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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 27, 2026 has been entered.
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) 2, 8-10, 12, 16, 20, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burren et al. (US 2008/0306445 A1) in view of Reich (US 2019/0269858 A1), and Schmid et al. (US 2018/0126083 A1).
With regard to claims 20, 8-10, 12, 16 and 21, Burren et al. teach an autoinjector comprising: a housing (Fig. 1 member 1); a product container (Fig. 2 member R, part of syringe); a torsion spring for a one-time discharge of a maximum content of the product container (Fig. 2 member 32, [0012] the spring may be a torsion spring); a drive element (Fig. 2 member 11); a propulsion element (Fig. 2 member 12), wherein, for discharging, the torsion spring is configured to rotate the drive element, and, while rotating, the drive element is configured to produce a propulsive movement of the propulsion element and of a piston in the product container ([0033], [0058] Fig. 2 piston 10). Burren et al. do not teach a rotation sensor or processing unit in a separable housing part. However, Reich teaches an injector which has an attachable rotation sensor to track dosage based on at least two rotational positions in conjunction with a processor which enhances use as it allows the user to record timing and quantity of a dose delivered (Figs. 2B, 2E, 3, 4, sensor 250 the components are in a separable housing that extends between a proximal and distal end wall, processing unit at least 305, positions of 420 [0002], [0018], [0019], [0024], [0035], [0037]). Additionally, a transceiver on the circuit board 300 transmits data to a third-party device ([0035]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a rotary sensor and controller in Burren et al. as in Reich as this is beneficial for recording and tracking dosage. As generally shown in Fig. 1 the device of Reich is provided to a dose setting and delivering injection pen similar to Burren et al. The button of Reich would be attached as in Reich via the locking/snap connection between 281 and 282, were torque to be provided at 281 and 282 the housing would be able to be irreversibly removed. This is an extension of the housing and thus defines an exterior sidewall of the housing. Further, Schmid et al. teach providing a housing portion that has electronics to be connected to the remainder of the housing via predetermined breaking points to allow removal for correct disposal and to show a device has already been used ([0034]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have a portion between the housing of the separable part of Burren et al. as combined with Reich and the housing of the injector pen which has a predetermined break lines as Schmid et al. teach this is beneficial for proper disposal and ensuring proper use. This would also effectively determine the position of the piston as the volume delivered is reflective of the position of the piston.
With regard to claim 2, member 12 is guided axially via a groove ([0033]).
Claim(s) 3, 4, 13-15, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burren et al. (US 2008/0306445 A1), Reich (US 2019/0269858 A1), Schmid et al. (US 2018/0126083 A1) as applied to claim 1 above, and further in view of Gentz et al. (US 2019/0217022 A1).
With regard to claims 3, 4, 13-15, and 17, Burren et al. as combined teach a device substantially as claimed and an indicator unit (Figs. 1, 2B, 2E, and 3 of Reich, a transceiver on the circuit board 300 transmits data to a third-party device, the signals are indicative of the rotation or fluid dispensed, [0023], [0024],[0035]) but do not disclose signaling after an expiration a needle protection sleeve or position detector. However, Gentz et al. teach a device cap (Fig. 1A member 12), a needle protective sleeve (Fig. 1A member 11), a needle protection spring (Figs. 3 member 14), and axial position detector (Figs. 2 and 4 via coils 22 in the proximal portion of the injector, [0054]). The detector detects movement of the sleeve when moved proximally when pressed on the injection site and when returned to its protection position after delivery, the information indicates dose delivery which incorporates determining a correct delivery based on a time delay, this provides an end of injection signal useful to characterizing the injection process and the time delay helps ensure proper handling of the device ([0015], [0025] [0029], [0053]-[0055]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate a holding time signal and needle protective cover with axial position detection in Burren et al. as in Gentz et al. as this protects the user from the needle, provides an end of injection signal useful to characterizing the injection process, and the time delay helps ensure proper handling of the device.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burren et al. (US 2008/0306445 A1) in view of Antonelli et al. (WO 2019/040117 A1) and Schmid et al. (US 2018/0126083 A1).
With regard to claim 22, Burren et al. teach an autoinjector comprising: a housing defining an exterior of the autoinjector (Fig. 1 member 1); a product container (Fig. 2 member R, part of syringe); a torsion spring for a one-time discharge of a maximum content of the product container (Fig. 2 member 32, [0012] the spring may be a torsion spring); a drive element (Fig. 2 member 11); a propulsion element (Fig. 2 member 12), wherein, for discharging, the torsion spring is configured to rotate the drive element, and, while rotating, the drive element is configured to produce a propulsive movement of the propulsion element and of a piston in the product container ([0033], [0058] Fig. 2 piston 10). Burren et al. do not teach a rotation sensor or electronic module with a separable housing. However, Antonelli et al. teach a separable housing containing an electronic module with a non-rotational sensing component, circuit, processor, and energy source (Figs. 4 and 5, Pg. 11 lines 13-23, housing 82, electronics 76 which includes a circuit board, processor and battery, non-rotational component 102 connected with sensing components 85 and 86) that cooperates with a rotational component which is part of the injector (Figs. 4 and 5 member 42, Pg. 17 lines 1-6). This is able to sense dosing information to record and transmit the information (Pg. 3). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a rotary sensor and controller in Burren et al. as in Antonelli et al. as this is beneficial for recording and tracking dosage. As generally shown in Figs. 1-4 the device of Antonelli et al. is provided over the actuator button of a delivering injection pen similar to Burren et al. The button of Antonelli et al. may be connected with frictional engagement, splines, a snap or press fit, sonic welding, or adhesive (Pg. 1 lines 1 and 2). The device of Burren et al. would be modified as needed such that its rotational dosing components may be detected by the button. Further, Schmid et al. teach providing a housing portion that has electronics to be connected to the remainder of the housing via predetermined breaking points to allow removal for correct disposal and to show a device has already been used ([0034]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have a portion between the housing of the separable part of Burren et al. as combined with Antonelli et al. and the housing of the injector pen which has a predetermined break lines as Schmid et al. teach this is beneficial for proper disposal and ensuring proper use.
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. Regarding claim 20, the claim recites a separable housing part that extends between a proximal and distal end wall. The proximal and distal end wall are not tied to a particular structure. The separable housing as provided by Reich necessarily extends between a proximal end distal end wall.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Matsuzaki et al. (WO 2021/170641) discloses a separable housing which attaches to an injection device along the side to detect rotation (exemplary Fig. 5A).
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.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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