DETAILED ACTION
This Office Action is in response to the amendment, filed on December 8, 2025. Primary Examiner acknowledges Claims 90-109 are pending in this application, with Claims 90, 106, and 109 having been currently amended, and Claims 1-90 having been cancelled.
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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 109 is rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Warren (2009/0000618).
As to Claim 109, Warren discloses a mask (10, best seen Figures 18 and 19, “a portable gas delivery system 10” Para 0091) configured to surround an opening of a patient’s airway (as shown in Figure 18 (in situ) encompassing the nose and mouth of the patient), the mask (10) comprising: a mask body (266, “In another variant, as illustrated in FIGS. 18 and 19, an air filtration mask 266 is provided. The mask 266 is removably attached to the hollow frame 56. … In still another variant, an air filtration mask 266 is provided. The mask 266 is removably attached to the hollow frame 56.” Paras 0110 and 0111) having a preformed shape (defined by the cupped configuration which encompasses the nose and mouth of the patient) that is configured to deflect fluids from the opening of a patient’s airways (as shown in Figure 18 (in situ) encompassing the nose and mouth of the patient) in an intended direction (away from the patient towards the ambient) and filter (“air filtration” Paras 0110 and 0111; also see: “It is beneficial to an otherwise healthy person to maintain a high quality supply of breathable air by either filtering the ambient air before inhalation, or providing an alternate source for the breathable air that excludes a large fraction of the ambient air.” Para 0004; “ It must be able to remove some potentially, perceived or actually harmful fraction of the ambient air, or must be able to provide at least a portion of the inhaled air by displacing at least a portion, if not all, of the ambient air with either air filtered by an air filtration pump, or air from a compressed gas tank of appropriate dimension so as to be worn on the body. In the alternative it may be required to do both functions, with some portion of the inhaled air coming through the filter, some portion coming from the gas tank, and the remaining air, if any, coming from the ambient air.” Para 0006) configured to filter contaminates from gases (“Environments that contain air-borne pollutants and infectious agents have received much publicity and awareness. Second hand cigarette smoke, carbon monoxide, SARS, dust, pollen and car exhaust, among other such pollutants can cause respiratory discomfort, damage or inefficiency.” Para 0003); wherein the mask (10) further comprises an interfacing feature (defined by the opening within 266 which receives 56, wherein 56 - “A single-sided, hollow frame 56 is provided. The frame 56 at least partially encloses the nosepiece 146, allowing the medical nasal cannula 50 to protrude through the nosepiece 146, for a snug fit into the nostrils 274.” Para 0091) configured to interface with a patient interface (146, “nosepiece 146” Para 0091) provided on the patient; and wherein the patient interface (146) comprises a pair of nasal prongs (26, best shown in Figure 19 (ex situ) with two prongs, “A nosepiece 146 is provided that has at least one nose port 26.” Para 0091) that extend into a patient’s nostrils (as shown in Figure 18 (in situ) and described to provide “for a snug fit into the nostrils 274.” Para 0091).
Regarding the claim limitation “gases exhaled by the patient”, the mask body (266) of Warren permits the filtration of gases both inhaled and exhaled by the patient by nature of the configuration of the mask body as best seen in Figure 18 (in situ) being configured to encompass the nose and mouth of the patient. It should be noted although Applicant’s claims focus on the concept of “gases exhaled by the patient”, the essence of patient breathing includes the consideration whereby gases which were formerly exhaled by the patient are diffused into the ambient environment and subsequently in part inhaled by the patient – resulting in at least a partial rebreathing of gases. The mask of Warren does not exhaust the gases exhaled by the patient to a remote location for separate treatment of exhaled gases as compared to inhaled gases. Consequently, the act of rebreathing will result in the treatment operation of the filter to remove contaminates from both the inhaled and exhaled gases of the patient. Thus, the mask of Warren meets the limitations of Claim 109 as currently recited.
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 90-99, 101-104, and 106-109 are rejected under 35 U.S.C. 103 as being unpatentable over Tatkov (2012/0305001) in view of Dugan et al. (2012/0285448).
As to Claim 106, Tatkov discloses an interfacing system (Figure 5, “FIG. 5 is a rear view of a sealed full face user interface including a nasal cannula with a pair of non-sealing nasal prongs positioned within the mask and coupled to a gas inlet in the mask by an internal supply conduit.” Para 0079), comprising: a non-sealing patient interface (505, “The arrangement of the nasal cannula 505 within the mask body 510 is illustrated in FIG. 5.” Para 0173; also see: “a nasal cannula with a pair of non-sealing nasal prongs” Para 0079) configured to deliver a gases flow (via 517, “The user interface 400, 500, 600 incorporates a swivelling mask conduit 417, 517, 617” Para 0171; also see: “coupled to a gas inlet in the mask by an internal supply conduit.” Para 0079) to a patient’s airways (via nose); a mask (500, “The interface 400, 500, 600 incorporates the features of the nasal interface 2, 200, 300, described previously, applied to a full face mask body 410, 510, 610. The mask body 410, 510, 610 encloses the user's mouth and nose in use.” Para 0169) comprising: a mask body (510, “The interface 400, 500, 600 incorporates the features of the nasal interface 2, 200, 300, described previously, applied to a full face mask body 410, 510, 610. The mask body 410, 510, 610 encloses the user's mouth and nose in use.” Para 0169) comprising a patient facing side (best seen Figure 5) and a non-patient facing side (best seen Figure 6 – which is a functional alternative embodiment of Figure 5 – which shows the exposure of the mask to the ambient environment), the patient facing side (best seen Figure 5) configured to form an interior space (defined by the region of Figure 5 which receives the “user's mouth and nose in use.” Para 0169) with a patient’s face when the mask (500) is in contact with a patient, the interior space (defined by the region of Figure 5 which receives the “user's mouth and nose in use.” Para 0169) configured to accommodate a portion of the non-sealing patient interface (505); a filter (530, “The mask body 410, 510, 610 includes a plurality of venting apertures 430, 530, 630 positioned adjacent a nasal bridge section. The venting apertures 430, 530, 630 are responsible for exhausting expired gases from the user interface 400, 500, 600 directly to the user's surroundings.” Para 0172; also see: “The conduit 507 may include one or more outlets (illustrated in broken lines 520 in FIG. 5) to the mask cavity 510 to flush expired gases toward the venting apertures 530.” Para 0178) configured to filter a fluid from a patient-facing side (best seen Figure 5) of the mask (500) to a non-patient facing side (best seen Figure 6 – which is a functional alternative embodiment of Figure 5 – which shows the exposure of the mask to the ambient environment) of the mask (500), wherein the non-patient facing side (best seen Figure 6 – which is a functional alternative embodiment of Figure 5 – which shows the exposure of the mask to the ambient environment) faces an ambient environment; and an interfacing feature (507, “The conduit 507 couples the cannula 505 to the mask inlet.” Para 0175) configured to interface with the non-sealing patient interface (505); wherein the non-sealing patient interface (505) comprises a pair of nasal prongs (“a pair of non-sealing nasal prongs positioned within the mask and coupled to a gas inlet in the mask by an internal supply conduit.” Para 0079) that extend into a patient’s nostrils (“The cannula comprises a pair of prongs that project into the user's nares.” Para 0107).
Regarding the directionality of the filter for processing of “gases exhaled by the patient”, Tatkov discloses the construction of the filter (530) may include “Variable restriction exhausts, can replace, or be provided in combination with, the fixed ventilation apertures 530. Preferably, some exhaust regulation is provided to assist regulation of pressure within the interface.” (Para 0176). Thus, it is clear the directionality of the filter is for processing by controlled exhaustion of gases exhaled by the patient.
Yet, Tatkov does not expressly disclose the specific type of processing of gases by the filter to include the “filter [of] contaminates from the gases exhaled by the patient”.
Dugan teaches an alternative mask (110, “Patient interface 110 sealably couples in a controlled seal (controlled in the sense that intentional leaks are permitted while unintentional leaks are reduced or eliminated) over at least one respiratory opening of patient 101 to form a hollow chamber into which fresh respiratory gas is coupled via breathing circuit 140. Although patient interface 110 is illustrated in FIG. 1 and throughout as covering both the nasal and oral cavities (nose and mouth), some embodiments may cover only a nasal cavity or oral cavity, or may capture the entire face or head of a patient.” Para 0050) comprising: a mask body (defined by the connected engagement of 125 and 120x, “Patient interface 110 comprises a frame 125, a facial skin interface 130, a compliant nose bridge seal 135, a domed front portion 120 (which may be fixed or may be a removable/interchangeable insert), and a head strap system 111.” Para 0054) comprising a patient facing side (defined by the region which receives “both the nasal and oral cavities (nose and mouth)” Para 0050) and a non-patient contacting side (best seen Figures 1 and 7 – showing the exposure of the mask to the ambient environment), the patient facing side (defined by the region which receives “both the nasal and oral cavities (nose and mouth)” Para 0050) configured to form an interior space (“to form a hollow chamber” Para 0050) with a patient’s face when the mask (110) is in contact with the patient.
Regarding the remaining limitations of the claims, Dugan teaches a portion of the mask body (defined by the connected engagement of 125 and 120x) includes a filter (123A – specifically referred to as 2724 in Figure 27 as a replaceable component, “an interchangeable patient interface insert 120D which includes built-in filter media 123A” Para 0071; also see: “In one embodiment, filter media 123A can be used in conjunction with or in place or exhaust gas vent ports 123 which have been depicted elsewhere herein. Typically, exhaust gas vent ports 123 are open to the atmosphere. … Filter media 123A provides a controlled pressure drop in addition to filtering contagions from exhaled gases as the exhaled gases pass through. … Media such as, but not limited to, filter cloth (e.g., cotton, polyester, or bamboo) or open cell foam may be utilized to form filter media 123A. A variety of factors including one or more of composition, thickness, surface area, and porosity of the media of filter media 123A can be selected, in some embodiments, to both filter contagions and provide a designated and intentional flow/leak rate to control internal pressure of patient interface 110. In one embodiment, interchangeable patient interface insert 120D can be removed and replaced with a new interchangeable patient interface insert 120D when filter media 123A becomes clogged, soiled, or has surpassed its recommended replacement interval. In another embodiment, filter media 123A is, itself, replaceable.” Para 0072; “As described previously with reference to FIG. 7, in one embodiment, filter media 123A can be used in conjunction with or in place or exhaust gas vent ports 123 which have been depicted elsewhere herein. Typically, exhaust gas vent ports 123 are open to the atmosphere. Instead of open vent holes, in one embodiment, filter media 123A is included in addition to vent ports 123 or alternatively utilized to replace vent ports 123. Filter media 123A filters contagions (e.g., bacteria, viruses, drugs (in particular aerosolized or nebulized drugs), and/or chemicals) from the exhaust gas which is exhausted through filter media 123A. The exhausted gas may comprise exhaled breath, excess fresh respiratory gas, or a combination thereof. In addition to filtering, filter media 123A diffuses the gases that are exhausted there through. Filter media can be composed of any known type of respiratory gas filter media, including, but not limited to, paper, activated carbon, synthetic woven fiber (e.g., polyester, Gortex.RTM. or similar expanded polytetrafluoroethylene (ePTFE)), open cell foam, glass fiber, natural woven fiber (e.g., bamboo, cotton), or combination thereof.” Para 0195; “ In one embodiment, interchangeable patient interface insert 120D can be removed and replaced with a new interchangeable patient interface insert 120D when filter media 123A becomes clogged, soiled, or has surpassed its recommended replacement interval. In another embodiment, filter media 123A is, itself, replaceable.” Para 0197; “In one embodiment, filter media 123A, may be imbued with a desiccant (e.g., silica, activated charcoal, or the like) in order to assist in controlling moisture level on the interior of patient interface 110 to reduce fogging and/or to improve patient comfort, and in order to maintain filter media 123A in a dry state which is can kill viruses and is non-conducive to formation of funguses. … In one embodiment, filter media 123A is imbued with an antibacterial, antimicrobial, and/or antifungal substance (e.g., silver, an antibiotic, etc.)” Para 0198; “FIG. 27 illustrates a replaceable filter cartridge 2724, in accordance with some embodiment. Filter cartridge 2724 is shown in an uninstalled state. Arrow 2750 illustrates where filter cartridge 2724 may be snap fit or otherwise coupled with interchangeable insert 120D, or a similar interchangeable or non-interchangeable domed front portion 120. This is one mechanism for changing for replacing filter media 123 when clogged or past a time of suggested usability. In other embodiments, filter media 123A is an integral portion of interchangeable insert 120D (rather than a replaceable cartridge), and the entirety of interchangeable insert 120D is removed and replaced in order to replace filter media 123. In some embodiments a larger portion of interchangeable insert 120D may be composed of filter media 123 than depicted in FIG. 27 or other figures herein.” Para 0199) which is configured to filter contaminates from gases exhaled by the patient (“Filter media 123A filters contagions (e.g., bacteria, viruses, drugs (in particular aerosolized or nebulized drugs), and/or chemicals) from the exhaust gas which is exhausted through filter media 123A” Para 0195).
In light of the teachings of Dugan, the modification of Tatkov’s filter (530) to be “used in conjunction with or in place” (e.g. Dugan: Para 0072 and 0195) of the filter of Dugan (123A) was well-known, routine, and conventional practice as taught by Dugan to enable the filtration of exhausted contaminates from the patient – including “contagions (e.g., bacteria, viruses, drugs (in particular aerosolized or nebulized drugs), and/or chemicals)” (Para 0195) - which if not properly treated may resulting in “undesirable or even dangerous to a care giver in some patient care circumstances” (Para 0072). Hence, the modification of the filter to process contaminates prevents harm to the ambient environment by proper treatment of the exhaled gases from the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the filter of Tatkov to include the functionality of contaminate filtration as taught by Dugan to prevent harm to the ambient environment by treating the gases exhaled from the patient.
As to Claim 107, the modified Tatkov, specifically Tatkov discloses the non-sealing patient interface (505) comprises a first retention mechanism (726, best seen Figure 7 -which is a functional alternative embodiment of Figure 5 – showing the 705 ex situ from the mask, “Couplings 726, 826 are arranged adjacent the lateral edges of the cheek bearing portion 725, 825 of the cannula 705, 805 illustrated in FIGS. 7 and 8. The couplings 726, 826 can engage with compatible headgear to support the cannula 305 when used independently of the mask.” Para 0154) configured to retain the non-sealing patient interface (505) on the patient’s face in use.
As to Claim 108, the modified Tatkov, specifically Tatkov discloses a second retention mechanism (lateral headgear attachments of Figure 5) configured to retain the mask (500) on the patient’s face, wherein the first retention mechanism (726) and the second retention mechanism (lateral headgear attachments of Figure 5) are separate such that the mask (500) is selectively securable to or removable from the patient independent of the non-sealing patient interface (505).
As to Claim 109, Tatkov discloses a mask (500, “The interface 400, 500, 600 incorporates the features of the nasal interface 2, 200, 300, described previously, applied to a full face mask body 410, 510, 610. The mask body 410, 510, 610 encloses the user's mouth and nose in use.” Para 0169) configured to surround an opening of the patient’s airways (“encloses the user's mouth and nose in use”), the mask (500) comprising: a mask body (510, “The interface 400, 500, 600 incorporates the features of the nasal interface 2, 200, 300, described previously, applied to a full face mask body 410, 510, 610. The mask body 410, 510, 610 encloses the user's mouth and nose in use.” Para 0169) having a preformed shape (defined by the cupped configuration which encloses the user's mouth and nose) that is configured to deflect fluids from the opening of a patient’s airways (encloses the user's mouth and nose) in an intended direction (away from the patient towards the ambient) and a filter (530, “The mask body 410, 510, 610 includes a plurality of venting apertures 430, 530, 630 positioned adjacent a nasal bridge section. The venting apertures 430, 530, 630 are responsible for exhausting expired gases from the user interface 400, 500, 600 directly to the user's surroundings.” Para 0172; also see: “The conduit 507 may include one or more outlets (illustrated in broken lines 520 in FIG. 5) to the mask cavity 510 to flush expired gases toward the venting apertures 530.” Para 0178) to enable the exhalation of gases from the patient, wherein the mask (500) includes an interfacing feature (507, “The conduit 507 couples the cannula 505 to the mask inlet.” Para 0175) configured to interface with a patient interface (505, “The arrangement of the nasal cannula 505 within the mask body 510 is illustrated in FIG. 5.” Para 0173; also see: “a nasal cannula with a pair of non-sealing nasal prongs” Para 0079) provided on the patient; and wherein the patient interface (505) comprises a pair of nasal prongs (“a pair of non-sealing nasal prongs positioned within the mask and coupled to a gas inlet in the mask by an internal supply conduit.” Para 0079) that extend into a patient’s nostrils (“The cannula comprises a pair of prongs that project into the user's nares.” Para 0107).
Regarding the directionality of the filter for processing of “gases exhaled by the patient”, Tatkov discloses the construction of the filter (530) may include “Variable restriction exhausts, can replace, or be provided in combination with, the fixed ventilation apertures 530. Preferably, some exhaust regulation is provided to assist regulation of pressure within the interface.” (Para 0176). Thus, it is clear the directionality of the filter is for processing by controlled exhaustion of gases exhaled by the patient.
Yet, Tatkov does not expressly disclose the specific type of processing of gases by the filter to include the “filter [of] contaminates from the gases exhaled by the patient”.
Dugan teaches an alternative mask (110, “Patient interface 110 sealably couples in a controlled seal (controlled in the sense that intentional leaks are permitted while unintentional leaks are reduced or eliminated) over at least one respiratory opening of patient 101 to form a hollow chamber into which fresh respiratory gas is coupled via breathing circuit 140. Although patient interface 110 is illustrated in FIG. 1 and throughout as covering both the nasal and oral cavities (nose and mouth), some embodiments may cover only a nasal cavity or oral cavity, or may capture the entire face or head of a patient.” Para 0050) comprising: a mask body (defined by the connected engagement of 125 and 120x, “Patient interface 110 comprises a frame 125, a facial skin interface 130, a compliant nose bridge seal 135, a domed front portion 120 (which may be fixed or may be a removable/interchangeable insert), and a head strap system 111.” Para 0054) comprising a patient facing side (defined by the region which receives “both the nasal and oral cavities (nose and mouth)” Para 0050) and a non-patient contacting side (best seen Figures 1 and 7 – showing the exposure of the mask to the ambient environment), the patient facing side (defined by the region which receives “both the nasal and oral cavities (nose and mouth)” Para 0050) configured to form an interior space (“to form a hollow chamber” Para 0050) with a patient’s face when the mask (110) is in contact with the patient.
Regarding the remaining limitations of the claims, Dugan teaches a portion of the mask body (defined by the connected engagement of 125 and 120x) includes a filter (123A – specifically referred to as 2724 in Figure 27 as a replaceable component, “an interchangeable patient interface insert 120D which includes built-in filter media 123A” Para 0071; also see: “In one embodiment, filter media 123A can be used in conjunction with or in place or exhaust gas vent ports 123 which have been depicted elsewhere herein. Typically, exhaust gas vent ports 123 are open to the atmosphere. … Filter media 123A provides a controlled pressure drop in addition to filtering contagions from exhaled gases as the exhaled gases pass through. … Media such as, but not limited to, filter cloth (e.g., cotton, polyester, or bamboo) or open cell foam may be utilized to form filter media 123A. A variety of factors including one or more of composition, thickness, surface area, and porosity of the media of filter media 123A can be selected, in some embodiments, to both filter contagions and provide a designated and intentional flow/leak rate to control internal pressure of patient interface 110. In one embodiment, interchangeable patient interface insert 120D can be removed and replaced with a new interchangeable patient interface insert 120D when filter media 123A becomes clogged, soiled, or has surpassed its recommended replacement interval. In another embodiment, filter media 123A is, itself, replaceable.” Para 0072; “As described previously with reference to FIG. 7, in one embodiment, filter media 123A can be used in conjunction with or in place or exhaust gas vent ports 123 which have been depicted elsewhere herein. Typically, exhaust gas vent ports 123 are open to the atmosphere. Instead of open vent holes, in one embodiment, filter media 123A is included in addition to vent ports 123 or alternatively utilized to replace vent ports 123. Filter media 123A filters contagions (e.g., bacteria, viruses, drugs (in particular aerosolized or nebulized drugs), and/or chemicals) from the exhaust gas which is exhausted through filter media 123A. The exhausted gas may comprise exhaled breath, excess fresh respiratory gas, or a combination thereof. In addition to filtering, filter media 123A diffuses the gases that are exhausted there through. Filter media can be composed of any known type of respiratory gas filter media, including, but not limited to, paper, activated carbon, synthetic woven fiber (e.g., polyester, Gortex.RTM. or similar expanded polytetrafluoroethylene (ePTFE)), open cell foam, glass fiber, natural woven fiber (e.g., bamboo, cotton), or combination thereof.” Para 0195; “ In one embodiment, interchangeable patient interface insert 120D can be removed and replaced with a new interchangeable patient interface insert 120D when filter media 123A becomes clogged, soiled, or has surpassed its recommended replacement interval. In another embodiment, filter media 123A is, itself, replaceable.” Para 0197; “In one embodiment, filter media 123A, may be imbued with a desiccant (e.g., silica, activated charcoal, or the like) in order to assist in controlling moisture level on the interior of patient interface 110 to reduce fogging and/or to improve patient comfort, and in order to maintain filter media 123A in a dry state which is can kill viruses and is non-conducive to formation of funguses. … In one embodiment, filter media 123A is imbued with an antibacterial, antimicrobial, and/or antifungal substance (e.g., silver, an antibiotic, etc.)” Para 0198; “FIG. 27 illustrates a replaceable filter cartridge 2724, in accordance with some embodiment. Filter cartridge 2724 is shown in an uninstalled state. Arrow 2750 illustrates where filter cartridge 2724 may be snap fit or otherwise coupled with interchangeable insert 120D, or a similar interchangeable or non-interchangeable domed front portion 120. This is one mechanism for changing for replacing filter media 123 when clogged or past a time of suggested usability. In other embodiments, filter media 123A is an integral portion of interchangeable insert 120D (rather than a replaceable cartridge), and the entirety of interchangeable insert 120D is removed and replaced in order to replace filter media 123. In some embodiments a larger portion of interchangeable insert 120D may be composed of filter media 123 than depicted in FIG. 27 or other figures herein.” Para 0199) which is configured to filter contaminates from gases exhaled by the patient (“Filter media 123A filters contagions (e.g., bacteria, viruses, drugs (in particular aerosolized or nebulized drugs), and/or chemicals) from the exhaust gas which is exhausted through filter media 123A” Para 0195).
In light of the teachings of Dugan, the modification of Tatkov’s filter (530) to be “used in conjunction with or in place” (e.g. Dugan: Para 0072 and 0195) of the filter of Dugan (123A) was well-known, routine, and conventional practice as taught by Dugan to enable the filtration of exhausted contaminates from the patient – including “contagions (e.g., bacteria, viruses, drugs (in particular aerosolized or nebulized drugs), and/or chemicals)” (Para 0195) - which if not properly treated may resulting in “undesirable or even dangerous to a care giver in some patient care circumstances” (Para 0072). Hence, the modification of the filter to process contaminates prevents harm to the ambient environment by proper treatment of the exhaled gases from the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the filter of Tatkov to include the functionality of contaminate filtration as taught by Dugan to prevent harm to the ambient environment by treating the gases exhaled from the patient.
As to Claim 90, Tatkov discloses a mask (500, “The interface 400, 500, 600 incorporates the features of the nasal interface 2, 200, 300, described previously, applied to a full face mask body 410, 510, 610. The mask body 410, 510, 610 encloses the user's mouth and nose in use.” Para 0169) configured to surround an opening of the patient’s airways (“encloses the user's mouth and nose in use”), the mask (500) comprising: a mask body (510, “The interface 400, 500, 600 incorporates the features of the nasal interface 2, 200, 300, described previously, applied to a full face mask body 410, 510, 610. The mask body 410, 510, 610 encloses the user's mouth and nose in use.” Para 0169) comprising a filter (530, “The mask body 410, 510, 610 includes a plurality of venting apertures 430, 530, 630 positioned adjacent a nasal bridge section. The venting apertures 430, 530, 630 are responsible for exhausting expired gases from the user interface 400, 500, 600 directly to the user's surroundings.” Para 0172; also see: “The conduit 507 may include one or more outlets (illustrated in broken lines 520 in FIG. 5) to the mask cavity 510 to flush expired gases toward the venting apertures 530.” Para 0178) configured to filter a fluid from a patient facing side (best seen Figure 5) of the mask (500) to a non-patient facing side (best seen Figure 6 – which is a functional alternative embodiment of Figure 5 – which shows the exposure of the mask to the ambient environment) of the mask (500), wherein the non-patient facing side (best seen Figure 6 – which is a functional alternative embodiment of Figure 5 – which shows the exposure of the mask to the ambient environment) faces an ambient environment; an interfacing feature (507, “The conduit 507 couples the cannula 505 to the mask inlet.” Para 0175) configured to interface with a patient interface (505, “The arrangement of the nasal cannula 505 within the mask body 510 is illustrated in FIG. 5.” Para 0173; also see: “a nasal cannula with a pair of non-sealing nasal prongs” Para 0079) provided on the patient; and wherein the patient interface (505) comprises a pair of nasal prongs (“a pair of non-sealing nasal prongs positioned within the mask and coupled to a gas inlet in the mask by an internal supply conduit.” Para 0079) that extend into a patient’s nostrils (“The cannula comprises a pair of prongs that project into the user's nares.” Para 0107); and wherein the filter (530) is configured to permit the gases to be exhaled by the patient.
Regarding the directionality of the filter for processing of “gases exhaled by the patient”, Tatkov discloses the construction of the filter (530) may include “Variable restriction exhausts, can replace, or be provided in combination with, the fixed ventilation apertures 530. Preferably, some exhaust regulation is provided to assist regulation of pressure within the interface.” (Para 0176). Thus, it is clear the directionality of the filter is for processing by controlled exhaustion of gases exhaled by the patient.
Yet, Tatkov does not expressly disclose the specific type of processing of gases by the filter to include the “filter [of] contaminates from the gases exhaled by the patient”.
Dugan teaches an alternative mask (110, “Patient interface 110 sealably couples in a controlled seal (controlled in the sense that intentional leaks are permitted while unintentional leaks are reduced or eliminated) over at least one respiratory opening of patient 101 to form a hollow chamber into which fresh respiratory gas is coupled via breathing circuit 140. Although patient interface 110 is illustrated in FIG. 1 and throughout as covering both the nasal and oral cavities (nose and mouth), some embodiments may cover only a nasal cavity or oral cavity, or may capture the entire face or head of a patient.” Para 0050) comprising: a mask body (defined by the connected engagement of 125 and 120x, “Patient interface 110 comprises a frame 125, a facial skin interface 130, a compliant nose bridge seal 135, a domed front portion 120 (which may be fixed or may be a removable/interchangeable insert), and a head strap system 111.” Para 0054) comprising a patient facing side (defined by the region which receives “both the nasal and oral cavities (nose and mouth)” Para 0050) and a non-patient contacting side (best seen Figures 1 and 7 – showing the exposure of the mask to the ambient environment), the patient facing side (defined by the region which receives “both the nasal and oral cavities (nose and mouth)” Para 0050) configured to form an interior space (“to form a hollow chamber” Para 0050) with a patient’s face when the mask (110) is in contact with the patient.
Regarding the remaining limitations of the claims, Dugan teaches a portion of the mask body (defined by the connected engagement of 125 and 120x) includes a filter (123A – specifically referred to as 2724 in Figure 27 as a replaceable component, “an interchangeable patient interface insert 120D which includes built-in filter media 123A” Para 0071; also see: “In one embodiment, filter media 123A can be used in conjunction with or in place or exhaust gas vent ports 123 which have been depicted elsewhere herein. Typically, exhaust gas vent ports 123 are open to the atmosphere. … Filter media 123A provides a controlled pressure drop in addition to filtering contagions from exhaled gases as the exhaled gases pass through. … Media such as, but not limited to, filter cloth (e.g., cotton, polyester, or bamboo) or open cell foam may be utilized to form filter media 123A. A variety of factors including one or more of composition, thickness, surface area, and porosity of the media of filter media 123A can be selected, in some embodiments, to both filter contagions and provide a designated and intentional flow/leak rate to control internal pressure of patient interface 110. In one embodiment, interchangeable patient interface insert 120D can be removed and replaced with a new interchangeable patient interface insert 120D when filter media 123A becomes clogged, soiled, or has surpassed its recommended replacement interval. In another embodiment, filter media 123A is, itself, replaceable.” Para 0072; “As described previously with reference to FIG. 7, in one embodiment, filter media 123A can be used in conjunction with or in place or exhaust gas vent ports 123 which have been depicted elsewhere herein. Typically, exhaust gas vent ports 123 are open to the atmosphere. Instead of open vent holes, in one embodiment, filter media 123A is included in addition to vent ports 123 or alternatively utilized to replace vent ports 123. Filter media 123A filters contagions (e.g., bacteria, viruses, drugs (in particular aerosolized or nebulized drugs), and/or chemicals) from the exhaust gas which is exhausted through filter media 123A. The exhausted gas may comprise exhaled breath, excess fresh respiratory gas, or a combination thereof. In addition to filtering, filter media 123A diffuses the gases that are exhausted there through. Filter media can be composed of any known type of respiratory gas filter media, including, but not limited to, paper, activated carbon, synthetic woven fiber (e.g., polyester, Gortex.RTM. or similar expanded polytetrafluoroethylene (ePTFE)), open cell foam, glass fiber, natural woven fiber (e.g., bamboo, cotton), or combination thereof.” Para 0195; “ In one embodiment, interchangeable patient interface insert 120D can be removed and replaced with a new interchangeable patient interface insert 120D when filter media 123A becomes clogged, soiled, or has surpassed its recommended replacement interval. In another embodiment, filter media 123A is, itself, replaceable.” Para 0197; “In one embodiment, filter media 123A, may be imbued with a desiccant (e.g., silica, activated charcoal, or the like) in order to assist in controlling moisture level on the interior of patient interface 110 to reduce fogging and/or to improve patient comfort, and in order to maintain filter media 123A in a dry state which is can kill viruses and is non-conducive to formation of funguses. … In one embodiment, filter media 123A is imbued with an antibacterial, antimicrobial, and/or antifungal substance (e.g., silver, an antibiotic, etc.)” Para 0198; “FIG. 27 illustrates a replaceable filter cartridge 2724, in accordance with some embodiment. Filter cartridge 2724 is shown in an uninstalled state. Arrow 2750 illustrates where filter cartridge 2724 may be snap fit or otherwise coupled with interchangeable insert 120D, or a similar interchangeable or non-interchangeable domed front portion 120. This is one mechanism for changing for replacing filter media 123 when clogged or past a time of suggested usability. In other embodiments, filter media 123A is an integral portion of interchangeable insert 120D (rather than a replaceable cartridge), and the entirety of interchangeable insert 120D is removed and replaced in order to replace filter media 123. In some embodiments a larger portion of interchangeable insert 120D may be composed of filter media 123 than depicted in FIG. 27 or other figures herein.” Para 0199) which is configured to filter contaminates from gases exhaled by the patient (“Filter media 123A filters contagions (e.g., bacteria, viruses, drugs (in particular aerosolized or nebulized drugs), and/or chemicals) from the exhaust gas which is exhausted through filter media 123A” Para 0195).
With specific consideration to the claimed limitation of “removable filter”, as referenced in the aforementioned paragraph, as best seen in Figure 27, the filter (2724) is removable form the mask body (510). Explicitly, “FIG. 27 illustrates a replaceable filter cartridge 2724, in accordance with some embodiment. Filter cartridge 2724 is shown in an uninstalled state. Arrow 2750 illustrates where filter cartridge 2724 may be snap fit or otherwise coupled with interchangeable insert 120D, or a similar interchangeable or non-interchangeable domed front portion 120. This is one mechanism for changing for replacing filter media 123 when clogged or past a time of suggested usability. In other embodiments, filter media 123A is an integral portion of interchangeable insert 120D (rather than a replaceable cartridge), and the entirety of interchangeable insert 120D is removed and replaced in order to replace filter media 123. In some embodiments a larger portion of interchangeable insert 120D may be composed of filter media 123 than depicted in FIG. 27 or other figures herein.” (Para 0199)
In light of the teachings of Dugan, the modification of Tatkov’s filter (530) to be “used in conjunction with or in place” (e.g. Dugan: Para 0072 and 0195) of the filter of Dugan (123A in its removable configuration of 2724) was well-known, routine, and conventional practice as taught by Dugan to enable the filtration of exhausted contaminates from the patient – including “contagions (e.g., bacteria, viruses, drugs (in particular aerosolized or nebulized drugs), and/or chemicals)” (Para 0195) - which if not properly treated may resulting in “undesirable or even dangerous to a care giver in some patient care circumstances” (Para 0072). Hence, the modification of the filter to process contaminates prevents harm to the ambient environment by proper treatment of the exhaled gases from the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the filter of Tatkov to include the functionality of contaminate filtration as taught by Dugan to prevent harm to the ambient environment by treating the gases exhaled from the patient, and to construct the filter to be removable as taught by Dugan to permit the replacement of the filter when “clogged or past a time of suggested usability”.
As to Claim 91, the modified Tatkov, specifically Dugan teaches the removable filter (2724 – the removable configuration of 123A) comprises a material that is permeable to fluid flow (“Filter media can be composed of any known type of respiratory gas filter media, including, but not limited to, paper, activated carbon, synthetic woven fiber (e.g., polyester, Gortex.RTM. or similar expanded polytetrafluoroethylene (ePTFE)), open cell foam, glass fiber, natural woven fiber (e.g., bamboo, cotton), or combination thereof.” Para 0195; also see: “Media such as, but not limited to, filter cloth (e.g., cotton, polyester, or bamboo) or open cell foam may be utilized to form filter media 123A. Para 0072).
As to Claim 92, the modified Tatkov, specifically Dugan teaches the removable filter (2724 – the removable configuration of 123A) comprises a material that is substantially impermeable to bulk flow of liquid water (“In one embodiment, filter media 123A, may be imbued with a desiccant (e.g., silica, activated charcoal, or the like) in order to assist in controlling moisture level on the interior of patient interface 110 to reduce fogging and/or to improve patient comfort, and in order to maintain filter media 123A in a dry state which is can kill viruses and is non-conducive to formation of funguses. … In one embodiment, filter media 123A is imbued with an antibacterial, antimicrobial, and/or antifungal substance (e.g., silver, an antibiotic, etc.)” Para 0198).
As to Claim 93, the modified Tatkov, specifically Dugan teaches an absorbent material (“a desiccant (e.g., silica, activated charcoal, or the like) in order to assist in controlling moisture level on the interior of patient interface 110 to reduce fogging and/or to improve patient comfort” Para 0198) to absorb liquid.
As to Claim 94, the modified Tatkov, specifically Tatkov discloses the patient interface (505) is non-sealing (“a nasal cannula with a pair of non-sealing nasal prongs” Para 0079).
As to Claim 95, the modified Tatkov, specifically Tatkov discloses the patient interface (505) is a non-sealing nasal cannula (“a nasal cannula with a pair of non-sealing nasal prongs” Para 0079) comprising at least one prong (“a pair of non-sealing nasal prongs” Para 0079) that is configured to extend into a patient’s nasal passage (“The cannula comprises a pair of prongs that project into the user's nares.” Para 0107), a pair of side arms (725, best seen Figure 7 -which is a functional alternative embodiment of Figure 5 – showing the 705 ex situ from the mask, “Couplings 726, 826 are arranged adjacent the lateral edges of the cheek bearing portion 725, 825 of the cannula 705, 805 illustrated in FIGS. 7 and 8. The couplings 726, 826 can engage with compatible headgear to support the cannula 305 when used independently of the mask.” Para 0154) that is configured to extend laterally along a patient’s face (“cheek”), and a patient conduit (517, “The user interface 400, 500, 600 incorporates a swivelling mask conduit 417, 517, 617” Para 0171; also see: “coupled to a gas inlet in the mask by an internal supply conduit.” Para 0079) configured to connect to a gases source for delivering a gases flow to the patient via the at least one prong (“a pair of non-sealing nasal prongs” Para 0079).
As to Claim 96, the modified Tatkov, specifically Tatkov discloses the mask (500) is selectively securable to or removable from the patient independent of the non-sealing patient interface (505), via the second retention mechanism (lateral headgear attachments of Figure 5).
As to Claim 97, the modified Tatkov, specifically Tatkov discloses the mask (500) does not comprise a gases removal conduit; does not comprise a connection port for connecting to a gases removal device; is not adapted to actively remove a flow of gases from the patient.
As to Claim 98, the modified Tatkov, specifically Tatkov discloses the mask (500) comprises a gases removal port (530) to transmit fluids from the patient facing side (best seen Figure 5) of the mask (500) to a remote filter (via 2724 – the removable configuration of 123A).
As to Claim 99, the modified Tatkov, specifically Dugan teaches a mask (110, “Patient interface 110 sealably couples in a controlled seal (controlled in the sense that intentional leaks are permitted while unintentional leaks are reduced or eliminated) over at least one respiratory opening of patient 101 to form a hollow chamber into which fresh respiratory gas is coupled via breathing circuit 140. Although patient interface 110 is illustrated in FIG. 1 and throughout as covering both the nasal and oral cavities (nose and mouth), some embodiments may cover only a nasal cavity or oral cavity, or may capture the entire face or head of a patient.” Para 0050) having a frame (125, “Patient interface 110 comprises a frame 125, a facial skin interface 130, a compliant nose bridge seal 135, a domed front portion 120 (which may be fixed or may be a removable/interchangeable insert), and a head strap system 111.” Para 0054), and wherein the a mask body (120x, “Patient interface 110 comprises a frame 125, a facial skin interface 130, a compliant nose bridge seal 135, a domed front portion 120 (which may be fixed or may be a removable/interchangeable insert), and a head strap system 111.” Para 0054) is releasably coupled to the frame (125).
As to Claim 101, the modified Tatkov, specifically Tatkov discloses the interfacing feature (507, “The conduit 507 couples the cannula 505 to the mask inlet.” Para 0175) comprises an aperture provided in the mask body (510) to allow a portion of the non-sealing nasal cannula (505) to extend through, optionally to allow the patient conduit (517) of the non-sealing nasal cannula (505) to extend through.
As to Claim 102, the modified Tatkov, specifically Tatkov discloses the mask (500) comprises a frame (defined by the unlabeled region lower than the leader line of 510 which includes the lateral headgear connection ports as best seen in Figure 6) shaped to conform to an external surface of the patient conduit (517) of the non-sealing nasal cannula (505) and wherein the interfacing feature (507, “The conduit 507 couples the cannula 505 to the mask inlet.” Para 0175) comprises a first mounting structure (via 517) to releasably couple the frame (defined by the unlabeled region lower than the leader line of 510 which includes the lateral headgear connection ports as best seen in Figure 6) to the patient conduit (517).
As to Claim 103, the modified Tatkov, specifically Tatkov discloses the interfacing feature (507) comprises at least one mounting mechanism (720, best seen Figure 7 -which is a functional alternative embodiment of Figure 5 – showing the 705 ex situ, “An exemplary coupling is illustrated in FIGS. 7 and 8. The pictured coupling 720, 820 projects from the distal end of the conduit 707, 807 and is configured to engage with a portion of the mask conduit 217, 317 projecting internally. The coupling 720, 820 comprises a base 721, 821, that connects with the cannula conduit 707, 807, and a segmented annular wall 722, 822. The segmented annular wall 722, 822 extends away from the base 721, 821, 807 to a distal end of the coupling 720, 820.” Paras 0145-0146; and “The coupling 720, 820 is aligned with, and forced over, the mask conduit extension to engage securely by interlocking with the circumferential recess and lip.” Para 0149) to couple the mask (500) to the non-sealing nasal cannula (505).
As to Claim 104, the modified Tatkov, specifically Tatkov discloses an attachment mechanism (“headgear coupled to the mask to retain the interface in position on a user's head.” Para 0017), wherein the attachment mechanism (“headgear”) is releasably attached to a patient’s face.
Claim 100 is rejected under 35 U.S.C. 103 as being unpatentable over Tatkov (2012/0305001) in view of Dugan et al. (2012/0285448), as applied to Claim 95, and further in view of Tiwari (2021/0353890).
As to Claim 100, the modified Tatkov, specifically Tatkov discloses the mask (500) comprises a cushion (511, “The user interface 400, 500, 600 includes a seal 411, 511, 611 arranged about a periphery of the mask body 410, 510, 610 to prevent significant leaks around the base of the interface 400, 500, 600 and enable adequate pressure to be developed within the mask.” Para 0177) configured to seal about or against the patient’s face, and an interfacing feature (507) which permits for the insertion of the non-sealing nasal cannula (505) into the mask (500).
Yet, the modified Tatkov does not expressly disclose the construction of “the interfacing feature comprises a recess or slot in the cushion, wherein the recess or slot conforms to an external surface of the non-sealing nasal cannula such that the cushion substantially seals about the side arms and/or the patient conduit of the non-sealing nasal cannula.”
Tiwari teaches an alternative construction of a mask (200, “Referring to FIG. 2, the face mask 200 comprises a mask body 202 defining a cavity configured to be positioned over the mouth and nose of a patient or user, an inlet port 210 for directing a flow of gas to the interior of the face mask 200, a malleable strip 206 to mold the mask around the patient's or user's nose, two side filters 204a and 204b allow the patient to breathe with minimal effort, strap attachments 214a and 214b to secure the mask body to the patient's or user's head, a ribbed tubing 208 designed to connect to a gas sampling tubing for sampling exhaled breath from a user or patient and a luer lock connector 212 attached to the end of ribbed tubing so as to connect the ribbed tubing with the gas sampling tubing.” Para 0026) having a cushion (via 202, “The peripheral edge of the mask body 202 is contoured so as to substantially seal against the surrounding facial tissue of the patient to establish an inner chamber portion or inner-space. The peripheral edge can be any shape as long as it is contoured so as to substantially seal against the surrounding facial tissue of the patient. The peripheral edge may be formed to include one or more recesses to allow nasal cannula to access the inner-space.” Para 0028) wherein there is an interfacing structure (“one or more recesses” Para 0028) located within the cushion (via 202) in the form of a recess, wherein the recess conforms to an external surface of the non-sealing nasal cannula (“nasal cannula” Para 0028) such that the cushion (via 202) substantially seals about the patient conduit (defined by the source conduit of the “nasal cannula”) of the non-sealing nasal cannula (“nasal cannula” Para 0028).
The resultant effect of this configuration allows for a defined and controlled “access the inner-space” whilst establishing “an inner chamber portion or inner-space” which delineates the patient facing side exposed to the nose and mouth of the patient from the non-patient facing side exposed to the ambient environment that effective enables the pressurized delivery of gases to the interior cavity within the patient facing side.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the interfacing feature of the modified Tatkov to include an interfacing feature which extends through the cushion of the mask as taught by Tiwari to enable a defined and controlled “access the inner-space” whilst establishing “an inner chamber portion or inner-space” which delineates the patient facing side exposed to the nose and mouth of the patient from the non-patient facing side exposed to the ambient environment that effective enables the pressurized delivery of gases to the interior cavity within the patient facing side.
Claim 105 is rejected under 35 U.S.C. 103 as being unpatentable over Tatkov (2012/0305001) in view of Dugan et al. (2012/0285448), as applied to Claim 90, and further in view of Turnberg (2,663,297).
As to Claim 105, the modified Tatkov, specifically Tatkov discloses the patient interface (505) is a non-sealing nasal cannula, having a mask body (510) and/or a filter (530); yet, does not expressly disclose the orientation of “a flexible material configured to conform to the non-sealing nasal cannula” as engaged with the mask body and/or filter.
Turnberg teaches an alternative mask (Figures) including a patient interface (30, “The cannula 30 is provided with a pair of spaced parallel cylindrical intercommunicating elements 31.” Column 2, Lines 15-35) comprising a non-sealing nasal cannula (31, “a pair of spaced parallel cylindrical intercommunicating elements 31.” Column 2, Lines 15-35) and a mask body (12, “This nasal adapter includes a body 12. The body 12 may be made from any suitable molded or sheet synthetic resinous material having the required characteristics of flexibility and resiliency. The body 12 is shaped and configurated to conform to the contours of a human being's nose and at the upper portions thereof is provided with a slot 14 therein. The body 12 about the slot 14 is provided with a padding of foam rubber 16 or of any other suitable soft yet resilient cushioning material. The slot 14 together with the pad 16 protects the bridge of the user's nose.” Column 2, Lines 1-15) comprising a flexible material (32, “A padding 32 of resilient material such as foam rubber is provided to cushion and protect the upper lip of a patient using this device.” Column 2, Lines 15-35) configured to conform to the non-sealing nasal cannula (31).
The resultant effect of the use of the flexible material (32) on the mask body (12) provides cushioning and protection to the upper lip of the patient when using the mask.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the mask body of the modified Tatkov to include the use of a flexible material on the mask body as taught by Turnberg to enable cushioning and protection to the upper lip of the patient when using the mask.
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNETTE F DIXON whose telephone number is (571)272-3392. The examiner can normally be reached M-F 9-5 EST with flexible hours.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
Prosecution Insights