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 .
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Claims 14-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, paragraphs 3-4 recites the following limitations once or more "the applicator,” “the application surface”, “the container,” “the valve” and “the microneedle sheet” . There is insufficient antecedent basis for this limitation in the claim as claim 1 in paragraph 2-3 recite "at least one applicator,” “at least one application surface”, “at least one container,” “at least one valve” and “at least one microneedle sheet”, thus it’s unclear if "the applicator,” “the application surface”, “the container,” “the valve” and “the microneedle sheet” is referring to one, more than one or all of the applicator, the application surface, the container, the valve and the microneedle sheets.
Claim 1 recites “microneedle sheet is capable being attached to the applicator” and then recites “microneedle sheet attached to the applicator”, this phrase are contradictory and is it unclear from the claim if the microneedle sheet is required to be attached to the applicator or if it simply needs to be capable of being attached.
Regarding claim 1, the phrases "preferably" and “more preferably” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 1 recites the limitation "the skin," “the lips” and “the scalp”. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-13 are rejected in view of their dependency on claim 1 as these claims do not cure the deficiencies of claim 1 and thus are deficient for the same reasons.
Claim 2 recites the following limitations once or more "the applicator,” and “the microneedle sheet” . There is insufficient antecedent basis for this limitation in the claim as claim 1 recites "at least one applicator,” and “at least one microneedle sheet”, thus it’s unclear if "the applicator,” and “the microneedle sheet” is referring to one, more than one or all of the applicator, and the microneedle sheets.
Claim 3 recites the following limitations "the base layer” . There is insufficient antecedent basis for this limitation as the claim previously recites "at least one base layer”, thus it’s unclear if "the base layer” is referring to one, more than one or all of the base layers.
Claim 4 recites the following limitations "the microneedle sheet” and “the adhesive layer” . There is insufficient antecedent basis for this limitation as the claim previously recites "at least one adhesive layer” and claim 1 recites “at least one microneedle sheet”, thus it’s unclear if "the microneedle sheet” and ”the adhesive layer” is referring to one, more than one or all of the microneedle sheets and adhesive layers.
Claim 5 recites the following limitations "the microneedle sheet,” “the adhesive layer” and “the base layer” . There is insufficient antecedent basis for this limitation as the claim previously recites "at least one adhesive layer” and claim 1 recites “at least one microneedle sheet” and claim 3 recites “the at least one base layer”, thus it’s unclear if "the microneedle sheet,” ”the adhesive layer” and “the base layer” is referring to one, more than one or all of the microneedle sheets, adhesive layers and base layers.
Claim 6 recites the following limitations "the microneedle sheet,” and “the releasing layer”. There is insufficient antecedent basis for this limitation as the claim previously recites "at least one releasing layer” and claim 1 recites “at least one microneedle sheet”, thus it’s unclear if "the microneedle sheet” and ”the releasing layer” is referring to one, more than one or all of the microneedle sheets and releasing layers.
Claim 7 recites the following limitations "the microneedle” . There is insufficient antecedent basis for this limitation as the claim previously recites "a plurality of microneedles”, thus it’s unclear if "the microneedle” is referring to one, more than one or all of the microneedles.
Regarding claim 7 the phrases "preferably" and “more preferably” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 8 recites the following limitations "the application surface” and “the applicator” . There is insufficient antecedent basis for this limitation as claim 1 recites "at least one application surface” and “at least one applicator”, thus it’s unclear if "the application surface” and “the applicator” is referring to one, more than one or all of the application surfaces and applicators.
Claim 9 recites the following limitations “the applicator” and “the cylindrical roller” . There is insufficient antecedent basis for this limitation as claim 1 and 9 recites "at least one cylindrical roller” and “at least one applicator”, thus it’s unclear if "the cylindrical roller” and “the applicator” is referring to one, more than one or all of the cylindrical rollers and applicators.
Claim 10 recites the following limitations "the housing” . There is insufficient antecedent basis for this limitation as the claim previously recites "at least one housing”, thus it’s unclear if "the housing” is referring to one, more than one or all of the housings.
Claim 11 recites the following limitations "the housing” . There is insufficient antecedent basis for this limitation as claim 10 recites "at least one housing”, thus it’s unclear if "the housing” is referring to one, more than one or all of the housings.
Regarding claim 11, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 12 recites the following limitations "the valve” . There is insufficient antecedent basis for this limitation as claim 1 recites "at least one valve”, thus it’s unclear if "the valve” is referring to one, more than one or all of the valves.
Claim 12 recites the following limitations "the cosmetic composition” . There is insufficient antecedent basis for this limitation as claim 1 recites "at least one cosmetic composition”, thus it’s unclear if "the cosmetic composition” is referring to one, more than one or all of the cosmetic compositions.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3-4 and 12-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP2015-136527. JP’527 is cited on the 12/15/2022. The Examiner has provided a copy of the machine translation relied upon below.
JP’527 discloses a microneedle unit including a microneedle and a container for the needle [0001] which reads on a kit.
JP’527 discloses Fig. 1, Fig. 2 and Fig. 3 as follows:
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Regarding claim 1: The above figures disclose a kit (10) comprising a microneedle sheet (31) having a substrate layer (32) and a plurality of microneedles (33) on the substrate layer [0021-0022]. The microneedles are taught to be made up of a water soluble polymer [0049].
Regarding the device of claim 1: The above figures show an applicator (12 and 13) comprising a container (12) and a liquid composition (51) which is stored in a storage space (11a) and a valve (21 and 13) [0025, 0045], (21) is taught to be a draw-out member composed of a stopper portion that closes the supply passage of 11b (reading on a valve). JP’527 teaches the liquid composition to be a cosmetic composition [0052-0052 and 0054].
Regarding “the microneedle sheet is capable of… attached to the applicator: The substrate layer (32) of the microneedle sheet is attached to the application surface (41) of the applicator (12 and 13). (21) is taught to be a draw-out member composed of a stopper portion that closes the supply passage of 11b which reads on a valve capable of controlling supply of the composition on the microneedle sheet.
Regarding claim 3: Fig 2 shows the substate layer (31) attached to an adhesive layer (41), which reads on a base layer.
Regarding claim 4: Fig 2 shows the substate layer (31) attached to an adhesive layer (41), which reads on an adhesive layer.
Regarding claim 12: Fig 1-2 show (21) is taught to be a draw-out member composed of a stopper portion that closes the supply passage of 11b, this reads on a gate valve.
Regarding claim 13: JP’527 teaches the cosmetic composition to comprise active substances that exhibit cosmetic effects [0054], reading on cosmetic active ingredient.
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.
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) 1-4, 7 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP2015-136527.
JP’527 discloses a microneedle unit including a microneedle and a container for the needle [0001] and teaches administering a cosmetic composition to the skin using the unit [0052], this reads on a cosmetic kit for the skin.
JP’527 discloses Fig. 1, Fig. 2 and Fig. 3 as follows:
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Regarding claim 1: The above figures disclose a kit (10) comprising a microneedle sheet (31) having a substrate layer (32) and a plurality of microneedles (33) on the substrate layer [0021-0022]. The microneedles are taught to be made up of a water soluble polymer [0049].
Regarding the device of claim 1: The above figures show an applicator (12 and 13) comprising a container (12) and a liquid composition (51) which is stored in a storage space (11a) and a valve (21 and 13) [0025, 0045], (21) is taught to be a draw-out member composed of a stopper portion that closes the supply passage of 11b (reading on a valve) [0029]. JP’527 teaches the liquid composition to be a cosmetic composition [0052-0052 and 0054].
Regarding “the microneedle sheet is capable of… attached to the applicator: The substrate layer (32) of the microneedle sheet is attached to the application surface (41) of the applicator (12 and 13). (21) is taught to be a draw-out member composed of a stopper portion that closes the supply passage of 11b which reads on a valve capable of controlling supply of the composition on the microneedle sheet.
Regarding claim 2: JP’527 teaches that the substrate layer (31) is held in place by a fitting groove and a fitting protrusion even if the adhesive strength between the microneedle (31) and the adhesive layer (41) is small [0046], which suggests that the microneedle sheet is detachable from the application surface, if detachment is desired.
Regarding claim 3: Fig 2 shows the substate layer (31) attached to an adhesive layer (41), which reads on a base layer.
Regarding claim 4: Fig 2 shows the substate layer (31) attached to an adhesive layer (41), which reads on an adhesive layer.
Regarding claim 7: JP’527 teaches that the protrusions (i.e. microneedles) (33) preferably have a height within the range of 10µm to 1000µm [0066], thus it would be obvious to formulate the microneedles to have this height.
Regarding claim 12: Fig 1-2 show (21) is taught to be a draw-out member composed of a stopper portion that closes the supply passage of 11b, this reads on a gate valve.
Regarding claim 13: JP’527 teaches the cosmetic composition to comprise active substances that exhibit cosmetic effects [0054], reading on cosmetic active ingredient.
Claim(s) 1-4, 5-6, 7 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP2015-136527, as applied to claims 1-4, 7 and 12-13 above, and further in view of Kato (US 2016/0325082).
As discussed above, JP’527 makes obvious the limitations of claims 1-4, 7 and 12-13, but does not teach at least one adhesive layer attached to the based layer as required by instant claim 5 and does not teach the microneedle sheet to comprise a releasing layer on the adhesive layer as recited by instant claim 6.
Regarding claim 5: Kato teaches a kit (10, Fig 1) comprising a microneedle sheet (11), 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)
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 JP’527 with those of Kato. One of skill in the art would have been motivated to include in the microneedle sheet of JP’527 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 JP’527 teaches kits comprising microneedle sheets along with adhesive layers.
Regarding claim 6: JP’527 also teaches that the adhesive layer (41) comes into contact with a portion of the subjected that is located around the substrate layer (32) [0093].
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 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 JP’527 with those of Kato. One of skill in the art would have been motivated to include a cover (i.e. releasing layer) over the adhesive layer (41) of JP’527 to prevent a user from touching the adhesive prior to use. One of skill in the art would have a reasonable expectation of success as both Kato and JP’527 teaches kits comprising microneedle sheets along with adhesive layers.
Claim(s) 1-4, 7, 8-9 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP2015-136527, as applied to claims 1-4, 7 and 12-13 above, and further in view of Jung (US 2018/0177991). Jung is cited on the 12/15/2022 IDS.
As discussed above, JP’527 makes obvious the limitations of claims 1-4, 7 and 12-13, but does not teach the applicator surface to be curved and for the applicator to comprise a cylindrical roller as recited by instant claims 8-9.
JP’527 teaches a projection forming surface (32a) and its opposing surface (32b) of the base 32 (i.e. the substrate forming layer) which is attached to the adhesive layer (41) may have a curved or a flat shape [0036].
Jung teaches a microneedle applicator for infiltrating microneedles into skin. The Applicator includes an application portion having a curved side surface that is configured to press the microneedles. The application portion is rolled on the skin so that the microneedles are sequentially applied to the skin in a longitudinal direction of the curved surface (Abs). The applicator is capable of accurately applying a microneedle to an uneven surface of skin [0011].
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 JP’527 with those of Jung. As discussed above, JP’527 teaches that the surfaces (32a and 32b) of the substrate layer (32) can be curved, as such a skilled artisan would have also been motivated to formulate the device of JP’527 to have both a curved substrate layer and a curved application surface and further apply the device of JP’527 using a cylindrical roller having the microneedle unit attached as Jung teaches that the use of a curved applicator is capable of accurately applying a microneedle to an uneven surface of skin.
Claim(s) 1-4, 7, 10-11 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP2015-136527, as applied to claims 1-4, 7 and 12-13 above, and further in view of Nagai (WO 2018/220926). Nagai is cited on the 12/15/2022. The Examiner has provided a copy of the machine translation relied upon below.
As discussed above, JP’527 makes obvious the limitations of claims 1-4, 7 and 12-13, but does 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 JP’527 with those of Nagai. A skilled artisan would have been motivated to store the microneedle unit of JP’527 in a packaging such as taught by Nagai to ensure that the microneedles are protected prior to use.
Conclusion
No claims are allowable.
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.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613