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 .
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, 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 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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 statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.831-1.834 because it does not contain a “Sequence Listing XML” as a separate part of the disclosure. A “Sequence Listing XML” is required because this application was filed on November 9, 2022, which is after July 1, 2022, and recites the amino acid sequence Leu-Leu-Phe-Thr-Thr-Gln. To facilitate compact prosecution, a search was conducted using the sequence listing in parent application 17/033,742. However, Applicant must comply with the formal requirements of ST.26.
Required response - Applicant must provide:
• A “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2.; together with
o A statement that indicates the basis for the amendment, with specific references to particular parts of the application as originally filed, as required by 37 CFR 1.835(a)(3);
o A statement that the “Sequence Listing XML” includes no new matter as required by 37 CFR 1.835(a)(4)
AND
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(a)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
o A statement that the substitute specification contains no new matter.
Claim Objections
Claims 1-3 are objected to because of minor grammatical errors. Appropriate correction is required. A proposed amendment is:
1. A liquid bandage containing a peptide anti-inflammatory active ingredient, comprising:
one or more film-forming agents;
one or more plasticizers, comprising glycerin;
one or more anti-inflammatory substances, comprising an oligopeptide with an amino acid sequence of Leu-Leu-Phe-Thr-Thr-Gln (SEQ ID NO.1); and
solvent, comprising deionized water.
2. The liquid bandage according to claim 1, wherein the film-forming agents comprise[[ing]]: polyvinyl alcohol, and modified chitosan.
3. The liquid bandage according to claim 2, wherein the modified chitosan is[[being]] hydroxycinnamic acid modified chitosan, and has dihydroxycoumarin grafted on the hydroxycinnamic acid modified chitosan.
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 4 and 6-10 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.
Claim 4 appears to be a product-by-process claim. However, grammatical errors in the claim make it unclear how the method steps recited in the claim limit the liquid bandage. A proposed amendment is as follows:
4. The liquid bandage according to claim 3, wherein the chitosan is modified by a method comprising the steps:
1) adding dimethyl sulfoxide into chitosan, stirring, then slowly dropping alkaline solution into the chitosan, and alkalinizing the chitosan for 1.8-2.2 h by stirring;
2) dissolving hydroxycinnamic acid in dimethyl sulfoxide, slowly dropping the dissolved hydroxycinnamic acid into the solution prepared in step 1) while stirring continuously during dropping[[;]] and then reacting the resulting solution at 58-62 0C for 5.5-6 h;
3) cooling the reaction prepared in step 2), and performing suction filtrationthe filtrate with deionized water, absolute ethanol and acetone in sequence, and drying the washed filtrate to obtain hydroxycinnamic acid modified chitosan.
Claim 6 appears to be a method. However, grammatical errors in the claim make it unclear which active method steps are required. A proposed amendment is as follows:
6. A method for preparing the liquid bandage according to claim 1, the method comprising the steps
dissolving the film-forming agent in the solvent,
stirring until the film-forming agent is completely dissolved,
adding oligopeptide,
adding plasticizer, and
stirring evenly to obtain the liquid bandage;
wherein based on weight, the liquid bandage[[s]] comprises[[ing]] 50-70 parts of film-forming agent, 1-1.2 parts of oligopeptide, 80-90 parts of plasticizer, and 150-200 parts of solvent
The term “natural” in claim 7 is a relative term which renders the claim indefinite. The term “natural” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear whether the claim requires that the method include steps of isolating the oligopeptide from a natural source or also includes using oligopeptides having a naturally-occurring sequence made by chemical synthesis.
Claim 8 is indefinite because it is not clear whether the claim requires an active method step of preparing the oligopeptide from tuna scraps prior to adding it to the dissolved film-forming agent. A proposed amendment is as follows:
8. The method according to claim 6[[7]], wherein the method further comprises preparing the oligopeptide from
Claim 9 appears to be a method. However, grammatical errors in the claim make it unclear which active method steps are required. A proposed amendment is as follows:
9, The method according to claim 8, wherein es[[ing]] the steps:
first hydrolyzing tuna protein with pepsin;
second hydrolyzing the pepsin hydrolysate with flavor protease;
s; and
isolating and purifying the oligopeptide.
A proposed amendment to claim 10 is as follows:
10. The method according to claim 9, wherein the aromatic amino acids are [[is]] removed by using activated carbon.
Allowable Subject Matter
Claim 5 is objected to as depending on an objected to claim.
Claims 1-10 would be allowable if rewritten or amended to overcome the objections to the claims and the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
CN 103006923 B discloses a liquid bandage but does not teach or suggest an oligopeptide of SEQ ID NO: 1.
CN 109045274 A teaches a peptide of SEQ ID NO: 1 and its use to treat ulcerative colitis (abstract). CN 109045274 A does not teach the peptide as an active agent in a composition comprising a film-forming agent, plasticizer and solvent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA MARCHETTI BRADLEY whose telephone number is (571)272-9044. The examiner can normally be reached Monday-Friday, 7 am - 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G 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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/CHRISTINA BRADLEY/Primary Examiner, Art Unit 1654