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 .
This office action is in response to the reply filed 6/11/2026.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-13, in the reply filed on 11/19/2025 is acknowledged.
Claims 14-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/19/2025.
Response to Amendments/Arguments
Applicants’ amendments filed 6/11/2026 were sufficient to overcome all of the 112, 102 and 103 rejections presented in the office action mailed 3/12/2026. New rejections are presented below which address the claims as newly amended.
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.
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.
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) 1-9 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banar (US 2015/0065950), JPH0433815 Y2 and Kato (US 2016/0325082). Banar and JP’815 are newly cited.
Regarding claim 1: Banar teaches a device for the percutaneous delivery of therapeutic agents, the device comprises a head, a wheel rotably mounted on the head, the wheel having an axis of rotation and an outer surface, a plurality of needles disposed upon the outer surface, each needle having a tip projecting away from the axis rotation of the wheel and a reservoir mounted on the body, the reservoir containing a fluid, the reservoir having an opening near to the wheel such that the fluid is disposed on the wheel through the opening (abs), this reads on microneedles attached to the application surface of the applicator.
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Banar teaches the device 100 to comprise a wheel 102 having an outer surface 104 (this reads on applicator comprising at least one applicator surface) and a reservoir 106 (reading on container) containing a fluid 107 [0026]. The fluid 107 can be a liquid, a gel, lotion, etc. and can include cometic agents [0033], reading on a cosmetic composition comprising a cosmetic active agent of instant claim 13. Banar teaches that the opening 102 can have a valve that stops the opening 108 when the device 100 isn’t in use [0036]. The valve prevents the fluid (i.e. cosmetic) from passing through the opening when the device isn’t in use, which reads on the valve is configured for controlling the supply of the cosmetic into the microneedles attached to the applicator and reads on the application surface, the container and at least one valve are configured to supply the cosmetic via the valve onto the microneedles attached to the applicator.
As seen above, the container/reservoir is in the form of a hollow container.
However, Banar does not teach the valve to comprise a rational disk as required.
Banar does teach that different types of valves are suitable for use, such as slit valves, check valves, the valve could include a stopper inserted in the opening, the valve could include a biasing means such as a spring, etc. [0036].
JP’815 discloses a device that prevents nail polish from hardening. A hardening agent is stored inside the cap and a blocking plate with a through hole at an eccentric position is used. The cap is closed,
and a through hole is provided at an eccentric position, and an inner cap is provided that is movable relative to the closing plate so that the through holes can be aligned with each other. Fig. 1-2 of JP’815
described that the bottom of the inner cap 26 is provided with a through hole 27 at an eccentric position, the closing plate 29 of the outer cap 25 is provided with a through hole 28 at an eccentric position on the moving path of the through hole 27, and by rotating the inner cap 26 and the outer cap 25 relative to
each other, the through holes 27 and 28 are located at corresponding positions, and the fluid can be discharged from the through hole 27 and the through hole 28 (pg. 3 and figures).
It would have been prima facie obvious for a person of skill in the art to formulate the container and valve of Banar to have an eccentric opening at its top surface and for the valve to have a rotational disk with an eccentric through hole that connects to the opening on the container to control the flow of the fluid based on the placement of the holes. One of skill in the art would have a reasonable expectation of success as both Banar and JP’815 teaches cosmetic compositions present in containers containing mechanisms which control the flow of a product with open and closed valves and Banar teaches the type of valve used isn’t limited and its prima facie obvious to pursue the known options within the technical grasp of a skilled artisan.
Regarding claim 2: Banar teaches that the needles maybe formed separately from the wheel and then attached [0031] and teaches that the needles are designed to break off into the skin which suggest that the microneedles are detachable from the application surface after being attached to said surface.
However, the above reference do not teach the microneedle to be a sheet comprising a substate layer and a plurality of microneedles on that substate layer as recited by instant claim 1 and do not teach the base layer and adhesive layers as recited by instant claims 3-5.
Banar teaches that the microneedles may be formed by polymers and can dissolve when released into the users tissue, suitable dissolvable substances include sodium hyaluronate (i.e. water soluble polymer). Banar teaches that the needles maybe formed separately from the wheel and then attached [0031].
Regarding claims 1 and 4: Kato teaches a kit (10, Fig 1) comprising a microneedle sheet (11), comprising a substate (12) and a plurality of microneedles (13), wherein the microneedle sheet comprises at least one adhesive layer (42) and the adhesive layer is fixed onto (see layers 42, 43 and 44 fixed together to form section 41 in Fig. 5) a base layer (44). Layer 43 is taught to be adhesive [0052] and is attached to the microneedle sheet (11) reading on adhesive layer fixed onto the substrate layer. Kato teaches that the facing surface 12a can be curved or flat [0028].
Regarding claims 3 and 5: Kato teaches a kit (10, Fig 1) comprising a microneedle sheet (11), comprising a substate (12) and a plurality of microneedles (13), wherein the microneedle sheet comprises at least one adhesive layer (42) and the adhesive layer is fixed onto (see layers 42, 43 and 44 fixed together to form section 41 in Fig. 5) a base layer (41).
One of skill in the art would have been motivated to include a microneedle sheet as taught by Kato attached to the surface of the wheel (i.e. applicator) of Banar and include an adhesive layer fixed onto a base layer as Kato teaches this provides a high rigidity to the microneedle sheet via the base layer that prevent separation of the microneedle and the target contact section [0062-0063] and provides an adhesive layer with easy-peel properties or an adhesive having re-adhesion properties [0057]. One of skill in the art would have a reasonable expectation of success as both Kato and Banar teaches devices comprising microneedle and Banar teaches that the needles maybe formed separately and then attached to the wheel.
Regarding claim 6: Kato teaches a kit (10, Fig 1) comprising a microneedle sheet (11), wherein the microneedle sheet comprises at least one releasing layer (31), and the releasing layer (i.e. a cover) is placed on an adhesive layer (42). This cover is located on the adhering section and prevents the adhesive from being touched by the user [0098].
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Banar with those of Kato. One of ordinary skill in the art would have been motivated to include a cover (i.e. releasing layer) over the adhesive layer (41) to prevent a user from touching the adhesive prior to use. One of ordinary skill in the art would have a reasonable expectation of success as both Kato and Banar teaches devices comprising microneedle.
Regarding claim 7: Banar teaches the microneedles to extend from the surface by a length of 0.001mm to 1mm (250-1000 µm).
Regarding claim 8-9: As seen in the Fig 1 and 6 of Banar of application surface (i.e. the wheel) is curved and the applicator is a cylindrical roller.
Regarding claim 12: As discussed above, the prior art makes obvious a valve that functions like a gate by alignment or misalignment of holes.
Claim(s) 1-9, 10-11 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banar (US 2015/0065950), JPH0433815 Y2 and Kato (US 2016/0325082), as applied to claims 1-9 and 12-13 above, and further in view of Nagai (WO 2018/220926).
As discussed above, the above references makes obvious the limitations of claims 1-9 and 12-13, but do not teach a housing that stores the microneedle sheet as recited by instant claims 10-11.
Regarding claim 10: Nagai teaches a microneedle patch and its packaging (reading on housing) [0001]. The packaging comprises an oil gel sheet and a storage sheet having a storage section having a plurality of microrecessed in which a plurality of microneedles are stored [0011] which protects the microneedles [0034].
Regarding claim 11: The oil gel sheet is taught to be formed on a support made from a woven or non-woven fabric [0017].
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of the above references with those of Nagai. A skilled artisan would have been motivated to store the microneedle unit made obvious above in a packaging such as taught by Nagai to ensure that the microneedles are protected prior to use.
Conclusion
No claims are allowable.
Applicants’ 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 Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
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, Brian Kwon can be reached at (571) 272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613
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