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 .
Response to Amendment
In response to the amendment filed 6/17/2026; claims 1 - 20 are pending.
Priority
The Examiner maintains that the effective filing date of the instant application was 7/25/2021.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1,11,17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Pirlot et al. (International Publication WO 2020/058760 A1, International Publication Date: 26 March 2020) in view of Devgon (US 2020/0100716 A1) and Ozaki et al. (US 2023/0245591 A1).
Re claims 1, 19 and 20:
Pirlot teaches 1. A surgical training and rehearsal system (Pirlot, [0004]), comprising:
a valve (Pirlot, fig. 54, 5402; [00180] – [00181]);
a pump fluidically coupled with the valve (Pirlot, [0093]; figs. 5A – 5B; [0171], “pump 4808”);
a tank for storing a fluid, the tank fluidically coupled with the valve (Pirlot, fig. 6, 306; [0086], “a tank”);
a surgical approach tube having an end covered by membrane (Pirlot, [00105], “a first membrane … a second membrane”; [00106], “membrane”), the surgical approach tube being fluidically coupled with the valve (Pirlot, [0180]; [0181], “fluid flow system 909 may include a Y-pipe 5500 at an intersection between outlet pipe 4804 and inlet pipe 4814 before flush valve 5402”);
an exit port fluidically coupled with a distal end of the surgical approach tube (Pirlot, [00180], “54, flush system 5400 may include external flush tubing 5404 that extends between a flush valve 5402 and a flush receptacle 5406. In some implementation flush system 5400 may include an external flush pump (e.g., as shown on flush tubing 5404 if FIG. 54)”; [0181], “fluid flow system 909 may include a Y-pipe 5500 at an intersection between outlet pipe 4804 and inlet pipe 4814 before flush valve 5402”);
an anatomical access cartridge removably coupled with the exit port, the anatomical access cartridge comprising a first tortuous path (Pirlot, [00182], “FIG. 58 illustrates a schematic side view of a patient-specific cartridge”; [00122], “a patients-specific cartridge 308 that includes a frame 2500 and a cardiac model 2502”; [0186], “The method may also include, prior to providing the patient-specific cartridge 308 in the tank 306, coupling first, second, and third interfacing portions 3100, 3103, and 3102 of the patient-specific model 2502 to corresponding first, second, and third openings 2609, 2611, and 2613 in a frame 2500 of the patient-specific cartridge 308. The method may also include circulating a blood simulation fluid 307 through the tank 306 and at least portions of the patient-specific model 2502 (e.g., using fluid control system 909)”; fig. 14; [0109], “how one or more fluidic openings such as fluidic openings 1406, 1410, and 1412 may be provided in tank 306, to allow flow of blood simulation fluid 307 around a patient-specific cartridge 308 that is mounted in tank 306 (e.g., in addition to and/or in place of fluid 307 flow into and/or out of the patient-specific structures of cartridge 308 via access ports 1404, 1408, and 718”); and
an anatomical cartridge removably coupled with the anatomical access cartridge, the anatomical cartridge comprising a second tortuous path (Pirlot, fig. 14; [0109], “how one or more fluidic openings such as fluidic openings 1406, 1410, and 1412 may be provided in tank 306, to allow flow of blood simulation fluid 307 around a patient-specific cartridge 308 that is mounted in tank 306 (e.g., in addition to and/or in place of fluid 307 flow into and/or out of the patient-specific structures of cartridge 308 via access ports 1404, 1408, and 718”).
19. A surgical training and rehearsal system (Pirlot, [0004]), comprising:
a housing, including a surgical approach tube having an end covered by membrane (Pirlot, [00105], “a first membrane … a second membrane”; [00106], “membrane”), the surgical approach tube including a port at a distal end (Pirlot, [00180], “54, flush system 5400 may include external flush tubing 5404 that extends between a flush valve 5402 and a flush receptacle 5406. In some implementation flush system 5400 may include an external flush pump (e.g., as shown on flush tubing 5404 if FIG. 54)”; [0181], “fluid flow system 909 may include a Y-pipe 5500 at an intersection between outlet pipe 4804 and inlet pipe 4814 before flush valve 5402”);
an anatomical access cartridge removably coupled with the port, the anatomical access cartridge comprising a first tortuous path (Pirlot, [00182], “FIG. 58 illustrates a schematic side view of a patient-specific cartridge”; [00122], “a patients-specific cartridge 308 that includes a frame 2500 and a cardiac model 2502”; [0186], “The method may also include, prior to providing the patient-specific cartridge 308 in the tank 306, coupling first, second, and third interfacing portions 3100, 3103, and 3102 of the patient-specific model 2502 to corresponding first, second, and third openings 2609, 2611, and 2613 in a frame 2500 of the patient-specific cartridge 308. The method may also include circulating a blood simulation fluid 307 through the tank 306 and at least portions of the patient-specific model 2502 (e.g., using fluid control system 909)”; fig. 14; [0109], “how one or more fluidic openings such as fluidic openings 1406, 1410, and 1412 may be provided in tank 306, to allow flow of blood simulation fluid 307 around a patient-specific cartridge 308 that is mounted in tank 306 (e.g., in addition to and/or in place of fluid 307 flow into and/or out of the patient-specific structures of cartridge 308 via access ports 1404, 1408, and 718”); and
an anatomical cartridge removably coupled with the anatomical access cartridge, the anatomical cartridge comprising a second tortuous path (Pirlot, fig. 14; [0109], “how one or more fluidic openings such as fluidic openings 1406, 1410, and 1412 may be provided in tank 306, to allow flow of blood simulation fluid 307 around a patient-specific cartridge 308 that is mounted in tank 306 (e.g., in addition to and/or in place of fluid 307 flow into and/or out of the patient-specific structures of cartridge 308 via access ports 1404, 1408, and 718”).
20. A surgical training and rehearsal system (Pirlot, [0004]), comprising:
a housing, including a surgical approach tube having an end covered by membrane (Pirlot, [00105], “a first membrane … a second membrane”; [00106], “membrane”), the surgical approach tube including a port at a distal end (Pirlot, [00180], “54, flush system 5400 may include external flush tubing 5404 that extends between a flush valve 5402 and a flush receptacle 5406. In some implementation flush system 5400 may include an external flush pump (e.g., as shown on flush tubing 5404 if FIG. 54)”; [0181], “fluid flow system 909 may include a Y-pipe 5500 at an intersection between outlet pipe 4804 and inlet pipe 4814 before flush valve 5402”);
an anatomical access cartridge removably coupled with the port, the anatomical access cartridge mimicking a first vasculature (Pirlot, [00182], “FIG. 58 illustrates a schematic side view of a patient-specific cartridge”; [00122], “a patients-specific cartridge 308 that includes a frame 2500 and a cardiac model 2502”; [0186], “The method may also include, prior to providing the patient-specific cartridge 308 in the tank 306, coupling first, second, and third interfacing portions 3100, 3103, and 3102 of the patient-specific model 2502 to corresponding first, second, and third openings 2609, 2611, and 2613 in a frame 2500 of the patient-specific cartridge 308. The method may also include circulating a blood simulation fluid 307 through the tank 306 and at least portions of the patient-specific model 2502 (e.g., using fluid control system 909)”; fig. 14; [0109], “how one or more fluidic openings such as fluidic openings 1406, 1410, and 1412 may be provided in tank 306, to allow flow of blood simulation fluid 307 around a patient-specific cartridge 308 that is mounted in tank 306 (e.g., in addition to and/or in place of fluid 307 flow into and/or out of the patient-specific structures of cartridge 308 via access ports 1404, 1408, and 718”); and
an anatomical cartridge removably coupled with the anatomical access cartridge, the anatomical cartridge mimicking a second vasculature (Pirlot, fig. 14; [0109], “how one or more fluidic openings such as fluidic openings 1406, 1410, and 1412 may be provided in tank 306, to allow flow of blood simulation fluid 307 around a patient-specific cartridge 308 that is mounted in tank 306 (e.g., in addition to and/or in place of fluid 307 flow into and/or out of the patient-specific structures of cartridge 308 via access ports 1404, 1408, and 718”).
Pirlot does not explicitly disclose a surgical approach tube having an end covered by self-healing membrane. Devgon et al. (US 2020/0100716 A1) teaches an apparatus includes a catheter, an introducer, and an actuator (Devgon, Abstract). Devgon teaches a surgical approach tube having an end covered by self-healing membrane (Devgon, [0060], “the seal 274 can be pierceable member, a self-sealing and/or self-healing member, a valve, a split septum, a membrane, a needle-free connector or valve, and/or any other suitable member”). Therefore, in view of Devgon, 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 surgical training and system described in Pirlot, by providing the self-healing membrane as taught by Devgon, since it was known in the art that self-healing membranes are materials capable of automatically repairing micro-cracks, punctures, and damages without human intervention.
Pirlot does not explicitly disclose wherein the anatomical access cartridge is separate from the anatomical cartridge, and wherein the anatomical access cartridge and the anatomical cartridge each comprise a standard sized frame enabling plug-and-play replacement of the cartridges.
Ozaki et al. (US 2023/0245591 A1) teaches a surgical simulator and a simulation method. The surgical simulator includes a blood vessel model. The blood vessel model includes an aorta model simulating a case of replacing a part of the thoracic aorta of a human body with an artificial blood vessel (Ozaki, Abstract). Ozaki further teaches wherein the anatomical access cartridge is separate from the anatomical cartridge, and wherein the anatomical access cartridge and the anatomical cartridge each comprise a standard sized frame enabling plug-and-play replacement of the cartridges (Ozaki, Abstract; [0007]; [0008], “a surgical simulator including: a blood vessel model, the blood vessel model including an aorta model simulating a case of replacing a part of the thoracic aorta of a human body with an artificial blood vessel, the aorta model including a simulated vessel and an artificial blood vessel, the aorta model including a connection between the simulated vessel and the artificial blood vessel, the connection including an annular end that forms the simulated vessel and an annular connection that forms the artificial blood vessel of the aorta mode”; fig. 2; [0024], “a blood vessel model 24” - anatomical cartridge; [0031], “a femoral artery model 40” - the anatomical access cartridge; [0070], “In the surgical simulator 10, the blood vessel model 24 includes the aorta model 38 simulating a case of replacing a part of the thoracic aorta of a human body with an artificial blood vessel, and the aorta model 38 includes the simulated vessel 42 and the artificial blood vessel 48, or a medical device, connected to the simulated vessel 42”).
Therefore, in view of Ozaki, 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 described in Pirlot, by providing the replaceable models as taught by Ozaki, in order to allow a trainee to repair and replace one or more simulated components (Ozaki, [0010], “the aorta model includes the simulated vessel and the artificial blood vessel, which enables simulation of Thoracic Endovascular Aortic Repair for complicated thoracic aorta cases. Therefore, it is possible to learn Thoracic Endovascular Aortic Repair efficiently”).
Re claim 11:
11. The surgical training and rehearsal system of claim 1, further comprising a drain port fluidically connected to the valve and the tank (Pirlot, fig. 54; fig. 56; [00180]).
Re claim 17:
17. The surgical training and rehearsal system of claim 1, wherein the anatomical access cartridge has at least one of a shape, a size, or mechanical properties that mimic those of a human blood vessel selected from an aortic arch, a radial artery, or a femoral artery (Pirlot, [0099]; [00137]; pg. 40, claim 3).
Re claim 18:
18. The surgical training and rehearsal system of claim 1, wherein the anatomical cartridge has at least one of a shape, a size, or mechanical properties that mimic those of a human blood vessel selected from a group subclavian artery, a common carotid artery, and a cerebral artery (Pirlot, [0099]; [00137]; pg. 40, claim 3).
Claims 2 - 3 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Pirlot, Devgon and Ozaki as applied to claim 1 above, and further in view of Allers et al. (US 2009/0221949 A1).
Re claim 2:
PIrlot teaches 2. The surgical training and rehearsal system of claim 1, further comprising: a return path fluidically coupling the second filter with the tank (Pirlot, [0171]; [0173], “fluid control system 909 may also include a filter 4806 on the outlet pipe”; [0174]). Pirlot teaches return path fluidically coupling the second filter with the tank (Pirlot, [0171]; [0173], “fluid control system 909 may also include a filter 4806 on the outlet pipe”; [0174]).
Pirlot does not explicitly disclose a first filter fluidically coupled with the anatomical cartridge to allow fluid exiting the anatomical cartridge to flow through a second filter. Allers et al. (US 2009/0221949 A1) teaches an apparatus for circulatory isolation and treatment of a part of a patient's body includes a fluid circulation loop having a first end and a second end (Allers, Abstract). Allers further teaches a first filter fluidically coupled with the anatomical cartridge to allow fluid exiting the anatomical cartridge to flow through a second filter (Allers, fig. 1, 162 - filter, 180 – Venous reservoir; [0032] – [0033]). Therefore, in view of Allers, 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 described in Pirlot, by providing the filter to the reservoir as taught by Allers, in order to remove debris such as partly dissolved clots (Allers, [0018]).
Re claim 12:
Pirlot does not explicitly disclose a second valve. Allers teaches a first and a second valve (Allers, fig. 1, 142, 118, 161, 187). Therefore, in view of Allers, 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 described in Pirlot, by providing valves as taught by Allers, in order to control the flow of the fluid through different components (Allers, [0032] – [0035]).
Re claim 3:
3. The surgical training and rehearsal system of claim 2, further comprising a window for viewing a content of the first filter (Pirlot, [00126], “the replicated fossa ovalis 400' can be seen clearly through the window 2600 formed in the right atrium model portion 2506, avoiding the need for fluoroscopy during the practice/planning procedure”; [00168]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Pirlot, Devgon, Ozaki and Allers as applied to claim 3 above, and further in view of Rappel et al. (US 2018/0344413 A1).
Re claim 4:
Pirlot teaches 4. The surgical training and rehearsal system of claim 3, wherein the window is transparent (Pirlot, [00126], “the replicated fossa ovalis 400' can be seen clearly through the window 2600 formed in the right atrium model portion 2506, avoiding the need for fluoroscopy during the practice/planning procedure”; [00168]).
Pirlot does not explicitly disclose a magnifying lens. Rappel et al. (US 2018/0344413 A1) teaches a personalized digital microscope system for use in microsurgery includes a camera system (Rappel, Abstract). Rappel teaches a magnifying lens (Rappel, [0051], “the human operator 50 performing a surgery at the operating site 72 will see the display 40 as if the display 40 was a magnifying transparent glass without the limitations of a magnifying glass”). Therefore, in view of Rappel, 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 described in Pirlot, by providing the magnifying lens as taught by Rappel, in order to observe small details in the microsurgery.
Claims 15 – 16 are rejected under 35 U.S.C. 103 as being unpatentable over Pirlot, Devgon, Ozaki and Allers as applied to claim 2 above, and further in view of Fernandez (US 20200/365057 A1).
Re claims 15 - 16:
Pirlot does not explicitly disclose clot insert port. Fernandez (US 2020/0365057 A1) teaches a cadaverous heart model and methods of making and using the cadaverous heart model (Fernandez, Abstract). Fernandez teaches 15. The surgical training and rehearsal system of claim 2, further comprising a clot insertion port connected to the anatomical cartridge and configured to insert a clot into the anatomical cartridge. 16. The surgical training and rehearsal system of claim 2, further comprising a clot cartridge connected to the anatomical access cartridge and configured to insert a clot into the anatomical access cartridge (Fernandez, [0059], “a reversal agent is injected into or otherwise added to the simulation blood to counteract or remove an anticoagulant”; [0061] – [0065]; i.e., [0064], “subsequent perfusion with the simulation blood causes the simulation blood to mix with a residual amount of the first fluid within the vessels of the cadaver, thereby creating an initial concentration that inhibits clotting”). Therefore, in view of Fernandez, 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 described in Pirlot, by simulating blood clot by Fernandez, in order to create realistic models for use in surgical training and medical research and for performing blood clot simulation (Fernandez, [0002]; [0010]).
Allowable Subject Matter
Claims 5 – 10, 13 and 14 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 in claim 5: the inclusion of the specific feature “The surgical training and rehearsal system … a mat; and a housing connected to the mat, one or more of the valve, the pump, the tank and the surgical approach tube being located in the housing, wherein the return path is at least partially located within the mat”. The closest prior art of record fail to teach, fairly suggest, nor support a prima facie case of obviousness against the cited limitations in the claims.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 – 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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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/JACK YIP/Primary Examiner, Art Unit 3715
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