often destroy activity. In addition to a core determinant sequence, the protein-protein interaction also relies on the flanking or noncontiguous residues (see p. 445 the second column, first paragraph, Pawson et al. 2003, Science 300:445-452). The optimal binding motif for a domain is not necessarily suitable for physiological or in vivo interaction. The predictive data always need to be validated by actual analyses in cells (see p. 445, the third column, second paragraph, Pawson et al. 2003, Science 300:445-452). Alaoui-lsmaili teaches that designing a mutein having predictable activities is difficult because of the complexity of the interactions between ligands and receptors (Alaoui-lsmaili et al., Cytokine Growth Factor Rev. 2009; 20:501-507). For example, given the complexity of BMP-BMP receptor interactions, it is difficult to design BMPs with improved affinity and/or specificity for one specific receptor. More importantly, predicting the in vivo biological activity of such altered BMPs remains a challenging undertaking (see p. 502, right col., 2th paragraph). Further, when multiple mutations are introduced, there is even less predictability because Guo et al. teaches that the effects of mutations on protein function are largely additive (see p. 9207, left col., 2th paragraph, Guo et al., PNAS 2004; 101:9205-9210).
Applicant fails to teach what other structures/amino acid sequences can or cannot be included/changed in all cyclic peptides or salts thereof comprising structurally and functionally undefined fragments within instant SEQ ID NO:1 to preserve the activity of P1 peptide consisting of the amino acid sequence of instant SEQ ID NO:1 in activating CREB in cultured primary cortical neurons compared to a scrambled peptide, increasing survival increasing levels of BDNF, PGC1a and TFEB and AMPK in cultured wild type mouse cortical neurons compared to a scramble peptide and in wild type mice or R6/2 mice, clearing soluble mutated HTT in Huntington’s patient (HD)-derived fibroblasts (GM04719) compared to a healthy individual (GM01650E) or in TDP-43 ∆NLS-HEK293 cells, increasing active mitochondrial mas in a cell model of HD (Q111) compared to the healthy cell (Q7), or increasing neuronal branching, activation of CREB or lysosomal acidification in GRN-deficient neurons.
The specification provides no identification of any particular portion of the structure that must be conserved. The instant specification fails to provide sufficient descriptive information, such as definitive structural or functional features of the claimed genus of other cyclic peptides or salts thereof comprising structurally and functionally undefined fragments within instant SEQ ID NO:1. There is no description of the conserved regions which are critical to the function of the genus claimed. There is no description of the sites at which variability may be tolerated and there is no information regarding the relation of structure of other structurally and functionally undefined cyclic peptides or salts thereof comprising structurally and functionally undefined fragments within instant SEQ ID NO:1 to the function of the cyclic peptide consisting of the amino acid sequence of instant SEQ ID NO:1.
Furthermore, the prior art does not provide compensatory structural or correlative teachings sufficient to enable one of skill to identify what other structurally and functionally undefined cyclic peptides or salts thereof comprising structurally and functionally undefined fragments within instant SEQ ID NO:1 might be. Since the common characteristics/features of other structurally and functionally undefined cyclic peptides or salts thereof comprising structurally and functionally undefined fragments within instant SEQ ID NO:1 are unknown, a skilled artisan cannot envision the functional correlations of the genus with the claimed invention. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the genus of cyclic peptides or salts thereof comprising fragments within instant SEQ ID NO:1.
Based on MPEP § 2161.01 and §2163, “to satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116”.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of cyclic peptides or salts thereof comprising fragments within instant SEQ ID NO:1, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483.
Therefore, the claimed cyclic peptide or salt thereof comprising an amino acid sequence of instant SEQ ID NO:1 has not met the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115). Applicant is directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, ¶ 1 "Written Description" Requirement. See MPEP § 2161.01 and 2163.
Double Patenting
10. 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 1-2, 4, 14, 32-35, 38, and 41-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12240921 (the ‘921 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the cyclic peptide or salt thereof recited in claims of the ‘921 patent anticipates the cyclic or salt recited in the claims of the instant Application.
Claims 1-2, 4, 14, 32-35, 38, and 41-42 of the instant application claim a cyclic peptide comprising an amino acid sequence of MTEPVEHEEDV (instant SEQ ID NO: 1), which includes fragments within SEQ ID NO:1.
Claims 1-11 of the ‘921 patent claims a cyclic lipidated peptide or a salt thereof, and a pharmaceutical composition comprising the cyclic lipidated peptide or the pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier, wherein the lipidated peptide comprises the structure of
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258
418
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. The cyclic peptide or salt thereof recited in the claims of the ‘921 patent comprises the sequence of TEQIEHEED, which meets the limitation “comprises an amino acid sequence “EHEEDV” of instant SEQ ID NO:1” recited in instant claim 1 and no more than 14 amino acid residues. Therefore, claims 1-2, 4, 14, 32-35, 38, and 41-42 of the instant Application are not patentably distinct from claims 1-11 of the ‘921 patent, because claims 1-2, 4, 14, 32-35, 38, and 41-42 of the instant Application are anticipated by claims 1-11 of the ‘921 patent.
The sequence search results disclose as follows:
SEQ ID NO:1
US-18-660-504-36
Sequence 36, US/18660504
Patent No. 12240921
GENERAL INFORMATION
APPLICANT: TEITUR TROPHICS APS (en)
TITLE OF INVENTION: NOVEL PEPTIDES (en)
FILE REFERENCE: 119744-5032-US_Sequence_Listing
CURRENT APPLICATION NUMBER: US/18/660,504
CURRENT FILING DATE: 2024-05-10
NUMBER OF SEQ ID NOS: 63
SEQ ID NO 36
LENGTH: 11
TYPE: PRT
FEATURE:
NAME/KEY: REGION
LOCATION: 1..11
QUALIFIERS: note = Cyclic peptide
FEATURE:
NAME/KEY: source
LOCATION: 1..11
QUALIFIERS: mol_type = protein
organism = synthetic construct
Query Match 54.5%; Score 6; Length 11;
Best Local Similarity 100.0%;
Matches 6; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 6 EHEEDV 11
||||||
Db 6 EHEEDV 11
Double Patenting
11. Claims 1-2, 4, 14, 32-35, 38, and 41-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 48-60 of copending Application No.18943186 (the ‘186 Application) or claims 25-48 of copending Application No.19511216 (the 216 Application). Although the claims at issue are not identical, they are not patentably distinct from each other because the cyclic peptide or salt thereof recited in claims of the ‘186 Application or the ‘216 Application anticipates the cyclic or salt recited in the claims of the instant Application.
. Claims 48-60 of the ‘186 Application) claims a cyclic lipidated peptide or a salt thereof, wherein the cyclic lipidated peptide comprises SEQ ID NO:10 and wherein the peptide is backbone cyclized and all residues of the peptide backbone are joined exclusively by peptide bonds. The cyclic peptide or salt thereof recited in the claims of the ‘186 Application comprises the sequence of MTEKIEHEED, which meets the limitation “comprises an amino acid sequence “EHEEDV” of instant SEQ ID NO:1” recited in instant claim 1 and no more than 14 amino acid residues. Therefore, claims 1-2, 4, 14, 32-35, 38, and 41-42 of the instant Application are not patentably distinct from claims 48-60 of the ‘186 Application, because claims 1-2, 4, 14, 32-35, 38, and 41-42 of the instant Application are anticipated by claims 48-60 of the ‘186 Application.
Claims 25-48 of the ‘216 Application claims a method for treatment or prophylaxis of a disease or disorder of the ear or mastoid process in a subject, comprising administration of a peptide or a pharmaceutically acceptable salt thereof, wherein the peptide is a lipidated cyclic peptide comprising SEQ ID NO:51 with residues recited in claim 25 or a cyclic peptide comprising SEQ ID NO:51 with residues recited in claim 25. The cyclic peptide or salt thereof recited in the claims of the ‘216 Application the cyclic peptide or salt thereof comprising instant SEQ ID NO:1 recited in instant claims, which anticipates instant claims. In addition, the cyclic peptide or salt thereof recited in the claims of the ‘216 Application includes different sequences that comprises an amino acid sequence “EHEEDV” of instant SEQ ID NO:1” recited in instant claim 1 and no more than 14 amino acid residues. Therefore, claims 1-2, 4, 14, 32-35, 38, and 41-42 of the instant Application are not patentably distinct from claims 25-48 of the ‘216 Application, because claims 1-2, 4, 14, 32-35, 38, and 41-42 of the instant Application are anticipated by claims 25-48 of the ‘216 Application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The sequence search results disclose as follows:
SEQ ID NO:1
Sequence 10, US/18943186
Publication No. US20250333444A1
GENERAL INFORMATION
APPLICANT: TEITUR TROPHICS APS (en)
TITLE OF INVENTION: NOVEL PEPTIDES (en)
FILE REFERENCE: 119744-5032-US01_Sequence_Listing
CURRENT APPLICATION NUMBER: US/18/943,186
CURRENT FILING DATE: 2024-11-11
NUMBER OF SEQ ID NOS: 63
SEQ ID NO 10
LENGTH: 11
TYPE: PRT
FEATURE:
NAME/KEY: REGION
LOCATION: 1..11
QUALIFIERS: note = Lipidated cyclic peptide
FEATURE:
NAME/KEY: LIPID
LOCATION: 4
QUALIFIERS: note = C18DA-yGlu-OEG-OEG-
FEATURE:
NAME/KEY: source
LOCATION: 1..11
QUALIFIERS: mol_type = protein
organism = synthetic construct
Query Match 54.5%; Score 6; Length 11;
Best Local Similarity 100.0%;
Matches 6; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 6 EHEEDV 11
||||||
Db 6 EHEEDV 11
SEQ ID NO:1
Sequence 36, US/18943186
Publication No. US20250333444A1
GENERAL INFORMATION
APPLICANT: TEITUR TROPHICS APS (en)
TITLE OF INVENTION: NOVEL PEPTIDES (en)
FILE REFERENCE: 119744-5032-US01_Sequence_Listing
CURRENT APPLICATION NUMBER: US/18/943,186
CURRENT FILING DATE: 2024-11-11
NUMBER OF SEQ ID NOS: 63
SEQ ID NO 36
LENGTH: 11
TYPE: PRT
FEATURE:
NAME/KEY: REGION
LOCATION: 1..11
QUALIFIERS: note = Cyclic peptide
FEATURE:
NAME/KEY: source
LOCATION: 1..11
QUALIFIERS: mol_type = protein
organism = synthetic construct
Query Match 54.5%; Score 6; Length 11;
Best Local Similarity 100.0%;
Matches 6; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 6 EHEEDV 11
||||||
Db 6 EHEEDV 11
Conclusion
Allowable Subject Matter
12. Claims 6-7, 36-37 and 39-40 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.
13. Claims 1-2, 4, 14, 32-35, 38, and 41-42 are rejected.
Sequence alignment
SEQ ID NO:1 1 MTEPVEHEEDV 11
SEQ ID NO:2 1 MTDPVDHDEDV 11
SEQ ID NO:3 1 MTAPVAHAEDV 11
SEQ ID NO:4 1 MIEPVEHEESR 11
SEQ ID NO:5 1 MIDPVDHDESR 11
SEQ ID NO:6 1 MIGSVEQEENA 11
SEQ ID NO:7 1 MIGSVDQDENA 11
14. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WO2019191571 teaches a peptide comprising an amino acid sequence of instant SEQ ID NO:1 (see the sequence alignment below).
SEQ ID NO:1
BGU29466
(NOTE: this sequence has 3 duplicates in the database searched)
ID BGU29466 standard; peptide; 39 AA.
XX
AC BGU29466;
XX
DT 14-NOV-2019 (first entry)
XX
DE Brevundimonas sp. lasso precursor peptide, SEQ 1156.
XX
KW LPP protein; lasso precursor peptide; peptide library;
KW protein production; screening.
XX
OS Brevundimonas sp.
XX
CC PN WO2019191571-A1.
XX
CC PD 03-OCT-2019.
XX
CC PF 29-MAR-2019; 2019WO-US024811.
XX
PR 30-MAR-2018; 2018US-0651028P.
PR 03-APR-2018; 2018US-0652213P.
XX
CC PA (LASS-) LASSOGEN INC.
XX
CC PI Burk MJ, Chen IB;
XX
DR WPI; 2019-837083/81.
DR N-PSDB; BGU29465.
XX
CC PT Producing and screening of one or more lasso peptides or one or more
CC PT lasso peptide analogs or their combination using a cell-free biosynthesis
CC PT reaction mixture, comprises combining and contacting one or more lasso
CC PT precursor peptides.
XX
CC PS Claim 6; SEQ ID NO 1156; 261pp; English.
XX
CC The present invention relates to a method for producing and screening
CC lasso peptides (LPs), lasso peptide analogs or their combination using a
CC cell -free biosynthesis (CFB) reaction mixture. The method involves: (a)
CC combining and contacting one or more lasso precursor peptides (LPP) of
CC SEQ ID NO:1-2630 (see BGU28311-BGU30940, only even number), one or more
CC lasso core peptide (LCP), or their combination, with a lasso cyclase
CC (LCase) enzyme, and optionally with a lasso peptidase (LPase) enzyme when
CC the one or more LPP is present, in a CFB reaction mixture; (b)
CC synthesizing the one or more lasso peptides or LP analogs in the CFB
CC reaction mixture; and (c) optionally screening the one or more lasso
CC peptides or LP analogs for one or more desired properties or activities
CC by screening the CFB reaction mixture, or screening the partially
CC purified or substantially purified lasso peptide or LP analog. The
CC invention also provides: a lasso peptide library, a LP analog library or
CC a combination; a CFB reaction mixture useful for the synthesis of lasso
CC peptides and lasso peptide analogs; a kit for the production of lasso
CC peptides and/or lasso peptide analogs; and a lasso cyclase library, which
CC comprises two lasso cyclases, where the lasso cyclases are encoded by
CC genes of a same organism or encoded by genes of different organism.
XX
SQ Sequence 39 AA;
Query Match 54.5%; Score 6; Length 39;
Best Local Similarity 100.0%;
Matches 6; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 4 PVEHEE 9
||||||
Db 27 PVEHEE 32
WO2017132550 teaches a peptide comprising an amino acid sequence of instant SEQ ID NO:1 (see the sequence alignment below).
BEE66375
ID BEE66375 standard; protein; 56 AA.
XX
AC BEE66375;
XX
DT 21-SEP-2017 (first entry)
XX
DE Human adenovirus B peptide SEQ: 3997.
XX
KW antibody detection; bacterial infection; diagnostic test;
KW fungal infection; immuno-diagnosis; microorganism detection;
KW vaccine, general; viral infection.
XX
OS Human adenovirus B.
XX
CC PN WO2017132550-A1.
XX
CC PD 03-AUG-2017.
XX
CC PF 27-JAN-2017; 2017WO-US015411.
XX
PR 28-JAN-2016; 2016US-0288011P.
XX
CC PA (BGHM ) BRIGHAM & WOMENS HOSPITAL INC.
CC PA (HARD ) HARVARD COLLEGE.
XX
CC PI Elledge SJ, Larman HB, Kula T, Xu G;
XX
DR WPI; 2017-52715F/55.
XX
CC PT Detecting antibody against pathogen in subject involves contacting
CC PT reaction sample comprising display library with biological sample
CC PT comprising antibodies, and detecting peptide bound to antibody.
XX
CC PS Example 9; SEQ ID NO 3997; 243pp; English.
XX
CC The present invention relates to a novel method for detecting an antibody
CC against a pathogen (viruses, bacteria or fungi) in a subject. The method
CC comprises contacting a reaction sample comprising a display library with
CC a biological sample comprising antibodies, and detecting a peptide bound
CC to at least one antibody. The invention claims: (a) a method for
CC identifying a pathogen associated with a disease; (b) a method for
CC improving vaccine design; and (c) a phage library displaying a plurality
CC of viral peptides. The present sequence represents a C4L peptide that
CC shares an eight amino acid sequence with the Clumping Factor B protein
CC from Staphylococcus aureus, useful to generate antibodies. The present
CC sequence represents an exemplary high confidence viral peptide containing
CC epitope that can bind antibodies generated by a subject in response to
CC the virus.
XX
SQ Sequence 56 AA;
Query Match 54.5%; Score 6; Length 56;
Best Local Similarity 100.0%;
Matches 6; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 4 PVEHEE 9
||||||
Db 45 PVEHEE 50
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANG-YU WANG whose telephone number is (571)272-4521. The examiner can normally be reached Monday-Thursday, 7:00am-5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Chang-Yu Wang
June 12, 2026
/CHANG-YU WANG/Primary Examiner, Art Unit 1675
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