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 September 10, 2026, is acknowledged.
Claims 1-12 are pending in this application.
Foreign Priority
4. Applicant claims foreign priority to CHINA 202211480053.9 (11/23/2022) and CHINA 202310368198.8 (04/07/2023). The certified copies have been received by the Office. However, certified English translations have not been provided. Therefore, the foreign priority dates have not been perfected. Thus, the effective filing date of instant application is 10/31/2023 until the foreign priority dates are perfected.
Restriction
5. Applicant's election with traverse of Invention 1 (claims 1 and 8-10) and elected “injection” as the species of the route of administration, and “intravenous injection” as the species of invention in the reply filed on September 10, 2026 is acknowledged. The traversal is on the ground(s) that the claims should be read in light of the specification. A person having ordinary skill in the art, reading the present specification as a whole, would not isolate or chop SEQ ID NO: 1 into random fragments. This is not found persuasive because although the claims have been amended to only read on the peptide comprising the full length of SEQ ID NO: 1, the lack of unity of invention was established at the time the restriction requirement was mailed. Therefore, Applicant’s arguments are moot.
The requirement is still deemed proper and is therefore made FINAL. Applicant indicates that claims 2-7 and 11-12 are withdrawn. Claims 2-7 and 11-12 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. A search was conducted on the SEQ ID NO: 1, and this appears to be free of prior art. However, claims have 35 U.S.C. 112 issues. Claims 1 and 8-10 are examined on the merits in this office action.
Objections
6. The abstract is objected to for the following minor informality:
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc.
In the instant case, the abstract recites, “The present invention relates to a polypeptide...” at line 1 of the abstract. Applicant should correct these informalities. See MPEP 608.01(b). For example, the abstract is recommended to be amended to recite, “ A polypeptide comprising SEQ ID NO: 1 and application…is described.”
7. The drawings are objected to because some of the drawings are hard to see (see for example, FIG. 2, FIG. 3). Additionally, some of the figures are missing the X- and Y-axes labels (see for example, FIG. 2, FIG. 3). Furthermore, FIG. 7 has the label 1 ug and this should be corrected to 1 mg. 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.
8. The specification is objected to for the following: At paragraphs [0030], [0048], [0051], [0053]-[0054], [0064] and so on recite ug and ul and um, and these should be corrected to mg and ml and mm.
9. 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, paragraphs [0053], [0061], [0064] of instant specification US 2025/0066425 disclose peptide sequence, but this is missing their sequence identifier. 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).
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.
10. Claims 1 and 8-10 are objected to for the following: Claim 1 recites, “A polypeptide, comprising the amino acid sequence as shown in SEQ ID NO. 1.” The claim has more than 1 period. A claim cannot have more than 1 period. Applicant is required to correct the sequence identifier as “SEQ ID NO: 1” to correct this error. Claims 8-10 are also objected to for being dependent from claim 1.
Rejections
U.S.C. 112(b)
11. 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.
12. Claims 9-10 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.
13. Claim 9 recites, “The anti-fibrosis drug according to claim 8, wherein the anti-fibrosis drug is a pharmaceutical preparation administered by injection, oral administration…or skin administration.” Claim 9 recites both products and methods (i.e., “administered by”). A claim can only claim a single invention. Because claim 10 depends from claim 9 without clarifying the point of confusion, claim 10 also must be rejected under 35 U.S.C. 112(b). Claims 9-10 have been interpreted as a product invention.
U.S.C. 112(d)
14. 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.
15. Claims 9-10 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.
16. Claim 9 recites, “The anti-fibrosis drug according to claim 8, wherein the anti-fibrosis drug is a pharmaceutical preparation administered by injection, oral administration…or skin administration.” Claim 9 depends from claim 8. Claim 8 recites, “An anti-fibrosis drug, comprising: the polypeptide according to claim 1, and a pharmaceutically acceptable carrier and/or an excipient.” Claim 9 recites a method of administering, an intended use. Therefore, claim 9 does not further limit the drug composition of instant claim 8. Claim 10 is also rejected under 35 U.S.C. 112(d) because claim 10 depends from claim 9. Applicant may overcome this rejection by amending the claims to recite the form of the drug, e.g., “drug is a pharmaceutical preparation in an oral, topical…form.”
CLOSEST ART
17. The closest art to instant SEQ ID NO: 1 is Silver et al (US 2015/0080296 or US Patent No. 9700071). Silver et al teach a 535 residue protein sequence that comprises the sequence RFQGQYFHSRQYKHPVGYEGK portion of instant SEQ ID NO: 1 (see residues 165-185). The sequence of Silver et al is missing the RKKRRQRR sequence at the N-terminal end. Additionally, Silver et al do not teach nor motivate one of ordinary skilled in the art to delete the residues 1-164 and residues 186-535 and add the sequence RKKRRQRR at the N-terminal end.
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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
9/21/2026
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