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 Status
The amendment submitted on August 19th, 2026 has been entered. Claims 1-2, 4-6, 8-11, 13-19, and 21-28 are currently pending and under consideration. Claims 25-28 have been newly added. Claims 1,6,8,11,13,14,16,19, and 22 have been amended. Claims 3,7,12, and 20 have been cancelled.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
Claim(s) 1-2, 6, 8, 14-15, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hsu et al. (U.S. Publication 2019/0175799) herein further referred to as Hsu, in view of Shelton et al. (U.S. Publication 2018/0055568) herein further referred to as Shelton.
Regarding claim 1, Hsu discloses a system (System of Fig. 25 with embodiment of ¶0205 wherein first instrument provides both irrigation and aspiration with medical instrument 100 of Fig. 16; with method 300 as implemented in kidney as depicted in Fig. 16) for controlling pressure within a kidney (Fig. 16 kidney 103, ¶0150 procedure for removing a kidney stone from a kidney; steps 310 and 312 drawn toward controlling pressure of irrigation and aspiration), comprising:
an irrigation channel 105 having a proximal end and a distal end (113), the distal end of the irrigation channel in fluid communication with an interior of a kidney 103;
an irrigation pump 608 configured as a variable speed pump (¶0143 irrigation may be toggled on/off by system showing two variations in speed; ¶0179 adjusts a characteristic of the irrigation, ¶0161 characteristic can be flow rate of the irrigation; ¶0159 pump can be configured to set a specific flowrate, ¶0166 pulsing irrigation shows variability of pump) in fluid communication with a source of irrigation fluid 610 and the irrigation channel and operable to control a fluid flow rate of irrigation fluid in the irrigation channel (¶0200 configured to control pump and the vacuum to provide directed fluidics (irrigation and aspiration to the treatment site through the first and second medical instruments)so as to deliver irrigation fluid to the interior of the kidney (Fig. 16 arrows show distal end 113 in fluid communication delivering irrigation fluid ¶0118);
a pressure sensor (¶0162 pressure sensor) configured to measure fluid pressure of irrigation fluid in the irrigation channel (¶0162 sensor positioned in the first fluid channel, in the second fluid channel)
an aspiration channel 108 having a proximal end (end opposite distal end) and a distal end (end placed within kidney as seen in Fig. 16), the aspiration channel in fluid communication with a drain reservoir (Fig. 25 collection chamber 614), the distal end of the aspiration channel in fluid communication with the interior of the kidney (distal end can be seen in Fig. 16 placed in kidney and in fluid communication as seen through arrow flow);
an aspiration pump (612 ¶0203 vacuum 612 can be replaced with a pump which pumps liquid from the treatment site) in fluid communication with the aspiration channel and configured to pump irrigation fluid from the distal end toward the proximal end of the aspiration channel (¶0203 pumps liquid from the treatment site) so as to remove irrigation fluid from the interior of the kidney (arrows of fluid flow of Fig. 16 show removal of irrigation fluid through aspiration channel 108; ¶0159 vacuum…draws fluid, the irrigate, from the treatment site); and
a controller 602; in communication with the pressure sensor (¶0207 output from sensors connected to the processor), the irrigation pump 608, and the aspiration pump 608 (¶0206 control a characteristic of at least one of the pump or the vacuum based on the determined characteristic) and configured to:
determine a fluid flow rate of irrigation fluid within the irrigation channel (¶0206 the characteristic can be an average flow rate of the irrigation or aspiration over a time interval) based on a fluid flow rate setting of the irrigation pump (¶0162 characteristic can be determined based on a flow rate set by the pump), receive a pressure measurement value from the pressure sensor (¶0207 output from sensors connected to processor such that the processor can use the output to determine characteristic), calculate a pressure within the interior of the kidney based at least in part on the determined fluid flow rate and the pressure measurement (¶0168 determined characteristic of the treatment site is internal pressure of the treatment site, i.e. kidney, which can be determined based on irrigation and aspiration pressure and irrigation and aspiration flow rate), compare the calculated kidney pressure to a target kidney pressure value (¶0206 configure the processor to determine a characteristic of one of the irrigation and the aspiration, ¶0169 determined characteristic of the treatment site can be compared to a threshold value, threshold value equivalent to target value), and based on the comparison, control at least one of the fluid flow rate of irrigation fluid in the irrigation channel and a fluid flow rate of irrigation fluid in the aspiration channel (¶0206 control a characteristic of at least one of the pump or the vacuum based on the determined characteristic; ¶0169 upon determination that the determined characteristic meets or exceed the threshold value the method can include at least one of reducing irrigation into the treatment site, increasing aspiration from the treatment site) via at least one of the irrigation pump and the aspiration pump (¶0206 control a characteristic of at least one of the pump or the vacuum based on the determined characteristic).
Hsu does not expressly disclose delivering irrigation fluid to the interior of the kidney at a fluid flow rate in a range of 80-100 mL/min inclusive. However, Shelton, in the same field of endeavor of kidney irrigation, teaches providing an irrigation rate between 50 and 160 mL/min to a kidney for the purpose of providing an optimal fluid flow based on feedback of detected fragment volume, i.e. cloudiness, received by a controller ( ¶0035 medium inflow rate can be between 50 and 160 ml/min).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flow rate of irrigation fluid of Hsu to have been between 50 and 160 mL/min for the purpose of providing a flow rate suitable for a particular removal rate of debris from the kidney as taught by Shelton (¶0035 based on one or more feedbacks. These feedbacks can include…if the field of view is blurry or clear based on image processing data, blurry image correlates to higher debris content in the kidney).
While Shelton does not expressly suggest the claimed range of 80-100 mL/min, this range falls within the range of 50 and 160 ml/min. As such it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified this range to be 80-100 ml/min since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, the range of 80-100 ml/min lies inside the range of 50-160 mL/min suggested by Yurek and as such there is seen to a prima facie case of obviousness. Further Hsu in view of Yurek would not operate differently in the claimed range and applicant appears to have placed no criticality on the claimed range simply stating, “In certain embodiments, the fluid flow rate of irrigation fluid is in a range of 80-100 mL/min inclusive” (Page 13 lines 20-21 of applicant’s specification). As such this limitation is seen to have been obvious to one of ordinary skill in the art before the effective filing date.
Regarding claim 2, Hsu in view of Shelton suggest the system of claim 1. Hsu further discloses the irrigation channel being free from internal structures or obstructions (aspiration channel 108 is the working channel into which objects are placed and thus irrigation channel remains the same throughout the procedure).
Regarding claim 6, Hsu in view of Shelton suggest the system of claim 1. Hsu further discloses when the calculated kidney pressure is greater than the target kidney pressure value (¶0169 if internal pressure of the treatment site is determined to be too high) the controller is configured to (¶0206 control a characteristic of at least one of the pump or the vacuum based on the determined characteristic) increase the fluid flow rate of irrigation fluid in the aspiration channel (¶0169 aspiration can be increased) via the aspiration pump (¶0206 control a characteristic of at least one of the pump or vacuum), decrease the fluid flow rate of irrigation fluid in the irrigation channel (¶0169 the irrigation can be decreased) via the irrigation pump (¶0206 control a characteristic of at least one of the pump or vacuum), or increase the fluid flow rate of irrigation fluid in the aspiration channel and decrease the fluid flow rate of irrigation fluid in the irrigation channel (¶0169 the irrigation can be decreased and/or the aspiration can be increased) via the aspiration and irrigation pumps respectively (¶0206 control a characteristic of at least one of the pump or the vacuum based on the determined characteristic).
Regarding claim 8, Hsu in view of Shelton suggest the system of claim 7. Hsu further discloses the aspiration pump being configured as a variable speed pump (0132 toggled on and off and adjusted by the system) and the controller controls the aspiration pump by powering on (¶0132 toggled on and off and adjusted by system), the controller controls the irrigation pump by powering off (¶0143 may be toggled on/off by the system).
Regarding claim 14, Hsu discloses a method 350 for controlling pressure within a kidney (¶0174 directed fluidics during a medical procedure…the object removal procedure is a procedure for removing a kidney stone from a kidney) comprising:
Pumping (354 provides irrigation, ¶0177 connected to irrigation source as described above, ¶0158 fluid channel connected to irrigation source through a pump…pump configured to move the irrigation through the fluid channel and into the treatment site) with an irrigation pump (¶0158 pump) configured as a variable speed pump (¶0143 irrigation may be toggled on/off by system showing two variations in speed; ¶0179 adjusts a characteristic of the irrigation, ¶0161 characteristic can be flow rate of the irrigation; ¶0159 pump can be configured to set a specific flowrate, ¶0166 pulsing irrigation shows variability of pump), irrigation fluid through an irrigation channel to an interior of the kidney (354 irrigation provided through medical instrument...irrigation can be provided through the first channel of the first medical instrument; Fig. 16 shows provision of irrigation to kidney through first channel);
removing 356 irrigation fluid from the interior of the kidney and directing the irrigation fluid through an aspiration channel toward a drain reservoir (356, ¶0178 aspiration provided through the second fluid channel…connected to a collection container; Fig. 16 shows removal of irrigation fluid through aspiration);
determining 358 a fluid flow rate of irrigation fluid within the irrigation channel (¶0178 determines a characteristic of the irrigation as described above; ¶0162 characteristic determined using one or more sensors; ¶0161 characteristic can be an instantaneous flow rate…can be an average flow rate) based on a fluid flow rate setting of the irrigation pump (¶0162 characteristic can be determined based on a flow rate set by the pump);
measuring a fluid pressure of irrigation fluid within the irrigation channel (¶0162 determination of pressure using pressure sensor inherently measures; ¶0162 sensor can be positioned in the first fluid channel; pressure thus representative of fluid pressure of fluid, irrigation, flowing through channel);
calculating a pressure within an interior of the kidney based at least in part on the determined fluid flow rate and the pressure measurement (¶0168 determined characteristic of the treatment site calculated based on one or more characteristics of the irrigation…internal pressure can be determined based on irrigation and aspiration pressure and flow rate);
comparing the calculated kidney pressure to a target kidney pressure value (¶0169 determined characteristic of the treatment site can be compared to a threshold value); and
based on the comparison, controlling at least one of a fluid flow rate of irrigation fluid in the aspiration channel and a fluid flow rate of irrigation fluid in the irrigation channel (¶0169 if the internal pressure of the treatment site is determined to be too high, the irrigation can be decreased and/or the aspiration can be increased) via at least one of the irrigation pump and the aspiration pump (¶0206 control a characteristic of at least one of the pump or the vacuum based on the determined characteristic).
Hsu does not expressly disclose delivering irrigation fluid to the interior of the kidney at a fluid flow rate in a range of 80-100 mL/min inclusive. However, Shelton, in the same field of endeavor of kidney irrigation, teaches providing an irrigation rate between 50 and 160 mL/min to a kidney for the purpose of providing an optimal fluid flow based on feedback of detected fragment volume, i.e. cloudiness, received by a controller ( ¶0035 medium inflow rate can be between 50 and 160 ml/min).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flow rate of irrigation fluid of Hsu to have been between 50 and 160 mL/min for the purpose of providing a flow rate suitable for a particular removal rate of debris from the kidney as taught by Shelton (¶0035 based on one or more feedbacks. These feedbacks can include…if the field of view is blurry or clear based on image processing data, blurry image correlates to higher debris content in the kidney).
While Shelton does not expressly suggest the claimed range of 80-100 mL/min, this range falls within the range of 50 and 160 ml/min. As such it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified this range to be 80-100 ml/min since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, the range of 80-100 ml/min lies inside the range of 50-160 mL/min suggested by Yurek and as such there is seen to a prima facie case of obviousness. Further Hsu in view of Yurek would not operate differently in the claimed range and applicant appears to have placed no criticality on the claimed range simply stating, “In certain embodiments, the fluid flow rate of irrigation fluid is in a range of 80-100 mL/min inclusive” (Page 13 lines 20-21 of applicant’s specification). As such this limitation is seen to have been obvious to one of ordinary skill in the art before the effective filing date.
Regarding claim 15, Hsu in view of Shelton suggest the method of claim 14. Hsu further discloses wherein when the calculated kidney pressure is greater than the target kidney pressure value the method comprises at least one of increasing a fluid flow rate of irrigation fluid in the aspiration channel, and decreasing a fluid flow rate of irrigation fluid in the irrigation channel (¶0169 if the internal pressure of the treatment site is determined to be too high, the irrigation can be decreased and/or the aspiration can be increased).
Regarding claim 24, Hsu in view of Shelton suggest the method of claim 14. Hsu further discloses providing a ureteroscope (¶0176 medical instrument can be endoscope, first medical instrument can be inserted through lumen of the patient, lumen of patient may be the ureter, first medical instrument can include one or more working channels configured to receive various tools, lithotripters, therefore the medical instrument is a ureteroscope) that includes the irrigation channel and the aspiration channel (¶0177 irrigation can be provided through the first fluid channel; ¶0178 aspiration can be provided through the second fluid channel; ¶0175 both irrigation and aspiration are provided through a single medical instrument).
The method 350 of Hsu does not expressly disclose whether the irrigation channel is free from internal structures or obstructions as it does not expressly state whether the working channel mentioned in ¶0176 is a separate channel or one of the fluid conducting channels, however, the embodiments described by Fig. 16 and 17 of an irrigation/aspiration device utilized in a kidney have the aspiration channel 108 provided as the working channel through which the tools are inserted (¶0116 working channel 108 through which tools can be inserted; ¶0127 working channel 108, through which various tools can be inserted) which would leave the irrigation channel formed by 105 free of tools and inserted devices.
It would have been obvious to try to one of ordinary skill in the art before the effective filing date of the claimed invention was made to have the working channel be the aspiration channel rather than the irrigation channel, thus leaving the irrigation channel free of any inserted tools as there are only a finite number of predictable solutions. Either the device utilized the aspiration or the irrigation channel as the working channel. Hsu teaches being able to utilize the working channel for aspiration rather than irrigation in a different embodiment and since “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp” it is likely that product was not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143. Because Hsu discloses the ability to utilize the working channel for aspiration rather than irrigation in a separate embodiment, it would have been obvious to one of ordinary skill in the art to try and apply the aspiration/irrigation flow model taught in Figs. 16 and 17 to the method disclosed by method 350 as a person of ordinary skill has good reason to pursue the known options within his or her technical grasp and there is only a finite number of available options for the working channel described in method 350, with the working channel either being a separate channel completely, being the same channel as the aspiration channel, or being the same channel as the irrigation channel, with Hsu specifically disclosing the use of the aspiration channel as a working channel in one of its embodiments showing it as a known option.
Claim(s) 4, 5, and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hsu et al. (U.S. Publication 2019/0175799) in view in view of Shelton et al. (U.S. Publication 2018/0055568) , Shah (U.S. Publication 2018/0289394), and Eisner (U.S. Publication 2017/0303941) herein further referred to as Shah and Eisner respectively.
Regarding claim 4, Hsu in view of Shelton suggest the system of claim 1. Hsu further discloses an access sheath 107 having a central passageway (passageway through which 105 is provided through as seen in Fig. 16) for receiving at least a portion of the aspiration and irrigation channels (Fig. 16 shows both 105 and 108 through access sheath central passageway) the sheath configured such that irrigation fluid can be drained via a drainage flow path between the sheath and the internal space of the kidney (¶0118 passively flowing through the access sheath, Fig. 16 shows arrows of fluid flow from the kidney space to the sheath).
Hsu does not expressly disclose the sheath being flexible or the sheath being inserted into a ureter such that irrigation fluid can be drained into the drain reservoir via the drainage flow path between the flexible sheath and the ureter.
Regarding the irrigation fluid flowing being drained into the drain reservoir, Shah, in the same field of endeavor of kidney stone removal, discloses an access sheath containing a drainage flow pathway between the sheath and the internal space of the kidney wherein the irrigation fluid is drained into a drain reservoir 17 for the purpose of collecting all the fluid drained through the sheath (¶0105 all fluid drains out by overflowing in the reservoir).
It would have been obvious to one of ordinary skill in the art to have connected the passive drainage pathway of Hsu fluidically to the collection reservoir, as taught by Shah, for the purpose of collecting the drained fluid in the collection reservoir as it would be advantageous to have all fluid draining into a designated collection container for better containment of drained fluids and fragments resulting from the kidney stone removal.
Regarding the sheath being positioned in a ureter and being flexible, Hsu in a different embodiment teaches providing an aspiration/irrigation device through a ureter of a patient (Fig. 17 shows through ureter rather than directly into the kidney as represented in Fig. 16; ¶0120 may enter through the kidney through the ureter), but does not disclose whether a sheath would be used or the sheath being flexible. However, Eisner, in the same field of endeavor of access sheaths for debris removal systems of surgical sites, teaches an access sheath 102 that is flexible (¶0064 flexible tube of the sheath 102) for the purpose of supporting the components of the removal device (¶0049 support the other components of the removal device) and allowing the sheath to conform to the contours of the passageway of the patient (¶0049 elastic enough to conform to the contours of the passageway of the patient).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Hsu to have been inserted through a ureter rather than percutaneously as Hsu discloses the ability to inserted the device in this way depending upon whether the intention of the surgery is to enter the kidney through a ureter fashion or percutaneously and since it has been held that a particular known technique was recognized as part of the ordinary skill in the art, one of ordinary skill in the art would have been capable of applying the known technique of entering through a ureter rather than percutaneously to the known device of Hsu Fig. 16 and the results would have been predictable to one of ordinary skill in the art. This known technique of entering through the ureter would have yielded the predictable result of being a less invasive procedure does not require an incision through the patient’s kidney in order to enter the kidney space for removal of the kidney stone. See MPEP 2143. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized a sheath to insert the device of Hsu through the ureter, as taught by Eisner for the purpose of supporting the components of the removal device (¶0049 support the other components of the removal device) and having the sheath made of a flexible material, as taught by Eisner for the purpose of conforming to the contours of the passageway of the patient (¶0049 elastic enough to conform to the contours of the passageway of the patient).
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the access sheath of Hsu out of a flexible material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 5, Hsu in view of Shelton, Shah, and Eisner suggest the system of claim 4. Hsu further discloses the flexible sheath having a proximal end (end positioned exterior to kidney in Fig. 16) and a distal end (end positioned interior to kidney, Fig. 16), the distal end of the sheath in fluid communication with the interior of the kidney (Fig. 16 shows fluid communication with the kidney through arrows) and the pressure sensor being positioned upstream from the proximal end of the flexible sheath (¶0162 sensor positioned in the first fluid channel, positioning of sensor within irrigation channel at any point within the channel would result in the sensor being upstream of the proximal end of the flexible sheath).
Regarding claim 21, Hsu in view of Shelton suggest the method of claim 14. Hsu further discloses the device being positioned within a ureter (¶0176 first medical instrument can be inserted through a lumen of the patient…the patient lumen may be the ureter.
Hsu, in this embodiment, does not expressly disclose a flexible sheath having a central passageway for receiving at least a portion of the aspiration and irrigation channels, and positioning the flexible sheath within a ureter such that irrigation fluid can be drained into the drain reservoir from a drainage flow path between the flexible sheath and the ureter.
However, Hsu, in the same field of endeavor of kidney aspiration/irrigation devices, in a separate embodiment teaches an access sheath 107 having a central passageway (passageway through which 105 is provided through as seen in Fig. 16) for receiving at least a portion of the aspiration and irrigation channels (Fig. 16 shows both 105 and 108 through access sheath central passageway) the sheath configured such that irrigation fluid can be drained via a drainage flow path between the sheath and the internal space of the kidney (¶0118 passively flowing through the access sheath, Fig. 16 shows arrows of fluid flow from the kidney space to the sheath).
Furthermore, Shah, in the same field of endeavor of kidney stone removal, teaches an access sheath having a central passageway (passageway through which device passes and continues into the kidney) containing a drainage flow pathway between the sheath and the internal space of the kidney wherein the irrigation fluid is drained into a drain reservoir 17 for the purpose of collecting all the fluid drained through the sheath (¶0105 all fluid drains out by overflowing in the reservoir).
Regarding the sheath being positioned in a ureter and being flexible, Hsu discloses providing the device through a ureter of a patient (¶0176 patient lumen may be the ureter), but does not disclose whether a sheath would be used. However, Eisner, in the same field of endeavor of access sheaths for debris removal systems of surgical sites, teaches an access sheath 102 that is flexible (¶0064 flexible tube of the sheath 102) for the purpose of supporting the components of the removal device (¶0049 support the other components of the removal device) and allowing the sheath to conform to the contours of the passageway of the patient (¶0049 elastic enough to conform to the contours of the passageway of the patient).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Hsu to have included a included a flexible sheath positioned within the ureter and having a central passageway for receiving at least a portion of the aspiration and irrigation channels as taught by Eisner for the purpose of supporting the components of the removal device (¶0049 support the other components of the removal device) and allowing the sheath to conform to the contours of the passageway of the patient (¶0049 elastic enough to conform to the contours of the passageway of the patient).
Furthermore, it would have been obvious to one of ordinary skill in the art to have provided a drainage flow path between the flexible sheath and the ureter as taught by the different embodiment of Hsu for the purpose of allowing both the active pumping of irrigation fluid out of the kidney as well as passive removal through the sheath (¶0118 of Hsu, pumped actively through the lithotripter 109 while the remainer of the irrigation through the access heat is passive) as the fluid flow dynamics of irrigation fluid being pumped into the kidney creates multiple directional flow areas and the presence of the ability to drain fluid at both the aspiration tip as well as the sheath would allow for any fragments that are pushed away from the aspiration tip to still be drained through the sheath (¶0119 flow is both directed toward and away from the object…may result in the object being pushed away from the medical instrument; Fig. 16 of Hsu shows the flow pathway of irrigation fluid when contacting object).
Furthermore, in view of the teachings of Shah, it would have been obvious to one of ordinary skill in the art to have connected the drainage flow path between the flexible sheath and the ureter to the drain reservoir for the purpose of collecting the drained fluid in the collection reservoir as it would be advantageous to have all fluid draining into a designated collection container for better containment of drained fluids and fragments resulting from the kidney stone removal.
Regarding claim 22, Hsu in view of Shelton suggest the method of claim 21. Hsu further discloses measuring the fluid pressure within the irrigation channel including measuring with a pressure sensor (¶0162 sensors positioned in the first fluid channel), and the flexible sheath has a proximal end (end located distal to the kidney) and a distal end (end located proximal to the kidney), the distal end of the flexible sheath in fluid communication with the interior of the kidney (Fig. 16 of Hsu shows sheath being fluidly connected to interior of kidney for passive fluid flow as described above in rejection of claim 21).
Claim(s) 9-10 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hsu et al. (U.S. Publication 2019/0175799) in view of Shelton et al. (U.S. Publication 2018/0055568) and in view of Takamatsu et al. (U.S. Patent No. 6,283,937).
Regarding claims 9 and 10, Hsu in view of Shelton suggest the system of claim 6. Hsu does not expressly disclose a drainage channel configured to provide fluid communication between the irrigation channel and the drain reservoir, the drainage channel configured with a safety valve operable to control a flow of irrigation fluid from the irrigation channel to the drain reservoir (Claim 9) wherein the controller is configured to control the safety valve by opening the safety valve so as to allow fluid communication between the irrigation channel and the drain reservoir.
However, Takamatsu, in the same field of endeavor of irrigation/aspiration apparatus, teaches a drainage channel 17 configured to provide fluid communication between an irrigation channel 3 and an aspiration channel 6 which is in fluid communication with a drain reservoir 9, the drainage channel configured with a safety valve 18 operable by a controller 10 to control a flow of irrigation fluid from the irrigation channel to the drain reservoir by opening the safety valve so as to allow fluid communication between the irrigation channel and the drain reservoir (Col. 3 lines 1-13 aspiration tube is in communication with the irrigation tube via a bypass tube and the fluid flow through the bypass tube is controlled by a control valve. That is to say, the pressure sensor detects the suction pressure at all times. When the suction pressure rises higher than a preset value, the valve 18 opens as necessary under the control by the control unit to permit the irrigation fluid to flow from the irrigation tube into the aspiration tube via the bypass tube) for the purpose of decreasing the suction pressure when an upper limit of suction pressure is reached.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Hsu to have included the drainage line between the irrigation line and the aspiration line including a valve controlled by the controller, as taught by Takamatsu, for the purpose of decreasing the suction pressure when an upper limit of suction pressure is reached.
Regarding claim 17, Hsu in view of Shelton suggest the method of claim 15. Hsu does not expressly disclose directing irrigation fluid through a drainage channel that is configured to provide fluid communication between the irrigation channel and the drain reservoir.
However, Takamatsu, in the same field of endeavor of irrigation/aspiration apparatus, teaches a drainage channel 17 configured to provide fluid communication between an irrigation channel 3 and an aspiration channel 6 which is in fluid communication with a drain reservoir 9, the drainage channel configured with a safety valve 18 operable by a controller 10 to control a flow of irrigation fluid from the irrigation channel to the drain reservoir by opening the safety valve so as to allow fluid communication between the irrigation channel and the drain reservoir (Col. 3 lines 1-13 aspiration tube is in communication with the irrigation tube via a bypass tube and the fluid flow through the bypass tube is controlled by a control valve. That is to say, the pressure sensor detects the suction pressure at all times. When the suction pressure rises higher than a preset value, the valve 18 opens as necessary under the control by the control unit to permit the irrigation fluid to flow from the irrigation tube into the aspiration tube via the bypass tube) for the purpose of decreasing the suction pressure when an upper limit of suction pressure is reached.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hsu to have included directing irrigation fluid through a drainage line between the irrigation line and the aspiration line, as taught by Takamatsu, for the purpose of decreasing the suction pressure when an upper limit of suction pressure is reached.
Claim(s) 11, 18, 25, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hsu et al. (U.S. Publication 2019/0175799) in view of Shelton et al. (U.S. Publication 2018/0055568) and in view of Plott et al. (U.S. Publication 2024/0049952).
Regarding claims 11 and 18, Hsu in view of Shelton suggest the system of claim 1 and the method of claim 14 respectively. Hsu further discloses comparing the calculated kidney pressure to the target kidney pressure value (¶0169 determined characteristic of the treatment site can be compared to a threshold value) and adjusting the irrigation and aspiration flow rate to adjust or maintain an internal fluid volume or pressure of the treatment site (¶0166), but does not expressly disclose the procedure associated with the calculated kidney pressure being less than the target kidney pressure.
However, Plott, in the same field of endeavor of irrigation/aspiration devices for use in a kidney, teaches increasing and decreasing input pressure in accordance with a predicted stead state kidney pressure for the purpose of reaching a targeted threshold range (¶0066 the input pressure and/or flowrate is automatically increased or decreased so that the predicted steady sate kidney pressure lies within a targeted threshold range).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Hsu to increase the fluid flow rate of irrigation fluid in the irrigation channel, as taught by Plott, for the purpose of maintaining the internal kidney pressure within a desired range (¶0066 of Plott).
Furthermore, it would have been obvious to try to one of ordinary skill in the art at the time the invention was made to have the controller either decrease the fluid flow rate of irrigation fluid in the aspiration channel, increase the fluid flow rate of irrigation fluid in the irrigation channel, or decrease the fluid flow rate of irrigation fluid in the aspiration channel and increase the fluid flow rate of the irrigation fluid in the irrigation channel, since there are only a finite number of predictable solutions.
Hsu discloses the ability to adjust the flowrates of aspiration and irrigation to arrive at a threshold intrarenal pressure (¶0169 upon determination that the determined characteristics meets or exceed the threshold value, the method can include at least one of reducing irrigation into the treatment site, increasing aspiration form the treatment site). The desired pressure can only be either a maximum threshold value or a minimum threshold value with Hsu discloses the example of the irrigation being decreased and/or aspiration increased when the value is above a maximum (¶0169 too high), the only other option available for establishing a threshold would include a minimum value which would inherently require the opposite increase of irrigation and/or decrease of aspiration to control and as such it would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp”. If this leads to the anticipated success, it is likely the product was not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143. Thus it would have been obvious, especially in light of the teachings of Plott teaching the establishment of a minimum value being a known option, to have either decreased the fluid flow rate of irrigation fluid in the aspiration channel, increased the fluid flow rate of irrigation fluid in the irrigation channel, or performed both in order to raise the kidney pressure to a target minimum pressure, as would be established if the calculated kidney pressure was less than the target kidney pressure.
Regarding claims 25 and 27, Hsu in view of Shelton suggest the method of claim 14 and the system of claim 1 respectively. Hsu further discloses providing a ureteroscope (¶0176 medical instrument can be endoscope, first medical instrument can be inserted through lumen of the patient, lumen of patient may be the ureter, first medical instrument can include one or more working channels configured to receive various tools, lithotripters, therefore the medical instrument is a ureteroscope) that includes the irrigation channel and the aspiration channel (¶0177 irrigation can be provided through the first fluid channel; ¶0178 aspiration can be provided through the second fluid channel; ¶0175 both irrigation and aspiration are provided through a single medical instrument).
The method 350 of Hsu does not expressly disclose the irrigation channel being configured such that an inner diameter is constant from a proximal end to a distal end of the irrigation channel.
However, Plott, in the same field of endeavor of irrigation/aspiration devices for use in a kidney, teaches an irrigation channel (9 ¶0072 working (e.g. irrigation) channel) being configured such that an inner diameter is constant from a proximal end to a distal end (¶0073 channel diameters are constant throughout the device, throughout the device shows constat diameter from one end to the other end).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the irrigation channel of Hsu that performs the function of a fluid channel for irrigation solution from an irrigation source to a kidney for the irrigation channel of Plott since these elements perform the same function of providing a fluid channel for directing of irrigation solution to a kidney. Simply substituting one fluid channel means for another would yield the predictable result of allowing a(n) irrigant to be provided to a kidney. See MPEP 2143.
Claim(s) 13 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hsu et al. (U.S. Publication 2019/0175799) in view of Shelton et al. (U.S. Publication 2018/0055568) and in view of Ma et al. (U.S. Publication 2021/0330309).
Regarding claims 13 and 23, Hsu in view of Shelton suggest the system of claim 1 and method of claim 14 respectively. Hsu further discloses establishing a target kidney pressure value maximum, but does not expressly disclose a value relating to said maximum or a range that encompasses said maximum.
However, Ma, in the same field of endeavor of irrigation/aspiration devices for use intrarenally, teaches a safe zone for intrarenal pressures being between about 10 and 30 mmHg.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the target kidney pressure value to have been in the range of about 10 and 30 mmHg, as taught by Ma, for the purpose of providing irrigation/aspiration within a safe range for the patient.
While Hsu in view of Ma do not expressly disclose a range of 10 to 40 mmHg, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the range of Hsu in view of Ma from between 10-30 mmHg to 10-40 mmHg as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Hsu would not operate differently with the claimed range and Ma teaches providing suction in a range found entirely within the claimed ranged. Further, applicant places no criticality on the ranged claimed, indicating simply that the kidney is capable of tolerating a limited pressure and that it has been shown that a pressure of 30-40 mmHg can be safely tolerated, only necessitating that the range be less than 40 mmHg (Page 1 of applicant’s specification).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hsu et al. (U.S. Publication 2019/0175799) in view of Shelton et al. (U.S. Publication 2018/0055568) and in view of Germain et al. (U.S. Publication 2015/0119795).
Regarding claims 16, Hsu in view of Shelton suggest method of claim 15. Hsu further discloses powering on/off the aspiration and irrigation pumps as well as adjusting said pumps (¶0132 aspiration toggled on/off and adjusted by system; irrigation toggled on/off by system), but does not expressly relate the step of increasing the fluid flow rate of irrigation fluid in the aspiration channel or the decreasing the fluid flow rate of irrigation fluid in the irrigation channel being accomplished through the powering on/off or increase/decrease of speed of the aspiration/irrigation pumps respectively as it does not expressly state what is meant by the term “adjusted”.
However, Germain, in the same field of endeavor of aspiration/irrigation control, teaches a method of controlling a pressure in a body cavity through selected pump speeds to increase, decrease, or maintain a volume of saline distention fluid in the cavity( ¶0058 the controller and control algorithm can operate the pumps at selected matching or non-matching speeds to increase, decrease, or maintain the volume of saline distention fluid in the uterine cavity. Thus, by independent control of the pumping rates of the first and second positive displacement pumps, a selected set pressure in the body cavity can be achieved and maintained in response to signals of intra-cavity pressure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the method of increasing the fluid flow rate of irrigation fluid in the aspiration channel and decreasing the fluid flow rate of irrigation fluid in the irrigation channel of Hsu for the method of increasing/decreasing fluid flow rates through control of pump speed of Germain since these elements perform the same function of controlling fluid flow rates provided to a patient’s internal cavity. Simply substituting one fluid flow rate control means for another would yield the predictable result of allowing a(n) irrigation/aspiration device to control irrigation/aspiration flow rates. See MPEP 2143.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hsu et al. (U.S. Publication 2019/0175799) in view of Shelton et al. (U.S. Publication 2018/0055568) and in view of Plott et al. (U.S. Publication 2024/0049952) and further in view of Germain et al. (U.S. Publication 2015/0119795).
Regarding claim 19, Hsu in view of Shelton and Plott suggest the method of claim 18. H discloses powering on/off the aspiration and irrigation pumps as well as adjusting said pumps (¶0132 aspiration toggled on/off and adjusted by system; irrigation toggled on/off by system), but does not expressly relate the step of increasing the fluid flow rate of irrigation fluid in the aspiration channel or the decreasing the fluid flow rate of irrigation fluid in the irrigation channel being accomplished through the powering on/off or increase/decrease of speed of the aspiration/irrigation pumps respectively as it does not expressly state what is meant by the term “adjusted”.
However, Germain, in the same field of endeavor of aspiration/irrigation control, teaches a method of controlling a pressure in a body cavity through selected pump speeds to increase, decrease, or maintain a volume of saline distention fluid in the cavity ¶0058 the controller and control algorithm can operate the pumps at selected matching or non-matching speeds to increase, decrease, or maintain the volume of saline distention fluid in the uterine cavity. Thus, independent control of the pumping rates of the first and second positive displacement pumps, a selected set pressure in the body cavity can be achieved and maintained in response to signals of intra-cavity pressure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the method of decreasing the fluid flow rate of irrigation fluid in the aspiration channel and increasing the fluid flow rate of irrigation fluid in the irrigation channel of Hsu for the method of increasing/decreasing fluid flow rates through control of pump speed of Germain since these elements perform the same function of controlling fluid flow rates provided to a patient’s internal cavity. Simply substituting one fluid flow rate control means for another would yield the predictable result of allowing a(n) irrigation/aspiration device to control irrigation/aspiration flow rates. See MPEP 2143.
Allowable Subject Matter
Claims 26 and 28 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The use of the equation P(kidney) = P(input) - Q/U where P(kidney)= the pressure within the interior of the kidney P(input)= the pressure measurement Q = the determined fluid flow rate U = a Hydro-mechanical constant of a ureteroscope that includes the irrigation channel and the aspiration channel, is not anticipated or suggested in the prior art as the prior art does not provide any suggestion or motivation to control, or utilizing a controller to control, the flow rate of irrigation fluid based the kidney pressure that is derived utilizing a pressure value of the fluid within the irrigation channel minus a calculated flow rate over a hydro-mechanical constant that requires the irrigation and aspiration channel physical parameters to remain constant as suggested by the claimed language.
As such if incorporated into their respective independent claims, claims 26 and 28 are seen to contain subject matter that would be allowable. However, as these claims are currently dependent upon a rejected claim they are herein objected to.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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