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 .
Response to Amendment
The Amendment filed 7/31/2025 has been entered. Claims 1, 4 and 6-9 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every 112(b) rejections previously set forth in the Non-Final Office Action mailed 5/12/2025.
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.
Claims 1, 4 and 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamamoto et al. (US 2016/0144160 A1).
Regarding claim 1, Yamamoto teaches a microneedle sheet 20 (figure 1) comprising:
a sheet body (body of element 20) having a main surface 21; and
at least one microneedle 22 formed on the sheet body (body of element 20) and lying along the main surface 21, wherein
each of the at least one microneedle 22 has a base (see “B” in figure 1 below) positioned on a first side (see “FS” in figure 1 below) of the sheet body (body of element 20) and a tip (see “T” in figure 1 below, examiner construes as a tip pointed part that comes in contact with the skin when bent and pierces inside the skin) oriented toward a second side (see “SS” in figure 1 below) of the sheet body that is opposite to the first side (see “FS” in figure 1 below),
a first end (an end of the element 20 that is gripped to pull element 20 away from the skin) of the sheet body (body of element 20) of the microneedle sheet 20 configured to be placed on skin is pulled in a direction away (figure 11) from the skin and
a first portion (portion of element 20 being bent by element 15 in figure 11) of the sheet body is bent from the first side by an acute angle (paragraph 0060), whereby the microneedle 22 positioned in the first portion is raised from the main surface (see figure 11 where element 22 is raised) and whereby a portion of the microneedle sheet that is not bent is configured to be placed on the skin, whereby a side surface (side surface of element 22) of each of the at least one microneedle is configured to be in contact with the skin without the tip (paragraph 0066, the tip is not exposed until bent and therefore tip is not coming in contact with the skin otherwise the tip could get caught or touched) of each of the at least one microneedle being in contact with the skin, and
the tip (see “T” in figure 1 below) of the microneedle 22 is exposed from the main surface and the exposed tip is configured to shave the skin (see “S”, where sliding the element 20 could shave the skin) while advancing on the skin along a direction (see figure 11) from the second side toward the first side, whereby the raised microneedle 22 is configured to be applied to the skin.
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Regarding claim 4, Yamamoto teaches wherein after the raised microneedle 22 is applied to the skin, the microneedle is configured to lie along the main surface 21 again (see figures 11, 12 and 21).
Regarding claim 6, Yamamoto teaches wherein the sheet body has a belt shape (figure 1), the at least one microneedle 22 is a plurality of microneedles 22, and the plurality of microneedles 22 are formed so as to be aligned in one row (see “R” in figure 1a below) in each of the first direction (see “FD” in figure 1a below) of the sheet body extending from the first side (see “FS” in figure 1 above) to the second side (see “SS” in figure 1 above) and a second direction (see “SD” in figure 1a below) orthogonal to the first direction.
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Regarding claim 7, Yamamoto teaches wherein the first portion is bent along the second direction (see “SD” in figure 1 above), whereby two or more microneedles 22 positioned in the first portion are simultaneously raised (see figures 11, 12).
Regarding claim 8, Yamamoto teaches wherein the microneedle sheet 20 is usable in combination with another transdermal absorption promoting technology 10, and the other transdermal absorption promoting technology 10 includes at least one of electricity, pressure (see figure 10 where elements 14, 15 and element 10 are applying pressure on element 20), a magnetic field, and ultrasound.
Regarding claim 9, Yamamoto teaches an applicator 10 (figures 8, 9) comprising: a microneedle sheet 20; and
a bending portion 15 configured to bend the microneedle sheet 20, wherein
the bending portion 15 bends (see figure 11) the first portion (portion of element 20 being bent by element 15 in figure 11) of the sheet body from the first side.
Regarding claim 10, Yamamoto teaches comprising
a first cartridge (see “FC” in figure 9 below, the structure of cartridge is not claimed and therefore, any structure capable to receive microneedle sheet could be construed as first cartridge) including the microneedle sheet 20 and the bending portion 15; and
a second cartridge (see “SC” in figure 9 below, the structure of cartridge is not claimed and therefore, any structure capable to receive a patch can be construed as second cartridge) configured to feed a patch (“SC” is configured to feed additional layer which could be a patch when the additional layer or patch is feed into the applicator along with the element 20 when putting element 20 into the applicator 10, alternatively if additional layer/patch is adhered to element 20 prior to feeding element 20 into the applicator 10 then “SC” in figure 9 below is capable to feed a patch) to the skin to which the microneedle 22 has been applied (microneedle has been applied is broad term and do not essentially refer to portion where element 22 was previously applied and now removed, instead this phrase could include the portion where element 22 are applied and remains in contact with the skin).
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Response to Arguments
Applicant's arguments filed 7/31/2025 have been fully considered but they are not persuasive.
Applicant argues on page 5, line 18-page 8, last line that Yamamoto fails to disclose a portion of the microneedle sheet that is not bent is configured to be placed on the skin, whereby a side surface of each of the at least one microneedle is configured to be in contact with the skin without the tip of each of the at least one microneedle being in contact with the skin. Applicant further argues that paragraphs 0057 and 0075 of Yamamoto discloses that the raised microneedles stick into the skin but Yamamoto fails to teach that the raised microneedles shave the skin and fails to teach the microneedle sheet placed on the skin is pulled in a direction away from the skin. Therefore, applicant argues that Yamamoto fails to disclose the claimed limitations. Examiner respectfully disagrees. As explained in the rejection of claim 1 above, paragraph 0066 of Yamamoto discloses the claimed limitation of preventing the microneedles from rising from the main surface. Additionally, claim 1 recites that microneedle sheet being configured to be placed on the skin whereby a side surface of each of the at last one microneedle is configured to be in contact with the skin without the tip of each of the at least one microneedle being in contact with the skin. As explained in paragraph 0066 of Yamamoto, the microneedle tip is not exposed until bent therefore, if the microneedle sheet is capable to be placed on the skin such that the side surface of each of the at least one microneedle is configured to be in contact with the skin without the tip of each of the at least one microneedle being in contact with the skin and if the tip of the raised microneedle is exposed from the main surface, the exposed tip is configured to shave the skin if the microneedle sheet is slid on the skin surface. Therefore, Yamamoto teaches each and every claimed limitation.
Conclusion
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).
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 NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783