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 .
Claim Objections
Claim 2 is objected to for reciting the limitation “at least one of the deformable channels is fluidly connected to a respective one of the plurality of curved rigid fluid channels by one or more ports”. This language could be unclear as it suggests that more than one deformable channel could be fluidly connected to one rigid fluid channel by more than one port.
For examination purposes, the limitation will be interpreted to mean that each of the plurality of deformable channels is to a respective curved rigid fluid channel by a port.
Claim 3 is objected to for reciting “at least one of the plurality of rigid fluid channels comprises a respective port.” This language could be unclear as it suggests that one of the plurality of rigid fluid channels comprises a port, while another of the plurality of rigid fluid channels does not comprise a port. For examination purposes, the limitation will be interpreted to mean that each of the plurality of curved rigid channels comprises a port.
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 1, 12 and all claims depending therefrom 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.
Regarding claims 1 and 12, the new matter is at least one level sensing device in communication with the first fluid tank or second fluid tank. Although Fig. 2 of the specification illustrates a system with an irrigation level sensor 211 and an aspiration level sensor 210, neither of these sensors is part of the cassette as required by the claimed invention. Further, no other part of the specification refers to a cassette comprising a level sensing device and being in communication with the first fluid tank or the second fluid tank.
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, 12-16, 18, 19 and 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Cull (U.S. Pub. 2005/0245888 A1, hereinafter “Cull”) in view of Gordon (U.S. Pat. 9,119,701 B2, hereinafter “Gordon”), further in view of Sorensen (U.S. Pub. 2010/0286651 A1, hereinafter “Sorensen”).
Regarding claim 1, Cull discloses a cassette 10 (Fig. 3) for distributing fluid during a surgical procedure, comprising:
a first fluid tank 36 (Fig. 1) and a second fluid tank (22 or 24; Fig. 3);
a plurality of rigid fluid channels (including but not limited to the various rigid paths within tank 22 leading to tank 24, and/or the rigid paths within tank 24, and/or the rigid paths within tank 36; these paths are interpreted to be rigid channels since they are defined by the rigid material of the cassette housing 12),
at least two valves (pinch valves each associated with conduits 24, 28, 42 and 44; paras [0015], [0018] and [0019]);
a pressure sensor 34 (Fig. 3 and para [0017]) in fluid communication with at least one of the plurality of fluid channels (pressure sensor 34 is in fluid communication with the channel 28; Fig. 3) and in fluid communication with the second tank (para [0017]);
at least one level sensing device in communication with the first fluid tank or the second fluid tank (floats 30 and 32 communicating with optical sensors to activate the peristaltic pump 60 to pump fluid from the portion of the cassette where the floats are located and into collection chamber 24; these floats are shown to be in fluid communication with the second fluid tank 22 or 24),
wherein the first fluid tank is in communication with a fluid source external to the cassette (first fluid tank 36 communicates to external fluid source via irrigation line 52; para [0025]).
It is noted that Cull does not appear to disclose another pressure sensor in fluid communication with the first tank 36.
Gordon discloses a cassette for distributing fluid during a surgical procedure, comprising a pressure sensor 1130 (Fig. 1) located in the cassette to measure the pressure of an irrigation path therein (col. 5, lines 25-30). The pressure sensor communicates with a controller to determine whether the measured pressure is at or below a desired pressure or within a pre-established desired pressure range (col. 6, lines 52-67).
A skilled artisan would have found it obvious at the time of the invention to modify the cassette of Cull to provide another pressure sensor in fluid communication with the first (irrigation) tank 36, in order to measure irrigation pressure for advantageously determining whether the measured pressure is at or below a desired pressure or within a pre-established desired pressure range (Gordon at col. 6, lines 52-67), thereby permitting a user to better control the irrigation of the fluid with a reasonable expectation of success.
Further, it is noted that Cull does not appear to disclose that the plurality of rigid fluid channels are curved; although the channels do route through the cassette in a tortuous way, the channels themselves have right angles and not curves.
Sorensen discloses a surgical peristaltic pump cassette, comprising a rigid cassette and a plurality of channels in the cassette, the channels being curved (see Fig. 4b, showing rigid substrate 105b with curved channels constructed therein).
A skilled artisan would have found it obvious at the time of the invention to modify the cassette of Cull so that the rigid fluid channels are curved, as taught in Sorensen, with a reasonable expectation of success. A skilled artisan would have had no reason to suspect that channels modified to be curved, in the manner shown in Sorensen (for example) would have had any meaningful deleterious effect on the flow of fluid through the cartridge; the predictability of the technology could have led the skilled artisan to modify the rigid channels in Cull to be curved; and Applicant has not presented any evidence that making its channels curved has any criticality or has solved a problem known to exist in the art at the time of the invention. For at least these reasons, modifying the channels of Cull to be curved instead of at strictly right angles would have been a matter of engineering choice in the absence of a new and unexpected result. See In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965).
Regarding claim 2, Cull discloses a plurality of deformable channels 26, 28, 42 and 44 (Fig. 3; para [0022] discloses that channels 26, 28, 42 and 44 are “compliant”), and for the purpose of examination the claim is interpreted to mean that at least one deformable channel is fluidly connected to a respective one of the rigid fluid channels by a port (channel 26 fluidly connects to rigid channels in tank 22 to those in tank 24; channel 28 fluidly connects the rigid channels in the tank 22 to the peristaltic pump but is normally closed in the pump’s operating mode to prevent fluid in the tank 22 from entering into the pump itself; channel 42 is a venting conduit that fluidly connects rigid channels within tank 36 to those within tank 22; and channel 44 is an irrigation conduit that fluidly connects the rigid channels within tank 36; each of these channels is understood to have a port on either end to permit fluid to flow through the deformable channels).
Regarding claim 3, Cull discloses that the plurality of rigid fluid channels comprise one or more ports (for the purpose of examination, this limitation is interpreted to mean at least one of the rigid channels comprises a port; in Cull, each channel is understood to have a port to permit fluid to flow from the rigid channel to the deformable channels to which they are connected).
Regarding claim 4, Cull discloses that the plurality of rigid fluid channels are nonlinear (Figs. 2 and 3; the rigid channels have turns to permit fluid to travel non-linearly through the rigid channels).
Regarding claim 5, Cull discloses that the valves are mechanically operable by a surgical console (para [0022] discloses that the valves could include baffles that would be manipulated by mating mechanisms in a pump console containing cassette 10).
Regarding claim 6, Cull discloses that the at least two valves comprise at least one stop (Cull discloses that the at least two valves comprise at least one stop (the pinch valves disclosed in Cull are known by those of ordinary skill in the art to have two stops on either side of the compliant tubing that pinch the tubing together to control the flow of fluid).
Regarding claims 12 and 14, Cull discloses a cassette 10 (Fig. 3) for use with a surgical console, comprising:
a first fluid tank 36 (Fig. 1) and a second fluid tank (22 or 24; Fig. 3);
a first set of fluid channels (such as the rigid paths within tank 36; these paths are interpreted to be rigid channels since they are defined by the rigid material of the cassette housing 12),
a second set of fluid channels (such as the rigid paths within tank 22 leading to tank 24, and/or the rigid paths within tank 24; these paths are interpreted to be rigid channels since they are defined by the rigid material of the cassette housing 12) having a first set of ports (each channel is understood to have a port to permit fluid to flow from the rigid channel to the deformable channels to which they are connected);
a first valve (pinch valve associated with either channel 42 or 44) in fluid communication with the first set of fluid channels (Fig. 3);
a second valve (pinch valve associated with either channel 26 or 28) in fluid communication with the second set of fluid channels (Fig. 3);
at least one level sensing device in communication with the first fluid tank or the second fluid tank (floats 30 and 32 communicating with optical sensors to activate the peristaltic pump 60 to pump fluid from the portion of the cassette where the floats are located and into collection chamber 24; these floats are shown to be in fluid communication with the second fluid tank 22 or 24);
a pressure sensor 34 (Fig. 3 and para [0017]) in fluid communication with at least one of the plurality of fluid channels (pressure sensor 34 is in fluid communication with the channel 28; Fig. 3) and in fluid communication with the second tank (para [0017]);
and
a plurality of deformable channels 26, 28, 42 and 44 (Fig. 3; para [0022] discloses that channels 26, 28, 42 and 44 are “compliant”);
wherein the deformable channels are fluidly connected to ones of the first set of ports and the second set of ports (channel 26 fluidly connects to rigid channels in tank 22 to those in tank 24; channel 28 fluidly connects the rigid channels in the tank 22 to the peristaltic pump but is normally closed in the pump’s operating mode to prevent fluid in the tank 22 from entering into the pump itself; channel 42 is a venting conduit that fluidly connects rigid channels within tank 36 to those within tank 22; and channel 44 is an irrigation conduit that fluidly connects the rigid channels within tank 36; each of these channels is understood to have a port on either end to permit fluid to flow through the deformable channels);
wherein the first fluid tank 22 is in communication with a fluid source 14 external to the cassette (i.e., the fluid tank 22 is in communication with the inlet 32 which receives fluid from a source outside the cassette; see col. 4, lines 9-11).
It is noted that Cull does not appear to disclose another pressure sensor in fluid communication with the first tank 36.
Gordon discloses a cassette for distributing fluid during a surgical procedure, comprising a pressure sensor 1130 (Fig. 1) located in the cassette to measure the pressure of an irrigation path therein (col. 5, lines 25-30). The pressure sensor communicates with a controller to determine whether the measured pressure is at or below a desired pressure or within a pre-established desired pressure range (col. 6, lines 52-67).
A skilled artisan would have found it obvious at the time of the invention to modify the cassette of Cull to provide another pressure sensor in fluid communication with the first (irrigation) tank 36, in order to measure irrigation pressure for advantageously determining whether the measured pressure is at or below a desired pressure or within a pre-established desired pressure range (Gordon at col. 6, lines 52-67), thereby permitting a user to better control the irrigation of the fluid with a reasonable expectation of success.
Further, it is noted that Cull does not appear to disclose that the first and second set of rigid fluid channels are curved; although the channels do route through the cassette in a tortuous way, the channels themselves have right angles and not curves.
Sorensen discloses a surgical peristaltic pump cassette, comprising a rigid cassette and a plurality of channels in the cassette, the channels being curved (see Fig. 4b, showing rigid substrate 105b with curved channels constructed therein).
A skilled artisan would have found it obvious at the time of the invention to modify the cassette of Cull so that the rigid fluid channels are curved, as taught in Sorensen, with a reasonable expectation of success. A skilled artisan would have had no reason to suspect that channels modified to be curved, in the manner shown in Sorensen (for example) would have had any meaningful deleterious effect on the flow of fluid through the cartridge; the predictability of the technology could have led the skilled artisan to modify the rigid channels in Cull to be curved; and Applicant has not presented any evidence that making its channels curved has any criticality or has solved a problem known to exist in the art at the time of the invention. For at least these reasons, modifying the channels of Cull to be curved instead of at strictly right angles would have been a matter of engineering choice in the absence of a new and unexpected result. See In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965).
Regarding claim 13, Cull shows that the plurality of deformable channels and the first set of fluid channels and the second set of fluid channels do not intersect (although the channels communicate with one another, they do not intersect).
Regarding claim 15, Cull discloses that the valves are mechanically operable by a surgical console (para [0022] discloses that the valves could include baffles that would be manipulated by mating mechanisms in a pump console containing cassette 10).
Regarding claim 16, Cull discloses that the at least two valves comprise at least one stop (the pinch valves disclosed in Cull are known by those of ordinary skill in the art to have two stops on either side of the compliant tubing that pinch the tubing together to control the flow of fluid).
Regarding claims 18 and 19, the combination of Cull and Gordon discloses that both the first and second set of fluid channels is in fluid communication with a pressure sensing device (interpreted to mean that the first set of fluid channels is in fluid communication with one of the first or second pressure sensor, and the second set of fluid channels is in fluid communication with the other of the first or second pressure sensor; in Cull the first pressure sensor 34 is in fluid communication with the second set of channels, and it would have been obvious to incorporate the second pressure sensor to be in fluid communication with the first set of channels (via communication with the tank 36 which communicates with the first set of channels).
Regarding claims 23 and 25, Cull discloses that the first fluid tank is an irrigation tank (para [0019]).
Regarding claims 24 and 26, Cull discloses that the second fluid tank is a vacuum tank (para [0021]-[0022]).
Claims 10, 11, 20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Cull in view of Gordon, and further in view of Sorensen, further in view of Beuchat (U.S. Pat. 5,267,956, hereinafter “Beuchat”).
Regarding claims 10 and 20, it is noted that Cull, in view of Gordon and Sorensen, does not appear to disclose a filter for hydrophobic filtering of air in the cassette.
Beuchat discloses a cassette in the analogous art to Applicant’s invention, comprising a filter 515 for hydrophobic filtering of air in the cassette (see col. 7, lines 30-37).
A skilled artisan would have found it obvious at the time of the invention to modify the invention of Cull, in view of Gordon and Sorensen, to incorporate a filter for hydrophobic filtering of air in the cassette (as taught in Beuchat at col. 7, lines 30-37), in order to prevent fluid from undesirably reaching the pump mechanism.
Regarding claim 11 and 22, it is noted that Cull, in view of Gordon, does not appear to disclose that the at least two valves are rotary valves.
Beuchat discloses, in the cassette, at least two valves 546, 558 (Fig. 8; see also col. 7, lines 65-66 disclosing that valve 546 is an irrigation fluid valve, and col.8, line 46 disclosing that valve 558 is a vent valve), and the at least two valves are rotary valves, such as stopcocks. Specifically, Beuchat discloses that both valves 546, 554 can have the same design as valve 526 in another embodiment, where valve 526 can be a stopcock, a known type of rotary valve (see col. 7, lines 8-13 describing valve 526; col. 7, line 39 disclosing that valve 546 is similar in design to valve 526; and col. 8, lines 13-15 disclosing that valve 558 is similar in design to valves 526 and 546).
A skilled artisan would have found it obvious at the time of the invention to modify the valves of Cull and Gordon to be rotary valves, as doing so would merely involve substituting one type of valve with another type of valve for the same purpose, with a reasonable expectation of success.
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered, but are moot in view of the new grounds of rejection.
Conclusion
THIS ACTION IS MADE FINAL. 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 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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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 01/26/2026