DETAILED ACTION
This Office Action is in response to the interview, conducted on April 9, 2026, and the amendment, filed on April 10, 2026. Primary Examiner acknowledges Claims 1-13 and 15-20 are pending in this application, with Claims 1, 5, 6, 9-11, 13, and 15-17 having been currently amended, and Claim 14 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 § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 7, 9, 10, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Muellinger et al. (2006/0191537) in view of Shannon (3,827,433), Piper et al. (5,479,920), Stenzler et al. (2004/0084048), and Beasley (3,221,733).
As to Claim 1, Muellinger discloses an aerosol mitigation apparatus (best seen Figures 1a and 8), comprising: a mask (50, best seen Figure 8, “In the embodiment according to FIGS. 1a to 4, a mask 50 is attached to the end of the flexible element 59 facing the patient, wherein the mask covers the mouth and nose of the patient so that contaminated air may only flow in or out of the interior of the flexible element 59 and thus to the expiration filter 53.” Para 0051) configured to cover a nose and mouth of the user (“the mask covers the mouth and nose of the patient” Para 0051); at least one oxygen supply port (51, best seen Figure 8, “ A "mouthpiece", i.e., a tube connection extends from the first air outlet opening 12 to an opening 51 in the inhalation mask 50.” Para 0060) associated with the mask (50) and configured to provide oxygen (via “Inhalation Device” of Figures 1a and 8) to the mask (50) for inhalation by the user; an aerosol supply structure (Figures 1a and 8) associated with the mask (50) and configured to supply aerosols for inhalation by the user, the aerosol supply structure (Figure 1a and 8) comprising one of the following items (i) to (iii); (i) an aerosol supply port (defined by the flow of gas from 30 into 51 to 50) associated with the mask (50), (ii) a nebulizer (30, “A mouthpiece 20, which the patient can put in his/her mouth for inhalation, is connected to a nebulizer 30.” Para 0049) associated with the mask (50), and (iii) a cannula (20, “A mouthpiece 20, which the patient can put in his/her mouth for inhalation, is connected to a nebulizer 30.” Para 0049) integrated with the mask (50); an exhaust port (52, best seen Figure 8, “Further, a second opening 52 is provided in the inhalation mask 50, the opening connecting the interior of the inhalation mask 56 to a suction device 54 via a filter 53.” Para 0060) associated with the mask (50) and configured to receive respiratory aerosols emitted by the user; a filter (53, “Further, a second opening 52 is provided in the inhalation mask 50, the opening connecting the interior of the inhalation mask 56 to a suction device 54 via a filter 53.” Para 0060) arranged downstream of the exhaust port (52) to receive and filter respiratory aerosols exhaled by the user; and a device (54,“Further, a second opening 52 is provided in the inhalation mask 50, the opening connecting the interior of the inhalation mask 56 to a suction device 54 via a filter 53.” Para 0060) configured to promote flow of respiratory aerosols from the exhaust port (52) to the filter (53).
Yet, Muellinger does not expressly disclose the mask including “a compliant portion configured to conform to portions of a face of a user”, the nebulizer is “a breath actuated nebulizer”, the filter is “a high efficiency filter … wherein the high efficiency filter is configured to trap viruses”, nor the device configured to promote flow of respiratory aerosols is in the form of a “fan”.
Regarding the concept of the “mask comprising a compliant portion configured to conform to portions of a face of a user”, although Muellinger discloses the mask (50) configured to cover the nose and mouth of the user (“the mask covers the mouth and nose of the patient” Para 0051), Muellinger is silent to the construction of “a compliant portion configured to conform to portions of a face of a user”. Nevertheless, Shannon teaches an additional mask (10, best seen Figures 1-3, “The figures show an infant's mask 10 having a translucent plastic facepiece 12 which is a maximum of about 5 inches wide, and a maximum of about 6 inches high.” Column 2, Lines 45-70) suitable for encompassing the nose and mouth of the user (Figure 1 – in situ), having a compliant portion (20, best seen Figure 3, “Disposed around the periphery of facepiece 12 is an approximately 1 inch wide molding 18, which is fabricated of a soft, resilient, air-tight material, and has an inner annular surface 20 defining a sealing region. The resilience enables the molding to follow the contours of an infant's face, while the softness assures that the pressure of the molding against the skin necessary to maintain a gas-tight seal will not injure or bruise the infant's face. A particularly useful material is closed cell silicone rubber foam (for example, that manufactured by Dow-Corning under the trade designation "medical grade silicone-rubber TRV foam, MDX-4-4521").” Column 2, Line 60 thru Column 3, Line 15) configured to conform to portions of a face of the user (“The resilience enables the molding to follow the contours of an infant's face”) in order to provide “a soft, resilient, air-tight material” about the face of the user. Thus, the resultant effect of the modification of Muellinger to include a “compliant portion” as claimed results in provide “a soft, resilient, air-tight material” about the face of the user.
Regarding the concept of “a breath actuated nebulizer”, although Muellinger discloses the nebulizer (30), Muellinger does not explicitly state the configuration of the nebulizer is “a breath actuated nebulizer”. Nevertheless, Piper teaches a nebulizer (22, “An apparatus for delivering medicinal aerosol on-demand during patient inhalation wherein delivery of aerosol from a nebulizer (22) is optimized by synchronizing delivery to the inspiration of a patient (58) is disclosed.” Abstract; also see: “1. A breath actuated apparatus for on-demand delivery of medicinal aerosol produced by a nebulizer containing medicament aerosolized by a flow of breathable gas …” Column 7, Lines 1-30) in the form of “a breath actuated nebulizer” was a known operational configuration to permit the “on-demand delivery of medicinal aerosol produced by a nebulizer” to the user. Thus, the resultant effect of the modification of Muellinger to include “a breath actuated nebulizer” as claimed results in the “on-demand delivery of medicinal aerosol produced by a nebulizer” to the user.
Regarding the concept of “a high efficiency filter … wherein the high efficiency filter is configured to trap viruses”, although Muellinger discloses the filter (53), Muellinger does not explicitly state the configuration of the filter being “a high efficiency filter … wherein the high efficiency filter is configured to trap viruses”. Nevertheless, Stenzler teaches a filter in the form of a HEPA filter (“If needed, filter materials with smaller porosity may also be used to capture bacteria or viruses. HEPA filters may also be used to capture even smaller viruses. Examples of commercially available gas filters suitable for this use include Allegiance Airlife.TM. (#001851) Bacteria/Viral Filter and Allegiance Airlife.TM. (#001852) HEPA Filter.” Para 0026) was known in order to “reduce exposure of harmful agents to others that may be in the same room as the patient using the mask, filters may be included in the mask or connected to an exit port. The filter may be used to filter any harmful agents including, but not limited to, infectious agents, anesthetic gas, or toxic or harmful chemicals or gas.” (Abstract). Thus, the resultant effect of the modification of Muellinger to include a HEPA filter as claimed results in the ability to “reduce exposure of harmful agents … including, but not limited to, infectious agents, anesthetic gas, or toxic or harmful chemicals or gas”.
Regarding the concept of “a fan”, although Muellinger discloses the device (54,“Further, a second opening 52 is provided in the inhalation mask 50, the opening connecting the interior of the inhalation mask 56 to a suction device 54 via a filter 53.” Para 0060), Muellinger does not explicitly state the device is in the form of a fan. Nevertheless, Beasley teaches a device to promote flow of respiratory aerosols in the form of a fan (24, "Mounted within the case 10 is a pump 16 for drawing or aspirating room air into the system through a filter 18 and compressing it. The pump is powered by the motor 20 which, in turn, is energized by an electric circuit 21 including a switch 22. Preferably, the motor 20 and pump 16 are cooled by means of a fan 24." Column 3, Lines 40-55) therein and connected to a compressor (16, "a pump 16 for drawing or aspirating room air into the system through a filter 18 and compressing it” Column 3, Lines 40-55) to provide a compressed gas flow profile within a breathing device. Thus, the resultant effect of the modification of Muellinger to utilize “a fan” as claimed results in the ability of air to be conveyed.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the mask of Muellinger to include a “a compliant portion”, as taught by Shannon to provide “a soft, resilient, air-tight material” about the face of the user, to modify the nebulizer of Muellinger to be in the form of “a breath actuated nebulizer”, as taught by Piper to provide “on-demand delivery of medicinal aerosol produced by a nebulizer” to the user, to modify the filter of Muellinger to be in the form of “a high efficiency filter … wherein the high efficiency filter is configured to trap viruses” as taught by Stenzler to “reduce exposure of harmful agents … including, but not limited to, infectious agents, anesthetic gas, or toxic or harmful chemicals or gas”, and to modify the device of Muellinger to be in the form of “a fan” as taught by Beasley to direct the conveyance of air.
As to Claim 2, the modified Muellinger, specifically Shannon teaches the construction of the compliant portion (20) comprises silicone (“closed cell silicone rubber foam (for example, that manufactured by Dow-Corning under the trade designation "medical grade silicone-rubber TRV foam, MDX-4-4521").” Column 2, Line 60 thru Column 3, Line 15).
As to Claim 3, the modified Muellinger, specifically Beasley teaches the compressor (16) operates concurrently with the fan (24) to facilitate the "peak flow requirement of a patient is approximately 80 liters per minute occurring near the beginning of inspiration and the maximum pressure requirement is in the range of 10 to 30 cm. of water occurring at the termination of inspiration." (Column 5, Lines 20-40) and further operational parameters to include "The main portion of flow from the pump 16, i.e. between 15 and 18 liters per minute, is routed by the flow divider 28 to the regulator 32." (Column 5, Lines 45-55).
In light of the teachings of Beasley, it was known to include a fan suitable for providing a flow rate within the claimed operational range of 10 to 800 LPM to facilitate the drawing in and aspiration of air for the operations of the breathing device.
Therefore, it would have been obvious to modify the fan of the modified Muellinger to operate within the claimed ranges a taught by Beasley to be known valuations suitable for facilitating the drawing in and aspiration of air for the breathing device.
As to Claim 4, the modified Muellinger, specifically Stenzler teaches an aerosol mitigation apparatus (Figures 1-3, and 7) having at least one oxygen port (via 56, “An additional safety or anti-asphyxiation valve 56 may also be positioned on the inspiratory flow path 50 to allow for entry of room air in the case of emergency or oxygen source failure. Because the dilution valve 72 also allows for room air to enter the inspiratory flow path 50 when the oxygen flow is insufficient to meet the tidal volume of the patient, the safety or anti-asphyxiation valve 56 is redundant and may be provided for additional safety of the mask.” Para 0032) includes an oxygen emergency port (56, “An additional safety or anti-asphyxiation valve 56 may also be positioned on the inspiratory flow path 50 to allow for entry of room air in the case of emergency or oxygen source failure. Because the dilution valve 72 also allows for room air to enter the inspiratory flow path 50 when the oxygen flow is insufficient to meet the tidal volume of the patient, the safety or anti-asphyxiation valve 56 is redundant and may be provided for additional safety of the mask.” Para 0032) configured to admit ambient air for inhalation by the user.
As to Claim 5, the modified Muellinger, specifically Muellinger discloses the orientation of the fan (54, Figures 1a and 8) arranged (A) downstream of the high efficiency filter (53, Figures 1a and 8).
As to Claim 7, the modified Muellinger, specifically Muellinger discloses a flexible hose (best seen Figures 1a and 8) extending between the exhaust port (52) and the high efficiency filter (53).
As to Claim 9, the modified Muellinger, specifically Muellinger discloses the aerosol supply structure (Figure 1a and 8) comprises (i) an aerosol supply port (defined by the flow of gas from 30 into 51 to 50) associated with the mask (50).
As to Claim 10, the modified Muellinger, specifically Muellinger discloses the aerosol supply structure (Figure 1a and 8) comprises (ii) a breath actuated nebulizer (30, “A mouthpiece 20, which the patient can put in his/her mouth for inhalation, is connected to a nebulizer 30.” Para 0049) associated with the mask (50).
As to Claim 12, the modified Muellinger, specifically Shannon teaches a head strap (defined by the combination of 50 and 60, “A flexible fastening strap 50 is secured at one end by a "velcro" closure to facepiece 12, and has perforations 52 near its other end by which it is hooked to the studs 54 secured to facepiece 12. A second strap 60 is secured to the forehead region of the mask by a "velcro" closure (not shown) and has perforations 52 near its other bifurcated end by which the sub-straps 62 are hooked to the studs 64 secured to the chin region of facepiece 12.” Column 3, Lines 10-30) coupled with the mask (10) and configured to secure the mask (10) to the face of the user without air leakage.
As to Claim 13, the modified Muellinger, specifically Stenzler teaches an aerosol mitigation apparatus (Figures 1-3, and 7) having a T joint (30 as engaged with 27, “The mask assembly 10 generally comprises a face piece 20, a hollow manifold housing 30, and a gas reservoir bag 40. A lumen 27 is provided on the face piece 20 that is adapted to receive the manifold housing 30 such that the face piece 20 and the manifold housing 30 are in fluid connection with each other.” Para 0022) coupled with the mask (20), wherein the aerosol supply port (via 50, “The manifold housing 30 is generally a hollow structure and may be comprised of tubing that form an inspiratory limb or flow path 50 and an expiratory limb or flow path 60. The inspiratory flow path 50 directs the oxygen supplied through a gas intake port 52 to the face piece 20. The expiratory flow path 60 directs the exhaled gas from the face piece 20 out to the atmosphere through an exit port 62.” Para 0024) and the exhaust port (via 60, “The manifold housing 30 is generally a hollow structure and may be comprised of tubing that form an inspiratory limb or flow path 50 and an expiratory limb or flow path 60. The inspiratory flow path 50 directs the oxygen supplied through a gas intake port 52 to the face piece 20. The expiratory flow path 60 directs the exhaled gas from the face piece 20 out to the atmosphere through an exit port 62.” Para 0024) are arranged at two legs of the T-joint (30 as engaged with 27).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Muellinger et al. (2006/0191537) in view of Shannon (3,827,433), Piper et al. (5,479,920), Stenzler et al. (2004/0084048), and Beasley (3,221,733), as applied to Claim 1, and further in view of Lee et al. (2009/0151571).
As to Claim 15, modified Muellinger, specifically Stenzler teaches the use of “a high efficiency filter … wherein the high efficiency filter is configured to trap viruses” (Para 0026); yet, does not expressly disclose the configuration “to provide 99.99% viral filtration”.
Lee teaches a HEPA filter treated with “a coating solution containing Kimchi lactic acid bacteria culture fluid” (Para 0040) results in a “virus reduction rate” of “99.99%” after 4 hours (Table 6) in order to produce “excellent antivirus effect” (Para 0044).
Therefore, it would have been obvious to modify the HEPA filter of the modified Muellinger to perform at the claimed ability “to provide 99.99% viral filtration” as taught by Lee in order to impart an “excellent antivirus effect”.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Muellinger et al. (2006/0191537) in view of Shannon (3,827,433), Piper et al. (5,479,920), Stenzler et al. (2004/0084048), and Beasley (3,221,733), as applied to Claim 1, and further in view of Walters et al. (5,829,428).
As to Claim 6, modified Muellinger, specifically Stenzler teaches the use of “a high efficiency filter … wherein the high efficiency filter is configured to trap viruses” (Para 0026); yet, does not expressly disclose "the high efficiency filter comprises a hygroscopic condenser humidifier as part of a hygroscopic condenser humidifier filter."
Walters teaches a breathing apparatus having a filter (via 300, "Vapor retention assembly 300 additionally comprises fluorophilic exchange element 310 having exterior surfaces 320 and 322 as well as hydrophilic exchange element 308 comprising exterior surfaces 316 and 318." Column 21, Lines 35-60) intermediary placed between the exhaust port and the ambient environment to treat by filtration exhausted gases from the patient.
Regarding the remaining limitations of the claims, Walters teaches various types of filters are known in the field of endeavor to include "The oldest and least efficient these devices is the heat and moisture exchanger (or HME) which consists of an aluminum insert and, optionally, a fibrous element. Because aluminum rapidly changes temperatures, moisture is deposited between the layers of the insert during exhalation. The retained heat and moisture is then returned, at least in part, during inhalation. Another type of exchange device is the heat and moisture exchanging filter (HMEF) which contains a hydrophobic fibrous insert that traps heat and adsorbs moisture on the patient side of the filter. Perhaps the most common type of exchange devices today are the hygroscopic condenser humidifiers (HGH) and hygroscopic condenser humidifying filters (HGHF) that use absorption to exchange heat and moisture. These devices comprise an element, typically paper, that is treated with lithium chloride or calcium chloride to increase the thermodynamic efficiency of the exchange. In the HGHF a bacterial filter is juxtaposed between the insert and the source of gas. While the use of artificial noses slightly increases flow resistance in the respiratory circuit, such devices have been found to provide safe and effective humidification for most patients." (Column 2, Line 55 thru Column 3, Line 10) to treat by filtration exhausted gases from the patient.
In light of the teachings of Walters, the decision to choose the filter constructed of the claimed configuration of "a hygroscopic condenser humidifier as part of a hygroscopic condenser humidifier filter" has the benefit of additionally controlling not only particulate filtration but heat and moisture supplied to the ambient environment.
Therefore, would have been obvious to one having ordinary skill in the art to modify the filter of Muellinger to be a hygroscopic condenser humidifier as part of a hygroscopic condenser humidifier filter, as taught by Walters to not only control particulate filtration but heat and moisture supplied to the ambient environment.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Muellinger et al. (2006/0191537) in view of Shannon (3,827,433), Piper et al. (5,479,920), Stenzler et al. (2004/0084048), and Beasley (3,221,733), as applied to Claim 1, and further in view of Fischer (4,248,218).
As to Claim 11, the modified Muellinger, specifically Muellinger discloses the configuration of the mask (50) having a cannula (20, “A mouthpiece 20, which the patient can put in his/her mouth for inhalation, is connected to a nebulizer 30.” Para 0049) integrated with the mask (50); yet, does not expressly disclose the configuration of the cannula as a “nasal cannula”.
Fischer teaches a mask (14, "The assembled invention shown in FIG. 1 is comprised of four major elements: a nosepiece 14, a cannula 10, first conduit means 12 for introducing gas into the cannula through a lateral wall 21a of the nosepiece, and second conduit means 15 for exhausting gas from the nosepiece through the other lateral wall 21b thereof." Column 3, Lines 15-25) having a compliant portion (13, "The nosepiece 14 is a cup-like structure of soft, flexible material designed to fit over the patient's nose, and shaped so that the rim 13 of the nosepiece 14 fits the contour of the patient's face." Column 3, Lines 20-30) to conform to portions of the face of the user and cover the nose of the user, at least one oxygen supply port (12, "first conduit means 12 for introducing gas into the cannula through a lateral wall 21a of the nosepiece" Column 3, Lines 15-25) associated with the mask (14) and configured to provide oxygen to the mask (14) for inhalation by the user; and an exhaust port (15, "second conduit means 15 for exhausting gas from the nosepiece through the other lateral wall 21b thereof" Column 3, Lines 15-25) associated with the mask (14) and configured to receive respiratory aerosols emitted by the user.
Regarding the remaining limitations of the claims, Fischer teaches a nasal cannula (10, "a cannula 10" Column 3, Lines 15-25) integrated with the mask (14) and configured to receive oxygen and/or aerosols, wherein the benefit of the addition of the nasal cannula is the ability to deliver the flow of gas "directly into the patient's nostrils." (Column 2, Lines 15-40).
Therefore it would have been obvious to modify the mask of the modified Muellinger to include the use of nasal cannula therewith as taught by Fischer to enable the direct and efficient delivery of gas immediately to the patient's nostrils.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Muellinger et al. (2006/0191537) in view of Shannon (3,827,433), Piper et al. (5,479,920), Stenzler et al. (2004/0084048), and Beasley (3,221,733), as applied to Claim 1, and further in view of Vrabel (5,009,225).
As to Claim 8, the modified Muellinger, specifically Muellinger discloses the aerosol mitigation apparatus (Figure 1a and 8) having a fan (54); yet, does not expressly disclose the configuration of a “portable battery pack or power supply coupled with the fan”.
Vrabel teaches an aerosol mitigation apparatus (best seen Figure 3) having a fan (124, "In a similar manner, the flow subsystem 112 includes a fan 124, a d.c. motor 126 for driving the fan, and an HEPA filer 128." Column 6, Lines 5-45) to promote flow of respiratory aerosols from the exhaust port (via engagement of 130 to 104) to the high efficiency filter (128).
Regarding the remaining limitations of the claims, Vrabel teaches a portable battery pack (136, "However, as in the instance of the mechanism 24, when the wearer of the mechanism 102 chooses to leave the vicinity of the power source 26, the cord 70 can be withdrawn from the fitting 134 and a backup battery 136 is then operable to simultaneously energize the motors 116, 126." Column 6, Lines 5-45) or power supply (via 70, "The power cord 70 is selectively connected to a receptacle 134 on the outer casing 108 to provide d.c. power to the motors 116, 126 as desired. However, as in the instance of the mechanism 24, when the wearer of the mechanism 102 chooses to leave the vicinity of the power source 26, the cord 70 can be withdrawn from the fitting 134 and a backup battery 136 is then operable to simultaneously energize the motors 116, 126." Column 6, Lines 5-45) coupled with the fan (124). The resultant effect is the ability of the aerosol mitigation apparatus to be operated remotely.
Therefore it would have been obvious to modify the aerosol mitigation apparatus of the modified Muellinger to include a portable battery pack or power supply, as taught by Vrabel to enable the aerosol mitigation apparatus to be operated remotely.
Claims 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Muellinger et al. (2006/0191537) in view of Shannon (3,827,433), Piper et al. (5,479,920), Stenzler et al. (2004/0084048), Beasley (3,221,733), and Lee et al. (2009/0151571).
As to Claim 16, Muellinger discloses a method for reducing aerosol release from a respiring user, the method comprising: supplying oxygen (via “Inhalation Device” of Figures 1a and 8) from at least one supply port (51, best seen Figure 8, “ A "mouthpiece", i.e., a tube connection extends from the first air outlet opening 12 to an opening 51 in the inhalation mask 50.” Para 0060) associated with a mask (50, best seen Figure 8, “In the embodiment according to FIGS. 1a to 4, a mask 50 is attached to the end of the flexible element 59 facing the patient, wherein the mask covers the mouth and nose of the patient so that contaminated air may only flow in or out of the interior of the flexible element 59 and thus to the expiration filter 53.” Para 0051), wherein the mask (50) is configured to cover a nose and mouth of the user (“the mask covers the mouth and nose of the patient” Para 0051), and the oxygen (via “Inhalation Device” of Figures 1a and 8) is to be inhaled by the user through the mask (50); supplying aerosols through an aerosol supply structure (Figures 1a and 8) associated with the mask (50) and configured to supply aerosols for inhalation by the user, the aerosol supply structure (Figure 1a and 8) comprising one of the following items (i) to (iii); (i) an aerosol supply port (defined by the flow of gas from 30 into 51 to 50) associated with the mask (50), (ii) a nebulizer (30, “A mouthpiece 20, which the patient can put in his/her mouth for inhalation, is connected to a nebulizer 30.” Para 0049) associated with the mask (50), and (iii) a cannula (20, “A mouthpiece 20, which the patient can put in his/her mouth for inhalation, is connected to a nebulizer 30.” Para 0049) integrated with the mask (50); and receiving aerosol products exhaled by the user from an exhaust port (52, best seen Figure 8, “Further, a second opening 52 is provided in the inhalation mask 50, the opening connecting the interior of the inhalation mask 56 to a suction device 54 via a filter 53.” Para 0060) associated with the mask (50), and creating a pressure differential using a device (54,“Further, a second opening 52 is provided in the inhalation mask 50, the opening connecting the interior of the inhalation mask 56 to a suction device 54 via a filter 53.” Para 0060) to cause aerosol products to flow to a filter (53, “Further, a second opening 52 is provided in the inhalation mask 50, the opening connecting the interior of the inhalation mask 56 to a suction device 54 via a filter 53.” Para 0060) arranged downstream of the exhaust port (52).
Regarding the concept of the “mask comprising a compliant portion configured to conform to portions of a face of a user”, although Muellinger discloses the mask (50) configured to cover the nose and mouth of the user (“the mask covers the mouth and nose of the patient” Para 0051), Muellinger is silent to the construction of “a compliant portion configured to conform to portions of a face of a user”. Nevertheless, Shannon teaches an additional mask (10, best seen Figures 1-3, “The figures show an infant's mask 10 having a translucent plastic facepiece 12 which is a maximum of about 5 inches wide, and a maximum of about 6 inches high.” Column 2, Lines 45-70) suitable for encompassing the nose and mouth of the user (Figure 1 – in situ), having a compliant portion (20, best seen Figure 3, “Disposed around the periphery of facepiece 12 is an approximately 1 inch wide molding 18, which is fabricated of a soft, resilient, air-tight material, and has an inner annular surface 20 defining a sealing region. The resilience enables the molding to follow the contours of an infant's face, while the softness assures that the pressure of the molding against the skin necessary to maintain a gas-tight seal will not injure or bruise the infant's face. A particularly useful material is closed cell silicone rubber foam (for example, that manufactured by Dow-Corning under the trade designation "medical grade silicone-rubber TRV foam, MDX-4-4521").” Column 2, Line 60 thru Column 3, Line 15) configured to conform to portions of a face of the user (“The resilience enables the molding to follow the contours of an infant's face”) in order to provide “a soft, resilient, air-tight material” about the face of the user. Thus, the resultant effect of the modification of Muellinger to include a “compliant portion” as claimed results in provide “a soft, resilient, air-tight material” about the face of the user.
Regarding the concept of “a breath actuated nebulizer”, although Muellinger discloses the nebulizer (30), Muellinger does not explicitly state the configuration of the nebulizer is “a breath actuated nebulizer”. Nevertheless, Piper teaches a nebulizer (22, “An apparatus for delivering medicinal aerosol on-demand during patient inhalation wherein delivery of aerosol from a nebulizer (22) is optimized by synchronizing delivery to the inspiration of a patient (58) is disclosed.” Abstract; also see: “1. A breath actuated apparatus for on-demand delivery of medicinal aerosol produced by a nebulizer containing medicament aerosolized by a flow of breathable gas …” Column 7, Lines 1-30) in the form of “a breath actuated nebulizer” was a known operational configuration to permit the “on-demand delivery of medicinal aerosol produced by a nebulizer” to the user. Thus, the resultant effect of the modification of Muellinger to include “a breath actuated nebulizer” as claimed results in the “on-demand delivery of medicinal aerosol produced by a nebulizer” to the user.
Regarding the concept of “a high efficiency filter … wherein the high efficiency filter is configured to trap viruses”, although Muellinger discloses the filter (53), Muellinger does not explicitly state the configuration of the filter being “a high efficiency filter … wherein the high efficiency filter is configured to trap viruses”. Nevertheless, Stenzler teaches a filter in the form of a HEPA filter (“If needed, filter materials with smaller porosity may also be used to capture bacteria or viruses. HEPA filters may also be used to capture even smaller viruses. Examples of commercially available gas filters suitable for this use include Allegiance Airlife.TM. (#001851) Bacteria/Viral Filter and Allegiance Airlife.TM. (#001852) HEPA Filter.” Para 0026) was known in order to “reduce exposure of harmful agents to others that may be in the same room as the patient using the mask, filters may be included in the mask or connected to an exit port. The filter may be used to filter any harmful agents including, but not limited to, infectious agents, anesthetic gas, or toxic or harmful chemicals or gas.” (Abstract). Thus, the resultant effect of the modification of Muellinger to include a HEPA filter as claimed results in the ability to “reduce exposure of harmful agents … including, but not limited to, infectious agents, anesthetic gas, or toxic or harmful chemicals or gas”.
Regarding the concept of “a fan”, although Muellinger discloses the device (54,“Further, a second opening 52 is provided in the inhalation mask 50, the opening connecting the interior of the inhalation mask 56 to a suction device 54 via a filter 53.” Para 0060), Muellinger does not explicitly state the device is in the form of a fan. Nevertheless, Beasley teaches a device to promote flow of respiratory aerosols in the form of a fan (24, "Mounted within the case 10 is a pump 16 for drawing or aspirating room air into the system through a filter 18 and compressing it. The pump is powered by the motor 20 which, in turn, is energized by an electric circuit 21 including a switch 22. Preferably, the motor 20 and pump 16 are cooled by means of a fan 24." Column 3, Lines 40-55) therein and connected to a compressor (16, "a pump 16 for drawing or aspirating room air into the system through a filter 18 and compressing it” Column 3, Lines 40-55) to provide a compressed gas flow profile within a breathing device. Thus, the resultant effect of the modification of Muellinger to utilize “a fan” as claimed results in the ability of air to be conveyed.
Regarding the ability of the HEPA filter “to provide 99.99% viral filtration”, although the modified Muellinger in view of Stenzler teaches the use of a HEPA filter, it does not recite the configuration of the HEPA filter “to provide 99.99% viral filtration”. Nevertheless, Lee teaches a HEPA filter treated with “a coating solution containing Kimchi lactic acid bacteria culture fluid” (Para 0040) results in a “virus reduction rate” of “99.99%” after 4 hours (Table 6) in order to produce “excellent antivirus effect” (Para 0044).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the mask of Muellinger to include a “a compliant portion”, as taught by Shannon to provide “a soft, resilient, air-tight material” about the face of the user, to modify the nebulizer of Muellinger to be in the form of “a breath actuated nebulizer”, as taught by Piper to provide “on-demand delivery of medicinal aerosol produced by a nebulizer” to the user, to modify the filter of Muellinger to be in the form of “a high efficiency filter … wherein the high efficiency filter is configured to trap viruses” as taught by Stenzler to “reduce exposure of harmful agents … including, but not limited to, infectious agents, anesthetic gas, or toxic or harmful chemicals or gas”, to modify the device of Muellinger to be in the form of “a fan” as taught by Beasley to direct the conveyance of air, and to modify the HEPA filter of the modified Muellinger in view of Stenzler “to provide 99.99% viral filtration” as taught by Lee in order to impart an “excellent antivirus effect”.
As to Claim 19, the modified Muellinger, specifically Muellinger discloses the configuration of the high efficiency filter (53) and the fan (54) are coupled with the mask (50).
As to Claims 17 and 18, Muellinger discloses a method for reducing aerosol release from a respiring user, the method comprising: supplying oxygen (via “Inhalation Device” of Figures 1a and 8) from at least one supply port (51, best seen Figure 8, “ A "mouthpiece", i.e., a tube connection extends from the first air outlet opening 12 to an opening 51 in the inhalation mask 50.” Para 0060) associated with a mask (50, best seen Figure 8, “In the embodiment according to FIGS. 1a to 4, a mask 50 is attached to the end of the flexible element 59 facing the patient, wherein the mask covers the mouth and nose of the patient so that contaminated air may only flow in or out of the interior of the flexible element 59 and thus to the expiration filter 53.” Para 0051), wherein the mask (50) is configured to cover a nose and mouth of the user (“the mask covers the mouth and nose of the patient” Para 0051), and the oxygen (via “Inhalation Device” of Figures 1a and 8) is to be inhaled by the user through the mask (50); supplying aerosols from a nebulizer (30, “A mouthpiece 20, which the patient can put in his/her mouth for inhalation, is connected to a nebulizer 30.” Para 0049) to an aerosol supply port (defined by the flow of gas from 30 into 51 to 50) associated with the mask (50), wherein the mask (50) is configured to cover a nose and mouth of the user (“the mask covers the mouth and nose of the patient” Para 0051), and the aerosols to be inhaled by the user through the mask (50); receiving aerosol products exhaled by the user from an exhaust port (52, best seen Figure 8, “Further, a second opening 52 is provided in the inhalation mask 50, the opening connecting the interior of the inhalation mask 56 to a suction device 54 via a filter 53.” Para 0060) associated with the mask (50), and creating a pressure differential using a device (54,“Further, a second opening 52 is provided in the inhalation mask 50, the opening connecting the interior of the inhalation mask 56 to a suction device 54 via a filter 53.” Para 0060) to cause aerosol products to flow to a filter (53, “Further, a second opening 52 is provided in the inhalation mask 50, the opening connecting the interior of the inhalation mask 56 to a suction device 54 via a filter 53.” Para 0060) arranged downstream of the exhaust port (52).
Regarding the concept of the “mask comprising a compliant portion configured to conform to portions of a face of a user”, although Muellinger discloses the mask (50) configured to cover the nose and mouth of the user (“the mask covers the mouth and nose of the patient” Para 0051), Muellinger is silent to the construction of “a compliant portion configured to conform to portions of a face of a user”. Nevertheless, Shannon teaches an additional mask (10, best seen Figures 1-3, “The figures show an infant's mask 10 having a translucent plastic facepiece 12 which is a maximum of about 5 inches wide, and a maximum of about 6 inches high.” Column 2, Lines 45-70) suitable for encompassing the nose and mouth of the user (Figure 1 – in situ), having a compliant portion (20, best seen Figure 3, “Disposed around the periphery of facepiece 12 is an approximately 1 inch wide molding 18, which is fabricated of a soft, resilient, air-tight material, and has an inner annular surface 20 defining a sealing region. The resilience enables the molding to follow the contours of an infant's face, while the softness assures that the pressure of the molding against the skin necessary to maintain a gas-tight seal will not injure or bruise the infant's face. A particularly useful material is closed cell silicone rubber foam (for example, that manufactured by Dow-Corning under the trade designation "medical grade silicone-rubber TRV foam, MDX-4-4521").” Column 2, Line 60 thru Column 3, Line 15) configured to conform to portions of a face of the user (“The resilience enables the molding to follow the contours of an infant's face”) in order to provide “a soft, resilient, air-tight material” about the face of the user. Thus, the resultant effect of the modification of Muellinger to include a “compliant portion” as claimed results in provide “a soft, resilient, air-tight material” about the face of the user.
Regarding the concept of “a breath actuated nebulizer”, although Muellinger discloses the nebulizer (30), Muellinger does not explicitly state the configuration of the nebulizer is “a breath actuated nebulizer”. Nevertheless, Piper teaches a nebulizer (22, “An apparatus for delivering medicinal aerosol on-demand during patient inhalation wherein delivery of aerosol from a nebulizer (22) is optimized by synchronizing delivery to the inspiration of a patient (58) is disclosed.” Abstract; also see: “1. A breath actuated apparatus for on-demand delivery of medicinal aerosol produced by a nebulizer containing medicament aerosolized by a flow of breathable gas …” Column 7, Lines 1-30) in the form of “a breath actuated nebulizer” was a known operational configuration to permit the “on-demand delivery of medicinal aerosol produced by a nebulizer” to the user. Thus, the resultant effect of the modification of Muellinger to include “a breath actuated nebulizer” as claimed results in the “on-demand delivery of medicinal aerosol produced by a nebulizer” to the user.
Regarding the concept of “a high efficiency filter … wherein the high efficiency filter is configured to trap viruses”, although Muellinger discloses the filter (53), Muellinger does not explicitly state the configuration of the filter being “a high efficiency filter … wherein the high efficiency filter is configured to trap viruses”. Nevertheless, Stenzler teaches a filter in the form of a HEPA filter (“If needed, filter materials with smaller porosity may also be used to capture bacteria or viruses. HEPA filters may also be used to capture even smaller viruses. Examples of commercially available gas filters suitable for this use include Allegiance Airlife.TM. (#001851) Bacteria/Viral Filter and Allegiance Airlife.TM. (#001852) HEPA Filter.” Para 0026) was known in order to “reduce exposure of harmful agents to others that may be in the same room as the patient using the mask, filters may be included in the mask or connected to an exit port. The filter may be used to filter any harmful agents including, but not limited to, infectious agents, anesthetic gas, or toxic or harmful chemicals or gas.” (Abstract). Thus, the resultant effect of the modification of Muellinger to include a HEPA filter as claimed results in the ability to “reduce exposure of harmful agents … including, but not limited to, infectious agents, anesthetic gas, or toxic or harmful chemicals or gas”.
Regarding the concept of “a fan”, although Muellinger discloses the device (54,“Further, a second opening 52 is provided in the inhalation mask 50, the opening connecting the interior of the inhalation mask 56 to a suction device 54 via a filter 53.” Para 0060), Muellinger does not explicitly state the device is in the form of a fan. Nevertheless, Beasley teaches a device to promote flow of respiratory aerosols in the form of a fan (24, "Mounted within the case 10 is a pump 16 for drawing or aspirating room air into the system through a filter 18 and compressing it. The pump is powered by the motor 20 which, in turn, is energized by an electric circuit 21 including a switch 22. Preferably, the motor 20 and pump 16 are cooled by means of a fan 24." Column 3, Lines 40-55) therein and connected to a compressor (16, "a pump 16 for drawing or aspirating room air into the system through a filter 18 and compressing it” Column 3, Lines 40-55) to provide a compressed gas flow profile within a breathing device. Thus, the resultant effect of the modification of Muellinger to utilize “a fan” as claimed results in the ability of air to be conveyed.
Regarding the ability of the HEPA filter “to provide 99.99% viral filtration”, although the modified Muellinger in view of Stenzler teaches the use of a HEPA filter, it does not recite the configuration of the HEPA filter “to provide 99.99% viral filtration”. Nevertheless, Lee teaches a HEPA filter treated with “a coating solution containing Kimchi lactic acid bacteria culture fluid” (Para 0040) results in a “virus reduction rate” of “99.99%” after 4 hours (Table 6) in order to produce “excellent antivirus effect” (Para 0044).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the mask of Muellinger to include a “a compliant portion”, as taught by Shannon to provide “a soft, resilient, air-tight material” about the face of the user, to modify the nebulizer of Muellinger to be in the form of “a breath actuated nebulizer”, as taught by Piper to provide “on-demand delivery of medicinal aerosol produced by a nebulizer” to the user, to modify the filter of Muellinger to be in the form of “a high efficiency filter … wherein the high efficiency filter is configured to trap viruses” as taught by Stenzler to “reduce exposure of harmful agents … including, but not limited to, infectious agents, anesthetic gas, or toxic or harmful chemicals or gas”, to modify the device of Muellinger to be in the form of “a fan” as taught by Beasley to direct the conveyance of air, and to modify the HEPA filter of the modified Muellinger in view of Stenzler “to provide 99.99% viral filtration” as taught by Lee in order to impart an “excellent antivirus effect”.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Muellinger et al. (2006/0191537) in view of Shannon (3,827,433), Piper et al. (5,479,920), Stenzler et al. (2004/0084048), Beasley (3,221,733), and Lee et al. (2009/0151571), as applied to Claim 16, and further in view of Vrabel (5,009,225).
As to Claim 20, the modified Muellinger, specifically Muellinger discloses the aerosol mitigation apparatus (Figure 1a and 8) having a fan (54); yet, does not expressly disclose the configuration of a “portable battery pack or power supply coupled with the fan”.
Vrabel teaches an aerosol mitigation apparatus (best seen Figure 3) having a fan (124, "In a similar manner, the flow subsystem 112 includes a fan 124, a d.c. motor 126 for driving the fan, and an HEPA filer 128." Column 6, Lines 5-45) to promote flow of respiratory aerosols from the exhaust port (via engagement of 130 to 104) to the high efficiency filter (128).
Regarding the remaining limitations of the claims, Vrabel teaches a portable battery pack (136, "However, as in the instance of the mechanism 24, when the wearer of the mechanism 102 chooses to leave the vicinity of the power source 26, the cord 70 can be withdrawn from the fitting 134 and a backup battery 136 is then operable to simultaneously energize the motors 116, 126." Column 6, Lines 5-45) or power supply (via 70, "The power cord 70 is selectively connected to a receptacle 134 on the outer casing 108 to provide d.c. power to the motors 116, 126 as desired. However, as in the instance of the mechanism 24, when the wearer of the mechanism 102 chooses to leave the vicinity of the power source 26, the cord 70 can be withdrawn from the fitting 134 and a backup battery 136 is then operable to simultaneously energize the motors 116, 126." Column 6, Lines 5-45) coupled with the fan (124). The resultant effect is the ability of the aerosol mitigation apparatus to be operated remotely.
Therefore it would have been obvious to modify the aerosol mitigation apparatus of the modified Muellinger to include a portable battery pack or power supply, as taught by Vrabel to enable the aerosol mitigation apparatus to be operated remotely.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot.
As addressed in the interview, the newly located Muellinger et al. (2006/0191537) alone, or in combination appears to meet the limitations of the proposed claims.
It is appreciated Applicant has further amended the claims as filed to further include the operational features of the HEPA filter to operate “to provide 99.99% viral filtration” as seen in independent Claims 16 and 17, however, further search and consideration has yielded newly located prior art reference Lee et al. (2009/0151571) which appears to teach these aforementioned features. Explicitly, Lee teaches a HEPA filter treated with “a coating solution containing Kimchi lactic acid bacteria culture fluid” (Para 0040) results in a “virus reduction rate” of “99.99%” after 4 hours (Table 6) in order to produce “excellent antivirus effect” (Para 0044).
Furthermore, the grounds of rejection now include a modification of Muellinger et al. (2006/0191537) in combination with Stenzler et al. (2004/0084048), whereby Stenzler teaches a filter in the form of a HEPA filter (“If needed, filter materials with smaller porosity may also be used to capture bacteria or viruses. HEPA filters may also be used to capture even smaller viruses. Examples of commercially available gas filters suitable for this use include Allegiance Airlife.TM. (#001851) Bacteria/Viral Filter and Allegiance Airlife.TM. (#001852) HEPA Filter.” Para 0026) was known in order to “reduce exposure of harmful agents to others that may be in the same room as the patient using the mask, filters may be included in the mask or connected to an exit port. The filter may be used to filter any harmful agents including, but not limited to, infectious agents, anesthetic gas, or toxic or harmful chemicals or gas.” (Abstract). Thus the limitations to the operation of the HEPA filter to “trap viruses” was known, as now claimed in independent Claim 1.
In light of the aforementioned reasoning the rejection of the claims has been maintained and made FINAL.
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.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
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