DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites multiple instances of “a liquid” and “a gas”. Since the claim language does not use antecedent basis (e.g. “the” or “said”), it is unclear if applicant is referring to the same first instance of “a liquid” or “a gas” multiple times or new instances of “a liquid” or “a gas”. For purposes of examination, it is assumed that the multiple instances of “a liquid” and “a gas” refers to the same first instance of “a liquid” or “a gas” found in claim 1.
Claim 2 recites the limitation “a gas” in line 4. Since the claim language does not use antecedent basis (e.g. “the” or “said”), it is unclear if applicant is referring to the same ones of “a gas” of claim 1 from which claim 2 depends or a second gas. For purposes of examination, it is assumed that “a gas” refers to the same ones of “a gas” found in claim 1.
Claim 2 recites the limitation “a liquid” in line 5. Since the claim language does not use antecedent basis (e.g. “the” or “said”), it is unclear if applicant is referring to the same ones of “a liquid” of claim 1 from which claim 2 depends or a second liquid. For purposes of examination, it is assumed that “a liquid” refers to the same ones of “a liquid” found in claim 1.
Claim 4 recites the limitation “the first time” in line 5. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, “the first time” will be read as “a first time”.
Claim 8 recites the limitation “the first time” in line 12. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, “the first time” will be read as “a first time”.
Claim 15 recites the limitation “a diaphragm model” in line 2. Since the claim language does not use antecedent basis (e.g. “the” or “said”), it is unclear if applicant is referring to the same ones of “a liquid” of claim 14 from which claim 15 depends or a second diaphragm model. For purposes of examination, it is assumed that “a diaphragm model” refers to the same ones of “a diaphragm model” found in claim 14.
Claim 15 recites the limitation “an outer shape of a diaphragm” in line 2. Since the claim language does not use antecedent basis (e.g. “the” or “said”), it is unclear if applicant is referring to the same ones of “an outer shape of a diaphragm” of claim 14 from which claim 15 depends or a second outer shape of a diaphragm. For purposes of examination, it is assumed that “an outer shape of a diaphragm” refers to the same ones of “an outer shape of a diaphragm” found in claim 14.
Claim 15 recites the limitation “a respiratory motion portion” in line 5. Since the claim language does not use antecedent basis (e.g. “the” or “said”), it is unclear if applicant is referring to the same ones of “a respiratory motion portion” of claim 14 from which claim 15 depends or a second respiratory motion portion. For purposes of examination, it is assumed that “a respiratory motion portion” refers to the same ones of “a respiratory motion portion” found in claim 14.
Claim 15 recites the limitation “a movement of the diaphragm model” in line 5. Since the claim language does not use antecedent basis (e.g. “the” or “said”), it is unclear if applicant is referring to the same ones of “a movement of the diaphragm model” of claim 14 from which claim 15 depends or a second movement of the diaphragm model. For purposes of examination, it is assumed that “a movement of the diaphragm model” refers to the same ones of “a movement of the diaphragm model” found in claim 14.
Claim 15 recites the limitation “a respiratory motion” in line 6. Since the claim language does not use antecedent basis (e.g. “the” or “said”), it is unclear if applicant is referring to the same ones of “a respiratory motion” of claim 14 from which claim 15 depends or a second respiratory motion. For purposes of examination, it is assumed that “a respiratory motion” refers to the same ones of “a respiratory motion” found in claim 14.
Claim 17 recites the limitation “gas” in line 8. Since the claim language does not use antecedent basis (e.g. “the” or “said”), it is unclear if applicant is referring to the same ones of “gas” of claim 17 line 5 or a second gas. For purposes of examination, it is assumed that “gas” refers to the same ones of “gas” found in claim 17 line 5.
Claim 17 recites the limitation “a liquid” in line 9. Since the claim language does not use antecedent basis (e.g. “the” or “said”), it is unclear if applicant is referring to the same ones of “a liquid” of claim 17 line 6 or a second liquid. For purposes of examination, it is assumed that “a liquid” refers to the same ones of “a liquid” found in claim 17 line 6.
Claim 18 recites the limitation “the supplying a gas” in line 6. Since the claim language does not use antecedent basis (e.g. “the” or “said”), it is unclear if applicant is referring to the same ones of “supplying gas” of claim 17 from which claim 18 depends or a different instance of supplying gas. For purposes of examination, it is assumed that “the supplying a gas” refers to the same ones of “supplying gas” found in claim 17.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 9, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carson et al. (US 20160027345 A1; hereinafter Carson).
Regarding claim 1, Carson discloses a human body simulation device (shown in Fig 4) comprising: an organ model that simulates an outer shape of an organ (cardiac module 2100 configured to be a replica of the left half of the human heart; ¶56) and has a liquid accommodating region to accommodate a liquid therein (fluid can be diverted or returned to the cardiac module 2100; ¶69); a gas-liquid separation tank having an internal space to accommodate a gas and a liquid in a separated state (has an arterial compliance chamber 18 acting as a reservoir that separates gas and liquid; ¶68); and a gas supply/suction device (air compressor 100 connected to the arterial compliance chamber 18; ¶73) that supplies a gas to the internal space of the gas-liquid separation tank or sucks a gas accommodated in the internal space of the gas-liquid separation tank (the arterial chamber pressurization valve 128 admits pressurized air into the arterial compliance chamber 18 in ¶74 and arterial pressurization chamber 128 is connected to the air compressor in ¶75 and Fig. 2), wherein the internal space of the gas-liquid separation tank and the liquid accommodating region of the organ model are in fluid communication (fluid from the cardiac module 2100, directly, or if diverted to and returned from the arterial compliance chamber 18 means they are in fluid communication; ¶69), allowing a liquid accommodated in the gas-liquid separation tank to flow through (fluid can be diverted or returned to the cardiac module 2100 from the arterial compliance chamber 18; ¶69), when a gas is supplied from the gas supply/suction device to the gas-liquid separation tank (air compressor pumps pressurized air through the arterial chamber 18; ¶73), a liquid in an amount corresponding to an amount of the supplied gas is supplied from the gas-liquid separation tank to the liquid accommodating region (Fluid can be drained by pumping pressurized air through Arterial chamber 18; ¶73), whereby the organ model expands (the action of pressurized air allows the cardiac simulator module 2100 to expand like a human heart; ¶78), and when a gas is sucked from the gas-liquid separation tank by the gas supply/suction device (the action of pressurized allows the cardiac simulator module 2100 to contract like a human heart; ¶78), a liquid in an amount corresponding to an amount of the sucked gas is sucked from the liquid accommodating region to the gas-liquid separation tank, whereby the organ model contracts (this is how the mechanism works here, the fluid moves through the use of pressurized air and the action of pressurized air allows for the contraction of the cardiac simulator module 2100; ¶78).
Regarding claim 2, Carson discloses wherein the gas-liquid separation tank includes a partition that partitions the internal space of the gas-liquid separation tank (there is a separation in Fig 13) into a first space to accommodate a gas (gas 26; Fig 13 and ¶68) and a second space to accommodate a liquid (cavity 22 used to store liquid; ¶68), the second space being located below the first space in a vertical direction (cavity 22 is below gas 26; Fig 13), has a first opening that provides fluid communication between the first space and the gas supply/suction device (air compressor 100 may be fluidly connected to the arterial compliance chamber 18 via tubing and connection through tubing means there is an opening; ¶73), and has a second opening that that provides fluid communication between the second space and the liquid accommodating region of the organ model (fluid from the cardiac module 2100 being returned or diverted to the arterial compliance chamber 18 means they are in fluid communication with each other in ¶69 and see Fig 2 to see how the arterial compliance chamber 18 is connected to other parts).
Regarding claim 9, Carson discloses wherein the organ model is a heart model simulating an outer shape of a heart (replica of the human heart; ¶56), and the gas supply/suction device and the gas-liquid separation tank function as a heartbeat portion that simulates beating of the heart model by expanding and contracting the heart model (contraction and expansion from pressurized air; ¶78).
Regarding claim 17, Carson discloses a method of simulation an organ of a human body simulation device (shown in Fig 4), the method comprising: providing fluid communication between an internal space of a gas-liquid separation tank (arterial compliance chamber 18; ¶68) and a liquid accommodating region of an organ model (fluid can be diverted or returned to the cardiac module 2100 from the arterial compliance chamber 18; ¶69); in response to supplying gas to the gas-liquid separation tank (the arterial chamber pressurization valve 128 admits pressurized air into the arterial compliance chamber 18 in ¶74 and arterial pressurization chamber 128 is connected to the air compressor in ¶75 and Fig. 2), supplying a liquid in an amount corresponding to an amount of the supplied gas to the liquid accommodating region, whereby the organ model expands (this is how the mechanism works here, the fluid moves through the use of pressurized air and the action of pressurized air allows for the expansion of the cardiac simulator module 2100; ¶78); and in response to sucking gas from the gas-liquid separation tank, sucking a liquid in an amount corresponding to an amount of the sucked gas from the liquid accommodating region to the gas-liquid separation tank, whereby the organ model contracts (this is how the mechanism works here, the fluid moves through the use of pressurized air and the action of pressurized air allows for the contraction of the cardiac simulator module 2100; ¶78).
Claim Rejections - 35 USC § 103
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.
Claims 10 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Carson in view of YONEYAMA et al. (JP2020091307A see-translation; hereinafter Yoneyama).
Regarding claims 10 and 14, Carson discloses wherein the organ model is a diaphragm model (the accumulator referred to as the arterial compliance chamber 18 is used with the cardiac module 2100 in ¶69, but alternately will use a diaphragm; ¶68). Carson does not explicitly disclose the diaphragm model simulating an outer shape of a diaphragm, and the gas supply/suction device and the gas-liquid separation tank function as a respiratory motion portion that simulates a movement of the diaphragm model associated with a respiratory motion by expanding and contracting the diaphragm model.
However, Yoneyama focuses on a vascular model and organ simulator that allows for the simulated organs imitate real organs, which relates to Carson because the mechanism in Carson wants to simulate cardiac and vascular functioning of organs. Yoneyama teaches the diaphragm model simulating an outer shape of a diaphragm (a diaphragm model 170 imitating a diaphragm model; ¶24). When it comes to the gas supply/suction device and the gas-liquid separation tank function as a respiratory motion portion that simulates a movement of the diaphragm model associated with a respiratory motion by expanding and contracting the diaphragm model (this will be done with a simple substitution of the heart model represented by the cardiac module 2100 with a diaphragm model to replace the heart model because a diaphragm model 170 mimics the contraction and expansion of a breathing motion through a breathing operation unit 70 that uses a pump; ¶31).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carson to implement the teachings of Yoneyama since it has been held that simple substitution of one known element for another yields predictable results. In this case Yoneyama notes that a diaphragm model 170 mimics the contraction and expansion of a breathing motion through a breathing operation unit 70 by pumping fluid or air (¶31), which has similar results in Carson by expanding and contracting the heart model to mimic a heartbeat. See MPEP 2143, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 15, the structure being claimed in the same structure claimed in claim 14, with the exception of the following. Claim 15 focuses on the diaphragm model simulating an outer shape of a diaphragm, the device further comprising another gas supply/suction device and another gas-liquid separation tank that function as a respiratory motion portion that simulates a movement of the diaphragm model associated with a respiratory motion by expanding and contracting the diaphragm model. However, this claimed structure of another gas supply/suction device and another gas-liquid separation tank is the exact same structure as the gas supply/suction device and the gas-liquid separation tank in claim 1 or 14. Furthermore, they also have the same exact purpose, to expand and contract the organ model in order to simulate a heartbeat or respiratory motion.
Since another gas supply/suction device and another gas-liquid separation tank have the exact same structure and function as the gas supply/suction device and the gas-liquid separation tank in claim 1 or 14, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carson with another gas supply/suction device and another gas-liquid separation tank since it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (see MPEP 2144.04, VI, B Duplication of Parts. In this case there is no new and unexpected result.
Regarding claim 16, Carson does not explicitly disclose further comprising a liquid tank in which the organ model is provided.
However, Yoneyama focuses on a vascular model and organ simulator that allows for the simulated organs imitate real organs, which relates to Carson because the mechanism in Carson wants to simulate cardiac and vascular functioning of organs. Yoneyama teaches further comprising a liquid tank (water tank 21; Fig 1) in which the organ model is provided (the model 10 includes a heart model 110 in ¶24 and model 10 is inside the water tank 21 as shown in Fig 1).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carson to implement the teachings of Yoneyama because the benefit of having the full model immersed in fluid is that it allows the model to be kept in a wet state like an actual human body, which allows for better and more realistic simulation.
Allowable Subject Matter
Claim 3, objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and with 112(b) issues addressed.
Conclusion
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/JOSE ANGELES/Examiner, Art Unit 3715
/Jay Trent Liddle/Primary Examiner, Art Unit 3715