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 .
This action is in response to the filing on 7/9/2025. Since the previous filing, claims 1-12, 14-16 and 18 have been amended, claim 17 has been cancelled and claims 22-29 have been added. Thus, claims 1-12 and 14-16 and 18-29 are pending in the application.
In regards to the previous 112 Rejections, Applicant has amended to overcome these rejections and they are therefore withdrawn with new rejections entered below.
In regards to the previous 103 Rejections, Applicant has amended to overcome these rejections and they are therefore withdrawn with new rejections entered below.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/9/2025 has been entered.
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 16 and 22 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 16 recites the limitation "said male mating end" in line 1-2. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests changing the dependency of claim 16 to depend from claim 14 as this is where “male mating end” is introduced.
Claim 22 recites the limitation "wherein said processor" in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests changing to “further comprising a processor, wherein said processor” to overcome this rejection.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 2, 14, 15 and 25-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams (US 2021/0113796) as evidenced by Lordo (US 5947115) and in view of Porter (US 2018/0272080) and Orr (US 8312878).
In regards to claim 1, Williams discloses a device for monitoring a flow rate of air passing through a tracheostomy tube in use on a tracheostomy patient (paragraph 291), a thermistor adapted to make breath rate measurements of a tracheostomy patient via temperature based sensing of air flowing from said tracheostomy tube (paragraph 293 and 335 and 347); and a microphone adapted to make pressure based velocity measurements of air flowing through the tube (Williams: velocity measured using microphone, paragraph 338; Lordo: microphones are pressure transducers, column 7 line 66-67).
Williams does not disclose an adapter having a tubular body with a first end proximal to and connected to said tracheostomy tube, a second end distal to said tracheostomy tube, a collar disposed about said body between said first and second ends thereof, and a channel extending through said body from said first end thereof to said second end thereof, wherein the sensors are housed in said collar.
However, Porter teaches an adapter containing sensors (adapter 90) having a tubular body with a first end proximal to and connected to said tracheostomy tube, a second end distal to said tracheostomy tube, and a channel extending through said body from said first end thereof to said second end thereof (paragraph 39, Fig 1 and 5).
Further, Orr teaches an adapter (Fig 2) having a tubular body and a collar disposed about said body between first and second ends thereof (see Annotated Fig 2), wherein the collar houses sensors (detector 68 is within gas sensing portion 36, column 7 line 54-55. Fig 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Williams to have an adapter having a tubular body with a first end proximal to and connected to said tracheostomy tube, a second end distal to said tracheostomy tube, and a channel extending through said body from said first end thereof to said second end thereof, a collar disposed about said body between first and second ends thereof, wherein the sensors are housed in the collar as taught by Porter and Orr as this would allow the sensors to be easily attached and detached form the tube as needed without disruptions in the flow through the tube and adapter.
PNG
media_image1.png
662
611
media_image1.png
Greyscale
Annotated Fig 2
In regards to claim 2, Williams as evidenced by Lordo and in view of Porter and Orr teaches the device of claim 1 and Williams further discloses wherein the breath rate measured by said thermistor is measured over a predetermined time period (lookback periods, paragraph 390 and 395) during which the measured breath rate is compared to a normal breath rate value (paragraph 395-396 and 400-401 and 439).
In regards to claim 14, Williams as evidenced by Lordo and in view of Porter and Orr teaches the device of claim 1.
While neither Porter nor Orr explicitly teaches wherein said first end includes a female mating end adapted to receive the tracheostomy tube, and wherein said second end comprises a male mating end, both Porter and Orr show the adapter having ends with one appearing as a female mating end and the other as a male mating end (Porter: Fig 5; Orr: see Annotated Fig 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Williams wherein said first end includes a female mating end adapted to receive the tracheostomy tube, and wherein said second end comprises a male mating end as taught by Porter and Orr as it has been held that drawings may be relied upon for what they may reasonably teach one of ordinary skill in the art (MPEP 2125) and this structure would provide easily identifiable and connectable connections to ensure the proper and secure attachment of the adapter.
In regards to claim 15, Williams as evidenced by Lordo and in view of Porter and Orr teaches the device of claim 1 and the combination further teaches wherein said sensors are mounted to said collar (Orr: detector 68 is within gas sensing portion 36, Fig 2) such that said first sensor measures the breath rate of the tracheostomy patient based on the temperature of the air flowing through said channel of said adapter from the tracheostomy tube and such that said second sensor measures the velocity of the air flowing through said channel of said adapter from the tracheostomy tube (Williams: paragraph 335 and 338).
In regards to claim 25, Williams as evidenced by Lordo and in view of Porter and Orr teaches the device of claim 14.
While the combination does not explicitly teach wherein said female mating end is adapted to press-fit to said tracheostomy tube, Porter does teach and adapter (adapter 110) which uses a press fit connection to connect to the tracheostomy tube (paragraph 40).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Williams wherein said female mating end is adapted to press-fit to said tracheostomy tube as taught by Porter as this is a well known method of attaching adjacent components.
In regards to claim 26, Williams as evidenced by Lordo and in view of Porter and Orr teaches the device of claim 1 and Williams further discloses comprising a data processor unit, communicatively coupled to said adapter and configured to simultaneously process data from said thermistor and said microphone (paragraph 337-339).
In regards to claim 27, Williams as evidenced by Lordo and in view of Porter and Orr teaches the device of claim 1 and the combination further teaches wherein said thermistor is positioned perpendicular to a longitudinal axis of said channel (Orr: detector aimed such that it detects from the interior of the channel, Fig 2).
In regards to claim 28, Williams as evidenced by Lordo and in view of Porter and Orr teaches the device of claim 1 and the combination further teaches wherein said microphone is positioned perpendicular to a longitudinal axis of said channel (Orr: detector aimed such that it detects from the interior of the channel, Fig 2).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams (US 2021/0113796) as evidenced by Lordo (US 5947115) and in view of Porter (US 2018/0272080) and Orr (US 8312878) as applied above and in further view of Reinberg (US 2018/0200466).
In regards to claim 3, Williams as evidenced by Lordo and in view of Porter and Orr teaches the device of claim 2.
While Williams teaches that a normal breath rate may be based on one or more patient parameters including those related to age (paragraph 439), Williams does not disclose wherein said normal breath rate value is dependent upon an age of the tracheostomy patient.
However, Reinberg teaches wherein it is known that normal breath rate value is depended upon an age of the tracheostomy patient (paragraph 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Williams wherein normal breath rate value is depended upon the age of the tracheostomy patient as taught by Reinberg as this is a known parameter by which to set a baseline normal breath rate against which a measured rate is compared to ensure patient health (Williams: normal breathing rate may be a fixed rate threshold set by clinician and/or based on patient parameters against which measured values may be compared, paragraph 439).
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams (US 2021/0113796) as evidenced by Lordo (US 5947115) and in view of Porter (US 2018/0272080) and Orr (US 8312878) as applied above and in further view of Burgess (US 2020/0179629) and Lee (US 2018/0153440).
In regards to claim 4, Williams as evidenced by Lordo and in view of Porter and Orr teaches the device of claim 2.
Williams does not disclose wherein the velocity of the air measured by said microphone is measured of said predetermined time period during which the air velocity measurement is used to obtain an approximate peak expiratory flow rate which is then compared to a normal vital peak expiratory flow rate value.
However, Burgess teaches that it is known to obtain flow rate of a gas using a gas velocity measurement (paragraph 148).
Further, Lee teaches wherein an approximate peak expiratory flow rate is compared to a normal vital peak expiratory flow rate value (paragraph 190).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Williams wherein the velocity of the air measured by said second sensor is measured of said predetermined time period during which the air velocity measurement is used to obtain an approximate peak expiratory flow rate which is then compared to a normal vital peak expiratory flow rate value as taught by Lee and Burgess as this is a known manner by which to obtain flow rate of a gas and a known method by which to evaluate that flow rate to ensure proper function and patient support.
In regards to claim 5, Williams as evidenced by Lordo and in view of Porter, Orr, Burgess and Lee teaches the device of claim 4 and the combination further teaches wherein an alarm signal when said approximate peak expiratory flow rate is a certain percentage below said normal vital peak expiratory flow rate value (Lee: paragraph 190).
Claim(s) 6-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams (US 2021/0113796) as evidenced by Lordo (US 5947115) and in view of Porter (US 2018/0272080), Orr (US 8312878), Burgess (US 2020/0179629) and Lee (US 2018/0153440) as applied above and in further view of Shouldice (US 2020/0297955).
In regards to claim 6, Williams as evidenced by Lordo and in view of Porter, Orr, Burgess and Lee teaches the device of claim 4 and the combination further teaches wherein said adapter is used in combination with a processor (Williams: processors 622; Lee: processors 210 and 602) adapted to determine when said measured breath rate is abnormal compared to said normal breath rate value (Williams: paragraph 438-439) and to determine when said approximate peak expiratory flow rate is abnormal compared to said normal vital peak expiratory flow rate (Lee: paragraph 190).
While Williams teaches the ability to identify blockages in airflow based on sensor data (paragraph 391) it does not disclose determining a degree of obstruction of the tube.
However, Shouldice teaches determining a degree of obstruction of the tube (paragraph 338-343).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Williams to determine a degree of obstruction of the tube as taught by Shouldice as this would allow the device to monitor the delivered airflow and determine if the patient is receiving the correct treatment and support.
In regards to claim 7, Williams as evidenced by Lordo and in view of Porter, Orr, Burgess, Lee and Shouldice teaches the device of claim 6 and the combination further teaches wherein said processor triggers an alarm if both said measured breath rate and said approximate peak expiratory flow rate are determined to be abnormal for said predetermined time period (Williams: paragraph 438; Lee paragraph 190).
In regards to claim 8, Williams as evidenced by Lordo and in view of Porter, Orr, Burgess, Lee and Shouldice teaches the device of claim 7 and the combination further teaches wherein said processor is located remote from said device and is configured for wireless communication therewith (Williams: paragraph 294).
In regards to claim 9, Williams as evidenced by Lordo and in view of Porter, Orr, Burgess and Lee teaches the device of claim 4.
Williams does not disclose wherein said second sensor measures breath sounds of the tracheostomy patient based on audio signals.
However, Shouldice teaches wherein said second sensor measures breath sounds of the tracheostomy patient based on audio signals (paragraph 95).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Williams wherein said second sensor measures breath sounds of the tracheostomy patient based on audio signals as taught by Shouldice as this is a known method by which to monitor a patient.
In regards to claim 10, Williams as evidenced by Lordo and in view of Porter, Orr, Burgess, Lee and Shouldice teaches the device of claim 9 and the combination further teaches wherein an alarm signals when said breath sounds are outside a predetermined normal range (Shouldice: paragraph 91 and 95).
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams (US 2021/0113796) as evidenced by Lordo (US 5947115) and in view of Porter (US 2018/0272080), Orr (US 8312878), Burgess (US 2020/0179629) and Lee (US 2018/0153440) and in further view of Shouldice (US 2020/0297955) and Franklin (US 2017/0148467).
In regards to claim 11, Williams as evidenced by Lordo and in view of Porter, Orr Burgess and Lee teaches the device of claim 4.
Williams does not disclose wherein said microphone measures breathing effort of the tracheostomy patient based on sound power levels calculated from voltage signals produced by said sensor.
However, Shouldice teaches wherein said microphone measures breathing effort of the tracheostomy patient based on breathing sound (microphone detects coughing and wheezing or evidence of asthma, paragraph 161-132).
Further, Franklin teaches wherein it is known that sound power levels are calculated from voltage signals produced by said microphone (paragraph 234).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Williams wherein said microphone measures breathing effort of the tracheostomy patient based on sound power levels calculated from voltage signals produced by said microphone as taught by Shouldice and Franklin as this is a known method of monitoring a patient’s status and the known manner in which microphones operate to transmit information.
In regards to claim 12, Williams as evidenced by Lordo and in view of Porter, Orr, Burgess, Lee, Shouldice and Franklin teaches the device of claim 11 and the combination further teaches wherein an alarm signals when said sound power levels are too high or too low (Williams: alarms sound when values alter from previous or expected values, paragraph 438-439; Lee: alarms trigger when threshold passed, paragraph 190; Franklin: sound power determined by voltage amplitude; paragraph 234).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams (US 2021/0113796) as evidenced by Lordo (US 5947115) and in view of Porter (US 2018/0272080) and Orr (US 8312878) as applied above and in further view of Ferrer (US 2019/0070376).
In regards to claim 16, Williams as evidenced by Lordo and in view of Porter and Orr teaches the device of claim 15 and Porter further teaches wherein one end of said adapter is configured for selective mating with a second group of retrofittable tracheostomy tube attachments (paragraph 39).
The combination does not teach wherein the attachments include a passy muir valve attachment and a heat and moisture exchanger attachment.
However, Ferrer teaches tracheostomy attachments including a passy muir valve (paragraph 48) and a heat and moisture exchanger (paragraph 46).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Williams wherein the attachments include a passy muir valve attachment and a heat and moisture exchanger attachment as taught by Ferrer as this would provide the adapter with functionality for the patient’s comfort and ability to communicate their needs.
Claim(s) 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams (US 2021/0113796) as evidenced by Lordo (US 5947115) and in view of Burgess (US 2020/0179629), Lee (US 2018/0153440), Shouldice (US 2020/0297955) and Franklin (US 2017/0148467).
In regards to claim 18, Williams discloses a method for monitoring a flow rate of air passing through a tracheostomy tube in use on a tracheostomy patient (paragraph 291), said method comprising the steps of: (a) measuring, for a predetermined time period, the breath rate of the tracheostomy patient based on the temperature of the air flowing from the tracheostomy tube (paragraph 293 and 335 and 347); (b) measuring, for said predetermined time period, simultaneously with step (a) and at the same location, the velocity of the air flowing from the tracheostomy tube based on the pressure of the air flowing from the tracheostomy tube (Williams: microphone used to measure velocity, paragraph 338, both sensor types may be combined to determine accurate data regarding flow through tube, paragraph 339; Lordo: microphones are pressure transducers, column 7 line 66-67); (c) comparing the breath rate measured in step (a) to a normal breath rate value and determining whether the measured breath rate is normal or abnormal (lookback periods, paragraph 390 and 395-396 and 400-401).
Williams does not disclose (d) converting the air velocity measured in step (b) to an approximate peak expiratory flow rate; (e) comparing the approximate peak expiratory flowrate to anormal vital peak expiratory flow rate value and determining whether the approximate peak expiratory flow rate is normal or abnormal; (f) determining a degree of obstruction of the tracheostomy tube by measuring breathing effort of the tracheostomy patient based on sound power levels calculated from the pressure of the air flowing from the tracheostomy tube and breath rate calculated from the temperature of the air flowing from the tracheostomy tube; (g) producing an alarm if both the measured breath rate and the approximate peak expiratory flow rate are determined to be abnormal for said predetermined time period.
However, Burgess teaches converting the measured air velocity to an approximate peak expiratory flow rate (paragraph 148).
Further, Lee teaches comparing the approximate peak expiratory flowrate to anormal vital peak expiratory flow rate value and determining whether the approximate peak expiratory flow rate is normal or abnormal; and producing an alarm if both the measured breath rate and the approximate peak expiratory flow rate are determined to be abnormal for said predetermined time period (paragraph 190).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Williams (d) converting the air velocity measured in step (b) to an approximate peak expiratory flow rate; (e) comparing the approximate peak expiratory flowrate to anormal vital peak expiratory flow rate value and determining whether the approximate peak expiratory flow rate is normal or abnormal; and (g) producing an alarm if both the measured breath rate and the approximate peak expiratory flow rate are determined to be abnormal for said predetermined time period as taught by Lee and Burgess as this is a known manner by which to obtain flow rate of a gas and a known method by which to evaluate that flow rate to ensure proper function and patient support.
While Williams teaches the ability to identify blockages in airflow based on sensor data (paragraph 391) including determination of breath rate based on temperature of the air (paragraph 93, 335 and 347), it does not disclose determining a degree of obstruction of the tube or producing an alarm if the degree of obstruction is determined to be abnormal nor wherein breathing effort of the patient is calculated based on sound power levels calculated from the pressure sensor.
However, Shouldice teaches determining a degree of obstruction of the tube (paragraph 338-343) and producing an alarm if the degree of obstruction is determined to be abnormal (alarm may be triggered based on information received from the management system, paragraph 91).
Further, Franklin teaches wherein it is known that sound power levels are calculated from signals produced by said sensor (paragraph 234).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Williams to determine a degree of obstruction of the tube or producing an alarm if the degree of obstruction is determined to be abnormal and wherein breathing effort of the patient is calculated based on sound power levels calculated form the pressure sensor as taught by Shouldice and Franklin as this would allow for the monitoring of the patient treatment and insurance that the patient is receiving sufficient treatment while alerting a medical professional if the treatment is interrupted or insufficient.
In regards to claim 19, Williams as evidenced by Lordo and in view of Burgess, Lee, Shouldice and Franklin teaches the method of claim 18 and the combination further teaches further comprising the step of producing an alarm when the approximate peak expiratory flow rate is a certain percentage below the normal vital peak expiratory flow rate value (Lee: paragraph 190).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams (US 2021/0113796) as evidenced by Lordo (US 5947115) and in view of Burgess (US 2020/0179629), Lee (US 2018/0153440), Shouldice (US 2020/0297955) and Franklin (US 2017/0148467) and in further view of Reinberg (US 2018/0200466).
In regards to claim 20, Williams as evidenced by Lordo and in view of Burgess, Lee, Shouldice and Franklin teaches the method of claim 18.
While Williams teaches that a normal breath rate may be based on one or more patient parameters including those related to age (paragraph 439), Williams does not disclose wherein the normal breath rate value used in step (e) is dependent upon the age of the tracheostomy patient.
However, Reingberg teaches wherein the normal breath rate value used in step (e) is dependent upon the age of the tracheostomy patient (paragraph 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Williams wherein the normal breath rate value used in step (e) is dependent upon the age of the tracheostomy patient as taught by Reinberg as this is a known parameter by which to set a baseline normal breath rate against which a measured rate is compared to ensure patient health (Williams: normal breathing rate may be a fixed rate threshold set by clinician and/or based on patient parameters against which measured values may be compared, paragraph 439).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams (US 2021/0113796) as evidenced by Lordo (US 5947115) and in view of Burgess (US 2020/0179629), Lee (US 2018/0153440), Shouldice (US 2020/0297955) and Franklin (US 2017/0148467) as applied above and in further view of Porter (US 2018/0272080).
In regards to claim 21, Williams as evidenced by Lordo and in view of Burgess, Lee, Shouldice and Franklin teaches the method of claim 18 and Williams further teaches a first sensor adapted to measure the breath rate of the tracheostomy patient based on the temperature of the air flowing from the tracheostomy tube (paragraph 293 and 335 and 347) and a second sensor adapted to measure the velocity of the air flowing from the tracheostomy tube based on the pressure of the air flowing from the tracheostomy tube (velocity measured using microphone, paragraph 338, Lordo: microphones are pressure transducers, column 7 line 66-67).
Williams does not disclose further comprising the step of attaching an adapter to the tracheostomy tube such that air flowing through the tracheostomy tube from the tracheostomy patient can flow through said adapter, said adapter including the first and second sensors.
However, Porter teaches the step of attaching an adapter to the tracheostomy tube such that air flowing through the tracheostomy tube from the tracheostomy patient can flow through said adapter, said adapter including the first and second sensors (adapter 90, paragraph 39, Fig 5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Williams to have the step of attaching an adapter to the tracheostomy tube such that air flowing through the tracheostomy tube from the tracheostomy patient can flow through said adapter, said adapter including the first and second sensors as taught by Porter as this would allow the sensors to be easily attached to the tubing.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams (US 2021/0113796) as evidenced by Lordo (US 5947115) and in view of Porter (US 2018/0272080) and Orr (US 8312878) as applied above and in further view of Freitag (US 2009/0107494).
In regards to claim 22, Williams as evidenced by Lordo and in view of Porter and Orr teaches the device of claim 1.
The modified Williams does not disclose wherein said processor is included in a wearable component worn by the patient.
However, Freitag teaches a respiratory support system wherein the processor (control unit 12 may be any type of microprocessor, paragraph 51) is included in a wearable component worn by the patient (control system 12 may be integrated into pump 1, paragraph 44, pump worn by user, Fig 1A).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Williams wherein said processor is included in a wearable component worn by the patient as taught by Freitag as this would allow the patient to be mobile while receiving needed treatment or support.
Claim(s) 23 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams (US 2021/0113796) as evidenced by Lordo (US 5947115) and in view of Porter (US 2018/0272080) and Orr (US 8312878) as applied above and in further view of Haveri (US 2013/0253336).
In regards to claim 23, Williams as evidenced by Lordo and in view of Porter and Orr teaches the device of claim 1.
Williams does not disclose wherein said adapter is disposable.
However, Haveri teaches an airway adapter (adapter 3) which is disposable (paragraph 24).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Williams wherein the adapter is disposable as taught by Haveri as this would help prevent potential contamination is used by multiple patients (Haveri: paragraph 24).
In regards to claim 24, Williams as evidenced by Lordo and in view of Porter and Orr teaches the device of claim 1.
Williams does not disclose wherein said adapter is portable.
However, Haveri teaches wherein the adapter is portable (paragraph 14).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Williams wherein the adapter is portable as taught by Haveri as this would allow the adapter to be easily transportable to the location of any patient who required it.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams (US 2021/0113796) as evidenced by Lordo (US 5947115) and in view of Porter (US 2018/0272080), Orr (US 8312878), Burgess (US 2020/0179629), Lee (US 2018/0153440) and Shouldice (US 2020/0297955) as applied above and in further view of Franklin (US 2017/0148467).
In regards to claim 29, Williams as evidenced by Lordo and in view of Porter, Orr, Burgess, Lee and Shouldice teaches the device of claim 6 and combination further teaches wherein said processor is configured to determine said degree of obstruction based on said breath rate measurements (Williams: paragraph 391; Shouldice: paragraph 338-343).
The modified Williams does not teach sound power levels calculated from voltage signals produced by said microphone.
However, Franklin teaches wherein it is known that sound power levels are calculated from voltage signals produced by said microphone (paragraph 234).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Williams wherein sound power levels calculated from voltage signals produced by said microphone as taught by Franklin as this is the known manner in which microphones operate to transmit information.
Response to Arguments
In regards to the arguments, these concern the amendments made to the claims and are addressed in the new rejections entered above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Arielle Wolff whose telephone number is (571)272-8727. The examiner can normally be reached Mon-Fri 8:00-4:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached on (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ARIELLE WOLFF/ Examiner, Art Unit 3785
/KENDRA D CARTER/ Supervisory Patent Examiner, Art Unit 3785