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.
Claim Objections
Claim 1 is objected to because of the following informalities: lines 15-16 should be amended to -the first [[microneedle]] microneedles, and the bottom surface of the at least one second microneedle is shaped like at least one segment of the bottom surface of the first [[microneedle]] microneedles;-. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: line 2 should be amended to - wherein the at least one second microneedles having different shapes-. Appropriate correction is required.
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 1-7 are 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.
Regarding claim 1:
The limitation “and an area of the bottom surface of the at least one second microneedle is smaller than or equal to an area of the bottom surface of the first microneedle, and the bottom surface of the at least one second microneedle is shaped like at least one segment of the bottom surface of the first microneedle” in lines 13-16 is new matter. The specification previously indicates that the first and second microneedles can have the same shape (see ¶0029) there is nothing indicating that the surface area of the first and second microneedles is the same or different size. The applicant has indicated in ¶0028 -¶0030 that the microneedles have the same cross-sectional area (see pages 6 and 7 of the remarks) but there is nothing indicating that this is the case in the original disclosure. The applicant has further indicated that this is shown in the figures, but this is not clearly shown since it is not possible to determine the correlation between the different microneedles and their cross-sectional area. For this reason, the amendments to the claims are considered new matter and are rejected.
Claims 2-7 are rejected due to their dependence on claim 1.
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 1-7 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.
Regarding claim 1:
The claim is unclear because of the limitation “the bottom surface” in line 12. Its unclear which bottom surface this limitation refers to since both the first microneedles and the second microneedles both include a bottom surface. For the sake of examination, the office has assumed that this limitation refers to the bottom surface of the second microneedles, however the applicant should amend the claim to clarify.
Claims 2-7 are rejected due to their dependence on claim 1.
Response to Arguments
Applicant’s arguments, see remarks, filed 7/15/26, with respect to the non-final rejection filed 4/16/26 have been fully considered and are persuasive.
Regarding the 35 USC 103 rejections of the claims:
The applicant’s amendments to the claims are persuasive and for this reason they are withdrawn.
Regarding the 35 USC 112(b) rejections of the claims:
The applicant’s amendments to the claims are persuasive and for this reason they are withdrawn. However, a new set of rejections have been made above due to the amendments to the claims.
Regarding the claim objections:
The applicant’s amendments to the claims have addressed the previous claim objections and for this reason they have been withdrawn.
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 WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
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