DETAILED ACTION
This Office Action is in response to the filing of a Request for Continued Examination (RCE) and amendments therein on 12/22/2025. As per the amendments, claims 21, 37, and 42 have been amended, and no claims have been added or cancelled. Thus, claims 21-43 are pending in the application.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/22/2025 has been entered.
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 21-27, 31, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Bowman et al. (US Pub. 2012/0167879) in view of Gradon et al. (US Pat. 6,951,218).
Regarding claim 21, Bowman discloses a patient interface comprising a mask frame (mask shell 410 and adapter 420 in Fig. 8, including the curved portion of mask shell 410 leading up to inlet 336), an elbow connected to the mask frame (see Fig. 8 where proximal hose connector 475 forms a bend as it connects into delivery tube 318, forming an elbow that is at least indirectly connected to the mask shell 410 and adapter 420, and is fluidically connected to them), the mask frame connected to a patient contacting portion (seal 480 in Fig. 8), the patient contacting portion being configured to be positioned between the mask frame and a face of a patient (see Figs. 3 and 8 where seal 480 touches the face of the patient, such that the seal is between the face and shell 410/ adapter 420), the mask frame comprising an inlet (see Fig. 8 delivery tube 318 connects to the mask shell 410 and acts as an inlet point substantially around inlet 336 and around HME 390), the inlet being configured to connect to a source of gases (see Figs. 3 and 8 where device 300 has a blower 610 (Figs. 4 and 11) within it, leading to delivery tube 318 and the inlet of the mask shell 410), and a heat and moisture exchanger integrated into the patient interface between the elbow and the patient contacting portion such that the head and moisture exchanger is downstream of the elbow when the gas flow from the source of gases to the patient interface (see Fig. 8 heat and moisture exchange element (HME) 390 which is located downstream the elbow of proximal hose connector 420 and between it and the mask shell 410/ adapter 420), and wherein the heat and moisture exchanger opens up into an interior space formed by the mask frame (see Figs. 3 and 8 where the HME 390 is located next to and in fluid connection with the inlet of mask shell 410 around inlet 336, such that the downstream side of the HME 390 opens into the space formed by mask shell 410 immediately downstream the HME), the heat and moisture exchanger being configured to humidify a gas passing into the patient interface (see [0121]).
Bowman lacks a detailed description of wherein an elbow is directly connected to the mask frame, the elbow configured to connect to a source of gas, with the heat and moisture exchanger being downstream of the elbow when gas flows from the source of gases to the patient interface. It is noted the Bowman does teach substantially similar embodiments, such as in Fig. 16, where the device 300 containing the blower is not attached to the head, but otherwise still has mask 316 as described in Figs. 3 and 8. Hence, it is understood that the above rejections directed to the Bowman reference can apply to Fig. 16, where Figs. 3 and 8 are used to show detail of the mask 316, but otherwise is substantially the same.
However, Gradon teaches a similar patient interface and connecting conduit portions, where an elbow is directly connected to the patient interface (see Figs. 3 and 12 where L-shaped elbow 45 connects to the gases outlet 42 of a patient interface 2; see also Col. 7 line 61 to Col. 8 line 3), the elbow configured to connect to a source of gas (see Fig. 3 where breathing conduit 41 is a gases inlet leading to elbow 45, and connects to a source of gas (blower 15 in Fig. 1)), with the heat and moisture exchanger being downstream of the elbow when gas flows from the source of gases to the patient interface (see Fig. 17 and Col. 9 lines 24-33 where space 516 of the patient interface can contain an HME material, and is positioned downstream of and connects to the elbow connector).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connection to the mask and HME of Bowman to have an elbow upstream of the HME material and the HME material incorporated into the patient interface as taught by Gradon, as it would provide a pivoting connection to allow free motion of the patient’s head without disconnection of the conduits, while still preventing drying of the passageways (Gradon; see Col. 9 lines 24-33).
Regarding claim 22, the modified Bowman device has wherein the heat and moisture exchanger is configured to be positioned within an airflow path from the elbow to the patient (Bowman; see Fig. 8 where the HME 390 is in the airflow path, and downstream and in the same airflow path as the elbow as taught by Gradon (see Figs. 3 and 12 and Col. 9 lines 24-33)).
Regarding claim 23, the modified Bowman device has wherein the heat and moisture exchanger is located adjacent to the elbow (Bowman; see Fig. 8 where the HME 390 is at the inlet section of the mask, and Gradon see Fig. 3 where the elbow joint 45 is adjacent to the patient interface of the modified Bowman device).
Regarding claim 24, the modified Bowman device has wherein the heat and moisture exchanger is integrated into an inlet of the mask frame (Gradon; see Fig. 17 and Col. 9 lines 24-33 where the modified interior space of the Bowman patient interface has the HME material, located at the inlet portion of the modified mask).
Regarding claim 25, the modified Bowman device has wherein the heat and moisture exchanger is located between the elbow and the mask frame (Gradon; see Fig. 17 and Col. 9 lines 24-33 where the modified interior space of the Bowman patient interface has the HME material, which is between the elbow which it is downstream of, and the mask).
Regarding claim 26, the modified Bowman device has wherein an inlet of the mask frame comprises an inlet passage (Bowman; see Fig. 8 where the inlet 336 forms an inlet passage for the airflow to flow through) and the elbow comprises an elbow passage (Gradon; see Figs. 3 and 12 where elbow joint 45 has an interior passage), the heat and moisture exchanger being positioned between the elbow and the inlet (Bowman; see Fig. 8 where the HME 390 is between an inlet 336, and the modified elbow as taught by Gradon in Figs. 3 and 12), and the inlet passage and the elbow passage being in fluid communication through the heat and moisture exchanger (Bowman; see Fig. 8 where the HME 390 is in fluid communication with an inlet 336, and the modified elbow as taught by Gradon in Figs. 3 and 12).
Regarding claim 27, the modified Bowman device has wherein the heat and moisture exchanger comprises a HME material (Bowman; see Fig. 8 where HME 390 is made of some HME material; see also [0121]).
Regarding claim 31, the modified Bowman device has wherein a chamber is defined between an inlet of the mask frame and an interior of the patient interface, the HME material being disposed in the chamber (Bowman; see Fig. 8 where shell 410 has an interior chamber that extends to the connection with delivery tube 318 (as modified to be and elbow as taught by Gradon, the connection point being an inlet of the mask frame), such that part of the interior chamber is between the patient interface of shell 410 and elbow, with the HME 390 disposed within said chamber).
Regarding claim 33, the modified Bowman device has wherein an exhaled gas passes through the HME material to pick up moisture and an inhaled gas passes through the heat and moisture exchanger to be humidified (Bowman; see [0121]).
Claims 28 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Bowman in view of Gradon as applied to claims 21 and 27 above, respectively, and further in view of Bowman et al. (US Pub. 2012/0097156; hereinafter Bowman ‘156).
Regarding claim 28, the modified Bowman device has the HME material.
The modified Bowman device lacks a detailed description of wherein the HME material comprises a metal mesh or a metal covered mesh, a metal of the metal mesh or the metal covered mesh comprising copper or aluminum.
However, Bowman ‘156 teaches a similar patient interface device, where an HME material comprises a metal mesh, a metal of the metal mesh comprising aluminum (see [0076] where an HME element is made of a mesh of aluminum).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the HME of the modified Bowman device to be an aluminum mesh as taught by Bowman ‘156, as it would be a simple substitution of one type of material for an HME for another, to yield the predictable result of still be able to absorb and exchange heat and moisture from the inhaled/ exhaled air.
Regarding claim 34, the modified Bowman device has the heat and moisture exchanger.
The modified Bowman device lacks a detailed description of wherein the heat and moisture exchanger comprises a disc shape.
However, Bowman ‘156 teaches a similar patient interface device, where an HME comprises a disc shape (see [0076] and Fig. 4C where HME 70 is formed from disc-like sheets, forming a disc shaped HME).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the HME of the modified Bowman device to be disc-shaped as taught by Bowman ‘156, as it would be a simple matter of design choice for one of ordinary skill in the art to choose different shaped HMEs depending on the shape of the housing around them, as they would still function as HMEs and would better fit within a cylindrical lumen.
Claims 29-30 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Bowman in view of Gradon as applied to claim 27 above, and further in view of Walstrom (US Pub. 2006/0219243).
Regarding claim 29, the modified Bowman device has the HME material.
The modified Bowman device lacks a detailed description of wherein the HME material comprises a polymer.
However, Walstrom teaches a similar HME system, where HMEs are commonly made from a polypropylene polymer (see the last 8 lines of [0005]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the HME of the modified Bowman device to be a polypropylene polymer as taught by Walstrom, as it would be a simple substitution of one type of HME material for another, to yield the predictable result of still acting as an HME.
Regarding claim 30, the modified Bowman device has the HME material.
The modified Bowman device lacks a detailed description of wherein the HME material comprises polypropylene or nylon.
However, Walstrom teaches a similar HME system, where HMEs are commonly made from a polypropylene polymer (see the last 8 lines of [0005]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the HME of the modified Bowman device to be a polypropylene polymer as taught by Walstrom, as it would be a simple substitution of one type of HME material for another, to yield the predictable result of still acting as an HME.
Regarding claim 32, the modified Bowman device has the HME exposed to an air flow path.
The modified Bowman device lacks a detailed description of an HME adjuster, the HME adjuster being configured to adjust a surface area of the HME material exposed to an air flow path.
However, Walstrom teaches a similar HME system, with an HME adjuster, the HME adjuster being configured to adjust a surface area of the HME material exposed to an air flow path (see Figs. 3A-3B and [0088] where vane like valve 124 is able to be adjusted so as to selectively open/ close access to the HME passage 34. It is noted that the claim does not require a changing of the surface area of the HME, but rather how much of the surface area is exposed to an air flow path (emphasis added)).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the HME chamber of the modified Bowman device to include a vane like valve for bypassing the HME as taught by Walstrom, as it would allow for selective control over whether to bypass the HME or not, to allow for enhanced usability by allowing a user/ practitioner to choose when to engage the HME.
Claims 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Bowman in view of Gradon as applied to claim 21 above, and further in view of Fukunaga et al. (US Pub. 2002/0017302).
Regarding claim 35, the modified Bowman device has the heat and moisture exchanger.
The modified Bowman device lacks a detailed description of wherein the heat and moisture exchanger is modular.
However, Fukunaga teaches a similar respiratory system, where different parts of a respiratory device can be made with fittings in order to be retrofitted into the system, thus forming a modular addition (see [0098] and Figs. 14-16 where a filter 190 having an HME can be integrated into a connector fitting 240, and further see [0103] where the fittings are containing the HME are used to retrofit to devices that need them).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the HME system of the modified Bowman device to include a fitting for modular connection as taught by Fukunaga, as it would allow for the replacement and retrofitting of devices to include an HME, ensuring easy connection to a wide range of respiratory masks.
Regarding claim 36, the modified Bowman device has the heat and moisture exchanger.
The modified Bowman device lacks a detailed description of wherein the heat and moisture exchanger is retrofittable into the patient interface.
However, Fukunaga teaches a similar respiratory system, where different parts of a respiratory device can be made with fittings in order to be retrofitted into the system, thus forming a modular addition (see [0098] and Figs. 14-16 where a filter 190 having an HME can be integrated into a connector fitting 240, and further see [0103] where the fittings are containing the HME are used to retrofit to devices that need them).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the HME system of the modified Bowman device to include a fitting for modular connection as taught by Fukunaga, as it would allow for the replacement and retrofitting of devices to include an HME, ensuring easy connection to a wide range of respiratory masks.
Claims 37 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Bowman in view of Gradon in view of Fukunaga.
Regarding claim 37, Bowman discloses a heat and moisture exchanger configured to humidify air (see Fig. 8 HME 390 and [0121]) supplied to a patient through a patient interface (see Fig. 8 mask 316), the heat and moisture exchanger comprising an inlet configured to connect to a mask frame (see Fig. 8 delivery tube 318 connects to the mask shell 410 (which includes the curved portion of mask shell 410 leading up to inlet 336) and has an inlet point substantially before HME 390 that connect to hose connector 476 of the mask frame assembly), that couples to a delivery tube that is connectable to a source of gas (see Figs. 3 and 8 where device 300 has a blower 610 (Figs. 4 and 11) within it, leading to proximal hose connector 475) such that the inlet of the heat and moisture exchanger is downstream of the conduit when connected when gas flows from the source of gases to the patient interface (see Fig. 8 heat and moisture exchange element (HME) 390 which is located downstream the tube 318), the heat and moisture exchanger also comprising an outlet (see inlet 336 in Fig. 8, being the outlet of HME 390), the outlet being configured to deliver gas to a patient (see Fig. 8 where gas flows through inlet 336 to the patient), a gas flow path being defined between the inlet and the outlet (see Fig. 8 the flow of gas from delivery tube 318, through HME 390, and out inlet 336), an HME material positioned along the gas flow path (see Fig. 8 the material of HME 390), the HME material being configured to exchange moisture or humidity between a patient exhaled gases flow and an inlet air flow (see [0121]) and wherein the heat and moisture exchanger opens up into an interior space formed by the patient interface (see Figs. 3 and 8 where the HME 390 is located next to and in fluid connection with the inlet of mask shell 410 around inlet 336, such that the downstream side of the HME 390 opens into the space formed by mask shell 410 of mask 316 immediately downstream the HME).
Bowman lacks a detailed description of the mask frame being coupled to an elbow, such that the heat and moisture exchanger is downstream of the mask frame and the elbow. It is noted the Bowman does teach substantially similar embodiments, such as in Fig. 16, where the device 300 containing the blower is not attached to the head, but otherwise still has mask 316 as described in Figs. 3 and 8. Hence, it is understood that the above rejections directed to the Bowman reference can apply to Fig. 16, where Figs. 3 and 8 are used to show detail of the mask 316, but otherwise is substantially the same.
However, Gradon teaches a similar patient interface and connecting conduit portions, where an elbow is directly connected to the patient interface (see Figs. 3 and 12 where L-shaped elbow 45 connects to the gases outlet 42 of a patient interface 2; see also Col. 7 line 61 to Col. 8 line 3), the elbow configured to connect to a source of gas (see Fig. 3 where breathing conduit 41 is a gases inlet leading to elbow 45, and connects to a source of gas (blower 15 in Fig. 1)), with the heat and moisture exchanger being downstream of the elbow and the outer frame of the patient interface when gas flows from the source of gases to the patient interface (see Fig. 17 and Col. 9 lines 24-33 where space 516 of the patient interface can contain an HME material, and is positioned downstream of and connects to the elbow connector, while also being downstream of the outer framework of outer flap 508).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connection to the mask and HME of Bowman to have an elbow and mask frame portion upstream of the HME material and the HME material incorporated into the patient interface as taught by Gradon, as it would provide a pivoting connection to allow free motion of the patient’s head without disconnection of the conduits, while still preventing drying of the passageways (Gradon; see Col. 9 lines 24-33).
The modified Bowman device lacks a detailed description of the heat and moisture exchanger capable of being retrofit to the patient interface.
However, Fukunaga teaches a similar respiratory system, where different parts of a respiratory device can be made with fittings in order to be retrofitted into the system, thus forming a modular addition (see [0098] and Figs. 14-16 where a filter 190 having an HME can be integrated into a connector fitting 240, and further see [0103] where the fittings are containing the HME are used to retrofit to devices that need them).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the HME system of Bowman to include a fitting for modular connection as taught by Fukunaga, as it would allow for the replacement and retrofitting of devices to include an HME, ensuring easy connection to a wide range of respiratory masks.
Regarding claim 41, the modified Bowman device has a housing configured to house the heat and moisture exchanger between a mask shell and a mask frame (Bowman; see Figs. 8-9 where the HME as taught by Gradon is located within the patient interface, and thus within the outer housing of mask shell 410 and mask frame 412).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Bowman in view Gradon in view of Fukunaga as applied to claim 37 above, and further in view of Walstrom.
Regarding claim 38, the modified Bowman device has the HME in the flow path.
The modified Bowman device lacks a detailed description of an adjustable aperture, the adjustable aperture being configured to alter a volume of at least one of the patient exhaled gases flow and the inlet air flow over surfaces of the HME material to adjust an exchange of moisture or humidity between the patient exhaled gases flow and the inlet air flow.
However, Walstrom teaches a similar HME system, with an adjustable aperture, the adjustable aperture being configured to alter a volume of the inlet air flow over surfaces of the HME material to adjust an exchange of moisture or humidity between the patient exhaled gases flow and the inlet air flow (see Figs. 3A-3B and [0088] where vane like valve 124 is able to be adjusted so as to selectively open/ close access to the HME passage 34, the section of HME inlet 108 being blocked by valve 124 being an aperture that is being adjusted, and the selective opening/closing of the valve controlling the flow of air over the HME, and thus the amount of moisture transferred via the HME).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the HME chamber of the modified Bowman device to include a vane like valve for bypassing the HME as taught by Walstrom, as it would allow for selective control over whether to bypass the HME or not, to allow for enhanced usability by allowing a user/ practitioner to choose when to engage the HME.
Claims 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Bowman in view of Gradon in view of Fukunaga as applied to claim 37 above, and further in view of Bowman ‘156.
Regarding claim 39, the modified Bowman device has the HME material.
The modified Bowman device lacks a detailed description of wherein the HME material is a sheet material.
However, Bowman ‘156 teaches a similar patient interface device, where an HME material comprises a sheet (see [0075]-[0076] where an HME element is a sheet).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the HME of the modified Bowman device to be a sheet as taught by Bowman ‘156, as it would be a simple substitution of one shape of material for an HME for another, to yield the predictable result of still be able to absorb and exchange heat and moisture from the inhaled/ exhaled air.
Regarding claim 40, the modified Bowman device has the HME material.
The modified Bowman device lacks a detailed description of wherein the HME material comprises a coiled metal mesh, a layered metal mesh, a stacked metal mesh, a coiled metal covered mesh, a layered metal covered mesh, a stacked metal covered mesh, a coiled polymer mesh, a layered polymer mesh, a stacked polymer mesh, and combinations thereof.
However, Bowman ‘156 teaches a similar patient interface device, where an HME material comprises a layered metal mesh (see [0075]-[0076] where an HME element is made of a layered mesh of aluminum).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the HME of Bowman to be a layered mesh as taught by Bowman ‘156, as it would be a simple substitution of one type of material for an HME for another, to yield the predictable result of still be able to absorb and exchange heat and moisture from the inhaled/ exhaled air.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Bowman in view of Gradon in view of Fukunaga.
Regarding claim 42, Bowman discloses a patient interface comprising: a mask frame (mask shell 410 and adapter 420 in Fig. 8, including the curved portion of mask shell 410 leading up to inlet 336) comprising an inlet (see Fig. 8 connector 476 which is an inlet into the mask assembly from tube 318); a patient contacting portion (seal 480 in Fig. 8) positioned between the mask frame and a face of a patient (see Figs. 3 and 8 where seal 480 touches the face of the patient, such that the seal is between the face and shell 410/ adapter 420); a removable heat and moisture exchanger (see Fig. 8 heat and moisture exchange element (HME) 390 which is a separate component and can be removed from the system), wherein the removable heat and moisture exchanger is attached to the inlet of the mask frame (see Fig. 8 where HME 390 is attached to the inlet of connector 476); and an inlet tube configured to receive gases from a source of gases (see Fig. 8 tube 318) and wherein the heat and moisture exchanger opens up into an interior space formed by the patient contacting portion (see Figs. 3 and 8 where the HME 390 is located next to and in fluid connection with the inlet of mask shell 410 around inlet 336, such that the downstream side of the HME 390 opens into the space formed by mask shell 410 immediately downstream the HME which then is integrally formed with the interior space formed by the seal 480, such that the interior space of mask shell 410 and seal 480 together define the same interior space of mask 316).
Bowman lacks a detailed description of an elbow comprising a first end and a second end, wherein the first end is configured to attach to the inlet of the mask frame and the second end is configured to attach to an inlet tube configured to receive gases from a source of gases. It is noted the Bowman does teach substantially similar embodiments, such as in Fig. 16, where the device 300 containing the blower is not attached to the head, but otherwise still has mask 316 as described in Figs. 3 and 8. Hence, it is understood that the above rejections directed to the Bowman reference can apply to Fig. 16, where Figs. 3 and 8 are used to show detail of the mask 316, but otherwise is substantially the same.
However, Gradon teaches a similar patient interface and connecting conduit portions, where an elbow is directly connected to the patient interface (see Figs. 3 and 12 where L-shaped elbow 45 connects to the gases outlet 42 of a patient interface 2; see also Col. 7 line 61 to Col. 8 line 3), the elbow configured to connect to a source of gas (see Fig. 3 where breathing conduit 41 is a gases inlet leading to elbow 45, and connects to a source of gas (blower 15 in Fig. 1)), with one end of the elbow connected to the inlet of the patient interface, and the other end of the elbow attached to an inlet tube for receiving a source of gas (see Figs. 3 and 12 where the elbow joint 45 has two ends, one which connects to the gases outlet 42 and patient interface 2, and the other which connects to breathing conduit 41).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connection to the mask and HME of Bowman to have an elbow upstream of the HME material and patient interface as taught by Gradon, as it would provide a pivoting connection to allow free motion of the patient’s head without disconnection of the conduits.
The modified Bowman device lacks a detailed description of the heat and moisture exchanger being removable. It is noted that the mask system of Bowman is a combination of separate components, and would be able to be separated and the HME removed therefrom.
In the alternative that the modified Bowman device does not have a heat and moisture exchanger being removable, then it is taught by Fukunaga. Fukunaga teaches a similar respiratory system, where different parts of a respiratory device can be made with fittings in order to be retrofitted into the system, thus forming a modular addition that is able to be removed (see [0098] and Figs. 14-16 where a filter 190 having an HME can be integrated into a connector fitting 240, and further see [0103] where the fittings are containing the HME are used to retrofit to devices that need them).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the HME system of Bowman to include a fitting for modular connection as taught by Fukunaga, as it would allow for the replacement and retrofitting of devices to include an HME, ensuring easy connection to a wide range of respiratory masks.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Bowman in view of Gradon in view of Fukunaga as applied to claim 42 above, and further in view of Bowman ‘156.
Regarding claim 43, the modified Bowman device has wherein: the mask frame is configured to connect to at least one headgear strap (Bowman; see Fig. 3 the plurality of headgear straps, including lower straps 343), the inlet of the mask frame comprises a conduit portion that protrudes from a patient- facing side of the mask frame (Bowman; see Fig. 8 where connector 476 is an inlet into the mask shell 410, forming a conduit member protruding from the mask shell), the removable heat and moisture exchanger is attached to the conduit portion and extends radially outward from the conduit portion (Bowman; see Fig. 8 where the HME 390 is within the conduit formed of connector 476, extending radially within the conduit, and is removable as taught by Fukunaga), the patient contacting portion comprises a housing and a seal-forming portion (Bowman; see Fig. 8 where the body of mask 316 is a housing about seal 480 which seals against the patient’s face), the removable heat and moisture exchanger fit a circular cross-section conduit (Bowman; see Fig. 8 where HME 390 is in connector 476), the first end of the elbow extends into the conduit portion (Gradon; see Figs. 3, 12, and 17 where the elbow joint 45 connects to the patient interface at gases outlet 42 as seen in Col. 9 lines 24-33, and thus connects to the connector 476 in Fig. 8 of Bowman), and the elbow comprises a plurality of bias flow holes (Gradon; see Fig. 16 where the elbow has a plurality of vents 412 to act as bias flow holes).
The modified Bowman device lacks a detailed description of wherein the heat and moisture exchanger comprises a disc shape.
However, Bowman ‘156 teaches a similar patient interface device, where an HME comprises a disc shape (see [0076] and Fig. 4C where HME 70 is formed from disc-like sheets, forming a disc shaped HME).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the HME of the modified Bowman device to be disc-shaped as taught by Bowman ‘156, as it would be a simple matter of design choice for one of ordinary skill in the art to choose different shaped HMEs depending on the shape of the housing around them, as they would still function as HMEs and would better fit within a cylindrical lumen.
Response to Arguments
Applicant's arguments filed 12/22/2025 have been fully considered but they are not persuasive.
Applicant argues on pages 7-8 of the remarks that Bowman in view of Gradon does not teach the amended claim language whereby the HME opens up into an interior space of the mask frame/ patient contacting portion as recited by amended claim 1. Applicant further argues that Gradon shows an HME material that is specifically located within a mouth of the patient, and thus does not open up to the interior spaces as required. The arguments are not well-taken. Firstly, due to the breadth of the term “opens up into,” it is understood that an HME material that is upstream of an interior space and fluidically connected will open up into the interior space. This is shown in the adjusted rejection above, where Bowman is understood to have an HME that touches and directly opens up into the interior spaces of the disclosed mask. Furthermore, the position of the HME within the mouth from Gradon is not part of the modified Bowman device. Gradon is merely relied upon to show 1) that an elbow can be attached on the upstream side of a patient interface to facilitate freedom of movement, and 2) that an HME is still downstream said elbow. Hence, the modified Bowman device retains its HME at the inlet directly next to the mask shell, and has a modified elbow placed on its upstream side, adjusting the freedom of movement of the delivery tube 318. Examiner further points to the substantially similar Fig. 16 of Bowman, where the positive pressure device 300 is not located on the head. Examiner holds that Fig. 16 of Bowman is equally applicable as a primary embodiment, relying on Figs. 3 and 8 for structure of the mask 316. Fig. 16 more clearly shows the benefits of adding an elbow to the connection between the delivery tube and mask, so that a person’s head can more easily move relative to the positive pressure device. These arguments apply to claims 37 and 42 as well.
For these reasons, the rejections hold.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D ZIEGLER whose telephone number is (571)272-3349. The examiner can normally be reached Mon-Fri 10:00-6:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785