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
This office action is responsive to the amendment filed on 11/20/2025. As directed by the amendment: claim 1 has been amended, no claims have been cancelled, and no new claims have been added. Thus, claims 1-3 and 8-12 are presently pending in this application, with claims 8-12 being withdrawn from consideration. Applicant’s amendments to the claims have overcome each and every 112(b) rejection set forth in the Non-Final Office Action mailed on 09/08/2025.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Knapp et al. (U.S Patent Pub. No. 20170232204 A1, “Knapp”) in view of Helmer et al. (U.S Patent Pub. No. 2018/0353699 A1, “Helmer”) in view of Whalley et al. (U.S Patent Pub. No. 20130310756 A1, “Whalley”) in view of Friedli (U.S Patent Pub. No. 2011/0270219 A1).
Regarding claim 1, Knapp discloses the limitations of (Claim 1) a dose measuring device (1200 in Fig. 12) for use with a pen injector (see para. 0099), comprising:
a fixed cap part (1202 in Fig. 12) configured to be attached to a body of the pen injector to enclose a reservoir compartment of the pen injector (see Fig. 12 and para. 0099 – examiner notes the pen injector and its body and reservoir compartment are functionally recited and thus the claim is interpreted as requiring a fixed cap part that is capable of being configured to be attached to a body of the pen injector to enclose a reservoir compartment, smart cap 1200 is illustrated as attached to a generic insulin pen which and is capable of being configured of attaching to enclose a reservoir compartment of said pen), the pen injector comprising a proximal end having a dispensing button and a distal end opposite the proximal end (see Fig. 12 and para. 0099 – examiner notes the injector pen is functionally recited and the fixed cap part needs only to be capable of being configured to attach to a pen injector comprising a proximal end having a dispensing button and distal end opposite thereof), wherein the fixed cap part (1202) comprises a locking hub (1210 in Fig. 12) arranged at a proximal end of the fixed cap part (1202) and configured to fix the fixed cap part (1202) to the body of the pen injector (see Fig. 12 and para. 0099 – locking hub 1210 fixes fixed cap part 1202 of the body of the illustrated pen injector in Fig. 12), and
a removable cap part (1208 in Fig. 12) attached to a distal end of the fixed cap part (1202) and removable from the fixed cap part (1202) to expose a pen needle of the pen injector (see Fig. 12 and para. 0099);
the fixed cap part (1202) comprising a dose sensor (1204, 1206 in Fig. 12) comprising a sensor array on an inside surface of the fixed cap part (1202) for detecting movement of a plunger within a medicament reservoir of the pen injector during an injection in real time (see para. 0099 – emitters 1204 and sensors 1206 are an array of sensors on inside surface of fixed cap part 1202 which detect movement of the plunger during injection);
While Knapp discloses that the fixed cap part (202 in Fig. 12) may comprise sensors such as the generic dose sensor discussed above and a skin contact sensor (see para. 0099), Knapp fails to disclose (Claim 1) a locking nut; a cap sensor for sensing when the removable cap part is removed from the fixed cap part, a proximity sensor for sensing when the pen injector is adjacent to a user, and a dose sensor comprising a sensor array on an inside surface of the fixed cap part for optically detecting movement of a plunger within a medicament reservoir of the pen injector during an injection in real time; further comprising a microcontroller in the fixed cap part, wherein the cap sensor causes the fixed cap part to turn on when the cap sensor senses that the removable cap part was removed, wherein the microcontroller determines that a complete dose was delivered if the proximity sensor senses that the pen injector is adjacent to the user for a predetermined period of time; and a display that displays a countdown during the injection that lasts the predetermined period of time.
Helmer discloses a measuring device (2 in Fig. 1-3) for use with a pen injector (10 in Fig. 3), wherein the measuring device (2) comprises a fixed cap part (20 in Fig. 3) and a removable cap part (12 in Fig. 3, see para. 0048 and 0053). Helmer teaches (Claim 1) the fixed cap part (20) comprising a cap sensor (30 in Fig. 2-3) for sensing when the removable cap part (12) is removed from the fixed cap part (20, see para. 0053 – outer needle cap sensor 30 within supplementary device 2 determines whether outer needle cap 12 is attached to injection device 10 or not); further comprising a microcontroller (24 in Fig. 3) in the fixed cap part (20, see Fig. 3 and para. 0057), wherein the cap sensor (30) causes the fixed cap part (20) to turn on when the cap sensor (30) senses that the removable cap part (12) was removed (see Fig. 3 and para. 0063), and a display (21, see Fig. 3 and para. 0053 – supplementary device 2 comprises display unit 21).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fixed cap part taught by Knapp to incorporate a cap sensor, microcontroller, and display as taught by Helmer. Helmer provides that incorporating a cap sensor in communication with a microcontroller allows for power saving operations and allows for indication to a user if the removable cap part is absent post-injection as this helps avoid needle clogging which can occur if the drug delivery device is stored without the outer needle cap (see para. 0023-0024). Helmer further provides incorporate a display in communication with a microcontroller allows for information to be displayed to a user such as present settings, information on a next injection to be give, or alarm signals (see para. 0059 and 0065).
Whalley discloses an autoinjector (210 in Fig. 2-4) comprising a dose detection system (200 in Fig. 2-4) with optical dose sensing (see para. 0041), wherein Whalley teaches (Claim 1) a locking nut (226 in Fig. 3) arranged at a proximal end of the cap part (224) and configured to fix the cap part (224) to the body (212 in Fig. 3) of the pen injector (210, see para. 0043 – cap part 224 comprises a proximal bore 226 which may incorporate threads for removably coupling the cap part 224 to the housing 212 of the injector 210 thus defining a locking nut), a dose sensor (644, 654 in Fig. 10) comprising a sensor array on an inside surface of housing for optically detecting movement of a plunger (614 in Fig. 10) within a medicament reservoir (612 in Fig. 10) of the injector during an injection in real time (see Fig 10 and para. 0062 – dose measurement system 600 comprises light sources 644 and sensors 654 on an inside surface for optically detecting movement of plunger 614 within medicament reservoir 612 at each position of the plunger 614 during an injection in real time as the plunger moves to each position seen for example in Fig. 11A-11C).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the locking hub taught by modified Knapp to have threads and thus be a locking nut as taught by Whalley and to have modified the generic dose sensor array in the fixed cap part taught by modified Knapp to be an optical dose sensor array as taught by Whalley. Whalley teaches that the cap part may include notches, grooves, detents, any other snap-fit mechanism or threads for removably coupling the dose measurement system to the drug delivery device in a secure and detachable manner (see para. 0043). Whalley further provides that modifying the generic emitters and detectors of modified Knapp to be optical emitters and detectors would have been obvious according to known methods to yield predictable results. One of ordinary skill in the art would have recognized that using optical emitters and detectors for sensing the movement of a plunger in a medicament reservoir is an obvious mechanism of dose sensing and would yield predictable results. Whalley further provides that using optical sensors allows for the quantity of electromagnetic radiation detected by the sensors to serve as a signature representative of the volume of liquid in the medicament reservoir (see para. 0029).
Friedli discloses an administration device comprising a touch sensor in communication with a controller and a display. Friedli teaches (Claim 1) a proximity sensor (20 in Fig. 3) for sensing when the injector (10a in Fig. 3) is adjacent to a user (see Fig. 3 and para. 0033 – infusion device 10a comprises touch sensor 20, see para. 0028 – touch sensor 20 is activated by being adjacent to a user), wherein the microcontroller (14 in Fig. 3) determines that a complete dose was delivered if the proximity sensor (20) senses that the injector (10a) is adjacent to the user for a predetermined period of time (see para. 0050 – controller 14 determines a completed dose when touch sensor 10a is activated and a predetermined period of time passes until deactivation), and a display (16) that displays a countdown during the injection that lasts the predetermined period of time (see Fig. 3 and 7a-7b and para. 0050 – when touch sensor 20 is activated, controller 14 of infusion device 10a starts a countdown timer which may be displayed on display 16 to display a countdown of a predefined period of time representing the time for carrying out a complete bolus administration).
Since in modified Knapp, Helmer discloses the microcontroller (24) may communicate with the display (21) to display an indication to the user to leave the needle of the injection device in the injection site for a predetermined length of time (see para. 0090), and Friedli discloses a microcontroller (14) in communication with a display (16) to start a countdown timer when touch sensor (20) is activated representing the time for carryout a complete bolus administration, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor assembly and display unit within the fixed cap part taught by modified Knapp to incorporate a proximity sensor and a countdown timer as taught by Friedli. The motivation for this modification is Friedli teaches incorporating a touch sensor as a safety feature to help prevent inadvertent activation of the infusion device as well as ensure full bolus administration is carried out by providing indications to the user (see para. 0050).
Regarding claim 2, modified Knapp discloses the dose measuring device of claim 1, as discussed above.
However modified Knapp fails to disclose (Claim 2) wherein the fixed cap part further comprises a wireless communication unit that communicates dose data to a remote device.
Helmer teaches (Claim 2) wherein the fixed cap part (20) further comprises a wireless communication unit (28 in Fig. 3) that communicates dose data to a remote device (see para. 0055 and 0060 – supplementary device 2 comprises communication module 28 for communicating injection data from the hall sensor 25 with an external device).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fixed cap part of modified Knapp to incorporate a wireless communication unit as taught by Helmer as Helmer provides that such communication tools allow for transmission and receipt of information to and from an external device in a wireless fashion (see para. 0062), wherein the external device may have additional capabilities for managing the user’s medical records and injection history (see para. 0087).
Regarding claim 3, modified Knapp discloses the dose measuring device of claim 2, as discussed above. In modified Knapp, Helmer discloses (Claim 3) wherein the remote device is a mobile phone (see para. 0021 – external device that is in communication with supplementary device 2 can be a smart phone).
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.
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/K.M.T./Examiner, Art Unit 3783 /COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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