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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
-Fig. 3B references element 378 which is not found within the specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1, 20, 32, 44, 53 are objected to because of the following informalities:
-Claim 1 recites “determine a modification” in line 7. Examiner recommends amending to –determining a modification—
-Claim 20 recites “pressurized air a second predetermined” in lines 2-3. Examiner recommends amending to –pressurized air at a second predetermined—
-Claim 32 recites “the recommendation” in line 3. Examiner recommends amending to –the therapy recommendation—
-Claim 44 recites “wherein” in line 3. Examiner recommends amending to –and wherein—
-Claim 53 recites “the first sensor” in line 6. Examiner recommends amending to –the first one of the one or more sensors—
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:
-Claim 44 recites “user interface” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to engage a portion of the user. According to the specification the user interface includes full face mask, nasal pillows mask, nasal mask [0172] and equivalents thereof.
-Claim 52 recites “electronic interface” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to receive physiological data associated with a user. According to the specification the electronic interface includes an antenna, receiver (RF receiver), transmitter (RF transmitter), transceiver [0042] and equivalents thereof.
-Claim 52 recites “control system” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to execute the machine-readable instructions. According to the specification the control system includes a processor located in a cloud, server, IoT device, [0097] and equivalents thereof.
-Claim 53 recites “one or more sensors/first sensor” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to generate physiological data associated with the user when the user is wearing the user interface and when the user is not wearing the user interface. According to the specification the sensors include EEG, ECG, EMG, EOG, acoustic, SpO2, GSR, CO2, O2, pressure, temperature, motion, microphone, flow, tension [0116-0117] and equivalents thereof.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, 3, 7, 8, 9, 10, 14, 16, 17, 18, 19, 20, 22, 27, 28, 32, 33, 36, 39, 40, 41, 44, 52, 53 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
-Claim 1 recites “a first emotion score” in line 3. It is unclear what is meant by an emotion score if the score as indicated in the claim is based on physiological data. While the specification discusses the emotion score being associated with anxiety/stress, it is not clear how the physiological data would determine scores in regards to this data. Further clarification should be provided.
-The term “at least in part” in claim 1 is a relative term which renders the claim indefinite. The term “at least in part” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While the specification references “at least in part” in regards to certain instances of physiological data, it does not further define what at least in part constitutes and whether it includes any amount, a defined quantity, or none. Further clarification should be provided.
-Claim 3 recites “visual prompt…or both, the visual prompt including…light source” in lines 2-3. It is unclear whether the limitation involving the light source is required by the claim since the visual prompt is listed in the alternative. Further clarification should be provided.
-Claim 8 recites “respiration rate” in line 2. It is unclear whether this is the same or different from the respiration rate originally referenced in claim 7, line 2. Further clarification should be provided.
-The term “at least in part” in claim 8 is a relative term which renders the claim indefinite. The term “at least in part” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While the specification references “at least in part” in regards to certain instances of physiological data, it does not further define what at least in part constitutes and whether it includes any amount, a defined quantity, or none. Further clarification should be provided.
-Claim 9 recites “the light source” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
-Claim 22 recites “the predetermined threshold” in line 3. There is insufficient antecedent basis for this limitation in the claim.
-Claim 28 recites “the implementation of the determined modification” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
-Claim 28 recites “a second emotion score” in line 6. It is unclear what is meant by a second emotion score if the score as indicated in the claim is based on second physiological data. While the specification discusses the emotion score being associated with anxiety/stress, it is not clear how the physiological data would determine scores in regards to this data. Further clarification should be provided.
-The term “at least in part” in claim 28 is a relative term which renders the claim indefinite. The term “at least in part” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While the specification references “at least in part” in regards to certain instances of physiological data, it does not further define what at least in part constitutes and whether it includes any amount, a defined quantity, or none. Further clarification should be provided.
-The term “at least in part” in claim 32 is a relative term which renders the claim indefinite. The term “at least in part” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While the specification references “at least in part” in regards to certain instances of physiological data, it does not further define what at least in part constitutes and whether it includes any amount, a defined quantity, or none. Further clarification should be provided.
-Claim 39 recites “at least a portion of the first sleep session” in lines 3-4. It is unclear whether this is the same or different from “at least a portion of a first sleep session” in claim 39, line 2. Further clarification should be provided.
-Claim 40 recites “a second emotion score” in line 4. It is unclear what is meant by a second emotion score if the score as indicated in the claim is based on second physiological data. While the specification discusses the emotion score being associated with anxiety/stress, it is not clear how the physiological data would determine scores in regards to this data. Further clarification should be provided.
-The term “at least in part” in claim 40 is a relative term which renders the claim indefinite. The term “at least in part” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While the specification references “at least in part” in regards to certain instances of physiological data, it does not further define what at least in part constitutes and whether it includes any amount, a defined quantity, or none. Further clarification should be provided.
-Claim 41 recites “the one or more prompts for aiding in modifying the determined first emotion score” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
-Claim 44 recites “the implementation of the determined modification” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
-Claim 52 recites “an emotion score” in line 6. It is unclear what is meant by an emotion score if the score as indicated in the claim is based on physiological data. While the specification discusses the emotion score being associated with anxiety/stress, it is not clear how the physiological data would determine scores in regards to this data. Further clarification should be provided.
-The term “at least in part” in claim 52 is a relative term which renders the claim indefinite. The term “at least in part” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While the specification references “at least in part” in regards to certain instances of physiological data, it does not further define what at least in part constitutes and whether it includes any amount, a defined quantity, or none. Further clarification should be provided.
-Claim 53 recites “when the user is wearing the user interface” in lines 7-8. It is unclear whether the limitation involving the user interface is required by the claim since the user interface is listed in the alternative in claim 53, lines 2-3. Further clarification should be provided.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1, 2, 3, 7, 8, 9, 10, 14, 16, 17, 18, 19, 20, 22, 27, 28, 32, 33, 36, 39, 40, 41, 44, 52, 53 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recites(s) a series of mental processes used to determine a modification of one or more settings of a respiratory therapy system. This judicial exception is not integrated into a practical application because the control system including one or more processors is recited as performing the generic computer function of determining values and modifying one or more settings of a respiratory therapy system. The control system executing machine readable instructions and a process of calculating scores and comparing these values is a generic function of computer-readable media. Further, mere instructions to apply a judicial exception using a generic control system does not impose meaningful limits on practicing the abstract idea. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements recited in claims 1, 2, 3, 7, 8, 9, 10, 14, 16, 17, 18, 19, 20, 22, 27, 28, 32, 33, 36, 39, 40, 41, 44, 52, 53 do not apply or use the judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition.
An analysis of the claims is shown below:
Step 1: Claims 1, 2, 3, 7, 8, 9, 10, 14, 16, 17, 18, 19, 20, 22, 27, 28, 32, 33, 36, 39, 40, 41, 44, are directed towards a method which is a statutory category of invention. Claims 52 and 53 are directed towards a system, which is a statutory category of invention.
Step 2A, prong 1: Claim 1 recites limitations that are directed to an abstract idea. Claim 1 recites determine a modification of one or more settings of a respiratory therapy system. Claim 52 recites modify one or more settings of a respiratory therapy system. These limitations, under their broadest reasonable interpretation, fall within the mental processes grouping of abstract ideas. It would be practically performable in a human’s mind, or with pen and paper, to determine a modification of one or more settings of a respiratory therapy device. Analyzing information and making a determination based on information is akin to an observation, evaluation or judgement that defines the mental process grouping. Independent claim 1 does not require use of the therapy system or any modification made to the system. Independent claim 52 doesn’t require configuration, use or modification of the system. While the limitations of claim 52 do specify modifying a setting, this could equate to making a decision that the setting should be changed based on data collected. Thus claims 1 and 52 are directed to a judicial exception, an abstract idea.
Step 2A, prong 2: Claims 1, 2, 3, 7, 8, 9, 10, 14, 16, 17, 18, 19, 20, 22, 27, 28, 32, 33, 36, 39, 40, 41, 44, 52, 53 do not recite additional elements that integrate the judicial exception into a practical application. Claims 1, 2, 3, 7, 8, 9, 10, 14, 16, 17, 18, 19, 20, 22, 27, 28, 32, 33, 36, 39, 40, 41, 44, 52, 53 recite the following additional elements:
-respiratory therapy system (claim 1, 52, 53)
-light source (claim 3)
-user device (claim 10)
-transducer (claim 14)
-respiratory therapy device (claim 17, 52)
-user interface (claim 18, 53)
-alternative medical device (claim 36)
-vent (claim 44)
-electronic interface (claim 52)
-memory (claim 52)
-control system (claim 52)
-conduit (53)
-one or more sensors (claim 53)
The respiratory therapy system, light source, user device, transducer, respiratory therapy device, user interface, alternative medical device, vent, electronic interface, memory, control system, conduit, one or more sensors are generically recited at a high level of generality. Further, mere instructions or programs to apply judicial exception using a generic control system independently does not impose meaningful limits on practicing the abstract idea.
Most notably, none of the additional elements recited in these claims apply or use the judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition. While the bodies of these claims discuss aspects related to respiration during sleep, modifying a respiration rate, emitting light pulses, supplying pressurized air and respiratory therapy, there is no claim limitation that recites a particular treatment method.
Thus claims 1, 2, 3, 7, 8, 9, 10, 14, 16, 17, 18, 19, 20, 22, 27, 28, 32, 33, 36, 39, 40, 41, 44, 52, 53 do not integrate the abstract idea into a practical application.
Step 2B: When considered individually and in combination, the claims do not recite additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to the integration of the abstract idea into a practical application, the additional elements of the determining first emotion scores, deterring prior emotion scores, determining whether first emotion scores satisfy a predetermined condition, determining a modification of settings, communicating prompts, modifying respiration rate of the user, determining that the first emotion score is less than the predetermined threshold, implementation of the determined modification of settings, determining second emotion score, further modifying one or more settings in response to the second emotion score not satisfying the predetermined condition, communicating recommendations, determining second emotion scores relative to prior emotion scores, determining the difference in prompts are also generically recited at a high level of generality. Mere determination or execution or control of a control system of a respiratory therapy device to apply a judicial exception using a generic setting of respiratory therapy equipment does not impose meaningful limits on practicing the abstract idea. Furthermore, the processes and steps can be considered nonfunctional descriptive material because there are no elements that show how the modification of settings occurs or how these processes interact with the control system of the respiratory therapy device.
In reconsidering the additional elements of the respiratory therapy system and methods, the additional elements were determined to be well-understood, routine and conventional based on the following evidence:
-Lee et al. U.S. 20180153440 discloses a respiratory therapy system [0046; “oximonitor system”], light source [0059; “light sources”], user device [0064; “display screen”], transducer [0062; “pressure transducers”], respiratory therapy device [0046; “CPAP”], user interface [0046; “face mask”], alternative medical device [0169; “nasal prongs/cannulas, face masks, venturi masks, nebulizer, CPAP masks, IPPV/NIPPV masks, or transtracheal catheters.”], vent [0050], electronic interface [0049; “Measurement sub-systems may be configured to communicate analog and/or digital signals to controller 210 via the respective connections.”], memory [0082; “non-volatile memory”], control system [0046; “control unit”], conduit [0050; “exit conduits”], one or more sensors [0067] in reference to a therapeutic device and method that provides respiratory characteristics of an individual. Therefore, these elements are demonstrated to be generic, well understood components that are commonly recited in the art.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 14, 16, 22, 32, 33, 36, 52 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Freeman (WO 2018085563).
Regarding Claim 1, Freeman teaches a method comprising: receiving first physiological data associated with a user [Pg. 15, lines 9-11]—reference to sensors acquiring physiological data; determining a first emotion score associated with the user based at least in part on the first physiological data [Pg. 15, line 14]—reference to calculating early warning score and [Pg. 62, lines 3-15]—reference to an early warning score being calculated by prediction/prevention of disease state and distress, due to the indefinite nature of the claim and the reference in the specification to the emotion score including that of stress, the early warning score is interpreted to be the first emotion score, the first emotion score being determined relative to a prior emotion score at which the user was able to fall asleep [Pg. 70, lines 16-19]—reference to comparison to baseline values measure before surgery, [Abstract; “calculates the early warning score, and compares to the early waring score to predetermined limits”] and [Pg. 71, lines 10-11]—reference to patient under the effects of anesthesia, interpreted to be user was able to fall asleep; and responsive to determining that the first emotion score satisfies a predetermined condition [Pgs. 53-54, lines 29-5; “In one embodiment, the RHI 30 is coupled with alarms that sound either when respiration falls below what is deemed as adequate, or within the range that is deemed adequate, if the patient experiences a very sudden change. In one embodiment, the device provides information to calculate an RHI. Preferably the device calculates and displays the RHI. In one embodiment, the Respiratory Health Index is compared against a universal calibration based on patient characteristics. In one embodiment, the RHI provides quantitative data with the system calibrated to a specific patient.”], determine a modification of one or more settings of a respiratory therapy system [Abstract; “if the score is outside the limits, triggers an alarm or actuates or modifies a treatment or medical intervention.”], and [Pg. 14, lines 16-26]—with reference to numerous respiratory therapies and systems such as CPAP, BiPAP and mechanical ventilation.
Regarding Claim 2, Freeman teaches further comprising causing one or more prompts to be communicated to the user to aid in modifying the first emotion score [Pg. 63, lines 1-7]—reference to external entry of data regarding the early warning scoring system and patient data, [Pg. 41, line 15; “The user is prompted to enter patient data.”]
Regarding Claim 3, Freeman teaches wherein the one or more prompts include a visual prompt, an audio prompt, or both [Pg. 60, lines 13-14; “If the score exceeds a predetermined level, one or more alarms (audible and/or visual) may be activated.”], the visual prompt including light emitted from a light source, this limitation is interpreted as not being required due to the indefinite nature of the claim.
Regarding Claim 14, Freeman teaches wherein the audio prompt is communicated to the user via a transducer [Pg. 19, lines 19-22]—reference to a microphone/speaker providing an assessment of the subject.
Regarding Claim 16, Freeman teaches wherein the determining the first emotion score associated with the user includes determining a movement, a respiration rate, a respiration rate variability, a respiration depth, a tidal volume, an inspiration amplitude, an inspiration duration, an expiration amplitude, an expiration duration, an inspiration-expiration ratio, a heart rate, a heart rate variability, a cardiac waveform, perspiration, blood oxygenation, blood pressure, peripheral arterial tone, cardiogenic oscillations, a galvanic skin response, a sympathetic nervous system response, a skin temperature, an ambient temperature, photoplethysmography, pulse transit time, a core body temperature, a trend associated with the respiration rate, a trend associated with the heart rate, a trend associated with the galvanic skin response, or any combination thereof [Pg. 60, lines 8-20]—with reference to respiration rate, tidal volume, oxygen saturation, blood pressure, heart rate, unresponsiveness/movement.
Regarding Claim 22, Freeman teaches wherein the determining that the first emotion score satisfies the predetermined condition includes determining that the first emotion score is less than the predetermined threshold [Pg. 45-46, lines 29-3]—reference to the impedance, tidal volume or minute volume (interpreted to be the first emotion score) varying from the baseline by a certain percentage.
Regarding Claim 32, Freeman teaches further comprising determining a therapy recommendation for the user based at least in part on the first emotion score and causing an indication of the recommendation to be communicated to the user, a third party, or both [Pg. 69, lines 10-23]—references the system making recommendations to the user involving further therapeutic steps (i.e. use of inhaler, repeating dosage, call physician or go to the hospital).
Regarding Claim 33, Freeman teaches wherein the therapy recommendation includes (a) a recommendation to modify a type of user interface for the respiratory therapy system and/or (b) a medication recommendation [Pg. 69, lines 16-21]—recommendation to use inhaler or repeat dosage (medication recommendation).
Regarding Claim 36, Freeman teaches wherein the therapy recommendation includes (a) a recommendation to cease using the respiratory therapy system and/or (b) a recommendation to use an alternative medical device [Pg. 69, lines 19-20]—reference to needs no further therapy (recommendation to cease using therapy device) and [Pg. 69, lines 16-17]—discusses use of an inhaler (alternative medical device).
Regarding Claim 52, Freeman teaches a system comprising: an electronic interface configured to receive physiological data associated with a user [Pg. 34, lines 22-23]—reference to transmitter receiver and remote probes including an array of electrodes to collect physiological data [Pg. 34, lines 3-6]; a memory storing machine-readable instructions [Pg. 23, lines 1-3]—reference to memory and [Pg. 23, lines 13-15]—reference to storage computer readable instructions; and a control system including one or more processors [Pg. 23, lines 20-24]—reference to CPUs and MPs, configured to execute the machine- readable instructions [Pg. 24, lines 13-14] to: determine an emotion score associated with the user based at least in part on the physiological data [Pg. 15, line 14]—reference to calculating early warning score and [Pg. 62, lines 3-15]—reference to an early warning score being calculated by prediction/prevention of disease state and distress, due to the indefinite nature of the claim and the reference in the specification to the emotion score including that of stress, the early warning score is interpreted to be the first emotion score, the emotion score being determined relative to a prior emotion score at which the user was able to fall asleep [Pg. 70, lines 16-19]—reference to comparison to baseline values measure before surgery, [Abstract; “calculates the early warning score, and compares to the early waring score to predetermined limits”] and [Pg. 71, lines 10-11]—reference to patient under the effects of anesthesia, interpreted to be user was able to fall asleep; and modify one or more settings of a respiratory therapy system responsive to determining that the emotion score satisfies a predetermined condition [Abstract; “if the score is outside the limits, triggers an alarm or actuates or modifies a treatment or medical intervention.”], [Pg. 14, lines 16-26]—with reference to numerous respiratory therapies and systems such as CPAP, BiPAP and mechanical ventilation and [Pgs. 53-54, lines 29-5; “In one embodiment, the RHI 30 is coupled with alarms …specific patient.”].
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) 7, 8, 9, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freeman (WO 2018085563) in view of Yun (U.S. 20190240468).
Regarding Claim 7, Freeman is silent on wherein the one or more prompts include a breathing exercise to aid in modifying a respiration rate of the user. Yun teaches wherein the one or more prompts include a breathing exercise to aid in modifying a respiration rate of the user [0088]—reference to breathing exercise that includes metered breathing.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate breathing exercises as taught by Yun to modify a respiration rate as suggested by Freeman, as Freeman discusses using respiration rate to derive the patients state and output early warning scores [Pg. 61, lines 5-7] with Yun because Yun teaches the breaths being metered at a rate above or below a respiratory rate [0088].
Regarding Claim 8, Freeman further teaches wherein the determining the first emotion score associated with the user includes determining a respiration rate associated with the user based at least in part on the first physiological data [Pg. 61, lines 5-7]—reference to determining a respiration rate in combination with other sensor data to determine early warning score—interpreted to be the first emotion score.
Regarding Claim 9, Freeman is silent on wherein one or more light pulses are emitted from the light source at a predetermined frequency to aid in modifying the respiration rate associated with the user. Yun teaches wherein one or more light pulses are emitted from the light source at a predetermined frequency to aid in modifying the respiration rate associated with the user [0074]—reference to light applied to a subject at pulsed frequencies and [0103]—includes combinatorial modulation with light and breathing exercises.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use light pulses as taught by Yun to modify a respiration rate as suggested by Freeman, as Freeman discusses using respiration rate to derive the patients state and output early warning scores [Pg. 61, lines 5-7] with Yun because Yun teaches the breaths being metered at a rate above or below a respiratory rate and controlled by a combination of light and breathing exercises [0103].
Regarding Claim 10, Freeman is silent on wherein the light source is physically coupled to or integrated in (a) a user device or (b) a portion of the respiratory therapy system. Yun teaches wherein the light source is physically coupled to or integrated in (a) a user device or (b) a portion of the respiratory therapy system [0082]—reference to user devices including wristbands, etc. to which a user device is interpreted to be a wearable device.
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 light source into a user device as taught by Yun to emit a visual stimulus to the user as suggested by Freeman, as Freeman discusses activating a visual alarm [Pg. 60, line 14] with Yun because Yun teaches the use of optical light to modulate the autonomic nervous system [0038].
Claim(s) 17-20, 27, 28, 39-41, 44, 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freeman (WO 2018085563) in view of Wren (U.S. 20220339380).
Regarding Claim 17, Freeman is silent on wherein the modification of the one or more settings of the respiratory therapy system causes a respiratory therapy device of the respiratory therapy system to supply pressurized air at a predetermined pressure. Wren teaches wherein the modification of the one or more settings of the respiratory therapy system causes a respiratory therapy device of the respiratory therapy system to supply pressurized air at a predetermined pressure [Fig. 2, elements 122 (respiratory therapy device) and 100 (respiratory therapy system)] and [0033]—reference to the respiratory device generating and supplying pressurized air at predetermined pressures.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide pressurized air at predetermined pressures as taught by Wren to the user by means of the respiratory therapy device as suggested by Freeman, as Freeman discusses using CPAP to provide mild air pressure on a continuous basis [Pg. 14, lines 13-16] with Wren because Wren teaches the use of this mechanism to prevent the individual’s airway from narrowing or collapsing during sleep [0003].
Regarding Claim 18, Freeman is silent on wherein the first physiological data is received when the user is wearing a user interface of the respiratory therapy system. Wren teaches wherein the first physiological data is received when the user is wearing a user interface of the respiratory therapy system [0005]—reference to the user engaged with the user interface of the respiratory device to supply pressurized air and generate first physiological data during a sleep session.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a user interface as taught by Wren for the user to wear when collecting data as suggested by Freeman, as Freeman discusses the patient wearing a High-Frequency Chest Wall Oscillation vest with a CPAP [Pg. 14, lines 16-23] with Wren because Wren teaches the use of the data collected during sleep to determine sleep-related parameters and generate reports indicative of sleep quality [0003].
Regarding Claim 19, Freeman is silent on wherein the respiratory therapy system supplies pressurized air at a first predetermined pressure prior to determining that the first emotion score satisfies the predetermined condition. Wren teaches wherein the respiratory therapy system supplies pressurized air at a first predetermined pressure prior to determining that the first emotion score satisfies the predetermined condition [0040]—discusses delivering pressurized air after the system has obtained respiration data from the user but prior to delivering a second predetermined pressure where the predetermined condition is interpreted to be regulating the second predetermined pressure to be lower than of the first predetermined pressure.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a first predetermined pressure as taught by Wren based on data collected from the user as suggested by Freeman, as Freeman discusses the use of CHFO, CPAP, BiPAP and CPEP that communicates with a sensor that acquires physiological bioelectrical impedance signal [Pg. 76, lines 22-28] with Wren because Wren teaches configuring the respiratory device to deliver two or more predetermines pressures within a predetermined range [0033].
Regarding Claim 20, Freeman is silent on wherein the modification of the one or more settings of the respiratory therapy system causes the respiratory therapy system to supply pressurized air a second predetermined pressure that is different than the first predetermined pressure. Wren teaches wherein the modification of the one or more settings of the respiratory therapy system causes the respiratory therapy system to supply pressurized air a second predetermined pressure that is different than the first predetermined pressure [0040]—discusses delivering pressurized air after the system has obtained respiration data from the user but prior to delivering a second predetermined pressure where the predetermined condition is interpreted to be regulating the second predetermined pressure to be lower than that of the first predetermined pressure.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a second predetermined pressure different than the first predetermined pressure as taught by Wren based on data collected from the user as suggested by Freeman, as Freeman discusses the use of CHFO, CPAP, BiPAP and CPEP that communicates with a sensor that acquires physiological bioelectrical impedance signal [Pg. 76, lines 22-28] with Wren because Wren teaches configuring the respiratory device to deliver two or more predetermines pressures within a predetermined range [0033].
Regarding Claim 27, Freeman is silent on wherein at least a portion of the first physiological data is associated with at least a portion of a first sleep session of the user. Wren teaches wherein at least a portion of the first physiological data is associated with at least a portion of a first sleep session of the user [Abstract; “A method includes receiving, from a first sensor, first physiological data associated with a first sleep session of a user.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to collect physiological data during a first sleep session as taught by Wren to associate this data with user sleep as suggested by Freeman, as Freeman discusses the patient’s disease states which include sleep disorders that the early warning signs are based on [Pg. 62, lines 23-28] with Wren because Wren teaches the user interface engaging the user during sleep sessions and generating respirator data associated with the user during these sessions [0008].
Regarding Claim 28, Freeman is silent on further comprising: receiving second physiological data associated with the user subsequent to the implementation of the determined modification of one or more settings of the respiratory therapy system, the second physiological data being associated with a first sleep session of the user; determining a second emotion score associated with the user based at least in part on the second physiological data, the second emotion score being determined relative to the prior emotion score; and further modifying the one or more settings of the respiratory therapy system responsive to determining that the second emotion score does not satisfy the predetermined condition. Wren teaches further comprising: receiving second physiological data associated with the user subsequent to the implementation of the determined modification of one or more settings of the respiratory therapy system [Fig. 4, elements 406 (the implementation of the determined modification of one or more settings) and 407 (receiving second physiological data)]—in this interpretation, Wren also teaches that the physiological data can include subjective stress reporting according to [0030] and [0076] therefore, the second physiological data is interpreted to be this self-report and/or second data collected and physiological data collected from the second sensors, the second physiological data being associated with a first sleep session of the user [Fig. 3, element 302 (second physiological data associated with the sleep session)]; determining a second emotion score associated with the user based at least in part on the second physiological data [0030]—as described above and [Fig. 3, element 304 (analysis of second physiological data to determine second set of sleep parameters)], the second emotion score being determined relative to the prior emotion score [0077]—references include data related to first pattern of events, average events per hour, etc. which is interpreted to be prior emotion score and further reference to this data collected prior to calibrating the second sensor collecting the second physiological data; and further modifying the one or more settings of the respiratory therapy system responsive to determining that the second emotion score does not satisfy the predetermined condition [0077]—reference to analyzing second physiological data and basing this analysis on the first physiological data to determine what events the user is experiencing and [0078]—disclosing modifying one or more parameters of the sensors based on first and second data collected followed by recharacterization and further adjustment of the parameters.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use secondary physiological data as taught by Wren to adjust non-invasive respiratory therapy as suggested by Freeman, as Freeman discusses taking a second set of RVM data and comparing this data to previous data collected [Pg. 69, lines 17-18] with Wren because Wren teaches the use of first and second physiological data to determine sleep-related parameters and/or generate reports indicating sleep quality [0003].
Regarding Claim 39, Freeman is silent on wherein the first physiological data is generated during at least a portion of a first sleep session and the user uses the respiratory therapy system with the modified one or more settings during at least a portion of the first sleep session. Wren teaches wherein the first physiological data is generated during at least a portion of a first sleep session [Fig. 4, elements 402 and 403]—with particular reference to first and second data analyzed to determine parameters during first portion of the sleep session, and the user uses the respiratory therapy system with the modified one or more settings during at least a portion of the first sleep session [0098]—reference to modifying parameters during the sleep session shown in [Fig. 4.] process, interpreted to be the first sleep session.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use secondary physiological data as taught by Wren to deliver and control treatments as suggested by Freeman, as Freeman discusses using scoring systems to deliver or control treatment or medical intervention when patient condition changes are detected [Pgs. 63-64, lines 30-5] with Wren because Wren teaches modification of the parameters including characterizing and adjustment followed by further recharacterization [0078].
Regarding Claim 40, Freeman is silent on further comprising: receiving second physiological data associated with the user during at least a portion of a second sleep session that is subsequent to the first sleep session; determining a second emotion score associated with the user based at least in part on the second physiological data, the second emotion score being determined relative to the prior emotion score; and causing one or more prompts to be communicated to the user to aid in modifying the determined second emotion score. Wren teaches further comprising: receiving second physiological data associated with the user during at least a portion of a second sleep session that is subsequent to the first sleep session [0080]—references the method 300 repeated a plurality of times which includes steps 301-305, the second sleep session is interpreted to be the second repetition of the method with reference to “a sleep session”; determining a second emotion score associated with the user based at least in part on the second physiological data [Fig. 4, elements 406 (the implementation of the determined modification of one or more settings) and 407 (receiving second physiological data)]—in this interpretation, Wren also teaches that the physiological data can include subjective stress reporting according to [0030] and [0076] therefore, the second physiological data is interpreted to be this self-report and/or second data collected and physiological data collected from the second sensors, the second emotion score being determined relative to the prior emotion score; and causing one or more prompts to be communicated to the user to aid in modifying the determined second emotion score [0077]—references include data related to first pattern of events, average events per hour, etc. which is interpreted to be prior emotion score and further reference to this data collected prior to calibrating the second sensor collecting the second physiological data and [Fig. 5, element 508 (display a prompt requesting feedback from the user] and [0112]-further describing the feedback collected by the prompt.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to repeat the method described including secondary data as taught by Wren to communicate a recommendation or prompt to the user as suggested by Freeman, as Freeman discusses using data to prompt a patent to perform an action [Pg. 69, lines 1-4] with Wren because Wren teaches using the patient feedback to determine further metrics related to quality of life and sleep scores [0114].
Regarding Claim 41, Freeman further teaches wherein the one or more prompts for aiding in modifying the determined second emotion score are different than the one or more prompts for aiding in modifying the determined first emotion score. Wren teaches wherein the one or more prompts for aiding in modifying the determined second emotion score are different than the one or more prompts for aiding in modifying the determined first emotion score [0078]—discusses prompting the user to follow instructions and modify parameters of the device in comparison to [0112]—which discusses prompting to user to provide feedback.
Regarding Claim 44, Freeman teaches wherein the respiratory therapy system includes a user interface configured to engage a portion the user [Fig. 41, element “face mask”], Freeman is silent on the user interface including a vent, wherein the implementation of the determined modification of the one or more settings of the respiratory therapy system includes modifying a position of the vent. Wren teaches the user interface including a vent [0035], wherein the implementation of the determined modification of the one or more settings of the respiratory therapy system includes modifying a position of the vent [0035]—reference to repositioning device.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include vents in the user interface as taught by Wren to regulate optimize O2 and CO2 levels in the patient as suggested by Freeman, as Freeman discusses using a HFCWO to increase turbulence in the lungs during inhalation and exhalation to achieve better O2 and CO2 transfer [Pg. 75, lines 10-15] with Wren because Wren teaches creating an air tight seal between the user interface and the user [0035].
Regarding Claim 53, Freeman teaches further comprising: the respiratory therapy system including a respiratory therapy device, a conduit, a user interface, or any combination thereof [Fig. 41, element “face mask”], [Pg. 76, lines 20-24] and [Pg. 71, lines 3-9] and one or more sensors configured to generate the physiological data [Pg. 15, lines 9-10]; wherein a first one of the one or more sensors is physically coupled to or integrated in the respiratory therapy system [Fig. 41, element “RVM electrode”]—depicting wired connection with the ventilator, the first sensor being configured to generate physiological data associated with the user when the user is wearing the user interface[Fig. 41, element “RVM electrode”]—depicting user wearing the RVM and [Pg. 72, lines 15-17]—describing the electrodes collecting continuous or intermittent measurements where physiological data is interpreted to be the respiratory volume monitoring data;
Freeman is silent on and wherein a second one of the one or more sensors is configured to generate physiological data associated with the user when the user is not wearing the user interface. Wren teaches and wherein a second one of the one or more sensors is configured to generate physiological data associated with the user when the user is not wearing the user interface [0069].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to allow for physiological measurement during and periods of time where the user is wearing and not wearing the mask interface of the device as taught by Wren to continuously or intermittently collect data as suggested by Freeman, as Freeman discusses providing trending data [Pg. 72, lines 15-17] with Wren because Wren teaches determining and quantifying differences between wearing the respirator and not wearing the system to show difference in sleep quality and to encourage and incentivize users to use the system and adhere to prescribed usage [0069].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-Tiron (WO 2020104465)-discloses screening people with disordered sleep breathing states
-Meger (U.S. 20180220897)-discusses health scores in reference to person with sleep apnea undergoing PAP
-Youngblood (U.S. 20200077942)-includes references to breathing exercises
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791