DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/17/26 has been entered.
Claim Objections
Claim 1 is objected to because of the following informalities: line 9 should be amended to -wherein the plurality of first microneedles comprises a conical shape-. Appropriate correction is required.
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.
Claim 5 is 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.
Regarding claim 5:
The claim limitation “further comprising a plurality of second microneedles” in lines 1-2 is unclear. Its unclear if this limitation is establishing a second set of second microneedles or is the same set as established in claim 1 (see “at least one second microneedle” in line 9 of claim 1 on which this claim depends). For the sake of examination, the office has assumed that these refer to the same microneedles. However, the applicant should amend the claims to clarify.
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) 1 and 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP 2021171460 A to Nada et al. (Nada) (see English language machine translation attached to this or a previous office action) in view of WO 2016010034 A1 to Shiomitsu (see English language machine translation attached to this or a previous office action).
Regarding claim 1:
Nada discloses:
A microneedle patch (figure 1), comprising a microneedle structural layer (2), an adhesive layer (32; ¶0015), and a carrier layer (31), wherein
the adhesive layer (32) is disposed between the microneedle structural layer (2) and the carrier layer (31), and is connected to the microneedle structural layer (2) and the carrier layer (31);
the microneedle structural layer (2) includes a base layer (22) and a plurality of microneedles (21); the base layer (22) has a first side (see the side B in figure 1 below) and a second side (see the side A in figure 1 below) opposite to the first side (B in figure 1 below); the first side (B in figure 1 below) faces the adhesive layer (32), the plurality of microneedles (21) are spaced apart from each other and disposed (see figure 1 below) on the second side (A in figure 1 below), and comprise a plurality of first microneedles (see the needle C in figure 1 below); wherein the first microneedle comprises a conical shape (see ¶0016 in the translation).
Nada fails to disclose:
At least one second microneedle;
Wherein the at least one second microneedle has a bottom surface, and is located at an edge of the microneedle structural layer, wherein the bottom surface is intersected by the edge of the microneedle structural layer;
wherein a height of the at least one second microneedle is less than a height of each first microneedle, and the at least one second microneedle comprises an incomplete conical shape.
Shiomitsu teaches:
A microneedle patch (see figure 11) comprising a microneedle structural layer (10) including a base layer (11) and a plurality of microneedles (12/13). Further, the plurality of microneedles includes a first plurality of microneedles (12) and a second plurality of needles (13). Further, the at least one second microneedle has a bottom surface (see the bottom surface E in figure 2 below), and is located at an edge (see the edge F in figure 2 below) of the microneedle structural layer, wherein the bottom surface (see the bottom surface E in figure 2 below) is intersected by the edge (see the edge F in figure 1 below) of the microneedle structural layer; wherein a height of the at least one second microneedle (see height Ht as shown in figure 1) is less than a height of each first microneedle (see the height Hn as shown in figure 1), and the at least one second microneedle comprises an incomplete conical shape (see page 8 ¶4 of the translation which teaches second microneedle 13 can be conical in shape and further figure 11 that shows the conical shape cut in part due to the edge F and further how it is flat on the top). The reference further teaches the microneedle 13 is added to control the depth that the first microneedles can penetrate (translation, page 8, ¶3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nada to further include a plurality of second microneedles (including the bottom surface located on the edge, having a height less than the first microneedles and including an incomplete conical shape) as taught by Shiomitsu in order to control the depth of penetration of the first microneedles (Shiomitsu, translation, page 8, ¶3).
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Figure 1 – figure 3 of Nada, annotated by the examiner
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Figure 2 – figure 11 of Shiomitsu, annotated by the examiner
Regarding claim 2:
Nada discloses:
The microneedle patch according to claim 1, wherein the plurality of first microneedles have the same height in a range of 150 to 1000 µm (¶0016).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP 2021171460 A to Nada et al. (Nada) and WO 2016010034 A1 to Shiomitsu as applied to claim 1 above, and further in view of US 20210069482 A1 to Ryu et al. (Ryu).
Regarding claim 3:
Nada and Shiomitsu fail to disclose:
The microneedle patch according to claim 1, wherein a distance between adjacent microneedles of the plurality of microneedles is 0.5 to 5 mm.
Ryu teaches:
A microneedle patch (figure 1b) includes microneedles (MN) where the microneedles can be arranged from 100 µm to 10 mm apart (¶0065 and 0104). Further, the reference teaches that smaller microneedles can be arranged outside of larger microneedles (see figure 1b). the reference further indicates this arrangement of microneedles allows for table insertion of the patch (¶0015).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nada and Shiomitsu to further include the microneedles spaced apart 100 µm to 10 mm (overlapping with 0.5 to 5 mm) as taught by Ryu in order to allow for stable insertion of the microneedles (Ryu, ¶0015).
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP 2021171460 A to Nada et al. (Nada) and WO 2016010034 A1 to Shiomitsu as applied to claim 1 above, and further in view of US 20220023605 to Zvezdin et al. (Zvezdin).
Regarding claim 4:
Nada and Shiomitsu fail to disclose:
The microneedle patch according to claim 1, wherein a shape of the at least one second microneedle is different from a shape of the plurality of first microneedles.
Zvezdin teaches:
A microneedle patch that includes microneedles (21 and 11) of different shapes and sizes (see figures 3 and 14). The reference further teaches that having different microneedles of different shapes and sizes prepares the skin to receive injection from other microneedles in the array (see ¶0047).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nada and Shiomitsu to make the second microneedles of different shapes as taught by Zvezdin in order to prepare the skin to receive the injection form the first microneedles (Zvezdin, ¶0047).
Regarding claim 5:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 4 by Nada, Shiomitsu and Zvezdin:
The microneedle patch according to claim 4, further comprising a plurality of second microneedles having different shapes (see the different shapes for the for the second microneedles as taught by Zvezdin incorporated into Nada).
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP 2021171460 A to Nada et al. (Nada) and WO 2016010034 A1 to Shiomitsu as applied to claim 1 above, and further in view of WO 2006062848 A1 to Carter et al. (Carter).
Regarding claim 6:
Nada and Shiomitsu fail to disclose:
The microneedle patch according to claim 1, further comprising a release film, the release film being disposed at the periphery of the base layer and at least partially along the periphery of the base layer.
Carter teaches:
A microneedle patch (figure 5) that includes a microneedles (32), microneedle structural layer (30), an adhesive layer (34), a carrier layer (26) and release film (242). The reference teaches that the release film is located at the periphery of the microneedle structural layer (as shown in figure 5). Further, the reference indicates the release film isolates the microneedles from the adhesive layer (page 8, lines 1-10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nada and Shiomitsu to further include a release layer around the periphery of the microneedle structural layer (in accordance with the 35 USC 112(b) claim rejection above) as taught by Carter for the purpose of isolating the microneedles form the adhesive layer (Carter, page 8, lines 1-10).
Regarding claim 7:
Nada discloses:
The microneedle patch according to claim 6, wherein the microneedle structural layer has a shape similar to a shape of the carrier layer (see figure 3 where the rectangular cross-section/shape of the structural layer 22 and the carrier layer 31); the carrier layer is equal to or larger than the microneedle structural layer (see figure 3 where the carrier layer 31 extends beyond the microneedle structural layer 22 and is therefore larger).
All of the following limitations of the claim are taught by the 35 USC 103 rejection of claim 6 by Nada, Shiomitsu and Carter:
And the release film surrounds the microneedle structural layer (see the release film layer 242 of Carter that surround the microneedle structural layer 30 of Carter as shown in figure 5 and would be incorporated into Nada accordingly).
Response to Arguments
Applicant’s arguments, see remarks, filed 3/17/26, with respect to the rejection(s) of claim(s) 1-7 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Nada and Shiomitsu.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
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