Prosecution Insights
Last updated: April 19, 2026
Application No. 17/945,632

Device and Method for Determining Information Related to a Medical Device

Final Rejection §102§103§112
Filed
Sep 15, 2022
Examiner
VU, QUYNH-NHU HOANG
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Sanofi-Aventis Deutschland GmbH
OA Round
4 (Final)
68%
Grant Probability
Favorable
5-6
OA Rounds
3y 5m
To Grant
96%
With Interview

Examiner Intelligence

Grants 68% — above average
68%
Career Allow Rate
660 granted / 971 resolved
-2.0% vs TC avg
Strong +28% interview lift
Without
With
+28.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
58 currently pending
Career history
1029
Total Applications
across all art units

Statute-Specific Performance

§101
0.8%
-39.2% vs TC avg
§103
41.4%
+1.4% vs TC avg
§102
21.6%
-18.4% vs TC avg
§112
27.8%
-12.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 971 resolved cases

Office Action

§102 §103 §112
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application is being examined under the pre-AIA first to invent provisions. Response to Amendment The amendment filed on 01/21/26 has been entered in the case. Claims 21-23, 25-42 are pending for examination and claims 1-20 are cancelled. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 21-23 & 25-42 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Nowhere in the original specification has described that: the mating unit is configured to remain attached to the medical device during an injection process, as recited in the claims 21 & 39. The specification states on page 26, lines 10-11 that: the user may then remove injection device 1 from the recess 31 (matting unit) and perform the actual injection, or Fig. 2b. In other words, the mating unit is not being attached to the injection device during the injection process. In addition, the acoustic sensor 27 can be produced the sound if the supplemental device 2 and the injection device 1 are placed nearby but not necessary being attached together to produce the sound. Note: Applicant states on page 2 of the Pre-Appeal 06/12/25 that: supplemental device 2 is shown in Figs. 2a & 4 to be attached to injection device 1 and includes an acoustic sensor 27 “configured to sense sounds produced by injection device 1… when a dose is ejected/injected.” (Specification at 31: 13-17). However, it is not persuasive. During the Pre-Appeal conference, the panel agreed with the Examiner that the rejection 112, 1st paragraph above is valid and still maintained. Therefore, the limitation “the mating unit is configured to remain attached to the medical device during an injection process” should be removed to overcome the 112, 1st paragraph, as new matter issue. Response to Arguments – Claim Rejection under 35 U.S.C 112, 1st paragraph Applicant argues on page 6-7 of the Remarks 01/21/26 that: the M.P.E.P. recognizes that implicit or inherent disclosure can support claim limitations. See M.P.E.P. § 2163(I)(B). Although the Examiner appears to assert that the Specification does not explicitly require the "mating unit" to be "remained attached" to the claimed "medical device during an injection process," the Specification has implicitly yet unambiguously described that the feature at issue is an inherent feature. In response, the M.P.E.P. § 2163(I)(B) states below that: PNG media_image1.png 288 846 media_image1.png Greyscale Since the original specification does not include the limitation “the mating unit is configured to remain attached to the medical device during an injection process”. Therefore, the limitation above is considered as new matter. Claim Rejections - 35 USC § 102 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 the appropriate paragraphs of pre-AIA 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 – (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States. Claims 21, 23, 25-28, 35-36, 39-40 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Klein (US 2007/0142777). Regarding claims 21 & 39, Klein discloses an apparatus 120 in Figs. 8-15b, comprising: A housing 121 with a mating unit 122a-124b is configured for releasably attaching a medical device, i.e., syringe 1 for ejecting a medicament, see Fig. 12a; and wherein the mating unit 122a-124b is configured to remain attached to the medical device during an injection apparatus, para [0095] & Fig. 8; One or more optical sensors 140 (Fig. 14) or 140a-b (Figs. 15a-b) for determining information related to the medical device 1; wherein the one or more optical sensors comprises at least one optical sensor 140/140a-b configured capture information representative of a color, i.e., black marking bars 82 of at least a part, i.e. plunger of the medical device or determine the color, i.e. black bars of at least the part of the medical device. For example: by counting the number of black bars that have passed the detectors to determine the position of the plunger 3 to determine the quantity of liquid drug within the reservoir. Regarding claims 23 & 40, Klein discloses that the at least one optical sensor is a camera unit or photometer 140. Regarding claim 25, Klein discloses that wherein the at least one optical sensor is configured to capture the information representative of the color, i.e., black marking bars, and the apparatus is configured to further process the captured information, paras [0084-0085 & 0093]. Regarding claim 26, Klein discloses that wherein the at least one optical sensor is configured to capture the information representative of the color, i.e., black marking bars, and the apparatus is configured to store the captured information. Note: Klein states in [0093] that: …The optical reader 120 with the photodetectors 140a, 140b is adapted for connection to the syringe. The optical quantitative analysis information it reads from the syringe 1 is processed and then the information sent to the computer system 151 via the wireless link transceiver 142. The processor 141 can process the optical information to infer quantitative analysis, or otherwise provide raw information which is then processed by the computer system 151. In order to send the captured data from the photodetectors to the computer system via the wireless network, the apparatus, i.e. optical reader 120 must be stored the captured information in the memory. Regarding claim 27, Klein discloses that wherein the at least one optical sensor is configured to capture the information representative of the color, i.e., black marking bars, and the apparatus is configured to provide the captured information to another device (computer system 151), Fig. 14. Regarding claim 28, Klein discloses that the apparatus comprising a processor 141. Regarding claim 35, Klein discloses that the apparatus comprising a wireless unit 142 which is configured to transmit information to another device in a wireless fashion via transceiver 142 & 143. Regarding claim 36, Klein discloses that the apparatus further comprises an interface, i.e., 141, 142, 143 or 151 configured to provide the captured information to another device via a wired or wireless connection 142/143, see Fig. 14. 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action: (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made. Claims 22, 24, 29-30 & 34 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Klein (US 2007/0142777) in view of Brown (EP1502614). Regarding claim 22, Klein discloses the invention substantially as claimed. As mentioned in the claim 21 above, Klein discloses that wherein the at least one optical sensor is configured to capture the information representative of the color, i.e., black marking bars. As best as understood, Klein also discloses that the apparatus is configured to recognize the color, i.e. black marking bars, of at least the part of the medical device, i.e., plunger from the capture information. In case, Applicant disagrees with Examiner (or assuming Klein does not disclose) that the apparatus is configured to recognize the color of at least the part of the medical device from the capture information. The claim 22 is being rejected as follow: Brown discloses an apparatus 10 in Fig. 4 comprising: a housing 11; one or more optical sensor 28 for determining information related to the medical device (e.g., measuring color of marking 490); wherein the one or more optical sensor comprises at least one optical sensor (located behind measurement window 403, para [0092]) configured to capture information representative of a color, i.e., color 491of the variable color marking, of at least a part, i.e., plunger of the medical device or determine the color 491 of the variable color marking, of at least a part, i.e., plunger of the medical device to determine the dose from the measured color, paras [0022, 0092]. Brown also discloses that the apparatus is configured to recognize the color 491 of variable color making of at least the part, i.e., plunger of the medical device from the captured information, paras [0022, 0092]. It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the device of Klein with obtaining an optical sensor being capable of reading a variable color marking along the plunger, as taught by Brown, in order to indicate of the quantity of liquid within syringe or to determine an injection dose delivered. Regarding claims 24 & 34, Klein discloses the invention substantially as claimed. Klein does not disclose that the photometer is a spectral photometer. Similarly with the analysis in the claim 22 above, Brown discloses an apparatus 10 in Fig. 4 comprising: a housing 11, one or more optical sensor 28 for reading a longitudinal-varying marking 419 along the plunger. Brown also states that: a reflected light (its intensity and/or spatial distribution) is indicative of the position of marking 491, para [0092]. A person skilled in the art would recognize that the photometer in Brown is a spectral photometer (measure intensity of light). In addition, the photometer is a spectral photometer (e.g., the indecent light comprises wavelength that are suitable for measuring typical plunger displacements … such wavelengths in visible or near-visible (infrared/ultraviolet) ranges, para [0018]; barrel 86 has side walls transparent at a wavelength of light emitted by a light source, as well as a control potion 88 opaque at a wavelength of light emitted by a control emitter, para [0084]; the plunger 90 has different optical transmission property from liquid 92 at the wavelengths measured by detecting element, para [0089]; wherein a light source which provides light of a certain wavelength or spectrum. It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the device of Klein with obtaining an optical sensor, i.e., a spectral photometer being capable of reading a variable color marking along the plunger, as taught by Brown, in order to indicate of the quantity of liquid within syringe or to determine an injection dose delivered. Regarding claims 29-30, Klein discloses the invention substantially as claimed. Klein does not disclose that the processor is configured to control light sources. Brown discloses an apparatus comprising: an optical sensor 32, a processor 36; wherein the processor 32 is configured to control light source 30 (e.g., a control means 34 in electrical communication with light source 30 and optical detector 32 controls the operation of light source 30 and optical detector 32, para [0079]), see Fig. 1-A; wherein light source comprises white and/or colored LEDs, para [0088]. It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the device of Klein with obtaining the processor being configured to control light source as taught by Brown, in order to control the operation of light source and optical detector. Claims 31-33, 37-38 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Klein (US 2007/0142777). Regarding claims 31-33, Klein discloses the invention substantially as claimed invention. Klein further discloses an apparatus 12, in Figs. 4-7 comprising: a processor 141 (e.g., the processor 141 can process the optical information to infer quantitative analysis, or otherwise provide raw information which is then processed by the computer system, para [0093]); wherein the process is configured to control a photometer (spectrum analyzer 16) that is configured to determine an optical property of a housing of the medical device (syringe) to determine a type of medicament contained in the medical device (composition of material within the syringe) based on the captured information. Regarding claims 37-38, Klein discloses all the claimed subject matter. Klein also discloses an apparatus, in Figs. 4-7 comprising: a housing 12 for receiving a syringe; a spectrum analyzer 16; wherein the syringe is adapted to use in conjunction with a qualitative analysis device such as spectrum analyzer 16 to determine the composition of material within the reservoir 2, para [0046]. It is noted that the spectrum analyzer is a device that measuring the color in the electromagnetic spectrum. Therefore, Klein discloses the limitations that: the apparatus 12 is configured to optically capture information corresponding to color codes (via spectrum analyzer 16) that are characteristic of typing of injection device (e.g., composition of material in the syringe); the apparatus 12 is configured to determine a type of medicament (composition of material in the syringe) provided in the medical device (syringe) on color recognition (via spectrum analyzer 16). Therefore, the apparatus is configured to optically capture information corresponding to color code or colors that are characteristics of different types of injection devices. The apparatus is configured to determine a type of medicament provided by the medical device based on color recognition. Alternatively, claims 31-33, 37-38 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Klein (US 2007/0142777) in view of Hjertman et al. (US 7,164,133). Regarding claims 31-33, Klein discloses the invention substantially as claimed. In case applicant disagrees with Examiner in the rejections 31-33 & 37-38 above. The apparatus in Klein can be modified as follow. In other words, assuming that the apparatus 120 in Klein does not disclose the limitations as required in claims 31-33 & 37-38. Hjertman discloses an apparatus, in Figs. 5-6 comprising: a cartridge 71; a label 50 is positioned on outer surface of the cartridge 71; a processor (col. 23, lines 21-27) is configured a photometer sensor 57 that is configured to determine an optical property of a housing component of the medical device, i.e., cartridge (e.g. the absorption level of the surface brings information about the cartridge type, content or concentration, or is used for calibration purposes, col. 23, lines 10-12); wherein the housing component is a housing of the medical device, i.e., cartridge. It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the device of Klein with obtaining the processor being configured to a photometer that being configured to determine an optical property of a component of the cartridge, as taught by Hjertman, in order to determine information about the cartridge type, content or concentration of the medicament inside the cartridge. Claims 41-42 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hartman (US 6,482,185) in view of Brown (EP1502614). Regarding claims 41-42, Hartman discloses an apparatus 30 comprising: a housing 31 with a mating unit 33 is configured for releasably attaching to a medical device 10 for ejecting a medicament and wherein the mating unit 33 is configured to remain attached to the medical device during an injection process; an optical sensor 40 for determining information related to the medical device; the apparatus is configured to detect a rotatable member 17 configured to rotate relative to a housing of the medical device; wherein the apparatus is configured to detect a rotation of the rotatable member (via displays 18 & 32 in Figs. 1-3; displaying a dose setting amount #12 on the display 18 of the injection device and on the display 32 of the apparatus) relative to the housing of the medical device. Harman does not disclose one or more optical sensors configured to capture information representative of a color of at least a part of the medical device or to determine the color of at least the part of the medical device. Brown discloses an apparatus 10 in Fig. 4 comprising: a housing 11; one or more optical sensor 28 for determining information related to the medical device (e.g., measuring color of marking 490); wherein the one or more optical sensor comprises at least one optical sensor (located behind measurement window 403, para [0092]) configured to capture information representative of a color, i.e., color 491of the variable color marking, of at least a part, i.e., plunger of the medical device or determine the color 491 of the variable color marking, of at least a part, i.e., plunger of the medical device to determine the dose from the measured color, paras [0022, 0092]. Brown also discloses that the apparatus is configured to recognize the color 491 of variable color making of at least the part, i.e., plunger of the medical device from the captured information, paras [0022, 0092]. It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the apparatus of Hartman with obtaining another optical sensor being capable of reading a variable color marking along the plunger, as taught by Brown, in order to indicate of the quantity of liquid within syringe or to determine an injection dose delivered. Examiner Notes As indicated in the above, the limitation “wherein the mating unit is configured to remain attached to the medical device during an injection process” involves 112, 1st paragraph, as new matter. In this case, assuming that the limitation above is to be removed, the previous rejection in Final Rejection 02/13/25 is still maintained. Please see the rejection as below: Claims 21-31, 34-36, 39-40 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Brown (EP 1,502,614 A2). Assuming that the limitation “wherein the mating unit is configured to remain attached to the medical device during an injection process” is being removed or not included in the claims 21 & 39. Regarding claims 21 & 39, Brown discloses an apparatus 10 in Figs. 1A-4, comprising: a housing 50 with a mating unit 52/352/452 in Fig. 2A, 3A & 4; wherein the mating unit 52/352/452 is configured for releasably attaching to a medical device for ejecting a medicament; one optical sensor 102, in Figs. 2B-2C for determining information (dose of an agent delivered with a syringe 22) related to the medical device 22, (for example: quantities of liquid in the syringe before and after the administration of the dose, or optical response values generated by the optical detector before and after the administration of the dose; the patient’s and/or the clinician’s computers then determine the dose administered to the patient from the dose data stored in the recording means, para [0093], also see abstract; para [0002, 0017, 0022, 0087] & Fig. 1A; wherein the optical sensor 102 configured to capture information (position of the syringe plunger and the quantity/position of the liquid within syringe 22, para [0082]; variable color markings 419, para [0092]) representative of the color (e.g., plunger 90 is opaque at those wavelengths, para [0089]) or to determine the color of at least the part of the medical device (longitudinally-variable color marking, para [0029]). Regarding claim 22, wherein the at least one optical sensor is configured to capture the information representative of the color (e.g., color marking varying longitudinally in brightness and/or hue, para [0022], plunger 90 is opaque at those wavelengths then blocks beam 108e, para [0089], marking 492 is a color marking but generally a shape marking, para [0092]), and the apparatus is configured to recognize the color of at least the part of the medical device from the captured information. Regarding claims 23 & 40, the at least one optical sensor is a photometer. Regarding claim 24, the photometer is a spectral photometer (e.g., the incident light comprises wavelengths that are suitable for measuring typical plunger displacements… such wavelengths in visible or near-visible (infrared/ultraviolet) ranges, para [0018]; barrel 86 has side walls transparent at a wavelength of light emitted by a light source, as well as a control portion 88 opaque at a wavelength of light emitted by a control emitter, para [0084]; the plunger 90 has different optical transmission property from liquid 92 at the wavelengths measured by detecting element 102e, para [0089]). Regarding claim 25, wherein the at least one optical sensor 102 is configured to capture the information representative of the color (e.g., the shape or color marking varying longitudinally in brightness and/or hue, paras [0022, 0029, 0092]; or the plunger 90 has different optical transmission property from liquid 92 at the wavelengths measured by detecting element 102e, the plunger 90 is opaque at those wavelength, para [0089]), and the apparatus is configured to further process the capture information, paras [0017, 0091, 0093]. Regarding claim 26, wherein the at least one optical sensor 102 is configured to capture the information representative of the color (from the marking of the plunger), and the apparatus is configured to store the capture information (via recording 40, Fig. 1A, paras [0017, 0024-0025, 0081, 0093, 0097]) Regarding claim 27, wherein the at least one optical sensor is configured to capture the information representative of the color, i.e., marking color to determine the plunger position, and the apparatus is configured to provide captured information to another device 24/26, Fig. 1A. Regarding claim 28, comprising a processor 36. Note: the processor is a part of the control means 34. Regarding claim 29, wherein the processor/control means 36 is configured to control light source 30 (e.g., a control means 34 in electrical communication with light source 30 and optical detector 32 controls the operation of light source 30 and optical detector 32, para [0079]); wherein the light source comprises white and/or colored LEDs, para [0088]. Regarding claim 31, the processor/control means 36 is configured to control a photometer (optical detector 102) that is configured to determine an optical property (marking color) associated with (a plunger of) the medical device. Regarding claim 34, comprising a light source 100 which provides light of a certain wavelength or spectrum. Regarding claim 35, Brown discloses that the port is adapted to download data stored in the cording device to the external computer device for communicating with another external computer device over a long-distance communication line, para [0070]. A person skilled in the art would recognize that transferring data via a long-distance communication line is being used a wireless fashion. In addition, nowadays, it is very common to transmit information to another device in wireless fashion. Regarding claim 36, an interface configured to provide the captured information to another device 24 or 26 via wired or wireless connection, Fig. 1A. Claim 31-33 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Brown (EP 1502614 A2) in view of Klein (US 2007/0142777). Regarding claims 31-33, Brown discloses the claimed invention as required except for the limitations that the process being configured to control photometer that is configured to determine an optical property associated with the medical device; wherein the optical property associated with the medical device comprises optical data indicated by a housing of the medical device; the processor is configured to determine a type of medical device or type of medicament contained in the medical device based on the captured information. Klein discloses an apparatus 12, in Figs. 4-7 comprising: a processor (in the system controller 14); wherein the process is configured to control a photometer (spectrum analyser 16) that is configured to determine an optical property associated of a housing of the medical device (syringe) to determine a type of medicament contained in the medical device (composition of material within the syringe) based on the captured information. Giving such a teaching by Klien, a person having ordinary skill in the art would have easily recognizes that modifying the device of Brown with including a device with spectrum analyzer being attached on the housing of the syringe, as taught by Klien, would provide the benefit of reading the liquid information that contained inside the container. Claims 37-38 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Brown (EP 1502614 A2) in view of Klein (US 2007/0142777). Regarding claims 33, 37-38, Brown discloses all the claimed subject matter except for the limitations as required in the claims 37-38. Klein discloses an apparatus, in Figs. 4-7 comprising: a housing 12 for receiving a syringe; a spectrum analyzer 16; wherein the syringe is adapted to use in conjunction with a qualitative analysis device such as spectrum analyzer 16 to determine the composition of material within the reservoir 2, para [0046]. It is noted that the spectrum analyzer is a device that measuring the color in the electromagnetic spectrum. Therefore, Klein discloses the limitations that: the apparatus 12 is configured to optically capture information corresponding to color codes (via spectrum analyzer 16) that are characteristic of typing of injection device (e.g., composition of material in the syringe); the apparatus 12 is configured to determine a type of medicament (composition of material in the syringe) provided in the medical device (syringe) on color recognition (via spectrum analyzer 16). Giving such a teaching by Klien, a person having ordinary skill in the art would have easily recognizes that modifying the device of Brown with including a device with spectrum analyzer being attached on the housing of the syringe, as taught by Klien, would provide the benefit of reading the liquid information that contained inside the container. Response to Arguments Applicant's arguments filed 01/21/26 have been fully considered but they are not persuasive. 1) Applicant argues that Klein fails to disclose nor teach the limitation that: at least one optical color is configured to capture information representative of a color of at least a part of the medical device. Applicant further states that: Nor does Klein’s alleged “at least one optical sensor” “determined the color of at least the part of the medical device. In response, Klein clearly discloses that: at least one optical sensor 140/140a-b (Figs. 14-15) configured capture information representative of a color, i.e., black marking bars 82 of at least a part, i.e. plunger of the medical device or determine the color, i.e. black bars of at least the part of the medical device. For example: by counting the number of black bars that have passed the detectors to determine the position of the plunger 3 to determine the quantity of liquid drug within the reservoir. 2) Applicant further states that: it is clear that Klein merely describes using optical receivers 140 or the two photodetectors 140a/140b to count the number of bars (marking 82) as the plunger 3 is moved relative to the reservoir 2. Applicant further states that Klein does not teach or suggest using the alleged “at least one optical sensor” to capture information representative of a color or determine a color, let alone such a color being a color or at least a part of the medical device. In response, first, the limitation “one or more optical sensors configured to capture information representative of a color of at least a part of the medical device or to determine the color of at least the part of the medical device” includes a conjunction “or”. Therefore, this limitation can be read as two scenarios: a) one or more optical sensors configured to capture information representative of a color of at least a part of the medical device; b) one or more optical sensors configured to determine the color of at least the part of the medical device. It is noted that the claimed invention does not require the prior art must be read on both scenarios a & b above. If the prior art reads on either scenario a) or b), then it can be read on the claimed invention. In this case, as mentioned the above, Klein discloses that the optical 140/140a & b in Klein is configured capture information representative of black color of the marking bar of the plunger (as a part of the medical device). Therefore, the prior art Klein reads on the claimed invention. 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 QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached M-F 7:30 am-4:00 pm. 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. /QUYNH-NHU H. VU/Primary Examiner, Art Unit 3783
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Prosecution Timeline

Sep 15, 2022
Application Filed
Sep 16, 2022
Response after Non-Final Action
Sep 12, 2024
Non-Final Rejection — §102, §103, §112
Dec 24, 2024
Response Filed
Feb 10, 2025
Final Rejection — §102, §103, §112
Apr 28, 2025
Applicant Interview (Telephonic)
Apr 29, 2025
Examiner Interview Summary
Jun 12, 2025
Response after Non-Final Action
Jun 12, 2025
Notice of Allowance
Jun 26, 2025
Response after Non-Final Action
Jul 17, 2025
Non-Final Rejection — §102, §103, §112
Jan 21, 2026
Response Filed
Feb 17, 2026
Final Rejection — §102, §103, §112 (current)

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Prosecution Projections

5-6
Expected OA Rounds
68%
Grant Probability
96%
With Interview (+28.1%)
3y 5m
Median Time to Grant
High
PTA Risk
Based on 971 resolved cases by this examiner. Grant probability derived from career allow rate.

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