DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the arguments filed on 12/8/2025.
Claims 22-30 and 41-43 are presented for examination on the merits. The following rejections are made.
Response to Applicants’ Arguments
Applicant’s arguments filed 12/8/2025 regarding the rejection of claims 22-30 and 41-43 made by the Examiner under 35 USC 103 over Byeong-jin (KR2011/0012986) in view of Ridden et al. (WO2015/044669) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 9/8/2025.
In regards to the 103 rejection, Applicant asserts the following:
A) Byeong’s teaching is replete with references to “raw material containing drug” and similar and it is clear from the reference that Byeong’s microneedle is molded from a raw material plus a drug and not an active pharmaceutical ingredient as claimed. Nothing in the references would lead one to a material containing 100% drug alone. Moreover, Byeong mentions “pad raw material and the medicinal component” which indicates that the microneedle contains raw material and drug.
In response to A, the Examiner is not persuaded. Byeong states that their method requires “applying a raw material in a molten state to a mold drum on which a plurality of mold microneedles are formed” (see page 2), “the rotating drum 83 and supplies a raw material in a molten state” (see page 7) and “applying a mold raw material in a molten state to a mold drum having a plurality of mold microneedles thereon” (see page 11). These statements by Byeong that the method utilizes “a raw material”, a material in the singular, reasonably suggests that the microneedle be formed from a single component. As acknowledged in the response, the “raw material” contains the drug substance and so a natural outcome would be employing the drug substance as the raw material of the microneedles and so one of ordinary skill in the art would envisage a microneedle comprising a single raw material being that of the drug substance as the language of the reference indicates that the microneedle be made from “a” singular raw material (i.e. the drug).
Regarding the pad material, the reference teaches that the pad material is a fabric material used as a support for the microneedle. Byeong teaches that the pad material can be continuously produced by applying a raw material including drug component to the continuously supplied mold fabric (i.e. the pad material). The method of making the microneedle embedded pad is considered distinct from the method of making the microneedles themselves although in the end the microneedle and the pad are integrated with one another. Regardless, the present claims are to a method of making a microneedle for which Byeong sufficiently describes.
Maintained Rejections, of Record
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 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.
Claim 22-30 and 41-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Byeong-jin (KR2011/0012986; translation provided; of record) in view of Ridden et al. (WO2015044669; of record).
Byeong-jin is directed therapeutic microneedles and a method for their manufacture, the method comprising applying a raw material containing a drug ingredient to a sheet-shaped mold fabric having a plurality of holes (see pages 8-9) and microneedle mold grooves, vacuum-sucking the raw material through the grooves so as to form a microneedle having a sharp tip and then cutting the mad to mass produce microneedle pads (shaping) (see pages 1, 3 and 12). The process requires the raw material (e.g. drug compound) to be in a powder states prior to being melted into the molten state (see page 13). After application of the molten raw material, the method further requires the molten material have time to cool so as to form the final microneedle (see page 12) (see instant claims 22 and 43). The microneedle once cured is to be separated from the molding apparatus (see page 9) (see instant claim 25).
It is observed that the interior surface of the mold would define the exterior surface of the microneedle (see instant claims 26, 27, 28 and 43).
Regarding the limitation of “melting by heating and then colling the active pharmaceutical ingredient in the micromold” as recited by instant claims 26 and 27, this is an obvious variation of Byeong-jin. Such a manipulation is nothing more than changing the sequence of adding ingredients to form a microneedle. That is, whether the agent is melted before being placed in the mold or melted after being placed in the mold is not seen as providing a critical difference in the outcomes, absent evidence otherwise. Both processes would yield a molten phase of the drug and allow for the shaping of the molten material within the molds.
Removal of the microneedles from the mold is performed using a centrifugal separator or a vacuum suction step (see pages 1 and 4) (see instant claims 29 and 43).
Byeong-jin only described the molten raw material in terms of the drug so it is presumed that Byeong-jin is interested in producing a microneedle that contains only the drug active. Thus, the microneedle would be expected to contain 100% drug, i.e. consist of the drug (see instant claims 23, 24, 40, 41, 42 and 43). As the teaching suggests the microneedle be only drug, it would follow that the resulting microneedle be free of a stabilizing material, polymer carbohydrate and/or resin (see instant claims 22 and 41).
Byeong-jin fails to teach the drug as being itraconazole.
Ridden is directed to compositions that contain a microneedle array for delivery of various active agents such as itraconazole (see page 15) (see instant claim 30). Ridden teaches that the microneedles can be used to deliver antifungal agents like itraconazole to target tissue in need of treatment (see page 16). Ridden, like Byeong-jin, teaches that microneedle delivery is advantageous as the delivery of the drug is non-invasive and overcomes issues resulting when the medicament is consumed orally (see page 30). It is also taught that microneedle delivery of drugs like itraconazole is advantageous as it bypasses the digestive and hepatic portal systems which reduce bioavailability of the drug.
Regarding the requirement that ‘the active pharmaceutical ingredient is meltable, solid at 25oC, and has an ability to form a glassy, amorphous form following melting by heating and cooling’, these are properties of the elected active ingredient (itraconazole). Instant claim 30 identifies itraconazole as the active ingredient and thus itraconazole would necessarily possess the properties of the claim from which it depends during the melting/cooling processes.
It would have been obvious to modify Byeong-jin’s method of making microneedles to include a drug like itraconazole with a reasonable expectation for success in producing itraconazole microneedles especially given that itraconazole microneedles were already suggested by the prior art. Combining prior art elements according to known methods to yield predictable results is supportive of a finding of obviousness. See MPEP2143(I)(A).
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611