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 .
Applicant’s arguments filed in the reply on March 30, 2026 were received and fully considered. Claims 138, 149, and 157 were amended. Please see below for more detail.
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.
Claim(s) 138-13, 141-144, 149-150, and 152-155 is/are rejected under 35 U.S.C. 103 as being unpatentable over Romem (US 2014/0206948) in view of Komaromi et al (US 2016/0162256) (“Komaromi”) and further in view of Imhof et al (“Closed-chamber transepidermal water loss measurement: microclimate, calibration and performance”) (“Imhof”) and further in view of McKechnie et al (WO 2016/071713) (“McKechnie”) and further in view of Beltran-Alvarez et al (WO 2018/130840) (“Beltran-Alvarez”).
Regarding Claim 138, while Romem teaches a sensor for detecting sweating by a person who is wearing a support structure (Abstract, Fig. 1, [0100] monitoring garment 100 / support structure includes multiple sensors), the sensor comprising:
A hygrometer configured to sense a humidity ([0157] one of the sensors used may be a humidity sensor also known as a hygrometer) configured to:
detect sudden and profuse sweating by sensing an increase in the humidity caused by the sweating of the person ([0121]-[0124], [0157] the humidity sweat sensor will monitor the patient and by its function will detect sudden and profuse sweating);
wherein the support structure is configured to maintain the sensor on a body of the person such that the person opening is placed against the body of the person ([0101]-[0102] sensors of system are maintained placed against the body of a person in accordance with their specific sensing modality), and
an output component configured to communicate a notification signal to a processor ([0103]-[0104] output component / wires 115 configured to communicate data to a processor / garment-processor 112 of garment-control device 110);
wherein the processor is configured to:
compare a value of a test aspect of a test portion with a value of a reference aspect of a reference template made from one or more portions of an electrocardiogram (ECG) signal of the person, wherein the ECG signal is sensed during a first time duration and a second time duration, to determine a difference (Fig. 6, [0192]-[0216] abnormality analysis of sensed, [0121]-[0124] sensor data of each sub-sensor is measured sequentially, one at a time [0194], [0197]-[0207] the values of a test aspect / sensed values of a test portion / the current dynamic interval are compared to a reference aspect of a reference template which are the normal values derived for a patient with adjustments for current patient parameters, [0114] the template for normal values includes one or more portions of an electrocardiogram (ECG) signal of the person), wherein the ECG signal is sensed during a first time duration and a second time duration, to determine a difference between the value of the test aspect and the value of the reference aspect ([0203]-[0209] a first time duration is fulfilled by the past durations used for the measurements in the history of measurements and a second time duration is fulfilled by the interval of the current sensed data, generating the comparative data to determine abnormal deviations by trend analysis, the deviation between the measured value and the normal state being the difference between the test aspect and the reference aspect);
use the detected ECG and sweating to detect whether the person is suffering an abnormal health condition ([0032], [0036], [0112]-[0113]), specifically an abnormal cardiac health condition ([0112]-[0113]); and
responsive to a determination that the difference exceeds an alert threshold, cause an output device to output an alert ([0214]-[0215]).
Romem fails to teach
a tube having a cavity, a person opening, and a ventilation opening opposite the person opening, wherein air in the cavity communicates with air outside the cavity by the person opening and by the ventilation opening,
wherein the support structure is configured to maintain the tube on the body of the person such that the person opening is placed against the body of the person; and
the hygrometer coupled to the tube and configured to
sense a humidity of air within the cavity, and
wherein the hygrometer is configured to detect sudden and profuse sweating of the person by sensing an increase in the humidity of air within the cavity caused by the sweating of the person; and
an output component configured to communicate, based on the detected sudden and profuse sweating, a notification signal corresponding to the detected sudden and profuse sweating to a processor.
However Komaromi teaches a sensor for detecting sweating by a person who is wearing a support structure (Abstract, [0008], [0089]-[0090]), the sensor comprising:
a unit having a cavity, a person opening and a ventilation opening opposite the person opening, wherein air in the cavity communicates with air outside the cavity by the person opening and by the ventilation opening (Figs. 7 and 9, [0073], [0089] opening 51 adjacent a body BP, opening 52 communicating with air); and
wherein the support structure is configured to maintain the unit on a body of the person such that the person opening is placed against the body of the person ([0005] various wearable support structures envisioned to maintain the system on a body of the person), and
a hygrometer coupled to the unit and configured to
sense a humidity of air within the cavity ([0073], [0089] sensors 1 and 2 measuring humidity to judge sweat rate),
wherein the hygrometer is configured to detect sudden and profuse sweating of the person ([0023] the humidity sensor is capable of detecting sudden changes as it may use this to contextually identify when the sensor is being worn) by sensing an increase in the humidity of air within the cavity caused by the sweating of the person ([0030] “In a first embodiment, the sensor and the other sensor are both humidity sensors sensing relative humidity. Hence, by subtracting the other sensor signal from the sensor signal, a relative humidity flux can be determined. In a second embodiment, the sensor and the other sensor are both temperature sensors. Hence, by subtracting the other sensor signal from the sensor signal, a heat flux can be determined which may be a measure for a trans-epidermal water loss the user experiences. In a third embodiment, the sensor and the other sensor are both humidity sensors sensing absolute humidity. Hence, by subtracting the other sensor signal from the first sensor signal, a relative absolute flux can be determined which is also referred to as sweat rate since it is provides a measure as to the amount of sweat the user produces. However, the three embodiments can also be combined. In a preferred combination, two humidity sensors sensing relative humidity each and two temperature sensors are provided. By means of such arrangement, the sweat rate can be determined, too, since the absolute humidity can be calculated from the relative humidity and the temperature as is known in the art.”), and
an output component configured to communicate a notification signal to a processor ([0090] the sensor is configured to communicate to a control unit performing calculations, [0065] where control unit may be structured as a processor, [0069] where wired interface is an output component to communicate data from a sensor to a control unit, this communication schema means the output component is configured to communicate any signal to a processor);
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate the structure of the worn humidity sensing device of Komaromi for measuring sweat to the humidity-based sweat sensor of Romem as Romem provides no detail for how a worn hygrometer should be structured. Thus Komaromi is providing necessary information to realize the system of Romem.
Yet their combined efforts fail to teach the unit being a tube.
However Imhof teaches a water loss of skin measurement (Abstract, p101 The measurement of TEWL) comprising a tube having a cavity, a person opening and a ventilation opening opposite the person opening, in which air in the cavity communicates with air outside the tube by the person opening and by the ventilation opening (P101-102, Open-Chamber method, Figure 2, an open tube with two relative humidity sensors for judging water loss from skin, p103, Condenser-chamber method, “Both open and condenser-chamber instruments record continuous flux density time-series readings. These enable time-dependent water loss processes such as sweat gland activity or the transient evaporation of surface water to be studied.”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the structure of the humidity sensing device of Komaromi could be substituted as a tube as taught by Imhof as Komaromi teaches that the channel for measuring water loss can be straight ([0032]) and it is a simple substitution of one humidity sensing channel on the skin for another to obtain predictable results of accurately assessed sweat levels. Furthermore, it would be obvious that detected signals of humidity will be of the air within the cavity of the tube as this is now positively claimed as the sensing environment.
Yet their combined efforts fail to teach:
an output component configured to communicate, based on the detected sudden and profuse sweating, a notification signal corresponding to the detected sudden and profuse sweating to a processor;
wherein the processor is configured to
responsive to the communicated notification signal from the output component, compare the value of the test aspect of the test portion with a value of the reference aspect of the reference template made from one or more portions of an electrocardiogram (ECG) signal of the person,
use the detected sudden and profuse sweating to detect whether the person is suffering a heart attack; and
wherein the hygrometer is calibrated to react to the sudden and profuse amount of sweating sensed by the increase in the humidity of air within the cavity of the tube, to detect an onset of the heart attack.
However McKechnie teaches a patient skin moisture detector (Abstract) where the skin moisture detector can be used to judge patient excessive sweating (Abst, p1, L. 3-5), monitoring conditions associated with excessive sweating (p. 5, L. 7-9), calibrating the moisture detector to identify what constitutes gradual change and what constitutes sudden change in moisture for a particular patient to reduce false alarms of excessive sweating based conditions (p. 8, L. 26 – p. 11, L. 24, based on the particular of how moisture changes over time, identifying the characteristic changes of a patient or sensor drift, and determining what is a sudden change in light of this context), notes that sudden and excessive sweating is an identifiable characteristic of certain cardiac conditions (p. 13, L. 20 – p. 14, L. 3, where heart disease is a broader category within which there is heart attack) and is reason for communicating to a healthcare provider that a subject should be monitored with more intense scrutiny (p. 13, L. 25 – p. 14, L. 3, “As well as being useful in monitoring for needle dislodgement, the device of the present invention is useful in monitoring patients for sudden excessive sweating which is generally caused by an underlying health problem, for example sudden changes in blood pressure or the onset of a hypoglycaemic state. The activation of the alert due to excessive sweating can be useful in alerting medical practitioners that a patient may be having difficulties, and should be the subject of more intensive scrutiny.”), and identifies heart attack as a condition monitored by excessive sweating (p. 21, L. 26 – p. 22, L. 3).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, apply the calibration steps for sudden and excessive sweating of McKechnie for particular cardiac conditions to the sweat sensing and cardiac monitoring Romem as this positively teaches how the cardiac condition of heart attack can be identified by the sweat data. This increases the utility of Romem by providing specific rules for the detection of heart attack. Also, the calibration steps reduce a false alarm rate of this type of sweat sensing (p. 8, L. 26 – p. 11, L. 24). Furthermore, Examiner will note that while McKechnie does not explicitly state that the specific condition of heart attack is characterized by both excessive and sudden sweating, it would be known in the art that acute coronary syndromes elicit this particular type of sweating (Beltran-Alvarez: p. 38, L. 27 – p.39, L. 6). Even further, McKechnie’s teaching that sudden and profuse sweating should lead to further scrutiny can be realized by the ECG monitoring in Romem with these combined teachings being how the “sensed data or trend is determined to be abnormal” in Romem. Consequently, the teachings can be combined to create a specific and standardized protocol in Romem where the hygrometer data of Romem, Komaromi, and Imhof is first evaluated for sudden and profuse sweating as taught by McKechnie and the output component of Romem then notifying the processor that a secondary evaluation of ECG data is needed to specifically identify the cardiac condition to be a heart attack. Finally, even though sweat sensing in Romem, Komaromi, and Imhof is humidity based and McKechnie is resistance based, identifying what constitutes a gradual baseline change by evaluating changes over time is applicable across datasets.
Regarding Claim 139, Romem, Komaromi, Imhof, McKechnie, and Beltran-Alvarez teach the sensor of claim 138, wherein only openings of the cavity are the person opening and the ventilation opening (See Claim 138 Rejection).
Regarding Claim 141, Romem, Komaromi, Imhof, McKechnie, and Beltran-Alvarez teach the sensor of claim 138, wherein the tube has a length, and a constant cross section throughout the length (See Claim 138 Rejection, Imhof Fig. 2).
Regarding Claim 142, Romem, Komaromi, Imhof, McKechnie, and Beltran-Alvarez teach the sensor of claim 138, wherein the tube has a circular or oval cross section (See Claim 138 Rejection, Imhof Fig. 2).
Regarding Claim 143, Romem, Komaromi, Imhof, McKechnie, and Beltran-Alvarez teach the sensor of claim 138, wherein the hygrometer is located wholly within the tube (See Claim 138 Rejection, Imhof Fig. 2).
Regarding Claim 144, Romem, Komaromi, Imhof, McKechnie, and Beltran-Alvarez teach the sensor of claim 143, further comprising: a support member across the tube and within the cavity, wherein the hygrometer is attached to the support member (See Claim 138 Rejection, Imhof Fig. 2, arm support member extends across tube and within the cavity to maintain humidity sensor at center of tube).
Regarding Claim 149, while Romem teaches a component (Abstract, Fig. 1, [0100] monitoring garment 100 / support structure includes multiple sensors), comprising:
A hygrometer configured to sense a humidity ([0157] one of the sensors used may be a humidity sensor also known as a hygrometer) and to detect whether a person is experiencing sweating by sensing an increase in the humidity caused by sweating of the person ([0121]-[0124], [0157] the humidity sweat sensor will monitor the patient and by its function will detect sudden and profuse sweating);
an output component configured to communicate a notification signal to a processor ([0103]-[0104] output component / wires 115 configured to communicate data to a processor / garment-processor 112 of garment-control device 110);
wherein the processor is configured to:
compare a value of a test aspect of a test portion with a value of a reference aspect of a reference template made from one or more portions of an electrocardiogram (ECG) signal of the person, wherein the ECG signal is sensed during a first time duration and a second time duration, to determine a difference (Fig. 6, [0192]-[0216] abnormality analysis of sensed, [0121]-[0124] sensor data of each sub-sensor is measured sequentially, one at a time [0194], [0197]-[0207] the values of a test aspect / sensed values of a test portion / the current dynamic interval are compared to a reference aspect of a reference template which are the normal values derived for a patient with adjustments for current patient parameters, [0114] the template for normal values includes one or more portions of an electrocardiogram (ECG) signal of the person), wherein the ECG signal is sensed during a first time duration and a second time duration, to determine a difference between the value of the test aspect and the value of the reference aspect ([0203]-[0209] a first time duration is fulfilled by the past durations used for the measurements in the history of measurements and a second time duration is fulfilled by the interval of the current sensed data, generating the comparative data to determine abnormal deviations by trend analysis, the deviation between the measured value and the normal state being the difference between the test aspect and the reference aspect);
use the detected ECG and sweating to detect whether the person is suffering an abnormal health condition ([0032], [0036], [0112]-[0113]), specifically an abnormal cardiac health condition ([0112]-[0113]); and
responsive to a determination that the difference exceeds an alert threshold, cause an output device to output an alert ([0214]-[0215]).
Romem fails to teach
a tube having a cavity, a person opening, and a ventilation opening opposite the person opening, wherein air in the cavity communicates with air outside the tube by the person opening and by the ventilation opening; and
the hygrometer coupled to the tube and configured to sense a humidity of air within the cavity, and to detect whether a person is experiencing sudden and profuse sweating by sensing an increase in the humidity of air within the cavity caused by the sweating of the person.
However Komaromi teaches a sensor component for detecting sweating by a person (Abstract, [0008], [0089]-[0090]), the sensor component comprising:
a unit having a cavity, a person opening and a ventilation opening opposite the person opening, wherein air in the cavity communicates with air outside the tube by the person opening and by the ventilation opening (Figs. 7 and 9, [0073], [0089] opening 51 adjacent a body BP, opening 52 communicating with air); and
a hygrometer coupled to the tube and configured to sense a humidity of air within the cavity ([0073], [0089] sensors 1 and 2 measuring humidity to judge sweat rate), and to detect whether a person is experiencing sudden and profuse sweating ([0023] the humidity sensor is capable of detecting sudden changes as it may use this to contextually identify when the sensor is being worn) by sensing an increase in the humidity of air within the cavity caused by the sweating of the person ([0030] “In a first embodiment, the sensor and the other sensor are both humidity sensors sensing relative humidity. Hence, by subtracting the other sensor signal from the sensor signal, a relative humidity flux can be determined. In a second embodiment, the sensor and the other sensor are both temperature sensors. Hence, by subtracting the other sensor signal from the sensor signal, a heat flux can be determined which may be a measure for a trans-epidermal water loss the user experiences. In a third embodiment, the sensor and the other sensor are both humidity sensors sensing absolute humidity. Hence, by subtracting the other sensor signal from the first sensor signal, a relative absolute flux can be determined which is also referred to as sweat rate since it is provides a measure as to the amount of sweat the user produces. However, the three embodiments can also be combined. In a preferred combination, two humidity sensors sensing relative humidity each and two temperature sensors are provided. By means of such arrangement, the sweat rate can be determined, too, since the absolute humidity can be calculated from the relative humidity and the temperature as is known in the art.”),
an output component configured to communicate a notification signal to a processor ([0090] the sensor is configured to communicate to a control unit performing calculations, [0065] where control unit may be structured as a processor, [0069] where wired interface is an output component to communicate data from a sensor to a control unit, this communication schema means the output component is configured to communicate any signal to a processor);
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate the structure of the worn humidity sensing device of Komaromi for measuring sweat to the humidity-based sweat sensor of Romem as Romem provides no detail for how a worn hygrometer should be structured. Thus Komaromi is providing necessary information to realize the system of Romem.
Yet their combined efforts fail to teach the unit being a tube.
However Imhof teaches a water loss of skin measurement (Abstract, p101 The measurement of TEWL) comprising a tube having a cavity, a person opening and a ventilation opening opposite the person opening, in which air in the cavity communicates with air outside the tube by the person opening and by the ventilation opening (P101-102, Open-Chamber method, Figure 2, an open tube with two relative humidity sensors for judging water loss from skin, p103, Condenser-chamber method, “Both open and condenser-chamber instruments record continuous flux density time-series readings. These enable time-dependent water loss processes such as sweat gland activity or the transient evaporation of surface water to be studied.”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the structure of the humidity sensing device of Komaromi could be substituted as a tube as taught by Imhof as Komaromi teaches that the channel for measuring water loss can be straight ([0032]) and it is a simple substitution of one humidity sensing channel on the skin for another to obtain predictable results of accurately assessed sweat levels.
Yet their combined efforts fail to teach:
an output component configured to communicate, based on the detected sudden and profuse sweating, a notification signal corresponding to the detected sudden and profuse sweating to a processor;
wherein the processor is configured to
responsive to the communicated notification signal from the output component, compare the value of the test aspect of the test portion with a value of the reference aspect of the reference template made from one or more portions of an electrocardiogram (ECG) signal of the person,
use the detected sudden and profuse sweating to detect whether the person is suffering a heart attack; and
wherein the hygrometer is calibrated to react to the sudden and profuse amount of sweating sensed by the increase in the humidity of air within the cavity of the tube, to detect an onset of the heart attack.
However McKechnie teaches a patient skin moisture detector (Abstract) where the skin moisture detector can be used to judge patient excessive sweating (Abst, p1, L. 3-5), monitoring conditions associated with excessive sweating (p. 5, L. 7-9), calibrating the moisture detector to identify what constitutes gradual change and what constitutes sudden change in moisture for a particular patient to reduce false alarms of excessive sweating based conditions (p. 8, L. 26 – p. 11, L. 24, based on the particular of how moisture changes over time, identifying the characteristic changes of a patient or sensor drift, and determining what is a sudden change in light of this context), notes that sudden and excessive sweating is an identifiable characteristic of certain cardiac conditions (p. 13, L. 20 – p. 14, L. 3, where heart disease is a broader category within which there is heart attack), and identifies heart attack as a condition monitored by excessive sweating (p. 21, L. 26 – p. 22, L. 3).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, apply the calibration steps for sudden and excessive sweating of McKechnie for particular cardiac conditions to the sweat sensing and cardiac monitoring Romem as this positively teaches how the cardiac condition of heart attack can be identified by the sweat data. This increases the utility of Romem by providing specific rules for the detection of heart attack. Also, the calibration steps reduce a false alarm rate of this type of sweat sensing (p. 8, L. 26 – p. 11, L. 24). Furthermore, Examiner will note that while McKechnie does not explicitly state that the specific condition of heart attack is characterized by both excessive and sudden sweating, it would be known in the art that acute coronary syndromes elicit this particular type of sweating (p. 38, L. 27 – p.39, L. 6). Even further, McKechnie’s teaching that sudden and profuse sweating should lead to further scrutiny can be realized by the ECG monitoring in Romem with these combined teachings being how the “sensed data or trend is determined to be abnormal” in Romem. Consequently, the teachings can be combined to create a specific and standardized protocol in Romem where the hygrometer data of Romem, Komaromi, and Imhof is first evaluated for sudden and profuse sweating as taught by McKechnie and the output component of Romem then notifying the processor that a secondary evaluation of ECG data is needed to specifically identify the cardiac condition to be a heart attack. Finally, even though sweat sensing in Romem, Komaromi, and Imhof is humidity based and McKechnie is resistance based, identifying what constitutes a gradual baseline change by evaluating changes over time is applicable across datasets.
Regarding Claim 150, Romem, Komaromi, Imhof, McKechnie, and Beltran-Alvarez teach the component of claim 149, wherein only openings of the cavity are the person opening and the ventilation opening (See Claim 149 Rejection, Imhof: Fig. 2).
Regarding Claim 152, Romem, Komaromi, Imhof, McKechnie, and Beltran-Alvarez teach the component of claim 149, wherein the tube has a length, and a substantially constant cross section throughout the length (See Claim 149 Rejection, Imhof: Fig. 2).
Regarding Claim 153, Romem, Komaromi, Imhof, McKechnie, and Beltran-Alvarez teach the component of claim 149, wherein the tube has a substantially circular cross section (See Claim 149 Rejection, Imhof: Fig. 2).
Regarding Claim 154, Romem, Komaromi, Imhof, McKechnie, and Beltran-Alvarez teach the component of claim 149, wherein the hygrometer is located wholly within the tube (See Claim 149 Rejection, Imhof: Fig. 2).
Regarding Claim 155, Romem, Komaromi, Imhof, McKechnie, and Beltran-Alvarez teach the component of claim 154, further comprising: a support member across the tube and within the cavity, and wherein the hygrometer is attached to the support member (See Claim 154 Rejection, Imhof: Fig. 2, arm support member extends across tube and within the cavity to maintain humidity sensor at center of tube).
Claim(s) 140 and 151 is/are rejected under 35 U.S.C. 103 as being unpatentable over Romem in view of Komaromi and further in view of Imhof and further in view of McKechnie and further in view of Beltran-Alvarez and further in view of Ariagno et al (“Dew-point hygrometry system for measurement of evaporative water loss in infants”) (“Ariagno”).
Regarding Claim 140, while Romem, Komaromi, Imhof, McKechnie, and Beltran-Alvarez teach the sensor of claim 138, their combined efforts fail to teach wherein the tube has a length between 1.25 cm and 5 cm.
However Arigano teaches a hygrometry-based water loss measurement system (Abstract) where the height of the system is 1.2 cm (Fig. 3B).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the structure of Imhof have a height of about 1.2 cm as taught by Ariagno as a teaching for the height of Imhof’s tube to appropriately measure water loss. Further, it would be obvious to modify the height to be between 1.25 cm and 5 cm as an optimization of desired height for the tube [“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)].
Regarding Claim 151, while Romem, Komaromi, Imhof, McKechnie, and Beltran-Alvarez teach the component of claim 149, Imhof fails to teach wherein the tube has a length between 1.25 cm and 5 cm.
However Arigano teaches a hygrometry-based water loss measurement system (Abstract) where the height of the system is 1.2 cm (Fig. 3B).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the structure of Komaromi and Imhof have a height of about 1.2 cm as taught by Ariagno as a teaching for the height of Komaromi and Imhof’s tube to appropriately measure water loss. Further, it would be obvious to modify the height to be between 1.25 cm and 5 cm as an optimization of desired height for the tube [“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)].
Claim(s) 145-146 and 156-157 is/are rejected under 35 U.S.C. 103 as being unpatentable over Romem in view of Komaromi and further in view of Imhof and further in view of McKechnie and further in view of Beltran-Alvarez and further in view of Rittenmeyer et al (US 2016/0242730) (“Rittenmeyer”).
Regarding Claim 145, while Romem, Komaromi, Imhof, McKechnie, and Beltran-Alvarez teach the sensor of claim 143, their combined efforts fail to teach the sensor further comprising: a grid between the hygrometer and the ventilation opening.
However Rittenmeyer teaches a physiological monitoring device (Abstract) with monitoring components opposite a cylindrical opening, and where a protective grid is placed between the cylindrical opening and monitoring components (Fig. 1, [0013], [0015]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the protective grid of Rittenmeyer near the ventilation opening of Imhof, and thus between the hygrometer monitoring components and the opening, to protect the internal hygrometers from tampering.
Regarding Claim 146, while Romem, Komaromi, Imhof, McKechnie, and Beltran-Alvarez teach the sensor of claim 138, their combined efforts fail to teach the sensor further comprising: a grid at the ventilation opening.
However Rittenmeyer teaches a physiological monitoring device (Abstract) with monitoring components opposite a cylindrical opening, and where a protective grid is placed between the cylindrical opening and monitoring components (Fig. 1, [0013], [0015]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the protective grid of Rittenmeyer at the ventilation opening of Imhof to protect the internal hygrometers from tampering.
Regarding Claim 156, while Romem, Komaromi, Imhof, McKechnie, and Beltran-Alvarez teach the component of claim 154, their combined efforts fail to teach the component further comprising: a grid between the hygrometer and the ventilation opening.
However Rittenmeyer teaches a physiological monitoring device (Abstract) with monitoring components opposite a cylindrical opening, and where a protective grid is placed between the cylindrical opening and monitoring components (Fig. 1, [0013], [0015]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the protective grid of Rittenmeyer near the ventilation opening of Imhof, and thus between the hygrometer monitoring components and the opening, to protect the internal hygrometers from tampering.
Regarding Claim 157, while Romem, Komaromi, Imhof, McKechnie, and Beltran-Alvarez teach the component of claim 149, their combined efforts fail to teach the component further comprising: a grid at the ventilation opening.
However Rittenmeyer teaches a physiological monitoring device (Abstract) with monitoring components opposite a cylindrical opening, and where a protective grid is placed between the cylindrical opening and monitoring components (Fig. 1, [0013], [0015]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the protective grid of Rittenmeyer at the ventilation opening of Imhof to protect the internal hygrometers from tampering.
Claim(s) 147 and 158 is/are rejected under 35 U.S.C. 103 as being unpatentable over Romem in view of Komaromi and further in view of Imhof and further in view of McKechnie and further in view of Beltran-Alvarez and further in view of Rittenmeyer and further in view of Moritani et al (US 2013/0123589) (“Moritani”).
Regarding Claim 147, while Romem, Komaromi, Imhof, McKechnie, Beltran-Alvarez, and Rittenmeyer teach the sensor of claim 146, their combined efforts fail to teach the sensor wherein the hygrometer is attached to the grid.
However Moritani teaches a physiological monitoring device (Abstract) where the protective mesh can have a sensor attached to the protective mesh ([0022]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the protective grid of Rittenmeyer to have one of the humidity sensors of Komaromi and Imhof attached as taught by Moritani as a simple substitution of one set distance placement between humidity sensors for another set distance placement between humidity sensors, while maintaining a protective function for both humidity sensors.
Regarding Claim 158, while Romem, Komaromi, Imhof, McKechnie, Beltran-Alvarez, and Rittenmeyer teach the component of claim 157, their combined efforts fail to teach the component wherein the hygrometer is attached to the grid.
However Moritani teaches a physiological monitoring device (Abstract) where the protective mesh can have a sensor attached to the protective mesh ([0022]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the protective grid of Rittenmeyer to have one of the humidity sensors of Komaromi and Imhof attached as taught by Moritani as a simple substitution of one set distance placement between humidity sensors for another set distance placement between humidity sensors, while maintaining a protective function for both humidity sensors.
Response to Arguments
Applicant’s amendments and arguments filed 3/30/2026 with respect to the claim objection has been fully considered, and is persuasive. Therefore, the objection has been withdrawn.
Applicant’s amendments and arguments filed 3/30/2026 with respect to the 35 USC 112(a) rejections of claims 138 and 149 have been fully considered, and are persuasive. Therefore, the rejection has been withdrawn.
Applicant’s amendments and arguments filed 3/30/2026 with respect to the 35 USC 103 rejections of claims 138 and 149 have been fully considered, but are not persuasive.
Applicant argues that cited references do not teach or render obvious the amended language of “responsive to the communicated notification signal from the output component, compare a value of a test aspect of a test portion with a value of a reference aspect of a reference template made from one or more portions of an electrocardiogram (ECG) signal of the person, wherein the ECG signal is sensed during a first time duration and a second time duration, to determine a difference between the value of the test aspect and the value of the reference aspect;” Examiner respectfully disagrees. Examiner considers the combination of references render the limitation obvious in light of McKechnie’s page 13, Lines 25-31. McKechnie specifically states that an activation of an alert due to excessive sweating is useful as a precursor to greater scrutiny related to heart problems. If this were applied to Romem’s abnormality evaluation then the sweat monitoring of Romem, identifying sudden and profuse sweating from the teachings of McKechnie and Beltran-Alvarez, can lead to an alert/output notification directly to the processor instead of a medical practitioner to enable the identification of patient abnormality at the processor. At this point the ECG data in Romem will be specifically monitored in relation to heart problems (i.e. heart attack) and would follow the outlined steps of Applicant. The rejection stands.
Consequently, claims 139-147 and 150-158 remain rejected due to their dependency on rejected independent claims 138 and 149.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
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