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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6 and 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR 2015/0085502 A1 to Shim et al. (“Shim”)(cited in Applicants’ IDS) in view of US 2016/0129164 A1 to Lee et al. (“Lee ‘164”)(cited in Applicants’ IDS).
As to claim 1, Shim discloses a microneedle structure comprising a needle-shaped portion on one surface side of a base material (see Fig 1), 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 (see [0015] – polycaprolactone), the needle-shaped portion having a surface and an interior that are formed with hole portions (see [0029] – after leaching, holes are produced).
Shim fails to disclose the base material having fluid permeability in its thickness direction and being a flexible sheet-like base material having at least one flow passage continuously extending from the one surface side to an opposite surface side of the base material.
In a similar invention, Lee ‘164 discloses base material having fluid permeability in its thickness direction and being a flexible sheet-like base material (see [0038] – “The liner 10 may provide mechanical strength to an array of the micro-needles 20 and may be rigid or flexible.”) having at least one flow passage continuously extending from the one surface side to an opposite surface side of the base material (see Fig 6B, element 10H).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the needles of Shim with the base material of Lee ‘164 in order to achieve the predictable result of allowing a substance to pass from the base material to the microneedle to allow additional drug release while also allowing the patch to conform to the skin.
As to claim 2, Shim further discloses wherein the needle-shaped portion is formed with a porous structure (see Fig 1).
As to claim 3, Shim further discloses wherein the low-melting-point resin is a water-insoluble resin (polycaprolactone is insoluble).
As to claim 4, Shim further discloses wherein the low-melting-point resin is a biodegradable resin (see [0015]).
As to claim 5, Shim further discloses wherein the biodegradable resin has a monomer acid dissociation constant of 4 or more (this inherently true of polycaprolactone).
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 8, Lee ‘164 further discloses wherein the base material is a porous base material (see [0039]-[0040] – woven base is porous).
As to claim 9, Lee ‘164 further discloses wherein the porous base material contains a water-insoluble material (see [0039]).
Claim(s) 7 and 11-13, abd 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shim in view of Lee’164 as applied to claim 1 above, and further in view of an article entitled “Porous microneedles on a paper for screening test of prediabetes” by Lee et al. (“Lee ‘20”).
As to claim 7, neither Shim nor Lee ‘164 discloses wherein the needle-shaped portion and the base material are directly bonded.
In a similar invention, Lee ’20 shows how a needle-shaped portion and the base material are directly bonded (see Fabrication section and Fig 2 and associated text). 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 Shim/Lee ‘164 with the direct bonding of Lee ’20 in order to achieve the predictable result that is a secure attachment of the base to the microneedles.
As to claim 11, as discussed in the treatment of claims 1 and 12, Shim/Lee ‘164 disclose
a needle-shaped portion having an interior formed with a hole portion; and
a base material having one surface side on which the needle-shaped portion is formed,
the base material being a flexible sheet-like base material having at least one flow passage continuously extending from the surface side on which the needle-shaped portion is formed to an opposite surface side of the base material, but fail to disclose
the method comprising a bonding step of heating a composition containing a low-melting-point resin having a melting point of 150 °C or lower to bond the heated low-melting-point resin and the base material.
This is shown by Lee ’20 (see above treatment of claim 7). 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 Shim/Lee ‘164 with the direct bonding of Lee ’20 in order to achieve the predictable result that is a secure attachment of the base to the microneedles.
As to claim 12, Shim in view of Lee ‘164 discloses a method for producing a microneedle structure comprising: a needle-shaped portion having an interior formed with a hole portion; and a base material having one surface side on which the needle-shaped portion is formed (see treatment of claim 1),
the base material being a flexible sheet-like base material having at least one flow passage continuously extending from the surface side on which the needle-shaped portion is formed to an opposite surface side of the base material (see treatment of claim 1 for reasons the combination is obvious).
Neither Shim nor Lee ‘164 discloses the method comprising a formation step of heating a composition containing a low-melting-point resin having a melting point of 150 °C or lower to form a projecting portion on the base material by the composition.
This is shown by Lee ’20 (see above treatment of claim 7). 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 Shim/Lee ‘164 with the direct bonding of Lee ’20 in order to achieve the predictable result that is a secure attachment of the base to the microneedles.
As to claim 13, Shim further discloses wherein
the low-melting-point resin is insoluble in water (polycaprolactone is insoluble in water),
the composition contains the water-insoluble low-melting-point resin and a water-soluble material (the composition contains NaCl or sugar, which are water soluble), 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 (see Shim [0025]).
As to claim 15, Shim further discloses
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 Shim in view of Lee’164 as applied to claim 1 above, and further in view of JP 2017/000724 A to Matsuhiko et al. (“Matsuhiko ‘724”)(cited in Applicants’ IDS).
As to claim 7, neither Shim nor Lee ‘164 discloses 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 may be made of the same material as the needle (see [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 Shim in view of Lee’164 as applied to claim 1 above, and further in view of WO 2016/195119 A1 to Matsuhiko et al. (“Matsuhiko ‘119”)(cited in previous Office action).
As to claim 14, neither Shim nor Lee ‘164 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/Lee ‘164 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.
Response to Arguments
Applicants’ arguments with respect to the pending claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicants’ 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 Eric Messersmith whose telephone number is (571)270-7081. The examiner can normally be reached M-Tu, 8:30 am - 5 pm.
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/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791
