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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-11, 14-25, and 27) in the reply filed on 8/10/2026 is acknowledged.
Claim 28 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/10/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/22/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-3 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Drasler et al. (US 6,135,977; hereinafter Drasler).
Regarding claim 1, Drasler teaches an irrigation system (high pressure catheter system, Fig. 1B; Note: system of 1B includes all of the features of catheter system 10 of Fig. 1A, col. 4, In 44-47; for delivering pressurized saline to a deposit to be treated, Abstract, col. 4, In 25 -28) comprising: a tube manifold (device body 12 together with manifoid 14, Fig. 1B, col. 4, In 56-62); a fluid reservoir (saline solution bag 48, Fig. 1B, col. 4, In 22-23) in fluid communication with the tube manifold (branch 38 of manifold 14 to supply the sterile saline solution to the device body, Fig. 1B, col. 4, In 15-17); a waste fluid trap (effluent is evacuated to disposable bag 30, Fig. 1B, col. 4, In 37-38) in fluid communication with the tube manifold (secondary branch 22 of manifold 14 coupled to evacuation lumen of device body 12 for removal of effluent to disposable bag 30, Fig. 1B, col. 4, In 31-38); and an emulsification system arranged at a distal end portion of the tube manifold (apparatus at distal end 56 of device body 12 to ablate and remove deposit, Fig. 1B, col. 4, In 4-6; forward shooting jets 192, 194 ablate plaque distal to the catheter, Fig. 3E, col. 7, In 6-7) and configured to be inserted into an anatomic space and emulsify organic material located within the anatomic space (distal end 56 is inserted into an artery and advanced to the site of the deposit to be treated, Fig. 1B, col. 3, In 67-col. 4, In 1; pressurization of saline solution to the distal end 56 of the device body to ablate tissue, col. 4, In 26-35; forward shooting jets 192, 194 ablate plaque distal to the catheter, Fig. 3E, col. 7, In 6-7).
Regarding claim 2, Drasler teaches the irrigation system of claim 1, wherein the fluid reservoir is in fluid communication with a flow module (saline is supplied from saline solution bag 48 to pressure piston pump 42, Fig. 1B, col. 4, In 23-26) that is configured to provide a positive pressure in the tube manifold (piston pump 42 provides saline having a pressure of about 30,000 psi to the device body 12, Fig. 1B, col. 4, In 25-31).
Regarding claim 3, Drasler teaches the irrigation system of claim 2, wherein the flow module generates a turbulent or laminar flow at the distal end portion of the tube manifold (piston pump 42 provides saline having a pressure of about 30,000 psi to the distal end 56 of device body 12, col. 4, In 25-31; creates distal flow via forward shooting jets 192, 194, Fig. 3E, col. 7, In 6-7; the flow via the jets 192, 194 is implicitly either laminar or turbulent).
Regarding claim 19, Drasler teaches the irrigation system of claim 1, wherein a distal end of the tube manifold forms a multi-lumen catheter (catheter 180 having multiple lumens, Fig. 9, col. 7, In 44-50) including a first channel in fluid communication with the fluid reservoir (small lumen 206 accommodating hypo tubing 208, Fig. 10, col. 7, In 47-50; high pressure fluid supplied via hypo tubing 208, Fig. 11, col. 7, In 55-59), a second channel in fluid communication with the waste fluid trap (evacuation lumen 200, Fig. 9; secondary branch of manifold 13 is coupled to evacuation lumen of device body 12 for removal of effluent to disposable bag 30, col. 4, In 31-38), and a third channel providing access to a balloon (lumen 196 is used to inflate balloon 190 through inflation port 198, Fig. 9-10, col. 7, In 44-46).
Claim(s) 1, 4, 10-11, and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Revela Medical, Inc. (WO 2021/119286 A1; hereinafter Revela).
Regarding claim 1, Revela teaches an irrigation system (apparatus 150, Fig. 8; provide irrigation during a procedure, pg. 19, In 1-4) comprising: a tube manifold (cannula 124, Fig. 8, pg. 19, In 1-4); a fluid reservoir (irrigation source 162, Fig. 8) in fluid communication with the tube manifold (irrigation source 162 coupled to cannula 124, pg. 19, In 1-4); a waste fluid trap (suction source or pump 164, Fig. 9; to extract the targeted tissue, pg. 19, In 18-22; the pump is implicitly connected to a waste reservoir for storing the extracted tissue) in fluid communication with the tube manifold (suction source or pump 164 coupled to cannula 124, pg. 19, In 1-4; therefore, the waste reservoir is implicitly coupled to the cannula); and an emulsification system arranged at a distal end portion of the tube manifold (actuator 108 having emulsification elements 112 located near distal end of cannula 124, Fig. 8, pg. 18, In 8-15) and configured to be inserted into an anatomic space and emulsify organic material located within the anatomic space (apparatus 150 [having actuator 108] is inserted through incision and into a target zone, pg. 24, In 22- 28;-the actuator to emulsify incoming tissue suctioned into cannula 124, pg. 18, In 8-10).
Regarding claim 4, Revela teaches the irrigation system of claim 1, wherein the waste fluid trap is in fluid communication with a vacuum module that is configured to provide a negative pressure in the tube manifold (suction source or pump 164, Fig. 9; to extract the targeted tissue, pg. 19, In 18-22).
Regarding claim 10, Revela teaches the irrigation system of claim 1, wherein the emulsification system includes a network of bars (network of emulsification elements 112, Fig. 4, 8, pg. 18, In 8-15) and comprises material including at least one of nylon, metal, or natural fibers (fins 102 of actuator 108 made of titanium, Fig. 4, 8; pg. 15, In 31-32).
Regarding claim 11, Revela teaches the irrigation system of claim 1, wherein the emulsification system includes a blade element disposed within the tube manifold (blade defined by emulsification element 112 is disposed within cannula 124, Fig. 8).
Regarding claim 15, Revela teaches the irrigation system of claim 1, wherein the tube manifold forms a single lumen catheter at a distal end (cannula 124 has a single lumen at a distal end, Fig. 8).
Regarding claim 1, (alternate interpretation) Revela teaches an irrigation system (apparatus 180, Fig. 10; provide irrigation during a procedure, pg. 19, In 1-4) comprising: a tube manifold (cannula 136, Fig. 10, pg. 20, in 9-10; a fluid reservoir (irrigation source 162, Fig. 10) in fluid communication with the tube manifold (irrigation source 162 coupled to cannula 134, pg. 19, In 1-4); a waste fluid trap (suction source or pump 164, Fig. 10; to extract the targeted tissue, pg. 19, In 18-22; the pump is implicitly connected to a waste reservoir for storing the extracted tissue) in fluid communication with the tube manifold (suction source or pump 164 coupled to cannula 134, pg. 19, In 1-4; therefore, the waste reservoir is implicitly coupled to the cannula); and an emulsification system arranged at a distal end portion of the tube manifold (actuator 182 having emulsifying elements 112 near distal end portion, Fig. 10, pg. 20, In 9-14) and configured to be inserted into an anatomic space and emulsify organic material located within the anatomic space (apparatus 180 [having actuator 182] is inserted through incision and into a target zone, pg. 24, In 22-28; the actuator to emulsify incoming tissue suctioned into cannula, pg. 18, In 8-10).
Regarding claim 14, Revela teaches the irrigation system of claim 11, wherein the emulsification system includes a cage configured to surround the agitator (end covering 184 surrounding elements 112, Fig. 10, pg. 20, in 18-21) to allow organic material in the anatomic space to reach the agitator (covering 184 having inlet holes 140 like region 138, pg. 20, In 18-19; inlet holes to induce tissue into the device, pg. 17, in 25-29) and prevent the agitator from engaging vital tissue forming the anatomic space (Fig. 10).
Claim(s) 1, 5-7, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Banko (US 8,641,658 B1; hereinafter Banko).
Regarding claim 1, Banko teaches an irrigation system (surgical hand piece for selectively discharging fluid, Abstract) comprising: a tube manifold (tip 130 having tubes 132, 134, Fig. 1A) a fluid reservoir in fluid communication with the tube manifold (irrigation fluid supplied over tip 130, Fig. 1A, col. 4, In 54-57; from an irrigation source, col. 6, In 10-13); a waste fluid trap in fluid communication with the tube manifold (aspiration source such as a peristaltic pump for aspirating fluid from the tip 130, col. 6, In 13-15; the system implicitly comprises a waste reservoir for the aspirated fluid); and an emulsification system arranged at a distal end portion of the tube manifold (vibration of the free end of the tube to emulsify tissue, Fig. 2, col. 5, In 13-17) and configured to be inserted into an anatomic space and emulsify organic material located within the anatomic space (work tip 30 is inserted into an incision in the eye, col. 7, In 3-9; vibration of the free end of the tube to emulsify tissue, Fig. 2, col. 5, In 13- 17).
Regarding claim 5, Banko teaches the irrigation system of claim 1 further comprising: a valve (valve 175, Fig. 4A-B, col. 6, In 9-28); and a valve actuator configured to actuate the valve (valve being a control valve, col. 4, In 61-63; an actuator implicitly actuates the valve) between fluidly coupling the reservoir and the distal end portion of the tube manifold (the valve 175 is in a position such that there is irrigation liquid flow is to line 164 meaning that there will be liquid in the second housing chamber 158 to be provided to the second tube 134 to flow out of its distal end, col. 6, In 15-19) and fluidly coupling the waste fluid trap and the distal end portion of the tube manifold (by switching the valve 175 the conditions will be reversed SO that there will be aspiration flow on line 164 causing the second tube 134 to perform an aspirating function, col. 6, In 23-28).
Regarding claim 6, Banko teaches the irrigation system of claim 5. Banko further teaches wherein the valve actuator is configured to alternate positive and negative pressure flow in the tube manifold (Fig. 4A where valve position creates an irrigation liquid flow through tube 134, col. 6, In 15-19; Fig. 4B where valve creates an aspiration flow through tube 134, col. 6, In 23-28; intended use, valve controller is capable of alternating the valve position as claimed).
Regarding claim 7, Banko teaches the irrigation system of claim 5, wherein the valve actuator controls negative pressure applied to the anatomic space (by switching the valve 175the conditions will be reversed so that there will be aspiration flow on line 164 causing the second tube 134 to perform an aspirating function, col. 6, In 23-28; aspiration by a negative pressure, col. 4, In 7-9).
Regarding claim 16, Banko teaches the irrigation system of claim 1, wherein the tube manifold includes a multi-lumen catheter having a first channel and a second channel (tip 130 having tubes 132, 134, Fig. 1A), wherein the first channel is in alternating fluid communication with the fluid reservoir and the waste fluid trap (Fig. 4A where valve position creates an irrigation liquid flow through tube 134, col. 6, In 15-19; Fig. 4B where valve creates an aspiration flow through tube 134, col. 6, In 23-28), and wherein the second channel is dimensioned to receive a balloon (Fig. 1A; intended use, tube 136 is sized to allow for reception of a balloon).
Claim(s) 20-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Klapper et al. (US 5,300,022; hereafter Klapper).
In regard to claim 20, Klapper discloses a method of hematuria irrigation (see abstract), the method comprising: inserting a catheter (10) into a bladder of a patient; introducing an irrigant into the bladder through the catheter (see col. 4, lines 25-47); causing solid or semi-solid organic material to engage an emulsification system (24) (see col. 4, lines 48-55); and draining the irrigant and organic material from the bladder into a waste fluid trap via a vacuum module (see col. 4, lines 25-47 and col. 4, lines 56-62).
In regard to claim 21, Klapper discloses further comprising propelling the irrigant to create a flow that is configured to emulsify organic material within the bladder (see col. 4, lines 25-47).
In regard to claim 22, Klapper discloses further comprising simultaneously or sequentially introducing the irrigant into the bladder and draining the irrigant and the organic material (see cited areas above; the irrigation and draining occur simultaneously and or sequentially).
In regard to claim 23, Klapper discloses further comprising controlling an actuator connected to the catheter to introduce the irrigant into bladder and drain the irrigant from the bladder through a common channel in the catheter (the actuator is container bag which is lifted to cause introduction of the fluid; see Fig. 5 where 14 and 16 are in fluid communication).
In regard to claim 24, Klapper discloses further comprising introducing the irrigant into the bladder through a first channel (16) and draining the irrigant from the bladder through a second channel (14) (see Fig. 6).
In regard to claim 25, Klapper discloses further comprising introducing an agitator (20) into the bladder after the irrigant is propelled into the bladder (openings 20 create a venturi).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Banko in view of Alcon Research, LTD. (US 2013/0150782 A1; hereinafter Alcon).
Regarding claim 8, Banko teaches the irrigation system of claim 5, but fails to teach wherein the valve actuator is in communication with a fluid sensor and is automatically actuated when the fluid sensor signal crosses a predetermined threshold.
Alcon teaches a system wherein a valve actuator (control system in console 30, para. [0043]) in communication with a fluid sensor (pressure sensor 63 detects aspiration pressure in aspiration line and is connected to control system in console 40, para. [0043]) and is automatically actuated when the fluid sensor signal crosses a predetermined threshold (control system may be configured to provide pre- set aspiration pressure levels, para. [0043]; when pressure readings from pressure sensor 63 exceed those thresholds, the control system may selectively move multi-purpose valve 562 by a predetermined amount to reduce the aspiration pressure within aspiration line, para. [0085]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the system of Bank could have been modified as claimed in view of Alcon to provide safety control of the aspiration.
Regarding claim 9, Banko in view of Alcon teach the irrigation system of claim 8. Alcon further teaches wherein the fluid sensor senses one of a volumetric flow rate, a mass flow rate, or a pressure differential (pressure sensor 63 detects and communicates pressure changes in aspiration line, para. [0048]; Note: pressure readings are known to be differential readings of pressure relative to either vacuum or atmospheric pressure).
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Banko in view of Nectero Medical, Inc. (WO 2020/198376 A1; hereinafter Nectero).
Regarding claim 17, Banko teaches the irrigation system of claim 16, but fails to teach wherein the balloon is inflated with a fluid to dynamically measure pressure within the anatomic space.
Nectero teaches a catheter (catheter 100, para. [0336]; may be a microcatheter, para. [0334]), wherein a balloon is inflated with a fluid to dynamically measure pressure (inflation lumen of catheter for inflating and/or deflating, para. [0336]; one or more of the inflation lumens and/or balloons described herein may be in fluid communication with one or more pressure sensors for monitoring pressure levels within the balloon, para. [0336]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the system of Banko could have been modified as claimed in view of Nectero to allow for measure of pressure in the space using pressure sensing device inserted separately.
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Banko in view of Abramson (US 4,508,533 A; hereinafter Abramson).
Regarding claim 18, Banko teaches the irrigation system of claim 16, but falls to teach wherein the multi-lumen catheter includes a third channel in continuous fluid communication with a fluid source.
Abramson teaches a surgical drain (Abstract) comprising a triple lumen catheter (Abstract) having an irrigation lumen (Abstract), a drainage lumen (Abstract), and a third lumen in fluid communication with a fluid source (air ventilation lumen, Abstract; air intake port 26 in fluid communication with air ventilation lumen 16, Fig. 1, col. 4, In 12-18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the system of Banko could have been modified as claimed in view of Abramson to provide for air ventilation of the target tissue.
Claim(s) 27 is rejected under 35 U.S.C. 103 as being unpatentable over Grabenkort et al. (US 5,382,229; hereafter Grabenkort) in view of Blott et al. (US US 2006/0155260; hereafter Blott).
In regard to claim 27, Grabenkort discloses an irrigation system having a fluid recycler system, comprising: a pump (24); a pressure regulator (12 and/or 14; a hanging bag can regulate pressure via changing the height of the bags); a fluid reservoir (38) configured to receive patient aspirate and irrigant; a filter (34 and or 40) in fluid communication with the fluid reservoir to separate the patient aspirate from the irrigant; a port (32) fluidly coupled to a suction generator (30);
Grabenkort fails to disclose a pressure sensor configured to monitor pressure of the recycler system.
In a similar art, Blott discloses a fluid recirculating system comprising a pressure sensor in the system that will detect excessive load or pressure, and shut down the pump (see par. [0596]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Grabenkort with the pressure sensor of Blott in order to provide a means for shutting the pump down at inappropriate pressures.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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