CTNF 18/792,950 CTNF 85494 DETAILED ACTION Examiner’s Note The Examiner notes that non-elected claim 29, which was restricted as set forth in paragraphs 2-3 of the action mailed 3/18/20269, has been rejoined and examined as set forth below. Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Objections 07-29-01 AIA Claim 16 is objected to because of the following informalities: for consistency, please amend the claim to recite either “tissue” (singular) or “tissues (plural) . Appropriate correction is required. 07-29-01 AIA Claim 16 is objected to because of the following informalities: for consistency, please amend the claim to recite “the one or more wet surfaces.” in the last line of the claim if that was what was intended . Appropriate correction is required. 07-29-01 AIA Claim 16 is objected to because of the following informalities: for consistency, please amend the claim to recite “phenylboronate ester bonds ” if that was what was intended . Appropriate correction is required. 07-29-01 AIA Claim 23 is objected to because of the following informalities: for consistency, please amend the claim in both instances to recite “the one or more wet surfaces” if that was what was intended . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 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. 07-34-01 Claims 16-28 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. Regarding claim 16 , it is unclear from the claim limitations if the recited “the surface” in lines 11-12 is the same as the “one or more wet surfaces” previously recited, or if the recited “the surface” in lines 11-12 is in addition to the “one or more wet surfaces” previously recited. Regarding claim 18 , it is unclear from the claim limitations what is, and is not, being claim ed as aldehydes, epoxides, isocyanates and catechol do not comprise amine groups. Claim 22 recites the limitation "the dry state" in line 4. There is insufficient antecedent basis for this limitation in the claim as a dry state has not been previously introduced. Claim 23 recites the limitation "the PVA and PAA networks" in line 3, line 4 and line 5. There is insufficient antecedent basis for this limitation in the claim as neither a PVA network or PAA network has not been previously introduced. Claim 25 recites the limitation "the pH-dependent de-crosslinking triggering agent" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim as neither a pH-dependent de-crosslinking triggering agent has not been previously introduced. 07-34-01 Claim 29 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. Regarding claim 29 , it is unclear from the claim limitations what is, and what is not, being claim given that the adhesive material is recited as a “dry” adhesive material, but is later recited to comprise a liquid content, which contrarily suggests that the adhesive material is not dry. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15-aia AIA Claim(s) 29 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Li et al. (US 2019/0091367 A1) . Regarding claim 29 , Li teaches an adhesive material for adhering one or more wet surfaces (para 0005) comprising a hydrogel comprising first and second polymer networks, a high-density primary amine polymer and a coupling agent (para 0006-0007), which said first polymer network comprises, inter alia , collagen (para 0008-0009) and which said second polymer network comprises, inter alia , alginate ( one or more hydrophilic polymer or copolymers ) (para 0010). Li continues to teach that the high-density primary amine polymer comprises, inter alia , chitosan (para 0014), and that a coupling agent such as, inter alia , N-hydroxysuccinimide (HNS), is included with the amine polymer (para 0015-0016). The Examiner notes that the combination of the amine polymer and amine coupling agent teach the presently claimed one or more amine coupling agents . Li also teaches that the first and second polymer networks are covalently coupled ( one or more cleavable covalent bonds ) (para 0072). The second polymer network comprises ionic crosslinks ( one or more crosslinkers ), and the hydrogel comprises a therapeutic agent ( therapeutic agent delivery device ) (para 0026). The hydrogels of Li comprise as little as 30% ( dry adhesive material has a liquid content , interaction with liquid of wet surfaces ) (para 0077). Li further teaches that the adhesive material is layered ( top and bottom surfaces ) (para 0095). The amine polymer provides primary amine groups that bind covalently with the carboxylic acid groups of the hydrogel and the on the wet surface ( covalent crosslinking via amine coupling agents(s) ); and that permeable wet surfaces are penetrated with the amine polymer and form physical entanglements ( cleavable physical bonds ) (para 0080). The recitation in the claims that the therapeutic agent delivery device is “ for triggerable detachment from the one or more wet surfaces for releasing one or more therapeutic agents to a target site ” is merely an intended use. Applicants attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim. It is the Examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art, and further that the prior art structure is capable of performing the intended use. Given that Li teaches the presently claimed invention, it is clear that the adhesive material of Li would be capable of performing the intended use presently claimed as required in the above cited portion of the MPEP . Allowable Subject Matter Claims 16-28 are allowable over the prior art. 13-03-01 AIA The following is a statement of reasons for the indication of allowable subject matter: The closest prior art reference is: US 2019/0091367 A1 to Li et al. teaches an adhesive material for adhering one or more wet surfaces ( method of adhering wet tissues , placing adhesive material in contact with one or more wet surfaces ) (para 0005) comprising a hydrogel comprising first and second polymer networks, a high-density primary amine polymer ( one or more hydrophilic polymer or copolymers ) and a coupling agent (para 0006-0007), which said first polymer network comprises, inter alia , collagen (para 0008-0009) and which said second polymer network comprises, inter alia , alginate (para 0010). Li continues to teach that the high-density primary amine polymer comprises, inter alia , chitosan (para 0014), and that a coupling agent such as, inter alia , N-hydroxysuccinimide (HNS), is included with the amine polymer (para 0015-0016). The Examiner notes that the combination of the amine polymer and amine coupling agent teach the presently claimed one or more amine coupling agents . Li also teaches that the first and second polymer networks are covalently coupled (para 0072). The amine polymer provides primary amine groups that bind covalently with the carboxylic acid groups of the hydrogel and the on the wet surface ( covalent crosslinking via amine coupling agents(s) ); and that permeable wet surfaces are penetrated with the amine polymer and form physical entanglements ( temporary crosslinking ) (para 0080). Li is silent to the high-density primary amine polymer grafted with one or more amine groups via cleavable physical and/or covalent bonds. Li is also silent to a process of introducing a triggering agent towards cleaving the cleavable physical and/or covalent bonds 07-43-01 AIA Claim s 16-28 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), 2nd paragraph, set forth in this Office action. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRANK D DUCHENEAUX whose telephone number is (571)270-7053. The examiner can normally be reached 8:30 PM - 5:00 PM. 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, Alicia A Chevalier can be reached at 571-272-1490. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /FRANK D DUCHENEAUX/Primary Examiner, Art Unit 1788 6/5/2026 Application/Control Number: 18/792,950 Page 2 Art Unit: 1788 Application/Control Number: 18/792,950 Page 4 Art Unit: 1788
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