DETAILED ACTION
Primary Examiner acknowledges Claims 21-39 are pending in this application, with Claims 21-39 having been newly added, and Claims 1-20 having been cancelled by preliminary amendment on October 16, 2024.
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
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
Reference character “4180” has been used to designate “oxygen delivery” and “supplemental oxygen”. Appropriate correction is required.
Reference character “4272” has been used to designate “pressure”, “pressure transducer”, and “pressure sensor”. Appropriate correction is required.
Reference character “4274” has been used to designate “flow”, “flow sensor”, and “flow transducer”. Appropriate correction is required.
Reference character “5002” has been used to designate “air inlet”, “humidifier inlet”, and “inlet”. Appropriate correction is required.
Reference character “5004” has been used to designate “air outlet”, “humidifier outlet”, and “outlet”. Appropriate correction is required.
Reference character “5200” has been used to designate “humidification chamber” and “humidifier chamber”. Appropriate correction is required.
Reference characters “5002” and “5206” have been used to designate “inlet”. 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 “4180” has been used to designate “oxygen delivery” and “supplemental oxygen”. Appropriate correction is required.
Reference character “4272” has been used to designate “pressure”, “pressure transducer”, and “pressure sensor”. Appropriate correction is required.
Reference character “4274” has been used to designate “flow”, “flow sensor”, and “flow transducer”. Appropriate correction is required.
Reference character “5002” has been used to designate “air inlet”, “humidifier inlet”, and “inlet”. Appropriate correction is required.
Reference character “5004” has been used to designate “air outlet”, “humidifier outlet”, and “outlet”. Appropriate correction is required.
Reference character “5200” has been used to designate “humidification chamber” and “humidifier chamber”. Appropriate correction is required.
Reference characters “5002” and “5206” have been used to designate “inlet”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21, 23-31, and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Anthony (2006/0012057) in view of Mulvaney (6,622,993).
As to Claim 21, Anthony discloses a device (Figure 3) for humidifying a flow of air (via 13, “In another embodiment shown on FIG. 3, said device comprises a housing 1 having a bottom 2, and a cover 4, wherein said housing 1 is provided with an inlet opening 5 for the supply of medical gas as illustrated with arrow 13, and an outlet opening 6 for the treated medical gas as illustrated with arrow 14, further comprising conditioning means for the humidification and warming of said gas.” Para 0033), the device (Figure 3) comprising: a humidification chamber (1, “In another embodiment shown on FIG. 3, said device comprises a housing 1 having a bottom 2, and a cover 4, wherein said housing 1 is provided with an inlet opening 5 for the supply of medical gas as illustrated with arrow 13, and an outlet opening 6 for the treated medical gas as illustrated with arrow 14, further comprising conditioning means for the humidification and warming of said gas.” Para 0033) having a first end (5, “In another embodiment shown on FIG. 3, said device comprises a housing 1 having a bottom 2, and a cover 4, wherein said housing 1 is provided with an inlet opening 5 for the supply of medical gas as illustrated with arrow 13, and an outlet opening 6 for the treated medical gas as illustrated with arrow 14, further comprising conditioning means for the humidification and warming of said gas.” Para 0033) configured to receive the flow of air and a second end (6, “In another embodiment shown on FIG. 3, said device comprises a housing 1 having a bottom 2, and a cover 4, wherein said housing 1 is provided with an inlet opening 5 for the supply of medical gas as illustrated with arrow 13, and an outlet opening 6 for the treated medical gas as illustrated with arrow 14, further comprising conditioning means for the humidification and warming of said gas.” Para 0033) opposite the first end (5) configured to direct the flow of air to a patient interface (via “delivered via nose or mouth to the lungs”, e.g. “However, when a patient is undergoing artificial respiration the nose is shunted by a flexible tube, whose distal end is inserted into the trachea.” Para 0002, and “According to an embodiment, the inlet 5 and outlet 6 have connection pipes, illustrated respectively as 5a and 6a on FIGS. 2 and 4, planned for attaching a tube. … The connecting pipe 6a on the outlet can be connected to tube, which supplies gas to a patient.” Para 0040, also see: “It also relates to any gas to be delivered to body cavities or organs of an individual in need thereof, such as for example such as normal air to be delivered via nose or mouth to the lungs, or O.sub.2/CO.sub.2 gas mixtures to be provided during laparoscopic surgery.” Para 0028); a water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3, “The space between the heating device and the rigid evaporating body may also be larger than 0.1 cm, and may be in such case further provided therein with a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like. For example, the space between the heating device and the rigid evaporating body may be provided with a second rigid evaporating body with water absorbing properties. The thin layer of water would be inserted in said second water absorbing properties.” Para 0011, wherein 7 – “a rigid evaporating body 7 arranged in said housing 1 between said inlet 5 and outlet 6, a heating device 8, and a water inlet 9, characterized in that said rigid evaporating body 7 and said heating device 8 are arranged in a concentric way forming a space 11 between them and wherein said water inlet 9 is connected to the housing such that a thin layer of water is able to be inserted between the heating device 8 and the rigid evaporating body 7. As illustrated FIG. 3, said rigid evaporating body 7 is surrounded by said heating device 8 in a concentric way forming a space 11 between them.” Para 0033 and wherein 8 – “a rigid evaporating body 7 arranged in said housing 1 between said inlet 5 and outlet 6, a heating device 8, and a water inlet 9, characterized in that said rigid evaporating body 7 and said heating device 8 are arranged in a concentric way forming a space 11 between them and wherein said water inlet 9 is connected to the housing such that a thin layer of water is able to be inserted between the heating device 8 and the rigid evaporating body 7. As illustrated FIG. 3, said rigid evaporating body 7 is surrounded by said heating device 8 in a concentric way forming a space 11 between them.” Para 0033) positioned inside of the humidification chamber (1) and shaped to substantially surround a path for the flow of air (via 13) through the humidification chamber (1); a heating element (8, “a rigid evaporating body 7 arranged in said housing 1 between said inlet 5 and outlet 6, a heating device 8, and a water inlet 9, characterized in that said rigid evaporating body 7 and said heating device 8 are arranged in a concentric way forming a space 11 between them and wherein said water inlet 9 is connected to the housing such that a thin layer of water is able to be inserted between the heating device 8 and the rigid evaporating body 7. As illustrated FIG. 3, said rigid evaporating body 7 is surrounded by said heating device 8 in a concentric way forming a space 11 between them.” Para 0033) configured to heat the water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3) to evaporate (via 7 - “a rigid evaporating body 7” Para 0033) absorbed water into the flow of air (via 13); and a reservoir (“a water reservoir” via 9, “The water inlet 9 is connected to said space 11. The water to be supplied is preferably held in a water reservoir that is connected to said inlet 9. Said water reaches the interior of the space 11 via the water supply inlet 9.” Para 0044; also see: “a water inlet 9, characterized in that said rigid evaporating body 7 and said heating device 8 are arranged in a concentric way forming a space 11 between them and wherein said water inlet 9 is connected to the housing such that a thin layer of water is able to be inserted between the heating device 8 and the rigid evaporating body 7.” Para 0033) positioned outside of the humidification chamber (1), the reservoir (“a water reservoir” via 9) configured to retain a water supply (“The water to be supplied is preferably held in a water reservoir that is connected to said inlet 9.” Para 0044), and the reservoir (“a water reservoir” via 9) being in fluid communication with the water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3) to direct the water supply (“water to be supplied” Para 0044) to the water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3).
Yet, Anthony does not expressly disclose the flow of air is “pressurized by a blower”
Mulvaney teaches a device (Figures 1-3) for humidifying a flow of air (defined by arrows as shown in Figures 1-3) pressurized by a blower (18, “A humidification unit 16 is provided and includes a blower assembly 18 comprising a housing 20 defining an air inlet 22 and an air outlet 24. An evaporative air flow path 26 extends between the air inlet 22 and the air outlet 24. The blower assembly 18 further includes a conventional motor 28 supported by the housing 20 and operably connected to a fan 30. The fan 30 includes a plurality of blades 32 for propelling air from the air inlet 22 through the air flow path 26 and out through the air outlet 24.” Column 4, Lines 35-55), the device (Figures 1-3) comprising a humidification chamber (20, “A humidification unit 16 is provided and includes a blower assembly 18 comprising a housing 20 defining an air inlet 22 and an air outlet 24.” Column 4, Lines 35-55) having a first end (22) and a second end (24), a water absorbent material (34, “An evaporative media, in the form of a wick 34, is provided in fluid communication with the water 14 within the reservoir 12. The wick 34 includes a lower portion 36 adapted to be received in adsorbing contact with the water 14 and an upper portion 38 extending upwardly into the air flow path 26 of the housing 20. The wick 34 may be of conventional design as consisting of an expanded cotton-cellulose material, such as that manufactured by Columbus Industries of Ashville, Ohio.” Column 4, Line 50 thru Column 5, Line 5), a heating element (“heat added from the motor 28”, “The air outlet temperature (T.sub.8) may be greater than the air inlet temperature (T.sub.6) at time (t.sub.5) due to heat added from the motor 28 to the air exiting the air outlet 24.” Column 10, Lines 10-30), and a reservoir (12, “An evaporative media, in the form of a wick 34, is provided in fluid communication with the water 14 within the reservoir 12.” Column 4, Line 50 thru Column 5, Line 5).
Regarding the remaining limitations of the claims, Mulvaney teaches the use of a blower (18) to impart a pressure differential across the humidification chamber (20) to convey the flow of air (defined by arrows as shown in Figures 1-3), whereby the operation of the blower (18) directs the flow of air from the first end (22) of the humidification chamber (20) to the second end (24) of the humidification chamber (20).
Although Mulvaney orients their blower (18) at the second end (24), the configuration of orienting the blower (18) at the first end (22) would be obvious to try choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to create a pressure differential across the humidification chamber to convey the flow of air to the patient.
In light of the teachings of Mulvaney, the modification of Anthony to include a blower oriented on the first end would yield the predictable results of providing the ability to convey the flow of air through a pressure differential from the source/supply to the patient.
Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with Anthony as modified by Mulvaney in order to provide the ability to convey the flow of air through a pressure differential from the source/supply to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the source/supply of air of Anthony to be pressurized by a blower, as taught by Mulvaney to be a known construction suitable for providing the ability to convey the flow of air through a pressure differential from the source/supply to the patient in humidification devices.
As to Claim 23, the modified Anthony, specifically Anthony discloses the heating element (8) is an electrical resistance heater (“Said heating device 8 can be a self-adjusting resistance of the PTC-type. It can comprise a heating component 10, which may be cylindrical as shown FIG. 3, which surround a metallic element cylinder, such as an anodized aluminum cylinder.” Para 0033).
As to Claim 24, the modified Anthony, specifically Anthony discloses the heating element (8) is positioned on an opposite side of the water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3) from the flow of air (via 13).
As to Claim 25, the modified Anthony, specifically Anthony discloses a housing (via 2 and 4, “In another embodiment shown on FIG. 3, said device comprises a housing 1 having a bottom 2, and a cover 4, wherein said housing 1 is provided with an inlet opening 5 for the supply of medical gas as illustrated with arrow 13, and an outlet opening 6 for the treated medical gas as illustrated with arrow 14, further comprising conditioning means for the humidification and warming of said gas.” Para 0033) that at least partly forms the humidification chamber (1).
As to Claim 26, the modified Anthony, specifically Anthony discloses the heating element (8) is positioned inside of the housing (via 2 and 4).
As to Claim 27, the modified Anthony, specifically Anthony discloses water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3) oriented within the housing (via 2 and 4).
Regarding the concept of the water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3) being removable from the housing (via 2 and 4), the modified Anthony, specifically Anthony discloses states “The present device according to the invention is made in such a way that the cleaning and/or replacement of the device is easily performed, allowing the device to be reused. … All the components of said device are heat resistant and said device can therefore be sterilized and reusable.” Para 0051). The aforementioned recitation appears to impart the ability of the components of the humidification chamber can undergo “cleaning and/or replacement” as desired.
Should Applicant respectfully disagree, the ability to expressly remove the water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3) from the housing (via 2 and 4) would be obvious to try choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability of the components to undergo “cleaning and/or replacement” as desired.
Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified Anthony, as the construction of the water absorbent material being removable from the housing would yield the predictable results of enabling the components to undergo “cleaning and/or replacement” as desired.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the water absorbent material to be expressly removable from the housing, a known result effective variable to ensure the proper “cleaning and/or replacement” as desired.
As to Claim 28, the modified Anthony, specifically Anthony discloses the reservoir (“a water reservoir” via 9) is positioned outside of the housing (via 2 and 4).
As to Claim 29, the modified Anthony, specifically Anthony discloses the water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3) is shaped to surround the path for the flow of air (via 13).
As to Claim 30, the modified Anthony, specifically Anthony discloses the water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3) is a tubular in shape (“Said rigid evaporating body and heating device may be of cylindrical shape, such as to form a cylindrical space when arranged concentrically. Other suitable shapes include but are not limited to rectangular, octagonal, and the like. In a preferred embodiment, said space between the heating device and the rigid evaporating body is cylindrical.” Para 0009).
As to Claim 31, the modified Anthony, specifically Anthony discloses the water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3) comprises paper (“blotting paper” Para 0011).
As to Claim 34, the modified Anthony, specifically Anthony discloses the water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3) consists of a single piece of water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3).
As to Claim 35, the modified Anthony, specifically Anthony discloses a conduit (9, “The water inlet 9 is connected to said space 11. The water to be supplied is preferably held in a water reservoir that is connected to said inlet 9. Said water reaches the interior of the space 11 via the water supply inlet 9.” Para 0044; also see: “a water inlet 9, characterized in that said rigid evaporating body 7 and said heating device 8 are arranged in a concentric way forming a space 11 between them and wherein said water inlet 9 is connected to the housing such that a thin layer of water is able to be inserted between the heating device 8 and the rigid evaporating body 7.” Para 0033) fluidly connecting the reservoir (“a water reservoir” via 9) to the water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3).
As to Claim 36, the modified Anthony, specifically Anthony discloses a valve (“A check valve may be mounted on the water inlet 9. Said check valve will help minimizing the effect of the counter-pressure due to the rigid evaporating body 7 which act as a vapor room, and also permit to reduce the effect of the water reservoir height difference.” Para 0048) configured to control a flow of water (via 9) through the conduit (9).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Anthony (2006/0012057) in view of Mulvaney (6,622,993), as applied to Claim 21, and further in view of Fuller et al. (2008/0160500).
As to Claim 22, the modified Anthony, specifically Anthony discloses the heating element (8); yet, does not expressly disclose the configuration of the “the heating element comprises carbon ink printed on the water-absorbent material”.
Fuller teaches a medical device for heating a fluid, wherein the medical device includes a heating element (42) to impart heat to the fluid. Specifically, Fuller teaches “The heating element 42 may comprise a resistive coil which generates heat when a current is passed therethrough. The heating element may comprise a ceramic plate with resistive carbon ink printed on top. Such a heating element may have a resistance of 18 ohms. The heating element 42 may alternatively comprise a Peltier device. The Peltier device functions as a heat pump and is preferably connected to a heat sink.” (Para 0136).
In light of the teachings of Fuller, the construction of a heating element with “carbon ink printed” is a known method of imparting resistive heating to generate heat to the fluid.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the heating element of the modified Anthony to include the use of a “carbon ink printed on the water absorbent material” as taught by Fuller to impart resistive heating to generate heat to the fluid.
Claims 32 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Anthony (2006/0012057) in view of Mulvaney (6,622,993), as applied to Claim 21, and further in view of Dension (0,576,041)
As to Claims 32 and 33, the modified Anthony, specifically Anthony discloses the water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3); yet, does not expressly disclose the configuration of “the water-absorbent material comprises a corrugated inner surface” (Claim 32), nor “an inner surface of the water-absorbent material is one or more of: dimpled, perforated, porous, woven, knitted, textured, and sintered” (Claim 33).
Dension teaches a medical device (Figures 1-5) including an absorbent material (C, “a packing of any suitable absorbent material, as wool or a strip of blotting-paper C, having perforations c or corrugations c', as in Fig. 4. to facilitate the passage of air or gas and loosely wound in a coil, the folds of which may be separated by a diaphragm, such as a strip or strips D, of gutta-percha or wire-gauze or other suitable material, the whole being a little less in diameter than the caliber of the box or chamber. This packing serves to hold and gradually disseminate the various combinations of germicidal and healing oils or other vaporized or vaporizable substances which are intended to be used.” (Page 1, Column 1, Line 45 thru Page 1, Column 2, Line 65).
In light of the teachings of Dension, the modification of the blotting paper of the modified Anthony to be formed by corrugation (Claim 32) and/or perforations (Claim 33) would have been obvious to one having ordinary skill in the art in order to impart ability to “hold and gradually disseminate” the vaporized fluid.
Therefore it would have been obvious to one having ordinary skill in the art to modify the water absorbent material of the modified Anthony in the form of blotting paper, to be shaped such that the inner surface includes corrugation (Claim 32) and/or perforations (Claim 33) as taught by Dension in order to provide the ability “hold and gradually disseminate” the vaporized fluid.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Anthony (2006/0012057) in view of Mulvaney (6,622,993), as applied to Claim 35, and further in view of Miller (6,095,505).
As to Claim 37, the modified Anthony, specifically Anthony discloses a conduit (9) fluidly connecting the reservoir (“a water reservoir” via 9) to the water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3); yet, does not expressly disclose the configuration of “a pump configured to direct a flow of water from the reservoir, through the conduit, and to the water-absorbent material.”
Miller teaches a humidification device (Figure 1) having a humidification chamber (18, “The humidifier comprises an evaporation module 18, a flow controller 20, and a temperature controller 22. Evaporation module 18 includes a contact chamber 24 defined by a rigid housing 26 and in part by a flash-resistant heat exchanger 28.” Column 2, Line 65 thru Column 3, Line 10), a water absorbent material (30, “A wicking layer 30 is positioned in contact with heat exchanger 28, and serves to receive and distribute liquid water entering contact chamber 24.” Column 2, Line 65 thru Column 3, Line 10), a heating element (31, “An electric resistive heater 31 is provided for heat exchanger 28 so as to evaporate liquid water arriving in contract chamber 24 from liquid water source 14.” Column 2, Line 65 thru Column 3, Line 10), and a reservoir (14, “An electric resistive heater 31 is provided for heat exchanger 28 so as to evaporate liquid water arriving in contract chamber 24 from liquid water source 14.” Column 2, Line 65 thru Column 3, Line 10).
Regarding the remaining limitations of the claims, Miller teaches the reservoir (14) is connected via a conduit (42, “Rigid housing 26 also includes a water inlet 36 for receiving water from water source 14 through a liquid water flow passageway 42.” Column 3, Lines 5-20; also see: “Positioned in liquid flow passageway 42 is flow controller 20. Flow controller 20 is preferably a fixed displacement, metering pump 46 operably associated with a time-proportioning pump controller 48. Various types of fixed displacement metering pumps are appropriate for use in the present invention, including peristaltic pumps, diaphragm pumps, piston pumps, bellows-style pumps, and the like. A preferred embodiment of the present invention employs a peristaltic tubing pump.” Column 3, Lines 20-35), and further includes a pump (46, “metering pump 46” Column 3, Lines 20-35; “Metering pump 46 has a fixed, precise delivery rate. By incorporating a timer function, time proportioning controller 48 serves to turn metering pump 46 on for a fixed time period, and thereby control the amount of liquid water delivered to evaporation module 18.” Column 3, Lines 30-40) to direct the flow of water from the reservoir (14), through the conduit (42) and to the absorbent material (30) in order to achieve humidification to the patient via a “a fixed, precise delivery rate” (Column 3, Lines 30-40).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the conduit of the modified Anthony to include the use of a pump, as taught by Miller to convey the passage of fluid/water to the absorbent material in a fixed, precise delivery rate.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Anthony (2006/0012057) in view of Mulvaney (6,622,993), as applied to Claim 21, and further in view of Nitta (6,394,084).
As to Claim 38, the modified Anthony, specifically Anthony discloses the water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3) connected to the reservoir (“a water reservoir” via 9); yet, does not expressly disclose the configuration of “capillary channels fluidly connecting the reservoir to the water-absorbent material”.
Nitta teaches a humidification device (Figures 1-4) having a humidification chamber (4, “In the embodiment shown in FIGS. 1 and 2, patient circuit 1 is mounted detachably to a humidification unit 4 that is provided with a short connection tube 5 as a support member, a mounting flange 6, and a humidifying element 7.” Column 4, Line 50 thru Column 5, Line 10) having a first end (via 1a proximate 3, “Connection tube 5 may be a straight tube with both end portions engaged (connected) in an airtight fashion to connection end portions 1a of patient circuit 1.” Column 4, Line 50 thru Column 5, Line 10) and a second end (via 1a proximate 31, Connection tube 5 may be a straight tube with both end portions engaged (connected) in an airtight fashion to connection end portions 1a of patient circuit 1.” Column 4, Line 50 thru Column 5, Line 10); a water absorbent material (13, “As shown in FIG. 3, humidifying element 7 comprises exothermic member 13, multiple hollow fibers 14 held at the outer surface of exothermic member 13, and a mesh cover tube 15 covering, exothermic member 13 and multiple hollow fibers 14.” Column 5, Lines 40-70); a heating element (16, “Exothermic member 13 comprises a heating wire 16 (a heater wire) and an electrically insulating member 17 enclosing the periphery of heating wire 16. Heating wire 16 is disposed in the inside of electrically insulating member 17 and has the function of generating heat upon receiving an electric current. A connection cord 18 is connected to heating wire 16 and extends from one end of exothermic member 13.” Column 5, Lines 40-70) and a reservoir (24, “As shown in FIG. 1, connector 21 of humidifying element 7 prepared in the manner as described herein above, is connected through a water supply tube 25 to a water bag 24 as a source of supplying water to the hollow fibers. Water bag 24 is filled with a predetermined amount of water, and the amount of water in the water bag 24 can be visually confirmed, because water bag 24 is made of a transparent or translucent material. Water bag 24 is mounted on a pole (not shown). Water bag 24 is further provided with a water outlet 24a at its lower portion and with an opening (not shown) at its upper portion through which the inside of the bag communicates to the outside.” Column 7, Line 55 thru Column 8, Line 5).
Regarding the remaining limitations of the claims, Nitta teaches the water absorbent material (13) is fluidly connected to the reservoir (24) via capillary channels (14, “As shown in FIG. 3, humidifying element 7 comprises exothermic member 13, multiple hollow fibers 14 held at the outer surface of exothermic member 13, and a mesh cover tube 15 covering, exothermic member 13 and multiple hollow fibers 14.” Column 5, Lines 40-70; also see: “The water drop counting device 27 is arranged so as to allow a flow of water to multiple hollow fibers 14 after the water has been dropped from water bag 24 into the water drop counting device 27.” Column 8, Lines 10-20; “multiple hollow fibers 14 are each extremely small in diameter.” Column 8, Line 60 thru Column 9, Line 10; and “On the other hand, each of the multiple hollow fibers can also be filled with water at a high speed and with high precision by supplying water to the multiple hollow fibers 14 from both ends. As the peripheral wall of each of the multiple hollow fibers 14 is provided with minute openings that are each large enough to allow water vapor to permeate therethrough, yet small enough to fail to permeate water therethrough, air present in each of the multiple hollow fibers 14 can be discharged through the minute openings formed in the peripheral walls of the multiple hollow fibers as the water is supplied thereto. Hence, each of the multiple hollow fibers 14 can always be filled in with water without the presence of ail therein. Furthermore, even if one end of the multiple hollow fibers should be blocked, water can still be supplied to the multiple hollow fibers 14 form the other end. This arrangement, therefore, enhances the reliability of the water supply to each of the multiple hollow fibers.” Column 9, Line 60 thru Column 10, Line 15).
In light of the configuration of Nitta, the resultant effect is a series of capillary channels which can each convey fluid from the source to the sink resulting in duplication of efforts in order to enhance efficiency should one of the pathways become blocked.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the connection of the reservoir and the water absorbent material of the modified Anthony to be in the form of a series of capillary channels, as taught by Nitta to provide duplication of efforts to each convey fluid in order to enhance efficiency should one of the pathways become blocked.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Anthony (2006/0012057) in view of Mulvaney (6,622,993), as applied to Claim 21, and further in view of Gradon et al. (2002/0005201).
As to Claim 39, the modified Anthony, specifically Anthony discloses a device (Figure 3) for humidifying a flow of air (via 13, “In another embodiment shown on FIG. 3, said device comprises a housing 1 having a bottom 2, and a cover 4, wherein said housing 1 is provided with an inlet opening 5 for the supply of medical gas as illustrated with arrow 13, and an outlet opening 6 for the treated medical gas as illustrated with arrow 14, further comprising conditioning means for the humidification and warming of said gas.” Para 0033), the device (Figure 3) comprising: a humidification chamber (1, “In another embodiment shown on FIG. 3, said device comprises a housing 1 having a bottom 2, and a cover 4, wherein said housing 1 is provided with an inlet opening 5 for the supply of medical gas as illustrated with arrow 13, and an outlet opening 6 for the treated medical gas as illustrated with arrow 14, further comprising conditioning means for the humidification and warming of said gas.” Para 0033) having a first end (5, “In another embodiment shown on FIG. 3, said device comprises a housing 1 having a bottom 2, and a cover 4, wherein said housing 1 is provided with an inlet opening 5 for the supply of medical gas as illustrated with arrow 13, and an outlet opening 6 for the treated medical gas as illustrated with arrow 14, further comprising conditioning means for the humidification and warming of said gas.” Para 0033) configured to receive the flow of air and a second end (6, “In another embodiment shown on FIG. 3, said device comprises a housing 1 having a bottom 2, and a cover 4, wherein said housing 1 is provided with an inlet opening 5 for the supply of medical gas as illustrated with arrow 13, and an outlet opening 6 for the treated medical gas as illustrated with arrow 14, further comprising conditioning means for the humidification and warming of said gas.” Para 0033) opposite the first end (5) configured to direct the flow of air to a patient interface (via “delivered via nose or mouth to the lungs”, e.g. “However, when a patient is undergoing artificial respiration the nose is shunted by a flexible tube, whose distal end is inserted into the trachea.” Para 0002, and “According to an embodiment, the inlet 5 and outlet 6 have connection pipes, illustrated respectively as 5a and 6a on FIGS. 2 and 4, planned for attaching a tube. … The connecting pipe 6a on the outlet can be connected to tube, which supplies gas to a patient.” Para 0040, also see: “It also relates to any gas to be delivered to body cavities or organs of an individual in need thereof, such as for example such as normal air to be delivered via nose or mouth to the lungs, or O.sub.2/CO.sub.2 gas mixtures to be provided during laparoscopic surgery.” Para 0028); a water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3, “The space between the heating device and the rigid evaporating body may also be larger than 0.1 cm, and may be in such case further provided therein with a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like. For example, the space between the heating device and the rigid evaporating body may be provided with a second rigid evaporating body with water absorbing properties. The thin layer of water would be inserted in said second water absorbing properties.” Para 0011, wherein 7 – “a rigid evaporating body 7 arranged in said housing 1 between said inlet 5 and outlet 6, a heating device 8, and a water inlet 9, characterized in that said rigid evaporating body 7 and said heating device 8 are arranged in a concentric way forming a space 11 between them and wherein said water inlet 9 is connected to the housing such that a thin layer of water is able to be inserted between the heating device 8 and the rigid evaporating body 7. As illustrated FIG. 3, said rigid evaporating body 7 is surrounded by said heating device 8 in a concentric way forming a space 11 between them.” Para 0033 and wherein 8 – “a rigid evaporating body 7 arranged in said housing 1 between said inlet 5 and outlet 6, a heating device 8, and a water inlet 9, characterized in that said rigid evaporating body 7 and said heating device 8 are arranged in a concentric way forming a space 11 between them and wherein said water inlet 9 is connected to the housing such that a thin layer of water is able to be inserted between the heating device 8 and the rigid evaporating body 7. As illustrated FIG. 3, said rigid evaporating body 7 is surrounded by said heating device 8 in a concentric way forming a space 11 between them.” Para 0033) positioned inside of the humidification chamber (1) and shaped to substantially surround a path for the flow of air (via 13) through the humidification chamber (1); a heating element (8, “a rigid evaporating body 7 arranged in said housing 1 between said inlet 5 and outlet 6, a heating device 8, and a water inlet 9, characterized in that said rigid evaporating body 7 and said heating device 8 are arranged in a concentric way forming a space 11 between them and wherein said water inlet 9 is connected to the housing such that a thin layer of water is able to be inserted between the heating device 8 and the rigid evaporating body 7. As illustrated FIG. 3, said rigid evaporating body 7 is surrounded by said heating device 8 in a concentric way forming a space 11 between them.” Para 0033) configured to heat the water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3) to evaporate (via 7 - “a rigid evaporating body 7” Para 0033) absorbed water into the flow of air (via 13); and a reservoir (“a water reservoir” via 9, “The water inlet 9 is connected to said space 11. The water to be supplied is preferably held in a water reservoir that is connected to said inlet 9. Said water reaches the interior of the space 11 via the water supply inlet 9.” Para 0044; also see: “a water inlet 9, characterized in that said rigid evaporating body 7 and said heating device 8 are arranged in a concentric way forming a space 11 between them and wherein said water inlet 9 is connected to the housing such that a thin layer of water is able to be inserted between the heating device 8 and the rigid evaporating body 7.” Para 0033) positioned outside of the humidification chamber (1), the reservoir (“a water reservoir” via 9) configured to retain a water supply (“The water to be supplied is preferably held in a water reservoir that is connected to said inlet 9.” Para 0044), and the reservoir (“a water reservoir” via 9) being in fluid communication with the water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3) to direct the water supply (“water to be supplied” Para 0044) to the water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3). Further, the modified Anthony, specifically Mulvaney teaches the use of a blower to provide a pressure differential to convey the fluid from the source to the patient.
Yet, the modified Anthony does not expressly disclose the “blower configured to pressurize air above ambient pressure for breathing by the patient during therapy”, the patient interface in the form of “a seal-forming structure configured to contact and seal against the patient's face; a connection port configured to receive air pressurized by the blower; and a positioning and stabling structure comprising at least one strap and configured to hold the seal-forming structure in sealing contact with the patient's face during therapy”, nor “an air circuit connected to the blower and the device and configured to direct pressurized air from the blower to the device, wherein the device is fluidly connected to the connection port of the patient interface.”
Gradon teaches a humidification device (defined by the combination of 6, 7, and 8 as shown in Figure 3, “Humidification chamber 6 is preferably formed from a plastics material and may have a highly heat conductive base (for example an aluminium base) which is in direct contact with a heater plate 7 of humidifier 8.” Para 0030) having a blower (15, “Blower 15 is provided with variable pressure regulating means or variable speed fan 21 which draws air or other gases through blower inlet 17. The speed of variable speed fan 21 is controlled by electronic controller 18 (or alternatively the function of controller 18 could carried out by controller 9) in response to inputs from controller 9 and a user set predetermined required value (preset value) of pressure or fan speed via dial 19.” Para 0032) configured to provide pressurized air above ambient pressure for breathing by a patient during therapy (CPAP, Abstract), a patient interface (2, “With reference to FIG. 3 a humidified Continuous Positive Airway Pressure (CPAP) system is shown in which a patient 1 is receiving humidified and pressurised gases through a nasal mask 2 connected to a humidified gases transportation pathway or inspiratory conduit 3.” Para 0030; also see: “Referring to FIG. 4 the nasal mask, according to the preferred embodiment of the present invention, is shown in detail. The mask includes a hollow body 102 with an inlet 103 connected to the inspiratory conduit 3. The mask 2 is positioned around the nose of the user 1 with the headgear 108 secured around the back of the head of the patient 1. The restraining force from the headgear 108 on the hollow body 102 and the forehead rest 106 ensures enough compressive force on the mask cushion 104, to provide an effective seal against the patient's face.” Para 0033) in the form of a nasal mask having a seal forming structure (104, best seen Figure 4, “The restraining force from the headgear 108 on the hollow body 102 and the forehead rest 106 ensures enough compressive force on the mask cushion 104, to provide an effective seal against the patient's face.” Para 0033; and “To further ensure user comfort and effective pressure on the mask cushion 104, the headgear 108 may be constructed either using two straps running around the back of the user's head as shown in FIG. 4 or with a partial skull cap or any other configurations as are known in the art.” Para 0038) configured to contact and seal against the patient’s face; a connection port (103 via 3, best seen Figure 4, “The mask includes a hollow body 102 with an inlet 103 connected to the inspiratory conduit 3.” Para 0033) configured to receive air pressurized by the blower (15); and a positioning and stabilizing structure (106/108, best seen Figure 4, “The mask 2 is positioned around the nose of the user 1 with the headgear 108 secured around the back of the head of the patient 1. The restraining force from the headgear 108 on the hollow body 102 and the forehead rest 106 ensures enough compressive force on the mask cushion 104, to provide an effective seal against the patient's face.” Para 0033; also see: “Referring now to FIGS. 4 and 5 the headgear 108 is shown connected to the hollow body 102. Rather than traditional fixed or adjustable attachments the present invention utilises a sliding engagement between the headgear 108 and the hollow body 102. This is achieved with a loop 120, running through harnessing clips 122, 124 on either side of the headgear 108 and over the top of the hollow body 102. The loop 120 is reciprocally engaged with guides 126, 128 mounted on the top surface of the hollow body 102. The guides constrain the loop 120 but allow it to slide in and out, meaning the headgear 108 can move laterally, independently of the hollow body 102.” Para 0035; “To further ensure user comfort and effective pressure on the mask cushion 104, the headgear 108 may be constructed either using two straps running around the back of the user's head as shown in FIG. 4 or with a partial skull cap or any other configurations as are known in the art.” Para 0038) comprising at least one strap (“two straps” Para 0038) and configured to hold the seal forming structure (104) in sealing contact with the patient’s face during therapy; and an air circuit (defined by the conduit between 21 and 16, as shown in Figure 3, “As the volume of water 6 within humidification chamber 5 is heated, water vapour begins to fill the volume of the chamber above the water's surface and is passed out of the humidification chamber 5 outlet 4 with the flow of gases (for example air) provided from a gases supply means or blower 15 which enters the chamber through inlet 16. Exhaled gases from the patient's mouth are passed directly to ambient surroundings in FIG. 3.” Para 0031) connected to the blower (15) and the device (defined by the combination of 6, 7, and 8 as shown in Figure 3) and configured to direct pressurized air from the blower (15) to the device (defined by the combination of 6, 7, and 8 as shown in Figure 3), wherein the device (defined by the combination of 6, 7, and 8 as shown in Figure 3) is fluidly connected to the connection port (103 via 3) of the patient interface (2). Gradon teaches the functionality of the system (Figure 3) for treating a respiratory disorder (“This invention relates to nasal masks particularly though not solely for use in providing CPAP therapy to patients suffering from obstructive sleep apnoea (OSA).” Para 0001) of the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the humidifier device of the modified Anthony, to be utilized with a blower suitable for imparting pressure above ambient pressure, a specific patient interface having a seal forming structure, connection port, and positioning and stabilizing structure, and the connection of an air circuit between the blower and the device so that the device is fluidly connected to the patient interface, as taught by Gradon to treat “patients suffering from obstructive sleep apnoea (OSA).” (Para 0001).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21, 23, 25, 27, 29-33, 35, and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 10, and 12 of U.S. Patent No. 10,518,061.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant independent claim, Claim 21, is merely broader than the patent claim, Claim 1. It is clear all of the elements of the instant claims are found in the patent claims. The difference lies in the fact that the patent claims include many more elements and are thus much more specific. Thus, the invention of the patent claims is in effect a “species” of the “generic” invention of the instant claims. It has been held that the “generic” invention is “anticipated” by the “species”. In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the instant claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Instant Claims – 18484554
Differences Underlined
Patent Claims – 10,518,061
Differences Underlined
21. (New) A device for humidifying a flow of air pressurized by a blower, the device comprising:
a humidification chamber having
a first end configured to receive the flow of air from the blower and
a second end opposite the first end configured to direct the flow of air to a patient interface;
a water-absorbent material positioned inside of the humidification chamber and shaped to substantially surround a path for the flow of air through the humidification chamber; a heating element configured to heat the water-absorbent material to evaporate absorbed water into the flow of air; and a reservoir positioned outside of the humidification chamber, the reservoir configured to retain a water supply, and the reservoir being in fluid communication with the water-absorbent material to direct the water supply to the water-absorbent material.
1. A humidifier for increasing absolute humidity of a flow of air to be delivered to a patient's airways by a respiratory therapy device, the humidifier comprising: a humidifier housing forming
a humidification chamber, the humidifier housing comprising:
an air inlet configured to receive the flow of air from a pressure device;
an air outlet configured to deliver the flow of air to a patient interface from the humidifier with added humidity; and a flow path for the flow of air from the air inlet, through the humidification chamber, and to the air outlet;
a reservoir configured to retain a first volume of water; a humidifier wick positioned within the humidification chamber and configured to retain a second volume of water, and the humidifier wick having a profiled shape to substantially enclose, in a radial direction, at least a portion of the flow path; a delivery mechanism configured to deliver a flow of water from the reservoir to the humidifier wick; a heating element positioned in thermal communication with the humidifier wick to heat the humidifier wick to vaporise the second volume of water to add absolute humidity to the flow of air; an air flow baffle configured to lengthen at least a portion of the flow path through the humidification chamber; and a wick frame positioned within the portion of the flow path enclosed by the humidifier wick and in contact with the humidifier wick to maintain thermal communication between the humidifier wick and the heating element to promote heat transfer from the heating element to the humidifier wick; wherein the humidifier wick is removable from the humidification chamber, and wherein the humidifier wick is anisotropically constructed such that the humidifier wick has a rate of wicking that is greater in a first direction than in a second direction.
22. (New) The device of claim 21, wherein the heating element comprises carbon ink printed on the water-absorbent material.
23. (New) The device of claim 21, wherein the heating element is an electrical resistance heater.
10. The humidifier as claimed in claim 1, wherein the heating element comprises a resistive electrical track disposed on a circuit board.
24. (New) The device of claim 21, wherein the heating element is positioned on an opposite side of the water-absorbent material from the flow of air.
25. (New) The device of claim 21, further comprising a housing that at least partly forms the humidification chamber.
1. A humidifier for increasing absolute humidity of a flow of air to be delivered to a patient's airways by a respiratory therapy device, the humidifier comprising: a humidifier housing forming
a humidification chamber, the humidifier housing comprising:
an air inlet configured to receive the flow of air from a pressure device …
26. (New) The device of claim 25, wherein the heating element is positioned inside of the housing.
27. (New) The device of claim 25, wherein the water-absorbent material is removable from the housing.
1. A humidifier for increasing absolute humidity of a flow of air to be delivered to a patient's airways by a respiratory therapy device, the humidifier comprising: … wherein the humidifier wick is removable from the humidification chamber …
28. (New) The device of claim 25, wherein the reservoir is positioned outside of the housing.
29. (New) The device of claim 21, wherein the water-absorbent material is shaped to surround the path for the flow of air.
1. A humidifier for increasing absolute humidity of a flow of air to be delivered to a patient's airways by a respiratory therapy device, the humidifier comprising: … the humidifier wick having a profiled shape to substantially enclose, in a radial direction, at least a portion of the flow path …
30. (New) The device of claim 21, wherein the water-absorbent material is tubular in shape.
3. The humidifier as claimed in claim 1, wherein the flow path enclosed by the humidifier wick is substantially cylindrical.
31. (New) The device of claim 21, wherein the water-absorbent material comprises one or more of paper, hydrophilic fibres, and cellulose fibres.
5. The humidifier as claimed in claim 1, wherein the humidifier wick comprises one or more of: paper, hydrophilic fibres, and cellulose fibres.
32. (New) The device of claim 21, wherein the water-absorbent material comprises a corrugated inner surface.
4. The humidifier as claimed in claim 1, wherein the humidifier wick comprises one or more of: a corrugated, a dimpled, a perforated, a porous, a woven, a knitted, a textured, and a sintered surface.
33. (New) The device of claim 21, wherein an inner surface of the water-absorbent material is one or more of: dimpled, perforated, porous, woven, knitted, textured, and sintered.
4. The humidifier as claimed in claim 1, wherein the humidifier wick comprises one or more of: a corrugated, a dimpled, a perforated, a porous, a woven, a knitted, a textured, and a sintered surface.
34. (New) The device of claim 21, wherein the water-absorbent material consists of a single piece of the water-absorbent material.
35. (New) The device of claim 21, further comprising a conduit fluidly connecting the reservoir to the water-absorbent material.
1. A humidifier for increasing absolute humidity of a flow of air to be delivered to a patient's airways by a respiratory therapy device, the humidifier comprising: …a delivery mechanism configured to deliver a flow of water from the reservoir to the humidifier wick
36. (New) The device of claim 35, further comprising a valve configured to control a flow of water through the conduit.
37. (New) The device of claim 35, further comprising a pump configured to direct a flow of water from the reservoir, through the conduit, and to the water-absorbent material.
38. (New) The device of claim 21, further comprising capillary channels fluidly connecting the reservoir to the water-absorbent material.
12. The humidifier as claimed in claim 1, wherein the delivery mechanism is configured to deliver the flow of water to the humidifier wick through a plurality of fluid connections.
39. (New) A system for treating a respiratory disorder of a patient, the system comprising: a blower configured to pressurize air above ambient pressure for breathing by the patient during therapy; a patient interface comprising: a seal-forming structure configured to contact and seal against the patient's face; a connection port configured to receive air pressurized by the blower; and a positioning and stabling structure comprising at least one strap and configured to hold the seal-forming structure in sealing contact with the patient's face during therapy; the device of claim 21; and an air circuit connected to the blower and the device and configured to direct pressurized air from the blower to the device, wherein the device is fluidly connected to the connection port of the patient interface.
Claims 21, 25-27, 29, 35, and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16, 24, and 26 of U.S. Patent No. 10,864,346.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant independent claim, Claim 21, is merely broader than the patent claim, Claim 24. It is clear all of the elements of the instant claims are found in the patent claims. The difference lies in the fact that the patent claims include many more elements and are thus much more specific. Thus, the invention of the patent claims is in effect a “species” of the “generic” invention of the instant claims. It has been held that the “generic” invention is “anticipated” by the “species”. In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the instant claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Instant Claims – 18484554
Differences Underlined
Patent Claims – 10,864,346
Differences Underlined
21. (New) A device for humidifying a flow of air pressurized by a blower, the device comprising:
a humidification chamber having a first end configured to receive the flow of air from the blower and a second end opposite the first end configured to direct the flow of air to a patient interface;
a water-absorbent material positioned inside of the humidification chamber and shaped to substantially surround a path for the flow of air through the humidification chamber;
a heating element configured to heat the water-absorbent material to evaporate absorbed water into the flow of air; and a reservoir positioned outside of the humidification chamber, the reservoir configured to retain a water supply, and the reservoir being in fluid communication with the water-absorbent material to direct the water supply to the water-absorbent material.
24. A respiratory therapy system configured to supply air at positive pressure to a patient for respiratory therapy, the respiratory therapy system comprising: a respiratory pressure therapy device configured to supply air at positive pressure; and the humidifier as claimed in claim 1, the humidifier being configured and positioned to humidify the air supplied by respiratory pressure therapy device.
Including
1. A humidifier for increasing an absolute humidity of a flow of air to be delivered to a patient's airways, the humidifier comprising:
a reservoir configured to retain a first volume of water;
a humidifier chamber comprising: an outer housing including: a water feed inlet; an inlet portion forming an air inlet configured to receive the flow of air; and an outlet portion forming an air outlet for delivering the flow of air with increased absolute humidity;
a humidifier wick positioned inside of the outer housing, the humidifier wick being configured to retain a second volume of water, the humidifier wick forming a path for the flow of air through the humidifier chamber, and the humidifier wick being removable from the humidifier chamber; a frame positioned inside of the outer housing and comprising: a wick remover engaged with the humidifier wick, the frame being removable from the humidifier chamber such that engagement of the wick remover with the humidifier wick removes the humidifier wick from the humidifier chamber when the frame is removed from the humidifier chamber; and an air flow baffle positioned within the path formed by the humidifier wick to lengthen a distance travelled by the flow of air along the path;
a heating element positioned and configured to heat the humidifier wick to vaporise the second volume of water to add absolute humidity to the flow of air travelling along the path formed by the humidifier wick; and a delivery mechanism configured to deliver water from the reservoir to the humidifier wick via the water feed inlet.
22. (New) The device of claim 21, wherein the heating element comprises carbon ink printed on the water-absorbent material.
23. (New) The device of claim 21, wherein the heating element is an electrical resistance heater.
24. (New) The device of claim 21, wherein the heating element is positioned on an opposite side of the water-absorbent material from the flow of air.
25. (New) The device of claim 21, further comprising a housing that at least partly forms the humidification chamber.
1. A humidifier for increasing an absolute humidity of a flow of air to be delivered to a patient's airways, the humidifier comprising: a reservoir configured to retain a first volume of water; a humidifier chamber comprising: an outer housing including: …
26. (New) The device of claim 25, wherein the heating element is positioned inside of the housing.
16. The humidifier as claimed in claim 1, wherein the heating element is removable from the humidifier chamber.
27. (New) The device of claim 25, wherein the water-absorbent material is removable from the housing.
1. A humidifier for increasing an absolute humidity of a flow of air to be delivered to a patient's airways, the humidifier comprising: a reservoir configured to retain a first volume of water; a humidifier chamber comprising: an outer housing including: …the humidifier wick being removable from the humidifier chamber …
28. (New) The device of claim 25, wherein the reservoir is positioned outside of the housing.
29. (New) The device of claim 21, wherein the water-absorbent material is shaped to surround the path for the flow of air.
1. A humidifier for increasing an absolute humidity of a flow of air to be delivered to a patient's airways, the humidifier comprising: a reservoir configured to retain a first volume of water; a humidifier chamber comprising: an outer housing including: … the humidifier wick forming a path for the flow of air through the humidifier chamber …
30. (New) The device of claim 21, wherein the water-absorbent material is tubular in shape.
31. (New) The device of claim 21, wherein the water-absorbent material comprises one or more of paper, hydrophilic fibres, and cellulose fibres.
32. (New) The device of claim 21, wherein the water-absorbent material comprises a corrugated inner surface.
33. (New) The device of claim 21, wherein an inner surface of the water-absorbent material is one or more of: dimpled, perforated, porous, woven, knitted, textured, and sintered.
34. (New) The device of claim 21, wherein the water-absorbent material consists of a single piece of the water-absorbent material.
35. (New) The device of claim 21, further comprising a conduit fluidly connecting the reservoir to the water-absorbent material.
1. A humidifier for increasing an absolute humidity of a flow of air to be delivered to a patient's airways, the humidifier comprising: a reservoir configured to retain a first volume of water; a humidifier chamber comprising: an outer housing including: …a delivery mechanism configured to deliver water from the reservoir to the humidifier wick via the water feed inlet.
36. (New) The device of claim 35, further comprising a valve configured to control a flow of water through the conduit.
37. (New) The device of claim 35, further comprising a pump configured to direct a flow of water from the reservoir, through the conduit, and to the water-absorbent material.
26. The humidifier as claimed in claim 1, wherein the delivery mechanism further comprises a water pump.
38. (New) The device of claim 21, further comprising capillary channels fluidly connecting the reservoir to the water-absorbent material.
39. (New) A system for treating a respiratory disorder of a patient, the system comprising: a blower configured to pressurize air above ambient pressure for breathing by the patient during therapy; a patient interface comprising: a seal-forming structure configured to contact and seal against the patient's face; a connection port configured to receive air pressurized by the blower; and a positioning and stabling structure comprising at least one strap and configured to hold the seal-forming structure in sealing contact with the patient's face during therapy; the device of claim 21; and an air circuit connected to the blower and the device and configured to direct pressurized air from the blower to the device, wherein the device is fluidly connected to the connection port of the patient interface.
Claims 21, 29, 31, 35, and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 8 of U.S. Patent No. 11,491,297.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant independent claim, Claim 21, is merely broader than the patent claim, Claim 1. It is clear all of the elements of the instant claims are found in the patent claims. The difference lies in the fact that the patent claims include many more elements and are thus much more specific. Thus, the invention of the patent claims is in effect a “species” of the “generic” invention of the instant claims. It has been held that the “generic” invention is “anticipated” by the “species”. In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the instant claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Instant Claims – 18484554
Differences Underlined
Patent Claims – 11,491,297
Differences Underlined
21. (New) A device for humidifying a flow of air pressurized by a blower, the device comprising:
a humidification chamber having a first end configured to receive the flow of air from the blower and a second end opposite the first end configured to direct the flow of air to a patient interface;
a water-absorbent material positioned inside of the humidification chamber and shaped to substantially surround a path for the flow of air through the humidification chamber;
a heating element configured to heat the water-absorbent material to evaporate absorbed water into the flow of air; and a reservoir positioned outside of the humidification chamber, the reservoir configured to retain a water supply, and the reservoir being in fluid communication with the water-absorbent material to direct the water supply to the water-absorbent material.
1. A humidifier for use with a respiratory pressure therapy (RPT) device that is configured to pressurize and direct a flow of air to an entrance to the airways of a patient for treatment of a respiratory disorder, the humidifier being configured to increase the absolute humidity of the pressurized flow of air, the increase being compared to the absolute humidity of ambient air, the humidifier comprising:
a reservoir configured to hold a first volume of liquid; and
a humidifier chamber comprising: a humidifier inlet configured to receive the pressurized flow of air; a humidifier outlet configured to direct the pressurized flow of air out of the humidifier chamber;
a humidifier wick configured to retain a second volume of liquid and at least partly form a flow path for the pressurized flow of air that flows from the humidifier inlet to the humidifier outlet during use; and
a heating element configured to heat the humidifier wick to vapourise the second volume of liquid to add absolute humidity to the pressurized flow of air that flows along the flow path during use; and wherein the humidifier wick comprises a fibrous sheet material, the fibrous sheet material comprising a fabric woven of fibres, wherein the fabric woven of fibres comprises a first plurality of fibres and a second plurality of fibres, the first plurality of fibres being different from the second plurality of fibres in at least one aspect, wherein the first plurality of fibres are each greater in thickness than each of the second plurality of fibres, and wherein the first plurality of fibres are positioned closer to the heating element than the second plurality of fibres, and the second plurality of fibres are positioned closer to the pressurized flow of air than the first plurality of fibres.
22. (New) The device of claim 21, wherein the heating element comprises carbon ink printed on the water-absorbent material.
23. (New) The device of claim 21, wherein the heating element is an electrical resistance heater.
24. (New) The device of claim 21, wherein the heating element is positioned on an opposite side of the water-absorbent material from the flow of air.
25. (New) The device of claim 21, further comprising a housing that at least partly forms the humidification chamber.
26. (New) The device of claim 25, wherein the heating element is positioned inside of the housing.
27. (New) The device of claim 25, wherein the water-absorbent material is removable from the housing.
28. (New) The device of claim 25, wherein the reservoir is positioned outside of the housing.
29. (New) The device of claim 21, wherein the water-absorbent material is shaped to surround the path for the flow of air.
1. A humidifier for use with a respiratory pressure therapy (RPT) device … a humidifier wick configured to retain a second volume of liquid and at least partly form a flow path for the pressurized flow of air that flows from the humidifier inlet to the humidifier outlet during use; …
30. (New) The device of claim 21, wherein the water-absorbent material is tubular in shape.
31. (New) The device of claim 21, wherein the water-absorbent material comprises one or more of paper, hydrophilic fibres, and cellulose fibres.
1. A humidifier for use with a respiratory pressure therapy (RPT) device … the humidifier wick comprises a fibrous sheet material, the fibrous sheet material comprising a fabric woven of fibres, wherein the fabric woven of fibres comprises a first plurality of fibres and a second plurality of fibres, the first plurality of fibres being different from the second plurality of fibres in at least one aspect, wherein the first plurality of fibres are each greater in thickness than each of the second plurality of fibres, and wherein the first plurality of fibres are positioned closer to the heating element than the second plurality of fibres, and the second plurality of fibres are positioned closer to the pressurized flow of air than the first plurality of fibres.
32. (New) The device of claim 21, wherein the water-absorbent material comprises a corrugated inner surface.
33. (New) The device of claim 21, wherein an inner surface of the water-absorbent material is one or more of: dimpled, perforated, porous, woven, knitted, textured, and sintered.
34. (New) The device of claim 21, wherein the water-absorbent material consists of a single piece of the water-absorbent material.
35. (New) The device of claim 21, further comprising a conduit fluidly connecting the reservoir to the water-absorbent material.
8. The humidifier of claim 1, further comprising: a water feed inlet configured to direct the first volume of liquid to the humidifier wick; and a deioniser positioned upstream of the water feed inlet and configured to deionise the first volume of liquid prior to vapourisation in the humidifier wick.
36. (New) The device of claim 35, further comprising a valve configured to control a flow of water through the conduit.
37. (New) The device of claim 35, further comprising a pump configured to direct a flow of water from the reservoir, through the conduit, and to the water-absorbent material.
38. (New) The device of claim 21, further comprising capillary channels fluidly connecting the reservoir to the water-absorbent material.
2. The humidifier of claim 1, wherein the fibrous sheet material is configured to distribute water through the humidifier wick via capillary action and retain it therein.
39. (New) A system for treating a respiratory disorder of a patient, the system comprising: a blower configured to pressurize air above ambient pressure for breathing by the patient during therapy; a patient interface comprising: a seal-forming structure configured to contact and seal against the patient's face; a connection port configured to receive air pressurized by the blower; and a positioning and stabling structure comprising at least one strap and configured to hold the seal-forming structure in sealing contact with the patient's face during therapy; the device of claim 21; and an air circuit connected to the blower and the device and configured to direct pressurized air from the blower to the device, wherein the device is fluidly connected to the connection port of the patient interface.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Each of the following each disclose a humidification device having a humidification chamber with a first end and second end, a water absorbent material, a heating element, and a reservoir.
US 4038980 A Fodor; Imre
US 4086305 A Dobritz; Gunter
US 5349946 A McComb; R. Carter
US 5509405 A Mashak; James N.
US 5769071 A Turnbull; Christopher Stratton
US 6010118 A Milewicz; Edek
US 20060124127 A1 Du; Hong-Lin et al.
US 20120012108 A1 AND US 20120017905 A1 Sata; Yasuhiko et al.
US 10307559 B2 Foote; Roger Mervyn Lloyd et al.
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
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