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 .
Response to Amendment
The Amendment filed February 10, 2026 has been entered. Claims 1-10 remain pending in the application.
Response to Arguments
Applicant’s arguments, see Remarks Page 7, filed February 10, 2026, with respect to the rejection(s) of claim(s) 1-10 under section 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ozawa et al. (JP 2012061104 A – cited in the IDS dated March 10, 2023) (“Ozawa”).
Claim Rejections - 35 USC § 102
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 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 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, 5 and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ozawa et al. (JP 2012061104 A – cited in the IDS dated March 10, 2023) (“Ozawa”).
Regarding claim 1, Ozawa discloses A blood pressure measuring cuff configured to compress a site to be measured to acquire a Korotkoff sound, the blood pressure measuring cuff comprising (Abstract and entire document):
an outer cloth extending in a longitudinal direction in a band shape and configured to surround the site to be measured (See at least FIG 13 and associated paragraphs, “outer cloth 16”);
a pressing fluid bag that is provided to extend along the longitudinal direction on a side of the outer cloth facing the site to be measured, and configured to compress the site to be measured (See at least FIG 13 and associated paragraphs, “air bag 14”);
a sound acquisition fluid bag that is provided between the outer cloth and the pressing fluid bag in a thickness direction perpendicular to the outer cloth, is arranged only in a region smaller than that of the pressing fluid bag in a plane direction along the outer cloth, and acquires a sound from the site to be measured via the pressing fluid bag, the sound including a Korotkoff sound component (See at least FIG 13 and associated paragraphs, “the K sound detecting air bag 50a and the second K sound detecting air bag 50b.”);
a first fluid pipe connected to the pressing fluid bag so as to be capable of flowing a fluid (See at least FIG 13 and associated paragraphs, “The air tube 4 as the first air tube is used for supplying and exhausting air to and from the air bag 14 of the armband 2, and the air tube 5 as the second air tube is a first that detects the K sound signal.”); and
a second fluid pipe connected to the sound acquisition fluid bag so as to be capable of flowing a fluid, separately from the first fluid pipe (See at least FIG 13 and associated paragraphs, “The air tube 4 as the first air tube is used for supplying and exhausting air to and from the air bag 14 of the armband 2, and the air tube 5 as the second air tube is a first that detects the K sound signal.” Pressing pipe 4 and sound pipe 5 are separate).
Regarding claim 2, Ozawa discloses The blood pressure measuring cuff according to claim 1, wherein a first fluid system including the pressing fluid bag and the first fluid pipe, and a second fluid system including the sound acquisition fluid bag and the second fluid pipe are separated from each other so as not to be capable of flowing a fluid (See at least FIG 13 and associated paragraphs, “The air tube 4 as the first air tube is used for supplying and exhausting air to and from the air bag 14 of the armband 2, and the air tube 5 as the second air tube is a first that detects the K sound signal.” Pressing pipe 4 and sound pipe 5 are separate).
Regarding claim 5, Ozawa discloses The blood pressure measuring cuff according to claim 1, wherein the pressing fluid bag includes a pair of sheets facing each other in the thickness direction, and the pair of sheets are annularly joined to each other to form a bag shape, the sound acquisition fluid bag includes a pair of sheets facing each other in the thickness direction, and the pair of sheets are annularly joined to each other to form a bag shape, and the sheet on a side of the pressing fluid bag out of the pair of sheets of the sound acquisition fluid bag is common to the sheet on a side of the sound acquisition fluid bag out of the pair of sheets of the pressing fluid bag (FIG. 13A and associated paragraphs, “The ischemic air bag 14, the first K sound detecting air bag 50a, and the second K sound detecting air bag 50b are formed of, for example, a transparent plastic sheet, for example, a polyurethane sheet.” Sharing a sheet with bag 14).
Regarding claim 9, Ozawa discloses A sphygmomanometer that calculates a blood pressure by a Korotkoff sound generated by a site to be measured, the sphygmomanometer comprising: the blood pressure measuring cuff according to claim 1 (Abstract and entire document and see claim 1);
a pressure device that is connected to the first fluid pipe so as to be capable of flowing a fluid, and supplies a fluid to the pressing fluid bag through the first fluid pipe to pressurize the pressing fluid bag or discharges the fluid from the pressing fluid bag through the first fluid pipe to depressurize the pressing fluid bag (FIG. 13 “drive pump 110”, “In FIG. 14, the control valve 111 and the two drive pumps 110 are operated to supply air to the air bag 14 shown in FIG. 13 to pressurize the upper arm to the time point t1, and then the control valve 111 is operated.”);
a microphone that is connected to the second fluid pipe so as to be capable of flowing a fluid, and detects the sound from the sound acquisition fluid bag through the second fluid pipe (FIG. 13, “microphone 125” through sound pipe 5);
an atmospheric release valve that is connected to the second fluid pipe so as to be capable of flowing a fluid, and is capable of closing the second fluid pipe or opening the second fluid pipe to atmospheric pressure (FIG. 13, “exhaust valve”, connected to second pipe through first pipe, to release pressure to atmosphere,);
a first fluid system including the pressing fluid bag and the first fluid pipe (See at least FIG 13 and associated paragraphs, “The air tube 4 as the first air tube is used for supplying and exhausting air to and from the air bag 14 of the armband 2, and the air tube 5 as the second air tube is a first that detects the K sound signal.”);
a second fluid system including the sound acquisition fluid bag and the second fluid pipe, the first fluid system and the second fluid system being maintained so as not to be capable of flowing a fluid to each other (See at least FIG 13 and associated paragraphs, “The air tube 4 as the first air tube is used for supplying and exhausting air to and from the air bag 14 of the armband 2, and the air tube 5 as the second air tube is a first that detects the K sound signal.” Pressing pipe 4 and sound pipe 5 are separate); and
a processor configured to: cause the pressure device to supply a fluid to the pressing fluid bag through the first fluid pipe to pressurize the pressing fluid bag or discharge the fluid from the pressing fluid bag through the first fluid pipe to depressurize the pressing fluid bag (FIG. 13, “control unit 120”, “cpu 170” and “The control valve 111 and the exhaust valve 112 evacuate and pressurize the air in the blood bag 14 for the ischemia, the first K sound detection air bag 50a, and the second K sound detection air bag 50b in the armband portion 2. This is a decompression means for decompressing the upper arm.”), and
act as a blood pressure calculation unit to open and close the atmosphere release valve as the pressure device pressurizes or depressurizes the pressing fluid bag, and to calculate a blood pressure of the site to be measured based on an output of the microphone according to the Korotkoff sound component included in the sound from the sound acquisition fluid bag (FIG. 13, “The control valve 111 and the exhaust valve 112 evacuate and pressurize the air in the blood bag 14 for the ischemia, the first K sound detection air bag 50a, and the second K sound detection air bag 50b in the armband portion 2. This is a decompression means for decompressing the upper arm.” And “The data memory 154 stores a program for performing a series of operations necessary for blood pressure measurement, and the control unit 120 performs a blood pressure measurement operation according to this program.” And “Thus, the control unit 120 can recognize the K sound, recognize the pulse wave, recognize the battery voltage, and synthesize voice guidance.”).
Regarding claim 10, Ozawa discloses The sphygmomanometer according to claim 9, wherein acting as the blood pressure calculation unit, the processor closes the atmosphere release valve to seal the second fluid system before the pressure device starts pressurizing the pressing fluid bag after the blood pressure measuring cuff is worn on the site to be measured (FIG. 13, “The air in air bag 50b for detecting K sound 2 is extracted. As described above, during the blood pressure measurement, when the upper arm is pressurized and depressurized, an operating sound is generated from the control valve 111. Therefore, in order to prevent the operating sound from being transmitted to the condenser microphone 125 through the air tube 4, the resistance tube 129A is provided. Is provided.”).
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Ozawa.
Regarding claim 6, Ozawa discloses The blood pressure measuring cuff according to claim 1, Ozawa fails to explicitly disclose wherein the site to be measured is an upper arm, a dimension of the pressing fluid bag in the longitudinal direction is set within a range of 167 mm to 380 mm, and a dimension of the pressing fluid bag in a width direction perpendicular to the longitudinal direction in a plane along the outer cloth is set within a range of 90 mm to 180 mm, and a dimension of the sound acquisition fluid bag in the longitudinal direction is set within a range of 41.8 mm to 380 mm, and a dimension of the sound acquisition fluid bag in the width direction is set within a range of 45 mm to 180 mm (FIG. 1, 13, 19, sized for upper arm).
It would have been obvious to one of ordinary skill in the art, through routine optimization, to determine the optimal sizing of the fluid bags. Since the cuffs/fluid bags are taught to fit the measurement site, it is within reason to expect the cuffs to be sized appropriately. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Since applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the fluid bags are this sizing, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 7, Ozawa discloses The blood pressure measuring cuff according to claim 1, Ozawa fails to explicitly disclose wherein the site to be measured is a wrist, a dimension of the pressing fluid bag in the longitudinal direction is set to 140 mm, and a dimension of the pressing fluid bag in a width direction perpendicular to the longitudinal direction in a plane along the outer cloth is set to 60 mm, and a dimension of the sound acquisition fluid bag in the longitudinal direction is set within a range of 35 mm to 140 mm, and a dimension of the sound acquisition fluid bag in the width direction is set within a range of 30 mm to 60 mm (FIG. 1, 13, 19, sized for upper arm/additionally sized for wrist).
It would have been obvious to one of ordinary skill in the art, through routine optimization, to determine the optimal sizing of the fluid bags. Since the cuffs/fluid bags are taught to fit the measurement site, it is within reason to expect the cuffs to be sized appropriately. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Since applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the fluid bags are this sizing, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 8, Ozawa discloses The blood pressure measuring cuff according to claim 6, Ozawa fails to explicitly disclose wherein the dimension of the sound acquisition fluid bag in the longitudinal direction is set to 1/2 of the dimension of the pressing fluid bag in the longitudinal direction, and the dimension of the sound acquisition fluid bag in the width direction is set to be identical with the dimension of the pressing fluid bag in the width direction (FIG. 1, 13, 19).
It would have been obvious to one of ordinary skill in the art, through routine optimization, to determine the optimal sizing of the fluid bags. Since the cuffs/fluid bags are taught to fit the measurement site, it is within reason to expect the cuffs to be sized appropriately. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Since applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the fluid bags are this sizing, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Ozawa in view of Souma (US 2010/0106031 A1) (“Souma”).
Regarding claim 3, Ozawa discloses The blood pressure measuring cuff according to claim 1, Ozawa further discloses wherein the sound acquisition fluid bag includes a pair of sheets facing each other in the thickness direction, and the pair of sheets are joined to each other to form a bag shape (FIG. 13A and associated paragraphs, “The ischemic air bag 14, the first K sound detecting air bag 50a, and the second K sound detecting air bag 50b are formed of, for example, a transparent plastic sheet, for example, a polyurethane sheet.”), and
Ozawa fails to disclose a spacer that prevents the pair of sheets from coming into close contact with each other is provided in a gap between the pair of sheets facing each other.
However, in the same field of endeavor, Souma teaches a spacer that prevents the pair of sheets from coming into close contact with each other is provided in a gap between the pair of sheets facing each other (As shown in FIG. 2B, the pairs of sheets are joined to form the air bags and a spacer is provided in each airbag see [0071]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the cuff as taught by Ozawa to include a spacer that prevents the pair of sheets from coming into close contact with each other is provided in a gap between the pair of sheets facing each other as taught by Souma to maintain thickness ([0071], “The second spacer member 114 prevents adhesion of the first and second sheet members after attachment, thereby maintaining the air layer having the same thickness as shown in 2B of FIG. 2.”).
Regarding claim 4, Ozawa as modified discloses The blood pressure measuring cuff according to claim 3, Ozawa fails to disclose wherein the spacer includes a protrusion integrally formed on the sheets.
However, in the same field of endeavor, Souma teaches wherein the spacer includes a protrusion integrally formed on the sheets (As shown in FIG. 2B, the pairs of sheets are joined to form the air bags and a spacer is provided in each airbag see [0071]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the cuff as taught by Ozawa to include wherein the spacer includes a protrusion integrally formed on the sheets as taught by Souma to maintain thickness ([0071], “The second spacer member 114 prevents adhesion of the first and second sheet members after attachment, thereby maintaining the air layer having the same thickness as shown in 2B of FIG. 2.”).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.A.T./Examiner, Art Unit 3791
/TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791