DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 25 November 2025 has been entered.
This Office Action is in response to Applicant’s Amendment and Remarks filed on 25 November 2025 in which claims 2 and 5 were canceled, and claim 1 was amended to change the scope and breadth of the claims.
Claims 1, 3 and 4 are pending in the current application and are examined on the merits herein.
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 .
Withdrawn Rejections
Applicant’s amendment, filed 25 November 2025, with respect to the rejection of claims 1, 4 and 5 under 35 U.S.C. § 102(a)(1)/(a)(2) as being anticipated by Levy et al., has been fully considered and is persuasive because claim 1 has been amended to recite “applying an external skin agent that contains adenosine and does not contain ultrafine bubbles”. The rejection is hereby maintained.
Response to Arguments
Applicant's arguments filed 25 November 2025 have been fully considered but they are not persuasive.
Applicant contends the claims as amended require a two-step process, and that neither Park nor Levy disclose or suggest using ultrafine bubbles in a separate step to promote skin permeation in a further step. Applicant further argues Park teaches delivering a drug encapsulated in a microcapsule has an effect of maximizing drug delivery efficiency. Thus, Applicant argues one of ordinary skill in the art reading Park would not be motivated to administer the specific component separately because this would render the method of Park unsatisfactory for its intended purpose (i.e. maximizing drug delivery efficiency).
The above arguments are not found persuasive when Park is considered in combination with Levy et al. While Park et al. teach an advantage of administering the drug together with the microcapsule is maximum drug delivery efficiency, Levy et al. suggest an advantage of applying the microbubbles before the drug ensures administering the therapeutic agent to the desired targeted region, rather than areas outside the desired targeted region. Levy et al. teach the method accommodates a patient’s anatomy and movement during delivery, thereby improving the release and/or activation of drugs for treatment. Thus, the ordinary artisan would have known there were other advantages to performing the method stepwise as taught by Levy et al.
Applicant also argues Levy does not provide any teaching to suggest adenosine would be effective in the absence of ultrafine bubbles combined together.
The above argument is not found persuasive. The purpose of the bubbles is to increase permeation in the skin, which Levy et al. teach. Thus, one of ordinary skill in the art would have expected the use of ultrafine bubbles preceding the application of adenosine to allow for the penetration of the subsequently applied adenosine.
The rejection is hereby maintained.
Maintained Rejections
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Levy et al. (WO 2019/002940, cited in previous Office Action) in view of Park et al. (US 2021/0259953, cited in previous Office Action).
Levy et al. teach a method for improving the targeted delivery of drugs, including in combination with nanobubble technology (para [0003]-[0006]). In one embodiment, microbubbles are generated, which when coupled with ultrasound, increases tissue permeability (para [0008]). A tissue permeability map can be created based on the use of microbubbles. After permeability has been induced, the therapeutic agent may be administered for treatment (para [0010]). Levy et al. teach “Once the mapped region is verified to substantially (e.g., ±5% or ±10% by volume) match the defined target region, the therapeutic agent may be administered to the target region for treatment.” (para [0010]; also see claim 23). Thus, Levy et al. very clearly teach first applying microbubbles, and then administering a therapeutic agent. Levy et al. teach the method accommodates a patient’s anatomy and movement during delivery, thereby improving the release and/or activation of drugs for treatment.
Levy et al. do not expressly disclose wherein the specific component is adenosine (present claim 1). Levy et al. do not expressly disclose water as a principle component of the liquid containing ultrafine bubbles (present claim 3).
Park teaches a drug delivery system having both nanobubbles and a drug encapsulated therein (claim 9). The drug is an active ingredient in cosmetics (claim 13). The nanobubbles have a diameter of 50 nm to 200 nm (claim 2). Park teaches a method of delivering a drug, comprising the steps of administering to an object, the drug delivery system (claims 16 and 17). The active cosmetic ingredient may include adenosine (para [0020]). Park teaches mixing the nanobubble solution with an aqueous solution containing a surfactant (see e.g. para [0035], [0055], [0067], [0070]). The composition may have effects such as skin whitening, skin elasticity improvement, and wrinkle improvement (para [0041]). Park teaches the drug delivery system having the nanobubbles enhances the permeability of the active agent (fig.6, para [0065]; ex.1).
The recitation “a principal component of the liquid is water” is broadly and reasonably interpreted to include a composition comprising water.
The recitation “ultrafine bubbles” is broadly and reasonably interpreted to include bubbles having a diameter of 1000 nm or less (see present Specification, para [0006]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply nanobubbles to the skin, followed by applying adenosine onto the skin.
In accordance with the method taught by Levy et al., the ordinary artisan would have been motivated to apply nanobubbles/microbubbles to the skin and wait until permeability has been induced to apply a drug because it improves the permeation of the drug. Levy et al. teach “Once the mapped region is verified to substantially (e.g., ±5% or ±10% by volume) match the defined target region, the therapeutic agent may be administered to the target region for treatment.” (para [0010]). The step-wise method of Levy et al. ensures optimal drug release.
While Park teaches administering adenosine as part of a bubble system, Park still teaches the use of adenosine with permeability enhancers. The ordinary artisan would have been motivated to apply adenosine separately, after permeation has been enhanced because the goal of both Levy and Park is to increase the permeation of an active agent across the skin barrier. Furthermore, Levy et al. teach an advantage of the method is that it accommodates a patient’s anatomy and movement during delivery, thereby improving the release and/or activation of drugs for treatment.
The skilled artisan would have been motivated to subsequently administer adenosine to the skin because Park teaches the composition may have effects such as skin whitening, skin elasticity improvement, and wrinkle improvement, and cosmetic skin active agents including adenosine are suitable for use with the nanobubble delivery system.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAHAR A CRAIGO whose telephone number is (571)270-1326. The examiner can normally be reached M-F: Noon-8pm ET.
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, Fereydoun Sajjadi can be reached at 571-272-3311. 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.
/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699
Prosecution Insights