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) 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Windum (US 2019/0366008 A1).
With regard to claim 20, Windum teaches an autoinjector comprising: a housing (Fig. 1 member 50); a product container (Fig. 1 member 20); a torsion spring for a one-time discharge of a maximum content of the product container (Figs. 4A and 7A member 240); a drive element (Fig. 5B 410); a propulsion element, wherein, for discharging, the torsion spring is configured to rotate the drive element, and the rotating drive element is configured to produce a propulsive movement of the propulsion element and of a piston in the product container (Fig. 5B member 420 [0102]); a rotation sensor (Fig. 3B member 155, [0053]); a processor unit for processing a rotation sensor signal ([0052]); and a separable housing part, wherein the processor unit and an energy source configured for supplying the processing unit are arranged on a printed circuit board that is configured to be irreversibly removed from the autoinjector together with the separable housing part ([0052], Fig. 3B components on PCB 140, battery 145, within housing 130/138).
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) 20 (in conjunction with the dependent claims) 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).
The Examiner notes claim 20 has not been amended, the original rejection of stand alone claim 20 remains as above. However, all dependent claims have been amended to now depend on claim 20. To address the dependent claim limitations a new rejection of claim 20 is needed as incorporated into those dependent claims. In the interest of clarity, instead of re-writing the limitations of claim 20 when addressing the dependent claims, it is just presented once, however, the context is that it is presented with each dependent as necessitated by the amendments.
With regard to claims 20, 8-12, 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. 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, 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. 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]).
With regard to claim 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. 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, 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. 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.
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. 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.
Response to Arguments
Applicant's arguments filed February 10, 2025 have been fully considered but they are not persuasive. Applicant argues Windum does not disclose components which can be irreversibly separated. The claim does not recite structure or how the components are separated. The identified components of Windum are capable of being irreversibly separated, in some way broken, to be removed. Regarding Applicant’s arguments regarding Burren et al. and Reich, the Examiner find that notches 281 form holes or lines and the device is capable of having torque applied between 282 and 281 which would break the components, thus, irreversibly separating them. In light of the amendments an additional reference to Schmid et al. is provided.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited references disclose a torsion spring autoinjector as well as various sensing modules.
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 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