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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 17, 2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on March 17, 2026. As directed by the amendment: claims 1 and 27 have been amended, no claims have been added, no claims have been canceled. Thus claims 1-2, 8-11, 21, 22, 25, 27, 30, and 32-37 are presently pending in this application, and claims 22, 25, 27, 30, and 32 remain withdrawn. Applicant’s amendments to the Claims have overcome each and every 35 U.S.C. 112(b) rejection previously set forth in the Final Office Action mailed December 19, 2025.
Response to Arguments
Applicant’s arguments, see Remarks, filed March 17, 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Gu, Hahn, and Ronnander do not disclose the amended limitations of claim 1, namely “a conductive polymer incorporated within the swellable and water-insoluble matrix with the conductive polymer distributed therein” Therefore, the rejection has been withdrawn. Due to their dependency on claim 1, the rejections of claims 2, 8-11, 21, and 33-37 have also been withdrawn for similar reasons. However, upon further consideration, in light of the amendments, a new ground(s) of rejection is below.
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.
Claims 1, 8-11, 21, and 33-37 are rejected under 35 U.S.C. 103 as being unpatentable over Francis et al. (US 20150141910), hereinafter Francis, in view of Christ (US 5843186), From et al. (WO 2010009087), hereinafter From, and Ronnander et al. (US 20200206489), hereinafter Ronnander.
Regarding claim 1, Francis discloses a microneedle array (Fig. 2, patch 24) comprising: a base (Fig. 2, patch 24 substrate 28) having microneedles disposed thereon (Fig. 2, microneedles 26 of patch 24 disposed on substrate 28), wherein each of the microneedles is formed of a swellable and water-insoluble matrix comprising a crosslinked polymer (Fig. 2 and [0042, 0055, 0061, 0066], microneedles 26 are made of a crosslinked polymer (HA with a suitable crosslinking agent) to make a swellable but dissolution preventing (insoluble) material); and wherein, when the microneedle array is used with an iontophoresis unit (Fig. 2 and [0028], mask 14 which holds patch 24 comprises an iontophoresis modality to use with the microneedles 26) electrical current from the iontophoresis unit is transmitted through the microneedles to facilitate delivery of an active agent from the microneedles to a subject ([0007, 0022, 0025, 0028], electrical current from the iontophoresis modality is transmitted through the patch 24 to enhance delivery of an active ingredient into the skin).
Francis fails to disclose a conductive material incorporated within the swellable and water-insoluble matrix with the conductive material distributed therein. However, Christ discloses a conductive material incorporated within the swellable and water-insoluble matrix with the conductive material distributed therein (Fig. 1-2 and C.4:14-32; C.8:28-40, matrix 40 may be a polymer matrix (similar to polymer matrix material of Francis) loaded with conductive material).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Francis to incorporate the disclosures of Christ and modify the swellable and water-insoluble matrix to have a conductive polymer distributed therein. Doing so would provide a matrix which may regulate the driving of ions (via iontophoresis) to target region for antimicrobial agent release (Christ, C.3:11-19; C.4:20-32).
Francis, in view of Christ, fails to disclose wherein the conductive material is a conductive polymer comprising poly(3,4-ethylenedioxythiophene)- poly(styrenesulfonate), polythiophene, polyethyne, poly(p-phenylene), or poly(p- phenylene vinylene). However, From discloses wherein the conductive material is a conductive polymer comprising poly(3,4-ethylenedioxythiophene)- poly(styrenesulfonate), polythiophene (p. 19: 3-15, polymer matrix may comprise a conducting polymer, such as polythiphene), polyethyne, poly(p-phenylene), or poly(p- phenylene vinylene).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Francis, in view of Christ, to incorporate the disclosures of From and modify the swellable and water-insoluble matrix to comprise a conductive polymer comprising poly(3,4-ethylenedioxythiophene)- poly(styrenesulfonate), polythiophene, polyethyne, poly(p-phenylene), or poly(p- phenylene vinylene). Doing so would provide a matrix which is tailored to deliver the active agents in a controlled manner resulting in improved delivery, bioavailability, and prolonged release (p.12:2-14; p.16:26-p.17:16).
Francis, in view of Christ and From, fails to disclose the iontophoresis unit comprising an anode and a cathode connected to the microneedle array. However, Ronnander discloses the iontophoresis unit comprising an anode and a cathode connected to the microneedle array (Fig. 8, iontophoresis unit has anode 20 and cathode 30 connected to microneedle array 22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Francis, in view of Christ and From, to incorporate the disclosures of Ronnander and modify the iontophoresis unit to comprise an anode and a cathode connected to the microneedle array. Doing so would allow for the iontophoresis unit to apply/regulate an electrical current through the microneedle array for sustained delivery of a therapeutic dose (Ronnander, [0016,0029, 0043]).
Regarding claim 8 and Francis, in view of Christ, From, and Ronnander, Francis further discloses the microneedle array of claim 1, wherein each of the microneedles has a length of 1000 µm or less (Fig. 2 and [0038], microneedles 26 may have a height in the range of 100-1000 µm, for example height 34 may be 200 µm).
Regarding claim 9 and Francis, in view of Christ, From, and Ronnander, Francis further discloses the microneedle array of claim 1, wherein the base comprises the crosslinked polymer which the swellable and water-insoluble matrix is formed of (Fig. 2 and [0047, 0055, 0061, 0066], substrate also comprises crosslinked polymer (HA with a suitable crosslinking agent) to make a swellable but dissolution preventing (insoluble) material).
Regarding claim 10 and Francis, in view of Christ, From, and Ronnander, Francis further discloses the microneedle array of claim 1, wherein (i) the base has a surface for an active agent to be disposed thereon and/or (ii) the swellable and water- insoluble matrix further comprises an active agent disposed therein (Fig. 2, [0064-0065], active agent is added to the polymer solution during manufacturing such that it is disposed in the polymer matrix).
Regarding claim 11 and Francis, in view of Christ, From, and Ronnander, Francis further discloses a device configured to deliver an active agent (Fig. 1-2, system 10), the device comprising: a microneedle array of claim 1 (Fig. 2, patch 24 and claim 1 rejection above); and an iontophoresis unit (Fig. 2 and [0028], mask 14 which holds patch 24 comprises an iontophoresis modality), wherein the iontophoresis unit is operable to deliver the active agent from the microneedle array ([0007, 0022, 0025, 0028], electrical current from the iontophoresis modality is transmitted through the patch 24 to enhance delivery of an active ingredient into the skin).
Francis, in view of Christ and From, fails to disclose the iontophoresis unit comprising an anode and a cathode connectable to the microneedle array. However, Ronnander further discloses the iontophoresis unit comprising an anode and a cathode connectable to the microneedle array (Fig. 8, iontophoresis unit has anode 20 and cathode 30 connected to microneedle array 22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Francis, in view of Christ, From, and Ronnander, to further incorporate the disclosures of Ronnander and modify the iontophoresis unit to comprise an anode and a cathode connectable to the microneedle array. Doing so would allow for the iontophoresis unit to apply/regulate an electrical current through the microneedle array for sustained delivery of a therapeutic dose (Ronnander, [0016,0029, 0043]).
Regarding claim 21, Francis, in view of Christ, From, and Ronnander, discloses the device of claim 11, as explained above. Francis fails to disclose wherein the active agent comprises an anaesthetic agent and/or a drug. However, Ronnander further discloses wherein the active agent comprises an anaesthetic agent and/or a drug (Fig. 8 and [0001; 0015-0017], active agent is a drug/drug macromolecule).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Francis, in view of Christ, From, and Ronnander, to further incorporate the disclosures of Ronnander and modify the active agent to be an anaesthetic agent and/or a drug. Doing so would allow for drug molecule delivery to the dermal layer for prophylaxis and therapy (Ronnander, [0001, 0017]).
Regarding claim 33 and Francis, in view of Christ, From, and Ronnander, Francis further discloses a method of delivering an active agent to a subject through the device of claim 11, the method comprising: applying the microneedle array on the subject (Fig. 2 and [0037], microneedles 26 of patch 24 are applied to the epidermis 30 of patient); and operating the iontophoresis unit to deliver the active agent from the microneedle array (Fig. 2 and [0022, 0028], iontophoresis modality is operated to transmit an electrical current through the patch 24 to enhance delivery of an active ingredient into the skin).
As noted above, Francis fails to disclose an anode and a cathode, and is thus silent to placing the anode and the cathode on the subject. However, Ronnander further discloses placing the anode and the cathode on the subject (Fig. 8 and [0043], anode 20 and cathode 30 are placed on the patient via the attachment of the device of Fig. 8 to the patient's skin).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Francis, in view of Christ, From, and Ronnander, to further incorporate the disclosures of Ronnander and modify the method to include placing the anode and the cathode on the subject. Doing so would allow for the iontophoresis unit to apply/regulate an electrical current through the microneedle array for sustained delivery of a therapeutic dose (Ronnander, [0016,0029, 0043]).
Regarding claim 34 and Francis, in view of Christ, From, and Ronnander, Francis further discloses the method of claim 33, wherein applying the microneedle array comprises inserting the microneedles into a first surface of the subject (Fig. 2 and [0037], microneedles 26 are applied to the epidermis 30 of patient).
Regarding claim 35, Francis, in view of Christ, From, and Ronnander, discloses the method of claim 34, as explained above. As noted above, Francis fails to disclose an anode and a cathode, and is thus silent to wherein placing the anode and the cathode on the subject comprises:(i) arranging the anode on the first surface proximal to where the microneedle is applied and arranging the cathode on a second surface distal to where the anode is arranged when the active agent is anionic; or (ii) arranging the cathode on the first surface proximal to where the microneedle is applied and arranging the cathode on a second surface distal to where the cathode is arranged when the active agent is cationic; or (iii) arranging either the anode or the cathode on the first surface proximal to where the microneedle is applied and arranging the cathode or the anode, respectively, on a second surface to where the anode or cathode is arranged, respectively, when the active agent is neutral. However, Ronnander further discloses wherein placing the anode and the cathode on the subject comprises:(i) arranging the anode on the first surface proximal to where the microneedle is applied and arranging the cathode on a second surface distal to where the anode is arranged when the active agent is anionic (Fig. 8 and [0043], anode 20 is arranged proximal to microneedles 22, cathode is arrange distal to microneedles 22 such that active agent may be anionic); or (ii) arranging the cathode on the first surface proximal to where the microneedle is applied and arranging the cathode on a second surface distal to where the cathode is arranged when the active agent is cationic; or (iii) arranging either the anode or the cathode on the first surface proximal to where the microneedle is applied and arranging the cathode or the anode, respectively, on a second surface to where the anode or cathode is arranged, respectively, when the active agent is neutral.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Francis, in view of Christ, From, and Ronnander, to further incorporate the disclosures of Ronnander and modify the method to include wherein placing the anode and the cathode on the subject comprises:(i) arranging the anode on the first surface proximal to where the microneedle is applied and arranging the cathode on a second surface distal to where the anode is arranged when the active agent is anionic; or (ii) arranging the cathode on the first surface proximal to where the microneedle is applied and arranging the cathode on a second surface distal to where the cathode is arranged when the active agent is cationic; or (iii) arranging either the anode or the cathode on the first surface proximal to where the microneedle is applied and arranging the cathode or the anode, respectively, on a second surface to where the anode or cathode is arranged, respectively, when the active agent is neutral. Doing so would allow for the iontophoresis unit to apply/regulate an electrical current through the microneedle array for sustained delivery of a therapeutic dose (Ronnander, [0016,0029, 0043]).
Regarding claim 36, Francis, in view of Christ, From, and Ronnander, discloses the method of claim 33, as explained above. As noted above, Francis fails to disclose the anode and cathode, and is thus silent to wherein operating the iontophoresis unit comprises passing an electrical current between the anode and the cathode to establish a voltage for delivering the active agent from the microneedle array. However, Ronnander further discloses wherein operating the iontophoresis unit comprises passing an electrical current between the anode and the cathode to establish a voltage for delivering the active agent from the microneedle array (Fig, 8 and [0029, 0043], iontophoresis operation comprises passing the electric current between the anode and cathode to establish a voltage/electric field for delivering the agent via microneedle 22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Francis, in view of Christ, From, and Ronnander, to further incorporate the disclosures of Ronnander and modify the method to include wherein operating the iontophoresis unit comprises passing an electrical current between the anode and the cathode to establish a voltage for delivering the active agent from the microneedle array. Doing so would allow for the iontophoresis unit to apply/regulate an electrical current through the microneedle array for sustained delivery of a therapeutic dose (Ronnander, [0016,0029, 0043]).
Regarding claim 37 and Francis, in view of Christ, From, and Ronnander, Francis further discloses the method of claim 33, wherein delivering the active agent from the microneedle array comprises delivering the active agent to and/or through (i) a dermal layer of the subject (Fig. 2 and [0037, 0040], microneedles 26 are applied to the epidermis 30/stratum corneum 32 of patient for delivery of the active agent to said region); and/or (ii) a mucosa of the subject; and/or (iii) a deep dermis layer of the subject; and/or (iv) a bone of the subject.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Francis (US 20150141910), in view of Christ (US 5843186), From (WO 2010009087), and Ronnander (US 20200206489), as applied to claim 1 above, and further in view of Gu et al. (US 20210145984), hereinafter Gu.
Regarding claim 2 and Francis, in view of Christ, From, and Ronnander, Francis further discloses the microneedle array of claim 1, wherein when each of the microneedles is formed of the swellable and water-insoluble matrix comprising the crosslinked polymer (Fig. 2 and [0042, 0055, 0061, 0066], each of the microneedles 26 are made of the crosslinked polymer (HA with a suitable crosslinking agent) to make a swellable but dissolution preventing (insoluble) material).
Francis, in view of Christ, From, and Ronnander, fails to disclose the crosslinked polymer comprises an acrylate-crosslinked hydrophilic polymer, a furan-crosslinked hydrophilic polymer, or a catechol-crosslinked hydrophilic polymer, wherein the acrylate-crosslinked hydrophilic polymer comprises methacrylate-crosslinked hyaluronic acid, methacrylate-crosslinked polyvinyl alcohol, methacrylate-crosslinked poly(methylvinyl ether), or cross-linked poly(ethylene glycol) diacrylate, wherein the methacrylate-crosslinked hyaluronic acid is formed from hyaluronic acid having an average molecular weight ranging from 3 kDa to 300 kDa. However, Gu discloses he crosslinked polymer comprises an acrylate-crosslinked hydrophilic polymer ([0055], polymer is methacrylated hyaluronic acid), a furan-crosslinked hydrophilic polymer, or a catechol-crosslinked hydrophilic polymer, wherein the acrylate-crosslinked hydrophilic polymer comprises methacrylate-crosslinked hyaluronic acid ([0055], polymer is methacrylated hyaluronic acid), methacrylate-crosslinked polyvinyl alcohol, methacrylate-crosslinked poly(methylvinyl ether), or cross-linked poly(ethylene glycol) diacrylate, wherein the methacrylate-crosslinked hyaluronic acid is formed from hyaluronic acid having an average molecular weight ranging from 3 kDa to 300 kDa ([0051], the hyaluronic acid is a hydrophilic polymer with a molecular weight between 10kDa and 200kDa).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Francis, in view of Christ, From, and Ronnander, to incorporate the disclosures of Gu and modify the crosslinked polymer to comprise an acrylate-crosslinked hydrophilic polymer, a furan-crosslinked hydrophilic polymer, or a catechol-crosslinked hydrophilic polymer, wherein the acrylate-crosslinked hydrophilic polymer comprises methacrylate-crosslinked hyaluronic acid, methacrylate-crosslinked polyvinyl alcohol, methacrylate-crosslinked poly(methylvinyl ether), or cross-linked poly(ethylene glycol) diacrylate, wherein the methacrylate-crosslinked hyaluronic acid is formed from hyaluronic acid having an average molecular weight ranging from 3 kDa to 300 kDa. Doing so would provide a crosslinked polymer base-layer/microneedle material which may comprise an antibiotic embedded in its microcavities for administration over a prolonged period of time (Gu, [0058, 0059]).
Conclusion
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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