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 .
DETAILED ACTION
Claims 12-19 withdrawn
Claims 1, 10, 20 amended
Claims 4-5 and 11 Cancelled
Claims 1-3, 6-10 pending
Claim 20 Allowed
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.
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) 1-2, 6 are rejected under 35 U.S.C. 103 as being unpatentable over Baek (PG Pub 2018/0185625 A1).
Consider Claim 1, Baek teaches the process of forming microstructure thin film (1) (abstract), for skin penetration ([0044]-[0045] figure 2), having microstructures /microneedles (2) protruding from the base thin film (3) (figure 2, [0044]). Beak teaches step of coating agent (C)/functional mixture by spraying process, where the coating is only in the tips/micro-needles (2) within any coating on the base thin film (3) (figure 4, [0056]).
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Although Beak does not explicitly teach the coating is irregular on the micro needles, however, it would be obvious for ordinary skilled person in the art and following paragraph [0062], where the upper portion microneedles are coated, such as upper fifth or more, that the totality of the coating of the microstructures to some degree would be irregular, with reasonable and predictable expectation of success.
Beak teaches use of spray coating, or atomization coating process [0056], therefore forming droplets structure.
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Beak teaches the spray direction on the microstructure that is at the center of the base this film (3) and another one on left of it, see the above figure 4b. Where this spray direction (directly over the central microstructure) is perpendicular to the base/plate which holds the plurality of microstructures (figure 4b). Therefore, the direction perpendicular to a spray direction is parallel to the base/plate plain, where the angle of both lines/directions (since they are on top of each other) is zero angle (0°q).
Leading that the distance being measured on a cross section (of the lines between the two adjacent microstructures) of a direction perpendicular to a spray direction of the functional mixture is zero, more than any size of a droplet diameter. Where this distance is measured at any height starting from a lower part of the microstructure, which is connected to the base thin film.
Consider Claim 2, Beak teaches the coating using sprayer (22) [0061] having a spraying angle (figure 4), where it would be obvious to ordinary skilled person in the art, that the sprayer (22) is adjusted to the designated position/angle prior to coating, to provide with best coating coverage.
Consider Claim 6, Beak teaches the microstructures thin film molded from biodegradable polymer [0011], or molded from insoluble such as PDMS [0012].
Claim(s) 3 are rejected under 35 U.S.C. 103 as being unpatentable over Baek (PG Pub 2018/0185625 A1), in view of Mir (PG Pub 2010/0100005 A1).
Consider Claim 3, Baek teaches the previous taught in claim 1.
Beak does not teach use of binder layer.
However, Mir is in the prior art of microneedles coated with allergen (abstract), teaches the process of coating binder layer on the microneedles prior to coating the allergen [0033].
A person having ordinary skill in the art before the effective date of the claimed invention would combine Beak with Mir to coat a binder layer before the functional mixtures, to provide with an increase the adhesion to the microneedles [0033].
Claim(s) 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Baek (PG Pub 2018/0185625 A1) in view of Yoshida (PG Pub 2015/0238434 A1).
Consider Claims 7-9, Baek teaches the previously in claim 6.
Beak does not teach the detailed molding process.
However, Yoshida is in the prior art of forming microneedles using molding process (abstract) including press molding (abstract) deforming the molding material (20) to the mold/plate (13) ([0097], figures 8A-8D), teaches process of coating the materials such as silicone resin (PDSM) [0089], and the molding using UV curing [0089], and then the drying then the peeling/separating the mold off the plate [0089].
A person having ordinary skill in the art before the effective date of the claimed invention would combine Beak with Yoshida to provide a transdermal absorption sheet and a manufacturing method for the transdermal absorption sheet that allow the drug to concentrate at the microneedles, while serving to improve production efficiency [0012].
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Baek (PG Pub 2018/0185625 A1) in view of Chang (PG Pub 2005/0178760 A1).
Consider Claim 10, Baek teaches the previously in claim 6.
Beak does not teach the forming of microneedles using cutting a flat plate.
However, Change is in the prior of forming microneedles (abstract), teaches the process of thin film plate (20) (fig 2), where a flat plate shape (40) is cut and bend using pressing process with projection (48) from tool (44) (figure 4A) forming thin film plate (40) (figure 4B) by pressing unit (56) (figure 5, [0029]), where the cutting (opening) and the bending in the thin film plate (40) is formed from the pressing and the bending of the projection (48) of the tool (44) having concave-convex portion (figure 4A).
A person having ordinary skill in the art before the effective date of the claimed invention would combine Beak with Chang to provide microstructure parameters at the nano level [0027].
Allowable Subject Matter
Regarding Claim 20:
The following is a statement of reasons for the indication of allowable subject matter:
None of the prior arts of records suggest of disclose the process of forming skin attachable thin film having a nanomicro thin film including a plurality of nanomicro structures each having a size smaller than that of the microstructure is prepared, and disposing the microstructured thin film and the nanomicro thin film to face each other to thus bring the functional mixture into contact with the microstructure, as claimed.
None of the prior of record disclose or suggest the process of forming a nanomicro thin film by a functional mixture is coated on the microstructure excluding the region of the base film of the microstructured thin film by coating the functional mixture on the nanomicro structure, and disposing the microstructured thin film and the nanomicro thin film to face each other to thus bring the functional mixture into contact with the microstructure, as claimed.
Response to Arguments
Applicant’s arguments, filed 09/22/2026, with respect to the rejection(s) of claim(s) 1-3, 6-10 under 103a 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 Beak.
The previously applied 112 claims rejection, in light of the amended claim are now withdrawn.
The applicant argued against the prior art of Beak, on the ground that Beak does not disclose the amended limitation of the previous claim 11 (now deleted), now in the amended claim 1.
However, the prior art of Beak disclose the spray direction on the microstructure that is at the center of the base this film (3) and another one on left of it, see the above figure 4b. Where this spray direction (directly over the central microstructure) is perpendicular to the base/plate which holds the plurality of microstructures (figure 4b). Therefore, the direction perpendicular to a spray direction is parallel to the base/plate plain, where the angle of both lines/directions (since they are on top of each other) is zero angle (0°q).
Leading that the distance being measured on a cross section (of the lines between the two adjacent microstructures) of a direction perpendicular to a spray direction of the functional mixture is zero, more than any size of a droplet diameter. Where this distance is measured at any height starting from a lower part of the microstructure, which is connected to the base thin film. Meeting the claimed limitation of claim 1.
Additionally, the applicant’s main argument are based on the figures 6B, 10A and 10B on the instant application, see below:
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However, the concept of the above figures, is to have the spraying direction parallel to the plain of the base/plate, while having the sides of microstructures intercept the sprayed materials (functional mixture) during spraying, for deposition on the sides of the microstructures. As well as having a single, and a narrow beam of spraying with a limited spraying area. Additionally, the placement/patterns of the microstructures itself have an effect on the claimed limitation, as the pattern in figure 6B is different from the pattern in figures 10A-B (as highlighted in each figure), as this alignment would have a major effect of the limitation and the coating efficiency. Moreover, the alignment of the microstructures patterns with the spraying direction beam also have a similar effect of the limitation as well.
Furthermore, none of the above statement/limitation are claimed, where the claim as stands, is broad that would read on various ways.
All other applicant arguments not specifically addressed above are deemed unpersuasive as either not commensurate in scope with the broadly drafted claims or are unsupported by factual evidence and are deemed mere attorney speculation.
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 Mohammad Mayy whose telephone number is (571)272-9983. The examiner can normally be reached Monday to Friday, 11:00AM-7:00PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gordon Baldwin can be reached at 571-272-5166. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Mohammad Mayy/
Art Unit 1718
/GORDON BALDWIN/Supervisory Patent Examiner, Art Unit 1718
Prosecution Insights