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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/15/2026 has been entered.
Response to Amendment
This office action is in response to the amendment filed on 06/15/2026. As directed by the amendment, claims 1 and 12 have been amended and claims 21-22 have been added. As such, claims 1-22 are pending in the instant application.
Response to Arguments
Applicant's arguments, see pages 6-12 of Remarks, filed 06/15/2026, pertaining to the
newly amended limitations have been noted. However, a new ground(s) of rejection has been
provided below to address the newly added limitations.
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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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.
Claim(s) 1-11 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hickey (US 20160106941 A1) in view of Haas (US 20120240933 A1).
Regarding claim 1, Hickey teaches a mask (facemask 10′, see Fig. 3 and [0050]) comprising:
a facial adaptive component (the facial adaptive component comprises of skin contact perimeter 22 and a portion of the body 12 which is adjacent to the skin contact perimeter as seen in Figs. 1 and 3) including a deformable member (skin contact perimeter 22, see Figs. 1 and 3; “…the skin contact perimeter 22 may be formed of a flexible, resilient material…” see [0044]) embedded in an interior region of the facial adaptive component (skin contact perimeter 22 is embedded in an interior region of the body 12 as seen in Figs. 1 and 3) and a plurality of circuits (control circuit 28, see Fig. 28; control circuit 28 comprises a plurality of circuits as seen in Fig. 2), each of the plurality of circuits being operable in an open-circuit state or a closed-circuit state (Hickey teaches an open-state circuit state when the plurality of circuits and electrical contacts/sensors are not connected to a user’s face and a closed-state circuit when the electrical contacts/sensors are concurrently actuated to indicate the facemask 10’ is properly sealed to a user’s face as seen in [0078] (which is similar to applicant’s closed state in [0031] of their specification));
a battery (power source 30, see Fig. 2; “The control circuit 28 may include a power source 30 (e.g., a battery) …” see [0046]);
a plurality of light elements (a plurality of visual indicators 36, see Fig. 3; “The facemask 10′ includes a plurality of visual indicators 36, such as light emitting diodes (LEDs), disposed on the facemask body 12.” See [0050]) coupled to the battery and positioned within the deformable member (the plurality of visual indicators 36 are coupled to the power source/battery 30 as seen in Fig. 2 and positioned within the skin contact perimeter 22 as seen in Fig. 3 (similarly to how the light components 114 in Fig. 2 of applicant’s drawings are positioned within the facial adaptive component which comprises of the deformable member (not shown/referenced in applicant’s drawings)); and
a plurality of sensors (sensors 24.sub.1, 24.sub.2 and 24.sub.3, see Figs. 1-3) positioned at a plurality of locations within the deformable member (sensors 24.sub.1, 24.sub.2 and 24.sub.3 are positioned at a plurality of locations within skin contact perimeter 22 as seen in Figs. 1 and 3), each of the plurality of sensors connected to one of the plurality of light elements (Hickey teaches when the electrical contact/sensors 24.sub.1, 24.sub.2 and 24.sub.3 is actuated, an adjacent LED 36 illuminates as seen in [0078]. Therefore, each of the plurality of sensors is connected to one of the pluralities of light elements as an electrical contact is connected to an adjacent LED),
wherein each of the plurality of circuits include the battery, one of the plurality of light elements, and at least one of the plurality of sensors (Hickey teaches when an electrical contact/sensor is actuated, an adjacent LED 36 illuminates as seen in [0078]. Hickey further teaches power source/battery 30 connected to each of the sensors as seen in Fig. 2 and [0046]. Therefore, each of the circuits includes power source/battery 30, one of the electrical contact/sensors and an adjacent LED 36), and
wherein one or more of the plurality of circuits change from operating in the open-circuit state to the closed-circuit state in response to one or more of the plurality of sensors contacting skin on an object that is external to the mask (“…the LEDs 36 (FIG. 3) may illuminate when the electrical contacts 24.sub.1, 24.sub.2, 24.sub.3 are concurrently actuated to indicate that the facemask 10′ is properly sealingly engaged with the child's face.” See [0078]. Hickey teaches an open-state circuit state when the plurality of circuits and electrical contacts/sensors are not connected to a user’s face and a closed-state circuit when the electrical contacts/sensors are concurrently actuated to indicate the facemask 10’ is properly sealed to a user’s face as seen in [0078])
but does not teach wherein the plurality of light elements emit varied light intensity based on a degree of contact between the plurality of sensors and the skin; and
wherein the plurality of light elements provide a visual indication of a partial seal between the facial adaptive component and the skin.
However, Haas teaches wherein the plurality of light elements emit varied light intensity based on a degree of contact between the plurality of sensors and the skin; and
wherein the plurality of light elements provide a visual indication of a partial seal between the facial adaptive component and the skin (Haas teaches a patient interface device 34 (see [0023]), sensor 22 configured to generate output signals conveying information related to the engagement between patient interface 34 and the face of subject 12 (see [0029] and [0032]-[0034]) and a user interface 20 with plurality of indicator lights 58 representing individual locations on the patient interface as seen in [0054]. The indicator lights 58 can be manipulated such that the brightness or other aspects of illumination given off by the appropriate one of the indicator lights 58 may indicate the amount of leakage present as seen in Figs. 2-3 and [0047]-[0048] and [0054]. As such, Haas teaches the indicator lights 48 to emit a brightness depending on a degree of leakage/contact based on engagement/contact signals from sensor 22, wherein a full contact the between patient interface and the face of the subject will have a different brightness than a partial contact).
Hickey teaches capacitive sensors which is configured to detect contact with skin (see [0009] and [0053]) and a plurality of visual indicators 36 to provide a visual stimulus for when the facemask is properly sealingly engaged with a user’s face as seen in [0078]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the mask taught by Hickey to have the plurality of light elements emit varied light intensity based on a degree of contact between the plurality of sensors and the skin; and the plurality of light elements provide a visual indication of a partial seal between the facial adaptive component and the skin as taught by Haas for a visual indication with varying brightness to show the specific location of where the mask is leaking/not fully sealed for the patient to make adjustments (see [0055]-[0056]).
Regarding claim 2, Hickey in view of Haas teaches the mask of claim 1, and Hickey further teaches wherein the closed-circuit state of the plurality of circuits is associated with a seal between the facial adaptive component and the object that is external to the mask (Hickey teaches the closed-state circuit to be when the electrical contacts/sensors are concurrently actuated to indicate the skin contact perimeter 22 of facemask 10’ is properly sealed to a user’s face as seen in [0078] and [0043]).
Regarding claim 3, Hickey in view of Haas teaches the mask of claim 1, and Hickey further teaches wherein at least a subset of the plurality of light elements are configured to illuminate, using the battery, responsive to at least one of the plurality of circuits changing from operating in the open-circuit state to the closed-circuit state (Hickey teaches power source/battery 30 connected to each of the sensors as seen in Fig. 2 and [0046]. Hickey further teaches an adjacent LED 36 is to illuminate when an electrical contact/sensor is actuated in response to facemask 10’ properly sealing a user’s face as seen in [0078], going from the open-circuit state to the closed-circuit state).
Regarding claim 4, Hickey in view of Haas teaches the mask of claim 3, and Hickey further teaches wherein the subset of the plurality of light elements are positioned adjacent to and coupled with the subset of the plurality of sensors contacting skin on the object that is external to the mask (Hickey teaches when electrical contact/sensor 24.sub.1, 24.sub.2 and 24.sub.3 is actuated when properly sealingly engaged to a user’s face, an adjacent LED 36 illuminates as seen in [0078]. Therefore, each of the plurality of sensors is coupled to one of the pluralities of light elements).
Regarding claim 5, Hickey in view of Haas teaches the mask of claim 1, and Hickey further teaches wherein each of the plurality of light elements is coupled to a respective sensor of the plurality of sensors (Hickey teaches when electrical contact/sensor 24.sub.1, 24.sub.2 and 24.sub.3 is actuated when properly sealingly engaged to a user’s face, an adjacent LED 36 illuminates as seen in [0078]. Therefore, each of the plurality of light elements is coupled to a respective electrical contact/sensor).
Regarding claim 6, Hickey in view of Haas teaches the mask of claim 1, and Hickey further teaches wherein each of the plurality of light elements is a light emitting diode (LED) that is powered by the battery (“The facemask 10′ includes a plurality of visual indicators 36, such as light emitting diodes (LEDs), disposed on the facemask body 12.” See [0050]; Hickey teaches the power source 30 to be a battery which is connected to the visual indicators 36 as seen in Fig. 2 and [0046]).
Regarding claim 7, Hickey in view of Haas teaches the mask of claim 1, and Hickey further teaches wherein the object that is external to the mask is a face of an individual (“…the LEDs 36 (FIG. 3) may illuminate when the electrical contacts 24.sub.1, 24.sub.2, 24.sub.3 are concurrently actuated to indicate that the facemask 10′ is properly sealingly engaged with the child's face.” See [0078]).
Regarding claim 8, Hickey in view of Haas teaches the mask of claim 7, and Hickey further teaches wherein the facial adaptive component includes a narrow portion that conforms to a nose on the face and a wide portion that conforms to a chin on the face (facemask body 12 includes a narrow portion that conforms to a nose (top portion of facemask body 12 near sensor 24.sub.1) and a wide portion that confirms to a chin on the face (bottom portion of facemask body 12 adjacent to sensors 24.sub.2 and 24.sub.3) as seen in Figs. 3 and 9A-9C).
Regarding claim 9, Hickey in view of Haas teaches the mask of claim 1, and Hickey further teaches further comprising a rigid component (body 12, see Figs. 1-3) disposed between the facial adaptive component and an external adaptive component (port 12, see Fig. 3 and [0042]) (body 12 is disposed between the skin contact perimeter 22 and port 12 as seen in Fig. 3).
Regarding claim 10, Hickey in view of Haas teaches the mask of claim 1, and Hickey further teaches further comprising an audio component (speaker 34, see Fig. 2).
Regarding claim 11, Hickey in view of Haas teaches the mask of claim 10, and Hickey further teaches wherein the audio component emits sound responsive to one or more of the plurality of circuits changing from operating in the open-circuit state to the closed-circuit state (“The control circuit 28 is configured to initiate output of an audible stimulus and/or a visual stimulus in response to receiving a concurrent signal from each of the plurality of electrical contacts or inputs 24.sub.1, 24.sub.2, 24.sub.3. For example, in the embodiment shown in FIG. 1, the control circuit 28 (or the controller 32) can be configured to send a signal to a speaker 34 such that the speaker outputs an audible stimulus.” See [0047]).
Regarding claim 21, Hickey in view of Haas teaches the mask of claim 1, but is unclear on wherein the light intensity increases as the degree of contact between the plurality of sensors and the skin increases as Haas teaches manipulating the brightness of the plurality of light elements to indicate leakage/contact between the patient interface and the face of the subject, such that a full contact the between patient interface and the face of the subject will have a different brightness than a partial contact.
However, a practitioner in the art would recognize the brightness to indicate leakage/contact between the patient interface and the face of the subject can either increase or decrease based on the degree of contact (e.g. full contact or partial contact). Therefore, it would be obvious to one of ordinary skill in the art to modify the mask taught by Hickey in view of Haas to have the brightness increase as the degree of contact between the plurality of sensors and the skin increases to indicate to the user the locations of the mask that are well sealed and to adjust the locations that are not bright enough/sealed.
Claim(s) 12-19 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hickey (US 20160106941 A1) in view of Haas (US 20120240933 A1) and Donenfeld (US 20160045691 A1).
Regarding claim 12, Hickey teaches a mask (facemask 10′, see Fig. 3 and [0050]) comprising:
a facial adaptive component (the facial adaptive component comprises of skin contact perimeter 22 and a portion of the body 12 which is adjacent to the skin contact perimeter as seen in Figs. 1 and 3) including a deformable member (skin contact perimeter 22, see Figs. 1 and 3; “…the skin contact perimeter 22 may be formed of a flexible, resilient material…” see [0044]) embedded in an interior region of the facial adaptive component (skin contact perimeter 22 is embedded in an interior region of the body 12 as seen in Figs. 1 and 3);
a plurality of light elements (a plurality of visual indicators 36, see Fig. 3; “The facemask 10′ includes a plurality of visual indicators 36, such as light emitting diodes (LEDs), disposed on the facemask body 12.” See [0050]) coupled to a plurality of sensor elements (electrical contacts/sensors 24.sub.1, 24.sub.2 and 24.sub.3, see Figs. 1-3) (Hickey teaches when the electrical contact/sensors 24.sub.1, 24.sub.2 and 24.sub.3 is actuated, an adjacent LED 36 illuminates as seen in [0078]. Therefore, the plurality of visual indicators 36 is coupled to the electrical contacts/sensors 24.sub.1, 24.sub.2 and 24.sub.3) and positioned within the deformable member (the plurality of visual indicators 36 are positioned within the skin contact perimeter 22 as seen in Fig. 3 (similarly to how the light components 114 in Fig. 2 of applicant’s drawings are positioned within the facial adaptive component which comprises of the deformable member (not shown/referenced in applicant’s drawings)); the plurality of sensor elements positioned at a plurality of locations within the deformable member (sensors 24.sub.1, 24.sub.2 and 24.sub.3 are positioned at a plurality of locations within skin contact perimeter 22 as seen in Figs. 1 and 3).
But does not teach a plurality of piezoelectric elements;
wherein each of the plurality of piezoelectric elements provides electrical power to a respective one of the plurality of light elements in response to each of the plurality of piezoelectric elements being pressed against skin on an object that is external to the mask, and
wherein the plurality of light elements emit varied light intensity based on a degree of contact between the plurality of sensors and the skin; and
wherein the plurality of light elements provide a visual indication of a partial seal between the facial adaptive component and the skin.
However, Haas teaches wherein the plurality of light elements emit varied light intensity based on a degree of contact between the plurality of sensors and the skin; and
wherein the plurality of light elements provide a visual indication of a partial seal between the facial adaptive component and the skin (Haas teaches a patient interface device 34 (see [0023]), sensor 22 configured to generate output signals conveying information related to the engagement between patient interface 34 and the face of subject 12 (see [0029] and [0032]-[0034]) and a user interface 20 with plurality of indicator lights 58 representing individual locations on the patient interface as seen in [0054]. The indicator lights 58 can be manipulated such that the brightness or other aspects of illumination given off by the appropriate one of the indicator lights 58 may indicate the amount of leakage present as seen in Figs. 2-3 and [0047]-[0048] and [0054]. As such, Haas teaches the indicator lights 48 to emit a brightness depending on a degree of leakage/contact based on engagement/contact signals from sensor 22, wherein a full contact between the patient interface and the face of the subject will have a different brightness than a partial contact).
Hickey teaches capacitive sensors which is configured to detect contact with skin (see [0009] and [0053]) and a plurality of visual indicators 36 to provide a visual stimulus for when the facemask is properly sealingly engaged with a user’s face as seen in [0078]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the mask taught by Hickey to have the plurality of light elements emit varied light intensity based on a degree of contact between the plurality of sensors and the skin; and the plurality of light elements provide a visual indication of a partial seal between the facial adaptive component and the skin as taught by Haas for a visual indication with varying brightness to show the specific location of where the mask is leaking/not fully sealed for the patient to make adjustments (see [0055]-[0056]).
However, Donenfeld teaches an alerting mechanism if a tube was to be disconnected, such as a as a piezoelectric sensor associated with a light as seen in [0029].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the mask taught by Hickey in view of Haas to replace the sensors with piezoelectric sensors as taught by Donenfeld for an alternative sensor used within an alerting mechanism (see [0029]). Modified Hickey teaches wherein each of the plurality of piezoelectric elements provides electrical power to a respective one of the plurality of light elements in response to each of the plurality of piezoelectric elements being pressed against skin on an object that is external to the mask (Hickey teaches when an electrical contact/sensor is actuated, an adjacent LED 36 illuminates as seen in [0078]. Donenfield teaches using a piezoelectric sensor associated with a light to alert personnel if something has been disconnected as seen in [0029]. Therefore, Hickey in view of Donenfield teaches the plurality of piezoelectric elements (taught by Donenfield) to provide electrical power to a respective one of LED 36 when it is actuated by being pressed on a user’s face (see [0078] of Hickey) (This is similar to the piezoelectric element in [0025]-[0026] of applicant’s specification, wherein the piezoelectric element will experience a certain level of mechanical pressure to generate an output voltage to a particular light emitting diode)).
Regarding claim 13, modified Hickey teaches the mask of claim 12, and Hickey further teaches wherein the object that is external to the mask is a face of an individual (“…the LEDs 36 (FIG. 3) may illuminate when the electrical contacts 24.sub.1, 24.sub.2, 24.sub.3 are concurrently actuated to indicate that the facemask 10′ is properly sealingly engaged with the child's face.” See [0078]).
Regarding claim 14, modified Hickey teaches the mask of claim 13, and Hickey further teaches wherein the facial adaptive component includes a narrow portion that conforms to a nose on the face (facemask body 12 includes a narrow portion that conforms to a nose (top portion of facemask body 12 near sensor 24.sub.1) as seen in Figs. 3 and 9A-9C).
Regarding claim 15, modified Hickey teaches the mask of claim 13, and Hickey further teaches wherein the facial adaptive component includes a wide portion that conforms to a chin on the face (facemask body 12 includes a wide portion that confirms to a chin on the face (bottom portion of facemask body 12 adjacent to sensors 24.sub.2 and 24.sub.3) as seen in Figs. 3 and 9A-9C).
Regarding claim 16, modified Hickey teaches the mask of claim 12, and Hickey further teaches further comprising: a battery (power source 30, see Fig. 2; “The control circuit 28 may include a power source 30 (e.g., a battery) …” see [0046]); and an audio component (speaker 34, see Fig. 2) coupled to the battery (speaker 34 is coupled to the power source/battery 30 as seen in Fig. 2), wherein the audio component emits sound responsive to each of the plurality of piezoelectric elements being pressed against skin on the object that is external to the mask (“The control circuit 28 is configured to initiate output of an audible stimulus and/or a visual stimulus in response to receiving a concurrent signal from each of the plurality of electrical contacts or inputs 24.sub.1, 24.sub.2, 24.sub.3. For example, in the embodiment shown in FIG. 1, the control circuit 28 (or the controller 32) can be configured to send a signal to a speaker 34 such that the speaker outputs an audible stimulus.” See [0047] and [0078]).
Regarding claim 17, modified Hickey teaches the mask of claim 12, and Hickey further teaches wherein further comprising a rigid component (body 12, see Figs. 1-3) disposed between the facial adaptive component and an external adaptive component (port 12, see Fig. 3 and [0042]) (body 12 is disposed between the skin contact perimeter 22 and port 12 as seen in Fig. 3).
Regarding claim 18, modified Hickey teaches the mask of claim 12, and Hickey further teaches wherein each of the plurality of light elements is a light emitting diode (LED) (“The facemask 10′ includes a plurality of visual indicators 36, such as light emitting diodes (LEDs), disposed on the facemask body 12.” See [0050]).
Regarding claim 19, modified Hickey teaches the mask of claim 12, and further teaches wherein each of the plurality of piezoelectric elements being pressed against skin on the object that is external to the mask is associated with a seal between the facial adaptive component and the object that is external to the mask (modified Hickey teaches a plurality of piezoelectric sensors (taught by Donenfield) that is actuated to indicate the facemask 10’ is properly sealingly engaged with a user’s face as seen in [0078] and [0043] and Figs. 1, 3 and 9C of Hickey).
Regarding claim 22, modified Hickey teaches the mask of claim 12, but is unclear on wherein the light intensity increases as the degree of contact between the plurality of sensors and the skin increases as Haas teaches manipulating the brightness of the plurality of light elements to indicate leakage/contact between the patient interface and the face of the subject, such that a full contact the between patient interface and the face of the subject will have a different brightness than a partial contact.
However, a practitioner in the art would recognize the brightness to indicate leakage/contact between the patient interface and the face of the subject can either increase or decrease based on the degree of contact (e.g. full contact or partial contact). Therefore, it would be obvious to one of ordinary skill in the art to modify the mask taught by Hickey in view of Haas to have the brightness increase as the degree of contact between the plurality of sensors and the skin increases to indicate to the user the locations of the mask that are well sealed and to adjust the locations that are not bright enough/sealed.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hickey (US 20160106941 A1) in view of Haas (US 20120240933 A1) and Donenfeld (US 20160045691 A1), as applied to claim 12 above, and further in view of Fu (US 20170361045 A1).
Regarding claim 20, modified Hickey teaches the mask of claim 12, but does not teach wherein the deformable member includes a silicone material.
However, Fu teaches wherein the deformable member (seal-forming structure 3100, see Fig. 12) includes a silicone material (“A seal-forming structure 3100 in accordance with the present technology may be constructed from a soft, flexible, resilient material such as silicone.” See [0145]).
Hickey teaches the skin contact perimeter 22 to be a flexible, resilient material but does not disclose the material. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the mask taught by modified Hickey to have the deformable member be made out of silicone as taught by Fu as it is a soft, flexible, resilient material (see [0145]) that is known to be used in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tina Zhang whose telephone number is (571)272-6956. The examiner can normally be reached Monday - Friday 9:00AM-5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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