Prosecution Insights
Last updated: October 02, 2026
Application No. 18/694,272

Controlling a sensor of a drug delivery device or of a drug delivery add-on device

Non-Final OA §103
Filed
Mar 21, 2024
Priority
Sep 24, 2021 — EU 21315172.3 +1 more
Examiner
CARPENTER, WILLIAM R
Art Unit
Tech Center
Assignee
Sanofi S.A.
OA Round
1 (Non-Final)
54%
Grant Probability
Moderate
1-2
OA Rounds
1y 1m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 54% of resolved cases
54%
Career Allowance Rate
550 granted / 1011 resolved
-5.6% vs TC avg
Strong +53% interview lift
Without
With
+52.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
52 currently pending
Career history
1080
Total Applications
across all art units

Statute-Specific Performance

§101
1.1%
-38.9% vs TC avg
§103
59.3%
+19.3% vs TC avg
§102
16.9%
-23.1% vs TC avg
§112
16.8%
-23.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1011 resolved cases

Office Action

§103
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. 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) 25-26, 36, 37, 39-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2020/0360614 (“Schabbach”) in view of U.S. Publication No. 2020/0246548 (“Bill”) and U.S. Patent No. 4,019,606 (“Caputo”). Regarding Claim 25-26, 36, Schabbach discloses a device/controller/processor (23) for controlling a sensor (215) of a drug delivery add-on device (700), wherein the sensor comprises a light emitter (Par. 30) and a light receiver (Par. 30), wherein the device is configured to perform operations comprising: Generating a first drive signal for the light emitter (Par. 107) and a second drive signal for the light receiver, the second drive signal being generated to acquire the output signal of the receiver when the first drive signal is generated to switch on the light emitter (Par. 107, 143, 173). Schabbach discloses the invention substantially as claimed except that the light receiver is a “phototransistor”. However, Bill discloses that in such add-on devices for a drug delivery system it is known that a light receiving device can be embodied as either a photodiode, a digital light sensor, or a phototransistor (Par. 50). It would have been obvious for one having ordinary skill in the art at the time the invention was made to utilize a phototransistor for the light receiving sensor component of the invention of Schabbach, as disclosed by Bill, whereby the prior art establishes the two components to be clear alternatives to one another and it has been held that simple substitution of known equivalents to obtain a predictable and expected outcome is obvious, requiring only routine and customary levels of skill in the art, see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Schabbach, as modified, discloses the invention substantially as claimed except that the second drive signal includes biasing the phototransistor when the first drive signal is generated to switch off the light emitter. However, Caputo discloses that in light sensors it is known that the response of the phototransistor can be enhanced by biasing the phototransistor when the light emitter is not on and in the default state (Col. 3). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the system of Schabbach to bias the phototransistor when the light emitter is not emitting light, as disclosed by Caputo, in order to improve accuracy and responsiveness of the phototransistor. Regarding Claim 37, Schabbach discloses generating the first drive signal to switch on the light emitter comprises generating an electric current pulse of a predefined pulse time (Par. 107 – i.e. a pulse at a controlled frequency, whereby the frequency establishes the pulse duration/time). Regarding Claim 39, Schabbach discloses generating the second drive signal to acquire an output signal of the phototransistor comprises generating a switching signal to connect a signal acquisition input with an output of the phototransistor to receive the output signal of the phototransistor for a predefined acquisition time (Par. 173). Regarding Claim 40, Schabbach discloses the predefined acquisition time is longer than the predefined pulse time (Par. 107). Regarding Claim 41, with respect to Schabbach there is no specific mention of the timing of the generation of the second drive signal to obtain the output of the phototransistor (i.e. the sampling rate of the phototransistor) and the timing of the generation of the first drive signal to switch on the light emitter. Discussion is made of the sampling frequency (Par. 107) and there is an implication that the light output and the sampling of the receiver are timed together, but this is not explicitly stated. However, the instant breadth of Claim 41 is found to cover all possible arrangements, i.e. either the two signals are generated at “approximately a same time” or the signals have a staggered delay whereby sampling of the receiver begins prior to light generation or light generation occurs prior to sampling of the receiver. Regarding Claim 42, Schabbach, as modified by Caputo, provides for the second drive signal is generated to bias the phototransistor by pulling an output of the phototransistor to a predefined voltage potential (Col. 3). Regarding Claim 43, Schabbach discloses the output signal of the phototransistor by sampled and converted into a digital signal (Par. 124). Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2020/0360614 (“Schabbach”) in view of U.S. Publication No. 2020/0246548 (“Bill”) and U.S. Patent No. 4,019,606 (“Caputo”) as applied above, and further in view of “Analog Devices – Photometric Front End, ADPD103 Data Sheet” (“ADPD103”) Regarding Claim 38, Schabbach, as modified, discloses the invention substantially as claimed except that the predefined pulse time is selected such that the output signal of the phototransistor may reach a predefined value of about 66% of a full scale of an analogue-to-digital converter. Firstly, it is noted that Applicant’s own disclosure indicates that the 66% value was “arbitrarily selected” as the target (Par. 63) suggesting that this value merely constitutes a convenient workable value and not an empirically optimized value. Furthermore, ADPD103 discloses a related light sensing system which like that of Schabbach operates in a pulsed/strobed mode, wherein ADPD103 particularly discusses selecting pulse duration to an optimal level to place the return signal within an optimized range of the ADC (such as 50% or 60%) to ensure appropriate signal acquisition while providing a suitable margin to prevent saturation of the system (Pg. 27 and 28). It would have been obvious for one having ordinary skill in the art at the time the invention was made to adjust the pulse duration of the invention of Schabbach in a manner which optimizes it for the ADC in order to ensure appropriate signal acquisition and output while avoiding saturation of the ADC by maintaining a suitable headroom/margin of the ADC scale, as disclosed by ADPD103, thereby ensuring more accurate and efficient data sampling, whereby selection of the 66% is found to be an obvious design choice based upon ADPD103’s representative “60%” margin/headroom as well as the fact that Applicant’s own disclosure recognizes the 66% value as being “arbitrarily” selected and therefore 66% and 60% are found to be obvious variants of one another and both expected to provide a workable range of headroom. Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2020/0360614 (“Schabbach”) in view of U.S. Publication No. 2020/0246548 (“Bill”) and U.S. Patent No. 4,019,606 (“Caputo”) as applied above, and further in view of WO 2008/044749 (“Hadwen”). Regarding Claim 27, Schabbach discloses an input for connecting to an output of the phototransistor to receive the output signal of the phototransistor (see Fig. 7), see also Bill, Fig. 3 with respect to modifications to Schabbach to particularly use a phototransistor-type receiving element). Whereby, as modified by Caputo, the system is configured to switch from the pre-biased i/o of the phototransistor to the actual measured value of light from the emitter. However, Schabbach fails to discuss that input can be controller-internally switched between a predefined voltage potential and an input of an analogue-to-digital converter comprised by the controller. Specifically, while Caputo does talk about biasing the phototransistor there is no discussion that such a bias results in i/o of a “predefined voltage”, particularly zero volts. However, Hadwen discloses a related photosensor system wherein the light receiver can be pre-biased and wherein the bias may be maintained at a constant zero volts during non-sampling periods (Pg. 11-14) to maintain the “dark current” of the system at a constant level to reduce error. It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the controller of modified Schabbach to switch between a predefined voltage potential of zero and the I/O of the ADC when sampling, as disclosed by Hadwen, in order to ensure that the pre-bias of the phototransistor creates a constant “dark current” that can be effectively accounted for without generating excess signal noise that might be mistaken for actual i/o from the ADC. Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2020/0360614 (“Schabbach”) in view of U.S. Publication No. 2020/0246548 (“Bill”), U.S. Patent No. 4,019,606 (“Caputo”), and WO 2008/044749 (“Hadwen”) as applied above, and further in view of U.S. Publication No. 2004/0169128 (“Mizuno”) Regarding Claim 28, Schabbach, as modified, discloses the invention substantially as claimed except that the input of the analogue-to-digital converter comprises an input capacitance for receiving an electric charge from the phototransistor and is selected to obtain a rising time of an input voltage of the analogue-to-digital converter being lower than a predefined rising time. However, Mizuno discloses a related system for controlling a photodetector circuit wherein the system comprises an ADC which monitors the rate change of voltage in a capacitor, re: a rising time of the input voltage, in order to compare it to a pre-defined reference value to provide enhanced photodetection while avoiding saturation of the sensor arrangement at high light input intensity while maintaining suitable sensitivity of the system during low light intensity (Abstract; Par. 8, 11, 21-26). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the system of modified Schabbach to include determining the rising time of input voltage of the ADC at the input capacitance, as disclose by Mizuno, in order to provide for improved accuracy of the system by avoiding saturation when the intensity of received light is high, but provide improved sensitivity when received light is low. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT). 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. /WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 09/21/2026
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Prosecution Timeline

Mar 21, 2024
Application Filed
Sep 23, 2026
Non-Final Rejection mailed — §103 (current)

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Prosecution Projections

1-2
Expected OA Rounds
54%
Grant Probability
99%
With Interview (+52.6%)
3y 7m (~1y 1m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1011 resolved cases by this examiner. Grant probability derived from career allowance rate.

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