DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/12/2026 has been entered.
Claim Objections
Claim 1 is objected to for reciting "consoled interface member" in line 10. The recitation should be amended to "console interface member" to correct an apparent typographical error.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-6, 8-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Muri et al (U.S. Pat. 8,070,712 B2, hereinafter “Muri”) in view of Sorensen et al (U.S. 2013/0150782 A1, hereinafter “Sorensen”).
Regarding claim 1, Muri discloses a system for distributing fluid, comprising:
a console interface (see Figs. 3A and 3B, and col. 6, lines 20-25 describing Figs. 3A and 3B showing components of the console that interface with the cassette);
a surgical cassette comprising:
a first valve 48 (see Fig. 2);
a second valve 58 (see Fig. 2);
and an irrigation tank 56 (see Fig. 2);
wherein the first valve 48 and the second valve 58 comprise respective first and second slots for accommodating respective first and second console interface members (such as valve drives 58b, 58a),
wherein the first valve 48 comprises a first connection to the irrigation tank (the first connection is at the outlet of the first valve 48 and the irrigation tank is a lumen inside the handpiece that allows irrigation fluid to flow from the console and/or the cassette into the eye; see col. 7, lines 49-54), a second connection to an external fluid source 46 (see Fig. 2; the second connection extends from the inlet of the first valve 48 to the external fluid source 46) and connects a first line to the irrigation tank in a first valve position (when the first valve 46 is closed, the line extending from the outlet of the first valve 48 is connected to the inlet of the handpiece 12) and connects the first line to the external fluid source in a second first valve position (when the first valve 48 is open, the first line mentioned above is connected to the irrigation source 46).
It is noted that Muri does not appear to disclose that the cassette comprises a pressure sensor configured to sense pressure in the first line, and the at least one of the first console interface member and second console interface member is controlled by the console interface responsive to at least one received signal indicative of at least one parameter associated with one of fluid pressure and fluid volume.
Sorensen discloses a system for selectively moving irrigation and aspiration valve elements in aspiration and irrigation conduits, comprising pressure sensors associated with both the aspiration line (see pressure sensor 63 disclosed in paras [0048]-[0049]) and the irrigation line (see pressure sensor positioned in irrigation line 50 disclosed in para [0040]), the system being configured to operate the valve elements responsive to at least one received signal indicative of at least one parameter associated with one of fluid pressure and fluid volume (as discussed in paras [0048]-[0050], the pressure sensors associated with the irrigation and aspiration lines connected to the valves that sense the pressure in the lines and can operate the valve elements to change the aspiration or irrigation pressure within the lines).
A skilled artisan would have found it obvious at the time of the invention to modify at least one of the first and second console interface members, in the invention of Muri, to be responsive to at least one received signal indicative of at least one parameter associated with one of fluid pressure and fluid volume, as taught in Sorensen, in order to lessen an effect of a post occlusion break surge and to permit selective and dynamic control of aspiration and irrigation levels within the aspiration and irrigation lines based on use preference, thereby providing quicker and more efficient lens removal (see Sorensen at para [0050]).
Further, it is noted that Muri does not appear to disclose that the first valve has a third connection to a first line, and wherein the first valve is configured to connect the first line to the irrigation tank and connect the first line to the fluid source.
Sorensen discloses a system for selectively moving irrigation and aspiration valve elements in aspiration and irrigation conduits, comprising a first valve 464 (see Fig. 8) that has a connection to an irrigation tank (line 50; see Fig. 8); a second connection to an external fluid source 448 (via supply line 473; see Fig. 8); and a third connection to a first line (shunt line 476; see Fig. 8). Sorensen discloses that the valve is configured to connect the first line to the irrigation tank (see para [0071], disclosing aligning second arm 474b with first line 476 and third arm 464c with tank 50) and connect the first line to the fluid source (see para [0071], disclosing aligning first branch 474a with shunt line 476 and third branch 474c with external fluid source 473).
A skilled artisan would have found it obvious at the time of the invention to modify the first valve of Muri to have a third connection to a first line, and wherein the first valve is configured to connect the first line to the irrigation tank and connect the first line to the fluid source, as taught in Sorensen, in order to permit the valve to be used for priming of the external fluid source and the pressure sensor, with a reasonable expectation of success (see Sorensen at para [0071]).
Regarding claims 2-4, Sorensen discloses the following features:
the at least one parameter is associated with a vacuum (as discussed above, a pressure sensor can sense pressure in the vacuum line and operate the valve elements to change the aspiration pressure);
the at least one parameter is associated with a positive pressure (as discussed above, a pressure sensor can sense pressure in the irrigation line and operate the valve elements to change the irrigation pressure);
the at least one parameter is associated with gravity (as discussed above, a pressure sensor can sense pressure in the irrigation line and operate the valve elements to change the irrigation pressure, and the irrigation pressure can be provided by an irrigation container that utilizes gravity to force infusion fluid out of the irrigation container into the irrigation line; see para [0075]).
Regarding claims 5-6, Muri discloses the following features:
the first valve and second valve are in fluid communication (via the pump 54; see Fig. 2); and
the second valve fluidly connects a line under vacuum to atmosphere (via a vent valve 44; see Fig. 2).
Regarding claim 8, Muri discloses that the second valve vents at least one fluidly connected line (using the solenoid vent valve in fluid communication with valve 58).
Regarding claim 9, Muri discloses that one of the first valve and the second valve may be partially open to at least one line (see col. 9, lines 12-16 and see also the first valve is an irrigation valve partially open to the irrigation line connected to irrigation source 46).
Regarding claim 10, Muri discloses a method for controlling fluids in a surgical cassette, comprising:
operating a first valve 48 (i.e., an irrigation valve; see Fig. 2) using a first valve interface member (a valve drive 48b);
operating a second valve 58 (i.e., a selector valve 58; see Fig. 2) using a second valve interface member (a valve drive 58b);
wherein the first valve interface member and the second valve interface member are associated with a surgical console (i.e., the valve drives are part of the console; see Fig. 2 and Fig. 3A),
wherein the first valve comprises a first connection to an irrigation tank (the first connection is at the outlet of the first valve 48 and the irrigation tank is a lumen inside the handpiece that allows irrigation fluid to flow from the console and/or the cassette into the eye; see col. 7, lines 49-54), and a second connection an external fluid source 46 (see Fig. 2; the second connection extends from the inlet of the first valve 48 to the external fluid source 46) and connects a first line to the irrigation tank in a first first valve position (when the first valve 48 is closed, the line extending from the outlet of the first valve 46 is connected to the inlet of the handpiece 12) and connects the first line to the external fluid source in a second first valve position (when the first valve 48 is open, the first line mentioned above is connected to the irrigation source 46).
It is noted that Muri does not appear to disclose that the first line comprises a pressure sensor, and at least one of the first and second valve interface members are responsive to at least one received signal indicative of at least one parameter associated with one of fluid pressure and fluid volume.
Sorensen discloses a system for selectively moving irrigation and aspiration valve elements in aspiration and irrigation conduits, comprising pressure sensors associated with both the aspiration line (see pressure sensor 63 disclosed in paras [0048]-[0049]) and the irrigation line (see pressure sensor positioned in irrigation line 50 disclosed in para [0040]), the system being configured to operate the valve elements responsive to at least one received signal indicative of at least one parameter associated with one of fluid pressure and fluid volume (as discussed in paras [0048]-[0050], the pressure sensors associated with the irrigation and aspiration lines connected to the valves that sense the pressure in the lines and can operate the valve elements to change the aspiration or irrigation pressure within the lines).
A skilled artisan would have found it obvious at the time of the invention to modify at least one of the first and second valve interface members of Muri to be responsive to at least one received signal indicative of at least one parameter associated with one of fluid pressure and fluid volume, as taught in Sorensen, in order to lessen an effect of a post occlusion break surge and to permit selective and dynamic control of aspiration and irrigation levels within the aspiration and irrigation lines based on use preference, thereby providing quicker and more efficient lens removal (see Sorensen at para [0050]).
Further, it is noted that Muri does not appear to disclose that the first valve has a third connection to a first line, and wherein the first valve is configured to connect the first line to the irrigation tank and connect the first line to the fluid source.
Sorensen discloses a system for selectively moving irrigation and aspiration valve elements in aspiration and irrigation conduits, comprising a first valve 464 (see Fig. 8) that has a connection to an irrigation tank (line 50; see Fig. 8); a second connection to an external fluid source 448 (via supply line 473; see Fig. 8); and a third connection to a first line (shunt line 476; see Fig. 8). Sorensen discloses that the valve is configured to connect the first line to the irrigation tank (see para [0071], disclosing aligning second arm 474b with first line 476 and third arm 464c with tank 50) and connect the first line to the fluid source (see para [0071], disclosing aligning first branch 474a with shunt line 476 and third branch 474c with external fluid source 473).
A skilled artisan would have found it obvious at the time of the invention to modify the first valve of Muri to have a third connection to a first line, and wherein the first valve is configured to connect the first line to the irrigation tank and connect the first line to the fluid source, as taught in Sorensen, in order to permit the valve to be used for priming of the external fluid source and the pressure sensor, with a reasonable expectation of success (see Sorensen at para [0071]).
Regarding claims 11-13, Sorenson discloses the following features:
the at least one parameter is associated with a vacuum (as discussed above, a pressure sensor can sense pressure in the vacuum line and operate the valve elements to change the aspiration pressure);
the at least one parameter is associated with a positive pressure (as discussed above, a pressure sensor can sense pressure in the irrigation line and operate the valve elements to change the irrigation pressure);
the at least one parameter is associated with gravity (as discussed above, a pressure sensor can sense pressure in the irrigation line and operate the valve elements to change the irrigation pressure, and the irrigation pressure can be provided by an irrigation container that utilizes gravity to force infusion fluid out of the irrigation container into the irrigation line; see para [0075]).
Regarding claims 14-15, Muri discloses the following features:
the first valve and second valve are in fluid communication (via the pump 54; see Fig. 2); and
the second valve fluidly connects a line under vacuum to atmosphere (via a vent valve 44; see Fig. 2).
Regarding claim 16, Muri discloses that a line attached to the first valve receives one of either pressurized fluid or gravity-fed fluid (the line attached to the first valve receives gravity-fed fluid from source 46).
Regarding claim 17, Muri discloses that the second valve vents at least one fluidly connected line (the solenoid vent valve is fluidly connected to the valve 58).
Regarding claim 18, Muri discloses a system for distributing fluid during a surgical procedure, comprising:
a plurality of valves, such as a first irrigation valve 48, a second irrigation valve 58, and an irrigation tank 56 (see Fig. 2), all at least partially enclosed in a surgical cassette 16 (see Fig. 2);
at least one vacuum source (e.g., 54; see Fig. 2) fluidly connected to a first of the plurality of valves (the valve 48 has an outlet that is in fluid communication with an outlet of the handpiece, which is in fluid communication with the aspiration flow path 52 [i.e., fluid flows out of the handpiece and then back into the handpiece in order to maintain the proper volume of fluid in the eye], which is then in fluid communication with the pump 54); and
wherein a second valve 58 the plurality of valves comprises a first connection to the irrigation tank (i.e., the valve 58 has an outlet that is in fluid communication with an inlet to the tank; see Fig. 2), a second connection to an external fluid source 46 (the inlet to the valve 58 is fluidly connected to the irrigation source 46 via the handpiece and the valve 48; see Fig. 2),
and connects a first line, e.g., line 52, to the irrigation tank in a first second valve position (i.e., in the open position, fluid flows from the line, through the valve 58 and into the tank 56) and connects the first line to the external fluid source in a second second valve position (i.e., in the closed position, the first line 52 is still connected to the external fluid source via the handpiece 12).
It is noted that Muri does not appear to disclose the first line comprising a pressure sensor, such that the at least one of the plurality of valves is responsive to at least one received signal indicative of at least one parameter associated with one of fluid pressure and fluid volume.
Sorensen discloses a system for selectively moving irrigation and aspiration valve elements in aspiration and irrigation conduits, comprising pressure sensors associated with both the aspiration line (see pressure sensor 63 disclosed in paras [0048]-[0049]) and the irrigation line (see pressure sensor positioned in irrigation line 50 disclosed in para [0040]), the system being configured to operate the valve elements responsive to at least one received signal indicative of at least one parameter associated with one of fluid pressure and fluid volume (as discussed in paras [0048]-[0050], the pressure sensors associated with the irrigation and aspiration lines connected to the valves that sense the pressure in the lines and can operate the valve elements to change the aspiration or irrigation pressure within the lines).
A skilled artisan would have found it obvious at the time of the invention to modify at least one of the first valve and second valve, in the invention of Muri, to be responsive to at least one received signal indicative of at least one parameter associated with one of fluid pressure and fluid volume, as taught in Sorensen, in order to lessen an effect of a post occlusion break surge and to permit selective and dynamic control of aspiration and irrigation levels within the aspiration and irrigation lines based on use preference, thereby providing quicker and more efficient lens removal (see Sorensen at para [0050]).
Further, it is noted that Muri does not appear to disclose that the first valve has a third connection to a first line, and wherein the first valve is configured to connect the first line to the irrigation tank and connect the first line to the fluid source.
Sorensen discloses a system for selectively moving irrigation and aspiration valve elements in aspiration and irrigation conduits, comprising a first valve 464 (see Fig. 8) that has a connection to an irrigation tank (line 50; see Fig. 8); a second connection to an external fluid source 448 (via supply line 473; see Fig. 8); and a third connection to a first line (shunt line 476; see Fig. 8). Sorensen discloses that the valve is configured to connect the first line to the irrigation tank (see para [0071], disclosing aligning second arm 474b with first line 476 and third arm 464c with tank 50) and connect the first line to the fluid source (see para [0071], disclosing aligning first branch 474a with shunt line 476 and third branch 474c with external fluid source 473).
A skilled artisan would have found it obvious at the time of the invention to modify the first valve of Muri to have a third connection to a first line, and wherein the first valve is configured to connect the first line to the irrigation tank and connect the first line to the fluid source, as taught in Sorensen, in order to permit the valve to be used for priming of the external fluid source and the pressure sensor, with a reasonable expectation of success (see Sorensen at para [0071]).
Regarding claim 20, Muri discloses that fluid level in the fluid source 56 is associated with vacuum pressure (see col. 9, lines 19-21).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered, but are moot in view of the new grounds of rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 06/09/2026