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 group I (claims 1-5) in the reply filed on 1/29/2026 is acknowledged.
Claims 6-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/29/2026.
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) 1-2, 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kemp et al. (US. 20130281935A1) (“Kemp”).
Re claim 1, Kemp discloses a therapeutic agent delivery system (Fig. 1-19, abstract, ¶0028), comprising: a housing ( 2) having a distal end portion (lower end portion, note that the art using a directional system opposite to the current application); a therapeutic agent delivery assembly carried by the housing (3), the therapeutic agent delivery assembly( close to the needle 4 comprising: a chamber (inside the syringe 3, ¶0074) comprising a first passageway configured to carry a therapeutic agent (lower passage close to the needle 4, ¶0074); a needle (4, ¶0074) in communication with the first passageway (Fig. 1-19); the therapeutic agent delivery assembly being translatable relative to the housing from a stowed configuration (Fig. 13) to a deployed configuration (Fig. 14-Fig. 18), in the deployed configuration the needle at least partially extending distally from the distal end portion of the housing (Fig. 14), and the therapeutic agent delivery assembly being translatable relative to the housing from the deployed configuration (Fig. 14) to a retracted configuration (Fig. 19), in the retracted configuration the needle being disposed proximally relative to the distal end portion of the housing (¶0098); a drive mechanism carried by the housing, the drive mechanism comprising: a torsion spring (11, ¶0078); a first release device (12, 13, ¶0078) being actuatable to permit the torsion spring to release energy and reconfigure from a higher energy storage configuration (Fig. 12-13) to an intermediate energy storage configuration (¶0078), the drive mechanism thereby translating the therapeutic agent delivery assembly from the stowed configuration (Fig. 13) to the deployed configuration (Fig. 14); and a second release device (20, 17, 19, 18, ¶0080, Fig. 2-3) being actuatable to permit the torsion spring to further release energy and reconfigure from the intermediate energy storage configuration (Fig. 14-18) to a lower energy storage configuration (Fig. 19), the drive mechanism thereby translating the therapeutic agent delivery assembly from the deployed configuration to the retracted configuration (¶0098, Fig. 18-Fig. 19).
Re claim 2, Kemp discloses comprising a user input (10) carried by the housing and configured to be actuated by a user, upon actuation the user input thereby actuating the first release device (¶0085).
Re claim 5, Kemp discloses further comprising the therapeutic agent carried in the first passageway of the chamber (¶0074).
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) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kemp in view of Ring (US 20190366011A1).
Re claim 3, Kemp fails to disclose further comprising an electronics assembly carried by the housing and operably coupled to the second release device, the electronics assembly sending a retraction signal to actuate the second release device.
However, Ring discloses a medical device (Fig. 1-7) and wherein an electronics assembly carried by the housing (circuit ¶0032, 16, Fig. 1) and operably coupled to the second release device (223), the electronics assembly sending a retraction signal to actuate the second release device (¶0049, ¶0002, such as shape memory wire).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kemp to include the electronics assembly so that the electronics assembly carried by the housing and operably coupled to the second release device, the electronics assembly sending a retraction signal to actuate the second release device as taught by Ring for the purpose of operating the delivering device and electrically controlling the advancing or retracting the syringe/needle (Ring, ¶0002).
Re claim 4, Kemp fails to disclose wherein the second release device comprises a wire, and the second release device is actuatable by contracting the wire.
However, Ring discloses a medical device (Fig. 1-7) and wherein the second release device comprises a wire, and the second release device is actuatable by contracting the wire (¶0049, ¶0002, such as shape memory wire which can be contracted at a desired temperature).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kemp to include the electronics assembly so that the second release device comprises a wire, and the second release device is actuatable by contracting the wire as taught by Ring for the purpose of using an art recognized elements for controlling the needle’s movement (Ring, ¶0002).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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