Office Action 2: Final Rejection (2024-11-29)
Rejection types: 101 - Patent-Eligible Subject Matter, 112 - Written Description/Enablement

CLAIMS:
Amendments to the Claims:

The following listing of claims will replace all prior versions, and listings, of claims in the application:

1\. (Currently Amended) A sphygmomanometer provided with an air system for blood pressure measurement and capable of performing air leakage testing on the air system, the air system comprising at least a cuff configured to surround a to-be-measured part, a pump connected to the cuff via a first fluid pipe, and a valve connected to the cuff via a second fluid pipe,
the sphygmomanometer comprising:
a processor;
a memory; and
a display, wherein the processor is configured to act as:
a main control unit to perform main control to make a firsttransition from a power-off state to a standby state in response to a power-on operation, to perform blood pressure measurement by driving the pump to feed an air to the cuff through the first fluid pipe to pressurize the cuff or driving the valve to exhaust the air from the cuff through the second fluid pipe to depressurize the cuff in response to a measurement start operation in the standby state, to make a second transition to the standby state after the blood pressure measurement, and to make a third transition to the power-off state in response to a power-off operation in the standby state;
an air leakage testing unit to perform, during the blood pressure measurement to the second transition, air leakage testing on the air system to obtain an air leakage testing result of the air leakage testing, and to cause the memory to store the air leakage testing result;and

a notification control unit to perform notification control to control display contents on the display based on the air leakage testing result stored in the memory, wherein the air leakage testing result includes at least three air leakage levels of a first air leakage level as an acceptable level indicating that an air leakage amount of the air system is smaller than a predetermined first reference value, a third air leakage level as a failure level indicating that the air leakage amount of the air system is larger than a second reference value set greater than the first reference value, and a second air leakage level indicating that the air leakage amount of the air system corresponds to a value between the first reference value and the second reference value,
the notification control includes:
when the air leakage testing result is the second air leakage level,
to make displaying, on the display, the air leakage testing result in a first display mode during the first transition,
to make, in the standby state, displaying, on the display, that the blood pressure measurement is enabled without displaying the air leakage testing result or with displaying

the air leakage testing result in a second display mode more inconspicuous than the first display mode,to make not displaying the air leakage testing result during the blood pressure measurement and the second transition, and
to make displaying, on the display, the air leakage testing result in a first display mode during the third transition.
2\. (Currently Amended) The sphygmomanometer according to claim 1, wherein when the air leakage testing result is the second air leakage level, the notification control includes, during the first or third transition, to stop the displaying the air leakage testing result in the first display mode, when a display stop operation is performed or a predetermined period elapses after having started to make the displaying the air leakage testing result in the first display mode.
3\. (Currently Amended) The sphygmomanometer according to claim 1, wherein
the notification control

 includes:to make not displayingthe air leakage testing result, during the first, second and third transitions,when the air leakage testing result is the first air leakage level, and
 to make displaying, on the display , an indication that the blood pressure measurement is disabled, during the first, second and third transitions, when the air leakage testing result is the third air leakage level.
4\. (Currently Amended) The sphygmomanometer according to claim 1, wherein
the processor acting as the air leakage testing unit causes, each time the air leakage testing is performed on the air system, the memory to store the air leakage testing result of the air leakage testing.
5\. (Currently Amended) The sphygmomanometer according to The sphygmomanometer according to
 wherein the cuff comprises a cuff unit having a cylindrical shape,the cuff unit includes an outer peripheral member having a cylindrical shape, a winding air bag annularly disposed along an inner circumferential surface of the outer peripheral member, a curler formed of a flexible plate material curved and disposed along an inner circumferential surface of the winding air bag, the curler being reduced in diameter when the winding air bag is pressurized to expand radially inward, and a measurement air bag disposed along an inner circumferential surface of the curler, the measurement air bag being pressurized for the blood pressure measurement to compress an upper arm as the to-be- measured part, and

the processor acting as the air leakage testing unit obtains the air leakage testing result based on a pressure difference between a pressure in the winding air bag and a pressure in the measurement air bag at a time when a blood pressure calculation is completed in a depressurization process for the blood pressure measurement.

6\. (Currently Amended) The sphygmomanometer according to claim 1, wherein the displaying the air leakage testing result in the first display mode is made as a displayingof a message notifying a replacement of the cuff, and
the displaying the air leakage testing result in the second display mode is made as a displayingof an icon corresponding to the air leakage testing result.

7\. (Currently Amended) The sphygmomanometer according to claim 1, wherein the displaying the air leakage testing result in the first display mode is made as a displayingwhere an icon corresponding to the air leakage testing result blinks, and
the displaying the air leakage testing result in the second display mode is made as a displayingwhere the icon is kept lit.

8\. (New) The sphygmomanometer according to claim 1, wherein the processor acting as the main control unit is further configured to perform to make, in response to a maintenance mode transition operation, a fourth transition from the power- off state to a maintenance mode where the measurement start operation is disabled and a maintenance of the sphygmomanometer is to be performed, and to make, in response to a setting mode transition operation, a fifth transition from the standby state to a setting mode where the measurement start operation is disabled and a setting for the sphygmomanometer is to be performed,
the notification control includes:
to make not displaying the air leakage testing result, during the fourth and fifth

transitions, when the air leakage testing result is the first air leakage level,to make displaying, on the display, the air leakage testing result in the first display mode, during the fourth and fifth transitions, when the air leakage testing result is the second air leakage level, and
to make displaying, on the display, the indication that the blood pressure measurement is disabled, during the fourth and fifth transitions, when the air leakage testing result is the third air leakage level.

OFFICE ACTION:
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
Claims 1-8 are currently pending. Claims 1-7 have been amended. Claim 8 has been added. The amendments to claims 1 and 2 have rendered the claim objections, the amendments to claim 1 have rendered the 35 U.S.C. 112(a) rejection, and the amendments to claim 1, 2, 4, and 6 have rendered the 35 U.S.C. 112(b) rejections set forth in the Non-Final Office Action moot. The amendments have rendered the 35 U.S.C. 112(f) claim interpretations moot.
Claim Objections
Claims 6 and 7 are objected to because of the following informalities:
“the displaying” in line 2 of claim 6 should read as “the displaying of”
“mode is made as a displaying of a message notifying” in lines 2-3 of claim 6 should read as “mode is displaying a message to notify”
“the displaying” in line 2 of claim 7 should read as “the displaying of”
“mode is made as a displaying where” in lines 2-3 of claim 7 should read as “mode is displaying”
“the displaying” in line 4 of claim 7 should read as “the displaying of”
“mode is made as a displaying” in lines 4-5 of claim 7 should read as “mode is displaying”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA  35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA  35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 2-8 are further rejected due to their dependency to claim 1.
Claim 1 recites “an air leakage testing unit to perform, during the blood pressure measurement to the second transition, air leakage testing on the air system” in lines 19-21. However, the disclosure does not provide support for this limitation. Fig. 4 shows that blood pressure is first measured (steps S1-S13) then the air leakage testing is performed (steps S14-S19) rather than the air leakage testing happening during the blood pressure measurement.
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 1-3 and 8 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. Claims 4-7 are further rejected due to their dependency to claim 1.
Claims 1-3 and 8 recite “to make displaying” and/or “to make not displaying” throughout the claims. However, it is unclear as to what it means for the notification control to “make displaying.” Clarification is requested.
The term “more inconspicuous” in claim 1 is a relative term which renders the claim indefinite. The term “more inconspicuous” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what it means for the display mode to be “more inconspicuous” or “inconspicuous.” Clarification is requested.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 5 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism.  See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 5 recites “the measurement air bag…to compress an upper arm as the to-be-measured part” in lines 9-11, which is claiming a human organism. Claim 1 recites that the “cuff is configured to surround a to-be-measured part” in lines 3-4. To follow the claim language of claim 1, Examiner suggests to amend lines 9-11 of claim 5 to read as “the measurement bag…configured to compress an upper arm as the to-be-measured part.”
Response to Arguments
Applicant’s arguments with respect to the 35 U.S.C. 101 rejection have been fully considered and are persuasive. The Examiner has performed a new 101 analysis on the amended claim 1. According to STEP 1 of the 101 analysis, the claim is directed to a machine, which is one of the statutory categories of invention. In STEP 2A, PRONG ONE, the claim is analyzed to determine whether it is directed to any judicial exception. The steps of the “to perform main control a first transition from a power-off state to a standby state in response to a power-on operation, to make a second transition to the standby state after the blood pressure measurement, and to make a third transition to the power-off state in response to a power-off operation in the standby state; and to perform, during the blood pressure measurement to the second transition, air leakage testing on the air system to obtain an air leakage testing result of the air leakage testing, and to cause the memory to store the air leaking testing result are steps that could be performed in the human mind or by hand. Thus, the claim is drawn to a mental process, which is an abstract idea. It is noted that these steps are performed by the main control unit and the air leakage testing unit. According to 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the abstract idea into a practical application. In STEP 2A, PRONG TWO, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. Claim 1 recites “to perform notification control to control display contents on the display based on the air leakage testing result stored in the memory… when the air leakage testing result is the second air leakage level,to make displaying, on the display, the air leakage testing result in a first display mode during the first transition,to make, in the standby state, displaying, on the display, that the blood pressure measurement is enabled without displaying the air leakage testing result or with displayingthe air leakage testing result in a second display mode more inconspicuous than the first display mode,to make not displaying the air leakage testing result during the blood pressure measurement and the second transition, andto make displaying, on the display, the air leakage testing result in a first display mode during the third transition,” which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The display of the air leakage testing result does not provide an improvement to the technological field, the machine does not effect a particular treatment or effect a particular change based on the displayed air leakage testing result, nor does the machine use a particular machine to perform the abstract idea. In STEP 2B, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure the claim amounts to significantly more than the exception. Besides the abstract idea, the claim recites the additional steps of to perform blood pressure measurement by driving the p ump to feed an air to the cuff through the first fluid pipe to pressurize the cuff or driving the valve to exhaust the hair from the cuff through the second fluid pipe to depressurize the cuff in response to a measurement start operation in the standby state, which is insignificant pre-solution activity of data gathering. The structural elements of the claim 1 were analyzed under the Berkheimer analysis as the structures are additional elements. Although Tsutsumi et al. ‘245 (US Pub No. 2019/0365245) teaches that the claimed cuff, pump, valve, processor, memory, and display are publically known (Fig. 1 and [0030]), there was no reference that teaches that these structures in combination with the air leakage testing unit is WURC. As such, the 101 analysis ends here and no 101 rejection was made.
Applicant’s arguments with respect to the 35 U.S.C. 102(a)(1) and 35 U.S.C. 103 rejections have been fully considered and are persuasive.  The 35 U.S.C. 102(a)(1) rejection of claim 1 has been withdrawn. Although it was found that Mori et al. ‘950 teaches the claimed structure, the main control unit and the steps performed by the main control unit, and the notification control unit, the steps performed by the notification control unit, and the air leakage testing unit, it was found that Mori et al. ‘950 does not teach the air leakage testing unit to perform the claimed steps during the blood pressure measurement to the second transition. An updated search and consideration was performed. Although the Examiner has found art that teaches performing an air leakage test in sphygmomanometers (such as Sawanoi et al. ‘221 (US Pub No. 2011/0282221), there was no art that was found to teach performing the air leakage test during the blood pressure measurement to the second transition. As such, the art rejection has been withdrawn.
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.

APPLICANT REBUTTAL: REMARKS
Claims 1-8 are pending in this application. By this Amendment, claims 1-7 are amended, and claim 8 is new. Support for the amendments to the claims may be found throughout the original application, for example, in [0012], [0015]-[0017], [0020], [0028]- [0029], [0032], [0038]-[0039], [0043]-[0053], [0059], [0061], [0063], [0064]-[0072], [0083]- [0084], and [0087]-[0088] and in Figs. 1, 3, 4, and 9-13. No new matter is added.
In view of the foregoing amendments and following remarks, reconsideration and allowance are respectfully requested.
I.    Interview
The courtesies extended to Applicant's representative by Examiner Tu during the
telephone interview held September 18, 2024 are appreciated. The reasons presented during the interview as warranting favorable action are incorporated into the remarks below, which constitute Applicant's record of the interview. II.   Claim Objections
The Office Action objects to claims 1 and 2 for an informality. Claims 1 and 2 are
amended. Specifically, in the amended Claims 1, 2, terms of the "first transition", the "second transition" and the "third transition" are introduced, and the "notification control" is specified in different cases by using these terms. Accordingly, as tentatively agreed during the interview, reconsideration and withdrawal of the objection are respectfully requested. III. Rejection Under 35 U.S.C. §101
The Office Action rejects claims 1-7 under 35 U.S.C. § 101 for allegedly being directed to non-statutory subject matter.
Claim 5 is rejected under section 101. Claim 1 is amended to recite
"a cuff configured to surround a to-be-measured part"
and the limitation is removed from claim 5.
Claim 1 is also amended to recite
"the air system comprising at least a cuff configured to su
rr
ound a to-be-measured part, a pump connected to the cuff via a first fluid pipe, and a valve connected to the cuff via a second fluid pipe."
The cuff, pump, and valve are substantive elements and not an abstract idea.
In addition, by reciting "to perform blood pressure measurement
by driving the pump to feed an air to the cuff through the first fluid pipe to pressurize the cuff or driving the valve to exhaust the air from the cuff through the second fluid pipe to depressurize the cuff,"
the alleged abstract idea is integrated into a practical application.
Further, the alleged abstract idea is integrated into a practical application by the
recitation of
"the processor is configured to act as:"
"an air leakage testing unit ... to perform,
during the blood pressure measurement to the second transition,
air leakage testing on the air system"
In addition, the notification control is amended to include "when the air leakage
testing result is..." thereby integrating the alleged abstract idea into a practical application.
Accordingly, as tentatively agreed during the interview, reconsideration and withdrawal of the rejection are requested. IV.    Rejection Under 35 U.S.C. §112(a)
The Office Action rejects claim 1 as failing to comply with the written description requirement under 35 U.S.C. § 112(a).
By this Amendment, claim 1 is amended to obviate the rejection and instead recite "in a second display mode more inconspicuous than the first display mode."
This is described in paragraph [0071] and shown in Figs. 15, 16. Another example of "in a second display mode more inconspicuous than the first display mode" is described in a paragraph [0076] and shown in Figs. 17A, 17C. In this example, as discussed during the interview, because ICl is blinking in Fig. 17A, ICl of Fig. 17C is more inconspicuous.
Accordingly, "inconspicuous" can be understood by a person skilled in the art based on the specification.
Accordingly, as tentatively agreed during the interview, reconsideration and withdrawal of the rejection are requested.
V.
Rejection Under 35 U.S.C. §112(b)
The Office Action rejects claims 1, 2, 4, and 6 as being indefinite under 35 U.S.C. § 112(b). By this Amendment, the claims are amended to obviate the rejection.
With respect to "the transition from the standby state to the power-off state," claim 1 is amended to recite ""a main control unit ...", "a
fir
st
transition from a power-off state to a standby state in response to a power-on operation", "a
second
transition to the standby state after the blood pressure measurement", and "a
third
transition to the power-off state in response to a power-off operation in the standby state."
With respect to "degree of enhancement," claim 1 is instead amended to recite "in a second display mode lower in degree of enhancement than the first display mode",
"in
a
second display mode more inconspicuous than the first display mode."
With respect to the indefiniteness rejection of claim 2, claim 2 is amended to recite
"the first or third
transition."
With respect to the indefiniteness rejection of claim 4, claim 1 is amended to recite "an air leakage testing unit to perform,
during the blood pressure measurement to the second transition
,
air leakage testing on the air system." In conformity with this, the second paragraph (lines 2-3) of original Claim 4 is removed. Claim 4 now recites the air leakage testing on the air system is performed
during the blood pressure measurement to the second transition.
With respect to the indefiniteness rejection of claim 6, "a message indicating a measure against the air leakage testing result" is changed into "a message
notifyin
g a
replacement of the cuff".
An example of the "message notifying a replacement of the cuff" is described in a paragraph [0068] and shown in Fig. 14.
Accordingly, as tentatively agreed during the interview, reconsideration and withdrawal of the rejection are requested. VI.   Claim Interpretation Under 35 U.S.C. §112(f)
The Office Action interprets claim elements as means-plus-function language under 35 U.S.C. §112(0.
While Applicant does not necessarily agree with this interpretation, by this Amendment, claims 1-7 amended to not invoke § 112(0.
Claim 1 recites a processor, wherein the processor is configured to act as... "a main control unit to perform ...", "an air leakage testing unit to perform ...", and "a notification control unit to perform ..." are recited.
Claims 4, 5, and 8 are similarly amended.
In addition, "a storage unit" and "a display device" are removed and specified as "a memory" and "a display", respectively.
Accordingly, as tentatively agreed during the interview, reconsideration and withdrawal of the means-plus-function interpretation are respectfully requested. VII.  Rejections Under 35 U.S.C. §102 and §103
The Office Action rejects:
"  claims 1 and 3-6 under 35 U.S.C. §102(a)(1) over U.S. Patent Application Publication
No. 2019/0104950 (" Mori");
"  claim 2 under 35 U.S.C. § 103 over Mori in view of U.S. Patent Application
Publication No. 2010/0331709 ("Matsumura"); and
"  claim 2 under 35 U.S.C. § 103 over Mori in view of U.S. Patent Application
Publication No. 2008/0319329 ("Tseng"). Applicant respectfully traverses the rejections.
By this Amendment, claim 1 is amended to recite: "the air leakage testing result
includes at least three air leakage levels..." and the notification control includes: when the air leakage testing result is..." As tentatively agreed during the interview, the asserted references do not teach or suggest at least this claim feature.
With respect to original claim 3 (portions of which are incorporated into proposed claim 1), the Office Action asserts that Mori teaches air leakage testing result includes three leakage levels.
Mori teaches:
" The first air leakage level indicates that an air leakage amount in the air system is smaller
than a reference value (an "unacceptable" leakage);
"  The third air leakage level indicates that the air leakage amount is larger than a second
reference value greater than the first(an "acceptable" leakage); and
"  The second air leakage level indicates that the air leakage amount corresponds to a value
between the first and second reference values (an "unacceptable" leakage). In contrast, in proposed claim 1 recites:
"  The first air leakage level is an
acceptable level-
indicating that an air leakage amount is
smaller than a predetermined first reference value;
"  The third air leakage level is a
failure level,
indicating that the air leakage amount is
larger than a second reference value set greater than the first reference value; and
"  The second air leakage level indicates that the air leakage amount corresponds to a value
between the first reference value and second reference value.
Accordingly, Mori teaches only one acceptable leakage and two unacceptable
leakages. In contrast, in proposed claim 1, the first air leakage level is "acceptable", and the third air leakage level is "unacceptable". The second air leakage level corresponds to a level between the first air leakage level and the third air leakage level, that is, an initial stage where
air has just started to leak from the air systems. See paragraph [0059] of the present application.
Claim 1 further recites that the "notification control" is specified for different cases (i.e., during the first transition, in the standby state, during the blood pressure measurement and the second transition, and during the third transition) when the air leakage testing result is the second air leakage level. Mori et al. '950 (and the other cited documents) neither teaches nor suggests the "notification control" specified in the amended Claim 1.
For at least the foregoing reasons, the asserted references do not anticipate, and would not have rendered obvious claim 1. Claims 2-7 depend from claim 1 and, thus, also are not anticipated by and would not have been rendered obvious by the asserted references.
Accordingly, reconsideration and withdrawal of the rejection are respectfully requested. VIII. New Claim
By this Amendment, new claim 8 is presented. New claim 8 depends from claim 1 and, thus, distinguishes over the applied references for at least the reasons discussed above with respect to claim 1, as well as for the additional features that it recites. Prompt examination and allowance of new claim 8 are respectfully requested.
IX.   Conclusion

NEXT OFFICE ACTION: EXAMINER'S AMENDMENT
An examiner’s amendment to the record appears below. Should the changes and/or additions be unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the payment of the issue fee.
Authorization for this examiner’s amendment was given in an interview with Mr. Luke Hibbeler on 26 March 2025.
The application has been amended as follows:
Claims 6 and 7 have been cancelled.
Claim 8:
“the indication” in line 15 should read as “an indication”
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance: The prior art of record fails to disclose, teach, or fairly suggest a sphygmomanometer provided with an air system for blood pressure measurement and capable of performing air leakage testing on the air system as claimed. The prior art that comes closest to teaching the limitations is Mori et al. ‘950, which teaches the claimed structure, the main control unit and the steps performed by the main control unit, and the notification control unit, the steps performed by the notification control unit, and the air leakage testing unit. However, it was found that Mori et al. ‘950 does not teach the air leakage testing unit to perform the claimed steps after the blood pressure measurement and before the second transition. An updated search and consideration was performed. Although the Examiner has found art that teaches performing an air leakage test in sphygmomanometers (such as Sawanoi et al. ‘221 (US Pub No. 2011/0282221), there was no art that was found to teach performing the air leakage test after the blood pressure measurement and before the second transition. It would require an unreasonable combination of references that would not suffice for a realistic case of obviousness.
It is noted that the Examiner and Mr. Hibbeler have discussed potential amendments for claim 1, in particular, lines 32-51. However, upon further consideration, Mr. Hibbeler and the Examiner have agreed that the language lines 32-51 do not need to be amended as lines 32-51 state what the processor acting as the notification control unit displays.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee.  Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion

CITED REFERENCE SUMMARIES: Ref US20190365245A1: Claims:
A blood pressure measurement device with a sound detection function comprising: a blood pressure measurement unit configured to measure a blood pressure of a subject; a sound detection unit configured to detect a body sound of the subject during blood pressure measurement by the blood pressure measurement unit; and processing circuitry coupled to a memory, the processing circuitry configured to record the blood pressure measured by the blood pressure measurement unit and the body sound detected by the sound detection unit in association with each other by time information, wherein the sound detection unit includes a microphone configured to detect sounds, the microphone is configured to detect the body sound including at least one of snoring, coughing, sneezing, hiccups, sleep talking and teeth grinding from a mouth of the subject, and the body sound affecting a blood pressure value to be measured, and the blood pressure measurement unit is configured to perform, in a blood pressure measurement mode, a plurality of blood pressure measurements at time intervals, and is configured to start recording the body sound by the microphone before a start of each of the blood pressure measurements when measuring the blood pressure in the blood pressure measurement mode.
a blood pressure measurement unit configured to measure a blood pressure of a subject;
a sound detection unit configured to detect a body sound of the subject during blood pressure measurement by the blood pressure measurement unit; and
processing circuitry coupled to a memory, the processing circuitry configured to record the blood pressure measured by the blood pressure measurement unit and the body sound detected by the sound detection unit in association with each other by time information,
wherein the sound detection unit includes a microphone configured to detect sounds,
the microphone is configured to detect the body sound including at least one of snoring, coughing, sneezing, hiccups, sleep talking and teeth grinding from a mouth of the subject, and the body sound affecting a blood pressure value to be measured, and
the blood pressure measurement unit is configured to perform, in a blood pressure measurement mode, a plurality of blood pressure measurements at time intervals, and is configured to start recording the body sound by the microphone before a start of each of the blood pressure measurements when measuring the blood pressure in the blood pressure measurement mode.
The blood pressure measurement device with a sound detection function according to claim 1 , wherein the blood pressure measurement unit includes a cuff configured to be attached to the subject, and the microphone is configured to be rotatably attached to the cuff via a rotation adjustment mechanism.
the microphone is configured to be rotatably attached to the cuff via a rotation adjustment mechanism.
The blood pressure measurement device with a sound detection function according to claim 1 , further comprising: a cuff integral with the blood pressure measurement device, wherein the microphone is provided on the blood pressure measurement device or the cuff so as to be directed to the mouth of the subject when the blood pressure measurement device is attached to an upper arm of the subject.
a cuff integral with the blood pressure measurement device,
wherein the microphone is provided on the blood pressure measurement device or the cuff so as to be directed to the mouth of the subject when the blood pressure measurement device is attached to an upper arm of the subject.
A blood pressure measurement method using a sound detection function comprising: measuring a blood pressure of a subject; detecting a body sound of the subject, the body sound including at least one of snoring, coughing, sneezing, hiccups, sleep talking and teeth grinding from a mouth, and affecting a blood pressure value to be measured, the detecting the body sound being started before a start of the blood pressure measurement; and recording the body sound detected in the detecting the body sound and the blood pressure measured in the measuring the blood pressure in association with each other by time information.
measuring a blood pressure of a subject;
detecting a body sound of the subject, the body sound including at least one of snoring, coughing, sneezing, hiccups, sleep talking and teeth grinding from a mouth, and affecting a blood pressure value to be measured, the detecting the body sound being started before a start of the blood pressure measurement; and
recording the body sound detected in the detecting the body sound and the blood pressure measured in the measuring the blood pressure in association with each other by time information.
Ref US20110282221A1: Claims:
A management device that performs management of an electronic sphygmomanometer that detects an inner pressure change of an air bladder with a sensor and calculates a blood pressure value based on an output value of the sensor, the management device comprising: a connecting unit that connects to the electronic sphygmomanometer; a test unit that tests an equipment performance of the electronic sphygmomanometer while being connected to the electronic sphygmomanometer with the connecting unit; a calibration unit that calibrates the equipment performance of the electronic sphygmomanometer according to a test result of the test unit; and a first output unit that outputs the test result of the test unit or presence or absence of calibration in the calibration unit.
a connecting unit that connects to the electronic sphygmomanometer;
a test unit that tests an equipment performance of the electronic sphygmomanometer while being connected to the electronic sphygmomanometer with the connecting unit;
a calibration unit that calibrates the equipment performance of the electronic sphygmomanometer according to a test result of the test unit; and
a first output unit that outputs the test result of the test unit or presence or absence of calibration in the calibration unit.
The management device according to claim 1 , wherein the test unit comprises: a first test unit that performs an operation that tests for air leakage inside the electronic sphygmomanometer; and a second test unit that performs an operation that tests for accuracy of the output value of the sensor while being connected to the electronic sphygmomanometer with the connecting unit, and wherein the calibration unit calibrates the output value of the sensor in the electronic sphygmomanometer according to the test result of the second test unit.
wherein the test unit comprises: a first test unit that performs an operation that tests for air leakage inside the electronic sphygmomanometer; and a second test unit that performs an operation that tests for accuracy of the output value of the sensor while being connected to the electronic sphygmomanometer with the connecting unit, and
a first test unit that performs an operation that tests for air leakage inside the electronic sphygmomanometer; and
a second test unit that performs an operation that tests for accuracy of the output value of the sensor while being connected to the electronic sphygmomanometer with the connecting unit, and
wherein the calibration unit calibrates the output value of the sensor in the electronic sphygmomanometer according to the test result of the second test unit.
The management device according to claim 2 , wherein the connecting unit comprises a communication unit that communicates with the electronic sphygmomanometer and a tube connecting unit that connects an air tube to configure a closed space with an interior of the electronic sphygmomanometer, wherein the first test unit comprises an air leakage determination unit that applies a predetermined pressure with respect to the closed space while being connected to the interior of the electronic sphygmomanometer with the tube connecting unit, and determines presence or absence of air leakage inside the electronic sphygmomanometer based on a temporal change of the predetermined pressure, and wherein the first output unit notifies on a screen when determined that air leakage is present inside the electronic sphygmomanometer by the air leakage determination unit.
wherein the connecting unit comprises a communication unit that communicates with the electronic sphygmomanometer and a tube connecting unit that connects an air tube to configure a closed space with an interior of the electronic sphygmomanometer,
wherein the first test unit comprises an air leakage determination unit that applies a predetermined pressure with respect to the closed space while being connected to the interior of the electronic sphygmomanometer with the tube connecting unit, and determines presence or absence of air leakage inside the electronic sphygmomanometer based on a temporal change of the predetermined pressure, and
wherein the first output unit notifies on a screen when determined that air leakage is present inside the electronic sphygmomanometer by the air leakage determination unit.
The management device according to claim 2 , wherein the connecting unit comprises a communication unit that communicates with the electronic sphygmomanometer and a tube connecting unit that connects an air tube to configure a closed space with an interior of the electronic sphygmomanometer, wherein the second test unit comprises: a measurement control unit that applies a predetermined pressure with respect to the closed space while being connected to the interior of the electronic sphygmomanometer with the tube connecting unit, and outputs a control signal that measures an inner pressure of the closed space with the sensor with respect to the electronic sphygmomanometer; an acquiring unit that acquires the inner pressure measured with the sensor from the electronic sphygmomanometer; and a pressure determination unit that determines whether or not a difference between the predetermined pressure and the inner pressure is within a tolerable range, and wherein the calibration unit comprises a calibration control unit that outputs a control signal that changes a relationship between the sensor signal from the sensor and the output value of the sensor with respect to the electronic sphygmomanometer when determined that the difference is outside the tolerable range by the pressure determination unit.
wherein the second test unit comprises: a measurement control unit that applies a predetermined pressure with respect to the closed space while being connected to the interior of the electronic sphygmomanometer with the tube connecting unit, and outputs a control signal that measures an inner pressure of the closed space with the sensor with respect to the electronic sphygmomanometer; an acquiring unit that acquires the inner pressure measured with the sensor from the electronic sphygmomanometer; and a pressure determination unit that determines whether or not a difference between the predetermined pressure and the inner pressure is within a tolerable range, and
a measurement control unit that applies a predetermined pressure with respect to the closed space while being connected to the interior of the electronic sphygmomanometer with the tube connecting unit, and outputs a control signal that measures an inner pressure of the closed space with the sensor with respect to the electronic sphygmomanometer;
an acquiring unit that acquires the inner pressure measured with the sensor from the electronic sphygmomanometer; and
a pressure determination unit that determines whether or not a difference between the predetermined pressure and the inner pressure is within a tolerable range, and
wherein the calibration unit comprises a calibration control unit that outputs a control signal that changes a relationship between the sensor signal from the sensor and the output value of the sensor with respect to the electronic sphygmomanometer when determined that the difference is outside the tolerable range by the pressure determination unit.
The management device according to claim 4 , wherein when determined that the difference is outside the range even after the calibration is carried out a predetermined number of times by the calibration unit, the first output unit displays on a screen that the sensor has a defect.
The management device according to claim 1 , wherein the electronic sphygmomanometer comprises a mode that carries out a measurement and a mode that carries out a test for operation modes, and wherein a second output unit that outputs a control signal that shifts the operation mode to the mode that carries out the test with respect to the electronic sphygmomanometer when detected as being connected to the electronic sphygmomanometer with the connecting unit is further arranged.
wherein the electronic sphygmomanometer comprises a mode that carries out a measurement and a mode that carries out a test for operation modes, and
wherein a second output unit that outputs a control signal that shifts the operation mode to the mode that carries out the test with respect to the electronic sphygmomanometer when detected as being connected to the electronic sphygmomanometer with the connecting unit is further arranged.
The management device according to claim 1 , further comprising a first storage unit that stores information related to when the calibration is carried out by the calibration unit.
The management device according to claim 1 , further comprising: a communication unit that communicates with another device, wherein the first output unit transmits the test result of the test unit or presence or absence of calibration in the calibration unit to the other device with the communication unit along with information that specifies the electronic sphygmomanometer.
a communication unit that communicates with another device,
wherein the first output unit transmits the test result of the test unit or presence or absence of calibration in the calibration unit to the other device with the communication unit along with information that specifies the electronic sphygmomanometer.
The management device according to claim 1 , further comprising a second storage unit that stores the test result of the test unit along with information that specifies the electronic sphygmomanometer.
A management system comprising: an electronic sphygmomanometer that detects an inner pressure change of an air bladder with a sensor and calculates a blood pressure value based on an output value of the sensor; and a management device, connected to the electronic sphygmomanometer, that manages the electronic sphygmomanometer, wherein the management device comprises: a test unit that carries out an operation that tests an equipment performance of the electronic sphygmomanometer while being connected to the electronic sphygmomanometer; a calibration unit that calibrates the equipment performance of the electronic sphygmomanometer according to a test result of the test unit; and an output unit that outputs the test result of the test unit or presence or absence of calibration in the calibration unit, and wherein the electronic sphygmomanometer comprises: a drive unit that operates the electronic sphygmomanometer according to a control signal output in the test unit; a measurement unit that transmits a signal corresponding to the output value of the sensor to the management device with the operation; and a changing unit that changes a relationship between the sensor signal from the sensor and the output value of the sensor according to a control signal output in the calibration unit.
an electronic sphygmomanometer that detects an inner pressure change of an air bladder with a sensor and calculates a blood pressure value based on an output value of the sensor; and
a management device, connected to the electronic sphygmomanometer, that manages the electronic sphygmomanometer,
wherein the management device comprises: a test unit that carries out an operation that tests an equipment performance of the electronic sphygmomanometer while being connected to the electronic sphygmomanometer; a calibration unit that calibrates the equipment performance of the electronic sphygmomanometer according to a test result of the test unit; and an output unit that outputs the test result of the test unit or presence or absence of calibration in the calibration unit, and
a test unit that carries out an operation that tests an equipment performance of the electronic sphygmomanometer while being connected to the electronic sphygmomanometer;
an output unit that outputs the test result of the test unit or presence or absence of calibration in the calibration unit, and
wherein the electronic sphygmomanometer comprises: a drive unit that operates the electronic sphygmomanometer according to a control signal output in the test unit; a measurement unit that transmits a signal corresponding to the output value of the sensor to the management device with the operation; and a changing unit that changes a relationship between the sensor signal from the sensor and the output value of the sensor according to a control signal output in the calibration unit.
a drive unit that operates the electronic sphygmomanometer according to a control signal output in the test unit;
a measurement unit that transmits a signal corresponding to the output value of the sensor to the management device with the operation; and
a changing unit that changes a relationship between the sensor signal from the sensor and the output value of the sensor according to a control signal output in the calibration unit.
The management system according to claim 10 , wherein the electronic sphygmomanometer further comprises: a first storage unit that stores the blood pressure value along with information that specifies time of measurement; a second storage unit that stores information indicating that the calibration has been carried out along with information that specifies time of calibration according to a control signal output in the output unit; and a processing unit that performs a process of adding information indicating a measurement result of before the calibration is carried out with respect to the blood pressure value from when a calibration immediately before the calibration is carried out until the time of calibration of the information stored in the first storage unit according to the control signal output in the output unit.
wherein the electronic sphygmomanometer further comprises: a first storage unit that stores the blood pressure value along with information that specifies time of measurement; a second storage unit that stores information indicating that the calibration has been carried out along with information that specifies time of calibration according to a control signal output in the output unit; and a processing unit that performs a process of adding information indicating a measurement result of before the calibration is carried out with respect to the blood pressure value from when a calibration immediately before the calibration is carried out until the time of calibration of the information stored in the first storage unit according to the control signal output in the output unit.
a first storage unit that stores the blood pressure value along with information that specifies time of measurement;
a second storage unit that stores information indicating that the calibration has been carried out along with information that specifies time of calibration according to a control signal output in the output unit; and
a processing unit that performs a process of adding information indicating a measurement result of before the calibration is carried out with respect to the blood pressure value from when a calibration immediately before the calibration is carried out until the time of calibration of the information stored in the first storage unit according to the control signal output in the output un
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