DETAILED ACTION
Status of Application
Claims 1-17 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 .
A preliminary amendment of claims 12-16 as submitted in a communication filed on 08/04/2026 is acknowledged.
Applicant’s election without traverse of Group II, claims 12-16, drawn to a preparation method of the transdermal photocuring forming hydrogel, as submitted in communication filed on 08/04/2026 is acknowledged.
Claims 1-11 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/04/2026.
Claims 12-16, are at issue and will be examined to the extent they encompass the elected invention.
Priority
Acknowledgment is made of a claim for foreign priority under 35 U.S.C. 119(a)-(d) to CHINA 2022112245930 filed on 10/08/2022. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/12/2023
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.
Drawings
The drawings submitted on 10/09/2023 have been reviewed and are accepted by
the examiner for examination purposes.
Claim Objections
Claim 12 is objected to due to the recitation of “wherein the anhydride is one of cyclic unsaturated anhydride or carboxyl-containing unsaturated anhydride or 4-pentenoic anhydride, crotonic anhydride and methacrylic anhydride”. To enhance clarity, it should be amended to recite “wherein the anhydride is cyclic unsaturated anhydride, carboxyl-containing unsaturated anhydride, 4-pentenoic anhydride, crotonic anhydride or methacrylic anhydride”. Appropriate correction is required.
Claims 12-13 are objected due to the recitation of “NHS” and “EDC”. Abbreviations, unless otherwise obvious and/or commonly used in the art, should not be recited in the claims without at least once reciting the entire phrase for which the abbreviation is used. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA )
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 12-16 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 12 (claims 13-16 dependent thereon) is indefinite in the recitation of “an appropriate chemical modification”, for the following reason: The term “appropriate” is a relative term which renders the claim indefinite. The term “appropriate chemical modification” is not defined by the claim, the specification does not provide a standard for ascertaining what chemical modifications would be deemed appropriate, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the appropriate chemical modification required is unclear in this case. Correction is required.
Claim 12 (claims 13-16 dependent thereon) recites the limitation "S5… with the recombinant collagen". There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 13 is indefinite in the recitation of “the modification degree”, for the following reason: it is unclear what the modification is in this case. Correction is required.
Claim 13 is indefinite in the recitation of “a molar ratio of 1: (1-3): (2-5)”, for the following reason: The numerical values are presented within parentheses. Therefore, it is unclear whether the numerical values are intended to define the required limitation or merely provide optional information in this case. Correction is required.
Claims 13-15 are indefinite in the recitation of “(the natural polysaccharide…NHS:EDC)” and “(amino vicinal-diol…properties)”, for the following reason: The limitations are presented within parentheses. Therefore, it is unclear whether the limitations are intended to be required limitations or merely provide optional limitations in this case. Correction is required.
Claim 15 is indefinite in the recitation of “the molar ratio is (1-10): 1”, for the following reason: The numerical values are presented within parentheses. Therefore, it is unclear whether the numerical values are intended to define the required limitation or merely provide optional information in this case. Correction is required.
Claim Rejections - 35 USC § 112(a) or First Paragraph (pre-AIA )
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 12-16 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.
As stated in MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow.
Claims 12-16 are directed in part to a preparation method of a transdermal photocuring forming hydrogel wherein, in step 5 (S5), an amino acid sequence of the recombinant collagen comprises N basic repetitive units, and each basic repetitive unit contains nl of the following characteristic amino acid sequences: "G-Xaai-Xaa2-G-E-Xaa"; the 3' end and the 5' end of the basic repetitive unit are connected to form the above characteristic amino acid sequence; wherein, N is an integer greater than 4; and nl is an integer greater than 3.
As indicated in MPEP § 2163, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show that Applicant was in possession of the claimed genus. In addition, MPEP § 2163 states that a representative number of species means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
This specification discloses the amino acid sequence of a recombinant collagen (SEQ ID NO: 2), which was connected 16 times to obtain SEQ ID NO: 1. However, the claims encompass essentially unlimited N and n1 values that could make an unlimited amount of sequence arrangements. The specification does not disclose a representative number of species commensurate with this scope of the claimed genus or sufficient identifying characteristics demonstrating possession of the broader genus.
Conclusion
No claim is in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SYNPHANE SHELTON whose telephone number is (571)272-6318. The examiner can normally be reached 9:00am-7pm.
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/S.L.S./Examiner, Art Unit 1652
/ROBERT B MONDESI/Supervisory Patent Examiner, Art Unit 1652
