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 .
Claim 1 is amended. Claims 2-4 and 16-19 are canceled. Claims 21-25 are newly added.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/17/2026 has been entered.
Response to Arguments
Applicant’s arguments, see pages 1-10, filed 04/17/2026, with respect to the rejection(s) of claim(s) of amended claim 1 under U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of by Mcallister (US 20170050010) in view of Cheng (US 20160058992) and KR 20190136436 hereinafter KR’436 listed in IDS translation attached.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 5-6, 7 , 10-12 and 14-18, 21=24, 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over by Mcallister (US 20170050010) in view of Cheng (US 20160058992) and KR 20190136436 hereinafter KR’436 listed in IDS translation attached. .
Regarding Claim 1, Mcallister discloses method for manufacturing a microneedle element comprising at least one microneedle (Figure 1, microneedle-130), the method comprising the following steps: providing a mold element for the microneedle elements to be manufactured (Figure 13, mold-1301); filling the mold element with a tip formulation (Figure 13, [0074]-[0075], formulation-1302), filling the mold element with a backing formulation (Figure 13, [0074]-[0075], formulation-1304): curing the formulation; and pressurizing the first formulation during curing ([0101]).
Mcallister fails to disclose that pressurization is carried out over a period of at least 30 minutes, such that formulation is at least partially cured, however, in the related field of endeavor pertaining to the art of manufacturing microneedle, Cheng discloses that under some pressure drying/curing can take place from 20 minutes to several hours which satisfy the claim limitation ([0106]).
It would have been obvious to one ordinary skill in the art to modify the manufacturing of microneedle as taught by Mcallister with pressurization over specific period of time, as suggested by Cheng, for the benefit of achieving desired mechanical strength in the product formed ([0090]), and for further benefit of effectively penetrating desired site ([0090]).
Further Mcallister didn’t disclose that tip and backing formulation simultaneously being cured and pressurized. In the related filed of endeavor pertaining to the art, KR’436 discloses that the formulation is simultaneously cured and pressurized ([0039]-[0040], translated). Also, KR’436 discloses that pressurization of the formulation will remove the bubble/pockets in the manufacturing process ([0039]).
It would have been obvious to one ordinary skill in the art to modify the manufacturing of microneedle as taught by Mcallister with the formulation simultaneously being cured and pressurized to remove bubbles for the purpose of eliminating defects.
Regarding Claim 5, Mcallister discloses wherein, when filling the mold element with the backing formulation, the mold element is overfilled so that the backing formulation emerges from the mold element ([0101], Figure 13 the mold element is filled with backing formulation then it would be obvious for one ordinary skilled in the art to comprehend that the if the mold element is overfilled then the first formulation emerges from the mold element ).
Regarding Claim 6, Mcallister discloses wherein drying, in particular air drying, takes place during curing ([0115]).
Regarding Claim 7, Mcallister discloses, wherein temperature is applied during curing ([0148]).
Regarding Claim 10, Mcallister discloses, wherein the mold element comprises several microneedle negative molds, and wherein the several microneedle negative molds in particular form a microarray negative mold (Figure 6. [0048]).
Regarding Claim 11, Mcallister discloses, wherein the mold element is filled with the backing formulation such that the backing formulation covers the several microneedle negative molds (Figure 13, first formulation-1302 ).
Regarding Claim 12, Mcallister discloses a microneedle element, in particular a microneedle or microarray, obtainable by a method according to claim 1 (abstract).
Regarding Claim 14, Mcallister discloses that the pressure is applied but didn’t disclose that wherein the pressurization and/or curing is carried out over a period of at least 60 minutes, however, in the related field of endeavor pertaining to the art, Cheng discloses that under some pressure drying/curing can take place from 20 minutes to several hours which satisfy the claim limitation ([0106]).
Regarding Claim 15, Mcallister discloses that the pressure is applied but didn’t disclose that wherein the pressurization and/or curing is carried out over a period of at least 90 minutes, however, in the related field of endeavor pertaining to the art, Cheng discloses that under some pressure drying/curing can take place from 20 minutes to several hours which satisfy the claim limitation ([0106]).
Regarding Claim 16, Mcallister discloses, wherein the first formulation is a backing formulation (Figure 13, first formulation-1302).
Regarding Claim 17, Mcallister discloses, wherein the second formulation is a tip formulation (Figure 13, second formulation-1304).
Regarding Claim 18, Mcallister discloses that wherein the method comprises after the step of filling the mold element with the second formulation, the following further step: curing the second formulation ([0102]). Cheng discloses that while applying some pressure drying/curing can be done ([0106]).
Regarding Claim 21, Mcallister discloses method for manufacturing a microneedle element comprising at least one microneedle (Figure 1, microneedle-130), the method comprising the following steps: providing a mold element for the microneedle elements to be manufactured (Figure 13, mold-1301); filling the mold element with a tip formulation (Figure 13, [0074]-[0075], formulation-1302), filling the mold with an intermediate solution ([0101]); filling the mold element with a backing formulation (Figure 13, [0074]-[0075], formulation-1304): curing the formulation; and pressurizing the tip, intermediate and backing formulation during curing ([0101]).
Mcallister fails to disclose that pressurization is carried out over a period of at least 30 minutes, such that formulation is at least partially cured, however, in the related field of endeavor pertaining to the art of manufacturing microneedle, Cheng discloses that under some pressure drying/curing can take place from 20 minutes to several hours which satisfy the claim limitation ([0106]).
It would have been obvious to one ordinary skill in the art to modify the manufacturing of microneedle as taught by Mcallister with pressurization over specific period of time, as suggested by Cheng, for the benefit of achieving desired mechanical strength in the product formed ([0090]), and for further benefit of effectively penetrating desired site ([0090]).
Further Mcallister didn’t disclose that tip and backing formulation simultaneously being cured and pressurized. In the related filed of endeavor pertaining to the art, KR’436 discloses that the formulation is simultaneously cured and pressurized ([0039]-[0040], translated). Also, KR’436 discloses that pressurization of the formulation will remove the bubble/pockets in the manufacturing process ([0039]).
It would have been obvious to one ordinary skill in the art to modify the manufacturing of microneedle as taught by Mcallister with the formulation simultaneously being cured and pressurized to remove bubbles for the purpose of eliminating defects.
Regarding Claim 22, Mcallister discloses wherein, when filling the mold element with the backing formulation, the mold element is overfilled so that the backing formulation emerges from the mold element ([0101], Figure 13 the mold element is filled with backing formulation then it would be obvious for one ordinary skilled in the art to comprehend that the if the mold element is overfilled then the first formulation emerges from the mold element ).
Regarding Claim 23, Mcallister discloses wherein drying, in particular air drying, takes place during curing ([0115]).
Regarding Claim 24, Mcallister discloses, wherein temperature is applied during curing ([0148]).
Regarding Claim 26, Mcallister discloses, wherein the mold element comprises several microneedle negative molds, and wherein the several microneedle negative molds in particular form a microarray negative mold (Figure 6. [0048]).
Regarding Claim 27, Mcallister discloses, wherein the mold element is filled with the backing formulation such that the backing formulation covers the several microneedle negative molds (Figure 13, backing formulation-1304 ).
Claim(s) 8, 20, 25 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over as Mcallister (US 20170050010) in view of Cheng (US 20160058992) and further in view of Francis (US 20180333899).
Regarding Claim 8 and 20, 25 and 27 Mcallister discloses the pressure is applied but fails to teach that pressurization is realized by means of overpressure and/or by means of a pressing device, in particular comprising a punch and/or a roller. In the related field of art, Francis discloses that pressure can be applied by rollers a pressing device ([0070]).
It would be obvious for one ordinary skilled in the art to combine KR’872 with that of Francis’s teaching of the pressure rollers for the purpose of to apply uniform pressure over the mold surface to ensure defect free production.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBJANI ROY whose telephone number is (571)272-8019. The examiner can normally be reached 9:30-5:30 pm.
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/DEBJANI ROY/Examiner, Art Unit 1741
/ALISON L HINDENLANG/Supervisory Patent Examiner, Art Unit 1741
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