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 § 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.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a) (1) as being anticipated by You (CN 104069585) hereinafter You.
Regarding claim 1, You teaches a microneedle assembly, comprising:
a mold (5, Fig 2) having one or more concave portions (pointed by 1) formed to correspond to shapes of microneedles (See Figure 1-2) the microneedles molded using the mold and accommodated in the mold (refer to); and
an applicator (2/3) configured to be detachably coupled to an upper surface of the mold, wherein the mold is a first part of a packaging container, which is configured to accommodate and protect the molded microneedles, an upper side of the molded microneedles is exposed in a state where the molded microneedles are accommodated in the mold, the applicator is a second part of the packaging container, which is configured to cover and protect the exposed upper side of the microneedles in a state where the applicator is coupled to the upper surface of the mold (see Figure 1),
when the microneedles are applied to a skin (4) of an object, the microneedles lie in a
state where they can be separated from the mold, through detaching the applicator from the mold (see Figure 2), and the applicator includes a pressing surface (surface of 2 pointed by downward arrows in Figure 2) which presses the microneedles toward the skin of the object while being in a contact with the microneedles.
Regarding claim 2, You teaches the applicator further includes an
adhesion portion (3) formed on the pressing surface, and the adhesion portion functions to separate the microneedles from the mold by attaching the microneedles (see Figure 2).
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) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over You in view of Kato et al. (WO 2015111672) hereinafter Kato.
Regarding claim 3, You fails to explicitly teach the applicator further includes one or more pressing protrusions formed at positions on the pressing surface corresponding to the microneedles, and wherein the adhesion portion is formed on the upper surface of the pressing protrusions. Kato teaches one or more pressing protrusions (layers 44 and 42) formed at positions on the pressing surface corresponding to the microneedles, and wherein the adhesion portion is formed on the upper surface of the pressing protrusions (surface 42 has an adhesion portion for cover 31, See Figure 6). It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to further provide pressing protrusions on the pressing surface to attach a cover as taught by Kato in the microneedle assembly of You, to further protect the microneedles before injection.
Regarding claim 4, modified You fails to teach a protection cover configured to be detachably coupled to the pressing surface of the applicator SO as to close the pressing surface. Kato teaches a protection cover (31) configured to be detachably coupled to the pressing surface of the applicator so as to close the pressing surface (See Figures 6-7). It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to further provide a cover as taught by Kato in the microneedle assembly of You, to further protect the microneedles before injection.
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest art of record You modified by Kato fail to teach the mold includes one or more guide protrusions formed to be coupled to the applicator, and the applicator includes one or more guide holes into which the guide protrusions are inserted, therefore the prior art of record neither anticipates nor rendered obvious the present invention as set forth in the independent claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDELMIRA BOSQUES whose telephone number is (571)270-5614. The examiner can normally be reached 9:00am-5:00pm M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Edelmira Bosques can be reached at 571-270-5614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
EDELMIRA BOSQUES
Supervisory Patent Examiner
Art Unit 3762
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772
Prosecution Insights