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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination (RCE) 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/18/2025 has been entered.
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 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.
In making the below rejections, the examiner has considered and addressed each of the applicants arguments. Claims 2-5 have been canceled and Claims 1 and 6-11 are currently pending and being examined.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, and 6-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eicher (USPN 6,132,755).
In reference to independent claim 1, Eicher discloses a microneedle (23, fig 1) having a needle main body (body of 23) that is porous ((col 4, lines 18-20 discloses “By subsequently melting the surface of the component in a controlled manner it is sealed so as to produce a porous container with a leak tight outer wall” the needle main body is a part of the container, see fig 1), a part of a surface of the needle main body (body of 23) coated with a coating member (26), wherein:
the needle main body (body of 23) includes a flow path inside formed to extend in a net shape or the needle main body is formed of a porous body and includes the flow path formed from void parts of the porous body (col 1, lines 14-23 discloses “the invention consists essentially of a reservoir for the drug and at least one--typically several--micro-pins provided with capillary openings which are connected to the reservoir in such a way that the drug in the form of a solution containing the active substance passes from the reservoir into the micro-pins. When the transcorneal system is placed on the skin, the Stratum corneum and possibly the epidermis are penetrated by the micro-pins so as to provide direct access to the innervated layer of the skin”),
the needle main body has, on the surface, a plurality of openings (disclosed as “capillary openings” in the cite above that are exposed and not covered by 26) communicating with the flow path (the “capillary openings” in the body of the needles 23, in the cite above, connect to the reservoir 24),
the coating member (26) is disposed so as to coat some openings other than a desired part out of the plurality of openings (shown in fig 1 the tips of the needles are exposed), and
the microneedle (23) is configured to, when being inserted into a skin, access a target portion on a surface of the skin or under the skin in a pinpoint manner (the cite above discloses focusing on the “innervated layer” while bypassing other layers due to the coating member 26) by use of openings of the desired part other than the openings coated with the coating member (by coating every part of the needle 23 other than the tip Eicher discloses targeting a specific area).
In reference to dependent claim 6, Eicher discloses the microneedle according to claim 1, wherein a plurality of the flow paths are formed, and each of the openings communicates with at least one of the flow paths (col 4, lines 18-23 discloses “By subsequently melting the surface of the component in a controlled manner it is sealed so as to produce a porous container with a leak tight outer wall. Areas of the wall which should be kept permeable, such as the ventilation devices and the tips of the pins, are kept below the melting temperature by cooling.”).
In reference to dependent claim 7, Eicher discloses the microneedle according to claim 1, wherein the coating member (26) is disposed so as to coat a part of the surface other than a tip part of the needle main body (pictured in fig 1, 26 coats a part of the needle 23 other than the tip).
In reference to dependent claim 8, Eicher discloses the microneedle according to claim 1, wherein the coating member (26) is made of an insulating material (col 4, lines 12-15 discloses “Materials which may be used to produce the container and the micro-pins include primarily thermoplastic materials which may be sintered in a mould starting from fine granules.”).
In reference to dependent claim 9, Eicher discloses a microneedle array having a plurality of the microneedles according to claim 1, wherein the microneedles are arranged side by side (needles 23 are shown side by side in fig 1).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Eicher (USPN 6,132,755) in view of claim 1 above and further in view of Yamabe (USPAP 2018/0326195) further in view of Johnson (USPN 7,846,488).
In reference to dependent claim 10, Eicher discloses a production method of microneedle for producing the microneedle according to claim 1 (col 4, lines 18-23 discloses “By subsequently melting the surface of the component in a controlled manner it is sealed so as to produce a porous container with a leaktight outer wall. Areas of the wall which should be kept permeable, such as the ventilation devices and the tips of the pins, are kept below the melting temperature by cooling.”), however
Eicher does not teach the production method of microneedle comprising:
a needle forming process of producing the needle main body with the flow path blocked with a soluble material dissolvable in a predetermined solution;
a coating process of first masking a part of the surface of the needle main body with a protective member, and subsequently applying the coating member on the surface of the needle main body; and
a flow path forming process of first removing the protective member, and subsequently dissolving the soluble material in the predetermined solution.
Yamabe, a similar microneedle, teaches the production method of microneedle comprising: a needle (11) forming process (para 0060) of producing the needle main body (body of 11) with the flow path blocked with a soluble material (13, fig 4) dissolvable in a predetermined solution;
and subsequently applying the coating member on the surface of the needle main body (para 0079 discloses “The coating layer 13 is formed by coating at least the tip end region of the hollow needle 11 with a solid material dissolving in the body (gelatin, water-soluble resin, etc.), and coating the other region with a variety of materials (polymer, hydrophobic resin, water-soluble resin, etc.).”); and
a flow path (path leading outside of 12 in fig 4) forming process of dissolving the soluble material in the predetermined solution (para 0079 discloses 13 being a water-soluble resin).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the coating member production method as taught by Yamabe on the microneedle of Eicher in order to seal the fluid pathways in Eicher to allow for storage, transport, and eventual administration of medication.
Yamabe, does not teach coating process of first masking a part of the surface of the needle main body with a protective member.
Johnson, a similar microneedle array discloses a coating process of first masking a part of the surface of the needle main body (masking needles 210 with the masking material 230 seen in fig 1) with a protective member (col 1, lines 57-63 discloses “a method of coating a microneedle array comprising providing a microneedle array having a substrate 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 the at least one needle remains at least partially exposed,”) and subsequently applying the coating member on the surface of the needle main body (col 1, lines 63-64 goes onto disclose “and applying a coating material to at least a portion of the exposed portion of the microneedle array.”) then removing the protective member (col 3, lines 3-5 discloses “shown in FIG. 3C, the coating fluid has completely evaporated to leave a dried coating 240 on the tips of the microneedles”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the masking method as taught in Johnson in the microneedle as taught by Eicher and Yamabe “to provide a consistent coating in one or more desired locations on the microneedle array” col 1, lines 47-48; Johnson.
In reference to dependent claim 11, Eicher discloses a production method of microneedle array for producing the microneedle array according to claim 9 (col 4, lines 18-23 discloses “By subsequently melting the surface of the component in a controlled manner it is sealed so as to produce a porous container with a leaktight outer wall. Areas of the wall which should be kept permeable, such as the ventilation devices and the tips of the pins, are kept below the melting temperature by cooling.”), however
Eicher does not disclose the production method of microneedle array comprising: a needle forming process of producing the needle main body with the flow path blocked with a soluble material dissolvable in a predetermined solution; a coating process of first masking a part of the surface of the needle main body with a protective member, and subsequently applying the coating member on the surface of the needle main body; and a flow path forming process of first removing the protective member, and subsequently dissolving the soluble material in the predetermined solution.
Yamabe, a similar microneedle, teaches the production method of microneedle comprising: a needle (11) forming process (para 0060) of producing the needle main body (body of 11) with the flow path blocked with a soluble material (13, fig 4) dissolvable in a predetermined solution;
and subsequently applying the coating member on the surface of the needle main body (para 0079 discloses “The coating layer 13 is formed by coating at least the tip end region of the hollow needle 11 with a solid material dissolving in the body (gelatin, water-soluble resin, etc.), and coating the other region with a variety of materials (polymer, hydrophobic resin, water-soluble resin, etc.).”); and
a flow path (path leading outside of 12 in fig 4) forming process of dissolving the soluble material in the predetermined solution (para 0079 discloses 13 being a water-soluble resin).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the coating member as taught by Yamabe with on the microneedle of Eicher in order to seal the fluid pathways in Eicher to allow for storage, transport, and eventual administration of medication.
Yamabe, does not teach coating process of first masking a part of the surface of the needle main body with a protective member.
Johnson, a similar microneedle array discloses a coating process of first masking a part of the surface of the needle main body (masking needles 210 with the masking material 230 seen in fig 1) with a protective member (col 1, lines 57-63 discloses “a method of coating a microneedle array comprising providing a microneedle array having a substrate 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 the at least one needle remains at least partially exposed,”) and subsequently applying the coating member on the surface of the needle main body (col 1, lines 63-64 goes onto disclose “and applying a coating material to at least a portion of the exposed portion of the microneedle array.”) then removing the protective member (col 3, lines 3-5 discloses “shown in FIG. 3C, the coating fluid has completely evaporated to leave a dried coating 240 on the tips of the microneedles”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the masking method as taught in Johnson in the microneedle as taught by Eicher and Yamabe “to provide a consistent coating in one or more desired locations on the microneedle array” col 1, lines 47-48; Johnson.
Response to Arguments
Applicant's arguments filed on 12/18/2025 have been considered but are moot in view of the new ground(s) of rejection.
Conclusion
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES W NICHOLS/Examiner, Art Unit 3783