Prosecution Insights
Last updated: August 30, 2026
Application No. 18/287,069

Electronic System for a Drug Delivery Device

Final Rejection §102
Filed
Oct 16, 2023
Priority
Apr 23, 2021 — EU 21315069.1 +2 more
Examiner
FORD, RENE D
Art Unit
3741
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Sanofi S.A.
OA Round
2 (Final)
80%
Grant Probability
Favorable
3-4
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 80% — above average
80%
Career Allowance Rate
360 granted / 452 resolved
+9.6% vs TC avg
Strong +23% interview lift
Without
With
+23.2%
Interview Lift
resolved cases with interview
Typical timeline
2y 10m
Avg Prosecution
19 currently pending
Career history
471
Total Applications
across all art units

Statute-Specific Performance

§101
0.4%
-39.6% vs TC avg
§103
39.3%
-0.7% vs TC avg
§102
23.7%
-16.3% vs TC avg
§112
33.2%
-6.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 452 resolved cases

Office Action

§102
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 . Claims 16-35 of the amended claim set received 6/30/2026 are pending. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claims 34-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schabbach (US 2020/0360614). Regarding Claim 34, Schabbach discloses a drug delivery device (element 1 of Fig. 1, element 2 of Figs. 2 and 4) comprising: an electronic system 700 (see Fig. 7) comprising: an electrical power supply 29; a memory 24; a processor 23 configured to control operation of the electronic system and coupled to the electrical power supply and to the memory; and a first light source (Figs. 9-13: LED of 215a as read at para. 0124), a second light source (LED of 215b), a first optical sensor 215a, and a second optical sensor 215b that are in communication with the processor 23 (see Fig. 7); and a dose setting and drive mechanism (comprising 70 and 210) (see Figs. 4 and 9-13) that is configured to perform a dose dialing operation for selecting a dose to be delivered by the drug delivery device (read para. 0118), and a dose delivery operation for delivering the dose (para. 0095), the dose setting and drive mechanism comprising: an encoder 70 rotatable in one or more of the dose delivery operation and the dose dialing operation, wherein the encoder 70 comprises a ring of a plurality of light reflecting teeth 70a spaced from each other (see Figs. 9-13), and wherein the electronic system is arranged such that depending on a rotational position of the encoder, light emitted by one of the first 215a and second 215b light sources is reflected by one of the teeth 70a and detected by the respective first or second optical sensor, while light emitted by the other one of the first and second light sources is not reflected by any of the teeth (the 01 and 10 readings of ‘Gray code’, shown in Fig. 11 and discussed at paras. 0122-0123, corresponding to one sensor aligned with and reflected by a tooth as shown in Fig. 12 and the other sensor not aligned with an of the teeth as shown in Fig. 13). Regarding Claim 35, Schabbach discloses in Fig. 1, a cartridge 14 containing a medicant (read para. 0088). Allowable Subject Matter Claims 16-33 are allowable. The following is a statement of reasons for the indication of allowable subject matter: Regarding Claim 16, Schabbach (US 2020/0360614) as discussed above is considered the closest prior art of record. Schabbach teaches the claimed electrical power supply, memory, processor, first and second light sources, first and second optical sensors, and encoder as discussed in the rejection of claim 34 above. Schabbach further discloses a first low-power-consumption state and at least one further state having a higher power consumption compared with the first low-power-consumption state (read para. 0112). However, transition between the two states is provided by a switch activated by the displacement of an injection button 210 as read at para. 0112, as opposed to the claimed “the processor is configured to (a) poll the first and second optical sensors in the first low-power-consumption state, (b) maintain the first low-power-consumption state when responses of the first and second optical sensors are identical to each other and identical to a preceding response, and (c) switch into the at least one further state when the responses of the first and second optical sensors are different from each other or are different from the preceding response.” No secondary reference is found to reasonably modify Schabbach to includes this processor configuration. It is noted that the Japanese Patent Office and PCT have each rejected claim 16 over different publications of Schabbach. These rejections lack detail and fall short of showing a teaching of the processor configuration highlighted above. Despite the JPO and PCT assertions, Schabbach is not found to disclose “the processor is configured to (a) poll the first and second optical sensors in the first low-power-consumption state, (b) maintain the first low-power-consumption state when responses of the first and second optical sensors are identical to each other and identical to a preceding response, and (c) switch into the at least one further state when the responses of the first and second optical sensors are different from each other or are different from the preceding response.” Claims 17-33 are allowable at least by basis on claim 16. Response to Arguments Applicant's arguments filed 6/30/2026 have been fully considered but they are not persuasive The Applicant contends that Schabbach, as applied above, does not disclose the claim 34 limitation, “a ring of a plurality of light reflecting teach spaced from each other.” As noted in the rejection, Schabbach teaches a ring 70 of teeth 70a spaced from each other shown in Figs. 9-13, reflective as read in para. 0119. Applicant argues that 70a is a region rather than a tooth which is not convincing because one can look at the cited figures and see that the regions 70a (the white portions of the protruding from the ring in the figures) are teeth that closely resemble the teeth 22 disclosed in the application. The claim does not prohibit inclusion of light absorbent material (the black portions 70b of the figures) included between the teeth. The Applicant then appears to argue that Schabbach does not disclose “wherein the electronic system is arranged such that depending on a rotational position of the encoder, light emitted by one of the first and second light sources is reflected by one of the teeth and detected by the respective first or second optical sensor, while light emitted by the other one of the first and second light sources is not reflected by any of the teeth”, as found in claim 34, because of the Schabbach para. 0120 recitation that “the encoder system 900 shown in FIGS. 9 and 10 has both IR sensors 215 target the same type of region 70 a, 70 b. In other words, the sensors 215 are arranged so that they both face reflective regions 70 a or both face absorbent regions 70 b at the same time.” It is noted that the claim as written does not eliminate the possibility of other rotational positions producing tooth reflections by both light sources or no tooth reflections by both light sources, i.e. the recitation does not say that the light sources 215 ‘only’ produce the claimed “light is reflected from one source and not by the other”, just that it depends on a rotational position. Figs. 10 and 11 show that they do not only face the same type region at the same time. One can see looking at Fig. 10 that rotation in the indicated direction will result in light source 215a facing a black region while light source 215b will still be facing a reflective tooth. One would understand, looking at Fig. 11 and reading associated paragraphs 0122 and 0123, that the Gray code 1 or 0 corresponding to reflection of light by a tooth to a sensor A or B changes to the other of 1 or 0 when there is no reflection by a tooth, where there are states 01 and 10 showing that there is reflection off a tooth to a first sensor and no reflection to the other sensor. In fact, the states 01 and 10 of reflection to one sensor and not to the other are used to discern clockwise from counter clockwise motion as discussed in para. 0123. This function would be disabled if the sensors ‘only’ both face a reflecting tooth, a 11 state, or each face an absorbent region, a 00 state, as the Applicant seems to be asserting. The rejection is maintained. 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. Contact Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENE D FORD whose telephone number is (571)272-8140. The examiner can normally be reached on M-F 9am-5pm. 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, Phutthiwat Wongwian can be reached on (571) 272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /R.D.F/Examiner, Art Unit 3741 /PHUTTHIWAT WONGWIAN/Supervisory Patent Examiner, Art Unit 3741
Read full office action

Prosecution Timeline

Oct 16, 2023
Application Filed
Apr 03, 2026
Non-Final Rejection mailed — §102
Jun 30, 2026
Response Filed
Jul 30, 2026
Final Rejection mailed — §102 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
80%
Grant Probability
99%
With Interview (+23.2%)
2y 10m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 452 resolved cases by this examiner. Grant probability derived from career allowance rate.

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