DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. 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 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.
Status of Claims
No claims have been amended, canceled or added with the reply filed 26 February 2026. Accordingly, claims 1-47 remain pending.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim(s) 1-2, 4, 6, 8-9, 11, 17, 20-25, 27-28, 30-32, 36, 38 and 45-47 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2004/0210153 A1 (previously cited, Tsukashima '153) in view of US 2012/0285461 A1 (previously cited, Pierro).
Regarding claim 1, Tsukashima '153 teaches and/or suggests an apparatus for assessing a condition of a patient, the apparatus comprising:
a patient interface (mask apparatus 36) configured to communicate a pressure treatment generated by a respiratory treatment apparatus (CPAP device 16 and/or treatment device 32, e.g., nebulizer, atomizer, humidifier, etc.) to the respiratory system of the patient (e.g., ¶ [0028]);
a sensing module (housing 27) comprising at least one physiological sensor (pH sensor 46), the physiological sensor(s) embedded within the patient interface (Figs. 1-3, housing 27 is enclosed by/set within an opening in mask apparatus 36); and one or more collectors configured to accumulate at least one of: exhaled breath that is exhaled to the patient interface; saliva that is in contact with the patient interface; and mucus that is in contact with the patient interface (¶ [0031] film 63 for collecting exhaled breath condensate and/or absorption means or pad 62 having the capability to continuously draw or extract some of the liquefied breath sample into its open-cell structure from the surface of film 63), wherein a port within the patient interface to the sensing module (a) is proximate to a patient's mouth so as to be exposed to patient exhalation gases and (b) provides the collector access to the exhaled breath (Fig. 2, opening in mask apparatus 36 in which housing 27 is attached/integrated).
Tsukashima '153 does not expressly teach the patient interface comprises a cushion on a surface of the patient interface configured to provide a pressure seal for the pressure treatment. However, Tsukashima '153 does disclose the apparatus is configured to minimize ambient air from entering the boundaries of the mask (e.g., ¶ [0024]).
Pierro teaches/suggests a comparable apparatus for assessing a condition of a patient, the apparatus comprising: a patient interface (patient interface 110) configured to communicate a pressure treatment generated by a respiratory treatment apparatus (ventilator 160; ¶ [0013]) to the respiratory system of the patient (¶ [0050]), the patient interface comprising a cushion on a surface of the patient interface, formed of a material (¶ [0057]) configured to provide a pressure seal for the pressure treatment (facial skin interface 130; ¶ [0057]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apparatus of Tsukashima '153 with the patient interface comprising a cushion on a surface of the patient interface formed of a material configured to provide a pressure seal for the pressure treatment as taught/suggested by Pierro in order to reduce/eliminate unintentional leaks (Pierro, ¶ [0050]); minimize ambient air from entering the boundaries of the mask (Tsukashima '153, ¶ [0024]); etc.
Tsukashima '153 as modified does not disclose the physiological sensor(s) is removably embedded within the material of the cushion of the patient interface and/or the port to the module is within the cushion, but does disclose different positions of the components of the disclosed invention can still achieve the goal of monitoring, diagnosing and treating respiratory and medical conditions in patients (¶ [0024]).
Pierro discloses an apparatus comprising a module removably embedded within the material of the cushion of the patient interface (Fig. 6; ¶¶ [0068]-[0070] facial skin interface 130 includes a self-sealing tube insertion region 630 through which a module, e.g., tube, may be removably inserted), the module being configured to at least sample, and/or collect a sample of, exhaled breath (e.g., ¶ [0069] breath sampling tube), wherein a port within the cushion to the module (opening 632 defined in tube insertion region 630) (a) is proximate to a patient's mouth so as to be exposed to patient exhalation gases (Fig. 6; ¶ [0069] where opening 632 is near the left cheek) and (b) provides the sensing module access to the exhaled breath (¶ [0069] tube may be inserted in opening 632 for sampling breath). Pierro further discloses the material of the cushion provides a sealing function of self-sealing around an inserted module, sealing the opening in the cushion when no module is inserted, etc. (¶ [0069]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apparatus of Tsukashima '153 with the port to the sensing module being within the cushion, wherein the sensing module, and physiological sensor and collector(s) thereof, is removably embedded within the material of the cushion of the patient interface as taught/suggested by Pierro in order to further facilitate providing a sealing function for self-sealing about the sensing module when inserted and sealing the port if or when the sensing module is removed (Pierro, ¶ [0069]), thereby reducing/eliminating unintentional leaks and/or minimizing ambient air from entering the boundaries of the mask, etc. (e.g., through the port, around the sensing module, etc.), regardless of whether the sensing module is currently being used by the patient, and/or as a simple substitution of one suitable means/method for integrating the module and patient interface that enables, e.g., breath collection, for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claim 2, Tsukashima '153 as modified teaches/suggests the sensing module comprises a plurality of sample collectors (¶ [0031] film 63 and absorption means/pad 62).
Regarding claim 4, Tsukashima '153 as modified teaches/suggests at least one collector comprises an absorbent material (absorption means or pad 62).
Regarding claim 6, Tsukashima '153 as modified teaches/suggests the module further comprises an electrochemical sensor, the electrochemical sensor configured to sense a chemical in breath condensate accumulated by at least one collector (pH sensor 46; ¶ [0033] sensor 46 is positioned such that it gets exposed to a sample of breath condensed on the film 63 and outputs analog pH information). Tsukashima '153 as modified does not teach the electrochemical sensor is oriented on an internal side of a surface of the cushion proximate to the patient's mouth so as to be exposed to patient exhalation gases. However, Tsukashima '153 as modified discloses the sensing module may be inserted into and embedded within the cushion by a user (e.g., Pierro, ¶ [0069]). Tsukashima '153 further discloses different positions of the components of the disclosed invention can still achieve the goal of monitoring, diagnosing and treating respiratory and medical conditions in patients (¶ [0024]). Accordingly, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify Tsukashima '153 with the electrochemical sensor being oriented on an internal side of a surface of the cushion proximate to the patient's mouth so as to be exposed to patient exhalation gases (e.g., the sensor component of the sensing module being arranged at an end of the module positioned within the interior cavity of the mask) because Applicant has not disclosed that the above-noted electrochemical sensor being oriented as claimed provides an advantage, is used for a particular purpose, or solves a stated problem, particularly for devices having a port within the cushion provides the collector(s) access to the exhaled breath (as required by claim 1) and/or devices in which the electrochemical sensor is configured to sense a chemical in breath condensate accumulated by at least one collector (as required by claim 6), for example, as opposed to sensing a chemical in exhaled gas directly. As no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the arrangement suggested by Tsukashima '153 as modified (e.g., the sensor oriented within or on an external side of the cushion/interface) because either arrangement can still achieve the goal of monitoring, diagnosing and treating respiratory and medical conditions in patients (Tsukashima '153, ¶ [0024]).
Regarding claim 8, Tsukashima '153 as modified teaches/suggests the apparatus further comprises said respiratory treatment apparatus (CPAP device 16 and/or treatment device 32), the respiratory treatment apparatus including a flow generator and a controller, including at least one processor, to control the flow generator to generate the pressure treatment to the patient interface (control means 20 and/or processing receiver 26 (or microprocessor 70 thereof); ¶ [0028]), and an electrochemical sensor, the electrochemical sensor configured to sense a chemical in breath condensate accumulated by at least one collector and generate a signal indicative of the chemical (pH sensor 46; ¶ [0033] pH sensor 46 is positioned such that it gets exposed to a sample of breath condensed on the film 63 and outputs analog pH information), wherein the controller is communicatively coupled with the sensor (Fig. 1; ¶ [0034]; etc.), and the processor is configured to store a measure derived from the signal (¶¶ [0042]-[0043]).
Regarding claim 9, Tsukashima '153 as modified teaches/suggests the electrochemical sensor is the electrochemical sensor is the physiological sensor (see discussion of claims 1 and 8 above, pH sensor 46).
Regarding claim 11, Tsukashima '153 as modified teaches and/or suggests the processor is configured to activate the electrochemical sensor after a set period of time (¶ [0012] pH data is transferred or updated at specific intervals).
Regarding claim 17, Tsukashima '153 as modified teaches and/or suggests the processor is configured to compare the measure derived from the signal and a threshold value (¶ [0044]).
Regarding claim 20, Tsukashima '153 as modified teaches/suggests the sensing module comprises one or more physiological sensors (see discussion of claim 1 above), wherein each of the physiological sensor(s) is a peroxide sensor, a nitrous oxide sensor, an acetone sensor, a carbon dioxide sensor, a pH sensor (pH sensor 46), a glucose sensor, or a lactate sensor.
Regarding claim 21, Tsukashima '153 as modified teaches/suggests at least one collector is configured to collect exhaled breath (e.g., ¶ [0032] breath condenses on the film 63 forming a pool of liquefied breath that is retained on the surface).
Regarding claims 22-25, Tsukashima '153 as modified teaches/suggests the limitations of claim 1, as discussed above, and further discloses the sensing module further comprises an electrochemical sensor (i.e., the physiological sensor comprises an electrochemical sensor), the electrochemical sensor configured to sense a chemical in fluid accumulated by the at least one collector, such as breath condensate (pH sensor 46; ¶ [0033] pH sensor 46 is positioned such that it gets exposed to a sample of breath condensed on the film 63 and outputs analog pH information). Tsukashima '153 as modified does not expressly disclose the collector is configured to accumulate saliva and/or mucus that is in contact with the patient interface. Applicant neither discloses, nor do the claims recite, a particular structure(s) that "configures" a collector to accumulate a specific type of fluid. At best, the limitation appears to amount a recitation of intended use and/or function of the collector(s). A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Functional claim language that is not limited to a specific structure covers all devices that are capable of performing the recited function. Accordingly, if the prior art structure is capable of performing the intended use/function, it meets the claim. Tsukashima '153 as modified discloses breath condensate contacts the collector(s) and accumulates thereon/therein, as noted above. Applicant discloses breath condensate may include saliva and/or sputum (¶ [0100]), which is consistent with knowledge that exhaled breath includes and/or carries respiratory droplets that include saliva and mucus (see "Respiratory Droplet," previously cited). Therefore, the collector(s) of Tsukashima '153 as modified is/are capable of accumulating saliva and/or mucus in contact with the patient interface when said saliva and/or mucus is included in and/or carried by exhaled breath. Accordingly, Tsukashima '153 as modified meets the limitations of claims 22-25.
Regarding claims 27-28, Tsukashima '153 as modified teaches/suggests the limitations of claim 8, as discussed above, and further discloses the electrochemical sensor is configured to detect a quantity of an analyte from a fluid, breath condensate, accumulated on the collector(s) (¶ [0033] pH sensor 46 outputs analog pH information). Tsukashima '153 as modified does not expressly disclose the electrochemical sensor is further configured to detect a quantity of an analyte from saliva and/or mucus, or the fluid accumulated on the collector comprises saliva and/or mucus. However, Applicant neither discloses, nor do the claims recite, a particular structure(s) that "configures" an electrochemical sensor to detect a quantity in a specific type of fluid. At best, the limitation appears to amount a recitation of intended use and/or function of the electrochemical sensor(s) associated with a collector(s). A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Functional claim language that is not limited to a specific structure covers all devices that are capable of performing the recited function. Accordingly, if the prior art structure is capable of performing the intended use/function, it meets the claim. Tsukashima '153 as modified discloses breath condensate contacts the collector and accumulates thereon/therein, and the electrochemical sensor associated therewith detects a quantity of an analyte in the accumulated fluid. Applicant discloses breath condensate may include saliva and/or sputum (¶ [0100]), which is consistent with knowledge that exhaled breath includes and/or carries respiratory droplets that include saliva and mucus (see "Respiratory Droplet," cited herewith). Accordingly, the electrochemical sensor of Tsukashima '153 as modified is capable of detecting a quantity of an analyte from saliva or mucus when the breath condensate accumulated on the collector includes saliva or mucus. Therefore, Tsukashima '153 as modified meets the limitations of claims 27-28.
Regarding claims 30 and 45, Tsukashima '153 teaches/suggests an apparatus for assessing a condition of a patient, the apparatus comprising:
a flow generator (CPAP device 16, or means thereof for generating air, ¶ [0026], ¶ [0028], etc.), adapted to couple with a patient interface configured to direct a flow of breathable gas (mask apparatus 36), the flow generator configured to generate a flow of breathable gas to the patient interface (e.g., ¶ [0028]);
a controller, including at least one processor, the controller being configured to control a pressure treatment protocol with the flow generator (control means 20 and/or processing receiver 26 (or microprocessor 70 thereof); ¶ [0028]); and
a sensing module (housing 27), at least a portion of the sensing module being embedded and/or integrated with the patient interface (Figs. 1-3, housing 27 is enclosed by/set within an opening in mask apparatus 36), the portion of the sensing module attached to/integrated with the patient interface including a collector configured to accumulate exhaled breath condensate that is exhaled to the patient interface (¶ [0031] film 63 for collecting exhaled breath condensate and/or absorption means or pad 62 having the capability to continuously draw or extract, from surface of film 63, some of the liquefied breath sample into its open-cell structure), at least one electrochemical sensor (pH sensor 46) configured to sense a chemical accumulated by the collector and generate a signal indicative of the chemical of the collector (¶ [0033] pH sensor 46 is positioned such that it gets exposed to a sample of breath condensed on the film 63 and outputs analog pH information).
Tsukashima '153 does not expressly teach the sensing module, or collector thereof, is removably embedded within the patient interface, but does disclose different positions of the components of the disclosed invention can still achieve the goal of monitoring, diagnosing and treating respiratory and medical conditions in patients (¶ [0024]).
Pierro teaches/suggests a comparable apparatus comprising: a patient interface (patient interface 110) configured to communicate a pressure treatment generated by a respiratory treatment apparatus (ventilator 160; ¶ [0013]) to the respiratory system of the patient (¶ [0050]), the patient interface comprising a cushion, formed of a material (¶ [0057]), configured to provide a pressure seal for the pressure treatment (facial skin interface 130; ¶ [0057]); and a module configured to at least collect at least exhaled breath that is removably embedded within the cushion material of the patient interface, such that the sensing module is integrated with a cushion surface of the patient interface (Fig. 6; ¶¶ [0068]-[0070] facial skin interface 130 includes a self-sealing tube insertion region 630 through which a module, e.g., breath sampling tube, may be removably inserted). Pierro further discloses the material of the cushion provides a sealing function of self-sealing around an inserted module, sealing the opening in the cushion when no module is inserted, etc. (¶ [0069]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apparatus of Tsukashima '153 with the patient interface comprising a cushion on a surface of the patient interface formed of a material configured to provide a pressure seal for the pressure treatment as taught/suggested by Pierro in order to reduce/eliminate unintentional leaks (Pierro, ¶ [0050]); minimize ambient air from entering the boundaries of the mask (Tsukashima '153, ¶ [0024]); etc. Further, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apparatus of Tsukashima '153 with the sensing module, including the electrochemical sensor and collector(s) thereof, being removably embedded within the patient interface, as taught/suggested by Pierro, such that the sensing module is integrated with a cushion surface of the patient interface or a structural element of the patient interface, in order to facilitate providing a sealing function for self-sealing about the sensing module when embedded and sealing the patient interface (i.e., an opening thereof) if/when the sensing module is removed (Pierro, ¶ [0069]), thereby further reducing/eliminating unintentional leaks (Pierro, ¶ [0050]) and/or minimizing ambient air from entering the boundaries of the mask (Tsukashima '153, ¶ [0024]) (e.g., through the port, around the sensing module, etc.), etc., regardless of whether the sensing module is currently being used by the patient, and/or as a simple substitution of one suitable means/method for integrating the sensing module and patient interface that enables collecting exhaled breath for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claim 31, Tsukashima '153 as modified teaches and/or suggests the controller is coupled with the sensor (Fig. 1; ¶ [0034]; etc.), and the processor is configured to store a measure derived from the signal (¶¶ [0042]-[0043]).
Regarding claim 32, Tsukashima '153 as modified teaches/suggests the sensing module comprises a plurality of sample collectors (¶ [0031] film 63 and absorption means or pad 62).
Regarding claim 36, Tsukashima '153 as modified teaches/suggests the sensing module comprises one or more of a peroxide sensor, a nitrous oxide sensor, an acetone sensor, a carbon dioxide sensor, a pH sensor, a glucose sensor, and a lactate sensor (pH sensor 46).
Regarding claim 38, Tsukashima '153 as modified teaches and/or suggests the processor is configured to activate one or more of the sensors after a set period of time (¶ [0012] pH data is transferred or updated at specific intervals).
Regarding claim 46, Tsukashima '153 as modified teaches and/or suggests the processor is configured to detect a quantity of an analyte from the exhaled breath condensate (¶ [0043] micro-processor 70 uses the sensor data to calculate an accurate pH level).
Regarding claim 47, Tsukashima '153 as modified teaches/suggests the limitations of claim 46, as discussed above, but does not expressly disclose the sample collector is configured to collect or accumulate saliva. Tsukashima '153 as modified does not expressly disclose the collector is configured to collect saliva. However, Applicant neither discloses, nor do the claims recite, a particular structure(s) that "configures" a collector to accumulate a specific type of fluid. At best, the limitation appears to amount a recitation of intended use and/or function of the collector(s). A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Functional claim language that is not limited to a specific structure covers all devices that are capable of performing the recited function. Accordingly, if the prior art structure is capable of performing the intended use/function, it meets the claim. Tsukashima '153 as modified discloses breath condensate contacts the collector(s) and accumulates thereon/therein, as noted above. Applicant discloses breath condensate may include saliva and/or sputum (¶ [0100]), which is consistent with knowledge that exhaled breath includes and/or carries respiratory droplets that include saliva and mucus (see "Respiratory Droplet," previously cited). Therefore, the collector(s) of Tsukashima '153 as modified is/are capable of collecting saliva when said saliva is included in and/or carried by exhaled breath. Accordingly, Tsukashima '153 as modified meets the limitations of claim 47.
Claim(s) 2-5, 22, 24 and 33-35 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tsukashima '153 in view of Pierro as applied to claim(s) 1 and 30 above, and further in view of US 2009/0255535 A1 (previously cited, Kanzer).
Regarding claims 2-5, 22 and 24, Tsukashima '153 as modified teaches and/or suggests the limitations of claim 1, but does not expressly disclose the collector(s) are adapted for replacement within the sensing module, or at least one collector of a plurality of collectors comprises an absorbent material including a preservative for preserving an analyte collected from the exhaled breath.
Kanzer teaches/suggests an apparatus for assessing a condition of a patient, the apparatus comprising: a patient interface (mask 27, mask 34, etc.); and a module (collection strip 2, collection swab 39, etc.) removably integrated with the patient interface (¶¶ [0027]-[0028]; ¶ [0062]; etc.), the module including one or more collectors (collection area(s) 3) configured to accumulate exhaled breath that is exhaled to the patient interface, saliva that is in contact with the patient interface, and mucus that is in contact with the patient interface (¶ [0096] where the device capable of capturing and storing biologic fluids, such as saliva, sputum, respiratory gases, etc.), wherein at least one collector comprises an absorbent material (¶¶ [0027]-[0028] where swab 39 is absorbent; ¶ [0063] collector material may comprise cotton, other fibrous materials including paper, etc.) having a preservative for preserving an analyte collected from the exhaled breath (¶ [0063] where collection materials may also be impregnated with substances useful for the storage and transport of acquired samples, including preservatives), wherein the module may comprise a plurality of collectors (¶ [0071] multiple separate or detachable collection areas), and/or at least one collector is adapted for replacement within the module (¶ [0057] where a collection area may comprise non-permanent, adhesively-mounted detachable collection material unit, indicating said collection area is capable of being removed and a new collection area attached).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apparatus of Tsukashima '153 with the sensing module removably embedded within the material of the cushion of the patient interface (e.g., removably insertable in the port or opening in the cushion of the patient interface) comprising a sensing module including one or more collectors comprising an absorbent material configured to accumulate exhaled breath that is exhaled to the patient interface, saliva that is in contact with the patient interface, and mucus that is in contact with the patient interface, wherein the absorbent material includes a preservative for preserving an analyte collected from the exhaled breath, as taught/suggested by Kanzer in order to further facilitate detecting communicable diseases and controlling outbreaks thereof (Kanzer, ¶ [0002]), which may be particularly advantageous for patients using the apparatus in a healthcare setting (Kanzer, ¶ [0011]). Furthermore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apparatus of Tsukashima '153 with the one or more collectors comprising a plurality of sample collectors and/or being adapted for replacement within the sensing module as taught and/or suggested by Kanzer in order to facilitate screening of pooled samples for rapid detection and collecting/storing a further sample for later individual testing, if required (e.g., Kanzer, ¶ [0071]).
Regarding claims 33-35, Tsukashima '153 as modified teaches/suggests the limitations of claim 30, and further discloses the collector comprises an absorbent material (absorption means or pad 62), but does not expressly disclose the collector is adapted for replacement within the sensing module, or the absorbent material includes a preservative for preserving an analyte collected from the exhaled breath.
Kanzer teaches/suggests an apparatus for assessing a condition of a patient, the apparatus comprising, inter alia, a module removably integrated with a patient interface, the module including one or more collectors configured to accumulate exhaled breath that is exhaled to the patient interface, saliva that is in contact with the patient interface, and/or mucus that is in contact with the patient interface, wherein the collector comprises an absorbent material (¶¶ [0027]-[0028] where swab 39 is absorbent; ¶ [0063] collector material may comprise cotton, other fibrous materials including paper, etc.) having a preservative for preserving an analyte collected from the exhaled breath (¶ [0063] where collection materials may also be impregnated with substances useful for the storage and transport of acquired samples, including preservatives), and wherein the collector is adapted for replacement within the module (¶ [0057] where a collection area may comprise non-permanent, adhesively-mounted detachable collection material unit, indicating said collection area is capable of being removed and a new collection area attached).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apparatus of Tsukashima '153 with the absorbent collector (i.e., absorption means or pad 62) including a preservative for preserving an analyte collected from the exhaled breath, and being adapted for replacement within the sensing module as taught/suggested by Kanzer in order to facilitate collecting a sample for pooled screening and collecting/storing a further sample for later individual testing, if required (e.g., Kanzer, ¶ [0071]) to detect and control outbreaks of communicable diseases (Kanzer, ¶ [0002]), which may be particularly advantageous for patients using the apparatus in a health-care setting (e.g., Kanzer, ¶ [0011]).
Claim(s) 7 and 29 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tsukashima '153 in view of Pierro as applied to claim(s) 6 and 27 above, and further in view of US 6,585,661 B1 (previously cited, Hunt).
Regarding claim 7, Tsukashima '153 as modified teaches/suggests the limitations of claim 6, as discussed above, but does not expressly disclose the module comprises a plurality of electrochemical sensors.
Hunt discloses an apparatus for assessing a condition of a patient comprising at least one an electrochemical sensor configured to sense a chemical in breath condensate accumulated by at least one collector (col. 1, lines 13-18, NH4+), disclosing both pH and NH4+ quantity are useful in evaluating a respiratory condition of a patient (e.g., determining presence, absence or status of asthma) (col. 14, lines 3-23).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apparatus of Tsukashima '153 the module comprising a plurality of electrochemical sensors, e.g., a first sensor configured to sense pH and a second sensor configured to sense NH4+, in order to provide a more comprehensive evaluation of respiratory condition (e.g., determining presence, absence or status of asthma) by considering an additional analyte quantity indicative thereof (Hunt, col. 14, lines 3-23).
Regarding claim 29, Tsukashima '153 as modified teaches/suggests the limitations of claim 27, as discussed above, but does not disclose the analyte is one or more of NH4+, acetate, NH3+, and Ca+.
Hunt discloses an apparatus comprising an electrochemical sensor configured to detect a quantity of an analyte from a fluid in contact therewith (electrode(s) 162 capable of determining selected chemical properties of condensate sample 103), wherein the analyte is NH4+ (col. 1, lines 13-18).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apparatus of Tsukashima '153 with the electrochemical sensor being configured to detect a quantity of NH4+ in the accumulated fluid as taught/suggested by Hunt in order to provide a more comprehensive evaluation of respiratory condition (e.g., determining presence, absence or status of asthma) by considering an additional analyte quantity indicative thereof (Hunt, col. 14, lines 3-23) and/or as a simple substitution of one known analyte indicative of a respiratory condition of the patient and useful for adjusting a treatment of said patient (Hunt, col. 14, lines 3-23) for another to yield no more than predictable results. See MPEP 2143(I)(B).
Claim(s) 10 and 37 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tsukashima '153 in view of Pierro as applied to claim(s) 8 and 36 above, and further in view of US 2012/0203126 A1 (previously cited, Kahlman).
Regarding claim 10, Tsukashima '153 as modified teaches/suggests the limitations of claim 8, as discussed above, but does not teach the processor is configured to synchronize an activation of the electrochemical sensor with an expiratory phase of a detected breath cycle.
Pierro discloses timing the analysis of exhaled breath to ensure the analysis is substantially undiluted by respiratory gases supplied for the patient's breathing (e.g., ¶ [0147]). Kahlman teaches and/or suggests an apparatus comprising a processor (processor 12) configured to synchronize an activation of a sensor with an expiratory phase of a detected breath cycle (¶ [0033] processor 12 identifies a selected part of exhalation and activates the NO sensor unit 10 during said part).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apparatus of Tsukashima '153 with the processor being configured to synchronize an activation of the electrochemical sensor with an expiratory phase of a detected breath cycle as taught/suggested by Kahlman in order to ensure the sensor output is substantially undiluted by respiratory gases supplied for the patient's breathing (Pierro, ¶ [0147]).
Regarding claim 37, Tsukashima '153 as modified teaches/suggests the limitations of claim 36, as discussed above, but does not teach the processor is configured to synchronize an activation of one or more of the sensors of the sensing module (e.g., pH sensor) with an expiratory phase of a detected breath cycle.
Pierro discloses timing the analysis of exhaled breath to ensure the analysis is substantially undiluted by respiratory gases supplied for the patient's breathing (e.g., ¶ [0147]). Kahlman teaches and/or suggests an apparatus comprising a processor (processor 12) configured to synchronize an activation of a sensor with an expiratory phase of a detected breath cycle (¶ [0033] processor 12 identifies a selected part of exhalation and activates the NO sensor unit 10 during said part).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apparatus of Tsukashima '153 with the processor being configured to synchronize an activation of one or more of the sensors of the sensing module (e.g., pH sensor) with an expiratory phase of a detected breath cycle as taught and/or suggested by Kahlman in order to ensure sensor output is substantially undiluted by respiratory gases supplied for the patient's breathing (Pierro, ¶ [0147]).
Claim(s) 11-12 and 38-39 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tsukashima '153 in view of Pierro as applied to claim(s) 8 and 36 above, and further in view of US 2007/0173731 A1 (previously cited, Meka).
Regarding claims 11-12, Tsukashima '153 as modified teaches/suggests the limitations of claim 8. Tsukashima '153 as modified further discloses the processor is configured to activate the electrochemical sensor after a set period of time (¶ [0012]), as discussed above. Alternatively, or additionally, Meka discloses a system comprising an electrochemical sensor (¶ [0076] electrodes on the micro-sized analysis device), the electrochemical sensor configured to sense a chemical in breath condensate accumulated by at least one collector and generate a signal indicative of the chemical (¶ [0046]; ¶ [0084] measuring pH of a patient's exhaled condensate; etc.); a controller and/or processor coupled with the sensor and configured to store a measure derived from the signal (¶ [0084]), wherein the processor is configured to activate the electrochemical sensor after a set period of time, the set period of time comprising a timed period of use of the apparatus (¶¶ [0084]-[0085] the instrument determines an amount of collection time necessary, and when such time is complete, the instrument automatically proceeds to analyze the sample/determine the pH level). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apparatus of Tsukashima '153 with the processor being configured to activate the electro-chemical sensor after a set period of time, the set period of time comprising a timed period of use of the respiratory treatment apparatus as taught and/or suggested by Meka in order to ensure a sufficient collection time between measurements (Meka, ¶ [0078]; ¶¶ [0084]-[0085]; etc.).
Regarding claims 38-39, Tsukashima '153 as modified teaches/suggests the limitations of claim 36. Tsukashima '153 as modified further discloses the processor is configured to activate the sensor (e.g., pH sensor) after a set period of time (¶ [0012]), as discussed above. Alternatively, or additionally, Meka discloses a system comprising an electrochemical sensor (¶ [0076] electrodes on the micro-sized analysis device), the electrochemical sensor configured to sense a chemical in breath condensate accumulated by at least one collector and generate a signal indicative of the chemical (¶ [0046]; ¶ [0084] measuring pH of a patient's exhaled condensate; etc.); a controller and/or processor coupled with the sensor and configured to store a measure derived from the signal (¶ [0084]), wherein the processor is configured to activate the electrochemical sensor after a set period of time, the set period of time comprising a timed period of use of the apparatus (¶¶ [0084]-[0085] the instrument determines an amount of collection time necessary, and when such time is complete, the instrument automatically proceeds to analyze the sample/determine the pH level). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apparatus of Tsukashima '153 with the processor being configured to activate one or more of the sensors (e.g., pH sensor) after a set period of time, the set period of time comprising a timed period of use of the respiratory treatment apparatus as taught/suggested by Meka in order to ensure a sufficient collection time between measurements (Meka, ¶ [0078]; ¶¶ [0084]-[0085]; etc.).
Claim(s) 13-16 and 40-43 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tsukashima '153 in view of Pierro as applied to claim(s) 8 and 30 above, and further in view of US 5,069,220 A (previously cited, Casparie).
Regarding claims 13-16, Tsukashima '153 as modified teaches/suggests the limitations of claim 8, as discussed above, but does not disclose the collector of the module comprises a variable aperture controlled by the processor.
Pierro discloses collection of an exhaled breath sample may be timed not to coincide with a time when respiratory gases, e.g., oxygen, are being supplied to the patient (¶ [0147]). Casparie teaches/suggests an apparatus comprising a processor (microprocessor); and a collector configured to accumulate exhaled breath (collection cell), wherein the collector comprises a variable aperture (inlet valve) controlled by the processor, wherein the processor is configured to synchronize opening of the variable aperture with an expiratory phase of a detected breath cycle and/or is configured to open the variable aperture for a set period of time, wherein the set period of time comprises one of the group consisting of a breath cycle count, a timed period of use of the respiratory treatment apparatus, and a number of treatment sessions with the respiratory treatment apparatus (col. 2, line 53 - col. 3, line 2, where a pump includes a piston that draws gas into the collection cell, under the control of the microprocessor, only during the end tidal period of the patient's exhalation, and when the sampling period (coinciding with the end tidal period) is over, as determined by the microprocessor, the piston is stopped and the inlet valve to the collection cell is closed until the next sampling period begins, such that the reservoir is filled with a series of end tidal samples extracted from several successive breaths, until the collection cell contains a suitable volume of exhaled gas for the gas concentration analysis to be performed).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apparatus of Tsukashima '153 with the collector comprising a variable aperture controlled by the processor as taught/suggested by Casparie in order to ensure exhaled breath/air of a sufficient volume is collected for further analysis (Casparie, col. 2, line 53 - col. 3, line 2) that is substantially undiluted by respiratory gases supplied to the patient (Pierro, ¶ [0147]).
Regarding claims 40-43, Tsukashima '153 as modified teaches/suggests the limitations of claim 30, as discussed above, but does not disclose the collector of the sensing module comprises a variable aperture controlled by the processor.
Pierro discloses collection of an exhaled breath sample may be timed not to coincide with a time when respiratory gases, e.g., oxygen, are being supplied to the patient (¶ [0147]). Casparie teaches/suggests an apparatus comprising a processor (microprocessor); and a collector configured to accumulate exhaled breath (collection cell), wherein the collector comprises a variable aperture (inlet valve) controlled by the processor, wherein the processor is configured to synchronize opening of the variable aperture with an expiratory phase of a detected breath cycle and/or is configured to open the variable aperture for a set period of time, wherein the set period of time comprises one of the group consisting of a breath cycle count, a timed period of use of the respiratory treatment apparatus, and a number of treatment sessions with the respiratory treatment apparatus (col. 2, line 53 - col. 3, line 2, where a pump includes a piston that draws gas into the collection cell, under the control of the microprocessor, only during the end tidal period of the patient's exhalation, and when the sampling period (coinciding with the end tidal period) is over, as determined by the microprocessor, the piston is stopped and the inlet valve to the collection cell is closed until the next sampling period begins, such that the reservoir is filled with a series of end tidal samples extracted from several successive breaths, until the collection cell contains a suitable volume of exhaled gas for the gas concentration analysis to be performed).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apparatus of Tsukashima '153 with the collector of the sensing module comprising a variable aperture controlled by the processor as taught/suggested by Casparie in order to ensure exhaled breath/air of a sufficient volume is collected for further analysis (Casparie, col. 2, line 53 - col. 3, line 2) that is substantially undiluted by respiratory gases supplied to the patient (Pierro, ¶ [0147]).
Claim(s) 18 and 44 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tsukashima '153 in view of Pierro as applied to claim(s) 17 and 31 above, and further in view of US 2006/0270940 A1 (previously cited, Tsukashima '940).
Regarding claim 18, Tsukashima '153 as modified teaches/suggests the limitations of claim 17, as discussed above, but does not expressly disclose the processor is configured to generate a warning based on the comparison.
Tsukashima '940 discloses a comparable system comprising, inter alia, an electrochemical sensor configured to sense a chemical in breath condensate and generate a signal indicative of the chemical (pH sensor 20); and a processor (processing receiver/data recorder 39) configured to compare a measure derived from the signal and a threshold value and generate a warning based on the comparison (¶ [0030] processing receiver/data recorder 39 can incorporate an alerting means that is initiated when certain pH parameters are measured, e.g., if pH enters a range known to be associated with a particular respiratory disease, a visual or audible alarm can be generated).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apparatus of Tsukashima '153 with the processor being further configured to generate a warning based on the comparison as taught/suggested by Tsukashima '940 in order to notify a patient and/or clinician thereof that a condition known to be associated with a particular respiratory disease has been detected (Tsukashima '940, ¶ [0030]) and/or therapy adjusted in response thereto (Tsukashima '153, ¶ [0044]).
Regarding claim 44, Tsukashima '153 as modified teaches/suggests the limitations of claim 31, as discussed above, and further teaches/suggests the processor is configured to compare the measure derived from the signal and a threshold value (¶ [0044]), but does not expressly disclose the processor is configured to generate a warning based on the comparison.
Tsukashima '940 discloses a comparable system comprising, inter alia, an electrochemical sensor configured to sense a chemical in breath condensate and generate a signal indicative of the chemical (pH sensor 20); and a processor (processing receiver/data recorder 39) configured to compare a measure derived from the signal and a threshold value and generate a warning based on the comparison (¶ [0030] processing receiver/data recorder 39 can incorporate an alerting means that is initiated when certain pH parameters are measured, e.g., if pH enters a range known to be associated with a particular respiratory disease, a visual or audible alarm can be generated).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apparatus of Tsukashima '153 with the processor being further configured to generate a warning based on the comparison as taught/suggested by Tsukashima '940 in order to notify a patient and/or clinician thereof that a condition known to be associated with a particular respiratory disease has been detected (Tsukashima '940, ¶ [0030]) and/or therapy adjusted in response thereto (Tsukashima '153, ¶ [0044]).
Claim(s) 19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tsukashima '153 in view of Pierro as applied to claim(s) 8 above; or alternatively, over Tsukashima '153 in view of Pierro as applied to claim(s) 8 above, and further in view of US 2010/0078014 A1 (previously cited, Hyde).
Regarding claim 19, Tsukashima '153 as modified teaches/suggests the limitations of claim 8, as discussed above, and further teaches/suggests the processor is configured to detect a quantity of an analyte from the exhaled breath (¶ [0043] microprocessor 70 uses the sensor data to calculate an accurate pH level). While Tsukashima '153 as modified does not expressly teach the collector is configured to collect analytes in the patient's breath over a period of time that ranges between 12 hours and two weeks, one of ordinary skill in the art would readily appreciate the collector disclosed by Tsukashima '153 collects analytes in the patient's breath for as long as the apparatus is used. Accordingly, since a user is capable of using the apparatus for a period of time that ranges between 12 hours and two weeks, Tsukashima '153 as modified is capable of this intended function and/or use.
Alternatively/Additionally, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify Tsukashima '153 with the collector being configured to collect analytes in the patient's breath over a period of time that ranges between 12 hours and two weeks because Applicant has not disclosed that the above-noted collection time range provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant expressly discloses the above-noted range as merely exemplary (¶ [0100]). As no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the arrangement suggested by Tsukashima '153 as modified because either configuration permits sufficient collection for achieving the goal of monitoring, diagnosing and treating respiratory and medical conditions in patients (Tsukashima '153, ¶ [0024]).
Further alternatively/additionally, Hyde discloses an apparatus comparable to the apparatus of Tsukashima '153 may be "worn at all times, and as such may continuously and in real time measure the pH of the expired [breath] condensate of a subject" (¶ [0048]). Accordingly, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify Tsukashima '153 with the collector(s) being configured to collect analytes in the patient's breath over a period of time that ranges between 12 hours and two weeks (e.g., "at all times" for day, week, etc.) in order to facilitate continuously and in real-time monitoring of pH during said time period (Hyde, ¶ [0048]).
Claim(s) 24 and 26 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tsukashima '153 in view of Pierro as applied to claim(s) 1 above, and further in view of US 2012/0318271 A1 (previously cited, Ho) and US 2009/0007918 A1 (previously cited, Darkin).
Regarding claims 24 and 26, Tsukashima '153 as modified teaches/suggests the limitations of claim 1, and further teaches/suggests the at least one collector is configured to accumulate mucus that is in contact with the patient interface, as discussed above. Alternatively/Additionally, Tsukashima '153 and/or Pierro discloses a suitable patient interface may cover both nasal and oral cavities, or may cover only a nasal cavity (Tsukashima '153, ¶ [0024]; Pierro, ¶ [0050]; etc.).
Ho teaches/suggests an apparatus comprising a patient interface (patient interface device 10) configured to communicate a pressure treatment generated by a respiratory treatment apparatus (pressure support system 12) to the respiratory system of the patient (¶ [0030]), the patient interface comprising a cushion (cushion 42 including base 44 and a pair of replaceable nasal pillows 46) configured to contact a mucosa of the patient and provide a pressure seal for the pressure treatment (¶ [0009] nasal pillows 46 sealingly engage the nares of the patient; ¶ [0038] nasal pillows 46, or outer portion 65 thereof, conform to nares of the patient), the cushion being formed of a material (¶ [0033] cushion 42 can be made from any suitable material, such as gel, silicone, foam, rubber, or a combination of materials; ¶ [0037]; etc.), wherein the patient interface comprises a nasal cannula comprising a plurality of prongs (cavity 45 extending upward to each of nasal apertures 47; ¶ [0029]; etc.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apparatus of Tsukashima '153 with the patient interface comprising: a nasal cannula comprising a plurality of prongs; and a cushion configured to contact a mucosa of the patient and provide a pressure seal for the pressure treatment as taught and/or suggested by Ho as a simple substitution of one suitable patient interface having a cushion for providing a pressure seal for a pressure treatment for another to yield no more than predictable results. See MPEP 2143(I)(B).
Tsukashima '153 as modified does not expressly disclose another sensing module is embedded in, or adhered to, at least one prong of the nasal cannula to contact a mucosa of the patient.
Darkin teaches/suggests an apparatus for assessing a condition of a patient, said apparatus comprising a patient interface including a nasal cannula and a sensing module embedded in, or adhered to at least one prong of the nasal cannula to contact a mucosa of the patient (¶ [0018] a sensor on a nasal prong for contact with the mucosal regions of the nares).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apparatus of Tsukashima '153 with another sensing module being embedded in, or adhered to, at least one prong of the nasal cannula to contact a mucosa of the patient as taught and/or suggested by Darkin in order to facilitate further and/or more comprehensively monitoring the condition of the user of the respiratory treatment apparatus, e.g., transcutaneously monitoring glucose, particularly for users with diabetes (Darkin, ¶ [0018]).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
Applicant asserts "the Office Action repeatedly reads Applicant's disclosure into Pierro, guided only by improper hindsight" because Pierro does not use the term "module" but instead discloses a tube may be inserted into the mask cushion (Remarks, pgs. 11-12).
The examiner respectfully disagrees. "Module" is a nonce term or generic placeholder (i.e., non-structural term having no specific structural meaning). The Office action is not reading Applicant's disclosure into Pierro, but merely referring to the element(s) of Pierro removably inserted through the mask cushion as a "module." It is acknowledged in the rejection(s) of record and the response to arguments in the prior Office action that the "module" of Pierro being referred to is a tube (see, e.g., pg. 5, 30, etc.).
Applicant further contends, "Thus, Pierro in merely inserting a tube, does not teach a sensor inserted into a cushion. In this light, what is admitted to be missing from Tsukashima '153 is also missing from Pierro because neither teach the claimed sensor configuration" (Remarks, pg. 12).
There has been no contention that Pierro alone discloses inserting a sensor into a cushion. The primary reference to Tsukashima '153 discloses a sensing module comprising at least one physiological sensor and a collector(s) embedded within a material of the patient interface. Tsukashima '153 neither discloses said sensing module is removably embedded, nor embedded within the material of a cushion of the patient interface. However, Tsukashima '153 as modified by Pierro discloses and/or suggests the patient interface comprises a cushion as claimed. Further, Tsukashima '153 does not disclose the position of the sensor module at the front of the mask is required, but rather expressly discloses different positions of the components of the disclosed invention can still achieve the goal of monitoring, diagnosing and treating respiratory and medical conditions in patients. Pierro discloses an apparatus comprising a module removably embedded within the material of the cushion of the patient interface. Pierro expressly discloses said module may comprise a breath sampling tube, thus reasonably teaching/suggesting the opening through the cushion in which said module is removably embedded provides said module access to the chamber defined by the interior mask from which breath of the user may be sampled. Further, Pierro discloses the material of the cushion provides a sealing function of self-sealing around a module inserted therein or sealing the opening in the mask cushion when no module is inserted. Accordingly, Pierro reasonably teaches/suggests that removably embedding the sensing module, and therefore the sensor thereof, of Tsukashima '153 within an opening/port of the self-sealing cushion material of the mask enables sealing around said sensing module when embedded and sealing the port when the sensing module removed, thereby reducing/minimizing unintentional leaks into and out of the mask, regardless of whether the sensing module is currently being used by the patient (i.e., embedded in the cushion), while still permitting the sensing module to access the interior of the mask to collect breath when desired (i.e., when monitoring is desired, the sensing unit is integrated with or embedded within the mask cushion, etc.).
Applicant further contends, "both references suggest that the sensor should not be configured as argued in the Office Action" (Remarks, pg. 12). With respect to Pierro, Applicant contends "its use of a 'sampling line' or 'tube' is a clear suggestion of a need or desire for a remote sensing configuration" (Remarks, pgs. 12-13).
The examiner respectfully disagrees. Pierro disclosing one configuration for breath sensing does not in and of itself amount to a suggestion of a "need or desire" for said configuration, or clear discouragement from other arrangements. Pierro does not criticize, discredit, or otherwise discourage the solution claimed.
Applicant contends, "Moreover, nothing in Pierro explicitly or implicitly describes anything other than flexible tubes being inserted into opening 632. Indeed, a skilled reader would readily recognize that a mere compliant/flexible tube near the patient can be so located because it can be comfortable when a patient will come in contact with it while sleeping on their side rather than some large or rigid structure that would clearly hurt and/or interfere with sleep such as by preventing sleeping on their side. Anything but a small flexible tube/line would interfere with the essential requirement of the mask to preserve its seal as a extended and rigid structure can act a lever when a patient is on their side causing the mask to lift from the face and opening the desired seal of the therapy mask so as to undermine the pressure therapy" (Remarks, pgs. 13-14).
The examiner respectfully disagrees. One of ordinary skill in the art would at least appreciate the tube/element disposed in said port should be at least more rigid than the self-sealing material of the cushion to ensure the tube/element remains open. The examiner is unable to locate any disclosure in Pierro relating to a degree of flexibility required in order to be utilized in the disclosed cushion port, as Applicant appears to suggest. The remaining of the above-noted arguments appear to all pertain to design considerations when a user is sleeping and/or lying on his/her side. However, the claims are not limited to use during sleep and/or user's that are lying down.
Applicant further contends, "[A] skilled reader would recognize that the sensing device of Tsukashima-153 would not be put in the port of Pierro as only proposed in the Office Action, not only because Pierro suggests otherwise but also because Tsukashima-153 has features that would be understood to need to be external," contending Tsukashima '153 is "more than a mere tube," citing Figs. 2-5 of Tsukashima '153, particularly the "perpendicular structure" thereof (Remarks, pgs. 15-16).
The examiner respectfully disagrees. The claims do not appear to require the sensing module, or sensor thereof, to be embedded within the material of the cushion by being wholly encapsulated by the cushion material. The entire length of the sensing module structure of Tsukashima '153 is not required to be inserted/embedded into the mask cushion to meet the limitations of the claims. Affixing the sensing module to the mask such that an end of the sensing module is exposed to breath by removably embedding at least a portion of the sensing module within a self-sealing opening in the mask cushion meets the requirements of the claim. Further, with respect to the "perpendicular structure," Tsukashima '153 expressly discloses other positions for said structure can be employed "without sacrificing any performance" (¶ [0033]).
Applicant further contends, "[The] design of Tsukashima-153 includes necessary mechanisms that suggest that it would not be embedded within a cushion as proposed only in the Office Action," citing heat sink (34) (Remarks, pgs. 16-17).
The examiner respectfully disagrees. As noted above, the proposed modification is not that the entire length of the tubular structure of Tsukashima '153, or all components within the sensing module, are wholly encapsulated by cushion material. Applicant's remarks appear to be arguing against a feature that has not been proposed.
Applicant further contends, "Indeed, Tsukashima-153's evident projection away for the patient as clearly shown in Fig. 2 of Tsukashima-153, is at the further point from the patient on the mask and as such, is clearly suggestive of the need for distance to achieve the desired cooling function. In sum, the necessity for cooling to the environment for sensing in the express teachings of Tsukashima-153 would lead the skilled reader away from what is proposed only in the Office Action. In this light, the prior art may be fairly understood to teach away from the claimed invention" (Remarks, pg. 17).
The examiner respectfully disagrees. Teaching away requires 'clear discouragement' from implementing a technical feature. In re Ethicon, Inc., 844 F.3d 1344, 1351 (Fed. Cir. 2017). Tsukashima '153 neither dislcoses any need for distance to achieve cooling, not discloses or suggests any benefit to the position of the sensing module illustrated in Figure 2. Rather, Tsukashima '153 discloses positioning the components of the disclosed system differently "can still achieve the goal of monitoring, diagnosing and treating respiratory and medical conditions in patients" (¶ [0024]).
Lastly, Applicant submits, "Furthermore, to do as identified only in the Office Action would simply make the device's performance less satisfactory. Such a resulting modification that renders the prior art invention being modified unsatisfactory for its intended purpose, indicates that there no suggestion or motivation to make the proposed modification" (Remarks, pg. 17).
The examiner respectfully disagrees. There is no evidence demonstrating the proposed modification would "make the device's performance less satisfactory." To the contrary, as noted above, Tsukashima '153 expressly discloses the goals of monitoring, diagnosing and treating respiratory and medical conditions in patients may still be achieved with components of the system in different positions.
Conclusion
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 Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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