CTFR 18/041,973 CTFR 97548 DETAILED ACTION 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. Applicant’s arguments, filed 21 April 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. 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 Claim 23 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. 07-34-03 AIA The term “ substantially ” in claim 23 is a relative term which renders the claim indefinite. The term “ substantially ” 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 what levels of metal ions may be contained for the solution to be considered as “substantially free” such that one of ordinary skill in the art would know whether a concentration of metal ions would infringe on the claimed invention . Claim Rejections - 35 USC § 103 07-103 AIA The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. 07-21-aia AIA Claim s 1-6 and 21-29 are rejected under 35 U.S.C. 103 as being unpatentable over Jus et al. (“Enzymatic cross-linking of gelatine with laccase and tyrosinase”, 2/1/2012, IDS reference) (hereinafter Jus) . Jus discloses cross-linking of porcine gelatine by incubating in a solution for 24 hours with 150 U of tyrosinase, then heating the reaction mixture to deactivate the enzyme. (p. 89, § Chemical et seq .). Accordingly, Jus discloses a method comprising providing porcine gelatin and incubating with tyrosinase. Together these would appear to provide a process for making DOPA-gelatin as instantly claimed. Although Jus does not explicitly disclose an instantly claimed shear strength, it appears Jus discloses incubating substantially the same porcine gelatin with substantially the same tyrosinase, thus one of ordinary skill in the art would reasonably expect the mixture of Jus to result in substantially the same DOPA-gelatin having substantially the same properties as the claimed invention, such as a shear strength of at least 2 MPa. Similarly, regarding claims 2 and 24-26 reciting various properties of the DOPA-gelatin, as discussed above, since one of ordinary skill in the art would reasonably expect the mixture of Jus to result in substantially the same DOPA-gelatin as the claimed invention having substantially the same properties, such as a burst pressure of at least 6 kPa; a load force of at least 60 N; a tensile stress of at least 3 MPa; and/or a storage modulus of at least 700 Pa like the claimed invention. Regarding claims 3, 4, 27, and 28 reciting an incubation time range (i.e. for more than 30 minutes or for more than 60 minutes, respectively) or a concentration of tyrosinase (i.e. between 100-200 U/ml), the claimed ranges would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. 24 hours and 150 U, respectively). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I). Regarding claim 6, since Jus appears to disclose providing substantially the same components (i.e. porcine gelatin and tyrosinase) and substantially the same process (i.e. incubating solution comprising porcine gelatin and tyrosinase) as instantly claimed, one of ordinary skill in the art would reasonably expect such process of Jus to make substantially the same DOPA-gelatin in a “one-step synthesis reaction” like the claimed invention. Regarding claims 21 and 22, although Jus does not explicitly disclose a percentage of tyrosinase residues, since Jus appears to disclose incubating substantially the same porcine gelatin with substantially the same tyrosinase, one of ordinary skill in the art would reasonably conclude the mixture of Jus to result in substantially the same DOPA gelatin having substantially the same properties as the claimed invention, such as wherein at least 80%, or 90%, respectively, of the tyrosine residues are converted to DOPA. Regarding claim 23, Jus does not disclose wherein the solution is required to contain metallic ions. Therefore, it would have been obvious to one of ordinary skill in the art that the solution of Jus is substantially free of metallic ions. Regarding claim 29, Jus further discloses that during incubation, the potential of a peak in particular spectral regions were assessed for cross-linking of gelatin, including a peak indicating presence of L-dopaquinone (p. 90, col. 1, last paragraph). As such, it would have been obvious to one of ordinary skill in the art that the process of Ju comprises monitoring formation of DOPA-quinone as instantly claimed . Response to Arguments Applicant mainly asserts on pages 6-7 of the Remarks of 21 April 2026 that Jus did not investigate the mechanical properties of the final product as the specific application of the resulting cross-linked gelatin was unknown at the time, giving the authors no indication on what the desirable mechanical properties might be. Applicant further asserts that the process parameters of Jus significantly differ from the Examples of the present invention, specifically in the incubation temperature, incubation time and tyrosinase concentration. Finally, Applicant asserts paragraphs [0048] and [0056] of the instant Specification discusses that the claimed invention experimentally determined the optimal condition exists for DOPA-gelatin that has the desired mechanical properties and bioactivity, and that the tradeoff between DOPA-quinone and unoxidized catechol form of DOPA in relations to its adhesion, which is not recognized by Jus. The Examiner does not find the Applicant’s assertions to be persuasive. First, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., incubation time, temperature, and tyrosinase concentration, as well as adhesion strength) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns , 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In the instant case, the instant claims as currently amended require merely a solution containing porcine gelatin, and incubating the solution with tyrosinase, such that it results in formation of DOPA-gelatin. Jus discloses incubating porcine gelatin and tyrosinase in a solution, thus rendering obvious the instant claims. Moreover, although Jus does not explicitly disclose producing a DOPA-gelatin exhibiting various desirable mechanical properties, rationale different from Applicant’s is permissible. It is not necessary for the prior art to suggest the combination to achieve the same advantage or result discovered by Applicant. See MPEP 2144(IV). Thus, it is not necessary for Jus to disclose producing the DOPA-gelatin for the same reason as Applicant. Finally, paragraphs [0048] and [0056] of the instant Specification are conclusory statements. Mere conclusory statements in the Specification, unsupported by objective evidence, are entitled to little weight when the PTO questions the efficacy of those statements. In re Greenfield , 571 F.2d 1185, 197 U.S.PQ. 227, 229 (C.C.P.A. 1978). See also See MPEP § 716.01(c). Applicant has not provided any showings providing objective factual evidence regarding the criticality of the process steps instantly claimed. As such, Applicant’s assertion is unpersuasive. Citation of Pertinent Prior Art 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Raia et al. (WO 2018/098299 A, 05/31/2018), directed to gelatin modified by one or more tyramine group, and the use of tyrosinase . Conclusion 07-39 AIA THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST. 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, SAHANA KAUP can be reached at (571) 272-6897. 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. /LUCY M TIEN/Examiner, Art Unit 1612 /SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612 Application/Control Number: 18/041,973 Page 2 Art Unit: 1612 Application/Control Number: 18/041,973 Page 3 Art Unit: 1612 Application/Control Number: 18/041,973 Page 4 Art Unit: 1612 Application/Control Number: 18/041,973 Page 5 Art Unit: 1612 Application/Control Number: 18/041,973 Page 6 Art Unit: 1612 Application/Control Number: 18/041,973 Page 7 Art Unit: 1612 Application/Control Number: 18/041,973 Page 8 Art Unit: 1612
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