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 .
Acknowledgment
Claim 1 is amended and filed on 4/152026.
Claim 5 is cancelled
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,) as to protrude outwardly from the tip beveled surface (at least some of 30 will be protruded from the beveled surface Fig. 7a, ¶0066 as 30 is transferred into the groove by immersing under the capillary effect so lower surface 30 will be protruded from the beveled surface because of the surface tension ¶0067), and wherein the engraved groove is not present in the rounded side wall surface (Fig, 5a), wherein the implantable solid substance delivering carrier further includes a coating layer (¶0071, protecting cover) covering the delivery target substance and an entirety or a portion of the surface of the bevel tip (¶0071); and wherein the solid delivery target substance nests within the engraved groove (¶0071), and wherein the coating layer secures the solid delivery target substance in the engraved groove (¶0071), 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 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).
Response to Arguments
Applicant’s arguments, see remark, filed 4/15/2026 with respect to the rejection(s) of claim(s) 1 and with respect to newly added limitation have been fully considered and are not persuasive.
The applicant argues with regards to solid drug agent and film. The new view of the Asai is applied and wherein the lower portion/surface of 30 will be protruded from the beveled surface Fig. 7a, ¶0066 as 30 is transferred into the groove by immersing under the capillary effect so lower surface 30 will be protruded from the beveled surface because of the surface tension ¶0067, and then the drug is feezed and a film can be applied see ¶0071 of Asai.
The applicant argues that Amir and Simmers are different drug than Asai’s drug and np motivation to combine. This is found not persuasive as all references are related to a drug attached to the microneedle and Asai discloses all the limitation and it is silent with regards the shape of the groove and how the drug is released which found in Amir and Simmers for the purpose releasing slow biodegradable substance into the defined layer of skin for more efficient augmentation of the target site (Amir, ¶0111, ¶0243) and for the purpose of increasing the opening’s size as desired (Simmers, ¶0050).
The applicant argues with regards to Back that it fails to disclose a bevel tip and there is no solid substance that nests with the groove. This is found not persuasive as these limitations were discloses in the primary refence and Back is introduce to have the shape of the core-shell material from a biodegradable material for protecting the solid substance from moisture .
The applicant argues with regards to Back that it has a coating to protect the active agent which is different that the claimed film in the current application which protect the solid agent to be in the groove. This is found not pervasive as the coat of Back is considered to be part of the solid material ( like a shell of the pill) and the film of Asai is film to cover the microneedle tip.
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 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
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