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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-13, in the reply filed on 20 February 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 7, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al (US 2020/0129748) in view of Kingsford (US 2008/0269670).
Regarding claim 1, Lee discloses:
A microneedle array (100; Fig. 1A), comprising: a plurality of microneedles (110, 120, 130, 140), wherein each of a respective microneedle of the plurality of microneedles (110-140) further comprises: a base (150); a needle tip (112); an elongated structure (114) therebetween the base (150) and the needle tip (112); and a preformed interlocking feature (160; ¶0033) configured about the elongated structure (114).
Lee is silent regarding “the preformed interlocking feature is arranged with a width that decreases in the needle tip direction and decreases in the base direction.” However, Kingsford teaches a transdermal drug delivery device (Abstract), thus being in the same field of endeavor, with needles (18; Fig. 1) with interlocking features (20) in the form of half-pyramid shaped barbs (20a, 20b; Figs. 3A, 3B), resulting in barbs that have a decreasing width toward both the tip and the base directions (Image 1). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the barbs of Lee to be in the form of barbs with a width that decreases in the needle tip direction and decreases in the base direction as taught by Kingsford because such a modification would be the result of a simple substitution of one known element (the barbs of Kingsford) for another known element (the barbs of Lee) to obtain predictable results (adhering a transdermal delivery device to a patient).
Image 1. Annotated portion of Fig. 3A
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Regarding claim 2, Lee in view of Kingsford discloses the microneedle array of claim 1, wherein the width of the preformed interlocking feature taught by Kingsford in the rejection of claim 1 increases in a first exist angle adjacent the needle tip direction and increases in a second exist angle adjacent the base direction, as seen by the shape in Image 1 above.
Regarding claim 3, Lee in view of Kingsford discloses the microneedle array of claim 2 but is silent regarding “wherein the first exist angle is at least 20 degrees.” It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the interlocking feature taught by Kingsford to have an angle adjacent the needle tip direction (first exist angle) of at least 20 degrees since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the barbs of Kingsford would not operate differently with the claimed angle since the barbs are formed to secure the device to skin. The device would function appropriately with the claimed exist angle. Furthermore, the instant application discloses that “it is to be noted they can be any angle that comports with the design parameters of the present invention” (instant ¶0074).
Regarding claim 4, Lee in view of Kingsford discloses the microneedle array of claim 2 but is silent regarding “wherein the second exist angle is at least 20 degrees.” It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the interlocking feature taught by Kingsford to have an angle adjacent the base direction (second exist angle) of at least 20 degrees since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the barbs of Kingsford would not operate differently with the claimed angle since the barbs are formed to secure the device to skin. The device would function appropriately with the claimed exist angle. Furthermore, the instant application discloses that “it is to be noted they can be any angle that comports with the design parameters of the present invention” (instant ¶0074).
Regarding claim 5, Lee in view of Kingsford discloses the microneedle array of claim 1 and further discloses that the microneedles can be made of swellable material that expands when fluid is absorbed from skin tissue (¶0053). However, Lee is silent regarding the swelling resulting in an “increase in width between 5 to 300 percent.” However, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the interlocking feature taught by Kingsford to specifically increase in width by 5 to 300 percent since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the barbs of Kingsford would not operate differently with the claimed width increase as the device of Lee is intended to swell when exposed to fluid tissue contact. The device would function appropriately with the claimed width increase. Furthermore, the instant application discloses several scenarios of width increase (¶0069, Fig. 6).
Regarding claim 7, Lee in view of Kingsford discloses:
The microneedle array of claim 1, wherein each of the plurality of microneedles comprises a hydrogel (¶0053).
Regarding claim 10, Lee in view of Kingsford discloses:
The microneedle array of claim 1, wherein each of the microneedles are configured from at least one of a natural polymer and a synthetic polymer (¶0054 – polyacrylic acid, which is a synthetic polymer).
Regarding claim 12, Lee in view of Kingsford discloses:
The microneedle array of claim 10, wherein the synthetic polymer further comprises a polymer selected from a polyvinyl alcohol (PVA), a polyethylene glycol (PEG), or a polyacrylic acid (PAA) (¶0054 – polyacrylic acid).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Lee (hereinafter Lee ‘748) in view of Kingsford further in view of Lee et al (US 2009/0182306, hereinafter Lee ‘306).
Regarding claim 11, Lee ‘748 in view of Kingsford discloses the microneedle array of claim 10 but is silent regarding the microneedles comprising “a polymer selected from a protein or a polysaccharide.” However, Lee ‘306 teaches a microneedle device (Abstract), thus being in the same field of endeavor, comprising a swellable material made of a polysaccharide (¶0011). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the swellable material of Lee ‘748 to be a polysaccharide as taught by Lee ‘306 as such a modification would be the result of a simple substitution of one known element (the material of Lee ‘306) for another known element (the material of Lee ‘748) to obtain predictable results (providing a swellable material for a microneedle device).
Allowable Subject Matter
Claims 6, 8, 9, and 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571)272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783