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 .
Status of Claims
Claims 1, 6-21, and 26-27 are examined.
Claims 22-25 are withdrawn without traverse.
Response to Amendment
The amendments to the claims overcome the previous claim objections; therefore, the objections are withdrawn.
The amendments to the claims overcome the previous 35 U.S.C. 102, 103 and 112 (b) rejections; therefore, the rejections are withdrawn.
Information Disclosure Statement
The information disclosure statement filed September 12, 2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Foreign patent document 1 (CL 202200207) is cited, but a copy is not provided.
Claim Interpretation
Claim 1 recites the limitation “a print pressure of at least 1 kg to 20 kg when measured using a 265 DEK Horizon or Horizon 01 printer”. The limitation “print pressure” in “kg” has been interpreted as kilogram-force per square centimeter and equivalent to approximately 0.98 bar (or 98 kPa and 0.098 MPa, through unit conversion) in line with the 265 DEK Horizon manual and Richard (see list of references cited).
Claim Rejections - 35 USC § 112
Claim 1, 6-21, and 26-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 contains the trademark/trade name DEK. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a measurement of pressure and, accordingly, the identification/description is indefinite. The limitation 1 kg to 20 kg will be interpreted as recited above.
As claims 6-21, and 26-27 ultimately depend on claim 1, claims 6-21 and 26-27 are rejected for indefiniteness.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 7-10, 12-13, and 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (KR 20190094065 A, previously presented and an English machine translation was previously provided) in view of Tokumoto (US 2010/0280457 A1).
Regarding claim 1, Lee discloses a method for manufacturing a microstructure (¶ [0001] – method for manufacturing micro-needle), the method comprising:
a step of (i) applying a microstructure composition (¶ [0040] – extruding first material and second material) to a perforated template (¶ [0047-0048] – extrudes first material through first nozzle by extruding a perforated plate; ¶ [0049-0050] – extruding second material through second nozzle by extruding a perforated plate) comprising through-holes (¶ [0048], [0050] – a perforated plate having a plurality of holes), wherein
the microstructure composition passes through a through-hole (¶ [0047-0048] – steps S110 and S120, extrudes first material through first nozzle by extruding a perforated plate having a plurality of holes; ¶ [0049-0050] – steps S130 and S140, extruding second material through second nozzle by extruding a perforated plate having multiple holes) and is deposited on a substrate (¶ [0048] – first material can be extruded through the first nozzle onto the base; ¶ [0050] – second material onto the first material formed on the base),
(ii) repeating the application of the microstructure composition one or more times (¶ [0052] – steps S110 to S140 repeatedly performed depending on the number of layers to be laminated), thereby forming a microstructure (¶ [0040], [0052] – manufacture a microneedle comprising first material and second material)
Lee discloses the technique implements microneedles with high precision of about 5 micrometers (¶ [0077]).
Lee does not explicitly disclose characterised in that the perforated template and/or the through-hole have a depth of at least 300 μm.
Tokumoto discloses a method of coating microneedles mounted on a microneedle device (Abstract, ¶ [0056]). The microneedle device 22 having a plurality of microneedles 21 is mounted on table 23 while a mask plate 25 having a plurality of apertures 24 is fixed to the frame member 26 (¶ [0056]). The coating solution is filled into apertures 24 (¶ [0056]). The coating thickness can be typically increased by applying a plurality of coating carrier films, that is, by repeating the coating step after the coating carrier is firmly adhered (¶ [0072]).
Tokumoto further discloses the through-hole have a depth of at least 300 μm (¶ [0058] – the thickness of the mask plate may be 10 to 500 μm, where a mask plate having a thickness of 200 to 500 μm, which overlaps with “at least 300 μm”). The mask plate having a thickness of 200 to 500 μm is used for a large amount of coating (¶ [0058]) and the coating amount and thickness to the microneedle can be freely increased or decreased by controlling the specifications of mask plate (¶ [0061]).
Lee and Tokumoto disclose a method with the same or similar components performing the same or similar function in forming microneedles with a perforated plate/mask plate with holes/apertures. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the mask plate with a thickness of 200 to 500 μm in Tokumoto to the perforated plates in Lee for forming microneedles with a large amount of coating (¶ [0058]) and the coating amount and thickness to the microneedle can be freely increased or decreased by controlling the specifications of mask plate (¶ [0061]).
Lee depicts extrusion by a plunger (Fig. 2), which would apply pressure to the perforated plate.
Lee does not disclose wherein the perforated template has a rigidity configured to resist deformation of a print pressure of at least 1 kg to 20 kg (see claim interpretation above).
Tokumoto discloses the coating amount to the microneedle can be adjusted by changing at least one of: … a spatula pressure (¶ [0022]). The spatula 28 is used as the filling means (¶ [0056]).
Tokumoto further discloses the perforated template has a rigidity configured to resist deformation of a print pressure of at least 1 kg to 20 kg (¶ [0060] - the spatula pressure is typically 0.001 to 0.4 MPa, preferably 0.01 to 0.2 MPa; which overlaps with 1 kg/0.098 MPa to 20 kg/1.96 MPa, therefore the mask plate would have a rigidity to 0.001 to 0.4 MPa of print pressure). The filling amount of coating solution is adjustable by controlling the pressure of spatula (¶ [0057]).
Lee and Tokumoto disclose a method with the same or similar components performing the same or similar function in forming microneedles with a perforated plate/mask plate with holes/apertures. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the mask plate that handles 0.001 to 0.4 MPa of print pressure in Tokumoto to the perforated plates in Lee to adjust the filling amount of coating solution by controlling the pressure of spatula (¶ [0057]) and the coating amount and thickness to the microneedle can be freely increased or decreased by controlling the specifications of mask plate (¶ [0061]).
Regarding claim 7, modified Lee discloses the method according to claim 1.
Lee discloses wherein the perforated template is moved away from the substrate and repositioned (¶ [0043] – manufacture microneedles by controlling the movement of first and second nozzle and the bed/base up and down or left and right) and aligned, such that the through hole aligns with the microstructure, between each application of the microstructure composition (¶ [0087] – alignment of the base and the chamber can be realigned).
Regarding claim 8, modified Lee discloses the method according to claim 7.
Lee further discloses the perforated template is repositioned using an alignment system (¶ [0087] – the alignment of the base and chamber can be realigned) of positional markings incorporated on a surface of the perforated template, and corresponding markers incorporated on the substrate onto which the microstructure composition is deposited (¶ [0087] – analyzes image information to allow chamber to find its proper position, a marking would be present to align the chamber to the base).
Regarding claim 9, modified Lee discloses the method according to claim 1.
Lee does not explicitly disclose the perforated template and/or the through-hole have a depth of at least 300 to 1000 μm.
Tokumoto further discloses the through-hole have a depth of at least 300 μm (¶ [0058] – the thickness of the mask plate may be 10 to 500 μm, where a mask plate having a thickness of 200 to 500 μm, which overlaps with “300 to 1000 μm”). The mask plate having a thickness of 200 to 500 μm is used for a large amount of coating (¶ [0058]) and the coating amount and thickness to the microneedle can be freely increased or decreased by controlling the specifications of mask plate (¶ [0061]).
Lee and Tokumoto disclose a method with the same or similar components performing the same or similar function in forming microneedles with a perforated plate/mask plate with holes/apertures. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the mask plate with a thickness of 200 to 500 μm in Tokumoto to the perforated plates in Lee for forming microneedles with a large amount of coating (¶ [0058]) and the coating amount and thickness to the microneedle can be freely increased or decreased by controlling the specifications of mask plate (¶ [0061]).
Regarding claim 10, modified Lee discloses the method according to claim 1.
Lee discloses the perforated template is formed of plastic (¶ [0085] – nozzle coated with non-reactive material such as Teflon, a plastic).
Regarding claim 12, modified Lee discloses the method according to claim 1.
Lee discloses microneedles have a diameter (¶ [0004]) and a diameter of the nozzle hole (¶ [0056]). Tokumoto discloses the opening diameter and shape of the aperture in the mask plate can be selected according to the needle configuration and pitch of the microneedle (¶ [0058]) and the specifications of aperture need to be set so as to give the shape and size required to insert the microneedles to a given level (¶ [0059]).
Although modified Lee does not explicitly disclose the through-hole of the perforated template is substantially circular, Lee and Tokumoto discloses the holes have a diameter, which is a measurement for circles/circular shapes. Therefore, one of ordinary skill in the art would understand that the shape of the holes would be “substantially circular”. Further, it would have been obvious to one of ordinary skill in the art to change the hole shape of the hole in modified Lee as the hole size can be determined by considering the material to be extruded, the aspect ratio of the microneedle to be manufactured (Lee ¶ [0051]), adjust the extrusion speed by a nozzle having a hole of a desired size (Lee ¶ [0079]), and to give the shape and size required to insert the microneedles to a given level (¶ [0059]).
Regarding claim 13, modified Lee discloses the method according to claim 1.
Lee does not explicitly disclose the through-hole of the perforated template has a cross-sectional width of between 50 and 600 μm.
Tokumoto discloses the through-hole of the perforated template has a cross-sectional width of between 50 and 600 μm (¶ [0059] – area of a single aperture is 100 to 90000 μm2, which means the width/diameter is approximately 11.3 to 338 μm and overlaps the claimed range).
Lee and Tokumoto disclose a method with the same or similar components performing the same or similar function in forming microneedles with a perforated plate/mask plate with holes/apertures. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the area of the aperture of is 100 to 90000 μm2 in Tokumoto to the perforated plates in Lee to give the shape and size required to insert the microneedles to a given level (¶ [0059]).
Regarding claim 15, modified Lee discloses the method according to claim 1.
Lee further discloses the perforated template is positioned within a supporting frame (¶ [0064-0065] – first chamber 210 and second chamber 220, FIG. 2 depicts 210, 220 hold perforated plates).
Furthermore, Tokumoto discloses mask plate 25 is fixed to the frame member 26 (¶ [0056]).
Regarding claim 16, modified Lee discloses the method according to claim 1.
Lee disclose the microstructure is one of an array of microstructures (FIG. 4 depicts an array of microstructures).
Regarding claim 17, modified Lee discloses the method according to claim 1.
Lee further discloses the microstructure is a microneedle (¶ [0001] – method for manufacturing micro-needle).
Regarding claim 18, modified Lee discloses the method according to claim 1.
Lee does not explicitly disclose the substrate is a PVC substrate, a metal substrate, a poly-lactic acid substrate, a glass substrate, a ceramic substrate, a polystyrene substrate, a cellulose based substrate, a poly-vinyl alcohol substrate, a polycarbonate substrate, a poly-methyl methacrylate substrate, a silicone substrate, a polyethylene terephthalate substrate, a polyurethane substrate or a nitrocellulose substrate.
Tokumoto further discloses the substrate is a metal substrate, a poly-lactic acid substrate, a silicone substrate, or a polyurethane substrate (¶ [0052] – material for substrate include silicon, metals, biodegradable polymers such as polylactic acid, polyurethane). The microneedle substrate is a foundation to support the microneedles and in consideration of the antigenicity of microneedle and the unit price of materials (¶ [0052]).
Lee and Tokumoto disclose a method with the same or similar components performing the same or similar function in forming microneedles with a perforated plate/mask plate with holes/apertures. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied use of a substrate including silicon, metals, polylactic acid, or polyurethane in Tokumoto to the first and second material in Lee to serve as a foundation to support the microneedles and in consideration of the antigenicity of microneedle and the unit price of materials (¶ [0052]).
Regarding claim 19, modified Lee discloses a method according to claim 1.
Lee does not discloses the substrate forms at least a part of a transdermal patch.
Tokumoto further discloses the substrate forms at least a part of a transdermal patch (¶ [0002] – microneedle device for enhancing transdermal drug absorption).
Lee and Tokumoto disclose a method with the same or similar components performing the same or similar function in forming microneedles with a perforated plate/mask plate with holes/apertures. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied use of a substrate for a microneedle device in Tokumoto to the base in Lee to enhance transdermal drug absorption (¶ [0002]).
Claim(s) 6, 11, 20-21, and 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (KR 20190094065 A) in view of Tokumoto (US 2010/0280457 A1) as applied to claim 1 above, in further view of Kirby (US 2008/0299290 A1).
Regarding claim 6, modified Lee discloses the method according to claim 1.
Lee does not disclose a step of exposing the microstructure composition deposited on the substrate to a curing agent.
Analogous art Kirby discloses a method of producing needle-like shapes (¶ [0085]; Fig. 4). A stencil 49 is brought into proximity to a first surface 41, and 49 is provided with 1000 apertures (¶ [0085]). Acrylate 42 is deposited on stencil 49 and urged into the apertures and urges 49 into contact with 41 (¶ [0085]). The needle-like shapes are approximately 0.7 mm (700 μm) height capable of penetration of human stratum corneum in vitro (¶ [0085]). The needles may be about 10 microns to 3 mm long, the most preferred length is about 200 to 400 microns (¶ [0049]).
Kirby further discloses a step of exposing the microstructure composition deposited on the substrate (¶ [0085] – portions of acrylate 51a, 51b on 41 are cured by exposure to UV radiation 57; UV-curable acrylate 42 adheres to 41) to a curing agent ((¶ [0085] – exposure to UV radiation). The curing forms solid structures 53a, 53b (¶ [0085]).
Lee and Kirby disclose methods with the same or similar components performing the same or similar function in forming microneedles with a perforated plate/stencil with holes/apertures. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the step of applying UV-curable acrylate to a first surface and exposing to UV radiation in Kirby to method in Kirby to form solid structures (¶ [0085]).
Regarding claim 26, modified Lee discloses the method according to claim 6.
Lee does not disclose wherein the curing agent is ultraviolet (UV) light.
Analogous art Kirby disclose the curing agent is ultraviolet (UV) light (¶ [0085] – exposure to UV radiation). The curing forms solid structures 53a, 53b (¶ [0085]).
Regarding claim 11, modified Lee discloses the method according to claim 1.
Lee does not disclose the microstructure composition comprises a polymer.
Kirby discloses the microstructure composition comprises a polymer (¶ [0037] – the solid, needle-like shape may comprises one or both of an organic or silicone polymer, including epoxy resins, acrylic polymers and silicone resins; ¶ [0085] - acrylate 42 is deposited on stencil 49 and urged into the apertures and urges 49 into contact with 41).
Lee and Kirby disclose methods with the same or similar components performing the same or similar function in forming microneedles with a perforated plate/stencil with holes/apertures. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the step of applying UV-curable acrylate in Kirby to method in Lee to form microneedles capable of penetration of human stratum corneum in vitro (¶ [0085]).
Regarding claim 27, modified Lee discloses the method according to claim 11.
Lee does not disclose the microstructure composition is a UV-curable polymer.
Kirby discloses the microstructure composition is a UV-curable polymer (¶ [0085] – portions of acrylate 51a, 51b on 41 are cured by exposure to UV radiation 57).
Regarding claim 20, modified Lee discloses a method according to claim 1.
Lee does not disclose the method comprises a further step of apply a composition to the microstructure.
Kirby further discloses the method comprises a further step of apply a composition to the microstructure (Kirby ¶ [0052] – needle-like structure includes pharmaceutically active material by introducing into liquid after solidification). The pharmaceutically active material penetrate the body through the skin for the delivery of drugs (Kirby ¶ [0002-0003])
Lee and Kirby disclose methods with the same or similar components performing the same or similar function in forming microneedles with a perforated plate/stencil with holes/apertures. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the introducing pharmaceutically active materials after solidification in Kirby to method in Lee for the delivery of drugs through skin (Kirby ¶ [0002-0003]).
Regarding claim 21, modified Lee discloses a method according to claim 20.
Modified Lee discloses the coating composition comprises an active pharmaceutical ingredient (Kirby ¶ [0052] – pharmaceutically active material).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (KR 20190094065 A) in view of Tokumoto (US 2010/0280457 A1), as applied to claim 1, in further view of Gartstein (US 2004/0164454 A1).
Regarding claim 14, modified Lee discloses a method according to claim 1.
Modified Lee does not explicitly disclose the through-hole of the perforated template is formed by electroforming, laser-drilling or a conventional drill bit.
Analogous art Gartstein discloses a method for manufacturing microstructures using a mask plate 310 with large number of openings or through-holes 312 (¶ [0082]). The mask plate 320 as depicted in Fig. 28 has a similar structure to the plate/stencil in modified Lee.
Gartstein further discloses the through-hole of the perforated template is formed by a conventional drill bit (¶ [0082] – the holes 312 made by drill). If 310 is made of metal, the holes can be made by stamping or drilled (¶ [0082]).
Lee and Gartstein disclose methods with the same or similar components performing the same or similar function in forming a microstructure. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the holes made by drilling in Gartstein to the method in Lee to form the through holes if the plate is made of metal (¶ [0082]). Further, one of ordinary skill in the art would find it obvious to try drilling to form the holes as it one of a finite number of identified, predictable solutions, with a reasonable expectation of success. The finite number of identified, predictable solutions are forming the holes by stamping or drilled. See MPEP § 2143 (IE).
Response to Arguments
Applicant’s arguments with respect to claim(s) 2 have been considered but are moot because the claim has been cancelled.
Applicant’s arguments with respect to claim(s) 1 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
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.
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/JONATHAN B WOO/Examiner, Art Unit 1754
/SUSAN D LEONG/ Supervisory Patent Examiner, Art Unit 1754