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 § 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, 3-5, 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 2018/0110926 (“Schrul”).
Regarding Claim 1, Schrul discloses an autoinjector comprising:
A housing (2);
A product container (13) axially fixed within the housing (see Fig. 2b – Par. 58);
A torsion spring (92);
A drive element (11);
A propulsion element (7); and
A needle protection sleeve (3),
Wherein, when the autoinjector is pressed against an injection site, the needle protection sleeve carries out an actuation movement in the proximal direction (Par. 62),
Wherein, for discharging liquid from the product container through an injection needle (13a) into the injection site, the torsion spring causes the drive element to rotate (Par. 65), wherein rotation of the drive element causes a movement of the propulsion element and of a piston (13b) in the product container in a distal direction (Par. 65),
Wherein the autoinjector comprises a coupling (91, 93), which does not include the propulsion element (i.e. the spring sleeve and spring shaft are separate and distinct components from the propulsion element) and which is adapted to release the drive element for rotation as a result of the actuation movement of the needle protection sleeve (Par. 62, 74, 75, 80-82, 85-86) - i.e. the release elements (5) cause unlocking of the control arms (93b) to release the coupling between the locking snap (93g) and the radial stop (91c) to thereby permit release of the stored energy of the spring, whereby actuation of the release element is predicated upon operation of the locking sleeve (8) which moves incident to the needle protection sleeve (3) being moved proximally; and
Wherein the coupling comprises a first coupling element (93g) configured to engage via a locking surface with a second coupling element (91c) in an engagement (Par. 80 – see Fig. 5B),
Wherein prior to the actuation movement, the engagement blocks the rotation of the drive element (by preventing release of the spring – Par. 80), and
Wherein during the actuation movement, an axial coupling stroke causes the engagement to be released such that one of the first coupling elements or the second coupling elements rotates relate to the other during rotation of the drive element (re: the spring shaft rotates upon release of the spring to rotate the threaded rod – Par. 17, 33).
Regarding Claim 3, Schrul discloses a length of the axial coupling stroke corresponds to a piercing depth of the injection needle (Par. 62).
Regarding Claim 4, Schrul discloses the propulsion element comprises an axial guide (7) for an exclusively linear propulsion movement in the housing (Par. 64).
Regarding Claim 5, Schrul discloses the drive element comprises a threaded rod (11) and the propulsion element comprises a propulsion sleeve (7).
Regarding Claim 12, Schrul discloses the first coupling element and the second coupling element comprise at least two locking surfaces or protrusions or corresponding recesses (see Fig. 3C).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 2018/0110926 (“Schrul”) as applied above, and further in view of U.S. Publication No. 2020/0171246 (“Byerly”).
Regarding Claims 13-14, Schrul discloses the invention substantially as claimed except that autoinjector further comprises a “rotation sensor” configured to detect a rotational position per revolution of the drive element during discharge, a processor unit configured to determine an axial piston position based on the detected rotational position, and a communication unit. However, such features are known to the art. For example, Byerly discloses a related autoinjector (10) which comprises a rotation sensor (86) configured to detect the rotational position per revolution of a drive element during a discharge process (Par. 5) and a processor unit (76; Par. 45) configured to determine an axial piston position of the piston in the product container based on the detected rotational positions of the drive element (Par. 22 – re: correlating the rotational position to the amount of a dose delivered which thereby corresponds to the axial position of the piston within the container pursuant to the remaining volume). Byerly discloses a communication unit (see Par. 46) configured to communicate with at least one of a third party device or indicator unit configured to indicate a state of the autoinjector. It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the device of Schrul with a rotation sensor and communication unit, as disclosed by Byerly, in order to monitor rotation of the drive element during dispensing to correlate a measured change in rotational position to axial movement of the piston element to determine the amount of dispensed dose and amount of remaining dose and communicate various status information about the autoinjector to a third party device for logging and monitoring of device usage.
Allowable Subject Matter
Claim(s) 6-11 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 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 WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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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.
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
01/20/2026