Prosecution Insights
Last updated: July 17, 2026
Application No. 18/337,683

METHODS AND SYSTEMS FOR OPTICAL-BASED FLUID CONTROL IN A FLUID DELIVERY SYSTEM

Final Rejection §103
Filed
Jun 20, 2023
Priority
Jun 28, 2022 — provisional 63/356,056
Examiner
VOKES, KATHLEEN PAIGE
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Insulet Corporation
OA Round
2 (Final)
57%
Grant Probability
Moderate
3-4
OA Rounds
1y 0m
Est. Remaining
78%
With Interview

Examiner Intelligence

Grants 57% of resolved cases
57%
Career Allowance Rate
35 granted / 61 resolved
-12.6% vs TC avg
Strong +21% interview lift
Without
With
+21.1%
Interview Lift
resolved cases with interview
Typical timeline
4y 0m
Avg Prosecution
33 currently pending
Career history
108
Total Applications
across all art units

Statute-Specific Performance

§103
93.3%
+53.3% vs TC avg
§102
1.8%
-38.2% vs TC avg
§112
0.3%
-39.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 61 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 . Response to Amendment The amendment filed 03/31/26 has been entered. Claims 1, 4, 13, and 17 have been amended. Claims 2, 5-12, 14-16, and 18-20 are in the original/ previously presented form. Claim 3 is cancelled. Thus, claims 1-2 and 4-20 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 12/31/25. Further, claims 1, 13, and 17 have been amended to recite further structure of the drive mechanism now comprising “a lead screw”. Therefore, the “drive mechanism” will no longer be interpreted under 112f (as previously applied in the Non-Final office action mailed 12/31/25, see pages 3-7) as the recitation of the “lead screw” now fails the 3-prong test for 112f interpretation at prong 3. 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 1-2, 5-13, 15-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Nazzaro et al. (U.S. PGPUB No. 2018/0043105), hereinafter Nazzaro, in view of Schmid (U.S. Patent No. 10,737,024). Regarding claim 1, Nazzaro discloses a fluid delivery device, comprising: a reservoir (704, see FIG. 7) storing a fluid (see [0056]: 704 described as drug container and thus contains drug/fluid); a pump (see [0019-0020]: disclosure is for a wearable drug delivery device with a drug container having a plunger connected to a drive system to expel fluid, aligning with Applicant disclosure in [0016], [0033], and [0036] disclosing a pump of a wearable device comprising a syringe-style pump) coupled to (see [0019-0020] and [0057] & [0065]: plunger coupled to drive mechanism/ pump to expel fluid and thus at least mechanically coupled to the reservoir) the reservoir (704), the pump comprising a drive mechanism (see [0057]: rod 718 and plunger 706 connected to drive mechanism—not shown in FIG. 7—to force fluid in direction of 720 out of reservoir 704, aligning with a drive mechanism as interpreted under 112f above.) to force the fluid from the reservoir (704); and an optical monitoring system comprising: at least one light source (712, see [0056]) operative to emit light incident on at least one element (plunger 706) of the drive mechanism (see [0061]: light emitted from source 712 to pipe 708 and along length of drug container 704 including plunger706==at least one element of the drive mechanism); and at least one sensor (714) configured to receive the light reflecting off of the at least one element (706, see [0062]: light intensity reflected by plunger back to sensor), wherein the at least one light source (712) and the at least one sensor (714) are arranged on a same lateral side (side 1, see ‘Modified FIG. 7’ below) of the at least one element (706). PNG media_image1.png 592 885 media_image1.png Greyscale Nazzaro is silent to “the at least one element comprising a lead screw”. However, Schmid teaches a fluid delivery device comprising a reservoir (130, see FIG. 12) storing a fluid (see col. 8 lines 61-65) and at least one element (154) of a drive mechanism (see col. 8 line 61- col. 9 line 8), the at least one element (154) comprising a lead screw (152). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one element formed of plunger rod of the drive mechanism disclosed in Nazzaro to comprise a lead screw as taught by Schmid (see Nazzaro in view of Schmid below) PNG media_image2.png 351 1237 media_image2.png Greyscale for the purpose of forming the drive mechanism as a clutch mechanism that enables changing of the thread pitch for other drug applications or for allowing the drive mechanism to be more easily inspected (see col. 10 lines 11-22), thus achieving “the at least one element comprising a lead screw”. Regarding claim 2, the modified system of Nazzaro teaches the fluid delivery device of claim 1, and Nazzaro further discloses the pump comprising a syringe-style pump (Applicant discloses the syringe-style pump in [0033] specifically incorporating U.S. PGPUB No. 20050238507, Dilanni et al., hereinafter Dilanni. Dilanni teaches a pump comprising a drive mechanism 250, see FIG. 2, formed of a rod and plunger, see [0031]. Therefore, Nazzaro similarly discloses a syringe-style pump including a drive mechanism formed of a rod 718 and plunger 706, see FIG. 7 and [0057]). Regarding claim 5, the modified system of Nazzaro teaches the fluid delivery device of claim 1, and Nazzaro further discloses the at least one light source (712, see FIG.7) comprising an infrared (IR) light source (see [0065]: optical monitoring system can use any type of radiation emitting/detecting pair including infrared). Regarding claim 6, the modified system of Nazzaro teaches the fluid delivery device of claim 1, and Nazzaro further discloses the at least one light source (712, see FIG.7) and the at least one sensor (714) arranged in a stacked configuration (712 and 714 vertically aligned in direction of fluid expulsion and are adjacent to one another, aligning with Applicant disclosure of stacked in [0041]). Regarding claim 7, the modified system of Nazzaro teaches the fluid delivery device of claim 1, and Nazzaro further discloses comprising at least one reflector element (722, see [0057]: reflective portion/ O-ring 722 on plunger) arranged on the at least one element (plunger 706), the at least one reflector element (722) configured to reflect light with a different characteristic (see [0061-0063]: reflected light depends on amount of light reflected by plunger portion and reflected portion 722 and thus the light reflected by 722 is different intensity than that of plunger 706) than the at least one element (706). Regarding claim 8, the modified system of Nazzaro teaches the fluid delivery device of claim 7, and Nazzaro further discloses the characteristic comprising at least one of intensity, frequency, or wavelength (see [0061-0063]: reflected light depends on amount of light reflected by plunger portion and reflected portion 722 and thus the light reflected by 722 is different intensity than that of plunger 706. Further [0057-0058] describe 722 as a “reflective” portion and thus by the description 722 is more reflective/ has higher intensity of reflective characteristic than that of the plunger 706). Regarding claim 9, the modified system of Nazzaro teaches the fluid delivery device of claim 7, and Nazzaro further discloses the at least one reflector element (722, see FIG. 7) arranged on a portion (head portion 716) of the at least one element (706) to indicate that the at least one element (706) has traveled a known distance (see [0061-0063], specifically [0062]: reflected intensities allow position/ traveled distances to be determined). Regarding claim 10, the modified system of Nazzaro teaches the fluid delivery device of claim 7, and Nazzaro further discloses the at least one element (706, see FIG. 7) having at least a portion with a reflective gradient (see [0062]: reflected intensity varies linearly with movement of plunger and thus the plunger comprises a “reflective gradient” and further [0064]: any portion of 706 can be reflective/ include reflective components) configured to reflect light with a different characteristic along a length of the portion (see [0062-0064]) of the at least one element (706). Regarding claim 11, the modified system of Nazzaro teaches the fluid delivery device of claim 7, and Nazzaro further discloses the reflective gradient (see [0062]: reflective intensities that vary linearly) configured to indicate a position (see [0061-0063]) of the at least one element (706) to provide a fill level of the reservoir (see [0065]: system ultimately determines how much liquid remains in reservoir). Regarding claim 12, Nazzaro discloses the fluid delivery device of claim 7, and Nazzaro further discloses the fluid delivery device comprising a wearable drug delivery pump (see [0002] and [0019-0020]), but Nazzaro is silent to the pump being specifically for the delivery of the medication of “insulin”. However, Schmid teaches a fluid delivery device (100, see FIG. 1) comprising a wearable drug delivery pump comprising a reservoir (130) for the delivery of insulin (see col. 6 lines 61-65), thus forming a wearable insulin pump (see also col. 1 lines 20-61). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the fluid in the reservoir of the drug delivery device disclosed in Nazzaro with insulin as taught by Schmid for the purpose of treating a specific disease, such as diabetes, by the sophisticated fluid delivery device with less toxicity to the patient (see col. 1 lines 20-37), thus achieving the pump being specifically for the delivery of the medication of “insulin”. Regarding claim 13, Nazzaro discloses an apparatus, comprising: at least one processor (see [0063] and [0065]: controller not shown in FIG. 7); the processor is caused to: receive optical information from an optical monitoring system for a fluid delivery device (see [0063-0065]: controller receives information from system), the optical monitoring system (see FIG. 7) comprising: at least one light source (712, see [0056]) operative to emit light incident on at least one element (plunger 706) of a drive mechanism (see [0061]: light emitted from source 712 to pipe 708 and along length of drug container 704 including plunger706==at least one element of the drive mechanism) configured to dispense fluid from a reservoir (704) of the fluid delivery device (see [0057]), and at least one sensor (714) configured to receive the light reflecting off of the at least one element (706, see [0062]: light intensity reflected by plunger back to sensor), wherein the at least one light source (712) and the at least one sensor (714) are arranged on a same lateral side (side 1, see ‘Modified FIG. 7’ above) of the at least one element (706) and the at least one element (706) has at least one of a reflector element (722) or a reflective gradient (see [0062]: reflected intensity varies linearly with movement of plunger and thus the plunger comprises a “reflective gradient” and further [0064]: any portion of 706 can be reflective/ include reflective components) arranged on a surface (722 formed on head surface 716 of plunger 706 or see [0064] for reflective gradient on surface of plunger 706) of the at least one element (706) configured to reflect light with a different characteristic (see [0061-0063]: reflected light depends on amount of light reflected by plunger portion and reflected portion 722 and thus the light reflected by 722 is different intensity than that of plunger 706 and see [0064]: the portion of 706 including the reflective components would have different intensity of reflection), determine a position of the at least one element based on the optical information (see [0063] and [0065]), and determine a fluid level of the reservoir based on the position (see [0065]). Nazzaro is silent to “a memory coupled to the at least one processor, the memory comprising instructions that, when executed by the at least one processor, cause the at least one processor to:” receive optical information from the optical monitoring system and “the at least one element comprising a lead screw”. However, Schmid teaches an apparatus comprising at least one processor, a memory coupled to the at least one processor, the memory comprising instructions that, when executed by the at least one processor, cause the at least one processor to: receive sensor data and automatically operate a method for a fluid delivery device (100, see FIG. 1 and col. 11 line 61- col. 12 line 17). Schmid further teaches the apparatus comprising a reservoir (130, see FIG. 12) storing a fluid (see col. 8 lines 61-65) and at least one element (154) of a drive mechanism (see col. 8 line 61- col. 9 line 8), the at least one element (154) comprising a lead screw (152). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor disclosed in Nazzaro to include a memory coupled to the processor and comprising instructions as taught by Schmid for the purpose of allowing the system to automatically operate based on sensor data supplied to the processor (see col. 12 lines 7-11), thus achieving “a memory coupled to the at least one processor, the memory comprising instructions that, when executed by the at least one processor, cause the at least one processor to:” receive optical information from the optical monitoring system. Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one element formed of plunger rod of the drive mechanism disclosed in Nazzaro to comprise a lead screw as taught by Schmid (see Nazzaro in view of Schmid below) PNG media_image2.png 351 1237 media_image2.png Greyscale for the purpose of forming the drive mechanism as a clutch mechanism that enables changing of the thread pitch for other drug applications or for allowing the drive mechanism to be more easily inspected (see col. 10 lines 11-22), thus achieving “the at least one element comprising a lead screw”. Regarding claim 17, Nazzaro discloses a computer-implemented method comprising: receiving optical information from an optical monitoring system for a fluid delivery device (see [0063-0065]: controller/ computer receives information from system), the optical monitoring system (see FIG. 7) comprising: at least one light source (712, see [0056]) operative to emit light incident on at least one element (plunger 706) of a drive mechanism (see [0061]: light emitted from source 712 to pipe 708 and along length of drug container 704 including plunger706==at least one element of the drive mechanism) configured to dispense fluid from a reservoir (704) of the fluid delivery device (see [0057]), and at least one sensor (714) configured to receive the light reflecting off of the at least one element (706, see [0062]: light intensity reflected by plunger back to sensor), wherein the at least one light source (712) and the at least one sensor (714) are arranged on a same lateral side (side 1, see ‘Modified FIG. 7’ above) of the at least one element (706) and the at least one element (706) has at least one of a reflector element (722) or a reflective gradient (see [0062]: reflected intensity varies linearly with movement of plunger and thus the plunger comprises a “reflective gradient” and further [0064]: any portion of 706 can be reflective/ include reflective components) arranged on a surface (722 formed on head surface 716 of plunger 706 or see [0064] for reflective gradient on surface of plunger 706) of the at least one element (706) configured to reflect light with a different characteristic (see [0061-0063]: reflected light depends on amount of light reflected by plunger portion and reflected portion 722 and thus the light reflected by 722 is different intensity than that of plunger 706 and see [0064]: the portion of 706 including the reflective components would have different intensity of reflection), determining a position of the at least one element based on the optical information (see [0063] and [0065]), and determining a fluid level of the reservoir based on the position (see [0065]). Nazzaro is silent to “the at least one element comprising a lead screw”. However, Schmid teaches a fluid delivery device comprising a reservoir (130, see FIG. 12) storing a fluid (see col. 8 lines 61-65) and at least one element (154) of a drive mechanism (see col. 8 line 61- col. 9 line 8), the at least one element (154) comprising a lead screw (152). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one element formed of plunger rod of the drive mechanism disclosed in Nazzaro to comprise a lead screw as taught by Schmid (see Nazzaro in view of Schmid below) PNG media_image2.png 351 1237 media_image2.png Greyscale for the purpose of forming the drive mechanism as a clutch mechanism that enables changing of the thread pitch for other drug applications or for allowing the drive mechanism to be more easily inspected (see col. 10 lines 11-22), thus achieving “the at least one element comprising a lead screw”. Regarding claims 15 and 19, the modified system of Nazzaro teaches the apparatus of claim 13 and the computer-implemented method of claim 17, and Navarro further discloses the characteristic comprising at least one of intensity, frequency, or wavelength (see [0061-0063]: reflected light depends on amount of light reflected by plunger portion and reflected portion 722 and thus the light reflected by 722 is different intensity than that of plunger 706. Further [0057-0058] describe 722 as a “reflective” portion and thus by the description 722 is more reflective/ has higher intensity of reflective characteristic than that of the plunger 706. And see [0064]: plunger 706 may have reflective portions and thus the reflective portions would have a higher intensity than the rest of the plunger). Regarding claims 16 and 20, the modified system of Nazzaro teaches the apparatus of claim 13 and the computer-implemented method of claim 17, and Navarro further discloses wherein the at least one element (706, see FIG. 7) has at least a portion with a reflective gradient (see [0064]: any portion of 706 can be reflective/ include reflective components) configured to reflect light with a different characteristic along a length of the portion of the at least one element (706, see [0064]: reflected portion would have higher intensity reflection such as described for reflective element 722 of the head portion 716 in [0061-0063]), and determining the position of the at least one element comprises sensing the reflective gradient (see [0061-0064]. reflected intensity varies linearly with movement of plunger and thus the plunger comprises a “reflective gradient” with reflective element 722 or by the reflective components as described in [0064]). Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Nazzaro in view of Schmid as applied to claim 1 above, and further in view of Yodfat et al. (U.S. PGPUB No. 2011/0213329), hereinafter Yodfat. Regarding claim 4, the modified system of Nazzaro teaches the fluid delivery device of claim 1, but Nazzaro is silent to “the lead screw arranged within a drive tube configured to rotate the lead screw, causing the lead screw to move in a fluid dispensing direction, wherein the drive tube comprises at least one window arranged to allow the light from the light source to travel into the drive tube and be incident on the lead screw.” However, Schmid teaches a fluid delivery device comprising a reservoir (130, see FIG. 12) storing a fluid (see col. 8 lines 61-65) and at least one element (154) of a drive mechanism (see col. 8 line 61- col. 9 line 8), the at least one element (154) comprising a lead screw (152), the lead screw (152) arranged within a drive tube (154) configured to rotate (see col. 9 lines 22-27: drive mechanism rotates tube 154 that causes lead screw to rotate by internal threads to advance plunger. See col. 9 lines 4-9 for internal threads) the lead screw (152), causing the lead screw (152) to move in a fluid dispensing direction (see col. 9 lines 22-27). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one element formed of plunger rod disclosed in Nazzaro to comprise a lead screw arranged within a rotating drive tube as taught by Schmid for the purpose of forming the drive mechanism as a clutch mechanism that enables changing of the thread pitch for other drug applications or for allowing the drive mechanism to be more easily inspected (see col. 10 lines 11-22), thus achieving “the lead screw arranged within a drive tube configured to rotate the lead screw, causing the lead screw to move in a fluid dispensing direction”. Nazzaro in view of Schmid remain silent to “wherein the drive tube comprises at least one window arranged to allow the light from the light source to travel into the drive tube and be incident on the lead screw.” However, Yodfat teaches a fluid delivery device comprising a reservoir (220, see Fig. 4a) storing a fluid (see [0062]: fluid is urged from reservoir 220 and therefore the reservoir stores a fluid) and a drive mechanism (see [0063]: 114 included in drive mechanism such as gears, rotating sleeve 114, electronics, and motor) comprising a lead screw (112), the lead screw (112) arranged within a drive tube (114) configured to rotate (see [0064]: rotation of sleeve 114 results in linear movement of lead screw) the lead screw (112), causing the lead screw to move in a fluid dispensing direction (see [0064]), wherein the drive tube (114) comprises at least one window (115 & 115’, see FIG. 7c) arranged to allow the light from a light source to travel into the drive tube (114) and be incident on (see [0069]: windows formed on body of rotating sleeve to monitor position of lead screw relative to tube 114 by a light source and light detector. When the lead screw advances, the light would be “blocked” by lead screw and thus the light would be “incident” on the lead screw.) the lead screw (112). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drive tube of the drive mechanism taught by Modified Nazzaro to include at least one window to allow light from the light source to be incident on the lead screw as taught by Yodfat for the purpose of using the lead screw to precisely (every half turn is monitored) indicate the position of the plunger and subsequently a fluid level remaining in the reservoir (see [0069]), thus achieving “wherein the drive tube comprises at least one window arranged to allow the light from the light source to travel into the drive tube and be incident on the lead screw”. Claims 14 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Nazzaro in view of Schmid as applied to claims 13 and 17, respectively, above, and further in view of Yodfat (U.S. PGPUB No. 2011/0213329). Regarding claim 14, the modified system of Nazzaro teaches the apparatus of claim 13 and the computer-implemented method of claim 17, but Nazzaro is silent to “wherein: the fluid delivery device comprises a lead screw arranged within a drive tube configured to rotate the lead screw, causing the lead screw to move in a fluid dispensing direction, and the drive tube comprises at least one window arranged to allow the light from the light source to travel into the drive tube and be incident on the lead screw, and determining the position of the at least one element comprises measuring the light from the light source passing through the window to determine if the drive tube is rotating a predetermined expected amount.” However, Schmid teaches a fluid delivery device (100, see FIG. 12), wherein: the fluid delivery device comprises a lead screw (152,) arranged within a drive tube (154) configured to rotate (see col. 9 lines 22-27: drive mechanism rotates tube 154 that causes lead screw to rotate by internal threads to advance plunger. See col. 9 lines 4-9 for internal threads) the lead screw (152), causing the lead screw (152) to move in a fluid dispensing direction (see col. 9 lines 22-27). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one element formed of plunger rod in the fluid delivery device disclosed in Nazzaro to comprise a lead screw arranged within a rotating drive tube as taught by Schmid for the purpose of forming the drive mechanism as a clutch mechanism that enables changing of the thread pitch for other drug applications or for allowing the drive mechanism to be more easily inspected (see col. 10 lines 11-22), thus achieving “wherein: the fluid delivery device comprises a lead screw arranged within a drive tube configured to rotate the lead screw, causing the lead screw to move in a fluid dispensing direction”. Nazzaro in view of Schmid remain silent to “and the drive tube comprises at least one window arranged to allow the light from the light source to travel into the drive tube and be incident on the lead screw, and determining the position of the at least one element comprises measuring the light from the light source passing through the window to determine if the drive tube is rotating a predetermined expected amount”. However, Yodfat teaches a fluid delivery device comprising a drive mechanism with a drive tube (114, see Fig. 4a and [0063]: 114 included in drive mechanism such as gears, rotating sleeve 114, electronics, and motor) comprising a lead screw (112) and configured to rotate the lead screw (112, see [0064]: rotation of sleeve 114 results in linear movement of lead screw), the drive tube (114) comprises at least one window (115 & 115’, see FIG. 7c) arranged to allow the light from the light source to travel into the drive tube and be incident on the lead screw (112, see [0069]: windows formed on body of rotating sleeve to monitor position of lead screw relative to tube 114 by a light source and light detector. When the lead screw advances, the light would be “blocked” and thus the light would be incident on the lead screw.), and determining the position of an at least one element (a plunger, see [0069]: position of plunger determined from measuring the light) comprises measuring the light from the light source passing through the window (see [0069]) to determine if the drive tube is rotating a predetermined expected amount (see [0069]: such as a half turn). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drive tube of the drive mechanism taught by Modified Nazzaro to include at least one window to allow light from the light source to be incident on the lead screw as taught by Yodfat for the purpose of using the lead screw to precisely (every half turn is monitored) indicate the position of the plunger and subsequently a fluid level remaining in the reservoir (see [0069]), thus achieving “and the drive tube comprises at least one window arranged to allow the light from the light source to travel into the drive tube and be incident on the lead screw,” Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor that receives optical information to determine a position of a plunger based on the optical information taught by Modified Nazzaro to determine the position of the plunger based on measured light through a window onto a lead screw to determine if the drive tube is rotating a certain amount as taught by Yodfat for the purpose of using the lead screw to precisely (every half turn is monitored) indicate the position of the plunger and subsequently a fluid level remaining in the reservoir (see [0069]), thus achieving “and determining the position of the at least one element comprises measuring the light from the light source passing through the window to determine if the drive tube is rotating a predetermined expected amount”. Response to Arguments Applicant's arguments filed 03/31/26 have been fully considered but they are not persuasive. On pages 8-9, Applicant submits that Nazzaro and/or Nazzaro in view of Schmid fail to teach the light source and the sensor on a same “lateral” side of the lead screw and therefore a rejection under Nazzaro or Nazarro in view of Schmid should be withdrawn. The examiner disagrees and has maintained the rejections. Specifically, on page 9, Applicant argues that the light pipe of Nazzaro would comprise the lead screw when Nazzaro is modified in view of Schmid. However, this is a mischaracterization of the rejection and of the modification of Nazzaro in view of Schmid. The lead screw of Schmid is incorporated into the plunger/ drive mechanism of Nazarro (see figure of ‘Nazzaro in view of Schmid’ provided for clarity in the rejections above), not into the light pipe. Therefore, the examiner maintains that Nazzaro in view of Schmid teach the light source and sensor on the same lateral/ axial side (as shown by Modified FIG. 7 above) and has maintained the claim rejections. No further arguments were presented. Therefore, all depending claim rejections were subsequently maintained by the examiner. 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 KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time. 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, Michael Tsai can be reached at (571) 270-5246. 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. /KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783 /MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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Prosecution Timeline

Jun 20, 2023
Application Filed
Dec 31, 2025
Non-Final Rejection mailed — §103
Mar 31, 2026
Response Filed
Jun 29, 2026
Final Rejection mailed — §103 (current)

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Prosecution Projections

3-4
Expected OA Rounds
57%
Grant Probability
78%
With Interview (+21.1%)
4y 0m (~1y 0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 61 resolved cases by this examiner. Grant probability derived from career allowance rate.

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