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 .
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.
Claim(s) 1-9, 11-13, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0405235 A1 to Kim et al. (“Kim”) in view of KR 2015/0085502 A to Shim et al. (“Shim”) (cited in Applicant’s IDS).
As to claim 1, Kim discloses a microneedle structure comprising a needle-shaped portion (see Fig 1, element 20) on one surface side of a base material (see Fig 1, element 10), the base material having fluid permeability in its thickness direction (see Fig 3, elements 12, 16, 17 and [0031] – “The micro flow passages 12 gradually merge as they approach the capillary tube pump part 16, and finally become a single flow passage and are connected to the intermediate flow passage 17.”).
Kim fails to disclose the needle-shaped portion being composed of a composition that contains a low-melting-point resin having a melting point of 150° C or lower, the needle-shaped portion having a surface and an interior that are formed with hole portions.
However, in a similar invention, Shim discloses a similar needle-shaped portion being composed of a composition that contains a low-melting-point resin having a melting point of 150° C or lower (see [0015] – polycaprolactone, for example), the needle-shaped portion having a surface and an interior that are formed with hole portions (see Fig 1 and [0029]). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the microneedle and base of Kim with the similar porous microneedle containing a low-melting-point resin having a melting point of 150° C or lower that is disclosed by Shim in order to provide the predictable result of requiring less energy to bring the material into a flowable state.
As to claim 2, Kim further discloses wherein the needle-shaped portion is formed with a porous structure (see Fig 4).
As to claim 3, Shim further discloses wherein the low-melting-point resin is a water-insoluble resin (polycaprolactone is insoluable).
As to claim 4, Shim further discloses wherein the low-melting-point resin is a biodegradable resin (polycaprolactone is biodegradable).
As to claim 5, Shim further discloses wherein the biodegradable resin has a monomer acid dissociation constant of 4 or more (this is inherently true as disclosed in [0030] of the Application specification).
As to claim 6, Shim further discloses wherein the low-melting-point resin is polycaprolactone or a copolymer of caprolactone and another monomer (see treatment of claim 1).
As to claim 7, Kim further discloses wherein the needle-shaped portion and the base material are directly bonded (see [0046]-[0047]).
As to claim 8, Kim further discloses wherein the base material is a porous base material (see Fig 3 showing the pores (capillary channels) of the base).
As to claim 9, Kim further discloses wherein the porous base material contains a water-insoluble material (see [0034]).
As to claim 11, Kim discloses a method for producing a microneedle structure comprising:
a needle-shaped portion having an interior formed with a hole portion (see Fig 4, element 21a); and
a base material having one surface side on which the needle-shaped portion is formed (see Fig 4, element 11), the method comprising a bonding step of heating a composition containing a and resin the base material (see Fig 5-6 and associated text).
Kim fails to disclose the resin comprising a low-melting- point resin having a melting point of 150°C or lower to bond the heated low-melting-point resin. However, in a similar invention, Shim discloses a similar needle-shaped portion being composed of a composition that contains a low-melting-point resin having a melting point of 150° C or lower (see [0015] – polycaprolactone, for example), the needle-shaped portion having a surface and an interior that are formed with hole portions (see Fig 1 and [0029]). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the microneedle and base of Kim with the similar porous microneedle containing a low-melting-point resin having a melting point of 150° C or lower that is disclosed by Shim in order to provide the predictable result of requiring less energy to bring the material into a flowable state.
As to claim 12, given that the bonding and the formation involve the same steps, the claim is rejected for the reasons provided in the treatment of claim 11.
As to claim 13, as combined, Kim further discloses wherein the low-melting-point resin is insoluble in water, the composition contains the water-insoluble low-melting-point resin and a water-soluble material (polycaprolactone is water insoluble ), and the method comprises a removal step of, after the formation step, removing with water the water-soluble material of the projecting portion formed of the composition to form a hole portion in the projecting portion (water in the body removes the water-soluble material).
As to claim 15, Shim further discloses method for producing a microneedle structure according to claim 11, comprising a filling step of applying the composition containing the low-melting-point resin to a mold having a recessed portion and heating the composition to a melting point of the low-melting-point resin or higher to fill the recessed portion with the composition (see Fig 2 and associated text).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Shim as applied to claim 9 above, and further in view of JP 2017/000724 A to Matsuhiko et al. (“Matsuhiko ‘724”) (cited in Applicant’s IDS).
As to claim 10, neither Kim nor Shim discloses wherein the wherein the water-insoluble material is a low-melting-point resin having a melting point of 150°C or lower. However, Matsuhiko ‘724 teaches that a base material can be the same as the needle materials (see, e.g., [0044]). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the microneedles of Kim using the same material as a base in order to achieve the predictable result that would be a more robust structure.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Shim as applied to claim 9 above, and further in view of WO 2016/195119 A1 to Matsuhiko et al. (“Matsuhiko ‘119”).
As to claim 14, neither Kim nor Shim discloses wherein the water-soluble material has a melting point of 150°C or lower. However, in a similar invention, Matsuhiko ‘119 discloses wherein the water-soluble material has a melting point of 150°C or lower (see p. 10 – “When the MNA is a porous body containing a material other than the hydrogel material, for example, a water-soluble porogen (for example, PEG) is added to a resin monomer (for example, glycidyl methacrylate) and then a polymerization reaction is carried out. By obtaining a resin containing porogen and then dissolving the porogen contained in the resin in water, an MNA having traces of porogen as a flow path is prepared, and anionic or cationic functionalities are formed on the surface of this MNA.”). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the microneedle of Kim/Shim with the PEG porogen of Matsuhiko ‘119 in order to achieve the further result lowering the required energy of the process by ensuring that both the soluble and insoluble portions are capable of flowing at lowered temperatures.
Conclusion
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/ERIC J MESSERSMITH/ Primary Examiner, Art Unit 3791