DETAILED ACTION
Status of the Application
Claims 1-18 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election with traverse of Group II, claims 10-11, drawn in part to a carboxylated silk fibroin, wherein a hydroxyl group of serine and/or tyrosine of the silk fibroin react with a dicarboxylic anhydride.in a communication filed on 05/18/2026 is acknowledged. Applicant’s species election without traverse of succinic anhydride as the dicarboxylic anhydride corresponding to claim 3, dimethyl sulfoxide as the solvent corresponding to claim 6 and ethylene as the R’ corresponding to claim 11 in a communication filed on 05/18/2026 is acknowledged.
Applicant’s traverse is on the grounds that the carboxylated silk fibroin of the present claims differs structurally from the carboxylated silk fibroin of Burke et al. In particular, the carboxylated silk fibroin of the present application has the following structure:
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, see claim 10, whereas the carboxylated silk fibroin of Burke et al. has a different structure:
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see the carboxylated serine in Figure 1 of Burke et al. Therefore, Applicant respectfully submits that the carboxylated silk fibroin of the present application constitutes a special technical feature distinguishing it from the prior art, and the groups of inventions identified by the examiner are so linked as to form a single general inventive concept. As such, Applicant respectfully requests a withdrawal of the present lack of unity rejection. However, Li et al. teaches a carboxylated silk fibroin, wherein the phenolic hydroxyl groups of tyrosine are reacted with succinic anhydride and the acylation reactions are provided in Figure 1 (see below) which does not differ in structure from the carboxylated silk fibroin of claim 10, so it does not qualify as a special technical feature under PCT Rule 13.2. The requirement is deemed proper and therefore is made FINAL.
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Claims 1-9 and 12-18 are withdrawn from further consideration pursuant to 37 CFR
1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on 05/18/2026.
Claims 10-11 are under consideration and are being examined herein.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119
(a)-(d). The certified copy has been filed in parent Application No. CN202110625401.6, filed on
06/04/2021. The instant application is a 371 national stage application of PCT/CN2022/093191
filled on 05/18/2022).
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 12/04/2023 and 05/18/2026 are
acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112(b)
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 11 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 11 is indefinite in the recitation of “ethylene” and “propylene” for the following reasons. “Ethylene” has the known structure of the alkene CH2=CH2 (gas) and “ethylene group” is known in the field to have the structure -CH2-CH2- as a structural bridge inside a larger molecule. It is unclear if the claim requires the structure to be the known structure of “ethylene” or the structure of an “ethylene group” as the term “ethylene” is not defined in the specification. “Propylene” has the known structure of the alkene CH2=CH-CH3 (gas) and “propylene group” is known in the field to have the structure -CH2-CH2-CH2- as a structural bridge inside a larger molecule. It is unclear if the claim requires the structure to be the known structure of “propylene” or the structure of an “propylene group” as the term “propylene” is not defined in the specification. For examination purposes, it will be assumed that the first part of claim 11 is directed to the carboxylated silk fibroin of claim 10, wherein, in Formula I, R’ is independently an ethylene group, a propylene group or 1,2-phenylene. Correction is required.
Claim 11 is indefinite in the recitation of “serine is modified by 20 to 90%, and the tyrosine is modified by 10 to 35%” for the following reasons. It is unclear (a) if the residues are modified by the recited percentages or (b) if the percentages are the amount of serine and tyrosine residues that are modified. If (a), it is unclear how the residues are modified by the recited percentages. For example, how would only 20% of a serine residue be carboxylated if the reaction occurs in the side chain hydroxyl group? Correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (Journal of Chemistry, published in 2013).
Claim 10 as interpreted is directed in part to:
a carboxylated silk fibroin, wherein, in the carboxylated silk fibroin, a hydroxyl group of serine and tyrosine of the silk fibroin react with a dicarboxylic anhydride to form a structure of formula I: or
a carboxylated silk fibroin, wherein, in the carboxylated silk fibroin, a hydroxyl group of serine of the silk fibroin react with a dicarboxylic anhydride to form a structure of formula I: or
a carboxylated silk fibroin, wherein, in the carboxylated silk fibroin, a hydroxyl group of tyrosine of the silk fibroin react with a dicarboxylic anhydride to form a structure of formula I:
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in Formula I, R' is a C2-C6 hydrocarbonylene group, which is determined by the structure of the dicarboxylic anhydride used in the carboxylation process.
Claim 11 as interpreted is directed in part to:
the carboxylated silk fibroin of claim 10, wherein, in Formula I, R' is independently an ethylene group (-CH2-CH2-), a propylene group (-CH2-CH2-CH2-), or 1,2-phenylene, and in the carboxylated silk fibroin, the serine is modified by 20 to 90%, and the tyrosine is modified by 10 to 35% or
wherein, in Formula I, R' is independently an ethylene group (-CH2-CH2-), a propylene group (-CH2-CH2-CH2-), or 1,2-phenylene or
in the carboxylated silk fibroin, the serine is modified by 20 to 90%, and the tyrosine is modified by 10 to 35%
Li et al. teaches an acylation modification of Antheraea pernyi silk fibroin where the phenolic hydroxyl groups of tyrosine are reacted with succinic anhydride and the potential reactions are shown in Figure 1 (see page 2, second column) with the -CH2-CH2- which is an ethylene group, a C2 hydrocarbonylene group. Therefore, Li et al. anticipates claims 10-11 as written/interpreted.
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Conclusion
No claim is in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALTON KIEFER, PhD whose telephone number is (571)272-1235. The examiner can normally be reached M-F 7:30-5 EST.
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/DALTON EDWARD KIEFER/Examiner, Art Unit 1652
/ROBERT B MONDESI/Supervisory Patent Examiner, Art Unit 1652
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