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 INTERPRETATION
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Such claim limitations is/are:
“a measured value acquisition unit that acquires a measured value including a systolic blood pressure, a diastolic blood pressure, and/or a pulse rate of a subject” (Claim 1)
“a determination unit that determines which of three ranges the measured value is classified into, the three ranges being a first range preset in a specification, a second range corresponding to a measured value that can be exhibited by a human, preset adjacent to a side lower than the first range, and a third range corresponding to an abnormal measured value that cannot be exhibited by a human, preset adjacent to a side lower than the second range” (Claim 1) / “the determination unit determines which of five ranges the measured value is classified into, the five ranges being, in addition to the first, second, and third ranges, a fourth range corresponding to a measured value that can be exhibited by a human, preset adjacent to a side higher than the first range, and a fifth range corresponding to an abnormal measured value that cannot be exhibited by a human, preset adjacent to a side higher than the fourth range,” (Claim 2)
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“a measured value acquisition unit that acquires a measured value including a systolic blood pressure, a diastolic blood pressure, and/or a pulse rate of a subject” (Claim 1): As identified by the Specification, the following is recognized as the corresponding structure to the measured value acquisition unit: “The control unit 110 includes a central processing unit (CPU) as a processor, and controls entire operation of the sphygmomanometer 100. Specifically, the control unit 110 acts as a pressure control unit according to a program for controlling the sphygmomanometer 100 stored in the memory 51, and performs control to drive the pump 32 and the valve 33 as pressure devices according to operation signals from the operation unit 52. Further, the control unit 110 acts as a measured value acquisition unit, a determination unit, and a display processing unit, and in this example, calculates a blood pressure value (the maximum blood pressure SYS and the minimum blood pressure DIA) by a publicly-known oscillometric method based on outputs of the pressure sensor 31, and controls the display 50 and the memory 51.” Or equivalents thereof.
“a determination unit that determines which of three ranges the measured value is classified into, the three ranges being a first range preset in a specification, a second range corresponding to a measured value that can be exhibited by a human, preset adjacent to a side lower than the first range, and a third range corresponding to an abnormal measured value that cannot be exhibited by a human, preset adjacent to a side lower than the second range” (Claim 1) / “the determination unit determines which of five ranges the measured value is classified into, the five ranges being, in addition to the first, second, and third ranges, a fourth range corresponding to a measured value that can be exhibited by a human, preset adjacent to a side higher than the first range, and a fifth range corresponding to an abnormal measured value that cannot be exhibited by a human, preset adjacent to a side higher than the fourth range,” (Claim 2): As identified by the Specification, the following is recognized as the corresponding structure to the determination unit: “The control unit 110 includes a central processing unit (CPU) as a processor, and controls entire operation of the sphygmomanometer 100. Specifically, the control unit 110 acts as a pressure control unit according to a program for controlling the sphygmomanometer 100 stored in the memory 51, and performs control to drive the pump 32 and the valve 33 as pressure devices according to operation signals from the operation unit 52. Further, the control unit 110 acts as a measured value acquisition unit, a determination unit, and a display processing unit, and in this example, calculates a blood pressure value (the maximum blood pressure SYS and the minimum blood pressure DIA) by a publicly-known oscillometric method based on outputs of the pressure sensor 31, and controls the display 50 and the memory 51.” Or equivalents thereof.
If applicant wishes to provide explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Objections
The Claims are objected to because of the following informalities:
In Claim 1, the term “displays deviation information indicating that the measured value is classified into the second range or the measured value in addition to the deviation information on the display screen when the measured value is classified into the second range” should be replaced with -- displays deviation information indicating that the measured value is classified into the second range or displays the measured value in addition to the deviation information on the display screen when the measured value is classified into the second range -- for claim clarity.
Appropriate correction is required and applicant should carefully review the Claims for any other informalities.
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.
Claims 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claim 1, the claim(s) recites “a determination unit that determines which of three ranges the measured value is classified into, the three ranges being a first range preset in a specification, a second range corresponding to a measured value that can be exhibited by a human, preset adjacent to a side lower than the first range, and a third range corresponding to an abnormal measured value that cannot be exhibited by a human, preset adjacent to a side lower than the second range;” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“a measured value acquisition unit that acquires a measured value including a systolic blood pressure, a diastolic blood pressure, and/or a pulse rate of a subject; “
“a display processing unit that performs processing of displaying information on a display screen, wherein
the display processing unit:
displays the measured value on the display screen when the measured value is classified into the first range;
displays deviation information indicating that the measured value is classified into the second range or the measured value in addition to the deviation information on the display screen when the measured value is classified into the second range; and
displays an indication of measurement error on the display screen with displaying neither the deviation information nor the measured value when the measured value is classified into the third range.”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities and generic postsolution activity.
Furthermore, acquisition units, determination units, processing units, and display screens are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of determining what range a returned measured value pertains to and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself. Dependent claims 2-10 also do not add significantly more to the exception as they merely add details to the mental steps, add details to the extrasolution data gathering steps, add general field of use components to facilitate the extrasolution data gathering, and add mental steps.
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 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.
Claim(s) 1-5 and 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brigham et al (US 2019/0313982) (“Brigham”) as evidenced by Applicant IDS dated 2/07/2024 in view of Maeda et al (US 2014/0276114) (“Maeda”) and further in view of Rajagopalan et al (US 2018/0300913) (“Rajagopalan”) and further in view of Purdy et al (US 2014/0024956) (“Purdy”) as evidenced by Varshneya et al (US 6,498,652) (“Varshneya”).
Regarding Claim 1, while Brigham teaches a blood-pressure-related information display device that displays information related to a blood pressure on a display screen (Abstract, Fig. 1, [0039]-[0042]), the blood-pressure-related information display device comprising:
a measured value acquisition unit that acquires a measured value including a systolic blood pressure, a diastolic blood pressure, and/or a pulse rate of a subject ([0039], [0042] blood pressure measurement, [0074]-[0075] specifically, a CPU 100 acquires pulse wave measured value to calculate systolic and diastolic blood pressure, [0081]-[0082] where an output pulse value is also pulse rate);
a determination unit that determines which of three ranges the measured value is classified into, the three ranges being a first range preset in a specification, a second range corresponding to a measured value that can be exhibited by a human, preset adjacent to a side higher than the first range, and a third range corresponding to a measured value that can be exhibited by a human, preset adjacent to a side higher than the second range ([0075]-[0077], [0082]-[0085], [0097]-[0098] display regions 502-504 display the measured values of blood pressures when classified into a second range and gives deviation information by where a risk range marker is found on a color-coded arc shaped region);
a display processing unit that performs processing of displaying information on a display screen ([0055], [0077] CPU 100 performs processing of displaying information), wherein
the display processing unit:
displays the measured value on the display screen when the measured value is classified into the first range (Fig. 11, [0082], [0085] display regions 502-504 display the measured values);
displays deviation information indicating that the measured value is classified into the second range or the measured value in addition to the deviation information on the display screen when the measured value is classified into the second range (Fig. 11, [0082], [0085], [0097]-[0098] display regions 502-504 display the measured values of blood pressures when classified into a second range and gives deviation information by where a risk range marker is found on a color-coded arc shaped region),
Maeda fails to teach
the three ranges including a second range corresponding to a measured value that can be exhibited by a human, preset adjacent to a side lower than the first range, and a third range corresponding to an abnormal measured value that cannot be exhibited by a human, preset adjacent to a side lower than the second range; and
the display processing unit:
displays an indication of measurement error on the display screen with displaying neither the deviation information nor the measured value when the measured value is classified into the third range.
However Maeda teaches a blood-pressure-related information display device that displays information related to a blood pressure on a display screen (Abstract, [0031], [0088] pulse rate is processed and displayed on a display device, where pulse rate is related to blood pressure), the blood-pressure-related information display device comprising:
a measured value acquisition unit that acquires a measured value including a systolic blood pressure, a diastolic blood pressure, and/or a pulse rate of a subject ([0030]-[0032], [0035] camera 11 and acquiring unit 13 that acquires images from the camera 11, [0036]-[0044], [0087] processing performed on acquired images to provide measured values such as a pulse wave and a pulse rate);
a determination unit that determines pulse wave related diagnostics ([0088]); and
a display processing unit that performs processing of displaying information on a display screen ([0031], [0088] computers are the display processing units that perform processing of displaying information on a display screen), wherein the display processing unit: displays the measured value on the display screen ([0088] “It is needless to say that the measurement result or the diagnostics result of the diagnostic computer program is also displayed on the pulse wave detection apparatus 10 or other terminal device of the person involved.”) and does not display deviation information nor a measured value when the measured value is classified outside a physiologically possible range ([0087] “The pulse wave detection unit 19 can therefore calculate the pulse rate h using the following Expression (23). If the pulse rate h is outside the possible range of the human pulse rate, e.g., 42 to 240 bpm, the pulse rate and the pulse waveform need not to be output.”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that ranges of measurements that cannot be exhibited by a human are considered and measurements in this range are not specifically output as taught in Maeda for the cardiovascular parameters in Brigham as a way to prevent unnecessary alarm or concern for a patient due to device malfunctioning.
Maeda fails to teach
the three ranges including a second range corresponding to a measured value that can be exhibited by a human, preset adjacent to a side lower than the first range, and a third range corresponding to an abnormal measured value that cannot be exhibited by a human, preset adjacent to a side lower than the second range; and
the display processing unit:
displays an indication of measurement error on the display screen with displaying neither the deviation information nor the measured value when the measured value is classified into the third range.
However Rajagopalan teaches a cardiovascular monitor (Abstract) comprising
a measured value acquisition unit that acquires a measured value including a systolic blood pressure, a diastolic blood pressure, and/or a pulse rate of a subject ([0038], [0055]-[0057] sensor for physiological parameter, the physiological parameter can be heart rate, where heart rate and pulse rate can be synonymous terms as noted in Purdy: [0142], [0614]);
a determination unit that determines which of three ranges the measured value is classified into, the three ranges being a first range preset in a specification, a second range corresponding to a measured value that can be exhibited by a human, preset adjacent to a side lower than the first range, and a third range corresponding to an abnormal measured value that cannot be exhibited by a human, preset adjacent to a side lower than the second range (Fig. 5, [0055]-[0056] determination of measured value, [0060]-[0061] five ranges shown for classification with a first range preset in a specification / range between low HR limit 520 and high HR limit 530, a second range corresponding to a measured value that can be exhibited by a human, preset adjacent to a side lower than the first range / range between low HR limit 520 and bradycardia limit 515, and a third range corresponding to an abnormal measured value that cannot be exhibited by a human, preset adjacent to a side lower than the second range / range between bradycardia limit 515 and zero, where a bradycardia limit would be understood to be about 30 beats per minute as noted in Varshneya: Col. 28, L. 54 – Col. 29, L. 7); and
the display processing unit:
displays the measured value on the display screen when the measured value is classified into the first range ([0055]-[0056], [0060]-[0061] current value 540 / measured value will be on the display screen, in relation with given ranges);
displays deviation information indicating that the measured value is classified into the second range or displays the measured value in addition to the deviation information on the display screen when the measured value is classified into the second range ([0055]-[0056], [0060]-[0061] current value 540 / measured value will be on the display screen, in relation with given ranges, where the arrow indicating the placement of the current value in the second range acts as deviation information).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to set the ranges of Brigham to further include ranges lower than normal cardiovascular values as taught by Rajagopalan in addition to the hypertension related ranges as a way to also consider whether the patient is experiencing hypotension or other low blood pressure related abnormalities. Thus, the arc-shaped region will be divided into a greater number of regions to adequately express patient state. Further, while Brigham’s ranges are blood pressure related and Rajagopalan’s ranges are pulse rate related, these measurement values are correlated with one another (Brigham: [0075]) and thus physiologically impossible pulse rate values would also correlate to physiologically impossible blood pressure values. Furthermore, it would be obvious to indicate measurement error on the display screen with displaying neither the deviation information nor the measured value when the measured value is classified into the third range as Maeda teaches that values outside of possible human pulse rates should not be shown ([0087]).
Yet their combined efforts fail to teach
displays an indication of measurement error on the display screen with displaying neither the deviation information nor the measured value when the measured value is classified into the third range.
However Purdy teaches a cardiac monitoring system (Abstract) where invalid cardiac measurements may cause a display of an indication of measurement error ([0450]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that invalid measurement of pulse rate measured by Maeda and Rajagopalan can result in a display of measurement error as taught by Purdy instead of no display at all as taught by Maeda as a simple substitution of one form of handling invalid data (Maeda: ignoring the invalid data) for another (Purdy: communicating the presence of invalid data) to obtain predictable results of only providing trusted cardiac data for review.
Regarding Claim 2, Brigham, Maeda, Rajagopalan, Purdy, and Varshneya teach the blood-pressure-related information display device according to claim 1, wherein
the determination unit determines which of a plurality of ranges the measured value is classified into, the ranges further including a fourth range corresponding to a measured value that can be exhibited by a human, preset adjacent to a side higher than the first range (See Claim 1 Rejection), and Rajagopalan further teaches wherein
the determination unit determines which of five ranges the measured value is classified into, the five ranges being, in addition to the first, second, and third ranges, a fourth range corresponding to a measured value that can be exhibited by a human, preset adjacent to a side higher than the first range, and a fifth range corresponding to an abnormal measured value that cannot be exhibited by a human, preset adjacent to a side higher than the fourth range (Fig. 5, [0055]-[0056] determination of measured value, [0060]-[0061] five ranges shown for classification with a fourth range preset in a specification / range between high HR limit 530 and tachycardia limit 535 and a fifth range corresponding to an abnormal measured value that cannot be exhibited by a human, preset adjacent to a side higher than the fourth range / range between tachycardia limit 530 and a value of 300 bpm , where a tachycardia limit would be understood to be about 250 beats per minute as noted in Varshneya: Col. 28, L. 54 – Col. 29, L. 7), and
the display processing unit:
displays deviation information indicating that the measured value is classified into the fourth range or the measured value in addition to the deviation information on the display screen when the measured value is classified into the fourth range, and
displays an indication of measurement error on the display screen with displaying neither the deviation information nor the measured value when the measured value is classified into the fifth range (See Claim 1 Rejection, the fourth range and fifth range limitations are obvious for the same reasons given in the Claim 1 Rejection in view of Brigham, Rajagopalan, Varshneya, and Purdy).
Regarding Claim 3, Brigham, Maeda, Rajagopalan, Purdy, and Varshneya teach the blood-pressure-related information display device according to claim 2, wherein
the display processing unit:
displays a mark indicating that the measured value is classified into the second or fourth range as the deviation information with respect to the measured value on the display screen when the measured value is classified into the second or fourth range (See Claim 2 Rejection, in Brigham’s Fig. 11, the risk range X1 is a mark that indicates the deviation information of the measured values of diastolic pressure and systolic pressure and Rajagopalan’s Figs. 5-6, [0060]-[0061] the arrow extending from the current heart rate is a mark indicating that the measured value is classified into a corresponding range in the displayed semicircular/rectangular shape).
Regarding Claim 4, Brigham. Maeda, Rajagopalan, Purdy, and Varshneya teach the blood-pressure-related information display device according to claim 2, and Rajagopalan teaches wherein
the display processing unit:
displays the measured value on the display screen in a first mode when the measured value is classified into the first range (Fig. 11, the measured values shown in display regions 502-504); and
displays the measured value on the display screen in a second mode distinguishable from the first mode as the deviation information indicating that the measured value is classified into the second or fourth range when the measured value is classified into the second or fourth range ([0097]-[0098] deviation information additionally shown in a second mode as the risk range X1 in relation to the ranges given by the arc-shaped region 510).
Regarding Claim 5, Brigham. Maeda, Rajagopalan, Purdy, and Varshneya teach the blood-pressure-related information display device according to claim 2, and Brigham teaches wherein
a measured value includes measured values of at least two measurement items of a systolic blood pressure, a diastolic blood pressure, and a pulse rate (Fig. 11),
the first to fifth ranges are set in advance for each of the measurement items (See Claim 2 Rejection, preset ranges taught in Brigham, specifically outlined with five ranges in Rajagopalan, where Brigham’s hypertension ranges could be considered sub-ranges within the fourth range),
the determination unit determines which of the first to fifth ranges the measured value is classified into for each of the measurement items (See Claim 2 Rejection), and
the display processing unit:
sets a display region for a measurement item for each of the measurement items in the display screen (See Claim 2 Rejection);
displays a measured value in a display region for a certain measurement item in the display screen when the measured value of the certain measurement item is classified into the first range (See Claim 2 Rejection, display regions 502-504);
displays deviation information indicating that the measured value is classified into the second or fourth range or the measured value in addition to the deviation information in the display region for the certain measurement item when the measured value of the certain measurement item is classified into the second or fourth range (See Claim 2 Rejection, deviation of both systolic pressure and diastolic pressure are shown by risk range X1); and
displays an indication of measurement error in the display region for the certain measurement item with displaying neither the deviation information nor the measured value when the measured value of the certain measurement item is classified into the third or fifth range (See Claim 2 Rejection, displaying a measurement error when values are outside of a physiologically possible value).
Regarding Claim 7, Brigham, Maeda, Rajagopalan, Purdy, and Varshneya teach the blood-pressure-related information display device according to claim 2, their combined efforts fail to teach the device further comprising:
a sphygmomanometer main body (Fig. 1, [0039]-[0040] sphygmomanometer 1’s main body 10),, wherein
a display forming the display screen, the measured value acquisition unit, the determination unit, and the display processing unit are mounted on the sphygmomanometer main body ([0042] display 50 forming the display screen, [0054] system sensing and processing units are housed within the main body 10 of sphygmomanometer 1).
Regarding Claim 8, Brigham, Maeda, Rajagopalan, Purdy, and Varshneya teach the blood-pressure-related information display device according to claim 2, and Brigham further teaches the device comprising:
a sphygmomanometer (See Claim 2 Rejection); and
the sphygmomanometer includes:
the measured value acquisition unit that measures and acquires the measured value including the systolic blood pressure, the diastolic blood pressure, and/or the pulse rate from the subject ([0042] display 50 forming the display screen, [0054] system sensing units are housed within the main body 10 of sphygmomanometer 1),
Rajagopalan teaches performing analysis in a distributed manner across computing terminals in a network ([0053]), indicating the use of
a medical institution terminal provided in a manner separated from the sphygmomanometer, wherein
a transmission unit that transmits information on the measured value acquired by the measured value acquisition unit, and
the medical institution terminal includes:
a receiving unit that receives the information on the measured value from the sphygmomanometer;
and Purdy teaches that a remote device for receiving and analyzing physiological measurements may be a display device ([0598]), indicating the use of a display that forms a first display screen acting as the display screen.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the processing performed at the sphygmomanometer of Brigham can additionally be performed at a remote location as taught by Rajagopalan as a way to provide patient analysis results to a remote healthcare provider, using a display device of Purdy. Thus, the processing unit of the remote device would be a first display processing unit that acts as the display processing unit that performs processing of displaying information on the first display screen based on the information on the measured value.
Regarding Claim 9, Brigham, Maeda, Rajagopalan, Purdy, and Varshneya teach the blood-pressure-related information display device according to claim 8, wherein the medical institution terminal further includes a first determination unit that acts as the determination unit (See Claim 8 Rejection, would be included to analyze the cardiovascular data).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brigham in view of Maeda and further in view of Rajagopalan and further in view of Purdy as evidenced by Varshneya and further in view of Hu et al (US 2018/0368683) (“Hu”).
Regarding Claim 10, while Brigham, Maeda, Rajagopalan, Purdy, and Varshneya teach the blood-pressure-related information display device according to claim 5, when, among the measured values, a measured value of a part of measurement items is classified into the first range and a measured value of remaining measurement items is classified into the second or fourth range by the determination unit,
the display processing unit:
displays the measured value of the part of measurement items classified into the first range in a display region for the part of measurement items in the display screen (See Claims 2 and 5 Rejections); and
and Rajagopalan teaches that current measured values may be displayed as either numeric values or as deviation information based on a desired configuration of the user ([0036]), their combined efforts fail to explicitly teach wherein
when, among the measured values, a measured value of a part of measurement items is classified into the first range and a measured value of remaining measurement items is classified into the second or fourth range by the determination unit,
the display processing unit:
displays only the deviation information without displaying the measured value of the remaining measurement items classified into the second or fourth range in a display region for the remaining measurement items in the display screen.
However Hu teaches a medical monitoring system (Abstract) for monitoring multiple metrics where a normal situation is displayed in one manner and an abnormal situation is displayed in another manner, with different information ([0047], [0049], [0051] a normal situation has a patient and their admission status associated with a bed unit and color. An abnormal situation where the patient’s physiological measurements have been delayed over a threshold a time will display a separate color and the measured time gap as a way to effectively monitor multiple sources of information).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to distinguish the displayed information of Brigham, Maeda, and Rajagopalan with distinct forms of communicating measurement item status taught in Rajagopalan as Hu teaches that representing abnormal values with different information than normal values is a way to draw attention to the abnormal values, specifically in a situation where multiple sources of information must be monitored. One of ordinary skill in the art would understand that a certain threshold for cardiovascular parameter values may indicate that urgency should be communicated to a patient/healthcare provider, rather than a numerical value, to motivate immediate treatment interventions.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brigham in view of Maeda and further in view of Rajagopalan and further in view of Purdy and further in view of Varshneya,
Regarding Claim 10, Brigham, Maeda, Rajagopalan, Purdy, and Varshneya teach the blood-pressure-related information display device according to claim 8, wherein
the sphygmomanometer further includes a second determination unit, a display forming a second display screen, and a second display processing unit that performs processing of displaying information on the second display screen,
the second determination unit determines whether the measured value is classified into any of the first range, the second to third ranges, and the fourth to fifth ranges, and
the second display processing unit:
displays the measured value on the second display screen when the measured value is classified into the first range; and
displays an indication of measurement error on the second display screen with displaying neither the deviation information nor the measured value when the measured value is classified into the third range or the fifth range (See Claim 2 Rejection, Brigham, Maeda, and Rajapgopalan teach the above happening at a local processing unit of the sphygmomanometer to provide local display results to a patient, where Claim 8’s rejection teaches how this could be applied remotely as well), and Brigham teaches that multiple thresholds as desired by user ([0059]) and customized to a subject as desired by a user ([0071]-[0072]) and Varshneya teaches that thresholds of possible values may differ by age (See Claim 1 Rejection, Col. 28, L. 54 – Col. 29, L. 7), their combined fail to explicitly teach a sphygmomanometer’s display processing includes displaying an indication of measurement error on the second display screen with displaying neither the deviation information nor the measured value when the measured value is classified into the second to third ranges or the fourth to fifth ranges.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the sphygmomanometer device with preset ranges for one individual as taught by Brigham, Maeda, Rajagopalan, Purdy, and Varshneya may set ranges that overlap with the ends of a high cardiovascular parameter and a low cardiovascular parameter that is possible in one subset of patients and impossible in another subset of patients. This range would be suitably applied for one patient’s high cardiovascular parameter alarm monitoring (i.e. a second and fourth range) and be representative of measurement error in another patient.
Conclusion
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights