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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 the arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. With regards to the discussion of Williams and the positioning of straps for amended claim 1, the arguments are moot because neither Williams nor Thompson (US 20190118009) is being applied for amended claim 1.
Election/Restriction
Applicants elected over the phone during call with Kenneth Wood on 9/18/25 as reflected in the non-final action dated 10/2/25. It is noted that applicant's reply did not include an affirmation of phone election made with traverse as requested in the NF dated 10/2/2025. Since Applicant canceled the non-elected claims, Applicant's reply will be considered an affirmation of the phone election being made without traverse in the interest of compact prosecution. The restriction is considered FINAL.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 23 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by WO 2018035207 to Thompson et al. using the PG Pub US 20210331003 (hereinafter Bassani) for paragraph numbers. Thompson is the first named inventor but due to a plurality of Thompson references discussed in the NF Bassani was used in the NF and for consistency/clarity it is still being used.
Regarding Claim 1, an interpretation of Bassani discloses a self-contained breathing apparatus (SCBA) facemask with a physiological monitoring system (abstract, [0026], Fig. 1), comprising:
a facemask configured to be worn by a user, the facemask defining an interior region adjacent the user's face when the facemask is donned by the user (abstract, [0026]-[0027], Figs. 1, 3 see also [0064]);
a physiological monitoring system that is resident on the facemask and that comprises an integrated physiological sensing unit that is attached to the facemask ([0030], [0033], [0036], Figs. 1-7 see also [0064]) and that is configured to obtain data correlated with a physiological parameter of the user of the facemask by way of a physiological sensor that is mounted in a housing of the physiological sensing unit within a contact area of an inward side of the housing of the physiological sensing unit ([0030], [0033], [0036], Figs. 1-7 see also [0064]),
wherein the facemask and the physiological sensing unit are configured so that upon the facemask being donned by the user facemask ([0026]-[0027], [0030], Figs. 1-7 see also [0064]), the contact area of the housing of the physiological sensing unit is pressed against the head of the user so that the physiological sensor is in position to obtain the data correlated with the physiological parameter of the user of the facemask ([0025], [0030], Figs. 1-6 see also [0026]-[0027], [0064]), and
wherein the housing of the physiological sensing unit is attached to an upper strap coupling element of the facemask ([0025], [0027], [0029]-[0031], [0036], Figs. 1-7 see also [0064]; the housing of the sensing unit is coupled to an upper strap coupling element), the upper strap coupling element being one of a pair of upper strap coupling elements that flank an upper portion of the facemask ([0025], [0027], [0029]-[0031], [0036], Figs. 1-7 see also [0064]; As described and shown in the figures the “upper strap coupling elements” are on opposites of the head “flanking” the upper face mask), so that when the upper strap coupling element is connected to a strap of a head harness and snugged tight in the process of donning the facemask ([0027] including “a plurality of strap coupling elements 40. The mask further includes a plurality of straps 54 that are coupled to the strap coupling elements 40 (for example, a first strap coupling element 40 a and a second strap coupling element 40 b)”, [0031]-[0032], [0036], see also [0064]), the contact area of the housing is pressed against the side of the head of the user in an area proximate a superficial temporal artery or a branch thereof ([0025], [0029]-[0031] including “element housing 64 a is in contact with the wearer's right temple”, [0036], Figs. 1-7 see also [0064]).
Regarding Claim 23, an interpretation of Bassani further discloses wherein the housing of the physiological sensing unit is disposed on an inward side of the upper strap coupling element ([0030]-[0031], Figs. 2, 4 see also [0064]) so that an outward portion of the housing of the physiological sensing unit is in contact with an inward surface of the upper strap coupling element ([0030]-[0031], Figs. 2, 4 see also [0064]).
Claim Rejections - 35 USC § 103
Claim(s) 2-3, 5-6, 9-10, 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bassani in view of US 20190180594 to Williams (hereinafter Williams; cited in IDS dated 2/20/25).
Regarding Claim 2, an interpretation of Bassani may not explicitly disclose wherein the physiological sensor comprises a contact temperature sensor.
However, in the same field of endeavor (medical devices), Williams teaches wherein the physiological sensor comprises a contact temperature sensor ([0027], [0032], [0040], Figs. 1, 4).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the facemask with physiological sensing as recited by Bassani to include the facemask integrated physiological sensors as recited by Williams such as temperature, oxygenation etc. because it allows an accurate detection of harmful conditions/alert determination ([0027]-[0028]) which can then be used to provide alerts to the user in a non-distracting way ([0004]-[0005], [0028]) and transmitted to other individuals so they can avoid particularly dangerous areas ([0028]).
Regarding Claim 3, an interpretation of Bassani discloses the physiological sensing system comprises a sensor control unit ([0043], [0049], [0055], Figs. 10-11 see also [0045]-[0047], [0052]-[0053], [0064]).
An interpretation of Bassani may not explicitly disclose processor receives temperature data from the contact temperature sensor and that is configured to use the temperature data to obtain an estimate of a body temperature of the user and to issue an alert signal if the estimated body temperature increases by a predetermined amount and/or if the estimated body temperature increases at a rate that is above a predetermined rate.
However, in the same field of endeavor (medical devices), Williams teaches processor ([0027], [0029]-[0030], [0032], Figs. 1-4) that receives temperature data from the contact temperature sensor and that is configured to use the temperature data to obtain an estimate of a body temperature of the user ([0027], [0029]-[0030], [0032], Figs. 1-4) and to issue an alert signal if the estimated body temperature increases by a predetermined amount ([0028] including “such as temperature exceeding a predetermined threshold”, Figs. 1-4).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the facemask with physiological sensing as recited by Bassani to include the facemask integrated physiological sensors as recited by Williams such as temperature, oxygenation etc. because it allows an accurate detection of harmful conditions/alerts ([0027]-[0028]) which can then be used to provide alerts to the user in a non-distracting way ([0004]-[0005], [0028]) and transmitted to other individuals so they can avoid particularly dangerous areas ([0028]).
Regarding Claim 5, an interpretation of wherein the sensor control unit of the physiological sensing system comprises a wireless transmitter ([0034], [0054]-[0055] Figs. 10-11 see also [0064]) that is configured to wirelessly transmit ([0034], [0054]-[0055] Figs. 10-11 see also [0064]).
An interpretation of Bassani may not explicitly disclose an alert signal based on the estimated body temperature.
However, in the same field of endeavor (medical devices), Williams teaches wireless transmitter to issue an alert signal based on the estimated body temperature ([0028]-[0029] including “a transmitter or transceiver to wirelessly alert another person or monitoring center that a harmful condition has occurred and optionally, what that harmful condition is, e.g., excess temperature”, Figs. 1-4).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the facemask with physiological sensing as recited by Bassani to include the facemask integrated physiological sensors as recited by Williams such as temperature, oxygenation etc. because it allows an accurate detection of harmful conditions/alerts ([0027]-[0028]) which can then be used to provide alerts to the user in a non-distracting way ([0004]-[0005], [0028]) and transmitted to other individuals so they can avoid particularly dangerous areas ([0028]).
Regarding Claim 6, an interpretation of Bassani may not explicitly disclose wherein the physiological sensing sensor comprises a photoplethysmographic sensor.
However, in the same field of endeavor (medical devices), Williams teaches wherein the physiological sensing sensor comprises a photoplethysmographic sensor ([0027], [0032]-[0033], [0040] see also [0056]; Examiner notes PHOSITA understand pulse oximeters which apply PPG to measure blood oxygen).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the facemask with physiological sensing as recited by Bassani to include the facemask integrated physiological sensors as recited by Williams such as temperature, oxygenation etc. because it allows an accurate detection of harmful conditions/alerts ([0027]-[0028]) which can then be used to provide alerts to the user in a non-distracting way ([0004]-[0005], [0028]) and transmitted to other individuals so they can avoid particularly dangerous areas ([0028]).
Regarding Claim 9, an interpretation of Bassani discloses the integrated physiological sensing unit comprises a first physiological sensor configured to obtain data correlated with a first physiological parameter of the user of the facemask ([0030], [0033], [0036], Figs. 1-7 see also [0064]).
An interpretation of Bassani may not explicitly disclose a second physiological sensor configured to obtain data correlated with a second physiological parameter of the user of the facemask, the second physiological parameter being different from the first physiological parameter.
However, in the same field of endeavor (medical devices), Williams teaches disclose multiple physiological sensors, including a second physiological sensor configured to obtain data correlated with a second physiological parameter of the user of the facemask ([0027] including “one or more sensors 12 includes at least one of a thermistor, solid state temperature sensor, blood-oxygen sensor, motion sensor, . . . and other sensors known in the art.”, [0032]-[0033] including “sensor data includes various measurements from at least two different types of sensor such as a temperature sensor and oxygen sensor, blood oxygen sensor, among other different types of sensors.”, [0040] see also [0056]), the second physiological parameter being different from the first physiological parameter ([0027], [0032]-[0033], [0040] see also [0056]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the facemask with physiological sensing as recited by Bassani to include the facemask integrated physiological sensors as recited by Williams such as temperature, oxygenation etc. because it allows an accurate detection of harmful conditions/alerts based on multiple parameters ([0027]-[0028], [0033]) which can then be used to provide alerts to the user in a non-distracting way ([0004]-[0005], [0028]) and transmitted to other individuals so they can avoid particularly dangerous areas ([0028]).
Regarding Claim 10, an interpretation of Bassani may not explicitly disclose wherein the first physiological sensor is a contact temperature sensor and wherein the second physiological sensor is a photoplethysmographic sensor.
However, in the same field of endeavor (medical devices), Williams teaches wherein the first physiological sensor is a contact temperature sensor ([0027], [0032]-[0033], [0040], Figs. 1, 4) and wherein the second physiological sensor is a photoplethysmographic sensor ([0027], [0032]-[0033], [0040] see also [0056]; Examiner notes PHOSITA understand pulse oximeters which apply PPG to measure blood oxygen).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the facemask with physiological sensing as recited by Bassani to include the facemask integrated physiological sensors as recited by Williams such as temperature, oxygenation etc. because it allows an accurate detection of harmful conditions/alerts based on multiple parameters ([0027]-[0028], [0033]) which can then be used to provide alerts to the user in a non-distracting way ([0004]-[0005], [0028]) and transmitted to other individuals so they can avoid particularly dangerous areas ([0028]).
Regarding Claim 12, an interpretation of Bassani further discloses an integrated bone conduction communication unit that comprises a bone conduction transmitter that is configured so that upon the facemask being donned by the user ([0020], [0025], [0029], [0043]), the bone conduction transmitter is pressed against the head of the user so that the bone conduction transmitter is in position to perform bone conduction transmission of sound waves to an inner ear of the user ([0020], [0025], [0029] including “vibrate to impart a corresponding mechanical vibration onto a wearer's facial and/or head bones”, [0034] including “bone conduction element 12 operates bidirectionally to capture wearer audio . . . and to vibrate to allow the wearer to hear audio”, [0043]-[0044] including “passed through the wearer's skull bones to the inner ear.”, [0056]).
As noted above in the rejection of claim 1, Bassani teaches a physiological sensor in the form of a bone conduction element. Claim 12 additionally requires a second element such that two elements are now required: (1) a physiological sensor; and, (2) a bone conduction transmitter. Because the bone conduction elements have been interpreted as comprising the physiological sensor of claim 1, an additional sensor is required.
However, in the same field of endeavor (medical devices), Williams teaches disclose multiple physiological sensors ([0027], [0032]-[0033], [0040] see also [0056]; Examiner also notes while not currently applied for this element the discussion of US 20180078798 in the pertinent art section).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the facemask with physiological sensing as recited by Bassani to include the facemask integrated physiological sensors as recited by Williams such as temperature, oxygenation etc. because it allows an accurate detection of harmful conditions/alerts ([0027]-[0028]) which can then be used to provide alerts to the user in a non-distracting way ([0004]-[0005], [0028]) and transmitted to other individuals so they can avoid particularly dangerous areas ([0028]).
Regarding Claim 13 wherein the bone conduction transmitter is mounted in the housing of the physiological sensing unit, within the contact area of the inward side of the housing of the physiological sensing unit ([0020], [0025], [0029], [0034], Figs. 1-7 see also [0056]).
Claim Rejections - 35 USC § 103
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bassani in view of Williams in further view of US 20030032893 to Koch et al. (hereinafter Koch).
Regarding Claim 4, an interpretation of Bassani may not explicitly disclose wherein the sensor control unit of the physiological sensing system is configured to issue an alert signal if the estimated core body temperature increases by a predetermined amount and/or if the estimated body temperature increases at a rate that is above a predetermined rate.
an interpretation of Williams discloses wherein the sensor control unit of the physiological sensing system is configured to issue an alert signal if the estimated body temperature increases by a predetermined amount ([0003] including “it is well known that body core temperature above 40 degrees Celsius can result in thermal injury.”, [0027], [0028] including “such as temperature exceeding a predetermined threshold”, Figs. 1-4; discloses a plurality of sensors including body temp and environmental temperature sensors).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the facemask with physiological sensing as recited by Bassani to include the facemask integrated physiological sensors as recited by Williams such as temperature, oxygenation etc. because it allows an accurate detection of harmful conditions/alerts ([0027]-[0028]) which can then be used to provide alerts to the user in a non-distracting way ([0004]-[0005], [0028]) and transmitted to other individuals so they can avoid particularly dangerous areas ([0028]).
An interpretation of Bassani may not explicitly disclose convert the estimated body temperature of the user to an estimated core body temperature of the user.
However, in the same field of endeavor (medical diagnostic devices), Koch teaches convert the estimated body temperature of the user to an estimated core body temperature of the user ([0033] including “The body core temperature of the headband user 4 is calculated in the evaluating electronic unit 21 from the values measured with the temperature sensors” see also [0017]-[0018]) and activating an alarm when the core body temperature is outside thresholds ([0033]-[0034]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the facemask with sensing and analysis as recited by Bassani in view of Williams to include analysis of converting the body temperature to a core body temperature as recited by Koch because provides determining an alarm condition for a user being at risk based on their core body temperature being outside threshold range ([0034]).
Claim Rejections - 35 USC § 103
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bassani in view of Williams in further view of US 20030062046 to Wiesmann et al. (hereinafter Wiesmann; cited in IDS dated 12/15/23)
Regarding Claim 7, an interpretation of Bassani further discloses a sensor control unit that receives data form the sensor ([0043], [0049], [0055], Figs. 10-11 see also [0045]-[0047], [0052]-[0053], [0064]).
an interpretation of Bassani may not explicitly disclose comprises processor receives photoplethysmographic data from the photoplethysmographic sensor and that is configured to use the photoplethysmographic data to monitor.
However, in the same field of endeavor (medical devices), Williams teaches wherein the physiological sensing system of the SCBA facemask comprises a sensor control unit that receives photoplethysmographic (PPG) data from the PPG sensor and that is configured to use the PPG data to monitor blood oxygenation ([0027], [0029]-[0030], [0032], Figs. 1-4; Examiner notes PHOSITA understand pulse oximeters which apply PPG to measure blood oxygen).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the facemask with physiological sensing as recited by Bassani to include the facemask integrated physiological sensors as recited by Williams such as temperature, oxygenation etc. because it allows an accurate detection of harmful conditions/alerts ([0027]-[0028]) which can then be used to provide alerts to the user in a non-distracting way ([0004]-[0005], [0028]) and transmitted to other individuals so they can avoid particularly dangerous areas ([0028]).
An interpretation of Bassani may not explicitly disclose configured to use the photoplethysmographic data to monitor at least one of heart rate
However, in the same field of endeavor (medical diagnostic devices), Wiesmann teaches the blood oxygen sensor is a photoplethysmographic sensor ([0060]-[0061], Figs. 3-5) that is configured to use the photoplethysmographic data to monitor at least one of heart rate ([0060]-[0061] including “microprocessor 161 to determine oxygen saturation and/or pulse rate”, Figs. 3-5).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the facemask with sensing including a blood oxygen sensor and analysis as recited by Bassani in view of Williams to include the a PPG sensor for sensing a heart rate or blood oxygen as recited by Wiesmann because the PPG data can be used to determine critical physiological information of the user and alert personnel of real time risks built into the SCBA system ([0003], [0006]-[0007]).
Claim Rejections - 35 USC § 103
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bassani in view of Wiesmann.
Regarding Claim 17, an interpretation of Bassani further discloses, a self-contained breathing apparatus (SCBA) ([0026] including “the regulator may be . . . a supplied-air/self-contained breathing apparatus (SCBA) . . .“comprising the SCBA facemask of claim 1 (see the rejection of claim 1).
an interpretation of Bassani may not explicitly disclose a supply of breathing air that is fluidly connected to the facemask.
However, in the same field of endeavor (regulator devices), Wiesmann teaches a supply of breathing air that is fluidly connected to the facemask ([0049], Figs. 1-2).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the facemask including for SCBA with sensing as recited by Bassani to include a supply of air as recited by Wiesmann because it was generally known that self-contained breathing apparatus (SCBA) systems include a source of bottled air for air supply to ensure a safe air supply in hazardous conditions ([0001]-[0002], [0024]). Alternatively, it is merely combining the facemask/regulator disclosure of Bassani with the inclusion of the air tank from Wiesmann according to known methods to yield predictable results of a self-contained breathing apparatus system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20180078798 see [0128]-[0129], [0131], [0192]- discloses a sensor housing with bone conduction elements with other sensor(s)
TY Abay et al. Photoplethysmography for blood volumes and oxygenation changes during intermittent vascular occlusions. J Clin Monit Comput. 2018 Jun;32(3):447-455. doi: 10.1007/s10877-017-0030-2. Epub 2017 May 25. PMID: 28547651; PMCID: PMC5943414. https://pmc.ncbi.nlm.nih.gov/articles/PMC5943414/ see abstract
Yuxuan Li et al., "Chewing Monitoring With Bone-Conduction Microphone for Body Area Network," in IEEE Access, vol. 7, pp. 99077-99085, 2019, doi: 10.1109/ACCESS.2019.2918988, https://ieeexplore.ieee.org/document/8723022.
See also the references recited in the previous rejection that are no longer relied upon
US 20190167211 to Everman et al. see [0054]
US 20070116314 to Grilliot et al. see Abstract – using sensed temperature approximate a body core temp
US 20250037562 (US App 18716282) – this is not 102 prior art – However Examiner notes depending on how the claims in the respective applications evolve has the protentional to be a double patenting issue.
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 JAMES R MOSS whose telephone number is (571)272-3506. The examiner can normally be reached Monday - Friday (9:30 am - 5:30 pm).
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/James Moss/Examiner, Art Unit 3792
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