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 Objections
Claims 2-3 are objected to because of the following informalities:
Recitation of “SP” in claims 2-3 should be spelled out as “solubility parameter (SP)”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claims 1-2, 4, 6-7 and 9 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by US 2017/0281535 A1 to Singh et al. (hereinafter “Singh”) as evidenced by Coleman et al., Polymer, 1990, Vol. 31, pages 1187-1203 (hereinafter “Coleman”).
Regarding claim 1, Singh discloses a microneedle array (corresponding to the microprojection array 60 (see Fig. 9B) formed of a needle portion (corresponding to microprojections 66) and a substrate portion (corresponding to the base part 68), the needle portion containing a valuable material e.g. parathyroid hormone (PTH) in a base containing a water-soluble polymer as a main component (see paragraph [0081]), the substrate portion does not contain the valuable material (paragraph [0081]), and the base of the substrate portion contains a water-insoluble polymer as a main component (paragraph [0081]).
Singh further discloses polyvinyl alcohol (PVA) as water soluble polymer (see Examples B1-B2 in Table 4-1 in paragraph [0127]) which has solubility parameter (SP) value of 12.6 (according to Table 3 of the present application). Singh further discloses Eudragit EPO 100 which is polymethacrylate (see paragraph [0083]) as water insoluble polymer (see Examples C1-C2 in Table 5-1 in paragraph [0130]), but does not disclose SP value.
Coleman discloses SP value of polymethacrylate i.e. poly(methyl methacrylate)(PMMA) of 9.1-12.8 (see Table 5 on page 1192). Hence, a difference between the SP value of the water-soluble polymer of PVA (12.6) in the needle portion and the SP value of the water insoluble polymer of PMMA (9.1-12.8) as disclosed in Singh is 4 or less (0.2-3.5).
Regarding claims 2 and 6, Singh discloses that the water-insoluble polymer in the substrate portion is a cellulose derivative such as cellulose acetate or ethyl cellulose which has SP value of 9.0 or more (according to Table 3 of the present application, SP value of ethyl cellulose is 10.3; SP value of cellulose acetate is 11.0 as disclosed in paragraph [0014] of the present application). Also, SP value of PMMA is 9.1-12.8.
Regarding claim 4, Singh discloses that the needle portion has a height of at least about 100 µm to 1 mm (within the claimed length of 0.02 to 1.5 mm) and has a conical shape or a triangular or polygonal pyramid shape (see paragraph [0063]).
Regarding claim 7, Singh discloses that a tip end portion (corresponding to the distal tip 62) of the needle portion contains a valuable material and a root portion (corresponding to the upper part near the flat base 64) of the needle portion does not contain a valuable material (paragraph [0081]) and includes a base mainly formed of a water-insoluble polymer (Fig. 9B; paragraph [0081]).
Regarding claim 9, Singh discloses a method for manufacturing the microneedle array (see Example 3; paragraphs [0123]-[0126]) comprising:
1) a step of preparing a mold having a concave microneedle pattern by a lithography method or a precision metal working method (see paragraphs [0068], [0076]);
2) a step of applying an aqueous solution containing a valuable material and a base water-soluble polymer i.e. first layer to a surface of the mold and drying the aqueous solution (see paragraphs [0082], [0084], [0125]);
3) a step of applying a base solution formed of an organic solvent of a base containing a water-insoluble polymer as a main component e.g. a second layer to a surface of a mold after the drying step and drying the base solution (see paragraphs [0082], [0084], [0126]); and
4) a step of taking out the formed microneedle array from the mold i.e. demolded (see Example 3; paragraph [0126]).
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.
Claims 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Singh.
Singh teaches the microneedle array as described above.
Claim 5 differs from Singh in reciting that the substrate portion has a thickness of 0.01 to 1.0 mm.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the substrate portion has a thickness of 0.01 to 1.0 mm depending on necessary support for needle portion of water soluble polymer, since 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.
Claim 8 differs from Singh in reciting that a length of the root portion formed of the base containing no valuable material and containing a water-insoluble polymer as a main component is 60% or less of a needle length of the entire needle portion.
Singh teaches that the root portion formed of the base contains no valuable material and contains a water-insoluble polymer as a main component (see paragraph [0081]; Fig. 9B).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a length of the root portion formed of the base to be 60% or less of a needle length of the entire needle depending on necessary support for tip portion of water soluble polymer, since 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.
Response to Arguments
Applicant’s arguments with respect to claims 1-2 and 4-9 have been considered but are moot because Singh discloses the limitation of claim 1 reciting “wherein a difference between the solubility parameter (SP) value of the water-soluble polymer in the needle portion and the solubility parameter (SP) value of the water-insoluble polymer in the substrate portion is 4 or less”. Singh discloses polyvinyl alcohol (PVA) as water soluble polymer (see Examples B1-B2 in Table 4-1 in paragraph [0127]) which has solubility parameter (SP) value of 12.6 (according to Table 3 of the present application). Singh further discloses Eudragit EPO 100 which is polymethacrylate (see paragraph [0083]) as water insoluble polymer (see Examples C1-C2 in Table 5-1 in paragraph [0130]), but does not disclose SP value. However, Coleman provides evidence that SP value of polymethacrylate i.e. poly(methyl methacrylate)(PMMA) of 9.1-12.8 (see Table 5 on page 1192). Hence, a difference between the SP value of the water-soluble polymer of PVA (12.6) in the needle portion and the SP value of the water insoluble polymer of PMMA (9.1-12.8) as disclosed in Singh is 4 or less (0.2-3.5).
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 JOHN KIM whose telephone number is (571)272-1142. The examiner can normally be reached Maxi 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, INSUK BULLOCK can be reached at 571-272-5954. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/John Kim/Primary Examiner, Art Unit 1772
JK
9/2/26
