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Claims 12-19 withdrawn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, 3-6, 11, 14 amended
Claims 1-11 and 20 pending and elected
Election/Restrictions
Applicant’s election without traverse of claims 1-11 and 20 in the reply filed on 04/13/2026 is acknowledged.
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.
Claims 1-11 and 20 are 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.
Claims 1 and 20 recites the limitation “base thin film” then later on “base film” without “thin”, therefore it is not clear if “base thin film” and “base film” are the same or not.
For the sake of expedite prosecution the examiner interprets the “base film” as “base thin film”.
Claim 10 recites the limitation "the thin film plate" in page 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 state “based on a cross section of the microstructure that corresponds to a certain height from a lower part”. However, this “certain” height is not a known standard point or a known reference point for measuring “certain” height, as this is not a concrete statement as to where the measurement taking from. Additionally, it not clear what is meant by “includes forming the microstructure for a distance between the two adjacent microstructures”, as forming a thing for a distance between two adjacent things. Furthermore, the claims ends with a limitation stating “based on a cross section of the microstructure that corresponds to…”, it is not clear what is this limitation that the cross section is “based” on.
It is recommended to rewrite the claim to clarify the intended limitations within this claim.
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, 4-6 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.
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 4, Beak teaches use of spray coating, or atomization coating process [0056], therefore forming droplets.
Consider Claim 5, Beak teaches coating of functional materials that include DNA vaccines (nucleic acid strung/fiber structure) [0059].
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
Claim 20 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.
The following is a statement of reasons for the indication of allowable subject matter:
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.
Conclusion
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