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 Amendment
This Office Action is in response to the amendment filed on 04/22/2026. Claims 1-2, 5-9, 12, 15, 18, 20, and 22 are amended. Claims 3, 11, 13, 17, 19, 21, and 25-26 are as previously presented. Claims 4, 10, 14, 16, and 23-24 are canceled. As such, claims 1-3, 5-9, 11-13, 15, 17-22, and 25-26 are pending in the instant application.
All objections are withdrawn in light of the amendments.
Claim Objections
Claims 1-2, 5, 9, 12, 18, and 20-21 are objected to because of the following informalities:
Claim 1, line 3: “the nose and/or mouth of the wearer” should read “a nose and/or a mouth of a wearer” for clarity and to establish antecedent basis.
Claim 1, line 10: “and second sensor window” should read “and the second sensor window” for clarity.
Claim 2, line 6: “and second sensor window” should read “and the second sensor window” for clarity.
Claim 5, line 2: “and second sensor window” should read “and the second sensor window” for clarity.
Claim 9 (line 3) and all further recitations: “a wearer” should read “the wearer” for clarity.
Claim 18, lines 1-2: “the first and second sensor windows” should read “the first sensor window and the second sensor window” for clarity.
Claim 21, line 3: “a wearer’s nose” should read “the nose of the wearer”, and “a wearer’s mouth” should read “the mouth of the wearer” for consistency and clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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)(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.
Claims 1-3, 5-8, 11-13, 15, 20-22, and 25-26 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yamamori (US 20080196715 A1).
Regarding claim 1, Yamamori discloses a respiratory apparatus (Fig. 1) comprising a sensor (5; Fig. 1) and a respiratory mask (nasal mask, see Fig. 1; first sentence of [0029]), the respiratory mask (nasal mask, see Fig. 1; first sentence of [0029]) comprising a mask body (body of nasal mask, see Fig. 1) having an enclosing wall (1; Fig. 1) that defines an interior cavity (space enclosed between nasal mask shell 1 and the user’s face 12, see Fig. 2) configured to receive the nose and/or mouth of the wearer (see Figs. 1-2, where user’s nose is enclosed within the interior cavity formed by nasal mask shell 1), and the sensor (5; Fig. 1) having a transmitter of electromagnetic radiation and a receiver of electromagnetic radiation (see Annotated Fig. 1 below; [0033], where light is a form of electromagnetic radiation), wherein the enclosing wall (1; Fig. 1) has a sensor portion (4; Fig. 1) including a first sensor window and a second sensor window (4 has two windows 17, one window 17 of 4 is on the left side and is not shown in Fig. 1 due to the angle of the drawing, and a second window 17 located on the right side of 4; Fig. 1; [0031]), a portion of the interior cavity being defined between the first sensor window and the second sensor window (the space within nasal tubes 6 and attachment portion 4 is fluidly connected to the space between the nasal mask shell 1 and the user’s face 12, see the first sentence of [0035] and Fig. 1, hence a portion of the space between the nasal mask shell 1 and the user’s face is defined between the windows 17, where windows 17 are positioned on opposing sides of attachment portion 4), and the sensor (5; Fig. 1) being mounted relative to the sensor portion of the respiratory mask (5 is mounted relative to 4, see Fig. 1 and 3), such that electromagnetic radiation from the transmitter is transmitted, in use, through the first sensor window, through the portion of the interior cavity defined between the first sensor window and second sensor window, through the second sensor window, to the receiver (light from the transmitter moves through a first window 17, located on a first side of attachment portion 4, through the portion of the interior cavity between windows 17 positioned on opposing sides of attachment portion 4, through a second window 17 – located on a second side of attachment portion 4, opposite the first side of attachment portion 4 – to the light receiver; see Fig. 1 and Annotated Fig. 1; [0033]).
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Regarding claim 2, Yamamori discloses a kit of parts (Fig. 1, where the kit of parts has already been assembled) comprising a sensor (5; Fig. 1) and a respiratory mask (nasal mask, see Fig. 1; first sentence of [0029]), the respiratory mask (nasal mask, see Fig. 1; first sentence of [0029]) comprising a mask body (body of nasal mask, see Fig. 1) having an enclosing wall (1; Fig. 1) that defines an interior cavity (space enclosed between nasal mask shell 1 and the user’s face 12, see Fig. 2), and the sensor (5; Fig. 1) having a transmitter of electromagnetic radiation and a receiver of electromagnetic radiation (see Annotated Fig. 1 below; [0033], where light is a form of electromagnetic radiation), wherein the enclosing wall (1; Fig. 1) has a sensor portion (4; Fig. 1) including a first sensor window and a second sensor window (4 has two windows 17, one window 17 of 4 is on the left side and is not shown in Fig. 1 due to the angle of the drawing, and a second window 17 located on the right side of 4; Fig. 1; [0031]), a portion of the interior cavity being defined between the first sensor window and second sensor window (the space within nasal tubes 6 and attachment portion 4 is fluidly connected to the space between the nasal mask shell 1 and the user’s face 12, see the first sentence of [0035] and Fig. 1, hence a portion of the space between the nasal mask shell 1 and the user’s face is defined between the windows 17, where windows 17 are positioned on opposing sides of attachment portion 4), and the sensor (5; Fig. 1) being mountable relative to the sensor portion of the respiratory mask (5 can be mounted relative to 4, see Fig. 1 and 3), such that electromagnetic radiation from the transmitter is transmitted, in use, through the first sensor window of the sensor portion of the enclosing wall, through the portion of the interior cavity defined between the first sensor window and the second sensor window, through the second sensor window, to the receiver (light from the transmitter moves through a first window 17, located on a first side of attachment portion 4, through the portion of the interior cavity between windows 17 positioned on opposing sides of attachment portion 4, through a second window 17 – located on a second side of attachment portion 4, opposite the first side of attachment portion 4 – to the light receiver; see Fig. 1 and Annotated Fig. 1; [0033]).
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Regarding claim 3, Yamamori discloses the invention as set forth in claim 1, wherein the sensor is a gas composition sensor ([0009]).
Regarding claim 5, Yamamori discloses the invention as set forth in claim 1, wherein each of the first sensor window and second sensor window windows have an interior surface and an exterior surface (it would be well understood by one of ordinary skill in the art that both windows 17 have an exterior surface – in contact with associated light transmitter and light receiver – and an interior surface – in fluid contact with expiratory gases flowing through attachment portion 4 via nasal tubes 6; Figs. 1 and 3).
Regarding claim 6, Yamamori discloses the invention as set forth in claim 5, wherein the sensor (5; Fig. 1) is mounted relative to the sensor portion (5 is mounted relative to 4, see Fig. 1 and 3) with the transmitter disposed adjacent to the exterior surface of the first sensor window and the receiver disposed adjacent to the exterior surface of the second sensor window (see [0033] and Figs. 1 and 3, where the transmitter and receiver are located on outer surfaces of windows 17, hence it would be readily understood by one of ordinary skill in the art that the light transmitter can be disposed adjacent to the exterior surface of a first window 17 and the light receiver can be disposed adjacent to the exterior surface of a second window 17).
Regarding claim 7, Yamamori discloses the invention as set forth in claim 6, wherein the sensor (5; Fig. 1) comprises a housing (housing of sensor, see Fig. 1) which accommodates the transmitter and the receiver (housing of sensor 5 accommodates the light transmitter and light receiver; Fig. 1; [0033]), and a portion of the housing that accommodates the transmitter and a portion of the housing that accommodates the receiver both project outwardly of the remainder of the housing (see Annotated Fig. 1 below), such that the transmitter is disposed adjacent to the exterior surface of the first sensor window and the receiver is disposed adjacent to the exterior surface of the second sensor window (see claim 6 above).
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Regarding claim 8, Yamamori discloses a respiratory mask (nasal mask, see Fig. 1; first sentence of [0029]) for use with a sensor (5; Fig. 1; [0031]) having a transmitter of electromagnetic radiation and a receiver of electromagnetic radiation (see Annotated Fig. 1 below; [0033], where light is a form of electromagnetic radiation), the respiratory mask (nasal mask, see Fig. 1; first sentence of [0029]) comprising a mask body (body of nasal mask, see Fig. 1) having an enclosing wall (1; Fig. 1) that defines an interior cavity (space enclosed between nasal mask shell 1 and the user’s face 12, see Fig. 2), the enclosing wall (1; Fig. 1) having a sensor portion (4; Fig. 1) including a first sensor window and a second sensor window (4 has two windows 17, one window 17 of 4 is on the left side and is not shown in Fig. 1 due to the angle of the drawing, and a second window 17 located on the right side of 4; Fig. 1; [0031]), a portion of the interior cavity being defined between the first sensor window and the second sensor window (the space within nasal tubes 6 and attachment portion 4 is fluidly connected to the space between the nasal mask shell 1 and the user’s face 12, see the first sentence of [0035] and Fig. 1, hence a portion of the space between the nasal mask shell 1 and the user’s face is defined between the windows 17, where windows 17 are positioned on opposing sides of attachment portion 4).
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Regarding claim 11, Yamamori discloses the invention as set forth in claim 1, wherein the respiratory mask (nasal mask, see Fig. 1; first sentence of [0029]) further comprises an inspiratory gas inlet port (2; Figs. 1-2) for delivering inspiratory gas to the wearer ([0029], lines 5-8), and the sensor portion (4; Fig. 1) is formed separately from the inspiratory gas inlet port (see Figs. 1-2, where attachment portion 4 is formed separately from inlet 2).
Regarding claim 12, Yamamori discloses the invention as set forth in claim 1, wherein the respiratory mask (nasal mask, see Fig. 1; first sentence of [0029]) further comprises an inspiratory gas inlet port (2; Figs. 1-2) for delivering inspiratory gas the wearer ([0029], lines 5-8), and the sensor portion (4; Fig. 1) is spaced from the inspiratory gas inlet port (see Figs. 1-2, where attachment portion 4 is spaced from inlet 2), and/or wherein the respiratory mask further comprises an expiratory gas outlet port for delivering expiratory gas from a wearer, the expiratory gas outlet port being arranged to connect to a gas outlet, and the sensor portion is spaced from the expiratory gas outlet port.
Regarding claim 13, Yamamori discloses the invention as set forth in claim 1, wherein the sensor portion is a discontinuity in the enclosing wall of the mask body (Fig. 2; first sentence of [0031]), and/or wherein the enclosing wall of the mask body has an external surface that forms the exterior of the mask body, and the sensing portion projects, either inwardly or outwardly, relative to the external surface of the mask body (see Fig. 1 and Annotated Fig. 2 below, where the attachment portion 4 projects inwardly, and it projects inwardly within the interior cavity, relative to the external surface of the mask body and groove 3).
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Regarding claim 15, Yamamori discloses the invention as set forth in claim 1, wherein the first sensor window and the second sensor window are transmissive of the electromagnetic radiation transmitted by the transmitter (light from the transmitter is transmitted through both windows 17 to be received by the receiver, see claim 1 above, hence both windows 17 are transmissive of the light transmitted by the light-transmitter; [0033]), and/or wherein the first sensor window and the second sensor window are more transmissive of the electromagnetic radiation transmitted by the transmitter than the remainder of any of the mask body, the enclosing wall of the mask body, an external surface of the mask body, the sensor portion, or any combination thereof.
Regarding claim 20, Yamamori discloses the invention as set forth in claim 1, wherein the mask body (body of nasal mask, see Fig. 1) further comprises a nose cavity portion (see Figs. 1-2, where user’s nose 11 is within the body of the nasal mask) and an inspiratory gas inlet port (2; Figs. 1-2) for delivering inspiratory gas to a wearer ([0029], lines 5-8), the inspiratory gas inlet port being formed in the nose cavity portion (inlet 2 is formed withing the body of the nasal mask positioned about the user’s nose 11, see Figs. 1-2).
Regarding claim 21, Yamamori discloses the invention as set forth in claim 1, wherein the sensor portion (4; Fig. 1) is formed in the mask body (see Fig. 2, where 4 is formed within the mask body) in a region of intersection between an expiratory flow from a wearer's nose and an expiratory flow from a wearer's mouth (4 is positioned in the mask body in between the user’s mouth and the user’s nose, see Fig. 2, hence 4 is located in a region of intersection between expiratory flow from the user’s nose and expiratory flow from the user’s mouth).
Regarding claim 22, Yamamori discloses the invention as set forth in claim 1, wherein the enclosing wall of the body (1; Figs. 1-2) has an external surface that forms the exterior of the mask body (the exterior surface of 1 forms the exterior surface of the mask body, see Figs. 1 and 2), and the sensor portion (4; Fig. 1) comprises a pair of side walls that are angled relative to the external surface of the mask body (see Annotated Figs. 1-2 below), wherein the first sensor window and the second sensor window are formed in the pair of side walls (windows 17 are formed in the side walls of attachment portion 4, see Annotated Figs. 1-2 below).
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Regarding claim 25, Yamamori discloses the invention as set forth in claim 1, wherein the sensor is releasably engageable with the sensor portion ([0009]; [0031], lines 6-7).
Regarding claim 26, Yamamori discloses the invention as set forth in claim 1, wherein the respiratory mask (nasal mask, see Fig. 1; first sentence of [0029]) is for protective purposes (protecting the user from sleep apnea events and potential respiratory failure, see [0001]; protecting the user from accumulating a hazardous concentration of carbon dioxide gas during therapy, see [0002]).
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Yamamori (US 20080196715 A1) in view of Miller (US 20140238400 A1).
Regarding claim 9, Yamamori discloses the invention as set forth in claim 1. Yamamori further discloses an expired gas outlet (16; Fig. 1) for delivering expiratory gas from the user ([0031], first sentence of [0035]), but is silent to the expiratory gas outlet port being arranged to connect to a gas outlet, or having a gas outlet integrally or detachably connected thereto, and wherein the sensor portion is formed separately from the expiratory gas outlet.
However, Miller teaches an analogous respiratory mask (see Fig. 1) with exhalation openings (18; Fig. 2; [0041] and [0046]) located on the mask body (10; Figs. 1-2).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the mask body taught by Yamamori (see claim 1 above) with the exhalation openings taught by Miller (Miller 18; Figs. 1-2; [0041] and [0046]) such that the expiratory gas outlet port (16; Fig. 1) being arranged to connect to a gas outlet (Yamamori 16 is fluidly connected to Miller 18 via the interior cavity; Yamamori Figs. 1-2; Miller Fig. 2; Miller [0041] and [0046]), and wherein the sensor portion (4; Fig. 1) is formed separately from the expiratory gas outlet (Miller 18 is formed within the respiratory mask body taught by Yamamori, hence Yamamori 4 and Miller 18 are formed separately; Yamamori Figs. 1-2; Miller Fig. 2; Miller [0041] and [0046]) to allow exhaled gases to exit the interior cavity and minimize rebreathing of exhaled gases (Miller [0018], lines 6-11; Miller [0046], lines 1-3).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Yamamori (US 20080196715 A1) in view of Haveri (US 20140330154 A1).
Regarding claim 17, Yamamori discloses the invention as set forth in claim 1. Yamamori further discloses a light transmitter and receiver, but does not explicitly disclose infrared radiation transmitted by the transmitter and received by the receiver.
However, Haveri teaches an analogous sensor (2; Figs. 4-5) with a radiation source (40; Fig. 4) transmitting infrared radiation (first sentence of [0031]), where the infrared radiation from the radiation source (40; Fig. 4) is received by a detector (41; Fig. 4; first sentence of [0031]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the light transmitter and light receiver taught by Yamamori (see claim 1 above) with the radiation source and detector taught by Haveri (see above), such that the electromagnetic radiation transmitted by the transmitter (Haveri 40; Fig. 4) and received by the receiver (Haveri 41; Fig. 4) is infrared radiation (first sentence of Haveri [0031]) as it would be obvious to one of ordinary skill in the art to simply substitute one know electromagnetic radiation transmitter and receiver for another electromagnetic radiation transmitter and receiver to measure the composition of expiratory gases (see MPEP §2143(I)).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Yamamori (US 20080196715 A1) in view of Rich (US 5693944 A).
Regarding claim 18, Yamamori discloses the invention as set forth in claim 1, but is silent to the first and second sensor windows are of a reduced thickness relative to the remainder of any of the mask body, the enclosing wall of the mask body, an external surface of the mask body, the sensor portions, or any combination thereof.
However, Rich teaches an analogous sensor portion (center section 126, see Fig. 1) to measure the concentration of a gas (Abstract) where the windows (142 and 144; Figs. 1 and 3) have a reduced thickness relative to the remainder of the sensor portions (see Fig. 1 where window 144 is recessed in retainer ring 176 due to the window’s reduced thickness relative to the walls of center section 126; see Fig. 3, where windows 142 and 144 have a reduced thickness relative to center section 126; col. 8, lines 64-67 and col. 9, lines 1-4).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the windows taught by Yamamori (see claim 1 above) with the window taught by Rich (142 and 144; Figs. 1 and 3), such that the first and second sensor windows (Rich 142 and 144; Rich Figs. 1 and 3) are of a reduced thickness relative to the remainder of any of the sensor portions (see Rich Fig. 1 where window 144 is recessed in retainer ring 176 due to the window’s reduced thickness relative to the walls of center section 126; see Rich Fig. 3, where windows 142 and 144 have a reduced thickness relative to center section 126; Rich: col. 8, lines 64-67 and col. 9, lines 1-4) to provide a flush fit between the windows and the inner surfaces of the sensor portion side walls to minimize errors that may occur due to debris collecting and obscuring the light transmitted from the light transmitter (Rich col. 9, lines 31-37).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Yamamori (US 20080196715 A1) in view of Yamamori et al. (JP 2003315264 A; hereinafter “Yamamori ‘264”).
Regarding claim 19, Yamamori discloses the invention as set forth in claim 1, but fails to explicitly disclose the mask body comprises a mouth cavity portion and the sensor portion is formed in the mouth cavity portion.
However, Yamamori does incorporate the sensor (5; Fig. 1) from Yamamori ‘264 (see Yamamori [0033]), where Yamamori ‘264 teaches the sensor (Yamamori ‘264: 1; Fig. 2b) being attached to an outer surface of a full face oxygen mask (Yamamori ‘264: mask 20; Fig. 9) to measure the composition of carbon dioxide gas in the air exhaled by the user (Yamamori ‘264: [0049], see provided translation).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the mask taught by Yamamori (see claim 1 above) with the mask taught by Yamamori ‘264 (Yamamori ‘264: mask 20; Fig. 9), such that the mask body (body of mask 20 taught by Yamamori ‘264, see Yamamori ‘264 Fig. 9) comprises a mouth cavity portion (portion of Yamamori ‘264 mask 20 retaining the user’s mouth, see Yamamori ‘264 Fig. 9 and provided translation of Yamamori ‘264 [0049]) and the sensor portion is formed in the mouth cavity portion (attachment portion 4 is within the interior cavity, see Fig. 2, hence the attachment portion 4 is within an interior cavity of the mask 20 taught by Yamamori ‘264, where the user’s mouth is also retained in the interior cavity of the mask 20 taught by Yamamori ‘264, see Yamamori ‘264 Fig. 9) as it would be obvious to one of ordinary skill in the art to simply substitute one know type of mask, such as the nasal mask taught by Yamamori, with another known type of mask, such as the face mask taught by Yamamori ‘264, to supply air to the user and measure the composition of carbon dioxide gas exhaled by the user (see MPEP §2143(I)).
Response to Arguments
Applicant's arguments filed on 04/22/2026 have been fully considered but they are not persuasive.
On page 8 of the Remarks, Applicant argues the attachment portion disclosed by Yamamori forms a small second chamber into which exhaled air is directed to and the sensor is attached to. As such, this second chamber is not formed by the enclosing wall that defined the interior cavity and does not itself form part of the interior cavity; hence, Yamamori fails to disclose or suggest “[a] mask comprising a mask body having an enclosing wall that defines an interior cavity configured to receive the nose and/or mouth of the wearer, … wherein the enclosing wall has a sensor portion including a first sensor window and a second sensor window, a portion of the interior cavity being defined between the first sensor window and the second sensor window” as recited in amended claim 1. However, neither the attachment portion (4) taught by Yamamori, nor the “second chamber” formed by the attachment taught by Yamamori, are taught to be the enclosing wall or cavity. Instead, Yamamori’s nasal mask shell (1) is taught to be the enclosing wall, and the volume enclosed by Yamamori’s nasal mask shell (1) is taught to be the interior cavity (see pg. 6 of the Office Action mailed on 01/28/2026; see 102(a)(2) rejection of amended claim 1 above). Furthermore, the volume enclosed by Yamamori’s nasal mask shell (1) does receive at least a user’s nose (see Yamamori Figs. 1-2), and Yamamori’s nasal mask shell (1) includes the attachment portion (4, see first sentence of [0031] and [0032], line 5), where the attachment portion (4) has two windows (17), and a portion of the volume enclosed by the nasal mask shell (1) is defined between the two windows (17; see Figs. 1-2; see [0035]; see 102(a)(2) rejection of amended claim 1 above).
Applicant further states “Yamamori teaches that keeping the inhaled and exhaled gases separate is required to prevent dilution of the inhaled gas… [t]his teaches directly away from a structure such as that recited in claim 1 of the present application, in which the exhaled gas re-enters the internal cavity” (see pg. 8 of the Remarks). In response to applicant's argument that the references teaches away from certain features of the invention, it is noted that the features upon which applicant relies (i.e., exhaled gas re-entering the internal/interior cavity) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Furthermore, it is believed the art referred to and the paragraph of Yamamori cited by Applicant ([0032], see Remarks pg. 8) have been misinterpreted. Paragraph [0032] states, “[o]n the upper side of the attachment portion 4, there is provided an Y-shaped nasal tube 6 for acquiring a passage that is used for guiding the expired gas, which is introduced to the inside of the attachment portion 4 from the nostrils 15, to the attachment portion 4 in the nasal mask shell 1 without allowing the expired gas to be diluted by gas coming from the inlet 2” to describe the exhaled air is provided from a user’s nostril, through the Y-shaped nasal tube, and into the attachment portion without being diluted by gas coming from the inlet, such that the carbon dioxide gas sensor may accurately measure a concentration of carbon dioxide in the exhaled gas ([0032] and [0035]). Yamamori further teaches that the exhaled gas moves through the attachment portion and is discharged back into the inside of the nasal mask shell by an expired gas outlet (first sentence of [0035]). As such, Applicant’s argument regarding claim 1 is not persuasive.
On page 9 of the Remarks, Applicant states claims 2, 3, 5-9, 11-13, 15, 17-22, 25, and 26 depend from and contain the limitation of claim 1, and as such are distinguishable and patentable over Yamamori in at least the same manner as claim 1. However, claim 1 is not distinguishable nor patentable over Yamamori (see response Applicant’s arguments regarding claim 1 above; see 102(a)(2) rejection of claim 1 above). Furthermore, claims 2 and 8 do not depend from claim 1, and do not include all limitations of claim 1. As such, Applicant’s arguments regarding claims 2, 3, 5-9, 11-13, 15, 17-22, 25, and 26 are not persuasive.
On page 9 of the Remarks, Applicant argues Miller fails to cure the deficiencies of Yamamori with respect to claim 1 (see pg. 8 of Remarks for deficiencies of Yamamori with respect to claim 1). For at least the same reasons provided for claim 1 above, Applicant’s arguments are not persuasive. Applicant further argues one of ordinary skill would not be motivated to combine the teachings of Yamamori and Miller in the manner suggested by the Office in the Office Action mailed on 01/28/2026, as Yamamori teaches “exhaled air is physically directed through the attachment portion and out of the mask… and does not re-enter the interior cavity of the mask; hence, Yamamori does not provide an outlet for the openings taught by Miller. However, in Yamamori, exhaled air is directed from the attachment portion, through an expired gas outlet, and back into the inside of the nasal mask shell ([0035]); therefore, it would have been obvious to a person of ordinary skill in the art to combine the teachings of Yamamori and Miller such that exhaled gases can be vented from the inside of the nasal mask shell to minimize rebreathing of exhaled gases. As such, Applicants arguments regarding claim 9 are not persuasive.
On page 10 of the Remarks, Applicant argues claims 17 and 18 are distinguishable and patentable over the prior art as Haveri and Rich fails to cure the deficiencies of Yamamori with respect to claim 1 (see pg. 8 of Remarks for deficiencies of Yamamori with respect to claim 1). For at least the same reasons provided for claim 1 above, Applicant’s arguments are not persuasive.
On page 10 of the Remarks, Applicant argues claim 19 are distinguishable and patentable over the prior art as Yamamori ‘264 fails to cure the deficiencies of Yamamori with respect to claim 1 (see pg. 8 of Remarks for deficiencies of Yamamori with respect to claim 1). For at least the same reasons provided for claim 1 above, Applicant’s arguments are not persuasive.
Additionally, on pages 10-11, Applicant argues a person of ordinary skill would not be motivated to combine the teachings of Yamamori and Yamamori ‘264 in the manner suggested by the Office in the Office Action mailed on 01/28/2026, as a key teaching of Yamamori is that the expired gas should not be diluted by gas coming from the inlet, and moving the sensor to a mouth cavity region would be contrary to the teachings of Yamamori. It is believed the art and paragraph of Yamamori referred to and cited by Applicant ([0032], see Remarks pg. 8) have been misinterpreted. Paragraph [0032] states, “[o]n the upper side of the attachment portion 4, there is provided an Y-shaped nasal tube 6 for acquiring a passage that is used for guiding the expired gas, which is introduced to the inside of the attachment portion 4 from the nostrils 15, to the attachment portion 4 in the nasal mask shell 1 without allowing the expired gas to be diluted by gas coming from the inlet 2” to describe the exhaled air is provided from a user’s nostril, through the Y-shaped nasal tube, and into the attachment portion without being diluted by gas coming from the inlet, such that the carbon dioxide gas sensor may accurately measure a concentration of carbon dioxide in the exhaled gas ([0032] and [0035]). Yamamori further teaches that the exhaled gas moves through the attachment portion and is discharged back into the inside of the nasal mask shell by an expired gas outlet (first sentence of [0035]). Hence, it would be obvious to one of ordinary skill in the art to modify the mask body taught by Yamamori with the mask taught by Yamamori ‘264 such that a mouth cavity portion and corresponding sensor portion are capable of receiving and measuring the carbon dioxide concentration of gases exhaled by a user’s mouth (see 103 rejection of claim 19 above; see MPEP §2143(I)). As such, Applicant’s argument regarding claim 19 is not persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Takatori et al. (US 11511067 B2): Regarding a respiratory assistance device with a gas sensor attaching portion to attach a gas sensor with measurement windows.
Gary et al. (WO 2019028550 A1): Regarding a respiratory airway circuit with a gas composition sensor having windows.
THIS ACTION IS MADE FINAL. 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 ABIGAYLE DALE whose telephone number is (571)272-1080. The examiner can normally be reached Monday-Friday from 8:45am to 5:45pm ET.
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, 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.
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.
/ABIGAYLE DALE/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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