DETAILED ACTION
Any rejections and/or objections made in the previous Office action and not repeated below are hereby withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
The new grounds of rejection set forth below for claim 40 is necessitated by Applicant’s amendment filed on Oct. 15, 2025. In particular, claim 40 is newly presented. The grounds of rejection set forth below for claims 38-39 are the same as those set forth in the previous Office action mailed on Apr. 16, 2025. For these reasons, the present action is properly made final.
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 .
Claim Rejections – 35 U.S.C § 112
Claims 38-40 are rejected under 35 U.S.C. § 112(a) 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(s), at the time the application was filed, had possession of the claimed invention.
Claim 38 recites a hyaluronan and a crosslinker at a volume ratio of 2:1. In the Remarks submitted on Apr. 8, 2025, Applicant points to Fig. 2 [presumably Fig. 2E] and ¶ [0157] of the published application for written descriptive support for the claim.
Fig. 2E describes a composition comprising a hyaluronic acid and PEGDA at a volume ratio of 2:1. The figure and the specification do not contain a broader disclosure regarding amounts of (generic) crosslinker or of crosslinkers other than PEGDA. Claim 38 therefore recites an amount of a generic crosslinker in a manner that is broader than the original disclosure.
Claim 39 recites the crosslinker PEG-diacrylate (PEGDA) hydrogel. Fig. 2E describes a solution of PEGDA, but it does not recite a hydrogel of PEGDA. Fig. 2E does not contain a disclosure of an amount of a hydrogel of PEGDA. Claim 39 also recites a crosslinker (a disulfide-containing derivative of a PEG-diacrylate hydrogel) for which there is no disclosure of amounts.
The claims therefore contain 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(s), at the time the application was filed, had possession of the claimed invention.
Claim 40 is dependent upon claim 38, and it fails to comply with the written description requirement for the same reason.
Allowable Subject Matter
Claims 27-30 and 32-37 are allowed.
Response to Arguments
Applicant's arguments filed Oct. 15, 2025 (herein “Remarks”) have been fully considered and they are persuasive in part.
The rejection under 35 U.S.C. § 102 over Wang has been withdrawn in light of the amendment of independent claim 27 to recite a thiol-modified hyaluronan.
Regarding the rejection under 35 U.S.C. § 112(a): Applicant argues that possession of claim 38 is established by the known chemical relationship between crosslinkers and their structure.
This argument is unpersuasive because it does not identify written descriptive support for amounts of (generic) crosslinker or of crosslinkers other than PEGDA.
Applicant argues that the issue regarding claim 39 is resolved by an amendment of the claim. This argument is unpersuasive because it does not identify written descriptive support for an amount of a hydrogel of PEGDA in a solution; or of an amount a disulfide-containing derivative of a PEG-diacrylate hydrogel.
The double patenting rejection has been withdrawn in light of the amendment of independent claim 27 to recite a thiol-modified hyaluronan.
Conclusion
This action is properly final because Applicant's amendment necessitated some of the new ground(s) of rejection presented in this Office action, and because the remainder of the rejections are on the same grounds as set forth in the previous Office Action mailed on Apr. 16, 2025. Accordingly, THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). See MPEP § 706.07(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 extension fee 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.
This action is a final rejection and is intended to close the prosecution of this application. Applicant's reply under 37 CFR § 1.113 to this action is limited either to an appeal to the Patent Trial and Appeal Board or to an amendment complying with the requirements set forth below.
If applicant should desire to appeal any rejection made by the examiner, a Notice of Appeal must be filed within the period for reply identifying the rejected claim or claims appealed. The Notice of Appeal must be accompanied by the required appeal fee.
If applicant should desire to file an amendment, entry of a proposed amendment after final rejection cannot be made as a matter of right unless it merely cancels claims or complies with a formal requirement made earlier. Amendments touching the merits of the application which otherwise might not be proper may be admitted upon a showing of good and sufficient reasons why they are necessary and why they were not presented earlier.
A reply under 37 CFR § 1.113 to a final rejection must include the appeal from, or cancellation of, each rejected claim. The filing of an amendment after final rejection, whether or not it is entered, does not stop the running of the statutory period for reply to the final rejection unless the examiner holds the claims to be in condition for allowance. Accordingly, if a Notice of Appeal has not been filed properly within the period for reply, or any extension of this period obtained under either 37 CFR 1.136(a) or (b), the application will become abandoned.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD A. HUHN whose telephone number is (571)270-7345. The examiner can normally be reached Monday through Friday, 9 AM to 6 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Arrie (Lanee) Reuther can be reached at (571) 270-7026. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RICHARD A. HUHN/Primary Examiner, Art Unit 1764