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 .
Response to Amendment
This office action is responsive to the amendment filed on February 23, 2026. As directed by the amendment: claims 1, 4, 5, 10, 12, and 13 have been amended, claim 27 been cancelled, and claim 28 has been added. Thus, claims 1-26 and 28 are presently pending in this application with claims 19-26 presently withdrawn.
Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed August 21, 2025.
Response to Arguments
Applicant’s arguments, filed February 23, 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive, specifically in regards to Kono not teaching or disclosing the newly added claim limitation. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Applicant’s amendments.
Applicant's arguments filed with respect to new claim 28 have been fully considered but they are not persuasive. Applicant argues on pg. 7 of the Remarks that “Kono teaches a pyramidal shape with a heigh[t] nearly equal to its width”. The examiner first notes that Kono discloses the microneedle can be conical in shape (pg. 2 of provided translation discloses “the needle-like protrusion 12 has a basic portion having a cone shape”, indicating that a cross-section of the microneedle would be round. The examiner also notes that the claim does not presently define the width. Kono teaches that the length of the body is at least four times a width of the fluid conduit 15, discussed in more detail below.
Claim Rejections - 35 USC § 112
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.
Claim 14 is 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.
Regarding claim 14, the claim is drawn to “the dissolvable material”. It is unclear if this limitation is directed to the dissolvable material of the molded tip or of the body. Since the materials have differing dissolution profiles, it is assumed that the materials would be different. For examination purposes, the limitation is interpreted to be drawn towards the material of the molded tip since that was the original scope of the claim.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 1-8, 10-12, and 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kono (JP 2013094224) in view of Ding (US 20140180201).
Regarding claim 1, Kono discloses a microneedle for delivering materials into a patient (microneedle device 10 in fig. 1) comprising:
a body (second material 14b in fig. 2) having a proximate end (see below) and a distal end (see below), wherein a cavity traverses an interior of the body along a longitudinal axis from the proximate end to the distal end (conduit 15 in fig. 2);
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a molded tip (first material 14a; the examiner notes that “molded” is a product-by-process limitation, however, fig. 6 shows the tip being made in a mold) comprising a dissolvable material attached to the distal end of the body (second paragraph of pg. 3 of provided translation discloses that the first material 14a comprises a soluble material which dissolves when in contact with skin); and
a reservoir having a volume capable of holding a bioactive agent (reservoir space 59 in fig. 9), wherein the reservoir is in fluid communication with proximate end of the body (fig. 9).
However, Kono does not teach or disclose the body comprises a dissolvable material having a longer dissolution profile than the dissolvable material of the molded tip.
Ding is directed towards a microneedle (fig. 2) comprising a tip (distal layer 14 in fig. 2) and a body (proximal layer 16 in fig. 2 and “any intermediate layers” form the “body”). Ding further the body comprises a dissolvable material having a longer dissolution profile than the dissolvable material of the tip (paragraph 81 discloses that the intermediate layer can comprise a biodegradable matrix with active ingredients which degrades more slowly than the tip to provide a more sustained drug release).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the body of Kono to comprise an intermediate layer comprised of a dissolvable material that has a longer dissolution profile, as taught by Ding. Ding teaches that this modification facilitates detachment of the tip and provides a more sustained release of an active agent (paragraph 81).
The examiner notes that once modified with Ding, modified Kono teaches that the body comprises a dissolvable material since the term “comprises” indicates that the body can be comprised of multiple materials.
Regarding claim 2, in the modified device of Kono, Kono discloses a plurality of microneedles are arranged in an array (fig. 3a-c).
Regarding claim 3, in the modified device of Kono, Kono discloses each microneedle of the plurality is arranged in a grid with equal spacing between each microneedle (fig. 3c).
Regarding claim 4, in the modified device of Kono, Kono discloses the molded tip is adapted to deliver materials into a tissue selected from a group consisting of skin tissue, heart tissue, inner ear tissue, cancerous tissue, diseased tissue, and eye tissue (the materials are configured to be delivered to any of the claimed tissues; fig. 11 shows the device inserted into skin tissue).
Regarding claim 5, in the modified device of Kono, Kono discloses the microneedle is fitted with an adapter to facilitate delivery of liquid or solid bio-cargo from a back side of the adapter using a standard Luer Tip or Luer Lock syringe (support base 56 in fig. 9).
Regarding claim 6, in the modified device of Kono, Kono discloses the body has a round or square cross-sectional shape (fig. 2 shows that a cross-sectional cut perpendicular to the longitudinal axis would yield a round cross-sectional shape).
Regarding claim 7, in the modified device of Kono, Kono discloses the tip is pyramid-shaped or cone-shaped (fig. 2 shows a cone shaped tip).
Regarding claim 8, in the modified device of Kono, Kono discloses the tip has a base diameter larger than a diameter of the body (see below; the outer diameter of the tip base is larger than an inner diameter of the body).
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Regarding claim 10, in the modified device of Kono, Kono discloses the body has a negative angle relative to a base to create a retaining geometry (fig. 1 shows the body having a tapered outer surface so as to have a negative angle relative to a base).
Regarding claim 11, in the modified device of Kono, Kono discloses the distal end of the body is shaped or roughened to facilitate attachment of the tip to the body (fig. 1 shows the tip is attached to the distal end of the body so that the body has a shape which facilitates this attachment).
Regarding claim 12, in the modified device of Kono, Kono discloses the cavity is tapered to facilitate demolding (fig. 1 shows conduit 15 as being tapered towards a smaller diameter towards the distal end).
Regarding claims 15 and 16, Kono discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the dissolvable tip has an encapsulated compound of an adjuvant or an anti-inflammatory compound as a secondary phase delivery.
As discussed above, Ding teaches a microneedle (microstructure 12 in fig. 2) comprising a dissolvable tip (distal layer 14 in fig. 1) which has an encapsulated compound of a drug as a secondary phase delivery (paragraph 56 discloses a “drug-in-tip” layer 14; paragraph 81 discloses multiple layers having drugs so that there would be multiple phases of delivery). Ding further teaches that an example encapsulated compound is an anti-inflammatory agent (paragraph 72). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the tip of Kono to have an encapsulated anti-inflammatory compound as a secondary phase delivery. This modification would enhance the therapeutic effect of the microneedle of Kono.
Regarding claim 17, in the modified device of Kono, Kono discloses the delivered material is selected from the group consisting of an RNA, mRNA, DNA, protein, viral, inactivated, or live-attenuated virus- based vaccine (the examiner notes that the “delivered material” is considered functional due to the “for delivering” language of the preamble of claim 1; the device of Kono is functionally capable of delivering any of the claimed materials).
Regarding claim 18, in the modified device of Kono, Kono discloses the microneedle is used for delivery into the oral cavity (buccal delivery), sublingually, or other mucosal membranes (the microneedle of Kono is functionally capable of being used in any of the claimed membranes).
Claim(s) 9, 13, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kono in view of Ding, as applied to claim 1 above, and further in view of Mefti (US 20120265145).
Regarding claim 9, modified Kono teaches all of the claimed limitations set forth in claim 1, as discussed above. In modified Kono, Ding discloses a layer disposed in the distal end of the body (paragraph 56 discloses “intermediate layers”). However, modified Kono does not explicitly teach or disclose the layer is made from poly(lactic-co-glycolic acid).
Mefti teaches a microneedle (fig. 1) in which two different polymers can be used to impart different dissolution rates (paragraph 75). Mefti teaches that the slower dissolving polymer can be made from poly(lactic-co-glycolic acid) (paragraph 75).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the intermediate layer of modified Kono to be made from PLGA, as taught by Mefti, since Mefti teaches that this is an example polymer which provides a longer dissolution.
Regarding claim 13, modified Kono teaches all of the claimed limitations set forth in claim 1, as discussed above. In modified Kono, Ding discloses a layer of disposed in the distal end of the body and separating the tip from the body (paragraph 56 discloses “intermediate layers”). However, modified Kono does not explicitly teach or disclose the layer is made from poly(lactic-co-glycolic acid).
Mefti teaches a microneedle (fig. 1) in which two different polymers can be used to impart different dissolution rates (paragraph 75). Mefti teaches that the slower dissolving polymer can be made from poly(lactic-co-glycolic acid) (paragraph 75).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the intermediate layer of modified Kono to be made from PLGA, as taught by Mefti, since Mefti teaches that this is an example polymer which provides a longer dissolution.
Regarding claim 14, modified Kono teaches all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the dissolvable material comprises at least one of polyvinyl alcohol, carboxymethlycellulose, trehalose, glucose, maltose, PVP, and maltodextrin.
Mefti teaches a microneedle (fig. 1) in which two different polymers can be used to impart different dissolution rates (paragraph 75). Mefti teaches that the faster dissolving polymer can be made from carboxymethlycellulose or maltose (paragraph 75).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the dissolvable material of the tip to be made from CMC or maltose, as taught by Mefti, since Mefti teaches that this is an example polymer which provides a rapid delivery of an agent.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kono.
Regarding claim 28, Kono discloses a microneedle for delivering materials into a patient (microneedle device 10 in fig. 1) comprising:
a body (second material 14b in fig. 2) having a proximate end (see below) and a distal end (see below), wherein a cavity traverses an interior of the body along a longitudinal axis from the proximate end to the distal end (conduit 15 in fig. 2);
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a molded tip (first material 14a; the examiner notes that “molded” is a product-by-process limitation, however, fig. 6 shows the tip being made in a mold) comprising a dissolvable material attached to the distal end of the body (second paragraph of pg. 3 of provided translation discloses that the first material 14a comprises a soluble material which dissolves when in contact with skin); and
a reservoir having a volume capable of holding a bioactive agent (reservoir space 59 in fig. 9), wherein the reservoir is in fluid communication with proximate end of the body (fig. 9),
wherein the body has a round or square cross-section (fig. 2 and pg. 2 of the provided translation discloses a conically shaped body, indicating that the cross-section would be round).
While Kono does not explicitly teach or disclose that the body has a length at least four times a width, Kono teaches that the overall microneedle preferably comprises a length between 1500-1800 micrometers with the tip having a length between 100-200 micrometers (pg. 3, 3rd paragraph of provided translation), indicating that the body could have a length between 1300-1700 micrometers. Kono teaches that a width of the channel, which is also an inner diameter/width of the body, is preferably between 10-50 micrometers (pg. 3, 4th paragraph of provided translation), so that the length of the body is at least four times a width.
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the microneedle of Kono to have the length of the body be at least four times a width of the channel (as noted above, the claim does not presently define the width), since these relative dimensions appear within the scope and intended design of Kono.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783