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 12/1/2025 has been entered. Claims 1-5, 9-13 and 15-20 remain pending in the application. Applicant’s amendments to the Specification each and every objection previously set forth in the Non-Final Office Action mailed 9/3/2025.
The specification was received on 12/1/2025. This specification is acceptable.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4 recites the limitation “the lower portion” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Appropriate correction is required.
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, 2, 5, 13 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Asai et al. (US 2017/0281919 A1).
Regarding claim 1, Asai teaches a microneedle applicator (figure 7A with embodiment of figure 10), comprising:
a microneedle array 15A;
an operation member 10 disposed on an upper portion (upper portion of element 15A) of the microneedle array 15A and operating such that a user applies an external force so as to insert a microneedle 17 into skin (see figure 5 where figure 7A will be operated in similar manner);
a housing 3 for accommodating the microneedle array 15A and the operation member 10;
a first guide member 71 disposed in at least one position on a lateral portion of the operation member 10 and protruding from an outer circumferential surface (outer surface of element 10) of the operation member 10;
a second guide member 72 which is disposed on an inner surface (inner surface of element 21) of the housing 3 in a position corresponding to the first guide member 71 and recessed from the inner surface of the housing so as to be engaged with the first guide member 71, and allows the first guide member 71 to slide so as to prevent the microneedle array 17 from rotating or horizontally distorting when the microneedle array 15A uniformly vertically descends due to the external force;
a locking member 25 provided to support a lower end (end of element 46 touching element 52) of the operation member,
wherein the microneedle array 15A is attached to a lower portion (portion of element 10 comprising element 10A) of the operation member 10,
wherein the locking member 25 is provided to protrude from an upper end (end of element 21 where element 25 is present) of the inner surface (inner surface of element 21) of the housing 3 toward a center (point through which element “C” passes) of the housing 3,
wherein the operation member 10 is configured to descend to a lower surface (surface where element 92 is present) of the housing 3 by passing through the locking member 25 when the external force is applied, and
wherein the second guide member 72 and the locking member 25 is formed on the inner surface (inner surface of element 21) of the housing 3.
Regarding claim 2, Asai teaches wherein the first guide member 71 is provided in a straight-line shape in a vertical direction (see figure 10) from the lateral portion of the operation member 10.
Regarding claim 5, Asai teaches wherein the operation member 10 presses the microneedle array 15A with a force of passing through the locking member 25 by the external force (paragraph 0055).
Regarding claim 13, Asai teaches a microneedle applicator (figure 7A with embodiment of figure 10), comprising:
a microneedle array 15A;
an operation member 10 disposed on an upper portion (upper portion of element 15A) of the microneedle array 15A and operating such that a user applies an external force so as to insert a microneedle 17 into skin (see figure 5 where figure 7A will be operated in similar manner);
a housing 3 for accommodating the microneedle array 15A and the operation member 10;
a support member 25 on an inner surface (inner surface of element 21) of the housing 3 to support the operation member 10 with a constant supporting force and release the supporting force by the external force (paragraph 0055) such that the operation member 10 joins the microneedle array 15A;
a first guide member 71 disposed in at least one position on a lateral portion of the operation member 10 and protruding from an outer circumferential surface (outer surface of element 10) of the operation member 10;
a second guide member 72 which is disposed on an inner surface (inner surface of element 21) of the housing 3 in a position corresponding to the first guide member 71 and recessed from the inner surface of the housing so as to be engaged with the first guide member 71, and allows the first guide member 71 to slide so as to prevent the microneedle array 17 from rotating or horizontally distorting when the microneedle array 15A uniformly vertically descends due to the external force;
wherein the first guide member 71 includes a plurality of protrusion (plurality of elements 71 are present) arranged on the outer circumferential surface of the operation member 10, and the second guide member 72 includes a plurality of recesses (plurality of elements 72 are present) arranged on the inner surface of the housing at positions corresponding to the plurality of protrusions,
wherein the microneedle array 15A is attached to a lower portion (portion of element 10 comprising element 10A) of the operation member 10, and
wherein the operation member 10 is configured to descend to a lower surface (surface where element 92 is present) of the housing 3 by passing through the locking member 25 when the external force is applied.
Regarding claim 15, Asai teaches wherein the support member 25 is a locking member 25 provided to protrude from an upper end (end of element 21 where element 25 is present) of the inner surface (inner surface of element 21) of the housing 3 toward a center (towards element “C”) of the housing 3, wherein the locking member 25 supports a lower end (end of element 10 supporting element 15A) of the operation member 10, and wherein the operation member 10 presses the microneedle array 15A with a force of releasing the supporting force by the locking member by the external force (paragraph 0055).
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.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Asai et al. (US 2017/0281919 A1) in view of Tokumoto et al. (US 2014/0243747 A1).
Regarding claim 3, Asai discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 2. Asai is silent regarding wherein the second guide member has a different width depending on a position on the horizontal cross-section of the housing.
However, Tokumoto teaches wherein the second guide member 60 has a different width (see figure 2) depending on a position on the horizontal cross-section of the housing for the purpose of allowing the operation member to slide only in the vertical direction with respect to the housing (paragraph 0043, lines 5-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the medical applicator of Wirtanen to incorporate wherein the second member has a different width depending on a position on the horizontal cross-section of the housing for the purpose of allowing the operation member to slide only in the vertical direction with respect to the housing (paragraph 0043, lines 5-9).
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Asai et al. (US 2017/0281919 A1) in view of Colburn et al. (US 2014/0236090 A1).
Regarding claim 4, Asai discloses the claimed invention substantially as claimed, as set forth above in claim 1. Asai is silent regarding an adhesive layer provided on the lower portion of the housing and configured to be attached to the skin, wherein the adhesive layer has an opening in a center of the adhesive layer and is provided with a peeling part such that one side protrudes to an outside.
However, Colburn teaches a design of a microneedle applicator (figure 4) comprising an adhesive layer 160 provided on the lower portion 112 of the housing 111, 112 and configured to be attached to the skin, wherein the adhesive layer 160 has an opening (hole in the center of element 160) in a center of the adhesive layer and is provided with a peeling part 170 such that one side (see “S” in figure 3 below) protrudes to the outside for the purpose of facilitating the attachment of the housing to the patient’s skin surface for performing a medical procedure (paragraph 0045, lines 1-7) and using a well-known alternative design configuration to facilitate the removal of the peeling part at the time of usage (figure 3, paragraph 0045).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify a housing of Asai to incorporate an adhesive layer provided on the lower portion of the housing and configured to be attached to the skin, wherein the adhesive layer has an opening in a center of the adhesive layer and is provided with a peeling part such that one side protrudes to an outside as taught by Colburn for the purpose of facilitating the attachment of the housing to the patient’s skin surface for performing a medical procedure (paragraph 0045, lines 1-7) and using a well-known alternative design configuration to facilitate the removal of the peeling part at the time of usage (figure 3, paragraph 0045).
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Response to Arguments
Applicant’s arguments with respect to claims 1 and 13 have been considered but are moot because the arguments do not apply in view of the present rejection.
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