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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-10 and 15-19) in the reply filed on 22 May 2026 is acknowledged.
Claims 11-14 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 22 May 2026.
Claims 1-10 and 15-19 are under current consideration.
Information Disclosure Statement
A U.S. patent application publication number was corrected in the IDS filed 10 July 2026 as noted on the annotated copy provided herewith.
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.
Claim 18 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 18 recites a Markush grouping of alternatives but is an open group (“selected from the group including”) rather than a closed group as required per MPEP 2173.05(h)(I), and thus it is unclear what other alternatives are intended to be encompassed by the claim, which renders the claim indefinite.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-10 and 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thi et al. (RSC Advances, 2017, Vol. 7, pages 34053-34062; of record) in view of Wei et al. (ACS Applied Materials & Interfaces, 2019, Vol. 11, pages 47707-47719; of record) as evidenced by Black et al. (US 2005/0053585 A1; published 10 March 2005; of record) and Weinhart et al. (US 2022/0280691 A1; published 08 September 2022; of record).
Thi et al. discloses an injectable hydrogel with high adhesiveness and hydrophobic drug delivery (abstract), reading on a claimed adhesive drug carrier comprising an injectable hydrogel comprising at least one medication. Thi et al. discloses that gelatin-tyramine is crosslinked with oxidized β-cyclodextrin having a cavity for a hydrophobic drug (abstract), reading on the claimed hydrogel comprising (i) a protein-based polymer functionalized with a functionalization agent (i.e., tyramine) that is able to form guest-host interactions with oxidized β-cyclodextrin, cross-linked with (ii) an oxidized β-cyclodextrin (oβ-CD) as matrix and the at least one medication (iii), wherein the protein-base polymer (i) is gelatin. Thi et al. discloses that the hydrogel is 1 wt% oβ-CD (abstract), reading on the amount of oβ-CD is from 0.1 to 10% by weight of the hydrogel. Thi et al. discloses that the hydrophobic drug is dexamethasone (abstract), reading on the at least one medication (iii) is a small drug molecule with a molecular weight of less than 1000 Daltons, as evidenced by Black et al. which discloses that dexamethasone has a molecular weight of 392.5 (paragraph [0114]).
Although Thi et al. does not disclose (iv) a protein-based polymer bearing quinone and/or catechol groups, wherein - the protein-based polymer (iv) is gelatin and has a molecular weight in the range of 50 to 200 kDa and bears from 15% to 70% of the total amino groups of combined catechol and/or quinone groups per molecule as claimed, Wei et al. discloses injectable hydrogel adhesives for delivery of therapeutic agents comprising gelatin modified with catechol functionality which can be injected and cured rapidly under mild and cytocompatible conditions (abstract) wherein the gelatin is type A from porcine skin with a gel strength of 300 (section 2.1 first paragraph page 47709) and the modified gelatin has 12.8-42.3% of amino groups converted to catechol groups (Table 1 page 47711), reading on the claimed protein-based gelatin polymer bearing quinone and/or catechol groups, wherein - the protein-based polymer (iv) has a molecular weight in the range of 50 to 200 kDa and bears from 15% to 70% of the total amino groups of combined catechol and/or quinone groups per molecule, as evidenced by Weinhart et al. which discloses that type A gelatin from porcine skin with gel strength 300 has a molecular weight of 50-100 kDa.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Thi et al. and Wei et al. by combining the injectable gelatin hydrogel adhesive of Thi et al. as discussed above with the injectable gelatin hydrogel adhesive of Wei et al. as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to make an injectable gelatin hydrogel adhesive for drug delivery because both hydrogels are used to deliver drugs and it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose, per MPEP 2144.06(I).
Such disclosed range of 12.8-42.3% amino groups converted to catechol groups as discussed above overlaps the claimed range of 15-70%, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
Regarding claim 2, Wei et al. discloses that catechols are oxidized to produce transient quinones (page 47709 first partial paragraph).
Regarding claim 3, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize adhesiveness and drug delivery effectiveness of the adhesive hydrogel composition of Thi et al. in view of Wei et al. as discussed above by varying the concentrations of the adhesive hydrogels of Thi et al. and Wei et al. in the mixture thereof through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that both hydrogels are adhesive and for drug delivery.
Regarding claim 4, the polymers of Thi et al. and Wei et al. are both gelatin as discussed above.
Regarding claim 5, the polymer of Thi et al. is functionalized with tyramine (i.e., primary aminoaklylphenol) as discussed above.
Regarding claim 6, the polymer of Wei et al. is made by modification with DOPA (page 47709 Section 2.2).
Regarding claim 7, Thi et al. discloses hydrophobic drug (i.e., medication) as discussed above.
Regarding claim 8, such claimed recitation of intended use adds no required additional structural limitations to the claimed product. Nevertheless, Thi et al. discloses that the hydrogel adheres to skin (i.e., tissue) and is for wound healing, drug delivery, and tissue engineering (i.e., for use in the treatment of medical disorders) (page 34061 Conclusion), and Wei et al. discloses that the hydrogel adheres to tissue and is for tissue repair (i.e., for use in the treatment of medical disorders) (Abstract).
Regarding claim 9, such claimed recitation of intended use adds no required additional structural limitations to the claimed product. Nevertheless, Thi et al. discloses that the hydrogel adheres to skin (i.e., tissue) (page 34061 Conclusion) and that tissue-adhesive biomaterials are used for bleeding control (page 34053 Introduction), and Wei et al. discloses that the hydrogel adheres to tissue (Abstract).
Regarding claim 10, such claimed recitation of a kit of parts adds no required additional structural limitations to the claimed product, and is satisfied by the parts as discussed above.
Regarding claim 15, the polymers of Thi et al. and Wei et al. are both gelatin as discussed above.
Regarding claims 16-17, the gelatin polymer of Thi et al. is functionalized with tyramine as discussed above.
Regarding claim 18, such claimed recitation of intended use adds no required additional structural limitations to the claimed product. Nevertheless, Thi et al. discloses that the hydrogel adheres to skin (i.e., tissue) and is for wound healing (i.e., for use in the treatment of trauma) (page 34061 Conclusion), and Wei et al. discloses that the hydrogel adheres to tissue and is for tissue repair (i.e., for use in the treatment of trauma) (Abstract).
Regarding claim 19, such claimed recitation of a kit of parts adds no required additional structural limitations to the claimed product, and is satisfied by the parts as discussed above, and such claimed recitation of intended use adds no required additional structural limitations to the claimed product.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
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