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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 7th, 2025 has been entered.
Response to Arguments
Applicant’s arguments, see pages 8-14, filed November 7th, 2025, with respect to the rejection(s) of claim(s) 1, 9 &16 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art that teaches the newly disclosed claim limitations.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 6-9, 11-18 & 22 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “the heated second portion of the fluid” in line 28. There is insufficient antecedent basis for this limitation in the claim.
Claims 6-8 are also rejected by virtue of their dependency on claim 1.
Claim 9 recites the limitation “the heated second portion of the fluid” in lines 24-25. There is insufficient antecedent basis for this limitation in the claim.
Claims 11-15 are also rejected by virtue of their dependency on claim 9.
Claim 16 recites the limitation “the heated second portion of the fluid” in lines 23-24. There is insufficient antecedent basis for this limitation in the claim.
Claims 17-18 & 22 are also rejected by virtue of their dependency on claim 16.
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.
Claims 1, 6-9 & 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bourne et al. (U.S. Pub. No. 20110144632, cited in IDS), herein referred to as “Bourne” in view of Winkler et al. (U.S. Pat. No. 6827142, previously cited), herein referred to as “Winkler”, Zhang et al. (U.S. Pub. No. 20240050142, earliest effective filing date & previously cited), herein referred to as “Zhang” and Flom et al. (U.S. Pat. No. 5830214), herein referred to as “Flom”.
Regarding claim 1, Bourne discloses an irrigation device (Title: Flooded Liquefaction Hand Piece Engine) comprising:
a housing (handpiece body 102) configured to be handheld (wherein a handpiece is seen as something configured to be handheld);
an inlet (fluid inlet port 121) configured to receive a fluid ([0016]: deliver fluid to a fluid inlet port 121 on the hand piece 100), the inlet disposed at a proximal portion of the housing ([0016]: A fluid source 115 may couple to one end of the hand piece body 102 (e.g., tubing from a surgical console may deliver fluid to a fluid inlet port 121 on the hand piece 100));
a tube (tip 104) comprising a single irrigation lumen (lumen of tip 104) and an outlet (outlet of tip 104), the tube disposed at a distal portion of the housing ([0017]: the single lumen tip 104 may provide both irrigation and fluidic pulses simultaneously through the same fluid pathway; see Fig. 1 where tip 104 is at a distal portion of handpiece body 102);
a first fluid line (flooded engine compartment 109) disposed inside the housing and downstream of the inlet (see Fig. 1 where 109 is downstream of 115), the first fluid line terminating upstream of the single irrigation lumen and configured to receive a first portion of the fluid from the inlet and deliver the first portion of the fluid to the single irrigation lumen ([0017]: surgical fluid may flow through the flooded engine compartment 109 and through the irrigation pathway 107 and recombine with the surgical fluid pulse (exiting from the pulse chamber 103) in a merging chamber 112 that joins the irrigation pathway 107 and the exit pulse pathway 112; see Fig. 1 where 109 terminates upstream of tip 104);
a second fluid line (exit pulse pathway 110/pulse chamber 103) disposed inside the housing and downstream of the inlet (see Fig. 1 where 110/103 is downstream of 115), the second fluid line terminating upstream of the single irrigation lumen and configured to receive a second portion of the fluid from the inlet and deliver the second portion of the fluid to the single irrigation lumen ([0017]: fluid pulse from the pulse chamber 103 and the fluid from the flooded engine compartment 109 may be delivered through a tip 104; see Fig. 1 where 110/103 terminates upstream of tip 104);
a heater (electrodes 106/108) disposed inside the housing ([0016]: As seen in FIG. 1, pulse chamber 103 may be sealed on both sides by electrodes 106 and 108), the heater configured to heat the second portion of the fluid flowing through the second fluid line such that a temperature of the second portion of the fluid at the outlet is within a range ([0016]: Surgical fluid (e.g., saline irrigating solution) from the fluid source 115 may enter the pulse chamber 103 from the inlet pulse pathway 105 after passing through the check valve 111. Electrical current from the electrodes 106 and 108 may travel through the surgical fluid causing it to boil (electrical current may be provided, for example, from a surgical console to the handpiece 100 through a power cable). The surgical fluid may then expand rapidly out of the pulse chamber 103 and into the exit pulse pathway 110); and
a valve (check valve 111) disposed inside the housing ([0016]: hand piece body 102 may include … check valve 111), and upstream of the single irrigation lumen ([0016]: Surgical fluid (e.g., saline irrigating solution) from the fluid source 115 may enter the pulse chamber 103 from the inlet pulse pathway 105 after passing through the check valve 111 … surgical fluid may then expand rapidly out of the pulse chamber 103 and into the exit pulse pathway 110; see Fig. 1 where 111 is upstream of tip 104),
wherein the single irrigation lumen of the tube is configured to switch between directing the second portion of the fluid through the outlet at a lens within a capsular bag of an eye to emulsify the lens ([0017]: The heated, pulsed fluid exiting the tip 104 may be useful, for example, in removing residual cataract debris inside a capsular bag of the eye post-lens nucleus removal) and directing the first portion of the fluid through the outlet and into the capsular bag ([0017]: The heated, pulsed fluid exiting the tip 104 may be useful, for example, in removing residual cataract debris inside a capsular bag of the eye post-lens nucleus removal; [0006]: heated pulses from the pulse chamber and cooler fluid from the flooded engine compartment may flow through a tip into the eye; wherein this describes an apparatus capable of directing cooler fluid/fluid from the first portion of the fluid into the capsular bag).
But Bourne fails to disclose:
a temperature sensor;
a valve disposed downstream of the heater;
wherein the temperature sensor is disposed at the second fluid line downstream of the heater and upstream of the valve.
However, Winkler discloses:
a first fluid line (see Fig. 4 with fluid line comprising valve 450) configured to receive a first portion of the fluid from the inlet and deliver the first portion of the fluid to the single irrigation lumen (see Fig. 4 where the fluid line flows from reservoir 402 through valve 450 to heat-load 406);
a second fluid line (see Fig. 4 with fluid line that passes through heater 434) configured to receive a second portion of the fluid from the inlet and deliver the second portion of the fluid to the single irrigation lumen (see Fig. 4 where the fluid line flows from reservoir 402 through the heater 434 to heat-load 406);
a temperature sensor (temperature sensor 442);
a heater (heater 434) configured to heat the second portion of the fluid flowing through the second fluid line such that a temperature of the second portion of the fluid at the outlet is within a range (Col. 6, lines 14-15: A heater 434 contains fluid that is maintained above the final temperature setpoint),
a valve (valve 448) disposed downstream of the heater (see Fig. 4 where valve 448 is downstream of heater 434);
wherein the temperature sensor (temperature sensor 442) is disposed at the second fluid line downstream of the heater and upstream of the valve (see Fig. 4 where temperature sensor 442 is downstream of heater 434 and upstream of valve 448);
wherein the single irrigation lumen of the tube is configured to switch between directing the second portion of the fluid through the outlet and directing the first portion of the fluid through the outlet (see Fig. 4 where the heat load (point of use) is a singular endpoint for the fluid flow such that this is seen as a single irrigation lumen of the tube is configured to switch between directing the second portion of the fluid through the outlet and directing the first portion of the fluid through the outlet).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the irrigation device of Bourne to comprise the elements and configuration of Winkler for the purpose of achieving precision temperature control of fluids (Winkler: Col. 5, line 50). Wherein in this modification, Winkler is only relied upon to teach the locations of a temperature sensor, valve and heater relative to each other.
But Bourne in view of Winkler fails to disclose wherein the second fluid line is coiled around the heater.
However, Zhang discloses wherein the second fluid line is coiled around the heater ([0074]: the input conduit 306 may be configured as a loop or helix to wrap around a heating element 308; see Fig. 3). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the irrigation device of Bourne in view of Winkler to the heater configuration of Zhang for the purpose of enabling the heater to be positioned in the handle to allow the distal end to be heated without enlarging the size of the distal end (Zhang: [0052]).
But Bourne in view of Winkler and Zhang fail to disclose the valve on the first fluid line and the second fluid line, the first fluid line configured to direct the first portion of the fluid from the inlet to the valve, the second fluid line configured to direct the second portion of the fluid from the inlet to the valve, and the valve configured to switch between impeding the first portion of the fluid from flowing through the first fluid line to the single irrigation lumen and the second portion of the fluid from flowing through the second fluid line to the single irrigation lumen; wherein the first portion of the fluid and the heated second portion of the fluid do not mix within the housing or the tube.
However, Flom discloses the valve (switch 116) on the first fluid line (suction tube 122; wherein a suction line is also capable of fluid delivery since it is a fluid path & is not structurally defined by the fluid direction) and the second fluid line (irrigation tube 124), the first fluid line configured to direct the first portion of the fluid from the inlet to the valve (Col. 10, lines 3-6: Suction tube 122 is connected to manifold housing 152 at a suction port 154 and irrigation tube 124 is connected to manifold housing 152 at an irrigation port 156; see fluid path in Fig. 9A), the second fluid line configured to direct the second portion of the fluid from the inlet to the valve (Col. 10, lines 3-6: Suction tube 122 is connected to manifold housing 152 at a suction port 154 and irrigation tube 124 is connected to manifold housing 152 at an irrigation port 156; see fluid path in Fig. 9B), and the valve configured to switch between impeding the first portion of the fluid from flowing through the first fluid line to the single irrigation lumen and the second portion of the fluid from flowing through the second fluid line to the single irrigation lumen (Col. 9, lines 62-64: switch 116 again comprises a button 118, shaft 128, and biasing spring 120; lines 66-67 & Col. 10, lines 1-20: A manifold 144 is attached to the inner end of shaft 128, and includes a Y-shaped fluid pathway with a suction inlet 146, an irrigation fluid inlet 148, and an outlet 150. Manifold 144 is movably mounted within a manifold housing 152. Suction tube 122 is connected to manifold housing 152 at a suction port 154 and irrigation tube 124 is connected to manifold housing 152 at an irrigation port 156. Manifold 144 is movable between an upper position (FIG. 9A) wherein suction inlet 146 is aligned with suction port 154, and a lower position (FIG. 9B) wherein irrigation fluid inlet 148 is aligned with irrigation port 156. In either position, outlet 150 is aligned with an outlet port 168 in manifold housing 152, to which lumen 126 in shaft 104 is fluidly connected by means of an outlet tube 160. In operation, in the normally outward position of FIG. 9A, suction inlet 146 is aligned with suction port 154 allowing suction to be applied through outlet tube 160 and shaft 104. In this position, irrigation fluid inlet 148 is not aligned with irrigation port 156, preventing the flow of irrigation fluid. When button 118 is depressed as in FIG. 9B, irrigation fluid inlet 148 is aligned with irrigation port 156, allowing irrigation fluid to flow through outlet tube 160 and shaft 104, while stopping suction); wherein the first portion of the fluid and the heated second portion of the fluid do not mix within the housing or the tube (Col. 10, lines 12-20: In operation, in the normally outward position of FIG. 9A, suction inlet 146 is aligned with suction port 154 allowing suction to be applied through outlet tube 160 and shaft 104. In this position, irrigation fluid inlet 148 is not aligned with irrigation port 156, preventing the flow of irrigation fluid. When button 118 is depressed as in FIG. 9B, irrigation fluid inlet 148 is aligned with irrigation port 156, allowing irrigation fluid to flow through outlet tube 160 and shaft 104, while stopping suction; see Figs. 9A&B where the fluid pathway results in the fluids staying separate in the housing 108 and tube 160).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the valve of Bourne in view of Winkler and Zhang to the valve of Flom for the purpose of enabling the irrigation port to be fluidly isolated from the inner lumen and the suction port is in fluid communication with the inner lumen and vice versa, the suction port to be fluidly isolated from the inner lumen and the irrigation port is in fluid communication with the inner lumen (Flom: Col. 2, lines 40-47). Wherein in this combination, Flom teaches a device with two fluid lines such that fluid lines are capable of fluid delivery or aspiration since fluid flow is not limited by direction. While Flom teaches the irrigation port to be fluidly isolated from the inner lumen and the suction port is in fluid communication with the inner lumen, the same fluid isolation would be true for two fluid delivery lines. Similarly, with Flom’s suction port being fluidly isolated from the inner lumen and the irrigation port is in fluid communication with the inner lumen, this structure would also work for two fluid delivery lines & fluid isolation.
Regarding claim 6, Bourne in view of Winkler, Zhang and Flom disclose wherein the valve (Flom: switch 116) comprises a spring (biasing spring 120) that biases the valve to a configuration that impedes the second portion of the fluid from flowing through the second fluid line to the single irrigation lumen and permits the first portion of the fluid to flow through the first fluid line to the single irrigation lumen (Col. 10, lines 12-20: In operation, in the normally outward position of FIG. 9A, suction inlet 146 is aligned with suction port 154 allowing suction to be applied through outlet tube 160 and shaft 104. In this position, irrigation fluid inlet 148 is not aligned with irrigation port 156, preventing the flow of irrigation fluid. When button 118 is depressed as in FIG. 9B, irrigation fluid inlet 148 is aligned with irrigation port 156, allowing irrigation fluid to flow through outlet tube 160 and shaft 104, while stopping suction).
Regarding claim 7, Bourne in view of Winkler, Zhang and Flom disclose a user interface (Flom: button 118) configured to be manipulated to overcome a biasing force of the spring to position the valve in another configuration that permits the second portion of the fluid to flow through the second fluid line to the single irrigation lumen and impedes the first portion of the fluid from flowing through the first fluid line to the single irrigation lumen (Col. 10, lines 12-20: In operation, in the normally outward position of FIG. 9A, suction inlet 146 is aligned with suction port 154 allowing suction to be applied through outlet tube 160 and shaft 104. In this position, irrigation fluid inlet 148 is not aligned with irrigation port 156, preventing the flow of irrigation fluid. When button 118 is depressed as in FIG. 9B, irrigation fluid inlet 148 is aligned with irrigation port 156, allowing irrigation fluid to flow through outlet tube 160 and shaft 104, while stopping suction).
Regarding claim 8, Bourne in view of Winkler discloses wherein the temperature sensor is disposed within a lumen of the second fluid line (Winkler: Col. 6, lines 15-16: A temperature sensor 442 senses the temperature exiting heater 434).
Regarding claim 9, Bourne discloses an irrigation device (Title: Flooded Liquefaction Hand Piece Engine) comprising:
a housing (handpiece body 102) configured to be handheld (wherein a handpiece is seen as something configured to be handheld);
an inlet (fluid inlet port 121) configured to receive a fluid ([0016]: deliver fluid to a fluid inlet port 121 on the hand piece 100), disposed at a proximal portion of the housing ([0016]: A fluid source 115 may couple to one end of the hand piece body 102 (e.g., tubing from a surgical console may deliver fluid to a fluid inlet port 121 on the hand piece 100));
a single irrigation outlet (tip 104) configured to deliver the fluid to within a capsular bag of an eye, the single irrigation outlet disposed at a distal portion of the housing ([0017]: the single lumen tip 104 may provide both irrigation and fluidic pulses simultaneously through the same fluid pathway … The heated, pulsed fluid exiting the tip 104 may be useful, for example, in removing residual cataract debris inside a capsular bag of the eye post-lens nucleus removal; see Fig. 1 where tip 104 is at a distal portion of handpiece body 102);
a first fluid line (flooded engine compartment 109) disposed inside the housing and downstream of the inlet (see Fig. 1 where 109 is downstream of 115), the first fluid line terminating upstream of the single irrigation outlet and configured to receive a first portion of the fluid from the inlet and direct the first portion of the fluid to the single irrigation outlet ([0017]: surgical fluid may flow through the flooded engine compartment 109 and through the irrigation pathway 107 and recombine with the surgical fluid pulse (exiting from the pulse chamber 103) in a merging chamber 112 that joins the irrigation pathway 107 and the exit pulse pathway 112; see Fig. 1 where 109 terminates upstream of tip 104);
a second fluid line (exit pulse pathway 110/pulse chamber 103) disposed inside the housing and downstream of the inlet (see Fig. 1 where 110/103 is downstream of 115), the second fluid line terminating upstream of the single irrigation outlet and configured to receive a second portion of the fluid from the inlet and direct the second portion of the fluid to the single irrigation outlet ([0017]: fluid pulse from the pulse chamber 103 and the fluid from the flooded engine compartment 109 may be delivered through a tip 104; see Fig. 1 where 110/103 terminates upstream of tip 104);
a heater (electrodes 106/108) disposed inside the housing ([0016]: As seen in FIG. 1, pulse chamber 103 may be sealed on both sides by electrodes 106 and 108), the heater configured to heat the second portion of the fluid flowing through the second fluid line ([0016]: Surgical fluid (e.g., saline irrigating solution) from the fluid source 115 may enter the pulse chamber 103 from the inlet pulse pathway 105 after passing through the check valve 111. Electrical current from the electrodes 106 and 108 may travel through the surgical fluid causing it to boil (electrical current may be provided, for example, from a surgical console to the handpiece 100 through a power cable). The surgical fluid may then expand rapidly out of the pulse chamber 103 and into the exit pulse pathway 110), and the first fluid line bypasses the heater (see Fig. 1 where flooded engine compartment 109 and exit pulse pathway 110/pulse chamber are two fluid lines in parallel that branch off from fluid inlet 121 & recombine at tip 104); and
a valve (check valve 111) disposed inside the housing ([0016]: hand piece body 102 may include … check valve 111), and upstream of the single irrigation outlet ([0016]: Surgical fluid (e.g., saline irrigating solution) from the fluid source 115 may enter the pulse chamber 103 from the inlet pulse pathway 105 after passing through the check valve 111 … surgical fluid may then expand rapidly out of the pulse chamber 103 and into the exit pulse pathway 110; see Fig. 1 where 111 is upstream of tip 104),
but Bourne fails to disclose a valve disposed downstream of the heater,
However, Winkler discloses:
a first fluid line (see Fig. 4 with fluid line comprising valve 450) configured to receive a first portion of the fluid from the inlet and direct the first portion of the fluid to the outlet (see Fig. 4 where the fluid line flows from reservoir 402 through valve 450 to heat-load 406);
a second fluid line (see Fig. 4 with fluid line that passes through heater 434) configured to receive a second portion of the fluid from the inlet and direct the second portion of the fluid to the outlet (see Fig. 4 where the fluid line flows from reservoir 402 through the heater 434 to heat-load 406);
a heater (heater 434) configured to heat the second portion of the fluid flowing through the second fluid line (Col. 6, lines 14-15: A heater 434 contains fluid that is maintained above the final temperature setpoint), wherein the second fluid line is disposed around the heater (see Fig. 4 where the heater is shown as being within the fluid line) and the first fluid line bypasses the heater (see Fig. 4 where the fluid line flows from reservoir 402 through valve 450 to heat-load 406),
a valve (valve 448) disposed downstream of the heater (see Fig. 4 where valve 448 is downstream of heater 434);
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the irrigation device of Bourne to comprise the elements of Winkler for the purpose of achieving precision temperature control of fluids (Winkler: Col. 5, line 50). Wherein in this modification, Winkler is only relied upon to teach the locations of a temperature sensor, valve and heater relative to each other.
But Bourne in view of Winkler fails to disclose wherein the second fluid line is disposed around the heater.
However, Zhang discloses wherein the second fluid line is disposed around the heater ([0074]: the input conduit 306 may be configured as a loop or helix to wrap around a heating element 308; see Fig. 3). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the irrigation device of Bourne in view of Winkler to the fluid line/heater configuration of Zhang for the purpose of enabling the heater to be positioned in the handle to allow the distal end to be heated without enlarging the size of the distal end (Zhang: [0052]).
But Bourne in view of Winkler and Zhang fails to disclose the valve on the first fluid line and the second fluid line, the first fluid line configured to direct the first portion of the fluid from the inlet to the valve, the second fluid line configured to direct the second portion of the fluid from the inlet to the valve, and the valve configured to switch between impeding the first portion of the fluid flowing downstream of the valve through the first fluid line to the single irrigation outlet and the second portion of the fluid flowing through the second fluid line to the single irrigation outlet wherein the valve is biased to impede the second portion of the fluid flowing through the second fluid line to the single irrigation outlet, and wherein the first portion of the fluid and the heated second portion of the fluid do not mix within the housing or the tube.
However, Flom discloses a valve (switch 116) on the first fluid line (suction tube 122; wherein a suction line is also capable of fluid delivery since it is a fluid path & is not structurally defined by the fluid direction) and the second fluid line (irrigation tube 124), the first fluid line configured to direct the first portion of the fluid from the inlet to the valve ((Col. 10, lines 3-6: Suction tube 122 is connected to manifold housing 152 at a suction port 154 and irrigation tube 124 is connected to manifold housing 152 at an irrigation port 156; see fluid path in Fig. 9A), the second fluid line configured to direct the second portion of the fluid from the inlet to the valve (Col. 10, lines 3-6: Suction tube 122 is connected to manifold housing 152 at a suction port 154 and irrigation tube 124 is connected to manifold housing 152 at an irrigation port 156; see fluid path in Fig. 9B), and the valve configured to switch between impeding the first portion of the fluid flowing downstream of the valve through the first fluid line to the single irrigation outlet and the second portion of the fluid flowing through the second fluid line to the single irrigation outlet wherein the valve is biased to impede the second portion of the fluid flowing through the second fluid line to the single irrigation outlet (Col. 9, lines 62-64: switch 116 again comprises a button 118, shaft 128, and biasing spring 120; lines 66-67 & Col. 10, lines 1-20: A manifold 144 is attached to the inner end of shaft 128, and includes a Y-shaped fluid pathway with a suction inlet 146, an irrigation fluid inlet 148, and an outlet 150. Manifold 144 is movably mounted within a manifold housing 152. Suction tube 122 is connected to manifold housing 152 at a suction port 154 and irrigation tube 124 is connected to manifold housing 152 at an irrigation port 156. Manifold 144 is movable between an upper position (FIG. 9A) wherein suction inlet 146 is aligned with suction port 154, and a lower position (FIG. 9B) wherein irrigation fluid inlet 148 is aligned with irrigation port 156. In either position, outlet 150 is aligned with an outlet port 168 in manifold housing 152, to which lumen 126 in shaft 104 is fluidly connected by means of an outlet tube 160. In operation, in the normally outward position of FIG. 9A, suction inlet 146 is aligned with suction port 154 allowing suction to be applied through outlet tube 160 and shaft 104. In this position, irrigation fluid inlet 148 is not aligned with irrigation port 156, preventing the flow of irrigation fluid. When button 118 is depressed as in FIG. 9B, irrigation fluid inlet 148 is aligned with irrigation port 156, allowing irrigation fluid to flow through outlet tube 160 and shaft 104, while stopping suction), and wherein the first portion of the fluid and the heated second portion of the fluid do not mix within the housing or the tube (Col. 10, lines 12-20: In operation, in the normally outward position of FIG. 9A, suction inlet 146 is aligned with suction port 154 allowing suction to be applied through outlet tube 160 and shaft 104. In this position, irrigation fluid inlet 148 is not aligned with irrigation port 156, preventing the flow of irrigation fluid. When button 118 is depressed as in FIG. 9B, irrigation fluid inlet 148 is aligned with irrigation port 156, allowing irrigation fluid to flow through outlet tube 160 and shaft 104, while stopping suction; see Figs. 9A&B where the fluid pathway results in the fluids staying separate in the housing 108 and tube 160).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the valve of Bourne in view of Winkler and Zhang to the valve of Flom for the purpose of enabling the irrigation port to be fluidly isolated from the inner lumen and the suction port is in fluid communication with the inner lumen and vice versa, the suction port to be fluidly isolated from the inner lumen and the irrigation port is in fluid communication with the inner lumen (Flom: Col. 2, lines 40-47). Wherein in this combination, Flom teaches a device with two fluid lines such that fluid lines are capable of fluid delivery or aspiration since fluid flow is not limited by direction. While Flom teaches the irrigation port to be fluidly isolated from the inner lumen and the suction port is in fluid communication with the inner lumen, the same fluid isolation would be true for two fluid delivery lines. Similarly, with Flom’s suction port being fluidly isolated from the inner lumen and the irrigation port is in fluid communication with the inner lumen, this structure would also work for two fluid delivery lines & fluid isolation.
Regarding claim 11, Bourne in view of Winkler, Zhang and Flom disclose wherein the valve is biased (Flom: biasing spring 120) to permit the first portion of the fluid to flow through the first fluid line to the single irrigation outlet (Col. 10, lines 12-20: In operation, in the normally outward position of FIG. 9A, suction inlet 146 is aligned with suction port 154 allowing suction to be applied through outlet tube 160 and shaft 104. In this position, irrigation fluid inlet 148 is not aligned with irrigation port 156, preventing the flow of irrigation fluid. When button 118 is depressed as in FIG. 9B, irrigation fluid inlet 148 is aligned with irrigation port 156, allowing irrigation fluid to flow through outlet tube 160 and shaft 104, while stopping suction).
Regarding claim 12, Bourne in view of Winkler, Zhang and Flom disclose a user interface (Flom: button 118) that is configured to be manipulated to overcome a biasing force of the valve to permit the second portion of the fluid to flow through the second fluid line to the single irrigation outlet (Col. 10, lines 12-20: In operation, in the normally outward position of FIG. 9A, suction inlet 146 is aligned with suction port 154 allowing suction to be applied through outlet tube 160 and shaft 104. In this position, irrigation fluid inlet 148 is not aligned with irrigation port 156, preventing the flow of irrigation fluid. When button 118 is depressed as in FIG. 9B, irrigation fluid inlet 148 is aligned with irrigation port 156, allowing irrigation fluid to flow through outlet tube 160 and shaft 104, while stopping suction).
Regarding claim 13, Bourne in view of Winkler and Flom fail to disclose wherein the second fluid line is coiled around the heater.
However, Zhang discloses wherein the second fluid line is coiled around the heater ([0074]: the input conduit 306 may be configured as a loop or helix to wrap around a heating element 308; see Fig. 3). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the irrigation device of Bourne in view of Winkler and Reid to fluid line/heater configuration of Zhang for the purpose of enabling the heater to be positioned in the handle to allow the distal end to be heated without enlarging the size of the distal end (Zhang: [0052]).
Regarding claim 14, Bourne fails to disclose a temperature sensor disposed at the single irrigation outlet.
However, Winkler discloses a temperature sensor (temperature sensor 442) disposed at the single irrigation outlet (wherein the fluid path exiting from heater 434 is seen as the outlet). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the device of Bourne to include the temperature sensor of Winkler for the purpose of achieving precision temperature control of fluids (Winkler: Col. 5, line 50).
Regarding claim 15, Bourne fails to disclose wherein the heater is configured to adjust energy output based on a temperature sensed by the temperature sensor.
However, Winkler discloses wherein the heater (heater 434) is configured to adjust energy output based on a temperature sensed by the temperature sensor (temperature sensor 442; Col. 6, lines 15-21: A temperature sensor 442 senses the temperature exiting heater 434 and feeds the value to a heater temperature controller 444. Heater temperature controller 444 compares its setpoint to the value returned by sensor 442, and controls the amount of heating provided by heater 434). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the heater of Bourne to the heater and heater control of Winkler for the purpose of achieving precision temperature control of fluids (Winkler: Col. 5, line 50).
Claims 16-17 & 22 are rejected under 35 U.S.C. 103 as being unpatentable over Bourne in view of Winkler and Flom.
Regarding claim 16, Bourne discloses an irrigation device (Title: Flooded Liquefaction Hand Piece Engine) comprising:
a housing (handpiece body 102) configured to be handheld (wherein a handpiece is seen as something configured to be handheld);
an inlet (fluid inlet port 121) configured to receive a fluid ([0016]: deliver fluid to a fluid inlet port 121 on the hand piece 100), the inlet disposed at a proximal portion of the housing ([0016]: A fluid source 115 may couple to one end of the hand piece body 102 (e.g., tubing from a surgical console may deliver fluid to a fluid inlet port 121 on the hand piece 100));
a tube (tip 104) comprising a single irrigation lumen (lumen of tip 104) and an outlet (outlet of 104) configured to deliver the fluid to a lens within a capsular bag of an eye, the tube disposed at a distal portion of the housing ([0017]: the single lumen tip 104 may provide both irrigation and fluidic pulses simultaneously through the same fluid pathway … The heated, pulsed fluid exiting the tip 104 may be useful, for example, in removing residual cataract debris inside a capsular bag of the eye post-lens nucleus removal; see Fig. 1 where tip 104 is at a distal portion of handpiece body 102);
a first fluid line (flooded engine compartment 109) disposed inside the housing and downstream of the inlet (see Fig. 1 where 109 is downstream of 115), the first fluid line terminating upstream of the single irrigation lumen and configured to receive a first portion of the fluid from the inlet and deliver the first portion of the fluid to the single irrigation lumen ([0017]: surgical fluid may flow through the flooded engine compartment 109 and through the irrigation pathway 107 and recombine with the surgical fluid pulse (exiting from the pulse chamber 103) in a merging chamber 112 that joins the irrigation pathway 107 and the exit pulse pathway 112; see Fig. 1 where 109 terminates upstream of tip 104);
a second fluid line (exit pulse pathway 110/pulse chamber 103) disposed inside the housing and downstream of the inlet (see Fig. 1 where 110/103 is downstream of 115), the second fluid line terminating upstream of the single irrigation lumen and configured to receive a second portion of the fluid from the inlet and deliver the second portion of the fluid to the single irrigation lumen ([0017]: fluid pulse from the pulse chamber 103 and the fluid from the flooded engine compartment 109 may be delivered through a tip 104; see Fig. 1 where 110/103 terminates upstream of tip 104);
a heater (electrodes 106/108) disposed inside the housing ([0016]: As seen in FIG. 1, pulse chamber 103 may be sealed on both sides by electrodes 106 and 108), the heater configured to heat the second portion of the fluid in the second fluid line to a temperature ([0016]: Surgical fluid (e.g., saline irrigating solution) from the fluid source 115 may enter the pulse chamber 103 from the inlet pulse pathway 105 after passing through the check valve 111. Electrical current from the electrodes 106 and 108 may travel through the surgical fluid causing it to boil (electrical current may be provided, for example, from a surgical console to the handpiece 100 through a power cable). The surgical fluid may then expand rapidly out of the pulse chamber 103 and into the exit pulse pathway 110), wherein the first fluid line bypasses the heater (see Fig. 1 where flooded engine compartment 109 and exit pulse pathway 110/pulse chamber are two fluid lines in parallel that branch off from fluid inlet 121 and recombine at tip 104); and
a valve (check valve 111) disposed inside the housing ([0016]: hand piece body 102 may include … check valve 111), and upstream of the single irrigation lumen ([0016]: Surgical fluid (e.g., saline irrigating solution) from the fluid source 115 may enter the pulse chamber 103 from the inlet pulse pathway 105 after passing through the check valve 111 … surgical fluid may then expand rapidly out of the pulse chamber 103 and into the exit pulse pathway 110; see Fig. 1 where 111 is upstream of tip 104).
but Bourne fails to disclose a valve disposed downstream of the heater,
However, Winkler discloses:
a first fluid line (see Fig. 4 with fluid line comprising valve 450) configured to receive a first portion of the fluid from the inlet and deliver the first portion of the fluid to the single irrigation lumen (see Fig. 4 where the fluid line flows from reservoir 402 through valve 450 to heat-load 406);
a second fluid line (see Fig. 4 with fluid line that passes through heater 434) configured to receive a second portion of the fluid from the inlet and deliver the second portion of the fluid to the single irrigation lumen (see Fig. 4 where the fluid line flows from reservoir 402 through the heater 434 to heat-load 406);
a heater (heater 434) configured to heat the second portion of the fluid in the second fluid line to a temperature (Col. 6, lines 14-15: A heater 434 contains fluid that is maintained above the final temperature setpoint), wherein the first fluid line bypasses the heater (see Fig. 4 where the fluid line flows from reservoir 402 through valve 450 to heat-load 406),
a valve (valve 448) disposed downstream of the heater (see Fig. 4 where valve 448 is downstream of heater 434).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the irrigation device of Bourne to comprise the elements of Winkler for the purpose of achieving precision temperature control of fluids (Winkler: Col. 5, line 50). Wherein in this modification, Winkler is only relied upon to teach the locations of a temperature sensor, valve and heater relative to each other.
But Bourne in view of Winkler fail to disclose the valve on the first fluid line and the second fluid line, the valve configured to selectively impede the first portion of the fluid from flowing through the first fluid line to the single irrigation lumen and the second portion of the fluid from flowing through the second fluid line to the single irrigation lumen, wherein the valve is configured to simultaneously impede the first portion of the fluid flowing downstream of the valve while permitting the second portion of the fluid to flow downstream of the valve, and wherein the first portion of the fluid and the heated second portion of the fluid do not mix within the housing or the tube.
However, Flom discloses a valve (switch 116) on the first fluid line (suction tube 122; wherein a suction line is also capable of fluid delivery since it is a fluid path & is not structurally defined by the fluid direction) and the second fluid line (irrigation tube 124), the valve configured to selectively impede the first portion of the fluid from flowing through the first fluid line to the single irrigation lumen and the second portion of the fluid from flowing through the second fluid line to the single irrigation lumen, wherein the valve is configured to simultaneously impede the first portion of the fluid flowing downstream of the valve while permitting the second portion of the fluid to flow downstream of the valve (Col. 9, lines 62-64: switch 116 again comprises a button 118, shaft 128, and biasing spring 120; lines 66-67 & Col. 10, lines 1-20: A manifold 144 is attached to the inner end of shaft 128, and includes a Y-shaped fluid pathway with a suction inlet 146, an irrigation fluid inlet 148, and an outlet 150. Manifold 144 is movably mounted within a manifold housing 152. Suction tube 122 is connected to manifold housing 152 at a suction port 154 and irrigation tube 124 is connected to manifold housing 152 at an irrigation port 156. Manifold 144 is movable between an upper position (FIG. 9A) wherein suction inlet 146 is aligned with suction port 154, and a lower position (FIG. 9B) wherein irrigation fluid inlet 148 is aligned with irrigation port 156. In either position, outlet 150 is aligned with an outlet port 168 in manifold housing 152, to which lumen 126 in shaft 104 is fluidly connected by means of an outlet tube 160. In operation, in the normally outward position of FIG. 9A, suction inlet 146 is aligned with suction port 154 allowing suction to be applied through outlet tube 160 and shaft 104. In this position, irrigation fluid inlet 148 is not aligned with irrigation port 156, preventing the flow of irrigation fluid. When button 118 is depressed as in FIG. 9B, irrigation fluid inlet 148 is aligned with irrigation port 156, allowing irrigation fluid to flow through outlet tube 160 and shaft 104, while stopping suction), and wherein the first portion of the fluid and the heated second portion of the fluid do not mix within the housing or the tube (Col. 10, lines 12-20: In operation, in the normally outward position of FIG. 9A, suction inlet 146 is aligned with suction port 154 allowing suction to be applied through outlet tube 160 and shaft 104. In this position, irrigation fluid inlet 148 is not aligned with irrigation port 156, preventing the flow of irrigation fluid. When button 118 is depressed as in FIG. 9B, irrigation fluid inlet 148 is aligned with irrigation port 156, allowing irrigation fluid to flow through outlet tube 160 and shaft 104, while stopping suction; see Figs. 9A&B where the fluid pathway results in the fluids staying separate in the housing 108 and tube 160).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the valve of Bourne in view of Winkler to the valve of Flom for the purpose of enabling the irrigation port to be fluidly isolated from the inner lumen and the suction port is in fluid communication with the inner lumen and vice versa, the suction port to be fluidly isolated from the inner lumen and the irrigation port is in fluid communication with the inner lumen (Flom: Col. 2, lines 40-47). Wherein in this combination, Flom teaches a device with two fluid lines such that fluid lines are capable of fluid delivery or aspiration since fluid flow is not limited by direction. While Flom teaches the irrigation port to be fluidly isolated from the inner lumen and the suction port is in fluid communication with the inner lumen, the same fluid isolation would be true for two fluid delivery lines. Similarly, with Flom’s suction port being fluidly isolated from the inner lumen and the irrigation port is in fluid communication with the inner lumen, this structure would also work for two fluid delivery lines & fluid isolation.
Regarding claim 17, Bourne fails to disclose a temperature sensor at the outlet, wherein the heater is configured to adjust energy output based on a sensed temperature at the outlet.
However, Winkler discloses a temperature sensor (temperature sensor 442) at the outlet (wherein the fluid path exiting from heater 434 is seen as the outlet), wherein the heater is configured to adjust energy output based on a sensed temperature at the outlet (Col. 6, lines 15-21: A temperature sensor 442 senses the temperature exiting heater 434 and feeds the value to a heater temperature controller 444. Heater temperature controller 444 compares its setpoint to the value returned by sensor 442, and controls the amount of heating provided by heater 434). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the heater of Bourne to the heater and heater control of Winkler for the purpose of achieving precision temperature control of fluids (Winkler: Col. 5, line 50).
Regarding claim 22, Bourne in view of Winkler and Flom disclose wherein the valve (Flom: switch 116) comprises a spring (biasing spring 118) that biases the valve to a configuration that impedes the second portion of the fluid flowing through the second fluid line to the single irrigation lumen and permits the first portion of the fluid to flow through the first fluid line to the single irrigation lumen (Col. 10, lines 12-20: In operation, in the normally outward position of FIG. 9A, suction inlet 146 is aligned with suction port 154 allowing suction to be applied through outlet tube 160 and shaft 104. In this position, irrigation fluid inlet 148 is not aligned with irrigation port 156, preventing the flow of irrigation fluid. When button 118 is depressed as in FIG. 9B, irrigation fluid inlet 148 is aligned with irrigation port 156, allowing irrigation fluid to flow through outlet tube 160 and shaft 104, while stopping suction).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Bourne in view of Winkler and Flom, as applied to claim 16, and further in view of Zhang
Regarding claim 18, Bourne fails to disclose wherein the second fluid line is disposed around the heater.
However, Zhang discloses wherein the second fluid line is disposed around the heater ([0074]: the input conduit 306 may be configured as a loop or helix to wrap around a heating element 308; see Fig. 3). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the irrigation device of Bourne in view of Winkler and Flom to fluid line/heater configuration of Zhang for the purpose of enabling the heater to be positioned in the handle to allow the distal end to be heated without enlarging the size of the distal end (Zhang: [0052]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571) 272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794