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 .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
According to the MPEP 609.05(a), “If an information disclosure statement does not comply with the requirements based on the time of filing of the IDS as discussed in MPEP § 609.04(b), including the requirements for fees and/or statement under 37 CFR 1.97(e), the IDS will be placed in the application file, but none of the information will be considered by the examiner... Applicant may then file a new information disclosure statement or correct the deficiency in the previously filed IDS, but the date that the new IDS or correction is filed will be the date of the IDS for purposes of determining compliance with the requirements based on the time of filing of the IDS (37 CFR 1.97 ).” The information disclosure statement filed 1/12/2025 originally failed to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because it was filed after the mailing of a first Office action on the merits and before the mailing data of a final action without an IDS fee or Certification Statement. It was then placed in the application file, but the information referred to therein was not considered as to the merits. This deficiency was corrected upon the Applicant filing a Request for Continued Examination on 11/19/2025, but that means the date that the Request for Continued Examination, i.e. the correction, was filed is the date of the IDS for purposes of determining compliance with the requirements based on the time of filing of the IDS. Hence, the date for determining compliance for the IDS is 11/19/2025. Moreover, any IDS filed on or after 1/19/2025 is subject to new IDS size fee and size fee assertion rules in 37 C.F.R. 1.17(v) and the amendments to 1.97(a), 1.98(a)(4), and 1.555(a). Thus, the IDS fails to comply with the provisions of 37 C.F.R. 1.17(v), 1.97(a), 1.98(a)(4), and 1.555(a) because it was filed without the size fee and the written size fee assertion statement. It is still in the application file, but the information referred to therein has not been considered as to the merits.
Response to Amendments
The Amendment filed 3/23/2026 has been entered. Claims 1, 3-5, and 7-20 were amended. Thus, claims 1-20 are pending in the application.
Claim Objections
Claim 10 is objected to because of the following informalities:
Claim 10 recites “over a range of received flow of breathable gas over a range comprising at least 0.5 to 15 liters per minute of the received flow of the breathable gas” in lines 20-21, and is suggested to read --over a range comprising at least 0.5 to 15 liters per minute of the received flow of the breathable gas-- in order to avoid redundancy.
Appropriate correction is required.
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 10-18 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.
Regarding claim 19, the limitations “at least one region” in lines 5 and 7 are confusing, as it is unclear whether these are meant to be a part of “a plurality of separated spatial regions” in lines 3-4, and/or whether these are meant to be the same or different regions from each other. For the purposes of examination, they will be interpreted as different regions both a part of “a plurality of separated spatial regions”.
Any remaining claims are rejected based on their dependency on a rejected base claim
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 5, 8-12, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Beard et al. (US 2016/0038709 A1) in view of Ostrowski et al. (US 2008/0075633 A1), Mace et al. (US 10,175,254 B2), and Gallagher (US 2019/0167171 A1).
Regarding claim 1, Beard discloses a face mask (oxygen face mask) (abstract), comprising:
a port configured to receive an incoming flow of gas (oxygen inlet port 320 for connecting to gas source, and so receive oxygen gas) (Fig. 18; para. [0164]);
a shell, configured to surround a mouth and nose of a human face, configured to mix the incoming flow of gas with exhaled gas from the mouth and nose of the human face to form a mixed flow of the gas within the shell (mask portion of face mask assembly 310 has space to surround the nose and mouth of a patient; oxygen delivered into the face mask assembly 310 space and expiratory gas in the face mask assembly 310 space would be able to mix) (Fig. 20; para. [0164]); and
a durable reversible colorimetric carbon dioxide indicator having a colorimetric response to carbon dioxide, the durable reversible colorimetric carbon dioxide indicator being positioned and configured within the shell for exposure to the mixed flow of gas (colorimetric CO2 detector-indicator 404; face mask surface 410 and colorimetric CO2 housing 402 as being the shell, with the colorimetric CO2 detector-indicator 404 inside) (Figs. 18-20, 25A-B; para. [0196]; para. [0198]), and to colorimetrically distinguish between;
(a) respiration-induced flow of carbon dioxide in the mixed flow of a gas from the mouth and nose of the human face, and (b) a respiratory obstruction (colorimetric CO2 detector-indicator 404 configured to detect CO2 in gas exhalation vent; there is no structure in the face mask assembly 310 to prevent oxygen delivered from oxygen inlet port 320 from moving to the gas exhalation vent, and so it can mix with the exhaled gas from the patient’s mouth and nose there or beforehand in the face mask assembly 310 space; the colorimetric CO2 detector-indicator 404 changes color in the presence of CO2 and reverts back in the absence of CO2, and so would be able to function to distinguish between respiration and respiratory obstruction as claimed) (Figs. 18-20, 25A-B; para. [0194]; para. [0200]),
over a range of the incoming flow of gas comprising at least 0.5 to 15 liters per minute (oxygen gas flows through the mask during inhalation and exhalation, and the oxygen gas is delivered to the mask assembly for inhalation at 4-10 L/min; all gases within the mask would be able to mix together) (para. [0123]; para. [0194]; para. [0200]),
wherein the durable reversible colorimetric carbon dioxide indicator comprises a ring (colorimetric CO2 detector-indicator 404 is a ring) (Figs. 25A-B).
Beard does not disclose the durable reversible colorimetric carbon dioxide indicator having a colorimetric response to a partial pressure of carbon dioxide over a range of at least 4 mmHg to 38 mmHg carbon dioxide; wherein the durable reversible colorimetric carbon dioxide indicator comprises different colorimetric responses to the partial pressure of carbon dioxide within the mixed flow of gas.
However, Mace teaches a carbon dioxide detection and measurement system for patient breathing therapies (Mace; abstract) wherein the durable reversible colorimetric carbon dioxide indicator has a colorimetric response to a partial pressure of carbon dioxide over a range of at least 4 mmHg to 38 mmHg carbon dioxide; wherein the durable reversible colorimetric carbon dioxide indicator comprises different colorimetric responses to the partial pressure of carbon dioxide within the mixed flow of gas (an indicator is adapted to change colors for 7.6 mmHg, 15.2 mmHg, 22.8 mmHg, 30.4 mmHg, and 38 mmHg partial pressures of carbon dioxide; each partial pressure has its own indication color) (Mace; col. 8, lines 56-67; col. 9, lines 1-5).
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 the Beard durable reversible colorimetric carbon dioxide indicator to have a colorimetric response to a partial pressure of carbon dioxide over a range of at least 4 mmHg to 38 mmHg carbon dioxide; wherein the durable reversible colorimetric carbon dioxide indicator comprises different colorimetric responses to the partial pressure of carbon dioxide within the mixed flow of gas, as taught by Mace, for the purpose of enabling the partial pressure of carbon dioxide in a breath sample to be determined (Mace; col. 8, lines 43-62).
Beard does not disclose the durable reversible colorimetric carbon dioxide indicator having an indication half-life of 1-5 seconds, so that the durable reversible colorimetric carbon dioxide indicator is configured to be reset between respiratory cycles.
However, Ostrowski teaches a carbon dioxide detector (Ostrowski; abstract) wherein the durable reversible colorimetric carbon dioxide indicator having an indication half-life of 1-5 seconds, so that the durable reversible colorimetric carbon dioxide indicator is configured to be reset between respiratory cycles (carbon dioxide detector with borosilicate and acrylic changes colors between purple and yellow with patient inhalation and exhalation gas flow; the response time during inhalation can be from 2-5 seconds) (Ostrowski; Table 4; para. [0077]).
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 Beard durable reversible colorimetric carbon dioxide indicator to have an indication half-life of 1-5 seconds, so that the durable reversible colorimetric carbon dioxide indicator is configured to be reset between respiratory cycles, as taught by Ostrowski, for the purpose of providing the device with a faster breath-to-breath response time (Ostrowski; para. [0077]).
Beard does not disclose wherein the durable reversible colorimetric carbon dioxide indicator comprises multiple film or paper indicator regions with different colorimetric responses.
However, Gallagher teaches a device using colorimetric substance (Gallagher; abstract) wherein the durable colorimetric indicator comprises multiple film or paper indicator regions with different colorimetric responses (layer 50, which can be litmus paper, has areas 54, 56 coated with different colorimetric substances to change color in the presence of different target substances) (Gallagher; Fig. 3; paras. [0068-0070]).
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 Beard durable reversible colorimetric carbon dioxide indicator to comprise multiple film or paper indicator regions with different colorimetric responses, as taught by Gallagher, for the purpose of enabling the one indicator to convey information regarding two different targets (Gallagher; paras. [0068-0069]).
Regarding claim 2, the modified Beard teaches further comprising a second port configured to permit flow of exhaled air from the human face out of the face mask (gas vents 316 and/or gas vents 418 which permit the gas to flow from inside to outside the mask) (Beard; Figs. 20, 25A-B; para. [0164]; para. [0198]).
Regarding claim 5, the modified Beard teaches wherein the range of the incoming flow of gas comprising at least 0.5 to 15 liters per minute comprises 0.5 to 20 liters per minute, and the durable reversible colorimetric carbon dioxide indicator is responsive to the mixed flow comprising the exhaled gas comprising carbon dioxide with the incoming flow of oxygen gas comprising oxygen gas over the range of the incoming flow of gas comprising 0.5-20 liters per minute (the colorimetric CO2 detector 400 detects CO2 in gas passing the exhalation vent, which would have been exhaled by the user into the mask after oxygen inhalation; oxygen gas flows through the mask during inhalation and exhalation, and the oxygen gas is delivered to the mask assembly for inhalation at 4-10 L/min; all gases within the mask would be able to mix together) (Beard; para. [0123]; para. [0194]; para. [0200]).
Regarding claim 8, the modified Beard teaches wherein the durable reversible colorimetric carbon dioxide indicator comprises at least two separated colorimetric carbon dioxide indicators in different locations (the Beard colorimetric CO2 detector-indicator 404 modified by Gallagher to have two different areas 54, 56 coated with different colorimetric substances to change color in the presence of different target substances, the target substances being different CO2 partial pressures as taught by Mace) (Beard, Figs. 25A-25B, para. [0198]; Mace, col. 8 lines 56-67, col. 9 lines 1-5; Gallagher, Fig. 3, paras. [0068-0069]).
Regarding claim 9, the modified Beard teaches the invention as previously claimed, but does not teach further comprising an illuminator configured to illuminate the durable reversible colorimetric carbon dioxide indicator and to project colored light from the durable reversible colorimetric carbon dioxide indicator.
However, Mace further teaches including an illuminator configured to illuminate the durable reversible colorimetric carbon dioxide indicator and to project colored light from the durable reversible colorimetric carbon dioxide indicator (electro-optical sensor assembly with a light source to transmit light to the colorimetric indicator, a photodiode to detect light reflected from the colorimetric indicator, and an optical fiber to remotely couple the indicator with the electro-optical sensor assembly) (Mace; abstract; col. 11, lines 37-48; col. 17, lines 6-11).
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 Beard mask to include an illuminator configured to illuminate the durable reversible colorimetric carbon dioxide indicator and to project colored light from the durable reversible colorimetric carbon dioxide indicator, as taught by Mace, for the purpose of quantifying the colorimetrically measured CO2 fast and accurately, thereby providing additional information for breathing therapy treatments to treat problems such as panic disorder, PTSD, anxiety, apnea, asthma, sedation, etc. (Mace; col. 2, lines 17-58).
Regarding claim 10, as best understood, Beard discloses a method of assessing breathing through a face mask configured to surround a mouth and nose of a human face (oxygen face mask which surrounds the nose and mouth is used with a colorimetric CO2 detector 400 to detect and monitor exhaled CO2) (Figs. 20, 25A-25B; abstract; paras. [0194-0195]), comprising:
providing a durable colorimetric carbon dioxide indicator comprising at least one region of the durable colorimetric carbon dioxide indicator being configured to be visually responsive at a carbon dioxide partial pressure of 4 mmHg or less (an absence of carbon dioxide partial pressure, i.e. 0 mmHg, would have the colorimetric CO2 detector-indicator 404 be another color) (para. [0200]);
receiving a flow of a breathable gas into an inlet port of the face mask (oxygen inlet port 320 for connecting to and receiving gas from a gas source) (Fig. 18; para. [0164]);
receiving a flow of an exhaled air from a patient wearing the face mask (colorimetric CO2 detector-indicator 404 detects CO2 in gas exhalation vent by receiving the exhaled gas) (Figs. 25A-B; para. [0194]; para. [0200]);
forming a mixed stream comprising the received flow of the breathable gas and the received flow of the exhaled air (mask portion of face mask assembly 310 surrounds the nose and mouth of a patient, so that the oxygen delivered into the face mask assembly 310 space and expiratory gas in the face mask assembly 310 space would be able to mix) (Fig. 20; para. [0164]); and
interacting the mixed stream with the durable reversible colorimetric carbon dioxide indicator, to colorimetrically show tidal variations in carbon dioxide partial pressure in the mixed stream and to colorimetrically distinguish between respiration-induced flow of carbon dioxide in the exhaled air and a respiratory obstruction (colorimetric CO2 detector-indicator 404 configured to detect CO2 in gas exhalation vent, wherein tidal variations in different partial pressures of CO2 would be colorimetrically indicated, e.g. if there is no CO2 detected there is no significantly high partial pressure of CO2, and when there is a tidal variation so that CO2 is increased and detected there is known to be a higher partial pressure of CO2; there is no structure in the face mask assembly 310 to prevent oxygen delivered from oxygen inlet port 320 from moving to the gas exhalation vent, and so it can mix with the exhaled gas there or beforehand in the face mask assembly 310 space; the detector changes color in the presence of CO2 and reverts back in the absence of CO2, and so would distinguish between respiration and respiratory obstruction as claimed) (Figs. 18-20, 25A-B; para. [0194]; para. [0196]; para. [0200]) over a range of received flow of breathable gas over a range comprising at least 0.5 to 15 liters per minute of the received flow of the breathable gas (oxygen gas flows through the mask during inhalation and exhalation, and the oxygen gas is delivered to the mask assembly for inhalation at 4-10 L/min; all gases within the mask would be able to mix together) (para. [0123]; para. [0194]; para. [0200]).
Beard does not disclose the durable colorimetric carbon dioxide indicator comprising a plurality of separated spatial regions, each with a quantitatively different response to a partial pressure of carbon dioxide, and at least one region of the durable colorimetric carbon dioxide indicator being configured to be saturated at a carbon dioxide partial pressure within the exhaled air at or below 35 mmHg.
However, Mace teaches a carbon dioxide detection and measurement system for patient breathing therapies (Mace; abstract) wherein the durable colorimetric carbon dioxide indicator comprises a plurality of quantitatively different responses to a partial pressure of carbon dioxide, and at least one region of the durable colorimetric carbon dioxide indicator being configured to be saturated at a carbon dioxide partial pressure within the exhaled air at or below 35 mmHg (indicator is adapted to change colors for 7.6 mmHg, 15.2 mmHg, 22.8 mmHg, and 30.4 mmHg partial pressures of carbon dioxide, and so those values would be the points of saturation for those chemical formulations having those colors) (Mace; col. 8, lines 56-67; col. 9, lines 1-5). Moreover, Gallagher teaches a device using colorimetric substance (Gallagher; abstract) wherein the durable colorimetric carbon dioxide indicator comprises a plurality of separated spatial regions, each with a quantitatively different response (layer 50, which can be litmus paper, has areas 54, 56 coated with different colorimetric substances to change color in the presence of different target substances) (Gallagher; Fig. 3; paras. [0068-0070]).
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 Beard reversible colorimetric carbon dioxide indicator to include a plurality of quantitatively different responses to a partial pressure of carbon dioxide, and at least one region of the durable colorimetric carbon dioxide indicator being configured to be saturated at a carbon dioxide partial pressure within the exhaled air at or below 35 mmHg, as taught by Mace, for the purpose of enabling the partial pressure of carbon dioxide in a breath sample to be determined (Mace; col. 8, lines 43-62). Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the modified Beard durable reversible colorimetric carbon dioxide indicator to include a plurality of separated spatial regions, each with a quantitatively different response, as taught by Gallagher, for the purpose of enabling the one indicator to convey information regarding two different targets (Gallagher; paras. [0068-0069]).
Beard does not disclose the durable reversible colorimetric carbon dioxide indicator having an indication half-life of 1-5 seconds; the durable reversible colorimetric carbon dioxide indicator is configured to be reset by the received flow of breathable gas between respiratory cycles.
However, Ostrowski teaches a carbon dioxide detector (Ostrowski; abstract) the durable reversible colorimetric carbon dioxide indicator having an indication half-life of 1-5 seconds; the durable reversible colorimetric carbon dioxide indicator is configured to be reset by the received flow of breathable gas between respiratory cycles (carbon dioxide detector with borosilicate and acrylic changes colors between purple and yellow with patient inhalation and exhalation gas flow; the response time during inhalation can be from 2-5 seconds) (Ostrowski; Table 4; para. [0077]).
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 Beard durable reversible colorimetric carbon dioxide indicator to have an indication half-life of 1-5 seconds; the durable reversible colorimetric carbon dioxide indicator is configured to be reset by the received flow of breathable gas between respiratory cycles, as taught by Ostrowski, for the purpose of providing the device with a faster breath-to-breath response time (Ostrowski; para. [0077]).
Regarding claim 11, the modified Beard teaches wherein the durable reversible colorimetric carbon dioxide indicator comprises a non-planar structure (detector device 400 has a housing 402 which is a 3D cylindrical ring shape) (Beard; Figs. 25A-B; para. [0198]).
Regarding claim 12, as best understood, the modified Beard teaches wherein the durable reversible colorimetric carbon dioxide indicator comprises a ring (colorimetric CO2 detector-indicator 404 is a ring) (Beard; Figs. 25A-B) having multiple indicator regions with respectively different colorimetric responses to the carbon dioxide partial pressure (Mace teaches an indicator is adapted to change colors for 7.6 mmHg, 15.2 mmHg, 22.8 mmHg, and 30.4 mmHg partial pressures of carbon dioxide, wherein each partial pressure has its own indication color; Gallagher layer 50 has areas 54, 56 coated with different colorimetric substances to change color in the presence of different target substances; the combination can thus have the Gallagher layer 50 with areas 54, 56 coated with different colorimetric substances to change color for Mace’s different target carbon dioxide partial pressures) (Gallagher, Fig. 3, paras. [0068-0069]; Mace, col. 8 lines 56-67, col. 9 lines 1-5).
Regarding claim 16, the modified Beard teaches further comprising attaching the durable reversible colorimetric carbon dioxide indicator to the face mask and removing the durable reversible colorimetric carbon dioxide indicator from the face mask (detector device 400 is attached to the face mask via a Luer fitting, which is a known reversible fitting) (Beard; para. [0109]; para. [0198]).
Regarding claim 18, the modified Beard teaches the method as previously claimed, but does not teach further comprising illuminating the durable reversible colorimetric carbon dioxide indicator with a light source, and projecting colored light from the durable reversible colorimetric carbon dioxide indicator, wherein a color of the projected colored light is selectively responsive to the carbon dioxide partial pressure in the mixed stream.
However, Mace further teaches including illuminating the durable reversible colorimetric carbon dioxide indicator with a light source, and projecting colored light from the durable reversible colorimetric carbon dioxide indicator, wherein a color of the projected colored light is selectively responsive to the carbon dioxide partial pressure in the mixed stream (electro-optical sensor assembly uses a light source to transmit light to the colorimetric indicator, a photodiode to detect light reflected from the colorimetric indicator via window 118, and an optical fiber to remotely couple the indicator with the electro-optical sensor assembly; the color of the light reflected from the colorimetric indicator via window 118 or from the optical fiber is responsive to the partial pressure of carbon dioxide in the patient’s sampled exhaled breath) (Mace; abstract; col. 8, lines 12-36, 56-62; col. 11, lines 12-21, 37-48; col. 17, lines 6-11).
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 Beard method to include illuminating the durable reversible colorimetric carbon dioxide indicator with a light source, and projecting colored light from the durable reversible colorimetric carbon dioxide indicator, wherein a color of the projected colored light is selectively responsive to the carbon dioxide partial pressure in the mixed stream, as taught by Mace, for the purpose of quantifying the colorimetrically measured CO2 fast and accurately, thereby providing additional information for breathing therapy treatments to treat problems such as panic disorder, PTSD, anxiety, apnea, asthma, sedation, etc. (Mace; col. 2, lines 17-58).
Claim 3 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Beard in view of Ostowski, Mace, and Gallagher as applied to claims 1 and 10 above, or alternatively further in view of Ratner (US 6,709,403 B1 A1).
Regarding claim 3, the modified Beard teaches the invention as previously claimed, including wherein the durable reversible colorimetric carbon dioxide indicator comprises the paper or film (detector-indicator 404 is made of paper) (Beard; para. [0198]) behind a grill (detector-indicator 404 is behind an arrangement of vents 412 in the surface of the mask shell; alternatively, when closing the gas vent on the mask, detector-indicator 404 is behind a sealing cap 422 with openings 427) (Beard; Figs. 18-20, 25A-26D; para. [0198]; paras. [0208-0209]).
Alternatively, if the modified Beard is not seen as teaching the durable reversible colorimetric carbon dioxide indicator is behind a grill, Ratner teaches a device with a dry indicator paper to detect CO2 (Ratner; abstract) wherein the durable reversible colorimetric carbon dioxide indicator is behind a grill (baffles 56, 62 in the bottom housing 18 would be behind the calorimetric indicator paper 36 in the top housing 16) (Ratner; Figs. 1-3; col. 2, lines 38-47; col. 3, lines 14-17).
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 Beard device to include a grill, such that the durable reversible colorimetric carbon dioxide indicator is behind a grill, as taught by Ratner, for the purpose of providing the device with a filter holding structure (Ratner; col. 2, lines 38-47), and thereby allowing for the patient’s exhaled air to be filtered to help prevent the environment from contamination by the patient.
Regarding claim 14, the modified Beard teaches wherein the durable reversible colorimetric carbon dioxide indicator comprises a film or paper (detector device 400 indicator 404 is made of paper) (Beard; para. [0198]) maintained behind a grill (Beard detector-indicator 404 is behind an arrangement of vents 412 in the surface of the mask shell; alternatively, when closing the gas vent on the mask, the Beard detector-indicator 404 is behind a sealing cap 422 with openings 427; as a further alternative, Ratner has baffles 56, 62 in the bottom housing 18 behind the calorimetric indicator paper 36 in the top housing 16) (Beard, Figs. 18-20, 25A-26D, para. [0198], paras. [0208-0209]; Ratner, Figs. 1-3, col. 2 lines 38-47, col. 3 lines 14-17).
Claims 4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Beard in view of Ostrowski, Mace, and Gallagher as applied to claims 1 and 10 above, and further in view of Yasick (US 2012/0048278 A1).
Regarding claim 4, the modified Beard teaches the invention as previously claimed, but does not teach wherein the durable reversible colorimetric carbon dioxide indicator comprises a film coating on an inner surface of the face mask.
However, Yasick teaches a device for monitoring patient ventilation (Yasick; abstract) wherein the durable reversible colorimetric carbon dioxide indicator comprises a film coating on an inner surface of the patient interface (reactive material 38 is coated on the surface of the flange portion closest to the patient and onto which the patient breathes; reactive material 38 changes color based on the amount of carbon dioxide present during inhalation/exhalation) (Yasick; Figs. 7, 9-10; paras. [0069-0070]).
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 Beard patient interface of a face mask to include the durable reversible colorimetric carbon dioxide indicator comprising a film coating on an inner surface of the face mask, as taught by Yasick, for the purpose of providing the face mask with an additional means of informing a practitioner that a patient is or is not breathing sufficiently (Yasick; para. [0071]), thereby providing a backup or alternative mechanism for monitoring patient breathing.
Regarding claim 13, the modified Beard teaches wherein the durable reversible colorimetric carbon dioxide indicator comprises a coating on an inner surface of the face mask (Yasick reactive material 38 is coated on the surface closest to the patient and onto which the patient breathes, and so would be on the inner surface of the Beard mask portion of face mask assembly 310 onto which a patient would breath; Yasick reactive material 38 changes color based on the amount of carbon dioxide present during inhalation/exhalation) (Beard, Fig. 20, para. [0164]; Yasick, Figs. 7 and 9-10, paras. [0069-0070]).
Claims 6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Beard in view of Ostrowski, Mace, and Gallagher as applied to claims 1 and 10 above, and further in view of Gartner (US 2012/0111330 A1).
Regarding claim 6, the modified Beard teaches the invention as previously claimed, but does not explicitly teach wherein the shell comprises clear plastic, further comprising an adjustable nose piece; and an adjustable head strap.
However, Gartner teaches a respiratory mask (Gartner; abstract) including wherein the shell comprises clear plastic (transparent mask made of plastic) (Gartner; para. [0014]), further comprising an adjustable nose piece (nose clip 18 for conforming the mask to the patient’s nose) (Gartner; Figs. 1-4; para. [0025]); and an adjustable head strap (adjustable or elastic strap 14) (Gartner; Figs. 1-4; para. [0025]).
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 Beard mask to include wherein the shell comprises clear plastic, further comprising an adjustable nose piece; and an adjustable head strap, as taught by Gartner, for the purpose of enabling the patient’s face to be visible so a practitioner can better ascertain their condition (Gartner; para. [0014]) and for the purpose of ensuring the mask conforms to and securely fits on the patient’s face (Gartner; para. [0014]; para. [0025]).
Regarding claim 15, the modified Beard teaches wherein the face mask comprises a shell formed of transparent plastic (transparent mask made of plastic) (Gartner; para. [0014]), wherein the durable reversible colorimetric indicator is visible through a portion of the transparent plastic (the Beard oxygen mask shell surface 410 and housing 402 would be modified to be transparent as taught by Gartner, and so the Beard colorimetric CO2 detector-indicator 404 within would be visible though that transparent material) (Beard, Figs. 18-20, 25A-25B, para. [0198]; Gartner, para. [0014]), further comprising: an adjustable nose piece (nose clip 18 for conforming the mask to the patient’s nose) (Gartner; Figs. 1-4; para. [0025]); and an adjustable head strap (adjustable or elastic strap 14) (Gartner; Figs. 1-4; para. [0025]).
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Beard in view of Ostrowski, Mace, and Gallagher as applied to claims 1 and 10 above, and further in view of Colburn (US 2010/0078030 A1).
Regarding claim 7, the modified Beard teaches the invention as previously claimed, including wherein the durable reversible colorimetric carbon dioxide indicator being attachable to and detachable from within the shell of the face mask (detector device 400 with indicator 404 inside is attached to the face mask via a Luer fitting, which is a known reversible fitting, such that the mobile and free floating indicator 404 would be attachable and detachable from the face mask surface 410 and colorimetric CO2 housing 402) (Beard; para. [0109]; para. [0198]), but does not teach the durable reversible colorimetric carbon dioxide indicator comprises metacresol purple in the paper or film indicator regions.
However, Colburn teaches an airway management device (Colburn; abstract) wherein the durable reversible colorimetric carbon dioxide indicator comprises metacresol purple in the paper or film indicator regions (carbon dioxide sensor 18 can be filter paper with its regions soaked or dipped in appropriate carbon dioxide sensing compounds, such as the chromogenic pH sensitive indicator of metacresol purple) (Colburn; paras. [0027-0028]; para. [0030]).
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 Beard durable reversible colorimetric carbon dioxide indicator to comprise metacresol purple in the paper or film indicator regions, as taught by Colburn, for the purpose of providing the device with a specific type of pH sensitive indicator for carbon dioxide which one of ordinary skill in the art could feasibly assume to work reasonably well for respiratory applications.
Regarding claim 17, the modified Beard teaches wherein the durable reversible colorimetric carbon dioxide indicator comprises at least two separate colorimetric carbon dioxide indicators having different sensitivity to carbon dioxide partial pressure (Mace teaches an indicator is adapted to change colors for 7.6 mmHg, 15.2 mmHg, 22.8 mmHg, and 30.4 mmHg partial pressures of carbon dioxide, wherein each partial pressure has its own indication color; Gallagher layer 50 has areas 54, 56 coated with different colorimetric substances to change color in the presence of different target substances; the combination can thus have the Gallagher layer 50 with areas 54, 56 coated with different colorimetric substances to change color for Mace’s different target carbon dioxide partial pressures) (Gallagher, Fig. 3, paras. [0068-0069]; Mace, col. 8 lines 56-67, col. 9 lines 1-5), and at least one of the at least two separate colorimetric carbon dioxide indicators comprises metacresol purple (carbon dioxide sensor 18 can have a chromogenic pH sensitive indicator such as metacresol purple) (Colburn; paras. [0027-0028]).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Beard in view of Fisher et al. (US 2007/0095348 A1), Mace, Gallagher, and Ostrowski.
Regarding claim 19, Beard discloses a face mask (oxygen face mask) (abstract), comprising:
an inlet port configured to receive an inflow of gas (oxygen inlet port 20 for connecting to and receiving gas from a gas source) (Figs. 1-4; para. [0113]);
a shell, configured to surround a mouth and nose of a human face (mask portion of face mask assembly 310 surrounds the nose and mouth) (Fig. 3; para. [0164]), the shell having a plurality of sealed sampling ports (mask can have multiple sampling ports, such as sampling ports 12, 14, 29; ports can include fittings, and these fittings may be closed with a membrane; other ports, such as vents 412, can be sealed by a device 400) (Figs. 1-7, 37A-37B; paras. [0101-0102]; para. [0104]; para. [0112]; para. [0200]; para. [0220]), and to mix the inflow of gas with exhaled air from the human face to produce a mixed stream of gas (mask portion of face mask assembly 310 surrounds the nose and mouth of a patient, so that the oxygen delivered into the face mask assembly 310 space and expiratory gas in the face mask assembly 310 space would be able to mix) (Fig. 20; para. [0164]);
an outlet port configured to permit flow of the mixed stream of gas out of the face mask (exhalation vents 16 to release the mixed air from inside to outside the mask) (Figs. 1-7; para. [0103]);
and a durable reversible colorimetric carbon dioxide indicator comprising a ring (colorimetric CO2 detector-indicator 404 is a ring) (Figs. 25A-B) being configured to receive the mixed stream of gas through at least one of the plurality of sealed sampling ports and to colorimetrically distinguish between (a) a respiration-induced flow of carbon dioxide in the mixed stream, and (b) a respiratory obstruction (colorimetric CO2 detector 400 configured to detect CO2 in gas exhalation vent, while the detector 400 is sealed over the gas vents 412 through which the mix with exhaled air flows; the detector changes color in the presence of CO2 and reverts back in the absence of CO2, and so would be able to function to distinguish between respiration and respiratory obstruction as claimed) (Figs. 25A-B; para. [0194]; para. [0200]), over a range of flow rates of the inflow of gas of 0.5 to 15 liters per minute (oxygen gas flows through the mask during inhalation and exhalation, and the oxygen gas is delivered to the mask assembly for inhalation at 4-10 L/min; all gases within the mask would be able to mix together) (para. [0123]; para. [0194]; para. [0200]), and visually responsive at a carbon dioxide partial pressure of less than or equal to 4 mmHg (an absence of carbon dioxide partial pressure, i.e. 0 mmHg, would have the colorimetric CO2 detector-indicator 404 be another color) (para. [0200]).
Beard does not disclose an inlet check valve.
However, Fisher teaches an oxygen delivery mask (Fisher; abstract) including an inlet check valve (one-way valve 16 at the gas entry port 10 to permit oxygen to pass into the face piece 4) (Fisher; Fig. 3; para. [0065]).
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 Beard device to include an inlet check valve, as taught by fisher, for the purpose of ensuring the exhaled gas is prevented from entering the gas entry port 10 (Fisher; para. [0065]), thereby preventing contaminates from the patient from reaching the inhalation gas source (Fisher; para. [0071]).
Beard does not disclose the durable reversible colorimetric carbon dioxide indicator having multiple indicator regions with respectively different colorimetric indicator dyes having quantitatively different visual responses to carbon dioxide partial pressure; and have a saturated visual response at a carbon dioxide partial pressure within the mixed stream at 38 mmHg, wherein the reversible colorimetric carbon dioxide indicator comprises having different visual responses to carbon dioxide partial pressure.
However, Mace teaches a carbon dioxide detection and measurement system for patient breathing therapies (Mace; abstract) wherein the durable reversible colorimetric carbon dioxide indicator has quantitatively different visual responses to carbon dioxide partial pressure; and has a saturated visual response at a carbon dioxide partial pressure within the mixed stream at 38 mmHg (indicator is adapted to change colors for 7.6 mmHg, 15.2 mmHg, 22.8 mmHg, 30.4 mmHg, and 38 mmHg partial pressures of carbon dioxide, and so those values would be the points of saturation for those chemical formulations having those colors; each partial pressure has its own indication color) (Mace; col. 8, lines 56-67; col. 9, lines 1-5). Moreover, Gallagher teaches a device using colorimetric substance (Gallagher; abstract) wherein the durable reversible colorimetric carbon dioxide indicator has multiple indicator regions with respectively different colorimetric indicator dyes having different visual responses (layer 50, which can be litmus paper, has areas 54, 56 coated with different colorimetric substances to change color in the presence of different target substances) (Gallagher; Fig. 3; paras. [0068-0070]).
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 Beard reversible colorimetric carbon dioxide indicator to include quantitatively different visual responses to carbon dioxide partial pressure; and a saturated visual response at a carbon dioxide partial pressure within the mixed stream at 38 mmHg, as taught by Mace, for the purpose of enabling the partial pressure of carbon dioxide in a breath sample to be determined (Mace; col. 8, lines 43-62). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the modified Beard reversible colorimetric carbon dioxide indicator to have multiple indicator regions with respectively different colorimetric indicator dyes having different visual responses, as taught by Gallagher, for the purpose of enabling the one indicator to convey information regarding two different targets (Gallagher; paras. [0068-0069]).
Beard does not disclose the reversible colorimetric carbon dioxide indicator having an indication half-life of 1-5 seconds, and being configured to be reset between respiratory cycles by the inflow of gas.
However, Ostrowski teaches a carbon dioxide detector (Ostrowski; abstract) wherein the durable reversible colorimetric carbon dioxide indicator having an indication half-life of 1-5 seconds, and being configured to be reset between respiratory cycles by the inflow of gas (carbon dioxide detector with borosilicate and acrylic changes colors between purple and yellow with patient inhalation and exhalation gas flow; the response time during inhalation can be from 2-5 seconds) (Ostrowski; Table 4; para. [0077]).
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 Beard durable reversible colorimetric carbon dioxide indicator to have an indication half-life of 1-5 seconds, and being configured to be reset between respiratory cycles by the inflow of gas, as taught by Ostrowski, for the purpose of providing the device with a faster breath-to-breath response time (Ostrowski; para. [0077]).
Regarding claim 20, the modified Beard teaches wherein the durable reversible colorimetric carbon dioxide indicator comprises a removable film or paper exposed to the mixed stream of gas (detector device 400 indicator 404 is made of paper, and is exposed to the mix of gas in the face mask to detect exhaled CO2) (Beard; para. [0196]; para. [0198]).
Response to Arguments
Applicant's arguments filed 3/23/2026 have been fully considered but they are not persuasive.
On page 10 in the "Information Disclosure Statement" section of the Applicant's remarks, the Applicant argues the IDS submitted on 1/12/2025 was fully in compliance with regulations. However, the Examiner respectfully disagrees. As explained in the Information Disclosure Statement section above in this office action, the IDS fails to comply with the provisions of 37 C.F.R. 1.17(v), 1.97(a), 1.98(a)(4), and 1.555(a) because it was filed without the size fee and the written size fee assertion statement. It is still in the application file, but the information referred to therein has not been considered as to the merits.
On page 10 in the "Specification" section of the Applicant's remarks, the Applicant argues that their specification has been amended to overcome the specification objections of the most recent office action. The Examiner agrees, and has thus withdrawn those specification objections.
On pages 10-11 in the "Claim Objections" section of the Applicant's remarks, the Applicant argues that the claims have been amended to address the claim objections of the previous office action. The Examiner partially agrees, and has thus withdrawn those claim objections which were addressed. However, one claim objection was not addressed in the claim amendments, and as such is being reiterated as detailed above. Thus, a claim objection is still being maintained.
On pages 11-13 in the "Claim Rejections - 35 USC 112" section of the Applicant's remarks, the Applicant argues that the claims have been amended to overcome the 35 U.S.C. 112(b) rejections of the previous office action. The Examiner agrees, and has thus withdrawn those 35 U.S.C. 112(b) rejections. However, the newly amended claims have raised a new 35 U.S.C. 112(b) rejection as detailed above.
On page 14 in the last paragraph of the Applicant's remarks, the Applicant argues that the Beard reference does not teach the claim limitations of the indicator having a colorimetric response to a partial pressure of carbon dioxide over a range of 4 to 35 or 38 mmHg, an indication half-life of 1-5 seconds, or the indicator being a ring with multiple indicator regions with different colorimetric responses to partial pressures of carbon dioxide, and thus cannot teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Beard alone is not used to teach the claim limitations mentioned, but rather it is the combination of Beard with the Ostrowski, Mace, and Gallagher references that teach the Applicant’s claimed invention as detailed above. Thus, the current combination of prior art can still be used to teach the Applicant’s claimed invention.
On page 15 in the first paragraph of the Applicant's remarks, the Applicant argues that the claimed limitation of a ring comprising multiple indicator regions with different colorimetric response to the partial pressure of carbon dioxide within the mixed flow of gas is functional and non-obvious, and thus Beard cannot tach this claimed limitation. However, the Examiner respectfully disagrees. As previously explained above, Beard alone is not being used to teach this claimed limitation. Rather, it is the combination of Beard, Ostrowski, Mace, and Gallagher used to teach this specific limitation (the Beard colorimetric CO2 detector-indicator 404 is a ring; Mace teaches an indicator is adapted to change colors for 7.6 mmHg, 15.2 mmHg, 22.8 mmHg, and 30.4 mmHg partial pressures of carbon dioxide, wherein each partial pressure has its own indication color; Gallagher layer 50 has areas 54, 56 coated with different colorimetric substances to change color in the presence of different target substances; the modified Beard colorimetric CO2 detector-indicator 404 ring can have Gallagher areas 54, 56 coated with different colorimetric substances to change color for Mace’s different target carbon dioxide partial pressures) (Beard, Figs. 25A-B; Gallagher, Fig. 3, paras. [0068-0069]; Mace, col. 8 lines 56-67, col. 9 lines 1-5). Thus, the current combination of prior art can still be used to teach the Applicant’s claimed invention.
On page 15 in the second paragraph of the Applicant's remarks, the Applicant argues that the durable reversible colorimetric carbon dioxide indicator of Beard is outside of the shell, and thus Beard thus cannot teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. In the 35 U.S.C. 103 rejection above, the claimed shell limitation is being taught by the mask portion of face mask assembly 310 including the face mask surface 410 and colorimetric CO2 housing 402, and so the colorimetric CO2 detector-indicator 404 is within the shell as it is inside the colorimetric CO2 housing 402 (Beard; Figs. 18-20, 25A-B; para. [0196]; para. [0198]). Thus, the prior art of record can still be used to teach the Applicant’s claimed invention.
On page 15 in the third paragraph to page 16 in the second paragraph of the Applicant's remarks, the Applicant argues that since the Mace device requires structures such as specific light emitters, photodiodes, a microprocessor, and a temperature controller to detect subtle chromogenic shifts impossible for the human eye to detect, Mace cannot be used to modify the Beard colorimetric indicator, and thus cannot teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. The color changes in the Mace reference for detecting different carbon dioxide partial pressures are not so subtle as to require all the equipment mentioned by the Applicant to detect changes. The Mace reference gives the example of the colorimetric indicator changing from blue, to blue-green, to green, to yellow with increasing amounts of carbon dioxide present, and even mentions the specific colors can be adjusted with different chemistry formulations (Mace; col. 8, lines 25-36). The human eye would be able to distinguish between such color changes without specialized equipment. Thus, the prior art can of record still be used to teach the Applicant’s claimed invention.
On page 16 in the third paragraph to the last paragraph of the Applicant's remarks, the Applicant argues that Ostrowski does not teach film or paper for the indicator, instead teaching liquid on a borosilicate glass, and thus cannot teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. Ostrowski is not being used to teach the film or paper for the indicator. Instead, Beard and/or Gallagher are used to teach this limitation (Beard detector-indicator 404 is made of paper; Gallagher layer 50 can be litmus paper) (Beard, para. [0198]; Gallagher, para. [0070]). Moreover, Ostrowski is not being used to change the structure of the Beard detector-indicator 404, but rather simply to teach the indicator can have a specific suitable half-life of 1-5 seconds (Ostrowski; Table 4; para. [0077]), particularly as the Beard indicator 404 would change colors with patient inhalation and exhalation (Beard; para. [0200]) which one of ordinary skill in the art would know to occur over a time period of seconds. Thus, the current prior art of record can still be used to teach the Applicant’s claimed invention.
On page 17 in the second paragraph of the Applicant's remarks, the Applicant argues that while Ostrowski does teach a rapid response, it does not teach utilizing the rapid response to provide a quantitative visual gradient across multiple regions, and thus cannot teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Ostrowski alone is not used to teach utilizing the rapid response to provide a quantitative visual gradient across multiple regions, but rather it is the combination of Beard with the Ostrowski, Mace, and Gallagher references that teach the Applicant’s claimed limitation. Specifically, Mace teaches an indicator is adapted to change colors for 7.6 mmHg, 15.2 mmHg, 22.8 mmHg, and 30.4 mmHg partial pressures of carbon dioxide, wherein each partial pressure has its own indication color, and Gallagher teaches a layer 50 has multiple areas 54, 56 coated with different colorimetric substances to change color in the presence of different target substances. The modified Beard colorimetric CO2 detector-indicator 404 ring can thus have Gallagher areas 54, 56 coated with different colorimetric substances to change color for Mace’s different target carbon dioxide partial pressures, which would respond during inhalation in 2-5 seconds as taught by Ostrowski (Beard, Figs. 25A-B; Gallagher, Fig. 3, paras. [0068-0069]; Mace, col. 8 lines 56-67, col. 9 lines 1-5; Ostrowski, Table 4, para. [0077]). Thus, the current combination of prior art can still be used to teach the Applicant’s claimed invention.
On page 17 in the third paragraph of the Applicant's remarks, the Applicant argues that Gallagher is non-analogous art as it is used to test for entirely different biological substances, and thus cannot teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. In response to applicant's argument that Gallagher is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both the Applicant’s claimed invention and Gallagher involve medical devices with colorimetric indicators (Applicant’s independent claims 1, 10, 19; Gallagher, abstract, paras. [0068-0070]), and thus Gallagher is analogous art that can still be used to teach the Applicant’s claimed invention.
On page 17 in the last paragraph of the Applicant's remarks, the Applicant argues that Gallagher teaches a liquid stop device, which if incorporated into Beard would suffocate the patient, and thus Gallagher cannot teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. The Examiner is not using Gallagher to modify Beard to include a liquid stop device. Rather, the Gallagher reference is simply used to teach the idea of a colorimetric indicator having multiple regions with colorimetric responses to different targets (Gallagher; Fig. 3; paras. [0068-0070]). Thus, this argument is moot, and the Gallagher reference can still be used to teach the Applicant’s claimed invention.
On page 17 in the last paragraph to page 19 in the first paragraph of the Applicant's remarks, the Applicant argues the claimed invention requires the multiple regions to have different responses to specific partial pressure of carbon dioxide while Gallagher’s regions correspond to different chemicals such as stomach acid, and thus Gallagher cannot teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Gallagher alone is not used to teach the claim limitations mentioned, but rather it is the combination of Beard with the Mace and Gallagher references that teach that claimed invention as previously explained above. Specifically, the modified Beard colorimetric CO2 detector-indicator 404 ring can have multiple Gallagher areas 54, 56 coated with different colorimetric substances to change color for Mace’s different target carbon dioxide partial pressures (Beard, Figs. 25A-B; Gallagher, Fig. 3, paras. [0068-0069]; Mace, col. 8 lines 56-67, col. 9 lines 1-5). Thus, the current combination of prior art can still be used to teach the Applicant’s claimed invention.
On page 19 in the second paragraph to page 20 in the last paragraph of the Applicant's remarks, the Applicant argues that the prior art of record used to teach other limitations in the dependent claims do not provide teachings for the Applicant’s independent claims, and thus the Applicant’s independent claims are allowable. However, the Examiner respectfully disagrees. The prior art of record introduced for teaching the dependent claims are not used to teach the independent claims, and thus this argument is moot.
On page 21 in the third paragraph of the Applicant's remarks, the Applicant argues that the current prior art of record cannot teach the newly amended claim limitations regarding a single contiguous ring comprising multiple physically distinct indicator regions simultaneously exposed to the mixed flow of gas, wherein each respective indicator region has a different saturation threshold corresponding to a different specific partial pressure of carbon dioxide, and thus cannot teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. The current prior art does teach this newly amended claim limitation. Firstly, the Beard colorimetric CO2 detector-indicator 404 is a ring which is wholly exposed to the mixed gas in the face mask portion. Secondly, Mace teaches an indicator is adapted to change colors for 7.6 mmHg, 15.2 mmHg, 22.8 mmHg, and 30.4 mmHg partial pressures of carbon dioxide wherein each partial pressure has its own indication color, and Gallagher teaches a layer 50 has multiple areas 54, 56 coated with different colorimetric substances to change color in the presence of different target substances. The Beard colorimetric CO2 detector-indicator 404 ring can thus be modified to have multiple Gallagher areas 54, 56 coated with different colorimetric substances to change color for Mace’s different target carbon dioxide partial pressures (Beard, Figs. 25A-B, para. [0164], para. [0196], para. [0198]; Gallagher, Fig. 3, paras. [0068-0069]; Mace, col. 8 lines 56-67, col. 9 lines 1-5). Thus, the current combination of prior art can still be used to teach the Applicant’s claimed invention.
On page 21 in the last paragraph of the Applicant's remarks, the Applicant generally argues in reference to their previous arguments that the current prior art of record is non analogous art, would render the primary reference inoperable, destroys the principle of the operation of the secondary refence, and fail to teach all the limitations of the amended independent claims, and thus cannot teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. As explained in detail in the Examiner’s responses to the Applicant’s arguments in the paragraphs above, the current prior art of record is analogous art, would not destroy or render inoperable the references used when combined, and does teach all of the limitations of the amended independent claims. Thus, the current prior art of record can still be used to teach the Applicant’s claimed invention.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE M PINDERSKI whose telephone number is (571)272-7032. The examiner can normally be reached Monday-Friday 7:00-4:00.
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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