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In response to the amendment filed 12/16/2025; claims 1 - 24 are pending; claims 19 – 24 have been withdrawn.
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 - 6, 9 - 11, 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Boutchko et al. (US 2010/0167251 A1) in view of Orden (US 4,167,070).
Re claim 1:
Boutchko teaches 1. A heart compression system for compressing a heart, the heart compression system (Boutchko, [0055], “pressure of the heart”) comprising:
a primary container defining a primary chamber that is configured to receive and house the heart and a pressurization medium (Boutchko, fig. 1A; [0008], “the cavity”; [0041]; [0030], “phantom 100 as schematically shown in FIG. 1A. The phantom 100 comprises an elastic casing 110, containing the rest of the phantom and filled with water (with or without contrast agents added)”); and
a pressurization system for deviating pressure within the primary chamber, thereby deviating compressive forces acting on outside surface of the heart (Boutchko, [0046], “a vacuum pump to collapse the lungs; solenoid valves to open/close the lungs to mimic respiratory motion by inflating the lungs; and computer controls to provide automation by sending trigger signals to the solenoid valves and pumps”; [0072], “Lung inflation is done by compressed air from a compressed air tank, deflation is assisted by a vacuum pump”; [0073]; [0030]; [0028], “the elastic motion phantom”; [0071], “track respiratory motion phases”; [0074], “the phantom prototype at various stages of inhalation (inflation)”; the motion of phantom deviates pressures on heart).
Boutchko teaches a method for mimicking heart beats are generated by pumping air into the simulated heart, therefore, Boutchko does not explicitly disclose thereby deviating compressive forces acting on outside surface of the heart so as to mimic heart beats of a beating heart.
Orden (US 4,167,070) teaches an educational lung simulator advantageously utilizable as a teaching aid (Orden, Abstract). Orden teaches thereby deviating compressive forces acting on outside surface of the organ (heart) so as to mimic expansions and contractions (heart beats of a beating heart) (Orden, col. 2, lines 20 – 30, “varying pressure within the chamber spaces but exterior to simulated lung enclosed-space, there is preferably connected to each chamber space, one to one chamber space and another to the other chamber space, separate bellows separately actuatable, such that collapse of the bellows increases pressure within the respective chamber and upon the simulated lung therein that space, and expansion of the bellows reducing gas pressure within that chamber space. This bellows, for each chamber, is preferably mounted over the simulated lung of that space”; col. 4, lines 16 – 26, “The simulator 4 includes preferably all transparent walls as exterior walls of the main casing”; col. 2, lines 31 – 41, “at least a portion of the otherwise rigid housing of the lung chamber”). Therefore, in view of Orden, 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 Boutchko, by varying pressure within a chamber instead of varying pressure in the heart, since one of an ordinary skill in the art would have recognized that both designs create pressure differences between the chamber and the heart.
Re claims 2 – 3:
2. The heart compression system of claim 1, wherein the primary container comprises a rigid out body (Orden, col. 2, lines 31 – 41, “at least a portion of the otherwise rigid housing of the lung chamber”) and an adjustable wall, the adjustable wall being a moveable wall or comprising a moveable wall portion, wherein the adjustable wall is moveable between an expanded configuration and a retracted configuration, thereby decreasing and increasing the volume of the primary chamber, respectively, and wherein the pressurization system is configured to oscillate the adjustable wall between its expanded and retracted configurations (Boutchko, [0046], “a vacuum pump to collapse the lungs; solenoid valves to open/close the lungs to mimic respiratory motion by inflating the lungs; and computer controls to provide automation by sending trigger signals to the solenoid valves and pumps”; [0072], “Lung inflation is done by compressed air from a compressed air tank, deflation is assisted by a vacuum pump”; [0073]; [0030]; [0028], “the elastic motion phantom”; [0071], “track respiratory motion phases”; [0074], “the phantom prototype at various stages of inhalation (inflation)”).
3. The heart compression system of claim 2, wherein: said pressurization system comprises an inflatable bladder in fluid communication with an air compressor; said expanded configuration of the adjustable wall comprises said inflatable bladder being in an inflated configuration; and said retracted configuration of the adjustable wall comprises said inflatable bladder being in a deflated configuration (Boutchko, [0046], “a vacuum pump to collapse the lungs; solenoid valves to open/close the lungs to mimic respiratory motion by inflating the lungs; and computer controls to provide automation by sending trigger signals to the solenoid valves and pumps”; [0072], “Lung inflation is done by compressed air from a compressed air tank, deflation is assisted by a vacuum pump”; [0073]; [0030]; [0028], “the elastic motion phantom”; [0071], “track respiratory motion phases”; [0074], “the phantom prototype at various stages of inhalation (inflation)”; inflatable / retracted configuration of bladder - lung).
Re claims 4 – 6:
4. The heart compression system of claim 3, wherein:
said motor is electrically connected to a programmable logic controller configured for controlling said motor and thereby movement of said movable wall between said expanded configuration and said retracted configuration (Boutchko, [0028], “the elastic motion phantom”; [0071], “track respiratory motion phases”; [0074], “the phantom prototype at various stages of inhalation (inflation)”; [0010], “the phantom further comprising: (4) a thick tube modeling human aorta allowing controlled flow of variable speed and direction”).
5. The heart compression system of claim 4, wherein: said programmable logic controller is configured to control speed, frequency, and inflation volume of said inflatable bladder (Boutchko, [0072], “Frequency, volume and profile of pumping are controlled by the central console. Lung inflation is done by compressed air from a compressed air tank, deflation is assisted by a vacuum pump”).
6. The heart compression system of claim 4, further comprising:
a user interface connected to said programmable logic controller and configured to allow adjustment of pressure within said primary chamber (Boutchko, [0072], “Referring now to FIG. 3, a control system is provided to provide control of the phantom. Central control console is the Lab View program running on an attached laptop computer … Frequency, volume and profile of pumping are controlled by the central console. Lung inflation is done by compressed air from a compressed air tank, deflation is assisted by a vacuum pump”).
Re claims 9 – 10:
9. The heart compression system of claim 1, further comprising the pressurization medium, wherein: said pressurization medium comprises an incompressible fluid. 10. The heart compression system of claim 9, wherein: said incompressible fluid is a clear liquid to facilitate visualization of the heart (Boutchko, [0030], “the rest of the phantom and filled with water (with or without contrast agents added)”; water is a known incompressible fluid).
Re claim 11:
11. The heart compression system of claim 1, further comprising a sealable access port extending through a wall of the primary container, thereby facilitating fluid communication between the heart positioned within the primary chamber and a perfusion system positioned outside of the primary chamber (Boutchko, fig. 1A, 180; [0030], “A set of liquid and air conduits or tubing 180 connecting the lungs, the heart, the aorta and the internal organs to the appropriate pumps also lead to/from the phantom”; [0037]; [0038], “The set of air and liquid ducts 170 and 180 connect to the different organs and a control of the ducts can include such controls as compressed air tank, air pump, valve boards, liquid pump(s), valves and liquid tanks (elevated or pressurized if needed) for liquid delivery and control in the internal organs, Pump and valve operation can be controlled by a central computer console or pneumatically”).
Re claim 15:
15. The heart compression system of claim 1, wherein said pressurization system comprises:
a fluid reservoir for holding compression fluid (Boutchko, fig. 4A, 402 - 408); and
a fluid conduit in fluid communication with the fluid reservoir and the primary chamber, thereby facilitating flow of compression fluid in and out of the primary chamber such that pressure in the primary chamber increases and decreases, respectively, wherein the pressurization medium comprises compression fluid (Boutchko, fig. 1A, 180; [0016], “the phantom provides technological solutions modeling of blood flow in aorta and other large blood vessels”; [0039], “A blood duct 184 is two-way flow driven by liquid pump, and used to achieve static phases or to model cardiac motion. Myocardial contrast inlet/outlet ducts 186 can also be used for real-time delivery of contrast agent to the (constant volume) myocardial cavity”),
Re claim 17:
17. The heart compression system of claim 1, wherein the primary container is radiolucent so as to facilitate x-rays of the heart while using the heart compression system for a procedure, wherein the procedure is at least one of testing a device, training personnel, and observing representative heart function (Boutchko, [0015], “Contrast agents include any compounds that are highly visible with a specific imaging modality, for example radioactive isotopes in nuclear imaging, gadolinium or boron in x-ray CT, paramagnetic fluids or fats in MRI etc.”; [0031] – [0032]).
Claims 7 - 8 are rejected under 35 U.S.C. 103 as being unpatentable over Boutchko et al. (US 2010/0167251 A1) and Orden (US 4,167,070) as applied to claim 1 above, and further in view of Eckert et al. (US 2019/0172371 A1)
Re claims 7 – 8:
Boutchko does not explicitly disclose a clear primary container. Eckert teaches systems, methods, and devices for modeling air leaks in lungs (Eckert, Abstract). Eckert teaches 7. The heart compression system of claim 1, wherein: a top wall of a rigid out body of said primary container is transparent to allow for visualization into said primary chamber (Eckert, [0059], “The first chamber 12 is transparent, e.g., has transparent walls”; [0079]). 8. The heart compression system of claim 7, wherein: a bottom wall and at least one side wall of said rigid outer body of said primary container is transparent to allow for visualization into said chamber, wherein the bottom wall is displaced vertically from the top wall and the at least one side wall extends vertically between the top wall and the bottom wall (Eckert, [0059], “The first chamber 12 is transparent, e.g., has transparent walls”; [0079]). Therefore, in view of Eckert, 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 Boutchko, by providing the transparent walls as taught by Eckert, in order to facilitate visualization of liquid transfer between organs and vessels (Eckert, [0059]).
Claims 12 - 14 are rejected under 35 U.S.C. 103 as being unpatentable over Boutchko et al. (US 2010/0167251 A1) and Orden (US 4,167,070) as applied to claim 11 above, and further in view of Walcerz et al. (US 5,374,194)
Re claims 12 – 14:
12. The heart compression system of claim 11, further comprising the perfusion system, wherein the perfusion system comprises:
a fluid reservoir for holding perfusion fluid (Boutchko, fig. 4A, 402 - 408); and
a fluid conduit extending from said fluid reservoir and through said sealable access port (Boutchko, fig. 1A, 180),
wherein the fluid conduit is in fluid communication with internal cavities of the heart when the perfusion system is in an engaged configuration (Boutchko, [0016], “the phantom provides technological solutions modeling of blood flow in aorta and other large blood vessels”; [0039], “A blood duct 184 is two-way flow driven by liquid pump, and used to achieve static phases or to model cardiac motion. Myocardial contrast inlet/outlet ducts 186 can also be used for real-time delivery of contrast agent to the (constant volume) myocardial cavity”).
Boutchko teaches blood modeling liquid used by heart pump to simulate the beat of a heart (Boutchko, [0020]; [0048]). Boutchko does not explicitly disclose a compression (i.e., CPR) on the heart to cause fluid move toward or leaving the heart. Walcerz et al. (US 5,374,194) teaches a simulator of the cardio-vascular system for use in open chest cardiac massage (OCCM) resuscitation technique instruction. Walcerz teaches wherein the fluid perfusion system is configured to bias perfusion fluid towards the heart when compression on the heart is at a low level, and wherein the fluid perfusion system is configured to receive perfusion fluid from the heart when compression on the heart is at a high level (Walcerz, col. 3, lines 1 – 10, “the practitioner reaches into the thoracic mannequin 50 and massages or squeezes the model heart 5 in rhythmic succession … Check valve 15 is set opposite to check valve 35 to allow discharge only from model heart 5 to reservoir 30; check valve 15 is set opposite to check valve 35 to allow intake only from reservoir 25 into model heart 1”). Therefore, in view of Walcerz, 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 Boutchko, by monitoring the blood flow during heart compression as taught by Walcerz, in order to provide CPR instruction where a user can observe the blood flow between the simulated heart and fluid reservoir.
13. The heart compression system of claim 12, wherein the biasing force for biasing perfusion fluid towards the heart is controlled by controlling the head of the profusion fluid within the fluid reservoir (Boutchko, [0047], “Cardiac motion is achieved by controlled pump-induced change in the volume of the innermost cavity of the heart. In one embodiment, the inner membrane of the heart 40 is pumped with a modified rodent respirator having a control box. In another embodiment, any appropriate pump having a control box is used. Suitable settings for generating and modeling the heart twisting motion are the ejection volume of the pump should be able to pump up to 30 mL and simulate up to 200 beats per minute”; [0072], “Heart pumping is done by a modified rodent respirator. Frequency, volume and profile of pumping are controlled by the central console”).
14. The heart compression system of claim 12, wherein the biasing force for biasing perfusion fluid towards the heart is controlled by controlling a pump in fluid communication with the profusion fluid within the fluid reservoir (Boutchko, [0047], “Cardiac motion is achieved by controlled pump-induced change in the volume of the innermost cavity of the heart. In one embodiment, the inner membrane of the heart 40 is pumped with a modified rodent respirator having a control box. In another embodiment, any appropriate pump having a control box is used. Suitable settings for generating and modeling the heart twisting motion are the ejection volume of the pump should be able to pump up to 30 mL and simulate up to 200 beats per minute”; [0072], “Heart pumping is done by a modified rodent respirator. Frequency, volume and profile of pumping are controlled by the central console”).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Boutchko et al. (US 2010/0167251 A1) and Orden (US 4,167,070) as applied to claim 1 above, and further in view of Koo et al. (US 2017/0042502 A1).
Re claim 16:
Boutchko does not explicitly disclose a said pressurization system comprises a secondary container; wherein and wherein the timing of the expansion and contraction of the secondary container controls the timing of the mimicked heart beats.
Koo teaches a lung phantom system provided with an elastic film that separates a first chamber and a second chamber having inner space that may be filled with liquid (Koo, Abstract). Koo further teaches 16. The heart compression system of claim 1, wherein said pressurization system comprises a secondary container positioned within the primary chamber, the secondary container being configured to expand and contract, thereby decreasing and increasing net volume of the primary chamber, respectively, wherein decreasing and increasing net volume of the primary chamber increases and decreases pressure within the primary chamber, respectively, and wherein the timing of the expansion and contraction of the secondary container controls the timing of the mimicked heart beats (Koo, [0044]; figs. 1 – 3; i.e., fig. 1, 10 – primary chamber; 20 or 42 – secondary container; [0011]). Therefore, in view of Koo, 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 Boutchko, by providing the secondary as taught by Koo, since it was known in the art use a piston (with piston chamber) to supplies or discharges pressurized fluid.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable Boutchko et al. (US 2010/0167251 A1) and Orden (US 4,167,070) as applied to claim 1 above, and further in view of Feins et al. (US 2017/0243522 A1).
Re claim 18:
Boutchko does not explicitly disclose an enforcement device (i.e., stent). Feins teaches simulator systems and methods for simulating fluoroscopic procedures or other medical procedures (Feins, Abstract). Feins teaches 18. The heart compression system of claim 1, further comprising an enforcement devices for supporting a blood vessel of the heart, thereby preventing collapse of the blood vessel when compressive forces acting on the heart are at a high level, wherein the blood vessel is at least one of the aorta and the vena cava, and wherein enforcement device comprises at least one of a tube inserted into the blood vessel, a hardened wall of the blood vessel, and an enforcing material encasing the blood vessel (Feins, [0023], “insertion of a catheter or other tool into at least a portion of the anatomical model”; [0043], “can be configured to receive a tool or catheter manipulated by a user during a simulation exercise. An exemplary wire-mesh stent SN for insertion into anatomical model 50”; [0044]). Therefore, in view of Feins, 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 Boutchko, by providing the enforcement devices as taught by Feins, in order to allow a trainee to practice medical procedure such as endovascular stent placement (Feins, Abstract; [0022]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 – 18 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.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, one of an ordinary skill in the art would have recognized that both designs (i.e., pressurize a chamber or pressurize a simulated heart) create pressure differences between the chamber and the heart.
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