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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/5/26 was filed after the mailing date of the previous Office Action on 9/5/25. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Colter et al (WO 2023/044385 A1 hereafter Cotler) in view of Salamore et al (US 2016/0303281 hereafter Salamore) and Zhou et al (CN 113736043 A hereafter Zhou).
Cotler discloses a hydrogel composition comprising a crosslinked methacrylate hyaluronic acid polymer comprising hormones that are encapsulated by the polymer [0026, 0109, 0115, 0121, 0217], meeting limitations of claim 1 and 13. The hydrogel is formulated for sustained release over a period of at least 1 week [0152], meeting limitations of claim 1. The hydrogel mixture further comprises a photoinitiator such as lithium phenyl-2,4,6-trimethylbenzoylphosphinate, where the hydrogel mixture is crosslinked by an ultraviolet light [0109, 0116, 0176], meeting the limitations of claims 5, 6 and 17. The hydrogels are biocompatible [0024, 0038], meeting the limitations of claims 12. The hydrogel formulation can be in the form of microparticles [0217-0218], meeting the limitations of claim 7 and 19. The hydrogel can have a diameter from 100-150 microns [0178], meeting limitations of claims 9, 11 and 20.
The reference, while disclosing a hydrogel comprising a crosslinked methacrylate hyaluronic acid polymer that encapsulates an active agent, which can include hormones, the reference is silent to the specific hormones of the instant claims. The use of testosterone and estradiol in hydrogel formulation is known in the art as seen in the Salamore.
Salamore discloses a crosslinked hydrogel comprising hyaluronic acid and methacrylate polymers [abstract, claims]. The hydrogels comprise estradiol and testosterone [claims 14], meeting the claims of 2-4, 14, 15 and 18. The hydrogels can be spherically shaped as microbeads with sizes from 75-250 microns [0103], meeting the limitations of claims 9-11 and 20. It would have been obvious to include the hormones of Salamore into the crosslinked hydrogel of Cotler as they comprise similar components and solve the same problem.
While the combination discloses a hydrogel formulation comprising crosslinked methacrylate hyaluronic acid polymer that encapsulates hormones, the reference is silent to the specific type of hyaluronic acid. Cotler disclose that the hyaluronic acid polymer is chemically modified, but is silent to the inclusion of sodium hyaluronic variations. The use of sodium hyaluronic acid in crosslinked hydrogels is known in the art as seen in the Zhou patent.
Zhou discloses a hydrogel composition comprising a crosslinked methacrylate hyaluronic acid formed from sodium hyaluronate (abstract). The crosslinking is formed via UV radiation where the crosslinked polymer encapsulates the active agent (Examples). It would have been obvious to include the sodium hyaluronate into the combination as it solves the same problem of forming a hydrogel formulation.
With these aspects in mind, it would have been obvious to combine the prior art in order to form a stable hydrogel useful for drug delivery to the body. It would have been obvious to combine the specific hormones of Salamore into the hydrogel of Cotler for sustained release as the hydrogels both comprise crosslinked methacrylate hyaluronic polymer solving the same problem. It would have been obvious to include the specific hyaluronate of the Zhou as it solves the same problem and delivers an active agent to the body. One of ordinary skill in the art would have been motivated to combine the prior art component into a stable crosslinked hydrogel for drug delivery to the body.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Salamore and Zhou are applied in a different manner, however their disclosures remain relevant.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618