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 .
Election/Restrictions
Applicant’s election without traverse of invention I in the reply filed on 9 April 2026 is acknowledged.
Claims 71-73, 76-78, 87, 93, 102, 103 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9 April 2026.
Specification
The extraordinarily lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Claim(s) 1-3, 6-8, 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brenneman (US 2008/0269657).
Regarding claim 1, Brenneman discloses a system for applying a patch onto at least a portion of an on-skin wearable medical device of a host, the system comprising:
an applicator for supporting the patch (element 1002) and configured to apply the patch onto at least the portion of the on-skin wearable medical device when the on-skin wearable medical device is disposed on a skin of the host (figures 10A-10C).
Regarding claim 2, Brenneman further discloses that the applicator includes a substrate for supporting the patch (element 1012).
Regarding claim 3, Brenneman further discloses that the substrate comprises a planar surface for the patch to be positioned upon and extend parallel with the planar surface (figures 10A-10C).
Regarding claim 6, Brenneman further discloses that the applicator includes an alignment body configured to align the patch with the on-skin wearable medical device (element 1010; paragraph [0057]).
Regarding claim 7, Brenneman further discloses that the alignment body comprises a protrusion configured to extend towards the skin of the host upon the applicator applying the patch onto at least the portion of the on-skin wearable medical device (paragraph [0057], where the opening of the housing/support inherently results in walls defining that opening, those walls being a “protrusion” facing the skin during application).
Regarding claim 8, Brenneman further discloses the protrusion includes a central opening configured to receive a portion of the on-skin wearable medical device (paragraph [0057]).
Regarding claim 32, Brenneman further discloses that the alignment body has a “leading edge”, and the applicator includes a substrate for supporting the patch, the substrate being positioned at the leading edge (figures 10A-10C; paragraphs [0056]-[0057]).
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) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brenneman.
Regarding claim 33, Brenneman further discloses that the alignment body has a “leading edge”, and the applicator includes a substrate for supporting the patch (figures 10A-10C; paragraphs [0056]-[0057]). Brenneman does not disclose the substrate being spaced from the leading edge, however, it would have been a mere matter of design choice for one of ordinary skill in the art at the time the invention was made to have spaced the substrate from the leading edge, since Applicant has not disclosed use of this particular configuration as providing a particular advantage, solving a stated problem, or serving a different purpose than that of the configuration of Brenneman. Moreover, it appears that any relative arrangement of substrate and leading edge would perform equally well to allow delivery of the patch, particularly as “being spaced” is disclosed as equally useful as being at the edge, and no particular distance or minimum spacing has been recited. As such, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have made the system of Brenneman with the substrate being spaced from the leading edge, because such a modification would have been considered a mere design consideration that fails to patentably distinguish over Brenneman.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brenneman in view of Lee (US 2022/0104773).
Regarding claim 17, Brenneman further discloses a substrate for supporting the patch (), but does not disclose the applicator further including a plunger configured to be operated by a user to displace the protrusion relative to the substrate. Lee teaches an applicator configured to applying a patch onto a host, the applicator comprising a plunger (element 574) configured to be operated by a user to displace a protrusion (the bottom of element 574 where it meets element 576) extending towards the skin relative to the area surrounding the protrusion (see figure 38). The Examiner notes that a “plunger” is defined as “a piston”, see https://www.oed.com/dictionary/plunger_n?tab=meaning_and_use&tl=true - 29754403 and https://www.merriam-webster.com/dictionary/plunger. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Brenneman with the applicator further comprising a plunger configured to displace the protrusion relative to the substrate, as taught by Lee, in order to ensure a secure delivery of the patch.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brenneman in view of Lee and Trautman (US 2005/0096586).
Brenneman does not disclose that the applicator further includes a first housing and a second housing, the first housing configured to slide relative to the second housing along an axis to apply the patch onto at least the portion of the on-skin wearable medical device, and the second housing including a cavity with a coil spring disposed therein, the coil spring biasing the first housing relative to the second housing and extending circumferentially about the axis.
Lee teaches an applicator for delivery of a patch to a user of an on-skin wearable medical device which includes a first housing and a second housing, the first housing configured to slide relative to the second housing along an axis to apply the patch, the second housing including a cavity (see figures 35-37; paragraphs [0269]-[0272]). Lee does not specify the actuation of the piston, particularly use of a coil spring. Trautman teaches an applicator for delivery of a patch which includes a first housing and a second housing, the first housing configured to slide relative to the second housing along an axis to apply the patch, and the second housing including a cavity with a coil spring disposed therein, the coil spring biasing the first housing relative to the second housing and extending circumferentially about the axis (figure 2). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Brenneman with the applicator further including first and second housings configured to slide relative to each other using a biased coil spring to apply the patch, as taught by Lee and Trautman, in order to ensure efficient delivery of the patch.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN E TOTH whose telephone number is (571)272-6824. The examiner can normally be reached Mon - Fri 9a-6p.
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, Jennifer Robertson can be reached at 571-272-5001. 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.
/KAREN E TOTH/Examiner, Art Unit 3791
Prosecution Insights