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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 14, 2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12, 14-19, 21, and 23-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 1 and 15 recite “the safety shield is configured to automatically deploy in response to the plunger reaching the bottom end of the barrel.” It is not clear how the shield is deployed automatically. The term automatic is not found in the specification. There are no particular structures recited which are engaged or disengaged by the plunger reaching the bottom which “automatically” release the shield. Applicant appears to include the term automatic to overcome prior art in which the user lifts the syringe off of the patient. In Applicant’s own syringe it would appear that if the user maintains pressure on the syringe against the skin the shield would not “deploy”. In the art previously used the user did not have to do anything beyond actuating the device to inject in order for the shield to deploy. Applicant has pointed to the specification where it recited that shield deployment is contingent on delivery of a full dose but it is not clear how delivery of the dose triggers the safety shield. As such it is unclear as to the scope of the term “automatically” as used in the claims. Claims 26 and 27 recites “movement of the housing member in a proximal direction relative to the safety shield and away from a distal end of the needle.” It is not clear if the housing is moving relative to the distal end of the needle or just in a direction opposite that of the needle. The specification recites movement of the hosing causes movement of the barrel and needle in the upward direction with respect to the safety shield ([0050]). For purposes of Examiner the claim is considered as the direction the housing is moved rather than a movement relative to the needle.
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) 1-12, 14-19, 21, and 23-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chevallier et al. (US 2010/0211017 A1) in view of Cabiri et al. (US 2016/0296716 A1) and Miller et al. (US 2008/0188813 A1).
With regard to claims 1, 3, and 23, Chevallier et al. teach an electronic injection monitoring system for a manually operated safety syringe having a needle (Fig. 1 member 14), a barrel (Fig. 1 member 10) housing a medicament, a plunger (Fig. 1 member 12) configured to be manually inserted into the barrel and advanced to a bottom end of the barrel to dispense a dose of medicament, a safety shield being deployable to cover at least a portion of the needle of the safety syringe (Fig. 1 member 18), and a flange having a pair of wings extending laterally outward (Fig. 1 10C each half is taken as a wing, alternatively members 24 form a pair of wings, both of which are directly attached to 16A), the electronic injection monitoring system comprising: a monitoring device comprising: a body having a proximal end and a distal end and configured to directly attach with and fit over the pair of wings of the flange so that the plunger extends proximally above the proximal end of the body so that the plunger is exposed to permit manual actuation by a finger of a user to cause insertion of the plunger into the barrel and so that at least a portion of each of the pair of wings of the flange is positioned A) below the proximal end of the body and B) above the distal end of the body (Fig. 1 body 16A); wherein the safety shield is configured to automatically deploy in response to the plunger reaching the bottom end of the barrel (when the plunger reaches the bottom end of the barrel, taken as the bottom half of the barrel, the proximal end of the plunger at 13 disengages tabs 19 and 20 to automatically release the shield, [0036]). Chevallier et al. do not disclose one or more deployment sensors or a communication module. However, Cabiri et al. teach a safety shield being deployable to cover at least a portion of the needle of the syringe (Fig. 4F member 430 to cover needle 410) and one or more deployment sensors configured to detect deployment of the safety shield (Fig. 4F sensor 403a). Cabiri et al. teach a processor which receives feedback from the sensor which can be used to asses device operations and provide indications ([0110], [0113]). This provides an indication to the user as to the operation of the device to ensure proper operation (abstract, [0040], [0041]). Further, Miller et al. teach an autoinjector which has a communication module to transmit timing and other data related to use so that the device may be monitored (Fig. 3, Fig. 25, [0001], [0022], [0073], [0074], [0103]). 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 sensor to detect shield deployment and a communication module with the injector of Chevallier et al. as in Cabiri et al. as this alerts the user to the device status and proper usage/errors and as in Miller et al. to use a communication module so that the data may be transmitted to allow device monitoring and analyzation of use by a physician. As combined the sensor would be placed within the body in the area of members 19 and 20 of the shield of Chevallier et al. as this is what is released to deploy the shield and is analogous to member 442 of Cabiri et al. (Figs. 4F-4H).
With regard to claims 2, 12, and 14, as combined the sensors are mounted on the interior of the body of Chevallier et al. which would also include a circuit board 426 (Fig. 4F of Cabiri et al., [0110]).
With regard to claims 4 and 5, Miller et al. teach wired or wireless communication ([0074]).
With regard to claims 6-9, sensor 403a is a switch which is activated by movement of the shield ([0102], [0110] of Cabiri et al.).
With regard to claim 10, see Fig. 4F 403a is within 430 of Cabiri et al, similarly the switch would extend into the recess of the shield of Chevallier et al.
With regard to claims 11 and 26, see Fig. 1 member 16 which includes members 17 and 19 which move relative to the shield in order to allow the switch to be activated. Alternatively, as combined with Cabiri et al. Chevallier et al. may incorporate a member like 442 to actuate the switch as needed. When the shield is released the shield and housing move relative to each other in directions F and S (Fig. 3).
With regard to claim 24, see Fig. 3 16A is around 18.
With regard to claims 15 and 25, Chevallier et al. teach an electronic injection monitoring system for a manually operated safety syringe having a needle (Fig. 1 member 14), a flange (Fig. 1 10C, alternatively members 24 form a flange, both of which are directly attached to 16A), a barrel (Fig. 1 member 10) housing a medicament, a plunger (Fig. 1 member 12) configured to be manually inserted into the barrel and advanced to a bottom end of the barrel to dispense a dose of medicament, and a safety shield (Fig. 1 member 18) being deployable to cover at least a portion of the needle of the syringe, the electronic injection monitoring system comprising: a monitoring device comprising: a body having a proximal end, a distal end, and one or more interior surfaces between the proximal end and the distal end disposed laterally externally around an external surface of the safety shield so that the plunger extends proximally above the proximal end of the body so that the plunger is exposed to permit manual actuation by a finger of a user to cause insertion of the plunger into the barrel (Fig. 1 body 16A), wherein the safety shield is configured to automatically deploy in response to the plunger reaching the bottom end of the barrel (when the plunger reaches the bottom end of the barrel, taken as the bottom half of the barrel, the proximal end of the plunger at 13 disengages tabs 19 and 20 to automatically release the shield, [0036]). Chevallier et al. do not disclose one or more deployment sensors or a communication module. However, Cabiri et al. teach a safety shield being deployable to cover at least a portion of the needle of the syringe (Fig. 4F member 430 to cover needle 410) and one or more deployment sensors configured to detect deployment of the safety shield (Fig. 4F sensor 403a). Cabiri et al. teach a processor which receives feedback from the sensor which can be used to asses device operations and provide indications ([0110], [0113]). This provides an indication to the user as to the operation of the device to ensure proper operation (abstract, [0040], [0041]). Further, Miller et al. teach an autoinjector which has a communication module to transmit timing and other data related to use so that the device may be monitored (Fig. 3, Fig. 25, [0001], [0022], [0073], [0074], [0103]). 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 sensor to detect shield deployment and a communication module with the injector of Chevallier et al. as in Cabiri et al. as this alerts the user to the device status and proper usage/errors and as in Miller et al. to use a communication module so that the data may be transmitted to allow device monitoring and analyzation of use by a physician. As combined the sensor would be placed within the body in the area of members 19 and 20 of the shield of Chevallier et al. as this is what is released to deploy the shield and is analogous to member 442 of Cabiri et al. (Figs. 4F-4H).
With regard to claims 16 and 17, sensor 403a is a switch which is activated by movement of the shield ([0102], [0110] of Cabiri et al.).
With regard to claim 18, see Fig. 4F 403a is within 430 of Cabiri et al, similarly the switch would extend into the recess of the shield of Chevallier et al.
With regard to claims 19 and 27, see Fig. 1 member 16 which includes members 17 and 19 which move relative to the shield in order to allow the switch to be activated. Alternatively, as combined with Cabiri et al. Chevallier et al. may incorporate a member like 442 to actuate the switch as needed. When the shield is released the shield and housing move relative to each other in directions F and S (Fig. 3).
With regard to claim 21, as combined the sensors are mounted on the interior of the body of Chevallier et al. which would also include a circuit board 426 (Fig. 4F of Cabiri et al., [0110]).
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. A new reference to Chevallier et al. is relied upon to try to better address the automatic limitations, however, as discussed above, the previous references may still have read on the amended limitation to the independent claims.
Conclusion
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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