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 .
This office action is in response to the application filed on 10/22/2024.
Claims 1-18 are pending.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3, 4, 13, 14, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okayama et al. (US20190244544A1), hereinafter Okayama in view of Christiansen et al. (US20150161347A1), hereinafter Christiansen, and further in view of Nakanishi et al. (JP2013213986A), hereinafter Nakanishi.
In regards to claim 1, Okayama teaches an organ model for a medical device, which is held in a container in a state of being filled with a liquid and into which a medical device can be inserted through an insertion part provided on the container (Par. [0025]; “The catheter simulator 100 illustrated in FIG. 1 has a container 10 that is filled with a liquid; a heart model 30 that is installed in the container in a state of being filled with a liquid”) and (Par. [0029]; “On the side walls of the container 10, connection units 11 g and 11 e for connecting the inlet tubes 50 and 52, through which a catheter operated by a trainee is introduced from the outside of the container 10, are formed. At the connection units 11 g and 11 e, communicating holes for inserting a catheter are formed.”)
the organ model comprising: a soft member including a holding part held in the container (Par. [0031]; “The heart model 30 is installed inside the container 10 by being inserted into holding protrusions provided at the inlet port 11 a and the connection unit 11 g.”) and (Par. [0034]; “For the heart model 30, it is preferable to use a material that has elasticity close to that of the actual human heart and is transparent so that after a catheter is inserted, the movement of the catheter can be understood… the heart model 30 can be formed using PVA (polyvinyl alcohol), polyurethane, an epoxy resin”);
Okayama does not explicitly teach a hard member including a plate-shaped part installed on an inner surface of the container and being integrated with the soft member. However, Christiansen teaches a hard, plate shaped structure installed within the system housing and integrated with multiple soft anatomical components (Fig. 1 shows the base 16 with the hard model 14, and soft model 18, integrated with the hard model) and Par. [0042]; “Base 16 can include a port 74 that can fluidly connect second component 14 to first component 12. In some embodiments, base 16 can include ports 76 and 78 that connect portions of second component 14 to respective conduits 46 and 50. In some embodiments, base 16 can include supports for supporting second component 14.”) and (Par. [0051]; “In some embodiments, third component 18 is constructed entirely or partially of a flexible material. In some embodiments, the flexible material can be a medical grade silicone”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Christiansen’s hard, plate shaped surface to support Okayama’s soft organ model in order to provide a stable structural foundation that maintains the anatomical geometry of the organ model and allow for rapid replacement of soft anatomical components. One of ordinary skill in the art would have recognized that such a modification applies a known support structure to improve durability and reliability of a medical simulator.
Neither Okayama nor Christiansen explicitly teach wherein the hard member is not fixed to the container, is attachable to and detachable from the soft member, and is positioned by being connected to the soft member. However, Nakanishi teaches an in-tank support arrangement in which a hard plate supports the soft organ model from below without being fastened to the container walls (Pg. 2, par. [17]; “The esophagus part 17 and the heart model 1 are supported by the acrylic plate 18 and the like slightly lifted from the pedestal 19a of the base 19,”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide that the hard plate shaped support is not fixed to the container walls but is positioned by its connection to the soft member in view of Okayama (Par. [0032]; “any configuration in which the heart model 30 can be installed so as to be in a state of floating in the liquid charged into the container 10, may be employed. For example, a configuration in which the heart model 30 is installed by means of the holding protrusion of the connection unit 11 e described above, or a holder for exclusive use is provided inside the container 10, and the heart model 30 is installed using the holder, may also be employed.”), similarly Christiansen dis(Par. [0031]; “In some cases, such table ties can be easily cut and discarded to allow one or more components of system 10 to be removed. In some embodiments, one or more components of system 10 can be removed and replaced to allow for a procedure to be repeated.”) One of ordinary skill in the art would have recognized that omitting a fixed plate yields predictable results to allow for rapid replacement of components for repeated procedures.
In regards to claim 3, Okayama further teaches wherein the holding part is provided at a plurality of sites, and at least one of the holding parts includes a catheter introducing port through which the catheter can be inserted (Par. [0031]; “The heart model 30 is installed inside the container 10 by being inserted into holding protrusions provided at the inlet port 11 a and the connection unit 11 g.”) and (Par. [0028]; “the inlet port 11 a may be configured to be proximately separated into two sites, with one of the sites being used for the connection of the extrusion tube 63 (inflow of pulsatile flow), and the other site being used for the introduction of a catheter.”).
In regards to claim 4, Okayama further teaches the at least one of the holding parts includes a liquid introducing port for introducing a liquid into the organ model in a state of being held in the container (Par. [0027]; “At the inlet port 11 a, as will be described below, an opening 31 a of the apex section of the heart model 30 is connected, and the liquid that has passed through the inlet port 11 a flows into the heart model 30”).
In regards to claim 13, Okayama further teaches the organ model for a medical device according to claim 1, wherein when the soft member is mounted on the hard member, a gap is formed between the soft member and the hard member (Par. [0058]; “As shown in FIG. 5(B), a gap G is produced between the inner surface of the coronary artery part 40 and the diseased portion 44 b, and the liquid that flows into the heart model 30 flows into this gap G and is stored therein.”)
In regards to claim 14, Okayama further teaches the organ model for a medical device according to claim 1, wherein the organ model has a lumen type form (Par. [0035]; “various simulated blood vessels of the coronary arteries 33 laid along the surface of the main body of heart”).
In regards to claim 15, Okayama further teaches the organ model for a medical device according to claim 1, wherein the medical device is a catheter (Par. [0029]; “On the side walls of the container 10, connection units 11 g and 11 e for connecting the inlet tubes 50 and 52, through which a catheter operated by a trainee is introduced from the outside of the container 10, are formed. At the connection units 11 g and 11 e, communicating holes for inserting a catheter are formed.”)
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okayama (US20190244544A1) in view of Christiansen (US20150161347A1), further in view of Nakanishi (JP2013213986A), and further in view of Smith (US4974461A).
In regards to claim 5, claim 5 depends on claim 1 and adds wherein the plate-shaped part includes a flat plate part that is in planar contact with any of inner surfaces of the container in which the organ model is installed. Smith teaches a flat pressure plate in planar contact with the back wall of the chamber (Fig. 2, and Col. 5, lines 67-68; Col. 6, lines 1; “left ventricle 10 is suspended in the back wall of chamber 30 at about the level of prosthetic mitral and aortic valves 14 and 16, respectively, by a pressure plate 56 sealed to chamber 30”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Smith’s flat pressure plate geometry in view of the teachings of Okayama, Christiansen and Nakanishi combined in order to provide stable support for the hard member within the container. One of ordinary skill in the art would have recognized that planar contact between the plate shaped part and inner surface of the container would improve positioning and stability of the organ model during catheter training procedures.
In regards to claim 6, Smith teaches the organ model for a medical device according to claim 5, wherein the flat plate part has a shape approximately the same as that of any of the inner surfaces of the container in which the organ model is installed. Smith’s pressure plate is shaped in correspondence with the inner surface of the chamber wall (Fig. 2, and Col. 5, lines 67-68; Col. 6, lines 1; “left ventricle 10 is suspended in the back wall of chamber 30 at about the level of prosthetic mitral and aortic valves 14 and 16, respectively, by a pressure plate 56 sealed to chamber 30”). Thereby, Smith discloses the organ model for a medical device according to claim 5, wherein the flat plate part has a shape approximately the same as that of any of the inner surfaces of the container in which the organ model is installed.
It would have been Prima face obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to shape the flat plate to correspond to the container’s inner surface to improve stability and support the attached organ model. One of ordinary skill in the art would have recognized that shaping the plate to correspond with the container’s inner surface to provide support for a structure is an obvious and routine engineering design choice that produces predictable results (see MPEP 2144.04). Claim 6 is therefore rejected for the reasons set forth above in claim 5.
Claim(s) 2, 7, 8, 10, 11, 12, 16, 17, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okayama (US20190244544A1) in view of Christiansen (US20150161347A1), and further in view of Nakanishi (JP2013213986A).
In regards to claim 2, Okayama teaches an organ model for a medical device, which is held in a container in a state of being filled with a liquid and in which a medical device can be inserted through an insertion part provided on the container (Par. [0025]; “The catheter simulator 100 illustrated in FIG. 1 has a container 10 that is filled with a liquid; a heart model 30 that is installed in the container in a state of being filled with a liquid”) and (Par. [0029]; “On the side walls of the container 10, connection units 11 g and 11 e for connecting the inlet tubes 50 and 52, through which a catheter operated by a trainee is introduced from the outside of the container 10, are formed. At the connection units 11 g and 11 e, communicating holes for inserting a catheter are formed.”), the organ model having a lumen type form in which a soft member and a hard member are integrated (Par. [0035]; “various simulated blood vessels of the coronary arteries 33 laid along the surface of the main body of heart”),
Christiansen teaches integration of a hard structural component with a soft anatomical component with the soft component being removable (Par. [0031]; “In some embodiments, one or more of the components can be secured or attached through various types of fasteners.), but neither Okayama nor Christian explicitly teach wherein a slit enabling attachment and detachment of the soft member is formed in the hard member.
However, Nakanishi teaches a slit attach/detach interface for a hard and soft composite removable part in a catheter training simulator (Pg. 3, par. [4]; “FIG. 3 is an enlarged plan view showing the part insertion portion 5. The figure shows a state in which the atrial septal defect part 21 is inserted partway through the slit of the part insertion part 5.Atrial septal defect part The atrial septal defect part 21 is made of a thin plate material having a section slightly smaller than the opening section of the slit, and a defect hole part simulating the defect hole of the atrial septum at the insertion side end. 21a is provided.”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to modify Okayama’s attachable/detachable coronary artery part with Nakanishi’s slit modular insert structure in order to allow for rapid replacement of various pathology models without disassembling the organ model. One of ordinary skill in the art would have recognized that the combination yields predictable results in a catheter training simulation field.
In regards to claim 7, Okayama further teaches the organ model for a medical device according to claim 2, wherein the slit formed in the hard member is formed along a longitudinal direction of a lumen or a longitudinal direction of a branched lumen (Par. [0046]; “As shown in FIG. 4(A), the mounting unit 33 e has, at the two ends, an edge 33 b that serves as a connection unit to the coronary artery part 40, and between the edges 33 b, a portion of the upper section and the lateral section on the upper section of the coronary artery 33 is made into an opening 33 c. In FIG. 4, the opening 33 c is formed so as to leave side sections 33 d of the coronary artery 33 between the opening and the heart model main body 30A, and the edges 33 b are continued by the side sections 33 d.”).
In regards to claim 8, Okayama does not teach the organ model for a medical device according to claim 2, wherein the slit formed in the hard member has a middle portion with a width larger than a width on an end part side.
However, Nakanishi teaches a slit in the part insertion part 5 having an opening section slightly larger than the atrial septal defect part 21 (Pg. 3, par. [6]; “The atrial septal defect part 21 is made of a thin plate material having a section slightly smaller than the opening section of the slit, and a defect hole part simulating the defect hole of the atrial septum at the insertion side end. 21a is provided.”) and (Pg. 3, par. [8]; “The atrial septal defect part 21 was formed in a silicon resin sheet having an opening simulating a defect hole part in the central part, an acrylic resin thin plate for fixing the silicon resin sheet, and the acrylic resin thin plate. It is comprised from the holding part 21b.”) and (Fig. 3 illustrate the atrial spectral defect part 21 partway through the slit part insertion part 5 during insertion).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide, in view of the slit interface of the Okayama, Christiansen, and Nakanishi combination, an opening section in which the middle part is wider than the end part in order to facilitate insertion and positioning of removable anatomical parts while maintaining secure retention after installation. One of ordinary skill in the art would have recognized that modifying the slit geometry to improve assembly and replacement of simulator components would yield predictable results.
In regards to claim 10, Okayama teaches the organ model for a medical device according to claim 2, wherein the soft member and the hard member include an overlapping part having a double structure overlapping an entire circumference each other, and the overlapping part has a length in a longitudinal direction shorter than a length in a longitudinal direction of a portion where the slit exists (Par. [0044]; “As shown in FIG. 3(B), the coronary artery 33 at the portion where the coronary artery part 40 is mounted and dismounted has two edges 33 b, and when the coronary artery part 40 formed as a separate body is plugged into these two edges 33 b, the coronary artery part 40 can be fixed in a mounted state.”) and (Par. [0051]; “Furthermore, when the side wall (portion corresponding to the vascular wall) of the coronary artery part 40 is made into a multiple structure with a double or higher structure”).
In regards to claim 11, Okayama further teaches the organ model for a medical device according to claim 2, wherein a plug-in part into which the soft member is inserted is formed at an end part of the slit formed in the hard member (Par. [0044]; “when the coronary artery part 40 formed as a separate body is plugged into these two edges 33 b, the coronary artery part 40 can be fixed in a mounted state.”) and (Par. [0046]; “the mounting unit 33 e has, at the two ends, an edge 33 b that serves as a connection unit to the coronary artery part 40”).
In regards to claim 12, Okayama further teaches the organ model for a medical device according to claim 10, wherein the portion having a double structure is provided with a bulging part or a stenotic part (Par. [0056]; “As shown in the diagram, the auxiliary part 44 is a tubular body having an opening 44 a at both ends, and in the longitudinally central region of the tubular body, a diseased portion 44 b that has been narrowed by making the diameter smaller than the diameters of other regions is formed.”) and (Par. [0060]; “Furthermore, the diseased portion 44 b of the auxiliary part 44 is not limited to stenosis where the diameter has been narrowed to be small”) and (Par. [0051]; “On the other hand, when a case in which a coronary artery 33 has stenosis, occlusion or the like is reproduced, the inner diameter R40 of the coronary artery part 40 is partially made smaller (reproducing stenosis)”).
In regards to claim 16, Okayama further teaches the organ model for a medical device according to claim 2, wherein when the soft member is mounted on the hard member, a gap is formed between the soft member and the hard member (Par. [0058]; “As shown in FIG. 5(B), a gap G is produced between the inner surface of the coronary artery part 40 and the diseased portion 44 b, and the liquid that flows into the heart model 30 flows into this gap G and is stored therein.”).
In regards to claim 17, Okayama further teaches the organ model for a medical device according to claim 2, wherein the lumen type is a blood vessel (Par. [0035]; “The heart model 30 of the present embodiment has, as illustrated in FIG. 2, the main body of heart 30A, which is a simulated organ simulating the human heart; and various simulated blood vessels of the coronary arteries 33 laid along the surface of the main body of heart,”).
In regards to claim 18, Okayama further teaches the organ model for a medical device according to claim 2, wherein the medical device is a catheter (Par. [0029]; “On the side walls of the container 10, connection units 11 g and 11 e for connecting the inlet tubes 50 and 52, through which a catheter operated by a trainee is introduced from the outside of the container 10, are formed. At the connection units 11 g and 11 e, communicating holes for inserting a catheter are formed.”)
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okayama (US20190244544A1) view of Christiansen (US20150161347A1), further in view of Nakanishi (JP2013213986A) and further in view of Kramer et al. (US20190172372A1), hereinafter Kramer.
In regards to claim 9, Okayama does not explicitly teach the organ model for a medical device according to claim 2, wherein the portion where the slit is formed has a double structure of a hard member and a soft member in a state in which a portion of the soft member is exposed.
However, Kramer teaches a hard carrier and soft insert arrangement in which a portion of the soft member is exposed (Par. [0009]; “a plug inserted in the first port, the plug having a surface exposed to the interior of the shell”) and (Par. [0036]; “When fully inserted in carrier 240, the top surface of plug 242 is substantially coplanar with the top edge of the carrier.”) and (Par. [0037]; “Plug 242 is formed from a material that simulates at least some of the physical and/or electrical properties of cardiac tissue in the vicinity of the bundle of His. In particular, the analogue material is relatively soft”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide, in view of the Okayama and Nakanishi combination, a double structure arrangement at the slit location in which the soft tissue is exposed to the interior as taught by Kramer. One of ordinary skill in the art would have recognized that this modification would preserve realistic tissue interaction while maintaining the structural support of the simulator.
Conclusion
Accordingly claims 1-18 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BUSHIRA MUSA whose telephone number is (571)272-9156. The examiner can normally be reached Mon-Fri 7:30am-5pm.
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/B.M./Examiner, Art Unit 3715
/KANG HU/Supervisory Patent Examiner, Art Unit 3715
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