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
Claims 1-8 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group or species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3 November 2025.
Applicant's election with traverse of Group 2 and Species 1 is acknowledged. The traversal is on the ground(s) that there is no distinction between groups 1 and 2. This is not found persuasive because claim 9 does not include the body passage details recited in claim 1. Accordingly, the pattern is ABsp in claim 1 and ABbr in claim 9 and the requirement for restriction is properly predicated. Applicant’s remarks regarding the species restriction are noted, and no claims are withdrawn based on that restriction at this time.
The requirement is still deemed proper and is therefore made FINAL.
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) 9-11, 13-14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2008/0091226 to Yeshurun et al. (Yeshurun hereinafter) in view of US Pre-Grant Publication 2018/0001071 to Simmers (Simmers) and US Pre-Grant Publication 2013/0345658 to Browne et al. (Browne).
Regarding claim 9, Yeshurun teaches a system for administration of agent to a shallow delivery destination comprising: an access assembly comprising: a body (24) with a first exterior surface (contacting 36 as illustrated in Fig. 7C) and a second exterior surface (26), at a non-orthogonal angle to the first exterior surface (see Fig. 7A-7C), the first and second exterior surface meeting at a corner of the body; a sharp bearing body (36) having at least one microneedle (30) projecting therefrom, a surface of the sharp bearing body from which the at least one microneedle projects being substantially even with the first exterior surface (see Fig. 7C); and an infusion device (syringe, see e.g. paragraph 63) in fluid communication with the access assembly.
Yeshurun does not teach an adhesive pad coupled to the second exterior surface. Simmers teaches that a microneedle apparatus for skin contact may include an adhesive (120) to attach the apparatus to the skin and have it remain coupled there (paragraph 43). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide an adhesive pad as taught by Simmers to the skin contact surface (26) of Yeshurun in order to have the apparatus remain in skin contact without external force application.
Yeshurun also does not teach an infusion device comprising: a reservoir; a pumping arrangement, and a controller. Browne teaches that an infusion site may be coupled to an infusion device (10) which may include a metering pump (14) operating at a controlled rate operable to deliver fluid form a reservoir (paragraph 21, “fluid source”) to the access assembly; a controller (30) configured to govern operation of pumping assembly to deliver at least one predefined volume of agent from the reservoir to the access assembly at at least one predefined rate over at least one predefined period of time. Browne teaches that this provides continuous delivery of a medical agent (paragraph 8). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a reservoir, pumping arrangement and controller as taught by Browne to the apparatus of Yeshurun in order to provide continuous delivery of a medical agent.
Regarding claim 10, Yeshurun teaches a passage (32) extending through the sharp bearing body which is at least indirectly couplable to a member (via the luer connector, see paragraph 63) disposed within the passage and having an flow path extending to the sharp bearing body.
Regarding claim 11, Yeshurun teaches a luer, or interference, fit, and a stop (the conical shoulder between the large and small diameter portions, see Fig. 7B) which inhibits displacement of the member within the passage.
Regarding claim 12, Browne teaches tubing (4) used to convey infused liquid to the patient. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide such tubing as taught by Browne in order to convey fluid to the patient.
Regarding claim 13, Yeshurun teaches a one-dimensional array of microneedles (28, see Fig. 7A).
Regarding claim 14, Yeshurun teaches a microneedle height of 200-500 microns (paragraph 73).
Regarding claim 15, Browne teaches a volume sensor (26) for detecting fluid volumes and air in line conditions (paragraph 30). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide such a volume sensor in order to accurately meter the pump flow to the access assembly of Yeshurun and to detect air in line conditions.
Regarding claim 16, Yeshurun teaches a luer connector (paragraph 63).
Regarding claim 17, Browne teaches a reusable portion (e.g. 14, 20), a cassette (5), a controller (30/36), the reservoir (considered to be included in the reservoir by its provision in fluid communication therewith), and a second portion of the pumping arrangement (12) including the components of the pumping arrangement, while a first portion (5) includes the cassette and reservoir.
Conclusion
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 15 November 2025