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 04/08/2026 has been entered. Claims 6-8 and 10 have been amended. Claims 13-20 are new. Claims 1-20 remain pending in this application.
Response to Arguments
Applicant's arguments filed 04/08/2026 have been fully considered but they are not persuasive.
Applicant argues that the accelerometer of Ajaelo would be incompatible with the device of Stowe and that a person having ordinary skill in the art would not be motivated to combine the accelerometer of Ajaelo with Stowe. However, as discussed in the rejection below a person having ordinary skill in the art would have found it obvious to modify the proximity sensor of Stowe such that it is configured to identify the eye, left or right, to which the applicator is applying the liquid to the eye of the user, as taught by Ajaelo, in order to distinguish between administration of the liquid to the right eye or the left eye (Ajaelo, ¶ 0103) such that accidental overdose of the liquid is prevented (Ajaelo, ¶ 0012). While the device of Ajaelo delivers a gravitationally directed drop, Ajaelo teaches that the values of the accelerometer relate to the anatomical downward tilt of each eye socket (¶ 0107). Thus, such measurements measured by the accelerometer of Ajaelo are independent of the device being a gravitationally directed drop device.
Regarding new claims 13-20, Stowe in view of Ajaelo make obvious such claims.
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) 1-7, 9-20 are rejected under 35 U.S.C. 103 as being unpatentable over Stowe (Pub. No.: US 2020/0360180 A1) and in view of Ajaelo (Pub. No.: US 2018/0193190 A1).
Regarding claim 1, Stowe discloses (fig. 1-) an ophthalmic applicator device (fluid delivery device 10) for treating an eye of a user (¶ 0003), comprising:
A housing (applicator 15);
A reservoir (cartridge 20), supported by the housing (¶ 0050), for containing a liquid for treating the eye (¶ 0052);
A nozzle (37) supported by the housing (¶ 0051, ¶ 0053) and operatively connected to the reservoir (¶ 0053, fig. 3) and being configured to direct a non-gravitationally directed dose of the liquid (¶ 0049); and
A proximity sensor (350, 355) (¶ 0071).
Stowe fails to disclose that the proximity sensor is configured to identify the eye, left or right, to which the applicator is applying the liquid to the eye of the user.
Ajaelo teaches (fig. 2) an ophthalmic applicator (electronic drop device 100, ¶ 0115) and thus in the same field of endeavor, comprising a proximity sensor (accelerometer 114) configured to detect the eye, left or right, to which the applicator is applying the liquid to the eye of the user (¶ 0103).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximity sensor of Stowe such that it is configured to identify the eye, left or right, to which the applicator is applying the liquid to the eye of the user, as taught by Ajaelo, in order to distinguish between administration of the liquid to the right eye or the left eye (Ajaelo, ¶ 0103) such that accidental overdose of the liquid is prevented (Ajaelo, ¶ 0012).
Regarding claim 2, Stowe discloses wherein the proximity sensor is configured to sense the presence of the user’s nose positioned laterally of the housing when the applicator is positioned to treat the eye (¶ 0077).
Regarding claim 3, Stowe in view of Ajaelo fail to explicitly disclose wherein the proximity sensor is configured to associate the applicator being used to treat left eye in response to detecting the user’s nose, and to associate the applicator being used to treat the right eye in response to not detecting the user’s nose.
However, Stowe discloses that the proximity sensor is configured to sense the presence of the user’s nose (¶ 0077). Stowe further discloses two proximity sensors (350, 355). Thus, in use, when the applicator is used to treat the left eye, the right proximity sensor (355) will be adjacent the user’s nose and when the applicator is used to treat the right eye, the right proximity sensor (355) will not be adjacent the user’s nose and will be adjacent the user’s ear (fig. 17).
Ajaelo teaches (fig. 2) wherein the proximity sensor is configured to associate the applicator being used to treat the left eye or right eye in response to detecting the user’s eye socket (¶ 0103).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the applicator of Stowe in view of Ajaelo such that the proximity sensor is configured to associate the applicator being used to treat the left eye or right eye, as taught by Ajaelo, such that the proximity sensor is configured to associate the applicator being used to treat left eye in response to detecting the user’s nose, and to associate the applicator being used to treat the right eye in response to not detecting the user’s nose using the proximity sensor (355) of Stowe, as the recognition of facial features is suitable for distinguishing between the right and left eye (Ajaelo, ¶ 0103).
Regarding claim 4, Stowe in view of Ajaelo fail to explicitly disclose wherein the proximity sensor is configured to associate the applicator being used to treat right eye in response to detecting the user’s nose, and to associate the applicator being used to treat the left eye in response to not detecting the user’s nose.
However, Stowe discloses that the proximity sensor is configured to sense the presence of the user’s nose (¶ 0077). Stowe further discloses two proximity sensors (350, 355). Thus, in use, when the applicator is used to treat the right eye, the left proximity sensor (350) will be adjacent the user’s nose and when the applicator is used to treat the left eye, the left proximity sensor (350) will not be adjacent the user’s nose and will be adjacent the user’s ear (fig. 17).
Ajaelo teaches (fig. 2) wherein the proximity sensor is configured to associate the applicator being used to treat the left eye or right eye in response to detecting the user’s eye socket (¶ 0103).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the applicator of Stowe in view of Ajaelo such that the proximity sensor is configured to associate the applicator being used to treat the left eye or right eye, as taught by Ajaelo, such that the proximity sensor is configured to associate the applicator being used to treat right eye in response to detecting the user’s nose, and to associate the applicator being used to treat the left eye in response to not detecting the user’s nose using the proximity sensor (355) of Stowe, as the recognition of facial features is suitable for distinguishing between the right and left eye (Ajaelo, ¶ 0103).
Regarding claim 5, Stowe discloses wherein the proximity sensor is configured to sense the presence of facial structure (¶ 0070) laterally of the housing in a direction generally perpendicular to a nozzle axis of the nozzle (¶ 0071, fig. 17).
Regarding claim 6, Stowe discloses where the proximity sensor comprises a miniature surface mounted infrared optical proximity sensor with a built in LED and photodetector (¶ 0071).
Regarding claim 7, Stowe discloses wherein two different proximity sensors (350, 355) pointing in opposite lateral directions (fig. 17, ¶ 0071), wherein the applicator can determine whether the applicator is held sufficiently close to the user’s face to warrant dosage of the liquid to the eye (¶ 0070-¶ 0071).
Stowe in view of Ajaelo fail to disclose that the two different proximity sensors are used for sensing the presence or absence of a user’s nose from either side, wherein the applicator is configured to thereby determine which eye is being treated.
However, Stowe discloses that the proximity sensor is configured to sense the presence of the user’s nose and ear (¶ 0077). Thus, in use, when the applicator is used to treat the right eye, the left proximity sensor (350) will be adjacent the user’s nose and detects the presence of a user’s nose and the right proximity sensor (355) will not be adjacent the user’s nose and detects the presence of the user’s ear, thus the absence of the user’s nose; and when the applicator is used to treat the left eye, the right proximity sensor (355) will be adjacent the user’s nose and detects the presence of a user’s nose and the left proximity sensor (350) will not be adjacent the user’s nose and detects the presence of the user’s ear, thus the absence of the user’s nose (fig. 17).
Ajaelo teaches (fig. 2) wherein the proximity sensor is used for sensing the eye socket (¶ 0103), wherein the applicator is configured to thereby determine which eye is being treated (¶ 0103).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the applicator of Stowe in view of Ajaelo such that it is configured to thereby determine which eye is being treated, as taught by Ajaelo, such the two different proximity sensors are used for sensing the presence or absence of a user’s nose form either side, as the recognition of facial features is suitable for distinguishing between the right and left eye (Ajaelo, ¶ 0103).
Regarding claim 9, Stowe discloses a controller (290).
Stowe in view of Ajaelo fail to disclose that the controller is configured to control the proximity sensor and the application of treatment in response to which eye, left or right, is detected.
Ajaelo teaches (fig. 2) a controller (microcontroller 108) configured to control the proximity sensor and the application of treatment in response to which eye, left or right, is detected (¶ 0103).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller of Stowe in view of Ajaelo such that it is configured to control the proximity sensor and the application of treatment in response to which eye, left or right, is detected, as taught by Ajaelo, in order to control administration of the liquid to the right eye or the left eye (Ajaelo, ¶ 0103) such that accidental overdose of the liquid is prevented (Ajaelo, ¶ 0012).
Regarding claim 10, Stowe in view of Ajaelo disclose wherein the controller is configured to compile a treatment log for the treatments applied to the user’s eyes to determine if one or both eyes were treated properly (Ajaelo ¶ 0017, ¶ 0099).
Regarding claim 11, Stowe discloses (fig. 6) a displacement valve (valve 70) and an actuator (wall 55) configured to actuate the displacement valve (¶ 0055), wherein the displacement valve is configured to, when actuated, force the liquid through the nozzle (¶ 0055), and wherein the controller is configured to control actuation of the actuator in response to a user input (¶ 0080, ¶ 0090-¶ 0091).
Regarding claim 12, Stowe discloses wherein the reservoir comprises a removable reservoir cartridge (¶ 0050).
Regarding claim 13, Stowe in view of Ajaelo fail to explicitly disclose wherein the proximity sensor is an optical sensor configured to, based on at least one optical signal reflected off the suer, identify the eye, left or right, to which the applicator is applying the liquid to the eye of the user.
However, Stowe discloses wherein the proximity sensor is an optical sensor configured to receive at least one optical signal reflected off the user (¶ 0071).
Further, Ajaelo teaches wherein the proximity sensor is configured to identify the eye, left or right, to which the applicator is applying the liquid to the eye of the user (¶ 0103), as discussed above in claim 1.
Accordingly, Stowe in view of Ajaelo disclose wherein the proximity sensor is an optical sensor configured to, based on at least one optical signal reflected off the user, identify the eye, left or right, to which the applicator is applying the liquid to the eye of the user.
Regarding claim 14, Stowe in view of Ajaelo fail to explicitly disclose wherein the proximity sensor comprises an LED and a photodetector configured to, based on at least one optical signal reflected off the user, identify the eye, left or right, to which the applicator is applying the liquid to the eye of the user.
Stowe discloses wherein the proximity sensor comprises an LED and a photodetector configured to receive at least one at least one optical signal reflected off the user (¶ 0071).
Further, Ajaelo teaches wherein the proximity sensor is configured to identify the eye, left or right, to which the applicator is applying the liquid to the eye of the user (¶ 0103), as discussed above in claim 1.
Accordingly, Stowe in view of Ajaelo disclose wherein the proximity sensor is an LED and a photodetector configured to, based on at least one optical signal reflected off the user, identify the eye, left or right, to which the applicator is applying the liquid to the eye of the user.
Regarding claim 15, Stowe in view of Ajaelo fail to explicitly disclose wherein the proximity sensor is configured to, based on whether or not the proximity sensor receives at least one optical signal reflected off a nose of the user, identify the eye, left or right, to which the applicator is applying the liquid to the eye of the user.
However, Stowe discloses that the proximity sensor is configured to sense the presence of the user’s nose (¶ 0077). Stowe further discloses two proximity sensors (350, 355). Thus, in use, when the applicator is used to treat the left eye, the right proximity sensor (355) will be adjacent the user’s nose and will receive at least one optical signal reflected off the nose of the user and when the applicator is used to treat the right eye, the right proximity sensor (355) will not be adjacent the user’s nose and will not receive at least one optical signal reflected off the nose of the user.
Further, Ajaelo teaches wherein the proximity sensor is configured to identify the eye, left or right, to which the applicator is applying the liquid to the eye of the user (¶ 0103), as discussed above in claim 1.
Accordingly, Stowe in view of Ajaelo disclose wherein the proximity sensor is configured to, based on whether or not the proximity sensor receives at least one optical signal reflected off a nose of the user, identify the eye, left or right, to which the applicator is applying the liquid to the eye of the user.
Regarding claim 16, Stowe discloses (fig. 1-3, 17-18) an ophthalmic applicator device (fluid delivery device 10) for treating the right eye of a user or the left eye of the user (¶ 0003), comprising:
A housing (applicator 15);
A reservoir (cartridge 20), supported by the housing (¶ 0050), for containing a liquid for treating the eye (¶ 0052);
A nozzle (37) supported by the housing (¶ 0051, ¶ 0053) and operatively connected to the reservoir (¶ 0053, fig. 3) and being configured to direct a non-gravitationally directed dose of the liquid (¶ 0049); and
A proximity sensor (350, 355) (¶ 0071) comprising:
One or more LEDSs (355a) configured to emit light towards the user (¶ 0071); and
A photodetector (355b) configured to receive reflected light from the emitted light (¶ 0071).
Stowe fails to disclose that the photodetector is configured to determine, based on the reflected light, at which eye of the right eye and the left eye that the applicator is aimed to apply the liquid.
Ajaelo teaches (fig. 2) an ophthalmic applicator (electronic drop device 100, ¶ 0115) and thus in the same field of endeavor, comprising a proximity sensor (accelerometer 114) configured to detect the eye, left or right, to which the applicator is applying the liquid to the eye of the user (¶ 0103) in order to distinguish between administration of the liquid to the right eye or the left eye (Ajaelo, ¶ 0103) such that accidental overdose of the liquid is prevented (Ajaelo, ¶ 0012).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximity sensor of Stowe such that it is configured to identify the eye, left or right, to which the applicator is applying the liquid to the eye of the user, as taught by Ajaelo, in order to distinguish between administration of the liquid to the right eye or the left eye (Ajaelo, ¶ 0103) such that accidental overdose of the liquid is prevented (Ajaelo, ¶ 0012).
Regarding claim 17, Stowe discloses wherein the reflected light reflects off the nose of the user (¶ 0077).
Regarding claim 18, Stowe discloses wherein the one or more LEDs comprise multiple LEDs (¶ 0071).
Regarding claim 19, Stowe discloses wherein the one or more LEDs comprise two LEDs (¶ 0071).
Regarding claim 20, Stowe discloses wherein the one or more LEDs comprise two LEDs (¶ 0071) on opposite sides of the photodetector (each sensor comprises an LED 355a and a photodetector 355b, the LEDs are on a right side and a left side, and thus opposite).
Allowable Subject Matter
Claim 8 is allowed.
The following is an examiner’s statement of reasons for allowance: claim 8 is allowed for reasons outlined in the Non-Final Rejection mailed 12/10/2025.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Decock (Pub. No.: US 2021/0113371 A1) discloses an ophthalmic applicator. Gavini et al. (Pub. No.: US 2016/0354559 A1) discloses an ophthalmic applicator having a sensor to detect which eye the applicator is applying the liquid to.
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 MEAGAN NGO whose telephone number is (571)270-1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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