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 .
This office action is in response to applicant’s communication of 1/9/2026. Currently elected claims 1-9, and 19-20 are pending and rejected below.
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-9 and 19-20) in the reply filed on 1/9/2026 is acknowledged.
Claims 11, 13-18, and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/9/2026
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 9, and 19 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kuwahara et al. (US 2010/0047327 A1).
Kuwahara discloses a kit, comprising at least one microneedle system and at least one dosage form for transmucosally administering at least one pharmaceutically active ingredient (see para [0038]-[0040]).
Concerning claim 2 and the at least one dosage form comprises an oral thin film comprising at least one matrix polymer and at least one pharmaceutically active ingredient (see para [0075]-[0076]).
Concerning claim 3 and the at least one matrix polymer comprises a water-soluble and/or water swellable polymer (see para [0078]).
Concerning claim 4 and the at least one pharmaceutically active ingredient comprises a pharmaceutically active ingredient with a logP 3 (see para [0012], and [0085] and examiner is of the position that the chosen ingredients would teach the logP 3 as contemplated topical method formulations).
Concerning claim 5 and the at least one pharmaceutically active ingredient comprises a pharmaceutically active ingredient with a molecular weight of greater than 300 g/mol (see para 0092] that examiner is of the position that the disclosed percentages of the weight would be greater than 300g.mol).
Concerning claim 6 and the at least one pharmaceutically active ingredient is selected from the group consisting of hypnotics, sedatives, antiepileptics, analeptics, psychoneurotropic drugs, neuroleptics, neuro-muscle blockers, antispasmodics, antihistamines, antiallergics, cardiotonics, antiarrhythmics, diuretics, hypotensives, vasopressors, antitussives, expectorants, analgesics, thyroid hormones, sexual hormones, glucocorticoid hormones, antidiabetics, antitumour drugs, antibiotics, chemotherapeutics, narcotics, anti-Parkinson drugs, anti-Alzheimer drugs and/or triptans (see para [0097]).
Concerning claim 9 and for use in the treatment of a patient (see para [0065]).
Concerning claim 19 and the water-soluble and/or water- swellable polymer is selected from the group consisting of starch and starch derivatives, dextrans, cellulose derivatives, such as carboxymethyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxypropyl methylcellulose, hydroxypropyl ethyl cellulose, sodium carboxymethyl cellulose, ethyl or propyl cellulose, polyacrylic acids, polyacrylates, polyvinylpyrrolidones, polyvinyl alcohols, poly(lactide-co-glycolide), hyaluronic acid, polyethylene oxide polymers, polyacrylamides, polyethylene glycols, gelatines, collagen, alginates, pectin, pullulan, tragacanth, chitosan, alginic acid, arabinogalactan, galactomannan, agar, agarose, carrageenan and natural gums. (see para 0078).
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.
Claim(s) 7-8 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuwahara et al. (US 2010/0047327 A1).
Concerning claim 7 and the microneedle system is a microneedle system based on glass, SiO2, steel, ceramic, starch and starch derivatives, dextrans, cellulose derivatives, such as carboxymethyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxypropyl methylcellu lose, hydroxypropyl ethyl cellulose, sodium carboxymethyl cellulose, ethyl or propyl cellulose, polyacrylic acids, polyacrylates, polyvinylpyrrolidones, polyvinyl alcohols, poly(lactide-co-glycolide), hyaluronic acid, polyethylene oxide polymers, polyacrylamides, polyethylene glycols, gelatines, collagen, alginates, pectin, pullulan, tragacanth, chitosan, alginic acid, arabinogalactan, galactomannan, agar, agarose, carrageenan and natural gums (The prior art does not explicitly state what the microneedles are “based” on or formed of). Kuwahara discloses the claimed invention except for a microneedle made of steel. It would have been obvious to one having ordinary skill in the art at the time the invention was made to form a microneedle of steel, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). Steel is a known material for a PHOSITA to form microneedles from as it is biocompatible, easy to sterilize, and rigid for penetration of an anatomical site).
Concerning claims 8-9 and the microneedle system has microneedles with a length from 100 pm to 600 pm, preferably from 250 pm to 350 pm, and/or the microneedle system has 50 to 400, preferably 200 to 250 microneedles per cm2 (as to claim 9) and the microneedle system has microneedles with a length from 250 pm to 350 pm and/or has 200 to 250 microneedles per cm2 (as to claim 20).
Kuwahara discloses the claimed invention except for explicitly stating the size of the microneedle with a length from 250 pm to 350 pm and/or has 200 to 250 microneedles per cm2. It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct microneedles with a length from 250 pm to 350 pm and/or has 200 to 250 microneedles per cm2, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955), and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955).
It is examiners position that the prior art teaches the transmucosal intended delivery and that a PHOSITA would construct a microneedle with a length from 250 pm to 350 pm and/or has 200 to 250 microneedles per cm2 in order to effectively treat a patient via transmucosal administration as those lengths and number of microneedles per cm2 would result in efficient, effective, and reliable administration of a pharmaceutical preparation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783