DETAILED ACTION
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/4/2025 has been entered.
Acknowledgment
Claims 1, 4, 9 are amended and filed on 12/4/2025
Claims 6-7 are canceled.
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) 1-3, 8-10, 12-13, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asai et al. (US. 2017008613A1) (“Asai ”) in view of Amir (US. 20150209563A1) and further in view of Simmers (US. 20160166819A1).
Re Claim 1, Asai discloses an implantable solid substance delivering carrier (¶0057, Fig. 1- 7b, ¶070, the microneedle/pin is discussed in Fig. 1, and the shape of pin the embodiment as in Fig. 5a) comprising: an elongated pin (10, Fig. 5a) having a vertical axis ( axis of 10), and including: a side wall having a rounded side wall surface extending around the vertical axis (round side surface of 10, Fig. 5a); and a bevel tip (tip surface around the hole with acute angle, ¶0077) having a beveled surface (top surface , ¶0077), the beveled surface including a groove engraved in the beveled surface of the bevel tip (103, Fig. 1a, Fig. 5a); and a solid delivery target substance inserted into the engraved groove ( 30 dried ¶0069, and the covering film that cover the opening or tip, ¶0071) as to protrude outwardly from the tip beveled surface ( at least the film is protruded as it cover the tip, ¶0071), and wherein the engraved groove is not present in the rounded side wall surface (Fig, 5a), but it fails to disclose wherein the solid delivery target substance is positioned to be detachable from the groove in its solid form, wherein the engraved groove has an L-shape or an L-shape with a rounded corner when viewed in a vertical cross-section of the pin.
However, Amir discloses a microneedle array (Fig. 1-6B) wherein the solid delivery target substance (beads and or particles [0113, [0123) is positioned (Fig. 5b-6b) to be detachable from the groove in its solid form (Fig 6b, ¶0112).
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 modified the solid delivery target substance of Asai so that the solid delivery target substance is positioned to be detachable from the groove in its solid form as taught by Amir for the purpose of releasing slow biodegradable substance into the defined layer of skin for more efficient augmentation of the target site (Amir, ¶0111, ¶0243).
Asai in view of Amir fails to discloses wherein the engraved groove has an L-shape or an L-shape with a rounded corner when viewed in a vertical cross-section of the pin
However, Simmers discloses a microneedle array (Fig. 1-8) wherein the engraved groove has an L-shape or an L-shape with a rounded corner when viewed in a vertical cross-section of the pin (groove 178, 176. Fig. 8, ¶0042).
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 modified groove shape of Asai so that the engraved groove has an L-shape or an L-shape with a rounded corner when viewed in a vertical cross-section of the pin as taught by Simmers for the purpose of increasing the opening’s size as desired (Simmers, ¶0050).
Re Claim 2, Asai discloses wherein the solid delivery target substance has a spherical or oval shape (Fig.5a, the shape is oval).
Re Claim 3, Asai discloses wherein the solid delivery target substance includes exosome, protein, peptide, spheroid cell body, hydrogel or dried solid body (dried solid body, abstract, ¶0061).
Re Claim 8, Asai discloses wherein the engraved groove is formed in the surface of the tip closer to a shorter side among a pair of parallel sides of the pin extending in a vertical direction in a vertical cross section of the pin (Fig. 5a).
Re Claim 9, Asai discloses wherein a surface face of the bevel tip is inclined at an angle of 45 degree to 80 degree (Fig.5a, the angle is close to 45 degree, ¶0006).
Re Claim 10, Asai discloses wherein a length of the pin is in a range of 300 micrometer to 30 cm (10-1000 micro, ¶0006).
Re Claim 12, Asai discloses wherein a thickness of the pin is in a range of 200 micrometer to 3.4 mm (width of 300 micrometer, ¶00006).
Re Claim 13, Asai discloses wherein a diameter of the engraved groove is in a range of 50 micrometer to 1 mm (Fig. 1b, diameter is lease than 300 micron,¶0006, ¶0022).
Re Claim 15, Kato discloses wherein a depth of the engraved groove is in a range of 50 µm to 2 mm (depth D, ¶00022).
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asai in view of Amir and Simmers and further in view of Beak (US. 20170189660A1).
Re Claim 4, Asai discloses wherein the solid delivery target substance can be any type (¶0078), but it fails to disclose that solid delivery target substance has a form of a core-shell in which the solid delivery target substance is located in a core of the core-shell and a biodegradable polymer or hydrogel surrounding the core is located in a shell of the core-shell.
However, Beak disclose a microneedle array (Fig. 1-11) and wherein the solid delivery target substance (¶0061) has a form of a core-shell in which the solid delivery target substance is located in the core-shell (active material, ¶0031) and a biodegradable polymer or hydrogel surrounding the core is located in the shell (the outside coat of the active material ¶0107,¶0108 Fig. 11).
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 modified the solid delivery target substance of Asai so that that solid delivery target substance has a form of a core-shell in which the solid delivery target substance is located in a core of the core-shell and a biodegradable polymer or hydrogel surrounding the core is located in a shell of the core-shell as taught by Beak for the purpose of protecting the active material from a moisture environment (Beak, ¶0015).
Re Claim 5, Asai fails to disclose wherein the implantable substance delivering carrier further includes a coating layer covering the solid delivery target substance and an entirety or a portion of the surface of the bevel tip.
However, Beak disclose a microneedle array (Fig. 1-11) and wherein the that solid delivery target substance (¶0031) has a form of a core-shell in which the solid delivery target substance is located in the core-shell (active material, ¶0031) and the delivering carrier further includes a coating layer covering the solid delivery target substance and an entirety or a portion of the surface of the bevel tip (the outside coat of the active material ¶0107,¶0108 Fig. 11).
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 modified the implantable substance delivering carrier of Asai to includes a coating layer covering the solid delivery target substance and an entirety or a portion of the surface of the bevel tip as taught by Beak for the purpose of protecting the active material from a moisture environment (Beak, ¶0015).
Response to Arguments
Applicant’s arguments, see remark, filed 12/4/2025 with respect to the rejection(s) of claim(s) 1 under Kato in view of Dalton with respect to newly added limitation 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 over Asai in view of Amir and Simmers.
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).
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783