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 1-20 are pending in the instant application and are examined on the merits herein.
Priority
The instant application claims priority to U.S. Provisional App. no. 63/559,267 filed on 02/29/2024.
Claims 1-20 receive priority to the prior-filed application, filed on 02/29/2024.
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 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 7, 10-14 and 16-20 are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by US/2014/0257205 A1 to Schaller.
Regarding claim 1, Schaller discloses a lubrication assembly for lubricating an eye of a patient during an ophthalmic procedure (para. 0021; Fig. 1, system 100 for moisturizing an eye during ocular surgery), the lubrication assembly comprising:
a mounting bracket configured to be coupled to a surgical microscope (para. 0030, nozzle mounting device may be a surgical microscope and may include a bracket to mount fluid nozzle/dispenser 120; Fig. 1, nozzle mounting device 160);
a dispenser coupled to the mounting bracket (para. 0023; para. 0030; Fig. 1, nozzle/dispenser 120);
a lubricant source fluidly coupled to the dispenser (para. 0022-0025; Fig. 1, fluid reservoir 110);
a fluid line for movement of a lubricant between the lubricant source and the dispenser (para. 0023-0025; Fig. 1, fluid lines 140a/140b); and
a first actuator for dispensing, from the dispenser, the lubricant onto the eye of the patient (para. 0026-0029; para. 0045-0055; Fig. 1, activation device 150).
Regarding claim 2, the cited prior art discloses the invention of claim 1. Schaller further discloses wherein the lubricant is automatically dispensed from the dispenser at a target dispense rate (para. 0024; para. 0026-0029; para. 0045-0055).
Regarding claim 3, the cited prior art discloses the invention of claim 2. Schaller further discloses wherein the target dispense rate is based on a type of the ophthalmic procedure performed (para. 0024; para. 0026-0029; para. 0045-0055; activation can be based on time or events occurring).
Regarding claim 4, the cited prior art discloses the invention of claim 2. Schaller further discloses wherein the target dispense rate is set by a user (para. 0024; para. 0026-0029; para. 0045-0055).
Regarding claim 5, the cited prior art discloses the invention of claim 2. Schaller further discloses wherein the target dispense rate is controlled by a controlled release valve coupled to the dispenser (para. 0024; para. 0026-0029; para. 0045-0055; Fig. 1, fluid control device 130 may be a valve appropriate for regulating fluid flow).
Regarding claim 7, the cited prior art discloses the invention of claim 1. Schaller further discloses a second actuator for moving the dispenser into a selected position relative to the eye of the patient (para. 0033).
Regarding claim 10, the cited prior art discloses the invention of claim 1. Schaller further discloses wherein the lubricant is automatically dispensed from the dispenser upon actuation of the actuator (para. 0026-0029; para. 0045-0055).
Regarding claim 11, Schaller discloses a method for lubricating an eye of a patient during an ophthalmic procedure (para. 0024; para. 0026-0030; para. 0033; para. 0045-0055) comprising:
moving a lubrication assembly into a selected position relative to the eye of the patient (para. 0030; para. 0033);
dispensing a lubricant from the lubrication assembly onto the eye of the patient (para. 0026-0030; para. 0045-0055);
monitoring a position of the lubrication assembly relative to the eye of the patient and a lubrication level of the eye of the patient for a duration of the ophthalmic procedure (para. 0030, position of surgical microscope may be adjustable to align dispenser 120 with the eye; para. 0033, dispenser may be moved electronically, pneumatically, magnetically, manually, or otherwise into position for moisturizing process and retracted afterwards; para. 0026-0030; para. 0045-0055); and
generating a message to adjust a dispense rate of the lubrication assembly or the position of the lubrication assembly in response to the monitoring (para. 0030, position of surgical microscope may be adjustable to align dispenser 120 with the eye; para. 0033, dispenser 120 may be moved electronically, pneumatically, magnetically, manually, or otherwise into position for moisturizing process and retracted afterwards; para. 0026-0030; para. 0045-0055; automatic activation requires generation of commands).
Regarding claim 12, the cited prior art discloses the method of claim 11. Schaller further discloses wherein dispensing the lubricant comprises: automatically dispensing the lubricant from the lubrication assembly at a target dispense rate (para. 0024; para. 0026-0030; para. 0045-0055).
Regarding claim 13, the cited prior art discloses the method of claim 11. Schaller further discloses wherein moving the lubrication assembly comprises: actuating an actuator coupled to the lubrication assembly to move a dispensing end of the lubrication assembly into the selected position (para. 0033, dispenser 120 may be moved electronically, pneumatically, magnetically, manually, or otherwise into position for moisturizing process and retracted afterwards; para. 0026-0030; para. 0045-0055).
Regarding claim 14, the cited prior art discloses the method of claim 11. Schaller further discloses wherein moving the lubrication assembly comprises: actuating a surgical microscope comprising the lubrication assembly into the selected position (para. 0030, position of surgical microscope may be adjustable to align dispenser 120 with the eye).
Regarding claim 16, the cited prior art discloses the method of claim 11. Schaller further discloses providing the message to a user of the lubrication assembly (para. 0026-0030).
Regarding claim 17, the cited prior art discloses the method of claim 11. Schaller further discloses providing the message to a controller of the lubrication assembly, wherein providing the message to the controller of the lubrication assembly causes the controller to automatically adjust the dispense rate of the lubrication assembly or the position of the lubrication assembly (para. 0030, position of surgical microscope may be adjustable to align dispenser 120 with the eye; para. 0033, dispenser 120 may be moved electronically, pneumatically, magnetically, manually, or otherwise into position for moisturizing process and retracted afterwards; para. 0026-0030; para. 0045-0055; automatic activation requires generation of commands).
Regarding claim 18, Schaller discloses a method for lubricating an eye of a patient during an ophthalmic procedure (para. 0024; para. 0026-0030; para. 0033; para. 0045-0055) comprising:
moving a lubrication assembly into a selected position relative to the eye of the patient (para. 0030; para. 0033);
dispensing a lubricant from the lubrication assembly onto the eye of the patient (para. 0026-0030; para. 0045-0055);
monitoring a position of the lubrication assembly relative to the eye of the patient and a lubrication level of the eye of the patient for a duration of the ophthalmic procedure (para. 0030, position of surgical microscope may be adjustable to align dispenser 120 with the eye; para. 0033, dispenser 120 may be moved electronically, pneumatically, magnetically, manually, or otherwise into position for moisturizing process and retracted afterwards; para. 0026-0030; para. 0045-0055); and
automatically adjusting a dispense rate of the lubrication assembly or the position of the lubrication assembly in response to the monitoring (para. 0030, position of surgical microscope may be adjustable to align dispenser 120 with the eye; para. 0033, dispenser may be moved electronically, pneumatically, magnetically, manually, or otherwise into position for moisturizing process and retracted afterwards; para. 0026-0030; para. 0045-0055; automatic activation requires generation of commands).
Regarding claim 19, the cited prior art discloses the method of claim 18. Schaller further discloses wherein monitoring the position of the lubrication assembly relative to the eye of the patient and the lubrication level of the eye of the patient comprises: determining the eye of the patient needs more of the lubricant (para. 0030, position of surgical microscope may be adjustable to align dispenser 120 with the eye; para. 0033, dispenser 120 may be moved electronically, pneumatically, magnetically, manually, or otherwise into position for moisturizing process and retracted afterwards; para. 0026-0030; para. 0045-0055).
Regarding claim 20, the cited prior art discloses the method of claim 18. Schaller further discloses wherein monitoring the position of the lubrication assembly relative to the eye of the patient and the lubrication level of the eye of the patient comprises: determining an area of the eye of the patient needs more of the lubricant (para. 0030, position of surgical microscope may be adjustable to align dispenser 120 with the eye; para. 0033, dispenser 120 may be moved electronically, pneumatically, magnetically, manually, or otherwise into position for moisturizing process and retracted afterwards; para. 0026-0030; para. 0045-0055).
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.
Claims 6 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Schaller.
Regarding claims 6 and 8-9, the cited prior art discloses the invention of claim 1. Schaller further discloses that the nozzle mounting device may be adjustable to align the dispenser with the eye (para. 0030; Fig. 1, nozzle mounting device 160), that the dispenser may be moved into position and retracted afterwards (para. 0033, dispenser 120 may be moved electronically, pneumatically, magnetically, manually, or otherwise into position for moisturizing process and retracted afterwards), and another embodiment wherein a dispensing end of the dispenser is positioned between the eye of the patient and the surgical microscope (para. 0034-0036; Fig. 2A, tube/dispensing end 212 of fluid nozzle/dispenser 210 positioned between eye 202 and surgical microscope 220).
Schaller differs from the instantly claimed invention in that the relied upon embodiment of Schaller fails to explicitly disclose
(Claim 6) wherein: the dispenser is disposed in a field of view (FOV) of the surgical microscope; and the dispenser is outside of a focal plane of the surgical microscope; and
(Claim 8) wherein a dispensing end of the dispenser is positioned at a center of an FOV of the surgical microscope; and
(Claim 9) wherein a dispensing end of the dispenser is positioned between the eye of the patient and the surgical microscope.
In light of these disclosures, even though it’s not explicit in Schaller, it would be considered obvious to one of ordinary skill in the art that the dispenser or dispensing end of the dispenser of Schaller is able to be positioned in a field of view (FOV) of the surgical microscope, outside of a focal plane of the surgical microscope, at a center of an FOV of the surgical microscope, and between the eye of the patient and the surgical microscope based on the adjustment of the nozzle mounting device or the dispenser itself.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Schaller as applied above, and further in view of US/2024/0350311 A1 to Gliner.
Regarding claim 15, the cited prior art discloses the method of claim 11. Schaller further discloses optical sensors that recognize the dryness of the cornea (para. 0026-0029) and that the nozzle mounting device may be adjustable to align the dispenser with the eye (para. 0030; Fig. 1, nozzle mounting device 160).
Gliner teaches a method of lubricating an eye during an ophthalmic procedure comprising monitoring the position of the lubrication assembly (para. 0067-0086) by
capturing an image of the patient’s eye (para. 0067-0086);
determining a position of the patient’s eye from the image (para. 0067-0086);
comparing the position of the lubrication assembly to the position of the patient’s eye (para. 0067-0086); and
determining whether to move the lubrication assembly based on the comparison (para. 0007; para. 0067-0086; if a needle has slipped out [is in an incorrect position] a user may determine whether or not to move the lubrication assembly based on the comparison).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Schaller to further comprise the steps as claimed in Gliner, because Gliner discloses methods of ensuring that a lubrication assembly is in the correct position to ensure correct usage and spill prevention (para. 0007).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent no. 9,597,445 B2 to Ha is directed to a fluid management system for an ophthalmic procedure. EP/2315562 B1 to Pearson and US/2010/0094232 A1 to Hull are directed to ophthalmic irrigators for ocular surgery.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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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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/Linnae E. Raymond/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781
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