DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. The Applicants submitted claim amendments on 1/7/2026 in response to the office action mailed on 10/9/2025. The status of the claims is as follows.
Claim Rejections - 35 USC § 102
3. Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) and rejected under 35 U.S.C. 102(a)(2) as being anticipated by (US 2020/0306183 A1) to Hughes et al. (hereinafter Hughes).
The above noted rejection is hereby withdrawn.
Claim Rejections - 35 USC § 103
4. Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over (US 2020/0306183 A1) to Hughes et al. (hereinafter Hughes).
The above noted rejection is hereby withdrawn.
NEW Claim Rejections - 35 USC § 103
5. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
6. 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.
7. Claims 1-6 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over (US 2020/0306183 A1) to Hughes et al. (hereinafter Hughes) in view of the teachings of (US 2019/0329209 A1) to Sciambi et al. (hereinafter Sciambi).
Hughes is directed toward polymer coated hydrogels for controlled release of agents. Hughes discloses at paragraph [0195] that there is a hydrogel comprising a polymer phase and an aqueous liquid phase. Hughes discloses at paragraph [0272] that the liquid polymer is the dispersed phase added to the continuous phase to form a water in oil emulsion, the two phases are immiscible. Hughes discloses at paragraph [0278] that the coated hydrogel process may be continuous using a microfluidic device. Hughes discloses at Fig.1 that a coated hydrogel is formed.
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Hughes discloses at paragraph [0047] that multiple layers of coatings may be applied to the particle core (see Fig. 1 above). Hughes discloses at paragraph [0047] that the coating is a polymer. Hughes discloses at paragraph [0045] that the hydrogel microbead is a drug. One skilled in the art would find it obvious to select the specific disclosed method to provide the desired coated hydrogel for delivery of the desired agent. Hughes discloses that a microfluidic device may be used, but is silent regarding the feature of the intersection of two microfluidic channels, which the majority of microfluidic devices contain.
Sciambi is directed toward polymer coated hydrogels made with a microfluidic device. Hughes and Sciambi are both directed toward polymer coated hydrogels made with a microfluidic device and therefore are analogous art. Sciambi teaches at paragraph [0059] that their microfluidic device allows for the ability to controllably generate droplets contain a gel bead therein, which would motivate one skilled in the art to combine the teachings. Sciambi teaches at paragraph [0064] that the microfluidic device has channels that intersect to form the coatings.
It would be obvious to one skilled in the art at the time of the filing of the disclosure of Hughes in view of the teachings of Sciambi to modify the method of Hughes to use a microfluidic device having intersecting channels to from a coating to form a prime facie case of obviousness for claims 1-6 and 9-11.
Response to Arguments
8. Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The rejection is made final.
Conclusion
9. 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).
10. 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.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY D WASHVILLE whose telephone number is (571)270-3262. The examiner can normally be reached M-F 9-5.
12. 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.
13. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Randy Gulakowski can be reached at 571-272-1302. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
14. 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.
/JEFFREY D WASHVILLE/ Primary Examiner, Art Unit 1766
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