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 .
Response to Amendment
Applicant filed a response and amended claim 1, 6, and 12 on 09/04/2025.
The claim objection is withdrawn in view of amendments.
Response to Arguments
Applicant presents arguments regarding the amended claims and the rejections over Takashi and Kabata. Applicant’s arguments related to Kabata were found persuasive, and the rejections are withdrawn. Applicant's amendment necessitated the revised ground(s) of rejection over Takashi presented in this Office action.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 4, 5, 7, 8, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Yamada (Machine Translation of JP2010142473) in view of Omichi (Machine Translation of JP 2006341089).
Regarding claim 1, Yamada teaches a process of manufacturing a microneedle array, comprising:
a material transfer step comprising transferring a base material having a structure in which a plastic material is stacked on a surface of a bearing sheet, to place the base material on a support member having a support surface in which a recess corresponding to the microneedle is formed, with the plastic material in contact with
the support surface (Figure 1, step a and b and [0018]);
a material support step comprising supporting the base material transferred
in the material transfer step, by the support member (Figure 1, step c and [0021]-[0022]);
disposing a support plate [0017]; and
a pressing step comprising pressing the base material in a direction toward
the support surface to fill the plastic material in the recess and form the
microneedle from the plastic material (Figure 1, step d and [0021]-[0022]).
Yamada does not teach transferring a base material having a structure in which a plastic material is stacked on a surface of a bearing sheet.
Omichi teaches preparing a layer of polymer material on a base material to be shaped for use as a drug delivery device [0025]. Omichi teaches a flat base material made of a flexible polymer material and spin-coating the base material with polymeric material [0029]-[0033]. Omichi teaches the flexible base material deforms to the human skin surface to allow for suitable use as a pharmaceutical product [0034]-[0035]. Omichi teaches transferring a base material having a structure in which a plastic material is stacked on a surface of a bearing sheet (Figure 4).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the process of Yamada with the base material of Omichi, a known suitable base material for supporting microneedles for pharmaceutical applications, to yield the predictable result of providing a durable and flexible drug delivery device.
Regarding claim 2, Yamada in view of Omichi teaches the process as applied to claim 1, wherein the plastic material has thermoplasticity (Yamada, [0018]); and
wherein the plastic material is heated before or during the pressing step (Yamada, Figure 1c and [0017], [0028]).
Regarding claim 4, Yamada in view of Omichi teaches the process as applied to claim 1, wherein the plastic material is eventually cooled after the pressing step by the absence of heating and to provide the final product ready for application.
Regarding claim 5, Yamada in view of Omichi teaches the process as applied to claim 1, wherein the bearing sheet is positioned relative to the support surface in the pressing step (Omichi, Figure 4 and Yamada, Figure 1), thereby engaging the bearing sheet comprising the plastic material against the support surface.
Regarding claim 7, Yamada in view of Omichi teaches the process as applied to claim 2, wherein the plastic material is eventually cooled after the pressing step by the absence of heating and to provide the final product ready for application.
Regarding claim 8, Yamada in view of Omichi teaches the process as applied to claim 2, wherein the bearing sheet is positioned relative to the support surface in the pressing step (Omichi, Figure 4), thereby engaging the bearing sheet comprising the plastic material against the support surface.
Regarding claim 11, Yamada in view of Omichi teaches the process as applied to claim 4, wherein the bearing sheet is positioned relative to the support surface in the pressing step (Omichi, Figure 4), thereby engaging the bearing sheet comprising the plastic material against the support surface.
Claim 3, 6, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Yamada (Machine Translation of JP2010142473) in view of Omichi (Machine Translation of JP 2006341089), as applied to claim 1, in further view of Kaplan (PG-PUB 2013/0338632) and Ding (PG-PUB 2014/0180201).
Regarding claim 3, Yamada in view of Omichi teaches the process as applied to claim 1.
Yamada in view of Omichi does not teach the plastic material contains a leaching material that leaches out in a leaching medium, and wherein the plastic material is turned into a porous body by being immersed in the leach medium after the pressing step.
Kaplan teaches a process of manufacturing microneedles (Figures 7A-7F). Kaplan teaches microneedles can comprises porous structures to modulate the release profiles of active agents into a biological barrier using techniques such as salt leaching [0105]. Kaplan teaches salt-leaching uses particular particles within the solution placed into a microneedle mold such that after the microneedles are formed, the microneedles are immersed in water or a solvent in which the particles are soluble to the particles, resulting in a porous structure [0106].
Ding teaches a process of manufacturing microstructures for use as microneedles comprising a distal layer with active ingredients of biodegradable, bioerodible, bioabsorbable, and biocompatible polymer matrix [0067] and a proximal layer of biodegradable material [0080]. Ding teaches providing biodegradability and dissolvability through different techniques [0068]-[0069], [0080]. Ding teaches
the microstructures may be fabricated such that all or a portion of the microstructures break off or dissolve off of the proximal layer, substrate or backing, or intermediate layer after insertion into skin [0084]- [0085]. Ding teaches the microstructures may further be shaped or formulated to promote detachment of all or a portion of the microstructures after insertion [0086]. Ding teaches the microstructure shape and content may be designed to promote and/or control detachment of at least a portion of the microstructure [0087].
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to improve the process of Yamada in view of Omichi with the technique of formulating porosity in microstructures using the leaching technique of Kaplan for the plastic material of Yamada in view of Omichi in order to promote detachment of the microneedle, in particularly the microneedle tip, by formulating the microstructure to promote detachment as taught by Ding. By modifying the process of Yamada in view of Omichi with the leaching technique of Kaplan, the drug delivery kinetics can be controlled as taught by Ding, thereby providing an improved process.
Accordingly, one of ordinary skill in the art would have been motivated to modify the plastic material of Yamada in view of Omichi with a leaching material that leaches out in a leaching medium and immersing the plastic material into a leach medium after pressing to provide a porous body.
Regarding claim 6, Yamada in view of Omichi teaches the process as applied to claim 2.
Yamada in view of Omichi does not teach the plastic material contains a leaching material that leaches out in a leaching medium, and wherein the plastic material is turned into a porous body by being immersed in the leach medium after the pressing step.
Kaplan teaches a process of manufacturing microneedles (Figures 7A-7F). Kaplan teaches microneedles can comprises porous structures to modulate the release profiles of active agents into a biological barrier using techniques such as salt leaching [0105]. Kaplan teaches salt-leaching uses particular particles within the solution placed into a microneedle mold such that after the microneedles are formed, the microneedles are immersed in water or a solvent in which the particles are soluble to remove the particles, resulting in a porous structure [0106].
Ding teaches a process of manufacturing microstructures for use as microneedles comprising a distal layer with active ingredients of biodegradable, bioerodible, bioabsorbable, and biocompatible polymer matrix [0067] and a proximal layer of biodegradable material [0080]. Ding teaches providing biodegradability and dissolvability through different techniques [0068]-[0069], [0080]. Ding teaches
the microstructures may be fabricated such that all or a portion of the microstructures break off or dissolve off of the proximal layer, substrate or backing, or intermediate layer after insertion into skin [0084]- [0085]. Ding teaches the microstructures may further be shaped or formulated to promote detachment of all or a portion of the microstructures after insertion [0086]. Ding teaches the microstructure shape and content may be designed to promote and/or control detachment of at least a portion of the microstructure [0087].
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to improve the process of Yamada in view of Omichi with the technique of formulating porosity in microstructures using the leaching technique of Kaplan for the plastic material of Yamada in view of Omichi in order to promote detachment of the microneedle, in particularly the microneedle tip, by formulating the microstructure to promote detachment as taught by Ding. By modifying the process of Yamada in view of Omichi with the leaching technique of Kaplan, the drug delivery kinetics can be controlled as taught by Ding.
Accordingly, one of ordinary skill in the art would have been motivated to modify the plastic material of Yamada in view of Omichi with a leaching material that leaches out in a leaching medium and immersing the plastic material into a leach medium after pressing to provide a porous body.
Regarding claim 9, Yamada in view of Omichi, Kaplan, and Ding teaches the process as applied to claim 3, wherein the plastic material is cooled after the pressing step by the absence of heating in order to produce the final product ready for application.
Regarding claim 10, Yamada in view of Omichi, Kaplan, and Ding teaches the process as applied to claim 3, wherein the bearing sheet is positioned relative to the support surface in the pressing step (Omichi, Figure 4 and Yamada, Figure 1), thereby engaging the bearing sheet comprising the plastic material against the support surface.
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 HANA C PAGE whose telephone number is (571)272-1578. The examiner can normally be reached M-F, 9:00-5:30.
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/HANA C PAGE/Examiner, Art Unit 1745
/MICHAEL A TOLIN/Primary Examiner, Art Unit 1745