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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The newly added limitation in claim 1, “wherein a height of the empty space of each of the plurality of microneedles is more than half of a height of each of the plurality of microneedles” is not described in the instant specification.
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.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over KAPLAN et al. (2013/0338632) and in further view of ENOMOTO et al. (2018/0250503).
Regarding claims 1-6, KAPLAN et al. discloses a transdermal drug delivery patch
[0127] comprising:
a flexible base layer [0013], [0088]; and
a plurality of microneedles disposed at one surface of the base layer (Fig.2),
including a biodegradable polymer [0046], [0099], [0112], [0163] and a drug [0027], [0034]-[0035], and having an empty space inside (microneedles are hollow [0035]),
wherein each of the plurality of microneedles is formed of a star-shape [0042].
As evidenced by ENOMOTO et al., star-shaped microneedles include a plurality
of protrusions extending in a radial direction, and a part between two protrusions adjacent along the circumferential direction among the plurality of protrusions is concave (Fig.20) as claimed.
KAPLAN et al. is silent to the hollow or empty space of each of the plurality of microneedles is more than half of a height of each of the plurality of microneedles. However, ENOMOTO et al. discloses hollow star-shaped microneedles have empty space in all of the conical tip part (112), the base (111) and the part having a star polygonal cross section (114) which construct the microneedle (110) (Fig.19, [0208]) and as shown in Fig.19, the height of the empty space is more than half of a height of the microneedle as claimed. Therefore, it would have been obvious to one of ordinary skill in the art a hollow microneedle would have empty space from the base to the tip part of the microneedle wherein the empty space height is more than half of the height of the microneedle.
Response to Arguments
Applicant's arguments filed 12/15/2025 have been fully considered but they are not persuasive.
Applicant argues Kaplan does not disclose the specific relationship between the
internal empty space height and the overall microneedle height as amended in instant claim 1.
Examiner agrees Kaplan does not disclose said feature but Enomoto et al. discloses hollow star-shaped microneedles have empty space in all of the conical tip part (112), the base (111) and the part having a star polygonal cross section (114) which construct the microneedle (110) (Fig.19, [0208]) and as shown in Fig.19, the height of the empty space is more than half of a height of the microneedle. Therefore, it would have been obvious to one of ordinary skill in the art a hollow microneedle would have empty space from the base to the tip part of the microneedle wherein the empty space height is more than half of the height of the microneedle.
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 STELLA KIM YI whose telephone number is (571)270-5123. The examiner can normally be reached Monday-Friday 8:00-5:00 EST.
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STELLA YI
Examiner
Art Unit 1742
/STELLA K YI/Primary Examiner, Art Unit 1742
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