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.
Acknowledgement of Papers Received: Amendment dated 1/05/26.
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) 1-4, 6-13 and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Daniloff et al (US 2005/0281883 hereafter Daniloff) in view of Zhou et al (CN 113736043 A hereafter Zhou) and Salamore et al (US 2016/0303281 hereafter Salamore).
Daniloff discloses a dual chamber syringe for administration of a compounds including hormones encapsulated in crosslinked hydrogel matrices [0105, abstract]. The crosslinked matrix comprises methacrylate and hyaluronic acid [0015, 0028]. The hyaluronic acid encapsulates the hormones such as estradiol [0032]. The matrix can be present as microspheres [0022, 0023]. The dual barrel syringe comprises one chamber comprising the hydrogel matrix and encapsulated drug, while the other comprises diluents [Examples, Figure 1]. Ultraviolet radiation can be used to crosslink the matrices of the formulation [0107], meeting the newly amended limitations of claims 1 and 9. The syringe comprises a separator that separates the chambers, a mixing chamber and a plunger that forces the mixture in the mi8xture chamber through the needle [Figure 1]. The mixture is delivered to the subcutaneous tissue for healing [0257].
While the refence discloses a crosslinked hydrogel that encapsulates a hormone delivered in a dual chamber syringe, however the specific crosslinking hydrogel of the instant claims is known in the prior art as seen in the Zhou patent.
Zhou discloses a crosslinked methacrylate hyaluronic acid [abstract]. The hydrogel is irradiating by applying an ultraviolet light to an uncrosslinked MHA mixture [claims]. A drug is encapsulated in the crosslinked hydrogel matrix [Examples]. It would have been obvious to include the crosslinked methacrylate hyaluronic acid as they are similar to the components of the Daniloff formulation.
The combination would provide a dual chamber syringe comprising a crosslinked MHA hydrogel encapsulating a hormone compound. The hormone compound is estradiol, and the reference is silent to the inclusion of testosterone. The inclusion of testosterone into the crosslinked hydrogel is known in the art as seen in the Salamone.
Salamone disclose a hydrogel formulation comprising estradiol and testosterone [claims]. The hydrogel comprises a mixture of hyaluronic and methacrylate polymer (claims). The hydrogel can be spherical in shape [0131, 0225]. It would have been obvious to include the hormones of Salamone as they comprise similar components to those in the combination.
With these aspects in mind it would have been obvious to combine the components of Zhou and Salamone into the dual chamber syringe of Daniloff as they comprise the same components. It would have been obvious to include the crosslinked formulation of Zhou as they both comprise methacrylate and hyaluronic acid hydrogels that encapsulate drugs. It would have been obvious to combine the formulations into a dual chamber syringe as the Zhou and Salamone hydrogels are injectable and comprise the same polymers for crosslinking. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a stable tissue healing formulation for drug delivery.
.
Response to Arguments
Applicant's arguments filed 1/5/26 have been fully considered but they are not persuasive. Applicant argues that the prior art combination does not render the newly amended claims obvious as they do not meet the limitations of the claims, specifically the crosslinking of the MHA polymer via ultraviolet radiation that encapsulates the hormone.
Regarding this argument remains that the position of the Examiner that the combination of the Daniloff, Zhou and Salamore continue to render the claims obvious. Daniloff discloses a double chamber syringe injector comprising at least a hydrophilic polymer such as a methacrylate can be crosslinked by ultraviolet light. The matrix formed by the crosslinking encapsulates an active agent. While Daniloff discloses a dual syringe that can deliver the crosslinked matrix formulation. The formulation however does not disclose the specific polymer of the instant claims, however is suggestive of similar polymers. Zhou discloses the use of the specific polymer of the instant claims, the methacrylate hyaluronic acid polymers that is uncrosslinked until it is crosslinked by ultraviolet light. As Daniloff delivers similar polymers that can also be crosslinked by ultraviolet light, it would have been obvious modifications to include this polymer into the kit of Daniloff. This combination, broadly discloses the entrapping of hormones in to the matrix, but is silent to the specific hormones of the instant claims. Salamore discloses a hydrogel matrix comprising estradiol and testosterone. As the polymers of Salamore are similar to those of Daniloff and Zhou, it would have been obvious to include these hormones into the combination as they solve the same problem. The resulting combination would be a kit comprising a double barrel injector system for delivery of a hydrogel to the body (Daniloff). The hydrogel would comprise uncrosslinked methacrylate hyaluronic acid that is crosslinked with ultraviolet light that when crosslinked, encapsulates the active agents that can be hormones (Daniloff and Zhou). These hormones can be estradiol and testosterone as seen in Salamore. This combination would have been an obvious modification as they al solve the same problem.
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.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618