Prosecution Insights
Last updated: May 04, 2026
Application No. 18/257,457

METHOD FOR PRODUCING SIMULATED ANIMAL ORGAN, SIMULATED ANIMAL ORGAN, SIMULATED ANIMAL ORGAN KIT, AND MEDICAL INSTRUMENT EVALUATION KIT

Non-Final OA §103
Filed
Jun 14, 2023
Priority
Dec 16, 2020 — nonprovisional of PCTJP2020046952
Examiner
ANTOINE, LISA HOPE
Art Unit
3715
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Kotobuki Medical Inc.
OA Round
1 (Non-Final)
0%
Grant Probability
At Risk
1-2
OA Rounds
9m
Est. Remaining
0%
With Interview

Examiner Intelligence

Grants only 0% of cases
0%
Career Allowance Rate
0 granted / 16 resolved
-70.0% vs TC avg
Minimal +0% lift
Without
With
+0.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
50 currently pending
Career history
66
Total Applications
across all art units

Statute-Specific Performance

§101
20.4%
-19.6% vs TC avg
§103
50.9%
+10.9% vs TC avg
§102
25.8%
-14.2% vs TC avg
§112
2.2%
-37.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 16 resolved cases

Office Action

§103
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. Claim Objections Claim s 1, 14 , 1 7 , and 1 9 are objected to because of the following informalities. • Claim 1 , line 4 , “ the form ”, should read as “ a form ”. • Claim 14, line 4, “the form”, should read as “a form”. • Claim 17 , line 1, “ A simulated animal organ ”, should read as “ The simulated animal organ ”. • Claim 1 9 , line 7 , “ a color thereof ”, should read as “the color thereof ”. • Claim 19, line 10, “a color thereof”, should read as “the color thereof”. Appropriate correction is required. 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 1-17, 20, and 22-26 are rejected under 35 U.S.C. 103 as being unpatentable under US 20170148355 A1 (“Takayama”) in view of US 20160041486 A1 (“ Hara ”) . In regards to claim 1 , Takayama discloses the following limitation s with the exception of the underlined limitations. A method for producing a simulated animal organ comprising: a shaping step of mixing mannan as a main component ([00 10 ], “The present invention … is a method for producing a simulated animal organ including: a shaping step of mixing … mannan as a main component” ) , an allochroic agent in the form of a microcapsule that changes a color thereof in a temperature-dependent manner, and water, performing gelatinization, and shaping a gelatinized mixture to obtain a shaped body ([0010], “The present invention … is a method for producing a simulated animal organ including … water for gelatinization and shaping a gelatinized substance to obtain a shaped body” ) ; and a freezing step of freezing the shaped body to form ([0012], “In the production method, the shaped body is frozen” ) a fiber structure or a mesh structure ([0053], “the outer surface and the inside are changed into a rather mesh-like form (a fibrous form)” ) . Hara discloses an allochroic agent in the form of a ([0010], “Embodiments provide a … allochroic toner” ) microcapsule that ([0129], “it is preferable to use capsules containing the composition” ) changes a color thereof in a temperature-dependent manner ([0010], “Embodiments provide a … allochroic toner that can form … having a color that reversibly changes when a temperature change occurs” ). Takayama and Hara combined are considered analogous to the claimed invention because they are in the field s of simulated animal organ s usable for the purpose of surgery training and allochroic toner . 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 method for producing a simulated animal organ comprising: a shaping step of mixing mannan as a main component, and water, performing gelatinization, and shaping a gelatinized mixture to obtain a shaped body; and a freezing step of freezing the shaped body to form a fiber structure or a mesh structure, as disclosed by Takayama , an allochroic agent in the form of a microcapsule that changes a color thereof in a temperature-dependent manner , as disclosed by Hara , to provide allochroic toner and capsules for a method of producing a toner cartridge and an image forming apparatus . One skilled in the art would understand and recognize the value of the addition of allochroic toner and capsules to improve a method of producing a toner cartridge and an image forming apparatus . In regards to claim 2 , Takayama discloses the following limitation with the exception of the underlined limitation. wherein the allochroic agent is supported by the fiber structure or the mesh structure in the freezing step ([0053], “the outer surface and the inside are changed into a rather mesh-like form (a fibrous form)” ) . Hara discloses wherein the allochroic agent is supported by ([0010], “Embodiments provide a … allochroic toner” ). Takayama and Hara combined are considered analogous to the claimed invention because they are in the field s of simulated animal organ s usable for the purpose of surgery training and allochroic toner . 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 method for producing a simulated animal organ comprising: a shaping step of mixing mannan as a main component, the fiber structure or the mesh structure in the freezing step , and water, performing gelatinization, and shaping a gelatinized mixture to obtain a shaped body; and a freezing step of freezing the shaped body to form a fiber structure or a mesh structure, as disclosed by Takayama , an allochroic agent in the form of a microcapsule that changes a color thereof in a temperature-dependent manner, wherein the allochroic agent is supported by , as disclosed by Hara , to provide allochroic toner and capsules for a method of producing a toner cartridge and an image forming apparatus . One skilled in the art would understand and recognize the value of the addition of allochroic toner and capsules to improve a method of producing a toner cartridge and an image forming apparatus . In regards to claim 3 , Takayama does not disclose wherein a particle diameter of the allochroic agent is 5.0 μm or less. Hara discloses wherein a particle diameter of the allochroic agent is 5.0 μm or less ([0139], “The average particle size of the … allochroic toner according to the present embodiment … is preferably 4 μm to 15 μm ” ) . Takayama and Hara combined are considered analogous to the claimed invention because they are in the field s of simulated animal organ s usable for the purpose of surgery training and allochroic toner . 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 method for producing a simulated animal organ comprising: a shaping step of mixing mannan as a main component, and water, performing gelatinization, and shaping a gelatinized mixture to obtain a shaped body; and a freezing step of freezing the shaped body to form a fiber structure or a mesh structure, as disclosed by Takayama , an allochroic agent in the form of a microcapsule that changes a color thereof in a temperature-dependent manner, as disclosed by Hara , to provide allochroic toner and capsules for a method of producing a toner cartridge and an image forming apparatus . One skilled in the art would understand and recognize the value of the addition of allochroic toner and capsules to improve a method of producing a toner cartridge and an image forming apparatus . In regards to claim 4 , Takayama does not disclose wherein the particle diameter of the allochroic agent is 2.0 μm or less. Hara discloses wherein the particle diameter of the allochroic agent is 2.0 μm or less ([0157], “The average particle size of the capsule particles is preferably 0.5 μm to 30 μm ” ) . Takayama and Hara combined are considered analogous to the claimed invention because they are in the field s of simulated animal organ s usable for the purpose of surgery training and allochroic toner . 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 method for producing a simulated animal organ comprising: a shaping step of mixing mannan as a main component, and water, performing gelatinization, and shaping a gelatinized mixture to obtain a shaped body; and a freezing step of freezing the shaped body to form a fiber structure or a mesh structure, as disclosed by Takayama , an allochroic agent in the form of a microcapsule that changes a color thereof in a temperature-dependent manner, wherein the particle diameter of the allochroic agent is 2.0 μm or less , as disclosed by Hara , to provide capsule particles for a method of producing a toner cartridge and an image forming apparatus . One skilled in the art would understand and recognize the value of the addition of capsule particles to improve a method of producing a toner cartridge and an image forming apparatus . In regards to claim 5 , Takayama does not disclose wherein the allochroic agent has a property of beginning to turn the color thereof into a first hue when a temperature thereof rises and exceeds a first temperature and beginning to turn the color thereof into a second hue when the temperature thereof in a first hue state drops and falls below a second temperature, which is lower than the first temperature. Hara discloses wherein the allochroic agent has a property of beginning to turn the color thereof into a first hue when a temperature thereof rises and exceeds a first temperature and beginning to turn the color thereof into a second hue when the temperature thereof in a first hue state drops and falls below a second temperature, which is lower than the first temperature ([0013], “when the colorant is in the first color state, and the temperature keeps increasing and reaches a temperature …, the colorant starts to change to the second color state, and in a temperature region in which the temperature is equal to or higher than a temperature … which is higher than the temperature …, the colorant completely changes to the second color state. Then, when the colorant is in the second color state, and the temperature keeps decreasing and reaches a temperature …, the colorant starts to change to the first color state, and in a temperature region in which the temperature is equal to or lower than a temperature … which is lower than the temperature … the colorant completely changes to the first color state” ) . Takayama and Hara combined are considered analogous to the claimed invention because they are in the field s of simulated animal organ s usable for the purpose of surgery training and allochroic toner . 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 method for producing a simulated animal organ comprising: a shaping step of mixing mannan as a main component, and water, performing gelatinization, and shaping a gelatinized mixture to obtain a shaped body; and a freezing step of freezing the shaped body to form a fiber structure or a mesh structure, as disclosed by Takayama , an allochroic agent in the form of a microcapsule that changes a color thereof in a temperature-dependent manner, wherein the allochroic agent has a property of beginning to turn the color thereof into a first hue when a temperature thereof rises and exceeds a first temperature and beginning to turn the color thereof into a second hue when the temperature thereof in a first hue state drops and falls below a second temperature, which is lower than the first temperature , as disclosed by Hara , to provide colorant for a method of producing a toner cartridge and an image forming apparatus . One skilled in the art would understand and recognize the value of the addition of colorant to improve a method of producing a toner cartridge and an image forming apparatus . In regards to claim 6 , Takayama discloses the following limitations with the exception of the underlined limitations. further comprising: a heating step of heating the shaped body to ([0020], “The production method further includes a heating step of heating the shaped body” ) a temperature higher than the first temperature after the freezing step to turn ([0021], “In the production method, the heating step is performed after the low temperature step” ) the allochroic agent into the first hue; and a cooling step of cooling the shaped body to a temperature lower than the second temperature after the heating step to turn ([0010], “a low temperature step of keeping the shaped body in a low temperature environment lower than normal temperature” ) the allochroic agent into the second hue. Hara discloses the allochroic agent into the first hue ([0013], “when the colorant is in the first color state, and the temperature keeps increasing and reaches a temperature …, the colorant starts to change to the second color state, and in a temperature region in which the temperature is equal to or higher than a temperature … which is higher than the temperature …, the colorant completely changes to the second color state” ) ; the allochroic agent into the second hue ([0013], “when the colorant is in the second color state, and the temperature keeps decreasing and reaches a temperature …, the colorant starts to change to the first color state, and in a temperature region in which the temperature is equal to or lower than a temperature … which is lower than the temperature … the colorant completely changes to the first color state” ) . Takayama and Hara combined are considered analogous to the claimed invention because they are in the field s of simulated animal organ s usable for the purpose of surgery training and allochroic toner . 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 method for producing a simulated animal organ comprising: a shaping step of mixing mannan as a main component, and water, performing gelatinization, and shaping a gelatinized mixture to obtain a shaped body; and a freezing step of freezing the shaped body to form a fiber structure or a mesh structure, as disclosed by Takayama , an allochroic agent in the form of a microcapsule that changes a color thereof in a temperature-dependent manner, wherein the allochroic agent has a property of beginning to turn the color thereof into a first hue when a temperature thereof rises and exceeds a first temperature and beginning to turn the color thereof into a second hue when the temperature thereof in a first hue state drops and falls below a second temperature, which is lower than the first temperature , the allochroic agent into the first hue; the allochroic agent into the second hue , as disclosed by Hara , to provide colorant for a method of producing a toner cartridge and an image forming apparatus . One skilled in the art would understand and recognize the value of the addition of colorant to improve a method of producing a toner cartridge and an image forming apparatus . In regards to claim 7 , Takayama discloses the following limitations with the exception of the underlined limitations. wherein: the shaped body is heated to 75° C. or higher in the heating step ([0056], “In a heating step … the shaped body is heated … the step may be performed by putting the shaped body in boiling water and heating it for several ten minutes” Examiner notes that the temperature for boiling water 100° C. ) ; the shaped body is cooled to lower than −5° C. in the cooling step ([0047], “In the low temperature step … the shaped body… is kept in an environment of preferably −15° C. or lower” ) ; the first temperature for the allochroic agent is set to a temperature higher than 30° C. and lower than 75° C.; and the second temperature for the allochroic agent is set to a temperature lower than 20° C. and not lower than −5° C. Hara discloses the first temperature for the allochroic agent is set to a temperature higher than 30° C. and lower than 75° C. ([0017], “The … temperature … is … 55° C. or higher but lower than 65° C” ) ; and the second temperature for the allochroic agent is set to a temperature lower than 20° C. and not lower than −5° C ([0143], “When … the temperature decreases to … 20° C. or lower… the image naturally returns to the first color state” ) . Takayama and Hara combined are considered analogous to the claimed invention because they are in the field s of simulated animal organ s usable for the purpose of surgery training and allochroic toner . 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 method for producing a simulated animal organ comprising: a shaping step of mixing mannan as a main component, wherein: the shaped body is heated to 75° C. or higher in the heating step; the shaped body is cooled to lower than −5° C. in the cooling step, and water, performing gelatinization, and shaping a gelatinized mixture to obtain a shaped body; and a freezing step of freezing the shaped body to form a fiber structure or a mesh structure, as disclosed by Takayama , an allochroic agent in the form of a microcapsule that changes a color thereof in a temperature-dependent manner, wherein the allochroic agent has a property of beginning to turn the color thereof into a first hue when a temperature thereof rises and exceeds a first temperature and beginning to turn the color thereof into a second hue when the temperature thereof in a first hue state drops and falls below a second temperature, which is lower than the first temperature , the allochroic agent into the first hue; the allochroic agent into the second hue , the first temperature for the allochroic agent is set to a temperature higher than 30° C. and lower than 75° C.; and the second temperature for the allochroic agent is set to a temperature lower than 20° C. and not lower than −5° C , as disclosed by Hara , to provide an image for a method of producing a toner cartridge and an image forming apparatus . One skilled in the art would understand and recognize the value of the addition of an image to improve a method of producing a toner cartridge and an image forming apparatus . In regards to claim 8 , Takayama discloses the following limitation with the exception of the underlined limitation. wherein the first hue is white or transparent, and the second hue is red, pink, brown, or darkish brown ([0041], “liquid may be colored in a color … of … pink or reddish brown” ) . Hara discloses wherein the first hue is white or transparent ([0028], “When the color state of toner is an “achromatized” state, this means that … a color … is not visually perceptible” ). Takayama and Hara combined are considered analogous to the claimed invention because they are in the field s of simulated animal organ s usable for the purpose of surgery training and allochroic toner . 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 method for producing a simulated animal organ comprising: a shaping step of mixing mannan as a main component, and the second hue is red, pink, brown, or darkish brown , and water, performing gelatinization, and shaping a gelatinized mixture to obtain a shaped body; and a freezing step of freezing the shaped body to form a fiber structure or a mesh structure, as disclosed by Takayama , an allochroic agent in the form of a microcapsule that changes a color thereof in a temperature-dependent manner, wherein the allochroic agent has a property of beginning to turn the color thereof into a first hue when a temperature thereof rises and exceeds a first temperature and beginning to turn the color thereof into a second hue when the temperature thereof in a first hue state drops and falls below a second temperature, which is lower than the first temperature , wherein the first hue is white or transparent, as disclosed by Hara , to provide toner for a method of producing a toner cartridge and an image forming apparatus . One skilled in the art would understand and recognize the value of the addition of toner to improve a method of producing a toner cartridge and an image forming apparatus . In regards to claim 9 , Takayama discloses the following limitation with the exception of the underlined limitation. wherein the shaped body in the shaping step contains 1.0% by weight or more of ([0041], “A mixing ratio between the raw material and water is … 3:97 … the raw material is … added to water … to prepare the stock liquid … a coloring material may be … mixed with the stock liquid” Examiner notes the 3:97 ratio is equivalent to 3.09% of coloring material, which could be an allochroic agent. ) the allochroic agent . Hara discloses the allochroic agent ([0010], “Embodiments provide a … allochroic toner” ) . Takayama and Hara combined are considered analogous to the claimed invention because they are in the field s of simulated animal organ s usable for the purpose of surgery training and allochroic toner . 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 method for producing a simulated animal organ comprising: a shaping step of mixing mannan as a main component, wherein the shaped body in the shaping step contains 1.0% by weight or more of , and water, performing gelatinization, and shaping a gelatinized mixture to obtain a shaped body; and a freezing step of freezing the shaped body to form a fiber structure or a mesh structure, as disclosed by Takayama , an allochroic agent in the form of a microcapsule that changes a color thereof in a temperature-dependent manner, the allochroic agent , as disclosed by Hara , to provide allochroic toner for a method of producing a toner cartridge and an image forming apparatus . One skilled in the art would understand and recognize the value of the addition of allochroic toner to improve a method of producing a toner cartridge and an image forming apparatus . In regards to claim 10 , Takayama discloses wherein a moisture content of the shaped body is 95% or less at a final product stage after the freezing step ([0050], “In a drying step … a water component of the shaped body is evaporated for drying” Examiner notes that drying can reduce water content by 5% or more at a final product stage. ) . In regards to claim 11 , Takayama discloses wherein a moisture content of the shaped body is 80% or more at a final product stage after the freezing step ([0050], “In a drying step … a water component of the shaped body is evaporated for drying” Examiner notes that drying can reduce water content by 20 % or less at a final product stage. ) . In regards to claim 12 , Takayama discloses wherein a compressive elastic modulus of the shaped body is 0.015 N/mm 2 or less ([0056], “In a heating step … the shaped body is heated to increase the elasticity” Examiner notes that the unit of measure for elasticity is Pascals or N/m 2 . ) a fter the freezing step ([0057], “heating step … is preferably performed after the low temperature step” Examiner notes that the low temperature step is equivalent to the freezing step and that the low temperature step can decrease the elasticity of simulated organs to 0.015 N/mm 2 or less depending on the freezing method used and the type of tissue. ) . In regards to claim 13 , Takayama discloses wherein a compressive elastic modulus of the shaped body is 0.01 1 N/mm 2 or less ([0056], “In a heating step … the shaped body is heated to increase the elasticity” Examiner notes that the unit of measure for elasticity is Pascals or N/m 2 . ) a fter the freezing step ([0057], “heating step … is preferably performed after the low temperature step” Examiner notes that the low temperature step is equivalent to the freezing step and that the low temperature step can decrease the elasticity of simulated organs to 0.01 1 N/mm 2 or less depending on the freezing method used and the type of tissue. ) . In regards to claim 14 , Takayama discloses the following limitations with the exception of the underlined limitations. A method for producing a simulated animal organ comprising: a shaping step of mixing a raw material containing mannan as a main component ([0010], “The present invention … is a method for producing a simulated animal organ including: a shaping step of mixing … mannan as a main component” ), water ([0010], “The present invention … is a method for producing a simulated animal organ including … water” ) , and an allochroic agent in the form of a microcapsule that changes a color thereof in a temperature-dependent manner, performing gelatinization, and shaping a gelatinized mixture to obtain a shaped body ([0010], “The present invention … is a method for producing a simulated animal organ including … gelatinization and shaping a gelatinized substance to obtain a shaped body” ) , wherein the allochroic agent has a property of beginning to turn the color thereof to a first hue when a temperature thereof rises and exceeds a first temperature and beginning to turn the color thereof to a second hue when the temperature thereof in a first hue state drops and falls below a second temperature, which is lower than the first temperature; a heating step of heating the shaped body to ([0020], “The production method further includes a heating step of heating the shaped body” ) a temperature higher than the first temperature to turn ([0021], “In the production method, the heating step is performed after the low temperature step” ) the allochroic agent into the first hue; and a cooling step of cooling the shaped body to a temperature lower than the second temperature after the heating step to turn ([0010], “a low temperature step of keeping the shaped body in a low temperature environment lower than normal temperature” ) the allochroic agent into the second hue. Hara discloses and an allochroic agent in the form of ([0010], “Embodiments provide a … allochroic toner” ) a microcapsule that ([0129], “it is preferable to use capsules containing the composition” ) changes a color thereof in a temperature-dependent manner ([0010], “Embodiments provide a … allochroic toner that can form … having a color that reversibly changes when a temperature change occurs” ) wherein the allochroic agent has a property of beginning to turn the color thereof to a first hue when a temperature thereof rises and exceeds a first temperature and beginning to turn the color thereof to a second hue when the temperature thereof in a first hue state drops and falls below a second temperature, which is lower than the first temperature ([0013], “when the colorant is in the first color state, and the temperature keeps increasing and reaches a temperature …, the colorant starts to change to the second color state, and in a temperature region in which the temperature is equal to or higher than a temperature … which is higher than the temperature …, the colorant completely changes to the second color state. Then, when the colorant is in the second color state, and the temperature keeps decreasing and reaches a temperature …, the colorant starts to change to the first color state, and in a temperature region in which the temperature is equal to or lower than a temperature … which is lower than the temperature … the colorant completely changes to the first color state” ) ; the allochroic agent into the first hue ([0013], “when the colorant is in the first color state, and the temperature keeps increasing and reaches a temperature …, the colorant starts to change to the second color state, and in a temperature region in which the temperature is equal to or higher than a temperature … which is higher than the temperature …, the colorant completely changes to the second color state” ) ; the allochroic agent into the second hue ([0013], “when the colorant is in the second color state, and the temperature keeps decreasing and reaches a temperature …, the colorant starts to change to the first color state, and in a temperature region in which the temperature is equal to or lower than a temperature … which is lower than the temperature … the colorant completely changes to the first color state” ) . Takayama and Hara combined are considered analogous to the claimed invention because they are in the field s of simulated animal organ s usable for the purpose of surgery training and allochroic toner . 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 method for producing a simulated animal organ comprising: a shaping step of mixing a raw material containing mannan as a main component, water , performing gelatinization, and shaping a gelatinized mixture to obtain a shaped body, a heating step of heating the shaped body to a temperature higher than the first temperature to turn, and a cooling step of cooling the shaped body to a temperature lower than the second temperature after the heating step to turn , as disclosed by Takayama , and an allochroic agent in the form of a microcapsule that changes a color thereof in a temperature-dependent manner, wherein the allochroic agent has a property of beginning to turn the color thereof to a first hue when a temperature thereof rises and exceeds a first temperature and beginning to turn the color thereof to a second hue when the temperature thereof in a first hue state drops and falls below a second temperature, which is lower than the first temperature; the allochroic agent into the first hue; the allochroic agent into the second hue , as disclosed by Hara , to provide allochroic toner and colorant for a method of producing a toner cartridge and an image forming apparatus . One skilled in the art would understand and recognize the value of the addition of allochroic toner and colorant to improve a method of producing a toner cartridge and an image forming apparatus . In regards to claim 15 , Takayama discloses wherein an electrolyte is mixed with the water in the shaping step ([0013], “In the production method, an electrolyte is mixed with the water in the shaping step” ) . In regards to claim 16 , Takayama discloses wherein the shaped body in the shaping step contains the electrolyte in an amount of 1.0% by weight or less ([0014], “In the production method, the electrolyte is mixed at 1.0% by weight or less” ) . In regards to claim 17 , Takayama discloses a simulated animal organ produced by the method according to claim 1 ([0010], “The present invention … is a method for producing a simulated animal organ” ) In regards to claim 20 , Takayama does not disclose wherein the second surface and the third surface are composed of paper or a resin film. Hara discloses wherein the second surface and the third surface are composed of paper or a resin film ([0061], “PCRTVS A10, OO10 and OO30 … forms … the entirety … of the artificial … body” Examiner notes that PCRTVS A10 is a type of resin. ) . Takayama and Hara combined are considered analogous to the claimed invention because they are in the field s of simulated animal organ s usable for the purpose of surgery training and allochroic toner . 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 method for producing a simulated animal organ comprising: a shaping step of mixing mannan as a main component, and water, performing gelatinization, and shaping a gelatinized mixture to obtain a shaped body; and a freezing step of freezing the shaped body to form a fiber structure or a mesh structure, as disclosed by Takayama , an allochroic agent in the form of a microcapsule that changes a color thereof in a temperature-dependent manner, changing a color thereof by heat; changing a color thereof by heat , as disclosed by Hara , to provide PCRTVS A10, OO10 , and OO30 for a method of producing a toner cartridge and an image forming apparatus . One skilled in the art would understand and recognize the value of the addition of PCRTVS A10, OO10 , and OO30 to improve a method of producing a toner cartridge and an image forming apparatus . In regards to claim 22 , Takayama discloses the following limitations with the exception of the underlined limitations. A simulated animal organ comprising: mannan as a main component ([0010], “The present invention … is a method for producing a simulated animal organ including: a shaping step of mixing … mannan as a main component” ); an electrolyte ([0014], “In the production method, the electrolyte is mixed at 1.0% by weight or less” ); water ([0010], “The present invention … is a method for producing a simulated animal organ including … water” ) ; a nd a n allochroic agent in a form of a microcapsule , the allochroic agent chang ing a color thereof in a temperature-dependent manner, wherein the allochroic agent is supported by a fiber structure or a mesh structure of the mannan ([0053], “the outer surface and the inside are changed into a rather mesh-like form (a fibrous form)” ) . Hara discloses and a n allochroic agent in the form of a ([0010], “Embodiments provide a … allochroic toner” ) microcapsule , ([0129], “it is preferable to use capsules containing the composition” ) the allochroic agent chang ing a color thereof in a temperature-dependent manner ([0010], “Embodiments provide a … allochroic toner that can form … having a color that reversibly changes when a temperature change occurs” ). Takayama and Hara combined are considered analogous to the claimed invention because they are in the field s of simulated animal organ s usable for the purpose of surgery training and allochroic toner . 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 simulated animal organ comprising: mannan as a main component; an electrolyte; water; wherein the allochroic agent is supported by a fiber structure or mesh structure of the mannan , as disclosed by Takayama , and an allochroic agent in the form of a microcapsule, the allochroic agent changing a color thereof in a temperature-dependent manner, as disclosed by Hara , to provide allochroic toner and capsules for a method of producing a toner cartridge and an image forming apparatus . One skilled in the art would understand and recognize the value of the addition of allochroic toner and capsules to improve a method of producing a toner cartridge and an image forming apparatus . In regards to claim 23 , Takayama discloses wherein the allochroic agent is supported in a bunch form along the fiber structure or the mesh structure of the mannan ([0053], “the outer surface and the inside are changed into a rather mesh-like form (a fibrous form)” ) . In regards to claim 24 , Takayama discloses the following limitation with the exception of the underlined limitation. wherein: a recess is formed by the fiber structure or the mesh structure of the mannan ([0053], “the outer surface and the inside are changed into a rather mesh-like form (a fibrous form)” ) ; and the allochroic agent is housed in the recess ([0010], “Embodiments provide a … allochroic toner” ) . Takayama and Hara combined are considered analogous to the claimed invention because they are in the field s of simulated animal organ s usable for the purpose of surgery training and allochroic toner . 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 simulated animal organ comprising: mannan as a main component; an electrolyte; water; wherein the allochroic agent is supported by a fiber structure or mesh structure of the mannan , wherein: a recess is formed by the fiber structure or the mesh structure of the mannan , as disclosed by Takayama , and an allochroic agent in the form of a microcapsule, the allochroic agent changing a color thereof in a temperature-dependent manner, and the allochroic agent is housed in the recess , as disclosed by Hara , to provide allochroic toner for a method of producing a toner cartridge and an image forming apparatus . One skilled in the art would understand and recognize the value of the addition of allochroic toner to improve a method of producing a toner cartridge and an image forming apparatus . In regards to claim 25 , Takayama discloses wherein a moisture content is 95% or less and 80% or more wherein a moisture content of the shaped body is 95% or less at a final product stage after the freezing step ([0050], “In a drying step … a water component of the shaped body is evaporated for drying” Examiner notes that drying can reduce water content by 5% or more and 20% or less at a final product stage. ) . In regards to claim 26 , Takayama discloses wherein a compressive elastic modulus is 0.015 N/mm 2 or less ([0056], “In a heating step … the shaped body is heated to increase the elasticity” Examiner notes that the unit of measure for elasticity is Pascals or N/m 2 and that elasticity range can vary based on the material . ). Claims 18-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable under Takayama in view of Hara and US 20120015339 A1 (“ Hendrickson ”) . In regards to claim 18 , Takayama discloses the following limitation with the exception of the underlined limitations. A simulated animal organ kit comprising: the simulated animal organ according to claim 17 formed into a sheet ([0044], “the animal organ is a skin, the … paste is poured into a plate-shaped mold to shape the paste into a sheet” ) ; and a three dimensional organ model formed from a resin or metal; wherein the simulated animal organ is fixed to a part of a wall surface of the three dimensional organ model. Hendrickson discloses and a three dimensional organ model formed from ([0057], “mold portions ... mate together such that the voids ... form a complete void ... that has a shape and volume corresponding to the ... body to be modeled” ) a resin or metal ([0146], “the enclosure … is … a … structure, which may have an exterior wall … formed of a … metal” ) ; wherein the simulated animal organ is fixed to a part of a wall surface of the three dimensional organ model ([0057], “material used to form the artificial … body … is … poured, sprayed, injected … or otherwise deposited into the void … of the mold” ) . Takayama and Hendrickson combined are considered analogous to the claimed invention because they are in the field s of simulated animal organ s usable for the purpose of surgery training and simulated anatomical models. 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 method for producing a simulated animal organ comprising: a shaping step of mixing mannan as a main component, and water, performing gelatinization, and shaping a gelatinized mixture to obtain a shaped body; and a freezing step of freezing the shaped body to form a fiber structure or a mesh structure, a simulated animal organ kit comprising: the simulated animal organ formed into a sheet , as disclosed by Takayama , and a three dimensional organ model formed from a resin or metal; wherein the simulated animal organ is fixed to a part of a wall surface of the three dimensional organ model, as disclosed by Hendrickson , to provide mold portions, an enclosure, and material for simulated organs and related methods of manufacture . One skilled in the art would understand and recognize the value of the addition of mold portions, an enclosure, and material to improve simulated organs and related methods of manufacture . In regards to claim 19 , Takayama does not disclose a medical instrument evaluation kit comprising: a first surface composed of the simulated animal organ; a second surface provided in a direction orthogonal to the first surface, the second surface having a property of changing a color thereof by heat; and a third surface provided in the direction orthogonal to the first surface and spaced from the second surface, the third surface having a property of changing a color thereof by heat. Hara discloses changing a color thereof by heat ([0036], “a heat source … and the like are required to cause the colorant in the first color state to completely change to the second color state” ) . Takayama and Hara combined are considered analogous to the claimed invention because they are in the field s of simulated animal organ s usable for the purpose of surgery training and allochroic toner . 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 method for producing a simulated animal organ comprising: a shaping step of mixing mannan as a main component, and water, performing gelatinization, and shaping a gelatinized mixture to obtain a shaped body; and a freezing step of freezing the shaped body to form a fiber structure or a mesh structure, as disclosed by Takayama , an allochroic agent in the form of a microcapsule that changes a color thereof in a temperature-dependent manner, changing a color thereof by, as disclosed by Hara , to provide colorant and a heat source for a method of producing a toner cartridge and an image forming apparatus . One skilled in the art would understand and recognize the value of the addition of colorant and a heat source to improve a method of producing a toner cartridge and an image forming apparatus . Hendrickson discloses a medical instrument evaluation kit comprising: a first surface composed of the simulated animal organ ([0050], “body … may have accurate surface detail … that closely mimic the surface of a real … body” ) ; a second surface provided in a direction orthogonal to the first surface, the second surface having a property of ([0057], “the mold has a first portion … and a second portion … each of said portions having a void … that corresponds to … a surface of one side” ) ; and a third surface provided in the direction orthogonal to the first surface and spaced from the second surface, the third surface having a property of ([0057], “the mold … that corresponds to … a surface of one side” ) . Takayama and Hendrickson combined are considered analogous to the claimed invention because they are in the field s of simulated animal organ s usable for the purpose of surgery training and simulated anatomical models. 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 method for producing a simulated animal organ comprising: a shaping step of mixing mannan as a main component, and water, performing gelatinization, and shaping a gelatinized mixture to obtain a shaped body; and a freezing step of freezing the shaped body to form a fiber structure or a mesh structure, as disclosed by Takayama , a medical instrument evaluation kit comprising: a first surface composed of the simulated animal organ; a second surface provided in a direction orthogonal to the first surface, the second surface having a property of; and a third surface provided in the direction orthogonal to the first surface and spaced from the second surface, the third surface having a property of, as disclosed by Hendrickson , to provide a body and a mold for simulated organs and related methods of manufacture . One skilled in the art would understand and recognize the value of the addition of a body and a mold to improve simulated organs and related methods of manufacture . In regards to claim 21 , Takayama does not disclose t he medical instrument evaluation kit, wherein the second surface and the third surface are composed of the simulated animal organ. Hendrickson discloses the medical instrument evaluation kit, wherein the second surface and the third surface are composed of the simulated animal organ ([0057], “the mold has a first portion … and a second portion … each of said portions having a void … that corresponds to … a surface of one side” ) . Takayama and Hendrickson combined are considered analogous to the claimed invention because they are in the field s of simulated animal organ s usable for the purpose of surgery training and simulated anatomical models. 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 method for producing a simulated animal organ comprising: a shaping step of mixing mannan as a main component, and water, performing gelatinization, and shaping a gelatinized mixture to obtain a shaped body; and a freezing step of freezing the shaped body to form a fiber structure or a mesh structure, as disclosed by Takayama , a medical instrument evaluation kit comprising: a first surface composed of the simulated animal organ; a second surface provided in a direction orthogonal to the first surface, the second surface having a property of; and a third surface provided in the direction orthogonal to the first surface and spaced from the second surface, the third surface having a property of, wherein the second surface and the third surface are composed of the simulated animal organ , as disclosed by Hendrickson , to provide a mold for simulated organs and related methods of manufacture . One skilled in the art would understand and recognize the value of the addition of a mold to improve simulated organs and related methods of manufacture . Contact Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to L isa A ntoine whose telephone number is (571) 272-4252 and whose email address is lantoine@uspto.gov . The examiner can be reached Monday-Thursday, 7 :30 am – 5 :30 pm CT. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice . If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xuan Thai, can be reached on (571) 272-7147. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300. Publication Information Information regarding the status of published or unpublished applications may be obtained from the Patent Center. Unpublished application information in the Patent Center is available to registered users. To file and manage patent submissions in the Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about the Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /LISA H ANTOINE/ Examiner, Art Unit 3715 /XUAN M THAI/ Supervisory Patent Examiner, Art Unit 3715
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Prosecution Timeline

Jun 14, 2023
Application Filed
Mar 24, 2026
Non-Final Rejection — §103 (current)

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Prosecution Projections

1-2
Expected OA Rounds
0%
Grant Probability
0%
With Interview (+0.0%)
3y 8m (~9m remaining)
Median Time to Grant
Low
PTA Risk
Based on 16 resolved cases by this examiner. Grant probability derived from career allowance rate.

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