DETAILED ACTION
Primary Examiner acknowledges Claims 1-20 are pending in this application, with Claims 7-15, 19, and 20 having been currently amended by preliminary amendment on February 28, 2023.
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 .
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
In this particular case, the drawings, filed on February 28, 2023, for Figures 3A-3C, 4A, 4B, 5A-5C, 6A, 6B, 7A, 7B, 8A, 8B, 9A, 9B, 17, and 20 are color photographs and do not appear to be in sufficient quality to permit a clear understanding of the claimed invention and to permit examination of this application. Appropriate correction is required.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
Reference character “48” has been used to designate “exhaust port” and “outlet”. Appropriate correction is required.
Reference character “92” has been used to designate “frontward opening” and “mask”. Appropriate correction is required.
Reference character “99” has been used to designate “subject” and “user”. Appropriate correction is required.
Reference characters “22” and “48” have been used to designate “exhaust port”. Appropriate correction is required.
Reference characters “36” and “48” have been used to designate “outlet”. Appropriate correction is required.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Reference character “48” has been used to designate “exhaust port” and “outlet”. Appropriate correction is required.
Reference character “92” has been used to designate “frontward opening” and “mask”. Appropriate correction is required.
Reference character “99” has been used to designate “subject” and “user”. Appropriate correction is required.
Reference characters “22” and “48” have been used to designate “exhaust port”. Appropriate correction is required.
Reference characters “36” and “48” have been used to designate “outlet”. Appropriate correction is required.
Claim Objections
Claim 5 is objected to because of the following informalities: Line 3 recites the term “filter” without a period ending the claim. Pursuant to MPEP 608.01(m), “ Each claim begins with a capital letter and ends with a period.”. Thus, Claim 5 requires a period at the end of the word “filter”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6 and 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Specifically, Claim 6, Line 1 recites the term “the filter” which lacks antecedent basis in the claims. It appears the recitation should be “the high efficiency filter” to meet consistent recitation of claim limitations, as first introduced in Claim 1. Appropriate correction and clarification is required.
Specifically, Claim 13 improperly depends from Claim 1. The limitation of “a aerosol supply port” was initially introduced in Claim 9, thus the reference to “the aerosol supply port requires the dependency of Claim 13 to Claim 9 instead of Claim 1. Appropriate correction and clarification is required.
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.
Claims 1, 5, 7, 8, 14, 16, 19, and 20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Vrabel (5,009,225).
As to Claim 1, Vrabel discloses an aerosol mitigation apparatus (best seen Figure 3), comprising: a mask (104, “In this embodiment, a surgical hood diagrammatically represented at 104 is provided which may be substantially similar to the hood 22.” Column 5, Line 50 thru Column 6, Line 10) comprising a compliant portion (106, “However, in this instance, a suitable seal is schematically represented at 106 as a construction in which the space enclosed by the face plate is suitably isolated from the atmosphere.” Column 5, Line 50 thru Column 6, Line 10) configured to conform to portions of a face of a user and cover a nose and mouth of the user (“A personal ventilating system for use with a surgical hood enveloping at least the wearer's face and isolating from the surrounding atmosphere the breathing space proximate the wearer's nose and mouth” Column 7, Lines 30-35; and Column 8, Lines 15-25); at least one oxygen supply port (via engagement of 120 to 104, “Additionally, a pressurized ventilation conduit 120 is sealingly connected via a projecting port member 122 to the outer casing 108 and serves to introduce air from the surrounding atmosphere into the surgical hood 104, particularly in the region of the face plate 34.” Column 6, Lines 5-45) associated with the mask (104) and configured to provide oxygen (Air is approximately 20% oxygen and other gases) to the mask (104) for inhalation by the user; an exhaust port (via engagement of 130 to 104, “Also, a suction ventilation conduit 130 is sealingly connected to the casing 108 via a projecting port member 132 and serves to draw air from the surgical hood 104 and particularly from the region behind the face plate.” Column 6, Lines 5-45) associated with the mask (104) and configured to receive respiratory aerosols emitted by the user; a high efficiency filter (128, “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) arranged downstream of the exhaust port (via engagement of 130 to 104) to receive and filter respiratory aerosols exhaled by the user; and 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).
As to Claim 5, Vrabel discloses the fan (124) is arranged between the exhaust port (via engagement of 130 to 104) and the high efficiency filter (128).
As to Claim 7, Vrabel discloses a flexible hose (130, “Also, a suction ventilation conduit 130 is sealingly connected to the casing 108 via a projecting port member 132 and serves to draw air from the surgical hood 104 and particularly from the region behind the face plate.” Column 6, Lines 5-45) extending between the exhaust port (via engagement of 130 to 104) and the high efficiency filter (128).
As to Claim 8, Vrabel discloses 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).
As to Claim 14, Vrabel discloses the high efficiency filter (128) comprises a HEPA filter (“an HEPA filer 128.” Column 6, Lines 5-45).
As to Claim 16, please see the rejection of Claim 1. Regarding the phrase “creating a pressure differential” the energizing of the fan (124) causes the exhaled aerosol from the user to be drawn from the mask (104) at the exhaust port (via engagement of 130 to 104) along the hose (130) through the fan (124) and to the high efficacy filter (128) before being exhausted to the ambient environment as shown in Figure 3.
As to Claim 19, Vrabel discloses the high efficiency filter (128) and the fan (124) are coupled with the mask (104).
As to Claim 20, Vrabel discloses the fan (124) comprises a battery powered fan (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).
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 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Vrabel (5,009,225) in view of Shannon (3,827,433).
As to Claim 2, Vrabel discloses a compliant portion (106) of the mask (104); yet, does not expressly disclose the material composition of the compliant portion to be silicone.
Shannon teaches a mask (12, “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 45-65) with a compliant portion (18, “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.” Column 2, Line 65 thru Column 3, Line 15) to conform to a portion of the users face covering the nose and mouth of the patient, and further having at least one oxygen supply port (24 via 34, “Formed integrally with the facepiece 12 are flanges 24, 26 over which are secured, respectively, an inhalation tube 34 and an exhalation tube 36 (both formed e.g., of "Tigon").” Column 3, Lines 10-25) and an exhaust port (26 via 36, “Formed integrally with the facepiece 12 are flanges 24, 26 over which are secured, respectively, an inhalation tube 34 and an exhalation tube 36 (both formed e.g., of "Tigon").” Column 3, Lines 10-25).
Regarding the material composition of the compliant portion (18) of the mask (12), Shannon teaches the use of silicone (“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"). In addition to forming gas-tight seals, the material has a "spongy" texture, so that it does not tend to slip along the skin.” Column 2, Line 65 thru Column 3, Line 15) to “maintain a gas-tight seal will not injure or bruise the infant's face.” (Column 2, Line 65 thru Column 3, Line 15).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the compliant seal of Vrabel to be made of silicone, as taught by Shannon to be a known material composition suitable for ensuring conformability and a gas tight seal without injuring or bruising the patient’s face.
As to Claim 12, Vrabel discloses a mask (104); yet, does not expressly disclose the use of “a head strap coupled with the mask and configured to secure the mask to the face of the user without air leakage”.
Shannon teaches a mask (12, “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 45-65) with a compliant portion (18, “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.” Column 2, Line 65 thru Column 3, Line 15) to conform to a portion of the users face covering the nose and mouth of the patient, and further having at least one oxygen supply port (24 via 34, “Formed integrally with the facepiece 12 are flanges 24, 26 over which are secured, respectively, an inhalation tube 34 and an exhalation tube 36 (both formed e.g., of "Tigon").” Column 3, Lines 10-25) and an exhaust port (26 via 36, “Formed integrally with the facepiece 12 are flanges 24, 26 over which are secured, respectively, an inhalation tube 34 and an exhalation tube 36 (both formed e.g., of "Tigon").” Column 3, Lines 10-25).
Regarding the remaining limitations of the claims, Shannon teaches a head strap (50/60, “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 (12) and configured to secure the mask (12) to the face of the user without air leakage.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the mask of Vrabel to include the use of a head strap, as taught by Shannon to secure the mask to the face of the patient so that the mask remains in a gas tight seal as conformed to the patient’s face.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Vrabel (5,009,225) in view of Beasley (3,221,733).
As to Claim 3, Vrabel discloses a fan (124); yet, does not expressly disclose the operational parameters met by the fan.
Beasley teaches a breathing device (10, “Referring to the drawings, and in particular to FIGURE 1, the respiration unit of the invention may be seen to comprise generally a case 1l0 with a front control panel 11 housing regulation and control equipment, and delivery means 12 including a suitable face mask 14 for supplying the compressed air and, optionally, nebulized medication or water to the patient.” Column 3, Lines 25-40) having 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 the breathing device (10).
Regarding the remaining limitations of the claims, 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 Vrabel 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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Vrabel (5,009,225) in view of Reinstadtler (2007/0163592).
As to Claim 4, Vrabel discloses a mask (104) with at least one oxygen supply port (via engagement of 120 to 104); yet, does not expressly disclose “the at least one oxygen port includes an oxygen emergency port configured to admit ambient air for inhalation by the user.”
Reinstadtler teaches an alternative mask (20, “The face piece 20 includes a clearance 27 to which the distributor housing 30 is connected. The distributor housing 30 is a hollow structure with a piping, which includes an inspiration passage or arm 50 and an expiration passage or arm 60” Para 0003) having at least one oxygen port (via the pathway of gas from 52 to 50 to 54 to 27 to 20, wherein “The inspiration arm conducts the oxygen supplied through a gas inlet connection 52 toward the face piece 20.” Para 0003).
Regarding the remaining limitations of the claims, Reinstadtler teaches an oxygen emergency port (56, “An anti-suffocation valve 56 is provided in parallel to the dilution valve 72, which is redundant in EP 1 402 915 A1.” Para 0007; also see: “ The release pressure of the anti-suffocation valve 56 must be greater with respect to its amount than this negative airway pressure because the gas supplied via the gas inlet connection 52 is otherwise diluted with ambient air.” Para 0034) configured to admit ambient air for inhalation by the user.
The resultant effect prevents the suffocation of the patient in the advent insufficient gas is provided by the gas inlet connection 52.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the at least one oxygen port of Vrabel to include the use of an oxygen emergency port, as taught by Reinstadtler to prevent the suffocation of the patient.
Claims 6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Vrabel (5,009,225) in view of Walters et al. (5,829,428).
As to Claim 6, Vrabel discloses the high efficiency filter (128) comprises a HEPA filter (“an HEPA filer 128.” Column 6, Lines 5-45) having “a 99.97% efficiency in removing particles down to 0.3 micron size.” (Column 4, Lines 35-50); 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 Vrabel 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.
As to Claim 15, please see the rejection of Claim 6. The difference between Claim 6 and Claim 15 is the expressed recitation of “a bacterial/viral filter”. Yet, the modified Vrabel, explicitly Walters teaches “HGHF [is] a bacterial filter” (Column 2, Line 55 thru Column 3, Line 10).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Vrabel (5,009,225) in view of Bordoni et al. (4,823,784).
As to Claim 15, Vrabel discloses the high efficiency filter (128) comprises a HEPA filter (“an HEPA filer 128.” Column 6, Lines 5-45) having “a 99.97% efficiency in removing particles down to 0.3 micron size.” (Column 4, Lines 35-50); yet, does not expressly disclose “the high efficiency filter comprises a bacterial/viral filter”.
Bordoni teaches a breathing apparatus having a filter (28, “A third conduit 27 extends from the intersection of the conduits 20, 22 and 24 to a bacteria-viral filter 28, via a one-way valve 29 which allows the patient to exhale into the ambient as indicated by the arrowheaded line 31, the filter 28 removing microorganisms, including viruses, and the aerosolized treating agent. In a realized embodiment of the apparatus, a commercially available filter sold under the Model No. 0811 by Amici Inc. of 740 Walnut Street, Rogersford, Pa. was used. Thus, the environment and personnel are protected.” Column 5, Lines 35-65) intermediary placed between the exhaust port and the ambient environment to treat by filtration exhausted gases from the patient to protect the ambient environment by “removing microorganisms, including viruses, and the aerosolized treating agent”
Therefore, it would have been obvious to one having ordinary skill in the art to modify the filter of Vrabel to be a “bacterial/viral filter” as taught by Bordoni to be a known filter type suitable to protect the ambient environment.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Vrabel (5,009,225) in view of Fischer (4,248,218).
As to Claim 11, Vrabel discloses a mask (104); yet, does not expressly disclose the use of “a nasal cannula integrated with the mask and configured to receive oxygen and/or aerosols.”
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 Vrabel 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.
Claims 9, 10, 13, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Vrabel (5,009,225) in view of Piper et al. (5,479,920).
As to Claim 9, Vrabel discloses a mask (104); yet, does not expressly disclose the use of “an aerosol supply port associated with the mask and configured to supply aerosols from a nebulizer to the mask to be inhaled by the user.”
Piper teaches a breathing apparatus (Figures 1 and 2) having a mask (66, “Referring also to FIG. 2, it can be seen that instead of using a mouthpiece 56 as shown in FIG. 1, a face mask 66 can be coupled to outlet 54. In this configuration, face mask 66 is a conventional face mask without an integral exhalation valve, and is substituted for mouthpiece 56.” Column 5, Lines 15-35) covering the nose and mouth of the user; at least one oxygen supply port (24, “A one-way (unidirectional) inhalation valve 24, which is a conventional flapper valve or the like wherein the valve opens to permit flow in one direction but closes to prevent flow in the other direction, is coupled to second leg 14. In the present invention, inhalation valve 24 permits ambient air to be drawn into second leg 14 during inhalation but closes during patient exhalation.” Column 4, Lines 10-35) associated (via pathway of flow from 24-14-16-52-54-66) with the mask (66) and configured to provide oxygen (Air is approximately 20% oxygen and other gases) to the mask (66) for inhalation by the user; an exhaust port (60, “Outlet 54, which serves as an aerosol outlet port, is coupled to a mouthpiece 56 which is inserted into the mouth of a patient 58, and a one-way (unidirectional) exhalation valve 60 is coupled to second leg 62 which serves as an exhalation gas outlet port. Similar to inhalation valve 24, exhalation valve 60 comprises a conventional flapper valve or the like wherein the valve opens to permit flow in one direction but closes to prevent flow in the other direction. In the present invention, exhalation valve 60 opens to permit exhalation gases to be vented during exhalation but closes during inhalation. Additionally, a filter 64 can be coupled to exhalation valve 60 for purposes of preventing medicine and bacteria present in the exhalation gases from entering the ambient air.” Column 5, Lines 1-20) associated (via pathway of flow from 66-54-62-60) with the mask (66) and configured to receive respiratory aerosols emitted by the user; a high efficiency filter (64, “Additionally, a filter 64 can be coupled to exhalation valve 60 for purposes of preventing medicine and bacteria present in the exhalation gases from entering the ambient air.” Column 5, Lines 1-20) arranged downstream of the exhaust port (60) to receive respiratory aerosols exhaled by the user.
Regarding the remaining limitations of the claims, Piper teaches an aerosol supply port (12, “Referring to FIG. 1, the present invention includes a conventional wye fitting 10 or the like which has a first leg 12 which serves as an aerosol inlet port, a second leg 14 which serves as an air inlet port, and an outlet 16 which serves as an aerosol outlet port. One end of an aerosol supply conduit 18 is coupled to first leg 12; the other end of aerosol supply conduit 18 includes conventional means for coupling to the aerosol outlet 20 of a conventional nebulizer 22 or the like.” Column 4, Lines 10-35) associated (via pathway of gas from 12-52-54-66) with the mask (66) and configured to supply aerosols from a nebulizer (22, “a conventional nebulizer 22” Column 4, Lines 10-35) to the mask (66) to be inhaled by the user.
The resultant effect is the ability to supply not only oxygen/air but additionally medicament to the user for inhalation support and treatment of the patient in a synchronized manner (“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).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the mask of Vrabel to additionally include an aerosol supply port in addition to the at least one oxygen supply port, as taught by Piper to enable “synchronizing delivery” to the patient of both oxygen/air but additionally medicament to the user for inhalation support and treatment of the patient.
As to Claim 10, please see the rejection of Claim 9. The difference between Claim 9 and Claim 10 is the requirement of the nebulizer to be “breath actuated”. The modified Vrabel, specifically Piper expressly discloses the nebulizer is breath actuated (“Breath Actuated Medicinal Aerosol Delivery Apparatus” Title).
As to Claim 17, please see the rejections of Claim 16 and 9, wherein Claim 16 addresses the features of the “pressure differential” and Claim 9 addresses the features of a “nebulizer” with associated aerosol supply port. The modified, Vrabel, specifically Piper teaches the claimed configuration to impart “optimized by synchronizing delivery to the inspiration of a patient (58).” Abstract).
As to Claim 18, please see the rejection of Claim 17. The difference between Claim 17 and Claim 18 is the requirement of the nebulizer to be “breath actuated”. The modified Vrabel, specifically Piper expressly discloses the nebulizer is breath actuated (“Breath Actuated Medicinal Aerosol Delivery Apparatus” Title).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ishikita (2013/0118484) and King (5,727,542) each disclose an additional aerosol mitigation apparatus suitable for imparting a patient interface, at least one oxygen supply port, an exhaust port, and a high efficiency filter; yet, do not expressly disclose the features of a fan to promote the flow of gases from the exhaust port to the high efficiency filter.
Dryden (3,960,148) and Rapoport et al. (2024/0277966) each disclose an additional aerosol mitigation apparatus suitable for imparting a patient interface, at least one oxygen supply port, an exhaust port, and a fan; yet, do not expressly disclose the features of a nebulizer with associated aerosol supply port.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra D Carter can be reached at 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785