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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 42, 43, 77, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Gradon (US 2005/005935, hereinafter Gradon in view of Holley et al (US 2011/0313689), hereinafter Holley.
Regarding claim 42, Gradon teaches a system for monitoring an airway of an individual (Figs. 1-2, paragraph 57, a method and apparatus for detecting apneas), the system comprising:
a respiratory system (Fig. 1) including: a respiratory device configured to supply pressurized air (Fig. 1: CPAP with blower 15, paragraph 60, blower provides pressurized air); and
a user interface coupled to the respiratory device via a conduit (Fig. 1: mask 2, conduit 3, paragraph 58) the user interface being configured to engage the individual and aid in directing the supplied pressurized air to the airway of the individual (paragraph 58, receives humidified and pressurized gas through nasal mask 2);
a memory storing machine-readable instructions (paragraph 58, electronic controller executing computer software commands stored in associated memory); and
a control system including one or more processors configured to execute the machine- readable instructions (paragraph 58, controller 9) to:
cause an acoustic signal to be directed, the user interface into the airway of the individual; (Paragraph 62, Fig. 2, transmitting ultrasonic transducer 201 emits an ultrasonic signal which is transmitted through the patient’s airways and will be reflected from various structures within the upper respiratory tract and back to the receiving transducer.)
generate acoustic data representative of one or more reflections of the acoustic signal (Paragraphs 62, the ultrasonic signal is reflected and received at receiving transducer- 63, the signal received back is analyzed ) caused by (i) a portion of the airway of the individual, (paragraph 63, may be caused by a narrowing of the airway) (ii) an obstruction within the airway of the individual, (paragraph 63, may be caused by a narrowing of the airway) or (iii) both (i) and (ii);
analyze the acoustic data to determine a value of a parameter associated with the airway of the individual; (Paragraph 63, the distance along the respiratory tract can be determined, paragraph 68, can diagnose or measure an obstruction in or narrowing of a patient’s airway tract) and
based on the determined value of the parameter, cause an action to be performed.(paragraph 68, treat the obstruction or narrowing accordingly, paragraph 62, may increase pressure for a narrowing of the airway)
Gradon teaches that the acoustic signal is directed the user interface but does not teach to cause the acoustic signal to be directed via the conduit and through the mask or comparing the determined value with a previously obtained baseline value.
However, Holley teaches an acoustic detection for a respiratory treatment apparatus (Abstract, Fig. 1) which teaches that the acoustic signal is directed through the conduit and the user interface. (Fig. 13: the noise source is the sound created by a flow generator so the noise would flow through the conduit and user interface, paragraph 68)
Holley further teaches compare the determined value of the parameter with a previously obtained baseline value of the parameter, where the baseline value of the parameter is previously obtained from the individual at a first time, and the determined value of the parameter is determined at a second time that is after the first time; (Paragraph 88, detecting a change may be based on the acoustic reflection by comparison to when it was unobstructed, Paragraph 113, acoustic reflection data may be analyzed to detect lung condition and/or monitor changes in lung condition. An apparatus may be configured to measure the acoustic reflection from the lungs over several days and then compare the data, paragraph 123, assessment may be made by comparison of current reflection data with prior reflection data)
based at least in part on the comparison, determine whether the individual has a respiratory associated disease or condition (Paragraph 88, paragraph 113, an obstruction or lung condition), and
responsive to a determination that the individual has a respiratory associated disease or condition, cause and action to be performed. (Paragraph 152, based on results closed airways or increased resistance may be detected. Depending on the problem or issue detected, the therapy may be adjusted accordingly)
It would have been obvious to a person of ordinary skill in the art to modify the device of Gradon to substitute the sound source with the flow generator as taught by Holley in order to use an existing source of sound in the CPAP system. It would have been obvious to a person of ordinary skill in the art to have included the comparison of previously obtained data in the device of Gradon as taught by Holley in order to increase accuracy of the detection of changes.
Regarding claim 43, Gradon in view of Holley teaches the system of claim 42, and Gradon further teaches wherein the parameter is an impedance of the airway of the individual, a resonant frequency of the airway of the individual, a location of the physical obstruction (paragraph 63, the distance along the respiratory tract), a size of the physical obstruction (Paragraph 68, measure an obstruction), or any combination thereof.
Regarding claim 77, Gradon in view of Holley teaches the system of claim 42, and Grandon further teaches wherein the one or more processors are further configured to execute the machine-readable instructions to receive additional data associated with the user (Paragraph 69, the algorithm uses flow sensor to determine if there is a flow limitation); and based on the determined value of the parameter in conjunction with the additional data, cause the action to be performed. (Paragraph 69, Fig. 7, if there is a flow limitation in combination with the obstruction the pressure is raised)
Regarding claim 78, Gradon in view of Holley teaches the system of claim 77, and Gradon further teaches wherein the additional data in conjunction with a first value of the parameter causes the action to be performed (Paragraph 69, Fig. 7, if the flow data indicates a flow limitation the pressure is raised), and wherein the additional data in conjunction with a second value of the parameter does not cause the action to be performed, the second value being different than the first value. (Paragraph 69, Fig. 7, if the flow data does not indicate a flow limitation, the pressure is not raised)
Claim 44 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Gradon in view of Holley, and further in view of Kayyali et al (US 7,942,824), hereinafter Kayyali.
Regarding claim 44, Gradon in view of Holley teaches the system of claim 42, but does not teach wherein the action includes causing a medicament to be injected into the air pathway, causing a notification or report to be transmitted or displayed to the individual or to a third party, generating a recommendation for therapy, or any combination thereof.
However Kayyali teaches an integrated sleep diagnostic system (Abstract) wherein when a sleep disorder occurs (Col. 4: lines 40-45, a medication may be administered, Col. 21: lines 5-10, chemical treatment for apneas) the action includes causing a medicament to be injected into the air pathway (Col. 48: lines 43-47, the device can have a nebulizer to inject medications), causing a notification or report to be transmitted or displayed to the individual or to a third party (Col. 32: lines 43-46, lines 59-65) an alert function wherein the monitor receives alerts of predetermined events), generating a recommendation for therapy (Col. 31: lines 10-13, report of recommended therapy), or any combination thereof.
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have incorporated the causing a medicament to be injected, generating an alert or generating a recommended therapy to the device of Gradon in view of Holley as taught by Kayyali in order to provide the best treatment to the user of the device.
Regarding claim 48, Gradon in view of Holley teaches the system of claim 42, but does not teach wherein the respiratory system initially operates as a positive airway pressure system, and wherein the action includes adjusting the respiratory system such that the respiratory system operates as an oxygen concentrator, a ventilator, or both.
However, Kayyali teaches an integrated sleep diagnostic system (Abstract) wherein the respiratory system initially operates as a positive airway pressure system (Col. 40: lines 30-35, operates as a CPAP), and wherein the action includes adjusting the respiratory system such that the respiratory system operates as an oxygen concentrator, a ventilator, or both. (Col. 48: lines 33-41, the device may connect to an oxygen tank to increase concentration of oxygen being delivered to the subject or connect to a carbon dioxide tank to increase concentration of carbon dioxide in the air or both. )
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided the system of Gradon in view of Holley with the ability to act as a ventilator as taught by Kayyali in order to provide oxygen or carbon dioxide when needed.
Claims 66 and 69 are rejected under 35 U.S.C. 103 as being unpatentable over Gradon in view of Holley, and further in view of Burgess et al (US 2020/0054847), hereinafter Burgess.
Regarding claim 66, Gradon in view of Holley teaches the system of claim 42, but does not teach wherein the one or more processors are further configured to execute the machine-readable instructions to:
receive additional data associated with the user; and
modify the value of the parameter based on the additional data.
However, Burgess teaches a respiratory flow apparatus (Abstract, Fig. 1) with acoustic sensors (Paragraph 11, acoustic transmitters) wherein one or more processors are further configured to execute the machine-readable instructions to:
receive additional data associated with the user (paragraph 11, receive data about humidity, temperature); and
modify the value of the parameter based on the additional data. (Paragraph 11, compensates for temperature difference between the acoustic transmitters)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have modified Gradon in view of Holley to include the additional data of the temperature and humidity sensors to increase accuracy of the data. (paragraph 11)
Regarding claim 69, Gradon in view of Holley and Burgess teaches the system of claim 66, and Burgess further teaches wherein the additional data includes data generated by one or more sensors (Paragraph 11, temperature sensors), data generated by one or more medical measurement devices, data generated by one or more smart devices, data received from an electronic medical record of the user, data received from a smart device, or any combination thereof.
Claims 66-70 and 72 are rejected under 35 U.S.C. 103 as being unpatentable over Gradon in view of Holley, and further in view of Kayyali et al (US Pat. No. 9,615,773), hereinafter Kayyali ‘773.
Regarding claim 66, Gradon in view of Holley teaches the system of claim 42, but does not teach wherein the one or more processors are further configured to execute the machine-readable instructions to:
receive additional data associated with the user; and
modify the value of the parameter based on the additional data.
However, Kayyali ‘773 teaches a method and device for sleep analysis (Abstract) wherein the one or more processors are further configured to execute the machine-readable instructions to:
receive additional data associated with the user; (Col. 5: lines 55-60, at least one acoustic sensor and at least 3 additional sensors, to determine respiratory effort, airflow, blood oxygen saturation and heart rate) and
modify the value of the parameter based on the additional data. (Col. 9:lines 5-17, may use data to determine quantitative level of severity of sleep disorder and symptoms, Col. 10: lines 58-67, Information about acoustic data, respiratory events, and body position are simultaneously correlated)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Gradon in view of Holley with the additional data as taught by Kayyali in order to provide a level in severity of the symptoms or to diagnose a sleep disorder. (Col. 3: lines 39-42)
Regarding claim 67, Gradon in view of Holley and Kayyali ‘773 teaches the system of claim 66, and Kayyali further teaches wherein the additional data includes personal data associated with the user. (Col. 17: lines 38-61)
Regarding claim 68, Gradon in view of Holley and Kayyali teaches the system of claim 67, and Kayyali further teaches wherein the personal data includes an age of the user, a sex of the user, a gender of the user, an ethnicity of the user, a location of the user (Col 20: lines 12-14, data can include sleeping location), a known medical condition of the user, a height of the user, a weight of the user, a neck circumference of the user, or any combination thereof.
Regarding claim 70, Gradon in view of Holley and Kayyali ‘773 teaches the system of claim 69, and Kayyali further teaches wherein the additional data includes breathing rate data, heart rate data, pulse oximetry data, or any combination thereof.(Col. 17: lines 38-61)
Regarding claim 72, Gradon in view of Holley and Kayyali ‘773 teaches the system of claim 66, and Kayyali further teaches wherein the action taken is based at least in part on the additional data. (Col. 22: lines 20-28, the data can be used to adjust the pressure output of the positive airway pressure device, Col. 11: lines 20-24, the results of the correlation of the various sensors can also be used in a closed or partially closed loop system to titrate the subject’s treatment)
Claims 73-74 and 79-80 are rejected under 35 U.S.C. 103 as being unpatentable over Gradon in view of Holley and further in view of Jung et al (“Predictive Value of Kushida Index and Acoustic Pharyngometry for Evaluation of Upper Airway in Subjects With or Without Obstructive Sleep Apnea”), hereinafter Jung.
Regarding claim 73, Gradon in view of Holley teaches the system of claim 42, but does not teach wherein the control system is configured to execute the machine-readable instructions to:
instruct the individual to move to a specified physical position; and
in response to determining that the individual has moved to the specified physical position, direct the acoustic signal into the airway of the individual.
However, Jung teaches a procedure for acoustic pharyngometry which instruct the individual to move to a specified physical position; (Page 663, col. 2 “subject is seated in a straight back exam chair”, “sequence is repeated in upright siting, supine, right and left lateral positions”)and
in response to determining that the individual has moved to the specified physical position, direct the acoustic signal into the airway of the individual. (Page 665, col. 2, technique is based on sending acoustic impulses along the respiratory tract)
It would have been obvious to automate the manual test procedure of Jung since using an automated means to replace a manual function to accomplish the same result does not distinguish over the prior art. Furthermore, implementing a known function on a computer has been deemed obvious to one of ordinary skill if the automation of the known function on a general purpose computer is nothing more than the predictable use of prior art elements according to their established functions.
Therefore, it would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have included in the machine readable instructions to instruct the individual to move to a specified position and to direct the acoustic signal in to the patient’s airways in order to evaluate the airways to determine a type of treatment (page 662)
Regarding claim 74, Gradon in view of Holley and Jung teaches the system of claim 73, and Jung further teaches wherein the specified physical position is a standing position, a seated position, an inclined position, or a laying position. (Page 663, seated, supine, lateral right, lateral left positions)
Regarding claim 79, Gradon in view of Holley teaches the system of claim 42, and Jung further teaches wherein the control system is configured to execute the machine-readable instructions to:
determine that the individual is currently in a first physical position; instruct the individual to move to a second physical position; (Page 663, col. 2, repeat the sequence to move from upright to supine)
in response to determining that the individual has moved from the first physical position to the second physical position, direct the acoustic signal into the airway of the individual; (Page 665, col. 2, technique is based on sending acoustic impulses along the respiratory tract)
and
analyze the acoustic data to determine the value of the parameter when the individual is in the second physical position. (Table 2, acoustic pharyngometry data)
It would have been obvious to automate the manual test procedure of Jung since using an automated means to replace a manual function to accomplish the same result does not distinguish over the prior art. Furthermore, implementing a known function on a computer has been deemed obvious to one of ordinary skill if the automation of the known function on a general purpose computer is nothing more than the predictable use of prior art elements according to their established functions.
Therefore, it would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have included in the machine readable instructions to instruct the individual to move to a specified position and to direct the acoustic signal in to the patient’s airways and analyze the acoustic data in order to evaluate the airways to determine a type of treatment (page 662)
Regarding claim 80, Gradon in view of Holley and Jung teaches the system of claim 79, and Jung further teaches wherein the determined value of the parameter is more accurate when the individual is in the second physical position than the first physical position. (Page 666, col. 1 “the cross sectional area in supine position is a potentially important parameter in evaluation of OSA”)
Claims 75-76 and 81-82 are rejected under 35 U.S.C. 103 as being unpatentable over Gradon in view of Holley and further in view of Viviano (“Acoustic Reflection: Review and Clinical Applications for Sleep Disordered Breathing”), hereinafter Viviano.
Regarding claim 75, Gradon in view of Holley teaches the system of claim 42, but does not teach wherein the control system is configured to execute the machine-readable instructions to:
instruct the individual to breathe according to a specified breathing pattern; and in response to determining that the individual is breathing according to the specified breathing pattern, direct the acoustic signal into the airway of the individual.
However, Viviano teaches instruct the individual to breathe according to a specified breathing pattern; and in response to determining that the individual is breathing according to the specified breathing pattern,(Page 135, standard operating procedure “take the readings at FRC or RV”)
direct the acoustic signal into the airway of the individual. (Page 130, Fig. 1, sound generated by wave tubes is reflected in the airway and recorded by microphones)
It would have been obvious to automate the manual test procedure of Viviano since using an automated means to replace a manual function to accomplish the same result does not distinguish over the prior art. Furthermore, implementing a known function on a computer has been deemed obvious to one of ordinary skill if the automation of the known function on a general purpose computer is nothing more than the predictable use of prior art elements according to their established functions.
Therefore, it would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have included in the machine readable instructions breathe according to a specified breathing pattern; and in response to determining that the individual is breathing according to the specified breathing pattern, direct the acoustic signal into the airway of the individual in order to properly perform an acoustic reflection test to determine the airway size.
Regarding claim 76, Gradon in view of Holley and Viviano teaches the system of claim 75, and further teaches wherein the specified breathing pattern includes the individual breathing heavily, the individual holding their breath, or both. (Page 135 measured at RV, residual volume which occurs after a forceful exhalation)
Regarding claim 81, Gradon in view of Holley teaches the system of claim 42, but does not teach wherein the control system is configured to execute the machine-readable instructions to:
determine that the individual is currently breathing according to a first breathing pattern;
instruct the individual to begin breathing according to a second breathing pattern;
in response to determining that the individual has begun to breath according to the second breathing pattern, direct the acoustic signal into the airway of the individual; and
analyze the acoustic data to determine the value of the parameter when the individual is breathing according to the second breathing pattern.
However, Viviano teaches an acoustic reflection technique to:
determine that the individual is currently breathing according to a first breathing pattern; (page 135 the test is completed at FRC or RV and the person observing would note this)
instruct the individual to begin breathing according to a second breathing pattern; ,(Page 135, standard operating procedure “take the readings at FRC or RV”)
in response to determining that the individual has begun to breath according to the second breathing pattern, direct the acoustic signal into the airway of the individual; (Page 130, Fig. 1, sound generated by wave tubes is reflected in the airway and recorded by microphones)
and
analyze the acoustic data to determine the value of the parameter when the individual is breathing according to the second breathing pattern. (Fig. 1: the data is process by the CPU and then displays the cross sectional area and distance along the airway.)
It would have been obvious to automate the manual test procedure of Viviano since using an automated means to replace a manual function to accomplish the same result does not distinguish over the prior art. Furthermore, implementing a known function on a computer has been deemed obvious to one of ordinary skill if the automation of the known function on a general purpose computer is nothing more than the predictable use of prior art elements according to their established functions.
Therefore, it would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have included in the machine readable instructions breathe according to a specified breathing pattern; and in response to determining that the individual is breathing according to the specified breathing pattern, direct the acoustic signal into the airway of the individual in order to properly perform an acoustic reflection test to determine the airway size.
Regarding claim 82, Gradon in view of Holley and Vivian teaches the system of claim 81, and Viviano further teaches wherein the determined value of the parameter is more accurate when the individual is breathing according to the second breathing pattern than the first breathing pattern.(page 178, “since end-expiration is the point at which the pharyngeal airway is most compromised and susceptible to collapse, pharyngometry readings are taken at that point. Recording acoustic readings consistently in this manner helps ensure reproducibility”
Response to Arguments
Applicant's arguments filed 3/26/26 have been fully considered but they are not persuasive. Applicant argues that the newly added limitations are not taught by either Gradon or Holley. The examiner respectfully disagrees as Holley discusses using comparisons with previous measurements to determine airway patency and lung conditions. (See Paragraphs 88, paragraph 113)
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 MARGARET M LUARCA whose telephone number is (303)297-4312. The examiner can normally be reached 6:30 am - 3:30 pm MT.
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/MARGARET M LUARCA/ Primary Examiner, Art Unit 3785
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