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 .
Response to Amendment
Applicant has amended claims 1, 5, and 13 which were previously objected to; Examiner accordingly withdraws the previous objections to claims 1, 5, and 13.
Claims 1-6, 11-14, and 16 remain pending.
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) 1, 4, and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rios et al. (US 20180136185, henceforth Rios ‘185) in view of Byerly et al. (US 20200171246, henceforth Byerly) and Moberg et al. (US 20030073954, henceforth Moberg).
Regarding claim 1, Rios ‘185 discloses a smart syringe system (smart injection system 200, fig. 2A), comprising: a syringe (syringe 220, fig. 2A) comprising: a barrel (syringe shaft 224, fig. 2A) and a plunger rod (stem shaft 214, fig. 2A) fixed such that movement of the plunger rod causes medicament to be displaced within the barrel (see [0048], the injection of medication is a result of movement of stem 210); and a smart cap (data cap 240, fig. 2A) which is removably attachable to the plunger rod (see [0046] data cap 240 can be removably arranged relative to proximal cap 212), the smart cap comprising: a power supply (power source 110, [0044], which can be a battery as in [0046]), a microcontroller (processor 106, fig. 1), and a dialing mechanism (the proximal most end of cap 240 opposite needle 230 has a recessed portion where a force 252 can be applied as shown in figs. 2A and 2B, and this portion can be considered to be a dialing mechanism as it is pushed distally by a user to deliver a specific dose as dialled by movement of the user’s thumb). Rios ‘185 additionally discloses that the removable assembly of its smart cap is achieved by moving the smart cap distally relative to the plunger rod such as to achieve a snap fit, and that a skilled artisan will appreciate that other means of coupling can be used ([0046]).
Rios ‘185 does not disclose the smart syringe system comprising the smart cap comprising a micro switch configured to close based on direct contact with the plunger rod of the syringe, wherein the microcontroller is operatively coupled to the power supply and the micro switch, such that power from the power supply is transmitted to the smart cap only when the micro switch is closed due to direct contact with the plunger rod upon attachment of the smart cap to the syringe. Byerly teaches a smart cap (module body 88, fig. 7) comprising a micro switch (wake-up switch 112, fig. 7) and a microcontroller (PCB 116, fig. 7) where the smart switch is configured to closed based on direct contact with a component of a syringe (see [0065], switch 112 is triggered when it is pressed due to contact with contact 114 of the main syringe portion as shown in figs. 7 and 8), wherein the microcontroller is operatively coupled to the power supply (see at least [0065], power can go from the power source or battery to the electronic components which includes the PCB which means they are operatively coupled together) and the micro switch (see [0065], since switch 112 is configured for allowing power to go from the power source to the electronic components which includes the PCB, the switch is also operatively coupled to the PCB at least via the power source), such that power from the power supply is transmitted to the smart cap only when the micro switch is closed due to direct contact with the portion of the syringe (see [0065], only when wake up switch 112 is triggered, or closed, due to direct contact with contact 114 as shown in figs. 7 and 8 does the power from the power source have the ability to transfer to the electronic components as closed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a micro switch as in Byerly to the smart cap of Rios ‘185 which is configured for providing power to the smart cap from the power source only when the switch is triggered by moving the smart cap distally relative to the syringe as this helps minimize inadvertent power loss or usage when the smart cap is not ready for use (see at least Byerly [0065], allowing power to transfer from the battery to the microprocessor causes inadvertent power losses which should be minimized).
In the modified system of Rios ‘185 and Byerly, it is not explicitly disclosed that the switch is configured to close based on direct contact between the micro switch and the plunger rod of the syringe. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arranged the micro switch as claimed since Byerly teaches the switch to be actuated based on a coming together movement of the smart cap and the syringe, and in Rios ‘185, this only occurs when the smart cap is assembled onto the plunger rod, and further because there are a limited number of places where the micro switch could be placed which would allow for closing based only on the movement of the smart data cap relative to the plunger rod since the smart data cap of Rios ‘185 is only connected to the syringe at the plunger rod in the chosen embodiment and arranging the micro switch to close based on direct contact with the plunger rod as claimed is the only physical connection which changes for the smart cap of Rios ‘185 during use (the smart cap has internal sensors which move, but there are no physical connections changing in the data cap of Rios ‘185 which would allow for actuation of the micro switch of Byerly other than the connection between the data cap and the plunger rod as shown in Rios ‘185 fig. 2B), and thus arranging the added micro switch as claimed would have been obvious to try to one of ordinary skill in the art and further because one of ordinary skill in the art would have had a reasonable expectation of success in adding the switch of Byerly to the data cap of Rios ‘185 in the claimed configuration since it would yield a switch placed between the smart cap and the syringe such that it could be actuated, or closed, by direct contact therebetween.
Rios ‘185 as modified discloses that distal advancement of the plunger rod causes distal advancement and displacement of the medicament into tissue of a subject to cause an injection (see at least [0007] and [0048]). Rios ‘185 does not explicitly disclose the smart syringe having a stopper, or that movement of the plunger rod causes the stopper to be displaced within the barrel. Moberg teaches a stopper (stopper 406, fig. 4) inside a barrel (reservoir 407, fig. 4) of an injection assembly (assembly of fig. 4), where a plunger rod (slide 405, fig. 4) is configured to be moved ([0068]) to cause the stopper to be displaced within the barrel ([0068]), which causes fluid such as medicament to be expelled from the barrel ([0068]). Moberg additionally teaches that its stopper includes o-ring seals (o-ring seals 140, shown in figs. 3 and 4) which are present to provide for compliance within the syringe ([0067]) such as to relieve fluid pressure in case of an occlusion ([0067)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the stopper and O-rings of Moberg to the smart syringe of Rios ‘185 for the benefit of providing compliance to relieve fluid pressure in the event of an occlusion (Moberg [0067]). Such a modification would entail adding the stopper and O-rings to the end of the plunger which is opposite from the smart cap as shown in Moberg where the stopper is placed inside the barrel on the opposite side from where the plunger rod is driven (see Moberg fig. 4). Further, the addition of a stopper onto the plunger rod of Rios ‘185 would have yielded the same, predictable result of a translatable plunger rod being able to be moved such as to inject medication.
Regarding claim 4, Rios ‘185 as modified discloses the smart syringe system of claim 1 wherein the barrel, the stopper, and the plunger rod are disposable (see [0045], and note that the claimed barrel is disclosed as part of the syringe, the claimed stopper is added to the end of the stem in the modified device, and the plunger rod is the disclosed stem).
{Examiner additionally notes that the claim only functionally requires that the barrel, stopper, and plunger rod are structurally and functionally capable of being disposed. Since a user could throw out the assembly before or after use, the structures are disposable as claimed.}
Regarding claim 5, Rios ‘185 as modified discloses the smart syringe system of claim 1 wherein the smart cap further comprises: a sensor (first sensor 102, see [0044] and note that it is disclosed that there can be multiple sensors; the chosen first sensor is a displacement sensor as in [0044]) configured to sense a movement of the plunger rod (displacement sensor of [0044] is understood to measure the displacement of the plunger rod which is a movement of the plunger rod); a memory (memory as in [0019]-[0022] and as in [0087] which discloses that software such as that of data cap 240 resides in memory); and an accelerometer (accelerometer as in [0044]) configured to sense a perturbation to which the plunger rod is subjected (see [0058]-[0061], the claimed perturbation is a movement of the syringe including the plunger rod being moved closer to the disclosed landmarks; while the 9-axis IMS is described, the accelerometer is listed as an equivalent and thus it is understood that an accelerometer could similarly be used for the sensing of the perturbation); wherein the microcontroller is configured to: determine an injection (see at least [0053], information about the amount and speed of an injection can be determined) based on an indication of a perturbation of the plunger rod (the indication that the syringe has been properly placed is disclosed in [0018] and is an indication that the system is targeting an approved injection zone and this is used in part for the determination of the injection where the injection occurs after it has been indicated whether or not the injection is occurring in an approved zone) received from the accelerometer (see above, it is understood that the accelerometer could be used to detect the perturbation which is used in part for the indication since the accelerometer is listed as in equivalent to the 9-axis IMS which is also used for the indication); calculate data (see Abstract, [0042], [0053], the calculated data is what is determined as a result of the sensing from sensors 102) comprising a dose administered to a patient (amount of medication provided as in [0053]), based on data received from the sensor and the accelerometer (see [0053], the sensed values are what is used to determine the amount of medicament delivered); and store the data in the memory (see [0050] and [0083], the data is stored in the memory).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rios et al. (US 20180136185, henceforth Rios ‘185) in view of Byerly et al. (US 20200171246, henceforth Byerly) and Moberg et al. (US 20030073954, henceforth Moberg) as applied to claim 1 above, and further in view of Biondi et al. (US 20190321555, henceforth Biondi).
Regarding claim 3, Rios ‘185 as modified discloses the smart syringe system of claim 1 wherein: the plunger rod comprises a first end (see fig. 6A for an exemplary equivalent to stem 210; there is an end of stem 610 which is opposite proximal cap 612, this is the first end) connected to the stopper (this is where the stopper of Moberg is added in the modified device of Rios ‘185) and a second end (proximal cap 212, fig. 2B; this is also shown as proximal cap 612 in the exemplary equivalent embodiment of fig. 6A), opposite the first end (see exemplary fig. 6A), and the smart cap is configured to be connected with a plunger cap onto the second end of the plunger rod (see [0046], cap body 244 of data cap 240 has a slot 246 which is configured to be connected to proximal cap 212 of stem 210, this is the claimed configuring; the claimed plunger cap is the body of the smart cap). Rios ‘185 additionally discloses that that the removable assembly of its smart cap is achieved by moving the smart cap distally relative to the plunger rod such as to achieve a snap fit, and that a skilled artisan will appreciate that other means of coupling can be used ([0046]).
Rios ‘185 as modified does not disclose the second end of the plunger rod having threading thereon, or that the plunger cap is configured to be threaded onto the second end of the plunger rod. Biondi discloses that a snap fit and a threaded connection are equivalent ways of coupling removable components onto plunger rods ([0012] and [0091]). Biondi also discloses that, in its threaded connection with a removable component and a rod, the rod has the threading (see fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the snap fit disclosed in Rios ‘185 with the threaded connection of Biondi since the two methods of connection are taught as art effective equivalents and further because such a substitution would have yielded the same, predictable result of a plunger cap being attached to a plunger rod. Such a modification would entail the second end of the plunger rod having threading as shown in Biondi (see fig. 2) and the plunger cap of Rios ‘185 being configured to be threaded onto the threaded second end of the plunger rod as claimed.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rios et al. (US 20180136185, henceforth Rios ‘185) in view of Byerly et al. (US 20200171246, henceforth Byerly) and Moberg et al. (US 20030073954, henceforth Moberg) as applied to claim 5 above, and further in view of Jespersen et al. (US 20110009821, henceforth Jespersen).
Regarding claim 6, Rios ‘185 as modified discloses the smart syringe system of claim 5 wherein the smart cap further comprises: an indicator (see [0008]-[0010]) comprising one of a visual indicator and an audible indicator (see [0008]-[0010]).
Rios ‘185 does not disclose the smart syringe comprising a timer configured to measure a time elapsed after the perturbation of the plunger rod; and to output an indication of a predetermined time having passed after the perturbation of the plunger rod. Jespersen discloses an injection device (assembly of fig. 2) comprising a timer (the controller of [0068], [0071], and [0077] is understood to have a timer because it correlates the sensor outputs with the time at which they are measured, as well as keeping track of the time after the injection has ended, thus there must be some component capable of keeping track of time, or a timer) configured to measure a time elapsed after an injection ([0077], the controller controls the user interface to indicate to the user when the needle may be safely withdrawn from the skin of the user, and since this is determined based on how much time has passed since the end of the injection as in [0049], [0052], and [0066]); and a microcontroller (the controller of [0068], [0071], and [0077]) configured to control an indicator ([0028] and [0077]) to output an indication of a predetermined time having passed after the injection ( [0049], “Still, alternatively, the user communication means may be adapted to exclusively indicate the instant when the needle can be safely retracted from the skin of the user”, where safe retraction of the needle is after the predetermined time has passed since the end of the injection as in [0049], [0052], and [0066]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the timer and predetermined time functionalities of Jespersen to the device of Rios ‘185 for providing information relating to the proper amount of time having passed after an injection as this is beneficial for minimizing the risk of backflow of medicament through the needle wound (see Jespersen [0066]). Such a modified device would then entail the use of the indicator of Rios ‘185 being used to deliver a notification that the predetermined waiting time of Jespersen has elapsed after an injection and after the smart syringe has been properly placed which includes the perturbation of the plunger rod as measured by the timer of Jespersen which is added to the modified device. This measuring of time after the injection has ended is a measuring of a time elapsed after the plunger rod of Rios ‘185 has been perturbed because it is a measuring of a time elapsed after an injection, which comes after the proper placement of the needle in the proper injection zone in the use of Rios ‘185’s device.
Claim(s) 16 and 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rios et al. (US 20180136185, henceforth Rios ‘185) in view of Byerly et al. (US 20200171246, henceforth Byerly) and Moberg et al. (US 20030073954, henceforth Moberg) as applied to claim 1 above, and further in view of Michael (US 20170182258, henceforth Michael).
Regarding claim 16, Rios ‘185 as modified discloses the smart syringe of claim 1 wherein the smart cap further comprises: a communication module (wireless transceiver 208, [0048]); and wherein the microcontroller is configured to: control the communication module to pair with an external device (see [0048], since there can be an external processing system which is communicated with via the transceiver 208, it is considered that the external processing system is an external device which is paired with) based on receiving power from the power supply (see [0044] and [0046], the battery powers the wireless transceiver).
Rios ‘185 as modified does not disclose the smart syringe wherein the microcontroller is configured to power off the smart cap based on a failure of the communication module to pair with the external device. Michael teaches a microcontroller (circuitry as in [0223]) being configured to power off a smart cap (adjunct device 1901, which is turned off as in [0231] which is a powering off) based on a failure of a communication module to pair with an external device (see [0231], failure to pair and communicate is confirmed by a lack of verification by a user, and this causes a timeout which turns the adjunct device off).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the microcontroller of Rios ‘185 to power off the smart cap based on a failure of the communication module to pair with the external device as in Michael for saving power and preserving battery life (see Michael [0155], [0158], and especially [1060], turning off and pausing of communications between devices yields the benefit of saving power and extending battery life).
Regarding claim 2, Rios ‘185 as modified discloses the smart syringe of claim 16 wherein the communication module comprises a Bluetooth chip (see [0048], wireless transceiver 208 can follow a Bluetooth wireless communications protocol, meaning that it is a Bluetooth chip).
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rios et al. (US 20180136185, henceforth Rios ‘185) in view of Byerly et al. (US 20200171246, henceforth Byerly).
Regarding claim 11, Rios ‘185 discloses a method of obtaining injection information (see [0048], information regarding an injection is relayed to an external device, and thus it is obtained both by sensors on smart injection system 200 and by the external device of [0048]), the method comprising: powering on a smart cap (data cap 240, fig.2B) comprising a dialing mechanism (the proximal most end of cap 240 opposite needle 230 has a recessed portion where a force 252 can be applied as shown in figs. 2A and 2B, and this portion can be considered to be a dialing mechanism as it is pushed distally by a user to deliver a specific dose as dialled by movement of the user’s thumb), a sensor (first sensor 102, see [0044] and note that it is disclosed that there can be multiple sensors; the chosen first sensor is a displacement sensor as in [0044]), and an accelerometer (accelerometer as in [0044]), by attaching the smart cap to a plunger rod (see fig. 2B and see [0046], data cap 240 is attached to shaft 214 of stem 210 which is a plunger rod; the attachment is a part of the assembly of the syringe and cap and this assembly allows the device to be powered on for use since it is only capable of use once assembled) of a syringe (smart injection system 200, fig. 2A); determining, via the sensor (first sensor 102, see [0044] and note that it is disclosed that there can be multiple sensors; the chosen first sensor is a displacement sensor as in [0044]), the accelerometer (accelerometer as in [0044]), and the dialing mechanism (the proximal most end of cap 240 opposite needle 230 has a recessed portion where a force 252 can be applied as shown in figs. 2A and 2B, and this portion can be considered to be a dialing mechanism as it is pushed distally by a user to deliver a specific dose as dialled by movement of the user’s thumb), data (see Abstract, [0042], [0053], the calculated data is what is determined as a result of the sensing from sensors 102 after a used administers a dose using the dosing mechanism) comprising a dose administered to a patient (amount of medication provided as in [0053]); and storing the data in a memory in the smart cap (memory as in [0019]-[0022] and as in [0087] which discloses that software such as that of data cap 240 resides in memory).
Rios ‘185 does not disclose a method of powering on a smart cap by closing a micro switch disposed in the smart cap by attaching the smart cap to at least one of the barrel and the plunger rod of the syringe. Further, Rios ‘185 does not disclose the smart syringe wherein the smart cap comprises a micro switch which is configured close based on the connection of the smart cap to at least one of the barrel and the plunger rod. Byerly teaches a smart syringe (assembly of fig. 5) having a smart cap (dose delivery detection system 80, fig. 8) which comprises a micro switch (wake up switch 112, fig. 7) which is configured to close based on the connection of the smart cap to the smart syringe (see figs. 7 and 8 and see [0065], wake up switch 112 closes based on contact with contact 114 of flange 38 of dose setting member 30 of the smart syringe).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the microswitch configured to control the power from the power source to the electronics based on its connection to the smart syringe of Byerly to the smart cap of Rios ‘185 for the minimization of inadvertent power loss or usage when the device is not in use as Byerly describes this as the benefit of the configuration of the microswitch ([0065]).
In the modified system of Rios ‘185 and Byerly, it is not explicitly disclosed that the switch is configured to close based on direct contact between the micro switch and the plunger rod of the syringe. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arranged the micro switch as claimed since Byerly teaches the switch to be actuated based on a coming together movement of the smart cap and the syringe, and in Rios ‘185, this only occurs when the smart cap is assembled onto the plunger rod, and further because there are a limited number of places where the micro switch could be placed which would allow for closing based only on the movement of the smart data cap relative to the plunger rod since the smart data cap of Rios ‘185 is only connected to the syringe at the plunger rod in the chosen embodiment and arranging the micro switch to close based on direct contact with the plunger rod as claimed is the only physical connection which changes for the smart cap of Rios ‘185 during use (the smart cap has internal sensors which move, but there are no physical connections changing in the data cap of Rios ‘185 which would allow for actuation of the micro switch of Byerly other than the connection between the data cap and the plunger rod as shown in Rios ‘185 fig. 2B), and thus arranging the added micro switch as claimed would have been obvious to try to one of ordinary skill in the art and further because one of ordinary skill in the art would have had a reasonable expectation of success in adding the switch of Byerly to the data cap of Rios ‘185 in the claimed configuration since it would yield a switch placed between the smart cap and the syringe such that it could be actuated, or closed, by direct contact therebetween.
Such a modified device would then include the smart syringe of Rios ‘185 as modified having its smart cap powered on by closing the added micro switch of Byerly which would be disposed in the smart cap by connecting the smart cap to at least one of the barrel and the plunger rod of the syringe as claimed since would yield the benefit of Byerly of minimizing inadvertent power loss or usage when the device is not in use.
Regarding claim 12, Rios ‘185 as modified discloses the method of claim 11 further comprising: transmitting the data from the memory in the smart cap to an external device (see [0048], the claimed transmission must occur for the external processing system to be able to process it as disclosed).
Regarding claim 13, Rios ‘185 as modified discloses the method of claim 11 wherein the determining the data comprises sensing, via the sensor, movement of the plunger rod (displacement sensor of [0044] is understood to measure the displacement of the plunger rod which is a movement of the plunger rod).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rios et al. (US 20180136185, henceforth Rios ‘185) in view of Byerly et al. (US 20200171246, henceforth Byerly) as applied to claim 11 above, and further in view of Jespersen et al. (US 20110009821, henceforth Jespersen).
Regarding claim 14, Rios ‘185 as modified discloses the method further comprising: determining that an injection of a dose has started based on an output from a sensor ([0008] discloses that injection rate is determined via the displacement sensor, and knowing the injection rate requires knowing when the injection has begun such as to start timing to calculate the volume of medicament delivered over time). Rios ‘185 additionally teaches that its accelerometer is a position sensor ([0044]).
Rios ‘185 does not disclose the method further comprising obtaining a time of an injection of the dose based on an output from the accelerometer. Jespersen teaches the use of sensors to determine when an injection has started ([0073]), particularly including position sensors ([0073)), and the use of timers to keep track of the times of injections (the controller of [0068], [0071], and [0077] is understood to have a timer because it correlates the sensor outputs with the time at which they are measured, as well as keeping track of the time after the injection has ended, thus there must be some component capable of keeping track of time, or a timer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have supplemented the use of the displacement sensor of Rios ‘185 for determining the start of an injection with an added timer and with the use of the accelerometer of Rios ‘185, which is a position sensor, in the manner taught by Jespersen to determine the start and duration of the injection as Jespersen teaches that the use of position sensors in an art effective way of determining whether an injection is occurring (Jespersen [0073]) to provide further confirmation that an injection has started.
Response to Arguments
Applicant's arguments filed 10/03/2025 have been fully considered but they are not persuasive.
Applicant has argued that Rios ‘185 as modified does not disclose a dialling mechanism as claimed. Examiner respectfully disagrees. The recessed portion of the proximal most surface of data cap 240 can be considered to be a dialling mechanism as claimed as Merriam Webster defines “dial” as a verb to mean “to manipulate a device (such as a dial) to operate, regulate, or select”. The recessed portion of the proximal most surface of data cap 240 achieves this function where it is manipulated for operation of the smart injection system and the data cap since it is pushed axially by a user to operate the smart system and to cause an injection. There is no specific structure required as a part of the dialing mechanism as claimed, nor is any specific functionality required of it beyond that it exists as a part of the data cap. Thus, this argument is unpersuasive.
Applicant further argues that Byerly does not teach the micro switch configured to close due to attachment of the smart cap to the plunger rod as claimed. This is not the assertion of the rejection above; Byerly is relied upon for teaching a switch which is configured to close when a cap member at a proximal end of a smart system is moved distally relative to a syringe, where the switch is closed based on direct contact with the syringe. It is the Examiner’s position that adding the switch 112 of Byerly would have been obvious to add to the system of Rios ‘185 for the benefit of helping to minimize inadvertent power loss or usage when the smart cap is not ready for use (see at least Byerly [0065], allowing power to transfer from the battery to the microprocessor causes inadvertent power losses which should be minimized). It is then found to be further obvious to have arranged the micro switch as claimed since the only time that the smart cap of Rios ‘185 moves distally relative to the syringe of Rios ‘185 is during the assembly of the smart cap onto the syringe, and since Byerly teaches the switch to be in direct contact with a portion of the syringe, and Rios ‘185 similarly has a portion that comes into direct contact with the syringe during the attachment of the smart cap to the syringe, it is the Examiner’s position that the claimed arrangement would have been obvious to try as there do not appear to be any other options to try for the configuration of adding the switch such that it comes into direct contact with the syringe and because one of ordinary skill in the art would have had a reasonable expectation of success in adding the switch of Byerly to the data cap of Rios ‘185 in the claimed configuration since it would yield a switch placed between the smart cap and the syringe such that it could be actuated by direct contact therebetween.
Applicant also argues that a skilled artisan could not combine Rios ‘185 and Byerly as proposed in the rejection. Examiner respectfully disagrees. Switch 112 of Byerly is taught as being provided such that power is not provided to electronic components when the switch is not activated, and that the activation comes from direct contact between a cap module and a syringe. It is further found to be obvious to arrange the structures as claimed, and then in the modified device, since power is delivered to the electronics one the smart cap is attached onto the syringe structures, the dose detecting of Rios ‘185 disclosed in [0046] would be possible.
Thus, Applicants arguments are respectfully found unpersuasive and the claims are rejected as indicated above.
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 SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783