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 1/05/26 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) 1-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Ho et al (US 2013/0183349 A1 hereafter Ho) in view of Davis et al (US 2022/020343 A1 hereafter Davis) and Salamore et al (US 2016/0303281 A1 hereafter Salamore).
Ho discloses a method for administering a hormone encapsulated by a hydrogel polymer in a syringe, where the injection is subcutaneous [0027, meeting limitation of claims 1, 7 and 13. The method comprises a crosslinked methacrylate hyaluronic acid polymer that encapsulates a hormone [0020 and 0024], meeting limitations of claims 1 and 8.
The reference while disclosing a method for the delivery of a hydrogel encapsulating hormone formulation via a syringe is silent to the specific structure of the syringe. The use of dual chamber syringe systems for mixing components before injection is known in the art as seen in the David patent.
Davis discloses a two part hydrogel system comprising a crosslinked methacrylate hydrogel that encapsulates an active compound in a core-shell microparticle where one part of the mixture is housed in one chamber of the syringe and the second part is housed in a second chamber [abstract, 0045-0048, claims]. One chamber comprises the methacrylate polymer while the other chamber comprises a stabilizer/diluent [Table 1]. The chambers are separated by a separator and once the separator is pierced through force of the plunger, the two components mix in the needle before injections [0136] meeting limitations of claims 1-3 and 8-10. It would have been obvious to use this double chamber system in order to keep the hydrogel from mixing too prematurely and improve shelf storage.
While the combination would provide a method of delivering a hydrogel subcutaneously to the body comprising a dual chamber syringe, where the injected hydrogel encapsulates a hormone, the combination is silent to the specific hormones of the instant claims. The use of testosterone and estradiol encapsulated in hydrogel is well known in the art as seen in the Salamore patent.
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 4-6, 11 and 12. It would have been obvious to include the hormones of Salamore into the crosslinked hydrogel of Ho as they comprise similar components and solve the same problem.
With these aspects in mind, it would have been obvious to combine the prior art in order to produce a stable method for delivery of hormones to the body. It would have been obvious to apply the crosslinked hydrogel of Ho into the dual chambered device of Davis in order to keep the hydrogel from prematurely crosslinking and improve shelf life stability. I would have been obvious to include the hormones of Salamore into the combination in order to treat various conditions as they solve the same problem and have similar hydrogel components. One of ordinary skill int heart would have been motivated to combine the prior art with an expected result of stable method of delivery of hormones to the body.
Response to Arguments
Applicant’s arguments, see Remarks, filed 1/5/26, with respect to the rejection(s) of claim(s) 1-13 under 35 103(a) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the above recited rejection.
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.
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, Michael Hartley can be reached at 5712720616. 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.
/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618