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 Objections
Claims 1-10 are objected to because of the following informalities: Claim 6 recites “sate” in lines 3 and 9, but instead should be --state--. Claim 6 recites “is in the attachment state” in line 9, but instead should be --are in the attachment state--. 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 1-10 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 “a sensing cuff that is not connected to the pump, includes a first sheet disposed to face an inner peripheral surface of the pressure cuff and a second sheet facing the first sheet, is configured in a bag shape, and extends in a circumferential direction so as to cross an artery passing portion of the measurement site” in lines 6-9, but is ambiguous. Is the “configured to” language referring to the first sheet, second sheet, and/or sensing cuff? Due to the placement of the limitation, it is unclear which element is being referenced. For examination purposes, Examiner’s position is that the sensing cuff is configured in a bag shape. Clarification required.
Claims not listed are rejected by virtue of claim dependency.
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 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Kohara et al. (US 20200345303), hereinafter Kohara, in view of Matsumura (US 20190313924), hereinafter Matsumura.
Regarding claim 1, a blood pressure gauge (figs. 1-18 and ¶[0052]) comprising: teaches a pump (14);
a bag-shaped pressure cuff that is connected to the pump, and extends along a circumferential direction of a measurement site in order to received supply of a pressurizing fluid from the pump (figs. 1-3 and 14-16, element 71);
a sensing cuff, includes a first sheet disposed to face an inner peripheral surface of the pressure cuff and a second sheet facing the first sheet, is configured in a bag shape, and extends in a circumferential direction so as to cross an artery passing portion of the measurement site (¶[0006,0100], “a pressing cuff and a sensing cuff formed in a bag shape” (emphasis added));
a back plate that is interposed between the pressure cuff and the sensing cuff, extends along a circumferential direction of the measurement site, and transmits a pressing force from the pressure cuff to the sensing cuff (¶[0099,011], “The cuff structure 6 is configured so that the pressing cuff 71, the back plate 72, and the sensing cuff 73 are stacked” and “back plate 72 transmits the pressing force from the pressing cuff 71 to the main surface of the sensing cuff 73”);
an opening valve that is connected to the sensing cuff and is in either an open state in which an inside of the sensing cuff is conducted to outside air or a closed state in which the inside of the sensing cuff is not conducted to the outside air ([0064], “The on-off valve 16 opens and closes a part of the flow path section. . . on-off valves 16 are provided, and selectively open and close the flow path leading from . . . the pump 14 to the sensing cuff 73”);
a pressure cuff controller that controls the pressure cuff to either a compression state in which a fluid is supplied to the pressure cuff and the measurement site is compressed via the pressure cuff or a release state in which the fluid is discharged from the pressure cuff and the compression of the measurement site via the pressure cuff is released (¶[0073-74,0132], “controller 55 controls the operations of the display 12, the pump 14, and the on-off valves 16 based on the electric signals output from the operation unit 13 and the pressure sensor,” “CPU 57 drives the pump 14 and the on-off valves 16 to send compressed air to the pressing cuff,” and “depressurizing the pressing cuff” (emphasis added));
an opening valve controller that controls the opening valve to be in either the open state or the closed state (¶[0074,0127], “the subordinate CPU 57 drives the pump 14 and the on-off valves " and "Upon receiving the electric signal, the controller 55, for example, opens the first on-off valve”); and
a blood pressure calculator that calculates a blood pressure on a basis of a pressure change of the sensing cuff when the opening valve is in the closed state ([0127-32], “opens the first on-off valve 16A and closes the second on-off valve 16B, drives the pump 14, and supplies compressed air to the pressing cuff 71 and the sensing cuff 73,” “[t]hereafter, the controller 55 controls the second on-off valve 16B to repeatedly open and close the second on-off valve 16B or adjust the opening degree of the second on-off valve 16B,” “the controller 55 calculates blood pressure,” and “the controller 55 calculates blood pressure in the process of pressurizing the pressing cuff 71, is described above. However, blood pressure may be calculated in the process of depressurizing the pressing cuff 71 or in both the processes of pressurizing and depressurizing the pressing cuff 71” (emphasis added)),
wherein the sensing cuff has restorability to make a volume in the sensing cuff a predetermined volume when the opening valve is in the open state (¶[0064-65,0112,0123], sensing cuff is inflated when the valve is in an open state).
Kohara fails to teach a sensing cuff that is not connected to the pump.
Matsumura teaches a blood pressure gauge comprising multiple pressure cuffs that each individually comprises a sensor, valve and pump (¶[0075,0087] and fig. 1 and 5, pressure cuffs 21a-21d, sensors 41-46, and pumps 33a-d). That is, there are multiple dual pressure and sensing cuffs that do not share a first pump.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Kohara, such that a sensing cuff that is not connected to the pump connected to a separate pressure cuff, as taught by Matsumura, to aid in increasing or decreasing the cuff pressure according to various condition to measure blood pressure (¶[0083] of Matsumura).
Regarding claim 6, Kohara teaches in a preparation stage before the blood pressure is calculated by the blood pressure calculator, the pressure cuff and the sensing cuff is in an attachment state in which the pressure cuff and the sensing cuff are attached to the measurement site, the pressure cuff controller controls the pressure cuff to the release state, and the opening valve controller brings the opening valve into the closed state after bringing the opening valve into the open state (¶[0126-32], before inflation starts, that is, after a past measurement that requires depressurization of the pressure cuff, the valves are brought to closed states. ¶[0131-32], “the controller 55 controls the second on-off valve 16B to repeatedly open and close the second on-off valve 16B or adjust the opening degree of the second on-off valve 16B” and “depressurizing the pressing cuff 71” ),
and in a measurement stage in which the blood pressure is calculated by the blood pressure calculator, the pressure cuff and the sensing cuff is in the attachment state, the pressure cuff controller controls the pressure cuff to be in the compression state, and the blood pressure calculator calculates a blood pressure on a basis of a pressure change of the sensing cuff (¶[0065,0131-132], “The pressure sensor 17 detects the pressure of the pressing cuff 71 and the sensing cuff 73,” “the sensing cuff 73 is sufficiently inflated and pressed toward the wrist 100 by the back plate 72 pressed by the pressing cuff,” and “blood pressure may be calculated in the process of depressurizing the pressing cuff 71 or in both the processes of pressurizing and depressurizing the pressing cuff .” That is, the change in pressure of the sensing cuff is guided by inflation of its fluid bladder, and the compression/decompression acted thereupon by the pressure cuff, to calculate the blood pressure).
Claims 2 and 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Kohara in view of Matsumura, as applied to claim 1, and further in view of Eto et al. (US 20110125035), hereinafter Eto.
Regarding claims 2 and 4-5, Kohara-Matsumura fail to teach wherein the sensing cuff comprises an elastic member, coil spring, or a spacer therewithin.
Eto teaches a blood pressure measurement device comprising a fluid bladder that is connected to a pressure sensor (abstract and ¶[0129]). The fluid bladder is configured to be filled with fluid and/or further comprise an elastic material such as a sponge or a spring (¶[0158] and fig. 15-B-C, “the filling material may be a combination of these materials”).
As such, it would have have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Kohara-Matsumura, such that the sensing cuff comprises an elastic member, coil spring, or a spacer therewithin, as taught by Eto, to aid in increasing the fluid bladded before pressurization and reducing blood pressure measurement errors (¶[0068,0158] of Eto).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kohara in view of Matsumura and Eto, as applied to claim 2, and further in view of Kishimoto et al. (US 20060058689), hereinafter Kishimoto.
Regarding claim 3, Eto teaches wherein the elastic member is a sponge, but fails to teach that it has an open cell structure.
Kishimoto teaches a blood pressure monitor cuff comprising a fluid bladder with an open cell sponge positioned therewithin (abstract, ¶[0025-26,0050], and fig. 3-4, “air-permeable member is a sponge” indicating that it has open cell architecture).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Kohara-Matsumura-Eto, such that the elastic member is a sponge with an open cell structure, as taught by Kishimoto, to aid in uniformly inflating the fluid bladder and improving the blood pressure measurement accuracy (¶[0027] of Kishimoto).
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kohara in view of Matsumura, as applied to claim 1, and further in view of Nishioka et al. (US 20150025400), hereinafter Nishioka.
Regarding claim 8 and 10, Kohara teaches a pressure sensor that detects a pressure of the sensing cuff (¶[0065], “The pressure sensor 17 detects the pressure of the pressing cuff 71 and the sensing cuff 73”); and
a substrate provided between the pressure cuff and the sensing cuff (¶[0108], the back plate comprises a substrate i.e. adhesive layer, double sided tape, or the like), but fails to teach wherein the opening valve, pressure sensor, opening valve controller and the blood pressure calculator are integrally mounted on the substrate.
Nishioka teaches a blood pressure measurement device that comprises a valve 32, a pressure sensor 33, valve controller 41, and blood pressure calculator 50 that are placed on the same plane on substrate 12 (abstract, ¶[0046-49], and fog. 2).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Kohara-Matsumura, such that the opening valve, pressure sensor, opening valve controller and the blood pressure calculator are integrally mounted on the substrate, as taught by Nishioka, to aid in arranging the elements in a compact size to reduce the size and thickness of the product (¶[0049], “the set areas of the pump unit 31, the valve 32, and the substrate 41 can be ensured and these elements can be arranged in a compact manner, which makes it possible to achieve a reduction in the size and thickness of the product”).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kohara in view of Matsumura, as applied to claim 1, and further in view of Nakajima et al. (US 20200281470), hereinafter Nakajima.
Regarding claim 9 Kohara-Matsumura fail to teach wherein the opening valve is a solenoid type valve or capacitance type valve.
Nakajima teaches blood pressure measurement device that comprises a solenoid valve to control the supply of fluid to the sensing cuff (abstract, fig. 1, and ¶[0199-210], “open/close valve 805 is, for example, a normally-open solenoid valve”).
As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Kohara-Matsumura, such that the opening valve is a solenoid valve, as taught by Nakajima, because Kohara requires a valve to open and close for the delivery of fluids into the cuffs, but fails to provide details on the type of valve, and Nakajima teaches that it can be accomplished using a solenoid valve.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Harrison teaches an air pump operably connected to at least one inflatable cell of the multiple inflatable cells, the air pump configured to increase a pressure within the at least one inflatable cell at least partially in response to receiving a first signal from the controller. US 11633114
Lee teaches a blood pressure measurement unit may have a form of a cuff and includes a circular rubber ring wearable on the wrist or the ankle and a coil spring built into the ring for providing a predetermined flexibility, a tension strength within a predetermined limit, and a reinforced endurance. US 20170014079
Sano teaches a blood pressure measurement device comprising a spacer incorporated into the axial direction end surface of the core. US 20150182133
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN NATHAN ORTEGA whose telephone number is (571)270-7801. The examiner can normally be reached M-F 7:10 am - 5:00 pm.
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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