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 Status
Claims 16-35 are pending for examination.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 16/771,030, filed on Jun 09, 2020.
Non-Statutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 16 - 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 19 of U.S. Patent No. 12,303,269 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims and the patented claims have very similar scope and the pending claims are obvious modification of the patented claims. Specifically, the combination of claims 16 and 32 of the pending application is directed to determining a due time for the next injection. The claims are substantially similar to the scope of claim 1 of the patented application which is also directed to determining of a time for a future injection.
Claims 16 - 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 20 of U.S. Patent No. 11,857,325 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims and the patented claims have very similar scope and the pending claims are obvious modification of the patented claims. Specifically, the combination of claims 16, 21, 32 and 33 of the pending application is directed to determining a date, time, volume of the past injection and the wellness of the patient to operate a vehicle. The claims are substantially similar to the scope of claim 1 of the patented application which is also directed to determining the date and time of the administered dosage and determining the driving ability of the user.
Claims 16 - 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 13 of U.S. Patent No. 11,426,108 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims and the patented claims have a very similar scope, and the pending claims are obvious modification of the patented claims. Specifically, the combination of claims 16, 21-23, 32 and 33 of the pending application is directed to determining a due time for the next injection, utilizing of a smart key for vehicle control, and determining the wellness of the patient to operate a vehicle. The claims are substantially similar to the scope of claim 1 of the patented application which is also directed to determining a due time for the subsequent medication, utilizing a smart key to control the vehicle, and determining the driving ability of the user.
Claim Objections
Regarding claim 22, is objected to because of the limitation “for controlling one or more operations of the vehicle based” in the last line. The limitation is grammatically incomplete. Specifically, the appearance of the term “based” at the end of the sentence offers no clear context.
Regarding claim 23, is also objected because it depends on claim 22.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 16 - 18, 24 and 27 - 32 are rejected under 35 U.S.C. 103 as being unpatentable over Cirillo (Pat. No.: US 10,773,032 B2).
Regarding claim 16, Cirillo teaches a supplementary device (Abstract, Fig. 1, monitoring device 1) comprising:
a sensor configured to measure or determine an injection history of an injection device when the supplementary device is attached to the injection device, the injection history being indicative of a past injection of a medicament from the injection device for a patient (Fig. 6 optical sensor 9, Fig. 7, steps 16-24, Col. 6 line 25 -47, “As indicated above, the monitoring device 1 described above can be incorporated into an insulin pen 2 during manufacture or retrofitted to existing insulin pens 2 to create smart insulin pens 2. As described in FIG. 7, in use, where movement of the push button 6/plunger shaft is detected 17 by the monitoring device, the dose display 7 is reset 18 to indicate motion (the plunger/push button 6 normal resting position being in the down disposition). The dose display 7 continually displays the dose corresponding with the plunger position dialled by the user 19 via the dose selector 5. The monitoring device 1 monitors 20 the Peak Value (the largest reading/movement i.e. dose measured by the optical sensor 9 which it is assumed the user will inject) to determine the start of injection while the display 1 O also displays additional warning/information messages 21 based on previous usage data stored in the memory 1. Completion of injection is detected 22 by measuring return travel of the shaft back to a fully down state. If the injection is complete 23, the display 10 is updated 24 to confirm acknowledgement of completion together with the time of the injection and the dosage.”. The monitoring device 1 is attachable to the insulin pen 2 and includes a sensor that detects movements of the button/plunger 6 of the insulin pen when injecting medication into the patient. The display 10 of the insulin pen displays a time and a completion message to indicate a successful injection.);
a memory configured to store a log of the injection history of the injection device (Fig. 6, and Col. 6 line 48 – 51, “All success/error data is logged 26 to the RAM memory 14 memory 14 together with other optional environmental information such as temperature or other sensor data where appropriate sensors are present in the monitoring device 1.”); and
a wireless unit configured to transmit data to one or more external devices, the data including data associated with an injection (Fig. 7, steps 27 - 28, the monitoring device transmits logged data to the smart phone;
wherein the supplementary device is configured to be releasably attached over a button of the injection device, and the sensor is configured to measure a position or a movement of the button (Fig. 4, Col. 6 line 3 – 12, “Where the monitoring device 1 is to be retrofitted to a conventional “non-smart” insulin pen 2, the monitoring device 1 can be secured to the insulin pen 2 via an intermediate mounting device such as an annular sleeve 15 adapted to be mounted securely on the insulin pen 2 whilst also removably supporting the monitoring device 1 in place. The sleeve 15 is shaped and sized to locate the monitoring device adjacent the dose selector 5 so that the optical sensor 9 can detect movement of the dose selector 5/push button 6 shaft.”. The removable monitoring device 1 is attached over the dose selector 5 / push button 6 to monitor their movements.).
Cirillo teaches the monitoring device records the time of the injection and transmits the collected data to the smartphone but fails to expressly teach the data include a time stamp.
However, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to transmit the time of the injection to the smartphone. Under the KSR rationale “obvious to try”, selecting the injection time from a finite number of recorded data options for transmission yields a predictable solution.
Regarding claim 17, Cirillo teaches the supplementary device of claim 16, wherein the sensor is configured to determine the injection history based on a position or a movement of one or more components of the injection device relative to the supplementary device (Fig. 7, steps 16 – 24, Col. 6 line 25 -47. The monitoring device determines the history or recorded injection time at step 24 based on the movement of the plunger detected by the optical sensor at steps 16-22).
Regarding claim 18, Cirillo teaches the supplementary device of claim 17, wherein the sensor is configured to measure the position or the movement of the one or more components of the injection device relative to the supplementary device without requiring direct contact between the sensor and the one or more components (Fig. 4, optical sensor does not require direct contact to detect movement.).
Regarding claim 24, Cirillo teaches the supplementary device of claim 16, comprising a second sensor configured to measure or determine information identifying the medicament (Fig. 19, temperature sensor).
Regarding claim 27, Cirillo teaches the supplementary device of claim 24, wherein the supplementary device further comprises a processor configured to compare the information identifying the medicament to stored information to verify that the medicament is for the patient (Fig. 6, CPU 13, Fig. 20 and Col. 8 line 47 – 51, “Following manual dose selection 52, 53 by the user, the monitoring device 1 then compares 59 the selected dose with the instruction received for the next injection and transmits a warning 60 to the user where the incorrect dose has been selected.”. The processor compares the selected medicament dosage and the expected dosage for verification of the correct dosage.).
Regarding claim 28, Cirillo teaches the supplementary device of claim 27, wherein the supplementary device is configured to produce an alarm signal when the processor does not verify that the medicament is for the patient (Fig. 20, step 60 and Col. 8 line 47 – 51, “Following manual dose selection 52, 53 by the user, the monitoring device 1 then compares 59 the selected dose with the instruction received for the next injection and transmits a warning 60 to the user where the incorrect dose has been selected.”. The monitoring device outputs a warning at step 60 if the selected dosage is incorrect).
Regarding claim 29, Cirillo teaches the supplementary device of claim 28, wherein the supplementary device further comprises a display and wherein the alarm signal comprises words or graphics displayed on the display (Fig. 6, Col. 6 line 35-40, “The monitoring device 1 monitors 20 the Peak Value (the largest reading/movement i.e. dose measured by the optical sensor 9 which it is assumed the user will inject) to determine the start of injection while the display 1 O also displays additional warning / information messages 21 based on previous usage data stored in the memory 1.”. The display 10 displays warning messages.).
Regarding claim 30, Cirillo teaches the supplementary device of claim 28, wherein the supplementary device further comprises an audio module and wherein the alarm signal comprises sound produced by the audio module (Col. 9 line 35-38, “As shown in the drawing, the monitoring device 1 can be additionally provided with an acoustical signal generator 7 4 to issue audible alarms to a user in addition to the visible display 10.”).
Regarding claim 31, Cirillo teaches the supplementary device of claim 28, wherein the supplementary device is further configured to use the wireless unit to transmit the alarm signal to the one or more external devices (Fig. 6, communication module 11, Fig. 7 steps 27-28.).
Regarding claim 32, Cirillo teaches the supplementary device of claim 16, wherein the one or more external devices are configured to determine a due time for an injection of a medicament based on the injection history (Fig. 7 step 32, Fig. 20, step 57, Col 8 line 43-47, “As shown in FIG. 20, the monitoring device 1 of the invention can also receive instructions/data from the external smart device or computer e.g. data on the next injection to be performed 57 which is displayed 58 on the device for the user.”. The smart device determines the next injection time at step 32 based on the received data of the last injection at step 31.).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Cirillo (Pat. No.: US 10,773,032 B2) in view of Krulevitch (Pub. No.: US 2011/0313349 A1).
Regarding claim 19, Cirillo teaches the supplementary device of claim 17, wherein the sensor is configured to measure the position or the movement of the one or more components of the injection device using
optical sensor 9 instead of magnetic induction sensing.
However, in the same field of injection device, Krulevitch teaches an attachment module 102 for an injection device 124 that includes a magnetic displacement sensor 114 for measuring the position of the dosage selector 120. See Fig. 5 and para [0018], “In yet a further aspect, the dosage sensor is selected from a group consisting of a rotary potentiometer, linear potentiometer, capacitive displacement sensor, optical displacement sensor, magnetic displacement sensor, encoder type displacement sensor, or combination thereof.” and para [0054], “Dosage sensor 114 is preferably a linear potentiometer and is used to measure the position of dosage selector 120 for determining the size of the bolus injected by the user.”.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Cirillo’s monitoring device with a magnetic displacement sensor taught by Krulevitch to improve accuracy.
Regarding claim 20, Cirillo teaches the supplementary device of claim 17, wherein the sensor is configured to measure the position or the movement of the one or more components of the injection device using optical sensor 9 instead of capacitive displacement sensing or Eddy current sensing.
However, in the same field of injection device, Krulevitch teaches an attachment module 102 for an injection device 124 that includes a capacitive displacement sensor 114 for measuring the position of the dosage selector 120. See Fig. 5 and para [0018], “In yet a further aspect, the dosage sensor is selected from a group consisting of a rotary potentiometer, linear potentiometer, capacitive displacement sensor, optical displacement sensor, magnetic displacement sensor, encoder type displacement sensor, or combination thereof.” and para [0054], “Dosage sensor 114 is preferably a linear potentiometer and is used to measure the position of dosage selector 120 for determining the size of the bolus injected by the user.”.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Cirillo’s monitoring device with a capacitive displacement sensor taught by Krulevitch to improve accuracy.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Cirillo (Pat. No.: US 10,773,032 B2) in view of Sjostedt (Pub. No.: US 2016/0279335 A1).
Regarding claim 21, Cirillo teaches the supplementary device of claim 16, wherein the injection history comprises a time of a past injection and a volume of the medicament administered in the past injection (Fig. 7, step 24 and Fig. 11).
Cirillo teaches the monitoring device records the time and volume but fails to record a date of the injection.
However, in the same field of medical device, Sjostedt teaches an injection device is configured to record the date, time and volume of the injection. See Fig. 16 and para [0124], “The electronic log comprises a database 200 which is stored in the memory 38 of processing unit 19. In step 600 an ejection event is stored in the memory of the device 1, the ejection event comprising information about the amount of ejected medicament and the time and date for this.”.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Cirillo’s monitoring device to record the date, time and volume of the injection as taught by Sjostedt to improve record keeping.
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Cirillo (Pat. No.: US 10,773,032 B2) in view of Kim (Pub. No.: US 2013/0226372 A1).
Regarding claim 22, Cirillo teaches the supplementary device of claim 16, wherein the monitoring device transmit the record data to a mobile device but fails to teach wherein the one or more external devices are configured to transmit control signals to a vehicle for controlling one or more operations of the vehicle based.
However, in the same field of mobile device, Kim teaches a mobile device 10 is configured to receive medical information from a database 30 (analogous to the memory of the monitoring device) and transmits a control signal to a vehicle to control the operation of the vehicle based on the medical information received from the database. See Fig. 3, steps 300-308, and Fig. 7 steps 700 – 709, para [0100], “The terminal controller 11 identifies a piece of vehicle control information for the vehicle control node controllable in response to the driver's private medical information, in step 707, and generates a vehicle control command according to the identified vehicle control information, in step 708.”.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Cirillo’s smart device to transmits a control signal to a vehicle to control the operation of the vehicle based on the medical information received from the monitoring device as taught by Kim to improve safety.
Regarding claim 23, Cirillo teaches the supplementary device of claim 22, wherein the one or more external devices comprise a smart key configured to transmit the control signals to the vehicle for controlling the one or more operations of the vehicle (Fig. 3, steps 300-308, and Fig. 7 steps 700 – 709, para [0100], “The terminal controller 11 identifies a piece of vehicle control information for the vehicle control node controllable in response to the driver's private medical information, in step 707, and generates a vehicle control command according to the identified vehicle control information, in step 708.”. The mobile terminal 10 is analogous to a smart key that transmits a control signal to command the operation of the vehicle), the one or more operations configured to be controlled when the patient is an occupant of the vehicle (para [0112], “Further, the head unit 20 may control the air direction of the air conditioner 902 toward the driver's feet in case the diabetes causes poor foot health as a side effect. In addition, since direct sunlight and reflected light may easily hurt the driver's eyes, the head unit 20 may control a sun visor 900 in front of the driver's seat to be automatically adjusted to efficiently prevent direct sunlight.”).
Allowable Subject Matter
Claims 25-26 and 33-35 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and a terminal disclaimer to overcome the non-statutory double patenting.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Brown (Pat. No.: US 5,792,117) teaches an apparatus for optically determining and electronically recording the dose of an agent delivered with a syringe.
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/ZHEN Y WU/Primary Examiner, Art Unit 2685
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