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 § 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, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alchas et al. (US 2005/0033230 A1) in view of Cabiri et al. (US 2016/0296716 A1) and Miller et al. (US 2008/0188813 A1).
With regard to claims 1 and 3, Alchas et al. teach an injection system for a manually operated safety syringe having a needle (Fig. 1 member 18), a barrel housing a medicament (Fig. 1 member 12, [0002], claim 21), a plunger configured to be manually inserted into the barrel and advanced to a bottom end of the barrel to dispense a dose of medicament (Fig. 1 member 32), a safety shield being deployable to cover at least a portion of the needle of the safety syringe (Fig. 1 member 22), and a flange having a pair of wings extending laterally outward (Fig. 1 member 40, each half is taken as a wing), the injection 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 40 connected and arranged with the flange at 42); wherein the safety shield is configured to deploy in response to the plunger reaching the bottom end of the barrel (see exemplary Fig. 3 of Alchas et al. corresponding to Figs. 4E and 4J of Cabiri et al. below, in Alchas et al. the shield deploys when the user removes it from the skin, the user may remove the device in response to the plunger reaching the bottom end). Alchas 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 Alchas et al. as 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.
With regard to claims 2, 12, and 14, as combined the sensors are mounted on the interior of 40 of Alchas 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 when the needle is uncovered ([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 Alchas et al.
With regard to claim 11, Fig. 1 member 47 of Alchas et al. is equivalent to member 442 of Cabiri et al. and is considered as a housing member which moves radially relative to the shield to activate the switch (Figs. 4F-4H).
With regard to claim 15, Alchas et al. teach an electronic injection monitoring system for a manually operated safety syringe having a needle (Fig. 1 member 18), a flange (Fig. 1 member 40), a barrel housing a medicament (Fig. 1 member 12, [0002], claim 21), a plunger configured to be manually inserted into the barrel and advanced to a bottom end of the barrel to dispense a dose of medicament (Fig. 1 member 32), and a safety shield being deployable to cover at least a portion of the needle of the syringe, the electronic injection monitoring system comprising (Fig. 1 member 22): 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 40); wherein the safety shield is configured to deploy in response to the plunger reaching the bottom end of the barrel (see exemplary Fig. 3 of Alchas et al. corresponding to Figs. 4E and 4J of Cabiri et al. below, in Alchas et al. the shield deploys when the user removes it from the skin, the user may remove the device in response to the plunger reaching the bottom end). Alchas 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 Alchas et al. as 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.
With regard to claims 16 and 17, sensor 403a is a switch which is activated by movement of the shield when the needle is uncovered ([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 Alchas et al.
With regard to claim 19, Fig. 1 member 47 of Alchas et al. is equivalent to member 442 of Cabiri et al. and is considered as a housing member which moves radially relative to the shield to activate the switch (Figs. 4F-4H).
With regard to claim 20, see exemplary Fig. 3 of Alchas et al. corresponding to Figs. 4E and 4J of Cabiri et al.
With regard to claim 21, as combined the sensors are mounted on the interior of 40 of Alchas et al. which would also include a circuit board 426 (Fig. 4F of Cabiri et al., [0110]).
Claim(s) 1-12, 14-19, 21, and 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barrelle (US 2008/0208140 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, Barrelle teaches an injection system for a manually operated safety syringe having a needle (Fig. 6 member 7), a barrel housing a medicament (Fig. 2 member 32, [0003]), a plunger configured to be manually inserted into the barrel and advanced to a bottom end of the barrel to dispense a dose of medicament (Fig. 2 member 4), a safety shield being deployable to cover at least a portion of the needle of the safety syringe (Figs. 3 and 9 including at least 6) and a flange having a pair of wings extending laterally outward (Fig. 3 see the flange of the syringe barrel at the end opposite the needle, each half is taken as a wing), the injection 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 a proximal end of the body and B) above a distal end of the body (Figs. 3 and 9 body including members 3 and 18, Fig. 3 shows the arrangement of the body relative to and in direct contact with the wings); wherein the safety shield is configured to deploy in response to the plunger reaching the bottom end of the barrel (see exemplary Fig. 9 of Barrelle corresponding to Figs. 4E and 4J of Cabiri et al. below, in Barrelle the shield deploys when the user removes pressure from the piston after delivery, the user may remove the device in response to the plunger reaching the bottom end, [0043], [0044]). Barrelle does 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 Barrelle as 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 17 of the shield (Figs. 1, 3, 9) 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 3 of Barrelle 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 when the needle is uncovered ([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 Barrelle.
With regard to claim 11, Fig. 1 member 17 of Barrelle is equivalent to member 442 of Cabiri et al. and is considered as a housing member which moves radially relative to the shield to activate the switch (Figs. 4F-4H).
With regard to claim 24, see exemplary Fig. 4, interior surface 3 is externally around 6.
With regard to claims 15 and 25, Barrelle teaches an electronic injection monitoring system for a manually operated safety syringe having a needle (Fig. 6 member 7), a flange (Fig. 3 see the flange of the syringe barrel at the end opposite the needle, each half is taken as a wing), a barrel housing a medicament (Fig. 2 member 32, [0003]), a plunger configured to be manually inserted into the barrel and advanced to a bottom end of the barrel to dispense a dose of medicament (Fig. 2 member 4), and a safety shield being deployable to cover at least a portion of the needle of the syringe (Figs. 3 and 9 including at least 6), 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 (Figs. 2, 3 and 9 body including members 3 and 18), wherein the safety shield is configured to deploy in response to the plunger reaching the bottom end of the barrel (see exemplary Fig. 9 of Barrelle corresponding to Figs. 4E and 4J of Cabiri et al. below, in Barrelle the shield deploys when the user removes pressure from the piston after delivery, the user may remove the device in response to the plunger reaching the bottom end, [0043], [0044]). Barrelle does 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 Barrelle as 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 17 of the shield (Figs. 1, 3, 9) 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 when the needle is uncovered ([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 Barrelle.
With regard to claim 19, Fig. 1 member 17 of Barrelle is equivalent to member 442 of Cabiri et al. and is considered as a housing member which moves radially relative to the shield to activate the switch (Figs. 4F-4H).
With regard to claim 21, as combined the sensors are mounted on the interior of 3 of Barrelle which would also include a circuit board 426 (Fig. 4F of Cabiri et al., [0110]).
Response to Arguments
Applicant's arguments filed December 18, 2025 have been fully considered but they are not persuasive. Applicant argues in Alchas et al. and Barrelle the shield is deployed when the user removes the devices after delivery. As explained in the rejection, in both Alchas et al. and Barrelle the deployment of the shield is controlled by the user and the shields may be deployed by the user in response to the plunger reaching the bottom end of the barrel. The user would remove the device in response to delivery being completed. There is no particular structure claimed between the plunger/barrel/shield which triggers deployment.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783