CTNF 18/570,924 CTNF 91138 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15-aia AIA Claim(s) 1-2, 4 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Frederickson et al. (US. 20080195035A1) (“Frederickson”) . Re claim 1 , Frederickson discloses a microstructure cartridge (cartridge 230 in Fig, 19-20, and the applicator 132 as in Fig. 14-15, Fig. 1-20) comprising: a base plate (232, 234, 236) including: a first plate region (232) to be inserted into a microstructure applicator (132, Fig. 14); a second plate region (236, 234) adjacent to the first plate region (Fig. 19) and constructed not to be inserted into the microstructure applicator (Fig. 14); and a bending or cutting guide line (top end of 234) as a boundary between the first plate region and the second plate region (Fig. 20, Fig. 3b, Fig. 16); and a microneedle (240, ¶0055) disposed on the first plate region of the base plate (Fig. 19), wherein the second plate region is constructed to be bent or cut along the guide line (Fig. 20). Re claim 2 , Frederickson discloses wherein the guide line is formed in a groove extending linearly along one direction (groove in pleated section of 234 of the inner circular direction, Fig. 19, ¶0055). Re claim 4 , Frederickson discloses a microstructure applicator (132, Fig. 1-20) comprising: a housing (132 housing) having a sidewall (134, Fig. 15) having a predetermined height (Fig. 15), wherein upper and lower ends of the housing are opened (opens for 138 and lower end for the microneedle cartridge 30/230); and a cartridge receiving portion having a cartridge receiving surface (138) for receiving the microstructure cartridge ( Fig. 15) of claim 1 ( see the rejection of claim 1) therein (Fig. 15), wherein the cartridge receiving surface is constructed to be inserted into the housing (Fig. 15),wherein the second plate region is exposed to an outside while not being received in the cartridge receiving portion (Fig. 15), wherein when the cartridge receiving portion is received in the housing (Fig. 16), the second plate region is engaged with the sidewall so as to be bent or cut (Fig. 16, Fig. 20). Re claim 6 , Frederickson discloses wherein a distance between one side of the receiving surface of the cartridge receiving portion and a portion of the sidewall of the housing facing the one side is greater than a thickness of the second plate region of the microstructure cartridge (space between 134 and 138 is distance at the lower end of 138 toward 134 is greater than the thickness of 34/234 see Fig. 15, the space for 34 to bend see Fig. 16) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim (s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frederickson in view of Genosar et al. (US.20120241466A1) (“Genosar”) . Re claim 3 , Frederickson fails to discloses, wherein the guide line includes a linear arrangement of holes arranged so as to be spaced from each other by a predetermined spacing along one direction. However, Genosar discloses an a drug delivery device (Fig. 1a-1i, and it can be a microneedle ¶0015) and guide line (14, 13) includes a linear arrangement of holes (¶0039) arranged so as to be spaced from each other by a predetermined spacing along one direction (Fig. 1e, ¶0039). Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify guide line of Frederickson includes a linear arrangement of holes arranged so as to be spaced from each other by a predetermined spacing along one direction.as taught by Genosar for the purpose of facilitating the folding of the line (Genosar, ¶0039) . 07-21-aia AIA Claim (s) 5, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frederickson in view of Gabel et al. (US.20030187395A1) (“Gabel”) . Re claim 5 , Frederickson fails to disclose wherein one side of the cartridge receiving surface is hingedly connected to the sidewall such that the cartridge receiving surface is inserted into the housing or is removed from the housing. However, Gabel discloses an applicator (10, Fig. 1- 6, ¶0042) for a microneedle array cartridge (14, ¶0042) and wherein one side of the cartridge receiving surface (32) is hingedly connected to the sidewall (hinge 34 connected to 22 ¶0045) such that the cartridge receiving surface is inserted into the housing or is removed from the housing (¶0048). Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify cartridge receiving portion of Frederickson so that one side of the cartridge receiving surface is hingedly connected to the sidewall such that the cartridge receiving surface is inserted into the housing or is removed from the housing as taught by Gabel for the purpose of using an art recognized connecters and applying the microneedle as the cartridge receiving surface is closed (Gabel, ¶0045, ¶0048, wherein the cartridge receiving surface -actuator- of Frederickson is replaced with the cover/ spring so that the actuation can be done by closing the cover). Re claim 7 , Frederickson fails to disclose comprising a band fastened to the housing for attaching the microstructure applicator to a user's body. However, Gabel discloses an applicator (10, Fig. 1- 6, ¶0042) for a microneedle array cartridge (14, ¶0042) and wherein one side of the cartridge receiving surface (32) is hingedly connected to the sidewall (hinge 34 connected to 22 ¶0045) and a band (26) fastened to the housing for attaching the microstructure applicator to a user's body (¶0044). Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify applicator of Frederickson to include a band so that the applicator is comprising a band fastened to the housing for attaching the microstructure applicator to a user's body as taught by Gabel for the purpose of using an art recognized element to attach the device to the patient’s arm (Gabel, ¶0044 Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST). 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, Chelsea Stinson can be reached at (571) 270-1744. 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. /HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783 Application/Control Number: 18/570,924 Page 2 Art Unit: 3783 Application/Control Number: 18/570,924 Page 3 Art Unit: 3783 Application/Control Number: 18/570,924 Page 4 Art Unit: 3783 Application/Control Number: 18/570,924 Page 5 Art Unit: 3783 Application/Control Number: 18/570,924 Page 6 Art Unit: 3783