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
The amendment filed March 26, 2026 has been entered. Claims 1-20 remain
pending in the application. Applicant amended claims 1, 2, 11-13, and 16 and added new claims 17-20. Examiner withdraws all claim objections. Examiner acknowledges Applicant’s foreign priority under 35 U.S.C. 119.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable under US 20180018904 A1 (“Okayama”) in view of WO 2019236654 A2 (“Iversen”).
In regards to claim 1, Okayama discloses the following limitations with the exception of the underlined limitations.
A heart model comprising ([0011], “an object of the present invention is to provide … a heart model”): a main body ([0020], “The … heart model … has a main body”) formed from an elastic material ([0111], “The … heart models … are formed from a material having elasticity”) and including a left atrium and a left ventricle ([0020], “The … heart model … has … a left atrium … and a left ventricle”), with a mitral valve installed at a boundary portion between the left atrium and the left ventricle ([0071], “there is no serious problem even if … a tricuspid valve … and a mitral valve are not formed inside the main body”);
and a vena cava provided in the main body ([0020], “The … heart model … has a … venae cavae (superior vena cava and inferior vena cava) that are connected to the main body of heart”), wherein the mitral valve includes an anterior leaflet and a posterior leaflet, both the leaflets extending to the left ventricle side and capable of opening and closing, the anterior leaflet and the posterior leaflet are each provided on a tip side with a plurality of string-shaped members extending into the left ventricle, and one terminal end of each of the string-shaped members is free.
Iversen discloses
wherein the mitral valve includes an anterior leaflet and a posterior leaflet ([0105], “the mitral valve … includes two leaflets, the anterior leaflet … and the posterior leaflet”), both the leaflets extending to the left ventricle side and capable of opening and closing ([0020], “Figure 3 is a … view of a … mitral valve with the leaflets closed”), and the anterior leaflet and the posterior leaflet are each provided on a tip side with a plurality of string-shaped members extending into the left ventricle ([0105], “The mitral valve … is anchored to the wall of the left ventricle … by … cord-like tendons that connect … the muscles … within the walls of the left ventricle … to the leaflets” Examiner notes that cord-like tendons are generally considered synonymous with string-shaped tendons.) and one terminal end of each of the string-shaped members is free ([0105], “mitral valve … is anchored to the wall of the left ventricle … by chordae tendineae” Examiner notes that chordae tendineae are string-shaped members.).
Okayama and Iversen combined are considered analogous to the claimed invention because they are in the field of catheter simulators, heart models, and valve repair devices and processes. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a heart model comprising: a main body formed from an elastic material and including a left atrium and a left ventricle, with a mitral valve installed at a boundary portion between the left atrium and the left ventricle; and a vena cava provided in the main body, as disclosed by Okayama, wherein the mitral valve includes an anterior leaflet and a posterior leaflet, both the leaflets extending to the left ventricle side and capable of opening and closing, and the anterior leaflet and the posterior leaflet are each provided on a tip side with a plurality of string-shaped members extending into the left ventricle, and one terminal end of each of the string-shaped members is free, as disclosed by Iversen, to provide a mitral valve, anterior and posterior leaflets, left ventricle, cord-like tendons, and chordae tendineae for valve repair devices and processes. One skilled in the art would recognize the value of the addition of a mitral valve, anterior and posterior leaflets, left ventricle, cord-like tendons, and chordae tendineae for valve repair devices and processes.
In regards to claim 2, Okayama does not disclose wherein a plurality of opening holes is formed along tip edges of the anterior leaflet and the posterior leaflet, and each of the string-shaped members includes one end thereof fastened to one of the
opening holes.
Iversen discloses
wherein a plurality of opening holes is formed along tip edges of the anterior leaflet and the posterior leaflet ([0034], “Figure 15 illustrates the mitral valve” Examiner notes that the attachment members depicted in annotated Iversen FIG. 15 can be designed to function as an opening or access point for a heart model.), and each of the string-shaped members includes one end thereof fastened to one of the opening holes ([0105], “The mitral valve … is anchored to … the left ventricle … by chordae tendineae …, which are cord-like tendons” Examiner notes that cord-like tendons are generally considered synonymous with string-shaped tendons and that chordae tendineae in a heart model can be fastened to an opening.).
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Okayama and Iversen combined are considered analogous to the claimed invention because they are in the field of catheter simulators, heart models, and valve repair devices and processes. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a heart model comprising: a main body formed from an elastic material and including a left atrium and a left ventricle, with a mitral valve installed at a boundary portion between the left atrium and the left ventricle; and a vena cava provided in the main body, as disclosed by Okayama, wherein the mitral valve includes an anterior leaflet and a posterior leaflet, both the leaflets extending to the left ventricle side and capable of opening and closing, and the anterior leaflet and the posterior leaflet are each provided on a tip side with a plurality of string-shaped members extending into the left ventricle, wherein a plurality of opening holes is formed along tip edges of the anterior leaflet and the posterior leaflet, and each of the string-shaped members includes one end thereof fastened to one of the opening holes, as disclosed by Iversen, to provide a mitral valve and chordae tendineae for valve repair devices and processes. One skilled in the art would recognize the value of the addition of mitral valve and chordae tendineae for valve repair devices and processes.
In regards to claim 3, Okayama discloses
wherein the string-shaped members are formed from a stretchable material ([0016], “The heart models … are formed from materials having elasticity” Examiner notes that elasticity implies that the material is stretchable.).
In regards to claim 4, Okayama does not disclose wherein the anterior leaflet and the posterior leaflet are held by a holder and the holder is installed at a boundary portion between the left atrium and the left ventricle.
Iversen discloses
wherein the anterior leaflet and the posterior leaflet are held by a holder ([0173], “The delivery member … can … include a suction device for holding valve tissue” Examiner notes that the anterior leaflet and the posterior leaflet are both made of valve tissue.) and the holder is installed at a boundary portion between the left atrium and the left ventricle ([0268], “a tortuous path is created with multiple holding points”).
Okayama and Iversen combined are considered analogous to the claimed invention because they are in the field of catheter simulators, heart models, and valve repair devices and processes. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a heart model comprising: a main body formed from an elastic material and including a left atrium and a left ventricle, with a mitral valve installed at a boundary portion between the left atrium and the left ventricle; and a vena cava provided in the main body, as disclosed by Okayama, wherein the mitral valve includes an anterior leaflet and a posterior leaflet, both the leaflets extending to the left ventricle side and capable of opening and closing, and the anterior leaflet and the posterior leaflet are each provided on a tip side with a plurality of string-shaped members extending into the left ventricle, and one terminal end of each of the string-shaped members is free, wherein the anterior leaflet and the posterior leaflet are held by a holder and the holder is installed at a boundary portion between the left atrium and the left ventricle, as disclosed by Iversen, to provide a mitral valve, anterior and posterior leaflets, left ventricle, cord-like tendons, chordae tendineae, suction device, and holding points for valve repair devices and processes. One skilled in the art would recognize the value of the addition of a mitral valve, anterior and posterior leaflets, left ventricle, cord-like tendons, chordae tendineae, suction device, and holding points for valve repair devices and processes.
In regards to claim 5, Okayama does not disclose wherein the holder can be attached to and detached from the boundary portion between the left atrium and the left ventricle.
Iversen discloses
wherein the holder ([0173], “The delivery member … can … include a suction device for holding valve tissue”) can be attached to and detached from the boundary portion between the left atrium and the left ventricle ([0268], “a tortuous path is created with multiple holding points”).
Okayama and Iversen combined are considered analogous to the claimed invention because they are in the field of catheter simulators, heart models, and valve repair devices and processes. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a heart model comprising: a main body formed from an elastic material and including a left atrium and a left ventricle, with a mitral valve installed at a boundary portion between the left atrium and the left ventricle; and a vena cava provided in the main body, as disclosed by Okayama, wherein the mitral valve includes an anterior leaflet and a posterior leaflet, both the leaflets extending to the left ventricle side and capable of opening and closing, and the anterior leaflet and the posterior leaflet are each provided on a tip side with a plurality of string-shaped members extending into the left ventricle, and one terminal end of each of the string-shaped members is free, wherein the anterior leaflet and the posterior leaflet are held by a holder and the holder is installed at a boundary portion between the left atrium and the left ventricle, wherein the holder can be attached to and detached from the boundary portion between the left atrium and the left ventricle, as disclosed by Iversen, to provide a mitral valve, anterior and posterior leaflets, left ventricle, cord-like tendons, chordae tendineae, suction device, and holding points for valve repair devices and processes. One skilled in the art would recognize the value of the addition of a mitral valve, anterior and posterior leaflets, left ventricle, cord-like tendons, chordae tendineae, suction device, and holding points for valve repair devices and processes.
In regards to claim 6, Okayama does not disclose wherein an insertion member for inserting the string-shaped members therethrough in a bundled state, is fastened to an inner wall of the left ventricle.
Iversen discloses
wherein an insertion member for inserting the string-shaped members therethrough in a bundled state, is fastened to an inner wall of the left ventricle ([0105], “The mitral valve … is anchored to the wall of the left ventricle … by chordae tendineae … which are cord-like tendons” Examiner notes that cord-like tendons are generally considered synonymous with string-shaped tendons and that chordae tendineae in a heart model can be represented in a bundled state.).
Okayama and Iversen combined are considered analogous to the claimed invention because they are in the field of catheter simulators, heart models, and valve repair devices and processes. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a heart model comprising: a main body formed from an elastic material and including a left atrium and a left ventricle, with a mitral valve installed at a boundary portion between the left atrium and the left ventricle; and a vena cava provided in the main body, as disclosed by Okayama, wherein the mitral valve includes an anterior leaflet and a posterior leaflet, both the leaflets extending to the left ventricle side and capable of opening and closing, and the anterior leaflet and the posterior leaflet are each provided on a tip side with a plurality of string-shaped members extending into the left ventricle, and wherein an insertion member for inserting the string-shaped members therethrough in a bundled state, is fastened to an inner wall of the left ventricle, as disclosed by Iversen, to provide a mitral valve, left ventricle, and chordae tendineae for valve repair devices and processes. One skilled in the art would recognize the value of the addition of a mitral valve, left ventricle, and chordae tendineae for valve repair devices and processes.
In regards to claim 7, Okayama does not disclose wherein the insertion member includes an insertion member for anterior leaflet for inserting therethrough a plurality of string-shaped members provided on the anterior leaflet, and an insertion member for posterior leaflet for inserting therethrough a plurality of string-shaped members provided on the posterior leaflet.
Iversen discloses
wherein the insertion member includes an insertion member for anterior leaflet for inserting therethrough a plurality of string-shaped members provided on the anterior leaflet, and an insertion member for posterior leaflet for inserting therethrough a plurality of string-shaped members provided on the posterior leaflet ([0105], “The mitral valve … is anchored … by chordae tendineae …, which are cord-like tendons that connect … the muscles located at the base of the chordae tendineae … to the leaflets”).
Okayama and Iversen combined are considered analogous to the claimed invention because they are in the field of catheter simulators, heart models, and valve repair devices and processes. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a heart model comprising: a main body formed from an elastic material and including a left atrium and a left ventricle, with a mitral valve installed at a boundary portion between the left atrium and the left ventricle; and a vena cava provided in the main body, as disclosed by Okayama, wherein the mitral valve includes an anterior leaflet and a posterior leaflet, both the leaflets extending to the left ventricle side and capable of opening and closing, and the anterior leaflet and the posterior leaflet are each provided on a tip side with a plurality of string-shaped members extending into the left ventricle, and wherein the insertion member includes an insertion member for anterior leaflet for inserting therethrough a plurality of string-shaped members provided on the anterior leaflet, and an insertion member for posterior leaflet for inserting therethrough a plurality of string-shaped members provided on the posterior leaflet, as disclosed by Iversen, to provide a mitral valve and chordae tendineae for valve repair devices and processes. One skilled in the art would recognize the value of the addition of a mitral valve and chordae tendineae for valve repair devices and processes.
In regards to claim 8, Okayama discloses
wherein a connection part connectable to a liquid suction part is formed ([0024], “the inflow tube … is connected to the connection unit … and … a pulsatile flow sent out by the … pump … and a liquid is supplied” Examiner notes that a pump may be used as a suction part.) at a cardiac apex of the left ventricle of the main body ([0024], “The … model has … a … tube … provided at the apex of the main body … inside of the main body … a left ventricle and the like are formed”).
In regards to claim 9, Okayama discloses
wherein in the main body, the left atrium and the vena cava are formed adjacently to each other ([0020], “The … heart model … has a main body of … superior vena cava and inferior vena cava … that are connected to … a left atrium”), with a partition wall interposed therebetween, and an opening for inserting a catheter therethrough is formed in the partition wall ([0012], “the present invention provides … a installation part for inserting a catheter from the outside of the container into … the heart model” Examiner notes that the outside of the container may interposed between the left atrium and the vena cava to function as a partition wall.).
In regards to claim 10, Okayama discloses
wherein in the main body, an esophagus for inserting a transesophageal echocardiography is formed adjacently to the vena cava ([0054], “the inlet tube … is connected to the … vena cava … formed in the … heart model” Examiner notes that an inlet tube can be used to represent the esophagus in a heart model and that placing it adjacent to the vena cava is anatomically correct.).
In regards to claim 11, Okayama discloses the following limitations with the exception of the underlined limitations.
A mitral valve model installed at a boundary portion between a left atrium and a left ventricle of a heart model ([0071], “there is no serious problem even if … a tricuspid valve … and a mitral valve are not formed inside the main body”), and comprising an anterior leaflet and a posterior leaflet formed from flexible members, with edge sides thereof bent to lie on top of each other, wherein the anterior leaflet and the posterior leaflet are mounted on a holder formed from a hard material harder than a material constituting the heart model ([0116], “The material … may be any material harder than the material for forming … the heart model”), the holder is installed at a boundary portion between the left atrium and the left ventricle, and the anterior leaflet and the posterior leaflet are each provided on the edge side with a plurality of string-shaped members.
Iversen discloses
and comprising an anterior leaflet and a posterior leaflet formed from flexible members, with edge sides thereof bent to lie on top of each other ([0105], “the mitral valve … includes two leaflets, the anterior leaflet … and the posterior leaflet”), formed from flexible members ([0103], “Each of these valves has flexible leaflets”), with edge sides thereof bent to lie on top of each other ([0109], “the anterior leaflet … and the posterior leaflet … coapt” Examiner notes that coapt refers to fitting tightly together and the state of being joined together.), wherein the anterior leaflet and the posterior leaflet are mounted on a holder ([0173], “The delivery member … can … include a suction device for holding valve tissue” Examiner notes that the anterior leaflet and the posterior leaflet are both made of valve tissue.) the holder is installed at a boundary portion between the left atrium and the left ventricle ([0268], “a tortuous path is created with multiple holding points”), and the anterior leaflet and the posterior leaflet are each provided on the edge side with a plurality of string-shaped members ([0105], “The mitral valve … is anchored to the wall of the left ventricle … by … cord-like tendons that connect … the muscles … within the walls of the left ventricle … to the leaflets” Examiner notes that cord-like tendons are generally considered synonymous with string-shaped tendons.).
Okayama and Iversen combined are considered analogous to the claimed invention because they are in the field of catheter simulators, heart models, and valve repair devices and processes. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a mitral valve model installed at a boundary portion between a left atrium and a left ventricle of a heart model, wherein the anterior leaflet and the posterior leaflet are mounted on a holder formed from a hard material harder than the material constituting the heart model, the holder is installed at a boundary portion between the left atrium and the left ventricle, as disclosed by Okayama, and comprising an anterior leaflet and a posterior leaflet formed from flexible members, with edge sides thereof bent to lie on top of each other, wherein the anterior leaflet and the posterior leaflet are mounted on a holder, the holder is installed at a boundary portion between the left atrium and the left ventricle, and the anterior leaflet and the posterior leaflet are each provided on the edge side with a plurality of string-shaped members, as disclosed by Iversen, to provide a mitral valve, anterior leaflet, posterior leaflet, suction device, and holding points for valve repair devices and processes. One skilled in the art would recognize the value of the addition of a mitral valve, anterior leaflet, posterior leaflet, suction device, and holding points for valve repair devices and processes.
In regards to claim 12, Okayama does not disclose wherein a plurality of opening holes are formed on the edge sides of the anterior leaflet and the posterior leaflet, and the string-shaped members are fastened to the opening holes.
Iversen discloses
wherein a plurality of opening holes are formed on the edge sides of the anterior leaflet and the posterior leaflet ([0034], “Figure 15 illustrates the mitral valve” Examiner notes that the attachment members depicted in annotated Iversen FIG. 15 can be designed to function as an opening or access point for a heart model.), and the string-shaped members are fastened to the opening holes ([0105], “The mitral valve … is anchored to … the left ventricle … by chordae tendineae …, which are cord-like tendons” Examiner notes that cord-like tendons are generally considered synonymous with string-shaped tendons and that chordae tendineae in a heart model can be fastened to an opening.).
Okayama and Iversen combined are considered analogous to the claimed invention because they are in the field of catheter simulators, heart models, and valve repair devices and processes. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a mitral valve model installed at a boundary portion between a left atrium and a left ventricle of a heart model, wherein the anterior leaflet and the posterior leaflet are mounted on a holder formed from a hard material harder than the material constituting the heart model, as disclosed by Okayama, and comprising an anterior leaflet and a posterior leaflet formed from flexible members, with edge sides thereof bent to lie on top of each other, and the anterior leaflet and the posterior leaflet are each provided on the edge side with a plurality of string-shaped members, and wherein a plurality of opening holes are formed on the edge sides of the anterior leaflet and the posterior leaflet, and the string-shaped members are fastened to the opening holes, as disclosed by Iversen, to provide a mitral valve, left ventricle, and chordae tendineae for valve repair devices and processes. One skilled in the art would recognize the value of the addition of a mitral valve, left ventricle, and chordae tendineae for valve repair devices and processes.
In regards to claim 13, Okayama discloses the following limitations with the exception of the underlined limitations.
A catheter simulator for practicing catheter manipulations in a state of holding a heart model in a container filled with a liquid ([0012], “the present invention provides a container for a catheter simulator comprising: an accommodating unit for accommodating a liquid, … the heart model is installed in the accommodating unit that is filled with a liquid”), the heart model including a main body formed from an elastic material ([0016], “The heart models … are formed from materials having elasticity”) and including a left atrium and a left ventricle ([0020], “The … heart model … has … a left atrium … and a left ventricle”), with a mitral valve installed at a boundary portion between the left atrium and the left ventricle ([0071], “there is no serious problem even if … a tricuspid valve … and a mitral valve are not formed inside the main body”), the mitral valve including an anterior leaflet and a posterior leaflet, both the leaflets extending toward the left ventricle side and being capable of opening and closing, and the anterior leaflet and the posterior leaflet being each provided on a tip side with a plurality of string-shaped members extending into the left ventricle, wherein the container includes a holding part for holding the heart model ([0011], “an object of the present invention is to provide a container for a … heart model”), and an introduction part capable of inserting a catheter ([0012], “the present invention provides … a installation part for inserting a catheter”), a pump for circulating the liquid to be filled in the container into the heart model is connected to the container ([0018], “the pump is connected to the container”), the pump is intermittently driven so that a pulsatile flow flows ([0124], “The pump … that is connected to the … model … is intermittently driven so as to generate a pulsatile flow”) from the left atrium toward the left ventricle in the heart model held in the container, and the mitral valve is configured to open when the string-shaped members are pulled toward a cardiac apex side by a sucking action of the pump.
Iversen discloses
the mitral valve including an anterior leaflet and a posterior leaflet ([0105], “the mitral valve … includes two leaflets, the anterior leaflet … and the posterior leaflet”), both the leaflets extending toward the left ventricle side and being capable of opening and closing ([0020], “Figure 3 is a … view of a … mitral valve with the leaflets closed”), and the anterior leaflet and the posterior leaflet being each provided on the tip side with a plurality of string-shaped members extending into the left ventricle ([0105], “The mitral valve … is anchored to the wall of the left ventricle … by … cord-like tendons that connect … the muscles … within the walls of the left ventricle … to the leaflets” Examiner notes that cord-like tendons are generally considered synonymous with string-shaped tendons.), on a mitral valve using ([0105], “the mitral valve … includes two leaflets, the anterior leaflet … and the posterior leaflet”)
and the mitral valve is configured to open when the string-shaped members ([0105], “Without the connection to the chordae tendineae … the mitral valve … would revert … back toward … the atrium”) are pulled toward a cardiac apex side by a sucking action of the pump ([0105], “The mitral valve opens … in response to pressure changes in the left atrium … and the left ventricle” Examiner notes that a pump relies on pressure differences to create suction.)
Okayama and Iversen combined are considered analogous to the claimed invention because they are in the field of catheter simulators, heart models, and valve repair devices and processes. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a catheter simulator for practicing catheter manipulations in a state of holding a heart model in a container filled with a liquid, the heart model including a main body formed from an elastic material and including a left atrium and a left ventricle, with a mitral valve installed at a boundary portion between the left atrium and the left ventricle, wherein the container includes a holding part for holding the heart model, and an introduction part capable of inserting a catheter, a pump for circulating the liquid to be filled in the container into the heart model is connected to the container, the pump is intermittently driven so that a pulsatile flow flows from the left atrium toward the left ventricle in the heart model held in the container, and a catheter surgery, and a catheter can be practiced against the anterior leaflet and the posterior leaflet of the heart model held by the holding part, as disclosed by Okayama, the mitral valve including an anterior leaflet and a posterior leaflet, both the leaflets extending toward the left ventricle side and being capable of opening and closing, and the anterior leaflet and the posterior leaflet being each provided on the tip side with a plurality of string-shaped members extending into the left ventricle, on a mitral valve using, and the mitral valve is configured to open when the string-shaped members are pulled toward a cardiac apex side by a sucking action of the pump, as disclosed by Iversen, to provide a mitral valve, an anterior leaflet, a posterior leaflet, left ventricle, cord-like tendons, chordae tendineae, and left atrium for valve repair devices and processes. One skilled in the art would recognize the value of the addition of a mitral valve, an anterior leaflet, a posterior leaflet, left ventricle, cord-like tendons, chordae tendineae, and left atrium for valve repair devices and processes.
In regards to claim 14, Okayama discloses
wherein the introduction part constitutes a holding part for holding a vena cava formed in the main body ([0047], “holding protrusions … are formed at the connection units … and thereby, a heart model can be … connected … by plugging in the terminals of the heart model.” Examiner notes that heart models may be designed with protrusions that function as holders and that the vena cava in the heart model may function as a connection unit.).
In regards to claim 15, Okayama discloses
wherein the container is provided with a liquid inflow part for allowing a liquid pushed out from the pump to flow into the container ([0024], “the inflow tube is open and is connected to … the container, and the inflow tube serves as a pathway through which … the … pump flows into the main body”), and a liquid suction part for sucking the liquid ([0024], “the inflow tube … is connected to the connection unit … and … a pulsatile flow sent out by the … pump … and a liquid is supplied” Examiner notes that a pump may be used as a suction part.) in the left atrium and the left ventricle ([0062], “the … main body … includes … a left atrium … and a left ventricle”) and sending the liquid to the pump ([0018], “the pump is connected to the container”), and a connection part connectable to the liquid suction part is formed at a cardiac apex of the left ventricle of the main body ([0024], “The … model has … a … tube … provided at the apex of the main body … inside of the main body … a left ventricle and the like are formed”).
In regards to claim 16, Okayama discloses
wherein in a liquid suction path for sucking a liquid using the pump, a one-way valve is disposed, and the one-way valve opens when the liquid is sucked by an intermittent drive and closes when the suction of the liquid is stopped ([0102], “a duckbill valve … is installed … and functions as a one-way valve” Examiner notes that a duckbill valve can open when liquid is sucked and close when suction stops.).
In regards to claim 17, Okayama discloses
wherein the liquid suction part includes a connection nozzle for connecting with a connection part formed at the cardiac apex, and a receiving part including a shape conforming to an inner surface of the cardiac apex is disposed so as to prevent the occurrence of a gap between the connection part formed at the cardiac apex and the tip of the connection nozzle ([0047], “the pump … (see FIG. 12) is connected to … the container” Examiner notes that annotated Okayama FIG. 12 depicts a pump (liquid suction part), a connection nozzle, and a receiving part.).
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In regards to claim 18, Okayama does not disclose wherein one terminal end of each of the string-shaped members is free.
Iversen discloses
wherein one terminal end of each of the string-shaped members is free ([0105], “mitral valve … is anchored to the wall of the left ventricle … by chordae tendineae” Examiner notes that chordae tendineae are string-shaped members.).
Okayama and Iversen combined are considered analogous to the claimed invention because they are in the field of catheter simulators, heart models, and valve repair devices and processes. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a catheter simulator for practicing catheter manipulations in a state of holding a heart model in a container filled with a liquid, the heart model including a main body formed from an elastic material and including a left atrium and a left ventricle, with a mitral valve installed at a boundary portion between the left atrium and the left ventricle, wherein the container includes a holding part for holding the heart model, and an introduction part capable of inserting a catheter, a pump for circulating the liquid to be filled in the container into the heart model is connected to the container, the pump is intermittently driven so that a pulsatile flow flows from the left atrium toward the left ventricle in the heart model held in the container, and a catheter surgery, and a catheter can be practiced against the anterior leaflet and the posterior leaflet of the heart model held by the holding part, as disclosed by Okayama, the mitral valve including an anterior leaflet and a posterior leaflet, both the leaflets extending toward the left ventricle side and being capable of opening and closing, and the anterior leaflet and the posterior leaflet being each provided on the tip side with a plurality of string-shaped members extending into the left ventricle, on a mitral valve using, and the mitral valve is configured to open when the string-shaped members are pulled toward a cardiac apex side by a sucking action of the pump, wherein one terminal end of each of the string-shaped members is free, as disclosed by Iversen, to provide a mitral valve, an anterior leaflet, a posterior leaflet, left ventricle, cord-like tendons, chordae tendineae, and left atrium for valve repair devices and processes. One skilled in the art would recognize the value of the addition of a mitral valve, an anterior leaflet, a posterior leaflet, left ventricle, cord-like tendons, chordae tendineae, and left atrium for valve repair devices and processes.
In regards to claim 19, Okayama does not disclose wherein one terminal end of each of the string-shaped members is not fixed to the holding parts.
Iversen discloses
wherein one terminal end of each of the string-shaped members is not fixed to the holding parts ([0105], “mitral valve … is anchored to the wall of the left ventricle … by chordae tendineae” Examiner notes that chordae tendineae are string-shaped members.).
Okayama and Iversen combined are considered analogous to the claimed invention because they are in the field of catheter simulators, heart models, and valve repair devices and processes. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a catheter simulator for practicing catheter manipulations in a state of holding a heart model in a container filled with a liquid, the heart model including a main body formed from an elastic material and including a left atrium and a left ventricle, with a mitral valve installed at a boundary portion between the left atrium and the left ventricle, wherein the container includes a holding part for holding the heart model, and an introduction part capable of inserting a catheter, a pump for circulating the liquid to be filled in the container into the heart model is connected to the container, the pump is intermittently driven so that a pulsatile flow flows from the left atrium toward the left ventricle in the heart model held in the container, and a catheter surgery, and a catheter can be practiced against the anterior leaflet and the posterior leaflet of the heart model held by the holding part, as disclosed by Okayama, the mitral valve including an anterior leaflet and a posterior leaflet, both the leaflets extending toward the left ventricle side and being capable of opening and closing, and the anterior leaflet and the posterior leaflet being each provided on the tip side with a plurality of string-shaped members extending into the left ventricle, on a mitral valve using, and the mitral valve is configured to open when the string-shaped members are pulled toward a cardiac apex side by a sucking action of the pump, as disclosed by Iversen, to provide a mitral valve, an anterior leaflet, a posterior leaflet, left ventricle, cord-like tendons, chordae tendineae, and left atrium for valve repair devices and processes. One skilled in the art would recognize the value of the addition of a mitral valve, an anterior leaflet, a posterior leaflet, left ventricle, cord-like tendons, chordae tendineae, and left atrium for valve repair devices and processes.
In regards to claim 20, Okayama does not disclose wherein the anterior leaflet and the posterior leaflet are held by a holder, and the holder is installed at a boundary portion between the left atrium and the left ventricle.
Iversen discloses
wherein the anterior leaflet and the posterior leaflet are held by a holder, and the holder is installed at a boundary portion between the left atrium and the left ventricle ([0173], “delivery member … can … include a suction device for holding valve tissue” Examiner notes that the anterior leaflet and the posterior leaflet are both made of valve tissue).
Okayama and Iversen combined are considered analogous to the claimed invention because they are in the field of catheter simulators, heart models, and valve repair devices and processes. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a catheter simulator for practicing catheter manipulations in a state of holding a heart model in a container filled with a liquid, the heart model including a main body formed from an elastic material and including a left atrium and a left ventricle, with a mitral valve installed at a boundary portion between the left atrium and the left ventricle, wherein the container includes a holding part for holding the heart model, and an introduction part capable of inserting a catheter, a pump for circulating the liquid to be filled in the container into the heart model is connected to the container, the pump is intermittently driven so that a pulsatile flow flows from the left atrium toward the left ventricle in the heart model held in the container, and a catheter surgery, and a catheter can be practiced against the anterior leaflet and the posterior leaflet of the heart model held by the holding part, as disclosed by Okayama, the mitral valve including an anterior leaflet and a posterior leaflet, both the leaflets extending toward the left ventricle side and being capable of opening and closing, and the anterior leaflet and the posterior leaflet being each provided on the tip side with a plurality of string-shaped members extending into the left ventricle, on a mitral valve using, and the mitral valve is configured to open when the string-shaped members are pulled toward a cardiac apex side by a sucking action of the pump, wherein the anterior leaflet and the posterior leaflet are held by a holder, and the holder is installed at a boundary portion between the left atrium and the left ventricle, as disclosed by Iversen, to provide a mitral valve, an anterior leaflet, a posterior leaflet, left ventricle, cord-like tendons, chordae tendineae, and left atrium for valve repair devices and processes. One skilled in the art would recognize the value of the addition of a mitral valve, an anterior leaflet, a posterior leaflet, left ventricle, cord-like tendons, chordae tendineae, and left atrium for valve repair devices and processes.
Response to Arguments
Applicant's arguments filed March 26, 2026 have been fully considered but are
not persuasive. Applicant amended claims 1, 2, 11-13, and 16 and added new claims 17-20. Claims 1-20 are pending in this application. With respect to amended claim 1, Applicant argues “neither Okayama nor Iverson, alone or in combination, teach or suggest each and every feature recited in Applicant's claim 1” (See Response under 37 C.F.R. 1.111, Remarks, Claim Rejections under 35 U.S.C. 103, page 7, paragraph 3.) Examiner acknowledges Applicant’s remarks. Regarding claim 1, Okayama discloses a heart model comprising ([0011], “an object of the present invention is to provide … a heart model”): a main body ([0020], “The … heart model … has a main body”) formed from an elastic material ([0111], “The … heart models … are formed from a material having elasticity”) and including a left atrium and a left ventricle ([0020], “The … heart model … has … a left atrium … and a left ventricle”), with a mitral valve installed at a boundary portion between the left atrium and the left ventricle ([0071], “there is no serious problem even if … a tricuspid valve … and a mitral valve are not formed inside the main body”); and a vena cava provided in the main body ([0020], “The … heart model … has a … venae cavae (superior vena cava and inferior vena cava) that are connected to the main body of heart”) and Iversen discloses
wherein the mitral valve includes an anterior leaflet and a posterior leaflet ([0105], “the mitral valve … includes two leaflets, the anterior leaflet … and the posterior leaflet”), both the leaflets extending to the left ventricle side and capable of opening and closing ([0020], “Figure 3 is a … view of a … mitral valve with the leaflets closed”), and the anterior leaflet and the posterior leaflet are each provided on a tip side with a plurality of string-shaped members extending into the left ventricle ([0105], “The mitral valve … is anchored to the wall of the left ventricle … by … cord-like tendons that connect … the muscles … within the walls of the left ventricle … to the leaflets” Examiner notes that cord-like tendons are generally considered synonymous with string-shaped tendons.) and one terminal end of each of the string-shaped members is free ([0105], “mitral valve … is anchored to the wall of the left ventricle … by chordae tendineae” Examiner notes that chordae tendineae are string-shaped members.). In claim 1, Applicant’s reference to “one terminal end of each of the string-shaped members is free” is not implied in the Applicant’s specification.
MPEP § 2111 discusses proper claim interpretation, including giving claims their
broadest reasonable interpretation (“BRI”) in light of the specification during
examination. Under BRI, the words of a claim must be given their plain meaning unless
such meaning is inconsistent with the specification, and it is improper to import claim
limitations from the specification into the claim. Applicant’s argument is not persuasive because the BRI is broader than what is argued. Therefore, the rejection of amended
claim 1, as obvious over Okayama in view of Iversen is maintained. Consequently, the rejections of dependent claims 2-10 are maintained.
With respect to amended claim 11, Applicant argues “neither Okayama nor Iverson, alone or in combination, teach or suggest each and every feature recited in Applicant's claim 11” (See Response under 37 C.F.R. 1.111, Remarks, Claim Rejections under 35 U.S.C. 103, page 8, paragraph 3.) Examiner acknowledges Applicant’s remarks. Regarding claim 11, Okayama discloses a mitral valve model installed at a boundary portion between a left atrium and a left ventricle of a heart model ([0071], “there is no serious problem even if … a tricuspid valve … and a mitral valve are not formed inside the main body”), formed from a hard material harder than a material constituting the heart model ([0116], “The material … may be any material harder than the material for forming … the heart model”) and Iversen discloses
and comprising an anterior leaflet and a posterior leaflet formed from flexible members, with edge sides thereof bent to lie on top of each other ([0105], “the mitral valve … includes two leaflets, the anterior leaflet … and the posterior leaflet”), formed from flexible members ([0103], “Each of these valves has flexible leaflets”), with edge sides thereof bent to lie on top of each other ([0109], “the anterior leaflet … and the posterior leaflet … coapt” Examiner notes that coapt refers to fitting tightly together and the state of being joined together.), wherein the anterior leaflet and the posterior leaflet are mounted on a holder ([0173], “The delivery member … can … include a suction device for holding valve tissue” Examiner notes that the anterior leaflet and the posterior leaflet are both made of valve tissue.) the holder is installed at a boundary portion between the left atrium and the left ventricle ([0268], “a tortuous path is created with multiple holding points”), and the anterior leaflet and the posterior leaflet are each provided on the edge side with a plurality of string-shaped members ([0105], “The mitral valve … is anchored to the wall of the left ventricle … by … cord-like tendons that connect … the muscles … within the walls of the left ventricle … to the leaflets” Examiner notes that cord-like tendons are generally considered synonymous with string-shaped tendons.).
MPEP § 2111 discusses proper claim interpretation, including giving claims their
broadest reasonable interpretation (“BRI”) in light of the specification during
examination. Under BRI, the words of a claim must be given their plain meaning unless
such meaning is inconsistent with the specification, and it is improper to import claim
limitations from the specification into the claim. Applicant’s argument is not persuasive because the BRI is broader than what is argued. Therefore, the rejection of amended
claim 11, as obvious over Okayama in view of Iversen is maintained. Consequently, the rejection of dependent claim 12 is maintained.
With respect to amended claim 13, Applicant argues “neither Okayama nor Iverson, alone or in combination, teach or suggest each and every feature recited in Applicant's claim 13” (See Response under 37 C.F.R. 1.111, Remarks, Claim Rejections under 35 U.S.C. 103, page 10, paragraph 5.) Examiner acknowledges Applicant’s remarks. Regarding claim 13, Okayama discloses a catheter simulator for practicing catheter manipulations in a state of holding a heart model in a container filled with a liquid ([0012], “the present invention provides a container for a catheter simulator comprising: an accommodating unit for accommodating a liquid, … the heart model is installed in the accommodating unit that is filled with a liquid”), the heart model including a main body formed from an elastic material ([0016], “The heart models … are formed from materials having elasticity”) and including a left atrium and a left ventricle ([0020], “The … heart model … has … a left atrium … and a left ventricle”), with a mitral valve installed at a boundary portion between the left atrium and the left ventricle ([0071], “there is no serious problem even if … a tricuspid valve … and a mitral valve are not formed inside the main body”), wherein the container includes a holding part for holding the heart model ([0011], “an object of the present invention is to provide a container for a … heart model”), and an introduction part capable of inserting a catheter ([0012], “the present invention provides … a installation part for inserting a catheter”), a pump for circulating the liquid to be filled in the container into the heart model is connected to the container ([0018], “the pump is connected to the container”), the pump is intermittently driven so that a pulsatile flow flows ([0124], “The pump … that is connected to the … model … is intermittently driven so as to generate a pulsatile flow”) from the left atrium toward the left ventricle in the heart model held in the container and Iversen discloses
the mitral valve including an anterior leaflet and a posterior leaflet ([0105], “the mitral valve … includes two leaflets, the anterior leaflet … and the posterior leaflet”), both the leaflets extending toward the left ventricle side and being capable of opening and closing ([0020], “Figure 3 is a … view of a … mitral valve with the leaflets closed”), and the anterior leaflet and the posterior leaflet being each provided on the tip side with a plurality of string-shaped members extending into the left ventricle ([0105], “The mitral valve … is anchored to the wall of the left ventricle … by … cord-like tendons that connect … the muscles … within the walls of the left ventricle … to the leaflets” Examiner notes that cord-like tendons are generally considered synonymous with string-shaped tendons.), on a mitral valve using ([0105], “the mitral valve … includes two leaflets, the anterior leaflet … and the posterior leaflet”) and the mitral valve is configured to open when the string-shaped members ([0105], “Without the connection to the chordae tendineae … the mitral valve … would revert … back toward … the atrium”) are pulled toward a cardiac apex side by a sucking action of the pump ([0105], “The mitral valve opens … in response to pressure changes in the left atrium … and the left ventricle” Examiner notes that a pump relies on pressure differences to create suction.).
MPEP § 2111 discusses proper claim interpretation, including giving claims their
broadest reasonable interpretation (“BRI”) in light of the specification during
examination. Under BRI, the words of a claim must be given their plain meaning unless
such meaning is inconsistent with the specification, and it is improper to import claim
limitations from the specification into the claim. Applicant’s argument is not persuasive because the BRI is broader than what is argued. Therefore, the rejection of amended
claim 13, as obvious over Okayama in view of Iversen is maintained. Consequently, the rejections of dependent claims 14-20 are maintained.
With respect to claim 3, Applicant argues “neither Okayama nor Iverson, alone or in combination, teach or suggest each and every feature recited in Applicant's claim 3” (See Response under 37 C.F.R. 1.111, Remarks, Claim Rejections under 35 U.S.C. 103, page 12, paragraph 3.) Examiner acknowledges Applicant’s remarks. Regarding claim 3, Okayama discloses wherein the string-shaped members are formed from a stretchable material ([0016], “The heart models … are formed from materials having elasticity” Examiner notes that elasticity implies that the material is stretchable.).
MPEP § 2111 discusses proper claim interpretation, including giving claims their
broadest reasonable interpretation (“BRI”) in light of the specification during
examination. Under BRI, the words of a claim must be given their plain meaning unless
such meaning is inconsistent with the specification, and it is improper to import claim
limitations from the specification into the claim. Applicant’s argument is not persuasive because the BRI is broader than what is argued. Claim 3 is dependent on claim 1. Therefore, the rejection of claim 3, as obvious over Okayama in view of Iversen is maintained.
With respect to claim 4, Applicant argues “neither Okayama nor Iverson, alone or in combination, teach or suggest each and every feature recited in Applicant's claim 4” (See Response under 37 C.F.R. 1.111, Remarks, Claim Rejections under 35 U.S.C. 103, page 12, paragraph 6.) Examiner acknowledges Applicant’s remarks. Regarding claim 4, Iversen discloses wherein the anterior leaflet and the posterior leaflet are held by a holder ([0173], “The delivery member … can … include a suction device for holding valve tissue” Examiner notes that the anterior leaflet and the posterior leaflet are both made of valve tissue.) and the holder is installed at a boundary portion between the left atrium and the left ventricle ([0268], “a tortuous path is created with multiple holding points”).
MPEP § 2111 discusses proper claim interpretation, including giving claims their
broadest reasonable interpretation (“BRI”) in light of the specification during
examination. Under BRI, the words of a claim must be given their plain meaning unless
such meaning is inconsistent with the specification, and it is improper to import claim
limitations from the specification into the claim. Applicant’s argument is not persuasive because the BRI is broader than what is argued. Claim 4 is dependent on claim 1. Therefore, the rejection of claim 4, as obvious over Okayama in view of Iversen is maintained.
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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/XUAN M THAI/Supervisory Patent Examiner, Art Unit 3715
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