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 . Claims included in the prosecution are claims 1, 2 and 6.
Applicants' arguments, filed 07/25/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2 and 6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a new matter rejection.
Claim 1 recites a waterproof coating portion coated on an entire outer surface of the base portion and the plurality of microneedles. Claim 1 also recites wherein the microneedles coated with the coating solution are entirely dipped into the palmitic acid solution so that the waterproof coating portion is coated on all outer surfaces of the coated needle body portion and the base portion, and wherein all of the outer surfaces of the coated needle body portion and the base portion is an entire outer surface of the array of microneedles including (i) the outer surface of the active ingredient coating portion, (ii) the outer surface of the coated needle body portion, (iii) the upper surface of the base portion, (iv) the lower surface of the base portion).
The claim fails to comply with the written description requirement since these limitations are not described in the specification. At best the instant specification discloses on page 4, lines 7-8 wherein a waterproof coating portion is configured to coat at least a portion of the surface of the active ingredient coating portion. Page 17, lines 14-15 of the instant specification discloses wherein the waterproof coating may be used to coat an upper end portion or the entire surface of the active ingredient coating portion. Page 18, lines 19-21 of the instant specification discloses wherein the waterproof coating portion may be coated by dip-coating the needle body portion coated with the active ingredient coating portion into a lipid-based coating solution. Thus, it appears from the instant specification that the waterproof coating portion is coated only on the active ingredient coating portion and there is no support in the instant specification to have the waterproof coating portion coated on all outer surfaces of the coated needle body portion and the base portion.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2 and 6 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 wherein the waterproof coating portion is coated on (i) the outer surface of the active ingredient coating portion and (ii) the outer surface of the coated needle body portion. The claim is indefinite since it is unclear how (i) and (ii) differ. The outer surface of the coated needle body portion is the active ingredient coating portion.
Claim 1 recites dipping the microneedles coated with the coating solution in a palmitic acid solution used for the waterproof coating portion and wherein the microneedles coated with the coating solution are entirely dipped. The claim also recites wherein the lower surface of the base portion is coated with the waterproof coating portion. The claim is indefinite since it is unclear how the lower surface of the base portion is coated if only the microneedles are dipped in the coating solution.
Claim Rejections - 35 USC § 103
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 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US 2008/0102192, May 1, 2008) (hereinafter Johnson) in view of Andrianov et al. (US 2009/0016935, Jan. 15, 2009) (hereinafter Andrianov), Melsheimer (US 2011/0034860, Feb. 10, 2011) (hereinafter Melsheimer), Ameri et al. (US 2015/0057605, Feb, 26, 2015) (hereinafter Ameri), Jung et al. (US 2014/0142492, May 22, 2014) (hereinafter Jung), Gill et al. (Coating Formulations for Microneedles, July 2007) (hereinafter Gill 1), Takada (US 2011/0046575, Feb. 24, 2011), Moore et al. (US 2014/0188041, Jul. 3, 2014) (hereinafter Moore), Matonick et al. (US 2016/0206865, Jul. 21, 2016) (hereinafter Matonick), and Gill et al. (US 2014/0170299, Jun. 19, 2014) (hereinafter Gill 2).
Johnson discloses a method of coating a microneedle array comprising providing a microneedle array having a substate and at least one needle; providing a removable masking layer on the microneedle array such that the substrate is at least partially covered by the masking layer and at least one needle remains at least partially exposed; and applying a coating material to at least a portion of the exposed portion of the microneedle array (claim 1). As the masking fluid is removed to expose the array, the coating material is subsequently applied to the exposed portion of the microneedle array (¶ [0031]). Fig. 1 shows the substrate 220 (i.e., base portion) having an upper surface and a lower surface and a plurality of microneedles 210 protruding from the substrate 220 (¶ [0028]). The coating material is applied from a coating solution comprising a carrier fluid (claim 3). The coating solution may contain additional excipients such as viscosity modifiers, stabilizers, and surfactants. Examples of suitable additional excipients include lactose (i.e., claimed first viscous material having a melting point greater than or equal to room temperature) (¶ [0036]). The coating solution may comprise one or more of a biologically active material, a pharmaceutically effective substance, and a therapeutically active substance. The microneedle device may be used to deliver any pharmacological agent(s) through the skin (¶ [0056]). The coating solution may be applied to the microneedle array by dipping (¶ [0050]). The coating solution has to completely evaporate to leave a dried coating on the microneedle (¶ [0028]). Drying may be performed at ambient conditions (e.g., approximately 20 to 23°C). In still another alternative, the array may be held in a drying oven (¶ [0034]).
Johnson differs from the instant claims insofar as not disclosing wherein the coating solution is applied by dipping the microneedles into a plurality of micro-wells.
However, Andrianov discloses wherein a formulation can be applied to a microneedle by dip-coating, wherein dip-coating can be performed by using various types of reservoirs suitable for coating, such as microwells (¶ [0062]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have the coating solution applied by dipping the microneedles into a plurality of micro-wells since Johnson discloses wherein the coating solution may be applied to the microneedle array by dipping and dip-coating through microwells is a known and effective dipping method as taught by Andrianov.
The combined teachings of Johnson and Andrianov do not teach wherein a waterproof coating portion is applied over the coating material.
However, Melsheimer discloses a micro-needle array that may be used to deliver a bioactive agent to a therapeutic target (abstract). One or more bioactive agents may be applied to the micro-needle array (¶ [0049]). One or more barrier layers (i.e., claimed waterproof coating portion) may be deposited over the layer containing the bioactive agent (¶ [0050]). The barrier layer (i.e., claimed waterproof coating portion) is placed over at least a portion of a bioactive agent. The barrier layer (i.e., claimed waterproof coating portion) may control the release of the bioactive agent from the device upon implantation (¶ [0023]). The barrier layer may include a biodegradable material (¶ [0051]).
Johnson discloses wherein the coating solution may comprise one or more of a biologically active material, a pharmaceutically effective substance, and a therapeutically active substance. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have coated a barrier layer (i.e., claimed waterproof coating portion) over the coating of Johnson since a barrier layer allows for controlled release of the biologically active material as taught by Melsheimer.
The combined teachings of Johnson, Andrianov, and Melsheimer do not teach wherein barrier layer (i.e., claimed waterproof coating portion) is coated over the entire microneedle array.
However, Ameri discloses wherein coating on microneedles can be formed by a variety of known methods such as dip-coating. Dip coating consists of partially or totally immersing the microneedles into a formulation. Alternatively, the entire device can be immersed into a formulation (¶ [0056]).
Johnson discloses wherein as the masking fluid is removed to expose the array; the coating material is subsequently applied to the exposed portion of the microneedle array. Thus, since the masking fluid is applied over the substrate of Johnson, the substrate may have the coating solution applied once the masking fluid is removed exposing the substrate. As discussed above, the coating solution comprises biologically active material and it would have been obvious to have coated the coating of Johnson with a barrier layer to allow for controlled release of the biologically active material. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have immersed the entire microneedle array in the barrier layer coating since this is a known and effective method of applying a coating over the substrate of a microneedle array as taught by Ameri.
In regards to instant claim 1 reciting drying the waterproof coating portion by taking out the microneedle from the solution and placing the microneedle in an oven for a predetermined temperature, this limitation would have been obvious since, as discussed above, it was known in the art as taught by Johnson that coating solutions may be dried in an oven.
In regards to instant claim 1 reciting placing the microneedle coated with the waterproof coating in an oven of 70°C, Johnson discloses in paragraph [0034] wherein the array may be held in a drying oven which can combine increased temperature and/or air flow to accelerate the rate of drying. Thus, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed oven temperature depending on the rate of drying desired. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
The combined teachings of Johnson, Andrianov, Melsheimer, and Ameri do not disclose wherein the barrier layer coating comprises palmitic acid.
However, Jung discloses an electro-microneedle integrated body wherein the microneedles are inserted into the skin of a human body (abstract). The electro-microneedle integrated body may comprise a biocompatible and biodegradable viscous material such as palmitic acid (claim 2).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Melsheimer discloses wherein the barrier layer may include a biodegradable material. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated palmitic acid into the barrier layer since it is a known and effective biodegradable material for microneedle arrays as taught by Jung et al.
The combined teachings of Johnson, Andrianov, Melsheimer, Ameri, and Jung do not disclose wherein the microneedles coated with the coating solution are dipped into the palmitic acid solution for about five seconds.
However, Gill 1 discloses wherein the thickness of a liquid film formed on a solid substrate after dipping depends on the withdrawal speed of the solid substrate and the physical properties of the coating solution (page 1370, left column, last paragraph).
Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed dipping time depending on the thickness of the barrier layer coating desired as taught by Gill 1. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
The combined teachings of Johnson, Andrianov, Melsheimer, Ameri, Jung, and Gill 1 do not disclose wherein the coating solution comprises a lipid-based material.
However, Takada discloses a self-dissolving microneedle which has a base and an active substance held in the base (¶ [0008]). The base contains an absorption rate controller for controlling the absorption rate of the active substance. The absorption enhancer may be a surfactant (¶ [0119]). Suitable surfactants include hydrogenated vegetable oils (i.e., claimed lipid-based material) (¶ [0123]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As discussed above, Melsheimer discloses wherein the barrier layer controls the release of the biologically active material. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated hydrogenated vegetable oils (i.e., claimed lipid-containing material) into the barrier layer coating since it is a known and effective material for controlling rate as taught by Takada.
The combined teachings of Johnson, Andrianov, Melsheimer, Ameri, Jung, Gill 1, and Takada do not disclose wherein the microneedle array is prepared from a mold comprising polydimethylsiloxane and wherein the microneedles comprise a viscous material and an active material.
However, Moore discloses a method for fabricating a microneedle or a microneedle array using a mold having at least a needle-forming cavity, which comprises the steps of: prefilling the needle-forming cavity with a solvent before applying a microneedle-forming composition, allowing the solvent and microneedle-forming composition to mix as a result of diffusion, removing the solvent, applying a flexible adhesive tape to on top of the mold, and lifting to pull the microneedles out of the mold to give an array of microneedles (abstract). The microneedle-forming composition forms a dissolvable material following drying (claim 7). The microneedle-forming composition may comprise may comprise an active substance to be delivered into an underlying tissue of a subject (¶ [0022]) and CMC (i.e., claimed second viscous material) as a dissolvable material (¶ [0024]). The mold is dried overnight under vacuum prior to demolding (¶ [0137]). Suitable materials for the mold include polydimethylsiloxane (¶ [0066]).
Matonick discloses a circular surgical stapler comprising a plurality of resorbable medicant-releasing microneedles (claim 1). The microneedles are impregnated and/or coated with the medicants (¶ [0060]). The microneedle is made of absorbable polymeric material impregnated with the medicant (¶ [0097]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the microneedle array of Johnson using the method of Moore since Johnson does not disclose wherein a particular microneedle array must be used and the microneedle array of Moore is a known and effective microneedle array. One of ordinary skill in the art would have had a reasonable expectation of success of using the active ingredient coating of Johnson on the active ingredient-comprising microneedle array of Moore since it was known in the art that microneedles may be impregnated and coated with medicants as taught by Matonick.
The combined teachings of Johnson, Andrianov, Melsheimer, Ameri, Jung, Gill 1, Takada, Moore, and Matonick do not disclose melting the lactose (i.e., claimed first viscous material) and the pharmacological agent(s) at a temperature greater than or equal to the melting point of lactose.
However, Gill 2 discloses coated microneedle devices (abstract). Certain drugs and certain coating liquids can be effectively and uniformly coated onto the microneedles (¶ [0077]). Multi-component molten coating liquids generally consist of a dissolving medium created by heating a solid above its melting point to form a liquid state, into which a drug is dissolved. For example, PEG may be heated to 55°C and then dexamethasone dissolved into it (¶ [0080]).
As discussed above, Johnson discloses forming a coating solution. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have melted the lactose (i.e., claimed first viscous material) and the pharmacological agent(s) at a temperature greater than or equal to the melting point of lactose since this is a known and an effective alternative method in making a coating solution for a microneedle as taught by Gill 2.
In regards to instant claim 1 reciting wherein the ratio of lactose (i.e., claimed first viscous material) to first active ingredient is within the range of 1:1 to 1:2, since Johnson discloses wherein excipients such as lactose affects the physical properties of the coating solution and the pharmacological agent(s) is to be delivered to the skin, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at amounts of lactose and pharmacological agent(s) based on the physical properties of the coating solution desired and the therapeutic effect desired by the pharmacological agent(s), respectively. Once amounts of lactose and pharmacological agent(s) have been determined, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed ratio of lactose (i.e., claimed first viscous material) to first active ingredient. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A).
In regards to instant claim 1 reciting wherein the ratio of CMC (i.e., claimed second viscous material) to second active ingredient is within the range of 2:1 to 3:1, since Moore discloses wherein CMC forms the microneedles and the active substance is to be delivered into an underlying tissue of a subject, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at amounts of CMC and active substance based on the size/amount of microneedles in the mold and the therapeutic effect desired by the active substance, respectively. Once amounts of CMC and active substance have been determined, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed ratio of CMC (i.e., claimed second viscous material) to second active ingredient. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A).
Response to Arguments
Applicant’s arguments have been considered but are moot because a new ground of rejection necessitated by Applicant’s amendment has been made.
Conclusion
Claims 1, 2 and 6 are rejected.
No claims are allowed.
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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/TRACY LIU/Primary Examiner, Art Unit 1614