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 .
Claims 1-16 are pending in the application.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Japan on 7/17/2020. It is noted, however, that applicant has not filed a certified copy of the JP2020-122621 application as required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/21/2023, 5/2/2023, 11/10/2023, 1/16/2024, 1/31/2024,3/5/2024, 4/9/2024, 7/22/2024, 1/27/2025, 4/14/2025 have been considered by the examiner.
Double Patenting-Warning
Applicant is advised that should claims 1-8 be found allowable, claims 9-16 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 1 and claim 9 only differ in one word, “preventive agent” vs. “vaccine agent” in preamble, and comprises exact same components in the body of the claim. Given broadest reasonable interpretation (BRI), a vaccine agent and a preventive agent for the Japanese encephalitis virus are so close in content that they both cover the same thing, a microneedle array that carries inactivated virus. Dependent claims 2-8 and 10-16 also covers same thing using same wording.
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 3, 8, 11 and 16 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.
Claim 3 and 11 recites the limitation "the number of administration" in line 2. There is insufficient antecedent basis for this limitation in the claim because claims 1 and 9 do not recite any limitation that directed to number of administration.
Claim 8 and 16 recites the limitation "the neutralizing antibody" in line 2. There is insufficient antecedent basis for this limitation in the claim because claims 1 and 9 do not recite any antibody.
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.
(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.
Claim(s) 1, 2, 4, 5, 6, 7, 9, 10, 12, 13, 14 and 15 is/are rejected under 35 U.S.C. 102(a1) (a2) as being anticipated by Shimada et al (US2021/0121674).
Shimada teaches a JEV vaccine containing microneedle array that comprises a sheet portions and a plurality of needle portions on the upper surface of the sheet portion (abstract). Shimada teaches the needle portion comprises a JEV vaccine that is an inactivated JEV (paragraph [0071] and [0072]).
Therefore, the teaching from Shimada et al. anticipates claims 1 and 9.
Regarding claims 2, 4, 5, 10, 12, 13, the wherein clause is directed to intended use of the claimed product, which does not further limit the product, a JEV preventive/vaccine agent. Therefore, the teaching from Shimada et al. anticipates these claims.
Regarding claims 6 and 14, Shimada et al. teach the microneedle array is autolytic (paragraph [0003]).
Regarding claims 7 and 15, Shimada et al. teach the needle portion comprise a water soluble polymer, a disaccharide, a surfactant, and sheet portion comprises at least water soluble polymer and a disaccharide (paragraph [0014] and [0015]).
Note: The 102(a1) rejection applied above is based on the priority of PCT/JP2021/026729, which is 7/16/2021 because the foreign priority document is not submitted (and perfected).
Claim(s) 1, 2, 4-6, 9, 10, 12-14 is/are rejected under 35 U.S.C. 102(a1)(a2) as being anticipated by Machida (US 2016/0000898).
Machida teaches a microneedle device that includes a plurality of microneedles and a based structure (Figure 1, and paragraph [0024] and [0025]). Machida teaches Japanese encephalitis vaccine composition is contained in the coating that is applied on the microneedle (paragraph [0026]). Therefore, the teaching from Machida anticipates the claimed invention of claims 1 and 9.
Regarding claims 2, 4, 5, 10, 12, 13, the wherein clause is directed to intended use of the claimed product, which does not further limit the product, a JEV preventive/vaccine agent. Therefore, the teaching from Machida et al. anticipates these claims.
Regarding claims 6 and 14, Machida teaches that the material for sheet and microneedle is preferably a biodegradable polymer (paragraph 0029]), which meets the limitation of autolytic.
Claim(s) 1, 2, 4, 5, 7, 9, 10, 12, 13 and 15 is/are rejected under 35 U.S.C. 102(a1) (a2) as being anticipated by Cigarini (US 8,790,658).
Cigarini teaches an antigen-adjuvant composition that is a vitreous composition may be used for coating of microneedle arrays (1st and 2nd col., bridging paragraph). Cigarini teaches that the antigens may include or be parts of cell, bacteria and viruses (col.4, line 63-65), wherein the virus includes Japanese Encephalitis virus (col.5, line 25-26). Therefore, the teaching from Cigarini anticipates the claimed invention of claims 1 and 9.
Regarding claims 2, 4, 5, 10, 12, 13, the wherein clause is directed to intended use of the claimed product, which does not further limit the product, a JEV preventive/vaccine agent. Therefore, the teaching from Cigarini et al. anticipates these claims.
Regarding claim 7 and 15, Cigarini teaches the composition containing antigen and adjuvant further comprises surfactants (col.6, line 35-36), water soluble polymer such as polyethylene glycol (col.8, line 30), and disaccharides (col.8, line 15).
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CELINE X QIAN whose telephone number is (571)272-0777. The examiner can normally be reached M-F (8-4:00).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at 571-272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CELINE X QIAN/ Primary Examiner, Art Unit 1637
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