DETAILED ACTION
Applicant’s arguments, filed on 10/09/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed on 10/09/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-17 are the current claims hereby under examination.
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
Claims 11-17 are objected to because of the following informalities:
In claim 11, line 2, “pump fluid” should read “pump the fluid”
In claim 12, line 2, “pump fluid” should read “pump the fluid”
In claim 13, line 2, “pump fluid” should read “pump the fluid”
In claim 14, line 2, “pump fluid” should read “pump the fluid”
In claim 15, line 2, “pump fluid” should read “pump the fluid”
In claim 16, line 2, “pump fluid” should read “pump the fluid”
In claim 17, line 2, “pump fluid” should read “pump the fluid”
Appropriate correction is required.
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 11-17 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.
Regarding claim 11, the claim recites the limitation “a flow path” in line 6. It is unclear if this is meant to refer to the flow path introduced earlier in the claim, or a different flow path. If it is referring to the flow path introduced earlier in the claim, it needs to refer back to it. If it is referring to a different flow path, it needs to be distinguished from the flow path introduced earlier in the claim. For purposes of examination, it is being interpreted as referring to the flow path introduced earlier in the claim.
Regarding claim 12, the claim recites the limitation “a flow path” in line 6. It is unclear if this is meant to refer to the flow path introduced earlier in the claim, or a different flow path. If it is referring to the flow path introduced earlier in the claim, it needs to refer back to it. If it is referring to a different flow path, it needs to be distinguished from the flow path introduced earlier in the claim. For purposes of examination, it is being interpreted as referring to the flow path introduced earlier in the claim.
Regarding claim 13, the claim recites the limitation “a flow path” in line 6. It is unclear if this is meant to refer to the flow path introduced earlier in the claim, or a different flow path. If it is referring to the flow path introduced earlier in the claim, it needs to refer back to it. If it is referring to a different flow path, it needs to be distinguished from the flow path introduced earlier in the claim. For purposes of examination, it is being interpreted as referring to the flow path introduced earlier in the claim.
Further regarding claim 13, the claim recites the limitation “the first valve” in line 6. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear if this is meant to read as “a first valve”, or if it is meant to depend on a different claim that introduces the first valve. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as reading as “a first valve”.
Further regarding claim 13, the claim recites the limitation “the second valve” in lines 6-7. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear if this is meant to read as “a second valve”, or if it is meant to depend on a different claim that introduces the second valve. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as reading as “a second valve”.
Regarding claim 14, the claim recites the limitation “a flow path” in line 6. It is unclear if this is meant to refer to the flow path introduced earlier in the claim, or a different flow path. If it is referring to the flow path introduced earlier in the claim, it needs to refer back to it. If it is referring to a different flow path, it needs to be distinguished from the flow path introduced earlier in the claim. For purposes of examination, it is being interpreted as referring to the flow path introduced earlier in the claim.
Regarding claim 15, the claim recites the limitation “a flow path” in line 6. It is unclear if this is meant to refer to the flow path introduced earlier in the claim, or a different flow path. If it is referring to the flow path introduced earlier in the claim, it needs to refer back to it. If it is referring to a different flow path, it needs to be distinguished from the flow path introduced earlier in the claim. For purposes of examination, it is being interpreted as referring to the flow path introduced earlier in the claim.
Further regarding claim 15, the claim recites the limitation “the second valve” in lines 6-7. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear if this is meant to read as “a second valve”, or if it is meant to depend on a different claim that introduces the second valve. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as reading as “a second valve”.
Regarding claim 16, the claim recites the limitation “a flow path” in line 6. It is unclear if this is meant to refer to the flow path introduced earlier in the claim, or a different flow path. If it is referring to the flow path introduced earlier in the claim, it needs to refer back to it. If it is referring to a different flow path, it needs to be distinguished from the flow path introduced earlier in the claim. For purposes of examination, it is being interpreted as referring to the flow path introduced earlier in the claim.
Further regarding claim 16, the claim recites the limitation “the first valve” in line 6. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear if this is meant to read as “a first valve”, or if it is meant to depend on a different claim that introduces the first valve. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as reading as “a first valve”.
Regarding claim 17, the claim recites the limitation “a flow path” in line 6. It is unclear if this is meant to refer to the flow path introduced earlier in the claim, or a different flow path. If it is referring to the flow path introduced earlier in the claim, it needs to refer back to it. If it is referring to a different flow path, it needs to be distinguished from the flow path introduced earlier in the claim. For purposes of examination, it is being interpreted as referring to the flow path introduced earlier in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4-6, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Soma (JP 2008005926) in further view of Soma ‘181 (JP 2008307181). Citations to JP 2008005926 and JP 2008307181 will refer to the English Machine Translations that accompany this Office Action.
Regarding independent claim 1, Soma teaches a fluid circuit ([0001]: “The present invention relates to a blood pressure measurement cuff and a blood pressure measurement device, and more particularly, to a blood pressure measurement cuff that performs non-invasive blood pressure measurement using an oscillometric method using an ischemic cuff and a blood pressure measurement device using the cuff.”), comprising:
a pressing cuff ([0015]: “This double cuff method is a method in which an air bag for ischemia used for compressing a blood vessel”) configured to be connected to a secondary side of a pump ([0037]: “a pressurization control unit 19 that controls the air pressure from the pump 18 and a decompression control unit 20 that performs decompression exhaust control are connected to the first pipe 6 of the cuff body 100 as shown in the figure”), the pump configured to pump a fluid into a flow path ([0018]: “a first pipe connected to the air bag for blood ischemia, and the air bag for detecting pulse waves”);
a first fluid resistor connected to a secondary side of the pressing cuff and in fluid communication with said flow path (hemostasis air bag 1 and the sub air bag 3 are connected to the first pipe 6 via branch portions 6a, 6b, 6c, and 6d, and a fluid resistance portion such as an orifice is provided between the branch portions 6b and 6d.”);
a second fluid resistor provided on a secondary side of the first fluid resistor ([0029]: “the second fluid resistor 11 is connected to the second pipe 7 as illustrated. Further, the cuff pressure detector 13 is branched from the branch portion 7a of the second pipe 7 and connected thereto, while the second fluid resistor 11 is branched from the first pipe 6k to the pressurized fluid inlet side”).
However, Soma does not teach the second fluid resistor configured to be in fluid communication with outside air.
Soma ‘181 discloses a blood pressure measuring instrument. Specifically, Soma ‘181 teaches the device configured to be in fluid communication with outside air ([0035]: “introduces outside air into the pump through the opening 23a”). Soma and Soma ‘181 are analogous arts as they are both related to blood pressure measuring devices.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the device being in fluid communication with outside air from Soma ‘181 into the device from Soma as it allows the device to use the outside air to inflate the cuffs, which can ensure the device works properly and can inflate correctly.
The Soma/Soma ‘181 combination teaches a sensing cuff provided between the first fluid resistor and the second fluid resistor (Soma, [0015]: “This double cuff method is a method in which an air bag for ischemia used for compressing a blood vessel and a detection air bag for detecting only a pulse wave at a central portion below the air bag”).
Regarding claim 4, the Soma/Soma ‘181 combination teaches the fluid circuit according to claim 1, wherein at least one of the first fluid resistor and the second fluid resistor is formed by connecting a plurality of orifices in parallel, in series, or in series and parallel (Soma, [0028]: “a fluid resistance portion such as an orifice is provided”. If each fluid resistor is an orifice and they are connected in parallel, then this constitutes as a plurality of orifices; “the check valve 22 connected in parallel with the first fluid resistor”. If the second valve is connected to the third fluid resistor and the valve is in parallel with the first fluid resistor, then the third fluid resistor and the first fluid resistor are in parallel.).
Regarding claim 5, the Soma/Soma ‘181 combination teaches a blood pressure measurement device (Soma, [0001]: “The present invention relates to a blood pressure measurement cuff and a blood pressure measurement device”), comprising: the pump that supplies the fluid to the secondary side of the pump (Soma, [0037]: “a pressurization control unit 19 that controls the air pressure from the pump 18 and a decompression control unit 20 that performs decompression exhaust control are connected to the first pipe 6 of the cuff body 100 as shown in the figure”); the fluid circuit according to claim 1.
However, the Soma/Soma ‘181 combination does not teach an on-off valve provided between the pump and the pressing cuff.
Soma ‘181 teaches an on-off valve provided between the pump and the pressing cuff ([0019]: “the sub-air bag, and the A third pipe connected to the pressure increasing / decreasing means via the on-off valve”), the on-off valve opening and closing the flow path to the outside air ([0045]: “the on-off valve 16 is opened to exhaust each air bag”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the on-off valve from Soma ‘181 into the Soma/Soma ‘181 combination as it allows the combination to turn the flow path on and off, which allows more control over the inflation of the cuff, leading to more control over the measurement process.
The Soma/Soma ‘181 combination teaches a pressure sensor connected to the sensing cuff (Soma, [0038]: “The pipe 7 is connected to a cuff pressure detection unit 13 including a pressure sensor”); and a control unit that controls the pump and the on-off valve based on a pressure detected by the pressure sensor (Soma, Abstract: “a pressurization control part (19) connected to a pressurizing means (18) for increasing pressure of a cuff assembly”; [0023]: “a step of converting the pulse wave into a detected pulse wave signal by the pressure detection unit”).
Regarding claim 6, the Soma/Soma ‘181 combination teaches the blood pressure measurement device according to claim 5, comprising a device body that houses the pump, the on-off valve, the pressure sensor, and the control unit (Soma, Abstract: “The sphygmomanometer apparatus is equipped with a main body (100) of a cuff including a cuff fabric (5), the blood blocking air bag (1), a sub air bag (3) arranged on the side of a heart, the pulse wave detecting air bag (2) for detecting pulse waves, first piping (6) connected through a first fluid resisting device (21), a check valve (22), and a second piping (7) connected through a second fluid resisting device (11), a cuff pressure detecting part (13), a pressurization control part (19) connected to a pressurizing means (18) for increasing pressure of a cuff assembly, a depressurization control part (20) for reducing pressure, a pulse wave detecting part (14) for detecting superimposed pulse waves by converting the pulse wave to detected pulse wave signals, a blood pressure detecting part (15) for determining a blood pressure value based on an output from the pulse wave detecting part and detected cuff pressure signals”), wherein the first fluid resistor and the second fluid resistor are integrally provided with the pressing cuff (Soma, [0022]: “a first fluid resistor connected between the hemostasis bladder and the sub-air bladder”; [0022]: “a second pipe connected to the pulse wave detection air bag via a second fluid resistor”).
Regarding claim 13, the Soma/Soma ‘181 combination teaches a blood pressure measurement device (Soma, [0001]: “The present invention relates to a blood pressure measurement cuff and a blood pressure measurement device”), comprising: the pump configured to pump fluid into the flow path the fluid circuit according to claim 4 (Soma, [0037]: “a pressurization control unit 19 that controls the air pressure from the pump 18 and a decompression control unit 20 that performs decompression exhaust control are connected to the first pipe 6 of the cuff body 100 as shown in the figure”).
However, the Soma/Soma ‘181 combination does not teach an on-off valve provided between the pump and the pressing cuff.
Soma ‘181 teaches an on-off valve provided between the pump and the pressing cuff ([0019]: “the sub-air bag, and the A third pipe connected to the pressure increasing / decreasing means via the on-off valve”), the on-off valve opening and closing a flow path to the atmosphere ([0045]: “the on-off valve 16 is opened to exhaust each air bag”), the on-off valve being different from the first valve and the second valve.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the on-off valve from Soma ‘181 into the Soma/Soma ‘181 combination as it allows the combination to turn the flow path on and off, which allows more control over the inflation of the cuff, leading to more control over the measurement process.
The Soma/Soma ‘181 combination teaches a pressure sensor connected to the sensing cuff (Soma, [0038]: “The pipe 7 is connected to a cuff pressure detection unit 13 including a pressure sensor”); and a control unit that controls the pump and the on-off valve based on a pressure detected by the pressure sensor (Soma, Abstract: “a pressurization control part (19) connected to a pressurizing means (18) for increasing pressure of a cuff assembly”; [0023]: “a step of converting the pulse wave into a detected pulse wave signal by the pressure detection unit”).
Claims 2, 8, 11, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over the Soma/Soma ‘181 combination as applied to claim 1 above, and further in view of Inoue (JP 2009101089). Citations to JP 2009101089 will refer to the English Machine Translation that accompanies this Office Action.
Regarding claim 2, the Soma/Soma ‘181 combination teaches the fluid circuit according to claim 1, comprising a first valve provided in parallel with the first fluid resistor (Soma, [0033]: “the check valve 22 connected in parallel with the first fluid resistor”).
However, the Soma/Soma ‘181 combination is silent on when the first valve opens.
Inoue discloses a blood pressure measuring apparatus and its control method. Specifically, Inoue teaches the first valve opening when a pressure of the sensing cuff is higher than a pressure of the pressing cuff by a predetermined value or more ([0025]: “since the small cuff 2 for pulse wave detection is attached to the cuff central portion A, the W1-A component is most easily detected as compared with the W1-B component and the W1-C component. Therefore, the characteristics of the W1-A component are largely reflected in the shape of the W1 component, compared to the characteristics of the W1-B component and the W1-C component.”; [0070]: “based on the pulse wave signal extracted in step S9, the value of the phase difference (t / T) of the pulse wave is sequentially derived for each pulse wave period in descending order of the corresponding cuff pressure. Then, a point where the value of the phase difference is smaller than a predetermined threshold is searched, and the cuff pressure value corresponding to the detected point is determined as the diastolic blood pressure value (step S10).”; [0071]: “After the determination of each blood pressure value, the pressure reduction control valve is fully opened (completely "open") to return the cuff pressure to the atmospheric pressure (step S12)”). Soma, Soma ‘181, and Inoue are analogous arts as they are all related to blood pressure measuring devices.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the valve opening timing from Inoue into the Soma/Soma ‘181 combination as the combination is silent on when the valve opens, and Inoue discloses a suitable control method in an analogous device.
Regarding claim 8, the Soma/Soma ‘181/Inoue combination teaches the fluid circuit according to claim 2, wherein at least one of the first fluid resistor and the second fluid resistor is formed by connecting a plurality of orifices in parallel, in series, or in series and parallel (Soma, [0028]: “a fluid resistance portion such as an orifice is provided”. If each fluid resistor is an orifice and they are connected in parallel, then this constitutes as a plurality of orifices; “the check valve 22 connected in parallel with the first fluid resistor”).
Regarding claim 11, the Soma/Soma ‘181/Inoue combination teaches a blood pressure measurement device (Soma, [0001]: “The present invention relates to a blood pressure measurement cuff and a blood pressure measurement device”), comprising: the pump configured to pump fluid into the flow path the fluid circuit according to claim 2 (Soma, [0037]: “a pressurization control unit 19 that controls the air pressure from the pump 18 and a decompression control unit 20 that performs decompression exhaust control are connected to the first pipe 6 of the cuff body 100 as shown in the figure”).
However, the Soma/Soma ‘181/Inoue combination does not teach an on-off valve provided between the pump and the pressing cuff.
Soma ‘181 teaches an on-off valve provided between the pump and the pressing cuff ([0019]: “the sub-air bag, and the A third pipe connected to the pressure increasing / decreasing means via the on-off valve”), the on-off valve opening and closing a flow path to the outside air ([0045]: “the on-off valve 16 is opened to exhaust each air bag”), the on-off valve being different from the first valve.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the on-off valve from Soma ‘181 into the Soma/Soma ‘181/Inoue combination as it allows the combination to turn the flow path on and off, which allows more control over the inflation of the cuff, leading to more control over the measurement process.
The Soma/Soma ‘181/Inoue combination teaches a pressure sensor connected to the sensing cuff (Soma, [0038]: “The pipe 7 is connected to a cuff pressure detection unit 13 including a pressure sensor”); and a control unit that controls the pump and the on-off valve based on a pressure detected by the pressure sensor (Soma, Abstract: “a pressurization control part (19) connected to a pressurizing means (18) for increasing pressure of a cuff assembly”; [0023]: “a step of converting the pulse wave into a detected pulse wave signal by the pressure detection unit”).
Regarding claim 15, the Soma/Soma ‘181/Inoue combination teaches a blood pressure measurement device (Soma, [0001]: “The present invention relates to a blood pressure measurement cuff and a blood pressure measurement device”), comprising: the pump configured to pump fluid into the flow path the fluid circuit according to claim 8 (Soma, [0037]: “a pressurization control unit 19 that controls the air pressure from the pump 18 and a decompression control unit 20 that performs decompression exhaust control are connected to the first pipe 6 of the cuff body 100 as shown in the figure”).
However, the Soma/Soma ‘181/Inoue combination does not teach an on-off valve provided between the pump and the pressing cuff.
Soma ‘181 teaches an on-off valve provided between the pump and the pressing cuff ([0019]: “the sub-air bag, and the A third pipe connected to the pressure increasing / decreasing means via the on-off valve”), the on-off valve opening and closing a flow path to the atmosphere ([0045]: “the on-off valve 16 is opened to exhaust each air bag”), the on-off valve being different from the first valve and the second valve.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the on-off valve from Soma ‘181 into the Soma/Soma ‘181/Inoue combination as it allows the combination to turn the flow path on and off, which allows more control over the inflation of the cuff, leading to more control over the measurement process.
The Soma/Soma ‘181/Inoue combination teaches a pressure sensor connected to the sensing cuff (Soma, [0038]: “The pipe 7 is connected to a cuff pressure detection unit 13 including a pressure sensor”); and a control unit that controls the pump and the on-off valve based on a pressure detected by the pressure sensor (Soma, Abstract: “a pressurization control part (19) connected to a pressurizing means (18) for increasing pressure of a cuff assembly”; [0023]: “a step of converting the pulse wave into a detected pulse wave signal by the pressure detection unit”).
Claims 3, 9, 12, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over the Soma/Soma ‘181 combination as applied to claim 1 above, and further in view of Inoue, Soma ‘477 (JP 2009022477), and Soma ‘956 (JP H05344956). Citations to JP 2009022477 and JP H0544956 will refer to the English Machine Translations that accompany this Office Action.
Regarding claim 3, the Soma/Soma ‘181 combination teaches the fluid circuit according to claim 1.
However, the Soma/Soma ‘181 combination does not teach the fluid circuit comprising: a second valve provided in parallel with the first fluid resistor, the second valve opening when a pressure of the pressing cuff is higher than a pressure of the sensing cuff by a predetermined value or more; and a third fluid resistor connected to a secondary side of the second valve, the third fluid resistor being provided in parallel with the first fluid resistor.
Soma ‘477 discloses a sphygmomanometry apparatus. Specifically, Soma ‘477 teaches the fluid circuit comprising: a second valve ([0035]: “Second open / close valve”). Soma, Soma ‘181, and Soma ‘477 are analogous arts as they are all related to blood pressure measuring devices.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the second valve form Soma ‘477 into the Soma/Soma ‘181 combination as it allows the device to have more control of the fluid by introducing another valve that can help control the flow.
The Soma/Soma ‘181/Soma ‘477 combination teaches provided in parallel with the first fluid resistor (Soma, [0033]: “the check valve 22 connected in parallel with the first fluid resistor”).
However, the Soma/Soma ‘181/Soma ‘477 combination is silent on when the first valve opens.
Inoue teaches the second valve opening when a pressure of the pressing cuff is higher than a pressure of the sensing cuff by a predetermined value or more ([0025]: “since the small cuff 2 for pulse wave detection is attached to the cuff central portion A, the W1-A component is most easily detected as compared with the W1-B component and the W1-C component. Therefore, the characteristics of the W1-A component are largely reflected in the shape of the W1 component, compared to the characteristics of the W1-B component and the W1-C component.”; [0070]: “based on the pulse wave signal extracted in step S9, the value of the phase difference (t / T) of the pulse wave is sequentially derived for each pulse wave period in descending order of the corresponding cuff pressure. Then, a point where the value of the phase difference is smaller than a predetermined threshold is searched, and the cuff pressure value corresponding to the detected point is determined as the diastolic blood pressure value (step S10).”; [0071]: “After the determination of each blood pressure value, the pressure reduction control valve is fully opened (completely "open") to return the cuff pressure to the atmospheric pressure (step S12)”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the valve opening timing from Inoue into the Soma/Soma ‘181/Soma ‘477 combination as the combination is silent on when the valve opens, and Inoue discloses a suitable control method in an analogous device.
However, the Soma/Soma ‘181/Soma ‘477/Inoue combination does not teach a third fluid resistor connected to a secondary side of the second valve.
Soma ‘956 discloses a blood pressure measuring device. Specifically, Soma ‘956 teaches a third fluid resistor connected to a secondary side of the second valve ([0005]: “a plurality of fluid resistors are provided for the cuff, and a valve or a valve for switching these is integrated”). Soma, Soma ‘181, Soma ‘447, Inoue, and Soma ‘956 are analogous arts as they are all related to blood pressure measuring devices.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the fluid resistor connected to the valve from Soma ‘956 into the Soma/Soma ‘181/Soma ‘477/Inoue combination as it allows the device to have control over the fluid flow, and can allow for the valve to control the fluid resistor and change the flow of the fluid when necessary.
The Soma/Soma ‘181/Soma ‘477/Inoue/Soma ‘956 combination teaches the third fluid resistor being provided in parallel with the first fluid resistor (Soma, [0033]: “the check valve 22 connected in parallel with the first fluid resistor”. If the second valve is connected to the third fluid resistor and the valve is in parallel with the first fluid resistor, then the third fluid resistor and the first fluid resistor are in parallel.).
Regarding claim 9, the Soma/Soma ‘181/Soma ‘477/Inoue/Soma ‘956 combination teaches the fluid circuit according to claim 3, wherein at least one of the first fluid resistor and the second fluid resistor is formed by connecting a plurality of orifices in parallel, in series, or in series and parallel (Soma, [0028]: “a fluid resistance portion such as an orifice is provided”. If each fluid resistor is an orifice and they are connected in parallel, then this constitutes as a plurality of orifices; “the check valve 22 connected in parallel with the first fluid resistor”).
Regarding claim 12, the Soma/Soma ‘181/Soma ‘477/Inoue/Soma ‘956 combination teaches a blood pressure measurement device (Soma, [0001]: “The present invention relates to a blood pressure measurement cuff and a blood pressure measurement device”), comprising: the pump configured to pump fluid into the flow path the fluid circuit according to claim 3 (Soma, [0037]: “a pressurization control unit 19 that controls the air pressure from the pump 18 and a decompression control unit 20 that performs decompression exhaust control are connected to the first pipe 6 of the cuff body 100 as shown in the figure”).
However, the Soma/Soma ‘181/Soma ‘477/Inoue/Soma ‘956 combination does not teach an on-off valve provided between the pump and the pressing cuff.
Soma ‘181 teaches an on-off valve provided between the pump and the pressing cuff ([0019]: “the sub-air bag, and the A third pipe connected to the pressure increasing / decreasing means via the on-off valve”), the on-off valve opening and closing a flow path to the atmosphere ([0045]: “the on-off valve 16 is opened to exhaust each air bag”), the on-off valve being different from the second valve.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the on-off valve from Soma ‘181 into the Soma/Soma ‘181/Soma ‘477/Inoue/Soma ‘956 combination as it allows the combination to turn the flow path on and off, which allows more control over the inflation of the cuff, leading to more control over the measurement process.
The Soma/Soma ‘181/Soma ‘477/Inoue/Soma ‘956 combination teaches a pressure sensor connected to the sensing cuff (Soma, [0038]: “The pipe 7 is connected to a cuff pressure detection unit 13 including a pressure sensor”); and a control unit that controls the pump and the on-off valve based on a pressure detected by the pressure sensor (Soma, Abstract: “a pressurization control part (19) connected to a pressurizing means (18) for increasing pressure of a cuff assembly”; [0023]: “a step of converting the pulse wave into a detected pulse wave signal by the pressure detection unit”).
Regarding claim 16, the Soma/Soma ‘181/Soma ‘477/Inoue/Soma ‘956 combination teaches a blood pressure measurement device (Soma, [0001]: “The present invention relates to a blood pressure measurement cuff and a blood pressure measurement device”), comprising: the pump configured to pump fluid into the flow path the fluid circuit according to claim 9 (Soma, [0037]: “a pressurization control unit 19 that controls the air pressure from the pump 18 and a decompression control unit 20 that performs decompression exhaust control are connected to the first pipe 6 of the cuff body 100 as shown in the figure”).
However, the Soma/Soma ‘181/Soma ‘477/Inoue/Soma ‘956 combination does not teach an on-off valve provided between the pump and the pressing cuff.
Soma ‘181 teaches an on-off valve provided between the pump and the pressing cuff ([0019]: “the sub-air bag, and the A third pipe connected to the pressure increasing / decreasing means via the on-off valve”), the on-off valve opening and closing a flow path to the atmosphere ([0045]: “the on-off valve 16 is opened to exhaust each air bag”), the on-off valve being different from the first valve and the second valve.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the on-off valve from Soma ‘181 into the Soma/Soma ‘181/Soma ‘477/Inoue/Soma ‘956 combination as it allows the combination to turn the flow path on and off, which allows more control over the inflation of the cuff, leading to more control over the measurement process.
The Soma/Soma ‘181/Soma ‘477/Inoue/Soma ‘956 combination teaches a pressure sensor connected to the sensing cuff (Soma, [0038]: “The pipe 7 is connected to a cuff pressure detection unit 13 including a pressure sensor”); and a control unit that controls the pump and the on-off valve based on a pressure detected by the pressure sensor (Soma, Abstract: “a pressurization control part (19) connected to a pressurizing means (18) for increasing pressure of a cuff assembly”; [0023]: “a step of converting the pulse wave into a detected pulse wave signal by the pressure detection unit”).
Claims 7, 10, 14, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over the Soma/Soma ‘181/Inoue combination as applied to claim 2 above, and further in view of Soma ‘477 and Soma ‘956.
Regarding claim 7, the Soma/Soma ‘181/Inoue combination teaches the fluid circuit according to claim 2.
However, the Soma/Soma ‘181/Inoue combination does not teach the fluid circuit comprising: a second valve provided in parallel with the first fluid resistor, the second valve opening when a pressure of the pressing cuff is higher than a pressure of the sensing cuff by a predetermined value or more; and a third fluid resistor connected to a secondary side of the second valve, the third fluid resistor being provided in parallel with the first fluid resistor.
Soma ‘477 discloses a sphygmomanometry apparatus. Specifically, Soma ‘477 teaches the fluid circuit comprising: a second valve ([0035]: “Second open / close valve”). Soma, Soma ‘181, and Soma ‘477 are analogous arts as they are all related to blood pressure measuring devices.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the second valve form Soma ‘477 into the Soma/Soma ‘181/Inoue combination as it allows the device to have more control of the fluid by introducing another valve that can help control the flow.
The Soma/Soma ‘181/Inoue/Soma ‘477 combination teaches provided in parallel with the first fluid resistor (Soma, [0033]: “the check valve 22 connected in parallel with the first fluid resistor”).
However, the Soma/Soma ‘181/Inoue/Soma ‘477 combination is silent on when the first valve opens.
Inoue teaches the second valve opening when a pressure of the pressing cuff is higher than a pressure of the sensing cuff by a predetermined value or more ([0025]: “since the small cuff 2 for pulse wave detection is attached to the cuff central portion A, the W1-A component is most easily detected as compared with the W1-B component and the W1-C component. Therefore, the characteristics of the W1-A component are largely reflected in the shape of the W1 component, compared to the characteristics of the W1-B component and the W1-C component.”; [0070]: “based on the pulse wave signal extracted in step S9, the value of the phase difference (t / T) of the pulse wave is sequentially derived for each pulse wave period in descending order of the corresponding cuff pressure. Then, a point where the value of the phase difference is smaller than a predetermined threshold is searched, and the cuff pressure value corresponding to the detected point is determined as the diastolic blood pressure value (step S10).”; [0071]: “After the determination of each blood pressure value, the pressure reduction control valve is fully opened (completely "open") to return the cuff pressure to the atmospheric pressure (step S12)”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the valve opening timing from Inoue into the Soma/Soma ‘181/Inoue/Soma ‘477 combination as the combination is silent on when the valve opens, and Inoue discloses a suitable control method in an analogous device.
However, the Soma/Soma ‘181/Inoue/Soma ‘477 combination does not teach a third fluid resistor connected to a secondary side of the second valve.
Soma ‘956 discloses a blood pressure measuring device. Specifically, Soma ‘956 teaches a third fluid resistor connected to a secondary side of the second valve ([0005]: “a plurality of fluid resistors are provided for the cuff, and a valve or a valve for switching these is integrated”). Soma, Soma ‘181, Soma ‘447, Inoue, and Soma ‘956 are analogous arts as they are all related to blood pressure measuring devices.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the fluid resistor connected to the valve from Soma ‘956 into the Soma/Soma ‘181/Inoue/Soma ‘477 combination as it allows the device to have control over the fluid flow, and can allow for the valve to control the fluid resistor and change the flow of the fluid when necessary.
The Soma/Soma ‘181/Inoue/Soma ‘477/Soma ‘956 combination teaches the third fluid resistor being provided in parallel with the first fluid resistor (Soma, [0033]: “the check valve 22 connected in parallel with the first fluid resistor”. If the second valve is connected to the third fluid resistor and the valve is in parallel with the first fluid resistor, then the third fluid resistor and the first fluid resistor are in parallel.).
Regarding claim 10, the Soma/Soma ‘181/Inoue/Soma ‘477/Soma ‘956 combination teaches the fluid circuit according to claim 7, wherein at least one of the first fluid resistor and the second fluid resistor is formed by connecting a plurality of orifices in parallel, in series, or in series and parallel (Soma, [0028]: “a fluid resistance portion such as an orifice is provided”. If each fluid resistor is an orifice and they are connected in parallel, then this constitutes as a plurality of orifices; “the check valve 22 connected in parallel with the first fluid resistor”).
Regarding claim 14, the Soma/Soma ‘181/Inoue/Soma ‘477/Soma ‘956 combination teaches a blood pressure measurement device (Soma, [0001]: “The present invention relates to a blood pressure measurement cuff and a blood pressure measurement device”), comprising: the pump configured to pump fluid into the flow path the fluid circuit according to claim 7 (Soma, [0037]: “a pressurization control unit 19 that controls the air pressure from the pump 18 and a decompression control unit 20 that performs decompression exhaust control are connected to the first pipe 6 of the cuff body 100 as shown in the figure”).
However, the Soma/Soma ‘181/Inoue/Soma ‘477/Soma ‘956 combination does not teach an on-off valve provided between the pump and the pressing cuff.
Soma ‘181 teaches an on-off valve provided between the pump and the pressing cuff ([0019]: “the sub-air bag, and the A third pipe connected to the pressure increasing / decreasing means via the on-off valve”), the on-off valve opening and closing a flow path to the atmosphere ([0045]: “the on-off valve 16 is opened to exhaust each air bag”), the on-off valve being different from the first valve and the second valve.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the on-off valve from Soma ‘181 into the Soma/Soma ‘181/Inoue/Soma ‘477/Soma ‘956 combination as it allows the combination to turn the flow path on and off, which allows more control over the inflation of the cuff, leading to more control over the measurement process.
The Soma/Soma ‘181/Inoue/Soma ‘477/Soma ‘956 combination teaches a pressure sensor connected to the sensing cuff (Soma, [0038]: “The pipe 7 is connected to a cuff pressure detection unit 13 including a pressure sensor”); and a control unit that controls the pump and the on-off valve based on a pressure detected by the pressure sensor (Soma, Abstract: “a pressurization control part (19) connected to a pressurizing means (18) for increasing pressure of a cuff assembly”; [0023]: “a step of converting the pulse wave into a detected pulse wave signal by the pressure detection unit”).
Regarding claim 17, the Soma/Soma ‘181/Inoue/Soma ‘477/Soma ‘956 combination teaches a blood pressure measurement device (Soma, [0001]: “The present invention relates to a blood pressure measurement cuff and a blood pressure measurement device”), comprising: the pump configured to pump fluid into the flow path the fluid circuit according to claim 10 (Soma, [0037]: “a pressurization control unit 19 that controls the air pressure from the pump 18 and a decompression control unit 20 that performs decompression exhaust control are connected to the first pipe 6 of the cuff body 100 as shown in the figure”).
However, the Soma/Soma ‘181/Inoue/Soma ‘477/Soma ‘956 combination does not teach an on-off valve provided between the pump and the pressing cuff.
Soma ‘181 teaches an on-off valve provided between the pump and the pressing cuff ([0019]: “the sub-air bag, and the A third pipe connected to the pressure increasing / decreasing means via the on-off valve”), the on-off valve opening and closing a flow path to the outside air ([0045]: “the on-off valve 16 is opened to exhaust each air bag”), the on-off valve being different from the first valve and the second valve.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the on-off valve from Soma ‘181 into the Soma/Soma ‘181/Inoue/Soma ‘477/Soma ‘956 combination as it allows the combination to turn the flow path on and off, which allows more control over the inflation of the cuff, leading to more control over the measurement process.
The Soma/Soma ‘181/Inoue/Soma ‘477/Soma ‘956 combination teaches a pressure sensor connected to the sensing cuff (Soma, [0038]: “The pipe 7 is connected to a cuff pressure detection unit 13 including a pressure sensor”); and a control unit that controls the pump and the on-off valve based on a pressure detected by the pressure sensor (Soma, Abstract: “a pressurization control part (19) connected to a pressurizing means (18) for increasing pressure of a cuff assembly”; [0023]: “a step of converting the pulse wave into a detected pulse wave signal by the pressure detection unit”).
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
With regards to the objections and the 112(b) rejections, the applicant has made amendments to overcome the rejections, however the amendments have introduced additional objections and 112(b) rejections.
Applicant’s arguments with respect to the 102 and 103 rejections of claims 1-17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN K MCCORMACK whose telephone number is (703)756-1886. The examiner can normally be reached Mon-Fri 7:30-5.
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, Jason Sims can be reached at 5712727540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about 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.
/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791