DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 14 is objected to because of the following informalities:
Claim 14 recites “and circuitry configured to control the sensory stimulation device…”, should read “and a circuitry configured to control the sensory stimulation device…” for clarity.
Appropriate correction is required.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
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”) in a claim creates a rebuttable presumption that the claim limitation is not 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 not 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 function without reciting sufficient structure, material or acts to entirely perform the recited 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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: sensory stimulation device in claim 14, 17, 18, 22, 25, 30, 32.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 14, 16, 27-32 is/are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by Sur (US10517330), hereafter Sur.
Regarding Claim 14, Sur discloses a flavor inhaler (Abstract, Fig. 1, col. 4 line 30-31, “the aerosol precursor composition comprises glycerin and nicotine.”; glycerin and nicotine have flavors) comprising: a sensory stimulation device configured to generate sensory stimulation (Abstract, “to control operation of at least one functional element of the aerosol delivery device”; col. 14 line 53-67 discloses the functional element may provide visual/audible/haptic stimulation); a heart rate sensor configured to obtain a heart rate of a user: and circuitry configured to control the sensory stimulation device (col. 14 line 52-56, “Functional element(s) of the control body 102 or the aerosol delivery device 100 may be controlled in any of a number of different manners in based on the electrocardiogram signal or heart rate.”) such that a cycle of operation of the sensory stimulation device is determined based on the heart rate obtained by the heart rate sensor (col. 14 line 53-67, “The feedback may include, for example, a visual readout of the electrocardiogram signal or heart rate… In these instances, the indicator may provide the user-perceptible feedback such as an alarm, buzzer, vibration or visual indicator (e.g., LED)”; the stimulation is controlled based on the heart rate, a cycle of operation is an inherently property of the stimulation, therefore, the prior art implies that the cycle of operation is determined based on the heart rate).
Regarding Claim 16, Sur discloses the flavor inhaler as claimed in claim 14, wherein the sensory stimulation device comprises a vibrator configured to vibrate the flavor inhaler (col. 9 line 8, “Other indicators such as audio indicators (e.g., speakers), haptic indicators (e.g., vibration motors) or the like”; col. 14 line 53-67, “the indicator may provide the user-perceptible feedback such as an alarm, buzzer, vibration or visual indicator”).
Regarding Claim 27, Sur discloses the flavor inhaler as claimed in claim 14, further comprising: a heater (Fig. 2 a heater 222) configured to heat an aerosol source to generate an aerosol (col. 11 line 7-10, “when a user draws on the aerosol delivery device 100, airflow is detected by the flow sensor 210, and the heater 222 is activated to vaporize components of the aerosol precursor composition”).
Regarding Claim 28, Sur discloses the flavor inhaler as claimed in claim 27, further comprising: a liquid storage configured to store the aerosol source (Fig. 2, reservoir 218, col. 10 line 46-47, “The flavor inhaler as claimed in claim 27, further comprising: a liquid storage configured to store the aerosol source; and a liquid guide configured to guide the aerosol source from the liquid storage to the heater.”); and a liquid guide configured to guide the aerosol source from the liquid storage to the heater (Fig. 2, liquid transport element 220, col. 10 line 48-52, “The reservoir can be in fluid connection with the liquid transport element 220. The liquid transport element can transport the aerosol precursor composition stored in the reservoir via capillary action to the heater 222”).
Regarding Claim 29, Sur discloses the flavor inhaler as claimed in claim 14, further comprising: a mouthpiece (Fig. 2, cartridge shell 216) having an air outlet hole (Fig. 2, opening 224, col. 9 ;line 45-47, “An opening 224 may be present in the cartridge shell 216 (e.g., at the mouthend) to allow for egress of formed aerosol from the cartridge 104.”).
Regarding Claim 30, Sur discloses a flavor inhaler (Abstract, Fig. 1, col. 4 line 30-31, “the aerosol precursor composition comprises glycerin and nicotine.”; glycerin and nicotine have flavors) comprising: a sensory stimulation device configured to generate sensory stimulation (Abstract, “to control operation of at least one functional element of the aerosol delivery device”; col. 14 line 53-67 discloses the functional element may provide visual/audible/haptic stimulation); a communication interface configured to receive heart rate data of a user from an external device (col. 16 line 20-26, “the control component 208 is configured to cause the communication interface 246 to wirelessly communicate the electrocardiogram signal or heart rate to the computing device 302 and/or service platform 314 configured to control operation of at least one of their respective functional elements based on the electrocardiogram signal or heart rate”); and circuitry configured to control the sensory stimulation device such that a cycle of operation of the sensory stimulation device is determined based on the heart rate data received by the communication interface (col. 16 line 27-32, “the communication interface may be caused to wirelessly communicate the electrocardiogram signal. In these examples, the computing device and/or service platform may calculate the heart rate of the user from the electrocardiogram signal, and control operation of their respective functional element(s) based on the heart rate so calculated.”; col. 14 line 53-67, “The feedback may include, for example, a visual readout of the electrocardiogram signal or heart rate… In these instances, the indicator may provide the user-perceptible feedback such as an alarm, buzzer, vibration or visual indicator (e.g., LED)”).
Regarding Claim 31, Sur discloses the flavor inhaler as claimed in claim 30, wherein the communication interface is configured to perform wireless communication (col. 16 line 20-22, “the control component 208 is configured to cause the communication interface 246 to wirelessly communicate”…).
Regarding Claim 32, Sur discloses a method for operating a flavor inhaler (Abstract), the method comprising: obtaining a heart rate of a user (Abstract, “And the device includes a heart rate monitor including a plurality of biopotential electrodes affixed to the housing”): and controlling a sensory stimulation device of the flavor inhaler (col. 14 line 52-56, “Functional element(s) of the control body 102 or the aerosol delivery device 100 may be controlled in any of a number of different manners in based on the electrocardiogram signal or heart rate.”) such that a cycle of operation of the sensory stimulation device is determined based on the heart rate (col. 14 line 53-67, “The feedback may include, for example, a visual readout of the electrocardiogram signal or heart rate… In these instances, the indicator may provide the user-perceptible feedback such as an alarm, buzzer, vibration or visual indicator (e.g., LED)”; the stimulation is controlled based on the heart rate, a cycle of operation is an inherently property of the stimulation, therefore, the prior art implies that the cycle of operation is determined based on the heart rate).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 15, 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sur, in view of Moloney et al. (US20230240380), hereafter Moloney.
Regarding Claim 15, Sur discloses the flavor inhaler as claimed in claim 14, wherein the heart rate sensor comprises biopotential electrodes (col. 3 line 19), but is silent on wherein the heart rate sensor comprises a pulse wave sensor.
The sole difference between Sur and the claimed subject matter is that Sur does not disclose the heart rate sensor comprising a pulse wave sensor. Sur measures heart rate by the use of biopotential electrodes.
However, Moloney teaches an aerosol inhaler (Fig. 1, Abstract), comprising of a heart rate sensor that comprises a pulse wave sensor (par. 0153, “delivery device typically comprise an LED light source and sensor; the sensor detects reflections from the light source after it has passed through the user's skin and been reflected back at least in part by blood as it pulses through veins and arteries; the pulsing action results in a characteristic variance in the amount of light reflected, and this may be detected to determine the user's heart rate.”). Moloney further teaches that a pulse wave sensor and electrodes can be used interchangeably for detecting heart rate (par. 0153, “It will also be appreciated that similar heart rate detectors based on electrodes are available (electrocardiogram or ECG sensors), which detect the electrical activity of the heart, or variations in electrical properties associated with blood pulses.”).
Moloney shows that the use of a pulse wave sensor for detecting heart rate in use of an aerosol inhaler device was known in the prior art at the time of the invention.
Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself- that is in the substitution of the pulse wave sensor of Moloney for the biopotential electrodes of Sur.
Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious before the effective filing date of the claimed invention.
Regarding Claim 24, Sur discloses the flavor inhaler as claimed in claim 14, but is silent on wherein the heart rate obtained by the heart rate sensor is a moving average of the heart rate of the user measured over a predetermined period.
However, Moloney teaches an aerosol inhaler (Fig. 1, Abstract), comprising of a heart rate sensor (par. 0153, “delivery device typically comprise an LED light source and sensor”), wherein the heart rate obtained by the heart rate sensor is a moving average of the heart rate of the user measured over a predetermined period (par. 0154, “he user's heart rate (whether instantaneous or averaged over a predetermined period of time) may be indicative of their state, and hence may be a physical property contributing to user factors of the user feedback system.”). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known inhaler of Sur, with the inhaler of Moloney, and measure the heart rate by measuring a moving average over a predetermined period to indicate the user’s state as taught by Moloney (Moloney, par. 0154).
Regarding Claim 25, Sur discloses the flavor inhaler as claimed in claim 14, further comprising: an air flow sensor configured to detect inhalation by the user (col. 11 line 7-10, “In use, when a user draws on the aerosol delivery device 100, airflow is detected by the flow sensor 210…”), wherein the circuitry is configured to start operation of the sensory stimulation device in response to detection of the inhalation by the air flow sensor (col. 8 line 51-56, “As shown, for example, the control body can be formed of a control body shell 206 that can include a control component 208 (e.g., a microprocessor, individually or as part of a microcontroller), a flow sensor 210, a power source 212 and one or more light-emitting diodes (LEDs) 214”; col. 3 line 14-21, “a microprocessor configured to operate in an active mode in which the control body is coupled with the cartridge… a heart rate monitor including a plurality of biopotential electrodes affixed to the housing and configured to obtain biopotential measurements from a user”) (Examiner Notes: the prior art discloses an airflow sensor that detects inhalation, and the circuitry enters an active mode when inhalation is detected, the sensor, power supply, and sensory stimulation device are all electrically connected, therefore, the sensor stimulation device is inherently activated when inhalation is detected).
The sole difference between Sur and the claimed subject matter is that Sur does not disclose a pressure sensor for detecting inhalation. Sur detects inhalation by an airflow sensor.
However, Moloney teaches a pressure sensor configured to detect inhalation by the user (par. 0136, “Optionally at least one sensor of a sensor platform may be adapted to sense at least two of puff profile, puff frequency, puff duration, number of puffs, session length, peak puff pressure and determine the state/mood of the user from the sensed information.”). Moloney further teaches that an airflow sensor and a pressure sensor can be used interchangeably for detecting user inhalation (par. 0146, “may be obtained using one or more sensors of a sensor platform, such as an airflow rate sensor, air speed sensor, dynamic pressure sensor, microphone, or the like”).
Moloney shows that the use of a pressure sensor for detecting inhalation in use of an aerosol inhaler device was known in the prior art at the time of the invention.
Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself- that is in the substitution of the pressure sensor of Moloney for the airflow sensor of Sur.
Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious before the effective filing date of the claimed invention.
Regarding Claim 26, the modified Sur discloses the flavor inhaler as claimed in claim 15, wherein the pulse wave sensor is disposed on a housing of the flavor inhaler at a position accessible to be contacted by a finger of the user (Sur Fig. 1, col. 14 line 28-31; Moloney par. 0151, “heart rate detector may detect a touch and other physiological properties of the user at the same time. Such a sensor may be located on a grip part of the delivery device, for example where one or more of the user's fingers and/or where the user's palm are likely to hold the device”; the prior art teaches the heart rate sensor is located on a housing and is accessible to a finger).
Claim(s) 17-23, 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sur, in view of Northen et al. (US20210169735), hereafter Northen.
Regarding Claim 17, Sur discloses the flavor inhaler as claimed in claim 14, but is silent on wherein the circuitry is configured to set the cycle of operation of the sensory stimulation device within a range of 80% to 120% of a cycle corresponding to the heart rate obtained by the heart rate sensor.
However, Northen teaches a therapeutic sensory stimulation device (par. 0046, Fig. 1), comprising of a heart rate sensor (par. 0185, “A heart rate monitor may measure the user's heart rate…”) a sensory stimulation device (Fig. 4, motor 30 and 32, the motors are vibration motors), and a circuitry that controls the sensory stimulation device base on a hear rate of the user (par. 0113, “Using this architecture, the beat frequency 80 may conveniently and easily be designed to overlap or nearly overlap with a naturally occurring physiological rhythm, such as heart rate or respiration”). Northen further teaches wherein the circuitry is configured to set the cycle of operation of the sensory stimulation device within a range of 80% to 120% of a cycle corresponding to the heart rate obtained by the heart rate sensor (par. 0113, “by applying a beat frequency which is near, but slightly lower than the user's resting heart rate…”; par. 0183, “may include vibration and/or compression pulses that are substantially synchronous with the heart rate…”) (Examiner Notes: The prior art discloses the beat cycle can be near and substantially synchronous the user’s heart rate, the term near and substantially synchronous implies that the range in the prior art overlaps and is close to the claimed range of 80% to 120%, “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known inhaler of Sur, with the sensory stimulation device and circuitry of Northen, to adjust the user’s heart rate based on the user’s level of relaxation or arousal as taught by Northen (Northen, par. 0113, 0183).
Regarding Claim 18, Sur discloses the flavor inhaler as claimed in claim 14, but is silent on wherein the circuitry is configured to control the sensory stimulation device such that a duration of operation within one cycle of operation is greater than or equal to 0.05 seconds and less than or equal to 0.5 seconds.
However, Northen teaches a therapeutic sensory stimulation device (par. 0046, Fig. 1), comprising of a heart rate sensor (par. 0185, “A heart rate monitor may measure the user's heart rate…”) a sensory stimulation device (Fig. 4, motor 30 and 32, the motors are vibration motors), and a circuitry that controls the sensory stimulation device base on a hear rate of the user (par. 0113, “Using this architecture, the beat frequency 80 may conveniently and easily be designed to overlap or nearly overlap with a naturally occurring physiological rhythm, such as heart rate or respiration”). Norther further teaches that wherein the circuitry is configured to control the sensory stimulation device such that a duration of operation within one cycle of operation is between 0.2 and 40 seconds (par. 0423, “The input signal may have an envelope period between 0.2 seconds and 40 seconds so that the vibration producing device is modulated at least at that periodicity.”)
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the duration of operation within one cycle of operation to be greater than or equal to 0.05 seconds and less than or equal to 0.5 seconds, as applicant appears to have placed no criticality on the claimed range (See applicant’s specification, par. 0014, “a period of time for which the sensory stimulation device operates may be…”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding Claim 19, Sur discloses the flavor inhaler as claimed in claim 14, but is silent on wherein the circuitry is configured to operate in an arousal mode and a calming mode.
However, Northen teaches a therapeutic sensory stimulation device (par. 0046, Fig. 1), comprising of a heart rate sensor (par. 0185, “A heart rate monitor may measure the user's heart rate…”) a sensory stimulation device (Fig. 4, motor 30 and 32, the motors are vibration motors), and a circuitry that controls the sensory stimulation device base on a hear rate of the user (par. 0113, “Using this architecture, the beat frequency 80 may conveniently and easily be designed to overlap or nearly overlap with a naturally occurring physiological rhythm, such as heart rate or respiration”). Northen further teaches wherein the circuitry is configured to operate in an arousal mode and a calming mode (par. 0183, “The analyzer 112 may analyze the data, in order to characterize, for example, the level of relaxation or arousal that the user is presently experiencing… to apply a stress lowering algorithm to motor controllers 40-48. There stress lowering algorithm may include vibration and/or compression pulses that are substantially synchronous with the heart rate but slightly lower.”; par. 0113, “Accordingly, by applying a beat frequency which is near, but slightly lower than the user's resting heart rate, may encourage the resting heart rate to be lowered as a result”; par. 0135, “In embodiments, by creating a secondary harmonic slower than the heartbeat of the user, the device may calm the user by slowing their heartbeat. In embodiments increasing the secondary harmonic above the frequency of the heartbeat may serve to elevate the user's heartbeat, increasing their arousal state.”) (Examiner Notes: The prior art discloses determining the level of relaxation or arousal of a user, and adjusting the operation values to raise/lower the user’s heartbeat). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known inhaler of Sur, with the sensory stimulation device and circuitry of Northen, to adjust the user’s heart rate based on the user’s level of relaxation or arousal as taught by Northen (Northen, par. 0113, 0183).
Regarding Claim 20, the modified Sur discloses the flavor inhaler as claimed in claim 19,wherein in the arousal mode, the circuitry is configured to set the cycle of operation to be shorter than a cycle corresponding to the heart rate obtained by the heart rate sensor (Northen, par. 0183, par. 0113; par. 0135, “In embodiments, by creating a secondary harmonic slower than the heartbeat of the user, the device may calm the user by slowing their heartbeat. In embodiments increasing the secondary harmonic above the frequency of the heartbeat may serve to elevate the user's heartbeat, increasing their arousal state.”, a higher frequency results in a shorter cycle).
Regarding Claim 21, the modified Sur discloses the flavor inhaler as claimed in claim 19, wherein in the calming mode, the circuitry is configured to set the cycle of operation to be longer than a cycle corresponding to the heart rate obtained by the heart rate sensor (Northen, par. 0183, par. 0113, “Accordingly, by applying a beat frequency which is near, but slightly lower than the user's resting heart rate, may encourage the resting heart rate to be lowered as a result”; par. 0135, “In embodiments, by creating a secondary harmonic slower than the heartbeat of the user, the device may calm the user by slowing their heartbeat. In embodiments increasing the secondary harmonic above the frequency of the heartbeat may serve to elevate the user's heartbeat, increasing their arousal state.”; a lower frequency results in a longer cycle).
Regarding Claim 22, the modified Sur discloses the flavor inhaler as claimed in claim 19, wherein the circuitry is configured to control the sensory stimulation device such that an operation intensity in the arousal mode is greater than an operation intensity in the calming mode (Northen, par. 0183, “There stress lowering algorithm may include vibration and/or compression pulses that are substantially synchronous with the heart rate but slightly lower”) (Examiner Notes: the prior art discloses the vibration pulse is lower than the heart rate in the calming mode, see Fig. 22, a lower pulse is a lower vibrational intensity, one of ordinary skill in the art would understand that in the arousal mode, the operation intensity would be greater than the heart rate, therefore greater than the intensity in the calming mode).
Regarding Claim 23, Sur discloses the flavor inhaler as claimed in claim 14, but is silent on wherein the circuitry is configured to: compare a first heart rate obtained at a beginning of a period and a second heart rate obtained at an end of the period; and determine whether the user has been aroused or calmed based on the comparison.
However, Northen teaches a therapeutic sensory stimulation device (par. 0046, Fig. 1), comprising of a heart rate sensor (par. 0185, “A heart rate monitor may measure the user's heart rate…”) a sensory stimulation device (Fig. 4, motor 30 and 32, the motors are vibration motors), and a circuitry that controls the sensory stimulation device base on a hear rate of the user (par. 0113, “Using this architecture, the beat frequency 80 may conveniently and easily be designed to overlap or nearly overlap with a naturally occurring physiological rhythm, such as heart rate or respiration”). Northen further teaches wherein the circuitry is configured to: compare a first heart rate obtained at a beginning of a period and a second heart rate obtained at an end of the period (par. 0229, “The AI will be informed of the desired arousal state, low or high. The AI will monitor the response of the user's biometric data over a moving time window of 5 seconds to 1 minute (depending on the biometric data being used).”; par. 0179, “Numerous biometric quantities (bioinformation)can be monitored, and they may include Heart Rate (HR)”); and determine whether the user has been aroused or calmed based on the comparison (par. 0185, “For example, the user may be a patient with high levels of stress, as evidenced by an elevated heart rate”; par. 0135; par. 0183, “The analyzer 112 may analyze the data, in order to characterize, for example, the level of relaxation or arousal that the user is presently experiencing”) (Examiner Notes: The prior art teaches an AI that monitors the user’s biometric data over a time, the biometric data includes the heart rate, therefore there is inherently a first and a second heart rate throughout the time period; the prior art further teaches increasing heart rate equals to arousal, and decreasing heart rate equals to calming). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known inhaler of Sur, with the sensory stimulation device and circuitry of Northen, to measure and adjust the user’s heart rate based on the user’s level of relaxation or arousal as taught by Northen (Northen, par. 0113, 0183).
Regarding Claim 33, Sur discloses the method as claimed in claim 32, but is silent on further comprising: operating the flavor inhaler in an arousal mode or a calming mode; and adjusting the cycle of operation to be shorter than a cycle corresponding to the heart rate in the arousal mode, or longer than the cycle corresponding to the heart rate in the calming mode.
However, Northen teaches a method for delivering therapeutic vibration (Abstract), comprising of an arousal mode or a calming mode; and adjusting the cycle of operation to be shorter than a cycle corresponding to the heart rate in the arousal mode, or longer than the cycle corresponding to the heart rate in the calming mode (Northen, par. 0183, par. 0113; par. 0135, “In embodiments, by creating a secondary harmonic slower than the heartbeat of the user, the device may calm the user by slowing their heartbeat. In embodiments increasing the secondary harmonic above the frequency of the heartbeat may serve to elevate the user's heartbeat, increasing their arousal state.”, a higher frequency results in a shorter cycle). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known inhaler of Sur, with the method of Northen, to measure and adjust the user’s heart rate based on the user’s level of relaxation or arousal as taught by Northen (Northen, par. 0113, 0183).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRIS HANYU GONG whose telephone number is (703)756-5898. The examiner can normally be reached M-F 8:30-4:30.
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/KRIS HANYU GONG/Examiner, Art Unit 3785 /VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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