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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 29, 2026 has been entered.
Status of Claims
Claims 1, 6-8, 10-21, and 26-27 are examined.
Claims 22-25 are withdrawn without traverse.
Claims 2-5 and 9 are cancelled.
Response to Amendment
The amendments to the claims overcome the previous 35 U.S.C. 112 and 103 rejections; therefore, the rejections are withdrawn.
Information Disclosure Statement
The information disclosure statement filed June 29, 2026 and July 15, 2026 are considered.
Claim Interpretation
Claim 1 recites the limitation “a print pressure of at least 1 kg to 20 kg, wherein the print pressure is a printer-controlled force applied to the perforated template”. The limitation “print pressure” in “kg” has been interpreted as kilogram-force in line with the applicant’s argument that print pressure is in terms of a printer-applied force or load.
Claim Rejections - 35 USC § 112
Claim 1, 6-8, 10-21, 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 recites the limitation “a print pressure of at least 1 kg to 20 kg”. The limitation is unclear as pressure is in units of force/area (Pa or N/m2), whereas the units are in mass (kg), rendering the limitation indefinite. Page 8, line 1-3 of the instant application recites “maintain the print pressure as it moves across the surface, such printers may apply a force of between 0 kg and 20 kg”, but does not recite units of pressure. For examination purposes and in line with the instant specification and remarks filed June 29, 2026, the “print pressure” will be interpreted as “force” and the “kg” will be interpreted as “kg force” and kg*m/s2, i.e. mass effected by standard gravitational field.
As claims 6-8, 10-21, and 26-27 ultimately depend on claim 1, claims 6-8, 10-21 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 300 μm to 1000 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 300 μm – 1000 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 μm – 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]).
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, wherein the print pressure is a printer-controlled force applied to the perforated template (see claim interpretation above).
Tokumoto discloses the spatula 28 is used as the filling means (¶ [0056]).
Tokumoto discloses wherein the print pressure is a printer-controlled force applied to the perforated template (¶ [0022] - the coating amount to the microneedle can be adjusted by changing at least one of: … a spatula 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 adjusting of spatula 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]).
Tokumoto further discloses the spatula pressure is typically 0.001 to 0.4 MPa, preferably 0.01 to 0.2 MPa (¶ [0060]). Tokumoto discloses the number of apertures is determined in accordance with the number of needles of the microneedles, and is 100 to 3000 apertures/cm2 and the area of a single aperture is 100 to 90000 µm2/aperture (¶ [0059]). In an example, an aperture diameter of 200 µm and 31 lines x 31 rows/square 1 cm2 (¶ [0080]). As depicted in Fig. 3 and 4, when the spatula goes over the apertures, it would go over a row/line of apertures.
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Tokumoto FIG. 3-4
Tokumoto does not explicitly disclose the perforated template has a rigidity configured to resist deformation of a print pressure of at least 1 kg to 20 kg (kilogram force). However, based on the area of the applied spatula, the force on the spatula area is determined. If the spatula was used over 1 cm2 area mask plate, which would make the length of the spatula approximately 1 cm, with an aperture diameter of 300 µm, corresponding to the width of the spatula, the force applied would be 0.3-1.2 kg*m/s2, which overlaps with the claimed range of 1 kg to 20 kg (kilogram force).
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Therefore 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 and modified the area and number of apertures of the mask area in the way discussed above in Tokumoto to the perforated plates in Lee to adjust the filling amount of coating solution (¶ [0057]), the coating amount and thickness to the microneedle can be freely increased or decreased by controlling the specifications of mask plate (¶ [0061]), and enable the fabrication of microneedle coated with a drug (¶ [0059]).
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 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 disclose 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 comprise 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 filed June 29, 2026 have been fully considered but they are not persuasive.
Applicant argues Lee merely discloses an extrusion-based method of microneedle production and production of a coated microneedle, whereas in contrast, the present invention includes the repeated deposition of droplets of microstructure composition to for the microstructure.
Lee discloses method for manufacturing micro-needle (¶ [0001]), which are microstructures and in line with the instant specification on page 1, line 26 which recites “microstructures, specifically microneedles” and page 10, line 4 which recites “microstructures may be microneedles”.
Lee further discloses steps S110 and S120, extrudes first material through first nozzle by extruding a perforated plate having a plurality of holes (¶ [0047-0048]), steps S130 and S140, extruding second material through second nozzle by extruding a perforated plate having multiple holes ¶ [0049-0050]) and steps S110 to S140 repeatedly performed depending on the number of layers to be laminated (¶ [0052]). Extrusion encompasses deposition; therefore, Lee discloses “repeated deposition of droplets of the microstructure composition to form the microstructure”.
Applicant argues Tokumoto does not disclose a method for manufacturing microneedles form scratch as claimed.
In response to applicant's argument that Tokumoto is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Tokumoto discloses a microneedle coating method using a mask plate (¶ [0056]) provided with a plurality of apertures (¶ 0058]), and is analogous to Lee’s disclosure of a method of extruding a microneedle (¶ [0001]) which extrudes first material through first nozzle by extruding a perforated plate having a plurality of holes (¶ [0047-0048]).
Applicant argues Tokumoto does not disclose a resistance of print pressures from 1-20 kg force.
The argument is addressed in the updated claim interpretation, necessitated by amendment and the updated 35 U.S.C. 103 rejection.
Applicant argues Tokumoto only teaches that a mask is used to fill apertures with a coating composition and does not teach requirement for the mask to have a certain level of rigidity.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Tokumoto discloses a microneedle coating method using a mask plate (¶ [0056]) provided with a plurality of apertures (¶ 0058]), and is analogous to Lee’s disclosure of a method of extruding a microneedle (¶ [0001]) which extrudes first material through first nozzle by extruding a perforated plate having a plurality of holes (¶ [0047-0048]).
Although Tokumoto does not place emphasis on the characteristics of the mask, one of ordinary skill in the art before the effective filing date of the claimed invention would have known that increasing the pressure or force applied to the mask would require increased mask rigidity and would have selected a mask made of material suitable for the applied pressure or force.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN B WOO whose telephone number is (571)272-5191. The examiner can normally be reached M-F 8:30 am - 5:00 pm ET.
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/JONATHAN B WOO/Examiner, Art Unit 1754
/SEYED MASOUD MALEKZADEH/Primary Examiner, Art Unit 1754
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