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 .
Applicant' s arguments, filed 10/30/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 10/30/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-14, 16-18, and 20 are the currently pending claims hereby under examination. Claims 15 and 19 have been canceled; claims 1, 10-12, 14, 16-17, and 20 have been amended.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over by Robitaille et al. (US 20170312464 A1), hereto referred as Robitaille, and further in view of Hess et al. (US 20190209044 A1), hereto referred as Hess.
Regarding claim 1, Robitaille teaches that a breathwork apparatus comprises: an exhalation side (Robitaille, ¶[0145]: "a breathing assistance apparatus includes a housing 400 having an exhalation chamber 402 and an inhalation chamber 404", ¶[0051]: "The one-way exhalation valve 20 communicates with an expiratory flow path", and Figs. 1, 5A: showing an exhalation side corresponding to exhalation path/tubing and the exhalation chamber); a transfer case (Robitaille, Fig. 2; ¶[0051]: "The one-way exhalation valve 20 communicates with an expiratory flow path 23... The one-way inhalation valve 21 communicates with an inspiratory flow path 22...", teaching that there are flow paths/tubing and valves connecting the mask assembly to the inhalation and exhalation chambers, which functions as the transfer case); an inhalation side (Robitaille, ¶[0145]: "a breathing assistance apparatus includes a housing 400 having an exhalation chamber 402 and an inhalation chamber 404", ¶[0051]: "The one-way inhalation valve 21 communicates with an inspiratory flow path 22", and Figs. 1, 5A: showing an inhalation side corresponding to inhalation path/tubing and the inhalation chamber); a mask assembly (Robitaille, Fig. 1; ¶[0049]: "Referring to FIGS. 1, 2, and 26, a breathing assistance apparatus includes a patient interface, shown as a mask 2", demonstrating a mask assembly used as the user interface through which inhalation and exhalation occur); and wherein the exhalation side and inhalation side are joined by the transfer case, which comprises a plurality of channels (Robitaille, Fig. 1; ¶[0051]: "The one-way exhalation valve 20 communicates with an expiratory flow path 23... The one-way inhalation valve 21 communicates with an inspiratory flow path 22...", where the inhalation and exhalation valves are joined at a common airway, and the transfer case includes at least two channels—the inspiratory and expiratory flow paths which connect the mask to the inhalation and exhalation chambers).
Also regarding claim 1, Robitaille does not teach that at least one first channel of the plurality of channels terminates in an exhalation rate meter. Rather, Robitaille teaches an expiratory flow path (23) that connects the one-way exhalation valve (20) to the exhalation chamber (402), allowing exhaled air to travel through a defined channel from the mask to the chamber (Robitaille, ¶[0051]; ¶[0145]). Robitaille also presents calculated quantities of exhaled air during simulated use (e.g., 258.75 cc), reflecting a concern with volume control and pressure thresholds (Robitaille, ¶[0111]). However, Robitaille does not disclose a channel that terminates with in a rate meter.
Hess, who investigates respiration controlled virtual experiences, teaches a flow sensor (46) capable of detecting gas parameters including flow and describes its use alongside pressure and temperature sensors (Hess, ¶[0100]). Hess expressly teaches supporting flow sensor 46 in-line within a gas passageway (“received within the passageway 96”) as part of the mask connection or at “remote locations” (Hess, ¶[0100]). Thus, the sensor may be placed in the mask adapter housing or elsewhere in the flow path circuit. Paragraph ¶[0103] further explains that the controller processes the detected gas parameters (including flow) to drive an interactive game, confirming that the sensor measures flow rate even though its output is used for game control (Hess, ¶[0103]). Although Hess does not spell out every possible mounting point, a person of ordinary skill in the art would have understood that known remote locations in the breathing circuit include distal regions of an expiratory tube or conduit where the airflow channel interfaces with monitoring hardware, because such locations mechanically support the sensor and keep its mass away from the patient interface while still in the flow path.
When used in conjunction with Robitaille’s separated expiratory channel, it would have been clear to a person of ordinary skill in the art to dispose Hess’s flow sensor 46 at the distal region of Robitaille’s expiratory flow path 23, because such locations routinely provide mechanical support and protect the sensor while keeping it in the flow stream. Under the broadest reasonable interpretation, configuring the expiratory flow path so that its distal region feeds the sensor in this manner corresponds to a channel “terminating in” an exhalation meter. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Robitaille in view of Hess to include at least one first channel of the plurality of channels terminating in an exhalation rate meter. This combination would have been possible because Robitaille already isolates expiratory flow and tracks volume, and Hess teaches a compatible flow sensor with flexible in-path and remote placement. Locating the sensor at the distal end region of the defined expiratory channel would be a predictable variation to obtain direct rate measurement while mechanically supporting the sensor. The benefit of the combination would be to enable targeted and accurate measurement of exhalation rate, supporting patient monitoring and feedback in a position that mechanically supports and protects the sensor and keeps its mass/bulk away from the patient interface while still in the flow path.
Also regarding claim 1, the modified Robitaille does not teach that at least one second channel of the plurality of channels terminates in an inhalation rate meter. Rather, it teaches an inspiratory flow path (22) that connects the one-way inhalation valve (21) to the inhalation chamber (404), enabling air to move toward the user through a defined inhalation-side channel (Robitaille, ¶[0051]; ¶[0145]). It also addresses volume expectations of the user's inhalation by matching flow path capacity to tidal volume (Robitaille, ¶[0056]), but it does not disclose a channel that terminates with in a rate meter.
Hess teaches the same flow sensor (46) for detecting respiratory gas parameters and again places it within a gas passageway or at remote locations in the breathing circuit (Hess, ¶[0100]). As with exhalation, a person of ordinary skill would understand that an inspiratory tube segment or connector at the distal end of an inspiratory channel is a routine remote location for a flow sensor so that the sensor is mechanically supported and protected while remaining in the inspiratory flow stream. Paragraph ¶[0103] confirms that flow measurements are processed in real time by the controller, which inherently requires the sensor to be positioned in a portion of the inspiratory channel through which the user’s inhaled gas passes.
When combined with the modified Robitaille’s discrete inspiratory flow channel 22, it would have been apparent to place Hess’s flow sensor 46 at the distal region of the inspiratory channel where it interfaces with the inhalation chamber or monitoring module, because such regions are routine remote locations for flow sensors. Under the broadest reasonable interpretation, arranging the inspiratory channel so that its distal portion communicates directly with the sensor in this way corresponds to the channel “terminating in” an inhalation meter. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Robitaille and Hess in view of Hess to include at least one second channel of the plurality of channels terminating in an inhalation rate meter. This combination would have been possible because the modified Robitaille already isolates inspiratory flow and quantifies volume capacity, and Hess provides the flow sensor and framework for capturing real-time flow data with flexible placement along the flow path. Placing the sensor at the distal end of the defined inspiratory channel is a logical and predictable implementation. The benefit of the combination would be to enable precise monitoring of inhalation rate, supporting therapy feedback and respiratory performance tracking in a position that mechanically supports and protects the sensor and keeps its mass/bulk away from the patient interface while still in the flow path.
Regarding claim 2, the modified Robitaille teaches that an exhalation check valve is included in the exhalation side (Robitaille, ¶[0051]: "The one-way exhalation valve 20 communicates with an expiratory flow path 23", this teaches that the exhalation side includes a check valve that permits flow in only the exhalation direction and blocks reverse flow).
Regarding claim 3, the modified Robitaille teaches that an inhalation check valve is included in the inhalation side (Robitaille, ¶[0051]: "The one-way inhalation valve 21 communicates with an inspiratory flow path 22", this teaches that the inhalation side includes a check valve that allows one-way flow during inhalation and prevents reverse flow).
Regarding claim 4, the modified Robitaille teaches that the inhalation side comprises a base, a cylinder floor, a cylinder wall, and a piston (Robitaille, Figs. 5A–F and 21: showing the inhalation chamber 404 configured with a movable element (e.g., bellows or piston 428), a defined cylindrical wall, floor, and an enclosing base, illustrating the inhalation side as a piston-driven cylindrical structure).
Regarding claim 5, the modified Robitaille teaches that the exhalation side comprises a base, a cylinder floor, a cylinder wall, and a piston (Robitaille, Figs. 5A–F and 21: showing the inhalation chamber 402 configured with a movable element (e.g., bellows or piston 410), a defined cylindrical wall, floor, and an enclosing base, illustrating the inhalation side as a piston-driven cylindrical structure).
Regarding claim 6, the modified Robitaille teaches that the mask assembly comprises a mask connection in the form of a hose (Robitaille, ¶[0049]: "a breathing assistance apparatus includes a patient interface, shown as a mask 2... may include a connector suited for connecting a respiratory tube", and Fig. 1: showing tubing connecting the mask to the remainder of the system, indicating a hose-based connection between the mask assembly and the airflow components).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over by Robitaille et al. (US 20170312464 A1), hereto referred as Robitaille, and further in view of Hess et al. (US 20190209044 A1), hereto referred as Hess, and further in view of Anderson (US 20190240435 A1), hereto referred as Anderson.
Regarding claim 9, the combined Robitaille and Hess do not teach that the mask assembly comprises an adapter with a dial selector, wherein the dial selector adjusts a restriction within the adapter. Rather, the modified Robitaille discloses a mask assembly (mask 2) used for inhalation and exhalation and connected via tubing to a system of valves and chambers (Robitaille, ¶[0049]; Fig. 1). It also teaches the concept of variable resistance or restriction to airflow in the form of adjustable valves. For example, the closing pressure of the valve can be altered by adjusting a spring-loaded mechanism (¶[0158]), and includes physical adjusters such as a PEEP adjuster and peak pressure adjuster (¶[0159]). These components allow fine-tuning of airflow characteristics and show the system supports variable restriction, though not within the mask adapter. However, Robitaille does not disclose any adapter located within the mask assembly that includes a dial selector for adjusting airflow restriction. Hess teaches a mask adapter (82) that includes an internal restriction (106) integrated within its housing. The restriction forms a reduced flow passageway between pressure sensing ports (Hess, ¶[0098]). However, Hess does not disclose that the restriction is adjustable, nor does it include a dial selector or mechanism to change flow resistance manually. Nonetheless, it places the restriction specifically inside the adapter that is part of the mask assembly. Anderson teaches that airflow through a connector body, such as one associated with a breathing apparatus, may be controlled via an "adjustable... valve for controlling natural breathing" (Anderson, ¶[0027]). This directly supports the notion of incorporating an adjustable restriction mechanism, akin to a dial selector, within a breathing adapter or connector. This is further reinforced by Fig. 3A of Robitaille, which illustrates thumb screws as the physical adjustment mechanism for the valves, confirming that the airflow restrictors are operable by the user and consistent with the concept of a dial selector. Additionally, the connector described in Anderson performs the same structural role as the adapter in the claimed mask assembly (connecting the nose and mouth portion to external tubing) and would be viewed as equivalent by a skilled artisan in the context of breathing circuit components. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Robitaille in view of Hess and Anderson to include an adapter in the mask assembly with a restriction that is adjustable by a selector. This combination would have been possible and logical because Hess provides the structural teaching of a restriction within the mask adapter, Robitaille demonstrates the use of user-adjustable mechanisms to regulate airflow elsewhere in the system, and Anderson confirms that adjustable airflow control can be implemented within connector components of breathing systems. A skilled artisan would recognize the benefit and feasibility of relocating Robitaille’s variable restriction functionality into the adapter structure taught by Hess, with Anderson confirming that such adjustability is known in connector-based breathing components. The benefit of the combination would be to allow direct, user-adjustable control of airflow resistance within the mask assembly itself, reducing complexity, enhancing usability, and consolidating control elements at the point of use.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over by Robitaille et al. (US 20170312464 A1), hereto referred as Robitaille, and further in view of Hess et al. (US 20190209044 A1), hereto referred as Hess, and further in view of Xu et al. (US 20040226563 A1), hereto referred as Xu.
The combined Robitaille and Hess teaches claim 1 as described above.
Regarding claim 7, the combined Robitaille and Hess do not fully teach that the mask assembly comprises a particulate filter. Rather, the modified Robitaille teaches a breathing system with a mask and tubing, and optionally includes a filter at a fresh air intake location (Robitaille, ¶[0069]). However, the modified Robitaille does not disclose that the filter is integrated within the mask assembly itself; rather, the filter is located in the intake path and is not explicitly a part of the structural components of the mask. Xu, who investigates respiratory masks, teaches a particulate filter that is integrated into the mask assembly. Specifically, Xu describes a filter housing 118 with a filter medium 120 that includes a particulate filter 120b, as part of facepiece 102 of the mask (Xu, Fig. 2; ¶[0066]–[0067]). This demonstrating that the filter is part of the mask assembly. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Robitaille and Hess in view of Xu to include a particulate filter integrated into the mask assembly. This combination would have been possible and logical because Robitaille already teaches the use of a filter in the fresh air intake path (Robitaille, ¶[0069]), indicating recognition of the importance of filtration in the breathing system. Xu teaches relocating that filter structure directly into the mask body. A person of ordinary skill in the art would have found it obvious to adapt Robitaille’s optional filter configuration based on Xu’s teachings by repositioning the filter into the mask assembly, providing a direct and known improvement using familiar components and techniques. The benefit of the combination would be to enhance filtration at the point of interface between the user and the system, improving user protection and simplifying design by consolidating components into the mask assembly.
Regarding claim 8, the combined Robitaille and Hess does not teach that the mask assembly comprises a nasal seal. Rather, the modified Robitaille discloses a mask assembly (mask 2) that interfaces with the user for inhalation and exhalation (Robitaille, ¶[0049]; Fig. 1). However, the modified Robitaille does not explicitly teach or depict a nasal seal within the mask structure. While the mask covers the nose region, it does not describe a sealing structure dedicated to isolating nasal airflow. Xu teaches a mask design with an internal separation piece (106/204) that divides the internal volume into distinct nose and mouth chambers, and specifically describes conforming contact with the user’s face to minimize air exchange between chambers (Xu, Fig. 2; Abstract). Xu further explains that the subject inhales with the nose and exhales with the mouth (Xu, ¶[0059]), making clear that the nasal region is structurally and functionally sealed off from the oral region. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Robitaille in view of Xu to include a nasal seal within the mask assembly. This combination would have been possible and logical because Robitaille already includes a mask that interfaces with the nose, and Xu teaches a functional sealing structure (separation piece 106) that ensures nasal inhalation by structurally separating and isolating nasal airflow. Integrating such a feature into Robitaille’s mask would have required only minor structural adaptation using known mask sealing techniques. The benefit of the combination would be to ensure unidirectional nasal airflow, improve respiratory isolation, and enhance effectiveness of respiratory training or filtration.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over by Robitaille et al. (US 20170312464 A1), hereto referred as Robitaille, and further in view of Xu et al. (US 20040226563 A1), hereto referred as Xu.
Regarding claim 10, Robitaille teaches that a breath training system, comprises: a breathwork apparatus (Robitaille, ¶[0063]: "The apparatus may also be used as a breathing exerciser for COPD and degenerative muscular disease patients to facilitate bronchial hygiene and to prevent atelectasis", demonstrating a breathwork apparatus for training purposes); and a mask assembly (Robitaille, Fig. 1; ¶[0049]: "Referring to FIGS. 1, 2, and 26, a breathing assistance apparatus includes a patient interface, shown as a mask 2", demonstrating a mask assembly used as the user interface through which inhalation and exhalation occur), wherein the breathwork apparatus has an exhalation side (Robitaille, ¶[0145]: "a breathing assistance apparatus includes a housing 400 having an exhalation chamber 402 and an inhalation chamber 404", ¶[0051]:“The one-way exhalation valve 20 communicates with an expiratory flow path”, and Figs. 1, 5A: showing an exhalation side corresponding to exhalation path/tubing and the exhalation chamber), an inhalation side (Robitaille, ¶[0145]: "a breathing assistance apparatus includes a housing 400 having an exhalation chamber 402 and an inhalation chamber 404", ¶[0051]: “The one-way inhalation valve 21 communicates with an inspiratory flow path 22”, and Figs. 1, 5A: showing an exhalation side corresponding to inhalation path/tubing and the inhalation chamber), and a transfer case between the inhalation side and the exhalation side (Robitaille, ¶[0051]: “The one-way exhalation valve 20 communicates with an expiratory flow path 23... The one-way inhalation valve 21 communicates with an inspiratory flow path 22”, showing that the user’s breath is routed through dedicated flow paths to either the inhalation or exhalation side depending on breath direction. These flow paths both connect to a shared mask and valve region, which functions as the system’s central routing interface; Fig. 5B: showing ports 420 and 438 on the respective exhalation and inhalation chambers, each connected to tubing that physically spans between the two chambers and converges toward the central interface. This physical configuration forms a structural bridge between the chambers. Taken together, the tubing network, valve junctions, and shared interface region serve as a transfer case—a structure functionally and spatially positioned between the inhalation and exhalation sides to direct airflow appropriately during the breathing cycle), and wherein the mask assembly is selectively attachable to the breathwork apparatus (Robitaille, ¶[0049]: "The exhalation valve 20 may be removably connected to an adaptor that is suited for connection to an apparatus used to clean and disinfect the expiratory flow path tubing", teaching that components of the mask can be selectively connected or disconnected. While Robitaille does not explicitly state that the entire mask is attachable or detachable, this removability combined with the depiction of inlet and outlet ports on the breathwork apparatus in Fig. 21 supports the structural expectation that the mask assembly is selectively attachable).
Also regarding claim 10, Robitaille does not teach that the mask assembly includes a nasal seal, such that when the mask assembly is detached from the breathwork apparatus in a detached mode, an operator of the mask assembly cannot exhale through the operator's nose. Rather, Robitaille discloses a mask assembly (mask 2) that interfaces with the user for inhalation and exhalation (Robitaille, ¶[0049]; Fig. 1). However, Robitaille does not explicitly teach or depict a nasal seal within the mask structure. While the mask covers the nose region, it does not describe a sealing structure dedicated to isolating nasal airflow.
Xu teaches a mask design that includes a separation member (106/204) made of impermeable material that divides the mask into distinct nasal and oral chambers, thereby minimizing gas communication between them "such that [the] inhalation air stream and exhalation air stream can be separated" (Xu, Abstract; Figs. 1–2, 10; ¶[0064]). Xu further explains that the subject inhales through the nose and exhales through the mouth (Xu, ¶[0059]), demonstrating that the separation member directs inhalation and exhalation into separate chambers. In addition, Xu teaches that the inhalation device includes a one-way valve for preventing exhaled air from passing therethrough (Xu, claim 6), so that exhaled air cannot flow back through the inhalation path. Xu further discloses that an additional one-way valve may optionally be provided between the nose chamber and the mouth chamber "for permitting the exhaled air to pass therethrough from the nose chamber to the mouth chamber and then to pass through [the] exhalation device" (Xu, ¶[0077]: "a one-way valve (not shown) can be provided in between the nose chamber and the mouth chamber..."). Because this valve is expressly optional, a person of ordinary skill in the art would understand that in the default configuration (without the optional nose-to-mouth one-way valve) the nose chamber is not connected to the exhalation device and has no disclosed exhalation route. In that configuration, the impermeable separation member, together with the one-way inhalation valve that prevents backflow, effectively seals the nasal chamber from exhalation, since exhaled air cannot pass out through either the inhalation device or any alternative nasal outlet.
Because this separation structure and valve arrangement are part of the mask itself, and not dependent on external connections or devices, the nasal seal remains effective even when the mask is detached from a larger system. When combined with Robitaille, this teaches that the mask assembly includes a nasal seal structure that prevents nasal exhalation regardless of whether the mask is attached to the breathwork apparatus. Thus, the combination supports that when the mask assembly is detached, an operator cannot exhale through the nose due to the internal sealing geometry.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Robitaille in view of Xu to include a nasal seal that continues to prevent nasal exhalation even when the mask is used independently of the breathwork apparatus. This combination would have been possible and logical because Robitaille already includes a mask that interfaces with the user's nose, and Xu teaches an internal sealing structure that is self-contained and not dependent on external components. Integrating this into Robitaille's system would have required only minor structural adaptation using known techniques. The benefit of the combination would be to maintain consistent unidirectional airflow, prevent nasal exhalation in both connected and disconnected states, and support more effective respiratory training and hygiene.
Regarding claim 11, the combined Robitaille and Xu does not explicitly teach that the mask assembly comprises an adapter, the adapter operable to connect the mask assembly to the breathwork apparatus, and the adaptor further operable to connect the mask assembly to a device that conditions air. Rather, the modified Robitaille discloses a mask assembly that includes adaptors to connect to multiple external systems. In ¶[0049], the exhalation valve is described as removably connected to an adaptor suited for connection to a cleaning or diagnostic apparatus, and another adaptor is described for receiving a pressure monitoring device. Additionally, the modified Robitaille teaches that an external source (51) can deliver conditioned air or oxygen into the flow path via a connector as well as filter the air (¶[0062], [0069]), and that this same connector may also receive a monitoring device. Robitaille further states that Although Robitaille does not explicitly state that the same adaptor is used for both connections, the disclosure of removable, multifunctional connectors in the mask assembly and flow path supports that one of ordinary skill in the art would understand these connectors as operable or adaptable for multiple functions. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Robitaille and Xu to use a single adaptor on the mask assembly that selectively connects either to the breathwork apparatus or to an external device that conditions air. This combination would have been possible and logical because Robitaille already supports multiple connections through adaptors and explicitly describes multifunctional connector points. It would involve a simple reconfiguration using existing connection types. The benefit of the combination would be to simplify the system architecture, reduce the number of unique interface components, and allow flexible use of the same mask assembly in both therapy and conditioning modes.
Regarding claim 12, the combined Robitaille and Xu does not explicitly teach that the device that conditions air is operably connected to the mask assembly in the detached mode. Rather, as discussed above for claim 11, the combined art teaches a breath training system in which a device that conditions air is in communication with the inhalation side and is connectable through adapter or connector structures associated with the mask assembly. Robitaille discloses multiple conditioning means including filtration (Robitaille, ¶[0062], ¶[0049]; ¶[0051]; Fig. 1, ¶[0069]), thereby filtering incoming ambient air before it enters the breathing circuit. As explained for claim 11, Robitaille also describes removable adapters/connectors on the mask assembly and flow path that can be used to connect to cleaning, diagnostic, or monitoring devices (Robitaille, ¶[0049]; ¶[0062]), indicating that the same interface regions are suitable for multiple external devices, including devices that condition air. However, it does not explicitly show that these devices are operably connected to the mask while it is in the detached mode.
Xu teaches a mask assembly having an inner face piece divided into nose and mouth chambers by a separation member, with inhalation occurring through the nose chamber and exhalation through the mouth chamber (Xu, ¶[0059]; ¶[0064]; ¶[0119]–[0121]). Xu further discloses inhalation and exhalation devices mounted directly on the mask, including filter and one-way valve structures that draw air from an exterior gas space into the interior gas space (Xu, ¶[0065]–[0067]; ¶[0083]–[0087]). This filtration is integral to the mask itself and would continue to operate in the same manner when the mask is detached from any external apparatus, so that the mask assembly functions as a standalone breathing interface in a detached mode.
A person of ordinary skill in the art would have understood that Robitaille’s conditioning functions (filtering fresh air at member 104 and supplying conditioned gas from source 51 through a connector) could be implemented at the mask interface using known mask-mounted inhalation devices as taught by Xu. Xu demonstrates that filters and one-way valves can be mounted directly on the mask to condition air drawn from the exterior gas space (Xu, ¶[0066]–[0067]; ¶[0083]–[0087]), and that these structures remain part of the mask when it is used in a detached mode. Under the broadest reasonable interpretation, a device that conditions air implemented as a mask-mounted filter and valve module that remains attached to the mask assembly during detached use is operably connected to the mask assembly in the detached mode because it remains in flow communication with the mask and continues to condition the air that the user inhales through the mask.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Robitaille and Xu in view of Xu so that the device that conditions air is operably connected to the mask assembly in the detached mode. This combination would have been possible and logical because Robitaille already contemplates conditioning the inhaled air by filtering incoming ambient air and supplying conditioned gas from an external source into the inhalation path through connectors associated with the mask and flow path (Robitaille, ¶[0062]; ¶[0069]), and Xu teaches locating inhalation conditioning structures, including filters and one-way valves, directly onto the mask so that they remain part of the mask (Xu, ¶[0066]–[0067]; ¶[0083]–[0087]). A person of ordinary skill in the art would have recognized that implementing Robitaille’s conditioning device as a Xu-type mask-mounted inhalation module at the mask adapter is a routine relocation of a known function to a known interface that does not change the principle of operation of either reference. The benefit of this configuration would be to allow the same mask assembly to provide conditioned, filtered air to the user both when attached to, and when detached from, the breath training apparatus, simplifying the system and improving flexibility of use without requiring different masks or conditioning components for different modes of operation.
Claims 13-14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over by Robitaille et al. (US 20170312464 A1), hereto referred as Robitaille hereto referred as Hess, and further in view of Xu et al. (US 20040226563 A1), hereto referred as Xu, and further in view of Hess et al. (US 20190209044 A1).
The combined Robitaille and Xu teaches claim 10 as described above.
Regarding claim 13, the combined Robitaille and Hess does not fully teach that the mask assembly includes a sensor assembly, wherein the sensor assembly comprises at least one sensor selected from the group consisting of pressure sensors, fluid velocity sensors, oxygen sensors, carbon dioxide sensors, carbon monoxide sensors, moisture content sensors, and spectrometers. Rather, the modified Robitaille discloses that a pressure sensor can be connected to the inhalation flow path via a connector (Robitaille, ¶[0062]), indicating support for pressure monitoring within the breathing system. However, it does not teach a sensor assembly integrated within the mask itself, nor does it disclose a broader range of sensor types. Hess teaches a system in which a sensor assembly, including pressure, flow, temperature, and gas composition sensors (Hess, ¶[0093], ¶[0097], ¶[0098], ¶[0103]), is connected through the mask adapter and interface region. Figures 2-3 and ¶[0093] show the sensor adapter mounted directly to the mask with pressure sensor tubes, establishing that the sensor assembly is part of the mask assembly. The sensor suite detects a range of parameters including pressure, velocity, carbon dioxide, temperature, and suggests more options are possible. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Robitaille in view of Hess to include a sensor assembly integrated into the mask, comprising pressure sensors, fluid velocity sensors, and carbon dioxide sensors. This combination would have been possible and logical because Robitaille already supports sensor integration via external connectors, and Hess demonstrates the feasibility and utility of incorporating multiple respiratory sensors directly on the mask assembly. Combining the two would involve applying known sensor technologies in an expected location. The benefit of the combination would be to enable real-time monitoring of respiratory parameters directly at the interface point, improving diagnostic capabilities and therapy responsiveness.
Regarding claim 14, the combined Robitaille, Xu, and Hess do not teach that the sensor assembly transmits data from at least one sensor in the sensor array to a mobile application. Rather, the combined Robitaille, Xu, and Hess teaches the integration of pressure sensors into the breathing circuit via a connector, as shown in claims 10–11 and 13 above, but does not explicitly disclose the transmission of sensor data to a mobile application. Hess, however, teaches that sensor data, including pressure, temperature, and flow, is processed by a controller and used to generate real-time outputs in the form of an interactive video game (Hess, ¶[0103]). Hess further discloses that the patient interface may be a mobile phone, tablet, or laptop (Hess, ¶[0190]). When this video game is played on a mobile phone, the video game constitutes a mobile application. Thus, Hess teaches that data from at least one sensor is transmitted to and used by a mobile application running on a mobile device. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Robitaille, Xu, and Hess in view of Hess to transmit data from the sensor assembly in the mask to a mobile application. This combination would have been possible and logical because Hess already demonstrates the use of sensor data for controlling an interactive application on a mobile device. Using the same system to send respiratory data to a mobile app for processing and feedback would involve only routine adaptation of existing interface technologies. The benefit of the combination would be to enable real-time, mobile monitoring and engagement with the user through applications like training games or therapeutic tools, improving usability, feedback, and accessibility in home or remote health environments.
Regarding claim 16, the combined Robitaille and Xu does not teach that a belt device measuring the expansion of an abdomen or rib cage of an operator during operation of the system. Rather, the modified Robitaille does not teach the use of a belt device for measuring expansion of the abdomen or rib cage during respiratory activity. Hess, however, explicitly states that breathing can be detected using abdomen belts (¶[0185]), clearly identifying the use of such belts as part of the respiratory monitoring system. The belt detects physical expansion and contraction associated with breathing, matching the claimed function. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Robitaille and Xu in view of Hess to incorporate a belt device for detecting respiratory movement. This combination would have been possible and logical because Hess demonstrates the feasibility and utility of using a belt to detect respiration, which complements the inhalation and exhalation monitoring described in Robitaille. The belt provides additional non-invasive data, enriching the system’s capability. The benefit of the combination would be to enhance the overall accuracy of respiratory monitoring by capturing thoracic or abdominal expansion, allowing more precise detection of breathing cycles and patterns during operation of the system.
Claims 17-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over by Robitaille et al. (US 20170312464 A1), hereto referred as Robitaille, and further in view of Fleury (US 4096855 A), hereto referred as Fleury, and further in view of Xu et al. (US 20040226563 A1), hereto referred as Xu.
Regarding claim 17, Robitaille teaches a method for operating a breath training system (Robitaille, ¶[0063]: "The apparatus may also be used as a breathing exerciser for COPD and degenerative muscular disease patients to facilitate bronchial hygiene and to prevent atelectasis", demonstrating a breathwork apparatus for training purposes), the method comprises providing a breathwork apparatus having an exhalation side (Robitaille, ¶[0145]: "a breathing assistance apparatus includes a housing 400 having an exhalation chamber 402 and an inhalation chamber 404", ¶[0051]:“The one-way exhalation valve 20 communicates with an expiratory flow path”, and Figs. 1, 5A: showing an exhalation side corresponding to exhalation path/tubing and the exhalation chamber), a transfer case (Robitaille, Fig. 1; ¶[0051]: “The one-way exhalation valve 20 communicates with an expiratory flow path 23... The one-way inhalation valve 21 communicates with an inspiratory flow path 22”, showing that the inhalation and exhalation sides are each connected to the central mask region through their respective flow paths and valves. This shared interface region, centered around the mask and adjoining valve structures, directs airflow from the user to both chambers and serves as a functional intermediary for respiratory flow), and an inhalation side (Robitaille, ¶[0145]: "a breathing assistance apparatus includes a housing 400 having an exhalation chamber 402 and an inhalation chamber 404", ¶[0051]: “The one-way inhalation valve 21 communicates with an inspiratory flow path 22”, and Figs. 1, 5A: showing an exhalation side corresponding to inhalation path/tubing and the inhalation chamber) generating fluid flow, by vacuum produced in lungs of an operator, through a hose inlet in the transfer case; (Robitaille, ¶[0051]: “The one-way inhalation valve 21 communicates with an inspiratory flow path 22... upon inhalation by the user” ¶[0059]: “During the inhalation sequence… a slight negative pressure may be realized”, showing that air is drawn into the system through a path due to negative pressure generated by lung vacuum); generating a negative pressure in the inhalation side through the transfer case, the negative pressure opening a check valve in the inhalation side; (Robitaille, ¶[0051]: "The one-way inhalation valve 21 communicates with an inspiratory flow path 22", teaching a check valve that opens due to negative pressure created by the user’s inhalation); and applying vacuum to a piston in the inhalation side (Robitaille, Fig. 5A; ¶[0145]: showing that the inhalation chamber 404 includes a movable piston or bellows component which is displaced by the air drawn in through vacuum inhalation).
The modified Robitaille does not teach a method of reading a scale to determine motion of the piston within the inhalation side. Rather, Robitaille teaches a system in which user-generated vacuum causes displacement of a bellows or piston within the inhalation chamber (Robitaille, Fig. 5A; ¶[0145]), and Fig. 11 charts inhalation chamber volume against pressure to characterize system performance. However, it does not disclose any visual scale, gauge, or measurement mechanism to determine piston position. Fleury teaches that a freely floating piston is vertically displaced by inhalation effort, and the position of the piston is visually read using graduation indicia aligned with the piston's top edge (Fleury, Fig. 1; col. 5, lines 1–15:). This provides a direct means to measure piston displacement and inspired volume. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Robitaille in view of Fleury to include a graduated scale for reading piston motion within the inhalation chamber. This combination would have been possible and logical because Robitaille already includes a piston actuated by lung vacuum, and Fleury demonstrates a simple and effective method for measuring piston displacement using graduations on the housing. The scale is an expected addition and uses known mechanical measurement techniques. The benefit of the combination would be to allow users to visually confirm and quantify inhalation volume and piston travel in real time, enhancing usability and therapeutic feedback. The system provides indirect performance data such as pressure and volume, but does not disclose any structure for determining piston motion via a readable scale.
Also regarding claim 17, the modified Robitaille does not teach that the mask assembly has a nasal seal such that the vacuum generated in the operator's lungs is transferred through the operator's nose. Rather, it discloses a breathing assistance mask that interfaces with the nose and mouth (¶[0049]; Fig. 1), but it does not include a nasal seal that ensures the vacuum is directed exclusively through the nose.
Xu teaches a mask design that includes a separation member (106/204) made of impermeable material that divides the mask into distinct nasal and oral chambers, thereby minimizing gas communication between them “such that [the] inhalation air stream and exhalation air stream can be separated” (Xu, Abstract; Figs. 1–2, 10; ¶[0064]). Xu further explains that the face mask “requires its wearer to inhale with the nose and exhale with the mouth” (Xu, ¶[0059]), demonstrating that the separation member directs inhalation airflow through the nasal chamber and exhalation airflow through the mouth chamber. In addition, Xu teaches that the inhalation device includes a one-way valve for preventing exhaled air from passing therethrough (Xu, claim 6), so that exhaled air cannot flow back through the inhalation path. Xu further discloses that an additional one-way valve may optionally be provided between the nose chamber and the mouth chamber “for permitting the exhaled air to pass therethrough from the nose chamber to the mouth chamber and then to pass through [the] exhalation device” (Xu, ¶[0077]). Because this valve is expressly optional, a person of ordinary skill in the art would understand that in the default configuration (without the optional nose-to-mouth one-way valve) the nose chamber is not connected to the exhalation device and has no disclosed exhalation route. In that configuration, the impermeable separation member, together with the one-way inhalation valve that prevents backflow, ensures that the vacuum generated in the operator’s lungs during inhalation is applied through the nasal chamber and is not relieved through an alternate nasal exhalation outlet. Under the broadest reasonable interpretation, such a configuration corresponds to a mask assembly having a nasal seal such that vacuum generated in the operator’s lungs is transferred through the operator’s nose.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Robitaille and Fleury in view of Xu to perform the claimed method with a mask assembly having a nasal seal such that vacuum generated in the operator’s lungs is transferred through the operator’s nose. This combination would have been possible and logical because the modified Robitaille already provides a nasal-interfacing mask and a monitored breathing system and Xu provides a well-known structural modification (an internal separation member) that enforces nasal inhalation by routing the inhalation vacuum through the nose. Integrating Xu’s nasal seal structure into Robitaille’s system would require only minor structural adaptation using known mask design techniques and would not change the principle of operation of the underlying breath training system. The benefit of the combination would be to enforce consistent, isolated nasal inhalation while the user is trained to achieve specific volume and/or pressure thresholds, thereby improving training specificity and potentially enhancing therapeutic control and filtering through the nasal pathway.
Regarding claim 18, the modified Robitaille teaches that the vacuum produced in the lungs of the operator is transferred through a mask assembly (Robitaille, Fig. 1; ¶[0049]: "a breathing assistance apparatus includes a patient interface, shown as a mask 2"; ¶[0051]: "The one-way inhalation valve 21 communicates with an inspiratory flow path 22... upon inhalation by the user", demonstrating that vacuum created by the user is transferred through the mask and into the system).
Regarding claim 20, the combined Robitaille, Fleury, and Xu do not explicitly teach that the mask assembly is configured to allow the operator to exhale through the operator’s mouth. Rather, it teaches a mask used for both inhalation and exhalation (as shown in claim 17 above) but does not explicitly disclose a configuration that allows exhalation through the mouth.
Xu teaches a mask design including a separation member (106/204) made of impermeable material that divides the mask into distinct nasal and oral chambers “such that [the] inhalation air stream and exhalation air stream can be separated” (Xu, Abstract; Figs. 1–2, 10; ¶[0064]). Xu further explains that the face mask “requires its wearer to inhale with the nose and exhale with the mouth” (Xu, ¶[0059]), and in the method description states that inhalation is performed through the nose while “the exhaled air is directed out of the interior gas space through [the] mouth portion” (Xu, ¶[0119]–[0121]). Under the broadest reasonable interpretation, these teachings correspond to a mask assembly configured to allow the operator to exhale through the mouth.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Robitaille, Fleury, and Xu in view of Xu to include a mask configuration that permits exhalation through the mouth. This combination would have been possible and logical because the modified Robitaille already employs a mask interfacing with both nose and mouth in a monitored breath-training apparatus, and Xu provides a well-known structural arrangement that channels exhaled air through the mouth chamber while isolating nasal inhalation with the separation member and one-way valves. Incorporating Xu’s exhalation-through-mouth configuration into the modified Robitaille’s system would require only minor adaptation of the mask geometry, without changing t