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 .
Applicant’s submission of a Response
Applicant’s submission of a response was received on 12/08/2025. Presently, claims 1, 3-4, and 6-15 are now pending.
Response to Arguments
Applicant's arguments filed on 12/08/2025 have been fully considered but they are not persuasive. Applicant’s representative asserts that the amended claims limitations are not met. However, the rejection of claims 1, 3-4, and 6-15 is maintained as presented below.
Applicant’s representative alleges the following:
In regards to Claim Rejections under 35 U.S.C. 103, the objective of the present application is to simulate the flow of fluid in a kidney, embody an object swimming by the fluid, and provide a respiration condition so as to provide training on inserting training equipment into the kidney and gripping a stone therein (as illustrated in [0023]), which is different from the medical training system taught by Slanda.
In regards to Claim Rejections under 35 U.S.C. 103, when a person skilled in the art attempts to simulate irregular and periodic motion of breathing, there is no motivation to refer to a six-axis motion platform of Durand that is used in the completely different field of semiconductor manufacturing.
In regards to Claim Rejections under 35 U.S.C. 103, the structure and use of the simulator provided by the present application is different from those of the kidney phantom taught by Ristolainen.
Regarding point (1), the examiner respectfully disagrees.
Applicant’s representative argues that Slanda teaches the fluid is used to "maintain a physiological pressure" instead of "making an object swimming in the kidney" as recited in claim 1 of the application. Furthermore, the clinical use of "irrigation and suction" is intended to flush away stone debris or assist in positioning, not to simulate an object swimming in the fluid so as to train how to capture stones from a turbulent flow that causes them to swim.
In response to the arguments above, the claim states “the renal surgery training system with which removing an object swimming in the kidney by the flow of the fluid in the kidney using training equipment is trained”. In dictionary.com swimming is defined as “immersed in or overflowing with water or some other liquid” which means that the method of “irrigation and suction” to flush away stone debris or assist in positioning does qualify as an object swimming in the fluid because the stone debris would be immersed in the liquid or overflowing with water or some liquid.
Regarding point (2), the examiner respectfully disagrees.
Applicant’s representative argues that the system of Durand is part of a precise positioning device (or machine) for the semiconductor industry, in particular for processing or control applications in a standard atmosphere or in empty tanks, or for the optical and optoelectronics industry, for the positioning of optics, optoelectronic components, etc. The technical field (i.e. semiconductor manufacturing) of Durand is obvious different from that (i.e. medical application) of the present application.
In response to the arguments above, although the preferred application of the invention is directed to the semiconductor industry, the disclosure explicitly states that the system can be used in other areas and industries. Take a look at the beginning of the disclosure where it mentions that this device is able to “carry an optical, mechanical, or other device” for the purpose of taking “measurements, processing, etc.” (col 1 lines 5-13).
Regarding point (3), the examiner respectfully disagrees.
Applicant’s representative argues that compared to Ristolainen that simulates kidney calyces by "connecting cavities with channels and pipes with outer reservoirs filled with different colors or x-ray opaque contrast liquids (designated for drainage training in interventional radiology)", the simulator as claimed in claims 2-7 forms specific, surrounding turbulence, allowing the object (which is a training target disposed at a bottom of the flow path) to swim along a flow of the fluid from the inlet channel to the flow path through the inlet holes.
In response to the arguments above, Ristolainen is used mainly for the structural limitations in claims 2-7. Although Ristolainen is used for a different type of surgical training procedure, it still focuses on the structure of a simulated kidney. The structure taught in Ristolainen specifically simulates the internal structure of a kidney by using multiple independent routes and it’s specifically designed to improve renal surgery training.
Applicant’s representative argues that regarding dependent claims 3-4, 6-15, since these claims contain all features of claim 1, these dependent claims overcome the obviousness rejections in the Office Action as a matter of law (In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988). However, in light of the remarks and standing rejection below, the examiner asserts the prior art of record teaches all the elements as claimed and these elements satisfy all structural, functional, operational, and spatial limitations currently in the claims. Therefore, the standing rejections are proper and maintained.
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, 3-4, and 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over Slanda et al. (US 20170278429 A1; hereinafter Slanda) in view of Durand et al. (US10393308B2; hereinafter Durand) in view of Ristolainen et al. (US10083632B2; hereinafter Ristolainen).
Regarding claim 1, Slanda discloses a renal surgery training system, comprising: an internal calyx fluid simulation device (Fig 1A) comprising a supply hose configured to supply fluid (inflow lumen 18a; Fig 1A); a simulator connected to the supply hose (combination of parts works a simulator as shown below in Fig 1A inside the square),
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through which the fluid supplied by the supply hose flows (inflow lumen delivers fluid; ¶4); a fluid receiver connected to the simulator such that the fluid flows (fluid being received by anatomical structure 14; Fig 1B), in which the fluid moved from the simulator is received (Fig 1B); and an outlet hose configured to discharge the fluid stored in the fluid receiver (outflow lumen 18b; Fig 1A), the internal calyx fluid simulation device configured to simulate a flow of fluid in a kidney (circulate fluid through an anatomical structure at a physiological pressure; ¶27); wherein the simulator comprises a cap covering a top of the flow path (cap on top of stopcock 26; Fig 1A), wherein the object which is a training target is disposed at a bottom of the flow path (target object 16; Fig 16) and configured to swim along a flow of the fluid from the inlet channel to the flow path through the inlet holes (inherent to this model because target object 16 is inside and there is fluid running through the model). Slanda does not disclose a translation device disposed below the internal calyx fluid simulation device and configured to perform a translational movement to translate the internal calyx fluid simulation device; the renal surgery training system with which removing an object swimming in the kidney by the flow of the fluid in the kidney using training equipment is trained; a first frame member forming an outermost shape of the simulator; an inlet channel formed by passing through the first frame member and communicating with the supply hose; a plurality of inlet holes communicating with an end of the inlet channel and configured to disperse the fluid moved from the inlet channel; a flow path communicating with the inlet holes and rising upward as approaching closer to the fluid receiver
However, Durand teaches a translation device disposed below the internal calyx fluid simulation device and configured to perform a translational movement to translate the internal calyx fluid simulation device (this translation device can carry another device and allow for movement in various degrees; col 1 lines 5-9).
Thus, 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 Slanda to implement the teachings of Durand to create translational movement that can help replicate realistic and effective training environments depending on what movement is wanted for the specific training.
Furthermore, Slanda does not explicitly disclose the renal surgery training system with which removing an object swimming in the kidney by the flow of the fluid in the kidney using training equipment is trained (medical tools used to remove kidney stone in ¶22 but not by the flow of the fluid, however removing stones by fluid is a well-known and common method).
Thus, 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 Slanda since it has been held that simple substitution of one known element for another yields predictable results. In this case Slanda uses medical tools to remove the simulated kidney stone in ¶22, but another well-known method of removing kidney stones is by a flow based system with irrigation and suction, which achieves the same result. See MPEP 2143, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
However, Ristolainen focuses on simulating the internal structure of a kidney by using multiple independent routes and it’s specifically designed to improve renal surgery training, which relates to Slanda because it also shows an anatomical model simulating a body organ for training medical professionals to access a cavity within the organ, in particular the calyces of the kidney. Ristolainen teaches wherein the simulator comprises: a first frame member forming an outermost shape of the simulator (frame structure holding fluid outer reservoirs 61, 62, 63; Fig 2); an inlet channel formed by passing through the first frame member and communicating with the supply hose (multiple channels and holes; col 4 lines 3-10); a plurality of inlet holes communicating with an end of the inlet channel (shown in Fig 1-3) and configured to disperse the fluid moved from the inlet channel (col 4 lines 3-10); a flow path communicating with the inlet holes and rising upward as approaching closer to the fluid receiver (rising upward is inherent because the fluid is being pumped the cavities like 51, 52, 53; col 4 lines 5-10).
Thus, 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 Slanda to implement the teachings of Ristolainen since to provide a support structure for the simulator. Having a frame that can support the fluid containers with the plurality of inlet holes and channels can provide core support and stability for the simulator.
Regarding claim 3, Ristolainen teaches wherein the flow path is formed with a first flow path, a second flow path, and a third flow path respectively connected to a plurality of supply hoses (multiple hoses as shown in Fig 1-3), wherein one end of the first flow path, one end of the second flow path, and one end of the third flow path are connected (all connected to the same frame shown in Fig 1-3).
Thus, 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 Slanda to implement the teachings of Ristolainen since to provide a support structure for the simulator. Having a frame that can support the fluid containers with the plurality of inlet holes and channels can provide core support and stability for the simulator.
Regarding claim 4, Ristolainen teaches wherein the inlet holes are arranged on three side surfaces curved with respect to the inlet channel (connected to multiple surfaces at the bottom of the fluid reservoirs; Fig 1 or 3).
Thus, 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 Slanda to implement the teachings of Ristolainen since to provide a support structure for the simulator. Having a frame that can support the fluid containers with the plurality of inlet holes and channels can provide core support and stability for the simulator.
Regarding claim 6, Slanda discloses wherein, in a state in which the top of the flow path is open as the cap is opened (cap being opened or closed is inherent for a stopcock), the object is configured to be put into the flow path or taken out of the flow path (well known in the art that removal of real kidney stones or simulated kidney stones through a flow based system is common).
Thus, 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 Slanda since it has been held that simple substitution of one known element for another yields predictable results. In this case Slanda uses medical tools to remove the simulated kidney stone in ¶22, but another well-known method of removing kidney stones is by a flow based system with irrigation and suction, which achieves the same result. See MPEP 2143, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 7, Slanda discloses the training equipment passing through an insertion hole (training equipment such as baskets or graspers to remove kidney stone can pass through inflow lumen 18a; ¶33). Slanda does not disclose wherein the fluid receiver comprises: a second frame member connected such that the fluid is introduced from the simulator; an equipment insertion hole formed on one side of the second frame member; and a fluid storage space in which the fluid is stored. But examiner notes that a storage space is commonly paired with the stopcock 26 found in Fig 1A.
However, Ristolainen teaches wherein the fluid receiver comprises: a second frame member connected such that the fluid is introduced from the simulator (outside of the outer fluid reservoirs 62 works as a second frame; Fig 1-3); an equipment insertion hole formed on one side of the second frame member (insertion hole at the bottom of the outer fluid reservoir 62; Fig 1); and a fluid storage space in which the fluid is stored (outer reservoir stores the fluid; col 4 lines 62-63).
Thus, 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 Slanda to implement the teachings of Ristolainen since to provide a support structure for the simulator. Having a frame that can support the fluid containers with the plurality of inlet holes and channels can provide core support and stability for the simulator.
Regarding claim 8, Durand teaches wherein the translation device comprises: a base (lower plate 5; Fig 1); a bridge disposed on the base (movement units U1 and U2); a holder disposed on the bridge (combination of plate 2 and mobile carriage 8; Fig 3) and configured to be movable in both directions along one axis with respect to the bridge (col 3 lines 60-63); and a driver configured to drive the holder (control modules M1 and M2; col 4 lines 32-36).
Thus, 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 Slanda to implement the teachings of Durand to create translational movement that can help replicate realistic and effective training environments depending on what movement is wanted for the specific training.
Regarding claim 9, Durand teaches wherein the bridge is provided as a pair of bridges on both sides of the base (movement units shown on 3 sides of the base; Fig 3), on which a sliding groove is formed in a longitudinal direction of the bridge (guide rail 7; col 5 lines 10-13), and the holder comprises: a slider configured to be movably inserted into the sliding groove (mobile carriage 8; Fig 3); and a plate disposed on the slider and configured to move along with the slider (plate 2; Fig 3).
Thus, 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 Slanda to implement the teachings of Durand to create translational movement that can help replicate realistic and effective training environments depending on what movement is wanted for the specific training.
Regarding claim 10, Durand teaches wherein the driver comprises: a body configured to provide rotational power (Can be configured to provide rotational movement; col 2 lines 20-32); a wheel disposed on a side surface of the body and configured to be rotationally driven (rotation system 9 with a ball bearing 10 in the shape of a wheel; Fig 4); a support having one side rotatably connected to the wheel and extending to the other side (Fastening element 11; Fig 4); and a connecting end to which the support is rotatably connected, connected to the holder (connected to each other when put together as seen in Fig 4 and col 5 lines 23-30).
Thus, 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 Slanda to implement the teachings of Durand to create translational movement that can help replicate realistic and effective training environments depending on what movement is wanted for the specific training.
Regarding claim 11, Durand teaches herein the internal calyx fluid simulation device further comprises: a control valve (pressure indicator 24; ¶27) disposed in the supply hose and configured to control a supply flow rate of the fluid (allow to circulate fluid at physiological pressure; ¶27).
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Slanda in view of Durand in view of Ristolainen in view of Kim Kum Bae et al. (KR101278727B1 SEE-translation; hereinafter Kim).
Regarding claim 12, Slanda discloses further comprising: a calyceal structure simulation device (anatomical structure 14; Fig 1B) comprising a frame into which the training equipment is inserted (anatomical model 12 acting as a frame; Fig 1A); a first route connected from one side of the frame up to a center of the frame and configured to simulate a ureter (first route is found going through an opening 15 as shown in figure 1B); a second route comprising a portion that is connected to the first route and has a cross-sectional area that increases as a distance from the first route increases (depicted as shown below in Fig 1B),
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and configured to simulate a major calyx of the kidney (simulating calyx of kidney; ¶23); and a third route formed to branch into a plurality of routes from the second route and configured to simulate a minor calyx of the kidney (minor calyx shown in Fig 1B), the renal surgery training system is configured to provide training on inserting the training equipment along a route simulating an actual internal structure of the kidney (training equipment such as baskets or graspers to remove kidney stone can pass through inflow lumen 18a; ¶33). Slanda does not explicitly disclose the calyceal structure simulation device disposed on the translation device, wherein, under a condition that the kidney moves by respiration.
However, Durand teaches the calyceal structure simulation device disposed on the translation device (can carry a device and allows for movement of this device; col 1 lines 5-9).
Thus, 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 Slanda to implement the teachings of Durand to create translational movement that can help replicate realistic and effective training environments depending on what movement is wanted for the specific training.
Kim teaches wherein, under a condition that the kidney moves by respiration (kidneys can move by respiration with a breathing simulator; ¶45).
Thus, 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 Slanda to implement the teachings of Kim to implement to simulate a more realistic training because the kidneys move as the diaphragm contracts and relaxes during respiration.
Regarding claim 14, Slanda discloses wherein the third route is formed as a plurality of third routes at each of an upper end and a lower end of the frame (plurality of routes shown in figure 1B), the third routes alternately disposed at the upper end and the lower end along a lateral direction not to completely overlap each other when the calyceal structure simulation device is viewed from above (not completely overlapping each other when viewed from above in Fig 5A or 5B).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Slanda in view of Durand in view of Ristolainen in view of Kim in view of Christopher C. Toly (US 8162668 B2; hereinafter Toly).
Regarding claim 13, Toly teaches the calyceal structure simulation device further comprises: a sensor disposed on one side of the third route (col 2 lines 49-53) and configured to sense whether the training equipment is reached (sensor data can be displayed; col 7 lines 33-37).
Thus, 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 Slanda to implement the teachings of Toly because sensors have become more common because they provide real time feedback during training to assess the performance during the training.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Slanda in view of Durand in view of Ristolainen in view of Kim in view of Toly.
Regarding claim 15, Ristolainen teaches a control device configured to set a route which is an insertion target among a plurality of routes formed inside the calyceal structure simulation device (inherent to this model because it has multiple routes inside the simulated kidney to specific cavities 51, 52, 53; See Fig 1-3).
Thus, 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 Slanda to implement the teachings of Ristolainen to mimic the real anatomy of a kidney because a kidney has multiple paths and requires very precise pathing for blood and urine circulation. Furthermore, when focusing on medical interventions like a stone removal, a specific path must also be used.
Toly teaches a determination device configured to determine whether the training equipment is inserted into the set route (sensor works as a determination device; col 2 lines 49-53); and an output device configured to display whether the training equipment is inserted into the set route (sensor data can be displayed; col 7 lines 33-37).
Thus, 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 Slanda to implement the teachings of Toly because sensors have become more common because they provide real time feedback during training to assess the performance during the training.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSE ANGELES whose telephone number is (703)756-5338. The examiner can normally be reached Mon-Fri 8am-5pm.
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/JOSE ANGELES/Examiner, Art Unit 3715
/STEVE ROWLAND/Primary Examiner, Art Unit 3715
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