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 .
Response to Election/Restriction filed on March 17, 2026 is acknowledged.
Claims 1-12 are pending in this application.
Sequence Non-Compliant
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).
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.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, 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.
Specific deficiency - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
The sequence disclosures are located at FIG. 1, FIG. 2, paragraph [0060] of instant specification US 2023/0414701.
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, 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;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
Priority
4. Applicant claims foreign priority to KOREA 10-2020-0074556 (6/18/2020) and KOREA 10-2021-0079219 (6/18/2021). The certified copies have been received by the Office. However, a certified English translations have not been provided. Therefore, the foreign priority dates have not been perfected. Thus, the effective priority of instant application is 6/18/2021 until the foreign priority dates are perfected.
Restriction
5. Applicant’s election without traverse of Group 1 (claims 1-6) and the election of Alzheimer’s disease as the species of cognitive dysfunction, and a modified peptide having an acetylated N-terminus and an amidated C-terminus as the species of modification in the reply filed on March 17, 2026 is acknowledged. Restriction is deemed to be proper and is made FINAL in this office action. Claims 7-12 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected invention, there being no allowable generic or linking claim. Claims 1-6 are examined on the merits in this office action.
Objections
6. The specification is objected to for containing referring to sequences without also identifying them by the sequence identifier assigned to them in the sequence listing as required by 37 CFR 1.821(d). The specification discloses peptide sequences, and these are missing their respective sequence identifiers. For example, FIG. 1, FIG. 2 and paragraph [0060] of instant specification US 2023/0414701 disclose peptide sequences, but these are missing their sequence identifiers. The examiner would like to bring the applicant’s attention to the following excerpt from MPEP §2422.03:
37 CFR 1.821(d) requires the use of the assigned sequence identifier in all instances where the description or claims of a patent application discuss sequences regardless of whether a given sequence is also embedded in the text of the description or claims of an application. This requirement is also intended to permit references, in both the description and claims, to sequences set forth in the "Sequence Listing" by the use of assigned sequence identifiers without repeating the sequence in the text of the description or claims. Sequence identifiers can also be used to discuss and/or claim parts or fragments of a properly presented sequence. For example, language such as "residues 14 to 243 of SEQ ID NO:23" is permissible and the fragment need not be separately presented in the "Sequence Listing." Where a sequence is embedded in the text of an application, it must be presented in a manner that complies with the requirements of the sequence rules.
The applicant is therefore required to amend the specification to comply with 37 CFR 1.821(d).
7. The drawings are objected to because the drawings have shadings that make the figures unclear (please see FIG. 1, FIG. 2A, and FIG. 2B). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Rejections
U.S.C. 112(b)
8. 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.
9. Claims 1-6 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.
10. Claim 1 recites, “A method of preventing or treating cognitive dysfunction in a subject in need thereof, comprising administering a pharmaceutical composition comprising a peptide represented by the amino acid sequence of SEQ ID NO: 1 as an active ingredient.” The metes and bounds of the claim is unclear. The instant specification appears to indicate that SEQ ID NO: 1 has the sequence PFTAIRE (see FIG. 1, FIG. 2, and Figure descriptions:
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). FIG. 1 has the following:
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. The figures and the description indicate that SEQ ID NO: 1 has the sequence PFTAIRE. However, the instant SEQ ID NO: 1 according to the sequence listing is as follows:
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. Thus, when instant SEQ ID NO: 1 (i.e., TFEAIRE) is searched, this would not lead to the sequence PFTAIRE. Therefore, the metes and bounds of the claim is unclear. Because claims 2-6 depend from indefinite claim 1 without clarifying the point of confusion, these claims are also rejected under 35 U.S.C. 112(b).
11. Claim 3 recites, “The method of claim 1, wherein any one or more of the N- and C-termini of the peptide are modified.” The metes and bounds of the claim is unclear. If is unclear what is meant by “any one or more of the N- and C-termini of the peptide”. Claim 3 depends from claim 1. Claim 1 recites a single amino acid sequence, i.e., SEQ ID NO: 1. SEQ ID NO: 1 is a 7 residue peptide sequence. It is unclear what “any one or more” is referring to in relation to SEQ ID NO: 1. Because claims 4 and 5 depend from indefinite claim 3, these claims are also rejected under 35 U.S.C. 112(b).
12. Claim 5 recites, “The method of claim 3, wherein a peptide with the modified N- and C-termini among peptides is formed in a cyclic shape due to bonding between the N- and C-termini by an amide bond.” It is unclear what “a peptide with the modified N- and C-termini among peptides” is referring to. Additionally, it is unclear how a peptide with both N- and C-terminal modifications can form a cyclic shape. From the Figure 2B, the cyclic peptide is formed by non-modified peptide sequence:
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(see FIG. 2B). Please note: the recitation of the claim is also indefinite. For example, the recitation of “wherein a peptide with the modified N- and C-termini among peptides is formed in a cyclic shape due to bonding between the N- and C-termini by an amide bond” is indefinite.
U.S.C. 112(d)
13. 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 pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
14. Claims 3-5 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. 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.
15. Claim 3 recites, “The method of claim 1, wherein any one or more of the N- and C-terminal of the peptide are modified.” Claim 3 depends from claim 1. Claim 1 recites, “A method of preventing or treating cognitive dysfunction in a subject in need thereof, comprising administering a pharmaceutical composition comprising a peptide represented by the amino acid sequence of SEQ ID NO: 1 as an active ingredient.” Claim 1 is drawn to a method of preventing or treating. Claim 3 does not further limit the method claim of claim 1 because claim 3 does not recite any active method steps.
16. Claim 4 recites, “The method of claim 3, wherein the modification is acetylation or amidation.” Claim 4 depends from claim 3, which depends from claim 1. Claim 4 does not further limit the method steps of instant claims 3 and 1, because claim 4 does not recite any active method steps.
17. Claim 5 recites, “The method of claim 3, wherein a peptide with the modified N- and C-terminal among peptides is formed in a cyclic shape due to bonding between the N- and C-termini by an amide bond.” Claim 5 depends from claim 3, which depends from claim 1. Claim 5 does not further limit the method steps of instant claims 3 and 1, because claim 5 does not recite any active method steps.
U.S.C. 112(a)
18. 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.
19. Claims 1-6 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 treating certain cognitive dysfunction, does not reasonably provide enablement for prevention of ALL cognitive dysfunction including Alzheimer’s disease, Parkinson’s disease, ALS, Huntington’s disease and so forth. 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.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: (1) the nature or the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. When the above factors are weighed, it is the examiner’s position that one skilled in the art could not practice the invention without undue experimentation.
(1) The nature of the invention and (5) The breadth of the claims:
Claims are drawn to a method of preventing or treating cognitive dysfunction in a subject in need thereof, comprising administering a pharmaceutical composition comprising a peptide represented by the amino acid sequence of SEQ ID NO: 1 as an active ingredient. Dependent claim defines that the cognitive dysfunction is selected from the group consisting of Alzheimer’s disease, cerebrovascular dementia, Pick’s disease, Creutzfeldt-Jacob disease, dementia caused by a head injury, Parkinson’s disease, amyotrophic lateral sclerosis, and Huntington’s disease.
(2) The state of the prior art:
In regards to “preventing cognitive dysfunction”, it is well known in the art that Alzheimer’s disease (AD) causes progressive cognitive deterioration and is characterized by beta-amyloid deposits and neurofibrillary tangles in the cerebral cortex and subcortical gray matter (see “Alzheimer Disease”, Merck Manual, pp. 1-14). The Merck manual indicates Alzheimer disease is sporadic (see p. 2 of “Alzheimer Disease” Merck Manual). The Merck Manual indicates that “distinguishing Alzheimer disease from other dementias is difficult (see pp. 6-9 “Alzheimer Disease” Merck Manual). The Merck Manual indicates symptomatic treatment and disease-modifying treatment (see pp. 10-11 “Alzheimer Disease” Merck Manual).
In regards to “preventing Creutzfeldt-Jacob disease”, the Merck Manual indicates that Creutzfeldt-Jakob disease (CJD) is the most common human prion disease…CJD symptoms include dementia, myoclonus and other central nervous system deficits; death usually occurs between 4 months and 2 years after onset, depending on the CJD form and subtype (see “Creutzfeldt-Jakob Disease (CJD)” from Merck Manual, pp. 1-7). The Merck Manual indicates:
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(see p. 3 “Creutzfeldt-Jakob Disease (CJD)” from Merck Manual). The Merck Manual indicates:
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(see pp. 5-6 “Creutzfeldt-Jakob Disease (CJD)” from Merck Manual). The Merck Manual indicates that there is no effective treatment. Therefore, there is no cure for CJD.
In regards to “preventing amyotrophic lateral sclerosis (ALS)” the Merck Manual indicates that ALS and other motor neuron diseases are characterized by steady, relentless, progressive degeneration of corticospinal tracts, anterior horn cells, bulbar motor nuclei or combination…treatment is supportive (see “Amyotrophic Lateral Sclerosis (ALS) and Other Motor Neuron Diseases (MNDs)” from Merck Manual, pp. 1-8). The Merck Manual indicates
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(see p. 3 “Amyotrophic Lateral Sclerosis (ALS) and Other Motor Neuron Diseases (MNDs)” from Merck Manual). The Merck Manual indicates that “No medication offers a substantial clinical benefit for patients with ALS” (see p. 7, “Amyotrophic Lateral Sclerosis (ALS) and Other Motor Neuron Diseases (MNDs)” from Merck Manual).
The art provide guidance in treating and providing support for the patients with these cognitive dysfunction. However, the art indicates that there are no treatment and/or cure for certain cognitive diseases such as ALS, CJD and AD.
(3) The relative skill of those in the art:
The relative skill of those in the art is high.
(4) The predictability or unpredictability of the art:
Applicant’s activity is based on the determination of predicting those who are susceptible to ALL cognitive dysfunction, such as Alzheimer’s disease (AD), Creutzfeldt-Jakob disease (CJD), and amyotrophic lateral sclerosis (ALS). Since the activity is based on determining the patient population that is susceptible to AD, CJD, ALS, the predictability in the art is low. This is due to the fact that the art has recognized the difficulty in determining the patient population who are susceptible to AD, CJD and ALS.
(6) The amount of direction or guidance presented and (7) The presence or absence of working examples:
The working Example 4 describes the analysis of binding capacity of peptide to Cyclin Y (CCNY) using ELISA. The working Example 5 describes the following:
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(see paragraphs [0073]-[0074]). The working Example 6 describes the improvement of cognitive function by the administering SEQ ID NO: 1 in mouse models. Although the specification provides guidance improving the cognitive function of cells and in mouse models, the specification has not provided any guidance in preventing ALL cognitive dysfunction and the dosage and time the pharmaceutical composition is administered for preventing the ALL cognitive dysfunction. Additionally, it is unclear as when to administer the pharmaceutical composition. The working examples are limited to brain tissue and mouse models, as well as ELISA system, to measure the improvement in cognitive function.
The specification has not provided guidance in the way of a disclosure as how to determine individuals that need protection against ALL cognitive dysfunction, including Alzheimer’s disease (AD), Creutzfeldt-Jakob disease (CJD), and amyotrophic lateral sclerosis (ALS). Since the prior art indicates that cognitive dysfunction, such as Alzheimer’s disease (AD), Creutzfeldt-Jakob disease (CJD), and amyotrophic lateral sclerosis (ALS) cannot be prevented, and there is no cure for these diseases, more guidance is necessary.
(8) The quantity of experimentation necessary:
Since it is uncertain to predict the patient population who are susceptible for cognitive dysfunctions such as AD, CJD and ALS, and the Applicant has not provided the appropriate time frame at which the compound should be administered, one of ordinary skill in the art would be burdened with undue “painstaking experimentation study” to determine if the SEQ ID NO: 1 would be effective in protecting a mammal against ALL cognitive dysfunction, such as AD, CJD, and ALS.
CLOSEST ART
20. Instant SEQ ID NO: 1 is known in the art. For example, Choi et al (US 2023/0303979) teach instant SEQ ID NO: 1 (see SEQ ID NO: 1). Choi et al do not teach a method of preventing or treating cognitive dysfunction in a subject in need thereof comprising administering a pharmaceutical composition comprising a peptide represented by the amino acid sequence of SEQ ID NO: 1 as an active ingredient.
CONCLUSION
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm 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, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIE HA/Primary Examiner, Art Unit 1654
5/7/2026
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