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 .
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) 1 and 7-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prausnitz et al. (US 6,611,707 B1) in view of Fohrman et al. (US 2015/0182703 A1) and Eicher et al. (US 6,132,755).
With regard to claims 1 and 7-13, Prausnitz et al. teach a transdermal delivery device (Col. 1 line 46) comprising: (a) a film having first and second outwardly facing major surfaces (Fig. 1A, first outwardly facing surface of substrate 12 is the surface with microneedles 14, second surface is opposite); (b) at least one liquid reservoir disposed within the film (Fig. 1A member 16); (c) at least one microfluidic channel having a major transverse dimension between about 100 nm and 0.5 mm disposed within the film and in fluid communication with the at least one liquid reservoir (Fig. 1A channel in 12 connected to 14, channel has the same dimension as the inner diameter of the 14, Col. 3 line 55); (d) at least one outlet port operatively connected to the first outwardly facing major surface of the film in fluid communication with the at least one microfluidic channel (Fig. 1A); (e) at least one microneedle in fluid communication with the at least one outlet port (Fig. 1A member 14). Prausnitz et al. teach a variety of drugs may be delivered and that the amount may be selected based on the particular substance and desired effect (Col. 9 lines 19-45) but do not specifically disclose delivering an analgesic in a solvent. However, Fohrman et al. teach effective agents which may be delivered includes acetaminophen, ibuprofen, or ketoprofen ([0178], [0181]) and that dosages can vary based on treatment including in the ranges listed ([0270]). Further, Eicher et al. mixing agents with a solvent to allow for satisfactory travel though the capillary openings of microneedles (Col. 1 lines 55-59). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to deliver acetaminophen, ibuprofen, or ketoprofen with a solvent in an amount as recited as Prausnitz et al. teach using a particular substance and amount based on a desired treatment, Fohrman et al. teach such to be an effective substance for treatment, and Eicher et al. teach a solvent is beneficial to allow for satisfactory travel through small openings.
Response to Arguments
Applicant's arguments filed October 3, 2025 have been fully considered but they are not persuasive. Applicant argues Prausnitz et al. do not disclose use with analgesics, Prausnitz et al. do disclose a variety of substances may be used and is not limited to use to a particular substance and that amounts are treatment dependent. Applicant argues Fohrman et al. does not teach using analgesics with a microfluidic patch that may be formed by 3D printing or additive manufacturing. The method of making a patch is not relevant to the claims. The Examiner finds Prauznitz et al. and Fohrman et al. are analogous as both are transdermal delivery devices which are placed against the skin to insert a plurality of needles through which substance is delivered. The substance of Fohrman et al. may be effectively delivered through the device of Prausnitz et al. for treatment.
Conclusion
THIS ACTION IS MADE FINAL. 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 EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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, Kevin Sirmons can be reached at 571-272-4965. 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.
/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783