Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see Remarks, filed 21 April 2026, with respect to the rejections of claims 1-4 and 6-20 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Tzvieli et al. (US 20190038180 A1).
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.
Claims 1-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Hess et al. (US 20190209044 A1) in view of Tzvieli et al. (US 20190038180 A1).
Regarding claim 1, Hess et al. discloses an inhaler monitoring system (figure 1) comprising: a medicament device (respiration device, para. 0010) configured to provide medication to a user wherein the medicament device comprises: a mouthpiece (a proximal end 76 configured to be sealably worn over a nose and/or mouth of the patient 12, para. 0097), wherein the mouthpiece comprise a sensor configured to measure an airflow through the mouthpiece and generate a signal associated with the airflow, wherein the sensor is oriented parallel to the airflow through the mouthpiece (pressure sensor 56, para. 0118), a processor (processor 70) and memory (memory 30) for storing instructions (para. 0009) that, when executed by the processor, cause the processor to:
transmit the signal from the sensor (via a transceiver 52 in electrical communication with the processor 28, and is in wireless communication with the patient interface 18 to define a wireless communication link 54, para. 0094), and facilitate an artificial reality environment (augmented reality may provide informational interactions for the patient. For example, a camera, a tablet (e.g., iPad) or smartphone can bring the patient's chosen object (e.g., animal) to life with virtually displayed information, para. 0142); and
an artificial reality headset configured to permit the user to interact in the artificial reality environment (para. 0142).
Hess et al. does not expressly disclose wherein the instructions to facilitate the artificial reality environment comprise an adherence protocol configured to modify breathing techniques.
Tzvieli et al. teaches virtual coaching wherein coaching instructions to a user include notifying a user about mouth breathing and suggesting to breathe through the nose, figure 28, suggests that next time the user should exhale while getting up, para. 0161, see also paras. 0166, 0172, 0173 for other instructions to modify breathing techniques that are protocol to prevent a severe reaction.
Hess et al. in view of Tzvieli et al. are analogous art because they are from the similar problem solving area of inhalation assistance. At the time of the invention, it would have been obvious to a person of ordinary skill in the art to add the coaching instruction procedure of Tzvieli et al. to the inhalation monitoring system of Hess et al. in order to obtain a recommended protocol for improvement of breathing technique. The motivation for doing so would be to improve a user’s inhalation for better health.
Regarding claim 2, Hess et al. discloses the inhaler monitoring system of claim 1, wherein the medicament device is a nebulizer (paras. 0090, 0145).
Regarding claim 3, Hess et al. discloses the inhaler monitoring system of claim 1, wherein the sensor measures barometric pressure (Examiner articulates that continuous PAP (CPAP) devices, spirometry devices, and other types of respiratory devices, para. 0010 measure barometric pressure).
Regarding claim 4, Hess et al. discloses the inhaler monitoring system of claim 1, wherein the sensor comprises a microphone (a small reusable wireless sensor, such as a contact microphone, may be secured to the mask 74 to sense audio vibrations through contact with the mask 74, para. 0102).
Regarding claim 5, Hess et al. discloses the inhaler monitoring system of claim 1, wherein the artificial reality environment is configured to be shared with at least other users and/or a health care provider (a nurse could have a smartphone connected via Bluetooth or Wi-Fi and be able to manually configure a breath-sensitivity level and/or one or more other parameters via that other device, para. 0176).
Regarding claim 6, Hess et al. discloses the inhaler monitoring system of claim 1, wherein the instructions to facilitate the artificial reality environment are based on a plurality of breathing measurements (para. 0142).
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.
Claims 8-12, 14-17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sezan et al. (US 20160106935 A1) in view of Rothschild et al. (US 20200126593 A1) and further in view of Tzvieli et al. (US 20190038180 A1).
Regarding claim 8, Sezan et al. discloses a method for using an inhaler monitoring system (figure 1A), the system comprising a medicament device (inhaler apparatus 154), wherein the method comprises:
receiving breathing data (using breathprint sensor system 152, para. 0051) for a user recorded by a medicament device sensor, where in the breathing data is converted to a transmission signal (receive a set of test data provided by the one or more first sensors based on an exposure of the one or more first sensors to gases during a test phase, para. 0007, 0025);
determining a plurality of breathing parameters associated with the breathing data (processors is configured to: analyze information derived from a breath sample produced by the person and determine the person has a breathing problem, para. 0017); and
responsive to receiving the breathing data, generating an interactive protocol in the artificial reality environment (a computer system to notify that an unverified person attempted to use the smart inhaler; deactivating the inhaler apparatus; prompting the person to provide an additional breath sample to the breathprint sensor system; or
prompting the person to provide alternative information to verify the person's identity
(e.g., by entering a secured password), para. 0074).
Sezan et al. does not expressly disclose a system comprising an artificial reality headset and generating an artificial reality environment associated with the plurality of breathing parameters, wherein the artificial reality environment is configured to display a user representation and provide accessibility to a shared artificial reality environment.
Rothschild et al. teaches the context of augmented or virtual reality, where the individual is wearing suitably equipped augmented reality ("AR") or virtual reality ("VR") glasses, goggles, headset or is equipped with another type of viewing display capable of rendering AR, VR, or other synthesized or real 3D imagery, the biometric data such as heart rate from the sensor, together with other data such as, for example, work-out run or speed, from a suitably equipped sensor, such as an accelerometer capable of measuring motion and velocity, could be viewable by the individual, superimposed on their viewing field, para. 0073 and that the invention is described herein in terms of certain biometric data (e.g., heart rate, breathing patterns, blood-alcohol level, etc.), para. 0051 and para. 0079.
Sezan et al. in view of Rothschild et al. are analogous art because they are from the similar problem-solving area of health monitoring. At the time of the invention, it would have been obvious to a person of ordinary skill in the art to add the augmented reality monitoring environment of Rothschild et al. to the monitoring environment of Sezan et al. in order to obtain AR monitoring using a headset. The motivation for doing so would be to visualize data for patient health.
Sezan et al. in view of Rothschild et al. does not expressly disclose facilitate an adherence protocol configured to modify breathing techniques.
Tzvieli et al. teaches virtual coaching wherein coaching instructions to a user include notifying a user about mouth breathing and suggesting to breathe through the nose, figure 28, suggests that next time the user should exhale while getting up, para. 0161, see also paras. 0166, 0172, 0173 for other instructions to modify breathing techniques that are procedures or guidelines to prevent a severe reaction.
Sezan et al. in view of Rothschild et al. in view of Tzvieli et al. are analogous art because they are from the similar problem solving area of inhalation assistance. At the time of the invention, it would have been obvious to a person of ordinary skill in the art to add the coaching instruction procedure of Tzvieli et al. to the inhaler apparatus of Sezan et al. in view of Rothschild et al. in order to obtain a recommended protocol for improvement of breathing technique. The motivation for doing so would be to improve a user’s inhalation for better health.
Regarding claim 9, Sezan et al. discloses the method of claim 8, wherein generating an interactive protocol comprises at least an adherence protocol involving use of the medicament device (the input/output device is capable of outputting information about the identity of a person determined by the breathprint sensor system 152. In some implementations, the input/output device is capable of outputting information about delivery of a drug (e.g., recommended dosage or time for administering the drug) based on information provided by the breathprint sensor system 152. For instance, the control system 156 can receive information from biological sensors of the breathprint sensor system indicative of a biological condition of the user. In response, the control system 156 may control the input/output device to output a recommendation about a dose of a drug based on the biological condition, para. 0055).
Regarding claim 10, Sezan et al. discloses the method of claim 8 further comprising, comparing the breathing parameters to a threshold for each of the plurality of breathing parameters (compare the test feature vector to a training feature vector derived from training data; and based on the comparison, determine whether the test data verifies the identity of the person, para. 0013).
Regarding claim 11, Sezan et al. discloses the method of claim 8 further comprising generating a real-time notification of the breathing data and transmitting the notification to a client device (sending a notice to another person notifying that an unverified person attempted to use the inhaler; deactivating the inhaler apparatus;
prompting the person to provide a breath sample to the breathprint sensor system, para. 0016).
Regarding claim 12, Sezan et al. discloses the method of claim 8, wherein the artificial reality environment is configured to be shared with at least other users or a health care provider (helpful for a doctor to remotely monitor an out-patient's inhalable drug administration using an automated system that can verify and keep track of the identities of patient, para. 0042).
Regarding claim 14, Sezan et al. discloses the method of claim 8 further comprising transmitting the breathing data to a remote computing device (a doctor to remotely monitor an out-patient's inhalable drug administration using an automated system that can verify and keep track of the identities of patient, para. 0042).
Regarding claim 15, Rothschild et al. discloses the method of claim 8, wherein artificial reality comprises at least one of: virtual reality, augmented reality, or mixed reality (see para. 0073).
Claim 16, a non-transitory computer readable storage medium claim, is rejected for the same reason as claim 8.
Claim 17, a non-transitory computer readable storage medium claim, is rejected for the same reason as claim 12.
Claim 19, a non-transitory computer readable storage medium claim, is rejected for the same reason as claim 10.
Claim 20, a non-transitory computer readable storage medium claim, is rejected for the same reason as claim 11.
Claims 13 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Sezan et al. (US 20160106935 A1) in view of Rothschild et al. (US 20200126593 A1) and further in view of Calvo Fernandez et al. (US 20220296827 A1).
Regarding claim 14, Sezan et al. in view of Rothschild et al. does not expressly disclose the method of claim 8, wherein determining a plurality of breathing parameters associated with the breathing data comprises a barometric pressure.
Calvo Fernandez et al. teaches a dose measuring device 1 comprises a control unit 6 (a circuit or hardware element with electronic control functions, implemented for example by means of a microcontroller), configured for detecting an inhalation produced in the inhaler 10 by means of analyzing the pressure of the air inside the inhalation mouthpiece 3, using the reading of the barometric pressure sensor 5, para. 0078.
Claim 18, a non-transitory computer readable storage medium claim, is rejected for the same reason as claim 13.
Sezan et al. in view of Rothschild et al. in view of Calvo Fernandez et al. are analogous art because they are from the similar problem-solving area of health monitoring. At the time of the invention, it would have been obvious to a person of ordinary skill in the art to add the barometric pressure sensor 5 of Calvo Fernandez et al. to the monitoring environment of Sezan et al. in view of Rothschild et al. in order to obtain useful data for patient diagnostics. The motivation for doing so would be to monitor data for patient health.
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS J LETT whose telephone number is (571)272-7464. The examiner can normally be reached Mon-Fri 9-6 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tammy Goddard can be reached at (571) 272-7773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS J LETT/ Primary Examiner, Art Unit 2611
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