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
Acknowledgement is hereby made of receipt and entry of the communication filed on Oct. 30, 2025. Claims 1, 5-6, 9, 11-12, 16-17, 25-26 and 52-61 are pending and currently examined.
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 of this title, 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.
(Previous Rejection – Maintained) Claims 1, 6, 9, 16, 52 and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Muller et al. (Scientific Reports, 2017, 7: 12644) in view of Kendall et al. (US 2011/0245776 A1, published on Oct. 6, 2011) and Lemaire et al. (US 2020/0368511 A1, published on Nov. 26, 2020; PCT filed on Aug. 3, 2018).
(Previous Rejection – Maintained) Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Muller et al. (Scientific Reports, 2017, 7: 12644) in view of Kendall et al. (US 2011/0245776 A1, published on Oct. 6, 2011) and Lemaire et al. (US 2020/0368511 A1, published on Nov. 26, 2020; PCT filed on Aug. 3, 2018), as applied above, and further in view of Duan et al. (US 2013/0253446 A1, published on Sep. 26, 2013).
(Previous Rejection – Maintained) Claims 11-12, 17, 25-26, 52-54 and 57-58 are rejected under 35 U.S.C. 103 as being unpatentable over Muller et al. (Scientific Reports, 2017, 7: 12644), in view of Kendall et al. (US 2011/0245776 A1, published on Oct. 6, 2011) and Lemaire et al. (US 2020/0368511 A1, published on Nov. 26, 2020; PCT filed on Aug. 3, 2018), as applied above, and further in view of Griffin et al. (Vaccine 35 (2017) 6676–6684).
(Previous Rejection – Maintained) Claims 55-56 and 59-60 are rejected under 35 U.S.C. 103 as being unpatentable over Muller et al. (Scientific Reports, 2017, 7: 12644), in view of Kendall et al. (US 2011/0245776 A1, published on Oct. 6, 2011), Lemaire et al. (US 2020/0368511 A1, published on Nov. 26, 2020; PCT filed on Aug. 3, 2018), and Griffin et al. (Vaccine 35 (2017) 6676–6684), as applied above, and further in view of Cormier et al. (US 2005/0025778 A1, published on Feb. 3, 2005).
Applicant argues that Muller only shows an image of a “shoulder-like feature” which is considered as claimed the “discontinuity” of the microprojection, but provide no description or discussion in its text of this feature, let alone their location or intended purpose; and that Muller discloses microprojections having different length and density than those presently claimed, and, thus, would not be capable to achieve the functions as claimed (e.g., intradermal administration and dose-sparing). Applicant argues that Kendall and Lemaire do not remedy the deficiency of Muller.
Applicant’s arguments are not persuasive. The SEM image of Muller of the microprojections is shown below:
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Each projection is shown to have two shoulders, located at about ¼ and ½ length, respectively, from the tip. There is no reason to consider that this SEM image is not descriptive enough. As to the argument about the differences in microprojection length and density, Muller provides values of these parameters, showing that they are considered in the study. One of skill in the art would have been able to modify these parameters to arrive at ones as claimed based on specific experimental needs and through routine experimental optimization unless there is evidence that the claimed ranges are critical.
As to applicant’s arguments that shorter projection length and the location of the shoulder feature close to the tip of Muller would be expected to result in only shallow penetration that is insufficient to achieve intradermal delivery of influenza vaccine, and would not be capable of achieving dose-sparing effect, the examiner does not agree. Applicant has not provided evidence showing that the microprojection array patch of Muller does not deliver vaccine intradermally and cannot achieve a dose-sparing effect. One the contrary, Muller teaches that the nanopatch delivery elicits faster antibody response kinetics, with less immunization that IM injection. See e.g., Abstract. Additionally, there is no evidence that the penetration would stop at the first shoulder feature instead of penetrating further into the skin. In this case, Applicant’s arguments are treated as arguments of counsel. Argument of counsel cannot take the place of evident in the record. MPEP 2145.
Conclusion
No claims are allowed.
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 extension fee 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 NIANXIANG (NICK) ZOU whose telephone number is (571)272-2850. The examiner can normally be reached on Monday - Friday, 8:30 am - 5:00 pm, EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JANET ANDRES, on (571) 272-0867, can be reached. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NIANXIANG ZOU/ Primary Examiner, Art Unit 1671